Source: Health Products Regulatory Authority (ZA) Revision Year: 2022 Publisher: PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead 191
ECCLADEX 100 ug/ml concentrated solution for intravenous infusion.
| Pharmaceutical Form |
|---|
|
Concentrated solution for intravenous infusion. ECCLADEX is a clear, colourless solution. |
Each ECCLADEX ampoule or vial contains 100 μg/ml of dexmedetomidine.
ECCLADEX 2 ml ampoule contains 200 μg dexmedetomidine.
ECCLADEX 4 ml vial contains 400 μg dexmedetomidine.
ECCLADEX 10 ml vial contains 1000 μg dexmedetomidine.
Sugar free.
For full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
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 hydrochloride |
ECCLADEX is packed in 5 x 2 ml glass ampoules in an outer carton.
ECCLADEX is packed in 4 x 4 ml glass vials closed with a fluoropolymer coated bromobutyl rubber stopper, secured with an aluminium over seal with a white plastic lid and packed in an outer carton.
ECCLADEX is packed in 4 x 10 ml glass vials closed with a fluoropolymer coated bromobutyl rubber stopper, secured with an aluminium over seal with a white plastic lid and packed in an outer carton.
Not all packs or pack sizes may be marketed.
PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead 191
50/2.9/0374
10 May 2022
| Drug | Countries | |
|---|---|---|
| ECCLADEX | South Africa |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.