International non-proprietary name:Human Chorionic Gonadotrophin (HCG)

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Composition
Active ingredient: highly purified human chorionic gonadotropin 5000 BV in 1 vial
(GHG) exists.
Solvent: 1 ampoule contains 1 ml of sterile and pyrogenic 0.9% isotonic sodium chloride solution.
Excipients: anhydrous disodium hydrophosphate, sucrose, mannitol, phosphoric acid (% 85) A.T., k.m. For pH adjustment (sufficient amount).

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Description
It is a white, sterile, pyrogenic, highly purified lyophilized powder. 
The solvent is a sterile, nonpyrogenic, colorless, transparent solution. 

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Pharmacotherapeutic group
Gonadotropins and other stimulators of ovulation.
Chorionic gonadotropin

ATC code:G03GA01

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pharmacological properties
Pharmacodynamics
Human chorionic gonadotropin (HCG) is a polypeptide gonadotropin hormone composed of alpha- and beta-subunits, produced by the couple during pregnancy and then excreted unchanged by the kidneys. It is extracted and purified from the urine of pregnant women. 
IXQ has a strong luteinizing property as a hormone of the anterior part of the pituitary gland. 
It is necessary for normal maturation of sexual organs in women and men and for the formation and physiological development of secondary sexual characteristics. Human chorionic gonadotropin stimulates the synthesis of sex hormones in the gonads (ovaries and testicles) - steroidogenesis. 
During a normal menstrual cycle, LH, together with FSH, participates in the development and maturation of the normal follicle in the ovaries; and in the middle of the cycle, the rise of the LH level ensures ovulation. IR can replace luteinizing hormone in this function. 
In women, it stimulates ovulation and the stromal cells of the corpus luteum, and helps protect pregnancy due to the normal synthesis of estrogen (estradiol) and progesterone hormones. Also, it supports the full formation and development of the couple. Chorionic gonadotropin, in addition to supporting the development of pregnancy, stimulates ovulation and significantly affects the reproductive activity of women before fertilization. This is crucial for the induction of superovulation before assisted reproductive techniques such as in vitro fertilization (IVF). 
In men, it stimulates the interstitial cells of the testicles (Leydig cells), improves the production of testosterone and other steroid sex hormones and spermatogenesis. 
In children with cryptorchidism, it helps the testes to descend into the scrotum.
Pharmacokinetics
Chorionic gonadotropin is injected intramuscularly. Depending on the dose, the maximum concentration in the blood is reached after 2-6 hours. It is removed from the body in 2 stages. T1/2 (half-life) of the first phase is approximately 8-12 hours, and the second phase is 23-37 hours. The drug is mainly excreted through the kidneys. 10-20% of the injected dose is found unchanged in the urine, and the main part is excreted by the kidneys in the form of beta chain fragments. 

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Instructions for use
In women and men 
Hypofunction of gonads due to hypothalamus and pituitary gland dysfunction (decreased functional capacity)

In women
•    Induction of ovulation in infertility due to anovulation or impaired follicular maturation (oligo-ovulation) 
•    To support corpus luteum function in patients with deficiency of the lutein phase of the menstrual cycle (while the estrogen function of the ovaries is preserved) 
•    Cultivation of follicles and preparation for puncture within the program of controlled ovarian hyperstimulation (assisted reproductive technologies) 
•    Induction of superovulation in assisted reproductive technology programs such as in vitro fertilization (IVM) 
•     In order to protect pregnancy in the early stages during miscarriage
•    Spontaneous abortion (miscarriage) risk 
•    Rare and minor functional bleeding (oligomenorrhea, primary and secondary amenorrhea) and Frelich syndrome

In men
•    Hypogonadotropic hypogonadism 
•    Infertility due to idiopathic impaired spermatogenesis (normogonadotropic oligospermia)
•    Oligo- and asthenospermia due to relative androgen deficiency 
•    Azoospermia

In boys
•    Delay of puberty due to lack of gonadotropic function of the pituitary gland 
•    Prepubertal cryptorchidism (except as a result of anatomical obstruction)

 

As a diagnostic method 
•    Evaluation of testicular (scrotal) function (Leydig test) before long-term stimulation treatment of hypogonadotropic hypogonadism in men.
•    Differential diagnosis of cryptorchidism and anorchism in boys 

 

