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Is LyoPlas N - w a single-donor plasma or pooled plasma?
LyoPlas N – w is a freeze-dried plasma product derived from a single donation. It undergoes obligatory quarantine storage. The plasma is only used, therefore, if the donor has been retested for the specified infection parameters after a minimum of 4 months and has additionally been tested for the viral genome equivalents of hepatitis A, hepatitis B, and parvovirus B19.
Are there any differences when it comes to using LyoPlas N - w as compared to FFP?
LyoPlas N - w is a freeze-dried plasma product derived from a single donation. It is used in the same indications as therapeutic frozen plasma.
What can be said about the compatibility of LyoPlas N - w?
Plasma transformed into LyoPlas N - w undergoes a cell-reduction step to render it virtually cell-free and highly compatible, unlike conventional FFP. To prevent pulmonary (TRALI) reactions, only plasma from donors, who have been tested negative for leukocyte antibodies, or plasma from donors with a negative history of immunization, is used to make LyoP N - w.
Are there any differences in the activity of the coagulation factors as compared to FFP?
In view of the fact that the plasma is obtained from single donations, the biological activities of its components are within the physiological range of variation, just like FFP. Lyophilization is a relatively gentle procedure with no adverse effect on the stability of the plasma components. This is demonstrated by testing the
factor VIII activity and fibrinogen concentration
in the source plasma before production of LyoPlas N - w, and in the end product.
Does it make any difference whether the transfer set is connected first to the bag with water for injection or to the lyophilisate bottle?
Yes, it does. First connect the transfer set to the bag with water for injection using a Luer lock connector. Then push the spike of the transfer set through the centre of the rubber stopper. The unit consisting of water bag, transfer set and glass bottle is now stable enough to hang freely.
What type of administration set is required?
An administration set with air vent and with a 170-230 µm standard filter is required for transfusion from the bottle.
An administration set with a 170-230 µm standard filter should be used for transfusion from the bag. (An air vent is not required.)
What could be the reason for water failing to flow into the bottle?
Check that the clamp and the air filter of the transfer set are open. Make sure that you do not squeeze the bag while the water is flowing into the glass bottle, because this could block the air filter.
After reconstitution some of the plasma units may vary in colour and turbidity. Does this reveal anything about the quality of the plasma?
LyoPlas N - w is a plasma product derived from a single donation (not pooled plasma). The turbidity and colour of the dissolved lyophilisate may vary depending on the source plasma (from various shades of yellow to a greenish colour), but this has no implications in terms of quality of the product.
The photo shows 6 bottles of LyoPlas N - w after freeze-drying and reconstitution.
At which temperature should LyoPlas N – w be reconstituted?
Lyophilized plasma may be stored at temperatures between +2°C and +25°C. For dissolution, the supplied water for injection and the freeze-dried plasma should be roughly at room temperature.
Can I speed up dissolution by shaking the bottle?
No, you can’t. To effectively dissolve the plasma gently swirl the bottle or use a roller mixer to ensure that the entire lyophilisate is rapidly absorbed by the water. Never shake the bottle and avoid foaming! The plasma is ready for use once all solid particles are dissolved.
Please read the package leaflet and ask your doctor or pharmacist about potential risks and side effects.