SPC changes
Accessing SPCs
The summaries of product characteristics and patient
information leaflets for medicines licensed in the UK are available online |
Byetta
Information about reported events of altered renal function and acute
pancreatitis have been added to the summary of product characteristics
for Byetta (exenatide; Lilly).
Calcort
Information about potentially severe psychiatric adverse reactions and
neuropsychiatric disturbances has been added to the summary of product
characteristics for Calcort (deflazacort; Shire).
Glivec
The special warnings section of the summary of product characteristics
for Glivec (imatinib; Novartis) now includes new information on cases
of liver injury.
Macugen
Additional administration information has been added to the summary of
product characteristics for Macugen (pegaptanib sodium; Pfizer). The
SPC now says: “After two consecutive injections of Macugen, if
a patient does not demonstrate a treatment benefit (loss of less than
15 letters of visual acuity) at the 12-week visit, consideration should
be given to stopping or withholding Macugen therapy.”
Minodiab
The summary of product characteristics for Minodiab (glipizide; Pfizer)
contains new information about a possible interaction with voriconazole.
Nizoral
The therapeutic indication for Nizoral (ketoconazole; Janssen-Cilag)
tablets has been restricted to patients resistant to, or intolerant
of, other effective antifungal therapies. A number of other changes
have also been made to the product’s summary of product characteristics
relating to a risk of serious hepatotoxicity.
Duration of treatment
has been highlighted as a main factor in the risk of serious hepatotoxicity.
Several drugs have been added to the list of drugs for which concomitant
use with Nizoral is contraindicated. Warnings about hepatotoxicity
and hepatic function before and during use of Nizoral have been updated.
Prevenar
Information about the potential risk of apnoea when administering the
primary immunisation series to very premature infants has been added
to the summary of product characteristics for Prevenar (pneumococcal
polysaccharide conjugate vaccine, adsorbed; Wyeth).
Salofalk
A once-daily dosage regimen has been added to the summary of product
characteristics for Salofalk (mesalazine; Dr Falk Pharma) gastro-resistant
prolonged-release granules. New information about warnings, precautions
and adverse events has also been added.
Sutent
The summary of product characteristics for Sutent (sunitinib; Pfizer)
now says that daily doses should neither exceed 75mg nor be decreased
below 25mg.
Tygacil
Warnings about anaphylaxis and anaphylactoid reactions have been updated
in the summary of product characteristics for Tygacil (tigecycline;
Wyeth).
Xeloda
Xeloda (capecitabine; Roche) is now indicated as monotherapy for metastatic
colorectal cancer. The product’s summary of product characteristics
has been updated.
Zonegran
New information on interaction studies of Zonegran (zonisamide; Eisai)
and drugs that are substrates of P-glycoprotein is now included in
the summary of product characteristics for Zonegran.
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