Asporelix Dosage/Direction for Use

Asporelix 0.25 should only be prescribed by a specialist experienced in this field.
Dosage: Asporelix 0.25 is not intended to be self-administered. This product is intended to be administered by healthcare professionals who are familiar with reconstitution techniques only. Administration of Asporelix 0.25 should be performed under the supervision of a physician and under conditions where treatment of possible allergic/pseudo-allergic reactions (including life-threatening anaphylaxis) is immediately available. The contents of 1 vial (0.25 mg cetrorelix) are to be administered once daily, at 24 h intervals, either in the morning or in the evening. 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 of such reactions should be immediately available.
Elderly: There is no relevant use of cetrorelix in the geriatric population.
Paediatric population: There is no relevant use of cetrorelix in the paediatric population.
Method of Administration: Asporelix 0.25 is for subcutaneous injection into the lower abdominal wall.
The injection site reactions may be minimised by rotating the injection sites, delaying injection at the same site and injecting the medicinal product in a slow rate to facilitate the progressive absorption of the medicinal product.
Administration in the morning: Treatment with Asporelix 0.25 should commence on day 5 or 6 of ovarian stimulation (approximately 96 to 120 hours after start of ovarian stimulation) with urinary or recombinant gonadotropins and is to be continued throughout the gonadotropin treatment period including the day of ovulation induction. The starting day of Asporelix 0.25 is depending on the ovarian response, i.e., the number and size of growing follicles and/or the amount of circulating oestradiol. The start of Asporelix 0.25 may be delayed in absence of follicular growth, although clinical experience is based on starting Asporelix 0.25 on day 5 or day 6 of stimulation.
Administration in the evening: Treatment with Asporelix 0.25 should commence on day 5 of ovarian stimulation (approximately 96 to 108 hours after start of ovarian stimulation) with urinary or recombinant gonadotropins and is to be continued throughout the gonadotropin treatment period until the evening prior to the day of ovulation induction. The starting day of Asporelix 0.25 is depending on the ovarian response, i.e., the number and size of growing follicles and/or the amount of circulating oestradiol. The start of Asporelix 0.25 may be delayed in absence of follicular growth, although clinical experience is based on starting Asporelix 0.25 on day 5 or day 6 of stimulation.
Instructions for Use: This product is not intended to be self-administered. This product is intended to be administered by healthcare professionals who are familiar with reconstitution techniques only. This medicine must be allowed to reach room temperature prior to injection. It should be removed from the refrigerator approximately 30 minutes before use.
The diluent for reconstitution (1 mL sterile water for injection) is provided together with the powder.
A ready-to-use solution is prepared by injecting 1 mL of the sterile water for injection (provided with pack) into the vial containing the dry powder. On reconstitution, the solid dissolves completely, leaving no visible residue as un-dissolved matter and should not be significantly less clear than an equal volume of the sterile water for injection in a similar vessel. The pH of reconstituted solution is between 4.0 to 6.0. The entire contents of the vial should be withdrawn to ensure a delivery to the patient of a dose of at least 0.23 mg Cetrorelix. Asporelix 0.25 powder must only be reconstituted with the sterile water for injection contained in the ampoule provided together in the box. Use the reconstituted solution immediately, do not store solution for later use. The contents of the vial is for single use only, any unused solution must be discarded in accordance with local requirements.
Asporelix 0.25 is for subcutaneous injection into the lower abdominal wall. The injection site reactions may be minimised by rotating the injection sites, delaying injection at the same site and injecting the medicinal product in a slow rate to facilitate the progressive absorption of the medicinal product.