SPC changes
Remicade
The summary of product characteristics for Remicade (infliximab; Schering-Plough)
has been updated to include an additional indication for the treatment
of moderate to severe ulcerative colitis in patients who have had an
inadequate response to conventional therapy (including corticosteroids
and
6-mercaptopurine or azathioprine) or who are intolerant to, or have contraindications
for, such therapies. The dose for this indication is 5mg/kg given as
an intravenous infusion over two hours followed by additional 5mg/kg
infusion doses, two and six weeks after the first infusion, then every
eight weeks thereafter. The SPC says that continued therapy after 14
weeks should be carefully reconsidered in patients who show no evidence
of therapeutic benefit within this time period. The SPC also states that
the safety and efficacy of readministration of Remicade for ulcerative
colitis, other than every eight weeks, has not been established and that
all patients with ulcerative colitis who are at increased risk for dysplasia
or carcinoma, or who have a prior history of dysplasia or colon carcinoma,
should be screened for dysplasia at regular intervals. See SPC.
Trileptal
The summary of product characteristics for Trileptal (oxcarbazepine;
Novartis) has been updated to clarify that Trileptal is not recommended
for children aged less than six years. Additional information has also
been added regarding increased clearance of oxcarbazepine’s pharmacologically
active metabolite (the monohydroxyl derivative, MHD) in children aged
four to 12 years when Trilepal is coadministered with carbamazepine,
phenytoin or phenobarbitone. Additional information on the pharmacokinetics
of Trileptal in children has also been added. See SPC.
Back to Top
|
The
Pharmaceutical Journal