SAYANA Suspension for Injection 104mg /0.6 Unknown
Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
Charakterystyka produktu
(SPC)
23-05-2024
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Składnik aktywny:
MEDROXYPROGESTERONE ACETATE
Dostępny od:
Pfizer Limited
Dawkowanie:
104mg /0.6 Unknown
Forma farmaceutyczna:
Suspension for Injection
Data autoryzacji:
2008-02-29
Charakterystyka produktu
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
SAYANA 104 mg/0.65 ml suspension for injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
SAYANA single dose pre-filled syringe containing 104 mg medroxyprogesterone acetate (MPA) in 0.65 mL
suspension for injection.
Excipients:
Methyl parahydroxybenzoate – 1.04 mg per 0.65ml
Propyl parahydroxybenzoate – 0.0975 mg per 0.65ml
Sodium – 2.47 mg per 0.65ml
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Suspension for 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 Special Warnings and Precautions for Use), 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 is available for intramuscular MPA in this
population.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The prefilled syringe of SAYANA should be vigorously shaken just before use to ensure that the dose being given
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