SPC changes
Miacalcic
Miacalcic (salcatonin; Novartis) ampoules and multidose vials are now
only indicated for prevention of acute bone loss due to sudden immobilisation
such as in patients with recent osteoporotic fractures, Paget’s
disease and hypercalcaemia of malignancy. Miacalcic nasal spray is indicated
for the treatment of established post-menopausal osteoporosis in order
to reduce the risk of vertebral fractures. Both formulations are now
contraindicated in patients with hypocalcaemia. The posology and method
of administration sections have been updated to reflect these changes
in indication. See SPCs.
Micardis
Dosage instructions for Micardis (telmisartan; Boehringer Ingelheim)
tablets have been updated. A lower starting dose of 20mg once daily
is now recommended in patients with severe renal impairment and in
those undergoing haemodialysis. In addition, it is no longer contraindicated
in patients with severe renal impairment. See SPC.
Reyataz
The summary of product characteristics for Reyataz (atazanavir; Bristol-Myers
Squibb) now states that Reyataz should no longer be administered with
proton pump inhibitors due to an important reduction in atazanavir
exposure. See SPC.
Viread
The summary of product characteristics for Viread (tenofovir disoproxil;
Gilead) tablets 245mg has been updated. It now states that co-administration
of tenofovir and didanosine is not recommended, especially in patients
with high viral load and low CD4 count. The SPC also now states that
patients should be informed that dizziness has been reported during
treatment. Increased transaminases and acute tubular necrosis have
been added to the undesirable effects section. See SPC.
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