United States - English - NLM (National Library of Medicine)

baxter healthcare corporation - daptomycin (unii: nwq5n31vkk) (daptomycin - unii:nwq5n31vkk) - daptomycin in sodium chloride injection is indicated for the treatment of adult and pediatric patients (1 to 17 years of age) for whom appropriate dosing can be achieved, with complicated skin and skin structure infections (csssi) caused by susceptible isolates of the following gram-positive bacteria: staphylococcus aureus (including methicillin-resistant isolates), streptococcus pyogenes, streptococcus agalactiae, streptococcus dysgalactiae subsp. equisimilis, and enterococcus faecalis (vancomycin-susceptible isolates only). daptomycin in sodium chloride injection is indicated for the treatment of adult patients for whom appropriate dosing can be achieved, with staphylococcus aureus bloodstream infections (bacteremia), including adult patients with right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates. daptomycin in sodium chloride injection is indicated for the treatment of pediatric patients (1 to 17 years of age) for whom appropriate dosing can be achieved with staphylococcus aureus bloodstream infections (bacteremia). daptomycin in sodium chloride injection is not indicated for the treatment of pneumonia. daptomycin in sodium chloride injection is not indicated for the treatment of left-sided infective endocarditis due to s. aureus . the clinical trial of daptomycin for injection in adult patients with s. aureus bloodstream infections included limited data from patients with left-sided infective endocarditis; outcomes in these patients were poor [see clinical studies (14.2)]. daptomycin for injection has not been studied in patients with prosthetic valve endocarditis. daptomycin in sodium chloride injection is not recommended in pediatric patients younger than 1 year of age due to the risk of potential effects on muscular, neuromuscular, and/or nervous systems (either peripheral and/or central) observed in neonatal dogs [see warnings and precautions (5.7) and nonclinical toxicology (13.2)] . appropriate specimens for microbiological examination should be obtained in order to isolate and identify the causative pathogens and to determine their susceptibility to daptomycin. to reduce the development of drug-resistant bacteria and maintain the effectiveness of daptomycin in sodium chloride injection and other antibacterial drugs, daptomycin in sodium chloride injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information is available, it 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. empiric therapy may be initiated while awaiting test results. daptomycin in sodium chloride injection is contraindicated in patients with known hypersensitivity to daptomycin [see warnings and precautions (5.1)]. risk summary limited published data on use of daptomycin for injection in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. in animal reproduction studies performed in rats and rabbits daptomycin was administered intravenously during organogenesis at doses 2 and 4–times, respectively, the recommended 6 mg/kg human dose (on a body surface area basis). no evidence of adverse developmental outcomes was observed. the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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 pregnant rats, daptomycin was administered intravenously at doses of 5, 20, or 75 mg/kg/day during the gestation days 6 to 18. maternal body weight gain was decreased at 75 mg/kg/day. no embryo/fetal effects were noted at the highest dose of 75 mg/kg/day, a dose approximately 2-fold higher than in humans at the recommended maximum dose of 6 mg/kg (based on body surface area). in pregnant rabbits, daptomycin was administered intravenously at doses of 5, 20, or 75 mg/kg/day during the gestation days 6 to 15. maternal body weight gain and food consumption were decreased at 75 mg/kg/day. no embryo/fetal effects were noted at the highest dose of 75 mg/kg/day, a dose approximately 4-fold higher than in humans at the maximum recommended dose of 6 mg/kg (based on body surface area). in a combined fertility and pre/postnatal development study, daptomycin was administered intravenously to female rats at doses of 2, 25, 75 mg/kg/day from 