SPC changes
Aricept
The summary of product characteristics for Aricept (donepezil; Eisai)
has been updated. The SPC now states the quantity of lactose in each
film-coated tablet. Information about mortality in vascular dementia
clinical trials has been added to the special warnings section. Diarrhoea,
nausea and headache have been moved from “common” to “very
common” in the table of undesirable effects. See SPC.
Celebrex
The summary of product characteristics for Celebrex (celecoxib; Pfizer)
has been updated to include a new indication for symptomatic relief
in the treatment of ankylosing spondylitis. The recommended dose for
this indication is 200mg taken once, or in two divided doses, each
day. In a few patients, with insufficient relief from symptoms, an
increased dose of 400mg once, or in two divided doses, each day may
increase efficacy, the SPC states. See SPC.
Emselex
The summary of product characteristics for Emselex (darifenacin; Novartis)
has been updated to include blurred vision and urinary retention as
possible side effects. See SPC.
NeoRecormon
The summaries of product characteristics for NeoRecormon (epoetin beta;
Roche) have been updated. The indications sections have been reworded
and now say: “Treatment of symptomatic anaemia in adult patients
with
non-myeloid malignancies receiving chemotherapy”. The administration
sections now state that the weekly dose of NeoRecormon for all patients
can be given as one injection per week or in divided doses three to seven
times a week. The recommended initial dose is 30,000IU per week. See
SPCs.
Neupogen
The summaries of product characteristics for Neupogen (filgrastim; Amgen)
have been updated to include a precaution that the needle cover of
the
pre-filled syringe contains dry natural rubber (a derivative of latex),
which may cause allergic reactions. The special warnings sections of
the SPCs also state: “Increased haematopoietic activity of the
bone marrow in response to growth factor therapy has been associated
with transient positive bone-imaging findings. This should be considered
when interpreting bone-imaging results.” See SPCs.
Rapamune
The summary of product characteristics for Rapamune (sirolimus; Wyeth)
now includes additional safety information. It states that the use
of Rapamune, mycophenolate mofetil and corticosteroids, in combination
with IL-2 receptor antibody induction, is not recommended in the de
novo renal transplant
setting. It now recommends periodic quantitative monitoring of urinary
protein excretion. Nephrotic syndrome has been added to the list of undesirable
effects. See SPC.
Rivotril
The summary of product characteristics for Rivotril (clonazepam; Roche)
has been updated to include new information on the treatment of overdose.
See SPC.
Roaccutane
The summary of product characteristics for Roaccutane (isotretinoin;
Roche) has been updated. Concurrent administration of Roaccutane with
topical keratolytic or exfoliative anti-acne agents should be avoided
as local irritation may increase, the SPC says. The SPC now includes
a warning that patients who experience drowsiness, dizziness or visual
disturbances should not drive or operate machinery. See SPC.
Tarceva
The summary of product characteristics for Tarceva (erlotinib; Roche)
has been updated to include a new indication for treatment, in combination
with gemcitabine, of patients with metastatic pancreatic cancer. The
special warnings section of the SPC now includes information about
rare cases of hepatic failure (including fatalities) reported during
use of Tarceva. The SPC also includes new information about drug interactions.
Alopecia is now included as a common adverse effect. See SPC.
Zonegran
The summary of product characteristics for Zonegran (zonisamide; Eisai)
has been updated with new information on the use of Zonegran during
pregnancy and the risk of birth defects. A warning about severe rash
and Stevens–Johnson syndrome has been given greater prominence
in the special warnings section. See SPC.
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