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Monday, May 21, 2012

Efisol

EFISOL®
Bactericidal - Antiphlogistic
Lozenges

KOMPOSISI
Tiap EFISOL Lozenge mengandung:
Dequalinium Klorida0,25mg
Vitamin C (Ascorbic Acid)           50,00mg


KHASIAT
  • Sangat efektif terhadap segala kuman dan jamur dalam rongga mulut dan tenggorokan terutama untuk radang infeksi gusi, selaput lendir mulut (sariawan), tenggorokan dan kerongkongan.
  • Bekerja sebagai antiseptik dimana antibiotika (Penisillin, dll.) tidak berdaya terhadap kekebalan kuman patogen yang resisten.
  • Tidak mengandung anestesi lokal sehingga tidak mengganggu fungsi rasa pada lidah.
  • Vitamin C berfungsi meningkatkan daya tahan tubuh terhadap infeksi.
  • Rasanya enak dan tidak menyebabkan gangguan/ iritasi terhadap lidah, mulut dan saluran pencernaan.
INDIKASI
Sariawan, infeksi di mulut dan kerongkongan : angina, faringitis, tonsilitis, gingivitis dan nafas mulut bau akibat infeksi tersebut.

DOSIS
  • Tiap EFISOL lozenges dibiarkan larut perlahan-lahan dalam mulut setiap 3 jam, tidak lebih dari 8 tablet sehari. Bila radang mereda, diulang setiap 4-5 jam.
  • Untuk anak-anak dan orang dewasa.
  • Kombinasi dengan EFISOL Liquid pada interval pemakaian EFISOL Lozenges dalam pengobatan sangat dianjurkan.
KEMASAN
Dus, 2 strip @ 10 Lozenges
No. Reg. DTL0333507712A1

Simpan pada suhu kamar (dibawah 30°C)

Diproduksi oleh:
NOVELL
PHARMACEUTICAL
LABORATORIES
BOGOR-INDONESIA
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Sunday, May 20, 2012

Pro Liver


Pro Liver

KOMPOSISI:
Tiap kaplet salut selaput mengandung:    % AKG
Curcuminoid20mg-
Silymarin phytosome                 70mg-
Choline bitartrate150mg-
Vitamin B62mg153.85


KEGUNAAN: 
Membantu memelihara kesehatan hati

DOSIS: 
Dewasa: 3 x sehari 1 kaplet salut selaput

KEMASAN: 
Good Life® Pro Liver:
Dus isi 5 strip @ 6 kaplet salut selaput

No. Reg. POM SD. 091 536 071

PT. SIMEX PHARMACEUTICAL INDONESIA
Sukabumi - Indonesia
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Saturday, May 19, 2012

Degirol

DEGIROL®
dequalinium chloride
LOZENGES

Composition :
Each lozenge contains :
Dequalinium chloride
(1,1'-Decamethylenebis-(4-aminoquinaldinum chloride) ......................................... 0.25 mg

Description :
DEGIROL® lozenges contain Dequalinium chloride, an effective antibacterial and anti fungal agent which is active against many Gram-positive and Gram-negative bacteria, Borrelia vincenti, Candida albicans and antibiotic-resistant micro-organisms after very short contact.
It is used sore throats and prevents infections of the mucous membrane of the mouth.
DEGIROL® lozenges are lemon-flavoured, can be given to children and adults.

Indications :

  • Sore throat.
  • Inflammation of the oral cavity and pharynx, such as gingivitis, periodontitis, pharyngitis, laryngitis and angina.
  • Infection of the mucous membrane of the mouth, such as stomatitis.

Contraindication :
Hypersensitivity to dequalinium chloride.

Warning and Precautions:
Not recommended for long time using repeatedly.

Dosage :
One DEGIROL® lozenges is allowed to dissolve slowly in the mouth. Repeat every 3-4 hours, or as directed by the physician. Don't exceed B tablets daily

Store at 25° - 30° C

Packaging:
Box of 5 strips @ 4 lozenges
Box of 25 strips @ 4 lozenges

Reg. No.: DBL 9104508712A1

Manufactured by :
PT Prafa
Citeureup, Bogor-Indonesia

For:
Darya-Varia
LABORATORIA Gunung Putri, Bogor-Indonesia
Under License from:
PHAROS CHEMIE
AMSTERDAM





DEGIROL®
dequalinium chloride
TABLET HISAP

Komposisi:
Tiap tablet hisap mengandung:
Dequalinium chloride
(1,1'-Decamethylenebis-(4-aminoquinaldinum chloride) 0.25 mg

Uraian:
Tablet hisap DEGIROL® mengandung Dequalinium chloride, suatu bahan anti-bakteri dan antijamur yang efektif untuk membunuh pelbagai bakteri Gram-positip dan Gram-negatip, Borrelia vincenti, Candida albicans dan bakteri yang resisten terhadap antibiotika.
Tablet hisap DEGIROL® untuk sakit tenggorokan serta mencegah infeksi pada selaput lendir mulut. Dengan rasa jeruk sitrun, DEGIROL® dapat diberikan baik kepada kanak-kanak maupun orang dewasa.

Indikasi:

  • Sakit tenggorokan.
  • Peradangan pada rongga mulut dan tenggorokan seperti gingiv~is, periodontitis, pharyngitis, laryngitis dan angina.
  • Infeksi selaput lendir mulut seperti stomatitis.

Kontra Indikasi:
Penderita hipersensitif terhadap dequalinium chloride.

Peringatan dan perhatian:
Hindari pemakaian jangka panjang dan berulang-ulang.

Aturan pakai:
Satu tablet DEGIROL® dibiarkan melarut perlahan-lahan di dalam mulut. Ulangi setiap 3 sampai 4 jam, atau sesuai dengan petunjuk dokter. Jangan melebihi 8 tablet sehari

Simpan pada suhu 25° - 30°

Kemasan:
Box berisi 5 strip @ 4 tablet hisap
Box berisi 25 strip @ 4 tablet hisap

No. Reg. : DBL 91 04508712A 1

Diproduksi:
PT Prafa
Citeureup, Bogor-Indonesia

Untuk:
Darya-Varia
LABORATORIA
Gunung Putri, Bogor-Indonesia

Atas lisensi dari:
PHAROS CHEMIE
AMSTERDAM

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Friday, May 18, 2012

GLOW

GLOW

Each softgel capsule contains:
SKHN Complex™
Consisting of
Marine Protein 100       mg
Horsetail Extract      71.43mg 
Green Tea Extract 50mg
Lemon Bioflavonoids 50mg
Hydrolyzed Collagen 30mg
Vitamin C 30mg
Tomato Extract 25mg
      Providing Lycopene 1.5mg
Grape Seed Extract 20mg
D. Salina Extract  15mg
      Providing Natural Betacarotene and other Carotenoids 4.5mg
Pine Bark Extract 10mg
Vitamin E (d-alpha-Tocopheryl Acetate) 7.5IU

Usage: 
As a supplement containing skin nutrients which may help in maintaining healthy skin.

Dosage:
Take 1 capsule twice daily with meals.

Kegunaan : 
Sebagai suplemen untuk menjaga kesehatan kulit

Petunjuk penggunaan : 
1 kapsul 2 kali sehari dengan makan

Packaging:
Unit carton containing 6 x 10 Softgel capsules blister packed.

Store below 25°C in a dry place, away from direct sunlight.
Keep out of reach of children.

Manufactured under license from :
MEGA LIFESCIENCES (AUSTRALIA) PTY. LTD.
Victoria 3175, Australia

By : MEGA LIFESCIENCES LTD.
Samutprakarn, Thailand

Imported by : PT. MEGA LIFESCIENCES
Jakarta, Indonesia
POM SI. 034 306 941
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Thursday, May 17, 2012

Disolf

DISOLF
Enteric-coated tablet

Composition:
Each tablet contains DLBS1033 Lumbricus rubellus 490 mg

Usage:
Helps to improve blood circulation

Dosage and administration:
For adults:
1-2 tablets 3 times daily, ½-1 hours before meals.

For children:
Safety and efficacy have not been proofed.

Warnings and precautions:
  • Only be used on doctor's recommendation.
  • During treatment, consult your doctor regularly.
Presentation and registration number:
Box, 5 strips @ 6 tablets: POM TR. 091 507 261

STORE AT TEMPERATURE BELOW 30°C,
PROTECT FROM LIGHT.
KEEP OUT OF REACH OF CHILDREN.

Manufactured by:
PT Dexa Medika
Jl. Letjen. Bambang Utoyo 138
Palembang-lndonesia



DISOLF
Tablet salut enterik

Komposisi:
Setiap tablet mengandung ekstrak DLBS1033 Lumbricus rubellus 490 mg

Kegunaan:
Membantu melancarkan sirkulasi darah

Dosis dan cara pemberian:
Untuk dewasa:
1-2 tablet, 3 kali sehari, ½-1 jam sebelum makan.

Anak-anak :
Keamanan dan khasiat belum dibuktikan.

Peringatan dan perhatian:
  • Hanya digunakan atas anjuran dokter.
  • Selama penggunaan produk ini konsultasikan pada dokter secara berkala.
Kemasan dan nomor registrasi:
Kotak 5 strip @ 6 tablet; POM TR. 091 507 261

SIMPAN PADA SUHU DI BAWAH 30°C,
TERLINDUNG DARI CAHAYA.
JAUHKAN DARI JANGKAUAN ANAK-ANAK.

Diproduksi oleh:
PT. Dexa Medika
Jl. Letjen. Bambang Utoyo 138
Palembang-Indonesia

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Wednesday, May 16, 2012

Oroxin

OROXIN®
Syrup

COMPOSITION
Each of 5 ml syrup contains:
Oxomemazine 1.65 mg
Guaifenesin 33.3 mg

PHARMACOLOGICAL PROPERTIES
PHARMACODYNAMIC PROPERTIES
SYSTEMIC ANTIHISTAMINE (R. RESPIRATORY SYSTEM)
Oxomemazine
H1 antihistamine, phenothiazine with aliphatic side chain, characterized by:
  • A marked sedative effect at usual doses, of histaminergic and central adrenolytic origin.
  • An anticholinergic effect responsible for peripheral adverse effects.
  • A peripheral adrenolytic effect, with potential hemodynamic consequences (risk of orthostatic hypotension).
Antihistamines share the common property of opposing, via competitive antagonism of varying degrees of reversibility, the effects of histamine, on the skin, bronchi, intestine and blood vessels in particular.

Guaifenesin
Expectorant.

PHARMACOKINETIC PROPERTIES
No information is available on the pharmacokinetics of oxomemazine. General features can be cited regarding all antihistamines and phenothiazines in particular:
  • Bioavailability is generally moderate.
  • The possibility exists metabolization, with formation of many metabolites, which explains the very low percentage of unchanged substance found in urine.
  • Half-life varies but is often long, offering the possibility of a single daily dose.
  • The large volume of distribution is due to the liposolubility of these substances.
Pathophysiological variations: risk of accumulation of antihistamines in the presence of impaired renal or liver function.

INDICATIONS
To reduce cough with sputum, accompanied by allergic condition.

DOSAGE AND METHOD OF ADMINISTRATION
For use only in adults and children over 2 year of age. Oral route.


In adults and children weighing more than 40 kg (i.e. age 12)
10 ml per dose, 4 times a day.

