Valsts: Izraēla
Valoda: angļu
Klimata pārmaiņas: Ministry of Health
MEDROXYPROGESTERONE ACETATE
PFIZER PFE PHARMACEUTICALS ISRAEL LTD
L02AB02
SUSPENSION FOR INJECTION
MEDROXYPROGESTERONE ACETATE 150 MG/ML
I.M
Required
PFIZER MANUFACTURING BELGIUM NV/SA
MEDROXYPROGESTERONE
MEDROXYPROGESTERONE
Palliation of inoperable recurrent or metastatic carcinoma of endometrium, breast, ovary and kidney.
2021-01-31
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 Izlasiet visu dokumentu