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

sandoz pty ltd - piperacillin sodium, quantity: 4.253 g; tazobactam sodium, quantity: 0.547 g (equivalent: tazobactam, qty 0.5 g) - injection, powder for - excipient ingredients: - pipertaz sandoz is used to treat 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, pipertaz sandoz is indicated for the treatment of serious intra-abdominal infections. it has not been evaluated in children below the age of 2 years. while pipertaz sandoz (piperacillin/tazobactam) 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 susceptibility to pipertaz sandoz (piperacillin/tazobactam). therapy with pipertaz sandoz (piperacillin/tazobactam), however, may be initiated before results of each test 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 are available, appropriate therapy should be continued. in serious infections, presumptive therapy with pipertaz sandoz (piperacillin/tazobactam) may be initiated before susceptibility test results are available. combination therapy with pipertaz sandoz (piperacillin/tazobactam) and aminoglycosides may be used int he treatment of serious infections caused by pseudomonas aeruginosa. both drugs shold be used in full therapeutic doses. as soon as results of culture and susceptibility tests become available, antimicrobial therapy should be adjusted.

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

sanofi-aventis australia pty ltd - haemophilus type b polysaccharide, quantity: 10 microgram; tetanus protein, quantity: 18 microgram - injection, powder for - excipient ingredients: trometamol; sucrose - for use in infants from 2 months to 5 years of age for active immunization against invasive disease caused by the haemophilus influenzae type b.

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

juno pharmaceuticals pty ltd - ceftazidime pentahydrate, quantity: 2.328 g (equivalent: ceftazidime, qty 2 g) - injection, powder for - excipient ingredients: sodium carbonate - ceftazidime juno 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 ceftazidime, and as an alternative to aminoglycosides in pseudomonal infection in patients in whom aminoglycoside toxicity is a cause for concern and other 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, 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.

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

juno pharmaceuticals pty ltd - ceftazidime pentahydrate, quantity: 1.164 g (equivalent: ceftazidime, qty 1 g) - injection, powder for - excipient ingredients: sodium carbonate - ceftazidime juno 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 ceftazidime, and as an alternative to aminoglycosides in pseudomonal infection in patients in whom aminoglycoside toxicity is a cause for concern and other 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, 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.

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

csl behring australia pty ltd - factor ix, quantity: 1000 iu - injection, powder for - excipient ingredients: phosphate; plasma proteins; antithrombin iii; heparin sodium; sodium; citrate; chloride - monofix-vf is indicated for the treatment of haemorrhages, for use in surgery, and as prophylaxis in patients with haemophilia b. monofix-vf is not indicated for the treatment factor ii, vii or x deficiencies because it does not contain therapeutic levels of these coagulation factors. monofix-vf is not indicated for the treatment of haemophilia a patients with factor viii inhibitors.

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

csl behring australia pty ltd - factor ix, quantity: 500 iu - injection, powder for - excipient ingredients: citrate; heparin sodium; antithrombin iii; sodium; chloride; plasma proteins; phosphate - monofix-vf is indicated for the treatment of haemorrhages, for use in surgery, and as prophylaxis in patients with haemophilia b. monofix-vf is not indicated for the treatment factor ii, vii or x deficiencies because it does not contain therapeutic levels of these coagulation factors. monofix-vf is not indicated for the treatment of haemophilia a patients with factor viii inhibitors.

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

alphapharm pty ltd - azithromycin, quantity: 500 mg - injection, powder for - excipient ingredients: sodium hydroxide; citric acid monohydrate - community acquired pneumonia caused by susceptible organisms in patients who require initial intravenous therapy. in clinical studies efficacy has been demonstrated against chlamydia pneumoniae, haemophilus influenzae, legionella pneumophilia, moraxella catarrhalis, mycoplasma pneumoniae, staphylococcus aureus and streptococcus pneumoniae.

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

takeda pharmaceuticals australia pty ltd - velaglucerase alfa, quantity: 400 u - injection, powder for - excipient ingredients: citric acid monohydrate; sucrose; polysorbate 20; sodium citrate dihydrate - vpriv is indicated for long-term enzyme replacement therapy (ert) for paediatric and adult patients with type 1 gaucher disease.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

sanofi pasteur - rabies virus inactivated - powder and solvent for suspension for injection

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

kent pharma (uk) ltd - amoxicillin trihydrate - powder for oral suspension - 3gram