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ndication

and parental adjusted SDS -1) in short children / adolescents born small
or gestational age (SGA), with a birth weight and / or length below -2
tandard deviations (SDs), who failed to show catch-up growth (height
velocity (HV) SDS 0 during the last year) byfour years of age or later.
Prader-Willi syndrome (PWS), for improvement of growth and body
omposition. The diagnosis of PWS should be confirmed by appropriate
genetic testing.
Adults
Replacement therapy in adults with pronounced growth hormone
deficiency. Patients with severe growth hormone deficiency in adulthood
are defined as patients with known hypothalamic pituitary pathology
and at least one known deficiency of a pituitary hormone not being
prolactin. These patients should undergo a single dynamic test in order
o diagnose or exclude a growth hormone deficiency. In patients with
hildhood-onset isolated GH deficiency (no evidence of hypothalamic-
pituitary disease or cranial irradiation), two dynamic tests should be
ecommended, except for those having low insulin-like-growth-factor-I
IGF-I) concentrations (SDS -2) who may be considered for one test. The
ut-off point of the dynamic test should be strict.
n adult women

 Anovulation (including polycystic ovarian syndrome) in women
who have been unresponsive to treatment with clomifene citrate

 Stimulation of multifollicular development in women
undergoing superovulation for assisted reproductive
technologies (ART) such as in vitro fertilisation (IVF), gamete
intra-fallopian transfer and zygote intra-fallopian transfer.

Ovaleap is indicated for the stimulation of spermatogenesis in men who
have congenital or acquired hypogonadotropic hypogonadism with
oncomitant human chorionic gonadotropin (hCG) therapy.
Ovaleap is indicated for the stimulation of spermatogenesis in men who
have congenital or acquired hypogonadotropic hypogonadism with

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