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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. 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)

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)

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)

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)

eugia us llc - 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 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 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 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 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 to 4% and 15 to 20%, respectively. clinical considerations labor or delivery the action of neuromuscular blocking agents may be enhanced by magnesium salts administered for the management of preeclampsia or eclampsia of pregnancy. data animal data two embryofetal developmental reproductive toxicity studies were conducted in rats. in a non- ventilated rat study, pregnant animals were treated with cisatracurium besylate subcutaneously twice per day from gestational day 6 to 15 using subparalyzing doses (2 and 4 mg/kg daily; equivalent to 6- and 12-times, respectively, the auc exposure in humans following a bolus dose of 0.2 mg/kg iv). in the ventilated rat study, pregnant animals were treated with cisatracurium besylate intravenously once a day between gestational day 6 to 15 using paralyzing doses (0.5 and 1 mg/kg; equivalent to 0.4- and 0.8-times, respectively, the exposure in humans following a bolus dose of 0.2 mg/kg iv based on mg/m2 comparison). neither of these studies revealed maternal or fetal toxicity or malformations. risk summary the 10 ml cisatracurium besylate injection multiple-dose vials contains the preservative benzyl alcohol. therefore, if cisatracurium besylate injection is needed during lactation, consider using a benzyl alcohol-free formulation (i.e., 5 ml cisatracurium besylate injection single-dose vials). because benzyl alcohol is rapidly metabolized by a lactating woman, benzyl alcohol exposure in the breastfed infant 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 data on the presence of cisatracurium besylate in human milk, the effects on the breastfed child, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for cisatracurium and any potential adverse effects on the breastfed child from cisatracurium or from the underlying maternal condition. the safety and effectiveness of cisatracurium as an adjunct to general anesthesia to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery in pediatric patients 1 month through 12 years of age were established from three studies in pediatric patients [see dosing and administration (2.2, 2.5) and clinical studies (14.2)] . the three open-label studies are summarized below. the safety and effectiveness of cisatracurium have not been established in pediatric patients less than 1 month of age. tracheal intubation a study of 0.15 mg/kg cisatracurium evaluated 230 pediatric patients (ages 1 month to 12 years). excellent or good intubating conditions were produced 120 seconds following 0.15 mg/kg of cisatracurium in 88 of 90 of patients induced with halothane and in 85 of 90 of patients induced with thiopentone and fentanyl. the study also evaluated 50 pediatric patients during opioid anesthesia, with maximum neuromuscular blockade achieved in an average of about 3 minutes and a clinically effective block for 36 minutes in patients ages 2 to 12 years, and maximum neuromuscular block in about 2 minutes and a clinically effective block for about 43 minutes in infants 1 to 23 months [see clinical studies (14.2)] . in a study of 0.1 mg/kg cisatracurium administered in 16 pediatric patients (ages 2 to 12 years) during opioid/nitrous oxide/oxygen anesthesia, maximum neuromuscular blockade was achieved in an average of 2.8 minutes with a clinically effective block for 28 minutes [see clinical studies (14.2)] . skeletal muscle relaxation during surgery in a study of cisatracurium administered during halothane/nitrous oxide/oxygen anesthesia, 18 pediatric patients (ages 2 to 12 years) were scheduled for surgical procedures that required neuromuscular block for 60 minutes or longer. the average duration of continuous infusion was 62.8 minutes (range: 17 to 145 minutes). the overall mean infusion rate for 9 patients whose infusion was 45 minutes or longer was 1.7 mcg/kg/minute (range: 1.19 to 2.14 mcg/kg/minute). serious adverse reactions in infants due to benzyl alcohol preservative in 10 ml multiple-dose vials serious adverse reactions including fatal reactions and the “gasping syndrome” occurred in premature neonates and infants in the neonatal intensive care unit who received drugs containing benzyl alcohol as a preservative. in these cases, benzyl alcohol dosages of 99 to 234 mg/kg/day produced high levels of benzyl alcohol and its metabolites in the blood and urine (blood levels of benzyl alcohol were 0.61 to 1.378 mmol/l). additional adverse reactions included gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. preterm, low-birth weight infants may be more likely to develop these