14-days pre-mating through lactation/postpartum day 20). no effects on pre/postnatal development were observed up to the highest dose of 75 mg/kg/day, a dose approximately 2-fold higher than the maximum recommended human dose of 6 mg/kg (based on body surface area)1 . risk summary limited published data report that daptomycin is present in human milk at infant doses of 0.1% of the maternal dose (see data) 2,3,4 . there is no information on the effects of daptomycin on the breastfed infant or the effects of daptomycin on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for daptomycin for injection and any potential adverse effects on the breastfed infant from daptomycin for injection or from the underlying maternal condition. the safety and effectiveness of daptomycin for injection in the treatment of csssi and s. aureus bloodstream infections (bacteremia) have been established in the age groups 1 to 17 years of age. use of daptomycin for injection in these age groups is supported by evidence from adequate and well-controlled studies in adults, with additional data from pharmacokinetic studies in pediatric patients, and from safety, efficacy and pk studies in pediatric patients with csssi and s. aureus bloodstream infections [see adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14.1, 14.2)] . safety and effectiveness in pediatric patients below the age of one year have not been established. avoid use of daptomycin in sodium chloride injection in pediatric patients younger than one year of age due to the risk of potential effects on muscular, neuromuscular, and/or nervous systems (either peripheral and/or central) observed in neonatal dogs [see warnings and precautions (5.7) and nonclinical toxicology (13.2)]. because of the limitations of the available strengths and administration requirements (i.e., administration of fractional doses is not recommended) of daptomycin in sodium chloride injection, and to avoid unintentional overdose, this product is not recommended for use if a dose of daptomycin in sodium chloride injection is required that does not equal 350 mg, 500 mg, 700 mg or 1,000 mg and an alternative formulation of daptomycin should be considered [see dosage and administration (2.3, 2.5)]. daptomycin in sodium chloride injection is not indicated in pediatric patients with renal impairment because dosage has not been established in these patients. daptomycin in sodium chloride injection has not been studied in pediatric patients with other bacterial infections. of the 534 adult patients treated with daptomycin for injection in phase 3 controlled clinical trials of complicated skin and skin structure infections (csssi), 27% were 65 years of age or older and 12% were 75 years of age or older. of the 120 adult patients treated with daptomycin for injection in the phase 3 controlled clinical trial of s. aureus bacteremia/endocarditis, 25% were 65 years of age or older and 16% were 75 years of age or older. in phase 3 adult clinical trials of csssi and s. aureus bacteremia/endocarditis, clinical success rates were lower in patients ≥65 years of age than in patients <65 years of age. in addition, treatment-emergent adverse events were more common in patients ≥65 years of age than in patients <65 years of age. the exposure of daptomycin was higher in healthy elderly subjects than in healthy young adult subjects. however, no adjustment of daptomycin in sodium chloride injection dosage is warranted for elderly patients with creatinine clearance (clcr ) ≥30 ml/min [see dosage and administration (2.6) and clinical pharmacology (12.3)]. daptomycin is eliminated primarily by the kidneys; therefore, a modification of daptomycin in sodium chloride injection dosage interval is recommended for adult patients with clcr <30 ml/min, including patients receiving hemodialysis or continuous ambulatory peritoneal dialysis (capd). in adult patients with renal impairment, both renal function and creatine phosphokinase (cpk) should be monitored more frequently than once weekly [see dosage and administration (2.6), warnings and precautions (5.2, 5.10), and clinical pharmacology (12.3)]. the dosage regimen for daptomycin in sodium chloride injection in pediatric patients with renal impairment has not been established.

