Pregnil side effects in women. Use in children. Cross-drug interactions

Indications for use:
Men:
decreased reproductive capacity associated with idiopathic dyspermia;
hypogonadotropic hypogonadism;
delay in sexual development in boys associated with insufficiency of the gonadotropic function of pituitary cells;
cryptorchidism (except due to anatomical occlusion).

Women:
in ART programs (assisted reproductive technologies) to prepare the follicle for puncture to prescribe controlled ovarian hyperstimulation;
induction of ovulation in case of infertility associated with impaired follicle maturation or anovulation;
luteal phase support menstrual cycle(including at the time of controlled ovarian hyperstimulation with assisted reproductive technologies) in combination with gonadotropin-releasing hormone analogues or other products to stimulate ovulation during female infertility, caused by anovulation due to insufficient activity of estrogens of endogenous origin (according to the WHO classification - ovarian failure of group I).

Pharmacological action:
The active ingredient of pregnil is human chorionic gonadotropin, which is obtained from the urine of pregnant women. Pregnyl stimulates education steroid hormones in the gonads due to the effect characteristic of human luteinizing hormone (LH). In female patients, the product causes an increase in the synthesis of progesterone and estrogen after ovulation; in male patients, pregnyl stimulates the synthesis of testosterone. The appearance of antibodies against human chorionic gonadotropin in the body was not observed when pregnyl was administered.

The maximum concentration of human chorionic gonadotropin (hCG) in the blood plasma in women is determined after 20 hours, in men - after 6 hours (subsequently administered intramuscularly once). Significant differences in pharmacokinetics between men and women are due in large part to the greater thickness of subcutaneous fat in women in the buttocks. After intramuscular injection HCG is well absorbed into the blood. The half-life of rotten is 33 hours. Approximately 80% of the product is destroyed in renal tissue. Elimination - with urine.

Pregnil method of administration and dosage:
Before introducing the lyophilized active substance of rotten, the supplied solvent is added. Administer intramuscularly slowly. The prepared solution cannot be stored, since further preservation of the sterility of the solution is not guaranteed. The indicated dosages are approximate; treatment should be adjusted by the doctor individually depending on the required response to the administration of pregnyl.

Preparing the follicle for puncture or inducing ovulation: pregnyl is administered once at a dosage of 3000–10,000 IU.
Support of the luteal phase of the menstrual cycle: dosage 1000–3000 IU 1 time per day. A total of 2-3 injections are prescribed: each 1 time in 9 days after the moment of embryo transfer or after ovulation (for example: after ovulation stimulation on days 3, 6 and 9).

At male infertility due to disturbances in the spermatogenesis process, it is prescribed in combination with follicle-stimulating hormone once a day or 2-3 times a week for at least 3 months until the quality and quantitative indicators spermograms. Can be used as monotherapy. The drug is prescribed in doses of 1000–2000 IU. During the administration of pregnyl, it is necessary to temporarily stop replacement treatment testosterone, if applicable.

Delayed sexual development in boys - pregnyl is prescribed in a dose of 1500 IU, the course of treatment is at least 6 months. The drug is administered 2-3 times a week.

Cryptorchidism: for children under 2 years of age, a dose of 250 IU is prescribed 2 times every 7 days for a course of at least 6 months; from 2 to 6 years – 2 times every 7 days, 500–1000 IU for a course of 6 months; for children over 6 years old - 2 times every 7 days for 6 months, 1500 IU. If the effect is insufficient, the course of treatment can be repeated.

Pregnil contraindications:
Adrogen-dependent tumors (suspected or established breast carcinoma in men, carcinoma prostate gland);
untreated endocrine diseases(adrenal insufficiency, hypothyroidism, hyperprolactinemia);
female infertility associated with obstruction fallopian tubes;
ovarian cancer
allergic reactions to gonadotropic hormonal products or any of the components is rotten.

Decayed side effects:
Women:
ovarian hyperstimulation syndrome,
unwanted ovarian hyperstimulation.

Men: fluid and sodium retention in the body due to increased formation of androgens, proliferative changes in prostate tissue, gynecomastia, erection and increase in penis size due to increased concentrations of testosterone in the blood, nipple hypersensitivity, slight enlargement of testicles in the inguinal canals, personality changes, characteristic of the first phase of puberty.

In men and women: possible disturbances at the injection site due to biological origin rotten (pain, hyperemia, bruising, itching, swelling). Hypersensitivity reactions (fever, rash) are also possible.

Pregnancy:
Pregnil is not contraindicated during pregnancy; it is prescribed to maintain the luteal phase of the menstrual cycle. However, it is not recommended to administer the product to nursing mothers.

