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Tuesday, March 3, 2015

Dumozol Infus

Dumozol
Metronidazole

Composition
Each 100 ml contains
Metronidazole 500 mg

Description
Trichomoniacide, anaerobicida
Disposition of Metronidazole in the body is similar for both oral and IV dosage forms, with an average elimination half life in healthy humans of 8 hours. Metronidazole appears in cerebrospinal fluid, saliva and human milk in concentrations similar to those found in plasma. Bactericidal concentrations of Metronidazole have also been detected in pus from hepatic abscesses.

Indications
  • Urethritis dan vaginitis (due to trichomonas vaginalis)
  • Amoebiasis (intestinal and hepatic amoebiasis)
  • Prevention of post operative anaerob infection
  • Giardiasis ( due to Giardia lambliasis)

Contra indications
  • Patients who hypersensitive to Metronidazole or other derivate of nitroimidazole.
  • The first trimester of pregnancy.

Side effects
  • Some times vomiting, anorexia, diarrhoea, painful on epigastrium.
  • Serious side effect occur have been reported: convulsive seizure and neurophaty perifer.
  • Unpleasant taste in the mouth, furred tongue, nausea, vomiting, or gastrointestinal disturbance have been reported.
  • Urticaria, pruritus, angiodema and anafilaksis may occur rarely.
  • Dizziness, drowsiness, headache, ataxia and darkening of the urine (due to Metronidazole metabolit) have been reported but very rarely.
  • Reversible a mild leucopenia has been reported in some patient.

Warning and Precautions
  • Use of Metronidazole should be carefully for lactating women because Metronidazole is excreted in human milk, the second and third trimester of pregnancy should be carefully because Metronidazole crosses the placental barrier.
  • Metronidazole should be administered with cautions to patient with central nervous system disturbance. (CNS disturbance on several cases have been reported, but it will disappear if the treatment is stop or reduced the dosage).
  • Alcoholic beverages should not be consumed during Metronidazole therapy, because abdominal cramps, nausea, vomiting, headaches and flushing may occur.
  • For the long term treatment laboratory blood test should be done.
  • Patients with severe hepatic (disease metabolize Metronidazole slowly) doses below those usually recommended should be administered cautiously.
  • Safety and effectiveness in children have not been established except in the treatment of amoebiasis.

Drug Interaction

  • It is best to take Metronidazole alone. If combined with antibiotic, Metronidazole and antibiotic should be given in a full dosage of normal therapy.
  • Metronidazole has been reported to potentiate the anticoagulant effect of warfarin and other oral coumarin anti coagulant, resulting in a prolongation of prothrombine time.
  • Cimetidine may prolong the half life and decrease plasma clearance of Metronidazole.
  • Psychotic reactions have been reported in alcoholic patients who are using Metronidazole and disulfiram concurrently.


Over dosage
Single oral doses of Metronidazole up to 15 g have been reported: over dosage like nausea, vomiting and ataxia.
Treatment: could be supportive therapy or therapy to eliminate the symptoms.

Dosage
Should be infused intravenously at rate 5 ml/minute. Immediately must be replace to oral dosage form.
  • Treatment of infections in which bacteria have been identified: Adult and children ‹ 12 years. In patients who can not treated by oral dosage form. Adult : 500 mg intravenously every 8 hours, Children: 7.5 mg/ kg body weight every 8 hours
  • Prevention for post abdomen operative infections, (priority to colorectal ) repeatedly gynecology every 2 hours.
  • Adult : 500 mg intravenously before operation, then immediately followed by 500 mg oral dosage every 8 hours. Children: 7.5 mg/kg body weight. (1.5 ml/kg body weight) every 8 hours.

