Reconstitution

1 Solutions containing sodium chloride can cause precipitation and SHOULD NOT be used for reconstitution or dilution of Xydalba.

Diagram illustrating reconstitution - Step 1

2 Using a syringe, draw out 25 ml of sterile water for injection. Using a suitable gauge needle and syringe, each 500 mg vial of Xydalba should be reconstituted by slowly adding 25 ml of sterile water for injection.

Diagram illustrating reconstitution - Step 2

3 Gently roll the vial to ensure all surfaces containing Xydalba have been wetted.

Diagram illustrating reconstitution - Step 3

4 Alternate between gentle swirling and inversion of the vial to completely dissolve the Xydalba. To avoid excessive foaming, do not shake the vial.

5 Visually inspect the vial to ensure that Xydalba has completely dissolved prior to proceeding to dilution with 5% glucose solution for infusion. The reconstituted vial should contain
20 mg/ml of Xydalba as a clear, colourless to yellow solution.

Diagram illustrating reconstitution - Step 5
1 Xydalba SmPC