Primjeri korištenja Msec na Engleski i njihovi prijevodi na Hrvatskom
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Msec, Release time: approx.
QTc interval greater than 500 msec on at least 2 separate ECGs.
One patient(< 1%)in each group experienced a QTcF> 500 msec.
QTcF of> 500 msec was observed in< 1% of these patients.
Twenty-one patients(1%) experienced a QTcF> 500 msec see section 4.4.
QTcF exceeding 500 msec was observed in< 1% of patients.
A central analysis of ECG data demonstrated new QTc> 500 msec in one patient 0.2.
Maximum PR interval was 286 msec and no second or third degree heart block was observed see section 4.4.
From baseline to end of study the median change for FIRMAGON was 12.0 msec and for leuprorelin it was 16.7 msec.
Maximum PR interval was 252 msec and no second or third degree heart block was observed see section 4.4.
The change from baseline in mean time-averaged QTcF interval at steady state was 6 msec.
QTc prolongation> 470 msec(females) or> 450 msec males.
The upper bound of one-sided 95% confidence interval(CI)for predicted effect on QTcF at Cmax was 4.8 msec.
No patient had an absolute QTcF> 500 msec while on the study medicinal product.
In clinical trials, 40% of patients treated with TRISENOX experienced at least one QT corrected(QTc)interval prolongation greater than 500 msec.
Both therapies showed QT/QTc intervals exceeding 450 msec in approximately 20% of the patients.
With Bazett's correction(QTcB interval),the upper bound of one-sided 95% confidence interval(CI) for predicted effect on QTcB at Cmax was 5.9 msec.
QTcF increase from baseline exceeding 60 msec was observed in< 1% of patients while on the study medicinal product.
In the Phase III study MEK116513 four patients(1%)treated with trametinib in combination with dabrafenib had a QTcB Grade 3 increase> 500 msec.
If during treatment the QTc exceeds 500 msec, please refer to the vemurafenib SmPC sections 4.2 and 4.4.
A pharmacokinetic analysis predicted a drug-related QTc interval prolongation at 80 mg of 14 msec with an upper bound of 16 msec 90% CI.
For QTc greater than 500 msec, corrective measures must be completed and the QTc reassessed with serial ECGs prior to considering using TRISENOX.
The mean QTcF prolongation compared to placebo decreased to 11.8 msec at 24 hours and to 7.5 msec at 48 hours.
QTc> 500 msec or> 60 msec change from baseline and torsade de pointes or polymorphic ventricular tachycardia or signs/symptoms of serious arrhythmia.
The mean changes from baseline in PR interval ranged from 11.0 to 24.0 msec in the 12 hour interval post dose.
If during treatment the QTc exceeds 500 msec, please refer to the vemurafenib SmPC(section 4.2) for dose modifications for vemurafenib.
BRINAVESS has been administered to patients with an uncorrected QT less than 440 msec without an increased risk of torsade de pointes.
If QTc increases by greater than or equal to 60 msec from baseline but QTc is< 500 msec, crizotinib should be withheld and cardiologist advice should be sought.
Vandetanib at a dose of 300 mg is associated with a substantial andconcentration dependent prolongation in QTc mean 28 msec, median 35 msec.