SAYANA PRESS

Krajina: Indonézia

Jazyk: indonézština

Zdroj: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Aktívna zložka:

MEDROXYPROGESTERONE ACETATE

Dostupné z:

PFIZER INDONESIA - Indonesia

INN (Medzinárodný Name):

MEDROXYPROGESTERONE ACETATE

Dávkovanie:

104 MG

Forma lieku:

SUSPENSI INJEKSI

Počet v balení:

DUS, 200 SINGLE-DOSE CONTAINER @ 0.65 ML

Výrobca:

PFIZER MANUFACTURING BELGIUM NV - Belgium

Dátum Autorizácia:

2020-02-25

Súhrn charakteristických

Generic Name: Medroxyprogesterone Acetate
Trade Name: SAYANA
®
PRESS
CDS Effective Date: November 01, 2019
Supersedes: July 17, 2017
Approved by BPOM:
2019-0053886
Page 1 of 15
PT. PFIZER INDONESIA
LOCAL PRODUCT DOCUMENT
Generic Name: Medroxyprogesterone Acetate
Trade Name: SAYANA
®
PRESS
CDS Effective Date: November 01, 2019
Supersedes: July 17, 2017
1.
NAME OF THE MEDICINAL PRODUCT
1.1.
PRODUCT NAME
SAYANA
®
PRESS
1.2.
STRENGTH
104 mg/0.65 mL
1.3.
PHARMACEUTICAL DOSAGE FORM
White to off-white suspension for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1.
QUALITATIVE DECLARATION
SAYANA
®
PRESS 104 mg/0.65 mL injectable suspension is a single dose container.
It
contains 104 mg medroxyprogesterone acetate (MPA) in 0.65 mL.
2.2.
QUANTITATIVE DECLARATION
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for subcutaneous (SC) injection
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
SAYANA
®
PRESS is indicated for contraception. Each subcutaneous injection
prevents
ovulation and provides contraception for at least 13 weeks (+/- 1
week). However, it should
be taken into consideration that the return to fertility (ovulation)
may be delayed for up to one
year.
Since loss of bone mineral density (BMD) may occur in pre-menopausal
women who use
SAYANA
®
PRESS injection long-term, a risk/benefit assessment, which also takes
into
consideration the decrease in BMD that occurs during pregnancy and/or
lactation, should be
considered.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Injectable suspensions should be shaken well before use.
DISETUJUI OLEH BPOM: 28/12/2020
EREG10024112000485
Generic Name: Medroxyprogesterone Acetate
Trade Name: SAYANA
®
PRESS
CDS Effective Date: November 01, 2019
Supersedes: July 17, 2017
Approved by BPOM:
2019-0053886
Page 2 of 15
Contraception
SAYANA
®
PRESS should be vigorously shaken just before use to ensure that the
dose being
administered represents a uniform suspension.
The recommended dose is 104 mg. SAYANA
®
PRESS must be given by subcuta