al azacitidine doses based on an average BSA value of 1.8 m2.
Dose mg/m2
(% of recommended starting dose)
Total dose based on BSA value of 1.8 m2
Number of vials required
Total volume of reconstituted suspension required
75 mg/m2 (100 %)
135 mg
2 vials
5.4 ml
37.5 mg/m2 (50 %)
67.5 mg
1 vial
2.7 ml
25 mg/m2 (33 %)
45 mg
1 vial
1.8 ml
Method of administration
Reconstituted Vidaza should be injected subcutaneously (insert the needle at a 45-90o angle) using a 25-gauge needle into the upper arm, thigh or abdomen.
Doses greater than 4 ml should be injected into two separate sites.
Injection sites should be rotated. New injections should be given at least 2.5 cm from the previous site and never into areas where the site is tender, bruised, red, or hardened.
Any unused product or waste material should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
Celgene Europe Ltd
1 Longwalk Road
Stockley Park
Uxbridge
UB11 1DB
United Kingdom
8. MARKETING AUTHORISATION NUMBER(S)
EU/1/08/488/001
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
17/12/2008
10. DATE OF REVISION OF THE TEXT
08/2011
Detailed information on this product is available on the website of the European Medicines Agency, http://www.ema.europa.eu
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