Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Alexion Europe SAS, 103-105 rue Anatole France, 92300, Levallois-Perret, France
KANUMA 2 mg/ml concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion (sterile concentrate). Clear to slightly opalescent, colourless to slightly coloured solution. |
Each ml of concentrate contains 2 mg sebelipase alfa*.
Each vial of 10 ml contains 20 mg sebelipase alfa.
* produced in egg white of transgenic Gallus by recombinant DNA (rDNA) technology.
Excipient with known effect: Each vial contains 33 mg sodium.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Sebelipase alfa |
Sebelipase alfa is a recombinant human lysosomal acid lipase (rhLAL). Replacement of LAL enzyme activity leads to reductions in liver fat content and transaminases, and enables metabolism of cholesteryl esters and triglycerides in the lysosome, leading to reductions in lowdensity lipoprotein (LDL) cholesterol and non-high-density lipoprotein (HDL) cholesterol, triglycerides, and increases in HDL cholesterol. Improvement in growth occurs as a result of substrate reduction in the intestine. |
| List of Excipients |
|---|
|
Sodium citrate |
Clear glass vial (Type I) with a siliconised butyl rubber stopper, and an aluminium seal with a plastic flipoff cap, containing 10 ml of concentrate.
Pack size: 1 vial.
Alexion Europe SAS, 103-105 rue Anatole France, 92300, Levallois-Perret, France
EU/1/15/1033/001
Date of first authorisation: 28 August 2015
| Drug | Countries | |
|---|---|---|
| KANUMA | Austria, Brazil, Canada, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, Turkey, 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.
