1. Name of the medicinal product
Depo-Provera 150 mg/ml
2. Qualitative and quantitative composition
Each ml of suspension contains 150 mg medroxyprogesterone acetate
Excipients with known effect:
Methylparaben (E218) – 1.35mg
Propylparaben (E216) – 0.15mg
Sodium chloride – 3.38mg
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Sterile suspension for injection.
4. Clinical particulars
4.1 Therapeutic indications
Progestogen: for contraception.
Depo-Provera is indicated for long-term female contraception. Each injection prevents ovulation and provides contraception for at least 12 weeks (+/- 5 days). 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).
Depo-Provera is suitable for use in women who have been appropriately counselled concerning the likelihood of menstrual disturbance and the potential for a delay in return to full fertility.
Depo-Provera may also be used for short-term contraception in the following circumstances:
1) For partners of men undergoing vasectomy, for protection until the vasectomy becomes effective.
2) In women who are being immunised against rubella, to prevent pregnancy during the period of activity of the virus.
3) In women awaiting sterilisation.
Since loss of bone mineral density (BMD) may occur in females of all ages who use Depo-Provera injection 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 before giving the injection of Depo-Provera.
Paediatric population (12-18 years)
In adolescents, Depo-Provera may be used, but only after other methods of contraception have been discussed with the patient and considered unsuitable or unacceptable.
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 patient before giving the injection of Depo-Provera.
4.2 Posology and method of administration
First injection: To provide contraceptive cover in the first cycle of use, an injection of 150 mg i.m. should be given during the first five days of a normal menstrual cycle. If the injection is carried out according to these instructions, no additional contraceptive cover is required.
Post Partum: To increase assurance that the patient is not pregnant at the time of first administration, this injection should be given within 5 days post partum if not breast-feeding.
There is evidence that women prescribed Depo-Provera in the immediate puerperium can experience prolonged and heavy bleeding. Because of this, the drug should be used with caution in the puerperium. Women who are considering use of the product immediately following delivery or termination should be advised that the risk of heavy or prolonged bleeding may be increased. Doctors are reminded that in the non breast-feeding, post partum patient, ovulation may occur as early as week 4.
If the puerperal woman will be breast-feeding, the initial injection should be given no sooner than six weeks post partum, when the infant's enzyme system is more fully developed. Further injections should be given at 12 week intervals.
Further doses: These should be given at 12 week intervals, however, as long as the injection is given no later than five days after this time, no additional contraceptive measures (e.g. barrier) are required. (N.B. For partners of men undergoing vasectomy, a second injection of 150 mg I.M. 12 weeks after the first may be necessary in a small proportion of patients where the partner's sperm count has not fallen to zero.) If the interval from the preceding injection is greater than 89 days (12 weeks and five days) for any reason, then pregnancy should be excluded before the next injection is given and the patient should use additional contraceptive measures (e.g. barrier) for fourteen days after this subsequent injection.
Elderly: Not appropriate.