In children
The daily dosage depends upon the weight of the child (1 ml of syrup per kg body weight and per day), i.e, by way of an indication:
  • Children between 10 and 20 kg (i.e. age 2 to 6) : 5 ml per dose, 2 to 3 times a day.
  • Children between 20 and 30 kg (i.e. age 6 to 10) : 10 ml per dose, 2 to 3 times a day.
  • Children between 30 and 40 kg (i.e. age 10 to 12) : 10 ml per dose, 3 to 4 times a day.
Doses should be taken as and when needed, with a minimum interval of 4 hours between them.
Evening administration should be preferred, because of the sedative effect of oxomemazine, especially at the start of treatment.

SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Warnings
  • Productive cough, a fundamental component of bronchopulmonary defence mechanisms, should not be suppressed.
  • It is illogical to combine an expectorant or mucolytic with this antitussive medicine.
  • Causes of cough requiring specific treatment must be ruled out before prescribing antitussive treatment.
  • If cough is resistant to an antitussive administered as usual dosage, the dose should not be increased but the clinical situation reassessed.
Precautions
Related to the presence of oxomemazine :
Given that phenothiazines are considered to be hypothetical risk factors in sudden infant death syndrome, it is recommended not to use them in children less than 2 year of age. Enhanced monitoring (clinical and possibly EEG) is required in epileptics because of the possibility of lowering the epileptogenic threshold.

Oxomemazine must be used cautiously
  • In the elderly with:
    • Greater susceptibility to orthostatic hypotension, vertigo and sedation.
    • Chronic constipation (risk of paralytic ileus).
    • Possible prostatic hypertrophy.
  • In individuals with certain cardiovascular disorders, because of the tachycardiac and hypertensive effects of phenothiazines.
  • In the presence of serely impaired liver and/or renal function (because of the risk of accumulation).
In children, it is important to rule out bronchial asthma or gastroesophageal reflux before using oxomemazines as an antitussive.
It is highly inadvisable to drink alcoholic beverages or take medicines containing alcohol during treatment (see Drug Interactions).
Because of the photosensitizing effect of phenothiazines, it is preferable to avoid exposure to the sun during treatment. The Sucrose content (3.7g/5 ml dose and 7.3 g/10 ml dose) should be taken into account in patients with diabetes or on a low carbohydrate diet.

ADVERSE EFFECT
The pharmacological characteristics of oxomemazine are responsible for adverse effects of unequal degree and dose-related or not (see Pharmacodynamic properties).
  • Automatic effects:
    • Sedation or drowsiness, more marked at the start of treatment.
    • Anticholinergic effect, e.g. dry mucous membranes, constipation, impaired accommodation, mydriasis, cardiac palpitations, risk of urinary retention.
    • Orthostatic hypotention.
    • Impaired balance, vertigo, impaired memory of concentration (commoner in elderly).
    • Motor incoordination, tremor.
    • Mental confusion, hallucinations.
    • More rarely, but especially in the newborn, effects in the form of excitation: agitation, nervousness, insomnia.
  • Sensitization reactions:
    • Erythema, eczema, pruritus, purpura, possibly giant urticaria.
    • Edema, more rarely angioneurotic edema. 
    • Anaphylactic shock.
    • Photosensitization.
  • Hematological disorders:
    • Leucopenia, neutropenia, extremely rarely: agranulocytosis.
    • Thrombocytopenia.
    • Hemolytic anemia.
OVERDOSAGE
  • Signs of oxomemazine overdose: convulsions (especially in infants and children), impaired consciousness, coma.
  • Symptomatic treatment should be provided in a specialist unit.
CONTRAINDICATIONS
This medicine is contraindicated in the following situations:
  • Allergy to any of the constituents, antihistamines in particular.
  • Because of the presence of oxomemazine :
    • History of a granulocytosis.
    • Risk of urinary retention related to urethroprostatic disorders.
    • Risk of closed angle glaucoma.
This medicine is generally inadvisable:


  • During the first trimester of pregnancy and while breast feeding.
  • In combination with sultopride (see Drug Interactions).

  • DRUG INTERACTIONS

    The interactions mentioned are related to the presence of oxomemazine.


    Inadvisable combinations:
    • Alcohol; Alcohol increases the sedative effect of H1 antihistamines. Impaired alertness may make driving and machinery operations dangerous. Avoid alcoholic drinks and medicines containing alcohol.
    • Sultopride; Increased risk of ventricular arrythmias, especially torsade de pointes/wave burst arrythmias, by addition of electrophysiological effects.
    Combinations needing to be taken into account:
    • Other central nervous system depressants (sedative antidepressants, barbiturates, benzodiazepines, clonidine and related substances, hypnotics, morphine derivatives (analgesics and antitussives), methadone, neuroleptics, tranquilizers) : Increased central depression. Impaired alertness may make driving and machinery operation dangerous.
    • Atropine and other atropine-like substances (imipramine antidepressants, anticholinergic parkinsonism drugs, atropine-like antispasmodics, disopyramide, phenothiazine neuroleptics); additions of atropine-like adverse effects, such as urinary retention, constipation, dry mouth.
    PREGNANCY AND BREAST FEEDING
    Decisions concerning possible use during pregnancy and breast feeding must take into account the presence of oxomemazine.

    Pregnancy
    Malformative Aspect:
    No reliable animal teratogenesis data are available.
    Sufficiently pertinent data do not exist at present to enable evaluation of any possible malformative or fetotoxic effect of oxomemazine when administered during pregnancy.

    Fetotoxic effect:
    There have been rare reports of digestive manifestations related to atropine-like properties (abdominaldistension, meconium ileus, delayed excretion of meconium, difficulty starting feeding, tachycardia, neurological problems, etc) in the newborn infants of mothers on long term treatment with anticholinergic medicines.
    In view of these data, use of this medicine is inadvisable during the first trimester of pregnancy. It should be prescribed later only if necessary, with limitation during the 3rd trimester to occasional use only.
    If this medicine is administered at the end of pregnancy, monitoring of the neurogical and digestive function of the newborn infant for a time seems justified.

    Breast feeding
    Excretion of oxomemazine in breast milk is not known. Because of the possibilities of sedation or paradoxical excitation of the newborn, and even more the risk of sleep apnea suggested with phenothiazines, this medicine is inadvisable while breast feeding.

    EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
    Attention is drawn, particularly that of drivers and machinery operators, the risk of drowsiness associated with the use of this medicine, especially at the start of treatment.
    This is accentuated by alcoholic drinks or medicines containing alcohol.

    Storage
    Store below 25°C.

    Presentation
    OROXIN®Syrup
    Box, bottle @ 60 ml
    Reg. No. DKL1021638437A1

    ON MEDICAL PRESCRIPTION ONLY
    HARUS DENGAN RESEP DOKTER

    Manufactured by :
    PHAROS
    Jakarta - Indonesia
    Continue reading...

    Tuesday, May 15, 2012

    Rhinos SR

    RHINOS® SR 
    KAPSUL LEPAS LAMBAT 

    Komposisi:
    Tiap kapsul mengandung:
    Lepas cepat 
    Loratadin 5 mg
    Pseudoefedrin HCl 60 mg

    Lepas lambat 
    Pseudoefedrin HCl 60 mg

    Farmakologi: 
    Loratadin merupakan suatu antihistamin trisiklik poten yang mempunyai masa kerja panjang dengan aktivitas antagonistik selektif pada reseptor H1 perifer. Pseudoefedrin (d-isoefedrin) adalah suatu stereo isomer efedrin. Bekerja sebagai obat simpatomimetik yang langsung merangsang reseptor adrenergik yang memberikan efek dekongestan. Dalam bentuk kapsul lepas lambat, masa kerja pseudoefedrin dapat berlangsung selama 12 jam atau lebih.

    Indikasi: 
    Meringankan gejala-gejala yang berkaitan dengan rinitis alergika seperti: bersin-bersin, hidung tersumbat, rinorea dan rasa gatal di hidung. Obat ini dianjurkan bila kedua sifat antihistamin dari loratadin dan efek dekongestan dari pseudoefedrin dibutuhkan.

    Kontraindikasi: 
    • Pemakaian obat simpatomimetik dikontraindikasikan pada penderita dengan penyakit kardiovaskular seperti: insufisiensi koroner, aritmia dan hipertensi berat.
    • Penderita yang sedang diterapi dengan penghambat monoamin oksidase (MAO) atau dalam waktu sepuluh hari setelah menghentikan pengobatan ini dan pada pasien dengan glaukoma sudut sempit, retensi urin, hipertensi berat, penyakit arteri koroner berat dan hipertiroidisme.
    • Hipersensitivitas terhadap pseudoefedrin dan loratadin.
    • Pemberian bersama ketokonazol dan derivat azol yang lain atau obat golongan makrolida.
    • Pada kegagalan pernafasan.
    • Pada mereka yang terbukti sensitif atau idiosinkrasi terhadap komponennya, pada preparat adrenergik atau lain yang memiliki struktur kimia yang serupa.
    Dosis: 
    Dosis dewasa dan anak 12 tahun: 1 kapsul setiap 12 jam.

    Peringatan dan perhatian: 
    • Hati-hati digunakan pada penderita hipertensi dan diabetes melitus. 
    • Keamanan penggunaannya pada masa kehamilan belum dibuktikan, sebaiknya diberikan hanya bila keuntungan terapeutik lebih besar dari risiko yang mungkin timbul terhadap janin.
    • Karena loratadin dan pseudoefedrin diekskresikan melalui air susu ibu, maka perlu hati-hati bila diberikan pada wanita menyusui. Simpatomimetik harus digunakan dengan hati-hati pada pasien yang sedang menerima digitalis.
    • Simpatomimetik dapat menyebabkan stimulasi sistem saraf pusat (SSP), eksitabilitas, konvulsi dan atau kolaps kardiovaskular yang disertai hipotensi.
    • Pada pasien berusia 60 tahun atau lebih, simpatomimetik juga lebih mungkin menyebabkan efek samping seperti halusinasi, konvulsi, depresi SSP dan kematian. Oleh karena itu, haruslah hati-hati bila memberikan suatu formulasi efek ulangan pada pasien usia lanjut.
    • Harus dihindarkan pemakaian pada penderita dengan insufisiensi hati. 
    • Pada penderita dengan insufisiensi ginjal, (GFR ‹ 30 ml/menit) dosis awal harus diturunkan karena bersihan (clearance) loratadin dan pseudoefedrin akan menurun.
    • Penyalahgunaan obat dan ketergantungan: tidak ada data yang menunjukkan adanya penyalahgunaan atau ketergantungan terhadap loratadin.
    • Pseudoefedrin seperti halnya stimulan SSP lainnya, pernah disalahgunakan. Pada dosis tinggi, subyek biasanya mengalami suatu peningkatan suasana hati (mood), berkurangnya nafsu makan dan suatu perasaan meningkatnya energi fisik, kapasitas mental dan kewaspasdaan.
    • Rasa cemas, iritabilitas dan lokualitas (banyak berceloteh) juga pernah dialami. Pemakaian terus menerus dari semua stimulan SSP mengakibatkan toleransi. Peningkatan dosis pada akhirnya menyebabkan toksisitas depresi dapat terjadi setelah penghentian obat secara cepat.
    • Pemakaian anak: keamanan dan khasiat pada anak-anak berusia ‹12 tahun belum ditetapkan.
    • Simpatomimetik harus digunakan dengan hati-hati pada pasien dengan glaukoma, tukak lambung stenosis, obstruksi piloroduodenal, hipertrofi prostat atau obstruksi leher kandung kemih, penyakit kardiovaskular, meningkatnya tekanan intraokular.
    Efek samping: 
    • Gangguan saluran cerna: anoreksia, mual, muntah, sakit perut dan mulut kering.
    • Kardiovaskular: palpitasi, takikardia dan ekstrasistol.
    • Efek samping lain yang pernah dilaporkan adalah nyeri abdomen dan dispepsia, alopesia, reaksi anafilaksis, angioedema, aritmia jantung, bronkospasme, gangguan mood, konvulsi, depresi, pusing, sakit kepala, insomnia, ikterus, gangguan fungsi hati termasuk peningkatan transaminase, gangguan haid, nyeri muskuloskeletai, nightmare, rash, keringat dingin, tremor dan gangguan visual.

