Pregnil - instructions for use, analogs, testimonials and release forms (injections in ampoules for injection 500 IU, 1500 IU, 5000 IU and 10,000 IU) of the drug on the basis of hCG for the treatment of infertility, stimulation of ovulation in IVF in adults, children and pregnancy

In this article, you can read the instructions for using the drug Pregnil. Presented are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors of specialists on the use of Pregnil in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Pregnil in the presence of existing structural analogues. Use to treat infertility,stimulation of ovulation with IVF, maintaining the phase of the yellow body in adults, children, as well as during pregnancy and lactation.

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 a substitute for the release in the middle of the cycle of endogenous LH 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.

Composition

Human chorionic gonadotropin + excipients.

Pharmacokinetics

The maximum concentration of hCG in the blood plasma after a single intramuscular or subcutaneous injection of hCG is reached after 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 IM 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 with respect to the duration of absorption and the apparent half-life value of approximately 33 hours. Considering the recommended dosing regimens and the half-life, no cumulation of the drug is expected.

Indications

Among women:

• induction of ovulation infertility due to anovulation or impaired follicular maturation;
• 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.

Forms of release

Lyophilizate for solution preparation for intramuscular and subcutaneous injection (injections in ampoules for injection) 500 IU, 1500 IU, 5000 IU and 10,000 IU.

Instructions for use and usage diagram

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

Among women:

• when induction of ovulation infertility due to anovulation or disturbance of maturation of follicles, one injection of the preparation Pregnil in a dose of 5000 to 10,000 IU is usually performed to complete the treatment with follicle stimulating hormone (FSH) preparations;
• when preparing follicles for puncture in programs of controlled ovarian hyperstimulation;
• to maintain the phase of the yellow body, 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) can be done.

In boys and men:

• with hypogonadotropic hypogonadism: 1000-2000 ME of 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, it is sufficient, in some cases, to have isolated use of hCG;
• at the delay of puberty, caused by insufficiency of the gonadotrophic function of the pituitary gland 1500 ME 2-3 times a week. The course of treatment - at least 6 months;
• with cryptorchidism, not due to anatomical obstruction;
• at the age of 2 years: 250 ME twice weekly for 6 weeks;
• at the age of 6 years: 500-1000 IU is administered twice a week for 6 weeks;
• over 6 years of age: 1500 IU is administered twice a week for 6 weeks.

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

Side effect

• generalized rash or fever;
• bruising, pain, redness, swelling and itching at the injection site;
• pain and / or rash at the injection site;
• thromboembolism;
• hydrothorax;
• abdominal pain;
• nausea;
• diarrhea;
• ascites;
• unwanted ovarian hyperstimulation;
• moderate or severe OHSS;
• tenderness of the mammary glands;
• small or medium increase in ovaries and ovarian cysts associated with moderate SWN;
• large ovarian cysts (prone to rupture), usually associated with severe SWC;
• weight gain as a sign of severe SWC;
• gynecomastia.

Contraindications

• increased sensitivity 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 (in addition):

• incorrect formation of genital organs, incompatible with pregnancy;
• fibroids of the uterus, incompatible with pregnancy.

Application in pregnancy and lactation

Application during pregnancy, during lactation is contraindicated.

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

Use in children

Possible use in children according to indications.

Contraindicated in boys with premature puberty.

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.

special instructions

In men and boys, treatment with HCG leads to an increase in the production of androgens.

Therefore:

• Patients with latent or overt heart failure, impaired renal function, 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.

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 have abnormalities in the fallopian tubes, the incidence 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 exposed to assisted reproductive technologies is higher than in the usual population;
• it is necessary to exclude the presence of uncontrolled extragonadal endocrinopathies (eg, thyroid, adrenal or pituitary diseases);
• the incidence 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 are no indications that an increased risk of congenital malformations is associated with the use of gonadotropins during ART;
• unwanted ovarian hyperstimulation:

in patients receiving combined FSH / HGH therapy for infertility due to anovulation or impaired follicular maturation, the use of FSH-containing drug may lead to unwanted ovarian hyperstimulation. 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, it is necessary to avoid pregnancy and not to introduce the drug 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.

Impact on the ability to drive vehicles and manage mechanisms

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

Drug Interactions

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 within 10 days after discontinuation of treatment, it can influence the values ​​of immunological tests for serum / urinary hCG, which can lead to a false positive result of the pregnancy test.

Analogues of the drug Pregnil

Structural analogs for the active substance:

• Gonadotropin is chorionic for injection;
• Profession;
• Horagon;
• Etchikimulin.

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