Malta - Ingliż - Malta Medicines Authority

fresenius kabi oncology plc lion court, farnham road, bordon, hampshire, gu35 0nf, united kingdom - capecitabine - film-coated tablet - capecitabine 150 mg - antineoplastic agents

Malta - Ingliż - Malta Medicines Authority

fresenius kabi oncology plc lion court, farnham road, bordon, hampshire, gu35 0nf, united kingdom - capecitabine - film-coated tablet - capecitabine 500 mg - antineoplastic agents

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - flumazenil, quantity: 0.1 mg/ml - injection, solution - excipient ingredients: acetic acid; sodium hydroxide; disodium edetate; sodium chloride; water for injections - flumazenil kabi is indicated for use in hospitalised patients for the reversal of acute benzodiazepine effects (overdose or therapeutic). hospitalised patients are patients admitted to hospital, inpatient care and under continued professional observation while under the influence of flumazenil. not to be used in outpatients or short stay patients. not to be used as a diagnostic.

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - flumazenil, quantity: 0.1 mg/ml - injection, solution - excipient ingredients: water for injections; acetic acid; sodium chloride; sodium hydroxide; disodium edetate - flumazenil kabi is indicated for use in hospitalised patients for the reversal of acute benzodiazepine effects (overdose or therapeutic). hospitalised patients are patients admitted to hospital, inpatient care and under continued professional observation while under the influence of flumazenil. not to be used in outpatients or short stay patients. not to be used as a diagnostic.

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - cefepime hydrochloride monohydrate, quantity: 1189.2 mg (equivalent: cefepime, qty 1 g) - injection, powder for - excipient ingredients: arginine - adults: cefepime kabi 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 kabi 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 kabi 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 kabi 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 kabi 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 kabi. 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.

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - cefepime hydrochloride monohydrate, quantity: 2378.5 mg (equivalent: cefepime, qty 2 g) - injection, powder for - excipient ingredients: arginine - adults: cefepime kabi 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 kabi 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 kabi 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 kabi 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 kabi 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 kabi. 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.

Awstralja - Ingliż - 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.

Awstralja - Ingliż - 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.

Awstralja - Ingliż - 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.

Awstralja - Ingliż - 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.