Страна: Австралія
мова: англійська
Джерело: Department of Health (Therapeutic Goods Administration)
tenofovir disoproxil phosphate, Quantity: 291 mg
Lupin Australia Pty Limited
tenofovir disoproxil phosphate
Tablet, film coated
Excipient Ingredients: microcrystalline cellulose; croscarmellose sodium; stearic acid; titanium dioxide; lactose monohydrate; hypromellose; triacetin; indigo carmine aluminium lake
Oral
HDPE bottle pack of 100, HDPE bottle pack of 30
(S4) Prescription Only Medicine
Tenofovir GH in combination with other antiretroviral agents is indicated for the treatment of HIV infected adults and paediatric patients 12 years of age and older. Tenofovir GH is indicated for the treatment of chronic hepatitis B in adults (see CLINICAL TRIALS). Tenofovir GH is indicated for the treatment of chronic hepatitis B in paediatric patients 12 years of age and older with compensated liver disease and with evidence of immune active disease, i.e. active viral replication, persistently elevated serum ALT levels or evidence of active inflammation.
Visual Identification: Blue coloured, oval shaped, biconvex film-coated tablets debossed with T1 on one side and plain on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2017-01-30
CONSUMER MEDICINE INFORMATION TENOFOVIR GH (TENOFOVIR DISOPROXIL PHOSPHATE) FILM-COATED TABLET WHAT IS IN THIS LEAFLET Read this leaflet carefully before you start taking Tenofovir GH. Also, read it each time you get your Tenofovir GH prescription refilled, in case something has changed. This information does not take the place of talking with your doctor or pharmacist when you start this medicine and at check- ups. You should stay under a doctor’s care when taking Tenofovir GH. It is extremely important that you do not change or stop your medicine without first talking with your doctor or pharmacist (see ‘How should I take Tenofovir GH and ‘Side effects’). Talk to your doctor or pharmacist if you have any questions about Tenofovir GH. WHAT TENOFOVIR GH IS USED FOR Tenofovir GH is an antiviral medication used to treat two different viruses: Chronic Hepatitis B (CHB) and Human Immunodeficiency Virus (HIV) infection. Tenofovir GH is a type of medicine called an HBV polymerase inhibitor and a nucleotide analogue reverse transcriptase inhibitor (NRTI). _HOW TENOFOVIR GH WORKS IN _ _THE TREATMENT OF CHB _ TENOFOVIR GH IS USED TO TREAT CHB (AN INFECTION WITH HEPATITIS B VIRUS [HBV]) IN ADULTS AND PAEDIATRIC PATIENTS AGED 12 YEARS AND OLDER AND WEIGHING AT LEAST 35 KG. Tenofovir GH works by interfering with the normal working of enzymes (HBV DNA polymerase) that are essential for HBV to reproduce itself. Tenofovir GH may help lower the amount of hepatitis B virus in your body by lowering the ability of the virus to multiply and infect new liver cells and can improve the inflammation and scar tissue caused by the hepatitis B virus in your liver. Lowering the amount of virus in your body may reduce the chance of developing cirrhosis, liver failure and liver cancer. We do not know how long Tenofovir GH may help treat your hepatitis. Sometimes viruses change in your body and medicines no longer work. This is called drug resistance. _HOW TENOFOVIR GH WORKS IN _ _THE TREATMENT OF HIV-_ _INFECTION _ TENOFOVIR GH IS ALS Прочитайте повний документ
AUSTRALIAN PRODUCT INFORMATION – TENOFOVIR GH (TENOFOVIR DISOPROXIL PHOSPHATE) FILM-COATED TABLET 1 NAME OF THE MEDICINE Tenofovir disoproxil phosphate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Tenofovir GH film-coated tablets contain 291 mg of tenofovir disoproxil phosphate. The innovator product contains 300 mg of tenofovir disoproxil fumarate - 291 mg of tenofovir disoproxil phosphate is equivalent to 300 mg of tenofovir disoproxil fumarate. List of excipients with known effects: lactose monohydrate For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Each Tenofovir GH film-coated tablet is blue, oval shaped, biconvex and debossed with 'T1' on one side and plain on other side. The tablets are supplied in bottles with a screw cap closure. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tenofovir GH in combination with other antiretroviral agents is indicated for the treatment of HIV- infected adults and paediatric patients 12 years of age and older. Tenofovir GH is indicated for the treatment of chronic hepatitis B in adults (see SECTION 5.1 PHARMACODYNAMIC PROPERTIES – CLINICAL TRIALS). Tenofovir GH is indicated for the treatment of chronic hepatitis B in paediatric patients 12 years of age and older with compensated liver disease and with evidence of immune active disease, ie. active viral replication, persistently elevated serum ALT levels or evidence of active inflammation. 4.2 DOSE AND METHOD OF ADMINISTRATION _EACH TENOFOVIR GH TABLET CONTAINS 291 MG OF TENOFOVIR DISOPROXIL PHOSPHATE. THE INNOVATOR PRODUCT _ _CONTAINS 300 MG OF TENOFOVIR DISOPROXIL FUMARATE – 291 MG OF TENOFOVIR DISOPROXIL PHOSPHATE IS _ _EQUIVALENT TO 300 MG OF TENOFOVIR DISOPROXIL FUMARATE. BIOEQUIVALENCE HAS BEEN ESTABLISHED BETWEEN _ _THE TWO SALT FORMS OF TENOFOVIR DISOPROXIL. _ Tenofovir GH v4 Page 2 of 44 (tenofovir disoproxil phosphate) film-coated tablet ADULTS _ _ The recommended dose of Tenofovir GH (tenofovir disoproxil phosphate) is 291 mg (one tablet) once daily taken orally. Прочитайте повний документ