Menopur lyophilized powder for preparation of solution for injection 75 IU bottle with solvent in ampoules 1 ml No. 10
Lyophilized powder for solution for injection Menopur is indicated for the following indications:
Female infertility due to anovulation (including polycystic ovary syndrome (PCOS)) in women who are not amenable to treatment with clomiphene citrate. In controlled ovarian hyperstimulation for the induction of multiple follicular formation as part of assisted reproductive technologies (ART).Composition
Active ingredient: 1 vial contains menotropin (highly purified LMH, LMH), containing follicle-stimulating hormone (FSH) 75 IU and luteinizing hormone (LH) 75 IU;
Excipients: lactose, polysorbate 20, sodium hydroxide, hydrochloric acid;
Solvent: 0.9% sodium chloride solution, diluted hydrochloric acid, water for injections.
Contraindication
Menopur is contraindicated in the following conditions:
Pituitary or hypothalamic tumors; carcinoma of the ovaries, uterus or mammary glands; pregnancy and breastfeeding; gynecological bleeding of unknown etiology; hypersensitivity to the active substance or to any of the excipients included in the preparation; ovarian enlargement or ovarian cysts not associated with polycystic ovary syndrome.Method of application
Treatment with Menopur should be initiated under the supervision of a physician experienced in the treatment of reproductive disorders.
Menopur is intended for subcutaneous or intramuscular use. The powder should be reconstituted immediately before administration using the solvent provided. Up to 3 vials of Menopur powder can be reconstituted in 1 ml of solvent. DO NOT shake. The solution should be used if it contains particles or is opaque.
The dosage regimens are identical for subcutaneous and intramuscular administration.
Application features
Pregnant women
Contraindicated.
Children
Do not use on children.
Overdose
The effects of overdose are unknown, ovarian hyperstimulation syndrome may develop. Treatment is symptomatic.
Side effects
The most commonly observed side effects were: ovarian hyperstimulation syndrome (OHSS), abdominal pain, headache, bloating, and pain at the injection site.
Interaction
When used in combination with gonadotropin-releasing factor agonists for pituitary desensitization, high doses of Menopur may be required to achieve the desired ovarian response.
Storage conditions
Store at a temperature not exceeding 25 °C in a place protected from light, out of the reach of children.
Do not use the drug after the expiration date indicated on the package.
The shelf life of the powder is 2 years.
The shelf life of the solvent is 3 years.
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