GONAL-F (Lyophilisates for solution)

Active material: Follitropin alfa
When ATH: G03GA05
CCF: Recombinant human follicle-stimulating hormone
When CSF: 15.06.05.01
Manufacturer: MERCK SERONO S.p.A. (Italy)

PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING

Valium for drug of a solution for s / c administration in the form of pellets or of a white color.

Excipients: sucrose, sodium phosphate dihydrate, sodium dïgïdrofosfata monohydrate, phosphoric acid, Sodium hydroxide.

Solvent: water d / and, and benzyl alcohol 0.9% (1 ml).

Bottles of colorless glass volume 3 ml (1) together with the solvent (syringe 2.25 ml – 1 PC.) – Plastic containers (1) with shpricami odnorazovыmi graduirovannыmi (6 PC.) – cardboard boxes.

Valium for drug of a solution for s / c administration in the form of pellets or of a white color.

Excipients: sucrose, sodium phosphate dihydrate, sodium dïgïdrofosfata monohydrate, phosphoric acid, Sodium hydroxide.

Solvent: water d / and, and benzyl alcohol 0.9% (2 ml).

Bottles of colorless glass volume 3 ml (1) together with the solvent (syringe 2.25 ml – 1 PC.) – Plastic containers (1) with shpricami odnorazovыmi graduirovannыmi (15 PC.) – packs cardboard.

DESCRIPTION OF ACTIVE SUBSTANCES.

Pharmacological action

Recombinant FSH, produced by genetic engineering of a Chinese hamster ovary cells. It stimulates the formation of follicles. The action is due to the, that when administered parenterally follitropin alfa is formed mature graafovyh bubbles.

Pharmacokinetics

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Testimony

Anovulatory infertility, hypothalamic-pituitary disorders – spanomenorrhea, amenorrhea (incl. in polycystic ovaries), superovulation (stimulation of the growth of multiple follicles) when technology auxiliary methods of reproduction.

Dosage regimen

Individual, depending on the applied treatment regimen.

Side effect

Maybe: ectopic pregnancy (female, with a history of tubal disease), polycyesis, ovarian hyperstimulation syndrome, fever, arthralgia; at the injection site – pain and redness.

Rarely: thromboembolism, allergic reactions.

Contraindications

The increase in the ovary or ovarian cyst, not related to polycystic ovary syndrome; gynecological bleeding of unknown cause; cancer âičnika, uterine or breast cancer; tumors of the hypothalamus or pituitary gland; lack of oocytes 1 order; abnormal development of the sexual organs, incompatible with pregnancy; uterine fibroma, incompatible with pregnancy; pregnancy; increased sensitivity to follitropin alfa.

Cautions

Prior to treatment should be to establish the fact of having marital infertility and possible contraindications for pregnancy. It is necessary to exclude concomitant endocrine diseases (gipotireoz, adrenal insufficiency, hyperprolactinemia, tumors of the hypothalamus and pituitary).

In the appointment of hCG increases the possibility of ovarian hyperstimulation syndrome, so in the event of excessive estrogen reaction of hCG is not indicated, and the patient to refrain from coitus for at least 4 days. The probability of occurrence of hyperstimulation can be reduced by Aspiration of all follicles prior to ovulation.

The risk of multiple pregnancies during assisted reproduction related to the number of substituted oocytes / embryos; However, most cases of multiple conceptions are twins gave.

Drug Interactions

While the use of other means to stimulate ovulation may increase the follicle formation reaction, while simultaneously the pituitary GnRH agonist desensitization may require increasing doses of follitropin alfa, causing an adequate response of the ovaries.