Contraindications  
In men and women
- Known hypersensitivity to IXQ or other gonadotropins (IMG, FSH).
- Hypersensitivity to any of the excipients contained in the preparation 
- Absence of gonads (congenital or after surgery) 
- Untreated endocrinopathy of the thyroid and adrenal glands 
-Organic lesions of the central nervous system (including tumors of the pituitary gland, hypothalamus)
-Thrombophlebitis of deep veins 
-Children under 3 years 

In women
-Pregnancy and lactation period
-Infertility that does not result in normal follicle maturation (eg, tubal or cervical origin)
-Ovarian cysts or enlarged ovaries unrelated to PCOS
-Obstruction of fallopian tubes 
-Ectopic pregnancy in the last 3 months 
-Vaginal bleeding and bloody discharge of unknown etiology (non-menstrual)
- Ovarian hyperstimulation syndrome
- Hyperprolactinemia
- Carcinoma of ovaries, endometrium or mammary glands

In men
-Infertility not due to hypogonadotropic hypogonadism 
-Androgen derivatives such as carcinoma of the testes, prostate or breast 
- Conditions of organic origin associated with undescended testicles (inguinal hernia, inguinal surgery, testicular ectopia)
In addition, in the following cases, positive results of treatment are not expected and therefore the drug should not be prescribed:
- Primary ovarian failure
- Developmental defects and deformations of female genital organs incompatible with normal pregnancy
- Benign growths of childhood incompatible with pregnancy (myoma) 
- Ovarian hyperstimulation syndrome in the anamnesis
-Early menopause

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It should be used with caution in the following cases
Ischemic heart disease, chronic heart failure, chronic renal failure, epilepsy, migraine, bronchial asthma, arterial hypertension, risk of thrombosis (in women), prepubescent boys, puberty.
Special warning
Long-term use is not recommended due to the formation of antibodies that reduce the effectiveness of treatment.

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Interaction with other drugs  
The interaction with other drugs has not been studied. 
Inform your doctor if you are taking any medication.
HCV increases the likelihood of ovarian hyperstimulation syndrome when used together with HMG (Human Menopausal Gonadotropin) or clomiphene citrate in the treatment of infertility. 
It is recommended to avoid using chorionic gonadotropin together with high doses of corticosteroids.

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Use during pregnancy and lactation
Consult your doctor before starting to use the drug.
It should not be used during pregnancy and lactation. 
If you discover that you are pregnant during treatment, inform your doctor immediately.

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Effects on the ability to drive vehicles and other potentially dangerous mechanisms
Does not affect.

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Special instructions and precautions
In men, the drug is ineffective if the amount of follicle-stimulating hormone (FSH) is high. Premature puberty may occur in adolescent boys with delayed physical and sexual development during long-term treatment or at high doses. During unreasonably long-term treatment of cryptorchidism (especially in cases where surgical intervention is required), degeneration of the gonads may occur. As a result of the increase in the synthesis of androgens and estrogens, the inhibition of FSH synthesis can cause atrophy of the seminiferous tubules. It is also possible to develop antibodies against the drug during long-term use. The drug increases the probability of multiple pregnancy. A pregnancy test may show a false positive result during treatment with the drug and within 7 days after stopping the drug. Treatment should be discontinued in patients with ovarian hyperresponsiveness (eg, ovarian hypertrophy, estradiol elevation).

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Method of use and dosage
Always use this medication as directed by your doctor.
It is used only as an intramuscular injection.

Khargamon lyophilized powder should be dissolved in sodium chloride solution immediately before use. 
1 vial (5000 IU) of Xargamon powder when mixed with 1 ml of solvent (0.9% isotonic sodium chloride solution) has a concentration of 5000 IU/ml, and when mixed with 10 ml of solvent it is 500 IU/ml. The preparation should be used immediately after mixing with the solvent. Unused balance must be discarded. 
The dosage of the drug and the duration of treatment are determined by the doctor depending on the disease, as well as the patient's age and weight, and can be changed to some extent. 
Khargoman should be used under the supervision of a doctor with experience in the treatment of infertility problems.

