PRECEDEX READY TO USE dexmedetomidine hydrochloride 400 micrograms/100 mL injection for intravenous infusion bottle Australia - English - Department of Health (Therapeutic Goods Administration)

precedex ready to use dexmedetomidine hydrochloride 400 micrograms/100 ml injection for intravenous infusion bottle

pfizer australia pty ltd - dexmedetomidine hydrochloride, quantity: 4.72 microgram/ml (equivalent: dexmedetomidine, qty 4 microgram/ml) - injection, intravenous infusion - excipient ingredients: sodium chloride; water for injections - intensive care unit (icu) sedation: for sedation of initially intubated adult patients during treatment in an intensive care setting. the use of precedex ready to use by continuous infusion in these patients should not exceed 24 hours.,procedural sedation: for sedation of non-intubated adult patients prior to and/or during surgical and other procedures.

PRECEDEX READY TO USE dexmedetomidine hydrochloride 200 micrograms/50 mL injection for intravenous infusion bottle Australia - English - Department of Health (Therapeutic Goods Administration)

precedex ready to use dexmedetomidine hydrochloride 200 micrograms/50 ml injection for intravenous infusion bottle

pfizer australia pty ltd - dexmedetomidine hydrochloride, quantity: 4.72 microgram/ml (equivalent: dexmedetomidine, qty 4 microgram/ml) - injection, intravenous infusion - excipient ingredients: sodium chloride; water for injections - intensive care unit (icu) sedation: for sedation of initially intubated adult patients during treatment in an intensive care setting. the use of precedex ready to use by continuous infusion in these patients should not exceed 24 hours.,procedural sedation: for sedation of non-intubated adult patients prior to and/or during surgical and other procedures.

PRECEDEX READY TO USE dexmedetomidine hydrochloride 80 micrograms/20 mL injection for intravenous infusion vial Australia - English - Department of Health (Therapeutic Goods Administration)

precedex ready to use dexmedetomidine hydrochloride 80 micrograms/20 ml injection for intravenous infusion vial

pfizer australia pty ltd - dexmedetomidine hydrochloride, quantity: 4.72 microgram/ml (equivalent: dexmedetomidine, qty 4 microgram/ml) - injection, intravenous infusion - excipient ingredients: sodium chloride; water for injections - intensive care unit (icu) sedation: for sedation of initially intubated adult patients during treatment in an intensive care setting. the use of precedex ready to use by continuous infusion in these patients should not exceed 24 hours.,procedural sedation: for sedation of non-intubated adult patients prior to and/or during surgical and other procedures.

PRECEDEX dexmedetomidine hydrochloride 200 micrograms/2mL injection vial Australia - English - Department of Health (Therapeutic Goods Administration)

precedex dexmedetomidine hydrochloride 200 micrograms/2ml injection vial

pfizer australia pty ltd - dexmedetomidine hydrochloride, quantity: 236 microgram (equivalent: dexmedetomidine, qty 200 microgram) - injection, concentrated - excipient ingredients: water for injections; sodium chloride - intensive care unit (icu) sedation: for sedation of initially intubated adult patients during treatment in an intensive care setting. the use of precedex by continuous infusion in these patients should not exceed 24 hours.,procedural sedation: for sedation of non-intubated adult patients prior to and/or during surgical and other procedures.

PRECEDEX- dexmedetomidine hydrochloride injection, solution
PRECEDEX- dexmedetomidine hydrochloride injection, solution, concentrate United States - English - NLM (National Library of Medicine)

precedex- dexmedetomidine hydrochloride injection, solution precedex- dexmedetomidine hydrochloride injection, solution, concentrate

