Ovitrel – sex hormones and modulators of a reproductive system.

Indications

• initiation of final maturing of follicles and a luteinization after stimulation of follicular growth at adult women when holding a procedure of a superovulation before use of the auxiliary reproductive technologies (ART), such as fertilization of SP vitro (IVF);
• initiation of an ovulation and luteinization at adult women with anovulation or oligoovulyatsiy after stimulation of follicular growth.

Structure

• active ingredient: choriogonadotropin alpha;
• 1 previously filled syringe (0.5 ml of solution) contains 250 mkg (6500 ME) a choriogonadotropin alpha;
• other components: a mannitol (E 421), methionine, half-oxameasures 188, the phosphoric acid concentrated sodium hydroxide, water for injections.

Contraindication

• Hypersensitivity to active ingredient or any excipient of drug.
• Tumour of a hypothalamus or hypophysis.
• Increase in ovaries or cysts which are not caused by a syndrome of polycystic ovaries.
• Gynecologic bleedings of an unknown etiology.
• Carcinoma of ovaries, uterus or mammary glands.
• Active forms of thromboembolic disorders.

Ovitrel cannot be applied in cases when it is impossible to receive the effective response to treatment, for example at:

• Primary insufficiency of ovaries.
• Vadakh of development of the genitals incompatible with pregnancy.
• Fibroidny tumors of a uterus incompatible with pregnancy.
• Subsequent menopauses.

Side reactions

from the immune system Rare: reactions of hypersensitivity from easy to heavy severity, including rash, anaphylactic reactions and shock.

– are extended by

from nervous system: headache.

Vascular disorders – rare: a thrombembolia (both it is connected, and it is not connected with SGSYa).

Gastrointestinal disorders – are extended by

: abdominal pain, abdominal stretching, nausea, vomiting. Are not widespread: abdominal discomfort, diarrhea.

– are extended by

from a reproductive system and mammary glands: easy or moderate SGSYa. Are not widespread: heavy SGSYa.

General disorders and reactions are extended by

in the injection site: reactions in the place of an injection.

Route of administration

Drug should be used under observation of the doctor having experience of treatment of infertility.

Drug is intended to

for hypodermic introduction. It is possible to enter only transparent solution which is not supporting strangers of particles.

Maximum dose of medicament – 250 mkg. It is necessary to apply the following modes of treatment.

Woman when carrying out a superovulation before use of auxiliary reproductive technologies, such as fertilization of SP vitro (IVF)

Contents of one previously filled syringe Ovitrela (250 mkg) is entered in 24-48 hours after the last injection of medicament of follicle-stimulating hormone (FSG) or a human menopausal gonadotrophin (lMG), that is at achievement of optimum stimulation of follicular growth.

Woman with anovulation or an oligoovulyation

Contents of one previously filled syringe Ovitrelu® (250 mkg) is entered in 24-48 hours after achievement of optimum stimulation of follicular growth. The patient is recommended to have the sexual intercourse in day of introduction of Ovitrel and next day.

Use during pregnancy or feeding by a breast

Indications of the medicament Ovitrel during pregnancy are not present

Feature of use

. The data obtained for a small amount of cases of use of medicament during pregnancy indicate lack of congenital defects or feto- or neonatal toxicity. The choriogonadotropin influence research an alpha on reproductive functions of animals was not conducted therefore the potential risk of such use for the person is unknown.

Ovitrel is not shown to

for use during feeding by a breast. Data on choriogonadotropin discharge an alpha in milk are absent.

Children

are not present

Indications of Ovitrel in pediatric group of patients.

Ability to influence speed of response at control of motor transport or other mechanisms

Ovitrel does not influence or almost does not affect ability of patients to drive the car and to work with mechanisms.

Overdose to

Effects of overdose of Ovitrel are unknown to

. However owing to overdose there is a possibility of development of SGSYa.

Interaction with other medicines and other types of interactions

Special researches of medicinal interactions Ovitrela with other medicines were not conducted by

, but during therapy using lHG no clinically significant cases of such medicinal interactions were observed.

Storage conditions

to Store

at a temperature of 2-8 °C (in the fridge). To store in original packing for protection against light. To store out of children's reach.

During an expiration date medicament can be stored at a temperature not over 25 With during to 30 days without repeated cooling. If solution was not used within 30 days, it should be utilized.