Pregnil - instructions for use, dose, side effects, contraindications

Solvent composition per 1 ampoule: sodium chloride 9 mg, water for injection up to 1 ml, sodium hydroxide q.s. (up to pH 4.5-7.0), hydrochloric acid q.s. (to a pH of 4.5-7.0).

Description:

Lyophilizate or a lyophilized powder of white color.

Solvent: colorless, clear solution.

Pharmacotherapeutic group:luteinizing agent

ATX: & nbsp

G.03.G.A.01 Gonadotropin chorionic

Pharmacodynamics:

The drug Pregnil® contains hCG (human chorionic gonadotropin). This hormone has biological activity similar to that of LH (luteinizing hormone).LH is indispensable for normal growth and maturation of female and male gametes and for the formation of sex hormones.

Among women:

Pregnil® is used as an ejection substitute in the middle of the endogenous LH cycle in order to induce the final phase of follicular maturation leading to ovulation. Pregnil® is also used as a substitute for endogenous LH during the luteal phase.

In men and boys:

Pregnil® is used to stimulate Leydig cells to accelerate the formation of testosterone.

Pharmacokinetics:

The maximum concentration of hCG in the blood plasma after a single intramuscular or subcutaneous injection of hCG is achieved in 6-16 hours in men and approximately in 20 hours in women. Despite the fact that there is a high individual variability, the sex differences in the rate of absorption of the drug after a single intramuscular injection are most likely associated with a greater thickness of subcutaneous fat in women. Approximately 80% of hCG undergoes metabolic transformations in the kidneys. It has been established that a single intramuscular or subcutaneous injection of hCG is bioequivalent in relation tothe duration of absorption and the apparent half-life value of approximately 33 hours. Given the recommended dosage regimens and half-life, no cumulation of the drug is expected.

Indications:

Among women:

- induction of ovulation with infertility due to anovulation or disturbance of maturation of follicles;

- preparation of follicles for puncture in controlled ovarian hyperstimulation programs (for assisted reproduction techniques);

- maintaining the phase of the yellow body.

In boys and men:

hypogonadotropic hypogonadism;

- delay in puberty due to deficiency in gonadotropic pituitary gland function;

- cryptorchidism, not due to anatomical obstruction.

Contraindications:

- Hypersensitivity to human gonadotropins or to any component of the drug;

- established or suspected tumors dependent on sex hormones (ovarian cancer, breast cancer and uterine cancer in women and prostate cancer, breast cancer in men).

In boys (optional)

premature puberty.

In women (optional)

- wrong formation of genital organs, incompatible with pregnancy;

- a fibrous tumor of the uterus, which is incompatible with pregnancy.

Carefully:

Among women, having risk factors for thrombosis (personal or family history, severe obesity (body mass index> 30 kg / m²) or thrombophilia), the risk of venous or arterial thromboembolism may be increased during or after treatment with gonadotropins. These women need to evaluate the benefits of in vitro fertilization (IVF) therapy and possible risks. It should be noted that pregnancy itself is also accompanied by an increased risk of thrombosis.

Men and boys .

Treatment of male patients with hCG leads to an increase in the production of androgens.

Therefore:

- Ppatients with latent or overt heart failure, impaired renal function, arterial hypertension, epilepsy, or migraine (or in the presence of these conditions in the anamnesis) should be under strict medical supervision, since exacerbation of the disease or relapse may sometimes result from increased production of androgens;

- HCG should be used with caution in boys in pre-pubertal age in order to avoid premature closure of the epiphyses or premature puberty.You should regularly monitor the development of the skeleton.

Pregnancy and lactation:

Pregnil® can be used to maintain the function of the ovarian's yellow body, but can not be used during pregnancy.

Pregnil® can not be used during lactation.

Dosing and Administration:

After the addition of the solvent to the lyophilizate, the reconstituted solution of Pregnil® is slowly administered intramuscularly or subcutaneously.

