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

takeda pharmaceuticals australia pty ltd - factor viii inhibitor bypassing fraction, quantity: 1000 mg - injection, powder for - excipient ingredients: sodium citrate dihydrate; sodium chloride - feiba-nf is indicated for routine prophylaxis, control of spontaneous bleeding episodes and use in surgery in haemophilia a or b patients with inhibitors.

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

pfizer australia pty ltd - somatropin, quantity: 12 mg/ml - injection, powder for - excipient ingredients: glycine; mannitol; monobasic sodium phosphate; dibasic sodium phosphate - short stature due to decreased or failed secretion of pituitary growth hormone. treatment of adults with severe growth hormone deficiency as diagnosed in the insulin tolerance test for growth hormone deficiency and defined by peak growth hormone concentrations of less than 2.5 nanogram/ml. growth disturbances associated with gonadal dysgenesis (turner's syndrome). improvement of body composition and treatment of short stature associated with prader-willi syndrome (pws) in paediatric patients. for treatment of growth disturbance in children with chronic renal insufficiency whose height is on or less than twenty-fifth percentile and whose growth velocity is on or less than twenty-fifth percentile for bone age. chronic renal insufficiency is defined as glomerular filtration rate of less than 50 ml/min/1.73m2.

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

pfizer australia pty ltd - somatropin, quantity: 5 mg/ml - injection, powder for - excipient ingredients: glycine; mannitol; monobasic sodium phosphate; dibasic sodium phosphate - short stature due to decreased or failed secretion of pituitary growth hormone. treatment of adults with severe growth hormone deficiency as diagnosed in the insulin tolerance test for growth hormone deficiency and defined by peak growth hormone concentrations of less than 2.5 nanogram/ml. growth disturbances associated with gonadal dysgenesis (turner's syndrome). improvement of body composition and treatment of short stature associated with prader-willi syndrome (pws) in paediatric patients. for treatment of growth disturbance in children with chronic renal insufficiency whose height is on or less than twenty-fifth percentile and whose growth velocity is on or less than twenty-fifth percentile for bone age. chronic renal insufficiency is defined as glomerular filtration rate of less than 50 ml/min/1.73m2.

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

celgene pty ltd - azacitidine, quantity: 100 mg - injection, powder for - excipient ingredients: mannitol - a)intermediate-2 and high-risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss), b)chronic myelomonocytic leukemia (cmmol 10%-29% marrow blasts without myeloproliferative disorder)), c) acute myeloid leukemia (aml) with 20-30% blasts and multi-lineage dysplasia, according to world health organisation classification (who). in whom allogenic stem cell transplantation is not indicated.

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

medis pharma pty ltd - gemcitabine hydrochloride, quantity: 228 mg (equivalent: gemcitabine, qty 200 mg) - injection, powder for - excipient ingredients: mannitol; sodium hydroxide; sodium acetate trihydrate - treatment of patients with locally advanced or metastatic non-small cell lung cancer. treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. treatment of patients with fu refractory pancreatic cancer. treatment of patients with bladder cancer, alone or in combination with cisplatin. treatment, in combination with paclitaxel, of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/ neoadjuvant chemotherapy. prior chemotherapy should have included an anthracycline unless clinically contraindicated. treatment, in combination with carboplatin, of patients with recurrent epithelial ovarian carcinoma, who have relapsed >six months following platinum based therapy.

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

takeda pharmaceuticals australia pty ltd - factor viii inhibitor bypassing fraction, quantity: 1000 u - injection, powder for - excipient ingredients: sodium citrate dihydrate; sodium chloride - feiba-nf is indicated for routine prophylaxis, control of spontaneous bleeding episodes and use in surgery in haemophilia a or b patients with inhibitors.

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

takeda pharmaceuticals australia pty ltd - factor viii inhibitor bypassing fraction, quantity: 500 u - injection, powder for - excipient ingredients: sodium citrate dihydrate; sodium chloride - feiba-nf is indicated for routine prophylaxis, control of spontaneous bleeding episodes and use in surgery in haemophilia a or b patients with inhibitors.

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

pfizer australia pty ltd - somatropin, quantity: 1.6 mg/ml - injection, powder for - excipient ingredients: glycine; mannitol; monobasic sodium phosphate; dibasic sodium phosphate - indications: short stature due to decreased or failed secretion of pituitary growth hormone. indications as at 13 june 2003: short stature due to decreased or failed secretion of pituitary growth hormone. treatment of adults with severe growth hormone deficiency as diagnosed in the insulin tolerance test for growth hormone deficiency and defined by peak growth hormone concentrations of less than 2.5 nanogram/ml. growth disturbances associated with gonadal dysgenesis (turner's syndrome). improvement of body composition and treatment of short stature associated with prader-willi syndrome (pws) in paediatric patients. for treatment of growth disturbance in children with chronic renal insufficiency whose height is on or less than twenty-fifth percentile and whose growth velocity is on or less than twenty-fifth percentile for bone age. chronic renal insufficiency is defined as glomerular filtration rate of less than 50 ml/min/1.73m2.

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

pfizer australia pty ltd - somatropin, quantity: 2.4 mg/ml - injection, powder for - excipient ingredients: glycine; mannitol; monobasic sodium phosphate; dibasic sodium phosphate - indications: short stature due to decreased or failed secretion of pituitary growth hormone. indications as at 13 june 2003: short stature due to decreased or failed secretion of pituitary growth hormone. treatment of adults with severe growth hormone deficiency as diagnosed in the insulin tolerance test for growth hormone deficiency and defined by peak growth hormone concentrations of less than 2.5 nanogram/ml. growth disturbances associated with gonadal dysgenesis (turner's syndrome). improvement of body composition and treatment of short stature associated with prader-willi syndrome (pws) in paediatric patients. for treatment of growth disturbance in children with chronic renal insufficiency whose height is on or less than twenty-fifth percentile and whose growth velocity is on or less than twenty-fifth percentile for bone age. chronic renal insufficiency is defined as glomerular filtration rate of less than 50 ml/min/1.73m2.

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

pfizer australia pty ltd - somatropin, quantity: 3.2 mg/ml - injection, powder for - excipient ingredients: glycine; mannitol; monobasic sodium phosphate; dibasic sodium phosphate - indications: short stature due to decreased or failed secretion of pituitary growth hormone. indications as at 13 june 2003: short stature due to decreased or failed secretion of pituitary growth hormone. treatment of adults with severe growth hormone deficiency as diagnosed in the insulin tolerance test for growth hormone deficiency and defined by peak growth hormone concentrations of less than 2.5 nanogram/ml. growth disturbances associated with gonadal dysgenesis (turner's syndrome). improvement of body composition and treatment of short stature associated with prader-willi syndrome (pws) in paediatric patients. for treatment of growth disturbance in children with chronic renal insufficiency whose height is on or less than twenty-fifth percentile and whose growth velocity is on or less than twenty-fifth percentile for bone age. chronic renal insufficiency is defined as glomerular filtration rate of less than 50 ml/min/1.73m2.