Patient Information leaflet

GONASI HP 5000 IU / 1 ml powder and solvent for solution for injection for intramuscular or subcutaneous

Each vial of powder contains:

Active Ingredient: Chorionic Gonadotrophin 5000 IU

PHARMACEUTICAL FORM 03.0 – Home Page

Powder and solvent for solution for injection

04.0 CLINICAL – Home Page

4.1 Therapeutic indications – Home Page

In children: cryptorchidism, hypogonadism, hypogonadism eunuchoidism.

In women: primary and secondary amenorrhea, ovarian hypoplasia, menometrorragia, recurrent miscarriage, threatened abortion, anovulatory infertility, sterility ovogenesi deficient.

In humans: azoospermia, oligoastenospermia, asthenospermia.

4.2 Posology and method of administration – Home Page

Guideline can be adopted the following scheme.

In women:

Amenorrhea, primary and secondary cycles anovulari: if an employee Deficit pituitary gonadotrophic secretion or lack of response to gonadal pituitary gonadotropins, obtained the optimal level of estrogen: 5000-10000 IUGonasi of HP.

Ovarian hypoplasia: 3-5 doses of 500-1000 U.I. HP Gonasi of the month.

Menometrorragie: 500-1000 U.I. every other day until termination of Gonasi HP bleeding, then 500 to 1,000 IU once a week to normalize the consecutive menstruation.

Recurrent miscarriage: 5,000 U.I. Gonasi of HP on alternate days during the first 3 months of pregnancy. Then for another 2 months, 1,000 U.I. every other day.

Threatened abortion: intervene promptly with 5,000 IU HP also Gonasi of 2 times per day until the threat of abortion. To follow the administration of 1,000 U.I. every 3 days.

Sterility deficient ovogenesi: after stimulation with human menopausal gonadotropin (HMG) injected at 24 hours after administration of 1-2 ampoules of HMG Gonasi HP 5000 IU waves lead to ovulation.

In humans:

Cryptorchidism: 250 – 500 – 1000 U.I. HP Gonasi of 2 or 3 times a week for periods of 40 days. Repeat the treatment after 30 days of suspension.

Hypogonadism: 125 – 250 – 500 U.I. of Gonasi HP 3 times a week.

Azoospermia, oligoastenospermia: 500 U.I.Gonasi of HP every other day for 3-4 months.

Asthenospermia: 1,000 to 2,000 U.I. Gonasi of HP every 4 days to 3 months.

Method of administration

The HP Gonasi must be injected intramuscularly or subcutaneously. The solution obtained by combining the solvent to dry powder should be used immediately after preparation.

3.4 Contraindications – Home Page

Precocious puberty. Hypertrophy or pituitary tumors, ovarian carcinoma, prostate or other androgen-dependent tumors, tumors of the testes. In the presence of other endocrine disorders (eg hypothyroidism, adrenocortical deficiency, hyperprolactinemia) must first be established adequate therapy. Primary testicular or ovarian failure, the absence of the uterus, early menopause, tubal occlusion (unless the patient is subjected to in vitro fertilization programs). Thrombophlebitis in the active phase. Hypersensitivity to the active substance or to any of the excipients.

4.4 Special warnings and precautions for use – Top

If signs of precocious puberty due to induction of androgen secretion promoted by chorionic gonadotropin, you must discontinue therapy.Because, in fact, androgens can cause fluid retention, chorionic gonadotrophin should be used with caution in patients with epilepsy, asthma or heart or kidney disease.

The joint use of chorionic gonadotropin (HCG) with human menopausal gonadotropin (HMG) should assume complete knowledge of the contraindications, precautions for use and possible side reactions, the main ones are: ovarian enlargement, ascites with or withoutpain, pleural reaction, ruptured ovarian cyst resulting in hemoperitoneum, multiple births, arterial thromboembolism.

Although not been no reported case of viral contamination associated with administration of gonadotropin extracted from human urine, the risk of transmission of pathogens known or unknown can not be totally excluded.

Keep out of reach and sight of children.

4.5 Interactions – Home Page

Avoid concomitant use of chorionic gonadotropin with high doses of corticosteroids.

6.4 Pregnancy and lactation – Home Page

As the hormone human placental origin is not contraindicated in pregnant women.

There are recognized indications of HCG coincident with breastfeeding.

4.7 Effects on ability to drive and use machines – Home Page

The product does not affect the ability to drive and use machines.

4.8 Undesirable Effects – Home Page

Have been reported headaches, fatigue, irritability, restlessness, depression, edema, precocious puberty, gynecomastia.

Reactions may rarely occur in the place of painful injections.

Following the administration of chorionic gonadotrophin in women undergoing ovulation induction treatments can cause multiple pregnancies and the occurrence of ovarian hyperstimulation syndrome which can be prevented through careful monitoring of treatments. This syndrome is mainly characterized by ovarian enlargement accompanied by pelvic pain, nausea, vomiting, weight gain and in severe cases, but rare, accumulation of fluid in the abdomen and thorax as well as more serious thromboembolic complications.

4.9 Overdose – Home Page

An overdose of chorionic gonadotropin in prepubertal children can lead to premature puberty and stunted growth.

05.0 Pharmacological Properties – Home Page

1.5 Pharmacodynamic Properties – Home Page

Pharmacotherapeutic group: Chorionic Gonadotropin

The HP Gonasi contains human chorionic gonadotropin obtained from the urine of pregnant women, collected between 60 ° – 90 ° day of pregnancy. The product obtained is further purified to obtain a title of 5000 IU / mg.

The chorionic gonadotropin extracted from the urine of pregnant women, in the Gonasi HP, has a biological action similar to that of luteinizing hormone, pituitary increto, which manifests itself in man by stimulation of Leydig cells in women with ‘induction of ovulation, maturation of the ovarian follicle sequentially.

Androgenic stimulation by human chorionic gonadotropin leading to the development of secondary sex characteristics and stimulate testicular descent when no anatomical impediment coexist. In women during the normal menstrual cycle causes the secretion of follicular estrogen, ovulation and then the secretion by the corpus luteum.

Chorionic gonadotropin is metabolized in the liver and excreted in the urine almost entirely.

06.0 Pharmaceutical – Home Page

6.1 Excipients – Home Page

Vial of powder: Lactose.

Solvent ampoule: sodium chloride, water for injections.

6.2 Special precautions for storage – Top

Store at temperatures not exceeding +25 ° C, in the original package to repair the product from light.

6.3 Nature and contents of the pack – Home Page

GONASI HP 5000 U.I. / 1 ml powder and solvent for solution for injection for intramuscular or subcutaneous

1 vial of powder + 1 ampoule of 1 ml