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Friday, July 31, 2009

Legreskin

Antioxidant and essential skin nutrients
Komposisi:
Tiap kaplet salut selaput mengandung :
% AKG*
Marine protein extract250 mg-
Collagen100 mg-
Vitamin E280 iu1000
Leucoselect phytosome100 mg-
Lycopene 5 % 10 mg-
* % AKG berdasarkan pada diet 2000 kkal.


Khasiat dan kegunaan :
Untuk memelihara kesehatan kulit.

Efek samping:
Tidak ada efek samping yang dilaporkan. Hentikan penggunaan jika timbul reaksi alergi (gatal, kemerahan) pada kulit.

Takaran Pemakaian :
Sehari 1-2 kaplet salut selaput.

Kemasan :
Dus @ 30 kaplet salut selaput
( 5 strip @ 6 kaplet salut selaput)
POM SD 051 521 491

SIMPAN DI BAWAH SUHU 30° C
TERLINDUNG DARI CAHAYA

PT SOHO INDUSTRI PHARMASI
Jl. Pulogadung No. 6
JAKARTA - INDONESIA
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Biochosil

KOMPOSISI
Silybum Marianum Extract35 mg
Curcuma Xanthorrhiza Extract10 mg
Phosphatidyl Choline300 mg

KHASIAT
Memelihara kesehatan fungsi hati.

URAIAN
BIOCHOSIL kapsul mengandung Ekstrak Silybum Marianum, Curcuma Xanthorrhiza dan Phosphatidyl Choline yang berfungsi untuk memelihara kesehatan fungsi hati. Kombinasi tersebut bekerja sinergis dalam regenerasi membran dan sel-sel hati, sehingga dapat mencegah terjadinya gangguan-gangguan fungsi hati.

KONTRAINDIKASI
Hipersensitif terhadap Silybum Marianum dan Curcuma Xanthorrhiza.

CARA PEMAKAIAN
3 kali sehari, 1 - 2 kapsul

KEMASAN
Box, 5 strips@ 6 capsules
POM SD, 041 317 821

SIMPAN Dl TEPAT SEJUK DAN KERING

PT. BIOVIT NUTRACEUTICAL FARMA
Jakarta-INDONESIA
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Thursday, July 30, 2009

Trolit

Komposisi:

Per Sachet % AKG
Angkak250 mg-
Ekstrak Psidii folium250 mg-
NaCl280 mg-
KCl10 mg-
Sodium Citrate 290 mg-
Dextrose 2187 mg-
Vitamin B1 1,2 mg119,92%
Vitamin B2 Sodium phosphate 1,3 mg107,52%
Vitamin B61,3mg 121,67%
Vitamin B12 2,4 mcg-
Zinc Gluconate 35 mg-
Acesulfame-K, Sweta, Ponceau 4R CI 16255, Flavour.

Uraian :
Trolit digunakan untuk membantu mengembalikan cairan tubuh dan elektrolit yang hilang pada kasus dimana diperlukan rehidrasi.

Kegunaan:
Membantu memperbaiki daya tahan tubuh serta membantu mengembalikan cairan tubuh dan elektrolit yang hilang.

Petunjuk Pemakaian :
Larutkan 1 sachet Trolit dalam 200 ml air, aduk dan siap diminum.
Maksimal 6 sachet per hari.

Kemasan :
Serbuk dalam sachet.
Tiap dus mengandung 6 sachet Trolit.

POM SD. 041 216 261

Simpan pada suhu kamar (maks. 30°C).
Suplemen Makanan.

Diproduksi oleh :
PT. BINTANG TOEDJOE
Jakarta-Indonesia
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Wednesday, July 29, 2009

Agulan

AGULAN®
ticlopidine hydrochloride

Film Coated tablet

COMPOSITION
Each film coated tablet contains:
ticlopidine hydrochloride ..................... 250 mg

PHARMACOLOGY
The ticlopidine inhibition activity at aggregation is to suppress all platelet activity level by:
  • Reducing platelet adherence.
  • Inhibiting platelet aggregation.
  • Inhibiting platelet granule constituents release.
  • Inducing the increase of disaggregation.
In a biological manner, these characteristics show an increase in bleeding time, without influence coagulation test. Antithrombotic effects of ticlopidine have been established both on experimental models and clinically in humans.

INDICATION
Pathological process including thrombogenic risks in patients who can not tolerate aspirin.

DOSAGE AND ADMINISTRATION
For oral use.
Doctor's prescription should be strictly followed.
Dosage: 1 tablet, 1 or 2 times daily after meal.

WARNING AND PRECAUTIONS
  • Avoid concomitant used of aspirin or anticoagulant without specific monitoring.
  • Physicians or dentists should be informed that their patients is in ticlopidine therapy before surgery or tooth extraction.
  • Consult the doctor if bleeding or hematoma occurs.
  • Discontinue therapy in the event of fever, sore throat or mouth ulcerations. Further treatment will be decided by the physician after performing blood count evaluation.
  • Avoid using ticlopidine for pregnant women, nursing mothers and children.
  • Hematological evaluation should be performed periodically.
SIDE EFFECTS
  • Minor gastrointestinal disorders.
  • Skin allergic reactions.
  • Agranulocytosis, thrombopenia or medullary aplasia such as in cholestatic icterus with or without elevated transaminase.
CONTRAINDICATIONS
  • Hemopathies and hemorrhagic diathesis where bleeding time is prolonged.
  • Organic lessions such as active ulcers or acute hemorrhagic strokes.
  • Known hypersensitivity to ticlopidine.
  • History of leukopenia, thrombopenia and agranulocytosis.
ON DOCTOR'S PRESCRIPTION ONLY
Store at 25° - 30° C

PRESENTATION
Box of 2 strips of 10 film coated tablet.
Reg. No. :DKL 9904513417A1

Manufactured by:
PT Prafa
Citeureup, Bogor-lndonesia
For:
Darya-Varia LABORATORIA
Gunung Putri, Bogor - Indonesia


AGULAN®
ticlopidine hydrochloride
Tablet salut selaput

KOMPOSISI
Tiap tablet salut selaput terdiri dari:
ticlopidine hydrochloride ..................... 250 mg

FARMAKOLOGI
Aktifitas penghambat dari ticlopidine pada aggregasi adalah menekan semua tingkat aktifitas platelet:
  • Mengurangi pelekatan.
  • Menghambat aggregasi.
  • Menghambat pelepasan.
  • Menginduksi peningkatan disaggregasi.
Secara hayati, sifat-sifat ini menggambarkan peningkatan waktu pendarahan, dengan tidak mempengaruhi tes-tes koagulasi. Efek antithrombotik dari ticlopidine telah dibuktikan pada hewan percobaan dan pasien manusia.

INDIKASI
Proses patologi meliputi resiko thrombogenik, pada pasien yang tidak dapat menerima aspirin.

POSOLOGI
Untuk pemakaian oral.
Resep dokter harus benar-benar ditaati.
Dosis: 1 tablet, 1 atau 2 kali sehari selama waktu makan.

PERINGATAN DAN PERHATIAN
  • Hindari penggunaan bersama-sama dengan antikoagulan atau aspirin tanpa pengawasan khusus.
  • Sebelum operasi pembedahan atau pencabutan gigi, beritahukan kepada ahli bedah bahwa pasien sedang dalam terapi ticlopidine.
  • Beritahukan kepada dokter yang merawat bila terjadi pendarahan atau kejadian hematoma.
  • Pada saat demam, luka tenggorokan atau tukak mulut, obat sebaiknya dihentikan dan tindakan lanjut akan diputuskan oleh dokter dengan melaporkan hasil hitung darah.
  • Hindari pemakaian ticlopidine pada wanita hamil, ibu menyusui dan anak-anak.
  • Sebaiknya dilakukan pengawasan hematologi secara rutin.

EFEK SAMPING
  • Gangguan fungsi minor yang mempengaruhi sistem gastrointestinal.
  • Alergi kulit
  • Agranulositosis, thrombopenia, atau aplasia medular, seperti pada kasus-kasus ikterus kolestatik dan atau kenaikan transaminase.
KONTRAINDIKASI
- Hemopatik dan hemorrhagik diatesis dimana waktu pendarahan meningkat.
- Luka-luka seperti tukak lambung atau stroke hemorrhagik akut.
- Riwayat penyakit alergi terhadap ticlopidine.
- Riwayat penyakit leukopenia, thrombopenia dan agranulositis.

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

KEMASAN
Box isi 2 strip @ 10 tablet salut selaput
Reg. No. : DKL 9904513417A1

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

Acetosal, Glycine
Oral Dispersible Tablet

Cardiovascular Risk
  • NSAIDs may cause increased risk of serious cardiovascular thrombotic events, Myocardial infarction and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk (see PRECAUTIONS AND WARNINGS).
  • PROXIME® oral dispersible tablet is contraindicated for the treatment of peri-operative pain in coronary bypass surgery (see PRECAUTIONS AND WARNINGS).
Gastrointestinal Risk
  • NSAlDs cause an increased risk of serious gastrointestinal adverse reactions including bleeding, ulceration and perforation of the stomach or intestines, which can be fatal. These reactions can occur at any time during use, without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal adverse reactions (see PRECAUTIONS AND WARNINGS).
Each oral dispersible tablet contains:
Acetosal .............................................. 100 mg
Glycine ................................................ 45 mg

PHARMACOLOGY
Acetosal inhibits cyclooxygenase enzyme activity. This reaction is probably caused by irreversible acetylation process. This inhibition activity prevents the formation of thromboxane A2, a vasoconstrictor agent which induces platelet aggregation that may cause blood clotting. It prevents formation of prostacyclin which is a vasodilator and inhibits platelet aggregation in the blood vessel walls.

