Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - dicloxacillin sodium, quantity: 271.2 mg (equivalent: dicloxacillin, qty 250 mg) - capsule, hard - excipient ingredients: gelatin; purified water; titanium dioxide; colloidal anhydrous silica; magnesium stearate; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - treatment of confirmed or suspected staphylococcal and other gram positive coccal infections, including skin and skin structure and wound infections, infected burns, cellulitis, osteomyelitis and pneumonia (note: benzylpenicillin is the drug of choice for the treatment of streptococcal pneumonia).,bacteriological studies should be performed to determine the causative organisms and their susceptibility to dicloxacillin. dicloxacillin has less intrinsic antibacterial activity and a narrower spectrum than benzylpenicillin. dicloxacillin should therefore not be used in infections due to organisms susceptible to benzylpenicillin.,important note: when it is judged necessary that treatment is initiated before definitive culture and sensitivity results are known, if the microbiology report later indicates that the infection is due to an organism other than a benzylpenicillin resistant staphylococcus sensitive to dicloxacillin, the physician is advised to continue therapy with a drug other than dicloxacillin or any other penicillinase-resistant penicillin

Spojené štáty - angličtina - NLM (National Library of Medicine)

sandoz inc - oxacillin sodium (unii: g0v6c994q5) (oxacillin - unii:uh95vd7v76) - oxacillin is indicated in the treatment of infections caused by penicillinase producing staphylococci which have demonstrated susceptibility to the drug. cultures and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug. (see clinical pharmacology: susceptibility test methods ). oxacillin may be used to initiate therapy in suspected cases of resistant staphylococcal infections prior to the availability of susceptibility test results. oxacillin should not be used in infections caused by organisms susceptible to penicillin g. if the susceptibility tests indicate that the infection is due to an organism other than a resistant staphylococcus , therapy should not be continued with oxacillin. to reduce the development of drug-resistant bacteria and maintain the effectiveness of oxacillin for injection, usp and other antibacterial drugs, oxacillin for injection, usp should be used only to treat or prevent infections that are proven or strongly susp

Írsko - angličtina - HPRA (Health Products Regulatory Authority)

teva pharma b.v. - piperacillin sodium, tazobactam (as sodium salt) - pdr for soln for infusion - 4g/500 milligram - combinations of penicillins, incl. beta-lactamase inhibitors

Írsko - angličtina - HPRA (Health Products Regulatory Authority)

ibigen srl - flucloxacillin sodium - powder for solution for injection/infusion - 500 milligram(s) - beta-lactamase resistant penicillins; flucloxacillin

Spojené štáty - angličtina - NLM (National Library of Medicine)

