Krajina: Austrália
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
entecavir, Quantity: 1 mg
Alphapharm Pty Ltd
entecavir monohydrate
Tablet, film coated
Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; magnesium stearate; crospovidone; titanium dioxide; hypromellose; polysorbate 80; macrogol 400
Oral
30
(S4) Prescription Only Medicine
Entecavir 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: A white, film-coated, round, biconvex, beveled edge tablet debossed with 'M' on one side of the tablet and 'EV2' on the other side.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2016-04-18
ENTECAVIR MYLAN _Entecavir (as monohydrate)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Entecavir Mylan. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking Entecavir Mylan against the benefits expected for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT ENTECAVIR MYLAN IS USED FOR This medicine belongs to a group of medicines called antiviral medicines. This medicine is used to treat adults infected with hepatitis B virus. Infection by hepatitis B virus can lead to damage to the liver. This medicine 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 Mylan is when taken for long periods. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is not addictive. This medicine is available only with a doctor's prescription. This medicine 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 MYLAN _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE ENTECAVIR MYLAN IF YOU HAVE AN ALLERGY TO: • any medicine containing entecavir monohydrate. • any of the ingredients listed at the end of this leaflet Some of the symptoms of an allergic reaction may include • chills fever • fast heart beat • wheezing or coughing • difficulty breathing • dizziness • flushing • sweating and swelling of the face, lips, tongue or other parts of the body DO NOT TAKE THIS MEDICINE AFTER THE EXPIRY DATE PRINTED ON THE PACK OR IF THE PACKAGING IS TORN OR SHOWS SIGNS OF TAMPERING. If it has expired or is damaged, return it to your pharmacist f Prečítajte si celý dokument
AUSTRALIAN PRODUCT INFORMATION ENTECAVIR MYLAN _entecavir (as monohydrate) film coated tablets _ 1 NAME OF THE MEDICINE Entecavir (as monohydrate) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ENTECAVIR MYLAN tablet contains 0.5 mg or 1 mg of entecavir (as monohydrate). Excipients with known effects: sugars (as lactose). For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM ENTECAVIR MYLAN 0.5 mg : A white, film-coated, round, biconvex, beveled edge tablet debossed with ‘M’ on one side of the tablet and ‘EV1’ on the other side. ENTECAVIR MYLAN 1 mg : A white, film-coated, round, biconvex, beveled edge tablet debossed with ‘M’ on one side of the tablet and ‘EV2’ on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Entecavir 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 lamivudine-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 should be taken orally, on an empty stomach (at least 2 hours after a meal and at least 2 hours before the next meal). The recommended oral dose of entecavir 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 decreased as creatinine clearance decreased (see section 5.1 PHARMACOKINETIC PROPERTIES: Special Populations). Dosage adjustment of entecavir is recommended for patients with creatinine clearance <50 mL/min, including patients on haemodialysis or Prečítajte si celý dokument