Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

dr.reddy's laboratories inc - dexmedetomidine hydrochloride (unii: 1018wh7f9i) (dexmedetomidine - unii:67vb76hono) - dexmedetomidine hydrochloride in 0.9% sodium chloride injection is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. dexmedetomidine hydrochloride in 0.9% sodium chloride injection should be administered by continuous infusion not to exceed 24 hours. dexmedetomidine hydrochloride in 0.9% sodium chloride injection has been continuously infused in mechanically ventilated patients prior to extubation, during extubation, and post-extubation. it is not necessary to discontinue dexmedetomidine hydrochloride in 0.9% sodium chloride injection prior to extubation. dexmedetomidine hydrochloride in 0.9% sodium chloride injection is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures. none. pregnancy category c there are no adequate and well-controlled studies of dexmedetomidine hydrochloride in 0.9% sodium chloride injection use in pregnant women. in an in vitro human placenta study, placenta

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

piramal critical care inc - dexmedetomidine hydrochloride (unii: 1018wh7f9i) (dexmedetomidine - unii:67vb76hono) - dexmedetomidine hydrochloride in 0.9% sodium chloride injection is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. dexmedetomidine hydrochloride in 0.9% sodium chloride injection should be administered by continuous infusion not to exceed 24 hours.  dexmedetomidine hydrochloride in 0.9% sodium chloride injection has been continuously infused in mechanically ventilated patients prior to extubation, during extubation, and post-extubation. it is not necessary to discontinue dexmedetomidine hydrochloride in 0.9% sodium chloride injection prior to extubation. dexmedetomidine hydrochloride in 0.9% sodium chloride injection is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures. none. pregnancy category c there are no adequate and well-controlled studies of dexmedetomidine hydrochloride in 0.9% sodium chloride injection use in pregnant women. in an in vitro human 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 dexmedetomidine hydrochloride in 0.9% sodium chloride injection should be used during pregnancy only if the potential benefits justify the potential risk to the fetus. teratogenic effects were not observed in rats following subcutaneous administration of dexmedetomidine during the period of fetal organogenesis (from gestation day 5 to 16) with doses up to 200 mcg/kg (representing a dose approximately equal to the maximum recommended human intravenous dose based on body surface area) or in rabbits following intravenous administration of dexmedetomidine during the period of fetal organogenesis (from gestation day 6 to 18) with doses up to 96 mcg/kg (representing approximately half the human exposure at the maximum recommended dose based on plasma area under the time-curve comparison). however, fetal toxicity, as evidenced by increased post-implantation losses and reduced live pups, was observed in rats at a subcutaneous dose of 200 mcg/kg. the no-effect dose in rats was 20 mcg/kg (representing a dose less than the maximum recommended human intravenous dose based on a body surface area comparison). in another reproductive toxicity study when dexmedetomidine was administered subcutaneously to pregnant rats at 8 and 32 mcg/kg (representing a dose less than the maximum recommended human intravenous dose based on a body surface area comparison) from gestation day 16 through weaning, lower offspring weights were observed. additionally, when offspring of the 32 mcg/kg group were allowed to mate, elevated fetal and embryocidal toxicity and delayed motor development was observed in second generation offspring. the safety of dexmedetomidine hydrochloride in 0.9% sodium chloride injection during labor and delivery has not been studied. it is not known whether dexmedetomidine is excreted in human milk. radio-labeled dexmedetomidine administered subcutaneously to lactating female rats was excreted in milk. because many drugs are excreted in human milk, caution should be exercised when dexmedetomidine hydrochloride in 0.9% sodium chloride injection is administered to a nursing woman. safety and efficacy have not been established for procedural or icu sedation in pediatric patients. 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 dexmedetomidine hydrochloride in 0.9% sodium chloride injection for this patient population. the use of dexmedetomidine hydrochloride in 0.9% sodium chloride injection for procedural sedation in pediatric patients has not been evaluated. 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 dexmedetomidine hydrochloride in 0.9% sodium chloride injection [ 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) and 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 dexmedetomidine-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 dexmedetomidine 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) and clinical pharmacology (12.3) ]. dexmedetomidine hydrochloride is not a controlled substance. the dependence potential of dexmedetomidine hydrochloride in 0.9% sodium chloride injection has not been studied in humans. however, since studies in rodents and primates have demonstrated that dexmedetomidine exhibits pharmacologic actions similar to those of clonidine, it is possible that dexmedetomidine hydrochloride in 0.9% sodium chloride injection may produce a clonidine-like withdrawal syndrome upon abrupt discontinuation [ see warnings and precautions (5.5) ].