Overdose:
Human chorionic gonadotropin is characterized by extremely low toxicity. Signs of acute overdose with parenteral administration have not been described. In women, due to an overdose of rotten, ovarian hyperstimulation may occur.

Use with other medications:
Unknown.

Release form:
Lyophilized powder for preparation injection solution in an ampoule of 1500 IU; 5000 IU. The kit includes a solvent. IN cardboard box 3 ampoules are rotten in a contour cell pack.

Storage conditions:
Pregnil should be stored in the refrigerator in dark conditions at a temperature of 2–15 ° C for no more than 3 years. When transporting, follow the instructions temperature conditions.

Rotten composition:
The composition is rotten.
Active ingredient: human chorionic gonadotropin.
Auxiliary ingredients: mannitol, anhydrous sodium dihydrogen phosphate, anhydrous sodium hydrogen phosphate, sodium carboxymethylcellulose.

Solvent composition: 0.9% sodium chloride solution.

Additionally:
There is an increased risk of multiple pregnancy with ovulation induction with human chorionic gonadotropin. In case of using auxiliary reproductive technologies the likelihood of miscarriage increases. If there are indications of tubal obstruction, the risk of ectopic (ectopic) pregnancy increases. In later cases, after the onset of pregnancy, the uterine localization of the ovum must be confirmed by ultrasound examination of the uterus. Before prescribing the product, it is necessary to exclude uncontrolled endocrinopathies of nongonal origin (dysfunction thyroid gland, pituitary or adrenal glands).

Pregnil, when prescribed to women with infertility caused by impaired follicle maturation or anovulation, can lead to unwanted ovarian hyperstimulation with the concomitant administration of follicle-stimulating hormone. In these cases, ultrasound monitoring is necessary before pregnyl therapy and during its use (at regular intervals) to assess follicle development. It is also recommended to periodically determine the content of estradiol in the blood serum. A rapid increase in estradiol (2 times over 2-3 days) may indicate the development large quantity follicles. Unwanted ovarian hyperstimulation can be confirmed by ultrasound examination of the ovaries. If the diagnosis is confirmed, it is necessary to immediately stop administering products that contain follicle-stimulating hormone, as there is a risk of developing ovarian hyperstimulation syndrome and inducing multiple ovulations. Particular care should be taken when treating patients with multifollicular ovaries.

Symptoms of mild ovarian hyperstimulation: nausea, abdominal pain, diarrhea, chest pain, mild or moderate increase ovarian size or the appearance of ovarian cysts. Symptoms of severe ovarian hyperstimulation: the development of significant ovarian cysts (which tend to rupture), weight gain, the appearance of ascites, the development of thromboembolic complications and hydrothorax.

Administration of human chorionic gonadotropin causes an increase in androgen synthesis, so deterioration may occur. general condition or relapse with pronounced or latent cardiovascular failure, migraine (including a history of migraine), arterial hypertension, renal dysfunction, epilepsy. The product is prescribed to such persons with caution under close medical supervision.

In order to prevent precocious puberty or epiphyseal maturation in young men during puberty, it is necessary to prescribe the product to them with caution during this period. In this case, the administration of rotten should be carried out under the control of the condition of the musculoskeletal system.

Pregnyl 10000 belongs to the group hormonal drugs. It is effective in the treatment of infertility. Can be prescribed without restrictions based on gender: women and men.

Other names and classification

Latin name - Pregnyl.

International nonproprietary name

Chorionic gonadotropin.

Registration number

P N014808/01-230709

Composition and dosage forms

The product can only be purchased in the form of a lyophilisate for preparing a solution. Before use, the powder is diluted with a solvent, which is NaCl (0.9%). Both substances are contained separately in clear glass ampoules (2 ml each).

The active component exhibiting hormonal activity is human chorionic gonadotropin.

Its dosage is different: 500, 1500 and 5000 IU. The drug is not available in quantities of 10,000 units. This dose can be prescribed only if the therapy uses lyophilisate in ampoules with a different concentration active substance.

Additionally, the powder contains components that are not active, but allow you to obtain the required consistency of the medicinal substance:

  • carmellose sodium;
  • mannitol;
  • sodium hydrogen phosphate;
  • sodium dihydrogen phosphate.

Number of ampoules in the package: solvent (3 pcs.), lyophilisate (3 pcs.).

Pharmacological group

Hormones of the hypothalamus, pituitary gland, gonadotropins and their antagonists.

