7. Replace needle with a new needle for the intravenous infusion.

8. Expel air, large bubbles, and any excess solution in order to obtain the required dose.

9. The reconstituted and diluted solution should then be infused intravenously over 30 minutes as directed in section 4.2.

The following have been shown to be compatible when added to Cubicin containing infusion solutions: aztreonam, ceftazidime, ceftriaxone, gentamicin, fluconazole, levofloxacin, dopamine, heparin and lidocaine.

Cubicin given as 2-minute intravenous injection

Water should not be used for reconstitution of Cubicin for intravenous injection. Cubicin should only be reconstituted with sodium chloride 9 mg/ml (0.9%).

A 50 mg/ml concentration of Cubicin for injection is obtained by reconstituting the lyophilised product with 10 ml of sodium chloride 9 mg/ml (0.9%) solution for injection.

The lyophilised product takes approximately 15 minutes to dissolve. The fully reconstituted product will appear clear and may have a few small bubbles or foam around the edge of the vial.

To prepare Cubicin for intravenous injection, please adhere to the following instructions:

Aseptic technique should be used throughout to reconstitute lyophilised Cubicin.

1. The polypropylene flip off cap should be removed to expose the central portions of the rubber stopper. Draw 10 ml of sodium chloride 9 mg/ml (0.9%) solution for injection into a syringe, then slowly inject through the centre of the rubber stopper into the vial pointing the needle towards the wall of the vial.

2. The vial should be gently rotated to ensure complete wetting of the product and then allowed to stand for 10 minutes.

3. Finally the vial should be gently rotated/swirled for a few minutes as needed to obtain a clear reconstituted solution. Vigorous shaking/agitation should be avoided to prevent foaming of the product.

4. The reconstituted solution should be checked carefully to ensure that the product is in solution and visually inspected for the absence of particulates prior to use. Reconstituted solutions of Cubicin range in colour from pale yellow to light brown.

5. Invert the vial in order to allow the solution to drain towards the stopper. Using a new syringe, insert the needle into the inverted vial. Keeping the vial inverted, position the needle tip at the very bottom of the solution in the vial when drawing the solution into the syringe. Before removing the needle from the vial, pull the plunger all the way back to the end of the syringe barrel in order to remove all of the solution from the inverted vial.

6. Replace needle with a new needle for the intravenous injection.

7. Expel air, large bubbles, and any excess solution in order to obtain the required dose.

8. The reconstituted solution should then be injected intravenously slowly over 2 minutes as directed in section 4.2.

Cubicin vials are for single-use only.

From a microbiological point of view, the product should be used immediately after reconstitution (see section 6.3).

Any unused product or waste material should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

 Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

8. MARKETING AUTHORISATION NUMBER(S)

 EU/1/05/328/002

EU/1/05/328/004

9. DATE OF FIRST A