Sayana Press 104mg/0.65ml Injection x1

Suspension for injection - white to off-white homogeneous suspension

Therapeutic indications
• 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