DABIGATRAN SPC PDF

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).

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No dose adjustment is necessary see section 5. Dabigatran AUC ,ss and C max,ss were increased on average by 1. For the full list of restrictions, see the package leaflet. Concomitant use contraindicated see section 4. No new safety findings were observed.

When Pradaxa was co-administered with a single oral dose of mg amiodarone, the extent and rate of absorption of amiodarone and its active metabolite DEA were essentially unchanged. One of these prevention studies compared Pradaxa with warfarin and the other compared Pradaxa with placebo a dummy treatment.

Pradaxa 75 mg hard capsules

Subjects randomized to mg Pradaxa twice daily had a significantly lower risk for major bleeds compared with warfarin hazard ratio 0. Name of the medicinal product 2. Dabigatran etexilate has not been clinically studied together with tacrolimus.

When taking Pradaxa capsules out of the blister pack, the following instructions should be followed: The incidence of the composite efficacy endpoint of death, thromboembolic events myocardial infarction, stroke, or systemic embolism or unplanned revascularization in the two dabigatran etexilate dual-therapy groups combined was non-inferior to the warfarin triple-therapy group Respiratory, thoracic and mediastinal disorders.

Tacrolimus has been found in vitro to have a similar level of inhibitory effect on P-gp as that seen with eabigatran and cyclosporine. This risk of bleeding spv be weighed against the urgency of intervention. Boehringer Ingelheim Pharmaceuticals, Inc. Close observation for signs of bleeding is recommended in patients concomitantly treated with NSAIDs see section 4.

Pradaxa 150 mg hard capsules

To email a medicine you must sign up and log in. Stroke and systemic embolism prevention in patients with atrial fibrillation.

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Diluted thrombin time dTTecarin clotting time ECT and activated partial thromboplastin time aPTT may provide useful information, but results should be interpreted with caution due to inter-test variability see section 5. Product details Name Pradaxa.

Table 3 shows coagulation test thresholds at trough that may be associated with an increased risk of bleeding see section 5. Half-life of total dabigatran in healthy subjects and subjects with impaired renal function. In phase I studies the exposure AUC of dabigatran after the oral administration of Pradaxa is approximately 2.

Risk factors Table 2 summarises factors which may increase the haemorrhagic risk. See further down and sections 4. Patients who have atrial fibrillation are also at risk of blood clots which can travel to the brain and cause a stroke.

Pradaxa is used for the following: There was no meaningful interaction observed when verapamil was given 2 hours after dabigatran etexilate increase of C max by about 1.

Dabigatran is a potent, competitive, reversible direct thrombin inhibitor and is the main active principle in plasma. The calibrated quantitative diluted TT dTT test provides an estimation of dabigatran plasma concentration that can be compared to the expected dabigatran plasma concentrations. To view the changes to a medicine you must sign up and log in. Therefore, surgical interventions may require the temporary discontinuation of Pradaxa. For the primary safety endpoint of major bleeding there was an interaction of treatment effect and age.

Pradaxa | European Medicines Agency

In dabigafran pre- and post-natal study, an increase in foetal mortality was observed at doses that were toxic to the dams a dose corresponding to a plasma exposure level 4-fold higher than observed in patients.

Qualitative and quantitative composition 3. Composite of total VTE including PE, proximal and distal DVT, whatever symptomatic scp asymptomatic detected by routine venography and all-cause mortality constituted the primary end-point for both studies.

This information is intended for use by health professionals. The greatest elevation of dabigatran exposure was observed with dabigatrn first dose of an immediate release formulation of verapamil administered one hour prior to the dabigatran etexilate intake increase of C max by about 2.

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However, the aPTT test has limited sensitivity and is not suitable for precise quantification of anticoagulant effect, especially at high plasma concentrations slc dabigatran. Clearance of dabigatran in patients with renal insufficiency may take longer see section 5. P-gp substrate Digoxin In a study performed with 24 healthy subjects, when Pradaxa was co-administered with digoxin, no changes on digoxin and no clinically relevant changes on dabigatran exposure have been observed.

Ranitidine Ranitidine administration together with Pradaxa had no clinically relevant effect on the extent of absorption of dabigatran. Prevention of stroke and systemic embolism in adult patients with NVAF with one or more risk factors.

Pradaxa mg hard capsules – Summary of Product Characteristics (SmPC) – (eMC)

UFH can be administered at doses necessary to maintain a patent central venous or arterial catheter or during catheter ablation for atrial dabihatran see section 4.

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.

This staggered intake is the recommended administration for start of ticagrelor with a loading dose. Skip to main content. Pradaxa should be temporarily discontinued. At doses that were toxic to the mothers representing a 5- to fold higher plasma exposure level to patientsa decrease in foetal body weight and embryofoetal viability along with an increase in foetal variations were observed in rats and rabbits.

The health information contained in this Website is provided for educational purposes only and is not intended to replace discussions with a healthcare professional. The relative risk of bleeding with dabigatran compared to warfarin increased with age.

In such cases a coagulation test see sections 4. 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.

Polypropylene bottle with a screw cap containing 60 hard capsules.