Ireland - English - HPRA (Health Products Regulatory Authority)

b. braun melsungen ag - dexmedetomidine - concentrate for solution for infusion - 100 microgram(s)/millilitre - dexmedetomidine

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

teva pharma australia pty ltd - dexmedetomidine hydrochloride, quantity: 236 microgram (equivalent: dexmedetomidine, qty 200 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 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.

Ireland - English - HPRA (Health Products Regulatory Authority)

as kalceks - dexmedetomidine - concentrate for solution for infusion - 100 microgram(s)/millilitre - dexmedetomidine

Australia - English - 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.

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.