Pharmacological action

Human chorionic gonadotropin is obtained by excretion from the urine of women during pregnancy. HCG is characterized by the same properties and mechanism of action on the body as luteinizing hormone, but differs in structure. Additionally, the substance exhibits follicle-stimulating properties. IN human body HCG is produced as a result of a natural process - during the period of bearing a child.

Gonadotropin synthesis is activated after the fertilized egg attaches to the uterine wall.

Human chorionic gonadotropin belongs to the group of gonadotropic hormones, which includes luteinizing and follicle-stimulating hormones. The latter are produced in the anterior lobe of the pituitary gland. HCG is produced during the development of the placenta, thanks to this hormone growth is supported corpus luteum. The introduction of Pregnil allows you to normalize the function of the female genital organs, while stimulating the growth of follicles. Other functions of human chorionic gonadotropin:

  • activation of progesterone synthesis in a woman’s body in the absence of a fertilized egg in the uterus;
  • increase in the intensity of production of estrogens and androgens (in small quantities).

The last possibility is realized with the participation of follicular apparatus ovaries. Thanks to Pregnil, the function of the genital organs is temporarily normalized, which eliminates the most common causes of infertility: lack of ovulation, disruption of the ovaries. Additionally, human chorionic gonadotropin enhances the production of corticoid hormones in the adrenal cortex, but hCG does not exhibit corticotropic properties.

Due to the introduction of human chorionic gonadotropin into the female body, the hormone levels are normalized and ovulation occurs. HCG supports ovarian function, thereby increasing the likelihood of pregnancy.

Pregnil is also used in the treatment of boys and men. With the help of human chorionic gonadotropin, the process of sperm production is restored. In adolescents, testosterone synthesis normalizes during the growth period. Thanks to this, the likelihood of developing pathologies of the genital organs is eliminated.

The active component of Pregnil is absorbed slowly.

Men and women have different absorption rates. Thus, in patients of the first group, the peak effectiveness of the drug is achieved after 6-16 hours. The rate of increase in the concentration of hCG in the body of women is lower, for this reason the peak effectiveness of human chorionic gonadotropin is achieved after 20 hours.

How much is withdrawn

The active component of Pregnil is excreted from the body after 33 hours. This is an approximate value, since the rate of removal of hCG is affected by various factors, including: the presence of other diseases, the condition of the kidneys (with the help of this organ, human chorionic gonadotropin is metabolized). Biological substances, which may contain the hormone, are urine and blood. Some time after cessation of therapy, hCG is not detectable in these media.

Indications for use of Pregnil 10000 units

The drug is prescribed to women in a number of cases:

  • maintaining the corpus luteum phase;
  • stimulation of the process of ovulation in women with anovulation or ovarian dysfunction;
  • preparatory stage for ovarian puncture, which is often required when using artificial insemination techniques (for example, IVF);
  • ovarian hyperstimulation (controlled process).

Indications for use in male patients:

  • dysfunction of the pituitary gland, which directly affects sexual development boys;
  • testicular insufficiency, during laboratory research determined low level testosterone;
  • a pathological condition in which the testicle does not descend into the scrotum.

Directions for use and dosage: Pregnil 10,000 units

How to divorce

For ease of use of the drug, the kit contains the same number of ampoules with lyophilisate and solvent. Before administering the product, it is necessary to mix the contents of the powder and solution; all manipulations should be performed using a syringe and a disposable needle: first, the solvent is taken, then it is introduced into an ampoule with lyophilisate, shaken until a homogeneous liquid is formed. Ready solution used for injection.

Where to inject

The drug is recommended to be administered intramuscularly, less often - subcutaneously. The injection can be given in the femoral part of the leg ( soft fabrics), buttock. However, to achieve best result and reduction pain Pregnyl should be injected into the buttock muscle (upper right corner of the conventional square).

How to prick

  • in case of impaired maturation of follicles, induction of ovulation by follicle-stimulating hormones, 10,000 units of Pregnyl are prescribed once, the injection is performed at the final stage of therapy;
  • preparation for follicle puncture: an injection is given with a dosage of hCG 10,000 units once, at the final stage of therapy after a course of treatment with follicle-stimulating hormones.

The drug with a dosage of 10,000 units is not used to maintain the corpus luteum, since this requires a smaller amount of the drug. In the treatment of male infertility or for the purpose of stimulating testosterone synthesis in adolescents against the background of disruption of the process of puberty, Pregnil in a dosage of 10,000 units is also not used. For this, a smaller amount of the product is sufficient: no more than 1500 units per week (single dose).

