OVITRELЬ

Active material: Horiogonadotropin alpha
When ATH: G03GA01
CCF: Recombinant human chorionic gonadotropin
ICD-10 codes (testimony): N97, Z31.1
When CSF: 15.06.05.03
Manufacturer: MERCK SERONO S. p. A. (Italy)

Pharmaceutical form, composition and packaging

The solution for the p / to the introduction clear or slightly opalescent, colorless or light yellow.

Excipients: mannitol, methionine, poloxamer 188, phosphoric acid, Sodium hydroxide, water d / and.

0.5 ml – syringes of colorless glass (1) complete with needles d/and (1 PC.) – Plastic containers (1) – packs cardboard.

Pharmacological action

Luteinizing drug, recombinant Alpha horiogonadotropin, which has the same amino acid sequence, that and the natural human chorionic gonadotropin. Associates a transmembrane receptors LH on the surface of cells of ovarian granulosa and theca. Causes ootsitarnogo initiation of meiosis, rupture of the follicle (Ovulation), the formation of the corpus luteum, production of progesterone and estradiol yellow body.

Pharmacokinetics

When s/to the introduction of absolute bioavailability of approximately 40%, T_1/2 – about 30 no.

Testimony

-induction Protocol should maturing follicles (superovuljacija) for assisted reproductive technologies (incl. for in vitro fertilization) to induce final follicular maturation and luteinization after stimulation with gonadotrophins preparations;

— When anovulatornom barrenness oligoovuljatornom or for the induction of ovulation and ljuteinizacii at the end of the stimulation of the growth of follicles.

Dosage regimen

The drug is administered s / c. Each syringe is intended for one-time use only.

When applied in induction of multiple protocol maturing follicles to assisted reproductive technologies (incl. for in vitro fertilization) with a view to the induction of final maturation of follicles and ljuteinizacii After stimulation drugs gonadotropinov Ovitrel^® dose 250 g (contents 1 syringe) enter once through 24-48 h after the last injection of FSH or LH and achieve optimal level of follicle development.

At oligoovuljatornom or anovulatornom barrenness for the induction of ovulation and ljuteinizacii at the end of follicle growth stimulation Ovitrel^® dose 250 g (contents 1 syringe) Once you enter through the 24-48 h after the last injection of FSH or LH and achieve optimal level of follicle development. It is recommended that sexual contact on the day of the introduction of the drug the next day.

Rules of administration

With self-use of the drug, patients should carefully read the instructions.

1. The injection should be performed under aseptic and antiseptic.

2. For the injection must decompose on the clean surface 2 propitannыh spirtom swab, prefilled syringe or ready-to-use syringe.

3. Next you should immediately undertake a injection (in the abdomen or anterior thigh). To do this, rub chosen on the advice of a doctor plot swab with alcohol. Strongly pull off the skin with your fingers and, sending the needle angle 45-90° in a skin fold, do p/injection. You should avoid drugs in Vienna. The drug is injected slowly, gently pressing down on the plunger, You must enter the entire volume of the solution. After extracting the needle in a circular motion to rub the injection site with an alcohol swab.

4. Should be placed immediately after the injection the used syringe in the container for storing sharp objects. Any unused amount should be disposed of.

In the case of high dosage or injection passes the patient should consult with a physician.

Side effect

CNS: often (>1/100, < 1/10) – headache; rarely (>1/1000, < 1/100) – depression, irritability, anxiety, fatiguability.

From the digestive system: often (>1/100, < 1/10) – nausea, vomiting, abdominal pain; rarely (>1/1000, < 1/100) – diarrhea.

On the part of the reproductive system: often (>1/100, < 1/10) – ovarian hyperstimulation syndrome (SGYA); rarely (>1/1000, < 1/100) – Severe OHSS, breast tenderness.

Dermatological reactions: rarely (>1/10 000) – reversible light skin rash.

Local reactions: often (>1/100, < 1/10) – pain and redness at the injection site.

Other: often (>1/100, < 1/10) – feeling tired; rarely (>1/10 000) – allergic reactions are mild.

Contraindications

— tumors in the area of the hypothalamus and pituitary;

-volumetric growths or cysts of the ovary, not associated with polycystic ovary;

is vaginal bleeding ambiguous Genesis;

— malignant neoplasm of ovary, uterine or breast cancer;

-ectopic pregnancy within 3 's previous months;

- Thromboembolism;

- Primary ovarian insufficiency;

-congenital malformations of genital organs, incompatible with pregnancy;

-uterine fibroids, incompatible with pregnancy;

— postmenopauza;

- Hypersensitivity to the drug.

FROM caution assign Ovitrel^® patients with severe systemic diseases in those cases, when pregnancy can lead to aggravation of the.

Cautions

Before treatment is necessary to establish the cause of infertility, the patient and her partner and assess prospective risks if pregnancy occurs. Be aware of the clinically pronounced hypothyroidism, adrenal insufficiency, hyperprolactinemia, the presence of pituitary tumors and hypothalamus, apply specific therapies.

During ovarian stimulation patients are at risk of OHSS due to simultaneous maturation of a large number of follicles. During clinical trials of OHSS (in most cases, mild and moderate) was awarded approximately 4% patients. Severe OHSS can be a serious complication of stimulation. In rare cases, severe complication of OHSS can be gemoperitoneum, acute respiratory distress syndrome, torsion of ovary and thromboembolism. In order to reduce the risk of OHSS follicle growth stimulation Protocol recommended careful monitoring of ovarian response using ultrasound and determination of the level of estradiol in the blood before treatment and during the.

In comparison with natural insemination during stimulation increases the risk of multiple pregnancy. In most cases, twins are born. When applying methods of assisted reproduction number corresponds to the number of babies born embryos, transferred into the uterus.

Stats of miscarriage after treatment anovuljatornogo infertility (incl. with the help of assisted reproductive technologies) higher than the average for the population, But compared with other types of infertility.

Introduction Ovitrelja^® may affect the immune serum HCG level picture blood and urine for 10 days and cause lozhnopolozhitelnoj reactions when holding a pregnancy test.

During therapy with Ovitrel^® possible slight stimulation of the thyroid gland.

Patients should be warned about the need to tell the doctor about strengthening of side effects or side effects, not described above.

Within expiry date allowed storage of outside the refrigerator at a temperature of no higher than 25° c 30 days. The drug should be destroyed, if during this period is not utilized.

Effects on ability to drive vehicles and management mechanisms

Ovitrel^® It does not affect the ability to drive vehicles and operate machinery.

Overdose

Data on drug overdose missing.

Symptoms: may develop ovarian hyperstimulation syndrome, characterized by the formation of large ovarian cysts with risk of breakage (perforation), development of ascites and circulatory disorders.

Treatment: If you have a high risk of OHSS is recommended to cancel introduction of HCG. Patients for at least 4 days is recommended to abstain from sexual intercourse or to use barrier methods of contraception.

Drug Interactions

So far, the data about the interaction with other drugs are not available.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

List B. Solution to the p/to the introduction should be stored in its original packaging in a location that is inaccessible to children at a temperature from 2° to 8° c; Do not freeze. Shelf life – 2 year.