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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The concomitant use of LMWHs, such as enoxaparin and dabigatran sp has not been specifically investigated. Bleeding events in a study testing the prevention of thromboembolic stroke and systemic embolism in patients with atrial fibrillation.

Hence, the integrity of the HPMC capsules should always be preserved in clinical use to daabigatran unintentionally increased bioavailability of dabigatran etexilate see section 4. Your risk of developing a spinal or epidural blood clot is higher if: There was no meaningful interaction observed when verapamil was given 2 hours after dabigatran etexilate increase of C max by about 1. When severe bleedings occur, treatment must be discontinued, the source of bleeding investigated and use of the specific reversal agent Praxbind idarucizumab may be considered see section 4.

The inducing effect was diminished resulting in dabigatran exposure close to the reference by day 7 after cessation of rifampicin treatment. Although rare in frequency in clinical trials, major or severe bleeding may occur and, regardless of location, may lead to disabling, life-threatening or even fatal outcomes. Substances influencing gastric pH. Pradaxa was as effective as enoxaparin in preventing the formation of blood clots or death.

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

A phase II study examined dabigatran etexilate and warfarin in a total of patients with recent mechanical valve replacement surgery i. Pradaxa has no or negligible influence on the ability to drive and use machines.

Spcc should be considered in advance of any procedures. The use of fibrinolytic medicinal products for the treatment of acute ischemic stroke may be considered dabigarran the patient presents with a dTT, ECT or aPTT not exceeding the upper limit of normal ULN according to the local reference range.

Pradaxa mg hard capsules. Based on dabigxtran concentrations as determined by the diluted thrombin time test and clinical assessment, the dose was adjusted to the target dose of 2. Subjects randomized to mg Pradaxa twice daily had a significantly higher risk for major GI bleeds compared with warfarin hazard ratio 1.

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Dabigatran is subject to conjugation forming pharmacologically active acylglucuronides. Concomitant administration of P-gp inhibitors see table dabigatraj is expected to result in increased dabigatran plasma concentrations. When excessive dabigatran exposure is identified in patients at high risk of bleeding, a reduced dose of mg taken as one mg capsule twice daily is recommended.

Based on the most current information available to Boehringer Ingelheim Pharmaceuticals, Inc. Patients on Pradaxa who undergo surgery or invasive procedures are at increased risk for bleeding. Myocardial infarction rates were slightly increased with dabigatran etexilate mg twice daily and mg twice daily compared to warfarin hazard ratio 1. The CHMP also noted that Pradaxa compared well with warfarin in reducing the risk of strokes in patients with atrial fibrillation without increasing the risk of major bleeding.

Blister and bottle 3 years Once the bottle is opened, the medicinal product must be used within 4 months. They have not been studied and are therefore not recommended for concomitant treatment with Pradaxa. When a loading dose of dabigtaran 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.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Concomitant use not recommended. For situations when rapid reversal of the anticoagulant effect of Pradaxa is required the specific reversal agent Praxbind, idarucizumab antagonizing the pharmacodynamic effect of Pradaxa is available see section 4.

A calibrated quantitative dTT test or repetitive dTT measurements allow prediction of the time by when certain dabigatran levels will be reached see section 5. In the studies looking at treatment of VTE and PE, blood clots or blood-clot related death occurred in 2.

Changes since initial authorisation of medicine List item. Concomitant administration of P-gp inhibitors dabgatran table 5 is expected to result in increased dabigatran plasma concentrations.

Steady state after day 3 geometric mean dabigatran peak soc concentration, measured around 2 hours after mg dabigatran etexilate administration, was Detailed information on this medicinal product is available on the website of the European Medicines Agency http: For patients with NVAF treated for prevention of stroke and systemic embolism with mg dabigatran etexilate twice daily. However, the aPTT test has limited sensitivity and is not suitable for dabigatraj quantification of anticoagulant effect, especially at high plasma concentrations of dabigatran.

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If you are a healthcare professional from outside the Dabigatarn. This is considered to be due to the carry-over effect of enoxaparin treatment, and regarded as not clinically relevant.

Carton containing 6 blister strips 60 x 1 in perforated aluminium unit dose white blisters. When severe bleedings occur, treatment must be discontinued, the source of bleeding investigated and use of the specific reversal agent Praxbind idarucizumab may be considered see section 4. Your message was not sent.

A study evaluating post-operative absorption of dabigatran etexilate, hours following surgery, demonstrated relatively slow absorption dabihatran with that in healthy volunteers, showing a smooth plasma concentration-time profile without high peak plasma concentrations. Itraconazole, cyclosporine Based on in vitro results a similar effect as with ketoconazole may be expected. Dose reductions are recommended for patients who receive concomitantly verapamil see table 1 above and sections 4.

To view the changes to a medicine you must sign up and log in. In young healthy male volunteers, the concomitant administration of dabigatran etexilate and clopidogrel resulted in no further prolongation of capillary bleeding times compared to clopidogrel monotherapy. This can lead to blood clots forming and increase your risk of a stroke.

Pradaxa 150 mg hard capsules

Marketing authorisation number s 9. Since thrombin serine protease enables the conversion of fibrinogen into fibrin during the coagulation cascade, its inhibition prevents the development of thrombus. Pre-dosing of the probe inducer rifampicin at a dose of mg once daily for 7 days decreased total dabigatran peak and total exposure by Plasma concentrations of dabigatran showed a biexponential decline with a mean terminal half-life of 11 hours in healthy elderly subjects.

When Pradaxa was co-administered with a single oral dose of mg amiodarone, the extent and rate of absorption of amiodarone and its dabigahran metabolite DEA were psc unchanged.

In patients with moderate renal impairment and concomitantly treated with verapamil, a dose reduction of Pradaxa to 75 mg daily should be considered see sections 4. No clinically relevant inter-ethnic differences among Caucasian, African-American, Hispanic, Japanese or Chinese patients were observed regarding dabigatran pharmacokinetics and pharmacodynamics. Table 4 shows coagulation test thresholds at trough that may be associated with an increased risk of bleeding see section 5.