New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - cisplatin 1 mg/ml - solution for injection - 1 mg/ml - active: cisplatin 1 mg/ml excipient: hydrochloric acid sodium chloride water for injection - cisplatin ebewe is indicated as palliative therapy to be employed as follows: metastatic non-seminomatous germ cell carcinoma: in established combination therapy with other approved chemotherapeutic agents in patients with metastatic non-seminomatous germ cell tumours who have already received appropriate surgical and/or radiotherapeutic procedures. metastatic ovarian tumours: cisplatin ebewe, as a single agent, is indicated as secondary therapy in patients with metastatic ovarian tumours refractory to standard chemotherapy who have not previously received cisplatin ebewe therapy. advanced and refractory carcinoma of the bladder: cisplatin ebewe, as a single agent, is indicated as secondary therapy in patients with advanced stage bladder cancer refractory to standard chemotherapy who have not previously received cisplatin ebewe therapy. squamous cell carcinoma of the head and neck (refractory to standard chemotherapy): cisplatin ebewe, as a single agent, is indicated as secondary therapy in patients with squamous cell carcinoma of the head and neck refractory to standard chemotherapy who have not previously received cisplatin ebewe therapy.

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

accord healthcare pty ltd - carboplatin, quantity: 450 mg - injection, solution - excipient ingredients: water for injections - carboplatin is indicated in the treatment of: advanced stage ovarian cancer of epithelial origin. small cell lung carcinoma. carcinoma of the head and neck. carcinoma of the testis. paediatric cerebral tumours. soft tissue sarcoma. neuroblastoma.

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

accord healthcare pty ltd - carboplatin, quantity: 150 mg - injection, solution - excipient ingredients: water for injections - carboplatin is indicated in the treatment of: advanced stage ovarian cancer of epithelial origin. small cell lung carcinoma. carcinoma of the head and neck. carcinoma of the testis. paediatric cerebral tumours. soft tissue sarcoma. neuroblastoma.

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

accord healthcare pty ltd - carboplatin, quantity: 50 mg - injection, solution - excipient ingredients: water for injections - carboplatin is indicated in the treatment of: advanced stage ovarian cancer of epithelial origin. small cell lung carcinoma. carcinoma of the head and neck. carcinoma of the testis. paediatric cerebral tumours. soft tissue sarcoma. neuroblastoma.

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

abraxis bioscience australia pty ltd - paclitaxel, quantity: 100 mg - injection, powder for - excipient ingredients: albumin; sodium octanoate; sodium acetyltryptophanate - metastatic breast cancer abraxane is indicated for the treatment of metastatic carcinoma of the breast after failure of anthracycline therapy. non-small cell lung cancer abraxane, in combination with carboplatin, is indicated for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation. metastatic adenocarcinoma of the pancreas abraxane, in combination with gemcitabine, is indicated for the first-line treatment of patients with metastatic adenocarcinoma of the pancreas.

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

abraxis bioscience australia pty ltd - paclitaxel, quantity: 250 mg - injection, powder for - excipient ingredients: albumin; sodium octanoate; sodium acetyltryptophanate - metastatic breast cancer abraxane is indicated for the treatment of metastatic carcinoma of the breast after failure of anthracycline therapy. non-small cell lung cancer abraxane, in combination with carboplatin, is indicated for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation. metastatic adenocarcinoma of the pancreas abraxane, in combination with gemcitabine, is indicated for the first-line treatment of patients with metastatic adenocarcinoma of the pancreas.

