Egyesült Államok - angol - 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

Egyesült Államok - angol - NLM (National Library of Medicine)

emd serono, inc. - somatropin (unii: nqx9kb6pcl) (somatropin - unii:nqx9kb6pcl) - somatropin 8.8 mg in 1 ml - zorbtive® is indicated for the treatment of short bowel syndrome in adult patients receiving specialized nutritional support. zorbtive® is contraindicated in patients with: - active malignancy - acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma or acute respiratory failure [see warnings and precautions (5.2)] - active proliferative or severe non-proliferative diabetic retinopathy - hypersensitivity to somatropin or any of the excipients of zorbtive® . systemic hypersensitivity reactions have been reported with postmarketing use of somatropin products [see warnings and precautions (5.4)] risk summary there are no available data on zorbtive® use in pregnant women to inform any drug associated risks. in animal reproduction studies, no fetal harm was reported with subcutaneous administration of somatropin during the period of organogenesis in rats and rabbits at doses of approximately up to 5 and 10 times, respectively, the recommended human dos

Egyesült Államok - angol - 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

Egyesült Államok - angol - NLM (National Library of Medicine)

novo nordisk - somatropin (unii: nqx9kb6pcl) (somatropin - unii:nqx9kb6pcl) - somatropin 5 mg in 1.5 ml - norditropin is indicated for the treatment of pediatric patients with: norditropin is indicated for the replacement of endogenous gh in adults with growth hormone deficiency (ghd) norditropin is contraindicated in patients with: risk summary limited available data with somatropin use in pregnant women are insufficient to determine a drug-associated risk of adverse developmental outcomes. in animal reproduction studies, there was no evidence of fetal or neonatal harm when pregnant rats were administered subcutaneous norditropin during organogenesis or during lactation at doses approximately 10-times higher than the maximal clinical dose of 0.016 mg/kg, based on body surface area (see data). the estimated background risk of birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data in an embryo-fetal development s

Egyesült Államok - angol - NLM (National Library of Medicine)

ferring pharmaceuticals inc. - somatropin (unii: nqx9kb6pcl) (somatropin - unii:nqx9kb6pcl) - somatropin 5 mg - zomacton 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 (hsds) ≤-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. zomacton is indicated for the replacement of endogenous gh in adults with gh deficiency. zomacton 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)] . - pediatric patients with prader-willi s

Új-Zéland - angol - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - somatropin 3.33mg equivalent to 10 iu ((3 mg plus 10% overage)) - injection with diluent - 3 mg - active: somatropin 3.33mg equivalent to 10 iu ((3 mg plus 10% overage)) excipient: dibasic sodium phosphate dihydrate mannitol monobasic sodium phosphate monohydrate benzyl alcohol sodium chloride water for injection - saizen is indicated for: 1. growth failure in children due to human growth hormone deficiency. 2. growth failure in girls with gonadal dysgenesis (turner syndrome), confirmed by chromosomal analysis. 3.saizen is indicated for replacement therapy in adults with pronounced growth hormone deficiency as diagnosed in 2 different dynamic tests for growth hormone deficiency and defined by peak gh concentrations of less than 2.5 nanogram/ml. adults must also fulfil the following criteria: childhood onset: patients who were diagnosed as growth hormone deficient during childhood, must be retested and their growth hormone deficiency confirmed before replacement therapy with saizen is started. adult onset: patients must have growth hormone deficiency as a result of hypothalamic or pituitary disease and at least one other hormone deficiency diagnosed (except for prolactin) and adequate replacement therapy instituted, before replacement therapy using growth hormone may begin. 4. growth disturbance (growth retardation) in pre-pubertal children due to chronic renal insufficiency (cri).

Új-Zéland - angol - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - somatropin 5.83 mg/ml - solution for injection - 5.83 mg/ml - active: somatropin 5.83 mg/ml excipient: citric acid phenol poloxamer sodium hydroxide sucrose water for injection - saizen is indicated for: 1. growth failure in children due to human growth hormone deficiency. 2. growth failure in girls with gonadal dysgenesis (turner syndrome), confirmed by chromosomal analysis. 3.saizen is indicated for replacement therapy in adults with pronounced growth hormone deficiency as diagnosed in 2 different dynamic tests for growth hormone deficiency and defined by peak gh concentrations of less than 2.5 nanogram/ml. adults must also fulfil the following criteria: childhood onset: patients who were diagnosed as growth hormone deficient during childhood, must be retested and their growth hormone deficiency confirmed before replacement therapy with saizen is started. adult onset: patients must have growth hormone deficiency as a result of hypothalamic or pituitary disease and at least one other hormone deficiency diagnosed (except for prolactin) and adequate replacement therapy instituted, before replacement therapy using growth hormone may begin. 4. growth disturbance (growth retardation) in pre-pubertal children due to chronic renal insufficiency (cri).

Új-Zéland - angol - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - somatropin 8 mg/ml - solution for injection - 8 mg/ml - active: somatropin 8 mg/ml excipient: citric acid phenol poloxamer sodium hydroxide sucrose water for injection - saizen is indicated for: 1. growth failure in children due to human growth hormone deficiency. 2. growth failure in girls with gonadal dysgenesis (turner syndrome), confirmed by chromosomal analysis. 3.saizen is indicated for replacement therapy in adults with pronounced growth hormone deficiency as diagnosed in 2 different dynamic tests for growth hormone deficiency and defined by peak gh concentrations of less than 2.5 nanogram/ml. adults must also fulfil the following criteria: childhood onset: patients who were diagnosed as growth hormone deficient during childhood, must be retested and their growth hormone deficiency confirmed before replacement therapy with saizen is started. adult onset: patients must have growth hormone deficiency as a result of hypothalamic or pituitary disease and at least one other hormone deficiency diagnosed (except for prolactin) and adequate replacement therapy instituted, before replacement therapy using growth hormone may begin. 4. growth disturbance (growth retardation) in pre-pubertal children due to chronic renal insufficiency (cri).

Egyesült Királyság - angol - MHRA (Medicines & Healthcare Products Regulatory Agency)

merck serono ltd - somatropin (rmc) - solution for injection - 5.825mg/1ml

Egyesült Királyság - angol - MHRA (Medicines & Healthcare Products Regulatory Agency)

merck serono ltd - somatropin (rmc) - solution for injection - 8mg/1ml