Ireland - English - HPRA (Health Products Regulatory Authority)

pharmathen s.a. - meropenem trihydrate - pdr for soln inj/inf - 500 milligram - carbapenems - antibacterials for systemic use, carbapenems. - used for the treatment of the following infections in adults and children over 3 months of age:
pneumonia, including community acquired pneumonia and nosocomial pneumonia;
broncho-pulmonary infections in cystic fibrosis;
complicated urinary tract infections;
complicated intra-abdominal infections;
intra- and post-partum infections;
complicated skin and soft tissue infections;
acute bacterial meningitis.

Ireland - English - HPRA (Health Products Regulatory Authority)

laboratorios karizoo s.a. - amoxicillin trihydrate - powder for use in drinking water - 1000 milligram(s)/gram - amoxicillin - chickens, ducks, pigs, turkeys - antibacterial

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

merck sharp & dohme (australia) pty ltd - tazobactam sodium, quantity: 537 mg (equivalent: tazobactam, qty 500 mg); ceftolozane sulfate, quantity: 1147 mg (equivalent: ceftolozane, qty 1000 mg) - injection, powder for - excipient ingredients: arginine; sodium chloride; citric acid - zerbaxa (ceftolozane/tazobactam) is indicated for the treatment of the following infections in adults suspected or proven to be caused by designated susceptible microorganisms: - complicated intra-abdominal infections in combination with metronidazole - complicated urinary tract infections, including pyelonephritis - nosocomial pneumonia, including ventilator-associated pneumonia (vap),consideration should be given to published therapeutic guidelines on the appropriate use of antibacterial agents.

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.

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.

Ireland - English - HPRA (Health Products Regulatory Authority)

v.m.d. n.v/s.a. - amoxicillin trihydrate - powder for use in drinking water - 500 milligram(s)/gram - amoxicillin - chickens, ducks, pigs, turkeys - antibacterial

Israel - English - Ministry of Health

merck sharp & dohme (israel - 1996) company ltd, israel - ceftolozane as sulfate; tazobactam as sodium - powder for concentrate for solution for infusion - tazobactam as sodium 0.5 g; ceftolozane as sulfate 1 g - ceftolozane and enzyme inhibitor - zerbaxa is indicated for the treatment of the following infections in adults:-complicated intra abdominal infections;-acute pyelonephritis caused by pathogens resistant to other treatments as confirmed by urine culture-complicated urinary tract infections.-hospital-acquired pneumonia (hap), including ventilator-associated pneumonia (vap).consideration should be given to official guidance on the appropriate use of antibacterial agents

European Union - English - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - imipenem monohydrate, cilastatin sodium, relebactam monohydrate - gram-negative bacterial infections - carbapenems, antibacterials for systemic use, - recarbrio is indicated for:- treatment of hospital-acquired pneumonia (hap), including ventilator associated pneumonia (vap), in adults (see sections 4.4 and 5.1).- treatment of bacteraemia that occurs in association with, or is suspected to be associated with hap or vap, in adults.- treatment of infections due to aerobic gram-negative organisms in adults with limited treatment options (see sections 4.2, 4.4, and 5.1).consideration should be given to official guidance on the appropriate use of antibacterial agents.

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

generics & specialities limited, tanzania - amoxicillin - capsules - 500