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):||20 January 2017|
|PDF File Size:||2.19 Mb|
|ePub File Size:||7.28 Mb|
|Price:||Free* [*Free Regsitration Required]|
Last updated on eMC: A risk management plan has been developed to ensure that Pradaxa is used as safely as possible.
After oral administration, dabigatran etexilate is rapidly and completely converted to dabigatran, which is the active form in plasma. Primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery.
To email a medicine you must sign up and log in. Blister and bottle 3 years Once the bottle is opened, the medicinal product must be used within 4 months.
Pradaxa 150 mg hard capsules
In patients at higher risk of bleeding or in major surgery where complete haemostasis may be required consider stopping Pradaxa vabigatran before surgery. Biotransformation Metabolism and excretion of dabigatran were studied following a single intravenous dose of radiolabeled dabigatran in healthy male subjects.
Clearance of dabigatran in patients with renal insufficiency may take longer see section 5. All patients received an initial oral dose of 1.
At the end of the follow-up VTE events in patients treated with dabigatran etexilate was 6.
Anatomical therapeutic chemical ATC code. Carton containing 6 blister strips 60 x 1 in perforated aluminium unit dose white blisters.
Pradaxa mg hard capsules – Summary of Product Characteristics (SmPC) – (eMC)
Of the enrolled patients, underwent atrial fibrillation ablation on uninterrupted dabigatran and underwent atrial fibrillation ablation on uninterrupted warfarin.
Not all pack sizes may be marketed. None of these diseases showed an impact on the effects of dabigatran on VTE-prevention or bleeding rates.
The primary endpoint was a combined endpoint of major bleeds based on ISTH definition or clinically relevant non-major bleeding event. Caution should be exercised when treatment is temporarily discontinued for interventions and anticoagulant monitoring is warranted.
Irrespective of therapy, the highest absolute risk of MI was seen in the following subgroups, with similar relative risk: In view slc the long half-life of amiodarone the potential for an interaction may exist for weeks after discontinuation of amiodarone see sections 4.
After oral administration of Pradaxa in healthy volunteers, the pharmacokinetic profile of dabigatran in plasma is characterized by a rapid increase in plasma concentrations with C max attained within 0.
Pradaxa 75 mg hard capsules
This exploratory study showed that dabigatran etexilate was associated with a significant reduction in MBE rate compared with INR-adjusted warfarin in the setting of ablation. 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.
Therefore, related medicinal dabitatran interactions are not expected with dabigatran. Since thrombin serine protease enables the conversion of fibrinogen into fibrin during the coagulation cascade, its inhibition prevents the development of thrombus. Composite of major VTE including PE and proximal DVT, whatever symptomatic or asymptomatic detected by routine venography and VTE-related mortality constituted a secondary end-point and is considered of better clinical relevance. The use of fibrinolytic medicinal dabigtran for the treatment of acute ischemic stroke may be considered if the patient presents with a dTT, ECT or aPTT not exceeding the upper limit of normal ULN according to the local reference range.
Primary prevention of venous thromboembolic events in adult patients who have undergone elective total-hip-replacement surgery or total-knee-replacement surgery.
Dabigatran etexilate is a substrate for the efflux transporter P-gp. In the event of haemorrhagic complications, Pradaxa treatment must be discontinued and the source of bleeding investigated.
Choose Pradaxa® (dabigatran etexilate) for AFib, DVT or PE
Concomitant use not recommended Tacrolimus Tacrolimus has been found dabigatraan vitro to have a similar level of inhibitory effect on P-gp as that seen with itraconazole and cyclosporine.
Statistical superiority was also analysed.
Concomitant use of Pradaxa with s;c to moderate P – glycoprotein P – gp inhibitors, i. Clopidogrel In spf healthy male volunteers, the concomitant administration of dabigatran etexilate and clopidogrel resulted in no further prolongation of capillary bleeding times compared to clopidogrel monotherapy. In the hip and knee studies, there was some evidence that the mg dose may be more effective than the mg dose. Patients should be instructed not to open the capsule as this may increase the risk of bleeding see sections 5.