Unjoni Ewropea - Ingliż - 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.

Iżrael - Ingliż - Ministry of Health

medison pharma ltd - lanreotide as acetate - solution for injection - lanreotide as acetate 60 mg/dose - lanreotide - lanreotide - somatuline autogel is indicated for the treatment of individuals with acromegaly when the circulating levels of growth hormone (gh) and/or insulin like growth factor-1 (igf-1) remain abnormal after surgery and/or radiotherapy, or in patients who otherwise require medical treatmfent .the goal of treatment in acromegaly is to reduce gh and igf-1 levels and where possible to normalize these values. somatuline autogel is also indicated for the treatment of symptoms associated with neuroendocrine (particularly carcinoid) tumors.somatuline autogel is also indicated for the treatment of grade 1 and a subset of grade 2 (ki67 index up to 10%) gastroenteropancreatic neuroendocrine tumors (gep-nets) of midgut, pancreatic or unknown origin where hindgut sites of origin have been excluded, in adult patients with unresectable locally advanced or metastatic disease.

Iżrael - Ingliż - Ministry of Health

medison pharma ltd - lanreotide as acetate - solution for injection - lanreotide as acetate 90 mg/dose - lanreotide - lanreotide - somatuline autogel is indicated for the treatment of individuals with acromegaly when the circulating levels of growth hormone (gh) and/or insulin like growth factor-1 (igf-1) remain abnormal after surgery and/or radiotherapy, or in patients who otherwise require medical treatmfent .the goal of treatment in acromegaly is to reduce gh and igf-1 levels and where possible to normalize these values. somatuline autogel is also indicated for the treatment of symptoms associated with neuroendocrine (particularly carcinoid) tumors.somatuline autogel is also indicated for the treatment of grade 1 and a subset of grade 2 (ki67 index up to 10%) gastroenteropancreatic neuroendocrine tumors (gep-nets) of midgut, pancreatic or unknown origin where hindgut sites of origin have been excluded, in adult patients with unresectable locally advanced or metastatic disease.

Iżrael - Ingliż - Ministry of Health

medison pharma ltd - lanreotide as acetate - solution for injection - lanreotide as acetate 120 mg/dose - lanreotide - lanreotide - somatuline autogel is indicated for the treatment of individuals with acromegaly when the circulating levels of growth hormone (gh) and/or insulin like growth factor-1 (igf-1) remain abnormal after surgery and/or radiotherapy, or in patients who otherwise require medical treatmfent .the goal of treatment in acromegaly is to reduce gh and igf-1 levels and where possible to normalize these values. somatuline autogel is also indicated for the treatment of symptoms associated with neuroendocrine (particularly carcinoid) tumors.somatuline autogel is also indicated for the treatment of grade 1 and a subset of grade 2 (ki67 index up to 10%) gastroenteropancreatic neuroendocrine tumors (gep-nets) of midgut, pancreatic or unknown origin where hindgut sites of origin have been excluded, in adult patients with unresectable locally advanced or metastatic disease.

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

ipsen pty ltd - lanreotide acetate, quantity: 149.4 mg (equivalent: lanreotide, qty 125.5 mg) - injection, solution - excipient ingredients: glacial acetic acid; water for injections - somatuline autogel is indicated for: - the treatment of acromegaly when the circulating levels of growth hormone and igf-1 remain abnormal after surgery and/or radiotherapy or in patients who are dopamine agonist treatment refractory -the treatment of symptoms of carcinoid syndrome associated with carcinoid tumours -the treatment of gastroenteropancreatic neuroendocrine tumours (gep-nets) in adult patients with unresectable locally advanced or metastatic disease.

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

ipsen pty ltd - lanreotide acetate, quantity: 113.6 mg (equivalent: lanreotide, qty 95.4 mg) - injection, solution - excipient ingredients: glacial acetic acid; water for injections - somatuline autogel is indicated for: - the treatment of acromegaly when the circulating levels of growth hormone and igf-1 remain abnormal after surgery and/or radiotherapy or in patients who are dopamine agonist treatment refractory -the treatment of symptoms of carcinoid syndrome associated with carcinoid tumours -the treatment of gastroenteropancreatic neuroendocrine tumours (gep-nets) in adult patients with unresectable locally advanced or metastatic disease.

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

ipsen pty ltd - lanreotide acetate, quantity: 77.9 mg (equivalent: lanreotide, qty 65.4 mg) - injection, solution - excipient ingredients: water for injections; glacial acetic acid - somatuline autogel is indicated for: - the treatment of acromegaly when the circulating levels of growth hormone and igf-1 remain abnormal after surgery and/or radiotherapy or in patients who are dopamine agonist treatment refractory -the treatment of symptoms of carcinoid syndrome associated with carcinoid tumours -the treatment of gastroenteropancreatic neuroendocrine tumours (gep-nets) in adult patients with unresectable locally advanced or metastatic disease.

Iżrael - Ingliż - Ministry of Health

ferring pharmaceuticals ltd - somatropin - powder and solvent for solution for injection - somatropin 10 mg - somatropin - somatropin - children :short stature due to inadequate or failed secretion of pituitary growth hormone or turner's syndrome. short stature in children with renal insufficiency.

Awstralja - Ingliż - 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 (growth retardation) in pre-pubertal children due to chronic renal insufficiency (cri).

Awstralja - Ingliż - 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 (growth retardation) in pre-pubertal children due to chronic renal insufficiency (cri).