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FIBRYGA (fibrinogen- human kit

  1. Patient Information
  2. Manufactured By:
  3. Distributed By:

Patient Information 

  • Inform patients of the early signs of hypersensitivity or allergic reactions to FIBRYGA, including hives, chest tightness, wheezing, hypotension, and anaphylaxis (seeWarnings and Precautions[5.1]). Advise them to notify their physician immediately if they experience any of these symptoms.
  • Inform patients that blood clots with or without consequent obstruction of blood flow may occur with FIBRYGA. Any symptoms of blood clots such as unexplained chest and/or leg pain or swelling of the legs or arms, coughing up blood, shortness of breath, increased rate of breathing or unexplained symptoms related to the nervous system such as stroke or weakness following administration of FIBRYGA should be reported to their physician immediately (seeWarnings and Precautions[5.2]).
  • Inform patients that FIBRYGA is made from human plasma (part of the blood) and may contain infectious agents, e.g., viruses and, theoretically, the Creutzfeldt-Jakob Disease agent, that can cause disease. Explain the risk that FIBRYGA may transmit an infectious agent has been reduced by screening the plasma donors, by testing the donated plasma for certain virus infections, and by two processes demonstrated to inactivate and/or remove certain viruses during manufacturing (seeWarnings and Precautions[5.3]). Symptoms of a possible virus infection include headache, fever, nausea, vomiting, weakness, malaise, diarrhea, or, in the case of hepatitis, jaundice.

Manufactured By: 

Octapharma Pharmazeutika Produktionsges.m.b.H.

Oberlaaer Strasse 235

A-1100 Vienna, Austria

Octapharma AB

Lars Forssells gata 23

SE - 112 75, Sweden

U.S. License No. 1646

Distributed By: 

Octapharma USA Inc.

121 River Street, Suite 1201

Hoboken, NJ 07030

Instructions for Use

FIBRYGA/fye bri ' gah /

Fibrinogen (Human)

Read these instructions carefully before using FIBRYGA for the first time. The general guidelines for mixing and infusing FIBRYGA are listed below. If you are unsure of any of these steps, please contact the manufacturer before using FIBRYGA.

FIBRYGA is supplied as a powder. Before it can be infused, it must be mixed with sterile Water for Injection.

FIBRYGA is provided with the Octajet transfer device for reconstitution of the FIBRYGA powder in sterile Water for Injection, and a particle filter to filter the reconstituted solution before injection.

Instructions for Mixing FIBRYGA

1. Warm both the powder and sterile Water for Injection (sWFI) in their closed bottles to room temperature. This temperature should be maintained during reconstitution. If a water bath is used for warming, prevent water from 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).

2. Remove the cap from the FIBRYGA bottle and the sWFI bottle to expose the central portion of the rubber stoppers. 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 package.

4. Take the Octajet in its outer package and invert it over the FIBRYGA bottle. Place the device while in the outer package onto the center of the FIBRYGA bottle until the clips of the product spike (colorless) are locked. While holding onto the FIBRYGA bottle, carefully remove the outer package from the Octajet, being careful not to touch the water spike (blue) and leave the Octajet attached firmly to the FIBRYGA bottle. (Fig. 1)

Image File

5. With the FIBRYGA bottle held firmly on a level surface, invert the sWFI bottle and place it at the center of the water spike. Push the blue plastic cannula of the Octajet firmly through the rubber stopper of the sWFI bottle. (Fig. 2)

Image File

6. Remove the distance ring (Fig. 3) and press the sWFI bottle down (Fig. 4). sWFI will flow into the FIBRYGA bottle.

Image File

7. When transfer of the sWFI is complete, gently swirl the FIBRYGA bottle until the powder is fully dissolved. To avoid foam formation, do not shake the bottle. The powder should be dissolved completely within approximately 5 to 10 minutes.

8. Turn the blue sWFI bottle connector (in either direction) to bring the position markers together and remove the sWFI bottle together with the water spike (Fig. 5). Keep the concentrate bottle upright to avoid leaking.

Image File

9. Firmly connect the provided particle filter on the remaining Luer Lock on the FIBRYGA bottle (Fig. 6) and withdraw the solution through the particle filter into a syringe. (Fig. 7,8)

Image File

10. Detach the filled syringe from the particle filter and discard the empty bottle and the filter.

Instructions for Injecting FIBRYGA

For intravenous use only after reconstitution.

  1. Inspect the reconstituted FIBRYGA solution in the syringe for visible particulate matter and discoloration prior to administration. Do not use if particulate matter or discoloration are observed.
  2. Do not administer FIBRYGA in the same tubing or container as other medications.
  3. Clean the chosen injection site with an alcohol swab.
  4. Attach a standard infusion set to the syringe. Insert the needle of the infusion set into the chosen vein.
  5. Perform intravenous infusion. The rate of administration should be determined by the patient s comfort level, at a recommended maximum rate of 5 mL per minute.
  6. After infusing FIBRYGA, remove and properly discard the infusion set. After the infusion, remove the peel-off label containing the batch number from the FIBRYGA bottle, and place it in the log book for record keeping. Discard the empty bottle.

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