neous species were performed.
6. Pharmaceutical particulars
6.1 List of excipients
Glycine
Water for injections
6.2 Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
6.3 Shelf life
2 years.
If dilution to lower concentrations is required, immediate use after dilution is recommended. The in-use stability of KIOVIG after dilution with a 5% glucose solution to a final concentration of 50 mg/ml (5%) immunoglobulin has been demonstrated for 21 days at 2°C to 8°C as well as 28°C to 30°C; however, these studies did not include the microbial contamination and safety aspect.
6.4 Special precautions for storage
Do not store above 25°C.
Do not freeze.
Keep the vial in the outer carton in order to protect from light.
For storage conditions after dilution of the medicinal product, see section 6.3.
6.5 Nature and contents of container
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.
6.6 Special precautions for disposal and other handling
The product should be brought to room or body temperature before use.
If dilution is required, 5% glucose solution is recommended. For obtaining an immunoglobulin solution of 50 mg/ml (5%), KIOVIG 100 mg/ml (10%) should be diluted with an equal volume of the glucose solution. It is recommended that during dilution the risk of microbial contamination is minimised.
The product should be inspected visually for particulate matter and discolouration prior to administration. The solution should be clear or slightly opalescent and colourless or pale yellow. Solutions that are cloudy or have deposits should not be used.
KIOVIG should only be administered intravenously. Other routes of administration have not been eva luated.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorisation holder
Baxter AG
Industriestrasse 67
A-1221 Vienna, Austria
8. Marketing authorisation number(s)
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
9. Date of first authorisation/renewal of the authorisation
Date of first authorization: 19 January 2006
Date of latest renewal: 06 December 2010
10. Date of revision of the text
09/ 2015
Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/. |
