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

Australia - English - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - dexmedetomidine hydrochloride, quantity: 118 microgram/ml - injection, intravenous infusion - excipient ingredients: water for injections; sodium chloride - icu sedation,for sedation of initially intubated patients during treatment in an intensive care setting. the use of dexmedetomidine sandoz by continuous infusion in these patients should not exceed 24 hours.,procedural sedation,for sedation of non-intubated patients prior to and/or during surgical and other procedures.

Australia - English - Department of Health (Therapeutic Goods Administration)

accord healthcare pty ltd - dexmedetomidine hydrochloride, quantity: 118 microgram/ml (equivalent: dexmedetomidine, qty microgram/ml) - injection, concentrated - excipient ingredients: sodium chloride; water for injections - icu sedation: for sedation of initially intubated adult patients during treatment in an intensive care setting. the use of dexmedetomidine accord 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.

Australia - English - Department of Health (Therapeutic Goods Administration)

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

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)

attix pharmaceuticals - medetomidine hydrochloride (unii: bh210p244u) (medetomidine - unii:mr15e85mqm) -

Australia - English - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - dexmedetomidine hydrochloride, quantity: 118 microgram/ml (equivalent: dexmedetomidine, qty 100 microgram/ml) - injection, concentrated - excipient ingredients: nitrogen; water for injections; sodium chloride - icu sedation:,for sedation of initially intubated adult patients during treatment in an intensive care setting. the use of dexmedetomidine viatris 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.

Australia - English - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - dexmedetomidine hydrochloride, quantity: 472 microgram (equivalent: dexmedetomidine, qty 400 microgram) - injection, concentrated - excipient ingredients: sodium chloride; water for injections - intensive care unit (icu) sedation,for sedation of initially intubated patients during treatment in an intensive care setting. the use of dexmedetomidine kabi by continuous infusion in these patients should not exceed 24 hours.,procedural sedation,for sedation of non-intubated patients prior to and/or during surgical and other procedures.

Australia - English - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia 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 patients during treatment in an intensive care setting. the use of dexmedetomidine kabi by continuous infusion in these patients should not exceed 24 hours.,procedural sedation,for sedation of non-intubated patients prior to and/or during surgical and other procedures.

Australia - English - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - dexmedetomidine hydrochloride, quantity: 1180 microgram (equivalent: dexmedetomidine, qty 1000 microgram) - injection, concentrated - excipient ingredients: sodium chloride; water for injections - intensive care unit (icu) sedation,for sedation of initially intubated patients during treatment in an intensive care setting. the use of dexmedetomidine kabi by continuous infusion in these patients should not exceed 24 hours.,procedural sedation,for sedation of non-intubated patients prior to and/or during surgical and other procedures.