Ovitrel

Ovitrel – luteinizing drug of recombinant choriogonadotropin an alpha, an analog of a human chorionic gonadotrophin (HGCh).

Form of release and structure

• Solution for hypodermic introduction: transparent or slightly opalescent liquid, colourless or light yellow (on 0,5 ml in the syringe of colourless glass complete with an injection cannula, 1 set in a container a plastic, 1 container in a cardboard pack);
• Lyophilisate for preparation of solution for hypodermic introduction: powder or porous mass of almost white or white color (on 0,25 mg in bottles, 1, 2 or 10 bottles complete with a solvent ampoule (respectively 1, 2 or 10 ampoules) in containers a plastic, 1 container in a cardboard pack).

Contains in 1 0,5 ml syringe:

• Active ingredient: choriogonadotropin an alpha – 0,25 mg (6500 International Units (IU));
• Auxiliary components: methionine, Mannitolum, half-oxameasures 188, sodium hydroxide, phosphoric acid, water for injections.

Contains in 1 bottle:

• Active ingredient: choriogonadotropin an alpha – 0,25 mg (6500 ME);
• Auxiliary components: phosphoric acid, sucrose, sodium hydroxide in volume necessary for maintenance of the pH level.

Solvent: water for injections.

Indications to use

Ovitrel is used in the protocol of induction of an ovulation with multiple maturing of follicles (superovulation) when carrying out ART (auxiliary reproductive technologies), including extracorporal fertilization, for induction of final maturing of follicles and formation of a yellow body after stimulation by drugs of gonadotrophins.

Also the indication to use of drug are anovulatory or oligoovulyatorny infertility at which Ovitrel apply to stimulation of ovaries for the purpose of receiving mature follicles and a luteinization at the end of process of stimulation of growth of follicles.

Contraindications

• Vaginal bleedings of the obscure genesis;
• Extrauterine pregnancy for 3 last months;
• Hysteromyoma incompatible with pregnancy;
• Tumors in a hypophysis and a hypothalamus;
• The ovary tumors which are not connected with a cyst ovary polycystosis;
• Primary egg insufficiency;
• Breast cancer, uterus or ovary;
• Thromboembolism;
• Inborn defects of development of generative organs which are incompatible with pregnancy;
• Postmenopause;
• Hypersensitivity to medicine components.

Ovitrel is used with care in the presence at patients of serious general diseases which aggravation can be provoked by pregnancy.

Route of administration and dosage

Solution for hypodermic introduction
The drug is administered subcutaneously. Each syringe is used only for single use.

The recommended dosing mode depending on indications:

• Use in the protocol of induction of an ovulation: syringe contents (0,25 mg) are entered once 24-48 hours later after the last injection of follicle-stimulating hormone (FSG) or the luteinizing hormone (LH) on condition of achievement of optimum level of development of a follicle;
• Anovulatory or oligoovulyatorny infertility: syringe contents (0,25 mg) are entered once 24-48 hours later after achievement of optimum level of development of a follicle. In day of an injection of drug and next day the sexual contact is recommended.

Lyophilisate for preparation of solution for hypodermic introduction
The solution prepared from lyophilisate is entered subcutaneously.

The recommended single dose – 0,25 mg, frequency rate of injections is defined by the attending physician depending on indications and the chosen scheme of therapy.

For independent use of Ovitrel patients need to study the instruction and to work according to the management:

1. The injection needs to be carried out, following rules of an asepsis and antiseptics;
2. For carrying out an injection it is necessary to prepare, having spread out on a pure surface, two tampons impregnated with alcohol and the syringe, previously filled or ready to use;
3. The injection needs to be carried out to the body part chosen according to the recommendation of the attending physician (a front part of a hip or area of a stomach). The injection site should be wiped with a tampon with alcohol, to pull together the disinfected site of skin with fingers, to enter into a skin fold a needle at an angle 45-90 °, carefully pressing the piston slowly to enter all volume of solution, to accurately take a needle then roundabouts to wipe the place of an injection with the second tampon with alcohol. It is required to avoid hit of solution in a vein;
4. After holding a procedure the used syringe should be placed in a container for utilization of sharp objects; the unused volume of drug needs to be destroyed.

At introduction of the raised Ovitrel's dose or in case of the admission of an injection the patient should see consultation the attending physician.

Side effects

• Reproductive system: often – SHSO (syndrome of hyper stimulation of ovaries); seldom – morbidity of mammary glands, heavy degree of SGYa;
• Alimentary system: often – an abdominal pain, nausea, vomiting; seldom – diarrhea;
• Central nervous system: often – a headache; seldom – concern, irritability, fatigue, a depression;
• Local reactions: often – pain and a hyperemia in the field of introduction;
• Integuments: very seldom – slight reversible skin rash;
• Another: often – fatigue; very seldom – hypersensitivity reactions benign.

Special instructions

Prior to therapy by Ovitrel it is required to establish the infertility reasons at the woman and her sexual partner and to estimate possible risk factors in case of pregnancy approach. It is necessary to consider existence of tumors of a hypothalamus and a hypophysis, adrenal insufficiency, clinically expressed hypothyroidism, giperprolaktinemiya, and also specific methods of treatment applied at the same time.

Because of the ripening at the same time large number of follicles at stimulation of ovaries of the woman are exposed to risk of development of SGYa. As a result of clinical trials it was established that SGYa (in the majority of episodes of average and easy degree) was noted approximately in 4% of cases. SGYa of heavy degree can become a serious complication of stimulation. Seldom owing to heavy SGYa the following complications are possible: acute respiratory distress syndrome, hemoperitoneum, thromboembolism, ovary torsion. In the protocol of stimulation of growth of follicles for decrease in risk of SGYa it is recommended to make careful observation of response of ovaries by means of ultrasonography and to determine oestradiol level in blood prior to the beginning of a course of therapy and during it.

During stimulation the risk of polycarpous pregnancy increases in comparison with natural process of fertilization; in most cases stimulated pregnancy twins are born. At use of ways of an auxiliary reproduction the number of the born children corresponds to number of the embryos transferred to a cavity of the uterus.

After therapy of anovulatory infertility (including with use of auxiliary reproductive technologies) on statistical data the quantity of abortions exceeds average values on population, but is comparable with other types of infertility.

Administration of drug can exert impact on an immunological picture of the HGCh level in urine and blood serum for 10 days and to give false positive reaction in case of test for pregnancy.

Ovitrel can slightly stimulate function of a thyroid gland.

It is necessary to report to the doctor about cases of strengthening of side effects and about all side reactions which are not described in the instruction.

Medicinal interaction

Data on Ovitrel's interaction with other medicinal substances / drugs are absent. Despite it the patient should inform the attending physician on all medicines, including nonprescription, accepted now, or recently.

Terms and storage conditions

It is necessary to store drug in original packaging, in the place unavailable to children, at a temperature of 2-8 °C, not to freeze.

Storage of drug is allowed at a temperature up to 25 °C (out of the refrigerator) for 30 days, within a period of validity. After this term unused solution should be destroyed.

Period of validity – 2 years.