Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
entecavir, Quantity: 1 mg
Sun Pharma ANZ Pty Ltd
Entecavir
Tablet, film coated
Excipient Ingredients: lactose monohydrate; povidone; crospovidone; microcrystalline cellulose; magnesium stearate; titanium dioxide; hypromellose; polysorbate 80; macrogol 400; iron oxide red
Oral
500, 30
(S4) Prescription Only Medicine
Entecavir monohydrate 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 na?ve and lamividine-resistant adult patients with HBeAg-positive or HBeAg-negative chronic HBV infection with compensated liver disease.
Visual Identification: Light pink to pink, triangular shaped film-coated tablets, debossed with 'RL2' on one side and plain on other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2016-05-19
ENTECAVIR RBX CMI v2 Page 1 of 3 ENTECAVIR RBX ENTECAVIR (AS MONOHYDRATE) _CONSUMER MEDICINE _ _INFORMATION _ WHAT IS IN THIS LEAFLET Read this leaflet carefully before taking ENTECAVIR RBX. This leaflet answers some common questions about ENTECAVIR RBX. 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 RBX 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 RBX IS USED FOR ENTECAVIR RBX contains entecavir (as monohydrate) and belongs to a group of medicines called antiviral medicines. ENTECAVIR RBX is used to treat adults infected with hepatitis B virus. _HOW ENTECAVIR RBX WORKS _ Infection by the hepatitis B virus can lead to damage to the liver. ENTECAVIR RBX 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 RBX is when taken for long periods. Your doctor may have prescribed ENTECAVIR RBX for another reason. Ask your doctor if you have any questions about why ENTECAVIR RBX has been prescribed for you. ENTECAVIR RBX IS NOT ADDICTIVE. THIS MEDICINE IS AVAILABLE ONLY WITH A DOCTOR'S PRESCRIPTION. ENTECAVIR RBX 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 RBX IT IS IMPORTANT THAT YOU CHECK THE INFORMATION BELOW BEFORE YOU TAKE ENTECAVIR RBX . _WHEN YOU MUST NOT TAKE ENTECAVIR _ _RBX _ You must not take ENTECAVIR RBX if you have a history of severe allergic reactions to ENTECAVIR RBX 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 and swel Read the complete document
Entecavir RBX PI v1.2 AUSTRALIAN PRODUCT INFORMATION ENTECAVIR RBX TABLETS entecavir (as monohydrate) 1 NAME OF THE MEDICINE Entecavir monohydrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 0.5 mg or 1 mg entecavir (a monohydrate) Excipients with known effects: lactose For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM ENTECAVIR RBX 0.5 mg film-coated tablet is white to white-off, triangular shaped film coated tablet, debossed with ‘RL1’ on one side and plain on other side. ENTECAVIR RBX 1 mg film-coated tablet is light pink to pink, triangular shaped film coated tablet, debossed with ‘RL2’ on one side and plain on other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Entecavir monohydrate 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 naïve and lamividine-resistant adult patients with HBeAg-positive or HBeAg-negative chronic HBV infection with compensated liver disease. 4.2 DOSE AND METHOD OF ADMINISTRATION RECOMMENDED DOSAGE ENTECAVIR RBX should be taken orally, on an empty stomach (at least 2 hours after a meal and 2 hours Entecavir RBX PI v1.2 before the next meal). The recommended oral dose of ENTECAVIR RBX 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. RENAL IMPAIRMENT In patients with renal impairment, the apparent oral clearance of entecavir monohydrate decreased as creatinine clearance decreased (see Section 5 . 2 PHARMACOKINETIC PROPERTIES, SPECIAL POPULATIONS). Dosage adjustment of ENTECAVIR RBX is recommended for patients with creatinine clearance <50 mL/min, including patients on hemodi Read the complete document