|1.||Remove the aluminium closures from the Bioplasma FDP and diluent (Water for Injection). Swab the exposed rubber stoppers with a suitable antibacterial agent.|
|2.||Insert the airvent needle into the small circular port (labelled B) of the diluent bottle.|
(See accompanying diagram of the rubber stopper) [OMITTED Ed. Please refer to original Package Insert]
|3. (a)||Bioplasma FDP 200 mL:|
Clamp the transfer set and then insert the transfer set needle into the larger circular port (labelled A) of the diluent bottle. Insert the opposite end of the transfer setneedle into the port of the Bioplasma FDP bottle. Raise the diluent bottle above the Bioplasma FDP bottle and release the clamp of the transfer set. The vacuum will draw the diluent into the bottle. Once the transfer is complete, remove the transfer set and the diluent bottle as a unit and discard.
|3. (b)||Bioplasma FDP 50 mL:|
Connect the needle to the syringe and insert the needle into the largest port (labelled A) of the diluent bottle. Draw up 50 mL of Water for Injection. Insert the needle into the port of the Bioplasma FDP bottle. The vacuum will draw the diluent into the bottle. Discard the needle, syringe and the remaining diluent.
NB: Lyophilised powders are packed under vacuum. If this vacuum is lost, it may be difficult to reconstitute this product as the diluent flow into the bottle will decrease and eventually stop. Should this occur, insert an airvent needle through the rubber stopper of the Bioplasma FDP bottle and draw the diluent into the bottle by gravity.
|4.||Gently swirl the bottle. Do not shake and avoid foaming. Allow the product to stand until completely dissolved, swirling occasionally. This may take up to 20 minutes.|
|Please note:||The reconstituted solution is slightly opalescent and may exhibit slight foaming.|
Do not use if preparation contains particles or is turbid.
Administer only once all the powder has completely dissolved.
Infuse immediately after reconstitution.
Insert the airvent set approximately 2 mm from the port of the rubber stopper to break the vacuum. Infuse the solution through an appropriate giving-set with an in-line filter, inserted into the port of the rubber stopper, with the airvent in place to vent the infusion.
|PRIVATE BAG X9043||10 EDEN ROAD|