Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Orion Corporation, Orionintie 1, FI-02200 Espoo, Finland
Dexdor 100 micrograms/ml concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion (sterile concentrate). The concentrate is a clear, colourless solution, pH 4.5–7.0. |
Each 1 ml of concentrate contains dexmedetomidine hydrochloride equivalent to 100 micrograms dexmedetomidine.
Each 2 ml ampoule contains 200 micrograms of dexmedetomidine.
Each 2 ml vial contains 200 micrograms of dexmedetomidine.
Each 4 ml vial contains 400 micrograms of dexmedetomidine.
Each 10 ml vial contains 1000 micrograms of dexmedetomidine.
The concentration of the final solution after dilution should be either 4 micrograms/ml or 8 micrograms/ml.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Dexmedetomidine |
Dexmedetomidine is a selective alpha-2 receptor agonist with a broad range of pharmacological properties. It has a sympatholytic effect through decrease of the release of noradrenaline in sympathetic nerve endings. The sedative effects are mediated through decreased firing of locus coeruleus, the predominant noradrenergic nucleus, situated in the brainstem. |
| List of Excipients |
|---|
|
Sodium chloride |
2 ml Type I glass ampoules.
2, 5 or 10 ml Type I glass vials (with filling volumes of 2, 4 and 10 ml), grey bromobutyl rubber closure with fluoropolymer coating.
Pack sizes:
5 × 2 ml ampoules
25 × 2 ml ampoules
5 × 2 ml vials
4 × 4 ml vials
4 × 10 ml vials
Not all pack sizes may be marketed.
Orion Corporation, Orionintie 1, FI-02200 Espoo, Finland
EU/1/11/718/001-002
EU/1/11/718/004
EU/1/11/718/006-007
Date of first authorisation: 16 September 2011
Date of latest renewal: 26 May 2016
| Drug | Countries | |
|---|---|---|
| DEXDOR | Austria, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Lithuania, Netherlands, Poland, United Kingdom |
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