In women
Induction of ovulation during anovulation and oligo-ovulation (follicle maturation disorder):When the dominant follicle has reached the appropriate size (greater than 18 mm), Khargamon is administered intramuscularly in a dose of 5000 IU or 10000 IU (1 or 2 ampoules) as a single injection (24 hours after the last injection of menotropin)._cc781905-5cde-3194-bb3b- 136bad5cf58d_
From the day of Khargoman injection, the patient is recommended to have sex. 
Support of the function of the corpus luteum during infertility due to the deficiency of the lutein phase of the menstrual cycle (while the estrogen function of the ovaries is preserved):1000 BV-5000 BV is injected consecutively on days 3, 6 and 9 after ovulation or embryo transfer. 
In the case of infertility caused by the shortening of the lutein phase of the menstrual cycle, Khargamon is injected intramuscularly in a dose of 5000 IU on the 21st, 23rd and 25th days of the menstrual cycle.
Cultivation of follicles and preparation for puncture within the program of controlled hyperstimulation of the ovaries:5000 IU or 10000 IU is administered as a single injection. 
In order to induce superovulation before assisted reproductive technologies such as in vitro fertilizationadministration of gonadotropins is carried out in two stages.
Stage 1:Menopausal gonadotropin (IMG) is prescribed as an intramuscular injection at a dose of 75 IU every day for 7-12 days (monitoring the increase in estrogen levels, which are indicators of follicle growth and maturation, and the results of ultrasound examination (the level of estradiol in the blood serum is 1.1-2.9 pmol/ml = 300-800 pg/ml; the diameter of the dominant follicle in USM is 18-22 mm)). 
2nd stage: In order to induce ovulation, 24-48 hours after the last injection of IMG (menotropin) or FSH (when stimulating the development of multiple follicles), Khargoman 1 or 2 ampoules (5000 IU or 10000 IU) are injected intramuscularly as a single injection. Oocyte collection is carried out after 34 - 36 hours. The patient is advised to have sex every day from the day of Khargoman injection until ovulation. Alternatively, intrauterine insemination (IUI) can be performed. If pregnancy does not occur, the treatment can be repeated in the same way. 
Protection of pregnancy in the early stages during a routine abortion: during the 2nd and 3rd months of pregnancy, Khargoman should be used at a dose of 5000 IU daily, and in the next two months at a dose of 1000 IU.
When there is a threat of spontaneous abortion (miscarriage) (if the symptoms are observed up to the 8th week of pregnancy), Khargoman is used immediately in a dose of 5000 IU from the moment the pregnancy is confirmed, then 5000 IU twice a week up to the 14th week of pregnancy (until the threat of abortion disappears) injected from After that, the dose should be reduced to 1000 IU and continued at this dose twice a week.
Rarely and in small amounts functional bleeding (oligomenorrhea, primary and secondary amenorrhea) and Frelich syndromefrom the 15th to the 24th day of the menstrual cycle, 500-1000 BV are prescribed daily. Alternative treatment scheme - on the 16th, 18th and 20th days of the menstrual cycle, it is prescribed from 1500 IU daily (total of 3 injections).

In men   
Hypogonadotropic hypogonadism:Xargamon can be prescribed by one of the following treatment schemes. 
1) 500-1000 BV 3 times a week for 3 weeks, then 500-1000 BV 2 times a week for 3 weeks; 
2) 4000 IU 3 times a week for 6-9 months, then 2000 IU 3 times a week for 3 months; 
3) Khargamon is injected together with subcutaneous injection of 2500 IU 2 times a week and FSH 150 IU 3 times a week for at least 6 months. 
The dosage regimen may vary to some extent depending on the time of initiation of treatment and the age of the patient. 
Idiopathic normogonadotropic oligospermia: together with menotropin, 5000 IU is prescribed once a week. The duration of treatment is 3 months. 
Oligo- and asthenospermia due to relative androgen deficiency: Khargamon 2000 BV every 5 days for 3 months (3 times a week together with menotropin (150 BV FSH + 150 BV LH)) or 500 BV daily (menotropin (75 BV FSH + 75 together with BV LH) is determined. 
If there is no response to treatment, Khargamon is prescribed 2-3 times a week from 2000 IU (3 times a week with menotropin (150 IU FSH + 150 IU LH)) for 3-12 months. When an improvement in spermatogenesis is achieved, in some cases further therapy can be carried out only with supporting doses of Khargamon.
Azoospermia: 5000 IU daily (with menotropin) is prescribed for 90-120 days.

