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

civica, inc. - cisatracurium besylate (unii: 80ys8o1mbs) (cisatracurium - unii:qx62kli41n) - cisatracurium besylate injection is indicated: limitations of use cisatracurium besylate injection is not recommended for rapid sequence endotracheal intubation due to the time required for its onset of action. risk summary there are no available clinical trial data on cisatracurium use in pregnancy to evaluate a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. animal studies conducted in rats administered cisatracurium besylate during organogenesis (gestational day 6 to 15) found no evidence of fetal harm at 0.8 times (ventilated rats) the exposure from a human starting iv bolus dose of 0.2 mg/kg (see data) . the estimated background risk for major birth defects and miscarriage in 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%, r

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

hikma pharmaceuticals usa inc. - cisatracurium besylate (unii: 80ys8o1mbs) (cisatracurium - unii:qx62kli41n) - cisatracurium besylate injection is indicated: - as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age - to provide skeletal muscle relaxation in adults during surgical procedures or during mechanical ventilation in the icu - to provide skeletal muscle relaxation during surgical procedures via infusion in pediatric patients 2 years and older limitations of use cisatracurium besylate injection is not recommended for rapid sequence endotracheal intubation due to the time required for its onset of action. cisatracurium besylate injection is contraindicated in patients with known hypersensitivity to cisatracurium. severe anaphylactic reactions to cisatracurium besylate injection have been reported [see warnings and precautions (5.4)] . risk summary there are no available clinical trial data on cisatracurium use in pregnancy to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. an

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

meitheal pharmaceuticals inc. - cisatracurium besylate (unii: 80ys8o1mbs) (cisatracurium - unii:qx62kli41n) - cisatracurium besylate injection is indicated: - as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age - to provide skeletal muscle relaxation in adults during surgical procedures or during mechanical ventilation in the icu - to provide skeletal muscle relaxation during surgical procedures via infusion in pediatric patients 2 years and older limitations of use cisatracurium besylate injection is not recommended for rapid sequence endotracheal intubation due to the time required for its onset of action. - cisatracurium besylate is contraindicated in patients with known hypersensitivity to cisatracurium. severe anaphylactic reactions to cisatracurium besylate have been reported [see warnings and precautions (5.4)] . - the use of 10 ml cisatracurium besylate multi-dose vials is contraindicated for use in pediatric patients less than 1 month of age and low birth-weight infants because the formulation contains benzyl alcohol [see warnin

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

caplin steriles limited - cisatracurium besylate (unii: 80ys8o1mbs) (cisatracurium - unii:qx62kli41n) - cisatracurium besylate injection is indicated: • as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age • to provide skeletal muscle relaxation in adults during surgical procedures or during mechanical ventilation in the icu • to provide skeletal muscle relaxation during surgical procedures via infusion in pediatric patients 2 years and older. limitations of use cisatracurium besylate injection is not recommended for rapid sequence endotracheal intubation due to the time required for its onset of action. cisatracurium besylate is contraindicated in patients with known hypersensitivity to cisatracurium. severe anaphylactic reactions to cisatracurium besylate have been reported [see warnings and precautions (5.4)] . the use of 10 ml cisatracurium besylate multiple-dose vials is contraindicated for use in pediatric patients less than 1 month of age and low birth-weight infants because the formulation contains ben

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

avet pharmaceuticals inc. - cisatracurium besylate (unii: 80ys8o1mbs) (cisatracurium - unii:qx62kli41n) - cisatracurium besylate injection, usp is indicated:        •as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age        •to provide skeletal muscle relaxation in adults during surgical procedures or during mechanical ventilation in the icu        •to provide skeletal muscle relaxation during surgical procedures via infusion in pediatric patients 2 years and older limitations of use cisatracurium besylate injection, usp is not recommended for rapid sequence endotracheal intubation due to the time required for its onset of action. cisatracurium besylate injection, usp is contraindicated in patients with known hypersensitivity to cisatracurium. severe anaphylactic reactions to cisatracurium besylate injection, usp have been reported [see warnings and precautions (5.4 )] . the use of 10 ml cisatracurium besylate injection, usp multiple-dose vials is contraindicated for use in pediatric patients less than 1 month of age and low birth w

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

piramal healthcare uk limited - cisatracurium besylate (unii: 80ys8o1mbs) (cisatracurium - unii:qx62kli41n) - cisatracurium besylate injection, usp is indicated:        •as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age        •to provide skeletal muscle relaxation in adults during surgical procedures or during mechanical ventilation in the icu        •to provide skeletal muscle relaxation during surgical procedures via infusion in pediatric patients 2 years and older limitations of use cisatracurium besylate injection, usp is not recommended for rapid sequence endotracheal intubation due to the time required for its onset of action. cisatracurium besylate injection, usp is contraindicated in patients with known hypersensitivity to cisatracurium. severe anaphylactic reactions to cisatracurium besylate injection, usp have been reported [see warnings and precautions (5.4 )] . the use of 10 ml cisatracurium besylate injection, usp multiple-dose vials is contraindicated for use in pediatric patients less than 1 month of age and low birth w

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

piramal healthcare uk limited - cisatracurium besylate (unii: 80ys8o1mbs) (cisatracurium - unii:qx62kli41n) - cisatracurium besylate injection, usp is indicated:        •as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age        •to provide skeletal muscle relaxation in adults during surgical procedures or during mechanical ventilation in the icu        •to provide skeletal muscle relaxation during surgical procedures via infusion in pediatric patients 2 years and older limitations of use cisatracurium besylate injection, usp is not recommended for rapid sequence endotracheal intubation due to the time required for its onset of action. cisatracurium besylate injection, usp is contraindicated in patients with known hypersensitivity to cisatracurium. severe anaphylactic reactions to cisatracurium besylate injection, usp have been reported [see warnings and precautions (5.4 )] . risk summary there are no adequate and well-controlled studies of cisatracurium besylate in pregnant women. animal studies conducted in rats administered cisatracur

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

zydus lifesciences limited - cisatracurium besylate (unii: 80ys8o1mbs) (cisatracurium - unii:qx62kli41n) - cisatracurium besylate injection is indicated: - as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age - to provide skeletal muscle relaxation in adults during surgical procedures or during mechanical ventilation in the icu - to provide skeletal muscle relaxation during surgical procedures via infusion in pediatric patients 2 years and older limitations of use cisatracurium besylate injection is not recommended for rapid sequence endotracheal intubation due to the time required for its onset of action. cisatracurium besylate injection is contraindicated in patients with known hypersensitivity to cisatracurium. severe anaphylactic reactions to cisatracurium besylate have been reported [see warnings and precautions (5.4)] . risk summary there are no adequate and well-controlled studies of cisatracurium besylate in pregnant women. animal studies conducted in rats administered cisatracurium besylate during organogen

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

aft pharmaceuticals pty ltd - cisatracurium besilate, quantity: 0.669 % w/v - solution - excipient ingredients: benzenesulfonic acid; water for injections - cisatracurium-aft is indicated for use during surgical and other procedures and in intensive care to relax skeletal muscles, and to facilitate tracheal intubation and mechanical ventilation. it is used as an adjunct to general anaesthesia, or sedation in the intensive care unit.

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

aft pharmaceuticals pty ltd - cisatracurium besilate, quantity: 0.268 % w/v - solution - excipient ingredients: water for injections; benzenesulfonic acid - cisatracurium-aft is indicated for use during surgical and other procedures and in intensive care to relax skeletal muscles, and to facilitate tracheal intubation and mechanical ventilation. it is used as an adjunct to general anaesthesia, or sedation in the intensive care unit.