البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
MEDROXYPROGESTERONE ACETATE
PFIZER PFE PHARMACEUTICALS ISRAEL LTD
G03AC06
TABLETS
MEDROXYPROGESTERONE ACETATE 5 MG
PER OS
Required
PFIZER INC, USA
MEDROXYPROGESTERONE
MEDROXYPROGESTERONE
In cases requiring progesterone supplement.
2022-11-30
Provera 5 mg PIL CC 281121 English_ _ 0073740 - 2021 ULATIONS (PREPARATIONS) ' REG HE PHARMACISTS IN ACCORDANCE WITH T NSERT PATIENT PACKAGE I 1986 - on only r’s prescripti a docto ith e is dispensed w medicin This PROVERA ® 5 MG TABLETS ACTIVE INGREDIENT Medroxyprogesterone acetate 5 mg A list of inactive and allergenic ingredients in the preparation is provided in section 6. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, contact the doctor or pharmacist. This medicine has been prescribed to treat you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar. This medicine is intended to treat women over the age of 18 years. 1. WHAT IS THIS MEDICINE INTENDED FOR? To treat cases requiring administration of exogenous progesterone. THERAPEUTIC GROUP: Progestogen, similar to the natural sex hormone progesterone. 2. BEFORE USING THE MEDICINE X DO NOT USE THE MEDICINE IF: × you are sensitive (allergic) to the active ingredient or to other similar hormonal medicines or to any of the other ingredients contained in the medicine (listed in section 6). × you are pregnant or think you may be pregnant. The doctor may ask you to perform a pregnancy test before starting treatment or during the treatment if your period is delayed. × you have breast cancer or have been diagnosed with breast cancer in the past. × you suffer from or have suffered in the past from formation of venous blood clots (venous thrombosis). × you suffer from or have suffered in the past from formation of arterial blood clots (arterial thrombosis). × you suffer from liver problems. × you suffer from porphyria - when your body lacks the ability to correctly produce certain enzymes, and it manifests with either neurological complications or with skin problems (or occasionally both). SPECIAL WARNINGS REGARDING THE USE OF THE MEDICINE ! Before treatment with the medicine, tell the do اقرأ الوثيقة كاملة
DEPO-PROVERA ® 500 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Depo-Provera ® 500 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Depot-medroxyprogesterone acetate injectable suspension is available as 500 mg/3.3 ml vial. Excipients with known effect: Methyl paraben Propyl paraben Sodium chloride For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for intramuscular injection. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS DEPO-PROVERA ® 500 is indicated for: Palliation of inoperable recurrent or metastatic carcinoma of endometrium, breast, ovary and kidney. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Injectable suspensions should be shaken well before use. The site of injection should be cleansed using standard methods prior to administration of the injection. _RECURRENT AND/OR METASTATIC BREAST CANCER_ INJECTABLE DMPA INITIAL DOSE 500 TO 1000 MG INTRAMUSCULARLY PER DAY FOR 28 DAYS. THE PATIENT SHOULD THEN BE PLACED ON A MAINTENANCE SCHEDULE OF 500 MG TWICE WEEKLY AS LONG AS SHE RESPONDS TO TREATMENT. _RECURRENT AND/OR METASTATIC ENDOMETRIAL OR RENAL CANCER_ INJECTABLE DMPA 400 TO 1000 MG INTRAMUSCULARLY PER WEEK IS RECOMMENDED INITIALLY. IF IMPROVEMENT IS NOTED WITHIN A FEW WEEKS OR MONTHS AND THE DISEASE APPEARS STABILIZED, IT MAY BE POSSIBLE TO MAINTAIN IMPROVEMENT WITH AS LITTLE AS 400 MG PER MONTH. _LONG-TERM USE_ Since loss of bone mineral density (BMD) may occur in pre-menopausal women who use DMPA injection long-term (SEE SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE AND SECTION 5.1 PHARMACODYNAMIC PROPERTIES, _CLINICAL TRIALS RELATING TO BONE MINERAL DENSITY_), a risk/ benefit assessment, which also takes into consideration the decrease in BMD that occurs during pregnancy and/or lactation, should be considered. _USE IN CHILDREN_ DMPA IM is not indicated before menarche. Data are available in adolescent females (12-18 years) (SEE SECTION 5.1 PHARMACODYNAMIC PROPERTIES, _CLINICAL TRIALS, CHANGES IN _ _BMD IN ADOLESCENT FEMALES (AGED اقرأ الوثيقة كاملة