SPC changes
Arava
Arava (leflunomide) is now additionally indicated for active psoriatic
arthritis (Aventis). The recommended dose for this indication is 20mg
daily. Trial data for this indication has been included in the updated
SPC. See SPC.
Remicade
Remicade (infliximab) is now additionally indicated, in combination with
methotrexate, for the reduction of signs and symptoms as well as the
improvement in physical function in patients with severe, active and
progressive disease not previously treated with methotrexate or other
disease modifying anti-rheumatic drugs (Schering-Plough). The summary
of product characteristics has been updated with more trial data. It
now also states that it is recommended that live vaccines are not given
concurrently to patients receiving anti-TNF therapy. See SPC.
Invanz
The summary of product characteristics for Invanz (ertapenem) no longer
states that the product requires refrigeration but states that it should
not be stored above 25C (Merck Sharp & Dohme). A new section on
post marketing experience has been added and additional information
on how to prepare the product has been included. The shelf life has
been reduced from three to two years. See SPC.
Videx
The summary of product characteristics for Videx (didanosine) tablets
and enteric-coated capsules now states that no specific dose adjustment
can be recommended in patients with hepatic impairment (Bristol-Myers
Squibb). These patients should be monitored closely for clinical evidence
of didanosine toxicity. Plasma level monitoring may help to identify
outliers but currently available data do not allow specific recommendations
with regard to target plasma levels. A new section has been added on
liver disease which includes information for patients with hepatitis.
More absorption and pharmacokinetic data have been included. See SPC.
Liquivisc
The summary of product characteristics for Liquivisc (carbomer 974P)
eye gel now states that benzalkonium chloride has been reported rarely
to cause punctate keratopathy and/or ulcerative keratopathy (Allergan).
Benzalkonium chloride may discolour contact lenses and therefore patients
should be instructed to wait until 30 minutes after instilling the
gel before inserting contact lenses. In case of concomitant use with
other eye-drops, Liquivisc should be the last medicine instilled. Caution
should be exercised when prescribing to pregnant or breast-feeding
women. See SPC.
Back to Top
|
The
Pharmaceutical Journal