Ovitrel solution for p / dermal introduction. 250 mcg / 0.5 ml syringe pen 1 pc. (Horyohonadotropyn Alpha Cellulose)

Latin name

Ovitrelle

Release form

Solution for subcutaneous administration

Packaging

1 syringe

Pharmacological action

Ovitrel has a gonadotropic, luteinizing effect.

Pharmacodynamics

Ovitrel® contains choriogonadotropin alpha (CG alpha), which is produced using recombinant DNA technology. It has the same amino acid sequence as natural human HCG. CG binds transmembrane LH receptors on the surface of theca and ovarian granulosa cells. It causes the initiation of oocytic meiosis, rupture of the follicles (ovulation), the formation of the corpus luteum, the production of progesterone and estradiol by the corpus luteum.

Pharmacokinetics

Absorption and distribution. After iv administration of CG, alpha is distributed into the extracellular fluid with a half-life of about 4.5 hours.

Stationary Vd and total clearance are 6 l and 0.2 l / h, respectively.

With subcutaneous administration of CG alpha, the absolute bioavailability is approximately 40%, the final T1 / 2 is about 30 hours.

Excretion and metabolism. Metabolism and excretion of CG alpha are similar to endogenous CG.

Indications

In the protocol for the induction of multiple follicular maturation (superovulation) for assisted reproductive technologies (including for IVF) to induce the final maturation of follicles and luteinization after stimulation with gonadotropins with anovulatory or oligovulatory infertility to induce ovulation and luteinization at the end of stimulation of follicular growth.

Contraindications

hypersensitivity to the active component and to any of the auxiliary components that make up the

tumor in the hypothalamus and pituitary

volumetric ovarian neoplasms or cysts unrelated to polycystic ovary

vaginal neoplasia of the ovary neoplasm uterine or mammary gland

ectopic pregnancy within the previous 3 months

thromboembolism

primary ovarian failure

congenital malformations of the genitals incompatible with pregnancy

uterine fibroids, incompatible with pregnancy

postmenopause.

Ovitrel® should be prescribed with caution to patients with serious systemic diseases in cases where pregnancy may lead to their exacerbation.

Use during pregnancy and lactation

During pregnancy and breastfeeding, OvitrelВ® is not prescribed. There is no data on the excretion of CG alpha in breast milk.

Composition

1 syringe contains:

Active ingredient: choriogonadotropin alpha 250 mcg

Excipients: mannitol - 27.3 mg.

Dosage and administration of

Ovitrel is administered sc. Each syringe is intended for single use only. When used in the protocol of induction of multiple maturation of follicles for assisted reproductive technologies (including IVF) with the aim of inducing the final maturation of follicles and luteinization after stimulation with gonadotropins Ovitrel at a dose of 250 μg (contents of 1 syringe ) is administered once 24-48 hours after the last administration of the FSH or LH preparation and achieving the optimal level of follicle development.

Side effects of the

On the part of the immune system: very rarely - from mild to severe hypersensitivity reactions, including anaphylactic reactions and shock.

From the side of the central nervous system: often - headache. infrequently - depression, irritability, agitation.

From the vascular system: often - thromboembolism, usually associated with severe ovarian hyperstimulation syndrome (OHSS).

From the digestive system: often - nausea, vomiting, abdominal pain, infrequently - diarrhea.

From the skin and subcutaneous tissue: very rarely - mild, reversible skin reactions in the form of a rash.

On the part of the reproductive system and mammary glands: often - OSS of mild or moderate severity, infrequently - severe form of OHS, soreness of the mammary glands.

General and local reactions: often - fatigue, reactions at the injection site.

Overdose

Symptoms: The development of a CSF characterized by the formation of large ovarian cysts with the risk of their rupture (perforation), the development of ascites and circulatory disorders.

Treatment: At high risk of developing CSF, it is recommended to cancel the administration of human HCG. Patients are advised to refrain from sexual intercourse or use barrier methods of contraception for at least 4 days.

Storage Conditions

In a dark place at a temperature not exceeding 15 ° C.

Shelf life

2 years

Deystvuyushtee substance

Choriogonadotropin alyfa

Terms and conditions

prescription

dosage form

injection

Prescribing

Prescribing

Adults as prescribed by the doctor, For women of childbearing age

Merck Serono, Switzerland



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