SPC changes
Glivec
The summary of product characteristics for Glivec (imatinib; Novartis)
now includes two additional indications. Glivec is now indicated for
the treatment of adult patients with myelodysplastic/myeloproliferative
diseases (MDS/MPD) associated with platelet-derived growth factor receptor
(PDGFR) gene rearrangements. The recommended dose for this indication
is 400mg/day.
Glivec is also now indicated for adult patients with advanced
hypereosinophilic syndrome (HES) or chronic eosinophilic leukaemia
(CEL) with FIP1L1-PDGFRa rearrangment. The recommended dose for this
indication
is 100mg/day. Doses of 400mg may be considered in the absence of adverse
drug reactions if assessments demonstrate an insufficient response
to therapy.
Information regarding cardiac safety in HES/CEL patients
has
been added to the SPC. Acute respiratory failure, anaphylactic shock,
hepatic necrosis and elevations of transaminases and bilirubin have
been added to the list of undesirable effects. The SPC also now states
that
patients with mild or moderate renal dysfunction should be given
the minimum recommended dose as a starting dose. See SPC.
Maxolon
The summary of product characteristics for Maxolon (metoclopramide hydrochloride;
Shire) SR capsules 15mg now includes details of the excipients of the
printing ink used on the capsules. See SPC.
Remicade
The summary of product characteristics for Remicade (infliximab; Schering-Plough)
now states that in carefully selected patients with rheumatoid arthritis
who have tolerated three initial two-hour infusions of Remicade, consideration
may be given to administering subsequent infusions over a period of
not less than one hour. See SPC.
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