SPC changes
ReFacto
The summary of product characteristics for ReFacto (moroctocog alfa;
Wyeth) now states that ReFacto, when reconstituted, contains polysorbate-80,
which increases the rate of di-(2-ethylhexyl)phthalate extraction from
polyvinyl chloride. This should be considered during preparation and
administration of ReFacto, including storage time elapsed in a PVC container
following reconstitution. See SPC.
Xagrid
The summary of product characteristics for Xagrid (anagrelide; Shire)
now recommends that patients with moderate or severe hepatic impairment
are not treated with anagrelide. The section on the impact of food
on the pharmacokinetics of Xagrid has also been updated. See SPC.
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