INDICATIONS
As prevention of Myocardial infarct, unstable angina or transient ischemic attacks (TIA).

CONTRA-INDICATIONS
  • Patients with allergy (including asthma), peptic ulcer or those who are ever or often experiencing hemorrhage beneath the skin (on medical advice).
  • Patients with anticoagulant therapy (on medical advice).
  • Patients with hemophilia and thrombocytopenia.
  • Do not use this drug for patients with chicken pox and flu symptoms.
  • Patients with known hypersensitivity to any of the ingredients.
  • Children under 12 years of age.
ADVERSE REACTIONS
  • Gastric irritation, nausea and vomiting.
  • Long term use may cause gastrointestinal bleeding and gastritis.
  • Hypersensitivity reactions (dyspnea attack, dermatitis).
  • Thrombocytopenia.
PRECAUTIONS AND WARNINGS
  • Caution should be taken on patients with impaired liver function, pregnancy and lactating mothers, or dehydration. Do not use for patients in the last trimester of pregnancy.
  • Consult with medical doctor before using this drug on patients with anticoagulant therapy.
  • Should be taken with food or after meals.
  • If tinnitus, hearing disorders and dizziness occurred, discontinue the therapy,
  • If there were manifestation of permanent gastric disorders, consult to medical doctor.
  • Using this drug with alcohol may increase the risk of gastric bleeding.
Cardiovascular Effects
Cardiovascular thrombotic events
Clinical trials with various selective COX-2 and non-selective NSAIDs for 3 years has shown increase risk of cardiovascular thrombotic events, myocard infarction and stroke which can be fatal. NSAIDs. both selective and non-selective COX-2, may cause similar risk. The risk may be greater on patients with known cardiovascular disease or risk factors for cardiovasculardisease. To reduce the risk of adverse reactions, NSAIDs should be given wtth the lowest effective dose and shortest duration possible. Medical doctors and patients should remain alert for the development of the adverse reactions, although there were no cardiovascular symptoms before. Patients should be given the information about the signs and/or symptoms of serious cardiovascular effects and the way that should be taken if that symptoms occur.
It has not been clinically established that concurrent use of Acetosal may reduce the increased risk of cardiovascular thrombotic events associated with NSAIDs, Concurrent use of NSAIDs with Acetosal does increase risk of gastrointestinal side effects (see WARNING Gastrointestinal Tract).
Two large, controlled, clinical trials of a selective COX-2 NSAIDs for the treatment of pain in the first 10 -14 days following coronary bypass surgery found an increased incidence of Myocardial infarction and stroke (see CONTRA-INDICATIONS).

Hypertension
NSAIDs including PROXIME® oral dispersible tablet, may lead to the onset of new hypertension or worsening of pre-existing hypertension, which may cause the increased incidence of cardiovascular events. NSAIDs may reduce antihypertension effects of thiazid and strong diuretics. NSAIDs including PROXIME® oral dispersible tablet should be used with caution in patients with hypertension. Blood pressure should be closely monitored during the initiation of therapy and throughout the course of therapy.

Congestive heart failure and edema
Fluid retention and edema have been observed in some patients taking NSAIDs. Therefore, PROXIME® oral dispersible tablet should be used with caution in patients with fluid retention or heart failure.

Gastrointestinal Effects
Risk of ulceration, bleeding anda perforation
NSAIDs including PROXIME® oral dispersible tablet can cause serious gastrointestinal events including inflammation, bleeding, ulceration and perforation of the stomach and intestine, which may be fatal. This serious doverse reactions can occur at any time, with or without warning symptoms. Only one in flve patients who developed a serious upper gastrointestinal adverse reactions showed the symptoms. Ulcer in the upper gastrointestinal tract, bleeding or perforation caused by NSAIDs were occured on 1 of the patients treated for 3 - 6 months and 2 - 4 of patients treated for one year. Longer duration of use may increase the likelihood of developing serious gastrointestinal adverse reactions. However, even short-term therapy is not without risk.
NSAIDs should be prescribed with extreme caution in patients with a prior history of ulcer disease or gastrointestinal bleeding. Patients with a prior hystory of ulcer disease and/or gastrointestinal bleeding who use NSAIDs have 10-fold increased risk for developing a gastrointestinal bleed compared to patients without either of these risk factors.
Other factors that increase the risk of gastrointestinal bleeding include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAIDs therapy, smoking, use of alcohol, older age and poor general health status. Most spontaneous reports of fatal gastrointestinal events are in elderly or debilitated patients. Therefore, special care should be taken in treating this population.
To reduce the risk for gastrointestinal adverse reactions in patients treated with NSAIDs. the lowest effective dose should be used for the shortest possible duration. Medical doctors and patients should remain alert for signs and symptoms of gastrointestinal ulceration and
bleeding during therapy with NSAIDs. If a serious gastrointestinal adverse reaction is suspected. Immediately initiate additional evaluation and treatment. For high-risk patients, alternate therapies that do not involve NSAIDs should be considered.

DRUG INTERACTIONS
  • Do not used concurrently with oral anticoagulants since it may increase anticoagulants activity.
  • High dose Acetosal may increase oral hypoglycemic effect especially chlorpropamid.
  • Do not use concurrently with corticosteroids or other NSAIDs because this may increase bleeding or lead to decreased renal function,
  • Concurrent use with spironolactone, furosemide and uricosuric reduce the effect of the drug.
DOSAGES
  • Adult: 1 tablet daily.
  • Myocardial infarction; Up to a maximum dose of 300 mg daily.
  • TIA: Up to a maximum dose of 1000 mg daily.
Usage
Disperse PROXIME® oral dispersible tablet on patient's tongue without water.
PROXIME® oral dispersible tablet has a pleasant taste and is easy to be swallowed. If you preferred, PROXIME® oral dispersible tablet can be swallowed wholly with water.

OVERDOSAGES
  • Salicylate in the stomach is eliminated by induction of vomiting or gastric emptying, followed by administration of activated charcoal in order to remove the salicylate and prevent absorbtion.
  • The administration of activated charcoal every 4 or 6 hours may increase clearance rate.
ON MEDICAL PRESCRIPTION ONLY

PRESENTATIONS
Box of 3 strips @ 10 tablets,
Reg. No.: DKL0722244581A1

STORAGE
Keep in a cool (15°-25°C) and dry place.

Manufactured by:
PT SANBE FABMA
Bandung - Indonesia

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Danalgin

Metampiron
Diazepam

Komposisi :
Tiap kaplet mengandung
Metampiron ... 500 mg
Diazepam ........ 2 mg

Farmakologi :
DANALGIN bekerja sebagai analgetik dan tranquillizer.
Metampiron bekerja sebagai analgetik, diabsorpsi dari saluran pencernaan dan mempunyai waktu paruh 1 - 4 jam.
Diazepam dimetabolisme terutama di hati dan terikat pada reseptor di daerah spinal cort, serebelum, sistem limbik dan korteks serebral. Mempunyai aktivitas sebagai ansiolitik dan hipnotik. Konsentrasi plasma puncak diazepam dicapai setelah 15-19 menit. Waktu paruh bervariasi antara 20-70 jam, tetapi metabolit aktif yang dominan yaitu desmetil diazepam mempunyai waktu paruh 30-100 jam. Waktu paruh diazepam dan desmetil diazepam biasanya meningkat pada neonatus, usia lanjut dan penderita dengan gangguan hati yang berat.

Indikasi:
Untuk meringankan rasa sakit sedang sampai berat terutama nyeri kolik dan sakit setelah operasi dimana diperlukan kombinasi dengan tranquillizer.

Kontra indikasi:
  • Penderita hipersensitif.
  • Bayi dibawah 6 bulan.
  • Wanita hamil dan menyusui.
  • Penderita dengan tekanan darah sistolik ‹ 100 mmHg.
  • Depresi pernapasan.
  • Gangguan pulmoner akut.
  • Glaukoma sudut sempit.
  • Keadaan psikosis akut.
Peringatan dan perhatian :
  • Jangan mengemudikan kendaraan atau menjalankan mesin selama minum obat ini.
  • Tidak untuk mengobati sakit otot pada gejala-gejala flu dan tidak untuk mengobati rematik, lumbago, sakit punggung, bursitis, sindroma bahu-lengan.
  • Karena dapat menimbulkan agranulositosis yang berakibat fatal, maka sebaiknya tidak digunakan dalam jangka panjang terus menerus.
  • Hati-hati pada penderita yang pernah mengalami gangguan pembentukan darah/kelainan darah, gangguan fungsi hati atau ginjal. Karena itu perlu dilakukan pemeriksaan uji fungsi hati dan darah pada penggunaan yang lebih lama dari penggunaan untuk mengatasi rasa sakit akut.
  • Hati-hati penggunaan pada penderita depresi berat atau yang mempunyai kecenderungan melakukan bunuh diri.
  • Obat ini dapat menyebabkan kelemahan otot dan ketergantungan secara fisik dan psikologis.
  • Hentikan pengobatan Jika terjadi reaksi-reaksi paradoksikal seperti keadaan-keadaan hipereksitasi akut, ansietas, halusinasi dan gangguan tidur.
Efek samping :
  • Reaksi hipersensitivitas : reaksi pada kulit misal kemerahan.
  • Mengantuk, ataksia, kelelahan.
  • Agranulositosis, konstipasi, depresi, diplopia, hipotensi, Jaundice, perubahan libido, mual, tremor, retensi urin, vertigo.
Interaksi obat:
Penggunaan bersama obat-obat depresan SSP atau alkohol dapat meningkatkan efek depresan.

