Država: Indonezija
Jezik: indonezijščina
Source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
TRIPTORELIN ACETATE
FERRING PHARMACEUTICALS INDUSTRY - Indonesia
TRIPTORELIN ACETATE
0.1 MG
LARUTAN INJEKSI
DUS, 7 PREFILLED SYRINGE @ 1 ML
FERRING GMBH - Federal Republic of Germany
2021-09-11
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 Preberite celoten dokument