wg critical care, llc - piperacillin sodium (unii: m98t69q7hp) (piperacillin anhydrous - unii:9i628532gx), tazobactam sodium (unii: uxa545abtt) (tazobactam - unii:se10g96m8w) - piperacillin anhydrous 3 g in 15 ml - piperacillin and tazobactam for injection is indicated in adults and pediatric patients (2 months of age and older) for the treatment of appendicitis (complicated by rupture or abscess) and peritonitis caused by beta-lactamase producing isolates of escherichia coli or the following members of the bacteroides fragilis group: b. fragilis , b. ovatus , b. thetaiotaomicron , or b. vulgatus . piperacillin and tazobactam for injection is indicated in adults and pediatric patients (2 months of age and older) for the treatment of nosocomial pneumonia (moderate to severe) caused by beta-lactamase producing isolates of staphylococcus aureus and by piperacillin and tazobactam-susceptible acinetobacter baumannii , haemophilus influenzae , klebsiella pneumoniae , and pseudomonas aeruginosa (nosocomial pneumonia caused by p. aeruginosa should be treated in combination with an aminoglycoside) [see dosage and administration (2)] . piperacillin and tazobactam for injection is indicated in adults for the treatment of uncomplicated and complicated skin and skin structure infections, including cellulitis, cutaneous abscesses and ischemic/diabetic foot infections caused by beta-lactamase producing isolates of staphylococcus aureus . piperacillin and tazobactam for injection is indicated in adults for the treatment of postpartum endometritis or pelvic inflammatory disease caused by beta-lactamase producing isolates of escherichia coli . piperacillin and tazobactam for injection is indicated in adults for the treatment of community-acquired pneumonia (moderate severity only) caused by beta-lactamase producing isolates of haemophilus influenzae . to reduce the development of drug-resistant bacteria and maintain the effectiveness of piperacillin and tazobactam for injection and other antibacterial drugs, piperacillin and tazobactam for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.  when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. piperacillin and tazobactam for injection is contraindicated in patients with a history of allergic reactions to any of the penicillins, cephalosporins, or beta-lactamase inhibitors. risk summary piperacillin and tazobactam cross the placenta in humans. however, there are insufficient data with piperacillin and/or tazobactam in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. no fetal structural abnormalities were observed in rats or mice when piperacillin and tazobactam was administered intravenously during organogenesis at doses 1 to 2 times and 2 to 3 times the human dose of piperacillin and tazobactam, respectively, based on body-surface area (mg/m2 ). however, fetotoxicity in the presence of maternal toxicity was observed in developmental toxicity and peri/postnatal studies conducted in rats (intraperitoneal administration prior to mating and throughout gestation or from gestation day 17 through lactation day 21) at doses less than the maximum recommended human daily dose based on body-surface area (mg/m2 ) [see data]. the background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data in embryo-fetal development studies in mice and rats, pregnant animals received intravenous doses of piperacillin/tazobactam up to 3000/750 mg/kg/day during the period of organogenesis. there was no evidence of teratogenicity up to the highest dose evaluated, which is 1 to 2 times and 2 to 3 times the human dose of piperacillin and tazobactam, in mice and rats respectively, based on body-surface area (mg/m2). fetal body weights were reduced in rats at maternally toxic doses at or above 500/62.5 mg/kg/day, minimally representing 0.4 times the human dose of both piperacillin and tazobactam based on body-surface area (mg/m2 ). a fertility and general reproduction study in rats using intraperitoneal administration of tazobactam or the combination piperacillin and tazobactam prior to mating and through the end of gestation, reported a decrease in litter size in the presence of maternal toxicity at 640 mg/kg/day tazobactam (4 times the human dose of tazobactam based on body-surface area), and decreased litter size and an increase in fetuses with ossification delays and variations of ribs, concurrent with maternal toxicity at ≥640/160 mg/kg/day piperacillin and tazobactam (0.5 times and 1 times the human dose of piperacillin and tazobactam, respectively, based on body-surface area). peri/postnatal development in rats was impaired with reduced pup weights, increased stillbirths, and increased pup mortality concurrent with maternal toxicity after intraperitoneal administration of tazobactam alone at doses ≥320 mg/kg/day (2 times the human dose based on body surface area) or of the combination piperacillin and tazobactam at doses ≥640/160 mg/kg/ day (0.5 times and 1 times the human dose of piperacillin and tazobactam, respectively, based on body-surface area) from gestation day 17 through lactation day 21. risk summary piperacillin is excreted in human milk; tazobactam concentrations in human milk have not been studied. no information is available on the effects of piperacillin and tazobactam on the breast-fed child or on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for piperacillin and tazobactam for injection and any potential adverse effects on the breastfed child from piperacillin and tazobactam for injection or from the underlying maternal condition. the safety and effectiveness of piperacillin and tazobactam for injection for intra-abdominal infections, and nosocomial pneumonia have been established in pediatric patients 2 months of age and older. use of piperacillin and tazobactam for injection in pediatric patients 2 months of age and older with intra-abdominal infections including appendicitis and/or peritonitis is supported by evidence from well-controlled studies and pharmacokinetic studies in adults and in pediatric patients. this includes a prospective, randomized, comparative, open-label clinical trial with 542 pediatric patients 2 to 12 years of age with intra-abdominal infections (including appendicitis and/or peritonitis), in which 273 pediatric patients received piperacillin and tazobactam [see adverse reactions ( 6.1) and clinical pharmacology (12.3)] . use of piperacillin and tazobactam for injection in pediatric patients 2 months of age and older with nosocomial pneumonia is supported by evidence from well-controlled studies in adults with nosocomial pneumonia, a simulation study performed with a population pharmacokinetic model, and a retrospective, cohort study of pediatric patients with nosocomial pneumonia in which 140 pediatric patients were treated with piperacillin and tazobactam for injection and 267 patients treated with comparators (which included ticarcillin-clavulanate, carbapenems, ceftazidime, cefepime, or ciprofloxacin) [see adverse reactions ( 6.1) and clinical pharmacology (12.3)]. the safety and effectiveness of piperacillin and tazobactam for injection have not been established in pediatric patients less than 2 months of age [see clinical pharmacology ( 12) and dosage and administration (2)] . dosage of piperacillin and tazobactam for injection in pediatric patients with renal impairment has not been determined. patients over 65 years are not at an increased risk of developing adverse effects solely because of age.  however, dosage should be adjusted in the presence of renal impairment [see dosage and administration (2) ]. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. piperacillin and tazobactam for injection contains 54 mg (2.35 meq) of sodium per gram of piperacillin in the combination product.  at the usual recommended doses, patients would receive between 648 and 864 mg/day (28.2 and 37.6 meq) of sodium.  the geriatric population may respond with a blunted natriuresis to salt loading.  this may be clinically important with regard to such diseases as congestive heart failure. this drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function.  because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. in patients with creatinine clearance ≤ 40 ml/min and dialysis patients (hemodialysis and capd), the intravenous dose of piperacillin and tazobactam for injection should be reduced to the degree of renal function impairment [see dosage and administration (2) ]. dosage adjustment of piperacillin and tazobactam for injection is not warranted in patients with hepatic cirrhosis [see clinical pharmacology (12.3 )]. as with other semisynthetic penicillins, piperacillin therapy has been associated with an increased incidence of fever and rash in cystic fibrosis patients.

