País: Nova Zelanda
Idioma: anglès
Font: Medsafe (Medicines Safety Authority)
Lamivudine 100mg;
GlaxoSmithKline NZ Limited
Lamivudine 100 mg
100 mg
Film coated tablet
Active: Lamivudine 100mg Excipient: Magnesium stearate Opadry butterscotch YS-1R-17307-A Powdered cellulose Sodium starch glycolate
Blister pack, 4x7, 28 tablets
Prescription
Prescription
Mylan Laboratories Limited
Zeffix is indicated for the treatment of adults and children aged 2 years and older with chronic hepatitis B and evidence of hepatitis B viruse (HBV) replication.
Package - Contents - Shelf Life: Blister pack, 4x7 - 28 tablets - 36 months unopened stored at or below 30°C
1997-07-10
ZEFFIX Tablets 1 ZEFFIX TABLETS _Lamivudine 100 mg _ NEW ZEALAND CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET? Please read this leaflet carefully before you start taking ZEFFIX tablets. This leaflet answers some common questions about ZEFFIX tablets. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking ZEFFIX against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE TABLETS. You may need to read it again. WHAT ZEFFIX TABLETS ARE USED FOR ZEFFIX tablets contain lamivudine which belongs to a group of medicines called antivirals. ZEFFIX is used to treat patients with long term (chronic) viral infection of the liver caused by hepatitis B and evidence of hepatitis B virus replication. Hepatitis B is a virus which damages the liver. Treatment with ZEFFIX can reduce the amount of hepatitis B virus in your body. This should lead to less liver damage. ZEFFIX does not reduce the risk of passing hepatitis B to others. You will still be able to pass on the hepatitis virus by sexual contact or through your blood. You should use appropriate precautions. ZEFFIX tablets are not addictive. Your doctor may have prescribed ZEFFIX tablets for another reason. If you are already taking medicines containing lamivudine for HIV infection (3TC, Combivir), your doctor will continue to treat you with the higher dose for that viral infection. If you have any questions about why ZEFFIX tablets have been prescribed for you, ask your doctor. BEFORE YOU TAKE ZEFFIX TABLETS _WHEN YOU MUST NOT TAKE _ _ZEFFIX _ Do not take ZEFFIX tablets if you have ever had an allergic reaction to lamivudine or any of the ingredients listed at the end of this leaflet. READ THE SIDE EFFECTS SECTION TO FIND OUT ABOUT THE SYMPTOMS OF ALLERGY. Do not take ZEFFIX tablets if you are pregnant, Llegiu el document complet
1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME ZEFFIX lamivudine 100 mg film coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film coated tablet contains 100 mg lamivudine. For the full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Film coated tablet. Butterscotch coloured, film coated capsule shaped, biconvex and engraved “GX CG5” on one face. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ZEFFIX is indicated for the treatment of adults and children aged 2 years and older with chronic hepatitis B and evidence of hepatitis B virus (HBV) replication. 4.2 DOSE AND METHOD OF ADMINISTRATION Dose _ADULTS AND ADOLESCENTS 12 YEARS AND OLDER: _the recommended dosage of ZEFFIX is 100 mg once daily. _CHILDREN FROM TWO TO ELEVEN YEARS: _the recommended dose is 3 mg/kg once daily up to a maximum of 100 mg daily. Treatment in this patient population should not be extended beyond one year's duration. ZEFFIX oral solution is available for use in children and those patients for whom the tablets are inappropriate. Patient compliance should be monitored while on ZEFFIX therapy. Discontinuation of ZEFFIX may be considered in immunocompetent patients when HBeAg and/or HBsAg seroconversion occurs. Discontinuation may also be considered when loss of efficacy occurs, as indicated by recurrent signs of hepatitis. If ZEFFIX is discontinued, patients should be periodically monitored for evidence of recurrent hepatitis (see section 4.4 Special warnings and precautions for use). 2 Discontinuation of treatment is not recommended in patients with decompensated liver disease. There are limited data regarding the maintenance of seroconversion long term after stopping treatment with ZEFFIX. ZEFFIX should be used in accordance with available official recommendations. Special Populations _Renal impairment _ Lamivudine serum concentrations (AUC) are increased in patients with moderate to severe renal impairment due to decreased renal clearance. The dosage should therefore be reduced for patients wi Llegiu el document complet