Irlande - anglais - HPRA (Health Products Regulatory Authority)

ever valinject gmbh - dexmedetomidine hydrochloride - concentrate for solution for infusion - 100 microgram(s)/millilitre - other hypnotics and sedatives; dexmedetomidine

Australie - anglais - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - dexmedetomidine hydrochloride, quantity: 236 microgram (equivalent: dexmedetomidine, qty 200 microgram) - injection, concentrated - excipient ingredients: water for injections; sodium chloride - intensive care unit (icu) sedation: for sedation of initially intubated adult patients during treatment in an intensive care setting. the use of precedex 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.

Nouvelle-Zélande - anglais - 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.

États-Unis - anglais - NLM (National Library of Medicine)

zoetis inc. - detomidine hydrochloride (unii: 95k4lkb6qe) (detomidine - unii:7n8k34p2xh) - dormosedan gel is indicated for sedation and restraint in horses. dormosedan gel is contraindicated in horses with known hypersensitivity to detomidine. intravenous potentiated sulfonamides should not be used in anesthetized or sedated horses as potentially fatal dysrhythmias may occur. do not use dormosedan gel in horses with pre-existing atrioventricular (av) or sino-atrial (sa) blocks, respiratory disease, or chronic renal failure. this summary contains important information about dormosedan (detomidine hydrochloride) gel. you should read this information before you administer dormosedan gel to your horse. this sheet is provided only as a summary and does not take the place of instructions from your veterinarian. talk to your veterinarian if you do not understand any of this information or if you want to know more about dormosedan gel. what is dormosedan gel? dormosedan gel is an oromucosal sedative containing detomidine hydrochloride. it is prescribed by veterinarians to allow procedures to be done in an

États-Unis - anglais - 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

Australie - anglais - Department of Health (Therapeutic Goods Administration)

interpharma pty ltd - dexmedetomidine hydrochloride, quantity: 1182 microgram (equivalent: dexmedetomidine, qty 1000 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.

Australie - anglais - Department of Health (Therapeutic Goods Administration)

interpharma pty ltd - dexmedetomidine hydrochloride, quantity: 472.8 microgram (equivalent: dexmedetomidine, qty 400 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.

États-Unis - anglais - NLM (National Library of Medicine)

piramal critical care inc - dexmedetomidine hydrochloride (unii: 1018wh7f9i) (dexmedetomidine - unii:67vb76hono) - 1.1 intensive care unit sedation 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. 1.2 procedural sedation dexmedetomidine injection is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures. none. 8.1 pregnancy pregnancy category c there are no adequate and well-controlled studies of dexmedetomidine 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 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 intravenous dose based on body surface area) or in rabbits following intravenous administration of dexmedetomidine during the period of fetal organogenesis (from gestation day 6 to 18) with doses up to 96 mcg/kg (representing approximately half the human exposure at the maximum recommended dose based on plasma area under the time-curve comparison). however, fetal toxicity, as evidenced by increased post-implantation losses and reduced live pups, was observed in rats at a subcutaneous dose of 200 mcg/kg. the no-effect dose in rats was 20 mcg/kg (representing a dose less than the maximum recommended human intravenous dose based on a body surface area comparison). in another reproductive toxicity study when dexmedetomidine was administered subcutaneously to pregnant rats at 8 and 32 mcg/kg (representing a dose less than the maximum recommended human intravenous dose based on a body surface area comparison) from gestation day 16 through weaning, lower offspring weights were observed. additionally, when offspring of the 32 mcg/kg group were allowed to mate, elevated fetal and embryocidal toxicity and delayed motor development was observed in second generation offspring. 8.2 labor and delivery the safety of dexmedetomidine injection during labor and delivery has not been studied. 8.3 nursing mothers it is not known whether dexmedetomidine hydrochloride is excreted in human milk. radio-labeled dexmedetomidine administered subcutaneously to lactating female rats was excreted in milk. because many drugs are excreted in human milk, caution should be exercised when dexmedetomidine injection is administered to a nursing woman. 8.4 pediatric use safety and efficacy have not been established for procedural or icu sedation in pediatric patients. one assessor-blinded trial in pediatric patients and two open label studies in neonates were conducted to assess efficacy for icu sedation. these studies did not meet their primary efficacy endpoints and the safety data submitted were insufficient to fully characterize the safety profile of dexmedetomidine injection for this patient population. the use of dexmedetomidine for procedural sedation in pediatric patients has not been evaluated. 8.5 geriatric use intensive care unit sedation a total of 729 patients in the clinical studies were 65 years of age and over. a total of 200 patients were 75 years of age and over. in patients greater than 65 years of age, a higher incidence of bradycardia and hypotension was observed following administration of dexmedetomidine injection [see warnings and precautions ( 5.2)]. therefore, a dose reduction may be considered in patients over 65 years of age [see dosage and administration ( 2.2, 2.3), clinical pharmacology ( 12.3)]. procedural sedation a total of 131 patients in the clinical studies were 65 years of age and over. a total of 47 patients were 75 years of age and over. hypotension occurred in a higher incidence in dexmedetomidine injection-treated patients 65 years or older (72%) and 75 years or older (74%) as compared to patients <65 years (47%). a reduced loading dose of 0.5 mcg/kg given over 10 minutes is recommended and a reduction in the maintenance infusion should be considered for patients greater than 65 years of age. 8.6 hepatic impairment since dexmedetomidine clearance decreases with increasing severity of hepatic impairment, dose reduction should be considered in patients with impaired hepatic function [see dosage and administration ( 2.2, 2.3) and clinical pharmacology ( 12.3)]. 9.1 controlled substance dexmedetomidine injection (dexmedetomidine hydrochloride) is not a controlled substance. 9.3 dependence the dependence potential of dexmedetomidine injection has not been studied in humans. however, since studies in rodents and primates have demonstrated that dexmedetomidine injection exhibits pharmacologic actions similar to those of clonidine, it is possible that dexmedetomidine injection may produce a clonidine-like withdrawal syndrome upon abrupt discontinuation [see warnings and precautions ( 5.5)].

