CETROTIDE INJECTION 0.25 MG [SIN11345P]

Product Info

CETROTIDE INJECTION 0.25 MG

[SIN11345P]

Indications
Prevention of premature ovulation in patients undergoing a controlled ovarian stimulation, followed by oocyte pick-up and assisted reproductive techniques.
In clinical trials Cetrotide® 0.25 mg was used with human menopausal gonadotropin (HMG), however, limited experience with recombinant FSH suggested similar efficacy.

Posology and method of administration
Cetrotide® 0.25 mg should only be prescribed by a specialist experienced in this field.

Posology
The first administration of Cetrotide should be performed under the supervision of a physician and under conditions where treatment of possible pseudo-allergic reactions is 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 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 of Cetrotide® 0.25 mg, 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.

Method of administration
Cetrotide® 0.25 mg 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 Cetrotide® 0.25 mg 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 Cetrotide 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 Cetrotide may be delayed in absence of follicular growth, although clinical experience is based on starting Cetrotide on day 5 or day 6 of stimulation.

Administration in the evening: Treatment with Cetrotide® 0.25 mg 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 Cetrotide 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 Cetrotide may be delayed in absence of follicular growth, although clinical experience is based on starting Cetrotide on day 5 or day 6 of stimulation.

Additional information on special populations:
There is no relevant indication for the use of Cetrotide in children or geriatric populations.

Contraindications
Cetrotide is not to be used in the presence of any of the conditions listed below:

• Hypersensitivity to cetrorelix acetate, extrinsic peptide hormones or mannitol.

• During pregnancy and lactation.

• Patients with severe renal impairment.