    Interaksi obat: 
    • Pemberian obat simpatomimetik pada penderita yang menerima monoamin oksidase dapat menimbulkan krisis hipertensi.
    • Antasid meningkatkan kecepatan absorpsi pseudoefedrin tetapi sebaliknya kaolin menurunkannya.
    • Bila diberikan bersama-sama dengan alkohol, loratadin tidak memiliki efek yang mempotensiasikan seperti yang diukur dengan studi tampilan psikomotor.
    • Efek antihipertensi dari metildopa, mecamylamine, reserpin dan alkaloida veratrum dapat dikurangi oleh simpatomimetik. Preparat penghambat beta adrenergik juga dapat berinteraksi dengan simpatomimetik.
    • Peningkatan aktivitas pacemaker ektopik dapat terjadi bila pseudoefedrin digunakan bersama-sama dengan digitalis.

    Kemasan dan nomor registrasi: 
    Kotak, 5 blister @ 10 kapsul, DKL9905028303A1
    Merek Daftar R No.: 463090

    HARUS DENGAN RESEP DOKTER.

    SIMPAN PADA SUHU DI BAWAH 30°C. TERLINDUNG DARI CAHAYA.

    Dibuat oleh:
    PT FERRON PAR PHARMACEUTICALS
    CIKARANG-INDONESIA

    Untuk:
    Dexa Medica
    JL. BAMBANG UTOYO 138
    PALEMBANG-INDONESIA
    Continue reading...

    Monday, May 14, 2012

    Celestamine

    CELESTAMINE®
    Tablets and Syrup
    Betamethasone Dexchlorpheniramine maleate
    Schering-Plough

    DESCRIPTION:
    Each scored Celestamine® Tablet contains 0.25 mg betamethasone, a synthetic derivative of prednisolone, and 2 mg dexchlorpheniramine maleate. One teaspoonful (5 ml) of  Celestamine®  Syrup is equivalent to one Celestamine® Tablet.

    ACTIONS:
    Celestamine® Tablet and Syrup combine the anti-inflammatory and antiallergic effects of the corticosteroid betamethasone with the antihistaminic activity of dexchlorpheniramine maleate.

    INDICATIONS AND USAGE:
    Celestamine® Tablets and Syrup are recommended in the treatment of difficult cases of respiratory, dermatologic and ocular allergies, as well as ocular inflammatory disorders, where adjunctive systemic corticosteroid therapy is indicated.

    DOSAGE AND ADMINISTRATION : 
    DOSAGE SHOULD BE INDIVIDUALIZED AND ADJUSTED ACCORDING TO THE SPECIFIC DISEASE BEING TREATED, ITS SEVERITY AND THE RESPONSE OF THE PATIENT.
    The recommended initial dosage of  Celestamine® Tablets and Syrup adults and children over 12 years is 1 to 2 tablets (or 1 to 2 teaspoonfuls) four times daily, after meals and at bedtime. The dose is not to exceed 8 tablets (or 8 teaspoonfuls) per day. In younger children dosage should be adjusted according to the severity of the condition, and the response of the patient, rather than by age or body weight.
    Children 6 to 12 years - The recommended dosage is ½ tablet (or  ½, teaspoonful) three times a day. If an additional daily dose is required, it should be taken, preferable at bedtime. The dose is not to exceed 4 tablets (or 4 teaspoonful) a day.
    Children 2 to 6 years - The initial dosage of  Celestamine® Syrup is to V, teaspoonful three times a day with adjustment of dosage according to patient response. Daily dose is not to exceed 2 teaspoonfuls.

    DRUG INTERACTIONS: 
    Betamethasone - Concurrent use of Phenobarbital, phenytoin, rifampin or ephedrine may enhance the metabolism of corticosteroids, reducing their therapeutic effects.
    Patients receiving both a corticosteroid and an estrogen should be observed for excessive corticosteroid effects. Concurrent use of corticosteroids with potassium-depleting diuretics may enhance hypokalemia. Concurrent use of corticosteroids with cardiac glycosides may enhance the possibility of arrhythmias or digitalis toxicity associated with hypokalemia. Corticosteroids may enhance the potassium depletion caused by amphotericin B. In all patients taking any of these drug therapy combinations, serum electrolyte determinations, particularly potassium levels, should be monitored closely.
    Concurrent use of corticosteroids with coumarin-type anticoagulants may increase or decrease the anticoagulant effects, possibly requiring adjustment in dosage.
    Combined effects of non-corticosteroid anti-inflammatory drugs or alcohol with glucocorticoids may result in an increased occurrence or increased severity of gastrointestinal ulceration.
    Corticosteroids may decrease blood salicylate concentrations Acetylsalicylic acid should be used cautiously in conjuction with corticosteroids in hypoprothrombinemia.
    Dosage adjustments of an antidiabetic drug may be necessary when corticosteroids are given to diabetics. Concomitant glucocorticoid therapy may inhibit the response to somatotropin.
    Dexchlorpheniramine Maleate - Monamine oxidase (MAO) inhibitors prolong and intensify the effects of antihistamines; severe hypotension may occur. Concomitant use of dexchlorpheniramine maleate with alcohol, tricyclic antidepressants, barbiturates or other central nervous system depressants may potentiate the sedative effect of dexchlorpheniramine. The action of oral anticoagulants may be inhibited by antihistamines.
    Drug/ Laboratory Test Interactions: Corticosteroids may affect the nitroblue tetrazolium test for bacterial infection and produce false negative results.

    ADVERSE REACTIONS : 
    The physician should be alerted to the possibility of any adverse effects associated with the use of corticosteroids and antihistamines, especially of the sedating type.
    Betamethasone : Adverse reactions to this component, which have been the same as those reported with other corticosteroids, are related to dose and duration of therapy. The small amount of corticosteroid in the combination makes the incidence of side-effects less likely.
    Adverse reactions reported for corticosteroids include:
    Fluid and electrolyte disturbances: sodium retention, potassium loss, hypokalemic alkalosis; fluid retention; congestive heart failure in susceptible patients; hypertension.
    Musculoskeletal: muscle weakness, corticosteroid myopathy, loss of muscle mass; aggravation of myasthenic symptoms in myasthenia gravis; osteoporosis; vertebral compression fractures; aseptic necrosis of femoral and humeral heads; pathologic fracture oflong bones; tendon rupture.
    Gastrointestinal : peptic ulcer with possible subsequent perforation and hemorrhage; pancreatitis, abdominal distention; ulcerative esophagitis.
    Dermatologic : impaired wound healing, skin atrophy, thin fragile skin; petechiae and ecchymoses; facial erythema; increased sweating; suppressed reactions to skin tests; reactions such as allergic dermatitis, urticaria, angioneuroric edema.
    Neurologic : convulsions; increased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment, vertigo; headache.
    Endocrine : menstrual irregularities; development of cushingoid state; suppression of fetal intrauterine or childhood growth; secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illness; decreased carbohydrate tolerance, manifestations of latent diabetes mellitus, increased requirements of insulin or oral hypoglycemic agents in diabetics.
    Ophthalmic: posterior subcapsular cataracts; increased intraocular pressure, glaucoma; exophthalmos. Metabolic: negative nitrogen balance due to protein catabolism.
    Psychiatric : euphoria, mood swings; severe depression to frank psychotic manifestations; personality changes; hyperirritability; insomnia.
    Other: anaphylactoid or hypersensitivity and  hypotensive or shock-like reactions.
    Dexchlorpheniramine Maleate - Adverse reactions to this component have been the same as those reported with other conventional (sedating) antihistamines, and rarely cause toxicity. Slight to moderate drowsiness is the most frequent side effect of dexchlorpheniramine maleate. Adverse effects of sedating antihistamines vary in incidence and severity. Among these are cardiovascular, hematologic (pancytopenia, thrombocytopenia, hemolytic anemia), neurologic (confusion, hallucinations, tremor), gastrointestinal, genitourinary (urinary retention), respiratory adverse reactions, and mood changes. The most common effects include sedation, sleepiness, dizziness, disturbed coordination, epigastric distress, rash, dry mouth and thickening of bronchial secretions.

    CONTRAINDICATIONS:
    Celestamine®  product, are contraindicated in patients with systemic fungal infections, newborn and premature infants, patients receiving MAO inhibitor therapy and in those who have shown hypersensitivity or idiosyncrasy to any component of these products or drugs of similar chemical structures.

