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

aft pharmaceuticals pty ltd - ceftriaxone sodium, quantity: 1.079 g (equivalent: ceftriaxone, qty 1 g) - injection, powder for - excipient ingredients: - 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.

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

aft pharmaceuticals pty ltd - ceftriaxone sodium, quantity: 539 mg (equivalent: ceftriaxone, qty 500 mg) - injection, powder for - excipient ingredients: - 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.

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

aft pharmaceuticals pty ltd - granisetron hydrochloride, quantity: 3.36 mg (equivalent: granisetron, qty 3 mg) - injection, concentrated - excipient ingredients: water for injections; sodium chloride; nitrogen; citric acid monohydrate; sodium citrate dihydrate - granisetron injection is indicated in:,adults: - for the prevention and treatment of nausea and vomiting induced by cytotoxic chemotherapy - for the prevention of nausea and vomiting induced by radiotherapy,children: - for the prevention of nausea and vomiting induced by cytotoxic chemotherapy

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

aft pharmaceuticals pty ltd - granisetron hydrochloride, quantity: 1.12 mg (equivalent: granisetron, qty 1 mg) - injection, concentrated - excipient ingredients: water for injections; sodium chloride; nitrogen; sodium citrate dihydrate; citric acid monohydrate - granisetron injection is indicated in:,adults: - for the prevention and treatment of nausea and vomiting induced by cytotoxic chemotherapy - for the prevention of nausea and vomiting induced by radiotherapy,children: - for the prevention of nausea and vomiting induced by cytotoxic chemotherapy

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

aft pharmaceuticals pty ltd - cefazolin sodium, quantity: 2.097 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. cefazolin is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of cefazolin 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 cefazolin

New Zealand - English - Medsafe (Medicines Safety Authority)

aft pharmaceuticals ltd - enoxaparin sodium 100 mg/ml;   - solution for injection - 100 mg/ml - active: enoxaparin sodium 100 mg/ml   excipient: water for injection - treatment of venous thromboembolic disease.

New Zealand - English - Medsafe (Medicines Safety Authority)

aft pharmaceuticals ltd - enoxaparin sodium 150 mg/ml;   - solution for injection - 150 mg/ml - active: enoxaparin sodium 150 mg/ml   excipient: water for injection - treatment of venous thromboembolic disease.

New Zealand - English - Medsafe (Medicines Safety Authority)

aft pharmaceuticals ltd - calcitriol 0.25ug;   - liquid filled capsule - 0.25 mcg - active: calcitriol 0.25ug   excipient: ascorbyl palmitate butylated hydroxyanisole gelatin glycerol iron oxide red medium-chain triglycerides sodium ethyl hydroxybenzoate sodium propyl hydroxybenzoate sorbitol titanium dioxide - - established postmenopausal osteoporosis.

New Zealand - English - Medsafe (Medicines Safety Authority)

aft pharmaceuticals ltd - calcitriol 0.5ug;   - liquid filled capsule - 0.5 mcg - active: calcitriol 0.5ug   excipient: ascorbyl palmitate butylated hydroxyanisole gelatin glycerol iron oxide red iron oxide yellow medium-chain triglycerides sodium ethyl hydroxybenzoate sodium propyl hydroxybenzoate sorbitol titanium dioxide - - established postmenopausal osteoporosis.

New Zealand - English - Medsafe (Medicines Safety Authority)

aft pharmaceuticals ltd - imatinib mesilate 119.47mg equivalent to imatinib 100 mg;   - capsule - 100 mg - active: imatinib mesilate 119.47mg equivalent to imatinib 100 mg   excipient: crospovidone gelatin iron oxide red iron oxide yellow lactose monohydrate magnesium stearate titanium dioxide - treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive chronic myeloid leukaemia (ph+cml). treatment of adult and paediatic patients with ph+cml in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy.