Transcription of NEW ZEALAND DATA SHEET - Medsafe
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Version: pfddepoi11017 Supersedes: pfddepoi11016 Page 1 of 18 NEW ZEALAND DATA SHEET 1. PRODUCT NAME depo - provera 150 mg/mL Injection (depot) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 mL vial contains 150 mg/mL Medroxyprogesterone acetate Each 1 mL disposable syringe contains 150 mg/mL Medroxyprogesterone acetate Excipients with known effects: Sodium Methyl hydroxybenzoate, Propyl hydroxybenzoate, For the full list of excipients, see section 3. PHARMACEUTICAL FORM depo - provera 150 mg/mL Injection (depot) is a white, aqueous, suspension containing medroxyprogesterone acetate (MPA) as the active ingredient. 4. CLINICAL PARTICULARS Therapeutic indications depo - provera is indicated for: ovulation suppression. Since loss of bone mineral density (BMD) may occur in pre-menopausal women who use depo - provera , particularly if treated long-term (greater than 2 years), women should be assessed for risk factors for low BMD including a review of their medical history, to determine the risk of developing osteoporosis.
Version: pfddepoi11017 Supersedes: pfddepoi11016 Page 1 of 18 NEW ZEALAND DATA SHEET. 1. PRODUCT NAME . DEPO-PROVERA® 150 mg/mL Injection (depot) . 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
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