Actilyse Caution For Usage

Handling Instructions: Under aseptic conditions the contents of an injection vial of 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 6.)

Click on icon to see table/diagram/image

For this purpose a transfer cannula is included with the pack-sizes of 50 mg.
Instructions for reconstituting Actilyse: 1. Reconstitute immediately before administration.
2. Remove the protective cap on the two vials containing the sterile water and 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 centre 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 ACTILYSE dry substance vertically above the transfer cannula and position the tip of the transfer cannula right in the centre 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 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 reconstituted solution consists of 1mg/mL ACTILYSE. It should be clear and colourless to pale yellow and it should not contain any particles.
12. Remove the amount required only by using a needle and 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 1mg/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 1mg/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.
ACTILYSE should not be mixed with other drugs, neither in the same infusion-vial nor the same venous line (not even with heparin).
Traceability: In order to improve traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded in the patient file.
Incompatibilities: Refer to Handling Instructions as previously mentioned for more information.
Special precautions for disposal and other handling: For handling instructions, see as previously mentioned.