Canada - English - Health Canada

omega laboratories limited - methacholine chloride - powder for solution - 480mg - methacholine chloride 480mg - other diagnostic agents

Canada - English - Health Canada

omega laboratories limited - methacholine chloride - powder for solution - 1600mg - methacholine chloride 1600mg - other diagnostic agents

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

hikma pharmaceuticals usa inc. - succinylcholine chloride dihydrate (unii: 8l0s1g435e) (succinylcholine - unii:j2r869a8yf) - succinylcholine chloride injection is indicated in adults and pediatric patients: - as an adjunct to general anesthesia - to facilitate tracheal intubation - to provide skeletal muscle relaxation during surgery or mechanical ventilation succinylcholine chloride injection is contraindicated: - in patients with skeletal muscle myopathies [see warnings and precautions (5.1)] - in patients with known hypersensitivity to succinylcholine. severe anaphylactic reactions to succinylcholine have been reported [see warnings and precautions (5. 2) ] - after the acute phase of injury following major burns, multiple trauma, extensive denervation of skeletal muscle, or upper motor neuron injury, which may result in severe hyperkalemia and cardiac arrest [see warnings and precautions (5.4)] - in patients with known or suspected genetic susceptibility to malignant hyperthermia [see warnings and precautions (5.5), clinical pharmacology (12.5)] risk summary available data from published literature from case reports and case series over several decades of use with succinylcholine during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. succinylcholine is used commonly during delivery by caesarean section to provide muscle relaxation.  if succinylcholine is used during labor and delivery, there is a risk for prolonged apnea in some pregnant women (see clinical considerations). animal reproduction studies have not been conducted with succinylcholine chloride. the estimated 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. clinical considerations maternal adverse reactions plasma cholinesterase levels are decreased by approximately 24% during pregnancy and for several days postpartum which can prolong the effect of succinylcholine. therefore, some pregnant patients may experience prolonged apnea. fetal/neonatal adverse reactions apnea and flaccidity may occur in the newborn after repeated high doses to, or in the presence of atypical plasma cholinesterase, in the mother. labor or delivery succinylcholine is commonly used to provide muscle relaxation during delivery by caesarean section. succinylcholine is known to cross the placental barrier in an amount that is dependent on the concentration gradient between the maternal and fetal circulation. risk summary there are no data on the presence of succinylcholine or its metabolite in either human or animal milk, the effects on the breastfed infant, or the effects on milk production.  the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for succinylcholine chloride injection and any potential adverse effects on the breastfed infant from succinylcholine chloride injection or from the underlying maternal condition. safety and effectiveness of succinylcholine chloride have been established in pediatric patient age groups, neonate to adolescent. because of a risk of ventricular dysrhythmias, cardiac arrest, and death from hyperkalemic rhabdomyolysis in pediatric patients, reserve the use of succinylcholine chloride injection in pediatric patients for emergency intubation or instances where immediate securing of the airway is necessary, e.g., laryngospasm, difficult airway, full stomach, or for intramuscular use when a suitable vein is inaccessible [see warnings and precautions (5.1)] . intravenous bolus administration of succinylcholine chloride injection in pediatric patients (including infants) may result in profound bradycardia or, rarely, asystole. the incidence and severity of bradycardia is higher in pediatric patients than adults [see warnings and precautions (5.6)] . the effective dose of succinylcholine chloride injection in pediatric patients may be higher than that predicted by body weight dosing alone [see dosage and administration (2.3)] . clinical studies of succinylcholine chloride 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.

Israel - English - Ministry of Health

kamada ltd, israel - methacholine chloride - powder for solution for inhalation - methacholine chloride 100 mg/vial - for the diagnosis of bronchial airway hyperactivity in subjects who do not have clinically apparent asthma.

Canada - English - Health Canada

hikma canada limited - succinylcholine chloride - solution - 20mg - succinylcholine chloride 20mg - neuromuscular blocking agents

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

sandoz inc - succinylcholine chloride (unii: i9l0ddd30i) (succinylcholine - unii:j2r869a8yf) - succinylcholine chloride 20 mg in 1 ml - anectine is indicated in adults and pediatric patients: anectine is contraindicated in patients with: hyperkalemia, which may result in cardiac arrest [see warnings and precautions (5.4)] risk summary available data from published literature from case reports and case series over decades of use with succinylcholine during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. succinylcholine is used commonly during delivery by caesarean section to provide muscle relaxation. if succinylcholine is used during labor and delivery, there is a risk for prolonged apnea in some pregnant women (see clinical considerations). animal reproduction studies have not been conducted with succinylcholine chloride. 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 to 4% and 15 to 20%, respectively. clinical considerations maternal adverse reactions plasma cholinesterase levels are decreased by approximately 24% during pregnancy and for several days postpartum which can prolong the effect of anectine. therefore, some pregnant or newly postpartum patients may experience prolonged apnea following administration of anectine. fetal/neonatal adverse reactions apnea and flaccidity may occur in the newborn after repeated high doses to, or in the presence of atypical plasma cholinesterase in the mother. labor or delivery succinylcholine is commonly used to provide muscle relaxation during delivery by caesarean section. succinylcholine is known to cross the placental barrier in an amount that is dependent on the concentration gradient between the maternal and fetal circulation. risk summary there are no data on the presence of succinylcholine or its metabolite in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for anectine and any potential adverse effects on the breastfed infant from anectine or from the underlying maternal condition. safety and effectiveness of succinylcholine chloride have been established in pediatric patients age groups, neonate to adolescent. since there is a risk of ventricular dysrhythmias, cardiac arrest, and death from hyperkalemic rhabdomyolysis in pediatric patients, reserve the use of anectine in pediatric patients for emergency intubation or instances where immediate securing of the airway is necessary, e.g., laryngospasm, difficult airway, full stomach, or for intramuscular use when a suitable vein is inaccessible [see warnings and precautions (5.1)] . intravenous bolus administration of anectine in infants or pediatric patients may result in profound bradycardia or, rarely, asystole. the incidence and severity of bradycardia is higher in pediatric patients than adults [see warnings and precautions (5.6)] . the effective dose of anectine in pediatric patients may be higher than that predicted by body weight dosing alone [see dosage and administration (2.3)] . clinical studies of succinylcholine chloride 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.

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

hospira, inc. - succinylcholine chloride (unii: i9l0ddd30i) (succinylcholine - unii:j2r869a8yf) - succinylcholine chloride 20 mg in 1 ml - quelicin is indicated in adults and pediatric patients: quelicin is contraindicated: risk summary available data from published literature from case reports and case series over decades of use with succinylcholine during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. succinylcholine is used commonly during delivery by caesarean section to provide muscle relaxation. if succinylcholine is used during labor and delivery, there is a risk for prolonged apnea in some pregnant women (see clinical considerations). animal reproduction studies have not been conducted with succinylcholine chloride. the estimated 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% a

Canada - English - Health Canada

dr reddy's laboratories ltd - succinylcholine chloride - solution - 20mg - succinylcholine chloride 20mg - neuromuscular blocking agents

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

australian pesticides and veterinary medicines authority - choline - unknown - choline vitamin-b complex active 0.0 - active constituent

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

australian pesticides and veterinary medicines authority - choline bitartrate - unknown - choline bitartrate vitamin-b complex active 0.0 - active constituent