Spojené štáty - angličtina - NLM (National Library of Medicine)

mitim s.r.l. - piperacillin sodium (unii: m98t69q7hp) (piperacillin anhydrous - unii:9i628532gx), tazobactam sodium (unii: uxa545abtt) (tazobactam - unii:se10g96m8w) - piperacillin anhydrous 2 g in 10 ml - piperacillin and tazobactam for injection, usp is a combination product consisting of a penicillin-class antibacterial, piperacillin, and a β-lactamase inhibitor, tazobactam, indicated for the treatment of patients with moderate to severe infections caused by susceptible isolates of the designated bacteria in the conditions listed below. appendicitis (complicated by rupture or abscess) and peritonitis caused by β-lactamase producing isolates of escherichia coli or the following members of the bacteroides fragilis group: b. fragilis , b. ovatus , b. thetaiotaomicron , or b. vulgatus . the individual members of this group were studied in fewer than 10 cases. uncomplicated and complicated skin and skin structure infections, including cellulitis, cutaneous abscesses and ischemic/diabetic foot infections caused by β-lactamase producing isolates of staphylococcus aureus . postpartum endometritis or pelvic inflammatory disease caused by β-lactamase producing isolates of escherichia coli . community-acquired pneumo

Spojené štáty - angličtina - NLM (National Library of Medicine)

mitim s.r.l. - oxacillin sodium (unii: g0v6c994q5) (oxacillin - unii:uh95vd7v76) - oxacillin is indicated in the treatment of infections caused by penicillinase producing staphylococci which have demonstrated susceptibility to the drug. cultures and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug. (see clinical pharmacology: susceptibility test methods ). oxacillin may be used to initiate therapy in suspected cases of resistant staphylococcal infections prior to the availability of susceptibility test results. oxacillin should not be used in infections caused by organisms susceptible to penicillin g. if the susceptibility tests indicate that the infection is due to an organism other than a resistant staphylococcus , therapy should not be continued with oxacillin. to reduce the development of drug-resistant bacteria and maintain the effectiveness of oxacillin for injection, usp and other antibacterial drugs, oxacillin for injection, usp should be used only to treat or prevent infections that are proven or strongly susp

Izrael - angličtina - Ministry of Health

a.l. medi-market ltd. - cloxacillin as sodium - powder for solution for inj/inf - cloxacillin as sodium 500 mg/vial - cloxacillin - cloxacillin is indicated for the treatment of sensitive staphylococcal infections:respiratory infections, otorhinolaryngologic infections, renal infections, urogenital infections, neuro-meningeal infections, bone and joint infections, endocarditis, and treatment of skin infections caused by sensitive staphylococci and/or streptococci.cloxacillin is also indicated as preventive treatment of postoperative infections in neurosurgery.

Spojené štáty - angličtina - NLM (National Library of Medicine)

wockhardt usa llc. - oxacillin sodium (unii: g0v6c994q5) (oxacillin - unii:uh95vd7v76) - oxacillin is indicated in the treatment of infections caused by penicillinase producing staphylococci which have demonstrated susceptibility to the drug. cultures and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug. (see clinical pharmacology: susceptibility test methods ). oxacillin may be used to initiate therapy in suspected cases of resistant staphylococcal infections prior to the availability of susceptibility test results. oxacillin should not be used in infections caused by organisms susceptible to penicillin g. if the susceptibility tests indicate that the infection is due to an organism other than a resistant staphylococcus , therapy should not be continued with oxacillin. to reduce the development of drug-resistant bacteria and maintain the effectiveness of oxacillin for injection, usp and other antibacterial drugs, oxacillin for injection, usp should be used only to treat or prevent infections that are proven or stron

Spojené kráľovstvo - angličtina - MHRA (Medicines & Healthcare Products Regulatory Agency)

milpharm ltd - clarithromycin - oral tablet - 500mg