In boys
Delayed puberty due to lack of gonadotropic function of the pituitary gland 
In order to accelerate the sexual development of boys, Khargamon is prescribed 1 ampoule (5000 IU) per week for at least 3-6 months or 1500 IU 2-3 times a week. If necessary, the course of treatment can be repeated.
Prepubertal cryptorchidism (except as a result of anatomical obstruction) 
Treatment is usually performed between 4-9 years of age. Khargamon is prescribed in the form of 4000 IU 3 times a week or 5000 IU daily (4 injections in total) for 3 weeks. The dosage regimen may vary to some extent depending on the time of initiation of treatment and the age of the patient. 
Alternative treatment regimens: 500 to 1000 IU in 15 injections over 6 weeks or 500 IU 3 times a week for 4-6 weeks (if this course of treatment is not successful, 1000 IU 3 times a day for 4-6 weeks after 1 month A new course of treatment can be started with a BV dose) is prescribed.
When the dose is adequate, usually after one course of treatment it can be decided whether testicular descent will occur or whether surgery will be needed. Thus, a course of treatment with XQG injections can be a valuable diagnostic method to determine the need for surgery. Failure to respond to treatment is indicative of anatomic obstruction. In addition, when surgery is required, pretreatment with chorionic gonadotropin can facilitate the procedure by increasing the size of the testicles and increasing the length of the ligaments. In the postoperative period, it is recommended to prescribe gonadotropic treatment to prevent retraction of the testicles.

As a diagnostic method
In patients with hypogonadotropic hypogonadism (before starting long-term stimulating treatment), 1 ampoule (5000 IU) is prescribed 1 time for evaluation of testicles (scrotum) function (Leydig test).
During the differential diagnosis of cryptorchidism and anarchism in boys, 1 ampoule (5000 IU) is prescribed once for the purpose of evaluating the function of the testicles. 
Before starting the test and 72-96 hours after the injection of Khargamon, the level of testosterone in the blood serum should be determined. In the case of anorchism, the test will be negative, which indicates the absence of testicular tissue; in the case of cryptorchidism, even if there is only one testicle, the test is evaluated positively (a 5-10-fold increase in the level of testosterone compared to the initial level is observed). If the test is weakly positive, the gonad should be detected (by abdominal ultrasound or laparoscopy) because of the high risk of malignancy.

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Side effects
As with all medicines, unwanted side effects may occur in people who are sensitive to any of the ingredients in the preparation.
Human chorionic gonadotropin is usually well tolerated by the body. Additional reactions are classified according to organ systems and frequency of occurrence as follows: very often (≥1/10); often (≥1/100 to <1/10); sometimes (≥1/1000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10000); with an unknown frequency (available data are insufficient to determine the frequency of occurrence).
Often: headache, mild ovarian hyperstimulation.
Sometimes: depression, agitation, irritability, severe ovarian hyperstimulation syndrome, edema, fatigue. 
Rare: angioneurotic edema, thromboembolism, vascular occlusion, temporary, reversible gynecomastia (in boys and men), temporary, reversible enlargement of the prostate gland, premature puberty, fluid and electrolyte retention, local reactions (pain at the injection site, redness).
Very rare: acne, systemic allergic reactions, allergic skin reactions.
Ovarian hyperstimulation syndrome may occur during the combined treatment of infertility in women with menotropin or clomiphene citrate. 
Consult your doctor if unwanted effects occur. 
If you experience any side effects not listed in this package insert, tell your doctor. 

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Overdose
Overdose symptoms are unknown, but women may develop ovarian hyperstimulation syndrome (OHSS) during infertility treatment. At this time, due to the cysts, there may be an increase in the size of the ovaries and the danger of bursting, as well as ascites and hydrothorax. YHSS is manifested by symptoms such as a feeling of tension and pain in the abdomen, vomiting, diarrhea, difficulty breathing, and an increase in body mass. Symptomatic treatment is carried out. When a severe form of YHSS occurs, treatment is carried out in an inpatient setting. 

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Release form
Lyophilized powder for preparation of intramuscular injection solution 5000 IU, in vial. 
1 ml of sterile and pyrogenic 0.9% isotonic sodium chloride solution in an ampoule. 
1 vial of powder and 1 ampoule of solvent are packed in a cardboard box with a leaflet.

  

Store condition
It should be stored at a temperature of 2-8ºС, protected from light and out of the reach of children. Do not freeze. The solution should be used immediately after preparation. Any unused portion should be discarded.

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Shelf life
3 years.
Do not use after the expiration date.

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Condition of release from pharmacy

It is released on the basis of a prescription.

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Producer
BSV BioScience GmbH, Germany.

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Licensee 
Tempus; LLC distributor company.