Among women:

Induction of ovulation infertility due to anovulation or impaired follicular maturation

Usually, one injection of Pregnil® in a dose of 5000 to 10,000 ME to complete treatment with follicle stimulating hormone (FSH).

When preparing follicles for puncture in controlled ovarian hyperstimulation programs

Usually, one injection of Pregnil® in a dose of 5000 to 10,000 ME to complete treatment with FSH.

To maintain the phase of the yellow body

May be done from two to three repeated injections of the drug in a dose of 1000 to 3000 ME each for 9 days after ovulation or embryo transfer (for example, on days 3, 6 and 9 after induction of ovulation).

In boys and men:

When hypogonadotropic hypogonadism

1000-2000 ME Pregnil® 2-3 times a week. In case of infertility, the combination of Pregnil® with an additional preparation containing follicotropin (FSH) 2-3 times a week is possible. The course of treatment should last at least 3 months, when you can expect any improvement in spermatogenesis. During this treatment, it is necessary to suspend testosterone replacement therapy. When the improvement of spermatogenesis is achieved, in order to maintain it, there is sufficient, in some cases, isolated use of hCG.

When delayed puberty, due to the lack of gonadotropic function of the pituitary gland

1500 ME 2-3 times a week. The course of treatment - at least 6 months.

In cryptorchidism, not due to anatomical obstruction:

- at the age of 2 years: 250 is entered ME twice a week for 6 weeks;

- under the age of 6 years: is introduced 500-1000 ME twice a week for 6 weeks;

- over the age of 6 years: 1500 is entered ME twice a week for 6 weeks.

The course of treatment, if necessary, can be repeated.

Side effects:

Immune system disorders

In rare cases, generalized rash or fever may occur.

General disorders and conditions at the site of administration

When using Pregnil®, reactions may occur at the injection site, for example, bruising, pain, redness, swelling, and itching. In some cases, allergic reactions were reported, most of which were manifested as pain and / or rash at the injection site.

Among women

Disorders of the vascular system

In rare cases, thromboembolism was associated with FSH / hCG therapy, usually associated with severe ovarian hyperstimulation syndrome (OSS).

Respiratory, thoracic and mediastinal disorders

Hydrotorax as a complication of severe SWC.

Gastrointestinal disorders

Abdominal pain and gastrointestinal symptoms, such as nausea and diarrhea associated with moderate SWC. Ascites as a complication of severe SWC.

Violations of the reproductive system and mammary glands

Undesirable ovarian hyperstimulation, moderate or severe ovarian hypertension.

Soreness of the mammary glands, small or medium increase in the ovaries and ovarian cysts associated with moderate SWC. Large ovarian cysts (prone to rupture), usually associated with severe SWC.

By the results of the study

An increase in body weight as a sign of severe SWC.

Men and boys

Metabolic and nutritional disorders

In some cases, with the introduction of high doses, water and sodium retention is observed; it is believed that this occurs as a result of excessive formation of androgens.

Violations of the reproductive system and mammary glands

Treatment of hCG sporadically can cause gynecomastia.

Overdose:

It was shown that acute toxicity of gonadotropin preparations obtained from human urine is very low. Nevertheless, it is likely that too high a dose of hCG can lead to CHD.

Interaction:

Since the interaction of the drug Pregnil® with other drugs has not been studied, this interaction can not be ruled out.

During treatment with Pregnil® and for 10 days after discontinuation of treatment, it may influence the values of immunological tests for serum / urinary HCG, which may lead to a false positive pregnancy test result.

Special instructions:

Among women

When pregnancy occurs after induction of ovulation with gonadotropic drugs, there is an increased risk of multiple pregnancies. Since infertile women undergoing assisted reproductive technologies,and in particular extracorporeal fertilization, often there are disorders of the fallopian tubes, the frequency of occurrence of ectopic pregnancies may increase. Therefore, it is important to have an early ultrasound confirmation that the pregnancy is intrauterine.

The frequency of pregnancy loss in women subjected to assisted reproductive technologies is higher than in the usual population.