    PRECAUTIONS:
    Betamethasone - Dosage adjustments may be required with remission or exacerbation of the disease process, the patient's individual response to therapy and exposure of the patient to emotional or physical stress such as serious infection, surgery or injury. Monitoring may be necessary for up to one year following cessation of long-term or high-dose corticosteroid therapy.
    The lowest possible dose of corticosteroid should be used to control the condition under treatment. A gradual dosage reduction is recommended.
    Corticosteroid effect is enhanced in patients with hypothyroidism or in those with cirrhosis.
    Cautious use of corticosteroids is advised in patients with ocular herpes simplex because of possible corneal perforation.
    Psychic derangements may appear with corticosteroid therapy. Existing emotional instability or psychotic tendencies may be aggravated by corticosteroids.
    Corticosteroids should be used with caution in nonspecific ulcerative colitis, if there is a probability of impending perforation, abscess, or other pyogenic infection; diverticulitis; fresh intestinal anastomoses; active or latent peptic ulcer, renal insufficiency, hypertension, osteoporosis, and myasthenia gravis. Since complications of glucocorticoid treatment are dependent on dosage and duration of treatment, a risklbenefit decision must be made with each patient.
    Corticosterids may mask some signs of infection and new infections may appear during use. When corticosteroids are used, decreased resistance and inability to localize infection may occur. Prolonged corticosteroid use may produce posterior subcapsular cataracts (especially in children), glaucoma with possible damage to the optic nerves, and may enhance secondary ocular infections due to fungi or viruses. Average and large doses of corticosteroids can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be considered. All corticosteroids increase calcium excretion.
    While on corticosteroid therapy patients should not be vaccinated against smallpox. Other immunization procedures should not be undertaken in patients receiving corticosteroids especially high doses, because of possible hazards of neurological complications and lack of antibody response.
    Patients who are in immunosuppressant doses of corticosteroids should be warned to avoid exposure to chicken pox or measles. and if exposed, to obtain medical advice. This is of particular importance in children.
    Corticosteroid therapy in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used in conjunction with an appropriate antituberculous regimen.
    If corticosteroids are indicated in patients with latent tuberculosis, close observation is necessary since reactivation of the disease may occur. During prolonged corticosteroid therapy, patients should receive chemoprophylaxis.
    Growth and development of children on prolonged corticosteroid therapy should be followed carefully, since corticosteroid administration can disturb growth rates and inhibit endogenous corticosteroid production in these patients.
    Corticosteroid therapy may alter the motility and number of spermatozoa.
    Dexchlorpheniramine Maleate - Celestamine® products should be used with caution in patients with narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, prostatic hypertrophy or bladder neck obstruction, cardiovascular disease including hypertension, in those with increase intraocular pressure or hyperthyroidism.
    Patients should be warned about engaging in activities requiring mental alertness, such as driving a car or operating appliances, machinery, etc.
    Conventional antihistamines may cause dizziness, sedation, and hypotension in patients over 60 years of age.
    Safety and effectiveness of Celestamine® products have not been established in children under 2 years of age.
    Usage in pregnancy and nursing mothers: The use of Celestamine® products during pregnancy, in nursing mothers or in women of child-bearing age requires that the possible benefits of the drug be weighed against potential hazards to mother and fetus or infant. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be observed carefully for signs of hypoadrenalism.
    Overdosage information: Celestamine® is a combination product and, therefore the potential toxicity of each of its components must be considered. Toxicity from a single excessive dose of Celestamine® results primarily from the dexchlorpheniramine component. The estimated lethal dose of the antihistamine dexchlorpheniramine maleate is 2.5 to 5.0 mg/kg.
    Overdosage reactions with conventional (sedating) antihistamines may vary from central nervous system depression (sedation, apnea, diminished mental alertness, cyanosis, arrhythmias, cardiovascular collapse) to stimulation (insomnia, hallucinations, tremors, convulsions) to death. Other signs and symptoms may include dizziness, tinnitus, ataxia, blurred vision and hypotension. In children, stimulation is dominant, as are atropine-like signs and symptoms (dry mouth; fixed, dilated pupils; flushing; fever, and gastrointestinal symptoms). Hallucinations, incoordination, and convulsions of the tonic-clonic type may occur. In adults, a cycle consisting of depression with drowsiness and coma, and an excitement phase leading to convulsions followed by depression may occur.
    A single excessive dose of betamethasone is not expected to produce acute symptoms. Except at the most extreme dosages, a few days of excessive glucocorticosteroid dosing is unlikely to produce harmful results except in patients at particular risk due to underlying conditions or on concomitant medications likely to interact adversely with the betamethasone.
    Treatment of Acute Overdosage: In the event of overdosage, emergency treatment should be started immediately. Consultation with a poison control center is recommended. Consider standard measures to remove any unabsorbed drug, e.g. activated charcoal, 'gastric lavage. Dialysis has -not -been found helpful. There is no specific antidote. Measures to enhance excretion (urinary acidification, hemodialysis) are not recommended.
    Treatment of the signs and symptoms of overdosage is symptomatic and supportive.

    STORAGE:
    Celestamine® Syrup : store below 30°C,
    Celestamine® Tablets : store below 25°C

    PRESENTATION
    Celestamine®  Tablets, box of  3 strips @ 10 tablets; Reg. No.: DKL9106604510A1
    Celestamine® Tablets, box of 15 strips@ 10 tablets; Reg. No.:  DKL9106604510A1
    Celestamine® Syrup, bottle of 60 ml; Reg. No.: DKL9106604l37Al
    Celestamine® Syrup, bottle of 30 ml; Reg. No.: DKL9106604l37Al

    HARUS DENGAN RESEP DOKTER

    Manufactured by:
    PT Schering-Plough Indonesia Tbk,
    Pandaan, EastJava,
    a subsidiary of Schering-Plough Corporation, USA.
    ® Registered Trade name
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    Sunday, May 13, 2012

    Natto-10

    NATTO®-10
    Supplemen makanan/ Food supplement

    KOMPOSISI/ COMPOSITION
    Nattokinase (NSK) II              100mg
    Co Q - 1030mg

    PETUNJUK PEMAKAIAN DAN DOSIS/ DIRECTION AND DOSAGE
    Sesuai anjuran dokter, 1 kali sehari, 1 - 3 kaplet salut selaput.
    As directed by the physician Once per day, 1 - 3 FC caplets.

    PERINGATAN/ PRECAUTION
    Hati-hati pada orang yang hipersensitif pada salah satu bahan.
    Hypersensitive with the active ingredients.

    PENYIMPANAN/ STORAGE
    Simpan di tempat sejuk (15 - 25°C) dan kering, terlindung dari cahaya.
    Store in a cool (15 - 25°C) and dry place, protect from light.

    POM SD. 111 541 911

    Manufactured by:
    PT. LAPI LABORATORIES
    SERANG - INDONESIA

    Under Licenced:
    Japan Bio Science Lab Co., LTD
    Japan
    Continue reading...

    Saturday, May 12, 2012

    Diprogenta

    Diprogenta® Cream and Ointment
    Betamethasone dipropionate
    Gentamicin sulfate

    COMPOSITION
    Each gram contains 0.64 mg betamethasone dipropionete equivalent to 0.5 mg betamethasone and 1.7 mg gentamicin sulfate equivalent to 1 mg gentamicin base.

    DESCRIPTION
    A combination of the corticosteroid betamethasone dipropionate and the antibiotic gentamacin sulfate with anti-inflammatory, antipruritic, vasoconstrictive and bactericidal properties, particularly against staphylococcal species.

    INDICATIONS
    For the reduce of inflammatory manifestations of corticosteroid- responsive dermatoses when complicated by secondary infection, caused by organisms susceptible to gentamicin, or when such infection is suspected.

    DOSAGE AND ADMINISTRATION
    A thin film should be applied to cover completely the affected area twice daily, in the morning and evening. Some patients may be maintained with less frequent application.

    PRECAUTIONS
    Discontinue treatment if irritation or sensitization develops.
    Any side-effect reported following use of systemic corticosteroids may occur, especially in infants and children. Systemic absorption of corticosteroids will increase if occlusive dressing is used or extensive areas are treated.
    Overgrowth of non-susceptible organisms may occur, should super-infection develop, discontinue treatment and initiate appropriate therapy.
    Systemic absorption of topically applied gentamicin may be increased if extensive body surface areas are treated, especially over prolonged time periods or in the presence of dermal disruption. In these cases, the undesirable effects which occur following systemic use of gentamicin may potentially occur. Cautious use is recommended under these conditions, particularly in infants and children.
    Not for ophthalmic use.
    Not to be used for extensive body surface areas or for long-term use, because of the nephrotoxicity and ototoxicity effect. The used of this combination more than seven days have no greater benefit than using steroid alone.
    Pediatric Use: Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalamic-pituitary adrenal (HPA) axis suppression and to exogenous corticosteroid effects than mature patients because of greater absorption due to a large skin surface area to body weight ratio.
    HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisal levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include a bulging fontanelle, headaches and bilateral papilledema.
    Not to be used for children under 2 years of age.
    Use during pregnancy and in nursing women: Since safety of topical corticosteroid use in pregnant women has not been established, drugs of this class should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
    Drugs of this class should not be used extensively in large amounts or for prolonged periods of time in pregnant patients.
    Since it is not known whether topical administration of corticosteroids can result insufficient systemic absorption to produce detectable quantities in breast milk, a decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug 10 the mother.
    Over dosage: Symptoms: Excessive or prolonged use of topical corticosteroids can suppress pituitary-adrenal function, resulting in secondary adrenal insufficiency, and produce manifestations of hypercorticism. including Cushing's disease.
    Excessive prolonged use of topical gentamicin may lead to overgrowth of lesions by fungi or non susceptible bacteria.
    Treatment: Appropriate symptomatic treatment is indicated. Acute hypercorticoid symptoms are usually reversible. Treat electrolyte imbalance, if necessary. In case of chronic toxicity, slow withdrawal of corticosteroids is advised.
    Appropriate anti fungal or antibacterial therapy is indicated if overgrowth occurs.

    ADVERSE REACTIONS
    Use of topical corticosteroids have resulted in local adverse reactions: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis. Use of occlusive dressing may increase the incidence of skin maceration, secondary infection, skin atrophy, striae, miliaria.
    Topical use of gentamicin has produced transient irritation (erythema and pruritus).

    CONTRA INDICATIONS
    Sensitivity to any ingredient.
    Vaccinia, varicelia, skin tuberculosis.
    Not to be used for infections caused by fungi and virus.

    PRESENTATIONS
    DIPROGENTA Cream, tube of 5 gram; Reg. No.: DKL7606605429A1
    DIPROGENTA Cream, tube of 10 gram; Reg. No.: DKL 7606605429A1
    DIPROGENTA Ointment, tube of   5 gram; Reg. No.: DKL 7606605530A1
    DIPROGENTA Ointment, tube of 10 gram; Reg. No.: DKL 7606605530Al

    HARUS DENGAN RESEP DOKTER
    ON DOCTOR'S PRESCRIPTION ONLY

    Store below 30°C.

    Manufactured by
    PT Schering-Plough Indonesia Tbk,
    Pandaan, Jawa- Timur,
    a subsidiary of
    Schering-Plough Corporation, USA.
    Continue reading...

    Friday, May 11, 2012

    Glucosamine MPL

    GLUCOSAMINE MPL 500mg
    UNTUK KESEHATAN SENDI

    Tulang rawan sendi merupakan jaringan spesifik dengan matriks ekstrasel yang luas, di mana glucosamine merupakan suatu derivate aminomonosakarida yang membentuk glikosaminoglikan di matriks sendi dan cairan sinovial.

    KOMPOSISI:
    Tiap kaplet salut film mengandung
    Glucosamine ..................... 500 mg

    KEGUNAAN:
    Memelihara kesehatan fungsi persendian.

    KONTRAINDIKASI:
    Penderita yang hipersensitif terhadap bahan aktif obat ini.

    EFEK SAMPING:
    Umumnya ringan berupa mual dan muntah.

    DOSIS dan CARA PEMAKAIAN:
    Sehari 3 kali 1 kaplet, setelah makan.
    Diberikan sampai terlihat tanda-tanda perbaikan atau umumnya 4 - 6 minggu.
    Untuk mempertahankan keadaan sendi yang baik, dianjurkan melanjutkan dengan dosis 2 kali 1 kaplet.

    KEMASAN:
    Dos berisi 10 blister @ 10 kaplet salut film.
    No. Reg. POM SD. 061 527 691

    Simpan pada suhu kamar (di bawah 30°C)

    Diproduksi oleh
    PT. Medikon Prima Laboratories
    Tangerang, Indonesia
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    Thursday, May 10, 2012

    Ikalep

    IKALEP®
    VALPROIC ACID 250 mg

    Composition :
    Each enteric coated tablet contains :
    Sodium Valproate equivalent to Valproic Acid 250 mg.

    Pharmacology:
    Sodium Valproate inhibits enzyme which outlines GABA (Gama Amino Butyric Acid) until the level of neurotransmitter in the brain increased. GABA function is to inhibit the release of electric charge on the pre and post synapse.

