Australia - Inggris - 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.

Australia - Inggris - 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.

Australia - Inggris - 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.

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

fresenius kabi australia pty ltd - ceftazidime pentahydrate, quantity: 2329.6 mg (equivalent: ceftazidime, qty 2 g) - injection, powder for - excipient ingredients: sodium carbonate - ceftazidime is indicated for the treatment of single and mixed infections caused by susceptible aerobic organisms with suspected or documented resistance to other antimicrobials, but not to ceftazidime, and as an alternative to aminoglycosides in pseudomonal infection in patients in whom aminoglycoside toxicity is a cause for concern and other pseudomonal antibiotics cannot be used. indications include: - sever infections in general: for expample septicaemia (including neonatal sepsis), bacteraemia, patients in intensive care units with specific problems, e.g infected burns. - respiratory tract infections: for example, pneumonia, broncho-pneumonia, infected pleurisy, infected bronchiectasis, bronchitis. - sever ear, nose and throat infections: for example, otitis media, mastoiditis. - urinary tract infections: for example, acute and chronic pyelonephritis, pyelitis, cystitis, urethritis (bacterial only), infections associated with bladder and renal stones. - skin and soft tissue infections: for example, erysipelas, abscesses, cellulitis, infected burns and wounds, mastitis. - gastrointestinal and abdominal infections: for example, intra-abdominal abscesses, enterocolitis. - bone and joint infections: for example, osteitis, osteomyelitis, septic arthritis, infected bursitis.

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

fresenius kabi australia pty ltd - ceftazidime pentahydrate, quantity: 1164.8 mg (equivalent: ceftazidime, qty 1 g) - injection, powder for - excipient ingredients: sodium carbonate - ceftazidime is indicated for the treatment of single and mixed infections caused by susceptible aerobic organisms with suspected or documented resistance to other antimicrobials, but not to ceftazidime, and as an alternative to aminoglycosides in pseudomonal infection in patients in whom aminoglycoside toxicity is a cause for concern and other pseudomonal antibiotics cannot be used. indications include: - sever infections in general: for expample septicaemia (including neonatal sepsis), bacteraemia, patients in intensive care units with specific problems, e.g infected burns. - respiratory tract infections: for example, pneumonia, broncho-pneumonia, infected pleurisy, infected bronchiectasis, bronchitis. - sever ear, nose and throat infections: for example, otitis media, mastoiditis. - urinary tract infections: for example, acute and chronic pyelonephritis, pyelitis, cystitis, urethritis (bacterial only), infections associated with bladder and renal stones. - skin and soft tissue infections: for example, erysipelas, abscesses, cellulitis, infected burns and wounds, mastitis. - gastrointestinal and abdominal infections: for example, intra-abdominal abscesses, enterocolitis. - bone and joint infections: for example, osteitis, osteomyelitis, septic arthritis, infected bursitis.

Australia - Inggris - 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.

Australia - Inggris - 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.

Australia - Inggris - 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.

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

fresenius kabi australia pty ltd - docetaxel, quantity: 160 mg - injection, concentrated - excipient ingredients: citric acid; polysorbate 80; ethanol absolute - breast cancer,metastatic breast cancer,docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer in whom previous chemotherapy has failed.,docetaxel in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior anthracycline containing chemotherapy.,docetaxel in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress her2 and who previously have not received chemotherapy for metastatic disease.,adjuvant treatment of breast cancer,docetaxel in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with node-positive breast cancer.,doxorubicin and cyclophosphamide followed by docetaxel in combination with trastuzumab (acth) is indicated for the adjuvant treatment of patients with operable breast cancer whose tumours overexpress her2.,docetaxel in combination with carboplatin and trastuzumab (tch) is indicated for the adjuvant treatment of patients with operable breast cancer whose tumours overexpress her2.,docetaxel in combination with cyclophosphamide is indicated for the adjuvant treatment of operable breast cancer with a primary tumour of ?1cm and <7cm.,non small cell lung cancer,docetaxel is indicated for the treatment of patients with locally advanced or metastatic non small cell lung cancer, including those who have failed platinum-based chemotherapy.,ovarian cancer,docetaxel is indicated for the treatment of metastatic carcinoma of the ovary after failure of firstline or subsequent chemotherapy.,prostate cancer,docetaxel is indicated for the treatment of patients with androgen independent (hormone refractory) prostate cancer.,head and neck cancer,docetaxel, in combination with cisplatin and fluorouracil is indicated as induction treatment prior to chemoradiotherapy, for the treatment of patients with locally advanced, squamous cell carcinoma of the head and neck, who have low probability of surgical cure, require organ preservation or where the tumour is technically unresectable.

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

fresenius kabi australia pty ltd - docetaxel, quantity: 20 mg - injection, concentrated - excipient ingredients: citric acid; polysorbate 80; ethanol absolute - breast cancer,metastatic breast cancer,docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer in whom previous chemotherapy has failed.,docetaxel in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior anthracycline containing chemotherapy.,docetaxel in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress her2 and who previously have not received chemotherapy for metastatic disease.,adjuvant treatment of breast cancer,docetaxel in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with node-positive breast cancer.,doxorubicin and cyclophosphamide followed by docetaxel in combination with trastuzumab (acth) is indicated for the adjuvant treatment of patients with operable breast cancer whose tumours overexpress her2.,docetaxel in combination with carboplatin and trastuzumab (tch) is indicated for the adjuvant treatment of patients with operable breast cancer whose tumours overexpress her2.,docetaxel in combination with cyclophosphamide is indicated for the adjuvant treatment of operable breast cancer with a primary tumour of ?1cm and <7cm.,non small cell lung cancer,docetaxel is indicated for the treatment of patients with locally advanced or metastatic non small cell lung cancer, including those who have failed platinum-based chemotherapy.,ovarian cancer,docetaxel is indicated for the treatment of metastatic carcinoma of the ovary after failure of firstline or subsequent chemotherapy.,prostate cancer,docetaxel is indicated for the treatment of patients with androgen independent (hormone refractory) prostate cancer.,head and neck cancer,docetaxel, in combination with cisplatin and fluorouracil is indicated as induction treatment prior to chemoradiotherapy, for the treatment of patients with locally advanced, squamous cell carcinoma of the head and neck, who have low probability of surgical cure, require organ preservation or where the tumour is technically unresectable.