Dosis :
Jika sakit 1 kaplet, berikutnya 1 kaplet tiap 6-8 jam, maksimum 4 kaplet sehari.

Kemasan:
Kotak berisi 10 strip x 10 kaplet.Reg.No. DPL8804405304A1
Kotak berisi 50 strip x 10 kaplet.Reg.No. DPL8804405304A1
Kaleng berisi 500 kaplet.Reg. No. DPL8804405304A1
Botol berisi 75 kaplet.Reg. No. DPL8804405304A1


Simpan pada suhu kamar (maks. 30°C).
HARUS DENGAN RESEP DOKTER

PT DANKOS FARMA, JAKARTA-INDONESIA
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Permyo

Komposisi:
Tiap tablet salut gula mengandung:
Eperisone HCl ................ 50 mg

Tiap tablet salut selaput mengandung:
Eperisone HCl ................ 50 mg

Farmakologi:
Eperisone HCl merupakan relaksan otot skeletal yang bekerja pada susunan syaraf pusat dan dapat meningkatkan aliran darah yang disebabkan efek dilatasinya pada otot polos vaskular.
Eperisone HCl dapat mengganggu terjadinya myotonia. Kerjanya terutama pada syaraf spinal, menghambat refleks spinal dan mengurangi sensitifitas otot melalui pengaruhnya terhadap τ efferents fibers.
Eperisone HCl juga memiliki efek terhadap vasodilatasi dan meningkatkan sirkulasi darah.

Indikasi:
Pengobatan simptomatik terhadap keadaan yong berhubungan dengan spasme muskutoskeletal,

Kontraindikasi:
  • Hipersensitif terhadap eperisone HCl.
  • Ibu yang sedang menyusui.
Dosis:
Dewasa
Dosis : 1 tablet 3 kali sehari setelah makan.
Dosis harus disesuaikan dengan umur pasien dan kondisi penyakitnya.

Efek samping:
  • Terhadap hati: gangguan fungsi hati kadang-kadang dapat terjadi, awasi keadaan fungsi hati.
  • Terhadap ginjal: hentikan pengobatan bila timbul kelainan.
  • Terhadap darah: jumlah eritrosit dan hemoglobin kadang-kadang dapat terjadi abnormal. Pemeriksaan darah dan tindakan lainnya harus diperhatikan, Hentikan pengobatan bila timbul kelainan,
  • Dermatologi: ruam kulit.
  • Psikoneurotik: insomnia, sakit kepala, mengantuk, kekakuan, rasa baal, gemetar pada anggota gerak,
  • Gastrointestinal: mual, muntah, anoreksia, perasaan tidak enak pada lambung, mulut kering, konstipasi, diare, nyeri abdomen, rasa penuh di abdomen, feses yong lunak atau gejala gangguan gastrointestinal lain kadang-kadang dapat terjadi.
Peringatan perhatian:
  • Hentikan pemberian obat ini atau dosis diturunkan bila terjadi gejala lemas, pusing, mengantuk.
  • Pasien yang minum obat ini sebaiknya tidak menjalankan mesin atau mengendarai kendaraan.
  • Hati-hati pemberian obat ini pada pasien gangguan fungsi hati.
  • Keamanan eperisone HCl pada ibu hamil dan anak-anak belum jelas.
  • Sebaiknya pemberian obat ini pada ibu hamil bila keuntungan terapeutik lebih besar dari resiko terhadap janin.
Interaksi obat:
Bila pemberian obat ini dikombinasi dengan methokarbamol dan tolperison HCl dapat menyebabkan gangguan pada akomodosi okular.

Kemasan dan Nomor Registrasi:
PERMYO® tablet salut gula:
Kotak, 10 strip @ 10 tablet salut gula, DKL9805026016A1
Kotak, 5 strip @ 10 tablet salut gula, DKL9805026016A1

PERMYO® tablet salut selaput:
Kotak, 5 strip @ 10 tablet salut selaput, DKL0205031117A1

HARUS DENGAN RESEP DOKTER.

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

Diproduksi oleh:
PT DEXA MEDICA
Palembang-lndonesia

Dipasarkan oleh:
PT FERRON PAR PHARMACEUTICALS
Cikarang-Indonesia
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Kedacillin

KEDACILLIN® for Injection
SODIUM SULBENICILLIN

Composition
KEDACILLIN for Injection is available in 1 g and 2 g vials, each of which contains :
The disodium salt equivalent to Sulbenicillin 1 g and 2 g (potency) respectively.
Sulbenicillin is a antibiotic, chemically 6 (2 - phenyl - 2 - sulphoacetamido) penicillanic acid.

Actions
  1. Sulbenicillin is effective against gram-negative bacteria, including Pseudomonas aeruginosa and anaerobic Bacteroides, and is also effective against gram-positive bacteria sensitive to Penicillin - G.
  2. Sulbenicillin is excreted into the urine and bile in high concentration.
    Therefore, urinary levels, well above those required to eradicate urinary pathogens, are achieved.
Indications
It is indicated the following infections due to Sulbenicillin susceptible Pseudomonas aeruginosa, Proteus, Retgerella, Klebsiella, Enterobacter, E. coli, Citrobacter cloacae, Pfeiffer's bacilli, Staphylococci, Streptococci, Pneumococcus and Bacteroides.
  • Urinary tract infections : pyelonephritis, pyelitis, pyonephrosis, cystitis and urethritis.
  • Bile-duct infections : cholecystitis and cholangitis.
  • Respiratory tract infections : acute and chronic bronchitis, bronchiectasis, bronchopneumonia, pneumonia and pulmonary suppuration.
  • Obstetrics and Gynecology : intrauterine infection, adnexitis, intrapelvic infection and Bartholinitis.
  • Otorhinological infections : otitis media, sinusitis, parotitis, submaxillitis, furuncle of the ear and furuncle of the nose.
  • Superfacial suppurative diseases : folliculitis, furuncle, carbuncle, abscess, panaris, phlegmon, tonsilitis, peritonsilitis, peritonsillar abscess, erysipelas, ophthalmia, blepharitis, corneal ulcer, dacryocystitis, stye, post-operative wound infection and traumatic and burn infections.
  • Peritonitis.
  • Septicemia and sub-acute bacterial endocarditis.
Administration and Dosage
  • Usually, 2-4 g daily for adults or 40-80 mg/kg body weight daily for children, intravenously, divided into two to four doses.
  • For severe and intractable infections caused by Pseudomonas aeruginosa and Proteus, increase the intravenous daily dose up to 20 g for adults or up to 400 mg/kg body weight for children, including new-born infants, according to condition. For septicemia and pneumonia patients, whose defensive power against infections if reduced by leucopenia, increase the intravenous daily dose up to 30 g.
  • For intravenous injection, dissolve each 1 g of the product in 20 ml distilled water for injection or glucose solution for injection. If the single dose becomes over 5 g, dissolve in 100 to 500 ml of solution for infusion and administer by intravenous drip over 1 to 2 hours.
  • For intramuscular use, KEDACILLIN (1 g in 3 ml) may be given intramuscularly but causes pain similar to other injectable Penicillins. For intramuscular use, a local anaesthetic such as Lidocaine or Mepivacaine must be included.
  • The solution may become warm due to heat of dissolution but quality is not affected.
Contraindication
KEDACILLIN must not be administered to patients with known hypersensitivity to Penicillin.

Side effects
Though very rare, side effects such as gastrointestinal disturbance, eruption, eyelid edema, fever, facial pallor and intradermal positive reaction are likely to be observed as with other synthetic Penicillins.

Precautions
  1. If the patient or his family has a history of allergic conditions such as bronchial asthma, eruption and urticaria, KEDACILLIN should be given cautiously. Anaphylactic reaction has been reported following administration of antibiotics of the Penicillin series.
  2. KEDACILLIN should be administered carefully to patients with severe renal or hepatic damage.
  3. As KEDACILLIN contains 4,8 mEq/g (potency) of sodium, KEDACILLIN should be given carefully by measuring electrolyte concentration periodically when the administration of high dosage for long term is required to the patients with cardiac or renal Insufficiency and hypertension.
  4. Periodical examination of hepatic or renal function and blood picture is desirable since KEDACILLIN may increase SGOT, SGPT and BUN, and decrease erythrocyte and leucocyte.
Store at room temperature (25-30°C).

Package
Box, 10 vials @ 1 g,
Box, 10 vials @ 2 g,

1 g, Reg.No. DKL7225100444B1.
2 g, Reg. No. DKL8625100444A1.

ON MEDICAL PRESCRIPTION ONLY

Manufactured by PT. Meiji Indonesia, Bangil
For PT. Takeda Indonesia, Bekasi, Indonesia
Licensed by Takeda Pharmaceutical Company Limited, Osaka, Japan


Injeksi KEDACILLIN®
NATRII SULBENICILLINUM

Komposisi
Injeksi KEDACILLIN tersedia dalam vial 1 g dan 2 g, yang masing-masing mengandung : Dinatrii Sulbenicillinum, setara dengan Sulbenicillinum1 g dan 2 g (potensi).
Sulbenicillin adalah suatu antibiotika, dengan nama kimia asam 6 (2 - phenyl - 2 - sulphoacetamido) penicillanic.

