All the Active Ingredient Drugs
Gonadotropin. Follitropin Alfa 600 IU/ml. PRE-FILLED PEN: Follitropin alfa 600 IU/
ml (eq. 44 μg/ml) 1 x 300 IU (eq. to 22
μg) + 5 needles; 1 x 450 IU (eq. to 33 μg)
+ 7 needles; 1 x 900 IU (eq. to 66 μg) +
14 needles. S.C. See lit.
Stim. follicular develop. and ovulat. in
WHO group II women, stim. multifollicular
develop. in pts. undergoing
ovulat. for assist. reproduct.
technologies.With concom. hCG ther.
stimulat. spermatogenes. in men who
have congen. or acquired
Gonadotropin. Follitropin Alfa 600 IU/ml. CARTRIDGE (Sol. for inj. with inj.
needles): 1 x 300 IU/0.5 mL, 450 IU/0.75
mL, 900 IU/1.5 mL.
Dosage must be adjust. individ.
accord. to pt. med. cond.
In adult women: Anovulation (incl.
PCOS) in women who have been
unrespons. to tmt. with clomifene citrate.
Stimul. of multifollicular develop. in
women underg. superovulation for ART,
such as IVF, GIFT and ZIFT. In association
with a LH prep. is recommend. for the
stimulation of follicular development in
women with severe LH and FSH defic. In
clinical trials these pts. were defined by
an endogenous serum LH level < 1.2
IU/L. In adult men: is indicated for the
stimul. of spermatogenesis in men who
have congen./acquir. hypogonadotropic
hypogonadism with concom. hCG ther.
C/I: Hypersens. to follitropin alfa, FSH or
to any of the excip.; tumors of the
hypothalamus or pituitary gland;
ovarian enlargement or ovarian cyst not
due to PCOS; gynaecological haemorrh.
of unknown aetiology; ovarian, uterine
or mammary carcinoma. Must not be
used when an effective response cannot
be obtained, such as: primary ovarian
failure; malformations of sexual organs
incompatible with pregnancy; fibroid
tumors of the uterus incompatible with
pregnancy; primary testicular