SPC changes
CellCept
New information on use of CellCept (mycophenolate mofetil; Roche) in
preganacy has been added to the summaries of product characteristics
for CellCept products.
The SPCs now states: “There is limited data
from the use of CellCept in pregnant women. However, congenital malformations
including ear malformations, ie abnormally formed or absent external/middle
ear, have been reported in children of patients exposed to CellCept in
combination with other immunosuppressants during pregnancy.”
The
use of CellCept is not recommended during pregnancy and should be reserved
for cases where no more suitable alternative treatment is available.
Competact
Use of Competact (metformin hydrochloride, pioglitazone; Takeda) in combination
with insulin is no longer contraindicated. The product’s summary
of product characteristics has been updated accordingly.
Episenta
The total daily dose of Episenta (sodium valproate; Beacon) solution
for injection can now be given by continuous infusion or divided in
three to four single infusions or slow intravenous injections, according
to the product’s summary of product characteristics.
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