SPC changes
Caelyx
The summary of product characteristics for Caelyx (doxorubicin hydrochloride;
Schering-Plough) now includes additional information about Caelyx’s
nephrotoxicity. See SPC.
Hycamtin
The summary of product characteristics for Hycamtin (topotecan; GSK)
now includes an additional indication, in combination with cisplatin,
for the treatment of patients with carcinoma of the cervix recurrent
after radiotherapy and for patients with stage IVB disease. Patients
with prior exposure to cisplatin require a sustained treament-free
interval to justify treatment with the combination. The initial dose
for this indications is 0.75mg/m2/day, administered as a 30-minute
intravenous infusion on days 1, 2 and 3. Cisplatin is administered
on day 1 at a dose of 50mg/m2/day following the topotecan dose. The
treatment schedule is repeated every 21 days for six courses or until
the disease progresses. See SPC.
Maxolon
The summaries of product characteristics for Maxolon (metoclopramide
hydrochloride; Shire) injection, paediatric liquid, syrup, tablets,
Maxolon High Dose injection and Maxolon SR capsules have been updated.
They now state that care should be taken when using Maxolon for patients
with a history of atopy, including asthma, and that very rarely hypersensitivity,
including anaphylaxis, has been reported in those using Maxolon.In
addition, anxiety has been added to the list of rare undesirable effects.
See SPC.
Rebetol
The summary of product characteristics for Rebetol (ribavirin; Schering-Plough)
now
states that the dose should be kept as close as possible to the recommended
standard dose. See SPC.
Remicade
The summary of product characteristics for Remicade (infliximab; Schering-Plough)
has been updated. It now states that Remicade is not recommended for
use in children under 17 years of age. There is also additional information
about infusion times, infusion-related reactions and juvenile rheumatoid
arthritis patients. See SPC.
ViraferonPeg
The summary of product characteristics for ViraferonPeg (peginterferon
alfa-2b; Schering-Plough) injection prefilled pen now states that,
when ViraferonPeg injection prefilled pen is administered in combination
with
ribavirin, subjects with impaired renal function should be carefully
monitored with respect to the development of anaemia. There is also
additional information about administration of ViraferonPeg to patients
with chronic
hepatitis C who are on stable methadone maintenance therapy and are
naive to peginterferon alfa-2b therapy. See SPC.
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