Actilyse Caution For Usage

Instructions for use/Handling: Under aseptic conditions the contents of an injection vial of Alteplase (Actilyse) (50 mg) dry substance is dissolved with sterilised water for injection according to the following table to obtain a final concentration of 1 mg alteplase per mL. (See Table 8.)

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For this purpose a transfer cannula is included with the pack-size of 50 mg.
Instructions for reconstituting Alteplase (Actilyse): 1. Reconstitute immediately before administration.
2. Remove the protective cap on the two vials containing the sterile water and Alteplase (Actilyse) dry substance by flipping them up with a thumb.
3. Swab the rubber top of each vial with an alcohol wipe.
4. Remove the transfer cannula* from its cover. Do not disinfect or sterilize the transfer cannula; it is sterile. Take one cap off.
5. Stand the sterile water vial upright on a stable surface. From directly above, puncture the rubber stopper vertically in the stopper center with the transfer cannula, by pressing gently but firmly, without twisting.
6. Hold the sterile water vial and the transfer cannula steady with one hand using the two side flaps.
Remove the remaining cap on top of the transfer cannula.
7. Hold the sterile water vial and the transfer cannula steady with one hand using the two side flaps.
Hold the vial with Alteplase (Actilyse) dry substance above the transfer cannula and position the tip of the transfer cannula right in the center of the stopper.
Push down the vial with the dry substance onto the transfer cannula from directly above, puncturing the rubber stopper vertically and gently but firmly without twisting.
8. Invert the two vials and allow the water to drain completely into the dry substance.
9. Remove the empty water vial together with the transfer cannula.
They can be disposed of.
10. Take the vial with reconstituted Alteplase (Actilyse) and swirl gently to dissolve any remaining powder, but do not shake, as this will produce foam.
If there are bubbles, let the solution stand undisturbed for a few minutes to allow them to disappear.
11. The solution consists of 1 mg/mL Alteplase (Actilyse). It should be clear and colourless to pale yellow and it should not contain any particles.
12. Remove the amount required using a needle and a syringe.
Do not use the puncture location from the transfer cannula to avoid leakage.
13. Use immediately.
Dispose of any unused solution.
(*if a transfer cannula is included in the kit. The reconstitution can also be performed with a syringe and a needle.)
The 1 mg/mL reconstituted solution may be diluted further with sterile sodium chloride 9 mg/mL (0.9%) solution for injection up to a minimal concentration of 0.2 mg/mL since the occurrence of turbidity of the reconstituted solution cannot be excluded.
A further dilution of the 1 mg/mL reconstituted solution with sterilised water for injections or in general, the use of carbohydrate infusion solutions, e.g. dextrose is not recommended due to increasing formation of turbidity of the reconstituted solution.
Alteplase (Actilyse) should not be mixed with other drugs, neither in the same infusion-vial nor the same venous line (not even with heparin).