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

alexion pharmaceuticals australasia pty ltd - eculizumab, quantity: 300 mg - injection, intravenous infusion - excipient ingredients: polysorbate 80; sodium chloride; water for injections; dibasic sodium phosphate heptahydrate; monobasic sodium phosphate monohydrate - soliris is indicated for the treatment of patients with: ? paroxysmal nocturnal haemoglobinuria (pnh) to reduce haemolysis. ? atypical haemolytic uraemic syndrome (ahus). ? adult patients with neuromyelitis optica spectrum disorder (nmosd) who are anti-aquaporin-4 (aqp4) antibody-positive. soliris is not intended for acute treatment of a nmosd relapse.

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

aspen pharmacare australia pty ltd - ciprofloxacin, quantity: 2 mg/ml - injection, intravenous infusion - excipient ingredients: lactic acid; glucose monohydrate; water for injections - aspen ciprofloxacin injection for intravenous infusion is indicated for use in the following. hospitalised adult patients in whom oral ciprofloxacin is indicated but cannot be administered or where the oral form is inappropriate. for the treatment of serious or life-threatening infections due to sensitive organisms involving the following organ systems. lower respiratory tract infections (gram-negative organisms), skin and skin structure, septicaemia, bone and joint, urinary tract. inhalational anthrax (post exposure): to reduce the incidence or progression of disease following exposure to aerosolized bacillus anthracis. ciprofloxacin serum concentrations achieved in humans serve as a surrogate endpoint reasonably likely to predict clinical benefit and provide the basis for this indication. note. because gram-positive organisms are generally less sensitive to ciprofloxacin, it may not be the drug of choice in cases with gram-positive infections, such as pneumonia due to streptococcus pneumoniae. if anaerobic organisms are suspected of contributing to the infection, use of other suitable drugs should be considered. strains neisseria gonorrhoea resistant to ciprofloxacin have been reported in australia. appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to ciprofloxacin. therapy with ciprofloxacin may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued. ciprofloxacin is suitable to treat mixed infections caused by susceptible strains of both gram-negative and gram-positive aerobic bacteria. if anaerobic organisms are suspected as accompanying aetiological agents, additional therapy should be considered.

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

aspen pharmacare australia pty ltd - ciprofloxacin, quantity: 2 mg/ml - injection, intravenous infusion - excipient ingredients: lactic acid; glucose monohydrate; water for injections - aspen ciprofloxacin injection for intravenous infusion is indicated for use in the following. hospitalised adult patients in whom oral ciprofloxacin is indicated but cannot be administered or where the oral form is inappropriate. for the treatment of serious or life-threatening infections due to sensitive organisms involving the following organ systems. lower respiratory tract infections (gram-negative organisms), skin and skin structure, septicaemia, bone and joint, urinary tract. inhalational anthrax (post exposure): to reduce the incidence or progression of disease following exposure to aerosolized bacillus anthracis. ciprofloxacin serum concentrations achieved in humans serve as a surrogate endpoint reasonably likely to predict clinical benefit and provide the basis for this indication. note. because gram-positive organisms are generally less sensitive to ciprofloxacin, it may not be the drug of choice in cases with gram-positive infections, such as pneumonia due to streptococcus pneumoniae. if anaerobic organisms are suspected of contributing to the infection, use of other suitable drugs should be considered. strains neisseria gonorrhoea resistant to ciprofloxacin have been reported in australia. appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to ciprofloxacin. therapy with ciprofloxacin may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued. ciprofloxacin is suitable to treat mixed infections caused by susceptible strains of both gram-negative and gram-positive aerobic bacteria. if anaerobic organisms are suspected as accompanying aetiological agents, additional therapy should be considered.

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

b braun australia pty ltd - glucose monohydrate, quantity: 55 g/l - injection, intravenous infusion - excipient ingredients: water for injections - for intravenous fluid therapy designed to correct deficiencies in hydration, electrolyte and energy levels. may also be used as solvents for intravenously administered drugs where compatibility has been established.

