Australien - engelsk - Department of Health (Therapeutic Goods Administration)

resmed pty ltd - 36862 - patient monitor module, interface - patient monitoring system

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

hill-rom pty ltd - 15325 - patient positioning device, vacuum stabilized, partial body - patient support and fixation accessories are medical accessories for operating tables which are intended to support, fixate and hold the patient on the operating table.

USA - engelsk - 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.

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

chs healthcare pty ltd - 38129 - overhead track patient lifting/transfer system - patient lifting solutions (pls) designs, develops and manufactures ceiling hoist solutions for the hospital, nursing home and domestic environment. pls can offer a patient lift for every ceiling and situation.

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

c r kennedy & co pty ltd - 40595 - patient data recorder, - device for recording the video data transmitted from within the patient's gi tract from a miniaturaised ccd camera within a non-digestible capsule. the device is designed for ambulatory use by the patient. the video data will be analysed at the hospital at a later date.

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

fisher & paykel healthcare pty ltd - 40595 - patient data recorder, - software to view patient and performance data recorded by device used for treatment of obstructive sleep apnea (osa).

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

philips electronics australia ltd - 35162 - patient data recorder, long-term, electrocardiograph - holter monitoring system for the long term monitoring of ambulatory patients.

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

device technologies australia pty ltd - 35162 - patient data recorder, long-term, electrocardiograph - to record patient heart function over long term (24 hrs+) and download data to analysis software for review by specialist

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

ge healthcare australia pty ltd - 35162 - patient data recorder, long-term, electrocardiograph - this device is for 24 hourly registration of a patient's heart activity which is connected to, and carried by the patient during the period of recording.

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

medusoft pty limited - 35162 - patient data recorder, long-term, electrocardiograph - a device used for a minimum of 24 hours for registration of a patient's heart activity, which is connected to, and carried by the patient during the period of recording. the signals are stored on a digital medium (no moving parts). the recording is analysed at the hospital or cardiologist surgery using a computer.