Australien - engelsk - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - oxaliplatin, quantity: 5 mg/ml - injection, concentrated - excipient ingredients: succinic acid; water for injections; sodium hydroxide - oxaliplatin, in combination with fluorouracil and folinic acid, is indicated for: - adjuvant treatment of stage iii (duke's c) colon cancer after complete resection of the primary tumour. - treatment of advanced colorectal cancer.

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - tazobactam sodium, quantity: 536.6 mg (equivalent: tazobactam, qty mg); piperacillin sodium, quantity: 4.17 g (equivalent: piperacillin, qty g) - injection, powder for - excipient ingredients: - piperacillin/tazobactam kabi is indicated in the treatment of serious bacterial infections caused by susceptible strains of beta-lactamase producing organisms in the conditions listed below: 1. lower respiratory tract infections. 2. urinary tract infections (complicated and uncomplicated). 3. intra-abdominal infections. 4. skin and skin structure infections. 5. bacterial septicaemia. 6. gynaecological infections.,,children under the age of 12 years:,in hospitalised children aged 2 to 12 years, piperacillin/tazobactam kabi injection is indicated for the treatment of serious intra-abdominal infections. it has not been evaluated in this indication for paediatric patients below the age of 2 years.,while piperacillin/tazobactam kabi injection is indicated only for the conditions listed above, it may be used as a single agent in the treatment of mixed infections caused by piperacillin susceptible and beta-lactamase producing piperacillin-resistant organisms. appropriate culture and susceptibility tests should be performed before treatment in order to identify organisms causing infection to determine their susceptibilities to piperacillin/tazobactam. therapy with piperacillin/tazobactam, however, may be initiated before results of such tests are known when there is a reason to believe the infection may involve any of the beta-lactamase producing organisms listed above; however, once these results become available, appropriate therapy should be continued.,in serious infections, presumptive therapy with piperacillin/tazobactam kabi may be initiated before susceptibility test results are available.,combination therapy with piperacillin/tazobactam kabi and aminoglycosides may be used in the treatment of serious infections caused by pseudomonas aeruginosa. both drugs should be used in full therapeutic doses. as soon as results of culture and susceptibility tests become available, antimicrobial therapy should be adjusted.

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - piperacillin sodium, quantity: 2.085 g (equivalent: piperacillin, qty g); tazobactam sodium, quantity: 268.3 mg (equivalent: tazobactam, qty mg) - injection, powder for - excipient ingredients: - piperacillin/tazobactam kabi is indicated in the treatment of serious bacterial infections caused by susceptible strains of beta-lactamase producing organisms in the conditions listed below: 1. lower respiratory tract infections. 2. urinary tract infections (complicated and uncomplicated). 3. intra-abdominal infections. 4. skin and skin structure infections. 5. bacterial septicaemia. 6. gynaecological infections.,,children under the age of 12 years:,in hospitalised children aged 2 to 12 years, piperacillin/tazobactam kabi injection is indicated for the treatment of serious intra-abdominal infections. it has not been evaluated in this indication for paediatric patients below the age of 2 years.,while piperacillin/tazobactam kabi injection is indicated only for the conditions listed above, it may be used as a single agent in the treatment of mixed infections caused by piperacillin susceptible and beta-lactamase producing piperacillin-resistant organisms. appropriate culture and susceptibility tests should be performed before treatment in order to identify organisms causing infection to determine their susceptibilities to piperacillin/tazobactam. therapy with piperacillin/tazobactam, however, may be initiated before results of such tests are known when there is a reason to believe the infection may involve any of the beta-lactamase producing organisms listed above; however, once these results become available, appropriate therapy should be continued.,in serious infections, presumptive therapy with piperacillin/tazobactam kabi may be initiated before susceptibility test results are available.,combination therapy with piperacillin/tazobactam kabi and aminoglycosides may be used in the treatment of serious infections caused by pseudomonas aeruginosa. both drugs should be used in full therapeutic doses. as soon as results of culture and susceptibility tests become available, antimicrobial therapy should be adjusted.

