Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Austria
Tyruko 300 mg concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion (sterile concentrate). Colourless, clear to slightly opalescent solution. |
Each mL of concentrate contains 20 mg of natalizumab.
When diluted (see section 6.6), the solution for infusion contains approximately 2.6 mg per mL of natalizumab.
Natalizumab is a recombinant humanised anti-α4-integrin antibody produced in a Chinese Hamster Ovary (CHO) cell line by recombinant DNA technology.
Excipient with known effect: Each vial contains 2.3 mmol (or 52 mg) sodium (see section 4.4 for further information).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Natalizumab |
Natalizumab is a selective adhesion-molecule inhibitor and binds to the α4-subunit of human integrins, which is highly expressed on the surface of all leukocytes, with the exception of neutrophils. |
| List of Excipients |
|---|
|
Sodium chloride |
15 mL concentrate in a vial (type I glass) with a stopper (bromobutyl rubber) and a seal (aluminium) with a flip-off cap.
Pack size of one vial per carton.
Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Austria
EU/1/23/1745/001
| Drug | Countries | |
|---|---|---|
| TYRUKO | Austria, Estonia, Spain, France, Croatia, Ireland, Italy, Lithuania, United Kingdom |
© 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.
