Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: PAION Deutschland GmbH, Heussstraße 25, 52078 Aachen, Germany Tel: +800 4453 4453 e-mail: info@paion.com
Byfavo 20 mg powder for solution for injection.
| Pharmaceutical Form |
|---|
|
Powder for solution for injection. White to off-white powder. |
Each vial contains remimazolam besylate equivalent to 20 mg remimazolam.
After reconstitution each mL contains 2.5 mg remimazolam.
Excipient with known effect: Each vial contains 79.13 mg of dextran 40 for injection.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Remimazolam |
Remimazolam is an ultra-short acting benzodiazepine sedative. The effects of remimazolam on the CNS are dependent on the dose administered intravenously and presence or absence of other medicinal products. Remimazolam binds to benzodiazepine sites of gamma amino butyric acid type A [GABAA] receptors with high affinity, while its carboxylic acid metabolite (CNS7054) has approximately 300 times lower affinity for these receptors. |
| List of Excipients |
|---|
|
Dextran 40 for injection |
Type 1 glass vial with a stopper (bromobutyl rubber) and seal (aluminium) with blue polypropylene flip-off cap.
Pack size: 10 vial pack.
PAION Deutschland GmbH, Heussstraße 25, 52078 Aachen, Germany
Tel: +800 4453 4453
e-mail: info@paion.com
EU/1/20/1505/001
Date of first authorisation: March 26, 2021
| Drug | Countries | |
|---|---|---|
| BYFAVO | Estonia, Finland, Croatia, Ireland, Lithuania, Poland, Romania, United Kingdom, United States |
© 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.
