Kanada - Ingliż - Health Canada

sandoz canada incorporated - fentanyl (fentanyl citrate) - solution - 50mcg - fentanyl (fentanyl citrate) 50mcg - opiate agonists

Kanada - Ingliż - Health Canada

sandoz canada incorporated - fentanyl (fentanyl citrate) - solution - 50mcg - fentanyl (fentanyl citrate) 50mcg - opiate agonists

Stati Uniti - Ingliż - NLM (National Library of Medicine)

jurox pty. limited - alfaxalone (unii: bd07m97b2a) (alfaxalone - unii:bd07m97b2a) - alfaxalone 10 mg in 1 ml - indications alfaxan is indicated for the induction and maintenance of anesthesia and for induction of anesthesia followed by maintenance with an inhalant anesthetic, in cats and dogs. contraindications: alfaxan is contraindicated in cats and dogs with a known sensitivity to alfaxalone or its components, or when general anesthesia and/or sedation are contraindicated. drug abuse and dependence: controlled substance: alfaxan contains alfaxalone, a neurosteroid anesthetic and a class iv controlled substance. abuse: alfaxalone is a central nervous system depressant that acts on gaba receptor associated chloride channels, similar to the mechanism of action of schedule iv sedatives such as benzodiazepines (diazepam and midazolam), barbiturates (phenobarbital and methohexital) and fospropofol. in a drug discrimination behavioral test in rats, the effects of alfaxalone were recognized as similar to those of midazolam. these biochemical and behavioral data suggest that alfaxalone has an abuse potential similar to oth

Stati Uniti - Ingliż - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - rocuronium bromide (unii: i65mw4ofhz) (rocuronium - unii:wre554rfez) - rocuronium bromide 10 mg in 1 ml - rocuronium bromide injection is indicated for inpatients and outpatients as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. rocuronium bromide is contraindicated in patients known to have hypersensitivity (e.g., anaphylaxis) to rocuronium bromide or other neuromuscular blocking agents [see warnings and precautions (5.2)] . developmental toxicology studies have been performed with rocuronium bromide in pregnant, conscious, nonventilated rabbits and rats. inhibition of neuromuscular function was the endpoint for high-dose selection. the maximum tolerated dose served as the high dose and was administered intravenously 3 times a day to rats (0.3 mg/kg, 15%–30% of human intubation dose of 0.6–1.2 mg/kg based on the body surface unit of mg/m2) from day 6 to 17 and to rabbits (0.02 mg/kg, 25% human dose) from day 6 to 18 of pregnancy. high-dose treatment caused acute symptoms of respiratory dysfunction due to the pharmacological activity of the drug. teratogenicity was not observed in these animal species. the incidence of late embryonic death was increased at the high dose in rats, most likely due to oxygen deficiency. therefore, this finding probably has no relevance for humans because immediate mechanical ventilation of the intubated patient will effectively prevent embryo-fetal hypoxia. however, there are no adequate and well-controlled studies in pregnant women. rocuronium bromide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. the use of rocuronium bromide in cesarean section has been studied in a limited number of patients [see clinical studies (14.1)] . rocuronium bromide is not recommended for rapid sequence induction in cesarean section patients. the use of rocuronium bromide has been studied in pediatric patients 3 months to 14 years of age under halothane anesthesia. of the pediatric patients anesthetized with halothane who did not receive atropine for induction, about 80% experienced a transient increase (30% or greater) in heart rate after intubation. one of the 19 infants anesthetized with halothane and fentanyl who received atropine for induction experienced this magnitude of change [see dosage and administration (2.6) and clinical studies (14.3)] . rocuronium bromide was also studied in pediatric patients up to 17 years of age, including neonates, under sevoflurane (induction) and isoflurane/nitrous oxide (maintenance) anesthesia. onset time and clinical duration varied with dose, the age of the patient, and anesthetic technique. the overall analysis of ecg data in pediatric patients indicates that the concomitant use of rocuronium bromide with general anesthetic agents can prolong the qtc interval. the data also suggest that rocuronium bromide may increase heart rate. however, it was not possible to conclusively identify an effect of rocuronium bromide independent of that of anesthesia and other factors. additionally, when examining plasma levels of rocuronium bromide in correlation to qtc interval prolongation, no relationship was observed [see dosage and administration (2.6), warnings and precautions (5.9), and clinical studies (14.3)] . rocuronium bromide is not recommended for rapid sequence intubation in pediatric patients. recommendations for use in pediatric patients are discussed in other sections [see dosage and administration (2.6) and clinical pharmacology (12.2)] . rocuronium bromide was administered to 140 geriatric patients (65 years or greater) in us clinical trials and 128 geriatric patients in european clinical trials. the observed pharmacokinetic profile for geriatric patients (n=20) was similar to that for other adult surgical patients [see clinical pharmacology (12.3)] . onset time and duration of action were slightly longer for geriatric patients (n=43) in clinical trials. clinical experiences and recommendations for use in geriatric patients are discussed in other sections [see dosage and administration (2.6), warnings and precautions (5.5), clinical pharmacology (12.2), and clinical studies (14.2)] . since rocuronium bromide is primarily excreted by the liver, it should be used with caution in patients with clinically significant hepatic impairment. rocuronium bromide 0.6 mg/kg has been studied in a limited number of patients (n=9) with clinically significant hepatic impairment under steady-state isoflurane anesthesia. after rocuronium bromide 0.6 mg/kg, the median (range) clinical duration of 60 (35–166) minutes was moderately prolonged compared to 42 minutes in patients with normal hepatic function. the median recovery time of 53 minutes was also prolonged in patients with cirrhosis compared to 20 minutes in patients with normal hepatic function. four of 8 patients with cirrhosis, who received rocuronium bromide 0.6 mg/kg under opioid/nitrous oxide/oxygen anesthesia, did not achieve complete block. these findings are consistent with the increase in volume of distribution at steady state observed in patients with significant hepatic impairment [see clinical pharmacology (12.3)] . if used for rapid sequence induction in patients with ascites, an increased initial dosage may be necessary to assure complete block. duration will be prolonged in these cases. the use of doses higher than 0.6 mg/kg has not been studied [see dosage and administration (2.6)] . due to the limited role of the kidney in the excretion of rocuronium bromide, usual dosing guidelines should be followed. in patients with renal dysfunction, the duration of neuromuscular blockade was not prolonged; however, there was substantial individual variability (range: 22-90 minutes) [see clinical pharmacology (12.3)] .

Awstralja - Ingliż - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - rocuronium bromide -

Ingilterra - Ingliż - MHRA (Medicines & Healthcare Products Regulatory Agency)

martindale pharmaceuticals ltd - atropine sulfate - solution for injection - 300microgram/1ml

Ingilterra - Ingliż - MHRA (Medicines & Healthcare Products Regulatory Agency)

merck sharp & dohme (uk) ltd - rocuronium bromide - solution for injection - 10mg/1ml

Ingilterra - Ingliż - MHRA (Medicines & Healthcare Products Regulatory Agency)

organon pharma (uk) ltd - rocuronium bromide - solution for injection - 10mg/1ml

Ingilterra - Ingliż - MHRA (Medicines & Healthcare Products Regulatory Agency)

hameln pharma ltd - atropine sulfate - solution for injection - 600microgram/1ml

Ingilterra - Ingliż - MHRA (Medicines & Healthcare Products Regulatory Agency)

martindale pharmaceuticals ltd - atropine sulfate - solution for injection - 200microgram/1ml