États-Unis - anglais - NLM (National Library of Medicine)

piramal critical care inc - dexmedetomidine hydrochloride (unii: 1018wh7f9i) (dexmedetomidine - unii:67vb76hono) - 1.1 intensive care unit sedation 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. 1.2 procedural sedation dexmedetomidine injection is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures. none. 8.1 pregnancy pregnancy category c there are no adequate and well-controlled studies of dexmedetomidine 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 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 intravenous dose based on body surface area) or in rabbits following intravenous administration of dexmedetomidine during the period of fetal organogenesis (from gestation day 6 to 18) with doses up to 96 mcg/kg (representing approximately half the human exposure at the maximum recommended dose based on plasma area under the time-curve comparison). however, fetal toxicity, as evidenced by increased post-implantation losses and reduced live pups, was observed in rats at a subcutaneous dose of 200 mcg/kg. the no-effect dose in rats was 20 mcg/kg (representing a dose less than the maximum recommended human intravenous dose based on a body surface area comparison). in another reproductive toxicity study when dexmedetomidine was administered subcutaneously to pregnant rats at 8 and 32 mcg/kg (representing a dose less than the maximum recommended human intravenous dose based on a body surface area comparison) from gestation day 16 through weaning, lower offspring weights were observed. additionally, when offspring of the 32 mcg/kg group were allowed to mate, elevated fetal and embryocidal toxicity and delayed motor development was observed in second generation offspring. 8.2 labor and delivery the safety of dexmedetomidine injection during labor and delivery has not been studied. 8.3 nursing mothers it is not known whether dexmedetomidine hydrochloride is excreted in human milk. radio-labeled dexmedetomidine administered subcutaneously to lactating female rats was excreted in milk. because many drugs are excreted in human milk, caution should be exercised when dexmedetomidine injection is administered to a nursing woman. 8.4 pediatric use safety and efficacy have not been established for procedural or icu sedation in pediatric patients. one assessor-blinded trial in pediatric patients and two open label studies in neonates were conducted to assess efficacy for icu sedation. these studies did not meet their primary efficacy endpoints and the safety data submitted were insufficient to fully characterize the safety profile of dexmedetomidine injection for this patient population. the use of dexmedetomidine for procedural sedation in pediatric patients has not been evaluated. 8.5 geriatric use intensive care unit sedation a total of 729 patients in the clinical studies were 65 years of age and over. a total of 200 patients were 75 years of age and over. in patients greater than 65 years of age, a higher incidence of bradycardia and hypotension was observed following administration of dexmedetomidine injection [see warnings and precautions ( 5.2)]. therefore, a dose reduction may be considered in patients over 65 years of age [see dosage and administration ( 2.2, 2.3), clinical pharmacology ( 12.3)]. procedural sedation a total of 131 patients in the clinical studies were 65 years of age and over. a total of 47 patients were 75 years of age and over. hypotension occurred in a higher incidence in dexmedetomidine injection-treated patients 65 years or older (72%) and 75 years or older (74%) as compared to patients <65 years (47%). a reduced loading dose of 0.5 mcg/kg given over 10 minutes is recommended and a reduction in the maintenance infusion should be considered for patients greater than 65 years of age. 8.6 hepatic impairment since dexmedetomidine clearance decreases with increasing severity of hepatic impairment, dose reduction should be considered in patients with impaired hepatic function [see dosage and administration ( 2.2, 2.3) and clinical pharmacology ( 12.3)]. 9.1 controlled substance dexmedetomidine injection (dexmedetomidine hydrochloride) is not a controlled substance. 9.3 dependence the dependence potential of dexmedetomidine injection has not been studied in humans. however, since studies in rodents and primates have demonstrated that dexmedetomidine injection exhibits pharmacologic actions similar to those of clonidine, it is possible that dexmedetomidine injection may produce a clonidine-like withdrawal syndrome upon abrupt discontinuation [see warnings and precautions ( 5.5)].

Australie - anglais - Department of Health (Therapeutic Goods Administration)

medsurge pharma 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 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.