Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
MEDROXYPROGESTERONE ACETATE
PCO Manufacturing
150 Mg/Ml
Solution for Injection
2006-04-07
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Depo-Provera 150 mg/ml Suspension for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 150mg of medroxyprogesterone acetate. Excipients: Methyl parahydroxybenzoate (E218) Propyl parahydroxybenzoate (E216) For a full list of excipients see section 6.1 3 PHARMACEUTICAL FORM Suspension for injection. _Product imported from Belgium:_ White, sterile, aqueous suspension. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As a progestogen, for parenteral administration: _Contraception_ Depo-Provera is indicated for contraception. Depo-Provera may also be used for short-term contraception in the following circumstances: i. For partners of men undergoing vasectomy, for protection until the vasectomy becomes effective. ii. In women who are being immunised against rubella, to prevent pregnancy during the period of activity of the virus. iii. In women awaiting sterilisation. Since loss of bone mineral density (BMD) may occur in females of all ages who use MPA injection long-term (See section 4.4 Special warnings and special 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. It is of the greatest importance that adequate explanations of the long-term nature of the product, of its possible side effects and of the impossibility of immediately reversing the effects of each injection are given to potential users and that every effort is made to ensure that each patient receives such counselling as to enable her to fully understand these explanations. Patient information leaflets are supplied by the manufacturer. It is recommended that the doctor uses these leaflets to aid counselling of the Read the complete document