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

pfizer australia pty ltd - somatropin, quantity: 8 mg/ml - injection, powder for - excipient ingredients: glycine; mannitol; monobasic sodium phosphate; dibasic sodium phosphate - 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 - raltitrexed, quantity: 2 mg - injection, powder for - excipient ingredients: sodium hydroxide; mannitol; dibasic sodium phosphate dodecahydrate - for use as a single agent in the palliative treatment of advanced colorectal cancer (distant metastases or unresectable local disease).

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

sanofi-aventis australia pty ltd - rabies virus, quantity: 2.5 iu - injection, powder for - excipient ingredients: albumin; neomycin - idications as at 12 july 2004: post exposure immunisation against rabies. pre-exposure immunisation in persons at special risk of contracting rabies.

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

teva pharma australia pty ltd - azacitidine, quantity: 100 mg - injection, powder for - excipient ingredients: monobasic sodium phosphate monohydrate; dibasic sodium phosphate dihydrate; sucrose - azacitidine-teva is indicated for the treatment of patients with: intermediate-2 and high-risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss), chronic myelomonocytic leukemia [cmmol (10 percent-29 percent marrow blasts without myeloproliferative disorder)], acute myeloid leukemia (aml) with 20-30 percent 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)

juno pharmaceuticals pty ltd - ertapenem sodium, quantity: 1.046 g (equivalent: ertapenem, qty 1 g) - injection, powder for - excipient ingredients: sodium bicarbonate; sodium hydroxide; nitrogen - treatment,ertapenem juno is indicated for the treatment of patients, aged 3 months or more, with moderate to severe infections (except meningitis, see precautions) caused by susceptible strains of microorganisms which are suspected or proven to be resistant to all other antibiotics, or for patients unable to tolerate other antibiotics.,ertapenem juno is also indicated for initial empiric therapy for the treatment of complicated intra-abdominal infections and acute pelvic infections including post-partum endomyometritis, septic abortion and post-surgical gynaecological infections.,ertapenem juno is also indicated for the treatment of diabetic foot infections, which require parenteral antibiotic therapy and are caused by susceptible bacterial pathogens which are suspected or proven to be resistant to all other registered antibiotics, or for patients unable to tolerate other antibiotics. ,appropriate specimens for bacteriological examination should be obtained in order to isolate and identify the causative organisms and to determine their susceptibility to ertapenem. therapy with ertapenem juno may be initiated empirically before the results of these tests are known; once these results become available, antimicrobial therapy,should be adjusted accordingly.

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

sandoz pty ltd - azacitidine, quantity: 100 mg - injection, powder for - excipient ingredients: mannitol - azacitidine is indicated for the treatment of patients with: ? intermediate-2 and high-risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss), ? chronic myelomonocytic leukemia [cmmol (10%-29% marrow blasts without myeloproliferative disorder)], ? 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)

juno pharmaceuticals pty ltd - azacitidine, quantity: 100 mg - injection, powder for - excipient ingredients: mannitol - azacitidine is indicated for the treatment of patients with: ? intermediate-2 and high-risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss), ? chronic myelomonocytic leukemia [cmmol (10%-29% marrow blasts without myeloproliferative disorder)], ? 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)

apotex pty ltd - remifentanil hydrochloride, quantity: 1.097 mg - injection, powder for - excipient ingredients: hydrochloric acid; glycine - remifentanil is indicated:,- as an opioid adjunct for use during induction and/or maintenance of general anaesthesia during surgical procedures, including cardiac surgery, in adults;,- as an opioid adjunct for use during induction and/or maintenance of general anaesthesia during surgical, but not cardiac procedures, in children aged 1?12 years;,- for continuation as an analgesic into the immediate post-operative period under the close supervision of medically-qualified persons trained in the use of anaesthetic agents, during transition to longer-acting analgesia following adult cardiac surgery ? when endotracheal intubation and controlled ventilation are anticipated;,- for provision of analgesia and sedation in mechanically-ventilated intensive care patients.

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

apotex pty ltd - remifentanil hydrochloride, quantity: 2.194 mg - injection, powder for - excipient ingredients: glycine; hydrochloric acid - remifentanil is indicated:,- as an opioid adjunct for use during induction and/or maintenance of general anaesthesia during surgical procedures, including cardiac surgery, in adults;,- as an opioid adjunct for use during induction and/or maintenance of general anaesthesia during surgical, but not cardiac procedures, in children aged 1?12 years;,- for continuation as an analgesic into the immediate post-operative period under the close supervision of medically-qualified persons trained in the use of anaesthetic agents, during transition to longer-acting analgesia following adult cardiac surgery ? when endotracheal intubation and controlled ventilation are anticipated;,- for provision of analgesia and sedation in mechanically-ventilated intensive care patients.

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

apotex pty ltd - remifentanil hydrochloride, quantity: 5.485 mg - injection, powder for - excipient ingredients: hydrochloric acid; glycine - remifentanil is indicated:,- as an opioid adjunct for use during induction and/or maintenance of general anaesthesia during surgical procedures, including cardiac surgery, in adults;,- as an opioid adjunct for use during induction and/or maintenance of general anaesthesia during surgical, but not cardiac procedures, in children aged 1?12 years;,- for continuation as an analgesic into the immediate post-operative period under the close supervision of medically-qualified persons trained in the use of anaesthetic agents, during transition to longer-acting analgesia following adult cardiac surgery ? when endotracheal intubation and controlled ventilation are anticipated;,- for provision of analgesia and sedation in mechanically-ventilated intensive care patients.