European Union - English - EMA (European Medicines Agency)

biopartners gmbh - somatropin - growth - pituitary and hypothalamic hormones and analogues, somatropin and somatropin agonists - somatropin biopartners is indicated for the replacement therapy of endogenous growth hormone in adults with childhood- or adult-onset growth-hormone deficiency (ghd).adult-onset: patients with ghd in adulthood are defined as patients with known hypothalamic-pituitary pathology and at least one additional known deficiency of a pituitary hormone excluding prolactin. these patients should undergo a single dynamic test in order to diagnose or exclude a ghd.childhood-onset: in patients with childhood-onset isolated ghd (no evidence of hypothalamic-pituitary disease or cranial irradiation), two dynamic tests should be performed after completion of growth, except for those having low insulin-like-growth-factor-i (igf-i) concentrations (< -2 standard-deviation score (sds)), who may be considered for one test. the cut-off point of the dynamic test should be strict.

United States - English - NLM (National Library of Medicine)

sandoz inc - somatropin (unii: nqx9kb6pcl) (somatropin - unii:nqx9kb6pcl) - somatropin 5 mg in 1.5 ml - omnitrope (somatropin) injection is indicated for the treatment of children with growth failure due to inadequate secretion of endogenous growth hormone (gh). omnitrope (somatropin) injection is indicated for the treatment of pediatric patients who have growth failure due to prader-willi syndrome (pws). the diagnosis of pws should be confirmed by appropriate genetic testing [see contraindications (4) and warnings and precautions (5.2)] . omnitrope (somatropin) injection is indicated for the treatment of growth failure in children born small for gestational age (sga) who fail to manifest catch-up growth by age 2 years. omnitrope (somatropin) injection is indicated for the treatment of growth failure associated with turner syndrome. omnitrope (somatropin) injection is indicated for the treatment of idiopathic short stature (iss), also called non-growth hormone-deficient short stature, defined by height standard deviation score (sds) ≤ -2.25, and associated with growth rates unlikely to permit attainment of adul

United States - English - NLM (National Library of Medicine)

emd serono, inc. - somatropin (unii: nqx9kb6pcl) (somatropin - unii:nqx9kb6pcl) - somatropin 5 mg in 3 ml - saizen (somatropin) is indicated for the treatment of pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone. saizen is indicated for replacement of endogenous growth hormone in adults with growth hormone deficiency who meet either of the following two criteria: adult onset patients who have growth hormone deficiency, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; or childhood onset patients who were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes. patients who were treated with somatropin for growth hormone deficiency in childhood and whose epiphyses are closed should be reevaluated before continuation of somatropin therapy at the reduced dose level recommended for growth hormone deficient adults. confirmation of the diagnosis of adult growth hormone deficiency in both groups invol

United States - English - NLM (National Library of Medicine)

eli lilly and company - somatropin (unii: nqx9kb6pcl) (somatropin - unii:nqx9kb6pcl) - somatropin 5 mg in 5 ml - humatrope is indicated for the treatment of pediatric patients with: - growth failure due to inadequate secretion of endogenous growth hormone (gh), - short stature associated with turner syndrome, - idiopathic short stature (iss), height standard deviation score (sds) <-2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range, - short stature or growth failure in short stature homeobox-containing gene (shox) deficiency, - short stature born small for gestational age (sga) with no catch-up growth by 2 years to 4 years of age. humatrope is indicated for the replacement of endogenous gh in adults with gh deficiency. humatrope is contraindicated in patients with: - acute critical illness after open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure due to the risk of increased mortality with use of pharmacologic doses of somatropin [see warnings and precautions (5.1)] . - pediatri

United States - English - NLM (National Library of Medicine)

emd serono, inc. - somatropin (unii: nqx9kb6pcl) (somatropin - unii:nqx9kb6pcl) - somatropin 4 mg in 1 ml - serostim (somatropin) is indicated for the treatment of hiv patients with wasting or cachexia to increase lean body mass and body weight, and improve physical endurance. concomitant antiretroviral therapy is necessary. - acute critical illness growth hormone therapy should not be initiated in patients with acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma or acute respiratory failure [see warnings and precautions (5.1)]. - active malignancy in general, somatropin is contraindicated in the presence of active malignancy. any preexisting malignancy should be inactive and its treatment complete prior to instituting therapy with somatropin. somatropin should be discontinued if there is evidence of recurrent activity [see warnings and precautions (5.3)] . - hypersensitivity serostim is contraindicated in patients with a known hypersensitivity to somatropin or any of its excipients. systemic hypersensitivity reactions have been reported with

United States - English - NLM (National Library of Medicine)

physicians total care, inc. - somatropin (unii: nqx9kb6pcl) (somatropin - unii:nqx9kb6pcl) - somatropin 5 mg in 1.5 ml - norditropin [somatropin (rdna origin) injection] is indicated for the treatment of children with growth failure due to inadequate secretion of endogenous growth hormone (gh). norditropin [somatropin (rdna origin) injection] is indicated for the treatment of children with short stature associated with noonan syndrome. norditropin [somatropin (rdna origin) injection] is indicated for the treatment of children with short stature associated with turner syndrome. norditropin [somatropin (rdna origin) injection] is indicated for the treatment of children with short stature born small for gestational age (sga) with no catch-up growth by age 2-4 years. norditropin [somatropin (rdna origin) injection] is indicated for the replacement of endogenous gh in adults with growth hormone deficiency (ghd) who meet either of the following two criteria: - adult onset (ao): patients who have ghd, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease

Ireland - English - HPRA (Health Products Regulatory Authority)

pfizer healthcare ireland - somatropin; somatropin - powder and solvent for solution for injection - 0.4 milligram(s) - somatropin and somatropin agonists; somatropin

Ireland - English - HPRA (Health Products Regulatory Authority)

pfizer healthcare ireland - somatropin; somatropin - powder and solvent for solution for injection - 1 milligram(s) - somatropin and somatropin agonists; somatropin

Ireland - English - HPRA (Health Products Regulatory Authority)

pfizer healthcare ireland - somatropin; somatropin - powder and solvent for solution for injection - 1.6 milligram(s) - somatropin and somatropin agonists; somatropin

Ireland - English - HPRA (Health Products Regulatory Authority)

pfizer healthcare ireland - somatropin; somatropin - powder and solvent for solution for injection - 1.8 milligram(s) - somatropin and somatropin agonists; somatropin