Pregnyl 5000 instructions

Pregnyl 1500 instructions

After an injection of hCG (Gonazi 5000 units): follicle development and ovulation

Pregnyl - Human Chorionic Gonadotropin: how to properly inject hCG

Special instructions

When the drug is prescribed to women during pregnancy planning, after the induction of ovulation by hCG hormones, the likelihood of multiple pregnancies increases.

If the patient has uterine pathologies, ultrasound examinations are regularly performed after fertilization. This measure allows you to determine whether the embryo is developing correctly. With such pathologies in women, the risk increases ectopic pregnancy.

When IVF is planned or other assisted reproductive technology is used, the woman should be warned that this increases the likelihood of miscarriage.

You cannot start treatment with Pregnil against the background of fibrous tumor of the uterus, diseases endocrine system, dysfunction of the pituitary gland.

The risk of fetal malformations increases.

If a woman is undergoing treatment with follicle-stimulating hormones, additional administration of a drug similar in properties to FSH may lead to ovarian hyperstimulation. However, in this case, the process of activating their function is uncontrolled and can provoke a number of complications.

Pregnil, even in an amount of 10,000 units, does not contribute to the development of disorders of psychomotor functions, vision or hearing, as well as cardiovascular system. For this reason, it is permissible to manage vehicle during therapy with this drug.

Side effects of Pregnil 10,000 units

During treatment there is a risk of developing numerous negative reactions:

  • feverish condition;
  • extensive rash on the body;
  • local reactions at the injection point: redness, soreness, mild or moderate swelling, itching;
  • vascular dysfunction, thromboembolism is more often diagnosed;
  • hydrothorax;
  • pathological conditions of the gastrointestinal tract that arose against the background hormone therapy HCG, such as ascites, may also cause nausea, diarrhea;
  • soreness in mammary glands ah, which is a consequence of the development of OHSS;
  • increase in the size of ovarian cysts.

Listed side effects occur more often in women. Men are characterized by metabolic disorders, which is manifested by a decrease in the intensity of fluid excretion from the body. In addition, sodium retention occurs. These complications are believed to be a consequence of increased androgen levels. Hypertrophy of the mammary glands and adipose tissue (gynecomastia) develops less frequently.

Contraindications

Pregnil in the amount of 10,000 units is not prescribed in a number of cases:

  • intolerance to the active substance (hCG) in the drug;
  • period of lactation, bearing a child (you must remember that artificial stimulation of the ovaries can be carried out only when planning pregnancy, and if human chorionic gonadotropin is administered after fertilization and against the background of embryo development, the risk of ovarian hyperstimulation syndrome increases);
  • early puberty boys;
  • pathologies of the female genital organs associated with disruption of their formation;
  • neoplasms in the uterus.

Mark a row relative contraindications conditions in which it is permissible to use Pregnil, but this should be done with caution:

  • thrombosis in women or a tendency to such a disease in the presence of risk factors, including obesity, a history of increased thrombosis (it must be taken into account that during pregnancy there is a risk of signs of this pathological condition increases);
  • heart failure, kidney dysfunction, hypertension, epilepsy, migraine in men (in these cases, constant monitoring of the patient's condition is required).

Therapy for boys adolescence suggests the need for specialist supervision, since during treatment with Pregnil the risk of premature sexual development increases. In addition, it is necessary to control the growth of bone tissue.

Overdose

The drug does not contain aggressive substances, which means that even the use large doses solution will not lead to the development negative manifestations. However, uncontrolled administration liquid substance may cause symptoms of ovarian hyperstimulation.

Interoperability and Compatibility

The effect of Pregnil on drugs from other groups has not been studied. With combination therapy there is a risk of developing negative reactions, so administer medicinal substance should be monitored with caution for symptoms.

Manufacturer

Organon, Netherlands.

Conditions for dispensing from pharmacies

The drug belongs to the group of prescription drugs.

Price

The cost depends on the number of ampoules in the package and ranges from 180-1260 rubles.

Conditions and shelf life

The drug must be protected from direct exposure sun rays. It should be stored at a temperature of +2...+15°C. Children must be denied access to the product.

Pregnil retains its properties for 3 years from the date of issue.

Analogs

Substitutes for the product in question:

  • Horagon;
  • Chorionic gonadotropin;
  • Profasi.

The first 2 drugs are direct analogues of Pregnil. They contain human chorionic gonadotropin, the concentration of the active substance is the same as in the case of the drug in question. Choragon and Human Chorionic Gonadotropin do not differ in indications for use and contraindications. When replacing one agent with another from a number of those mentioned, it is not necessary to recalculate the amount of the substance.

Prophasia is another analogue based on human chorionic gonadotropin, but the active substance is contained in a different amount. This may cause a change in treatment regimen.