hospira, inc. - dexmedetomidine hydrochloride (unii: 1018wh7f9i) (dexmedetomidine - unii:67vb76hono) - dexmedetomidine 4 ug in 1 ml - precedex is indicated for sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. precedex should be administered by continuous infusion not to exceed 24 hours. precedex has been continuously infused in mechanically ventilated adult patients prior to extubation, during extubation, and post-extubation. it is not necessary to discontinue precedex prior to extubation. precedex is indicated for sedation of non-intubated adult patients prior to and/or during surgical and other procedures. precedex is indicated for sedation of non-intubated pediatric patients aged 1 month to less than 18 years prior to and during non-invasive procedures. none. risk summary available data from published randomized controlled trials and case reports over several decades of use with intravenously administered dexmedetomidine during pregnancy have not identified a drug-associated risk of major birth defects and miscarriage; however, the reported exposures occurred after the first trimester. most of the available data are based on studies with exposures that occurred at the time of caesarean section delivery, and these studies have not identified an adverse effect on maternal outcomes or infant apgar scores. available data indicate that dexmedetomidine crosses the placenta. in animal reproduction studies, fetal toxicity that lower fetal viability and reduced live fetuses occurred with subcutaneous administration of dexmedetomidine to pregnant rats during organogenesis at doses 1.8 times the maximum recommended human dose (mrhd) of 17.8 mcg/kg/day. developmental toxicity (low pup weights and adult offspring weights, decreased f1 grip strength, increased early implantation loss and decreased viability of second-generation offspring) occurred when pregnant rats were subcutaneously administered dexmedetomidine at doses less than the clinical dose from late pregnancy through lactation and weaning (see error! hyperlink reference not valid. ) . 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. data animal data increased post-implantation losses and reduced live fetuses in the presence of maternal toxicity (i.e. decreased body weight) were noted in a rat embryo-fetal development study in which pregnant dams were administered subcutaneous doses of dexmedetomidine 200 mcg/kg/day (equivalent to 1.8 times the intravenous mrhd of 17.8 mcg/kg/day based on body surface area [bsa]) during the period of organogenesis (gestation day [gd] 6 to 15). no malformations were reported. no malformations or embryo-fetal toxicity were noted in a rabbit embryo-fetal development study in which pregnant does were administered dexmedetomidine intravenously at doses of up to 96 mcg/kg/day (approximately half the human exposure at the mrhd based on auc) during the period of organogenesis (gd 6 to 18). reduced pup and adult offspring birth weights, and grip strength were reported in a rat developmental toxicology study in which pregnant females were administered dexmedetomidine subcutaneously at doses of 8 mcg/kg/day (0.07 times the mrhd based on bsa) during late pregnancy through lactation and weaning (gd 16 to postnatal day [pnd] 25). decreased viability of second generation offspring and an increase in early implantation loss along with delayed motor development occurred in the 32 mcg/kg/day group (equivalent to less than the clinical dose based on bsa) when first generation offspring were allowed to mate. this study limited dosing to hard palate closure (gd 15 to 18) through weaning instead of dosing from implantation (gd 6 to 7) to weaning (pnd 21). in a study in the pregnant rat, placental transfer of dexmedetomidine was observed when radiolabeled dexmedetomidine was administered subcutaneously. risk summary available published literature reports the presence of dexmedetomidine in human milk following intravenous administration (see error! hyperlink reference not valid. ) . there is no information regarding the effects of dexmedetomidine on the breastfed infant or the effects on milk production. advise women to monitor the breastfed infant for irritability. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for precedex and any potential adverse effects on the breastfed infant from precedex or from the underlying condition. data in two published clinical studies, a total of 14 women were given intravenous dexmedetomidine 6 mcg/kg/hour for 10 minutes after delivery followed by continuous infusion of 0.2–0.7 mcg/kg/hour. breast milk and maternal blood samples were collected at 0, 6, 12, and 24 hours after discontinuation of dexmedetomidine. plasma and milk dexmedetomidine concentrations were detectable up to 6 hours in most subjects, up to 12 hours in one subject and undetectable in all at 24 hours. the milk-to-plasma ratio from single paired maternal milk and plasma concentrations at each time point ranged from 0.53 to 0.95. the relative infant dose was estimated to range from 0.02 to 0.098%. sedation for non-invasive procedures the safety and efficacy of precedex have been established in pediatric patients 1 month to less than 18 years of age for sedation during non-invasive procedures. use in this age group is based on one randomized double-blind, dose-ranging safety and efficacy trial in non-intubated pediatric patients 1 month to less than 17 years of age who required sedation prior to undergoing mri scans [see error! hyperlink reference not valid. ] . an increase in frequency of bradypnea, bradycardia, hypertension and hypotension was observed in pediatric patients treated with precedex [see error! hyperlink reference not valid. ]. the overall safety profile of precedex in pediatric patients was consistent with the known safety profile in adults [see error! hyperlink reference not valid. ] . the safety and effectiveness of precedex have not been established in pediatric patients less than 1 month of age. icu sedation the safety and efficacy of precedex have not been established in pediatric patients for icu sedation. one assessor-blinded trial in pediatric patients and two open label studies in neonates were conducted to assess efficacy for icu sedation. these studies did not meet their primary efficacy endpoints and the safety data submitted were insufficient to fully characterize the safety profile of precedex for these patient populations. intensive care unit sedation a total of 729 patients in the clinical studies were 65 years of age and over. a total of 200 patients were 75 years of age and over. in patients greater than 65 years of age, a higher incidence of bradycardia and hypotension was observed following administration of precedex [see warnings and precautions (5.2)] . therefore, a dose reduction may be considered in patients over 65 years of age [see dosage and administration (2.2, 2.3), clinical pharmacology (12.3)]. procedural sedation a total of 131 patients in the clinical studies were 65 years of age and over. a total of 47 patients were 75 years of age and over. hypotension occurred in a higher incidence in precedex-treated patients 65 years or older (72%) and 75 years or older (74%) as compared to patients <65 years (47%). a reduced loading dose of 0.5 mcg/kg given over 10 minutes is recommended and a reduction in the maintenance infusion should be considered for patients greater than 65 years of age. since precedex clearance decreases with increasing severity of hepatic impairment, dose reduction should be considered in patients with impaired hepatic function [see dosage and administration (2.2, 2.3), clinical pharmacology (12.3)] . precedex (dexmedetomidine hydrochloride) is not a controlled substance. the dependence potential of precedex has not been studied in humans. however, since studies in rodents and primates have demonstrated that precedex exhibits pharmacologic actions similar to those of clonidine, it is possible that precedex may produce a clonidine-like withdrawal syndrome upon abrupt discontinuation [see warnings and precautions (5.5)] .

