Canada - English - Health Canada

omega laboratories limited - dexmedetomidine (dexmedetomidine hydrochloride) - solution - 100mcg - dexmedetomidine (dexmedetomidine hydrochloride) 100mcg

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

medical purchasing solutions, llc - 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 teratogenic effects: 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 intraven

New Zealand - English - Medsafe (Medicines Safety Authority)

medsurge pharma limited - dexmedetomidine hydrochloride 0.118 mg/ml equivalent to dexmedetomidine 0.100 mg/1 ml - concentrate for infusion - active: dexmedetomidine hydrochloride 0.118 mg/ml equivalent to dexmedetomidine 0.100 mg/1 ml excipient: sodium chloride water for injection - icu sedation: for sedation of initially intubated patients during treatment in an intensive care setting. the use of dexmedetomidine 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.

New Zealand - English - Medsafe (Medicines Safety Authority)

medsurge pharma limited - dexmedetomidine hydrochloride 0.118 mg/ml equivalent to dexmedetomidine 0.100 mg/1 ml - concentrate for infusion - active: dexmedetomidine hydrochloride 0.118 mg/ml equivalent to dexmedetomidine 0.100 mg/1 ml excipient: sodium chloride water for injection - icu sedation: for sedation of initially intubated patients during treatment in an intensive care setting. the use of dexmedetomidine 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.

New Zealand - English - Medsafe (Medicines Safety Authority)

medsurge pharma limited - dexmedetomidine hydrochloride 0.118 mg/ml equivalent to dexmedetomidine 0.100 mg/1 ml - concentrate for infusion - active: dexmedetomidine hydrochloride 0.118 mg/ml equivalent to dexmedetomidine 0.100 mg/1 ml excipient: nitrogen sodium chloride water for injection - icu sedation: for sedation of initially intubated patients during treatment in an intensive care setting. the use of dexmedetomidine 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.

New Zealand - English - Medsafe (Medicines Safety Authority)

medsurge pharma limited - dexmedetomidine hydrochloride 0.118 mg/ml equivalent to dexmedetomidine 0.100 mg/1 ml - concentrate for infusion - active: dexmedetomidine hydrochloride 0.118 mg/ml equivalent to dexmedetomidine 0.100 mg/1 ml excipient: nitrogen sodium chloride water for injection - icu sedation: for sedation of initially intubated patients during treatment in an intensive care setting. the use of dexmedetomidine 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.

New Zealand - English - Medsafe (Medicines Safety Authority)

medsurge pharma limited - dexmedetomidine hydrochloride 0.118 mg/ml equivalent to dexmedetomidine 0.100 mg/1 ml - concentrate for infusion - active: dexmedetomidine hydrochloride 0.118 mg/ml equivalent to dexmedetomidine 0.100 mg/1 ml excipient: sodium chloride water for injection - icu sedation: for sedation of initially intubated patients during treatment in an intensive care setting. the use of dexmedetomidine 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.

New Zealand - English - Medsafe (Medicines Safety Authority)

medsurge pharma limited - dexmedetomidine hydrochloride 0.118 mg/ml equivalent to dexmedetomidine 0.100 mg/1 ml - concentrate for infusion - active: dexmedetomidine hydrochloride 0.118 mg/ml equivalent to dexmedetomidine 0.100 mg/1 ml excipient: sodium chloride water for injection - icu sedation: for sedation of initially intubated patients during treatment in an intensive care setting. the use of dexmedetomidine 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.

Canada - English - Health Canada

accord healthcare inc - dexmedetomidine (dexmedetomidine hydrochloride) - solution - 100mcg - dexmedetomidine (dexmedetomidine hydrochloride) 100mcg - miscellaneous anxiolytics sedatives and hypnotics

Canada - English - Health Canada

eugia pharma inc. - dexmedetomidine (dexmedetomidine hydrochloride) - solution - 100mcg - dexmedetomidine (dexmedetomidine hydrochloride) 100mcg