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

b braun australia pty ltd - glucose monohydrate, quantity: 55 g/l - injection, intravenous infusion - excipient ingredients: water for injections - for intravenous fluid therapy designed to correct deficiencies in hydration, electrolyte and energy levels. may also be used as solvents for intravenously administered drugs where compatibility has been established.

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

b braun australia pty ltd - sodium chloride, quantity: 9 g/l - injection, intravenous infusion - excipient ingredients: water for injections - for intravenous fluid therapy designed to correct deficiencies in hydration, electrolyte and energy levels. may also be used as solvents for intravenously administered drugs where compatibility has been established. may also be used for irrigation of wounds and moistening of wound dressings.

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

b braun australia pty ltd - sodium chloride, quantity: 9 g/l - injection, intravenous infusion - excipient ingredients: water for injections - for intravenous fluid therapy designed to correct deficiencies in hydration, electrolyte and energy levels. may also be used as solvents for intravenously administered drugs where compatibility has been established. may also be used for irrigation of wounds and moistening of wound dressings.

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

csl behring australia pty ltd - tetanus immunoglobulin, quantity: 4000 iu; human immunoglobulin g, quantity: 50 mg/ml - injection, intravenous infusion - excipient ingredients: maltose; water for injections; human immunoglobulin a - tetanus immunoglobulin-vf (for intravenous use) is used in the management of clinical tetanus.

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

bayer australia ltd - moxifloxacin, quantity: 1.6 mg/ml (equivalent: moxifloxacin hydrochloride, qty 1.744 mg/ml) - injection, intravenous infusion - excipient ingredients: hydrochloric acid; sodium chloride; water for injections; sodium hydroxide - avelox (moxifloxacin hydrochloride) tablets are indicated for the treatment of adults with infections caused by susceptible organisms in the conditions. acute bacterial sinusitis, community acquired pneumonia, acute exacerbations of chronic bronchitis. avelox iv (moxifloxacin hydrochloride) intravenous solutions are indicated for treatment of adults who require initial iv therapy for the treatment of infections in the conditions. community acquired pneumonia (caused by susceptible organisms). acute exacerbations of chronic bronchitis when caused by organisms bacteriologically proven to be resistant to other classes of antibiotics or when there is intolerance to other antibiotics. avelox iv (moxifloxacin hydrochloride) intravenous solutions are indicated for treatment of adults with severe and complicated skin and skin structure infections who require initial parenteral therapy, and who have intolerance to alternative agents. (especially penicillin allergy), and when caused by organisms known to be susceptible to moxifloxacin. appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to moxifloxacin. therapy with moxifloxacin may be initiated. in some conditions, before results of these tests are known. once results become available, therapy should be continued with the most appropriate antibiotic therapy.

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

bayer australia ltd - moxifloxacin, quantity: 1.6 mg/ml (equivalent: moxifloxacin hydrochloride, qty 1.744 mg/ml) - injection, intravenous infusion - excipient ingredients: water for injections; sodium chloride; sodium hydroxide; hydrochloric acid - avelox (moxifloxacin hydrochloride) tablets are indicated for the treatment of adults with infections caused by susceptible organisms in the conditions. acute bacterial sinusitis, community acquired pneumonia, acute exacerbations of chronic bronchitis. avelox iv (moxifloxacin hydrochloride) intravenous solutions are indicated for treatment of adults who require initial iv therapy for the treatment of infections in the conditions. community acquired pneumonia (caused by susceptible organisms). acute exacerbations of chronic bronchitis when caused by organisms bacteriologically proven to be resistant to other classes of antibiotics or when there is intolerance to other antibiotics. avelox iv (moxifloxacin hydrochloride) intravenous solutions are indicated for treatment of adults with severe and complicated skin and skin structure infections who require initial parenteral therapy, and who have intolerance to alternative agents. (especially penicillin allergy), and when caused by organisms known to be susceptible to moxifloxacin. appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to moxifloxacin. therapy with moxifloxacin may be initiated. in some conditions, before results of these tests are known. once results become available, therapy should be continued with the most appropriate antibiotic therapy.