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

akorn - dexmedetomidine hydrochloride (unii: 1018wh7f9i) (dexmedetomidine - unii:67vb76hono) - dexmedetomidine 100 ug in 1 ml - dexmedetomidine hydrochloride injection is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures. none teratogenic effects. pregnancy category c there are no adequate and well controlled studies of dexmedetomidine hydrochloride 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 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 intra

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

actavis pharma, inc. - dexmedetomidine hydrochloride (unii: 1018wh7f9i) (dexmedetomidine - unii:67vb76hono) - dexmedetomidine 100 ug in 1 ml - dexmedetomidine hydrochloride injection is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures. none teratogenic effects: pregnancy category c there are no adequate and well-controlled studies of dexmedetomidine hydrochloride 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 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 intra

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

fresenius kabi usa, llc - dexmedetomidine hydrochloride (unii: 1018wh7f9i) (dexmedetomidine - unii:67vb76hono) - dexmedetomidine 100 ug in 1 ml - 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 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 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 base

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

jiangsu hengrui medicine co., ltd. - dexmedetomidine hydrochloride (unii: 1018wh7f9i) (dexmedetomidine - unii:67vb76hono) - dexmedetomidine 100 ug in 1 ml - dexmedetomidine injection is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. dexmedetomidine injection should be administered by continuous infusion not to exceed 24 hours. dexmedetomidine injection has been continuously infused in mechanically ventilated patients prior to extubation, during extubation, and post-extubation. it is not necessary to discontinue dexmedetomidine injection prior to extubation. dexmedetomidine 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 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 human

Canada - English - Health Canada

sandoz canada incorporated - dexmedetomidine (dexmedetomidine hydrochloride) - solution - 100mcg - dexmedetomidine (dexmedetomidine hydrochloride) 100mcg - miscellaneous anxiolytics sedatives and hypnotics

Canada - English - Health Canada

hikma canada limited - dexmedetomidine (dexmedetomidine hydrochloride) - solution - 100mcg - dexmedetomidine (dexmedetomidine hydrochloride) 100mcg

Canada - English - Health Canada

hikma canada limited - dexmedetomidine (dexmedetomidine hydrochloride) - solution - 4mcg - dexmedetomidine (dexmedetomidine hydrochloride) 4mcg

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

eugia us llc - dexmedetomidine hydrochloride (unii: 1018wh7f9i) (dexmedetomidine - unii:67vb76hono) - dexmedetomidine 100 ug in 1 ml - dexmedetomidine injection is indicated for sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. dexmedetomidine injection should be administered by continuous infusion not to exceed 24 hours. dexmedetomidine 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 injection prior to extubation. dexmedetomidine 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) injection and precedextm (dexmedetomidine hydrochloride) in sodium chloride injection. however, due to hospira inc.’s marketing exclusivity rights, this drug product is not labeled with that information. none. risk summary available data from published randomized controll

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

accord healthcare inc. - dexmedetomidine hydrochloride (unii: 1018wh7f9i) (dexmedetomidine - unii:67vb76hono) - dexmedetomidine 100 ug in 1 ml - dexmedetomidine injection is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. dexmedetomidine injection should be administered by continuous infusion not to exceed 24 hours. dexmedetomidine injection has been continuously infused in mechanically ventilated patients prior to extubation, during extubation, and post-extubation. it is not necessary to discontinue dexmedetomidine injection prior to extubation. dexmedetomidine 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 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 t

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

putney, inc. - dexmedetomidine hydrochloride (unii: 1018wh7f9i) (dexmedetomidine - unii:67vb76hono) - dexmedetomidine 0.5 mg in 1 ml - indications: dexmedetomidine hcl is indicated for use as a sedative and analgesic in dogs and cats to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. dexmedetomidine hcl is also indicated for use as a preanesthetic to general anesthesia in dogs and cats. contraindications: do not use dexmedetomidine hcl in dogs or cats with cardiovascular disease, respiratory disorders, liver or kidney diseases, or in conditions of shock, severe debilitation, or stress due to extreme heat, cold or fatigue. as with all alpha2 -adrenoceptor agonists, the potential for isolated cases of hypersensitivity, including paradoxical response (excitation), exists.