Presentation
Individual box contains 1 bottle@ 100 ml
Reg. No.: DKL03055 11449A1

Storage
Store at room temperature between 25°C- 30°C.
Protect from light

HARUS DENGAN RESEP DOKTER

Manufactured by :
PT Finusolprima Farma Internasional
Bekasi-Indonesia

For
PT Actavis Indonesia,
Jakarta (Actavis Group, Iceland)
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Monday, March 2, 2015

Sohobal Injeksi

SOHOBAL®
Injeksi

KOMPOSISI:
Tiap ml mengandung:
Mecobalamin 500 μg


FARMAKOLOGI:
  • Mecobalamin meningkatkan metabolisme asam nukleat, protein dan lemak.
  • Mecobalamin dikirim secara efisien ke jaringan saraf dan memperbaiki gangguan metabolisme.
  • Mecobalamin memperbaiki jaringan saraf dalam suatu percobaan kerusakan saraf.
  • Mecobalamin menghambat rangsangan transmisi abnormal oleh jaringan saraf.

INDIKASI:
Untuk mengobati neuropati perifer.

DOSIS:
Dewasa: 1 ampul, 3 x seminggu diberikan secara intramuskular atau intravena.
Dosis sebaiknya disesuaikan dengan usia pasien dan tingkat keparahan penyakit.


EFEK SAMPING:
  1. Hipersensitivitas: Penggunaan obat harus dihentikan jika terjadi gejala hipersensitivitas seperti erupsi.
  2. Jarang terjadi: nyeri, mengerasnya daerah tempat injeksi, sakit kepala, berkeringat dan demam.

KONTRA INDIKASI:
Hati-hati pada pasien yang hipersensitif terhadap komponen obat ini.

PERHATIAN DAN PERINGATAN:
  1. SOHOBAL® injeksi tidak dianjurkan penggunaannya lebih dari 1 bulan jika respon klinik sangat terbatas pada pasien dengan anemia megaloblastik atau pada gangguan saraf periferal khususnya karena defisiensi vitamin B12.
  2. Untuk penggunaan intramuskular, harus digunakan hati-hati dan sesuai dengan anjuran di bawah untuk menghindari efek samping pada jaringan atau saraf.
    1. Injeksi yang berulang kali pada tempat yang sama harus dihindari. Pemberian SOHOBAL® injeksi harus hati-hati pada janin, bayi prematur, anak-anak.
    2. Hindari terkena saraf pada daerah penyuntikan.
    3. Jika pasien mengeluh sakit atau tejadi refluks darah ke syringe, segera tarik kembali jarum suntik dan coba lagi pada daerah yang berbeda.
  3. Bila tidak ada perubahan dari keadaan pasien, pengobatan perlu dihentikan. 
  4. Oleh karena obat mudah terurai oleh cahaya, maka obat harus segera digunakan setelah kemasan dibuka.

INTERAKSI OBAT:
Tidak diketahui apakah SOHOBAL® injeksi dapat menyebabkan interaksi klinis yang signifikan dengan obat lain.

KEMASAN:
Box, 10 ampul @ 1 ml.
DKL 0824225443A1

HARUS DENGAN RESEP DOKTER

SIMPAN DI BAWAH SUHU 25°C
TERLINDUNG DARI CAHAYA

Diproduksi oleh:
PT ETHICA
JAKARTA - INDONESIA

Untuk:
PT SOHO INDUSTRI PHARMASI
JAKARTA - INDONESIA
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Sunday, March 1, 2015

Flagyl Suppository

Flagyl®
Suppository
Metronidazole

Composition
Flagyl 0.5 g suppository: each contains 500 mg metronidazole
Flagyl 1 g suppository: each contains 1 g metronidazole.

Mechanism
Trichomoniacide, Anaerobicide


Indications
  • Treatment of infections in which anaerobic bacteria have been identified: septicaemia, bacteremia, peritonitis, brain abscess, necrotising pneumonia, osteomyelitis, puerperal sepsis, pelvic cellulitis.
  • Prevention of post operative infections due to anaerobic bacteria, particularly species of bacteroides and anerobic streptococci.

