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

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

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

New Zealand - English - 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).

New Zealand - English - 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).

New Zealand - English - 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).

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - somatropin 8.8mg ((includes 0.8 mg overfill)) - injection with diluent - 8 mg - active: somatropin 8.8mg ((includes 0.8 mg overfill)) excipient: phosphoric acid sodium hydroxide sucrose metacresol 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).

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

csl behring australia pty ltd - normal immunoglobulin, quantity: 2 g - injection, solution - excipient ingredients: polysorbate 80; proline; water for injections - replacement therapy in adults and children in: - primary immunodeficiency disease (pid) and - symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. immunomodulatory therapy in: - chronic inflammatory demyelinating polyneuropathy (cidp) as maintenance therapy after stabilisation with ivig.

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

csl behring australia pty ltd - normal immunoglobulin, quantity: 1 g - injection, solution - excipient ingredients: water for injections; proline; polysorbate 80 - replacement therapy in adults and children in: - primary immunodeficiency disease (pid) and - symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. immunomodulatory therapy in: - chronic inflammatory demyelinating polyneuropathy (cidp) as maintenance therapy after stabilisation with ivig.

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

csl behring australia pty ltd - normal immunoglobulin, quantity: 1 g - injection, solution - excipient ingredients: water for injections; proline; polysorbate 80 - replacement therapy in adults and children in: - primary immunodeficiency disease (pid) and - symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. immunomodulatory therapy in: - chronic inflammatory demyelinating polyneuropathy (cidp) as maintenance therapy after stabilisation with ivig.