États-Unis - anglais - 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.

États-Unis - anglais - 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)].

Australie - anglais - 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.

Australie - anglais - Department of Health (Therapeutic Goods Administration)

jd healthcare group pty ltd -

Israël - anglais - Ministry of Health

j-c health care ltd - risperidone - powder for suspension for injection - risperidone 25 mg/vial - risperidone - risperidone - risperdal consta is indicated for the treatment of schizophrenia and schizoaffective disorders.risperdal consta is indicated as monotherapy for the maintenance treatment of bipolar i disorder to delay occurrence of mood episodes.risperdal consta is indicated for adjunctive maintenance treatment to delay occurrence of mood episodes in patients with frequently relapsing bipolar disorder.

Israël - anglais - Ministry of Health

j-c health care ltd - risperidone - powder for suspension for injection - risperidone 37.5 mg/vial - risperidone - risperidone - risperdal consta is indicated for the treatment of schizophrenia and schizoaffective disorders.risperdal consta is indicated as monotherapy for the maintenance treatment of bipolar i disorder to delay occurrence of mood episodes.risperdal consta is indicated for adjunctive maintenance treatment to delay occurrence of mood episodes in patients with frequently relapsing bipolar disorder.

Israël - anglais - Ministry of Health

j-c health care ltd - risperidone - powder for suspension for injection - risperidone 50 mg/vial - risperidone - risperidone - risperdal consta is indicated for the treatment of schizophrenia and schizoaffective disorders.risperdal consta is indicated as monotherapy for the maintenance treatment of bipolar i disorder to delay occurrence of mood episodes.risperdal consta is indicated for adjunctive maintenance treatment to delay occurrence of mood episodes in patients with frequently relapsing bipolar disorder.

États-Unis - anglais - NLM (National Library of Medicine)

nucare pharmaceuticals,inc. - omeprazole (unii: kg60484qx9) (omeprazole - unii:kg60484qx9) - omeprazole 20 mg - omeprazole delayed-release capsules, usp are indicated for short-term treatment of active duodenal ulcer in adults. most patients heal within four weeks. some patients may require an additional four weeks of therapy. omeprazole delayed-release capsules, usp in combination with clarithromycin and amoxicillin, are indicated for treatment of patients with h. pylori infection and duodenal ulcer disease (active or up to 1-year history) to eradicate h. pylori in adults. omeprazole delayed-release capsules, usp in combination with clarithromycin are indicated for treatment of patients with h. pylori infection and duodenal ulcer disease to eradicate h. pylori in adults. eradication of h. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see  clinical studies (14.1) and dosage and administration (2)] . among patients who fail therapy, omeprazole delayed-release capsules, usp with clarithromycin are more likely to be associated with the development of clarithromycin resist

États-Unis - anglais - NLM (National Library of Medicine)

nucare pharmaceuticals, inc. - omeprazole (unii: kg60484qx9) (omeprazole - unii:kg60484qx9) - omeprazole 20 mg - omeprazole delayed-release capsules are indicated for short-term treatment of active duodenal ulcer in adults. most patients heal within four weeks. some patients may require an additional four weeks of therapy. omeprazole delayed-release capsules, in combination with clarithromycin and amoxicillin, are indicated for treatment of patients with h. pylori infection and duodenal ulcer disease (active or up to 1-year history) to eradicate h. pylori in adults. omeprazole delayed-release capsules, in combination with clarithromycin are indicated for treatment of patients with h. pylori infection and duodenal ulcer disease to eradicate h. pylori in adults. eradication of h. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see clinical studies (14.1) and dosage and administration (2) ]. among patients who fail therapy, omeprazole delayed-release capsul

États-Unis - anglais - NLM (National Library of Medicine)

nucare pharmaceuticals,inc. - menthol (unii: l7t10eip3a) (menthol - unii:l7t10eip3a), capsaicin (unii: s07o44r1zm) (capsaicin - unii:s07o44r1zm), methyl salicylate (unii: lav5u5022y) (salicylic acid - unii:o414pz4lpz) - carefully consider the potential benefits and risks of etodolac and other treatment options before deciding to use etodolac. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). etodolac tablets, usp are indicated: - for acute and long-term use in the management of signs and symptoms of the following: osteoarthritis rheumatoid arthritis - osteoarthritis - rheumatoid arthritis - for the management of acute pain etodolac is contraindicated in patients with known hypersensitivity to etodolac. etodolac should not be given to patients who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, rarely fatal, anaphylactic-like reactions to nsaids have been reported in such patients (see warnings, anaphylactoid reactions and precautions, pre-existing asthma ). - etodolac tablets are contraindicated in the setting of coronary arter