PRECEDEX- dexmedetomidine hydrochloride injection, solution, concentrate United States - English - NLM (National Library of Medicine)

precedex- dexmedetomidine hydrochloride injection, solution, concentrate

general injectables and vaccines, inc. - dexmedetomidine hydrochloride (unii: 1018wh7f9i) (dexmedetomidine - unii:67vb76hono) - 1.1 intensive care unit sedation precedex™ is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. precedex should be administered by continuous infusion not to exceed 24 hours. precedex has been continuously infused in mechanically ventilated patients prior to extubation, during extubation, and post-extubation. it is not necessary to discontinue precedex prior to extubation. 1.2 procedural sedation precedex is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures. none 8.1 pregnancy pregnancy category c there are no adequate and well-controlled studies of precedex use in pregnant women. in an in vitrohuman placenta study, placental transfer of dexmedetomidine occurred. in a study in the pregnant rat, placental transfer of dexmedetomidine was observed when radiolabeled dexmedetomidine was administered subcutaneously. thus, fetal exposure should be expected in humans, and precedex should

PRECEDEX- dexmedetomidine hydrochloride injection, solution United States - English - NLM (National Library of Medicine)

precedex- dexmedetomidine hydrochloride injection, solution

hospira, inc. - dexmedetomidine hydrochloride (unii: 1018wh7f9i) (dexmedetomidine - unii:67vb76hono) - precedex is indicated for sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. precedex should be administered by continuous infusion not to exceed 24 hours. precedex has been continuously infused in mechanically ventilated adult patients prior to extubation, during extubation, and post-extubation. it is not necessary to discontinue precedex prior to extubation. precedex is indicated for sedation of non-intubated adult patients prior to and/or during surgical and other procedures. precedex is indicated for sedation of non-intubated pediatric patients aged 1 month to less than 18 years prior to and during non-invasive procedures. none. risk summary available data from published randomized controlled trials and case reports over several decades of use with intravenously administered dexmedetomidine during pregnancy have not identified a drug-associated risk of major birth defects and miscarriage; however, the reported exposures occurred after the first trimester. most of the available data are based on studies with exposures that occurred at the time of caesarean section delivery, and these studies have not identified an adverse effect on maternal outcomes or infant apgar scores. available data indicate that dexmedetomidine crosses the placenta. in animal reproduction studies, fetal toxicity that lower fetal viability and reduced live fetuses occurred with subcutaneous administration of dexmedetomidine to pregnant rats during organogenesis at doses 1.8 times the maximum recommended human dose (mrhd) of 17.8 mcg/kg/day. developmental toxicity (low pup weights and adult offspring weights, decreased f1 grip strength, increased early implantation loss and decreased viability of second-generation offspring) occurred when pregnant rats were subcutaneously administered dexmedetomidine at doses less than the clinical dose from late pregnancy through lactation and weaning (see data) . 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. data animal data increased post-implantation losses and reduced live fetuses in the presence of maternal toxicity (i.e. decreased body weight) were noted in a rat embryo-fetal development study in which pregnant dams were administered subcutaneous doses of dexmedetomidine 200 mcg/kg/day (equivalent to 1.8 times the intravenous mrhd of 17.8 mcg/kg/day based on body surface area [bsa]) during the period of organogenesis (gestation day [gd] 6 to 15). no malformations were reported. no malformations or embryo-fetal toxicity were noted in a rabbit embryo-fetal development study in which pregnant does were administered dexmedetomidine intravenously at doses of up to 96 mcg/kg/day (approximately half the human exposure at the mrhd based on auc) during the period of organogenesis (gd 6 to 18). reduced pup and adult offspring birth weights, and grip strength were reported in a rat developmental toxicology study in which pregnant females were administered dexmedetomidine subcutaneously at doses of 8 mcg/kg/day (0.07 times the mrhd based on bsa) during late pregnancy through lactation and weaning (gd 16 to postnatal day [pnd] 25). decreased viability of second generation offspring and an increase