Fibryga Caution For Usage

Incompatibilities: This medicinal product must not be mixed with other medicinal products.
Special precautions for disposal and other handling: General Instructions: The reconstituted solution should be almost colourless and slightly opalescent. Do not use solutions that are cloudy or have deposits.
Reconstitution: 1. Warm both the powder (FIBRYGA) and the solvent (WFI) in unopened containers up to room temperature. This temperature should be maintained during reconstitution. If a water bath is used for warming, care must be taken to avoid water coming into contact with the rubber stoppers or the caps of the containers. The temperature of the water bath should not exceed +37°C (98°F).
2. Remove the cap from the powder (FIBRYGA) bottle and the solvent to expose the central portion of the infusion stopper. Clean the rubber stoppers with an alcohol swab and allow the rubber stoppers to dry.
3. Peel away the lid of the outer package of the Octajet transfer device. To maintain sterility, leave the Octajet device in the clear outer packaging.
4. Take the Octajet in its outer package and invert it over the powder (FIBRYGA) bottle. Place device while in the outer package onto the centre of the powder bottle until the clips of the product spike (colourless) are locked. While holding onto the powder bottle, carefully remove the outer package from the Octajet, being careful to not touch the water spike (blue) and leave the Octajet attached firmly to the powder bottle.
5. With the powder (FIBRYGA) bottle held firmly on a level surface, invert the solvent vial and place it at the centre of the water spike. Push the blue plastic spike of the Octajet firmly through the rubber stopper of the solvent vial.
6. Remove the distance ring and press the solvent vial down. Solvent will flow into the powder (FIBRYGA) bottle.
7. When transfer of the solvent is complete, gently swirl the product bottle until the powder is fully dissolved. Do not shake the bottle to avoid foam formation. The powder should be dissolved completely within approximately 5 minutes. It should not take longer than 30 minutes to dissolve the powder. If the powder is not dissolved within 30 minutes the product should be discarded.
8. Turn the blue solvent vial connector (both directions possible) to bring position markers together and remove solvent vial together with the water spike.
9. Attach a syringe to the provided filter and connect the filter to the Octajet Luer Lock on the powder bottle. Withdraw the solution through the filter into the syringe.
10. Detach the filled syringe from the filter and discard the empty bottle.
A standard infusion set is recommended for intravenous application of the reconstituted solution at room temperature.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.