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

fresenius kabi australia pty ltd - flucloxacillin sodium monohydrate, quantity: 1088.1 mg (equivalent: flucloxacillin, qty 1000 mg) - injection, powder for - excipient ingredients: - for the treatment of confirmed or suspected staphylococcal infections and other gram-positive coccal infections. indications include pneumonia, osteomyelitis, skin and skin structure and wound infections, infected burns and cellulitis.

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

fresenius kabi australia pty ltd - flucloxacillin sodium monohydrate, quantity: 544.1 mg (equivalent: flucloxacillin, qty 500 mg) - injection, powder for - excipient ingredients: - for the treatment of confirmed or suspected staphylococcal infections and other gram-positive coccal infections. indications include pneumonia, osteomyelitis, skin and skin structure and wound infections, infected burns and cellulitis.

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

echo therapeutics pty ltd - mitomycin, quantity: 20 mg - injection, powder for - excipient ingredients: nitrogen; mannitol; hydrochloric acid; sodium hydroxide - mitomycin is indicated in the palliative treatment of carcinoma of the stomach, pancreas, colon, lung (non-small cell), breast, cervix, head and neck, liver and bladder.

Australia - englanti - 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

Australia - englanti - 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

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

aft pharmaceuticals pty ltd - cefepime hydrochloride monohydrate, quantity: 595 mg (equivalent: cefepime, qty 500 mg) - 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 - englanti - 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 - englanti - 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 - englanti - Department of Health (Therapeutic Goods Administration)

wockhardt bio pty ltd - voriconazole, quantity: 200 mg - injection, powder for - excipient ingredients: sodium chloride; hydroxypropylbetadex - voriconazole wockhardt is indicated for treatment of the following fungal infections:,invasive aspergillosis.,serious candida infections (including c. krusei), including systemic candida infections (hepatosplenic candidiasis, disseminated candidiasis, candidaemia).,serious fungal infections caused by scedosporium spp and fusarium spp.,other serious fungal infections, in patients intolerant of, or refractory to, other therapy.,prophylaxis in patients who are at high risk of developing invasive fungal infections. the indication is based on studies including patients undergoing haematopoietic stem cell transplantation.

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

wockhardt bio pty ltd - voriconazole, quantity: 200 mg - injection, powder for - excipient ingredients: sodium chloride; hydroxypropylbetadex - voriwok is indicated for treatment of the following fungal infections:,invasive aspergillosis.,serious candida infections (including c. krusei), including systemic candida infections (hepatosplenic candidiasis, disseminated candidiasis, candidaemia).,serious fungal infections caused by scedosporium spp and fusarium spp.,other serious fungal infections, in patients intolerant of, or refractory to, other therapy.,prophylaxis in patients who are at high risk of developing invasive fungal infections. the indication is based on studies including patients undergoing haematopoietic stem cell transplantation.