Страна: Австралія
мова: англійська
Джерело: Department of Health (Therapeutic Goods Administration)
tenofovir disoproxil maleate, Quantity: 300 mg
Alphapharm Pty Ltd
tenofovir disoproxil maleate
Tablet, film coated
Excipient Ingredients: lactose monohydrate; hyprolose; magnesium stearate; microcrystalline cellulose; colloidal anhydrous silica; titanium dioxide; hypromellose; triacetin; indigo carmine aluminium lake
Oral
30
(S4) Prescription Only Medicine
TENOFOVIR DISOPROXIL VIATRIS 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 DISOPROXIL VIATRIS is indicated for the treatment of chronic hepatitis B in adults (see CLINICAL TRIALS).,TENOFOVIR DISOPROXIL VIATRIS 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: Light blue colored, 12 mm round, biconvex, film coated tablets debossed with 'TM300' on one side of the tablet and 'M' on 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
2016-12-15
TENOFOVIR DISOPROXIL VIATRIS _tenofovir disoproxil maleate 300 mg_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET Read this leaflet carefully before you start taking TENOFOVIR DISOPROXIL VIATRIS. Also, read it each time you get your TENOFOVIR DISOPROXIL VIATRIS 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 DISOPROXIL VIATRIS. 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 DISOPROXIL VIATRIS and WHAT ARE THE POSSIBLE SIDE EFFECTS OF TENOFOVIR DISOPROXIL VIATRIS). Talk to your doctor or pharmacist if you have any questions about TENOFOVIR DISOPROXIL VIATRIS. WHAT TENOFOVIR DISOPROXIL VIATRIS IS USED FOR Tenofovir disoproxil maleate is an antiviral medication used to treat two different viruses; • Chronic Hepatitis B (CHB) and • Human Immunodeficiency Virus (HIV) infection. TENOFOVIR DISOPROXIL VIATRIS is a type of medicine called HBV polymerase inhibitor and a nucleotide analogue reverse transcriptase inhibitor (NRTI). _HOW TENOFOVIR_ _DISOPROXIL VIATRIS WORKS_ _IN THE TREATMENT OF CHB:_ TENOFOVIR DISOPROXIL VIATRIS 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 DISOPROXIL VIATRIS works by interfering with the normal working of enzymes (HBV DNA polymerase) that are essential for HBV to reproduce itself. TENOFOVIR DISOPROXIL VIATRIS 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 k Прочитайте повний документ
AUSTRALIAN PRODUCT INFORMATION TENOFOVIR DISOPROXIL VIATRIS _Tenofovir disoproxil maleate film coated tablets _ 1 NAME OF THE MEDICINE Tenofovir disoproxil maleate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each TENOFOVIR DISOPROXIL VIATRIS tablet contains 300 mg of tenofovir disoproxil as maleate (equivalent to 245 mg of tenofovir disoproxil) as the active ingredient. Excipients with known effect: Sugars as lactose. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM TENOFOVIR DISOPROXIL VIATRIS (tenofovir disoproxil maleate) 300 mg: Light blue colored, 12 mm round, biconvex, film coated tablets debossed with ‘TM300’ on one side of the tablet and ‘M’ on other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TENOFOVIR DISOPROXIL VIATRIS 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 DISOPROXIL VIATRIS is indicated for the treatment of chronic hepatitis B in adults (see Section 5.1 PHARMACODYNAMIC PROPERTIES: Clinical trials). TENOFOVIR DISOPROXIL VIATRIS 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. 4.2 DOSE AND METHOD OF ADMINISTRATION ADULTS: The recommended dose is 300 mg (one tablet) once daily taken orally. In order to optimise the absorption of tenofovir, it is recommended that TENOFOVIR DISOPROXIL VIATRIS be taken with food. PAEDIATRIC PATIENTS (≥ 12 YEARS OF AGE AND ≥ 35 KG): The recommended dose for paediatric patients (12 years of age and older), who weigh ≥ 35 kg, is 300 mg (one tablet) once daily taken orally. In order to optimise the absorption of tenofovir, it is recommended that TENOFOVIR DISOPROXIL VIATRIS be taken with food. The safety and efficacy of tenofovir disoproxil in patients under Прочитайте повний документ