DEPO-PROVERA 500

देश: इसराइल

भाषा: अंग्रेज़ी

स्रोत: Ministry of Health

सक्रिय संघटक:

MEDROXYPROGESTERONE ACETATE

थमां उपलब्ध:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

ए.टी.सी कोड:

L02AB02

फार्मास्यूटिकल फॉर्म:

SUSPENSION FOR INJECTION

रचना:

MEDROXYPROGESTERONE ACETATE 150 MG/ML

प्रशासन का मार्ग:

I.M

प्रिस्क्रिप्शन प्रकार:

Required

द्वारा बनाया गया:

PFIZER MANUFACTURING BELGIUM NV/SA

चिकित्सीय समूह:

MEDROXYPROGESTERONE

चिकित्सीय क्षेत्र:

MEDROXYPROGESTERONE

चिकित्सीय संकेत:

Palliation of inoperable recurrent or metastatic carcinoma of endometrium, breast, ovary and kidney.

प्राधिकरण की तारीख:

2021-01-31

उत्पाद विशेषताएं

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