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.

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.

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

actavis pharma, inc. - dexmedetomidine hydrochloride (unii: 1018wh7f9i) (dexmedetomidine - unii:67vb76hono) - dexmedetomidine 100 ug in 1 ml - 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 injection 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 injection 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 intra

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

akorn - dexmedetomidine hydrochloride (unii: 1018wh7f9i) (dexmedetomidine - unii:67vb76hono) - dexmedetomidine 100 ug in 1 ml - 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 injection 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 injection 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 intra

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.

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

laboratorios syva s.a.u. - medetomidine hydrochloride 1 mg/ml - eq. medetomidine 0,85 mg/ml - solution for injection - 1 mg/ml - medetomidine hydrochloride 1 mg/ml - medetomidine - dog; cat

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

cp-pharma handelsgesellschaft gmbh - medetomidine hydrochloride 1 mg/ml - eq. medetomidine 0,85 mg/ml - solution for injection - 1 mg / ml - medetomidine hydrochloride 1 mg/ml - medetomidine - dog; cat