Posology : מינונים

4.2    Posology and method of administration
The site of injection should be cleansed using standard methods prior to administration of the injection.


Depo Provera 150 mg/ml - DMPA intramuscular (IM) suspension should be vigorously shaken just before use to ensure that the dose being administered represents a uniform suspension.

The recommended dose is 150 mg of DMPA injectable suspension every 12 weeks administered by intramuscular injection in the gluteal or deltoid muscle. The IM suspension is not formulated for subcutaneous injection.


First injection
The initial IM injection should be given during the first 5 days after the onset of a normal menstrual period; within 5 days postpartum if not breast-feeding; or, if exclusively breast-feeding, at or after 6 weeks postpartum.


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.
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 Switching from other Methods of Contraception

When switching from other contraceptive methods, DMPA IM should be given in a manner that ensures continuous contraceptive coverage based upon the mechanism of action of both methods, (e.g., patients switching from oral contraceptives should have their first injection of DMPA within 7 days after taking their last active pill).

Long-Term Use
Since loss of bone mineral density (BMD) may occur in pre-menopausal women who use DMPA injection long-term (see Section 4.4 Special warnings and precautions for use and Section 5.1 – Pharmacodynamic properties, Clinical Studies, Bone Mineral Density Studies), 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 Children
DMPA IM is not indicated before menarche. Data are available in adolescent females (12-18 years) (see Section 5.1-Pharmacodynamic properties, Clinical Studies, BMD Changes in Adolescent Females (12-18 years). Other than concerns about loss of BMD, the safety and effectiveness of DMPA IM are expected to be the same as for postmenarcheal adolescent and adult females.



Hepatic Insufficiency

No clinical studies have evaluated the effect of hepatic disease on the pharmacokinetics of MPA.
However, MPA is almost exclusively eliminated by hepatic metabolism and steroid hormones may be poorly metabolized in patients with severe liver insufficiency, (see Section 4.3 - Contraindications).

Renal Insufficiency

No clinical studies have evaluated the effect of renal disease on the pharmacokinetics of MPA.
However, since MPA is almost exclusively eliminated by hepatic metabolism, no dosage adjustment should be necessary in women with renal insufficiency.