País: Australia
Idioma: inglés
Fuente: Department of Health (Therapeutic Goods Administration)
entecavir, Quantity: 1 mg
Sandoz Pty Ltd
Entecavir
Tablet, film coated
Excipient Ingredients: purified talc; hypromellose; titanium dioxide; lactose monohydrate; crospovidone; magnesium stearate; microcrystalline cellulose; macrogol 6000; iron oxide red; iron oxide yellow
Oral
30 tablets
(S4) Prescription Only Medicine
Entecavir Sandoz is indicated for the treatment of chronic hepatitis B virus infection in adults 16 years or older with evidence of active liver inflammation. This indication is based on histologic, virologic, biochemical and serological responses in nucleoside-treatment naive and lamividine-resistant adult patients with HBeAg-positive or HBeAg-negative chronic HBV infection with compensated liver disease.
Visual Identification: Pink, round film coated tablet with debossment on both sides, "SZ", on one side and "109" on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius
Licence status A
2015-12-10
ENTECAVIR SANDOZ ® 1 ENTECAVIR SANDOZ ® _Entecavir (as monohydrate) _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET Read this leaflet carefully before taking Entecavir Sandoz. This leaflet answers some common questions about Entecavir Sandoz. It does not contain all 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 Entecavir Sandoz against the benefits they expect it will have for you. If you have any concerns about taking this medicine, ask your doctor or pharmacist. Keep this leaflet with the medicine. You may need to read it again. WHAT ENTECAVIR SANDOZ IS USED FOR Entecavir Sandoz contains entecavir monohydrate and belongs to a group of medicines called antiviral medicines. Entecavir Sandoz is used to treat adults infected with hepatitis B virus. _HOW ENTECAVIR SANDOZ _ _WORKS _ Infection by the hepatitis B virus can lead to damage to the liver. Entecavir Sandoz reduces the amount of virus in your body, and has been shown to improve the condition of the liver. It is not known how safe Entecavir Sandoz is when taken for long periods. Your doctor may have prescribed it for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. ENTECAVIR SANDOZ IS NOT ADDICTIVE. THIS MEDICINE IS AVAILABLE ONLY WITH A DOCTOR'S PRESCRIPTION. Entecavir Sandoz is not recommended for use in children under 16 years, as there have been no studies of its effects in children. BEFORE YOU TAKE ENTECAVIR SANDOZ It is important that you check the information below before you take Entecavir Sandoz. _WHEN YOU MUST NOT TAKE IT _ You must not take Entecavir Sandoz if you have a history of severe allergic reactions to Entecavir Sandoz or to any of the ingredients listed at the end of this leaflet. Symptoms of a severe allergic reaction may include; chills, fever, fast heart beat, wheezing or coughing, difficulty breathing, dizziness, flushing, sweating Leer el documento completo
200221-Entecavir Sandoz-pi Page 1 of 25 AUSTRALIAN PRODUCT INFORMATION ENTECAVIR SANDOZ ® (ENTECAVIR MONOHYDRATE) FILM-COATED TABLETS 1 NAME OF THE MEDICINE Entecavir monohydrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ENTECAVIR SANDOZ 0.5 mg film-coated tablet contains 0.5 mg entecavir (as monohydrate). Each ENTECAVIR SANDOZ 1 mg film-coated tablet contains 1 mg entecavir (as monohydrate). _List of excipients with known effect:_ lactose monohydrate For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM ENTECAVIR SANDOZ 0.5 mg film coated tablet – white, round with debossment on both sides, “SZ” on one side and “108” on the other side. ENTECAVIR SANDOZ 1 mg film coated tablet – pink, round with debossment on both sides, “SZ” on one side and “109” on the other side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS ENTECAVIR SANDOZ is indicated for the treatment of chronic hepatitis B virus infection in adults 16 years or older with evidence of active liver inflammation. This indication is based on histologic, virologic, biochemical and serological responses in nucleoside-treatment naive and lamividine-resistant adult patients with HBeAg-positive or HBeAg-negative chronic HBV infection with compensated liver disease. 4.2 D OSE AND METHOD OF ADMINISTRATION DOSAGE The recommended oral dose of ENTECAVIR SANDOZ in adults and adolescents older than 16 years is 0.5 mg once daily. For lamivudine-refractory patients [history of hepatitis B viremia while receiving lamivudine therapy or known lamivudine resistance (LVD R commonly called YMDD mutations)], the recommended dose is 1 mg once daily (or alternatively 2 tablets of 0.5 mg once daily). _Duration of Therapy _ The optimal duration of treatment with entecavir monohydrate for patients with chronic hepatitis B infection and the relationship between treatment and long-term outcomes such as cirrhosis and hepatocellular carcinoma are unknown. 200221-Entecavir Sandoz-pi Page 2 of 25 METHOD OF ADMINISTRATION E Leer el documento completo