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  • Cetrotide
    / Merck


    Active Ingredient
    Cetrorelix (as acetate) 0.25 mg/vial

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    1 X 0.25 mg

    partial basket chart 9434

    Vial

    7 X 0.25 mg

    partial basket chart 22906 3111

    Dosage

    This product should only be prescribed by a specialist experienced in this field. The first administration should be performed under the supervision of a physician and under conditions where treatment of possible allergic/pseudo-allergic reactions (including lifethreatening anaphylaxis) is immediately available. The following injections may be self-administeredas 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. This product 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 product in a slow rate to facilitate the progressive absorption of the product.
    Administration in the morning: Treatment with this product 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.
    Administration in the evening: Treatment with this product 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.
    See prescribing information for full details.


    Indications

    Prevention of premature ovulation in patients undergoing a controlled ovarian stimulation, followed by oocyte pick-up and assisted reproductive techniques.


    Contra-Indications

    Hypersensitivity to the active substance or any structural analogues of gonadotropin-releasing hormone (GnRH), extrinsic peptide hormones or to any of the excipients.
    Pregnancy and lactation.
    Postmenopausal women.
    Patients with moderate and severe renal and hepatic impairment.


    Special Precautions

    Special care should be taken in women with signs and symptoms of active allergic conditions or known history of allergic predisposition. Treatment with this product is not advised in women with severe allergic conditions. During or following ovarian stimulation an ovarian hyperstimulation syndrome can occur. This event must be considered as an intrinsic risk of the stimulation procedure with gonadotropins.
    An ovarian hyperstimulation syndrome should be treated symptomatically, e.g. with rest, intravenous electrolytes/colloids and heparin therapy. Luteal phase support should be given according to the reproductive medical centre´s practice. There is limited experience up to now with the administration of this product during a repeated ovarian stimulation procedure. Therefore this product should be used in repeated cycles only after a careful risk/benefit evaluation. See prescribing information for full details.


    Side Effects

    The most commonly reported side effects are local injection site reactions such as erythema, swelling and pruritus that are usually transient in nature and mild in intensity. In clinical trials, these effects were observed with a frequency of 9.4% following multiple injections of this product. Mild to moderate ovarian hyperstimulation syndrome (OHSS) (WHO grade I or II) have been commonly reported and should be considered as an intrinsic risk of the stimulation procedure. Inversely, severe OHSS remains uncommon. Uncommonly, cases of hypersensitivity reactions including pseudo-allergic/anaphylactoid reactions have been reported.
    See prescribing information for full details


    Drug interactions

    In vitro investigations have shown that interactions are unlikely with medicinal products that are metabolized by cytochrome P450 or glucuronised or conjugated in some other way. However, although there has been no evidence of drug-interactions, especially with commonly used medicinal products, gonadotropins or products that may induce histamine release in susceptible individuals, the possibility of an interaction cannot be totally excluded.
    See prescribing information for full details.


    Pregnancy and Lactation

    This product is not intended to be used during pregnancy and lactation. Studies in animals have indicated that cetrorelix exerts a dose related influence on fertility, reproductive performance and pregnancy. No teratogenic effects occurred when the medicinal product was administered during the sensitive phase of gestation.
    See prescribing information for full details.


    Overdose

    Overdose 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.
    See prescribing information for full details.


    Important notes

    The solution should be used immediately after preparation.
    Do not store above 25 °C. Keep the vial(s) in the outer carton in order to protect from light.
    This product 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.
    See prescribing information for full details.


    Manufacturer
    Merck KgaA, Germany
    Licence holder
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