Biostate Caution For Usage

Special precautions for disposal: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Incompatibilities: Compatibility studies have not been conducted, therefore Biostate must not be mixed with other medicinal products.
Reconstitution: 1. Ensure that the Biostate and Water for Injections vials are at room temperature (20°C to 30°C). Remove the flip-top caps from the Biostate and Water for Injections vials. Apply an appropriate disinfectant to both rubber stoppers and allow to dry. Remove the lid of the Mix2Vial packaging. If the seal of the lid is not intact or there are any concerns about the integrity of the Mix2Vial, do not use it but return it to the appropriate Blood Transfusion Service.
2. Place the Water for Injections vial upright on a level surface. Pick up the Mix2Vial in its outer package and invert it. Holding the Water for Injections vial securely, push the blue end of the Mix2Vial vertically down through the Water for Injections vial stopper.
3. Carefully remove the Mix2Vial outer package. Ensure the Mix2Vial remains attached to the Water for Injections vial.
4. Place the Product vial upright on a level surface, invert the Water for Injections vial with the Mix2Vial attached. Holding the Product vial securely, push the clear end of the Mix2Vial vertically down through the Product vial stopper. The Water for Injections will be drawn out of its vial and into the Product vial by the vacuum within the Product vial. In the unlikely event that the vial does not contain a vacuum, do not use the product, but return it to the appropriate Blood Transfusion Service.
5. Leaving the system connected, gently swirl to ensure that the product is fully dissolved. Unscrew the Mix2Vial into two separate pieces. Discard the Water for Injections vial and the blue end of the Mix2Vial.
6. Keeping the Product vial upright, attach the syringe to the clear end of the Mix2Vial. Invert the system and draw the reconstituted product into the syringe. When the product has been transferred, discard the Mix2Vial and Product vial.
Note: The Mix2Vial is intended to filter the contents of a single vial of Biostate only. If multiple vials of Biostate are to be administered, a separate Mix2Vial must be used for each vial.
Do not refrigerate Biostate once it has been reconstituted.
Biostate is a white or pale yellow powder contained in a glass vial. Upon reconstitution it forms a colourless to slightly yellow solution with a clear to opalescent appearance. After filtering/withdrawal, the reconstituted product should be inspected visually for particulate matter and discolouration prior to administration. Do not use visibly cloudy solutions or solutions still containing flakes or particles. If a clot or gel forms, do not use the product but return it to the appropriate Blood Transfusion Service.
NOTE: Whilst the physicochemical stability of the active ingredients has been demonstrated for 8 hours following reconstitution at room temperature (below 25°C), Biostate does not contain an antimicrobial preservative. Therefore, it is recommended that the reconstituted product should be used as soon as practicable.
Use in one patient on one occasion only.
Spillage and breakages: Should a break in the container or spillage occur, due precautions should be taken to avoid contamination of cuts and abrasions, as well as to avoid inhalation or swallowing of the spillage. Adequate disinfection can be obtained with the application of 1% sodium hypochlorite for 15 minutes. Commercial bleaches may be diluted appropriately to obtain this concentration.