SAYANA

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

MEDROXYPROGESTERONE ACETATE

متاح من:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

ATC رمز:

G03AC06

الشكل الصيدلاني:

SUSPENSION FOR INJECTION

تركيب:

MEDROXYPROGESTERONE ACETATE 104 MG / 0.65 ML

طريقة التعاطي:

S.C

نوع الوصفة الطبية :

Required

المصنعة من قبل:

PFIZER MANUFACTURING BELGIUM NV/SA

المجموعة العلاجية:

MEDROXYPROGESTERONE

المجال العلاجي:

MEDROXYPROGESTERONE

الخصائص العلاجية:

* SAYANA is indicated for long-term female 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 may occur in females of all ages who use SAYANA long-term, a risk/benefit assessment, which also takes into consideration the decrease in bone mineral density that occurs during pregnancy and/or lactation, should be considered.* Use in Adolescents (12-18 years)In adolescents, use of SAYANA is only indicated when other contraceptive methods are considered unsuitable or unacceptable, due to unknown long-term effects of bone loss associated with SAYANA during the critical period of bone accretion.SAYANA has not been studied in women under the age of 18 years but data is available for intramuscular medroxyprogesterone acetate in this population.

تاريخ الترخيص:

2015-06-30

نشرة المعلومات

Sayana PIL CC
161023
0080695
-
2
202
;
081831
0
-
2022
1
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خصائص المنتج

Sayana LPD Israel CC 161023
2022-0080695
Page 1 of 19
SAYANA
®
1.
NAME OF THE MEDICINAL PRODUCT
SAYANA
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
SAYANA
®
single-dose pre-filled syringe containing 104 mg depot
medroxyprogesterone acetate
(DMPA) in 0.65 ml suspension for injection.
Excipients
with
known effect:
Methyl parahydroxybenzoate – 1.04 mg per 0.65 ml
Propyl parahydroxybenzoate – 0.0975 mg per 0.65 ml
Sodium – 2.47 mg per 0.65 ml
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for
subcutaneous injection
White to off-white homogeneous suspension
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
SAYANA
®
is indicated for long-term female 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 (see section
4.4).
Since loss of bone mineral density (BMD) may occur in females of all
ages who use SAYANA
®
long-
term (see section 4.4), 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 Adolescents (12-18 years)
In adolescents, use of SAYANA
®
is only indicated when other contraceptive methods are considered
unsuitable or unacceptable, due to unknown long-term effects of bone
loss associated with SAYANA
®
during the critical period of bone accretion (see section 4.4).
SAYANA
®
has not been studied in women under the age of 18 years but data are
available for
intramuscular MPA in this population.
4.2
Posology and method of administration
The pre-filled syringe of SAYANA
®
should be vigorously shaken just before use to ensure that the
dose being given represents a uniform suspension. The treatment should
be initiated by a doctor or
healthcare assistant and administered as a subcutaneous injection (SC)
into the anterior thigh or
Sayana LPD Israel CC 161023
2022-0080695
P