urs of reconstitution and dilution. When reconstitution and dilution are performed under aseptic conditions, Remicade infusion solution can be used within 24 hours if stored at 2°C to 8°C. Do not store any unused portion of the infusion solution for reuse.
5. No physical biochemical compatibility studies have been conducted to eva luate the co-administration of Remicade with other agents. Do not infuse Remicade concomitantly in the same intravenous line with other agents.
6. Visually inspect Remicade for particulate matter or discolouration prior to administration. Do not use if visibly opaque particles, discolouration or foreign particles are observed.
7. Any unused product or waste material should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
Janssen Biologics B.V.
Einsteinweg 101
2333 CB Leiden
The Netherlands
8. MARKETING AUTHORISATION NUMBER(S)
EU/1/99/116/001
EU/1/99/116/002
EU/1/99/116/003
EU/1/99/116/004
EU/1/99/116/005
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 13 August 1999.
Date of latest renewal: 2 July 2009.
10. DATE OF REVISION OF THE TEXT
26 July 2011
11. LEGAL CATEGORY
Prescription Only Medicine
Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Remicade/EU/07-11/47 |
