Estados Unidos - inglés - NLM (National Library of Medicine)

wyeth piperacillin division of wyeth holdings corporation, a subsidiary of pfizer - tazobactam sodium (unii: uxa545abtt) (tazobactam - unii:se10g96m8w), piperacillin sodium (unii: m98t69q7hp) (piperacillin anhydrous - unii:9i628532gx) - tazobactam 4.5 g in 180 ml - zosyn (piperacillin and tazobactam for injection, usp) is indicated for the treatment of patients with moderate to severe infections caused by piperacillin-resistant, piperacillin/tazobactam-susceptible, β-lactamase producing strains of the designated microorganisms in the specified conditions listed below: appendicitis (complicated by rupture or abscess) and peritonitis caused by piperacillin-resistant, β‑lactamase producing strains 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 less than 10 cases. uncomplicated and complicated skin and skin structure infections, including cellulitis, cutaneous abscesses, and ischemic/diabetic foot infections caused by piperacillin-resistant, β‑lactamase producing strains of staphylococcus aureus . postpartum endometritis or pelvic inflammatory disease caused by piperacillin-resistant, β‑lactamase producing strains of escher

Estados Unidos - inglés - NLM (National Library of Medicine)

wyeth pharmaceuticals inc., a subsidiary of pfizer inc. - piperacillin sodium (unii: m98t69q7hp) (piperacillin anhydrous - unii:9i628532gx), tazobactam sodium (unii: uxa545abtt) (tazobactam - unii:se10g96m8w) - piperacillin anhydrous 2 g in 50 ml - zosyn is indicated for the treatment of patients with moderate to severe infections caused by piperacillin-resistant, piperacillin/tazobactam-susceptible, β-lactamase producing strains of the designated microorganisms in the specified conditions listed below: appendicitis (complicated by rupture or abscess) and peritonitis caused by piperacillin-resistant, β‑lactamase producing strains 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 less than 10 cases. uncomplicated and complicated skin and skin structure infections, including cellulitis, cutaneous abscesses, and ischemic/diabetic foot infections caused by piperacillin-resistant, β‑lactamase producing strains of staphylococcus aureus . postpartum endometritis or pelvic inflammatory disease caused by piperacillin-resistant, β‑lactamase producing strains of escherichia coli . community-acquired pneumonia (modera

Estados Unidos - inglés - NLM (National Library of Medicine)

wyeth pharmaceuticals inc., a subsidiary of pfizer inc. - tazobactam sodium (unii: uxa545abtt) (tazobactam - unii:se10g96m8w), piperacillin sodium (unii: m98t69q7hp) (piperacillin anhydrous - unii:9i628532gx) - tazobactam 4.5 g in 180 ml - zosyn (piperacillin and tazobactam for injection, usp) is indicated for the treatment of patients with moderate to severe infections caused by piperacillin-resistant, piperacillin/tazobactam-susceptible, β-lactamase producing strains of the designated microorganisms in the specified conditions listed below: appendicitis (complicated by rupture or abscess) and peritonitis caused by piperacillin-resistant, β-lactamase producing strains 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 less than 10 cases. uncomplicated and complicated skin and skin structure infections, including cellulitis, cutaneous abscesses, and ischemic/diabetic foot infections caused by piperacillin-resistant, β-lactamase producing strains of staphylococcus aureus . postpartum endometritis or pelvic inflammatory disease caused by piperacillin-resistant, β-lactamase producing strains of escher

Estados Unidos - inglés - NLM (National Library of Medicine)

wyeth pharmaceuticals llc, a subsidiary of pfizer inc. - tazobactam sodium (unii: uxa545abtt) (tazobactam - unii:se10g96m8w), piperacillin sodium (unii: m98t69q7hp) (piperacillin anhydrous - unii:9i628532gx) - tazobactam 0.375 g in 15 ml - zosyn 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 . zosyn 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/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)] . zosyn is indicated in adults for the treatment of uncomplicated and complicated skin and skin structure infections, including cellulitis, cutaneous abscesses and i

