CETROTIDE<\/p>\n
Lyophilisate for solution for subcutaneous injection<\/p>\n
1 vial contains:<\/p>\n
Active substance: cetrorelix acetate;<\/p>\n
Excipients: mannitol.<\/p>\n
1 unit.<\/p>\n
Cetrotide \u2014 antigonadotropic agent.<\/p>\n
Pharmacodynamics<\/p>\n
Cetrorelix, being a GnRH analogue, binds to receptors on pituitary cell membranes and competitively inhibits the binding of endogenous GnRH to these receptors. Cetrorelix dose-dependently inhibits the secretion of pituitary gonadotropins: LH and FSH. In the absence of prior stimulation, suppression of pituitary secretory function begins virtually immediately after administration of the medicinal product, and the duration of cetrorelix action depends on the administered dose. In women, cetrorelix delays the LH surge and, consequently, ovulation. Following a single administration of 3 mg cetrorelix, the effect of the medicinal product lasts for at least 4 days (on the 4th day after administration, secretory function is suppressed by 70%). Regular administration of cetrorelix at a dose of 0.25 mg every 24 hours maintains the effect of the medicinal product. The effects of cetrorelix are fully reversible after treatment is discontinued.<\/p>\n
Pharmacokinetics<\/p>\n
Absorption and distribution. Rapidly absorbed following subcutaneous injection; absolute bioavailability is approximately 85%. Vd is 1.1 L\/kg.<\/p>\n
Pharmacokinetic parameters following a single subcutaneous administration of 0.25 mg and repeated administration (for 14 days), respectively: plasma Cmax \u2014 4.17\u20135.92 ng\/mL and 5.18\u20137.96 ng\/mL; Tmax \u2014 0.5\u20131.5 h and 0.5\u20132 h; AUC \u2014 23.4\u201342 ng\u00b7h\/mL and 36.7\u201354.2 ng\u00b7h\/mL.<\/p>\n
Elimination. T1\/2 is 2.4\u201348.8 h and 4.1\u2013179.3 h following single and repeated (for 14 days) subcutaneous administration of a 0.25 mg dose, respectively. Following subcutaneous administration of single doses of cetrorelix (0.25 to 3 mg), as well as daily administration for 14 days, the pharmacokinetics of the medicinal product demonstrate a linear relationship. The mean terminal T1\/2 following intravenous and subcutaneous administration is 12 and 30 h, respectively, indicating absorption at the injection site.<\/p>\n
Cetrorelix is excreted by the kidneys. Total plasma and renal clearance are 1.2 mL\/min\u00b7kg and 0.1 mL\/min\u00b7kg, respectively. The terminal T1\/2 following intravenous and subcutaneous administration is approximately 12 and 30 h, respectively.<\/p>\n
Cetrotide, indications for use<\/strong><\/p>\n Prevention of premature ovulation in patients undergoing controlled ovarian stimulation for oocyte retrieval and assisted reproductive technologies.<\/p>\n Cetrotide should only be prescribed by a specialist gynecologist. To achieve maximum effectiveness of treatment with Cetrotide, these recommendations should be carefully reviewed. After the first injection, the patient should remain under medical supervision for 30 minutes to ensure that no allergic or pseudoallergic reaction to the medicinal product occurs. Appropriate facilities and medications for the treatment of such reactions should be readily available. Cetrotide at a dose of 0.25 mg (1 vial) should be administered once daily at 24-hour intervals, either in the morning or in the evening.<\/p>\n Morning administration: treatment with Cetrotide should be initiated on day 5 or 6 of ovarian stimulation (approximately 96\u2013120 h after the start of stimulation) with a gonadotropin preparation, either recombinant or urine-derived, and continued throughout the entire period of gonadotropin stimulation, including the day on which the ovulation-inducing dose of chorionic gonadotropin (hCG) is administered.<\/p>\n Evening administration: treatment with Cetrotide should be initiated on day 5 of ovarian stimulation (approximately 96\u2013108 h after the start of stimulation) with a gonadotropin preparation, either recombinant or urine-derived, and continued throughout the entire period of gonadotropin stimulation, including the evening preceding the day on which the ovulation-inducing dose of hCG is administered.