Pajjiż: Awstralja
Lingwa: Ingliż
Sors: Department of Health (Therapeutic Goods Administration)
atazanavir sulfate
Alphapharm Pty Ltd
Registered
AUSTRALIAN PRODUCT INFORMATION ATAZANAVIR MYLAN _atazanavir (as sulfate) capsule _ 1 NAME OF THE MEDICINE Atazanavir (as sulfate) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains either 150 mg, 200 mg or 300 mg of atazanavir (as sulfate) as the active ingredient. Excipients with known effect: lactose monohydrate. For the full list of excipients, see Section 6.1 List of Excipients. 3 PHARMACEUTICAL FORM ATAZANAVIR MYLAN 150 mg capsule: a.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 MYLAN 200 mg capsule: a.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 MYLAN 300 mg capsule: a.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 is indicated for the treatment of HIV-1 infection, in combination with other antiretroviral agents. This indication is based on analyses of plasma HIV-1 RNA levels and CD4 cell counts from controlled studies (see section 5.1 Pharmacodynamic Properties – Clinical Trials). 4.2 DOSE AND METHOD OF ADMINISTRATION GENERAL DOSING RECOMMENDATIONS ATAZANAVIR MYLAN capsules must be taken with food. ATAZANAVIR MYLAN capsules should be taken WHOLE. The recommended doses are to be administered using combinations of registered capsule strengths; e.g. a dose of 300 mg may be administered as one 300 mg capsule or two 150 mg capsules. The recommended oral dosage of atazanavir depends on the treatment history of the patient and the use of other co-administered drugs. When co-administered with H 2 -receptor antagonists, or pr Aqra d-dokument sħiħ