SPC changes
Aranesp SureClick
The summary of product characteristics for Aranesp SureClick (darbepoetin
alfa; Amgen) has been updated. It now states that the needle cover of
the pre-filled pen contains dry natural rubber (a derivative of latex)
which may cause allergic reactions. Warnings have also been added that
Aranesp should be used with caution in patients with epilepsy and that
convulsions have been reported in patients with chronic renal failure
receiving Aranesp. The SPC also now states that once a pre-filled pen
has been removed from the refrigerator and has reached room temperature
it must either be used within seven days or disposed of. See SPC.
Humira
The summary of product characteristics for Humira (adalimumab; Abbott)
has been updated to include an additional indication for the treatment
of adults with severe ankylosing spondylitis who have had an inadequate
response to conventional therapy. The recommended dose for this indication
is 40mg administered every other week as a single dose via subcutaneous
injection. Hyperglycaemia, pharyngeal erythema, wheezing, skin exfoliation,
rheumatoid nodule, shoulder pain and feeling hot have been added as
side effects.
See SPC.
Implanon
The summary of product characteristics for Implanon (etonogestrel; Organon)
68mg implant for subdermal use has been updated.The SPC now provides
further information on verifying the presence of the implant in the
applicator before insertion and a statement has been added to ensure
that both the health care professional and the woman palpate the implant
after insertion to confirm its presence. A warning about migration
of the implant from the insertion site has been added. The SPC now
states that, when the implant is placed too deeply, paraesthesia and
migration of the implant may occur. The text has also been revised
to provide further information about changing from combined hormonal
contraceptives to Implanon. A new section has been added to provide
instructions on replacement of Implanon. The text also now gives reasons
for the possibility of expulsion of the implant and clarifies that
Implanon should be stored in the original package to prevent damage.
See SPC.
Nu-Seals
The summaries of product characteristics for Nu-Seals (aspirin, Alliance)
tablets 75mg and 300mg have been updated to include new information
about haematological effects, drug interactions and use in pregnancy.
The undesirable effects and overdose sections have been reworded and
include new information. See SPCs.
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