GONAL-F 900IU/1.5ML 1 SYRING
ACTIVE-INGREDIENT OF GONAL-F 900IU/1.5ML 1 SYRING
fsh, follitropin alpha
In adult women
• Anovulation (including polycystic ovarian syndrome) in women who have been unresponsive to treatment with clomiphene citrate.
• Stimulation of multi follicular development in women undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilization (IVF), gamete intra-fallopian transfer, and zygote intra-fallopian transfer.
• in association with a luteinizing hormone (LH) preparation is recommended for the stimulation of follicular development in women with severe LH and FSH deficiency. In clinical trials, these patients were defined by an endogenous serum LH level of < 1.2 IU/L.
In adult men
• s indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human Chorionic Gonadotropin (hCG) therapy.
pregnancy and lactation
There is no indication for use of GONAL-f during pregnancy. Data on a limited number of exposed pregnancies (less than 300 pregnancy outcomes) indicate no malformative or feto/neonatal toxicity of follitropin alfa.
No teratogenic effect has been observed in animal studies (see section 5.3).
In case of exposure during pregnancy, clinical data are not sufficient to exclude a teratogenic effect of GONAL-f.
GONAL-f is not indicated during breastfeeding.