    Indications :
    Used for petit mal epilepsy type (absence of simple and complex seizure) Enhance GABA-suppressing effect of stimulus sensitivity of the nerve cells

    Contra Indications :
    - Pregnant woman.
    - Patients with impaired liver functions.
    - Hypersensitivity to Sodium Valproat.

    Warning and Precautions:
    Liver functions and serum amylase test should be performed routinely at least the first 6 months using drugs. Also recommended to test the number of platelet and blood clotting time. If there is a case of abnormal rate, the dose should be reduced, then if it is found that the normal rate dose should be adjusted again.
    Do not drive a motor-car or operate heavy machinery. Use caution in nursing mothers because sodium valproate is excreted through breast milk.
    Use caution in children because it can cause a fatal hepatotoxic.

    Side Effects:
    • Gastro disturbances : nausea, vomiting, diarrhea, abdominal cramp, constipation, heartburn.
    • Central nervous system: sedation, tremor, headache, sleepy, dizziness, alopecia.
    • Skin: hair loss, skin rash, photo-sensitivity.
    • Thrombositopenia, hyperamoniae, depression, psychosis.
    Drug Interactions :
    • Because of the possibility of blood clotting time extension, treatment should be considered with oral anticoagulant acetyl salicylic acid.
    • Sodium valproate increases plasma concentrations of phenobarbital.
    • Anti epileptic drugs carbamazepine, phenobarbital, phenytoin decrease the concentration of sodium valproate in serum, particularly in children.
    • Increased effect of Primidone.
    Posologi:
    Initial dose 15 mg/kg BW/day. Weekly dose may be increased 5-10 mg/kg BW/day, the recommended maximum dose 60. mg/kg BW/day. When doses exceeding 250 mg/day given in divided dose.

    Packaging:
    Box, bottle @ 30 tablets
    Reg. No: DKL9409309015B1

    STORE IN A COOL (15-25°C) AND DRY PLACE 
    ON MEDICAL PRESCRIPTION ONLY

    Produced by:
    PT. IKAPHARMINDO PUTRAMAS
    PHARMACEUTICAL LABORATORIES
    JAKARTA - INDONESIA



    IKALEP®
    ASAM VALPROAT 250 mg

    Komposisi:
    Tiap tablet salut enterik mengandung:
    Natrium Valproat setara dengan Asam Valproat 250 mg.

    Cara Kerja:
    Natrium Valproat menghambat enzim yang menguraikan GABA (Gama Amino Butyric Acid) hingga kadar neurotransmitor di otak meningkat. Fungsi GABA adalah menghambat pelepasan muatan listrik di pra dan di post sinaps.

    Indikasi:
    Digunakan untuk epilepsi jenis petit mal (absence seizure yang simpel dan kompleks).
    Meningkatkan efek penekan GABA terhadap kepekaan rangsangan dari sel syaraf.

    Kontra Indikasi :
    - Wanita hamil.
    - Pasien dengan kerusakan fungsi hati.
    - Hipersensitif terhadap Natrium Valproat.

    Peringatan dan Perhatian :
    Harus dilakukan tes fungsi liver/hepar dan serum amilase secara rutin minimal 6 bulan pertama sejak menggunakan obat ini, juga dianjurkan untuk tes jumlah platelet dan waktu pembekuan darah. Jika terjadi angka yang abnormal, dosis harus diturunkan, kemudian jika sudah didapatkan angka yang normal dosis harus disesuaikan lagi.
    Jangan mengendarai kendaraan bermotor atau menjalankan mesin. Hati-hati pemakaian pada ibu menyusui karena diekskresi melalui air susu. Hati-hati penggunaan pada anak-anak karena dapat menyebabkan hepatotoksik yang fatal.

    Efek Samping:

    • Gangguan gastrointestinal: mual, muntah, diare, kejang perut, konstipasi, heartburn.
    • Susunan syaraf pusat: sedasi, tremor, sakit kepala, mengantuk, pusing, alopecia.
    • Kulit: rontok rambut, skin rash, fotosensitivitas.
    • Trombositopenia, hyperamonia, depresi, psikosis.

    Interaksi Obat:

    • Karena terjadi kemungkinan perpanjangan waktu pembekuan darah harus diperhatikan pengobatan bersama dengan oral antikoagulan asetl salisilic acid.
    • Natrium Valproat menaikan konsentrasi phenobarbital dalam plasma.
    • Obat-obat antiepilepsi lain carbamazepine, phenobarbital dan phenytoin dapat menurunkan konsentrasi Nalrium Valproat dalam serum, khususnya pada anak-anak.
    • Meningkatkan efek dari Primidone.

    Posologi:
    Dosis awal 15 mg/kgBB/hari.
    Tiap minggu dosis dapat dinaikan 5-10 mg/kgBB/hari, dosis maksimal yang dianjurkan 60 mg/kgBB/hari.
    Bila dosis melebihi 250 mg/hari diberikan dalam dosis bagi.

    Kemasan:
    Dus, Botol @ 30 tablet
    No. Reg.: DKL9409309015B1

    SIMPAN DI TEMPAT SEJUK (15-25°C) DAN KERING
    HARUS DENGAN RESEP DOKTER

    Diproduksi oleh:
    PT. IKAPHARMINDO PUTRAMAS

    PHARMACEUTICAL LABORATORIES
    JAKARTA - INDONESIA
    Continue reading...

    Wednesday, May 9, 2012

    Kendaron

    KENDARON® 
    amiodarone hydrochloride 
    Tablet 

    COMPOSITION 
    Each tablet contains:
    amiodarone hydrochloride ............... 200 mg

    PHARMACOLOGY 
    • Increase coronary blood flow 
    • Reduce myocardial oxygen consumption 
    • Maintain cardiac output 
    • Non competitive α and β adrenergic inhibition 
    • Increase action potential duration and refractory periods of cardiac cells. 
    INDICATIONS 
    Only for the treatment of recurrent and life threatening ventricular arrhythmia's when no improvement with adequate dosage of anti arrhythmic or others anti arrhythmic could not be tolerated:
    1. Recurrent ventricular fibrillation
    2. Ventricular tachycardia with unstable hemodynamically.

    DOSAGE 
    Starting dose: 1 tablet 3 times daily for a week, reducing to 1 tablet 2 times daily for a week.
    Maintenance dose: 1 tablet daily or less.
    The tablet should be taken during or at the end of meals.

    WARNINGS AND PRECAUTIONS 
    KENDARON® is intended for use only in patients with the indicated life-threatening arrhythmia's, because its use is accompanied by substantial toxicity.
    Safety and effectiveness of KENDARON® in children have not been established.
    Amiodarone is not recommended during lactation since it is excreted in milk.

    SIDE EFFECTS 
    Corneal microdeposits :
    These are reversible and not contraindicated for the continuation of treatment. Reduce the dose in the event of the colored halos (a sign of over dosage).
    Photosensitization and Pigmentation:
    The incidence of these effects is low. It is recommended to avoid exposure to sunlight in the case.
    Hyperthyroidism or hypothyroidism (reflected in the occurrence of asthenia, loss of spirit, the recurrence of tachycardia or on the contrary in excessive bradycardiac). Cases of reversible diffused interstitial pneumopathy or peripheral neurophaty.
    Nausea, vomiting, constipation, anorexia, abdominal pain, headache weakness, myalgia, treamor, ataxia, paraesthesia, congestive heart failure (CHF), pulmonary inflammation or fibrosis.

    CONTRAINDICATIONS 

    • Sinus bradycardia (below 50 beats/min) and sinoatrial block
    • Atrioventricular block
    • Dysthyroidism
    • Pregnancy-except when the use of the drug is required as life-saving measure as a thyroid hazard to the fetus involved. 
    • Hypersensitivity to amiodarone.

    DRUG INTERACTIONS 
    Do not use with wave burst arrythmia drugs. It is recommended not to use KENDARON® in combination therapy with MAOI or bradycardiac medications (β-blockers and some calcium antagonists). In the event of concomitant administration with digitalis or digoxin, KENDARON® may increase the serum digoxin concentration and may reach toxic levels.
    In patients on anticoagulant therapy (Warfarin), it is recommended to monitor the prothrombin time regularly when instituting Kendarone treatment. The dose of the anticoagulant should be reduced by one third to half.

    ON DOCTOR'S PRESCRIPTION ONLY 
    Store at 25° - 30° C

    PRESENTATION 
    Box of 3 strips of 10 tablet
    Reg. No.: DKL0004515410A1

    Diproduksi oleh:
    PT Prafa
    Citeureup, Bogor-Indonesia
    Untuk:
    Darya-Varia
    LABORATORIA
    Gunung Putri, Bogor - Indonesia





    KENDARON®
    amiodarone hydrochloride 
    Tablet 

    KOMPOSISI
    Tiap tablet mengandung:
    amiodarone hydrochloride ............... 200 mg

    FARMAKOLOGI
    • Meningkatkan aliran darah koroner.
    • Mengurangi penggunaan oksigen oleh otot jantung.
    • Mempertahankan curah jantung.
    • Menghambat aktifitas adrenergik alfa dan beta secara non-kompetitif.
    • Meningkatkan masa potensial aksi dan periode refrakter dari sel jantung.
    INDIKASI
    KENDARON® hanya diindikasikan untuk pengobatan kasus-kasus aritmia ventrikuler yang kambuh dan mengancam jiwa pasien, jika pengobatan dengan dosis yang memadai dari obat antiaritmia yang tersedia tidak memberikan perbaikan atau bila obat-obat tersebut tidak dapat ditoleransi.
    1. Fibrilasi ventrikuler yang berulang (sering kambuh)
    2. Takikardia ventrikuler dengan hemodinamik yang tidak stabil.

    POSOLOGI
    Dosis awal: Sehari 3 x 1 tablet selama 1 minggu, kemudian dikurangi menjadi sehari 2 x 1 tablet selama seminggu.
    Dosis pemeliharaan: Sehari 1 tablet atau kurang.
    Tablet boleh dimakan selama atau pada saat selesai makan.

    PERINGATAN DAN PERHATIAN
    KENDARON® dimaksudkan hanya digunakan pada pasien dengan aritmia yang membahayakan jiwa pasien karena pemakaiannya diikuti oleh toksisitas.
    Keamanan dan efektifitas KENDARON® pada anak-anak belum diketahui.
    Hati-hati penggunaan pada wanita menyusui karena Amiodarone di ekskresikan melalui air susu.

    EFEK SAMPING 
    Mikrodeposit pada kornea:
    Keadaan ini reversible dan tidak dikontraindikasikan apabila  KENDARON® diperlukan untuk pengobatan lanjutan.
    Pada keadaan adanya tanda yang berwarna (suatu tanda kelebihan dosis), maka kurangi dosis.
    Fotosensitisasi dan pigmentasi :
    Kejadian dari efek ini rendah. Pada kasus ini dianjurkan untuk menghindari terkena sinar matahari.
    Hipertiroidism atau hipotiroidism (dengan gejala-gejala berupa astenia, tidak bersemangat, kambuhnya takikardia, atau sebaliknya juga ditemukan bradikardia yang berlebihan). Pneumopati intertitial difus yang reversible atau neuropati perifer.
    Mual, muntah, konstipasi, nafsu makan berkurang, nyeri abdomen, sakit kepala, lemah, nyeri otot, tremor, ataksia, pareaestesia, gagal jantung kongestif, inflamasi paru atau fibrosis.

