Instruction for use: Puregon

ATX CodeG03GA06 Follitpopin beta

Active substance Follitpopin beta

Pharmacological group

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

Nosological classification (ICD-10)

N97 Female infertility

Female infertility in anovulation, Hyperprolactinemic infertility, Hyperprolactinaemia with infertility, Endocrine infertility, Infertility due to hypothalamic-pituitary dysfunction, Infertility infertility, Infertility, Infertility on the background of hyperprolactinaemia, Functional infertility, Marriage is infertile, Infertility of ovarian genesis, Stimulation of the growth of a single follicle

Composition and form of release

1 ampoule with lyophilizate for solution for intramuscular and subcutaneous administration contains foliotropin-beta 50 or 100 IU; In a planar cell package, complete with a solvent in ampoules of 2 ml, in a box of 1, 3, 5 or 10 sets.

pharmachologic effect

Pharmacological action - follicle-stimulating.

Replenishes the FSH deficiency. Regulates normal growth and maturation of follicles, the synthesis of sex steroid hormones.

Indications

Female infertility in anovulation (including polycystic ovary syndrome, refractory to clomiphene citrate); Carrying out programs of assisted reproduction, incl. In vitro fertilization (for induction of superovulation).

Contraindications

Hypersensitivity, swelling of the ovaries, breast, uterus, pituitary or hypothalamus, primary ovarian failure, ovarian cysts or ovarian enlargement not associated with polycystic ovary syndrome, anatomy of genitals or uterine fibroids, incompatible with pregnancy.

pregnancy and lactation

Contraindicated in pregnancy. Lactating women should give up breastfeeding.

Side effects

Ovarian hyperstimulation (abdominal pain, nausea, diarrhea, ovarian enlargement and cysts, rarely - ovarian cyst rupture, ascites, hydrothorax, weight gain); At the injection site - swelling, pain, redness, itching. After induction of ovulation, the risk of multiple proliferation increases, and with extracorporeal fertilization, an ectopic pregnancy.

Dosing and Administration

V / m, n / to (slowly). Anovulation begins with the daily administration of 50-75 IU for 7 days, in the absence of ovarian response, the dose is gradually increased (the optimal daily increase in the concentration of estradiol in plasma by 40-100%); When a dominant follicle reaches a diameter of 18 mm or an estradiol level of 300-900 pg / ml, Puregon is canceled and human chorionic gonadotropin is injected. Induction of superovulation of the ovaries during in vitro fertilization in the first 4 days - 100-200 IU, then the dose is selected individually, based on the response of the ovaries; Usually enough 75-375 IU per day for 1-2 weeks; In the presence of 3 follicles with a diameter of 16-20 mm and an estradiol concentration in the plasma of 300-400 pg / ml / follicle, the final phase of maturation of the follicle is stimulated by human chorionic gonadotropin; After 34-35 hours, aspiration of eggs is carried out.

Precautionary measures

It is recommended to constantly change the place of administration. When there are symptoms of ovarian hyperstimulation (excluding preparation for in vitro fertilization) therapy should be discontinued. Before the beginning of treatment it is necessary to exclude diseases of the thyroid gland, adrenal glands and pituitary gland.

special instructions

Before use, the drug is dissolved in the attached solvent and used immediately (unused portion is destroyed).

Storage conditions

In the dark place at a temperature of 2-30 ° C. Do not freeze.

Keep out of the reach of children.

Shelf life

Lyophilizate for the preparation of a solution for intramuscular and subcutaneous administration of 50 IU - 2 years. Solvent - 3 years.

Lyophilizate for the preparation of a solution for intramuscular and subcutaneous administration of 100 IU - 2 years. Solvent - 3 years.

Solution for intramuscular and subcutaneous administration of 100 IU - 3 years. Solvent - 3 years.

Solution for subcutaneous administration of 300 IU - 3 years. Solvent - 3 years.

Solution for subcutaneous administration of 600 IU - 3 years. Solvent - 3 years.

Solution for subcutaneous administration of 900 IU - 3 years. Solvent - 3 years.

Do not use after the expiry date printed on the package.