Quốc gia: New Zealand
Ngôn ngữ: Tiếng Anh
Nguồn: Medsafe (Medicines Safety Authority)
Atazanavir sulfate 170.872mg (equiv 150 mg atazanavir)
Teva Pharma (New Zealand) Limited
Atazanavir sulfate 170.872 mg (equiv 150 mg atazanavir)
150 mg
Capsule
Active: Atazanavir sulfate 170.872mg (equiv 150 mg atazanavir) Excipient: Crospovidone Gelatin Indigo carmine Lactose monohydrate Magnesium stearate Titanium dioxide
Prescription
Laurus Labs Limited
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.
Package - Contents - Shelf Life: Blister pack, OPA/Al/PVC // Al blisters in cardboard carton - 60 capsules - 24 months from date of manufacture stored at or below 30°C - Bottle, HDPE bottle with CR polypropylene cap - 60 capsules - 24 months from date of manufacture stored at or below 30°C 3 months opened, Not Specified
2017-07-21
Version 1.0 1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME Atazanavir 150 mg Capsules, Hard (Teva) Atazanavir 200 mg Capsules, Hard (Teva) Atazanavir 300 mg Capsules, Hard (Teva) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Atazanavir 150 mg Hard Capsules: Each capsule contains 150 mg of atazanavir (as sulfate). Atazanavir 200 mg hard capsules: Each capsule contains 200 mg of atazanavir (as sulfate). Atazanavir 300 mg hard capsules: Each capsule contains 300 mg of atazanavir (as sulfate). Excipient with known effect: lactose monohydrate For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule ATAZANAVIR 150 MG HARD CAPSULES: Atazanavir hard capsules 150 mg are non-transparent capsules, size 1, with dark blue cap, and black mark 150 on light blue body. The content of the capsule is light yellow powder. ATAZANAVIR 200 MG HARD CAPSULES: Atazanavir hard capsules 200 mg are non-transparent capsules, size 0, with blue cap, and black mark 200 on blue body. The content of the capsule is light yellow powder. ATAZANAVIR 300 MG HARD CAPSULES: Atazanavir hard capsules 300 mg are non-transparent capsules, size 00, with red cap, and black mark 300 on blue body. The content of the capsule is light yellow powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Atazanavir 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 5.1 Pharmacodynamic properties – Clinical efficacy and safety). 4.2 DOSE AND METHOD OF ADMINISTRATION _General Dosing Recommendations _ Atazanavir capsules must be taken with food. Atazanavir capsules should be taken WHOLE. The recommended doses are to be administered using combinations of registered capsule strengths; eg a dose of 300 mg may be administered as one 300 mg capsule or two 150 mg capsules. The recommended oral dosage of Atazanavir capsules depend Đọc toàn bộ tài liệu