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

sun pharma anz pty ltd - pantoprazole sodium, quantity: 42.29 mg (equivalent: pantoprazole, qty 40 mg) - injection, powder for - excipient ingredients: - short-term use where oral therapy is not appropriate for the following conditions. 1. symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion, e.g. duodenal ulcer, gastric ulcer, reflux oesophagitis, gastrointestinal lesions refractory to h2 blockers, zollinger-ellison syndrome. 2. maintenance of healed reflux oesophagitis in patients previously treated for moderate to severe reflux oesophagitis.,note: patients whose gastric or duodenal ulceration is not associated with ingestion of nonsteroidal anti-inflammatory drugs require treatment with antimicrobial agents in addition to anti-secretory drugs, whether on first presentation or recurrence.

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

strides pharma science pty ltd - cefepime, quantity: 2000 mg - injection, powder for - excipient ingredients: arginine - adults:. cefepime 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;. - empirical treatment in febrile neutropenic patients (see precautions).. cefepime 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 is indicated in paediatric patients over 2 months of age for the treatment of the infections listed below when caused by susceptible bacteria. . - urinary tract infections, both complicated, including pyelonephritis, and uncomplicated infections;. - skin and skin structure infections;. - septicaemia;. - empirical 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. empirical therapy with cefepime 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 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. 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 - English - Department of Health (Therapeutic Goods Administration)

strides pharma science pty ltd - cefepime, quantity: 1000 mg - injection, powder for - excipient ingredients: arginine - adults:. cefepime 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;. - empirical treatment in febrile neutropenic patients (see precautions).. cefepime 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 is indicated in paediatric patients over 2 months of age for the treatment of the infections listed below when caused by susceptible bacteria. . - urinary tract infections, both complicated, including pyelonephritis, and uncomplicated infections;. - skin and skin structure infections;. - septicaemia;. - empirical 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. empirical therapy with cefepime 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 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. 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 - English - Department of Health (Therapeutic Goods Administration)

btc speciality health pty ltd - mannitol, quantity: 40 mg - inhalation, powder for - excipient ingredients: gelatin - bronchitol is indicated for the treatment of cystic fibrosis (cf) in both paediatric and adult populations six years and above as either an add-on therapy to dornase alfa or in patients intolerant to, or inadequately responsive to dornase alfa.

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

csl behring australia pty ltd - fibrinogen, quantity: 900 mg - injection, powder for - excipient ingredients: sodium citrate; albumin; arginine hydrochloride; sodium chloride - treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenaemia and hypofibrinogenaemia.

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

sandoz pty ltd - teicoplanin, quantity: 400 mg - injection, powder for - excipient ingredients: sodium chloride - teicoplanin sandoz is indicated for the treatment of the following serious infections due to staphylococci or streptococci, which cannot be treated satisfactorily with less toxic agents, including beta-lactam antibiotics: bone (osteomyelitis); joints (septic arthritis); blood (non-cardiac bacteraemia, septicaemia).

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

alphapharm pty ltd - cefazolin sodium, quantity: 2198 mg - injection, powder for - excipient ingredients: - treatment of the following serious infections due to susceptible organisms.. respiratory tract infections due to strep. pneumoniae, klebsiella sp., h. influenzae, staph. aureus (penicillin sensitive and penicillin resistant) and group a beta-haemolytic streptococci. injectable benzathine penicillin is considered to be the drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. cephazolin is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of cephazolin in the subsequent prevention of rheumatic fever are not available at present.. genitourinary tract infections due to e. coli, p. mirabilis, klebsiella sp. and some strains of enterobacter and enterococci.. skin and skin structure infections due to staph. aureus (penicillin sensitive and penicillin resistant) and group a beta-haemolytic streptococci and other strains of streptococci.. bone and joint infections due to staph. aureus.. septicaemia due to strep. pneumoniae, staph. aureus (penicillin sensitive and penicillin resistant), p. mirabilis, e. coli and klebsiella sp.. endocarditis due to staph. aureus (penicillin sensitive and penicillin resistant) and group a beta-haemolytic streptococci.. appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cephazolin.

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

juno pharmaceuticals pty ltd - fludarabine phosphate, quantity: 50 mg - injection, powder for - excipient ingredients: mannitol; sodium hydroxide - treatment of b-cell chronic lymphocytic leukaemia

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

sandoz pty ltd - pantoprazole sodium sesquihydrate, quantity: 45.12 mg (equivalent: pantoprazole, qty 40 mg) - injection, powder for - excipient ingredients: nitrogen - pantoprazole sandoz is indicated for short-term use where oral therapy is not appropriate for the following conditions: 1. symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion, e.g. duodenal ulcer, gastric ulcer, reflux oesophagitis, gastrointestinal lesions refractory to h2 blockers, zollinger-ellison syndrome. 2. maintenance of healed reflux oesophagitis in patients previously treated for moderate to severe reflux oesophagitis. note: patients who gastric or duodenal ulceration is not associated with ingestion of non-steroidal anti-inflammatory drugs require treatment with anti-microbial agents in addition to anti-secretory medicines, whether on first presentation or recurrence.

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

amgen australia pty ltd - romiplostim, quantity: 625 microgram - injection, powder for - excipient ingredients: dilute hydrochloric acid; mannitol; polysorbate 20; histidine; sucrose - adults,nplate is indicated for treatment of thrombocytopenia in adult patients with primary immune thrombocytopenia (itp) who are:,? non-splenectomised and have had an inadequate response, or are intolerant, to corticosteroids and immunoglobulins;,? splenectomised and have had an inadequate response to splenectomy.,paediatrics,nplate is indicated for treatment of thrombocytopenia in paediatric patients aged 1 year and older with primary immune thrombocytopenia itp for at least 6 months who are:,? non-splenectomised and have had an insufficient response, or are intolerant, to corticosteroids and immunoglobulins;,? splenectomised and have had an inadequate response to splenectomy.