Cara kerja
  1. Sulbenicillin berkhasiat terhadap bakteria gram-negatif, termasuk Pseudomonas aeruginosa dan Bacteroides anaerob, dan juga terhadap bakteria gram-positif yang peka terhadap Penisilin - G.
  2. Sulbenicillin mudah dikeluarkan ke dalam urin dan empedu.
    Oleh karena itu, konsentrasi dalam urin lebih dari cukup guna membasmi mikroba patogen dalam urin.
Indikasi
Untuk mengatasi Infeksi-infeksi yang disebabkan oleh bakteri yang peka terhadap Sulbenicillin, yaitu Pseudomonas aeruginosa, Proteus, Retgerella, Klebsiella, Enterobacter, E. coli, Citrobacter cloacae, Pfeiffer's bacilli, Staphylococci, Streptococci, Pneumococcus dan Bacteroides.
  • Infeksi pada saluran kemih : pielonefritis, pielitis, pionefrosis, sistitis dan uretritis.
  • Infeksi pada kelenjar empedu : koleslstitis dan kolangitis.
  • Infeksi pada saluran pemafasan : bronkitis akut dan menahun, bronkiektasis, bronkopneumonia, pneumonia dan paru-paru bernanah.
  • Obstetrik dan ginekologi : infeksi intrauterin, adneksitis, infeksi intrapelvic dan bartolinitis.
  • Infeksi pada daerah telinga dan hidung (Otorhinological infections) : otitis media, sinusitis, parotitis, submaksilitis, furunkel pada telinga dan hidung.
  • Infeksi bernanah pada permukaan : folikulitis, furunkel, karbunkel, abses, panaris, flegmon, tonsilitis, peritonsilitis, abses peritonsilar, erisipelas, oftalmia, blefaritis, ulkus kornea, dakriosistitis, timbil, infeksi pada luka setelah operasi atau luka bakar.
  • Peritonitis.
  • Septikemia dan sub-akut endokarditis karena bakteri.
Cara pemakaian dan dosis
  • Dosis yang biasa untuk orang dewasa adalah 2-4 g sedangkan untuk anak-anak 40-80 mg/kg berat badan, diberikan terbagi dalam 2-4 kali sehari, secara intravena.
  • Untuk infeksi yang parah, disebabkan oleh Pseudomonas aeruginosa dan Proteus, dosis dapat dinaikkan seharinya menjadi 20 g untuk dewasa dan 400 mg/kg berat badan, untuk anak-anak, termasuk juga bayi yang baru lahir, sesuai dengan kondisi badan. Bagi penderita septikemia dan pneumonia, yang daya tahannya menurun akibat dari leukopenia, dosis dapat dinaikkan seharinya menjadi 30 g.
  • Untuk pemakaian secara intravena, larutkan tiap 1 g KEDACILLIN ke dalam 20 ml air suling untuk injeksi atau larutan glukosa untuk injeksi. Apabila dosis tunggal menjadi 5 g atau lebih, larutkan ke dalam larutan infus sebanyak 100-500 ml dan berikan secara drip intravena selama 1-2 jam.
  • Untuk pemakaian secara intramuskular: KEDACILLIN (1 g dalam 3 ml) dapat diberikan secara i.m., tetapi seperti juga preparat-preparat Penisilin lainnya, akan terasa nyeri. Untuk ini sebaiknya ditambahkan anestetika lokal, misalnya lidokain atau mepivakain.
  • Sewaktu melarutkan KEDACILLIN, akan timbul panas, akan tetapi tidak akan mempengaruhi kualitas obat.
Kontraindikasi
KEDACILLIN tidak boleh diberikan kepada pasien yang hipersensitif terhadap Penisilin.

Efek samping
Walaupun jarang, efek samping seperti gangguan pada lambung dan usus, erupsi, edema kelopak mata, demam, wajah pucat dan reaksi intradermal positif, dapat terjadi seperti juga dengan Penisilin sintetik lainnya.

Perhatian
  1. Kalau pasien atau keluarganya pernah mempunyai penyakit alergi, seperti asma bronkial, urtikaria, maka pemberian KEDACILLIN harus hati-hati sekali. Reaksi anafilaktik dilaporkan pemah terjadi setelah pemberian antibiotika golongan Penisilin.
  2. KEDACILLIN juga harus diberikan dengan hati-hati terhadap pasien dengan gangguan ginjal dan hati yang berat.
  3. Karena KEDACILLIN tiap g (potensi) mengandung 4,8 mEq Natrium, apabila pemakaian dosis tinggi dan dalam jangka waktu lama diperlukan bagi pasien yang menderita penyakit jantung, ginjal atau hipertensi, maka harus diberikan hati-hati sekali sambil diukur konsentrasi elektrolitnya secara periodik.
  4. Diperlukan pemeriksaan. secara periodik-teriiadap fungsi hati atau ginjal.dan darah rutin, karena KEDACILLIN dapat menaikkan SGOT, SGPT dan BUN serta menurunkan jumlah eritrosit dan leukosit.
Simpan pada suhu kamar (25-30°C).

Kemasan
Dus, 10 vial@ 1 g.
Dus, 10 vial @2 g.

1 g, No. Reg. DKL7225100444B1.
2g, No. Reg. DKL8625100444A1.

HARUS DENGAN RESEP DOKTER

Dibuat oleh PT. Meiji Indonesia, Bangil
Untuk PT. Takeda Indonesia, Bekasi, Indonesia
Dengan lisensi dari Takeda Pharmaceutical Company Limited, Osaka, Jepang
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Tuesday, July 28, 2009

Kalmoxilin

Composition
Each capsule contains:
Amoxicillin Trihydrate equivalent to Amoxicillin 250 mg
Each caplet contains :
Amoxicillin Trihydrate equivalent to Amoxicillin 500 mg
Each 5 ml of the suspension contains:
Amoxicillin Trihydrate equivalent to Amoxicillin 125 mg
Each 5 ml of the suspension contains :
Amoxicillin Trihydrate equivalent to Amoxicillin 250 mg
Each vial contains:
Sodium Amoxicillin equivalent to Amoxicillin 1000 mg

Pharmacology
Amoxicillin is a semi synthetic derivative of penicillin which is active against Gram-positive and Gram-negative microorganisms.
Excretion is inhibited when is administered with probenecid, which cause prolonged
therapeutic effect.

Capsules, Caplets and Dry Syrup
Amoxicillin is stable in acid gastrointestinal. Amoxicillin is rapidly and welt absorbed through digestive tract, not depend on food availability.
Amoxicillin especially is excreted in unchanged form in urine.

Injection
Administration of 250 mg or 500 mg amoxicillin injection intramuscular, produces serum level about 5.5-10 ug/ml for 60 minutes.
The major route of excretion for amoxicillin injection is through the kidney. In normal renal function about 70 of amoxicillin will be excreted in unchanged form (rapid i.m. and i.v. administration) after 6 hours.

Indications
Amoxicillin injection is given if the oral administration is not possible.
Amoxicillin is indicated for the infections therapy caused by sensitive bactena strain :
  • Skin and soft tissue Infections : Slaphylococcus sp. nonpeniclllinase-producing strains, Streptococcus sp., E. coli,
  • Respiratory tract Infections: Haemophilus intluenzae. Streptococcus sp. including Streptococcus pneumoniae, Slaphylococcus sp. nonpenicillinase-producing strains, E. coli.
  • Urogenital tract infections : E co//, P. mirabilis and Streptococcus faecalis.
  • Gonorrhoea : N. gononrrhoea (nonpenicillinase-producing strains).
Dosage and Administration
Capsules, Caplets and Dry Syrup
  • Adult and Children › 20 kg : 250 - 500 mg every 8 hours.
  • Children ‹ 20 kg : 20 - 40 mg/kg body weight/day in divided dose, every 8 hours.
  • Patient with renal dysfunction, necessary to reduce the dosage, The maximum recommended dose for patient with peritoneal dialysis is 500 mg/day.
  • Gonococcus urethritis : 3 g as a single dose.
Injection
Patients with normal renal function:
  • Upper respiratory tract infections, urogenital tract infections, skin and soft tissue infections:
    • Adult: 250 mg every 6-8 hours, depends on patient's condition.
    • Children (‹ 20 kg): 20 mg/kg/day In divided dose every 6-8 hours.
    • In severe infection, dosage can be increased up to 500 mg every 6 - 8 hours
    • (adult) and 40 mg/kg/day in divided dose every 6-8 hours (children).
  • Lower respiratory tract infections :
    • Adult: 500 mg every 6-8 hours.
    • Children (‹ 20 kg); 40 mg/kg/day in divided dose every 6-8 hours.
  • Bacterial septicemia:
    • Adult: for more serious infections : 1 gram every 6 hours with intermittent i.v.
    • injection or i.v. infuse for 30-60 minutes.
    • Children (‹ 20 kg): 20 - 40 nig/kg every 6 hours.
Patients with renal function Impairment:
Creatinine clearance › 30ml/minuteNo dose adjustment is needed.
Moderate impairment
(Creatinine clearance 10-30ml/minute)
1g injection amoxicillin followed by 500 mg injection amoxicillin 12 hourly.
Severe impairment
(Creatinine clearance ‹ 10ml/minute)
1g injection amoxicillin followed by 500 mg injection amoxicillin 24 hourly.

