DECAPEPTYL INJECTION 0.1 mg/ml

INJECTION

**4.2 Posology and method of administration** The dosage regimen of DECAPEPTYL® is 100 micrograms given once daily as a 1 mL subcutaneous injection into the lower abdominal wall. 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. Ovarian response should be monitored clinically (including ovarian ultrasound alone or preferably in combination with measurement of oestradiol levels) and the dose of gonadotrophins adjusted accordingly. When a suitable number of follicles have reached an appropriate size, treatment with DECAPEPTYL® and gonadotrophin is stopped and a single injection of human chorionic gonadotrophin (hCG) is administered to induce the final follicular maturation. If downregulation is not confirmed after 4 weeks (determined by ultrasound documentation of a shedded endometrium alone or preferably in combination with measurement of oestradiol levels), discontinuation of DECAPEPTYL® should be considered. The total duration of treatment is usually 4–7 weeks. When using DECAPEPTYL®, luteal phase support should be provided according to the reproductive medical centre's practice. _Patients with renal or hepatic impairment_ No specific dose recommendations are given for subjects with renal or hepatic impairment. A clinical study indicated that the risk of accumulation of triptorelin in patients with severe liver and renal impairment is small (see section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Paediatric population_ There is no relevant use of DECAPEPTYL® 0.1 mg/1 ml in the paediatric population. Method of administration Treatment with DECAPEPTYL® 0.1 mg/1 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. For instructions for use and handling, see section 6.6 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.