Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Takeda Manufacturing Austria AG, Industriestrasse 67, A-1221, Vienna, Austria
KIOVIG 100 mg/ml solution for infusion.
| Pharmaceutical Form |
|---|
|
Solution for infusion. The solution is clear or slightly opalescent and colourless or pale yellow. |
Human normal immunoglobulin (IVIg).
One ml contains: Human normal immunoglobulin 100 mg (purity of at least 98% IgG).
Each vial of 10 ml contains: 1 g of human normal immunoglobulin.
Each vial of 25 ml contains: 2.5 g of human normal immunoglobulin.
Each vial of 50 ml contains: 5 g of human normal immunoglobulin.
Each vial of 100 ml contains: 10 g of human normal immunoglobulin.
Each vial of 200 ml contains: 20 g of human normal immunoglobulin.
Each vial of 300 ml contains: 30 g of human normal immunoglobulin.
Distribution of IgG subclasses (approx. values):
IgG1 ≥56.9%
IgG2 ≥26.6%
IgG3 ≥3.4%
IgG4 ≥1.7%
The maximum IgA content is 140 micrograms/ml.
Produced from the plasma of human donors.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Immunoglobulins, normal human, IV |
Human normal immunoglobulin contains mainly immunoglobulin G (IgG) with a broad spectrum of antibodies against infectious agents. The mechanism of action in indications other than replacement therapy is not fully elucidated, but includes immunomodulatory effects. |
| List of Excipients |
|---|
|
Glycine |
10, 25, 50, 100, 200 or 300 ml of solution in a vial (Type I glass) with a stopper (bromobutyl).
Pack size: 1 vial.
Not all presentations may be marketed.
Takeda Manufacturing Austria AG, Industriestrasse 67, A-1221, Vienna, Austria
EU/1/05/329/001
EU/1/05/329/002
EU/1/05/329/003
EU/1/05/329/004
EU/1/05/329/005
EU/1/05/329/006
Date of first authorization: 19 January 2006
Date of latest renewal: 06 December 2010
| Drug | Countries | |
|---|---|---|
| KIOVIG | Austria, Brazil, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, Singapore, Tunisia, Turkey, 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.