Warnings and Precautions
  • Careful inquiry should be made in patient with lymphatic leukemia because it can cause hypersensitivity reaction such as skin rash.
  • Severe colitis can be occurred.
  • Before initiating therapy with amoxicillin, sensitivity reaction with penicillin should be tested.
  • Amoxicillin should be used by caution when administered to pregnant and nursing women.
  • Prolonged therapy with amoxicillin should be accompanied with renal, hepatic and hematopoietic function assessment.
  • Superinfection can be occured (usually caused by Enlerobacterium, Pseudomonas, Staphylococcus auraus, Candida). If this case is happened, treatment should be discontinued and others alternative antimicroba is given.
  • Patient with renal dysfunction, plasma and urine level monitoring should be maintained. Dosage adjustment should be taken.
  • Oral amoxicillin is not recommended for meningitis and bone and joint infections because the amoxicillin oral cannot penetrate In cerebrospinal and sinovial liquid.
  • Injection amoxicillin should not be mixed with blood products or other proteinaceous fluids, e.g. protein hydrolysates or with intravena lipid emulsion.
  • Prescribed concurrently with an aminoglycoside, should not be mixed In the same syringe/infuse fluid container because the activity of the aminoglycoside will decrease.
  • During treatment with high doses of amoxicillin, particularly by bolus Injection, an adequate fluid intake and urinary output must be maintained.
  • Amoxicillin injection is stable with commonly used intravena fluids at 23°C, if Infused over a period not exceeding 6 hours.
  • Solutions should be changed after 1 hour if amoxicillin injection is administered in fluids containing dextrose or other carbohydrates, or within 3 hours in solutions containing sodium lactate.
Adverse Reactions
  • Hypersensitivity reaction such as erythemalous maculopapular rashes, urticaria, serum sickness.
  • Serious and fatal hypersensitivity reaction : anaphylaxis especially occurs In patient with hypersensitivity to penicillin.
  • Gastrointestinal tract disturbance such as : vomiting, nausea, diarrhoea.
  • Haematological reactions (usually reversible).
  • Especially for injection administration can cause phlebitis and pain at injection site.
Contraindications
Patient with hypersensitivity or with known history of hypersensitivity to beta ladam
antibiotics (penicillin, cephalosphorin).

Drug Interactions
  • Probenecide can increase and prolong amoxicillin concentration in plasma.
  • It may increase skin reaction when amoxicillin is administered with allopurinol
Presentation
Capsule 250 mg:Box of 10 strips x 10 capsulesReg. No. DKL7411607301A1
Caplet 500 mg:Box of 3 strips x 10 CapletsReg, No. DKL7811607404A1

:Box of 10 strips x 10 capletsReg. No. DKL7811607404A1
Dry syrup 125 mg/5 ml:Box of bottle 60 mlReg. No. DKL9911629538A1
Dry syrup 250 mg/5 ml:Box of bottle 60 mlReg.No.DKL7611600638A1
Injection 1000 mg:Box of 10 vials @ 1000 mgReg. No. DKL9611600644A1


Should be administered Immediately after reconstruction.
After reconstruction :
  • Store at room temperature maximal 1 hour.
  • Store at refrigerator maximal 3 hours.
Capsules, Caplets and Dry Syrup
Store below 30°C.

Injection
Store below 25°C.

On medical Prescription only

Injection
Manufactured by:
PT Bernofarm Pharmaceutical
Surabaya - Indonesia
For:
PT. KALBEFARMA Tbk.
Bekasi - Indonesia

Capsules, Caplets and Dry Syrup
Manufactured by:
PT DANKOS FARMA
Jakarta - Indonesia
For:
PT. KALBEFARMA Tbk.
Bekasi - Indonesia
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Irvask Caplet

Composition
Each IRVASK caplet contains: Irbesartan 150 and 300 mg

Pharmacology
Irbesartan is a selective and competitive antagonist of AT1 receptors with a much greater affinity ( › 8500-fold ) for the AT1 receptor than for the AT2 receptor. Irbesartan is expected to block all actions of angiotensin-II mediated by AT1 receptor, regardless of the source or route of synthesis of angiotensin-II. The selective antagonism of angiotensin-II (AT1) receptors results in increases in plasma renin levels and angiotensin-II levels, and a decrease in plasma aldosterone concentration. Serum potassium levels are not significantly effected by Irbesartan alone at the recommended doses. Irbesartan does not inhibit ACE (Khinase-II), an enzyme which generates angiotensin-II and also degrades bradykinin into inactive metabolites. Irbesartan does not require metabolic activation for its activity.

Pharmacokinotic
After oral administration, Irbesartan is well absorbed, with an absolute bioavailability of 60-80%. Concomitant food intake does not affect the bioavailability of Irbesartan. Plasma protein binding is approximately 96, the average volume of distribution is 53 - 93 liters. Irbesartan is metabolized by the liver via giucuronide conjugation and oxidation. Peak plasma concentrations of Irbesartan are attained at 1.5 - 2 hours after oral administration, total plasma and renal clearances are in the range of 157 -176 and 3.0 - 3.5 ml/min, respectively. The plasma elimination half-life ranges from 11 to 15 hours and steady-state plasma concentrations are achieved wrthin 3 days after initiation dose. Irbesartan and its metabolites are excreted by both biliary and renal routes.

Indication
IRVASK are used for treating hypertension. It may be used alone or in combination with other antihypertansive agents.

Dosage and administration
The usual recommended initial and maintenance dose is 150 mg once daily, can be increased to 300 mg once daily, may be administered with or without food. Irbesartan at a dose of 150 mg once daily generally provides a better blood pressure control than 75 mg. The addition of a diuretic agent such as Hydrochlorothlazide has bean shown to have an additive effect with Irbesartan.

Renal Impairment
No dosage adjustment is necessary in patients with impaired renal function, but a lower starting dose (75 mg) should be considered for patients undergoing haemodialysis.

Hepatic impairment
No dosage adjustment is necessary in patients with mild to moderate hepatic impairment. There is no clinical experience in patients with severe hepatic impairment.

Elderly use
No dosage adjustment is necessary.

Pediatric use
Safety and effectiveness in pediatric patients have not been established.

Contraindications
  • Hypersensitivity to Irbesartan.
  • Second and third trimester of pregnancy.
  • Lactation.
Warnings and precautions
Intravascular volume depletion
Volume and/or sodium depletion should be corrected prior to administration of Irbesartan.

Renovascular hypertension
There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis are treated with drugs that affect the renin-angiotensin-aldosteron system. While this is not documented with Irbesartan, a similar effect should be anticipated with angiotensin II receptor antagonists.

Renal impairment and kidney transplantation
When Irbesartan is used in patients with impaired renal function, a periodic monitoring of potassium and creatinine serum levels is recommended. There is no experience regarding the administration of Irbesartan in patients with kidney transplantation.

Hyperkalemia
Close monitoring of serum potassium in patients with renal impairment, overt proteinuria due to diabetic renal disease and/or heart failure is recornmended, because hyperkalemia may occur during the treatment with Irbesartan in that patients.

Aortic and mitral vain stenosis
Special caution is indicated in patents suffering from aortic or mitral stenosis.

Primary aldosteronism
Patients with primary aldosteronism generally will not respond to antihypertensive drugs acting through inhibition of the renin-angiotensin-aldosteron system. Therefore, the use of Irbesartan is not recommended.

Hypertensive patients with type-2 diabetes and renal disease
The effect of Irbesartan both on renal and cardiovascular events were not uniform
across all subgroups. In an analysis carried out in the study with patients with advanced renal disease. In particular, they appeared less favourable in women and non-white subjects.

Lithium
The combination of Lithium and Irbesartan is not recommended.

General
In patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure or uderlying renal disease. Including renal artery stenosis), treatment with angiotensin convening enzyme inhibitors or angiotensin-ll receptor antagonist that affect this system has been associated with acute hypotension, azotaemia, digouria, or rarely acute renal failure. As with any antihypertensive agent, excessive blood pressure decrease in patients with ischaemic cardiopathy or ischaemic canjiovascular disease could result in a myocardial infarction or stroke. As observed for angiotensin converting enzyme inhibitors, Irbesartan and the other angiotensin antagonists are apparently less effective in lowering blood pressure in Mack people than in non-blacks, possibly because of higher prevalence of low-renin states in the black hypertensive population.

Adverse reactions
Respiratory tract infection, headache, myalgia, dizziness, fatigue, diarrhea, cough, nausea, musculoskdetal trauma, chest pain, dyspepsia/heart bum, edema, abdominal pain, rash, tachycardia, anxiety.

Drug Interactions
Diuretics and other antihypertensive agents may increase the hypotensive effects of Irbesartan; however Irbesartan has been safely administered with other antihypertensive agents, such as p-blockers, calcium channel blockers.
The administration of Irbesartan in patients receiving maintenance doses of Warfarin or Digoxin, had no effect on the pharmacodynamics of the Warfarin (prothrombin time) or the onarmacokinetics of Digoxin. Potassium supplements and potassium-sparing diuretics may lead to increases potassium in serum.
Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors. Similar effecis have been very rarely reported with Irbesartan so far.
NSAIDs: When angiotensin-II antagonists are administered simultaneously with NSAIDs (i.e. selective COX-2 inhibitors, Acetosal ( › 3 a/day ) and non selective NSAIDs, attenuation of the antihypertensive effect may occur. As with ACE-inhibitors, concomitant use of angiotensin II antagonist and NSAIDs may lead to an increase risk of worsening of renal function, including possible acute renal failure, and an increase in serum potassium, especially in patiens with poor pre-existing renal function. The combination should be administered with caution, especially in the elderly. Patients should be adequately hydrated and consideration should be given to monitoring renal function after irritation of concomitant therapy and periodically thereafter.

Overdosage
The most likely manifestations of overdosage are expected to be hypotension and tachycardia, bradycardia, might also occur from overdosage. No specific information is available on the treatment of overdosage with Irbesartan. The patient should be closely monitored and treatment should be symptomatic and supportive. Suggested measures include induction of omosis and/or gastric lavage. Activated charcoal may be usefull in the treatment of overdosage. Irbesartan Is not remove by haemodialysis.

Presentations
IRVASK 150 mg : Box of 3 strips x 10 caplets Reg. No. DKLOB11638604A1
IRVASK 300 mg : Box of 3 Strips x 10 caplets Reg. No. DKL0811638604B1

Store below 30°C.

