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Handling & Reconstitution
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Presentation
fibryga® is presented in vials containing 1 g of fibrinogen as lyophilised powder for reconstitution with 50 mL sterile water for injection (WFI).
The package also includes a octajet® transfer device, designed to ensure rapid and thorough reconstitution, enabling prompt initiation of treatment.
Do not store above 25 °C. Do not freeze. Keep the bottle in the outer carton to protect from light. The shelf life is two years at room temperature.
Handling
Prior to use, allow fibryga® to reach room temperature. fibryga® is intended for intravenous infusion or injection only.
fibryga® should be administered slowly intravenously at a recommended maximum rate of 5 mL per minute for patients with congenital hypo- or afibrinogenaemia and at a recommended maximum rate of 10 mL per minute for patients with acquired fibrinogen deficiency. A standard infusion set is recommended for intravenous application of the reconstituted solution.
After reconstitution with 50 mL water for injections fibryga® contains approximately 20 mg/mL human fibrinogen.
Reconstitution
Warm both the powder (fibryga ®) and the solvent (WFI) in unopened bottles 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 bottles. The temperature of the water bath should not exceed +37°C (98°F).
Remove the cap from the fibryga ® bottle and the solvent to expose the central portion of the infusion stopper. Clean the rubber stoppers of both bottles with an alcohol swab and allow the rubber stoppers of the bottles to dry.
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 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 concentrate bottle (Figure A).
5. With the fibryga® bottle held firmly on a level surface, invert the solvent bottle and place it at the centre of the water spike. Push the blue plastic cannula of the octajet® firmly through the rubber stopper of the solvent bottle (Figure B).
6. Remove the distance ring (Figure C) and press the solvent bottle down (Figure D). Solvent will flow into the 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 bottle connector (both directions possible) to bring position markers together and remove solvent bottle together with the water spike (Figure E).
9. Attach a syringe to the provided filter (Figure F) and connect the filter to the octajet® Luer Lock on the powder bottle (Figure G). Withdraw the solution through the filter into the syringe (Figure H).
10. Withdraw the solution through the filter into the syringe (Figure H).
Detach the filled syringe from the filter and discard the empty bottle.
fibryga® should be inspected visually for particulate matter and discoloration prior to administration. The reconstituted solution should be almost colourless and slightly opalescent. Do not use non-homogenous solutions, or those that are cloudy or have deposits.
The chemical and physical in-use stability of the reconstituted solution has been demonstrated for 24 hours at room temperature (maximum 25°C). From a microbiological point of view the product should be used immediately after reconstitution. If not used immediately, in-use storage times and conditions are the responsibility of the user. The reconstituted solution must not be frozen or stored in a refrigerator. Partially used bottles should be discarded.
Any unused product or waste material should be disposed of in accordance with local requirements for blood products.
fibryga® should not be mixed with other medicinal products. A separate intravenous line should be used for injection.
Watch the reconstitution with octajet
References
SPC