It is necessary to exclude the presence of uncontrolled extragonadal endocrinopathies (for example, thyroid, adrenal or pituitary diseases).

The frequency of congenital malformations after assisted reproductive technologies (ART) may be slightly higher than as a result of spontaneous conception. It is believed that this slightly increased frequency is associated with the characteristics of the parents (maternal age, sperm characteristics), as well as the high frequency of multiple pregnancies after ART. There is no indication that an increased risk of congenital malformations is associated with the use of gonadotropins during ART.

Undesirable ovarian hyperstimulation

In patients receiving combined FSH / HCG therapy for infertility,caused by anovulation or disturbance of maturation of follicles, the use of FSH-containing drug can lead to undesirable hyperstimulation of the ovaries. Therefore, before starting FSH treatment and at regular intervals during FSH treatment, it is necessary to perform an ultrasound study to evaluate the development of follicles and to determine the levels of estradiol. Estradiol levels can rise very rapidly, for example, for more than two or three consecutive days, more than a daily doubling can be observed, and can reach extremely high values. The diagnosis of undesirable hyperstimulation of the ovaries can be confirmed by ultrasound. In the case of undesirable ovarian hyperstimulation (i.e., not as part of a treatment directed toward in vitro fertilization with embryo transfer (IVF / PE), intrapuber transfer of gametes (GIFT), or intraplasmatic sperm injection (ICSI)), the administration of FSH the drug must be discontinued immediately. In this case, avoid pregnancy and do not administer Pregnil®, since the administration of LH-active gonadotropin at this stage can cause,in addition to multiple ovulation, HSH. This warning is especially important in patients with polycystic ovaries.

Clinical symptoms of CHD of moderate severity are gastrointestinal disturbances (pain, nausea, diarrhea), soreness of the mammary glands and enlargement of the ovaries and cysts of the ovaries from small to moderate degree. There have been reports of liver abnormalities in liver function tests associated with CHD that indicate hepatic dysfunction, which may be accompanied by morphological changes in liver biopsy.

In rare cases, a severe SHS occurs, which can pose a threat to life. It is characterized by large ovarian cysts (prone to rupture), ascites, weight gain, often hydrothorax and, in some cases, thromboembolism.

Pregnil® should not be used to reduce body weight. HCG does not affect fat metabolism, fat distribution, or appetite.

Effect on the ability to drive transp. cf. and fur:

According to available data, the drug does not affect the speed of psychomotor reactions and concentration of attention.

Form release / dosage:

Lyophilizate for the preparation of solution for intramuscular and subcutaneous injection, 1500 and 5000 ME (together with solvent - sodium chloride solution 0,9%).

Packaging:

By 1500 ME lyophilizate into ampoules of colorless glass type 1 (EF) with a capacity of 2 ml. On the top ampoules - two rings of blue and a black point under them.

By 5000 ME lyophilizate into ampoules of colorless glass type 1 (EF) with a capacity of 2 ml. On the top ampoules - a ring of yellow color and a black point under it.

1 ml of the solvent into ampoules of colorless glass type 1 (EF) with a capacity of 1 ml. On the top ampoules - a ring of green color and a black point under it.

3 ampoules each ME lyophilizate, complete with 3 ampoules of the solvent, each ampoule fixed with two fixatives, placed in a cardboard box together with an instruction for use.

1 ampoule each ME lyophilizate complete with 1 ampoule of solvent, each ampoule fixed with two fixatives, placed in a cardboard box together with instructions for use.

Storage conditions:

Store at a temperature of 2 to 15 ° C, in a place protected from light.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N014808 / 01

Date of registration:19.12.2008

The owner of the registration certificate:Organon, N.V.Organon, N.V. Netherlands

Manufacturer: & nbsp

ORGANON, N.V. Netherlands

Representation: & nbspMSD Pharmaceuticals Ltd.MSD Pharmaceuticals Ltd.

Information update date: & nbsp23.12.2015

Illustrated instructions

Instructions

Pregnil® (Pregnyl®)