    KONTRAINDIKASI

    • Bradikardia sinus (denyut jantung dibawah 50 kali/menit) dan Blok Sinoatrial.
    • Blok Atrioventrikuler.
    • Distiroidism.
    • Kehamilan- kecuali pada keadaan dimana pemakaian obat ini diperlukan untuk menyelamatkan jiwa, seperti adanya efek hormon tiroid yang membahayakan terhadap fetus.
    • Hipersensitif terhadap obat.

    INTERAKSI OBAT
    Jangan digunakan bersama dengan obat-obat yang dapat menimbulkan gelombang aritmia yang kuat. Tidak dianjurkan menggunakan KENDARON® dalam bentuk kombinasi dengan MAOI atau obat-obat yang menyebabkan bradikardia (beta bloker dan beberapa antagonis kalsium). Pada pemakaian secara bersamaan dengan digitalis atau digoksin dapat meningkatkan konsentrasi serum digoksin yang dapat
    mencapai tingkat yang toksik.
    Pada pasien yang mendapat pengobatan bersamaan dengan antikoagulan (Warfarin) dianjurkan untuk memantau masa protrombin secara teratur. Dosis dari antikoagulan sebaiknya dikurangi sepertiga atau setengahnya.

    HARUS DENGAN RESEP DOKTER
    Simpan pada suhu 25° - 30° C

    KEMASAN
    Box isi 3 strip @ 10 tablet
    Reg. No. : DKL0004515410A1

    Diproduksi oleh:
    PT Prafa
    Citeureup, Bogor-Indonesia
    Untuk:
    Darya-Varia
    LABORATORIA
    Gunung Putri, Bogor - lndonesia
    Continue reading...

    Tuesday, May 8, 2012

    Zinkid

    Zinkid® 
    Zinc 

    Zinkid® 20 mg dispersible tablet and Zinkid®  10 mg/5 ml syrup complement the treatment of child diarrhea in connection with Oral Re-hydration Salts.

    Composition 
    Each dispersible tablet contains zinc sulfate 54.9 mg equivalent to zinc 20 mg.
    Each 5 ml syrup contains zinc sulfate 27.45 mg equivalent to zinc 10 mg.

    Mechanism of action 
    • The treatment of diarrhea aims at preventing of treating dehydration (use of DRS), and to prevent nutritional damage (use of zinc).
    • By giving zinc as soon as diarrhea starts, at the same time as DRS, the duration and severity of the episode as well as the risk of dehydration will be reduced. By continuing zinc supplementation after diarrhea stops, the zinc lost in the stools will be replaced. The risk of the child having new episodes of diarrhea in the following 2 to 3 months is reduced.
    Indications
    Zinkid® complements the treatment of diarrhea in children under 5 years of age, always in connection with the use of Oral Re-hydration Salts (DRS) solution.

    Dosage 
    • For infants between 2 and 6 months of age: half a tablet (Zinkid®  10 mg) or 5 ml syrup to be administered everyday for 10 consecutive days (even if diarrheal episode has stopped).
    • For children between 6 months and 5 years of age: one full tablet (Zinkid®  20 mg) or 10 ml syrup to be administered everyday for 10 consecutive days (even if diarrheal episode has stopped).
    In the case of vomiting within ½ hour following the intake of drug, give another one.

    Direction for using tablet 
    - Place the tablet in a teaspoon (5 ml).
    - Add a bit of water (or mother's milk).
    - Dot not use tea water.
    - Let the tablet dissolve (around 30 seconds).
    - Give the entire spoonful to the child.

    Precautions 
    • No particular precaution is necessary for the use of zinc sulfate in this dose.
    • During diarrhea, zinc supplement and Oral Re-hydration Salts should be administered. Nursing mother is recommended to keep breastfeeding or increase frequency of breast-feeding during and after diarrhea.
    Side Effects 
    The toxicity of zinc in oral administration, in adult can occur at dose more than 150 mg/day (about 10 times of the recommended dose) during long periods.
    High dose of zinc for long periods can cause the decrease of lipoprotein plasma concentration and copper absorption.

    Drug Interactions 
    If given in connection with iron, it is recommended to give zinc a few hours before or after the iron.

    Storage 
    Tablet: Keep tablets in a dry, shaded place, under 30°C.
    Syrup: Store at 15 - 25°C, protect from light, in a well closed container.

    Packaging and Registration Number
    Zinkid®  20 mg dispersible tablet, box of 10 blisters @ 10 dispersible tablets
    Reg. No. DTL0720934681A1
    Zinkid®  10 mg/5 ml syrup, box of 1 bottle @ 100 ml syrup
    Reg. No. DTL0920936637A1

    INDOFARMA
    BEKASI - INDONESIA





    Zinkid® 
    Zinc


    Tablet dispersibel  Zinkid® 20 mg dan Sirup  Zinkid® 10 mg/5 ml merupakan pelengkap untuk pengobatan diare pada anak-anak, digunakan bersama oralit.

    Komposisi 
    Tiap tablet dispersibel mengandung zinc sulfate 54,9 mg setara dengan zinc 20 mg.
    Tiap 5 ml sirup mengandung zinc sulfate 27,45 mg setara dengan zinc 10 mg.


    Cara Kerja Obat 
    Pengobatan diare bersama oralit bertujuan untuk mencegah atau mengobati dehidrasi dan untuk mencegah kekurangan nutrisi. Pemberian zinc bersama oralit sesegera mungkin setelah terjadi diare akan mengurangi lama dan tingkat keparahan dari dehidrasi. Setelah diare berhenti, berikan zinc secara kontinyu untuk menggantikan kandungan zinc yang hilang. Resiko anak akan mengalami diare kembali dalam waktu 2 - 3 bulan ke depan dapat berkurang.

    Indikasi 
    Zinkid®  merupakan pelengkap untuk pengobatan diare pada anak-anak di bawah 5 tahun, diberikan bersama larutan oralit.

    Dosis
    • Bayi 2 - 6 bulan: ½ tablet dispersibel ( Zinkid® 10 mg) atau 5 ml sirup diberikan setiap hari selama 10 hari berturut-turut (bahkan ketika diare telah berhenti).
    • Anak 6 bulan - 5 tahun. 1 tablet dispersibel ( Zinkid® 20 mg) atau 10 ml sirup diberikan setiap hari selama 10 hari berturut-turut (bahkan ketika diare telah berhenti).
    Jika terjadi muntah dalam waktu ½. jam setelah pemberian obat, berikan lagi obat yang masih baru.

    Cara Penggunaan tablet 
    - Letakkan tablet pada sendok 5 ml.
    - Tambahkan air minum hangat secukupnya (atau ASI).
    - Jangan menggunakan air teh.
    - Biarkan tablet terlarut (sekitar 30 detik).
    - Berikan pada anak.

    Peringatan dan Perhatian 
    • Tidak ada peringatan khusus pada penggunaan zinc sulfate dalam dosis ini.
    • Selama diare masih berlangsung, selain diberikan suplemen zinc, juga diberikan oralit. Para ibu menyusui dianjurkan untuk tetap menyusui atau meningkatkan frekuensi menyusui pada anak selama dan setelah diare.
    Efek Samping 
    Toksisitas zinc secara oral pada dewasa dapat terjadi akibat asupan zinc dosis ›150 mg/hari (kurang lebih 10 kali dosis yang dianjurkan) selama periode yang lama.
    Dosis tinggi zinc untuk periode lama dapat menyebabkan penurunan konsentrasi lipoprotein plasma dan absorpsi tembaga.

    Interaksi Obat 
    Jika diberikan bersamaan dengan zat besi, direkomendasikan untuk memberikan zinc terlebih dahulu yaitu beberapa jam sebelum memberikan zat besi.

    Cara Penyimpanan 
    Tablet: Simpan di tempat kering dan sejuk, di bawah 30°C.
    Sirup: Simpan pada 15 - 25 ° C, terlindung dari cahaya, dalam wadah tertutup rapat

    Kemasan dan Nomor Registrasi 
    Zinkid® 20 mg tablet dispersibel, kotak 10 blister @ 10 tablet dispersibel No. Reg. DTL0720934681A1
    Zinkid® 10 mg/5 ml sirup, kotak @ 1 botol @ 100 mi sirup No. Reg. DTL0920936637A1

    P No 1 
    Awas Obat Keras 
    Bacalah aturan memakainya

    INDOFARMA
    BEKASI - INDONESIA

    Continue reading...

    Monday, May 7, 2012

    Naprex

    Naprex
    Analgesic-Antipyretic
    Paracetamol
    60 mg/0.6 mL Drops
    250 mg/5 mL Suspension

    COMPOSITION
    Naprex Drops
    Each 0.6 mL contains: Paracetamol 60 mg

    Naprex Suspension
    Each 5 mL (1 measuring spoon) contains: Paracetamol 250 mg

    ACTION
    Analgesic-Antipyretic

    • As analgesic - by increasing the pain threshold.
    • As antipyretic - by working directly on the pain center in hypothalamus.

    INDICATIONS
    To reduce fever and relieve pain, such as headache and toothache.

    DOSAGE (3 - 4 times a day)
    Age
    Naprex Drops
    60 mg/ 0.6 mL
    Naprex Suspension
    250 mg/ 5 mL
         If necessary every 4 hours per dosage,
         but not more than 5 times a day
       Below 1 year               0.6 mL (60 mg)
       1 - 2 years     0.6 - 1.2 mL (60 - 120 mg)
       2 - 6 years   2.5 mL
       (½ measuring spoon)
       6 - 12 years   5-10 mL
       (1 - 2 measuring spoons)
    Or as prescribed by the physician

    CONTRAINDICATIONS

    • Patients with serious liver dysfunction.
    • Patients with hypersensitivity to any component of this drug.

    SIDE EFFECTS

    • Overdose and long term usage might lead to liver dysfunction.
    • Hypersensitivity reaction.

    PRECAUTIONS
    • Caution to patients with renal impairment.
    • If fever persists after 2 days of medication or if pain is not relieved within 5 days after medication, consult a physician or health care unit immediately.
    • Alcohol can increase the risk of liver dysfunction.
    • Do not exceed the recommended dose as it may lead to liver dysfunction.
    PRESENTATIONS
    Naprex Drops
    Bottle of 15 mL - Reg. No. DBL0204518236A1

    Naprex Suspension
    Bottle of 60 mL • Reg. No. DBL0304518633A1

    SHAKE WELL BEFORE USING

    STORE AT ROOM TEMPERATURE (25° - 30°C)
    PROTECT FROM LIGHT

    Manufactured by:
    PT Darya-Varia Laboratoria Tbk.
    Gunung Putri,
    Bogor - Indonesia
    PEDIATRICA





    Naprex
    Analgesik-Antipiretik
    Parasetamol
    60 mg/0,6 mL Drops
    250 mg/5 mL Suspensi

    KOMPOSISI
    Naprex Drops
    Setiap 0,6 mL mengandung: Parasetamol 60 mg

    Naprex Suspensi
    Setiap 5 mL (1 sendok takar) mengandung: Parasetamol 250 mg

    CARA KERJA OBAT
    Analgesik-Antipiretik

    • Sebagai analgesik, bekerja dengan meningkatkan ambang rangsang rasa sakit.
    • Sebagai antipiretik, diduga bekeqa langsung pada pusat pengatur panas di hipotalamus.