Estados Unidos - inglés - NLM (National Library of Medicine)

wyeth pharmaceuticals llc, a subsidiary of pfizer inc. - tazobactam sodium (unii: uxa545abtt) (tazobactam - unii:se10g96m8w), piperacillin sodium (unii: m98t69q7hp) (piperacillin anhydrous - unii:9i628532gx) -       zosyn 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 . zosyn 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)] . zosyn is indicated in adults for the treatment of uncomplicated and complicated skin and skin structure infections, including cellulitis, cutaneous abscesse

Estados Unidos - inglés - NLM (National Library of Medicine)

baxter healthcare corporation - piperacillin sodium (unii: m98t69q7hp) (piperacillin anhydrous - unii:9i628532gx), tazobactam sodium (unii: uxa545abtt) (tazobactam - unii:se10g96m8w) - zosyn 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 . zosyn 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)] . zosyn 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 . zosyn is indicated in adults for the treatment of postpartum endometritis or pelvic inflammatory disease caused by beta-lactamase producing isolates of escherichia coli . zosyn 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 zosyn and other antibacterial drugs, zosyn 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. zosyn 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 2-4% and 15-20%, respectively. data animal data in embryo-fetal development studies in mice and rats, pregnant animals received intravenous doses of piperacillin and 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 zosyn and any potential adverse effects on the breastfed child from zosyn or from the underlying maternal condition. the safety and effectiveness of zosyn for intra-abdominal infections, and nosocomial pneumonia have been established in pediatric patients 2 months of age and older. use of zosyn 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 zosyn 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 zosyn 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)]. because of the limitations of the available strengths and administration requirements (i.e., administration of fractional doses is not recommended) of zosyn injection supplied in galaxy containers, and to avoid unintentional overdose, this product is not recommended for use if a dose of zosyn injection in galaxy containers that does not equal 2.25 g, 3.375 g, or 4.5 g is required and an alternative formulation of zosyn should be considered [see dosage and administration (2.1, 2.5, and 2.6)] . the safety and effectiveness of zosyn have not been established in pediatric patients less than 2 months of age [see clinical pharmacology (12) and dosage and administration (2)] . dosage of zosyn 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. zosyn contains 65 mg (2.84 meq) of sodium per gram of piperacillin in the combination product. at the usual recommended doses, patients would receive between 780 and 1040 mg/day (34.1 and 45.5 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 zosyn should be reduced to the degree of renal function impairment [see dosage and administration (2)] . dosage adjustment of zosyn 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.

Australia - inglés - APVMA (Australian Pesticides and Veterinary Medicines Authority)

basf australia ltd. - afidopyropen - dispersible concentrate - afidopyropen active 100.0 g/l - insecticide

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

neoss australia pty ltd - 58503 - pliable-polymer dental regeneration membrane, tacked - neoss neogen membrane is an implantable temporary non-resorbable device (membrane) for use as a spacer creation barrier in the treatment of local defects in the oral cavity in conjunction with tissue regeneration or augmentation. neoss membranes are intended to be submerged and clinically implanted more than 30 days with an expected duration of implantation of three to nine months or until bone regeneration is complete.

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

zimmer biomet pty ltd - 33178 - revision uncoated hip femur prosthesis - the femoral stem is manufactured from zimaloy? cobalt-chromium-molybdenum alloy and is for cemented use. a collar at the base of the neck has two screw holes for attaching the build-up block to the stem. holes along the proximal portion of the stem may be used for soft tissue attachment. modular connection of the femoral stem is a morse-type 12/14 taper designed to mate with the corresponding bore of a femoral head component. the versys crc hip system is indicated for total hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck, or portions of the proximal femur. arthroplasty should be performed only when more conservative methods of treatment have failed to provide symptomatic relief and when there is progressive disability.

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

zimmer biomet pty ltd - 59688 - femoral head/stem prosthesis adaptor - the versys endo femoral head adaptor is used if a longer neck configuration is needed. the head adaptor is made from zimaloy alloy and employs a 12/14 taper. longer neck lengths are achieved by attaching the corresponding adaptor onto the stem taper. then placing the head on the adaptor. the adaptors are designed not to attach to the standard femoral heads. the versys endoprosthesis femoral head adaptor is a modular component used with the endo femoral head, in hemi-hip arthroplasty, when a longer neck configuration is needed.