SPC changes
Eprex
The summary of product characteristics for Eprex (epoetin alfa; Janssen-Cilag)
solution for injection in pre-filled syringe 40,000IU/ml has been updated.
The contraindication for use of the subcutaneous route in patients with
chronic renal failure has been removed, and additional information about
the potential for pure red cell aplasia to occur and the use of Eprex
for patients with chronic renal failure has been added. See SPC.
Pegasys
The summary of product characteristics for Pegasys (peginterferon alfa-2a;
Roche) has been updated to include information about the new option
for a shorter, 24-week course of Pegasys in combination with ribavirin
for certain patients with hepatitis C virus infection. See SPC.
Rabies Vaccine
The summary of product characteristics for Rabies Vaccine BP (sanofi
pasteur MSD) has been updated. The subcutaneous route of administration
has been removed and the SPC now says that only the intramuscular route
is recommended. The SPC now states that caution must be exercised when
the vaccine is administered to subjects with hypersensitivity to betapropiolactone,
neomycin and other antibiotics of the same class. It states that Rabies
Vaccine should not be given to patients with bleeding disorders such
as haemophilia or thrombocytopenia or to people taking anticoagulant
therapy unless the potential benefit clearly outweighs the risk. The
SPC now includes new advice about administering the vaccine to people
who are taking corticosteroids or immunosuppressive treatments, and
information on use in breastfeeding. The following adverse events have
been added to the SPC: lymphadenopathy, dyspnoea and wheezing, encephalitis,
convulsion, diarrhoea, vomiting, chills. See SPC.
Raptiva
The summary of product characteristics for Raptiva (efalizumab; Serono)
has been updated. The special warnings section now states: “Cases
of inflammatory polyradiculoneuropathy have been observed in post-marketing
surveillance. … Patients have recovered after discontinuation of
Raptiva, therefore Raptiva should be stopped following the diagnosis
of inflammatory polyradiculoneuropathy.” The undesirable effects
section of the SPC has been updated accordingly. See SPC.
Reyataz
The summary of product characteristics for Reyataz (atazanavir; Bristol-Myers
Squibb) contains additional information about osteonecrosis. It states
that cases of osteonecrosis have been reported, particularly in patients
with advanced HIV-disease or long-term exposure to combination antiretroviral
therapy. Patients are advised to seek medical advice if they experience
joint aches and pain, joint stiffness or difficulty in movement. See
SPC.
Synacthen Depot
The summary of product characteristics for Synacthen Depot (tetracosactide
acetate 1mg/ml) has been updated and now states that Synacthen Depot
contains benzyl alcohol 50mg/5ml. The SPC states: “The benzyl
alcohol contained as an excipient in Syncathen Depot may provoke toxic
and anaphylactoid reactions in children aged under three years.” See
SPC.
Zyvox
The summary of product characteristics for Zyvox (linezolid; Pfizer)
has been updated and now states that linezolid is not active against
infections caused by Gram negative pathogens and specific therapy against
Gram negative organisms must be initiated concomitantly if a Gram negative
pathogen is documented or suspected. The SPC also now states that for
patients with complicated skin and soft tissue infections with known
or possible co-infection with Gram negative organisims, linezolid should
only be used if there are no other treatment options available and
in combination with Gram negative cover. See SPC.
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