    INDIKASI
    Untuk menurunkan demam dan meringankan rasa sakit pada keadaan sakit kepala dan sakit gigi.

    ATURAN PAKAI (3 - 4 kali sehari)
    Usia
    Naprex Drops
    60 mg/ 0.6 mL
    Naprex Suspensi
    250 mg/ 5 mL
         Bila perlu satu dosis setiap 4 jam,
         namun tidak lebih dari 5 kali sehari.  
       Di bawah 1 tahun               0.6 mL (60 mg)
       1 - 2 tahun     0.6 - 1.2 mL (60 - 120 mg)
       2 - 6 tahun   2.5 mL
       (½ sendok takar)
       6 - 12 tahun   5-10 mL
       (1 - 2 sendok takar)
    Atau menurut petunjuk dokter.

    KONTRAINDIKASI

    • Penderita dengan gangguan fungsi hati yang berat.
    • Penderita yang hipersensitif terhadap komponen obat ini.

    EFEK SAMPING

    • Penggunaan untuk jangka waktu lama dan dosis besar dapat menyebabkan kerusakan fungsi hati.
    • Reaksi hipersensitifitas. 
    PERINGATAN DAN PERHATIAN
    • Hati-hati penggunaan obat ini pada penderita penyakit ginjal.
    • Bila setelah dua hari demam tidak menurun atau setelah 5 hari nyeri tidak menghilang segera hubungi dokter atau unit pelayanan kesehatan.
    • Penggunaan obat ini pada penderita yang mengkonsumsi alkohol, dapat meningkatkan risiko gangguan fungsi hati.
    • Tidak boleh melebihi dosis yang dianjurkan, karena dapat menyebabkan kerusakan hati.

    KEMASAN
    Naprex Drops
    Botol berisi 15 mL· Reg. No. DBL0204518236A1

    Naprex Suspensi
    Botol berisi 60 mL - Reg. No. DBL0304518633A1

    KOCOK DAHULU SEBELUM DIGUNAKAN

    SIMPAN PADA SUHU KAMAR (25° - 30°C)
    TERLINDUNG DARI CAHAYA

    Diproduksi oleh:
    PT Darya-Varia Laboratoria Tbk.
    Gunung Putri, Bogor - Indonesia
    PEDIATRICA
    Continue reading...

    Sunday, May 6, 2012

    Folamil Genio

    FOLAMIL GENIO
    Soft Capsule

    Composition:
    Each soft capsule contains:
    Folic acid1mg
    Betacarotene  10,000IU
    Vitamin B13mg
    Vitamin B23.4mg
    Nicotinamide 20mg
    Vitamin B62mg
    Calcium D-pantothenate 7.5mg
    Calcium carbonate100mg
    Vitamin B124mcg
    Vitamin D3400IU
    Vitamin K150mcg
    Biotin30mcg
    Copper gluconate0.1mg
    Iron Polymaltose Complex (IPC) 30mg
    DHA (docahexaenoic acid) from algae 40mg
    ARA (arachidonic acid)8mg

    Description:
    FOLAMIL GENIO is a supplement containing DHA, multivitamin and mineral which are needed by pregnant and lactating women. In pregnant woman, DHA and ARA have important role for the development of the nerve system of fetus and to boost growth of fetus's brain. As a food supplement for pregnant and lactating women, it helps to fulfill the requirement of vitamin and mineral for the baby. Addition of multivitamin and mineral are needed because of increased requirements, insufficiency of vitamin and mineral intake or the failure of food absorption.
    Folic acid lowers the risk of neural tube defects. Folate coenzymes play a vital role in DNA metabolism.
    Betacarotene may have antioxidant activity.
    Vitamin B1 plays an essential role in the metabolism of carbohydrates, a major source of energy in our cells.
    Vitamin B2 (riboflavin) is important for energy production and tissue repair. Riboflavin may also work in conjunction with iron for iron-deficiency anemia. Nicotinamide, via its major metabolite NAD+ (nicotinamide adenine dinucleotide), is involved in the production of energy, the synthesis of fatty acids, cholesterol and steroids, signal transduction. It may also have antioxidant activity.
    Vitamin B6 is required by the body to turn iron into hemoglobin, and to produce red blood cells.
    Calcium is useful in maintaining strong, healthy bones. It is involved in blood clotting and the transmission of nerve impulses. It aids in the absorption of many nutrients, especially vitamin B12.
    Vitamin B12 is required for nucleoprotein and myelin synthesis, cell reproduction and the maintenance of erythropoiesis. Vitamin B12 plays a role In blood formation; it is needed to form red blood cells in the marrow.
    Vitamin D3 is important for the absorption of calcium from the stomach and for the functioning of calcium in the body, can be benefit to neonate, helping osteogenesis
    Vitamin K1 has hemostatic activity and may have anti osteoporotic and antioxidant activities.
    Biotin is necessary for the metabolism of carbohydrates, fats and proteins. It may have antioxidant activity.
    Copper may have antioxidant activity. Copper helps our body absorbs and use iron to synthesize hemoglobin. It plays a role in maintaining the integrity of myelin. Iron Polymaltose Complex (IPC) is used as a source of iron for iron deficiency anemia. DHA is the predominant essential fatty acids in the human brain. DHA is vital for the development of the fetus's and infant's brain.
    ARA (arachidonic acid) is a polyunsaturated fatty acid that is present in the phospholipids (especially phosphatidylethanolamine, phosphatidylcholine and phosphatidylinositides) of membranes of the body's cells, and is highly enriched in the brain.

    Usage:
    Supplement of multivitamin and mineral during pregnancy and lactating period, that contains DHA for brain's nutrition.

    Contraindications:
    FOLAMIL GENIO contraindicated in patients hypersensitive to any component of the product.

    Dosage and administration:
    Pregnant and lactating women: 1 soft capsule daily after meal.

    Warning and precautions:
    • Pregnant women and nursing mothers should avoid using FOLAMIL GENIO in a dose greater than suggested dose.
    • Vitamin D should not be used in those with hypercalcemia and vitamin D toxicity, 
    • Supplementary copper should not be used in patients with Wilson's disease (hepatolenticular degeneration), a disease of abnormal copper accumulation, whilst patients with chronic liver and renal failure should exercise extreme caution in the use of copper supplements.
    • Supplementary calcium should not be used in patients with hypercalcemia (conditions causing hypercalcemia include sarcoidosis, hyperparathyroidism, hypervitaminosis D and cancer).
    • Supplementary iron should not be used in patients with iron overload, chronic polyarthritis, bronchial asthma, infectious renal complaints in acute phase, uncontrolled hyperparathyroidism, decompensated hepatic cirrhosis, infectious hepatitis, and during the first trimester of pregnancy.
    • Betacarotene should be used with caution in patients with impaired renal or liver function because safe use of the drug in the presence of these conditions has not been established.
    • Riboflavin absorption is increased in hypothyroidism and decreased in hyperthyroidism.
    • Vitamin B12 should not be used in those With Leber's optic atrophy (a congenital disorder associated with chronic cyanide intoxication [e.g., from tobacco smoke]). Decreased levels of vitamin B12 have been associated with reduced ability to detoxify the cyanide in exposed individuals and vitamin B 12 may increase the risk of irreversible neurological damage from optic atrophy in those affected with the disorder.
    Adverse reactions:
    Serious adverse reactions for using FOLAMIL GENIO soft capsule at commonly recommended dosage have not yet been found.

    Drug interactions:
    • Chronic use of loop diuretics may result in thiamin deficiency. Substances in food (e.g. sulfite, caffeine) may inactivate thiamin. Although the clinical importance is unknown, thiamin reportedly may enhance the effect of neuromuscular blocking agents.
    • Probenecid may inhibit the absorption of riboflavin and also inhibit renal tubular secretion of riboflavin. Use of oral contraceptive agents may result in decreased serum levels of riboflavin.
    • Women, who are taking folic acid supplements, especially if they are current or former users of oral contraceptives, are at risk for lower plasma zinc concentrations. 
    • The use of oral contraceptives may increase vitamin B6 requirements. Chronic and excessive use of alcoholic beverages can result in vitamin B6 deficiency.
    • Metformin may decrease the absorption of vitamin B12; this possible effect may be reversed with oral calcium supplementation. Folic acid may work synergistically with vitamin B12 in lowering homocysteine levels.
    • Supplementary vitamin D should be used cautiously in those on digoxin or any cardiac glycoside. Hypercalcemia in those on digoxin may precipitate cardiac arrhythmias.
    • Broad-spectrum antibiotics may sterilize the bowel and decrease the vitamin K1 contribution to the body by the intestinal microflora. Cephalosporins containing side chains of N-methylthiotetrazole or methylthiadizole can cause vitamin K deficiency and hypoprothrombinemia.
    • Vitamin K1 can antagonize the effect of warfarin; therefore the use of warfarin should be avoided, unless specifically prescribed by physician. Antibiotics may decrease the biotin contribution to the body made by the microflora of the large intestine.
    • No interactions between DHA and aspirin, other NSAIDs or herbs, such as Allium sativum (garlic) have been reported. Such interactions, if they were to occur, might be manifested by nosebleeds and increased susceptibility to bruising.
    Overdosage:
    There are no reports of overdosage.

    Presentations and registration number:
    Box, bottle @ 30 soft capsules, POM SD. 071 329 911

    STORE AT TEMPERATURE 15-25°C, IN A DRY PLACE, PROTECT FROM LIGHT.
    KEEP OUT OF REACH OF CHILDREN.

    Manufactured by:
    PT Nova Chemie Utama
    Jakarta-Indonesia

    For:
    DEXA MEDICA
    JI. Bambang Utoyo 138 Palembang-Indonesia





    FOLAMIL GENIO
    Kapsul Lunak

    Komposisi:
    Tiap kapsul lunak mengandung:
    Folic acid1mg
    Betacarotene  10,000IU
    Vitamin B13mg
    Vitamin B23.4mg
    Nicotinamide 20mg
    Vitamin B62mg
    Calcium D-pantothenate 7.5mg
    Calcium carbonate100mg
    Vitamin B124mcg
    Vitamin D3400IU
    Vitamin K150mcg
    Biotin30mcg
    Copper gluconate0.1mg
    Iron Polymaltose Complex (IPC) 30mg
    DHA (docahexaenoic acid) dari alga  40mg
    ARA (arachidonic acid)8mg


