Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

primegro limited - insulin-like-growth factor-i (igf-i) - unknown - insulin-like-growth factor-i (igf-i) hormone active 0.0 - active constituent

European Union - English - EMA (European Medicines Agency)

ipsen pharma - mecasermin - laron syndrome - pituitary and hypothalamic hormones and analogues - for the long-term treatment of growth failure in children and adolescents with severe primary insulin-like-growth-factor-1 deficiency (primary igfd).severe primary igfd is defined by:height standard deviation score ≤ -3.0 and;basal insulin-like growth factor-1 (igf-1) levels below the 2.5th percentile for age and gender and;growth hormone (gh) sufficiency;exclusion of secondary forms of igf-1 deficiency, such as malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids.severe primary igfd includes patients with mutations in the gh receptor (ghr), post-ghr signalling pathway, and igf-1 gene defects; they are not gh deficient, and therefore, they cannot be expected to respond adequately to exogenous gh treatment. it is recommended to confirm the diagnosis by conducting an igf-1 generation test.

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

anumed international llc - mecasermin (unii: 7gr9i2683o) (mecasermin - unii:7gr9i2683o) - mecasermin 30 [hp_c] in 30 ml - increase endurance & lean mass, improve muscle tone, enhance mental clarity & memory, control appetite, balance symptoms of hormonal fluctuations increase endurance & lean mass, improve muscle tone, enhance mental clarity & memory, control appetite, balance symptoms of hormonal fluctuations

Australia - English - Department of Health (Therapeutic Goods Administration)

ipsen pty ltd - mecasermin, quantity: 10 mg/ml - injection, solution - excipient ingredients: sodium chloride; benzyl alcohol; polysorbate 20; glacial acetic acid; sodium acetate trihydrate; water for injections - for the long-term treatment of growth failure in children and adolescents from 2 to 18 years with severe primary insulin-like growth factor 1 deficiency (primary igfd).,severe primary igfd is defined by:,? height standard deviation score less than or equal to ?3.0 and,? baseline height velocity less than the 25th percentile for bone age, based on two measurements over 12 months and,? basal igf-1 levels below the 2.5th percentile for age and gender and,? gh sufficiency.,? exclusion of secondary forms of igf-1 deficiency, such as malnutrition, hypopituitarism, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids.,igf-1 and gh levels must be performed using validated assays with paediatric normal ranges.

Australia - English - Department of Health (Therapeutic Goods Administration)

merck healthcare pty ltd - somatropin, quantity: 8 mg/ml - injection, solution - excipient ingredients: phenol; sucrose; citric acid; poloxamer; water for injections; sodium hydroxide - saizen is indicated for:,1. treatment of growth failure in children due to human growth hormone deficiency.,2. treatment of growth failure in girls with gonadal dysgenesis (turner syndrome), confirmed by chromosomal analysis.,3. replacement therapy in adults with pronounced growth hormone deficiency as diagnosed in 2 different dynamic tests for growth hormone deficiency and defind by peak gh concentrations of less than 2.5 nanogram/ml. adults must also fulfill 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. treatment of growth disturbance (grow

Australia - English - Department of Health (Therapeutic Goods Administration)

merck healthcare pty ltd - somatropin, quantity: 8 mg/ml - injection, solution - excipient ingredients: sucrose; poloxamer; sodium hydroxide; water for injections; citric acid; phenol - saizen is indicated for:,1. treatment of growth failure in children due to human growth hormone deficiency.,2. treatment of growth failure in girls with gonadal dysgenesis (turner syndrome), confirmed by chromosomal analysis.,3. replacement therapy in adults with pronounced growth hormone deficiency as diagnosed in 2 different dynamic tests for growth hormone deficiency and defind by peak gh concentrations of less than 2.5 nanogram/ml. adults must also fulfill 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. treatment of growth disturbance (grow

Australia - English - Department of Health (Therapeutic Goods Administration)

merck healthcare pty ltd - somatropin, quantity: 5.83 mg/ml - injection, solution - excipient ingredients: poloxamer; sodium hydroxide; sucrose; citric acid; phenol; water for injections - saizen is indicated for:,1. treatment of growth failure in children due to human growth hormone deficiency.,2. treatment of growth failure in girls with gonadal dysgenesis (turner syndrome), confirmed by chromosomal analysis.,3. replacement therapy in adults with pronounced growth hormone deficiency as diagnosed in 2 different dynamic tests for growth hormone deficiency and defind by peak gh concentrations of less than 2.5 nanogram/ml. adults must also fulfill 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. treatment of growth disturbance (grow

Singapore - English - HSA (Health Sciences Authority)

siemens healthcare pte. ltd. - clinical chemistry - for in vitro diagnostic use with the immulite 2000 system analyzers - for the quantitative measurement of insulin-like growth factor i (igf-i) in serum or heparinized plasma, as an aid in the evaluation of growth disorders.

Singapore - English - HSA (Health Sciences Authority)

siemens healthcare pte. ltd. - clinical chemistry - for in vitro diagnostic use with the immulite and immulite 1000 analyzers - for the quantitative measurement of insulin-like growth factor i (igf-i) in serum or heparinized plasma, as an aid in the evaluation of growth disorders.

Israel - English - Ministry of Health

pfizer pharmaceuticals israel ltd - pegvisomant - powder and solvent for solution for injection - pegvisomant 10 mg - pegvisomant - pegvisomant - treatment of adult patient with acromegaly who have had an inadequate response to surgery and/or radiation therapy and in whom an appropriate medical treatment with somatostatin analogues did not normalize igf-i concentrations or was not tolerated.