Примери за използване на Qtc interval prolongation на Английски и техните преводи на Български
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QTc interval prolongation.
Medicinal products known to cause QT/QTc interval prolongation, hypokalemia or hypomagnesaemia.
QTc interval prolongation with.
A pharmacokinetic analysis with TAGRISSO predicted a concentration- dependent increase in QTc interval prolongation.
QT/ QTc interval prolongation.
Хората също превеждат
Furthermore, the bradycardiac effect of digoxin may increase the risk of vandetanib QTc interval prolongation and Torsade de Pointes.
Known QTc interval prolongation or congenital long QT syndrome.
However, if administered intravenously,continuous ECG monitoring must be performed for QTc interval prolongation and for ventricular arrhythmias.
QT/QTc interval prolongation may lead to an increased risk for ventricular arrhythmias.
In the Phase 3 REFLECT trial(see section 5.1),QT/QTc interval prolongation was reported in 6.9% of lenvatinib-treated patients.
QTc interval prolongation may lead to an increased risk for ventricular tachyarrhythmias(e.g. torsade de pointes) or sudden death.
Permanently discontinue TAGRISSO in patients who develop QTc interval prolongation with signs/symptoms of life threatening arrhythmia.
QTc interval prolongation has been reported in clinical studies of patients with ITP and thrombocytopenic patients with HCV.
Osimertinib should be permanently discontinued in patients who develop QTc interval prolongation in combination with any of the following: Torsade de pointes, polymorphic ventricular tachycardia.
QTc interval prolongation may lead to an increased risk for ventricular tachyarrhythmias(e.g. torsade de pointes) or sudden death.
In the pivotal Phase 3 SELECT trial(see section 5.1),QT/QTc interval prolongation was reported in 8.8% of lenvatinib-treated patients and 1.5% of patients in the placebo group.
In cases of suspected overdose, symptomatic and supportive therapy should be given as appropriate,including ECG monitoring because of the possibility of QTc interval prolongation(see section 4.4).
The QTc interval prolongation potential of TAGRISSO was assessed in 210 patients who received osimertinib 80 mg daily in AURA2.
Therapeutic and supra-therapeutic doses of darifenacin resulted in no increase in QT/QTc interval prolongation from baseline compared to placebo at maximum darifenacin exposure.
No reports of QTc interval prolongation greater than 500 ms or increases greater than 60 ms occurred in the everolimus-treated group.
When clinically appropriate, consideration should be given to obtaining an ECG from all patients before the last of the three daily doses is taken and approximately 4-6 hours after the last dose,since the risk of QTc interval prolongation may be greatest during this period(see section 5.2).
QT/QTc interval prolongation was not accompanied by any events of arrhythmia or contracture on the guinea pig heart model at any assay concentration.
That piperaquine absorption is increased inthe presence of food, therefore to reduce this risk of QTc interval prolongation, the patients should be advised to take the tablets with water, without food, no less than three hours after the last food intake.
The company that markets Eurartesim will provide all doctors expected to prescribe or use Eurartesim with an educational pack containing important information on the correct use of the medicine, including a checklist of the medicines that Eurartesim mustnot be given with, to reduce the risk of QTc interval prolongation.
In the DTC study(see Lenvima SmPC),QT/QTc interval prolongation was reported in 8.8% of lenvatinibtreated patients and 1.5% of patients in the placebo group.
Using comprehensive serial ECG assessments at times corresponding to either therapeutic or greater than therapeutic exposures, none of the patients in the evaluable orintent-to-treat(ITT) populations were observed to develop QTc interval prolongation considered as“severe”(i.e. equal to or greater than Grade 3 by Common Terminology Criteria for Adverse Events[CTCAE] version 3.0).
According to the ICH E14-Guideline(“The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs”, 2005) drugs“that prolong the mean QT/QTc interval by> 20 ms have a substantially increase likelihood of being proarrhythmic…”.
A single 32-mg dose of lenvatinib did not prolong the QT/QTc interval based on results from a thorough QT study in healthy volunteers; however,QT/QTc interval prolongation has been reported at a higher incidence in patients treated with lenvatinib than in patients treated with placebo(see sections 4.4 and 4.8).
Severe hepatotoxicity, cardiac toxicity including QTc interval prolongation, severe skin reactions, Clostridium difficile associated colitis, tendon and muscular toxicity(including rhabdomyolysis) are important identified risks of the treatment with moxifloxacin which are already described in the product information(PI) and under close monitoring.
In view of the safety available data the Committee concluded that cases of fatal hepatotoxicity,risk factors for QTc interval prolongation should be reflected in the product information, and that the warnings on Clostridium difficille-associated colitis and bullous skin reactions should be strengthen.