Treatment of Congenital Fibrinogen Deficiency

RIASTAP dosing, duration of dosing and frequency of administration should be individualized based on the extent of bleeding, laboratory values, and the clinical condition of the patient.

Preparation and Reconstitution

The procedures below are provided as general guidelines for preparation and reconstitution of RIASTAP.

Use aseptic technique when preparing and reconstituting RIASTAP.

Reconstitute RIASTAP at room temperature as follows:

1. Remove the cap from the product vial to expose the central portion of the rubber stopper.
2. Clean the surface of the rubber stopper with an antiseptic solution and allow it to dry.
3. Using an appropriate transfer device or syringe, transfer 50 mL of Sterile Water for Injection into the product vial.
4. Gently swirl the product vial to ensure the product is fully dissolved. Do not shake the vial.

After reconstitution, the RIASTAP solution should be colorless and clear to slightly opalescent. Inspect visually for particulate matter and discoloration prior to administration. Do not use if the solution is cloudy or contains particulates. Discard partially used vials.

RIASTAP is stable for 8 hours after reconstitution when stored at 20-25°C; administer within this time period.

​Before administration, filter reconstituted RIASTAP solution with a 17-micron filter (not supplied) into an appropriate syringe.

Administration

Do not mix RIASTAP with other medicinal products or intravenous solutions. Administer through a separate injection site.

Use aseptic technique when administering RIASTAP.

Administer RIASTAP at room temperature by slow intravenous injection at a rate not exceeding 5 mL per minute.