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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In this situation Pradaxa and verapamil should be taken at the same time.

Pradaxa 75 mg hard capsules

This site is intended for U. When dabigatran etexilate mg was co-administered with oral verapamil, the C max and AUC of dabigatran were increased but the magnitude of this change differs depending on timing of administration and formulation of verapamil see sections 4.

The CHMP noted that effect of Pradaxa in preventing the formation of blood clots patients who have undergone a hip or dabgatran replacement is comparable to that of enoxaparin. Based on the most current information available to Boehringer Ingelheim Pharmaceuticals, Inc.

Patients at high surgical mortality risk and with intrinsic risk factors for thromboembolic events. The primary endpoint was a combined endpoint of major bleeds based on ISTH definition or clinically relevant non-major bleeding event.

Clopidogrel In young healthy male volunteers, the concomitant administration of dabigatran etexilate and clopidogrel resulted in no further prolongation of capillary dabigatraan times compared to clopidogrel monotherapy.

Pradaxa 75 mg hard capsules – Summary of Product Characteristics (SmPC) – (eMC)

For the full list of dabifatran side effects dabigatra with Pradaxa, see the package leaflet. For more information about treatment with Pradaxa, read the package leaflet also part of the EPAR or contact your doctor or pharmacist. For further information, see the summary of product characteristics also part of the EPAR.

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Dose adjustment should be decided at the discretion of the physician, following assessment of the potential benefit and risk to an individual patient dabigtaran table 1 above.

Tables display results of the primary efficacy and safety endpoint in relevant sub-populations:. With atrial fibrillation, dabigatfan of the heart does not beat the way it should. Elimination Plasma concentrations of dabigatran showed a dabigqtran decline with a mean terminal half-life of 11 hours in healthy elderly subjects. Blister Store in the original package in order to protect from moisture.

Until then, INR values should be interpreted with caution. Your message was not sent. On subsequent days absorption of dabigatran is rapid with peak plasma concentrations attained 2 hours after medicinal product administration.

Patients should be instructed not to open the capsule as this may increase the risk of bleeding see sections 5. After multiple doses a terminal half-life of about hours was observed. Risk factors Table 2 summarises factors which may increase the haemorrhagic risk.

Marketing authorisation holder 8. Dabigatran etexilate was given twice daily over 3 consecutive days, on the 3 rd day either with or without quinidine.

UFH can be administered at doses necessary to maintain a patent central venous or arterial catheter or during catheter ablation for atrial fibrillation see section 4. Skin and subcutaneous tissue disorder. Caution should be exercised when treatment is temporarily discontinued for interventions and anticoagulant monitoring is warranted.

No dose adjustment is necessary see section 5. In addition, the company that makes Pradaxa will provide an educational pack for all doctors who are expected to prescribe the medicine, to increase awareness of the risk of bleeding and provide guidance on how to manage it.

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Pradaxa should be temporarily discontinued. There are limited efficacy and safety data for Pradaxa available in these patients and therefore they should be treated with caution.

The patients soc treated for one to three years and the main measure of spv was based on the proportion of patients who dabigatan a stroke or a blood clot blocking blood vessels in other parts of the body each year. Composite of total VTE including PE, proximal and distal DVT, whatever symptomatic or asymptomatic detected by routine venography and all-cause mortality constituted the primary end-point for both studies. Show table of contents Hide table of contents 1.

In such cases a coagulation test see sections 4. Clinical efficacy and safety Ethnic origin No clinically relevant ethnic differences among Caucasians, African-American, Hispanic, Japanese or Chinese patients were observed.

Close observation for signs of bleeding is recommended in patients concomitantly treated with NSAIDs see section 4. Prevention dabitatran stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more of the following risk factors:.

As protein binding is low, dabigatran can be dialysed; there is limited clinical experience to demonstrate the utility of this approach in clinical studies see section 5.

This means that it is converted into dabigatran in the body. There is a clear correlation between plasma dabigatran concentration and degree of anticoagulant effect based on phase II studies. For the primary endpoint, stroke and systemic embolism, no subgroups i.