United States - English - NLM (National Library of Medicine)

baxter healthcare corporation - vasopressin (unii: y4907o6mfd) (vasopressin - unii:y4907o6mfd) - vasopressin in sodium chloride injection is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines. vasopressin in sodium chloride injection is contraindicated in patients with a known allergy or hypersensitivity to 8-l-arginine vasopressin. risk summary there are no available data on vasopressin in sodium chloride injection use in pregnant women to inform a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. animal reproduction studies have not been conducted. clinical considerations there are no data on the presence of vasopressin injection in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. safety and effectiveness of vasopressin in sodium chloride injection in pediatric patients with vasodilatory shock have not been established. clinical studies of vasopressin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. 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 [see warnings and precautions (5), adverse reactions (6), and clinical pharmacology (12.3)].

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

masimo australia pty ltd - 37323 - patient monitor module, electroencephalograph - a device used in a multiparameter patient monitor, for the detection and recording of electroencephalogram (eeg) signals which are caused by the electrical activity of the brain and detected via electrodes affixed to the patient's forehead or scalp. this module is intended to be used during anaesthesia and critical care treatment.

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

jd healthcare group pty ltd -

United States - English - NLM (National Library of Medicine)

rx pharma-pack, inc. - bupivacaine hydrochloride (unii: 7tqo7w3vt8) (bupivacaine - unii:y8335394ro) - bupivacaine hydrochloride anhydrous 5 mg in 1 ml - marcaine is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia. (see warnings .) experience with nonobstetrical surgical procedures in pregnant patients is not sufficient to recommend use of 0.75% concentration of marcaine in these patients. marcaine is not recommended for intravenous regional anesthesia (bier block). see warnings . the routes of administration and indicated marcaine concentrations are: - local infiltration - peripheral nerve block - retrobulbar block - sympathetic block - lumbar epidural 0.25%, 0.5%, and 0.75% (0.75% not for obstetrical anesthesia) - caudal - epidural test dose - dental blocks (see dosage and administration for additional information). standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of marc

United States - English - NLM (National Library of Medicine)

rx pharma-pack, inc. - lidocaine hydrochloride anhydrous (unii: ec2cnf7xfp) (lidocaine - unii:98pi200987) - lidocaine hydrochloride anhydrous 10 mg in 1 ml - lidocaine hcl is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type. sodium chloride injection, usp, 0.9% preparations are indicated for diluting or dissolving drugs for intramuscular, intravenous or subcutaneous injection according to instructions of the manufacturer of the drug to be administered. sodium chloride injection, usp, 0.9% is also indicated for use in flushing of intravenous catheters. antiseptic antiseptic skin preparation antiseptic for preparation of the skin prior to injection.

United States - English - NLM (National Library of Medicine)

rx pharma-pack, inc. - bupivacaine hydrochloride (unii: 7tqo7w3vt8) (bupivacaine - unii:y8335394ro) - bupivacaine hydrochloride anhydrous 5 mg in 1 ml - marcaine is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia. (see warnings .) experience with nonobstetrical surgical procedures in pregnant patients is not sufficient to recommend use of 0.75% concentration of marcaine in these patients. marcaine is not recommended for intravenous regional anesthesia (bier block). see warnings . the routes of administration and indicated marcaine concentrations are: - local infiltration - peripheral nerve block - retrobulbar block - sympathetic block - lumbar epidural  0.25%, 0.5%, and 0.75% (0.75% not for obstetrical anesthesia) - caudal - epidural test dose - dental blocks (see dosage and administration for additional information). standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of mar

United States - English - NLM (National Library of Medicine)

rx pharma-pack, inc. - bupivacaine hydrochloride (unii: 7tqo7w3vt8) (bupivacaine - unii:y8335394ro) - bupivacaine hydrochloride anhydrous 5 mg in 1 ml - marcaine is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia. (see warnings .) experience with nonobstetrical surgical procedures in pregnant patients is not sufficient to recommend use of 0.75% concentration of marcaine in these patients. marcaine is not recommended for intravenous regional anesthesia (bier block). see warnings . the routes of administration and indicated marcaine concentrations are: - local infiltration - peripheral nerve block - retobulbar block - sympathetic block - lumbar epidural  0.25%, 0.5%, and 0.75%  (0.75% not for obstetrical anesthesia) - caudal - epidural test dose - dental blocks (see dosage and administration for additional information). standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of ma

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

aspen pharmacare australia pty ltd - azathioprine, quantity: 50 mg - injection, powder for - excipient ingredients: sodium hydroxide - indications as at 11 february 2005: imuran is used as an immunosuppressant antimetabolite either alone, or more commonly, in combination with other agents (usually corticosteroids) and procedures which influence the immune response. therapeutic effect may be evident only after weeks or months and can include a steroid-sparing effect, thereby reducing the toxicity associated with high dosage and prolonged usage of corticosteroids. imuran, in combination with corticosteroids and/or other immunosuppressive agents and procedures, is indicated in the management of patients receiving organ transplants. imuran, either alone or more usually in combination with corticosteroids and/or other procedures, has been used with clinical benefit which may include reduction of dosage or discontinuation of corticosteroids, in a proportion of patients suffering form the following: severe rheumatoid arthritis; systemic lupus erythematosus; dermatomyositis/polymyositis; autoimmune chronic active hepatitis; pemphigus vulgaris; polya

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

ge healthcare australia pty ltd - 36552 - patient monitoring system module, carbon dioxide - patient monitoring