Dosage and Administration
  1. Treatment of infections in which anaerobic bacteria have been identified.
    • Adults: 1 gram suppository at 8 hourly intervals until oral medication becomes possible. If the suppository administration is more than 3 days, reduced the further doses into 1 gram at 12 hourly intervals. 
    • Children: 7.5 mg/kg body-weight at 8 hourly intervals.
  2. Prevention of post operative infections due to anaerobic bacteria:
    • Adults: 1 gram suppository 2-4 hours before surgery, then at 8 hourly intervals until oral medication becomes possible.
    • Children: ½ or ¼ of 500 mg suppository at 8 hourly intervals.
Warnings and Precautions:

  • Care must be taken for: Lactating woman as metronidazole is secreted in breast milk. Second and third trimesters of pregnancy as metronidazole can pass the placenta barrier.
  • FLAGYL should be administered with caution to patients with CNS diseases. The CNS interference has been reported in some cases, but will disappear on the withdrawn or on the reduced doses of metronidazole.
  • When taken together with alcohol, metronidazole can provoke a disulfiram-like reaction.
  • Count the blood examination is recommended for a long term treatment.
  • For patients with hepatic insufficiency, doses below those usually recommended should be administered caustiously.
  • Safety in children has not been established, except in amoebiasis.

Side Effects
  • Sometimes appear nausea, anorexia, epigatris distress.
  • Serious adverse reactions are reported: convulsive seizures and peripheral neuropathy.
  • An unpleasant taste in the mouth, furred tongue, nausea, vomiting or other gastro intestinal disturbance have been most common reported. 
  • Urticaria, skin rash, pruritus, angiodema and rarely anaphylaxis have occured.
  • Drowsiness, dizziness, headache, ataxia and darkening of the urine (due to metabolites) have been reported rarely.
  • A moderate, reversible leucopenia has been reported in some patients.

Contra Indications
  • Metronidazole should not be used in patients with an established history of bone marrow depresion.
  • Patients who are known to be hypersensitive to metronidazole. 
  • First trimester of pregnancy.

Drug Interactions
  • FLAGYL may be given alone. In combination with other antibiotic: both should be given in full normal therapeutic doses.
  • Prior to simultaneous administration with Warfarin, the anticoagulant should be checked and if possible to be suitably reduced.
  • Cimetidine prolongs the plasma clearance of metronidazole, presumably by inhibiting metabolic enzymes, toxic concentrations of metronidazole may be produced.

Storage
Store below 25°C
Protect from Light

Presentation
Flagyl 0.5 g suppository :
Box of 2 Blisters @ 5 suppositories. Reg. No. DKL0121201453A1

Flagyl1 g suppository :
Box of 2 Blisters @ 5 suppositories. Reg. No. DKL0121201453B1

HARUS DENGAN RESEP DOKTER
ON MEDICAL PRESCRIPTION ONLY

Manufactured by
PT Aventis Pharma,
Jakarta - Indonesia
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Saturday, February 28, 2015

Neurobat Forte Injeksi

NEUROBAT® FORTE
INJEKSI

KOMPOSISI:
Tiap 3 ml mengandung:
Vitamin B1 (Thiamine disulfide)100mg
Vitamin B6 (Pyridoxine HCl)100mg
Vitamin B12 (Cyanocobalamin)5.000mcg

KHASIAT:
Vitamin B1 berperan sebagai koenzim pada dekarboksilasi asam alfa keto dan berperan dalam metabolisme karbohidrat. Vitamin B6 di dalam tubuh berubah menjadi pyridoxal phosphate dan pyridoxamine phosphate yang dapat membantu dalam metabolisme protein dan asam amino. Vitamin B12 berperan dalam sintesa asam nitrat dan berpengaruh pada pematangan sel dan memelihara integritas jaringan saraf.

INDIKASI:
Untuk pengobatan kekurangan Vitamin B1, Bdan B12 seperti pada beri-beri dan neuritis.

KONTRAINDIKASI:
Penderita yang sensitif terhadap Vitamin B1, Vitamin Batau Vitamin B12.

EFEKSAMPING:
Efek samping yang serius jarang terjadi.


PERINGATAN/PERHATIAN:
  • Jangan diberikan pada penderita yang sensitif terhadap Vitamin Batau B12 karena dapat menyebabkan anaphylactic shock.
  • Penderita dengan anemia megaloblastik jangan diberikan terlalu sering.

