Australien - engelska - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - ceftriaxone sodium, quantity: 1193 mg (equivalent: ceftriaxone, qty 1000 mg) - injection, powder for - excipient ingredients: - ceftriaxone viatris is indicated for the treatment of the following infections when caused by susceptible aerobic organisms: lower respiratory tract infections caused by s. pneumoniae, streptococcus species (excluding enterococci), methicillin sensitive s. aureus, h. influenzae, h. parainfluenzae, klebsiella species (including k. pneumoniae), e. coli, e. aerogenes, proteus mirabilis and serratia marcescens. . skin and skin structure infections caused by methicillin sensitive s. aureus, methicillin sensitive s. epidermidis, streptococcus group b, streptococcus group g, streptococcus pyogenes, streptococcus viridans, streptococcus species (excluding enterococci), peptostreptococcus species, e. coli, e. cloacae, klebsiella species (including k. pneumoniae, k. oxytoca), proteus mirabilis, morganella morganii, serratia marcescens. . urinary tract infections (complicated and uncomplicated) caused by e. coli, proteus mirabilis, proteus vulgaris, m. morganii and klebsiella species (including k. pneumoniae). uncomplicated gonorrhoea (cervical/urethral and rectal) caused by neisseria gonorrhoea, including both penicillinase and non penicillinase producing strains. bacterial septicemia caused by s. pneumoniae, e. coli and h. influenzae. . bone infections caused by methicillin sensitive s. aureus, methicillin sensitive s. epidermidis, streptococcus group b, s. pneumoniae, streptococcus species (excluding enterococci), e. coli, enterobacter species, p. mirabilis and k. pneumoniae. joint infections caused by methicillin sensitive s. aureus, s. pneumoniae, streptococcus species (excluding enterococci), e. coli, p. mirabilis, k. pneumoniae and enterobacter species. meningitis: the initial treatment, as a single agent, of meningitis in children and immunocompetent adults when presumed or proven to be caused by haemophilus influenzae type b, neisseria meningitidis, streptococcus pneumoniae or enterobacteriaceae pending culture and sensitivity results. surgical prophylaxis: the preoperative administration of a single 1 g dose of ceftriaxone may reduce the incidence of post-operative infections in patients undergoing vaginal or abdominal hysterectomy or cholecystectomy in high risk patients, surgical procedures which are classified as contaminated or potentially contaminated and patients undergoing coronary artery bypass surgery. although ceftriaxone has been shown to have been as effective as cefazolin in the prevention of infection following coronary artery bypass surgery, no placebo-controlled trials have been conducted. susceptibility testing: before instituting treatment with ceftriaxone, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. therapy may be instituted prior to obtaining results of susceptibility testing.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - ceftriaxone sodium, quantity: 2386 mg (equivalent: ceftriaxone, qty 2000 mg) - injection, powder for - excipient ingredients: - ceftriaxone viatris is indicated for the treatment of the following infections when caused by susceptible aerobic organisms: lower respiratory tract infections caused by s. pneumoniae, streptococcus species (excluding enterococci), methicillin sensitive s. aureus, h. influenzae, h. parainfluenzae, klebsiella species (including k. pneumoniae), e. coli, e. aerogenes, proteus mirabilis and serratia marcescens. skin and skin structure infections caused by methicillin sensitive s. aureus, methicillin sensitive s. epidermidis, streptococcus group b, streptococcus group g, streptococcus pyogenes, streptococcus viridans, streptococcus species (excluding enterococci), peptostreptococcus species, e. coli, e. cloacae, klebsiella species (including k. pneumoniae, k. oxytoca), proteus mirabilis, morganella morganii, serratia marcescens. urinary tract infections (complicated and uncomplicated) caused by e. coli, proteus mirabilis, proteus vulgaris, m. morganii and klebsiella species (including k. pneumoniae). uncomplicated gonorrhoea (cervical/urethral and rectal) caused by neisseria gonorrhoea, including both penicillinase and non penicillinase producing strains. bacterial septicemia caused by s. pneumoniae, e. coli and h. influenzae. . bone infections caused by methicillin sensitive s. aureus, methicillin sensitive s. epidermidis, streptococcus group b, s. pneumoniae, streptococcus species (excluding enterococci), e. coli, enterobacter species, p. mirabilis and k. pneumoniae. joint infections caused by methicillin sensitive s. aureus, s. pneumoniae, streptococcus species (excluding enterococci), e. coli, p. mirabilis, k. pneumoniae and enterobacter species. meningitis: the initial treatment, as a single agent, of meningitis in children and immunocompetent adults when presumed or proven to be caused by haemophilus influenzae type b, neisseria meningitidis, streptococcus pneumoniae or enterobacteriaceae pending culture and sensitivity results. surgical prophylaxis: the preoperative administration of a single 1 g dose of ceftriaxone may reduce the incidence of post-operative infections in patients undergoing vaginal or abdominal hysterectomy or cholecystectomy in high risk patients, surgical procedures which are classified as contaminated or potentially contaminated and patients undergoing coronary artery bypass surgery. although ceftriaxone has been shown to have been as effective as cefazolin in the prevention of infection following coronary artery bypass surgery, no placebo-controlled trials have been conducted. . susceptibility testing: before instituting treatment with ceftriaxone, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. therapy may be instituted prior to obtaining results of susceptibility testing.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