in early implantation loss along with delayed motor development occurred in the 32 mcg/kg/day group (equivalent to less than the clinical dose based on bsa) when first generation offspring were allowed to mate. this study limited dosing to hard palate closure (gd 15 to 18) through weaning instead of dosing from implantation (gd 6 to 7) to weaning (pnd 21). in a study in the pregnant rat, placental transfer of dexmedetomidine was observed when radiolabeled dexmedetomidine was administered subcutaneously. risk summary available published literature reports the presence of dexmedetomidine in human milk following intravenous administration (see data) . there is no information regarding the effects of dexmedetomidine on the breastfed infant or the effects on milk production. advise women to monitor the breastfed infant for irritability. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for precedex and any potential adverse effects on the breastfed infant from precedex or from the underlying condition. data in two published clinical studies, a total of 14 women were given intravenous dexmedetomidine 6 mcg/kg/hour for 10 minutes after delivery followed by continuous infusion of 0.2–0.7 mcg/kg/hour. breast milk and maternal blood samples were collected at 0, 6, 12, and 24 hours after discontinuation of dexmedetomidine. plasma and milk dexmedetomidine concentrations were detectable up to 6 hours in most subjects, up to 12 hours in one subject and undetectable in all at 24 hours. the milk-to-plasma ratio from single paired maternal milk and plasma concentrations at each time point ranged from 0.53 to 0.95. the relative infant dose was estimated to range from 0.02 to 0.098%. sedation for non-invasive procedures the safety and efficacy of precedex have been established in pediatric patients 1 month to less than 18 years of age for sedation during non-invasive procedures. use in this age group is based on one randomized double-blind, dose-ranging safety and efficacy trial in non-intubated pediatric patients 1 month to less than 17 years of age who required sedation prior to undergoing mri scans [see clinical studies (14.2)] . an increase in frequency of bradypnea, bradycardia, hypertension and hypotension was observed in pediatric patients treated with precedex [see adverse reactions (6.1)]. the overall safety profile of precedex in pediatric patients was consistent with the known safety profile in adults [see adverse reactions (6.1)] . the safety and effectiveness of precedex have not been established in pediatric patients less than 1 month of age. icu sedation the safety and efficacy of precedex have not been established in pediatric patients for icu sedation. one assessor-blinded trial in pediatric patients and two open label studies in neonates were conducted to assess efficacy for icu sedation. these studies did not meet their primary efficacy endpoints and the safety data submitted were insufficient to fully characterize the safety profile of precedex for these patient populations. intensive care unit sedation a total of 729 patients in the clinical studies were 65 years of age and over. a total of 200 patients were 75 years of age and over. in patients greater than 65 years of age, a higher incidence of bradycardia and hypotension was observed following administration of precedex [see warnings and precautions (5.2)] . therefore, a dose reduction may be considered in patients over 65 years of age [see dosage and administration (2.2, 2.3), clinical pharmacology (12.3)]. procedural sedation a total of 131 patients in the clinical studies were 65 years of age and over. a total of 47 patients were 75 years of age and over. hypotension occurred in a higher incidence in precedex-treated patients 65 years or older (72%) and 75 years or older (74%) as compared to patients <65 years (47%). a reduced loading dose of 0.5 mcg/kg given over 10 minutes is recommended and a reduction in the maintenance infusion should be considered for patients greater than 65 years of age. since precedex clearance decreases with increasing severity of hepatic impairment, dose reduction should be considered in patients with impaired hepatic function [see dosage and administration (2.2, 2.3), clinical pharmacology (12.3)] . precedex (dexmedetomidine hydrochloride) is not a controlled substance. the dependence potential of precedex has not been studied in humans. however, since studies in rodents and primates have demonstrated that precedex exhibits pharmacologic actions similar to those of clonidine, it is possible that precedex may produce a clonidine-like withdrawal syndrome upon abrupt discontinuation [see warnings and precautions (5.5)] .

