PROLUTON DEPOT INJECTION 250MG/ML

BAYER (SOUTH EAST ASIA) PTE LTD

BAYER (SOUTH EAST ASIA) PTE LTD

Therapeutic

Prescription Only

INJECTION

**Dosage and method of administration** - **How to use Proluton Depot** Proluton Depot must be administered always as a deep intramuscular injection, preferably intragluteal, alternatively into the upper arm. The injection must be administered extremely slowly (see section “Undesirable effects” – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - Abortion According to the present state of scientific knowledge, medicinal therapy should be given in early pregnancy only if it is absolutely essential. This is also valid for the use of hormone preparations such as Proluton Depot for the maintenance of pregnancy. Consequently, Proluton Depot should only be prescribed if there is an urgent desire for children – primarily in the presence of corpus luteum insufficiency or a case history of abortion. Proluton Depot is indicated for both prophylaxis and treatment of abortion because it compensates for the hormone deficit, induces quiescence of the uterus and stimulates growth of an underdeveloped uterus. Prolonged treatment with an adequate dosage of Proluton Depot is necessary to achieve this objective and to maintain pregnancy. Because Proluton Depot places the uterus at rest, it is possible for an already dead embryo to be retained. In the case of protracted therapy, it is therefore necessary to check the continued existence of pregnancy by means of appropriate examinations and immunological tests. - Habitual abortion As soon as pregnancy has been confirmed by diagnosis, 250 – 500 mg Proluton Depot are injected i.m. at weekly intervals during the initial months or, in individual cases, for even longer. - Imminent abortion The therapy is initiated with an i.m. injection of 500 mg Proluton Depot 2 – 3 times weekly until the bleeding ceases, bed rest being urgently recommended. The treatment must then be continued for several weeks with 250 mg Proluton Depot i.m. twice weekly until the patient remains free from complaints and bleeding despite mobilization. Whether Proluton Depot should be given prophylactically even beyond this point will depend on the individual case. 8 to 14 days after unsuccessful treatment of imminent abortion and subsequent curettage withdrawal bleeding may occur in isolated cases owing to the continuing effect of Proluton Depot which subsides only gradually. However, no further measures are necessary.