Grifols UK Ltd

In Section 6.6 the instructions have now been adapted for the Easysol solvent including new illustrations:

To prepare the solution:

1.       Warm the vial and syringe but not above 30 ºC
2.       Attach plunger to syringe containing solvent.
3.       Remove filter from packaging. Remove cap from syringe tip and attach syringe to filter.
4.       Remove vial adaptor from packaging and attach to syringe and filter.
5.       Remove cap from vial and wipe stopper with swabs provided.
6.       Pierce vial stopper with adaptor needle.
7.       Transfer all solvent from syringe to vial.
8.       Gently shake vial until all product is dissolved. As with other parenteral solutions, do not use if product is not properly dissolved or particles are visible.
9.       Briefly separate the syringe/filter from vial/adaptor to release the vacuum.
10.   Turn the vial upside down and draw the solution into the syringe.
11.   Prepare injection site, separate syringe and inject product using the butterfly needle provided. Injection rate should be 3 ml/min into a vein and never more than 10 ml/min to avoid vasomotor reactions.

 
After reconstitution with the Water for Injections solvent provided, the product should be used immediately.
Do not re-use the administration sets.
Any unused product or waste material should be disposed of in accordance with local requirements. 
The solution should be clear or slightly opalescent. Do not use solutions that are cloudy or have deposits. Reconstituted product should be inspected visually for particulate matter and discoloration prior to administration.