INTERAKSI OBAT:
Pemberian pada pasien yang menerima Levodopa dapat menurunkan efek Levodopa.

ATURAN PAKAI:
1 ampul (3 ml) per hari, diberikan secara injeksi intramuskular.

KEMASAN:
Kotak berisi 20 ampul @ 3ml
Reg.No.:DKL9817611643B1

HARUS DENGAN RESEP DOKTER

SIMPAN DI BAWAH 25°C
TERLINDUNG DARI CAHAYA
JANGAN DISIMPAN
DALAM LEMARI PEMBEKU

Diproduksi oleh:
PT. Interbat
Jl. H.R.M. Mangundiprojo no.1
Buduran, Sidoarjo-61252
Jawa Timur, Indonesia
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Friday, February 27, 2015

KA-EN-MG3

Multiple Electrolyte Solution With Glucose
K A - E N - M G 3

KA-EN MG3 is generally recommended for the supply or replenishment of water and electrolytes which are needed for daily maintenance.The composition is based on the average required amounts of water and electrolytes in normal humans.

These solution is used as a maintenance solution for patients with difficulties in the oral in take of water and electrolytes alter surgery, or for hypertonic dehydration with hypokalaemia.

COMPOSITION
Each 1000 mL of the solutions contains the following ingredients.
Sodium Chloride1.75g
Potassium Chloride1.50g
Sodium Lactate2.24g
Anhydrous Dextrose      100.00g

Electrolytes mEq / LGlucose
(g/L)
kcal/L
Na+K+Cl-Lactate-
KA-EN MG3
50
20
50
20
100
400

INDICATION
KA-EN MG3 is indicated in patients with carbohydrate and electrolyte imbalance, in following cases:
  • insufficient oral intake, for example: unconsciousness at cerebral stroke, anorexia due to malignant tumors, general marasmus, meningitis, encephalitis, malnutrition, pneumonia.
  • Surgery procedure, Neonatology, Diabetic acidosis etc.

DOSAGE AND ADMINISTRATION
  • The usual dosage is 500-1000 mL at one time by gradual intravenous drip infusion. The dosage should be adjusted according to the patients condition (loss amounts of body water and electrolytes, etc.).
  • 500 mL solution in bottle of 1000 mL : allowing or admixture with e.g. Amino Acid infusion.

PRECAUTIONS
The use of this solution should be carefully supervises in the following cases:
  • Renal failure without complicating hyperkalemia. 
  • Cardiac failure.
  • Severe hepatic injury.
  • Reduced urinary output due to obstructive urinary tract diseases. 
  • Diabetes mellitus.
  • The safety of this solution during pregnancy and lactation has not been assessed, but its use during these periods in not considered to constitute hazard.

PRECAUTION IN USE
During infusion of the solution, the desirable amount of urea is at least 500 mL per day or 20 mL per hour.

ADVERSE REACTION
Cerebral, pulmonary and peripheral edema, water intoxication, hyperkalemia and thrombophlebitis may occur with a large volume and/or acute infusion.

CONTRA INDICATION
  • Lactiacidemia
  • Hyperkalemia, oliguria, Addison's disease, severe burns, and azotemia.
  • Cardiac arrhythmia.

DESCRIPTION
KA-EN MG3 is a clear, colorless or slightly yellowish, sterile and pyrogen free solution.

pHSpecific gravity (20°C)Osmotic pressure*
Average immediately after manufactureSpecification
KA-EN-MG3 about 5.03.5 - 7.01.042About 2
* Ratio to saline solution

STORAGE
At room temperature (25°C - 30°C)

HOW TO SUPPLIED
Plastic bottles 250 mL, 500 mL, 1000 mL, and 500 mL in bottle of 1000 mL

REGISTERED NO:
250 mL: DKL 9118702049Al
500 mL: DKL 9118702049Al
1000 mL: DKL 9118702049A2
500 mL in bottle of 1000 mL: DKL 9118702049Al

HARUS DENGAN RESEP DOKTER

Manufactured by :
PT Otsuka Indonesia
Lawang - East Java
Indonesia
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