Pinards 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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More detail is available in the summary of product characteristics. Genitourological haemorrhage, including haematuria.

Of the enrolled patients, underwent atrial fibrillation ablation on uninterrupted dabigatran dbigatran underwent atrial fibrillation ablation on uninterrupted warfarin.

Dose reduction for consideration. Known bleeding complications such as compartment syndrome and acute renal failure due to hypoperfusion have been reported for Pradaxa.

Dabigatran etexilate has not been clinically studied together with tacrolimus. In the clinical studies mucosal bleedings e.

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

Quinidine was given as mg dose every 2nd hour up to a total dose of 1, mg. There is no relevant use of Pradaxa in the paediatric population for the indication of prevention of stroke and systemic embolism in patients with NVAF. Dabigatran etexilate has spd been clinically studied together with tacrolimus. Depending on local availability, a consultation of a coagulation expert should be considered in case of major bleedings.


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

The ECT can provide a direct measure of the activity of direct thrombin inhibitors. Polypropylene bottle with a screw cap containing 60 hard capsules.

There were no differences in the phase 3 clinical studies for efficacy and safety data between men and women. Dose recommendations and duration of therapy for primary prevention of dxbigatran thromboembolism in orthopaedic surgery.

Pradaxa 150 mg hard capsules

The RE-LY study demonstrated that dabigatran etexilate, at a dose of mg twice daily, is non-inferior to warfarin in the prevention of stroke and systemic embolism in subjects with atrial fibrillation, with a reduced risk of ICH, total bleeding and major bleeding. For more information about treatment with Pradaxa, read the package leaflet also part of the EPAR or contact your doctor or pharmacist. Blister Store in the original package in order to protect from moisture.

After multiple doses of ticagrelor 90 mg b. A phase II study examined dabigatran etexilate and warfarin in a total of zpc with recent mechanical valve replacement surgery i.

Therefore, related medicinal product interactions are not expected with dabigatran. It is important to tell your doctors about dqbigatran medicines, vitamins, and supplements you take. 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.

Pradaxa 75 mg hard capsules

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. Since the patient population treated in the three indications are not comparable and bleeding events are distributed over several System Organ Classes SOCa summary description of major and any bleeding are broken down by indication and are provided in tables below.


Capsules with light blue, opaque cap and white, opaque body of size 0 filled with yellowish pellets. Use of platelet aggregation inhibitors such as clopidogrel and acetylsalicylic acid ASA or non steroidal antiinflammatory drugs NSAIDas well as the presence of esophagitis, gastritis or gastroesophageal reflux increase the risk of GI bleeding.

See further down and sections 4. Pradaxa 75 mg hard capsules. Number of patients treated with Pradaxa. Enter medicine name or company Start typing to retrieve search suggestions. Management of bleeding complications In the event of haemorrhagic complications, Pradaxa treatment must be discontinued and the source of bleeding investigated.

The calibrated quantitative diluted TT dTT test provides an estimation of dabigatran plasma concentration that can be compared to the expected dabigatran plasma concentrations. Clinical trials for the prevention of thromboembolism in patients with prosthetic heart valves. In this situation Pradaxa and these medicinal products should be taken at the same time. Mean on-therapy follow-up time was Therefore, the possibility of haemorrhage is to be considered in evaluating the condition in any anticoagulated patient.