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

aft pharmaceuticals pty ltd - ceftazidime pentahydrate, quantity: 2.33 g - injection, powder for - excipient ingredients: sodium carbonate - ceftazidime-aft 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: ? severe infections in general: for example septicaemia, including neonatal sepsis, bacteraemia, and in patients in intensive care units with specific problems, eg, infected burns. ? respiratory tract infections: for example, pneumonia, broncho-pneumonia, infected pleurisy, infected bronchiectasis and bronchitis. ? severe ear, nose and throat infections: for example, otitis media, mastoiditis. ? urinary tract infections: for example, acute and chronic pyelonephritis, pyelitis, cystitis, urethritis (bacterial only), and 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.

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

arrotex pharmaceuticals pty ltd - bivalirudin, quantity: 250 mg - injection, powder for - excipient ingredients: mannitol; sodium hydroxide - bivalirudin is indicated for use as an anticoagulant: ? in the treatment of patients with moderate to high risk acute coronary syndromes (acs) (unstable angina/non-st segment elevation myocardial infarction (ua/nstemi) who are undergoing early invasive management, and ? in patients undergoing percutaneous coronary intervention (pci). bivalirudin is intended for use with aspirin. a p2y12 antagonist (e.g. clopidogrel or ticlopidine) may be used in addition to aspirin.

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

aft pharmaceuticals pty ltd - piperacillin sodium, quantity: 4170 mg (equivalent: piperacillin, qty 4000 mg); tazobactam sodium, quantity: 540 mg (equivalent: tazobactam, qty 500 mg) - injection, powder for - excipient ingredients: nitrogen - piptaz-aft 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, piptaz-aft 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 piptaz-aft 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 piptaz-aft. therapy with piptaz-aft, however, may be initiated before results of such tests are known when there is 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 piptaz-aft may be initiated before susceptibility test results are available. combination therapy with piptaz-aft 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.

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

janssen-cilag pty ltd - bortezomib, quantity: 3 mg - injection, powder for - excipient ingredients: mannitol; nitrogen - - velcade, in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy. - velcade, as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma. - velcade is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease. - velcade in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.

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

dr reddys laboratories australia pty ltd - azacitidine, quantity: 100 mg - injection, powder for - excipient ingredients: mannitol - azacitidine juno is indicated for the treatment of patients with intermediate-2 and high-risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss), chronic myelomonocytic leukemia (cmmol (10-29 percent marrow blasts without myeloproliferative disorder)), acute myeloid leukemia (aml) with 20-30 percent blasts and multi-lineage dysplasia, according to world health organisation classification (who), in whom allogenic stem cell transplantation is not indicated.

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

dr reddys laboratories australia pty ltd - azacitidine, quantity: 100 mg - injection, powder for - excipient ingredients: mannitol - azadine is indicated for the treatment of patients with intermediate-2 and high-risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss), chronic myelomonocytic leukemia (cmmol (10-29 percent marrow blasts without myeloproliferative disorder)), acute myeloid leukemia (aml) with 20-30 percent blasts and multi-lineage dysplasia, according to world health organisation classification (who), in whom allogenic stem cell transplantation is not indicated.

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)

strides pharma science pty ltd - ceftazidime pentahydrate, quantity: 1175 mg (equivalent: ceftazidime, qty 1000 mg) - injection, powder for - excipient ingredients: sodium carbonate - ceftazidime for injection 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 the following:,severe infections in general: ,for example: septicaemia including neonatal sepsis, bacteraemia; and in patients in intensive care units with specific problems, e.g., infected burns.,respiratory tract infections: ,for example: pneumonia, broncho-pneumonia, infected pleurisy, infected bronchiectasis and bronchitis.,severe ear, nose and throat infections: ,for example: otitis media, mastoiditis.,urinary tract infections: ,for example: acute and chronic pyelonephritis, pyelitis, cystitis, urethritis (bacterial only), and 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.

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

strides pharma science pty ltd - ceftazidime pentahydrate, quantity: 2349 mg (equivalent: ceftazidime, qty 2000 mg) - injection, powder for - excipient ingredients: sodium carbonate - ceftazidime for injection 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 the following:,severe infections in general: ,for example: septicaemia including neonatal sepsis, bacteraemia; and in patients in intensive care units with specific problems, e.g., infected burns.,respiratory tract infections: ,for example: pneumonia, broncho-pneumonia, infected pleurisy, infected bronchiectasis and bronchitis.,severe ear, nose and throat infections: ,for example: otitis media, mastoiditis.,urinary tract infections: ,for example: acute and chronic pyelonephritis, pyelitis, cystitis, urethritis (bacterial only), and 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.