PROLUTON DEPOT INJECTION 250MGML

Χώρα: Σιγκαπούρη

Γλώσσα: Αγγλικά

Πηγή: HSA (Health Sciences Authority)

Δραστική ουσία:

Hydroxyprogesterone Caproate

Διαθέσιμο από:

BAYER (SOUTH EAST ASIA) PTE LTD

Φαρμακολογική κατηγορία (ATC):

G03DA03

Φαρμακοτεχνική μορφή:

INJECTION

Σύνθεση:

Hydroxyprogesterone Caproate 0.250g/ml

Οδός χορήγησης:

INTRAMUSCULAR

Τρόπος διάθεσης:

Prescription Only

Κατασκευάζεται από:

Bayer AG (Berlin, Müllerstraβe)

Καθεστώς αδειοδότησης:

ACTIVE

Ημερομηνία της άδειας:

2015-10-27

Αρχείο Π.Χ.Π.

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