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In anaesthetised dogs, a 3mg/kg intravenous dose reduced blood pressure due to the vasodilator activity without affecting cardiac output, and in conscious dogs oral doses up to 20mg/kg had no effect on heart or respiration rate or ECG waveform. There were no changes in PR and QT intervals produced by or by inference, its metabolites. Additional data from clinical studies was provided on the effects of on platelet and retinal function. There were no treatment related effects observed on bleeding time and also, no effects on retinal function were observed. The effect on or in vitro cardiac electrophysiology has not been investigated. However, no adverse cardiovascular effects were observed. Since its potential effects on cardiac electrophysiology are based on clinical data, the applicant has committed to conduct a hERG channel assay with as a post-authorisation follow-up measure. Pharmacodynamics · In vitro studies Studies in isolated human and rabbit corpus cavernosum slices demonstrated that vardenafil dose dependently increased the concentration of cGMP, both in unstimulated and in stimulated slices (MSOffice8).
Approximate Word count = 624
Approximate Pages = 2.5
(250 words per page double spaced)
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