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

sandoz inc - cisatracurium besylate (unii: 80ys8o1mbs) (cisatracurium - unii:qx62kli41n) - cisatracurium 2 mg in 1 ml - 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. 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 organogenesis 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. the 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

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

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

jiangsu hengrui medicine co., ltd. - cisatracurium besylate (unii: 80ys8o1mbs) (cisatracurium - unii:qx62kli41n) - cisatracurium 2 mg in 1 ml - 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 have been reported [see warnings and precautions ( 5.4)] . the use of 10 ml cisatracurium 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 warnings and

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

jiangsu hengrui medicine co., ltd. - cisatracurium besylate (unii: 80ys8o1mbs) (cisatracurium - unii:qx62kli41n) - cisatracurium 2 mg in 1 ml - 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 have been reported [see warnings and precautions ( 5.4)] . the use of 10 ml cisatracurium 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 warnings and

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

sandoz inc - cisatracurium besylate (unii: 80ys8o1mbs) (cisatracurium - unii:qx62kli41n) - cisatracurium 2 mg in 1 ml - 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)

fresenius kabi usa, llc - cisatracurium besylate (unii: 80ys8o1mbs) (cisatracurium - unii:qx62kli41n) - cisatracurium 2 mg in 1 ml - cisatracurium besylate injection is an intermediate-onset/intermediate-duration neuromuscular blocking agent indicated for inpatients and outpatients as an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation in the icu. cisatracurium is contraindicated in patients with known hypersensitivity to the product and its components.  the 10 ml multiple dose vials of cisatracurium is contraindicated for use in premature infants because the formulation contains benzyl alcohol (see warnings and  precautions,  pediatric use ).

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

piramal critical care 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

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

teva parenteral medicines, 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 have been reported [see warnings and precautions (5.4 )] . the use of 10 ml cisatracurium 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 warnings a

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. 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)] . the use of 10 ml cisatracurium besylate injection 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 warnings and precautions (5.2) and use in specific populations (8.4)] . 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 organogenesis found no evidence of fetal harm at 0.8 times (ventilated rats) the exposure from a

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