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

sandoz 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 the 10 ml cisatracurium besylate multiple-dose vials contain the preservative benzyl alcohol. therefore, if cisatracurium besylate is needed during pregnancy, consider using a benzyl alcohol-free formulation (i.e., 5 ml and 20 ml cisatracurium besylate single-dose vials). because benzyl alcohol is rapidly metabolized by a pregnant woman, benzyl alcohol exposure in the fetus is unlikely. however, adverse reactions have occurred in premature neonates and low birth weight infants who received intravenously administered benzyl alcohol-containing drugs [see contraindications (4), warnings and precautions (5.2), and use in specific populations (8.4)] . there are no available clinical trial data on cisatracurium use in pregnancy to evaluate a drug associated risk of major birth defects, miscarria

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

hospira, 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 the 10 ml cisatracurium besylate injection multiple-dose vials contain the preservative benzyl alcohol. therefore, if cisatracurium besylate injection is needed during pregnancy, consider using a benzyl alcohol-free formulation (i.e., 5 ml and 20 ml cisatracurium besylate injection single-dose vials). because benzyl alcohol is rapidly metabolized by a pregnant woman, benzyl alcohol exposure in the fetus is unlikely. however, adverse reactions have occurred in premature neonates and low birth weight infants who received intravenously administered benzyl alcohol-containing drugs [see contraindications (4), warnings and precautions (5.2), and use in specific populations (8.4)] . there are no available clinical trial data on cisatracurium use in pregnancy to evaluate a drug-associated risk of

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

hospira, 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 the 10 ml cisatracurium besylate injection multiple-dose vials contain the preservative benzyl alcohol. therefore, if cisatracurium besylate injection is needed during pregnancy, consider using a benzyl alcohol-free formulation (i.e., 5 ml and 20 ml cisatracurium besylate injection single-dose vials). because benzyl alcohol is rapidly metabolized by a pregnant woman, benzyl alcohol exposure in the fetus is unlikely. however, adverse reactions have occurred in premature neonates and low birth weight infants who received intravenously administered benzyl alcohol-containing drugs [see contraindications (4), warnings and precautions (5.2), and use in specific populations (8.4)] . there are no available clinical trial data on cisatracurium use in pregnancy to evaluate a drug-associated risk of

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 the 10 ml cisatracurium besylate multiple-dose vials contain the preservative benzyl alcohol. therefore, if cisatracurium besylate is needed during pregnancy, consider using a benzyl alcohol-free formulation (i.e., 5 ml and 20 ml cisatracurium besylate single-dose vials). because benzyl alcohol is rapidly metabolized by a pregnant woman, benzyl alcohol exposure in the fetus is unlikely. however, adverse reactions have occurred in premature neonates and low birth weight infants who received intravenously administered benzyl alcohol-containing drugs [see contraindications (4), warnings and precautions (5.2), and use in specific populations (8.4)] . there are no available clinical trial data on cisatracurium use in pregnancy to evaluate a drug associated risk of major birth defects, miscarria

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)

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)

sagent pharmaceuticals - 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 benzyl alcohol [see warning

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)

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