SPC changes
Bezalip and Bezalip Mono
The summaries of product characteristics for Bezalip (bezafibrate; Roche)
tablets 200mg and Bezalip Mono tablets 400mg have been updated. The posology
and method of administration sections now say that patients who experience
gastrointestinal symptoms should slowly increase the dosage over five
to seven days. The Bezalip SPC now states that in elderly patients the
dosage should be adjusted for renal function, based on serum creatinine
clearance. The Bezalip Mono SPC states that the product should not be
used in elderly patients if their creatinine clearance is below 60ml/min.
Bezalip is now contraindicated in dialysis patients and in patients with
predisposing factors for myopathy taking HMG CoA reductase inhibitors.
The SPCs now state that Bezalip and Bezalip Mono have been shown to cause
dizziness and can have minor to moderate effects on ability to drive
or use machines. The overdose sections now include rhabdomyolysis as
a known effect of acute overdose. The pharmacokinetic properties sections
of the SPCs have also been updated. See SPCs.
CellCept
The summaries of product characteristics for CellCept (mycophenolate
mofetil; Roche) capsules 250mg, tablets 500mg, powder for oral suspension
1g/5ml and intravenous infusion 500mg have been updated to include
isolated reports of aplastic anaemia and bone marrow depression in
patients treated
with CellCept, some of which have been fatal. See SPCs.
Invanz
The summary of product characteristics for Invanz (ertapenem; MSD) has
changed and now includes a licence for the treatment of diabetic foot
infections of the skin and soft tissue. In the special warnings and
precautions for use section, the following statement has been added: “Efficacy
of ertapenem in the treatment of diabetic foot infections with concurrent
osteomyelitis has not been established.” See SPC.
Invirase
The summary of product characteristics for Invirase (saquinavir; Roche)
capsules 200mg and film-coated tablets 500mg has been update. The interactions,
undesirable effects, pharmacodynamic properties and pharmacokinetic
properties sections have been updated to include new information on
the licensed ritonavir-boosted saquinavir dosing regimen. See SPC.
Konakion MM
The summary of product characteristics for Konakion MM Paediatric (phytomenadione;
Roche) 2mg/0.2ml now states that the product can be given by intramuscular,
intravenous or oral administration depending on the indication. Konakion
MM Paediatric is indicated for the prophylaxis and treatment of vitamin
K deficiency bleeding (VKDB) in neonates and infants. The intramuscular
route for VKDB prophylaxis has been added to the SPC for healthy neonates
of 36 weeks’ gestation or older. Konakion MM Paediatric is now
indicated as an antidote to coumarin-type anticoagulants in infants
and children. The SPC says that the drug must be administered by intravenous
injection when used for this indication. The posology and method of
administration section has been updated to include dosages for these
new indications. The special warnings and precautions section now states
that infants with cholestatic disease must receive Konakion MM Paediatric
by intramuscular or intravenous injection since oral absorption is
impaired in these patients. The SPC states that the product should
not be given by intravenous infusion or diluted before injection. The
pharmacokinetic properties section has been updated to include information
about the intramuscular route. See SPC.
Pegasys
The summary of product characteristics for Pegasys (peginterferon alpha
2a; Roche) now includes suicidal ideation, suicide, psychotic disorder
and hallucinations as uncommon to rare serious adverse events (<1
to <0.1 per cent). See SPC.
Propess
The summary of product characteristics for Propess (dinoprostone; Ferring)
has been updated to include information on risk of developing disseminated
intravascular coagulation. The adverse events section has been tabulated
and includes new text on genital oedema and gastrointestinal effects.
See SPC.
Roaccutane
The summary of product characteristics for Roaccutane (isotretinoin;
Roche) has been updated. The special warnings section now states that
available data suggest that the level of maternal exposure from the
semen of male patients receiving isotretinoin is not of a sufficient
magnitude to be associated with the teratogenic effects of isotretinoin.
See SPC.
Back to Top
|
The
Pharmaceutical Journal