DEPO-PROVERA STERILE AQUEOUS SUSPENSION 50 mgml

מדינה: סינגפור

שפה: אנגלית

מקור: HSA (Health Sciences Authority)

מרכיב פעיל:

MEDROXYPROGESTERONE ACETATE

זמין מ:

PFIZER PRIVATE LIMITED

קוד ATC:

G03AC06

כמות:

50 mg/ml

טופס פרצבטיות:

INJECTION

הרכב:

MEDROXYPROGESTERONE ACETATE 50 mg/ml

מסלול נתינה (של תרופות):

INTRAMUSCULAR

סוג מרשם:

Prescription Only

תוצרת:

PFIZER MANUFACTURING BELGIUM NV

מצב אישור:

ACTIVE

תאריך אישור:

1990-05-29

עלון מידע

  
1
1. 
TRADE NAME OF THE MEDICINAL PRODUCT 

Depo-Provera Sterile Aqueous Suspension 50 mg/mL. 
Depo-Provera Sterile Aqueous Suspension 150 mg/mL. 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Depo-Provera Sterile Aqueous Suspension
50 mg/mL: Each mL of injectable 
suspension contains 50 mg medroxyprogesterone acetate. 

Depo-Provera Sterile Aqueous Suspension 150
mg/mL: Each mL of injectable 
suspension contains 150 mg medroxyprogesterone acetate. 

For excipients, see SECTION 6.1. 

3. PHARMACEUTICAL 
FORM 

Suspension for intramuscular injection. 

4. CLINICAL 
PARTICULARS 

4.1 
THERAPEUTIC INDICATION 

Medroxyprogesterone acetate (MPA) injectable suspension is
indicated for: 

_CONTRACEPTION _
Contraception (ovulation suppression). 

_GYNECOLOGY _
Treatment of endometriosis. 
Treatment of menopausal vasomotor symptoms. 

_ONCOLOGY _
Adjunctive and/or palliative treatment of recurrent and/or
metastatic endometrial or 
renal carcinoma. 

Treatment of hormonally-dependent, recurrent breast
cancer in post-menopausal 
women. 

_LONG-TERM USE_: 
Since loss of bone mineral density (BMD) may occur in
pre-menopausal women

who 
use MPA injection long-term (see SECTION 4.4,
SPECIAL WARNINGS AND PRECAUTIONS FOR 
USE - ADDITIONAL WARNINGS & PRECAUTIONS FOR SPECIFIC USE OR FORMULATION, 
_CONTRACEPTION/ENDOMETRIOSIS - INJECTABLE FORMULATIONS_, LOSS OF
BONE MINERAL 
DENSITY (BMD) and SECTION 5.1, PHARMACODYNAMIC
PROPERTIES - _CLINICAL STUDIES_, 
BONE MINERAL DENSITY STUDIES), a risk/benefit assessment,
which also takes into 
consideration the decrease in BMD that
occurs during pregnancy and/or lactation, 
should be considered. 

2
_USE IN CHILDREN: _
MPA IM is not indicated before menarche. 

Data are available in adolescent
females (12-18 years) (see SECTION 5.1, 
PHARMACODYNAMIC PROPERTIES - _CLINICAL STUDIES, _BMD CH

מאפייני מוצר

Page 1 of 20
DEPO-PROVERA™
Sterile Aqueous Suspension 50 mg/mL
1.
NAME OF THE MEDICINAL PRODUCT
Depo-Provera Sterile Aqueous Suspension 50 mg/mL.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Depo-Provera Sterile Aqueous Suspension 50 mg/mL: Each mL of
injectable
suspension contains 50 mg of medroxyprogesterone acetate.
For excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
Suspension for intramuscular (IM) injection.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATION
Medroxyprogesterone acetate (MPA) injectable suspension is indicated
for:
_CONTRACEPTION_
Contraception (ovulation suppression).
_GYNECOLOGY_
Treatment of endometriosis.
Treatment of menopausal vasomotor symptoms.
_ONCOLOGY_
Adjunctive and/or palliative treatment of recurrent and/or metastatic
endometrial or
renal carcinoma.
Treatment of hormonally-dependent, recurrent breast cancer in
post-menopausal
women.
_LONG-TERM USE_
Since loss of bone mineral density (BMD) may occur in pre-menopausal
women who
use MPA injection long-term (see SECTION 4.4 SPECIAL WARNINGS AND
PRECAUTIONS FOR
USE - ADDITIONAL WARNINGS AND PRECAUTIONS FOR SPECIFIC USE OR
FORMULATION,
_CONTRACEPTION/ENDOMETRIOSIS - INJECTABLE FORMULATIONS_, LOSS OF BONE
MINERAL
DENSITY (BMD) and SECTION 5.1 PHARMACODYNAMIC PROPERTIES -_ CLINICAL
STUDIES_,
BMD STUDIES), a risk/benefit assessment, which also takes into
consideration the
decrease in BMD that occurs during pregnancy and/or lactation, should
be considered.
Page 2 of 20
_USE IN CHILDREN_
MPA IM is not indicated before menarche.
Data are available in adolescent females (12-18 years) (see SECTION
5.1
PHARMACODYNAMIC PROPERTIES -_ CLINICAL STUDIES, _BMD CHANGES IN
ADOLESCENT
FEMALES (12-18 YEARS)). The safety and effectiveness of MPA IM are
expected to be
the same for post-menarcheal adolescent and adult females.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Injectable suspensions should be shaken well before use.
_CONTRACEPTION_
_Contraception (Ovulation Suppression)_
MPA intramuscular injectable suspension should be vig