Yes, 1 ml liquid product contains 2000 or 5000 units of hCG.

Hormonal disorders affect both the male and female bodies equally.

Diseases arise, the manifestations and consequences of which are not the most pleasant.

To combat them, many hormonal drugs have been created, such as Pregnil. Today we will look at its action in more detail.

Pharmacological action

The drug belongs to hormonal drugs. Pregnil actively stimulates the production of testosterone in men, and estrogen and progesterone in women (after ovulation).

Pregnil contains human chorionic genadotropin. This substance exhibits luteinizing and follicle-stimulating effects. The provision of these effects by the drug is vital for the processes of growth and maturation of gametes, as well as for the secretion of sex hormones.

For the female body, the use of Pregnil can replace the natural endrogenic luteinizing hormone. Thanks to its release, follicles mature. The final stage of the process is ovulation.

The product has a beneficial effect on the maturation of follicles

The maximum level of hCG after an injection of Pregnil is achieved after 6 hours (provided intramuscular injection) or after 16 hours (provided subcutaneous injection). This time of hormone accumulation is typical for male body, for women it takes about 20 hours.

This difference depends on individual characteristics organisms of heterosexual people. One factor may be that women have much more fatty tissue in the buttocks than men.

The metabolism of the drug Pregnil occurs mostly in the kidneys.

The half-life is approximately 33 hours. Provided the dosage and other instructions are followed, there cannot be excessive accumulation of the drug in the body.

Composition and release form

Pregnil is produced by pharmaceutical company from the Netherlands “N.V. Organon."

The product comes into production in ampoules in the form of powder for preparation aqueous solution, which is used for injection.

Pregnil drug Available in doses:

  1. 500 IU;
  2. 1500 IU;
  3. 5000 IU;
  4. 10000 IU.




Thanks to this, the drug can be used not only to treat adults, but also children. Cardboard packages are equipped with 1+1 or 3+3 ampoules.

The first option contains 1 ampoule of Pregnil powder and 1 saline solution. In the second type of packaging there are 3 ampoules with the drug, and the same amount of sodium chloride.

The main active ingredient is human chorionic genadotropin.

The drug also contains additional components:

  • Carmellose sodium;
  • Sodium hydrogen phosphate;
  • Dihydrate;
  • Sodium dihydrogen phosphate.

Clinical analysis of the drug

Indications for use

The drug Pregnil is used to solve certain hormonal disorders.

Decayed during pregnancy

This medicine Contraindicated during pregnancy.

If pregnancy occurs after ovulation induction, several fetuses may develop.

Contraindications

For some diseases, the use of Pregnil is contraindicated. First of all, the drug should not be used by those who are intolerant to any component of the drug.

  • Ovaries;
  • Mammary glands;
  • Uterus;
  • Testicles;
  • Pituitary gland;
  • Prostate;
  • Hypothalamus.

There are some contraindications that apply only to women's health.

It is necessary to refuse treatment with Pregnil if:

  • Congenital pathology of the genital organs;
  • Fibroid tumors;
  • Vaginal bleeding of unknown origin;
  • Cysts on the ovaries or enlarged ovaries.

Side effects

The use of Pregnil, like other hormonal agents, can cause unwanted reactions organism, which depends on individual characteristics.

Before using it, many women wonder whether Pregnil can cause breast pain. Indeed, such an adverse reaction is possible from the drug, but it is not the only one.

Common manifestations of the body not accepting the drug are fever and generalized rashes.

To determine whether a drug causes an adverse reaction (AR), use the Naranjo method; if, after answering the questions, the indicator is 0, then it is unlikely that the drug causes an ADR. If the indicator is greater than 0, then the drug causes PR and needs to be replaced

Incompatibility of Pregnil with female body may manifest itself:

  • Pain in the abdominal area;
  • Hydrothorax;
  • Nausea;
  • Ascitoma;
  • Diarrhea;
  • Undesirable ovarian hyperstimulation;
  • Increased ovarian cysts;
  • Enlarged ovaries;
  • Increased body weight.

The drug may cause symptoms in men adverse reactions in the form:

  1. Gynecomastia;
  2. Retention of sodium ions and water in tissues.

After administration of Pregnil, there may be bruising, redness, swelling, itching and soreness at the injection site.

Drug interactions

The possibility of interaction between Pregnil and other medications cannot be ruled out. But any combination should occur on the recommendation of a doctor and under strict supervision.

Useful video:

Dosage and overdose

The dosage of the drug should be prescribed only by a doctor. Since it belongs to hormonal drugs, patients are always interested in: “How long does it take for Pregnil to be removed from the body?”