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - meropenem trihydrate, quantity: 1140 mg (equivalent: meropenem, qty 1000 mg) - injection, powder for - excipient ingredients: sodium carbonate - indications,meropenem kabi is indicated for treatment of the following infections, in adults and children (aged 3 months and over), when the causative organisms are known or suspected to be resistant to commonly used antibiotics:,? community acquired lower respiratory tract infection ,? hospital acquired lower respiratory tract infection,? complicated urinary tract infection,? febrile neutropaenia,? intra-abdominal and gynaecological (poly microbial) infections,? complicated skin and skin structure infections,? meningitis,? septicaemia

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - meropenem trihydrate, quantity: 570 mg (equivalent: meropenem, qty 500 mg) - injection, powder for - excipient ingredients: sodium carbonate - indications,meropenem kabi is indicated for treatment of the following infections, in adults and children (aged 3 months and over), when the causative organisms are known or suspected to be resistant to commonly used antibiotics:,? community acquired lower respiratory tract infection ,? hospital acquired lower respiratory tract infection,? complicated urinary tract infection,? febrile neutropaenia,? intra-abdominal and gynaecological (poly microbial) infections,? complicated skin and skin structure infections,? meningitis,? septicaemia

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - dexmedetomidine hydrochloride, quantity: 236 microgram (equivalent: dexmedetomidine, qty microgram) - injection, concentrated - excipient ingredients: sodium chloride; water for injections - icu sedation: for sedation of initially intubated patients during treatment in an intensive care setting. the use of dexmedetomidine fresenius by continuous infusion in these patients should not exceed 24 hours. procedural sedation: for sedation of non-intubated patients prior to and/or during surgical and other procedures.

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - gemcitabine hydrochloride, quantity: 2277.2 mg (equivalent: gemcitabine, qty 2000 mg) - injection, concentrated - excipient ingredients: sodium hydroxide; hydrochloric acid; water for injections - gemcitabine kabi is indicated for treatment of patients with locally advance or metastatic non-small cell lung cancer. gemcitabine kabi is indicated for treatment of patients with locally advance or metastatic adenocarcinoma of the pancreas. gemcitabine is also indicated for patients with 5-fu refractory pancreatic cancer. gemcitabine kabi, alone or in combination with cisplatin, is indicated for treatment of patients with bladder cancer. gemcitabine kabi, in combination with paclitaxel, is indicated for the treatment 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. gemcitabine kabi, in combinatin with carboplatin, is indicated for the treatment of patients with recurrent epithelial ovarian carcinoma, who have relapsed > 6 months following platinum-based therapy.

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - gemcitabine hydrochloride, quantity: 1138.6 mg (equivalent: gemcitabine, qty 1000 mg) - injection, concentrated - excipient ingredients: sodium hydroxide; hydrochloric acid; water for injections - gemcitabine kabi is indicated for treatment of patients with locally advance or metastatic non-small cell lung cancer. gemcitabine kabi is indicated for treatment of patients with locally advance or metastatic adenocarcinoma of the pancreas. gemcitabine is also indicated for patients with 5-fu refractory pancreatic cancer. gemcitabine kabi, alone or in combination with cisplatin, is indicated for treatment of patients with bladder cancer. gemcitabine kabi, in combination with paclitaxel, is indicated for the treatment 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. gemcitabine kabi, in combinatin with carboplatin, is indicated for the treatment of patients with recurrent epithelial ovarian carcinoma, who have relapsed > 6 months following platinum-based therapy.

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - gemcitabine hydrochloride, quantity: 227.72 mg (equivalent: gemcitabine, qty 200 mg) - injection, concentrated - excipient ingredients: sodium hydroxide; hydrochloric acid; water for injections - gemcitabine kabi is indicated for treatment of patients with locally advance or metastatic non-small cell lung cancer. gemcitabine kabi is indicated for treatment of patients with locally advance or metastatic adenocarcinoma of the pancreas. gemcitabine is also indicated for patients with 5-fu refractory pancreatic cancer. gemcitabine kabi, alone or in combination with cisplatin, is indicated for treatment of patients with bladder cancer. gemcitabine kabi, in combination with paclitaxel, is indicated for the treatment 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. gemcitabine kabi, in combinatin with carboplatin, is indicated for the treatment of patients with recurrent epithelial ovarian carcinoma, who have relapsed > 6 months following platinum-based therapy.

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - dexmedetomidine hydrochloride, quantity: 472 microgram (equivalent: dexmedetomidine, qty 400 microgram) - injection, concentrated - excipient ingredients: sodium chloride; water for injections - intensive care unit (icu) sedation,for sedation of initially intubated patients during treatment in an intensive care setting. the use of dexmedetomidine kabi by continuous infusion in these patients should not exceed 24 hours.,procedural sedation,for sedation of non-intubated patients prior to and/or during surgical and other procedures.