SPC changes
Accessing SPCs
The summaries of product characteristics and patient
information leaflets for medicines licensed in the UK are available online |
Caelyx
Treatment of progressive multiple myeloma, in combination with bortezomib
and for patients who have received at least one previous therapy and
who have already undergone (or are unsuitable for) bone marrow transplant,
has been added to the summary of product characteristics for Caelyx (liposomal
doxorubicin).
Apidra
Information about dose proportionality with Apidra (insulin glulisine;
Sanofi-Aventis) compared with regular human insulin has been added
to the product’s summary of product characteristics.
Avastin
First-line treatment of advanced or metastatic renal cell cancer, in
combination with interferon alfa-2a, has been added as an indication
in the summary of product characteristics for Avastin (bevacizumab;
Roche).
Alimta
Information about uncommon reports from clinical trials of patients who
are taking Alimta (pemetrexed; Lilly) and have interstitial pneumonitis
with respiratory insufficiency (which is sometimes fatal) and colitis
has been added to the product’s summary of product characteristics.
Cases
of radiation pneumonitis have also been reported in patients treated
with radiation either before, during or after pemetrexed therapy.
Diovan
Information on doses up to 320mg for the treatment of essential hypertension
has been added to the summary of product characteristics for Diovan
(valsartan; Novartis).
Durogesic DTrans
Further detail about initial dose selection has been added to the summary
of product characteristics for Durogesic DTrans (fentanyl; Janssen-Cilag)
transdermal patch, including a recommendation that Durogesic DTrans
should be used in patients who have demonstrated opioid tolerance as
well as further advice for opioid-naive patients and a statement that
opioid withdrawal symptoms are possible after conversion or dose adjustment.
In
addition, a warning about opioid-naive patients and respiratory depression
and fatality has been added as well as information about
interactions with CYP3A4 inhibitors.
Lustral
Lustral (sertraline; Pfizer) should not be used to treat children or
adolescents under the age of 18 years, except those with obsessive
compulsive disorder, the product’s summary of product characteristics
now states. Information from paediatric clinical trials has also been
added to the SPC.
Mimpara
Additional information about hypotension and worsening heart failure
has been added to the summary of product characteristics for Mimpara
(cinacalcet; Amgen). The SPC also now states that Mimpara is not indicated
for patients with chronic kidney disease who are not on dialysis. Studies
have shown that such patients are at greater risk of hypocalcaemia
when taking cinacalcet than those on dialysis.
Prescal
Information on dose adjustment during co-administration with cimetidine
has been added to the summary of product characteristics for Prescal
(isradipine; Novartis).
In addition, information has been added about:
• Dose adjustment in elderly
patients and patients with hepatic or renal dysfunction or chronic
heart failure
• Use in patients with angina
pectoris
• Discontinuation if hypersensitivity develops; and use while
driving or using machinery
The SPC also now includes information about
co-administration with rifampicin and other enzyme-inducing drugs,
CYP4503A inhibitors,
oral baclofen, diclofenac and phenytoin.
Remicade
The indication for the treatment of ankylosing spondylitis has been extended
in the summary of product characteristics for Remicade (infliximab;
Schering-Plough).
Remicade is now indicated for the treatment of severe,
active ankylosing spondylitis in adult patients who have responded
inadequately to conventional therapy. The requirements that patients
have severe axial symptoms and elevated serological markers of inflammatory
activity have been removed.
ViraferonPeg
The indication for use of ViraferonPeg (peginterferon alfa-2b; Schering-Plough)
in combination with ribavirin has been expanded to include patients
with chronic hepatitis C who have failed previous treatment with interferon
alpha (pegylated or non-pegylated) and ribavirin combination therapy
or interferon alpha monotherapy.
Zavedos
Information about administration in patients with severe mucositis has
been added to the summary of product characteristics for Zavedos powder
for solution for injection (idarubicin; Pfizer).
Hypersensitivity,
cardiac events, persistent myelosuppression and previous treatment
with maximum cumulative doses have been added to the list of contraindications.
Additional
information has also been included in the warnings, interactions and
adverse events sections. The SPC now recommends that men undergoing
Zavedos treatment should use contraceptive measures.
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