Rapilysin is usually given in a hospital. The medicine is supplied in vials as a powder for injection. Before use, the powder for injection must be dissolved in the water for injection supplied in the prefilled syringe that is in the package. Do not add any other medicines . The resulting solution must be used immediately. The solution must be examined to ensure that only clear, colourless solution is injected. If the solution is not clear and colourless it should be thrown away.
Treatment with Rapilysin 10 U should be started as soon as possible after the symptoms of heart attack begin.
Heparin and Rapilysin cannot be mixed in the same solution . Other medicines may also not mix well with Rapilysin. No other medicines should be added to the injection solution (see below). Rapilysin should be injected preferably through an intravenous line that is used only for the injection of Rapilysin. No other medicines should be injected through the line reserved for Rapilysin, either at the same time, or before or after Rapilysin injection. This applies to all medicines including heparin and acetylsalicylic acid, which are given before and after Rapilysin to reduce the risk of new blood clots forming.
If the same line has to be used, this line (including Y-line) must be flushed thoroughly with a 0.9 % sodium chloride or 5 % dextrose solution before and after the Rapilysin injection.
Dosage of Rapilysin
Rapilysin is given as a 10 U injection followed by a second 10 U injection 30 minutes later (double bolus).
Each injection should be given slowly within 2 minutes. The injection must not be given mistakenly outside the vein. Therefore, be sure to tell the medical staff if you experience pain during the injection.
Heparinand acetylsalicylicacid are given before and after Rapilysin to reduce the risk of new blood clots forming.
Dosage of Heparin
The recommended dose of heparin is 5000 I.U. given as a single injection before Rapilysin, followed by an infusion of 1000 I.U. per hour starting after the second Rapilysin injection. Heparin should be given for at least 24 hours, preferably for 48 - 72 hours, in order to keep aPTT values 1.5 to 2 times normal.
Dosage of Acetylsalicylic Acid
The dose of acetylsalicylic acid given before Rapilysin should be at least 250 mg ? 350 mg and should be followed by 75 ? 150 mg/day, at least until discharge from hospital.
Instructions for use/handling
Incompatibility of some prefilled glass syringes (including Rapilysin) with certain needle free connectors has been reported. Therefore, the compatibility of the glass syringe and intravenous access should be ensured before use. In case of incompatibility an adaptor can be used and removed together with the glass syringe immediately after administration
Use aseptic technique throughout.
1. Remove the protective flip-cap from the vial of Rapilysin 10 U and clean the rubber closure with an alcohol wipe.
2. Open the package containing the reconstitution spike, remove both protective caps from the reconstitution spike.
3. Insert the spike through the rubber closure into the vial of Rapilysin 10 U.
4. Take the 10 ml syringe out of the package. Remove the tip cap from the syringe. Connect the syringe to the reconstitution spike and transfer the 10 ml of solvent into the vial of Rapilysin 10 U.
5. With the reconstitution spike and syringe still attached to the vial, swirl the vial gently to dissolve the Rapilysin 10 U powder. DO NOT SHAKE.
6. The reconstituted preparation results in a clear, colourless solution. If the solution is not clear and colourless it should be discarded.
7. Withdraw 10 ml of Rapilysin 10 U solution back into the syringe. A small amount of solution may remain in the vial due to overfill.
8. Disconnect the syringe from the reconstitution spike. The dose is now ready for intravenous administration.
9. No other medicines should be injected through the line reserved for Rapilysin either at the same time, or prior to, or following Rapilysin injection. This applies to all products including heparin and acetylsalicylic acid, which should be administered before and following the administration of reteplase to reduce the risk of re-thrombosis.
10. In those patients where the same line has to be used, this line (including Y-line) must be flushed thoroughly with a 0.9 % sodium chloride or 5 % dextrose solution prior to and following the Rapilysin injection.
If more Rapilysin is used than recommended:
In the event of overdosage there may be an increased risk of bleeding.