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

aft pharmaceuticals pty ltd - cefepime hydrochloride monohydrate, quantity: 2.378 g (equivalent: cefepime, qty 2 g) - injection, powder for - excipient ingredients: arginine - adults: cefepime-aft is indicated in the treatment of the infections listed below when caused by susceptible bacteria. ? lower respiratory tract infections, including pneumonia and bronchitis. ? urinary tract infections, both complicated, including pyelonephritis, and uncomplicated infections. ? skin and skin structure infections. ? intra-abdominal infections, including peritonitis and biliary tract infections. ? gynaecological infections. ? septicaemia ? empiric treatment in febrile neutropenic patients (see precautions) cefepime-aft is also indicated for surgical prophylaxis in patients undergoing intra-abdominal surgery. in this indication it is essential that metronidazole also be administered. paediatrics: cefepime-aft is indicated in paediatric patients over 2 months of age for the treatment of the infections listed below when caused by susceptible bacteria: ? pneumonia ? urinary tract infections, both complicated, including pyelonephritis, and uncomplicated infections ? skin and skin structure infections ? septicaemia ? empiric treatment in febrile neutropenic patients (see precautions) culture and susceptibility studies should be performed when appropriate to determine susceptibility of the causative organism(s) to cefepime. empiric therapy with cefepime-aft may be instituted before results of susceptibility studies are known; however, once these results become available, the antibiotic treatment should be adjusted accordingly. because of its broad spectrum of bactericidal activity against gram-positive and gram-negative bacteria, cefepime-aft can be used appropriately as monotherapy prior to identification of the causative organisms(s). in the treatment of febrile neutropenia, consideration should be given to the need for other antibiotics in combination with cefepime-aft. in patients who are at risk of mixed aerobic-anaerobic infection, including infections in which bacterioides fragilis may be present, concurrent initial therapy with an anti-anaerobic agent is recommended before the causative organism(s) is known.

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

aft pharmaceuticals pty ltd - cefepime hydrochloride monohydrate, quantity: 1.189 g (equivalent: cefepime, qty 1 g) - injection, powder for - excipient ingredients: arginine - adults: cefepime-aft is indicated in the treatment of the infections listed below when caused by susceptible bacteria. ? lower respiratory tract infections, including pneumonia and bronchitis. ? urinary tract infections, both complicated, including pyelonephritis, and uncomplicated infections. ? skin and skin structure infections. ? intra-abdominal infections, including peritonitis and biliary tract infections. ? gynaecological infections. ? septicaemia ? empiric treatment in febrile neutropenic patients (see precautions) cefepime-aft is also indicated for surgical prophylaxis in patients undergoing intra-abdominal surgery. in this indication it is essential that metronidazole also be administered. paediatrics: cefepime-aft is indicated in paediatric patients over 2 months of age for the treatment of the infections listed below when caused by susceptible bacteria: ? pneumonia ? urinary tract infections, both complicated, including pyelonephritis, and uncomplicated infections ? skin and skin structure infections ? septicaemia ? empiric treatment in febrile neutropenic patients (see precautions) culture and susceptibility studies should be performed when appropriate to determine susceptibility of the causative organism(s) to cefepime. empiric therapy with cefepime-aft may be instituted before results of susceptibility studies are known; however, once these results become available, the antibiotic treatment should be adjusted accordingly. because of its broad spectrum of bactericidal activity against gram-positive and gram-negative bacteria, cefepime-aft can be used appropriately as monotherapy prior to identification of the causative organisms(s). in the treatment of febrile neutropenia, consideration should be given to the need for other antibiotics in combination with cefepime-aft. in patients who are at risk of mixed aerobic-anaerobic infection, including infections in which bacterioides fragilis may be present, concurrent initial therapy with an anti-anaerobic agent is recommended before the causative organism(s) is known.

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

dr reddys laboratories australia pty ltd - bosentan monohydrate, quantity: 129.082 mg - tablet, film coated - excipient ingredients: maize starch; pregelatinised maize starch; sodium starch glycollate type a; povidone; glycerol dibehenate; magnesium stearate; hypromellose; titanium dioxide; triacetin; purified talc; iron oxide yellow; iron oxide red; ethylcellulose; cetyl alcohol; sodium lauryl sulfate - for the treatment of ? idiopathic pulmonary arterial hypertension ? familial pulmonary arterial hypertension ? pulmonary arterial hypertension associated with scleroderma or ? pulmonary arterial hypertension associated with congenital systemic to pulmonary shunts including eisenmenger?s physiology,in patients with who functional class ii, iii or iv symptoms

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

dr reddys laboratories australia pty ltd - bosentan monohydrate, quantity: 64.541 mg - tablet, film coated - excipient ingredients: maize starch; pregelatinised maize starch; sodium starch glycollate type a; povidone; glycerol dibehenate; magnesium stearate; hypromellose; titanium dioxide; triacetin; purified talc; iron oxide yellow; iron oxide red; ethylcellulose; cetyl alcohol; sodium lauryl sulfate - for the treatment of ? idiopathic pulmonary arterial hypertension ? familial pulmonary arterial hypertension ? pulmonary arterial hypertension associated with scleroderma or ? pulmonary arterial hypertension associated with congenital systemic to pulmonary shunts including eisenmenger?s physiology,in patients with who functional class ii, iii or iv symptoms