ON MEDICAL PRESCRIPTION ONLY.

Manufactured by: PT. DANKOS FARMA, Jakarta - Indonesia
For : PT. KALBE FARMA Tbk., Bekasi - Indonesia
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Bon-One Tablet

Active Form of Vitamin D3

Powerful drug
Designated drug
Alfacalcidol

Composition
Each tablet of Bon-One contains 0.25, 0.5 or 1.0μg of alfacalcidol.

Indications
Improvement of various symptoms (hypocalcemia, telany, bone pain, bone lesions, etc.) due to abnormal metabolism of vitamin D in the below-listed conditions.:
  • Chronic renal failure
  • Hypoparathyroidism
  • Vitamin D -resistant rickets and osteomalacia
Dosage and Administration
The dosage should be adjusted under careful monitoring of serum calcium level.
  • Chronic renal failure and ostcoporosis: For adults, Bon-One is orally administered at 0.5-1.0 μg as alfacalcidol once a day. The dose may be adjusted according to the age of patient and severity of symptoms.
  • Hypoparathyroidism and other diseases associated with abnormality of vitamin D metabolism: For adults, Bon-One is orally administered at 1.0-4.0μg as alfacalcidol once a day. The dose may be adjusted according to the age of patient, severity of symptoms and the type of disease.
Precautions for Use
General precautions
  1. To avoid overdose, it should be adjusted to keep the serum Ca level within normal range by the regular monitoring. Frequency of monitoring. Plasma calcium levels should be measured at weekly and monthly intervals depending on the progress of the patient. Frequent estimations are necessary in the early stages of treatment (particularly when the plasma calcium is already relatively high) and later when there is evidence of bone healing. Plasma calcium is levels should also be estimated regularly during the initial treatment of disorders without significant bone in involvement, e.g.hypoparathyroidism.
  2. In case of hypercalcemia, treatment with Bon-One should be stopped immediately. After the serum Ca level returns to normal, the treatment shall reinitialed at a lower dose. The risk of hypercalcemia depends on factors such as the degree of any mineralization defect, renal function and the dose of Bon One. Hypercalcemia will occure if the dose of Bon-One is not reduced appropriately when these is biochemical evidence of bone healing (e.g.return to words nominal is the level of plasma alkaline phosphatase). Prolonged hypercalcemia should be avoided particularly in chronic renal failure. In patients with renal bone disease, Bon-One should be given in combination with a phosphate, binding agent to prevent hyperphosphatemia which is known to increase the risk of metastatic calcification.
  3. Administration to Elderly: Careful administration shall be required due to generally lower physiologic functions.
  4. Administration to pregnant women: Delayed bone formation was observed in fetal rats at high doses. Since the safety of Bon-One during pregnancy has not been established, administration to pregnant women or women suspected in pregnancy should be limited to the cases where the therapeutic benefit is judged to outweigh the potential risks.
  5. Administration to Children: Acute toxicity was observed in young rats more than matured rats. For administration to children, it should be carefully used to avoid overdose by gradual dose increase after initial lower dose under close monitoring of serum Ca level, urinary Ca level, and creatinine.
  6. Overdose administration: Many cases of adverse reactions are considered to be caused by hypercalcemia. Therefore, in case of adverse reaction, monitoring of serum Ca level is appropriate. Refer to General Precautions for the treatment. Severe hypercalcemia may require additional treatment with a loop diuretic, intra venous fluids and corticosteroids.
  7. Others: In case of administration to patients with hyper phosphatemia, the serum phosphate level should be controlled using phosphate binders (such as aluminium hydroxide gel).
SIDE EFFECT
Adverse reactions (rarely : ‹ 0.1%, occasionally : 0.1% ‹ 5%, no adverb: ≥ 5% or incidence unknown).
  1. Digestive organs: Anorexia, nausea vomiting, stomach distention, diarrhea, constipation, stomach pain, stomach discomfort may occasionally occur. Dyspepsia, intraoral discomfort and thirst may rarely occur.
  2. Psychoneurotic system: Headache, insomnia, irritation, malaise, dizziness, feeling of numbness, sleepines, failure of memory, tinnitus, senile deafness, back pain, shoulder stiffness, feeling of spasticity of the lower limbs, and chest pain may rarely occur.
  3. Cardiovascular organs: Slight increase of blood pressure and palpitationmay rarely occur.
  4. Liver: Elevation of GOT, GPT, LDH, and/or γ-GTP may occasionally occur.
  5. Kidney: Elevation of BUN or sCr (indicating deterioration of kidney function) and renal calculus may rarely occur.
  6. Skin: Pruritus and eruption may occasionally occur. Feeling hot may rarely occur.
  7. Eye: Conjunctival congestion may occasionally occur.
  8. Bone: Ectopic calcification around joints may rarely occur.
  9. Others: Edema calculus and husky voice may rarely occur.
CONTRA INDICATION
Hypercalcemia, metastatic calcification.

DRUG INTERACTION
  • Magnesium containing drugs, hypermagnesemia has been reported.
  • Digitalis preparations, cardiac arrythmia may occur.
  • Calcium preparations, hypercalcemia may occur.
  • Vit.D and its derivates, hypercalcemia may occur.
  • Barbiturates or other anti convulsants may need larger doses of Bon-One to produce the desired effect.
Pharmacology
Following oral administration, the drug is rapidly absorbed at the intestine into the circulately blood, hydroxylated at the 25-position of the sidechain by a hepatic microsome. 25-hydroxylase, to be converted to an activity developing substance, 1 α , 25-(OH)2D3.
The substance binds with receptor existed at the intestinal tract and the target tissue such as the bone, and develops series physiological activites, e.g., enhancement of calcium absorption from the intestine, dissolving activity of bone mineral and bone remodeling activity.

Description
1. Description of the preparation
  • Bon-One tablet is white, round non-coated tablet. It has no odour. The content of the active ingredient is indicated on the tablet.
2. Physiochemical properties of the active ingredient
  • Generic name: Alfacalcidol
  • Chemical name: 9,10-secocholesta-5,7,10(19)-triene-l α, 3 β-diol
  • Molecular formula: C27H4402
  • Molecular amount: 400.64
  • Melting point: 137-142 °C
  • Description: Alfacalcidol is a white crystal or crystalline powder, and is freely soluble in methanol, dehydrated ethanol, chloroform or dichloromethan, soluble in acetone or ethanol, and practically insoluble in water or hexane.
Precautions in Handling
  1. Regulatory classification: This preparation is a powerful and designated drug.
  2. Storage: Store at room temperature shielded from humidity and light.
  3. Expiration date: 3 years. Refer to the expiration date indicated on the case.
Package
PTP package

0.25μg:
100 tablets (10 tablets X 10),
30 tablets (10 tablets X 3),
Reg. No. DKI 0258400110 Al

0.5μg:
100 tablets (10 tablets X 10),
30 tablets (10 tablets X 3),
Reg. No. DKI 0258400110 B 1

1.0μg:
100 tablets (10 tablets X 10),
30 tablets (10 tablets X 3),
Reg. No. DKI 0258400110 C1

Harus Dengan Resep Dokter

Importir, PT. Dipa Pharmalab Intersains
Jakarta-Indonesia

Manufactured by
TEIJIN PHARMA LIMITED
2-1, Hinode-cho, Iwakuni, Yamaguchi, Japan
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Monday, July 27, 2009

Inolin Pediatric drops

BRONCHODILATOR
Reg. No. DKL8325200136A1

COMPOSITION AND DESCRIPTION
Generic name:Trimetoquinol hydrochloride
Chemical name:(-)-1,2,3,4-Tetrahydro 1 (3,4,5-trimethoxybenzyl) isoquinoline-6, 7-diol hydrochloride monohydrate.

  • Trimetoquinol hydrochloride is odourless and consists of white crystalline powder having a bitter taste.
  • It is slightly soluble in water, very slightly soluble in absolute alcohol and practically insoluble in acetone, absolute ether chloroform and benzene.
  • Melting point : about 151°C (with decomposition).

Product's namesEach mL containsDescription of the product
INOLIN®
Pediatric drops
Trimeloquinol HCl 1,0 mg
Alcohol 1,25%
Colourless to light yellowish brown clear solution with an aromatic odour
pH:3,0-5,0

ACTION
Trimetoquinol hydrochloride dilates bronchial muscle selectively by stimulating Beta 2-receptors.
The bronchodilating action of Trimetoquinol hydrochloride (Beta 2-stimulating actions) was stronger than increasing action of heart rate (Beta 1-stimulating action), hypotensive action of diastolic blood pressure (Beta 2-stimulating action), and action to soleus muscle tension (Beta 2-stimulating action in experimental model tremor). Its blood concentration reached the maximum within 30 minutes after administration and then promptly decreased.

INDICATIONS
For the relief of bronchoconstriction associated with bronchitis, asthmatic bronchitis and bronchial asthma.

CONTRAINDICATIONS
INOLIN® is contraindicated in the patients who are hypersensitive to this product.

DOSAGE AND ADMINISTRATION
The following daily dosage is administered orally by dividing in 3 to 4.
  • Under 1 year old : 1 - 2 mL
  • 1 to 2 years old : 2 - 4 mL
  • 3 to 4 years old : 4 - 6 mL

PRECAUTION
  1. In the even that the appropriate use of INOLIN® does not bring about good results, discontinue the administration of the drug as it is probable that the drug does not suit for such a patient. When the drug is given to infants or children, the correct use should be instructed and patients should be also carefully observed in the course of treatment.
  2. Great care should be exercised with respect to the successive and less excessive administration of INOLIN® because it is possible that the cardiac arrhythmia and in certain circumstances cardiac arrest will happen on the repeated excessive administration of INOLIN®, as with other sympathomimetic agents.
  3. Use with caution in case of :
    • Hyperthyroidism
    • Hypertension
    • Heart diseases
    • Diabetes mellitus
  4. The safety of the products in pregnant women has not been established.
  5. Use in the elderly should be under careful supervision.