PRECEDEX- dexmedetomidine hydrochloride injection, solution United States - English - NLM (National Library of Medicine)

precedex- dexmedetomidine hydrochloride injection, solution

hospira, inc. - dexmedetomidine hydrochloride (unii: 1018wh7f9i) (dexmedetomidine - unii:67vb76hono) - precedex is indicated for sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. precedex should be administered by continuous infusion not to exceed 24 hours. precedex has been continuously infused in mechanically ventilated adult patients prior to extubation, during extubation, and post-extubation. it is not necessary to discontinue precedex prior to extubation. precedex is indicated for sedation of non-intubated adult patients prior to and/or during surgical and other procedures. precedex is indicated for sedation of non-intubated pediatric patients aged 1 month to less than 18 years prior to and during non-invasive procedures. none. risk summary available data from published randomized controlled trials and case reports over several decades of use with intravenously administered dexmedetomidine during pregnancy have not identified a drug-associated risk of major birth defects and miscarriage; however, the reported exposures occurred after

PRECEDEX DEXMEDETOMIDINE HCI CHLORIDE- dexmedetomidine hydrochloride, sodium chloride injection, solution United States - English - NLM (National Library of Medicine)

precedex dexmedetomidine hci chloride- dexmedetomidine hydrochloride, sodium chloride injection, solution

fareva amboise - dexmedetomidine hydrochloride (unii: 1018wh7f9i) (dexmedetomidine - unii:67vb76hono) - precedex is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. precedex should be administered by continuous infusion not to exceed 24 hours. precedex has been continuously infused in mechanically ventilated patients prior to extubation, during extubation, and post-extubation. it is not necessary to discontinue precedex prior to extubation. precedex is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures. none. risk summary available data from published randomized controlled trials and case reports over several decades of use with intravenously administered dexmedetomidine during pregnancy have not identified a drug-associated risk of major birth defects and miscarriage; however, the reported exposures occurred after the first trimester. most of the available data are based on studies with exposures that occurred at the time of caesarean section delivery, and these studies have not i

Medel Medel Control Automatic Blood Pressure Monitor. Singapore - English - HSA (Health Sciences Authority)

medel medel control automatic blood pressure monitor.

duo medical pte. ltd. - general hospital - medel control automatic blood pressure monitor is intended to be used for measuring human systolic/ diastolic blood pressure and heart rate.