SPC changes
Efexor XL capsules
The summary of product characteristics for Efexor XL (venlafaxine) capsules from Wyeth Laboratories has been revised. Efexor XL is now additionally licensed for use in the treatment of generalised anxiety disorder. The recommended dose for this indication is 75mg once daily.
Viracept powder and tablets
There are now new summaries of product characteristics for Viracept (nelfinavir) oral powder and Viracept tablets. The main change is that, in patients aged over 13 years, these products can now be given at a dose of 1,250mg twice daily. Some of the other changes now follow.
Under the therapeutic indications section, the statement: “Combinations of
Viracept with antiretroviral agents have been shown to decrease plasma
viral load and to increase circulating CD4 lymphocyte counts”, has been
removed. This section also now states that in protease inhibitor-experienced
patients, the choice of nelfinavir should be based on individual viral
resistance testing and treatment history.
The interactions section now states that no dose adjustment is required during
co-administration of Viracept with methadone.
The revised SPCs now contain the statement: “Viracept has no influence on
the ability to drive and use machines”.
The section on preclinical safety data now states that “nelfinavir is unlikely
to be a carcinogen in humans”.
The new SPCs confirm that there are no special requirements for handling or
disposing of Viracept.
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