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hat have been reported Post-Marketing that are not listed above are:Immune system disordersVery rare: Hypersensitivity, manifested by isolated spontaneous reports including, but not limited to; pulmonary eosinophilia, vesicobullous rash with mucous membrane involvement and sensation of oropharyngeal swelling.Very rare: AnaphylaxisVery rare: There have been isolated cases of infusion reactions including the following symptoms: tachycardia, wheezing, pyrexia, rigors, systemic flushing, vertigo, syncope and metallic taste.Musculoskeletal, connective tissue and bone disordersVery rare: RhabdomyolysisIsolated cases of rhabdomyolysis have been reported; when clinical information on the patients was available to make a judgement, approximately 50% of the cases occurred in patients with pre-existing renal insufficiency, or in those receiving concomitant medications known to cause rhabdomyolysis.InvestigationsIn some cases of myopathy involving raised CPK and muscle symptoms, the patients also presented with elevated transaminases. These transaminase increases were likely to be related to the skeletal muscle effects. The majority of transaminase elevations were of Grade 13 toxicity and resolved upon discontinuation of treatment.
Manufacturer
Novartis
Drug Availability
(POM)
Updated
11 August 2009
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