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

fresenius kabi usa, llc - dexmedetomidine hydrochloride (unii: 1018wh7f9i) (dexmedetomidine - unii:67vb76hono) - dexmedetomidine hydrochloride in 0.9% sodium chloride is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. dexmedetomidine hydrochloride in 0.9% sodium chloride should be administered by continuous infusion not to exceed 24 hours. dexmedetomidine hydrochloride in 0.9% sodium chloride has been continuously infused in mechanically ventilated patients prior to extubation, during extubation, and post-extubation. it is not necessary to discontinue dexmedetomidine hydrochloride in 0.9% sodium chloride prior to extubation. dexmedetomidine hydrochloride in 0.9% sodium chloride injection is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures. none. pregnancy category c there are no adequate and well-controlled studies of dexmedetomidine hydrochloride use in pregnant women. in an in vitro human placenta study, placental transfer of dexmedetomidine occurred. in a study in the pregnant rat, p

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

slayback pharma llc - dexmedetomidine hydrochloride (unii: 1018wh7f9i) (dexmedetomidine - unii:67vb76hono) - dexmedetomidine hydrochloride in 0.9% sodium chloride injection is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. dexmedetomidine hydrochloride in 0.9% sodium chloride injection should be administered by continuous infusion not to exceed 24 hours. dexmedetomidine hydrochloride in 0.9% sodium chloride injection has been continuously infused in mechanically ventilated patients prior to extubation, during extubation, and post-extubation. it is not necessary to discontinue dexmedetomidine hydrochloride in 0.9% sodium chloride injection prior to extubation. dexmedetomidine hydrochloride in 0.9% sodium chloride injection is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures. none pregnancy category c there are no adequate and well-controlled studies of dexmedetomidine hydrochloride in 0.9% sodium chloride injection use in pregnant women. in an in vitro human placenta study, placent

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

gland pharma limited - dexmedetomidine hydrochloride (unii: 1018wh7f9i) (dexmedetomidine - unii:67vb76hono) - dexmedetomidine hydrochloride in 0.9% sodium chloride injection is indicated for sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. dexmedetomidine hydrochloride in 0.9% sodium chloride injection should be administered by continuous infusion not to exceed 24 hours. dexmedetomidine hydrochloride in 0.9% sodium chloride injection has been continuously infused in mechanically ventilated adult patients prior to extubation, during extubation, and post-extubation. it is not necessary to discontinue dexmedetomidine hydrochloride in 0.9% sodium chloride injection prior to extubation. dexmedetomidine hydrochloride in 0.9% sodium chloride injection is indicated for sedation of non-intubated adult patients prior to and/or during surgical and other procedures. pediatric use information is approved for hospira inc.’s precedextm (dexmedetomidine hydrochloride) in sodium chloride injection. however, due to hospira inc.’s marketing exclusivity rights

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

zydus lifesciences limited - dexmedetomidine hydrochloride (unii: 1018wh7f9i) (dexmedetomidine - unii:67vb76hono) - dexmedetomidine hydrochloride injection is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures. none pregnancy category c there are no adequate and well-controlled studies of dexmedetomidine hydrochloride use in pregnant women. in an in vitro human 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 dexmedetomidine hydrochloride should be used during pregnancy only if the potential benefits justify the potential risk to the fetus. teratogenic effects were not observed in rats following subcutaneous administration of dexmedetomidine during the period of fetal organogenesis (from gestation day 5 to 16) with doses up to 200 mcg/kg (representing a dose approximately equal to the maximum recommended human intravenous dose based on body surface area) o

Australija - engleski - Department of Health (Therapeutic Goods Administration)

medsurge pharma pty ltd - dexmedetomidine hydrochloride, quantity: 236 microgram (equivalent: dexmedetomidine, qty 200 microgram) - injection, concentrated - 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 dexmedetomidine hydrochloride 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.

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

civica, inc. - dexmedetomidine hydrochloride (unii: 1018wh7f9i) (dexmedetomidine - unii:67vb76hono) - dexmedetomidine hydrochloride in 0.9% sodium chloride injection is indicated for sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. dexmedetomidine hydrochloride in 0.9% sodium chloride injection should be administered by continuous infusion not to exceed 24 hours.   dexmedetomidine hydrochloride in 0.9% sodium chloride injection has been continuously infused in mechanically ventilated adult patients prior to extubation, during extubation, and post-extubation. it is not necessary to discontinue dexmedetomidine hydrochloride in 0.9% sodium chloride injection prior to extubation. dexmedetomidine hydrochloride in 0.9% sodium chloride injection is indicated for sedation of non-intubated adult 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 h

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

slayback pharma llc - dexmedetomidine hydrochloride (unii: 1018wh7f9i) (dexmedetomidine - unii:67vb76hono) - dexmedetomidine hydrochloride in 0.9% sodium chloride injection is indicated for sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. dexmedetomidine hydrochloride in 0.9% sodium chloride injection should be administered by continuous infusion not to exceed 24 hours. dexmedetomidine hydrochloride in 0.9% sodium chloride injection has been continuously infused in mechanically ventilated adult patients prior to extubation, during extubation, and post-extubation. it is not necessary to discontinue dexmedetomidine hydrochloride in 0.9% sodium chloride injection prior to extubation. dexmedetomidine hydrochloride in 0.9% sodium chloride injection is indicated for sedation of non-intubated adult 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 hav

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

mylan institutional llc - dexmedetomidine hydrochloride (unii: 1018wh7f9i) (dexmedetomidine - unii:67vb76hono) - dexmedetomidine hydrochloride in 0.9% sodium chloride injection is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. dexmedetomidine hydrochloride in 0.9% sodium chloride injection should be administered by continuous infusion not to exceed 24 hours. dexmedetomidine hydrochloride in 0.9% sodium chloride injection has been continuously infused in mechanically ventilated patients prior to extubation, during extubation, and post-extubation. it is not necessary to discontinue dexmedetomidine hydrochloride in 0.9% sodium chloride injection prior to extubation. dexmedetomidine hydrochloride in 0.9% sodium chloride injection 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 dr