국가: 싱가포르
언어: 영어
출처: HSA (Health Sciences Authority)
Hydroxyprogesterone Caproate
BAYER (SOUTH EAST ASIA) PTE LTD
G03DA03
INJECTION
Hydroxyprogesterone Caproate 0.250g/ml
INTRAMUSCULAR
Prescription Only
Bayer AG (Berlin, Müllerstraβe)
ACTIVE
2015-10-27
Proluton Depot_SG_CCDSv4_Aug 2022 BAYER LOGO PROLUTON DEPOT NAME OF THE MEDICINAL PRODUCT Proluton Depot, 250mg, solution for intramuscular injection QUALITATIVE AND QUANTITATIVE COMPOSITION 1ml Proluton Depot contains 250 mg hydroxyprogesterone caproate in oily solution. PHARMACEUTICAL FORM Oily solution for intramuscular injection. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS Habitual and imminent abortion 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“). • 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. Proluton Depot_SG_CCDSv4_Aug 2022 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 t 전체 문서 읽기