Quốc gia: Israel
Ngôn ngữ: Tiếng Anh
Nguồn: Ministry of Health
TENOFOVIR DISOPROXIL AS FUMARATE
GILEAD SCIENCES ISRAEL LTD
J05AF07
FILM COATED TABLETS
TENOFOVIR DISOPROXIL AS FUMARATE 245 MG
PER OS
Required
GILEAD SCIENCES IRELAND UC, IRELAND
TENOFOVIR DISOPROXIL
TENOFOVIR DISOPROXIL
Viread is indicated for the treatment of :1. HIV 1 infected adults and pediatric patients 12 years of age and older in combination with other antiretroviral medicinal products for the treatment of HIV. 2. Chronic hepatitis B in adults with: • Compensated liver disease, with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis. • Decompensated liver disease
2014-02-28
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed according to a doctor’s prescription only VIREAD ® Film-coated tablets ACTIVE INGREDIENT: each film-coated tablet contains - Tenofovir disoproxil 245 mg (as fumarate) Inactive ingredients and allergens: See section 6: "_Additional Information_". READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This leaflet contains essential information about this medicine. If you have any further questions, ask your doctor or pharmacist. Keep this leaflet. You may need to read it again. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar to yours. If you experience any side effects, talk to your doctor or pharmacist. Even if you experience any side effects that are not listed in this leaflet (see section 4). The medicine is not intended for children under the age of 12 years. IF VIREAD HAS BEEN PRESCRIBED FOR YOUR CHILD, PLEASE NOTE THAT ALL THE INFORMATION IN THIS LEAFLET IS ADDRESSED TO YOUR CHILD (IN THIS CASE PLEASE READ “YOUR CHILD” INSTEAD OF “YOU”). 1. WHAT IS VIREAD INTENDED FOR? • Viread is used to treat HIV (Human Immunodeficiency Virus) in adults and paediatric patients 12 years of age and older. • Viread is also used to treat chronic hepatitis B, an infection with hepatitis B virus (HBV), in adults. It is not known if Viread is safe and effective for treatment of HBV in children under the age of 18 years. THERAPEUTIC GROUP: Antiviral for systemic use; nucleoside and nucleotide reverse transcriptase inhibitors. Viread contains the active substance _tenofovir disoproxil_. This active substance is an _antiretroviral_ or antiviral medicine which is used to treat HIV or HBV infection or both. Tenofovir is a _nucleotide reverse transcriptase inhibitor_, generally known as an NRTI and works by interfering with the normal workin Đọc toàn bộ tài liệu
1 VIREAD ® Tenofovir disoproxil (as fumarate) Film-coated tablets 1. NAME OF THE MEDICINAL PRODUCT Viread ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 245 mg of tenofovir disoproxil (as fumarate). Excipient with known effect Each tablet contains 156 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Light blue, almond-shaped, film-coated tablets, of dimensions 16.8 mm x 10.3 mm, debossed on one side with “GILEAD” and “4331” and on the other side with “300”. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _HIV-1 infection _ Viread is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected adults and paediatric patients 12 years of age and older. The choice of Viread to treat antiretroviral experienced patients with HIV-1 infection should be based on individual viral resistance testing and/or treatment history of patients. _Hepatitis B infection_ Viread is indicated for the treatment of chronic hepatitis B in adults with: • compensated liver disease, with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis (see section 5.1). • decompensated liver disease (see sections 4.4, 4.8 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Therapy should be initiated by a physician experienced in the management of HIV infection and/or treatment of chronic hepatitis B. 2 Posology _HIV-1 _ _Adults and adolescents aged 12 to < 18 years and weighing ≥ 35 kg: _ The recommended dose of Viread for the treatment of HIV or for the treatment of chronic hepatitis B is 245 mg (one tablet) once daily taken orally with food. _Chronic hepatitis B_ _Adults_ The recommended dose of Viread for the treatment of HIV or for the treatment of chronic hepatitis B is 245 mg (one tablet) once daily taken orally with food. Duration of therapy in adults w Đọc toàn bộ tài liệu