RAPILYSIN Powder and solvent for solution for injection Ref.[8915] Active ingredients: Reteplase

Treatment with reteplase should be initiated as soon as possible after the onset of AMI symptoms.

Rapilysin should be prescribed by physicians experienced in the use of thrombolytic treatment and with the facilities to monitor its use.

Posology

Dosage of Rapilysin

Rapilysin is administered as a 10 U bolus dose followed by a second 10 U bolus dose 30 minutes later (double bolus).

Each bolus is administered as a slow intravenous injection within 2 minutes. Ensure that the injection is not mistakenly given paravenously.

Heparin and acetylsalicylic acid should be administered before and following the administration of Rapilysin to reduce the risk of re-thrombosis.

Dosage of Heparin

The recommended dose of heparin is 5000 I.U. given as a bolus injection prior to reteplase therapy followed by an infusion of 1000 I.U. per hour starting after the second reteplase bolus. Heparin should be administered for at least 24 hours, preferably for 48-72 hours, aiming to keep aPTT values 1.5 to 2 times normal.

Dosage of Acetylsalicylic Acid

The initial dose of acetylsalicylic acid prior to thrombolysis should be at least 250 mg (250-350 mg) followed by 75-150 mg/day at least until discharge.

Paediatric population

No data are available.

Method of administration

Reteplase is supplied as a freeze-dried substance in vials. The lyophilisate is reconstituted with the contents of the accompanying syringe. For instructions on reconstitution of the medicinal product before administration, see section 6.6.

Rapilysin should be injected preferably through an intravenous line whose sole purpose is the injection of Rapilysin. No other medicines should be injected through the line reserved for Rapilysin, neither at the same time, nor prior to, nor 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.

In those patients where the same line has to be used, this line (including Y-line) must be flushed thoroughly with 0.9 % sodium chloride or 5% glucose solution prior to and following the Rapilysin injection.

In the event of overdosage one might expect depletion of fibrinogen and other blood coagulation components (e.g. coagulation factor V) with a consequent risk of bleeding.

For further information see section 4.4, section bleeding.

Shelf-life as package for sale: 3 years.

Reconstituted product:

Chemical and physical in-use stability has been demonstrated for 8 hours between 2° and 30°C after dissolving with water for injection.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

Do not store above 25°C.

Keep the vial in the outer carton in order to protect from light.

For storage conditions after reconstitution of the medicinal product, see section 6.3.

Each pack contains:

2 colourless glass vials (type I) with a rubber (butyl) closure and an aluminium flip-off cap, containing 0.56 mg of powder.

2 pre-filled glass syringes (borosilicate, type I) for single use, with a bromobutyl plunger stopper and a bromobutyl rubber tip cap, containing 10 ml of solvent.

2 reconstitution spikes.

2 needles 19 G1.

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. 10
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. The reconstituted solution must be used immediately. Visual inspection of the solution is necessary after reconstitution. Only clear, colourless solutions should be injected. If the solution is not clear and colourless it should be discarded.
10. 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
11. 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% glucose solution prior to and following the Rapilysin injection (see section 4.2 Posology and method of administration).

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