Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Merck Europe B.V., Gustav Mahlerplein 102, 1082 MA Amsterdam, The Netherlands
Prevention of premature ovulation in patients undergoing a controlled ovarian stimulation, followed by oocyte pick-up and assisted reproductive techniques.
In clinical trials Cetrotide was used with human menopausal gonadotropin (HMG), however, limited experience with recombinant follicle-stimulating hormone (FSH) suggested similar efficacy.
Cetrotide should only be prescribed by a specialist experienced in this field.
The first administration of Cetrotide 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 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, 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.
There is no relevant use of Cetrotide in the geriatric population.
There is no relevant use of Cetrotide in the paediatric population.
Cetrotide 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.
Treatment with Cetrotide 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.
Treatment with Cetrotide 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.
For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Overdosage in humans may result in a prolonged duration of action but is unlikely to be associated with acute toxic effects.
In acute toxicity studies in rodents non-specific toxic symptoms were observed after intraperitoneal administration of cetrorelix doses more than 200 times higher than the pharmacologically effective dose after subcutaneous administration.
Unopened vial: 2 years.
After reconstitution: use immediately.
Store in a refrigerator (2°C–8°C). Do not freeze or place next to the freezer compartment or a freezer pack.
Store in the original package in order to protect from light.
The unopened medicinal product may be stored in the original package at room temperature (not above 30°C) for up to three months.
This medicinal product must be allowed to reach room temperature prior to injection. It should be removed from the refrigerator approximately 30 minutes before use.
Powder: 2 ml vials (Type I glass) with a stopper (bromobutyl rubber) and flip-off aluminium cap. 1 vial contains 0.25 mg cetrorelix.
Solvent: Pre-filled syringe (Type I glass) with plunger stopper (siliconised bromobutyl rubber) and tip cap (polypropylene and styrene butadiene rubber). 1 pre-filled syringe contains 1 ml of water for injections.
Pack sizes: 1 vial and 1 pre-filled syringe or 7 vials and 7 pre-filled syringes.
Additionally, for each vial the pack contains:
Not all pack sizes may be marketed.
This medicinal product must be allowed to reach room temperature prior to injection. It should be removed from the refrigerator approximately 30 minutes before use.
Cetrotide should only be reconstituted with the solvent provided, using a gentle, swirling motion. Vigorous shaking with bubble formation should be avoided.
The reconstituted solution is without particles and clear. Do not use if the solution contains particles or if the solution is not clear.
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.
The solution should be used immediately after reconstitution.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