The period of partial elimination of the drug from the body is approximately 33 hours and directly depends on the dosage used.

One more exciting question is: “How much to inject Pregnil per 1 follicle?” The answer depends on the size of the follicle. The dosage of the drug can be both minimum and maximum. It is also important that the procedure may not be a one-time procedure.

An approximate course of treatment looks like this:

If treatment with Pregnil occurs under the supervision of doctors, then there simply cannot be an overdose.

But, if for some reason poisoning does occur, it may lead to ovarian hyperstimulation.

Instructions for use

The drug is dosed depending on the complexity of the problem and age. To the question: “How and where to inject Pregnil?” - the answer is clear.

The package contains two types of ampoules: with powder and saline solution. Before injection, the components must be mixed and shaken well to completely dissolve the dry substance. Fill the syringe and inject Pregnil subcutaneously or intramuscularly.

Instructions on how to properly administer intramuscular injections

How long does it take for Pregnil to ovulate? Depending on the individual perception of the body, the effect is possible in a period of time from 24 to 36 hours. In some situations - 72 hours.

Dosage of the drug Pregnil:

No.CauseDose for women, IUDose for men, IUDose for children, IU
1 Infertility5000-10000
2 Preparing follicles for puncture5000-10000
3 Corpus luteum phase support1000-3000 (every 9 days after ovulation)
4 Hypogonadotropic hypogonadism 1000-2000 2-3 times/week
5 Delayed puberty 1500 2-3 r/week
6 Cryptorchidism Up to 2 years - 250 2r/week;
Up to 6 years - 250 2r/week;
Over 6 years old - 1500 2 rubles/week.

Instructions for use in video format:

Ovulation test

There is no need to do a test immediately after Pregnil injection. Its result will be false positive.

Shelf life and storage of the drug

Pregnyl must be stored at a temperature not lower than +2 ̊ C and not higher than +15 ̊ C. The medicine should not be frozen or exposed to direct sunlight.

Subject to the above standards, the drug Pregnil is valid for 3 years from the date of production.

Special instructions

At artificial insemination And simultaneous use Decayed, possible disruption of the fallopian tubes. For this reason, pregnancy may not be intrauterine, but ectopic.

The use of the drug Pregnil as an assisted reproductive technology has more high risk miscarriage than during normal fertilization.

Before starting to take the drug Pregnil, disorders in the endocrine system should be ruled out.

Planned conception of a child using Pregnil and others similar drugs characterized by risk birth defects in the fetus.

The drug is not used for weight loss.

Pregnil has no effect on psychomotor skills and concentration.

Price of the drug in pharmacies

When asked how much Pregnil costs, you can answer that the price of this drug depends on the number of ampoules in the package, the dosage of the active substance and the pharmacy network. One ampoule - from 185 rubles, package No. 3 - from 1300 and above.

Conditions for dispensing from pharmacies

The drug Pregnil is dispensed by prescription.

Analogues substitutes

Similar in action medicines sufficient quantity. Substitutes for Pregnil include:

  • Mestranol;
  • Dimestrol.

Photos of analogues:


Name: Pregnyl

Indications for use:
Men:
decreased reproductive capacity associated with idiopathic dyspermia;
hypogonadotropic;
delay in sexual development in boys associated with insufficiency of the gonadotropic function of pituitary cells;
(except due to anatomical occlusion).

Women:
in ART programs (assisted reproductive technologies) to prepare the follicle for puncture to prescribe controlled ovarian hyperstimulation;
induction of ovulation in case of infertility associated with impaired follicle maturation or anovulation;
support of the luteal phase of the menstrual cycle (including at the time of controlled ovarian hyperstimulation with assisted reproductive technologies) in combination with gonadotropin-releasing hormone analogues or other products to stimulate ovulation in female infertility caused by anovulation due to insufficient activity of estrogens of endogenous origin (according to WHO classification - ovarian failure group I).

Pharmacological action:
The active ingredient of pregnil is human chorionic gonadotropin, which is obtained from the urine of pregnant women. Pregnil stimulates the formation of steroid hormones in the gonads due to the effect characteristic of human luteinizing hormone (LH). In female patients, the product causes an increase in the synthesis of progesterone and estrogen after ovulation; in male patients, pregnyl stimulates the synthesis of testosterone. The appearance of antibodies against human chorionic gonadotropin in the body was not observed when pregnyl was administered.

