SAYANA PRESS 104MG INJ 1s 0.65ML

SAYANA PRESS 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 (BMD) may occur in females of all ages who use SAYANA PRESS 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 PRESS is only indicated when other contraceptive methods are considered unsuitable or unacceptable, due to unknown long-term effects of bone loss associated with SAYANA PRESS during the critical period of bone accretion. • SAYANA PRESS has not been studied in women under the age of 18 years but data are available for intramuscular depot-medroxyprogesterone acetate (DMPA-IM) 150mg in this population. Features Nature and contents of container: • SAYANA PRESS suspension for injection is supplied in a single-dose container in the form of a pre-filled injector containing 0.65 ml. The injector comprises a linear low density polyethylene laminate reservoir with a siliconized AISI Type 304 Stainless Steel 23 gauge thin wall needle attached via a low density polyethylene port and valve. • The pack sizes are one single-dose container and 200 single-dose containers. Special precautions for storage: • Do not refrigerate or freeze Shelf life: • Unopened: 3 years • Once opened: use immediately, discard any unused portion