SPC changes
Co-Diovan
The summary of product characteristics for Co-Diovan (valsartan, hydrochlorothiazide;
Novartis) now includes an indication for the treatment of essential hypertension
in patients whose blood pressure is not adequately controlled on valsartan
or hydrochlorothiazide monotherapy. See SPC.
Glivec
The summary of product characteristics for Glivec (imatinib; Novartis)
now states that there is evidence to suggest that, for the treatment
of chronic myeloid leukaemia, a dose increase to 800mg daily offers
benefit in some chronic phase patients. See SPC.
NeoRecormon
The summary of product characteristics for NeoRecormon (epoetin beta;
Roche) has been updated. NeoRecormon is no longer indicated for the
prevention of anaemia in patients with solid tumours. Restrictions
on the use of NeoRecormon in patients receiving platinum-based chemotherapy
have also been removed from the SPC and the intervention and target
haemoglobin levels have been lowered: NeoRecormon treatment is now
indicated in patients with an Hb value of <=11g/dl (6.83mmol/L).
Thromboembolic events are now described as common adverse events. See
SPC.
Saquinavir
The summaries of product characteristics for Fortovase (saquinavir; Roche)
and Invirase (saquinavir; Roche) have been updated. Rifampicin has
been added to the list of drugs which should not be given together
with saquinavir. See SPC.
Trileptal
The summary of product characteristics for Trileptal (oxcarbazepine;
Novartis) now states that serious dermatological reactions have been
associated with Trileptal use and that patients with serious dermatological
reactions may require admission to hospital. It also states that as
oxcarbazepine may lead to impairment of cardiac conduction, patients
with pre-existing conduction disturbances should be followed carefully.
See SPC.
Viracept
The summary of product characteristics for Viracept (nelfinavir; Roche)
has been updated. Rifampicin has been added to the list of drugs which
should not be given together with nelfinavir. The SPC also now states
that co-administration of nelfinavir with inhibitors of CYP2C19 may
be expected to increase plasma nelfinavir levels. See SPC.
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