The maximum concentration of human chorionic gonadotropin (hCG) in the blood plasma in women is determined after 20 hours, in men - after 6 hours (subsequently administered intramuscularly once). Significant differences in pharmacokinetics between men and women are due in large part to the greater thickness of subcutaneous fat in women in the buttocks. After intramuscular administration, hCG is well absorbed into the blood. The half-life of rotten is 33 hours. Approximately 80% of the product is destroyed in the kidney tissue. Elimination - with urine.

Pregnil method of administration and dosage:
Before introducing the lyophilized active substance of rotten, the supplied solvent is added. Administer intramuscularly slowly. The prepared solution cannot be stored, since further preservation of the sterility of the solution is not guaranteed. The indicated dosages are approximate; treatment should be adjusted by the doctor individually depending on the required response to the administration of pregnyl.

Preparing the follicle for puncture or inducing ovulation: pregnyl is administered once at a dosage of 3000–10,000 IU.
Support of the luteal phase of the menstrual cycle: dosage 1000–3000 IU 1 time per day. A total of 2-3 injections are prescribed: each 1 time in 9 days after the moment of embryo transfer or after ovulation (for example: after ovulation stimulation on days 3, 6 and 9).

In case of male infertility due to disturbances in the process of spermatogenesis, it is prescribed in combination with follicle-stimulating hormone 1 time a day or 2-3 times a week for at least 3 months until the qualitative and quantitative indicators of the spermogram increase. Can be used as monotherapy. The drug is prescribed in doses of 1000–2000 IU. During the administration of pregnyl, it is necessary to temporarily stop testosterone replacement treatment, if any.

Delayed sexual development in boys - pregnyl is prescribed in a dose of 1500 IU, the course of treatment is at least 6 months. The drug is administered 2-3 times a week.

Cryptorchidism: for children under 2 years of age, a dose of 250 IU is prescribed 2 times every 7 days for a course of at least 6 months; from 2 to 6 years – 2 times every 7 days, 500–1000 IU for a course of 6 months; for children over 6 years old - 2 times every 7 days for 6 months, 1500 IU. If the effect is insufficient, the course of treatment can be repeated.

Pregnil contraindications:
Adrogen-dependent tumors (suspected or established breast cancer in men, prostate carcinoma);
untreated endocrine diseases (adrenal insufficiency);
infertility of women associated with obstruction of the fallopian tubes;
,
allergic reactions to gonadotropic hormonal products or any of the components of rotten.

Pregnil side effects:
Women:
ovarian hyperstimulation syndrome,
unwanted

Men: fluid and sodium retention in the body due to increased formation of androgens, proliferative changes in the prostate tissue, erection and increase in penis size due to increased concentrations of testosterone in the blood, nipple hypersensitivity, slight enlargement of the testicles in the inguinal canals, personality changes characteristic of first phase of puberty.

In men and women: disturbances at the injection site are possible due to the biological origin of decay (pain, bruising, itching, swelling). Hypersensitivity reactions (fever, rash) are also possible.

Pregnancy:
Pregnil is not contraindicated during pregnancy; it is prescribed to maintain the luteal phase of the menstrual cycle. However, it is not recommended to administer the product to nursing mothers.

Overdose:
Human chorionic gonadotropin is characterized by extremely low toxicity. Signs of acute overdose with parenteral administration have not been described. In women, due to an overdose of rotten, ovarian hyperstimulation may occur.

Use with other medications:
Unknown.

Release form:
Lyophilized powder for the preparation of injection solution in an ampoule of 1500 IU; 5000 IU. The kit includes a solvent. In a cardboard box there are 3 ampoules, rotted in a contour cell pack.

Storage conditions:
Pregnil should be stored in the refrigerator in dark conditions at a temperature of 2–15 ° C for no more than 3 years. During transportation, observe the specified temperature conditions.

Rotten composition:
The composition is rotten.
Active ingredient: human chorionic gonadotropin.
Auxiliary ingredients: anhydrous sodium dihydrogen phosphate, anhydrous sodium hydrogen phosphate, sodium carboxymethylcellulose.

Solvent composition: 0.9% sodium chloride solution.

Additionally:
There is an increased risk of multiple pregnancy with ovulation induction with human chorionic gonadotropin. When assisted reproductive technologies are used, the likelihood of miscarriage increases. If there are indications of tubal obstruction, the risk of ectopic (ectopic) pregnancy increases. In later cases, after the onset of pregnancy, the uterine localization of the ovum must be confirmed by ultrasound examination of the uterus. Before prescribing the product, it is necessary to exclude uncontrolled endocrinopathies of nongonal origin (dysfunction of the thyroid gland, pituitary gland or adrenal glands).

