nded that MabCampath should be prepared for intravenous infusion using aseptic techniques and that the diluted solution for infusion should be administered within 8 hours after preparation and protected from light. The required amount of the vial contents should be added to 100 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose (5%) solution for infusion. The bag should be inverted gently to mix the solution. Care should be taken to ensure the sterility of the prepared solution particularly as it contains no antimicrobial preservatives.
Other medicinal products should not be added to the MabCampath infusion solution or simultaneously infused through the same intravenous line (see section 4.5).
Caution should be exercised in the handling and preparation of the MabCampath solution. The use of latex gloves and safety glasses is recommended to avoid exposure in case of breakage of the vial or other accidental spillage. Women who are pregnant or trying to become pregnant should not handle MabCampath.
Procedures for proper handling and disposal should be observed. Any spillage or waste material should be disposed of by incineration.
7. MARKETING AUTHORISATION HOLDER
Genzyme Europe BV
Gooimeer 10
1411 DD Naarden
Netherlands
8. MARKETING AUTHORISATION NUMBER(S)
EU/1/01/193/002
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 06/07/2001
Date of latest renewal: 10/07/2011
10. DATE OF REVISION OF THE TEXT
05/2011
Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu. |
