.0 mg
25 ml
3.0 mg
37.5 ml
4.0 mg
50 ml
Figure 3
11. The syringe should then be removed from the filter and a new needle placed on the suspension-filled syringe. The bag injection site should be wiped with an alcohol pad and the suspension in the syringe should be injected into the original bag containing the remaining 50 ml of sodium chloride 9 mg/ml (0.9%) solution for injection (Figure 4).
Figure 4
12. The bag should be gently swirled to mix the solution.
13. Patient identification, time and date should be added to the label on the bag containing the reconstituted, filtered and diluted liposomal suspension.
14. Chemical and physical in-use stability has been demonstrated for 6 hours at room temperature (between approximately 20°C – 25°C).
15. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 6 hours at room temperature.
16. The liposomal suspension is infused intravenously over about one hour.
Disposal
No special requirements.
7. MARKETING AUTHORISATION HOLDER
IDM PHARMA SAS
11-15 Quai De Dion Bouton
92816 Puteaux Cedex
France
8. MARKETING AUTHORISATION NUMBER(S)
EU/1/08/502/001
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
06/03/2009
10. DATE OF REVISION OF THE TEXT
05/01/2011 |
