Feiba Caution For Usage

Incompatibilities: No compatibility studies have been performed with the product. Therefore, FEIBA must not be mixed with other medicinal products or solvents before administration as this might impair the efficacy and safety of the product. It is advisable to rinse a common venous access with isotonic saline prior to and after infusion of FEIBA.
Coagulation factors derived from human plasma may be adsorbed by the inner surfaces of certain types of injection/infusion devices. If this were to occur, it could result in failure of therapy. Therefore, only approved plastic injection/infusion devices may be used with FEIBA.
Instructions for Use/Handling/Disposal: FEIBA is to be reconstituted just prior to administration. Aseptic technique should be used throughout the entire reconstitution process and the solution should then be used immediately (as the preparation contains no preservatives).
Swirl gently until all material is dissolved. Ensure that FEIBA is completely dissolved; otherwise, active material will not pass through the device filter.
After reconstitution, the solution should be inspected for particulate matter and discoloration prior to administration.
Do not use solutions which are turbid or have deposits.
Any unused solution must be discarded appropriately.
Mixing of FEIBA with other products or substances must be avoided. It is advisable to flush venous access lines with isotonic saline prior to and after infusion of FEIBA.
If devices other than those supplied with FEIBA are used, ensure use of an adequate filter.
Reconstitution of dried substance: 1. Warm the unopened vial containing the solvent (sterilised water for injections) to room temperature, e.g. using a sterile water bath for warming within several minutes (max. +37°C).
2. Remove protective caps from the concentrate vial and solvent vial and disinfect the rubber stoppers of both.
3. Remove protective covering from one end of the supplied "transfer needle" by twisting and pulling. Insert the exposed needle through the rubber stopper of the solvent vial.
4. Remove protective covering from the other end of the transfer needle taking care not to touch the exposed end.
5. Invert the solvent vial over the concentrate vial, and insert the free end of the transfer needle through the rubber stopper of the concentrate vial. The solvent will be drawn into the concentrate vial by vacuum.
6. Disconnect the two vials by removing the needle from the concentrate vial. Gently agitate or rotate the concentrate vial to accelerate dissolution.
7. Upon complete reconstitution of the concentrate, insert the enclosed "aeration needle" provided and any foam will collapse. Remove aeration needle.
Injection/Infusion: 1. Remove protective covering from the supplied "filter needle" by twisting and pulling and fit the needle onto a sterile disposable syringe. Draw the solution into the syringe.
2. Disconnect the filter needle from the syringe and slowly inject the solution intravenously with the enclosed "winged set for injection" (or the enclosed disposable needle).
If administered by infusion, a disposable infusion set with adequate filter is to be used.
Do not exceed an injection/infusion rate of 2 units FEIBA per kg of body weight per minute.