<\/p>\n Instructions for administration: the first injection should be administered by a specialist physician. After receiving appropriate instructions from the physician regarding symptoms that may indicate an allergic reaction, the possible consequences of such a reaction, and the need for treatment, the patient may administer Cetrotide herself. Cetrotide should be administered subcutaneously into the lower anterior abdominal wall, preferably in the area around the navel. To avoid local irritation with repeated administration, the injection site should be changed daily. Cetrotide should only be dissolved using the supplied solvent. During reconstitution, the vial should be gently swirled. To avoid the formation of bubbles, vigorous shaking should not be used to accelerate dissolution. Do not use the solution if it is cloudy or contains undissolved particles. The entire contents of the vial should be drawn into the syringe. This ensures administration of a cetrorelix dose of at least 0.23 mg when using Cetrotide 0.25 mg and at least 2.82 mg when using Cetrotide 3 mg. The solution should be administered immediately after preparation.<\/p>\n Instructions for self-administration:<\/p>\n Cetrotide is not intended for use during pregnancy or breastfeeding.<\/p>\n Immune system disorders:<\/em> uncommon \u2014 systemic allergic or pseudoallergic reactions, including life-threatening anaphylaxis.<\/p>\n Nervous system disorders: uncommon \u2014 headache.<\/p>\n Gastrointestinal disorders: uncommon \u2014 nausea.<\/p>\n Reproductive system and breast disorders: common \u2014 mild to moderate ovarian hyperstimulation syndrome (OHSS), WHO Grade I\u2013II; uncommon \u2014 severe OHSS, WHO Grade III.<\/p>\n General disorders and administration site conditions: common \u2014 injection-site reactions (redness, swelling, itching), generally transient and mild.<\/p>\n Cetrotide 0.25 mg is best administered regularly at 24-hour intervals. If a scheduled dose is missed, the injection may be administered at any other time during the same day. In vitro studies have demonstrated a low likelihood of drug interactions when Cetrotide is administered concomitantly with medicinal products metabolized by cytochrome P450 isoenzymes or undergoing conjugation reactions. Symptoms:<\/em> prolongation of the duration of action of the medicinal product; however, this is not accompanied by symptoms of acute toxicity.<\/p>\n Treatment: no special measures are required in the event of overdose.<\/p>\n 2 years<\/p>\n Z31.1 Artificial insemination<\/p>\n Store at a temperature not exceeding +25\u00b0C.<\/p>\n","protected":false},"excerpt":{"rendered":" Latin Name CETROTIDE Dosage Form Lyophilisate for solution for subcutaneous injection Composition 1 vial contains: Active substance: cetrorelix acetate; Excipients: mannitol. Packaging 1 unit. Pharmacological Action Cetrotide \u2014 antigonadotropic agent. Pharmacodynamics Cetrorelix, being a GnRH analogue, binds to receptors on pituitary cell membranes and competitively inhibits the binding of endogenous GnRH to these receptors. Cetrorelix […]<\/p>\n","protected":false},"featured_media":0,"menu_order":0,"template":"","class_list":["post-612","pharmacy_product","type-pharmacy_product","status-publish","has-post-thumbnail","hentry"],"yoast_head":"\nContraindications<\/h3>\n
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Method of Administration and Dosage<\/h3>\n
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Use During Pregnancy and Breastfeeding<\/h3>\n
Adverse Reactions<\/h3>\n
Special Warnings and Precautions<\/h3>\n
\nOvarian hyperstimulation syndrome may occur during or after ovarian stimulation; in such cases, symptomatic treatment should be provided.
\nLuteal phase support should be provided in accordance with generally accepted assisted reproductive technology practices.
\nThere is currently insufficient experience with repeated ovarian stimulation using Cetrotide; therefore, if a repeated course of treatment is required, the medicinal product should only be prescribed after assessing the potential risks and expected effectiveness of treatment.
\nEffects on the ability to drive and operate machinery:<\/em> Cetrotide does not affect the ability to drive vehicles or operate machinery.<\/p>\nInteractions<\/h3>\n
\nSince the possibility of drug interactions during concomitant administration cannot be completely excluded, the attending physician should be informed of any medicinal products taken shortly before starting treatment with Cetrotide or currently being taken.<\/p>\nOverdose<\/h3>\n
Shelf Life<\/h3>\n
Indications for Use<\/h3>\n
Storage Conditions<\/h3>\n