DEPO-PROVERA STERILE AQUEOUS SUSPENSION 50 mgml

国家: 新加坡

语言: 英文

来源: HSA (Health Sciences Authority)

有效成分:

MEDROXYPROGESTERONE ACETATE

可用日期:

PFIZER PRIVATE LIMITED

ATC代码:

G03AC06

剂量:

50 mg/ml

药物剂型:

INJECTION

组成:

MEDROXYPROGESTERONE ACETATE 50 mg/ml

给药途径:

INTRAMUSCULAR

处方类型:

Prescription Only

厂商:

PFIZER MANUFACTURING BELGIUM NV

授权状态:

ACTIVE

授权日期:

1990-05-29

资料单张

DEPO-PROVERA
TABLE OF CONTENT
_Please click on either of the following links to access the required
information:_
PRESCRIBING INFORMATION
PATIENT INFORMATION LEAFLET
Page 1 of 19
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 19
_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

产品特点

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