reactions because they may be less able to metabolize benzyl alcohol. when prescribing the 10 ml multiple-dose cisatracurium vials in infants consider the combined daily metabolic load of benzyl alcohol from all sources including cisatracurium (multiple-dose vials contain 9 mg of benzyl alcohol per ml) and other drugs containing benzyl alcohol. the minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known [see warnings and precautions (5.2)] . this warning is not applicable to the 5 ml and 20 ml cisatracurium single-dose vials because these vials do not contain benzyl alcohol. the use of 10 ml cisatracurium multiple-dose vials is contraindicated in pediatric patients less than 1 month of age and low birth-weight infants because these patients are more likely to develop benzyl alcohol toxicity. of the total number of subjects (135) in clinical studies of cisatracurium, 57, 63, and 15 subjects were 65 to 70 years old, 70 to 80 years old, and greater than 80 years old, respectively. the geriatric population included a subset of patients with significant cardiovascular disease [see clinical pharmacology (12.3)] . because the time to maximum neuromuscular blockade is approximately 1 minute slower in geriatric patients compared to younger patients, consider extending the interval between administering cisatracurium and attempting intubation by at least 1 minute to achieve adequate intubation conditions [see dosage and administration (2.2)  and clinical pharmacology (12.2)] . the time to maximum neuromuscular blockade is approximately 1 minute slower in geriatric patients, a difference that should be taken into account when selecting a neuromuscular blocking agent (e.g., the need to rapidly secure the airway) and when initiating laryngoscopy [see clinical pharmacology (12.3)] . minor differences in the pharmacokinetics of cisatracurium between elderly and young adult patients were not associated with clinically significant differences in the recovery profile of cisatracurium following a single 0.1 mg/kg dose. besides the differences noted above, no overall differences in safety or effectiveness were observed between geriatric and younger subjects, and other reported clinical experience has not identified differences in responses between geriatric and younger subjects, but greater sensitivity of some older individuals to cisatracurium cannot be ruled out. the time to 90% neuromuscular blockade was 1 minute slower in patients with end-stage renal disease than in patients with normal renal function. therefore, consider extending the interval between administering cisatracurium and attempting intubation by at least 1 minute to achieve adequate intubation conditions [see dosage and administration (2.2)  and clinical pharmacology (12.2)] . there was no clinically significant alteration in the recovery profile of cisatracurium in patients with end-stage renal disease following a 0.1 mg/kg dose of cisatracurium. the recovery profile of cisatracurium is unchanged in patients with renal impairment, which is consistent with predominantly organ-independent elimination [see clinical pharmacology (12.3)] . the pharmacokinetic study analysis in patients with end-stage liver disease undergoing liver transplantation and healthy subjects undergoing elective surgery indicated slightly larger volumes of distribution in liver transplant patients with slightly higher plasma clearances of cisatracurium. the times to maximum neuromuscular blockade were approximately one minute faster in liver transplant patients than in healthy adult patients receiving 0.1 mg/kg cisatracurium. these minor differences in pharmacokinetics were not associated with clinically significant differences in the recovery profile of cisatracurium [see clinical pharmacology (12.3)] . patients with burns have been shown to develop resistance to nondepolarizing neuromuscular blocking agents. the extent of altered response depends upon the size of the burn and the time elapsed since the burn injury. cisatracurium has not been studied in patients with burns. however, based on its structural similarity to another neuromuscular blocking agent, consider the possibility of increased dosage requirements and shortened duration of action if cisatracurium is administered to burn patients. patients with hemiparesis or paraparesis may demonstrate resistance to nondepolarizing neuromuscular blocking agents in the affected limbs. to avoid inaccurate dosing, perform neuromuscular monitoring on a non-paretic limb. profound and prolonged neuromuscular blockade may occur in patients with neuromuscular diseases (e.g., myasthenia gravis and myasthenic syndrome) and carcinomatosis. therefore, a lower maximum initial bolus is recommended in these patients [see dosage and administration (2.2)] .

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

auromedics pharma llc - 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)] . risk summary there are no adequate and well-controlled studies of cisatracurium in pregnant women. animal studies conducted in rats administered cisatracurium besylate during organogenesis found no evidence o