seqirus pty ltd - ferric carboxymaltose, quantity: 1800 mg (equivalent: iron, qty 500 mg) - injection, solution - excipient ingredients: sodium hydroxide; hydrochloric acid; water for injections - ferinject is indicated for the treatment of iron deficiency in adults and adolescents aged 14 years and older when:,? oral iron preparations are ineffective ? oral iron preparations cannot be used ? there is a clinical need to deliver iron rapidly,the diagnosis of iron deficiency must be based on laboratory tests.,ferinject is indicated for the treatment of iron deficiency anaemia in children aged 1 to 13 years when:,? oral iron preparations are ineffective ? oral iron preparations cannot be used,the diagnosis of iron deficiency anaemia must be based on laboratory tests.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

seqirus pty ltd - ferric carboxymaltose, quantity: 360 mg (equivalent: iron, qty 100 mg) - injection, solution - excipient ingredients: sodium hydroxide; hydrochloric acid; water for injections - ferinject is indicated for the treatment of iron deficiency in adults and adolescents aged 14 years and older when:,? oral iron preparations are ineffective ? oral iron preparations cannot be used ? there is a clinical need to deliver iron rapidly,the diagnosis of iron deficiency must be based on laboratory tests.,ferinject is indicated for the treatment of iron deficiency anaemia in children aged 1 to 13 years when:,? oral iron preparations are ineffective ? oral iron preparations cannot be used,the diagnosis of iron deficiency anaemia must be based on laboratory tests.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - midazolam, quantity: 50 mg - injection, solution - excipient ingredients: sodium chloride; water for injections; hydrochloric acid; sodium hydroxide - intravenously (iv) as an agent for: . - conscious sedation prior to short surgical, diagnostic, therapeutic or endoscopic procedures such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography and cardiac catheterisation, either alone or in conjunction with an opioid . - induction of anaesthesia preliminary to administration of other anaesthetic agents. with the use of an opioid premedicant, induction of anaesthesia can be attained with a narrower dose range and in a shorter period of time. .,intermittent iv administration or continuous infusion for: . - sedation in intensive care units, intermittent administration or continuous infusion.,intramuscularly (im) for: . - preoperative sedation (induction of sleepiness or drowsiness and relief of apprehension) and to impair memory of perioperative events

Australien - engelska - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - midazolam, quantity: 5 mg - injection, solution - excipient ingredients: sodium hydroxide; hydrochloric acid; water for injections; sodium chloride - intravenously (iv) as an agent for: . - conscious sedation prior to short surgical, diagnostic, therapeutic or endoscopic procedures such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography and cardiac catheterisation, either alone or in conjunction with an opioid . - induction of anaesthesia preliminary to administration of other anaesthetic agents. with the use of an opioid premedicant, induction of anaesthesia can be attained with a narrower dose range and in a shorter period of time. .,intermittent iv administration or continuous infusion for: . - sedation in intensive care units, intermittent administration or continuous infusion.,intramuscularly (im) for: . - preoperative sedation (induction of sleepiness or drowsiness and relief of apprehension) and to impair memory of perioperative events

Australien - engelska - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - midazolam, quantity: 5 mg - injection, solution - excipient ingredients: water for injections; sodium chloride; sodium hydroxide; hydrochloric acid - intravenously (iv) as an agent for: . - conscious sedation prior to short surgical, diagnostic, therapeutic or endoscopic procedures such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography and cardiac catheterisation, either alone or in conjunction with an opioid . - induction of anaesthesia preliminary to administration of other anaesthetic agents. with the use of an opioid premedicant, induction of anaesthesia can be attained with a narrower dose range and in a shorter period of time. .,intermittent iv administration or continuous infusion for: . - sedation in intensive care units, intermittent administration or continuous infusion.,intramuscularly (im) for: . - preoperative sedation (induction of sleepiness or drowsiness and relief of apprehension) and to impair memory of perioperative events

Australien - engelska - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - midazolam, quantity: 15 mg - injection, solution - excipient ingredients: water for injections; hydrochloric acid; sodium hydroxide; sodium chloride - intravenously (iv) as an agent for: . - conscious sedation prior to short surgical, diagnostic, therapeutic or endoscopic procedures such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography and cardiac catheterisation, either alone or in conjunction with an opioid . - induction of anaesthesia preliminary to administration of other anaesthetic agents. with the use of an opioid premedicant, induction of anaesthesia can be attained with a narrower dose range and in a shorter period of time. .,intermittent iv administration or continuous infusion for: . - sedation in intensive care units, intermittent administration or continuous infusion.,intramuscularly (im) for: . - preoperative sedation (induction of sleepiness or drowsiness and relief of apprehension) and to impair memory of perioperative events

Australien - engelska - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - enoxaparin sodium -

Australien - engelska - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - ramipril, quantity: 10 mg - tablet, uncoated - excipient ingredients: sodium bicarbonate; lactose monohydrate; pregelatinised maize starch; sodium stearylfumarate; croscarmellose sodium - treatment of hypertension. data are currently not available to support the use of tryzan tabs in renovascular hypertension. post myocardial infarction heart failure. prevention of progressive renal failure in patients with persistent proteinuria in excess of 1 g/day. for reducing the risk of myocardial infarction, stroke, cardiovascular death or the need for revascularisation procedures in patients 55 years of age or more who have clinical evidence of coronary artery disease, stroke, or peripheral vascular disease. for reducing the risk of myocardial infarction, stroke, cardiovascular death or revascularisation procedures in diabetic patients 55 years or more with one or more of the following risk factors: systolic blood pressure >160 mmhg or diastolic blood pressure >90 mmhg (or on antihypertensive treatment); total cholesterol >5.2 mmol/l; hdl cholesterol <0.9 mmol/l; current smoker; known microalbuminuria; any evidence of previous vascular disease.