SPC changes
Accessing SPCs
The summaries of product characteristics and patient
information leaflets for medicines licensed in the UK are available online |
Daktarin Oral Gel
Daktarin Oral Gel (miconazole; Janssen-Cilag) is now contraindicated
for children less than four months of age, according to its new summary
of product characteristics.
Further details about medicines that should
not be co-administered with Daktarin Oral Gel have also been added
to its SPC.
Invega
The summary of product characteristics for Invega (paliperidone; Janssen-Cilag)
has been updated to include additional information about drug interactions.
The SPC states that “in vitro studies have shown that paliperidone
is a P-glycoprotein (P-gp) substrate”, and new details about
interaction of paliperidone with carbamazepine have also been included.
Repevax
The summary of product characteristics for Repevax (diphtheria, tetanus,
pertussis [acellular] and poliomyelitis [inactivated] vaccine; Sanofi
Pasteur MSD) has been updated to include additional precautions with
regard to administration of the vaccine.
Tracleer
An additional indication “to reduce the number of new digital ulcers
in patients with systemic sclerosis and ongoing digital ulcer disease” is
now included in the summaries of product characteristics for Tracleer
(bosentan; Actelion).
For this indication, treatment should be initiated
at a dose of 62.6mg twice daily for four weeks and then increased to
the maintenance dose of 125mg twice daily, the SPCs state.
Velcade
Velcade (bortezomib; Janssen-Cilag) is now contraindicated in acute diffuse
infiltrative pulmonary and pericardial disease, its new summary of
product characteristics states.
A pre-treatment chest radiograph is
recommended to determine if any additional diagnostic measures are
necessary and to serve as a baseline for potential post-treatment
pulmonary changes, the SPC warns.
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