"The cystic fibrosis (CF) drug Orkambi (Vertex Pharmaceuticals) has received a green light from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP).
Orkambi is a fixed-dose oral combination "...
Serious adverse events have not been reported in healthy subjects with dosages up to 5 times the normal clinical dose (maximum dose investigated).
High doses of manganese can have negative inotropic and vasodilatory effects as well as effects on heart rhythm and conduction because of calcium antagonism.
Treatment of an overdose should be symptomatic and directed towards the support of vital functions. There is no antidote to this contrast medium.
Mangafodipir and its metabolites are dialysable whereas manganese is not dialysable because of protein binding (see also Pharmacokinetic properties under CLINICAL PHARMACOLOGY).
Hypersensitivity to the active substance or to any of the excipients.
Pregnancy and lactation.
Severely reduced liver function (Child - Pugh class C), especially severe obstructive hepatobiliary disease.
Severely reduced renal function.
Last reviewed on RxList: 3/3/2009
Additional Teslascan Information
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