البلد: نيوزيلاندا
اللغة: الإنجليزية
المصدر: Medsafe (Medicines Safety Authority)
Ribavirin 200mg; ;
Clinect NZ Pty Limited
Ribavirin 200 mg
200 mg
Film coated tablet
Active: Ribavirin 200mg Excipient: Colloidal silicon dioxide Croscarmellose sodium Crospovidone Magnesium stearate Microcrystalline cellulose Opadry white 03F180000 Povidone
Prescription
Aurobindo Pharma Limited
Ibavyr is indicated in combination with other oral agents for the treatment of chronic hepatitis C (CHC) in adults.
Package - Contents - Shelf Life: Bottle, plastic, white, round HDPE, polypropylene child resistant screw cap with induction seal liner. - 28 tablets - 60 months from date of manufacture stored at or below 25°C protect from light - Bottle, plastic, white, round HDPE, polypropylene child resistant screw cap with induction seal liner. - 100 tablets - 60 months from date of manufacture stored at or below 25°C protect from light
2015-06-03
IBAVYR® 200 mg, 400 mg, 600 mg ribavirin tablets 1 IBAVYR® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING IBAVYR? IBAVYR contains the active ingredient ribavirin. IBAVYR is used in combination with other oral agents for the treatment of chronic hepatitis C (CHC). CHC is a viral infection of the liver. For more information, see Section 1. Why am I using IBAVYR? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE IBAVYR? Do not use if you have ever had an allergic reaction to ribavirin or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use IBAVYR? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with IBAVYR and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE IBAVYR? • Take IBAVYR exactly as your doctor has directed. More instructions can be found in Section 4. How do I use IBAVYR? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING IBAVYR? THINGS YOU SHOULD DO • Use IBAVYR Tablets exactly as your doctor has prescribed. • Use contraception in order to avoid pregnancy. • Stop using IBAVYR Tablets if you become pregnant and immediately tell your doctor. • If you are male and your partner becomes pregnant while you are using IBAVYR, ask your partner to tell her doctor immediately. THINGS YOU SHOULD NOT DO • Do not stop taking IBAVYR or change the dose without first checking with your doctor. • Do not take any other medicines whether they require a prescription or not without first telling your doctor or pharmacist. DRIVING OR USING MACHINES • Be careful driving or operating machinery until you know how IBAVYR affects you اقرأ الوثيقة كاملة
1 NEW ZEALAND DATA SHEET 1. IBAVYR 200 MG, 400 MG AND 600 MG TABLETS IBAVYR (ribavirin) 200 mg, 400 mg and 600 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each IBAVYR (ribavirin) 200 mg tablet contains 200 mg ribavirin. Each IBAVYR (ribavirin) 400 mg tablet contains 400 mg ribavirin. Each IBAVYR (ribavirin) 600 mg tablet contains 600 mg ribavirin. For the full list on excipients, see section 6.1 3. PHARMACEUTICAL FORM IBAVYR (ribavirin) 200 mg tablet is a white, capsule-shaped, coated tablet, debossed with “200” on one side and nothing on the other side. IBAVYR (ribavirin) 400 mg tablet is a light pink, capsule-shaped, coated tablet, debossed with “400” on one side and scored on the other side. IBAVYR (ribavirin) 600 mg tablet is a white, capsule-shaped, coated tablet, debossed with “600” on one side and nothing on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS IBAVYR (ribavirin tablets) is indicated in combination with other oral agents for the treatment of chronic hepatitis C (CHC) in adults. 4.2 DOSAGE AND METHOD OF ADMINISTRATION _DOSE _ Ribavirin monotherapy is not effective and IBAVYR must only be used in combination with other oral agents for the treatment of CHC. Treatment with IBAVYR should be initiated and monitored by a physician experienced in the management of CHC. IBAVYR is administered orally in two daily divided doses with food. The recommended dose and treatment duration should be individualised to the patient depending on body weight, baseline disease characteristics (e.g., genotype), response to therapy, and underlying conditions. The recommended dose and treatment duration for combination therapy with sofosbuvir are shown in Table 1. When IBAVYR is used in combination treatment with any other oral agent, refer to the appropriate Product Information for dosage information. _Table 1: Recommended Dose/Treatment Duration for IBAVYR in Combination Therapy with Sofosbuvir _ 2 HCV GENOTYPE TREATMENT DURATION IBAVYR DOSE (DAILY) 1 SOFOSBUVIR DOSE (DAILY) Pat اقرأ الوثيقة كاملة