    Uraian:
    FOLAMIL GENIO adalah suplemen yang mengandung DHA, multivitamin dan mineral yang dibutuhkan oleh wanita hamil dan menyusui. Pada wanita hamil, DHA dan ARA mempunyai fungsi utama untuk perkembangan sistem saraf janin dan mendorong perkembangan otak janin, Sebagai suplemen makanan untuk wanita hamil dan menyusui, FOLAMIL GENIO membantu untuk memenuhi kebutuhan vitamin dan mineral untuk bayi. Tambahan multivitamin dan mineral dibutuhkan karena kebutuhan yang meningkat, ketidakcukupan asupan vitamin dan mineral atau kegagalan absorpsi makanan.
    Folic acid menurunkan risiko kerusakan neural tube. Koenzim folat berperan penting pada metabolisme DNA.
    Betacarotene mempunyai aktivitas antioksidan.
    Vitamin B 1 memegang peran penting pada metabolisme karbohidrat, sumber energi utama pada sel kita,
    Vitamin B2 (riboflavin) penting untuk menghasilkan energi dan perbaikan jaringan, Riboflavin juga dapat bekerja bersama dengan besi untuk anemia defisiensi besi. Nicotinamide, melalui metabolit utamanya NAD+ (nicotinamide adenine dinucleotide) terlibat menghasilkan energi, sintesis asam lemak, kolesterol dan steroid, transduksi sinyal. Nicotinamide mungkin juga mempunyai aktivitas antioksidan. Vitamin B6 dibutuhkan oleh tubuh untuk mengubah zat besi menjadi hemoglobin dan menghasilkan sel-sel darah merah.
    Calcium berguna untuk memelihara tulang yang sehat, kuat. Calcium terlibat dalam pembekuan darah dan transmisi impuls saraf. Calcium membantu absorpsi dari banyak nutrien, terutama vitamin B12.
    Vitamin B12 dibutuhkan untuk sintesis nukleoprotein dan mielin, reproduksi sel dan memelihara erythropoiesis. Vitamin B12 memegang peranan penting pada pembentukan darah; vitamin B12 dibutuhkan untuk membentuk sel-sel darah merah dalam sumsum tulang.
    Vitamin D3 penting untuk absorpsi calcium dari lambung dan agar calcium dalam tubuh berfungsi, dapat bermanfaat bagi bayi, membantu pembentukan tulang. Vitamin K1 mempunyai aktivitas hemostatic dan juga mempunyai aktivitas antiosteoporosis dan antioksidan.
    Biotin dibutuhkan untuk melabolisme karbohidrat, lemak dan protein. Biotin mempunyai aktivitas antioksidan.
    Copper mempunyai aktivitas antioksidan. Copper membantu tubuh kila untuk mengabsorpsi dan menggunakan zat besi untuk mensintesis hemoglobin. Copper mempunyai peran untuk memelihara keutuhan mielin.
    Iron Polymaltose Complex (IPC) digunakan sebagai sumber besi untuk anemia defisiensi besi.
    DHA adalah asam lemak esensial utama dalam otak manusia. DHA vital untuk perkembangan otak janin dan bayi.
    ARA (arachidonic acief) adalah polyunsaturatad fatty acid yang ada pada phospholipid (terutarna phosphatidylethanolamine, phosphatidylcholine dan phosphatkJylinositides) dari membran sel tubuh, dan sangat tinggi kadarnya dalam otak.

    Penggunaan:
    Multivitamin dan mineral selama masa kehamilan dan menyusui yang mengandung DHA untuk nutrisi otak.

    Kontraindikasi:
    FOLAMIL GENIO dikontraindikasikan untuk pasien yang hipersensitif terhadap salah satu komponen produk.

    Dosis dan cara pemberian:
    Wanita hamil dan menyusui:
    1 kapsul lunak per hari setelah makan.

    Peringatan dan perhatian:
    • Wanita hamil dan menyusui sebaiknya menghindari menggunakan FOLAMIL GENIO pada dosis yang lebih tinggi daripada dosis yang disarankan
    • Vitamin D sebaiknya tidak digunakan pada pasien dengan hypercalcemia dan toksisitas vitamin D.
    • Suplemen copper sebaiknya tidak digunakan pada pasien dengan penyakit Wilson (hepatolenticular degeneration), suatu penyakit akibat akumulasi copper yang tidak normal, sedangkan pasien dengan gagal hati kronik dan gagal ginjal kronik sebaiknya sangat berhati-hati pada penggunaan suplemen copper. Suplemen calcium sebaiknya tidak digunakan pada pasien dengan hypercalcemia (kondisi yang dapat menyebabkan hypercalcemia termasuk sarcoidosis, hyperparathyroidism, hipervitaminosis D dan kanker).
    • Suplemen besi sebaiknya tidak digunakan pada pasien dengan kelebihan zat besi, polyarthritis kronik, asma bronkial, keiuhan infeksi ginjal pada fase akut, hyperparathyroidism yang tidak terkontrol, sirosis hati yang tidak terkompensasi, infeksi hepatitis, dan selama trimester pertama kehamilan.
    • Betacarotene sebaiknya digunakan dengan hati-hati pada pasien dengan gangguan fungsi ginjal atau hati karena keamanan penggunaan obat ini pada kondisi-kondisi tersebut belum ada.
    • Absorpsi riboflavin meningkat pada hypothyroidism dan menurun pada hyperthyroidism.
    • Vitamin B12 sebaiknya tidak digunakan pada pasien Leber's optic atrophy (kelainan kongenital yang berhubungan dengan intoksikasi cyanida kronik [misalnya dari asap rokok]). Penurunan kadar vitamin B12 diasosiasikan dengan penurunan kemampuan untuk mendetoksifikasi cyanide pada individu yang terpapar dan vitamin B 12 meningkatkan risiko kerusakan saraf irreversible dari atrofi optik pada pasien yang terkena gangguan tersebut.
    Efek samping:
    Belum ada keluhan efek samping yang serius pada penggunaan kapsul lunak FOLAMIL GENIO pada dosis lazim yang direkomendasikan.

    Interaksi obat:

    • Penggunaan loop diuretic kronik menyebabkan defisiensi thiamin. Zat yang terkandung dalam makanan (seperti Sulfit, kafein) dapat menginaktivasi thiamin. Meskipun manfaat klinis belum dikelahui, thiamin dilaporkan meningkatkan efek neuromuscular blocking agent.
    • Probenecid menghambat absorpsi riboflavin dan dapat menghambat sekresi tubular ginjal riboflavin. Penggunaan obat kontrasepsi oral dapat mengakibatkan penurunan kadar serum riboflavin.
    • Wanita, yang menggunakan suplemen asam folat, terutama jika mereka pernah menggunakan atau sedang memakai kontrasepsi oral, mempunyai risiko konsentrasi zinc dalam plasma yang lebih rendah.
    • Penggunaan kontrasepsi oral dapat meningkatkan kebutuhan vitamin B6. Penggunaan alkohol yang kronik dan berlebihan dapat berakibat pada defisiensi vitamin B6.
    • Metformin dapat menurunkan absorpsi vitamin B12; efek ini mungkin dapat dipulihkan dengan pemberian suplemen calcium oral. Folic acid dapat bekerja sinergis dengan vitamin B12 pada penurunan kadar homocysteme.
    • Suplemen vitamin D sebaiknya digunakan dengan hati-hati pada pasien yang menggunakan digoksin atau glikosida jantung lainnya. Hypercalcemia pada pasien yang menggunakan digoksin dapat menimbulkan aritmia jantung:
    • Antibiotik berspektrum luas dapat mensterilkan usus dan menurunkan kontribusi vitamin K1 dari mikroflora usus untuk tubuh. Cephalosporins mengandung rantai samping N-methylthiotetrazole alau methylthiadizole yang dapat menyebabkan defisiensi vitamin K dan hypoprothrombinemia.
    • Vitamin K1 dapat melawan efek warfarin; karena itu penggunaan warfarin. sebaiknya dihindari, kecuali bila diresepkan secara spesifik oleh dokter.
    • Antibiotik dapat menurunkan kontribusi biotin dari mikroflora usus besar untuk tubuh.
    • Tidak ada interaksi antara DHA dan aspirin, NSAIDs lainnya atau herbs, seperti Allium sativum (bawang putih) yang telah dilaporkan. Interaksi seperti itu, jika terjadi dapat timbul berupa mimisan dan meningkatnya kerentanan untuk memar.

    Overdosis:
    Tidak ada laporan terjadinya overdosis.

    Kemasan dan nomor registrasi:
    Kotak, botol @ 30 kapsul lunak, POM SD. 071 329 911

    SIMPAN PADA SUHU 15-25°C, DI TEMPAT KERING, TERLINDUNG DARI CAHAYA. JAUHKAN DARI JANGKAUAN ANAK-ANAK.

    Dibuat oleh:
    PT Nova Chemie Utama
    Jakarta-Indonesia

    Untuk:
    Dexa Medica
    JI. Bambang Utoyo 138 Palembang-Indonesia
    Continue reading...

    Saturday, May 5, 2012

    Nutrimama 2

    NUTRIMAMA® 2

    KOMPOSISI/ COMPOSITION :
    Folic acid800   mcg                Vitamin B124     mcg
    FOS50mgVitamin C100mg
    Tuna Oil200mgVitamin D        400iu
        - Omega - 3    70mgCa Panthotenat7.5mg
        - DHA52mgFe25mg
        - EPA13mgMagnesium100mg
    Vitamin A     5000iuNiacinamide20mg
    Vitamin B110mgPotassium Yodide        0.1mg
    Vitamin B22,5mgSodium Fluoride1mg
    Vitamin B615mgZinc7.5mg


    INFORMASI NILAI GIZI / Nutritional Informatian:
    Takaran saji per 1 kapsul lunak/ Dish dosage a day 1 softgel
    Jumlah sajian perkemasan 30 kapsul lunak/ Total dish each box 30 softgels
    Nilai Gizi / Nutritional Value
    Per Takaran Saji / Each Dish Dosage       %AKG
    Folic acid800mcg200
    Vitamin A5000iu500.5
    Vitamin B110mg833.33
    Vitamin B22.5mg192.307
    Vitamin B615mg1153.846
    Vitamin B12 4mcg166.666
    Vitamin C100mg166.66
    Vitamin D400iu200
    Fe25mg86.206
    Niacinamide20mg125
    Magnesium100mg38.461
    Potassium Yodide0.1mg0.0028
    Sodium Fluoride1mg0.0416
    Zinc7.5mg71.428

    % AKG berdasarkan diet pada 2000 kalori/
    % AKG for adult base on 2000 kcal dietry

    URAIAN/ Description :

    Nutrimama 2 tidak hanya mengandung vitamin dan mineral yang dibutuhkan sebagai nutrisi tetapi juga DHA dan EPA untuk pertumbuhan otak bayi.
    Nutrimama 2 not only contain vitamin and mineral as need as nutrition but also contain of DHA and EPA for baby's brain growth. 

    KEGUNAAN/ Usage: 
    Nutrimama 2 membantu memenuhi kebutuhan vitamin, mineral dan asam folat pada masa prenatal (kehamilan) trimester kedua.
    Nutrimama 2 helping to complete of vitamin, mineral and folic acid at second pregnancy trimester (on prenatal phase).

    PERHATIAN DAN PERINGATAN/ Warning: 
    Efek samping Feses berwarna hitam. Jangan diberikan pada pasien yang mengalami transfusi darah berulang atau anemia yang bukan dikarenakan kekurangan zat besi.
    The side effect may cause black fesses. Do not give for patient which getting repeat blood transfusion or anemia caused by less iron intake also.

    PETUNJUK PEMAKAIAN/ Direction : 
    1 kali sehari 1 kapsul lunak atau sesuai petunjuk dokter.
    1 softgel a day or as doctor recommendation. 

    KEMASAN/ Package : 
    4 Blister @ 4 kapsul lunak.
    4 Blister @ 4 softgels. 

    Diproduksi oleh/ Manufactured by: 
    PT. Nova Chemie Utama
    Jakarta - Indonesia

    Dipasarkan oleh/ Marketed by :
    Nutrindo
    Jakarta - Indonesia
    POM SD. 071 330 771
    Continue reading...
     

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