DECAPEPTYL

Land: Indonesien

Sprog: indonesisk

Kilde: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Aktiv bestanddel:

TRIPTORELIN ACETATE

Tilgængelig fra:

FERRING PHARMACEUTICALS INDUSTRY - Indonesia

INN (International Name):

TRIPTORELIN ACETATE

Dosering:

0.1 MG

Lægemiddelform:

LARUTAN INJEKSI

Enheder i pakken:

DUS, 7 PREFILLED SYRINGE @ 1 ML

Fremstillet af:

FERRING GMBH - Federal Republic of Germany

Autorisation dato:

2021-09-11

Produktets egenskaber

DECAPEPTYL
® 0.1 MG/ML
Triptorelin acetate
Solution for injection
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe of 1 ml solution for injection contains 100
micrograms triptorelin acetate
equivalent to 95.6 micrograms triptorelin free base.
Excipients: Sodium chloride, Acetic acid, glacial (for pH adjustment),
Water for injections
PHARMACEUTICAL FORM
Solution for injection
Clear colourless solution.
THERAPEUTIC INDICATIONS
DECAPEPTYL
®
0.1 mg/ml is indicated for downregulation and prevention of premature
luteinizing
hormone
(LH)
surges
in
women
undergoing
controlled
ovarian
hyperstimulation
for
assisted
reproductive technologies (ART).
In clinical trials DECAPEPTYL
®
0.1 mg/ml has been used in cycles where urinary and recombinant
human follicle stimulating hormone (FSH) as well as human menopausal
gonadotrophin (HMG) were
used for stimulation.
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with DECAPEPTYL
®
0.1 mg/ml should be initiated under the supervision of a physician
experienced in the treatment of infertility. DECAPEPTYL
®
is intended for subcutaneous injection once
daily into the lower abdominal wall. Following the first
administration, it is advised that the patient be
kept under medical supervision for 30 minutes to ensure there is no
allergic/pseudo-allergic reaction to
the injection. Facilities for the treatment for such reactions should
be immediately available. The
following injections may be self-administered as long as the patient
is made aware of the signs and
symptoms that may indicate hypersensitivity, the consequences of such
a reaction and the need for
immediate medical intervention. The injection site should be varied to
prevent lipoatrophy.
Treatment can be started in the early follicular phase (day 2 or 3 of
the menstrual cycle) or in the
mid-luteal phase (day 21-23 of the menstrual cycle or 5-7 days before
expected start of menses).
Controlled ovarian hyperstimulation with gonadotrophins should be
started after approximately 2-4
weeks of DECAPEPTYL
®
treatment. Ov