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.

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.

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.

Malta - English - Medicines Authority

fresenius kabi italia s.r.l via camagre 41, 37063 isola della scala (vr) , italy - dexmedetomidine - concentrate for solution for infusion - dexmedetomidine 100 µg/ml - psycholeptics

Malta - English - Medicines Authority

fresenius kabi italia s.r.l via camagre 41, 37063 isola della scala (vr) , italy - dexmedetomidine - concentrate for solution for infusion - dexmedetomidine 100 µg/ml - psycholeptics

Malta - English - Medicines Authority

fresenius kabi italia s.r.l via camagre 41, 37063 isola della scala (vr) , italy - dexmedetomidine - concentrate for solution for infusion - dexmedetomidine 100 µg/ml - psycholeptics

Ireland - English - HPRA (Health Products Regulatory Authority)

fresenius kabi deutschland gmbh - dexmedetomidine hydrochloride - concentrate for solution for infusion - 100 microgram(s)/millilitre - dexmedetomidine

Ireland - English - HPRA (Health Products Regulatory Authority)

baxter holding b.v. - dexmedetomidine hydrochloride - concentrate for solution for infusion - 100 microgram(s)/millilitre - dexmedetomidine