New Zealand - English - Medsafe (Medicines Safety Authority)

aft pharmaceuticals ltd - cefazolin sodium 2.097 g equivalent to 2 g cefazolin - powder for injection - 2 g - active: cefazolin sodium 2.097 g equivalent to 2 g cefazolin - cefazolin-aft is indicated in the treatment of the following serious infections due to susceptible organisms: respiratory tract infection: due to s. pneumoniae, klebsiella sp, h. influenzae, staph, aureus (including penicillinase-producing strains), and group a ?-haemolytic streptococci. injectable penicillin g benzathine is considered to be the medicine of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. cefazolin-aft 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.

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

aft pharmaceuticals pty ltd - ropivacaine hydrochloride, quantity: 2 mg/ml - injection, intravenous infusion - excipient ingredients: sodium chloride; sodium hydroxide; hydrochloric acid; water for injections - analgesia (adults and children over 12 years of age) ? continuous epidural infusion or intermittent bolus epidural administration for analgesia in postoperative pain or labour pain (excluding intermittent top up injections) ? field block (minor nerve block and infiltration) ? continuous peripheral nerve block infusion or intermittent injections for post ? operative pain management ? continuous wound infusion for postoperative pain management (adults only) analgesia (children aged 0 - 12 years) ? continuous epidural infusion in infants (> 30 days and over 2500 g weight) and children up to and including 12 years,for peri- and postoperative pain management. there are no safety or efficacy data to support the use of ropivacaine-aft for analgesia for longer than 72 hours. (data for peripheral nerve block administered as a continuous peripheral infusion or intermittent injections and for continuous wound infusion support the use for up to 48 hours only).

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

aft pharmaceuticals pty ltd - ropivacaine hydrochloride, quantity: 2 mg/ml - injection, intravenous infusion - excipient ingredients: sodium chloride; sodium hydroxide; hydrochloric acid; water for injections - analgesia (adults and children over 12 years of age) ? continuous epidural infusion or intermittent bolus epidural administration for analgesia in postoperative pain or labour pain (excluding intermittent top up injections) ? field block (minor nerve block and infiltration) ? continuous peripheral nerve block infusion or intermittent injections for post ? operative pain management ? continuous wound infusion for postoperative pain management (adults only) analgesia (children aged 0 - 12 years) ? continuous epidural infusion in infants (> 30 days and over 2500 g weight) and children up to and including 12 years,for peri- and postoperative pain management. there are no safety or efficacy data to support the use of ropivacaine-aft for analgesia for longer than 72 hours. (data for peripheral nerve block administered as a continuous peripheral infusion or intermittent injections and for continuous wound infusion support the use for up to 48 hours only).

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

aft pharmaceuticals pty ltd - paracetamol, quantity: 10 mg/ml - injection, intravenous infusion - excipient ingredients: hydrochloric acid; cysteine hydrochloride monohydrate; dibasic sodium phosphate dihydrate; mannitol; nitrogen; water for injections; sodium hydroxide - paracetamol-aft 10mg/ml, solution for infusion is indicated for the relief of mild to moderate pain and the reduction of fever where an intravenous route of administration is considered clinically necessary.

New Zealand - English - Medsafe (Medicines Safety Authority)

aft pharmaceuticals ltd - tropisetron hydrochloride 1.13 mg/ml equivalent to tropisetron 1 mg/ml - solution for injection - 1 mg/ml - active: tropisetron hydrochloride 1.13 mg/ml equivalent to tropisetron 1 mg/ml excipient: acetic acid sodium acetate trihydrate sodium chloride water for injection - prevention of nausea and vomiting induced by cytoxic therapy (5mg/5ml ampoule only).

New Zealand - English - Medsafe (Medicines Safety Authority)

aft pharmaceuticals ltd - bortezomib 3.5mg (as a mannitol boronic ester) - powder for injection - 3.5 mg - active: bortezomib 3.5mg (as a mannitol boronic ester) excipient: mannitol - bortezomib-aft, in combination with melphalan and prednisone, is indicated for the treatment of patients with previously untreated multiple myeloma, who are not suitable for high dose chemotherapy. bortezomib-aft, as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma. bortezomib-aft is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease.

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

aft pharmaceuticals pty ltd - cefepime hydrochloride monohydrate, quantity: 595 mg (equivalent: cefepime, qty 500 mg) - injection, powder for - excipient ingredients: arginine - adults: cefepime-aft 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 ? empiric treatment in febrile neutropenic patients (see precautions) cefepime-aft 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-aft is indicated in paediatric patients over 2 months of age for the treatment of the infections listed below when caused by susceptible bacteria: ? pneumonia ? urinary tract infections, both complicated, including pyelonephritis, and uncomplicated infections ? skin and skin structure infections ? septicaemia ? empiric 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. empiric therapy with cefepime-aft 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-aft 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-aft. 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)

aft pharmaceuticals pty ltd - cefepime hydrochloride monohydrate, quantity: 2.378 g (equivalent: cefepime, qty 2 g) - injection, powder for - excipient ingredients: arginine - adults: cefepime-aft 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 ? empiric treatment in febrile neutropenic patients (see precautions) cefepime-aft 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-aft is indicated in paediatric patients over 2 months of age for the treatment of the infections listed below when caused by susceptible bacteria: ? pneumonia ? urinary tract infections, both complicated, including pyelonephritis, and uncomplicated infections ? skin and skin structure infections ? septicaemia ? empiric 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. empiric therapy with cefepime-aft 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-aft 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-aft. 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)

aft pharmaceuticals pty ltd - cefepime hydrochloride monohydrate, quantity: 1.189 g (equivalent: cefepime, qty 1 g) - injection, powder for - excipient ingredients: arginine - adults: cefepime-aft 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 ? empiric treatment in febrile neutropenic patients (see precautions) cefepime-aft 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-aft is indicated in paediatric patients over 2 months of age for the treatment of the infections listed below when caused by susceptible bacteria: ? pneumonia ? urinary tract infections, both complicated, including pyelonephritis, and uncomplicated infections ? skin and skin structure infections ? septicaemia ? empiric 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. empiric therapy with cefepime-aft 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-aft 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-aft. 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)

aft pharmaceuticals pty ltd - ceftriaxone sodium, quantity: 2.159 g (equivalent: ceftriaxone, qty 2 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.