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

1 ampoule with solvent (sodium chloride solution 0.9%) contains: sodium chloride 0.0 mg, hydrochloric acid diluted 10% 0.007-0.02 mg, water for injection 995.4 mg.

Description:

Lyophilizate: lyophilized porous mass from almost white to light yellow color;

solvent: colorless clear solution.

Pharmacotherapeutic group:luteinizing agent

ATX: & nbsp

G.03.G.A.01 Gonadotropin chorionic

Pharmacodynamics:

Hormonal drug released from the urine of pregnant women. Has luteinizing and follicle-stimulating action. Stimulates the synthesis of sex hormones in the ovaries and testes,ovulation, spermatogenesis, provides the function of the yellow body; stimulates the development of genital organs and secondary sexual characteristics.

Pharmacokinetics:

The maximum plasma concentration is reached 4-12 hours after the injection. The half-life is 29-30 hours, so in the case of daily intramuscular injections, cumulation of the drug may occur.

Gonadotropin chorionic is excreted by the kidneys. 10-20% The administered dose is found unchanged in the urine, while the bulk is excreted as fragments of the β-chain.

Indications:

Hypofunction of the sex glands (due to disruption of the hypothalamus and pituitary gland).

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 reproductive technologies);

- 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:

Are common: organic lesions of the central nervous system, for example, tumors of the pituitary gland, hypothalamus; gonadal dysgenesis; hypersensitivity to the drug Horagon® or to any of the components of the drug; hypothyroidism; adrenal insufficiency; hyperprolactinemia; deep vein thrombophlebitis.

Among women: hormone-dependent tumors currently or suspected of them (breast cancer, breast cancer); syndrome of ovarian hyperstimulation (HNS) in the anamnesis; primary ovarian failure, bleeding or spotting from the vagina (not associated with menstruation) of unclear etiology; malformations of the reproductive organs, in which the onset of pregnancy is impossible; fibroid tumors of the uterus, in which the onset and bearing of pregnancy is impossible; Infertility not associated with ovulation (eg, tubal or cervical origin); early menopause; obstruction of the fallopian tubes; normal pregnancy and lactation.

In men: androgen-dependent tumors (cancer of the prostate, breast, testicular tumor); infertility, not associated with hypogonadotropic hypogonadism; severe renal failure.

The boys: children under 3 years; premature puberty.

If you have any of these diseases, consult a doctor before taking the drug.

Carefully:

Horagon® is used in patients with coronary heart disease, chronic heart failure; epilepsy, migraine (including in the anamnesis); bronchial asthma, chronic renal failure, arterial hypertension;

among women, with risk factors for thrombosis (thrombosis or thromboembolism in history, or in relatives of the first degree of kinship, obesity (body mass index> 30 kg / m²), thrombophilia);

boys - in the pre-pubertal period.

Pregnancy and lactation:

Choragon® is not used during the period of normal pregnancy and breastfeeding.

Dosing and Administration:

Choragon® is administered intramuscularly. Treatment with the drug should be carried out only under the supervision of a doctor who has the appropriate specialization and experience in treating infertility. The injection solution should be prepared immediately prior to administration using the supplied solvent. The prepared solution should be used immediately.Do not use if the solution contains undissolved particles or it is opaque.

Among women:

In order to induce ovulation and prepare follicles for puncture, 5000 ME or 10,000 ME.

To maintain the phase of the ovary's yellow body at 3, 6 and 9 days after ovulation, 1500-5000 ME preparation.

In boys and men:

For differential diagnosis of cryptorchidism and anarchism in boys and with the purpose of evaluating the function of the testicles in hypogonadotropic hypogonadism, 5000 ME.

When hypogonadotropic hypogonadism is administered for 1500-6000 ME 1 time per week in combination with menopin preparationsayhuman gonadotropin (MHP, for example, the preparation of Menopur®).

For the treatment of cryptorchidism, boys 3-6 years of age are injected once a week for 1500 ME of the drug for 3 weeks (if necessary, in combination with gonadotropin releasing hormone (GnRH)).

To accelerate puberty, boys are given 1500 ME 2-3 times a week for 3 months.

Side effects:

Local reactions - soreness in the injection site, hyperemia; headache, fatigue, irritability, anxiety, depression; allergic reactions (fever, skin rashes, angioedema); suppression of gonadotrophic pituitary gland function.

Among women with combined treatment of infertility (in combination with menotropin or clomiphene) - HSH syndrome (large ovarian cysts (prone to rupture), hemoperitoneum, hydrothorax, ascites, weight gain, swelling, dyspnea, soreness mammary glands, oliguria, increased blood viscosity, in rare cases - thromboembolic complications.

In men - edema, increased sensitivity of the nipples of the mammary glands, gynecomastia, an increase in the testicles in the inguinal canal (with cryptorchidism), prostatic hyperplasia, acne vulgaris, penis enlargement, premature puberty.

If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose:

In connection with the use of high doses of the drug Horagon ® in women with the induction of ovulation, it is possible to develop severe degree of HSH syndrome.

Symptoms: acute pain in the abdominal cavity (especially in the inguinal region), nausea, vomiting, diarrhea, swelling of the intestine, oliguria, tachypnea, swelling of the lower extremities, in severe cases - hypovolemia, thickening of the blood, disturbance of the water-electrolyte balance, ascites, peritonitis, hydrothorax, acute pulmonary insufficiency, thromboembolic complications.This condition is accompanied by the development of large ovarian cysts with the danger of their rupture and intra-abdominal bleeding, ascites, hydrothorax and the danger of developing thromboembolic complications.

Treatment: cancellation of the drug, if necessary - hospitalization, the appointment of symptomatic therapy for correction of water-salt balance, hemostasis disorders and other violations. For details, see "Special instructions".

Cases of overdose on other indications were not observed.

Interaction:

Horagon® do not mix with other medicines!

It should avoid the combined use of Horagon ® with high doses of glucocorticosteroids.

Choragon® may exacerbate the symptoms of hypertension that occurs as a result of the use of MHP preparations (for example, the drug Menopur®) and clomiphene.

Special instructions:

Long-term use of the drug Horagon® is not recommended in connection with the possible formation of antibodies that reduce the effectiveness of treatment.

In men Choragon® is ineffective with a high content of follicle-stimulating hormone (FSH).

Among women Before the appointment of Horagon®, follicle growth (ultrasound) and the cervical index (within two days before the onset of the stimulation effect) should be evaluated.In the process of stimulation, ultrasound and control of the concentration of estradiol in the blood plasma should be performed daily. The ovarian response can also be assessed using the cervical index.

When gonadotropic drugs are used, the development of the syndrome is possible.

Syndrome SHG 1 st degree of treatment does not require, accompanied by a slight increase in the size of the ovaries (up to 5-7 cm), increased concentration of sex steroids and abdominal pain. The patient should be informed about her condition and carefully monitored.

HSH syndrome 2 nd degree requires hospitalization and symptomatic treatment, including intravenous infusions of solutions to maintain bcc (in case of increased hemoglobin concentration). Ovarian cysts up to 8-10 cm in size are accompanied by abdominal symptoms, nausea and vomiting.

For HSH syndrome of the 3rd degree, ovarian cysts measuring 10 cm or more, ascites, hydrothorax, an increase in abdominal pain, dyspnea, a violation of the water-electrolyte balance in the blood and increase its viscosity, accompanied by increased adhesion of platelets with the risk of development of thromboembolic complications. Hospitalization is compulsory.

In the case of development of the syndrome of CHD, treatment with the drug Horagon® should be discontinued.

In the case of pregnancy, the manifestations of HSH syndrome may become worse.

When pregnancy occurs after induction of ovulation with gonadotropic drugs, the risk of multiple pregnancy increases and, accordingly, the risk to the mother (complicated course of pregnancy and childbirth) and newborns (low body weight). Also, in women with infertility, who are offered reproductive technologies (especially, in vitro fertilization), pathology of the fallopian tubes is often found, which can lead to an increased risk of ectopic pregnancy, and in the early stages of pregnancy, ultrasound should be performed to clarify the location of the fetal egg .

During treatment with Horagon® and for 10 days after discontinuation of treatment, it can influence the importance of immunological tests for HCG in the blood / urine, which can lead to a false positive pregnancy test.

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

The intake of the drug does not adversely affect the ability to drive vehicles and other mechanisms.

Form release / dosage:

Lyophilizate for solution for intramuscular injection, 1500 ME and 5000 ME.

Packaging:

By 1500 ME or 5000 ME lyophilizate into flasks of colorless glass type I, sealed with a bromobutyl stopper with aluminum rolling and a plastic cap of the "flip-off" type.

1 ml of solvent in ampoules of colorless glass type 1 with possible color coding as a color point and / or one or more rings.

3 vials with lyophilizate and 3 ampoules with a solvent in the contour mesh package. 1 contour pack with instructions for use in a cardboard box.

Storage conditions:

At a temperature of no higher than 25 ° C.

Vials with lyophilisate should be stored in a cardboard bundle, protected from light.

Keep out of the reach of children.

Shelf life:

Lyophilizate: 3 years.

Solvent: 3 years.

Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:P N 012469 / 01-2000

Date of registration:06.05.2008

The owner of the registration certificate: Ferring GmbH Ferring GmbH Germany

Manufacturer: & nbsp

FERRING, GmbH Germany

HAUPT PHARMA WULFING, GmbH Germany

Representation: & nbspFERRING PHARMACEUTICALS BV FERRING PHARMACEUTICALS BV Netherlands

Information update date: & nbsp23.12.2015

Illustrated instructions

Instructions

Horagon® (Choragon®)