PRADAXA safely and effectively. See full prescribing information for. PRADAXA. PRADAXA® (dabigatran etexilate mesylate) capsules, for oral use. Initial U.S. produce dabigatran exposure similar to that observed in severe renal impairment . Consider reducing the dose of PRADAXA to 75 mg twice daily [see Drug. This is a summary of the European public assessment report (EPAR) for Pradaxa. It explains how the Committee for Medicinal Products for Human Use (CHMP).
|Published (Last):||18 August 2016|
|PDF File Size:||5.10 Mb|
|ePub File Size:||12.17 Mb|
|Price:||Free* [*Free Regsitration Required]|
Pradaxa mg hard capsules – Summary of Product Characteristics (SmPC) – History – (eMC)
These studies compared dabigatran etexilate mg bid with warfarin target INR 2. Stroke and systemic embolism prevention in patients with atrial fibrillation. The primary endpoint was a combined endpoint of major bleeds based on ISTH definition dabigatra clinically relevant non-major bleeding event.
Pregnancy There is limited amount of data from the use of Pradaxa in pregnant women.
Pradaxa 75 mg hard capsules
At doses that were toxic to the mothers 5- to fold the plasma exposure level in patientsa decrease in foetal body weight and viability along with an increase in foetal variations were observed in rats and rabbits. The primary objective in this study was to determine if dabigatran etexilate was non-inferior to warfarin in reducing the occurrence of the composite endpoint stroke and systemic embolism. When taking a hard capsule out of the bottle, the following instructions should be observed: The most commonly reported events are bleedings occurring in approximately For the full list of restrictions, see the package leaflet.
Consideration should also be given to administration of platelet concentrates in cases where thrombocytopenia is present or long acting antiplatelet medicinal products have been used.
Studies in animals have shown reproductive toxicity see section 5.
Pradaxa 150 mg hard capsules
There is some experimental evidence to support the role of these medicinal products in reversing the anticoagulant effect of dabigatran, but data on their usefulness in clinical settings and also on the possible risk of rebound thromboembolism is very limited. Haemorrhagic risk Pradaxa should be used with caution in conditions with an increased risk of bleeding or with concomitant use of medicinal products affecting haemostasis by inhibition of platelet aggregation. When a loading dose of mg ticagrelor was given 2 hours after mg dabigatran etexilate in steady statethe increase of dabigatran AUC ,ss and C max,ss was reduced to 1.
No further increase in bioavailability was observed after another 7 days. Depending on the clinical situation appropriate supportive treatment, such as surgical haemostasis and blood volume replacement, should be undertaken at the prescriber’s discretion.
Choose Pradaxa® (dabigatran etexilate) for AFib, DVT or PE
Depending on the clinical situation appropriate supportive treatment, such as surgical haemostasis and blood volume scp, should be undertaken at the prescriber’s discretion. Better results were seen with the mg dose where the point estimate of Major VTE was slightly better than enoxaparin table Veterinary regulatory Overview Research and development Marketing authorisation Post-authorisation.
Tell your doctor right away if you have back pain, tingling, numbness, muscle weakness especially in your legs and feetloss of control of the bowels or bladder incontinence. When the calibrated dTT assay delivers a dabigatran plasma concentration result at or below the limit of quantification, an additional coagulation assay such as TT, ECT or aPTT should be considered. Clinical efficacy and safety Ethnic origin No clinically relevant ethnic differences among Caucasians, African-American, Hispanic, Japanese or Chinese patients were observed.
In the second prevention study, blood clots or blood-clot related death occurred in 0. General disorders and administration site conditions. Carton containing 6 blister strips 60 x 1 in perforated aluminium unit dose white blisters.
Patients who have atrial fibrillation are also at risk of blood clots which can travel to the brain and cause a stroke. Totals of 2, patients knee and 3, hip dabigatean treated respectively. Blister Store in the original package in order to protect from moisture.
Other patients at increased risk of bleeding.
BIPI is not responsible for the way information is processed by sites linked to this cabigatran. In general, it can be assumed that these measures of anti-coagulant activity may reflect dabigatran levels and can provide guidance for the assessment of bleeding risk, i. Dabigatran etexilate has not been clinically studied together with tacrolimus. Table of contents Overview Authorisation details Product information Assessment history.
In clinical trials, Pradaxa was associated with higher rates of major gastrointestinal GI bleeding. For subjects with gastritis, esophagitis, or gastroesophageal reflux, a dose reduction may be considered due to the elevated risk of major gastro-intestinal bleeding see table 1 above and section 4.
After oral administration, dabigatran etexilate is rapidly and completely converted to dabigatran, which is the active form in plasma.
Posaconazole Posaconazole also inhibits P-gp to some extent but has not been clinically studied. After multiple doses of ticagrelor 90 mg b. Subjects randomized to mg Pradaxa twice daily had a significantly higher risk for major GI bleeds compared with warfarin hazard ratio 1.
Tabulated list of adverse reactions Table 8 shows the adverse reactions ranked under headings of System Organ Classes SOC and frequency using the following convention: No dose dabigatrann is recommended see section 4.