Pregnil, when prescribed to women with infertility caused by impaired follicle maturation or anovulation, can lead to unwanted ovarian hyperstimulation with the concomitant administration of follicle-stimulating hormone. In these cases, ultrasound monitoring is necessary before pregnyl therapy and during its use (at regular intervals) to assess follicle development. It is also recommended to periodically determine the content of estradiol in the blood serum. A rapid increase in estradiol (2 times over 2-3 days) may indicate the development of a large number of follicles. Unwanted ovarian hyperstimulation can be confirmed by ultrasound examination of the ovaries. If the diagnosis is confirmed, it is necessary to immediately stop administering products that contain follicle-stimulating hormone, as there is a risk of developing ovarian hyperstimulation syndrome and inducing multiple ovulations. Particular care should be taken when treating patients with multifollicular ovaries.

Symptoms of mild ovarian hyperstimulation: nausea, abdominal pain, diarrhea, chest pain, slight or moderate increase in ovarian size or the appearance of ovarian cysts. Symptoms of severe ovarian hyperstimulation: the development of significant ovarian cysts (which tend to rupture), weight gain, the appearance of ascites, the development of thromboembolic complications and hydrothorax.

The administration of human chorionic gonadotropin causes an increase in the synthesis of androgens, so a deterioration in the general condition or a relapse may be observed in cases of severe or latent cardiovascular failure, migraine (including a history), arterial hypertension, impaired renal function, and epilepsy. The product is prescribed to such persons with caution under close medical supervision.

In order to prevent precocious puberty or epiphyseal maturation in young men during puberty, it is necessary to prescribe the product to them with caution during this period. In this case, the administration of rotten should be carried out under the control of the condition of the musculoskeletal system.

Attention!
Before using the medication "Rotten" You should consult your doctor.
The instructions are provided for informational purposes only. Decayed».

For women:

- during pregnancy that occurs after ovulation induction with gonadotropic drugs, there is increased risk multiple pregnancy;

- since infertile women undergoing assisted reproductive technologies, and especially in vitro fertilization, often have disorders of the fallopian tubes, the incidence of ectopic pregnancies may increase. Therefore, early ultrasound confirmation that the pregnancy is intrauterine is important;

— the frequency of pregnancy loss in women undergoing assisted reproductive technologies is higher than in the general population;

- the presence of uncontrolled extragonadal endocrinopathies (for example, diseases of the thyroid gland, adrenal glands or pituitary gland) should be excluded;

— the incidence of congenital malformations after assisted reproductive technologies (ART) may be slightly higher than as a result of spontaneous conceptions. This slightly increased frequency is thought to be related to parental characteristics (maternal age, sperm characteristics) as well as high frequency multiple pregnancy after ART. There is no indication that an increased risk of congenital malformations is associated with the use of gonadotropins during ART;

- unwanted ovarian hyperstimulation:

in patients receiving combination therapy with FSH/hCG for infertility caused by anovulation or impaired follicular maturation, the use of an FSH-containing drug may lead to undesirable ovarian hyperstimulation. Therefore, before starting FSH treatment and at regular intervals during FSH treatment, ultrasound examinations should be performed to assess follicular development and estradiol levels should be determined. Estradiol levels can rise very quickly, for example, more than a daily doubling may be observed over two or three consecutive days, and can reach extremely high values. The diagnosis of unwanted ovarian hyperstimulation can be confirmed by ultrasound examination. If unwanted ovarian hyperstimulation occurs (i.e. not as part of treatment to prepare for in vitro fertilization with embryo transfer (IVF/ET), intratubal gamete transfer (GIFT) or intraplasmic sperm injection (ICSI), the administration of the FSH-containing drug must be stopped immediately. In this case, it is necessary to avoid pregnancy and not administer the drug Pregnil, since the administration of LH-active gonadotropin at this stage can cause, in addition to multiple ovulation, OHSS. This warning is especially important for patients with polycystic ovaries. Clinical symptoms Moderate OHSS are gastrointestinal disorders(pain, nausea, diarrhea), breast tenderness and enlarged ovaries and ovarian cysts from small to moderate degree. Temporary abnormalities in liver function tests associated with OHSS have been reported, indicating hepatic dysfunction that may be accompanied by morphological changes with liver biopsy.

IN in rare cases Severe OHSS occurs, which can be life-threatening. It is characterized large cysts ovaries (prone to rupture), ascites, weight gain, often hydrothorax and in some cases thromboembolism;

— Pregnil should not be used for weight loss. HCG has no effect on fat metabolism, fat distribution, or appetite.

Effect on the ability to drive vehicles and operate machinery: according to available data, the drug does not affect the speed of psychomotor reactions and concentration.