Country: Նոր Զելանդիա
language: անգլերեն
source: Medsafe (Medicines Safety Authority)
Medroxyprogesterone acetate 150 mg/mL
Pfizer New Zealand Limited
Medroxyprogesterone acetate 150 mg/mL
150 mg/mL
Injection (depot)
Active: Medroxyprogesterone acetate 150 mg/mL Excipient: Hydrochloric acid Macrogol 3350 Methyl hydroxybenzoate Polysorbate 80 Propyl hydroxybenzoate Sodium chloride Sodium hydroxide
Syringe, Disposable, 1 mL
Prescription
Prescription
Valdepharm
Adjunctive and/or palliative treatment of recurrent and/or metastatic endometrial or renal carcinoma
Package - Contents - Shelf Life: Syringe, Disposable - 1 mL - 60 months from date of manufacture stored at or below 25°C - Vial, glass, 1ml - 1 mL - 36 months from date of manufacture stored at or below 30°C
1969-12-31
DEPO-PROVERA ® 1 DEPO-PROVERA ® _Medroxyprogesterone acetate 150 mg/mL injection(depot)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about DEPO-PROVERA. 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 being treated with DEPO-PROVERA against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT DEPO- PROVERA IS USED FOR The active ingredient of DEPO- PROVERA, medroxyprogesterone acetate, is a chemical similar to the natural hormone progesterone. Progesterone is produced by your ovaries during the second half of your monthly cycle. There are several reasons why your doctor may have prescribed DEPO- PROVERA for you. DEPO-PROVERA is used for the following reasons: CONTRACEPTION DEPO-PROVERA is an injectable form of contraception. Each injection protects you from pregnancy for 3 months. DEPO-PROVERA works by inhibiting the hormones that are needed for the release of the eggs from the ovaries. ENDOMETRIOSIS Endometriosis is a condition in which cells from the lining of the uterus (womb) grow in places outside the uterus. During your period, these cells may grow and break down in the same way as those in the lining of the uterus. This causes pain and discomfort. DEPO-PROVERA helps to stop the growth of the cells found outside the uterus. CANCER DEPO-PROVERA is also used in the treatment of certain types of cancer including cancer of the breast, kidney and endometrium (lining of the uterus). It works by inhibiting the growth of these types of cancer cells. DEPO-PROVERA is not a cure for cancer. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is available only with a doctor's pre read_full_document
Version: pfddepoi10220 Supersedes: pfddepoi11017 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 6.1. 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 4.1 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. This should be conducted before the commencement of treatment. A careful re-evaluation of the risks and benefits of treatment beyond 2 years should be carried out in those patients who need to remain on DEPO-PROVERA. Women under the age of 18 years may be at risk of failing to achieve their predicted peak BMD (see section 4.4). • the treatment of endometriosis. • adjunctive and/or palliative treatment of recurrent and/or metastatic endometrial or renal carcinoma. • the treatment of hormonally-dependent recurrent breast cancer in post-menopausal women. Version: pfddepoi10220 Supersedes: pfddepoi11017 Page 2 of 18 4.2 DOSE AND METHOD OF ADMINISTRATION OVULATION SUPPRESSION DEPO-PROVERA should be vigorously shaken just before use to ensure that the dose being administered represents a uniform suspension. The IM suspension is not formulated for subcutaneous injection. The recommended dose is 150 mg of DEPO-PROVERA every 3 months administered by IM injection in the gluteal or read_full_document