Adverse reactions :
1. Cardiovascular system:Palpitation may occur occasionally, and alteration of blood pressure and precordial pain may appear rarely.
2. Psychoneurotic system:Headache may occur occasionally.
Tremor, dizziness, feverish sensation may also be encountered in a rare incidence.
3. Digestive system:Occasionally, nausea and anorexia may appear.
4. Hypersensitiveness:Discontinue the administration of the drug when hypersensitive symptoms such as eruption appear.
5. Miscellaneous:Dry mouth may occur infrequently.

Interactions :
Since the concurrent use of the drug with catecholamines such as Epinephrine and Isoproterenol may induce arrythmia or cardiac arrest in some cases, concurrent use is not recommended.

CAUTION IN HANDLING
This product is to be kept in 8° - 15°C.
To avoid possible contamination, handle this product cleanly after opening

PRESENTATION
Bottle of 30 mL net (supplied with measuring pipette).

ON DOCTOR'S PRESCRIPTION ONLY
HARUS DENGAN RESEP DOKTER

Under license from
TANABE SEIYAKU CO., LTD.
Osaka,Japan

Manufactured by
PT. TANABE INDONESIA
Bandung, Indonesia
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Friday, July 24, 2009

Bisolvon Flu

Bromhexine HCl, Paracetamol, Chlorpheniramine maleate, Phenylephrine HCl
For Flu and Cough

Composition
5 ml syrup contains :
Bromhexine hydrochloride 4 mg
Paracetamol 150 mg
Chlorpheniramine maleate 2 mg
Phenylephrine hydrochloride 5 mg

Excipients
Sodium benzoate, Aspartame, Sodium saccharine, Disodium edetate dihydrate, Tartaric acid, Peppermint, FD & C Yellow No.6, FD & C Blue No.l, Glycerol 100%, Sodium Carboxymethycellulose, Sorbitol 70%, Pufified water, PEG 1450, Propylene glycol, Menthol.

Properties
BISOLVON FLU is a combination of the secretolytic agent Bromhexine hydrochloride with analgesic-antipyretic (Paracetamol), antihistamine (Chlorpheniramine maleate) and decongestant (Phenylephrine).

Bromhexine is a synthetic derivative of the herbal active ingredient vasicine.
Preclinically, it has been shown to increase The proportion of serous bronchial secretion. Bromhexine enhances mucus transport by reducing mucus viscosity and
by activating the ciliated epithelium (mucociliary clearance).

In clinical studies, Bromhexine showed a secretolytic and secretornotor effect in the bronchial tract area, which facilitates expectoration and eases cough.

Paracetamol is an analgesic-antipyretic used ir temporary relief of headache and reduction of fever. Paracetamol is a clinically proven analgesic/antipyretic.
Paracetamol produces analgesia by elevation of the pain threshold and antipyresis through action on the hypothalamic heat regulating center.

Chlorpheniramine maleate is an alkylamine derivative antihistamin.

Phenylephrine HCL Is a decongestant for the symptomatic relief of nasal congestion and to ease breathlessness.

Indications
To relieve flu symptoms such as fever, headache, nasal congestion and sneezing following by cough.

Dosage and Administration
Adults and children over 12 years : 10 ml 3 times daily
Children 6 -12 years : 5 ml 3 times dally
Children under6years : on doctor's recommendation

Special Warning and Precautions
  • See Box Warning.
  • Caution in usage for patients with liver dysfunction, renal dysfunction, glaucoma, prostate hypertrophy hyperthyroid, and urinary retention. Caution in concomitant administration with other CNS depressants.
  • Phenylephrina may cause a prolonged rise in blood pressure. It Induces tachycardia or reflex bradycardia and should therefore be avoided in severe hyperthyroidism and used with caution in severe Ischemic heart disease. Hypertension and hypertension with pulmonary oedema have been described in infants.
  • Use with caution when driving a motor vehicle or operating machinery.
  • Not recommended for children under 6 years old, women who are pregnant or in lactation period, unless under doctor's recommendation.
  • Use with caution when taking this drug together with sedatives and tranquilizers.
  • Avoid alcoholic beverages while taking this product. Caution must be considered in patients who consume alcohol since this may increase th6 risk of liver dysfunction.
  • There have been very rare reports of severe skin lesions such as Stevens Johnson syndrome and Lyell's syndrome in temporal association with the administration of mucolytic substances such as Bromhexine. Mostly this could be explained by the severity of the underlying disease or concomitant medication. If new skin or mucosal lesions occur, medical advice should be sought immediately and treatment with Bromhexine discontinued as a precaution.
Contraindications
  • See Box Warning.
  • See Special Warnings and Precautions.
  • Patients with hypersensitivity with any component of this product.
  • Patients with severe liver dysfunction.
  • Patients with cardiac dysfunction and diabetes mellitus.
Side Effects
  • Drowsiness, gastro-intestinal disturbances (diarrhoea, nausea, vomiting), headache, insomnia, nervousness, tremor, tachicardia, ventriculary arrythmia, dry mouth, palpitations, difficulties in urination.
  • Allergic reactions including skin rashes, urticaria, bronchospasm, angio-oedema and anaphylaxis have also been reported.
  • Long term usage of paracetamol in high doses can cause liver damage.
Interactions
  • Not recommended to be given concomitantly with MAO inhibitor depressants, or within 2 weeks of stopping such therapy.
  • Administration of Bromhexine together with antibiotics (Amoxicillin, Cefuroxime, Eryhtromycin, Doxycycline) leads to higher antibiotic concentration.
  • Chlorpheniramine maleate has been reported to be incompatible with Calcium chloride, Kanamycin sulfate, Noradrenaline acid tartrate, Pentobarbital sodium and Meglumine adipidone.
  • Phenylephrine is stated to be incompatible with the local anaesthetic Butacaine.
Presentation
Bottle of 60 ml
Reg. No. DTL0733703837A1

Manufactured by:
PT. Boehringer Ingelheim Indonesia
Bogor, Indonesia

Under license from:
Boehringer Ingelheim International GmbH.
ingelheim am Rhein
Germany



  • Do not use for patients who are sensitive to other sympathomimetic drugs (e.g. Ephedrine, Phenylpropanolamine, Pseudoephedrine), who has severe high blood pressure and who are taking MAO inhibitor depressants.
  • Do not exceed the recommended dose.
  • Caution for patients who have hypertension or increasing blood pressure or stroke, such as overweight patients or elderly.
  • Consult the physicians or healthcare centre if the symptoms do not improve within 3 days.
  • Stop use if getting sleepless, dizzy or increasing heart rate.

Store in temperature 25-30°C, in a well-dosed container.
Store in a save place, out of the reach of children.



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Clinmas

KOMPOSISI
Clinmas®-150:
Tiap kapsul mengandung Clindamycin HCl setara dengan Clindamycin 150 mg

Clinmas®-300:
Tiap kapsul mengandung Clindamycin HCl setara dengan Clindamycin 300 mg

Mekanisme kerja dan spektrum antibakteri
Clinmas® bekerja menghambat sintesis protein kuman dengan jalan mengikat ribosom subunit 50S pada kuman.
Obat ini aktif terhadap berbagai kuman gram positif misalnya S. aureus (termasuk galur-galur penghasil penisilinase). S.epidermidis, Str. pyogenes, Sir. viridans, D. pneumoniae, dll. Clinmas® terutama bermanfaat untuk menghambat pertumbuhan kuman anaerob seperti Bacteroides fragilis, Bacteroides melaninogenicus. Fusobactenum sp., Peptococcus, Peptostreptococcus, Clostridium perfringens (welchii) San Clostridium tetani.

Farmakokinetik
Berbeda dengan linkomycin, pemberian Clinmas® bersama makanan tidak mempengaruhi absorbsinya. Dengan dosis 150 mg tercapai Radar puncak 2,5 mcg/ml setelah 45 menit.
Masa paruh eliminasi Clinmas® pada orang normal ialah 2,4 jam. namun sedikit meningkat pada penderita dengan gangguan faal hati yang berat.
Dengan dosis lazim (150 - 300 mg tiap 6 jam) tercapai kadar obat yang cukup untuk menghambat kebanyakan kuman patogen selama 6 jam. Clinmas® mampu menembus dengan baik ke dalam tulang. Sifat ini umumnya tidak dimiliki antimikroba lain.

INDIKASI
Clinmas® diindikasikan pada infeksi berat oleh kuman-kuman yang peka terhadap clindamycin, yaitu:
  1. Infeksi saluran nafas bagian bawah, terutama bronkopneumonia, abses paru dan pneumonia aspirasi yang disebabkan oleh kuman anaerobik.
  2. Infeksi kulit dan jaringan lunak.
  3. Infeksi tulang dan sendi, misalnya osteomielitis oleh kokus gram positif.
  4. Infeksi intra abdominal, misalnya peritonitis dan abses.
  5. Infeksi dalam rongga panggul wanita. misalnya endometritis, abses tuba-ovarian, selulitis pelvis, dll.

KONTRAINDIKASI
Hipersensitivitas terhadap Clindamycin atau linkomycin.

EFEKSAMPING
  • Diare (lihat Peringatan dan Perhatian), mual. muntah, rasa kecap logam (metallic taste).
  • Reaksi hipersensitivitas pada kulit berupa urtikaria atau kemerahan.
  • Neutropenia, eosinofillia, perubahan hasil uji faal hati atau ginjal yang semuanya bersifat sementara.

