Pregnancy & Lactation : הריון/הנקה

4.6 Fertility, pregnancy and lactation
3. PHARMACEUTICAL FORM Pregnancy
Suspension for intramuscular injection.
Depo-Provera® is contraindicated during pregnancy.
4. CLINICAL PARTICULARS Notifications suggest, in certain circumstances, an association between intrauterine exposure to progestogen medications during the first three months of pregnancy and the occurrence of genital 4.1 Therapeutic indications anomalies in the foetus.
DEPO-PROVERA® 500 is indicated for: Palliation of inoperable recurrent or metastatic carcinoma Children resulting from unintentional pregnancies that took place 1 to 2 months after administration of endometrium, breast, ovary and kidney. of Depo-Provera® can present an increased risk of being born with low weight, which in turn is 4.2 Posology and method of administration associated with an increased risk of neonatal death. The risk attributed is low since pregnancy during treatment with Depo-Provera® is infrequent. There is no definitive information on the other Posology formulations of medroxyprogesterone acetate (see Section 5.2 Distribution).
Injectable suspensions should be shaken well before use. If the pregnancy occurs during the therapy, the patient should be informed about the potential risks The site of injection should be cleansed using standard methods prior to administration of the for the foetus.
injection. Breastfeeding Recurrent and/or Metastatic Breast Cancer Medroxyprogesterone acetate and its metabolites are excreted in breast milk. There is no evidence Injectable DMPA initial dose 500 to 1000 mg intramuscularly per day for 28 days. The that this fact represents a risk to the infant (see Section 5.2 Distribution).
patient should then be placed on a maintenance schedule of 500 mg twice weekly as Fertility long as she responds to treatment.
Depo-Provera® has a prolonged contraceptive effect. In the event of conception, the average time Recurrent and/or Metastatic Endometrial or Renal Cancer for this to occur is after 10 months (ranging from 4-31 months) after the last administration, but there Injectable DMPA 400 to 1000 mg intramuscularly per week is recommended initially. If is no relation to the duration of the treatment.
improvement is noted within a few weeks or months and the disease appears stabilized, it may be possible to maintain improvement with as little as 400 mg per month.