Nchi: Australia
Lugha: Kiingereza
Chanzo: Department of Health (Therapeutic Goods Administration)
fosamprenavir calcium, Quantity: 853.2 mg (Equivalent: fosamprenavir, Qty 700 mg)
ViiV Healthcare Pty Ltd
Fosamprenavir calcium
Tablet, film coated
Excipient Ingredients: povidone; croscarmellose sodium; microcrystalline cellulose; magnesium stearate; colloidal anhydrous silica; titanium dioxide; hypromellose; triacetin; iron oxide red
Oral
1 x 60 tablets
(S4) Prescription Only Medicine
Telzir, in combination with low dose ritonavir, is indicated for the treatment of Human Immunodeficiency Virus Type 1 (HIV-1) infected adults, adolescents and children of 6 years and above in combination with other antiretroviral medicinal products. In antiretroviral experienced adults Telzir in combination with low dose ritonavir has not been shown to be as effective as lopinavir/ritonavir. No comparative studies have been undertaken in children or adolescents.
Visual Identification: Pink, film-coated, capsule-shaped, biconvex tablets, debossed GX LL7 on one face.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Registered
2004-05-27
TELZIR TABLETS _fosamprenavir_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET? Please read this leaflet carefully before you start TELZIR tablets. This leaflet answers some common questions about TELZIR tablets. It does not contain all of 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 TELZIR in combination with ritonavir against the expected benefits it will have for you. As you will be taking TELZIR together with low doses of ritonavir, you should also carefully read the Patient Leaflet for that product before starting treatment with this combination. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE TABLETS. You may need to read it again. WHAT TELZIR TABLETS ARE USED FOR TELZIR tablets contain fosamprenavir which belongs to a group of antiretroviral medicines called protease inhibitors. The low doses of ritonavir you take together with TELZIR are designed to increase the amount of the active ingredient, amprenavir, available to control your HIV infection. TELZIR, taken with ritonavir, are used together with other antiretroviral medicines to slow down the progression of human immunodeficiency virus (HIV) infection, which can lead to Acquired Immune Deficiency Syndrome (AIDS) and other related illnesses (eg AIDS-related Complex or ARC). TELZIR does not cure AIDS or kill the HIV virus, but prevents further damage to the immune system by stopping production of new viruses. TELZIR does not reduce the risk of passing the infection to others. You will still be able to pass on the HIV virus by sexual activity or by contamination with infected blood. You should still use proper precautions to prevent this. While taking TELZIR and/or any other therapy for HIV disease, you may continue to develop other infections and other complications of HIV infection. You should keep in regular contact with the doctor who is looking aft Soma hati kamili
1 AUSTRALIAN PRODUCT INFORMATION TELZIR (FOSAMPRENAVIR CALCIUM) TABLETS 1 NAME OF THE MEDICINE Fosamprenavir calcium 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each TELZIR tablet contains 700 mg of fosamprenavir, as fosamprenavir calcium. Fosamprenavir is converted in humans to amprenavir. Each TELZIR 700 mg tablet is equivalent to approximately 600 mg of amprenavir. Fosamprenavir calcium is a white to cream coloured solid. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM TELZIR are biconvex, capsules-shaped, pinked coloured tablets marked with GXLL7 on one face. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TELZIR, in combination with low dose ritonavir, is indicated for the treatment of Human Immunodeficiency Virus Type 1 (HIV-1) infected adults, adolescents and children of 6 years and above in combination with other antiretroviral medicinal products. In antiretroviral experienced adults TELZIR in combination with low dose ritonavir has not been shown to be as effective as lopinavir/ritonavir. No comparative studies have been undertaken in children or adolescents. 4.2 DOSE AND METHOD OF ADMINISTRATION A physician experienced in the management of HIV infection should initiate therapy. Fosamprenavir is administered orally. The tablet can be taken with or without food. Higher than approved dose combinations of fosamprenavir with ritonavir are not recommended for use (see Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). 2 ADULTS (GREATER THAN OR EQUAL TO 18 YEARS OF AGE) _ANTIRETROVIRAL NAÏVE PATIENTS._ The recommended dose is 1400 mg fosamprenavir once daily with 200 mg ritonavir once daily or 700 mg (one tablet) fosamprenavir twice daily with 100 mg ritonavir twice daily. Both regimens must be administered in combination with other antiretroviral agents. _PROTEASE INHIBITOR EXPERIENCED PATIENTS._ The recommended dose 700 mg (one tablet) fosamprenavir twice daily with 100 mg ritonavir twice daily. This regimen must be administered in combination with other anti Soma hati kamili