PERINGATAN DAN PERHATIAN
Pemberian Clinmas® dapat menimbulkan kolitis berat (Antibiotic Associated Pseudomembranous Colitis) yang mungkin fatal. Oleh karena itu obat ini hanya
diindikasikan untuk infeksi-infeksi berat yang tidak lagi responsif terhadap antibiotik lain yang lebih aman. Efek samping ini disebabkan oleh toksin yang dilepaskan oleh kuman Cl. difficile. Untuk mengatasi keadaan ini, terapi Clinmas® harus segera dihentikan dan kepada penderita diberikan metronidazol oral (4 x 250 - 500 mg/hari), basitrasin oral (4 x 25.000 unit/hari) dan kolestiramin (3x4 g/hari).

Selain itu Clinmas® harus diberikan dengan hati-hati pada penderita dengan :
1. Riwayat kolitis
2. Gejala atopik

Pada pengobatan jangka panjang, faal hati dan ginjal perlu dipantau. Keamanan Clinmas® pada wanita hamil atau menyusui belum diketahui dengan pasti.

INTERAKSI OBAT
Clinmas® tidak dianjurkan diberikan bersama erythromycin atau chloramphenicol karena
terjadi antagonisme secara in vitro. Obat ini mungkin meningkatkan efek obat-obat
penghambat neuromuscular.

DOSIS DAN CARA PEMAKAIAN
Dewasa:
sehari 4 kali 150 - 300 mg. Bila perlu, dosis dapat ditingkatkan menjadi 4 kali 300-450mgsehari.

Anak:
8 - 16 mg / Kg BB / hari yang dibagi dalam 3 - 4 dosis. Bila perlu, dosis dapat ditingkatkan hingga 16 - 20 mg / Kg BB / hari.

Untuk menghindari iritasi tenggorokan. Clinmas® harus diminum dengan air segelas penuh.
Pemberian bersama makanan tidak mempengaruhi absorbsi Clinmas®.

KEMASAN
Clinmas®-150 kapsul : Kotak berisi 3 strip @ 10 kapsul No. Reg. DKL 9513304801 A1
Clinmas®-300 kapsul : Kotak berisi 3 strip @ 10 kapsul No. Reg. DKL 9513304801 B1

HARUS DENGAN RESEP DOKTER
Simpan di tempat sejuk (15-25°C) dan kering.

PT. LAPI LABORATORIES
CIKANDE - INDONESIA
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Ferokid Syrup

Suplemen makanan

Komposisi
Tiap 5 ml Ferokid™ Sirup mengandung:
Fe15 mg
Folic acid150 mcg
Mg5 mg
Vit A2.000 IU
Cu0,2 mg
Vit B13 mg
Vit B22 mg
Vit B65 mg
Vit B125 mcg

Uraian
Ferokid™ adalah preparat besi dengan supleman vitamin A, B kompleks, tembaga, dan magnesium.

Besi dibutuhkan untuk pembentukan hemoglobin pada sel darah merah. Hemoglobin penting sebagai alat transport oksigen dalam sel darah merah. Oksigen dibutuhkan untuk proses oksidasi jaringan.

Vitamin A berguna untuk meningkatkan penyerapan zat besi. Selain itu vitamin A berguna untuk pembentukan sel, serta pertumbuhan dan perbaikan Jaringan.

Suplemen vitamin B kompleks dalam jumlah kebutuhan sehari-hari berguna pada
keadaan defisiensi relatif akibat meningkatnya kebutuhan, tidak cukupnya asupan, atau akibat gangguan absorpsi nutrisi.

Vitamin B12 dan asam folat juga berperan dalam pembentukan sel darah merah,
sehingga apabila terjadi defisiensi vitamin B12 atau asam folat dapat terjadi anemia megaloblastik.

Cu (tembaga) merupakan kofaktor dari berbagai sistem enzim dan merupakan antioksidan. Defisiensi Cu dapat menyebabkan timbulnya anemia mikrositik.

Mg (Magnesium) dapat memperbaiki kelainan sel darah merah. Defisiensi magnesium
terjadi pada anemia dan thalassemia.

Kegunaan
Membantu memenuhi kebutuhan Vit A, Vit B, dan mineral pada anak-anak serta dapat digunakan pada penderita anemia.

Kontraindikasi
Senyawa besi merupakan kontraindikasi bagi penderita dengan hemokromatosis primer dan siderosis akibat transfusi.
Zat besi tidak boleh diberikan pada penderita yang mendapat transfusi darah berulang-ulang karena dapat menimbulkan kelebihan zat besi dengan kemungkinan hemokromatosis sekunder.
Penderita yang hipersensitif terhadap salah satu komponen obat.

Peringatan
Anemia hemolitik tanpa kekurangan zat besi tidak boleh diobati dengan senyawa besi karena dapat menimbulkan kelebihan zat besi. Kelebihan zat besi juga dapat terjadi pada penderita yang mendapat preparat besi oral dan suntikan sekaligus, dan pada penderita dengan hemoglobinopati atau anemia rerakter lainnya yang salah didiagnosis sebagai anemia kekurangan zat besi. Pemberian jangka panjang zat besi dalam dosis tinggi harus dihindari kecuali pada penderita dengan perdarahan yang terus-menerus, pendarahan haid yang bertebihan atau kehamilan yang berulang-ulang. Zat besi dapat menyebabkan feses berwarna hitam, tetapi tidak berbahaya dan hilang bila pemakaian dihentikan.

Efek samping
Pemberian preparat besi sacara oral dapat menimbulkan gangguan saluran pencernaan, terutama rasa mual. nyeri ulu hati, diare atau konstipasi. faeses berwarna hitam.

Aturan pakai
Anak-anak 2 - 6 tahun : 1 kali sahari 1/2 sendok takar (2,5 ml).
Anak-anak 7-12 tahun : 1 kali sehari 1 sendok takar (5 ml).
Diberikan bersama makanan atau sehabis makan.
Gunakan sesuai aturan pakai.

Kemasan
DOS berisi 1 botol sirup Ferokid™, netto 100 ml.

Suplemen makanan. POM SD. 061 629 731 &

Simpan pada suhu di bawah 30° C.
Lindungi dari cahaya.

Diproduksi oleh:PT HEXPHARM JAYA, Cipanas - Indonesia
Untuk:PT DANKOS FARMA, Jakarta - Indonesia
Dipasarkan oleh:PT KALBE FARMA Tbk, Bekasi - Indonesia

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Deconal Tablet

Tablet warna berbintik-bintik

Box warning
  • Tidak boleh diberikan pada penderita yang peka terhadap obat simpatomimetik lain (misal efedrin, pseudoefedrin, fenilefrin), penderita tekanan darah tinggi berat, dan yang mendapat terapi obat anti depresan tipe penghambat Monoamin Oksidase (MAO).
  • Tidak boleh melebihi dosis yang dianjurkan.
  • Hati-hati penggunaan pada penderita tekanan darah tinggi atau yang mempunyai potensi tekanan darah tinggi atau stroke seperti pada penderita dengan berat badan berlebih (over weight) atau penderita usia lanjut.
  • Bila dalam 3 hari gejala flu tidak berkurang segera hubungi dokter atau unit pelayanan kesehatan.
  • Hentikan penggunaan obat ini jika terjadi susah tidur, jantung berdebar dan pusing.
Komposisi:
Tiap tablet mengandung:
Paracetamol 500 mg
Fenilpropanolamin HCl 12,5 mg
Klorfeniramin maleat 1 mg

Cara kerja obat:
Bekerja sebagai Analgesik-Antipiretik, dekongestan hidung dan Antihistamin

Indikasi:
Untuk meringankan gejala flu seperti demam, sakit kepala, hidung tersumbat dan bersin-bersin.

Peringatan dan perhatian:
  • Lihat Box Warning.
  • Hati-hati penggunaan pada penderita dengan gangguan fungsi hati dan ginjal, glaukoma, hipertrofi prostat, hipertiroid, dan retensi urin.
  • Tidak dianjurkan penggunaan pada anak usia di bawah 6 tahun, wanita hamil dan menyusui, kecuali atas petunjuk dokter.
  • Selama minum obat ini tidak boleh mengendarai kendaraan bermotor atau menjalankan mesin.
  • Hati-hati penggunaan bersamaan dengan obat-obat lain yang menekan susunan saraf pusat.
  • Penggunaan pada penderita yang mengkonsumsi alkohol dapat meningkatkan resiko kerusakan fungsi hati.
Kontra indikasi:
  • Lihat Box Warning
  • Penderita dengan gangguan jantung dan diabetes mellitus.
  • Penderita dengan gangguan fungsi hati yang berat.
Aturan pemakaian:
3 atau 4 kali sehari
- Anak-anak 6-12 tahun : 1/2 tablet
- Dewasa : 1 tablet

Efek samping :
  • Mengantuk, gangguan pencernaan, gangguan psikomotor, takikardi, aritmia, mulut kering, palpitasi, retensi urin.
  • Penggunaan dosis besar dan jangka panjang menyebabkan kerusakan hati.
  • Interaksi obat:
  • Penggunaan bersama antidepresan tipe pengbambat MAO dapat mengakibatkan krisis hipertensi.

Kemasan : Doos berisi 15 catch cover @ 10 tablet.
DAPAT MENYEBABKAN KANTUK
SIMPAN DITEMPAT KERING DAN SEJUK
Reg. No.: DTL. 0220100910A1

PT APEX PHARMA INDONESIA
TANGERANG - INDONESIA
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