Țară: Noua Zeelandă
Limbă: engleză
Sursă: Medsafe (Medicines Safety Authority)
Atazanavir sulfate 341.7mg equivalent to Atazanavir 300mg; Atazanavir sulfate 341.7mg equivalent to Atazanavir 300mg
Viatris Limited
Atazanavir sulfate 341.7 mg (equivalent to Atazanavir 300mg)
300 mg
Capsule
Active: Atazanavir sulfate 341.7mg equivalent to Atazanavir 300mg Excipient: Brilliant blue FCF Crospovidone Erythrosine Gelatin Iron oxide red Iron oxide yellow Lactose monohydrate Magnesium stearate Purified water Titanium dioxide Active: Atazanavir sulfate 341.7mg equivalent to Atazanavir 300mg Excipient: Crospovidone Gelatin Iron oxide red Iron oxide yellow Lactose monohydrate Magnesium stearate Patent blue V Purified water TekPrint black SW-9008 Titanium dioxide
Prescription
Mylan Laboratories Limited
Atazanavir Viatris is indicated for the treatment of HIV 1 infection, in combination with other antiretroviral agents, in adult patients and in paediatric patients 6 to 18 years of age. This indication is based on analyses of plasma HIV-1 RNA levels and CD4 cell counts from controlled studies.
Package - Contents - Shelf Life: Bottle, plastic, HDPE with CRC cap - 60 capsules - 36 months from date of manufacture stored at or below 25°C
2016-12-12
Page 1 of 5 NEW ZEALAND CONSUMER MEDICINE INFORMATION ATAZANAVIR VIATRIS _ATAZANAVIR (AS SULFATE) CAPSULES 150 MG & 200 MG _ WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start taking Atazanavir Viatris. This leaflet answers some common questions about Atazanavir Viatris. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Atazanavir Viatris against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT ATAZANAVIR VIATRIS IS USED FOR Atazanavir Viatris is used in combination with other anti-HIV agents to treat adults and children aged between 6 and 18 years of age who are infected with Human Immunodeficiency Virus (HIV). This medicine belongs to a group of medicines called protease inhibitors. Atazanavir Viatris contains the active ingredient atazanavir sulfate. It belongs to a group of medicines called protease inhibitors. _WHAT IS HIV_ HIV is a virus that kills important cells in the immune system over time (e.g. CD4 cells). When HIV has killed enough of the immune cells, your body becomes prone to certain types of infections. Some infections are the cause of "AIDS-defining" illnesses. This is when someone is said to have developed Acquired Immunodeficiency Syndrome or AIDS. AIDS is a serious condition and can lead to death. _HOW ATAZANAVIR VIATRIS _ _WORKS_ When HIV infects cells in the immune system, it takes over part of the cell's internal workings and uses the contents of the cell to produce new viruses. Atazanavir Viatris helps to block HIV protease, an enzyme that is needed for the HIV virus to multiply. Atazanavir Viatris may lower the amount of HIV in your blood and help your body keep its supply of CD4 and T-cells. Interfering with the production of new viruses helps to reduce the Citiți documentul complet
Page 1 of 50 NEW ZEALAND DATA SHEET ATAZANAVIR VIATRIS 1. PRODUCT NAME Atazanavir Viatris 150 mg capsules Atazanavir Viatris 200 mg capsules Atazanavir Viatris 300 mg capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Atazanavir Viatris 150 mg: each capsule contains 150 mg of atazanavir (as sulfate). Atazanavir Viatris 200 mg: each capsule contains 200 mg of atazanavir (as sulfate). Atazanavir Viatris 300 mg: each capsule contains 300 mg of atazanavir (as sulfate). Excipient with known effect: Lactose Allergen declaration: Sugars as lactose. For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Hard gelatin capsules. Atazanavir Viatris 150 mg capsules: No.1, greenish-blue opaque cap and blue opaque body, hard- shell gelatin capsule filled with white to pale yellow powder. The capsule is axially printed with MYLAN over AR150 in black ink on both the cap and body. Atazanavir Viatris 200 mg capsules: No.0, blue opaque cap and greenish-blue opaque body, hard- shell gelatin capsule filled with white to pale yellow powder. The capsule is axially printed with MYLAN over AR200 in black ink on both the cap and body. Atazanavir Viatris 300 mg capsules: No.00, red opaque cap and greenish-blue opaque body, hard- shell gelatin capsule filled with white to pale yellow powder. The capsule is axially printed with MYLAN over AR300 in black ink on both the cap and body. 4. CLINICAL PARTICULARS _4.1 _ _THERAPEUTIC INDICATIONS_ Atazanavir Viatris is indicated for the treatment of HIV 1 infection, in combination with other antiretroviral agents in adult patients and in paediatric patients 6 to 18 years of age. This indication is based on analyses of plasma HIV-1 RNA levels and CD4 cell counts from controlled studies (see section 5.1). Page 2 of 50 _4.2_ _DOSE AND METHOD OF ADMINISTRATION_ GENERAL DOSING RECOMMENDATIONS Atazanavir Viatris capsules must be taken with food. Atazanavir Viatris capsules should be taken WHOLE. The recommended doses are to be administered using combinations of registered capsule strengths; Citiți documentul complet