SPC changes
Cyprostat
The summary of product characteristics for Cyprostat (cyproterone acetate;
Schering) has been updated. The special warnings and special precautions
for use section has been reworded and includes new information about
thromboembolic events. See SPC.
Depakote
The summary of product characteristics for Depakote (valproate semisodium;
sanofi-aventis) has been updated. The posology and method of administration
section of the SPC contains new information on initiating Depakote
treatment for patients already taking anticonvulsants. New information
about discontinuing Depakote and about the risks associated with Depakote
use in pregnancy is included in the SPC. See SPC.
Eprex
The summary of product characteristics for Eprex (epoetin alfa; Janssen-Cilag)
prefilled syringes and that for Eprex vial have been changed. The SPCs
now state that in patients with chronic renal failure for whom intravenous
access is not available Eprex can now be administered subcutaneously.
The precautions and undesirable effects sections have been updated
to reflect this. See SPCs.
Keppra
The summary of product characteristics for Keppra (levetiracetam; UCB
Pharma) has been updated to include a new indication as monotherapy
in the treatment of partial-onset seizures with or without secondary
generalisation in patients from 16 years of age with newly diagnosed
epilepsy. The undesirable effects section now includes the following:
balance disorders, disturbance in attention, memory impairment, weight
increase, blurred vision, myalgia, nasopharyngitis, eczema, pruritus
and thrombocytopenia. Aggression and irritability are now listed as
common side effects. A sentence about carcinogenicity has been removed
from the preclinical safety data section of the SPC. See SPC.
Lyrica
The summary of product characteristics for Lyrica (pregabalin; Pfizer)
has been updated to include hypersensitivity, headache and nausea as
rare undesirable effects. See SPC.
Meningitec
The summary of product characteristics for Meningitec (meningococcal
group C conjugate vaccine; Wyeth) has been updated. It now includes
additional information in the interactions section and, in the undesirable
effects
section, information about hypotonic-hyporesponsive episodes. See SPC.
Suprecur and Suprefact
The summaries of product characteristics for Suprecur (buserelin; sanofi-aventis)
nasal spray and Suprefact (buserelin) injection have been updated.
The contraindications sections and the pregnancy and lactation sections
have been reworded. The undesirable effects sections have been rearranged
and new side effects have been added. See SPCs.
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