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

teva pharma australia pty ltd - dexmedetomidine hydrochloride, quantity: 236 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.

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

interpharma pty ltd - dexmedetomidine hydrochloride, quantity: 236.4 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 ever pharma 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)

pharmacy retailing (nz) ltd t/a healthcare logistics - dexmedetomidine hydrochloride 118 µg/ml equivalent to equivalent to 100 micrograms/ml dexmedetomidine - concentrate for injection - 200 mcg/2ml - active: dexmedetomidine hydrochloride 118 µg/ml equivalent to equivalent to 100 micrograms/ml dexmedetomidine 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 accord 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)

pharmacy retailing (nz) ltd t/a healthcare logistics - dexmedetomidine hydrochloride 0.1182 mg/ml equivalent to dexmedetomidine 0.1mg/ml - concentrate for injection - active: dexmedetomidine hydrochloride 0.1182 mg/ml equivalent to dexmedetomidine 0.1mg/ml excipient: sodium chloride water for injection - for sedation of initially intubated patients during treatment in an intensive care setting. the use of dexmedetomidine hydrochloride ever pharma by continuous intubation in these patents should not exceed 24 hours. for sedation of non-intubated patients prior to and/or during surgical and other procedures.

New Zealand - English - Medsafe (Medicines Safety Authority)

teva pharma (new zealand) limited - dexmedetomidine hydrochloride 118 µg/ml (equiv 100 µg/ml dexmedetomidine) - concentrate for infusion - 100 mcg/ml - active: dexmedetomidine hydrochloride 118 µg/ml (equiv 100 µg/ml dexmedetomidine) excipient: sodium chloride water for injection - for sedation of initially intubated patients during treatment in an intensive care setting. the use of dexmedetomidine-teva by continuous intubation in these patents should not exceed 24 hours. for sedation of non-intubated patients prior to and/or during surgical and other procedures.

European Union - English - EMA (European Medicines Agency)

accord healthcare s.l.u. - dexmedetomidine - premedication - psycholeptics - for sedation of adult icu (intensive care unit) patients requiring a sedation level not deeper than arousal in response to verbal stimulation (corresponding to richmond agitation-sedation scale (rass) 0 to -3).for sedation of non-intubated adult patients prior to and/or during diagnostic or surgical procedures requiring sedation, i.e. procedural/awake sedation.

Israel - English - Ministry of Health

pharmalogic ltd - dexmedetomidine as hydrochloride - concentrate for solution for infusion - dexmedetomidine as hydrochloride 100 mcg / 1 ml - dexmedetomidine - dexmedetomidine ever pharma is indicated:for sedation of adult icu (intensive care unit) patients requiring sedation level not deeper than arousal in response to verbal stimulation (corresponding to richmond agitation-sedation scale (rass) 0 to -3).for sedation of non-intubated adult patients prior to and/or during diagnostic or surgicalprocedures requiring sedation, i.e. procedural/awake sedation.

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; sodium chloride; water for injections - ? icu sedation,for sedation of initially intubated patients during treatment in an intensive care setting. the use of dexmedetomidine alphapharm 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: 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 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.

Ireland - English - HPRA (Health Products Regulatory Authority)

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