Summary of product characteristics dabigatran








Pradaxa 110 mg hard capsules - Summary of Product

9/21/2014
03:14 | Author: Allison King

Summary of product characteristics emea
Pradaxa 110 mg hard capsules - Summary of Product

Pradaxa 110 mg hard capsules - Summary of Product Characteristics (SPC) by Boehringer Ingelheim Limited.

Therefore surgical interventions may require the temporary discontinuation of dabigatran etexilate. Caution should be exercised when treatment is temporarily discontinued for interventions and anticoagulant monitoring is warranted. Preoperative phase. In such cases a coagulation test (see sections 4.4 and 5.1) may help to determine whether haemostasis is still impaired. This should be considered in advance of any procedures. Patients on dabigatran etexilate who undergo surgery or invasive procedures are at increased risk for bleeding.

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Pradaxa 150 mg hard capsules - Summary of Product

7/20/2014
01:12 | Author: Jeremy Rodriguez

Summary of product characteristics emea
Pradaxa 150 mg hard capsules - Summary of Product

When a pharmaceutical company changes an SPC or PIL, a new Patients with NVAF concomitantly receiving dabigatran etexilate and.

Black Triangle (CHM): YES.

Last Updated on eMC 10-Jul-2014 View document| Boehringer Ingelheim Limited Contact details.

Black Triangle (CHM): NO.

4.4 Special warnings and precautions for use.

4.2 Posology and method of administration.

Date of revision of text on the SPC: 13-Apr-2012 Legal Category: POM.

Free-text change information supplied by the pharmaceutical company:

Patients with NVAF concomitantly receiving dabigatran etexilate and verapamil, the dose of Pradaxa.

recommended administration for start of ticagrelor with a loading dose.

Dabigatran, the active moiety of dabigatran etexilate mesilate, is persistent in the environment.

POM - Prescription Only Medicine.

Black Triangle (CHM): YES www.boehringer-ingelheim.co.uk.

Free-text change information supplied by the pharmaceutical company:

etexilate increased the adjusted dabigatran AUC τ, ss and Cmax,ss 1.26-fold and 1.29-fold.

Reasons for adding or updating:

… and a multipack containing 2 packs of 50 x 1 hard capsules (100 hard capsules) …

Patients with mild and moderate renal impairment had at steady state an.

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European Medicines Agency - Find medicine - Pradaxa

5/19/2014
01:18 | Author: Chloe Allen

Summary of product characteristics emea
European Medicines Agency - Find medicine - Pradaxa

Pradaxa. dabigatran etexilate What is Pradaxa used for? Pradaxa is. More detail is available in the summary of product characteristics.

Although the studies showed a small higher risk of heart problems with Pradaxa than with warfarin, the benefits of Pradaxa were still considered to outweigh its risks. In addition, the CHMP noted that the overall benefit of Pradaxa in the treatment and prevention of DVT and PE is comparable to that of warfarin. However, the number of bleeding events was lower for Pradaxa than for warfarin.

Patients undergoing hip or knee replacement surgery are at a high risk of blood clots forming in their leg veins.

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Pradaxa (dabigatran etexilate) resources and information PRADAXA

3/18/2014
03:04 | Author: Chloe Allen

Summary of product characteristics emea
Pradaxa (dabigatran etexilate) resources and information PRADAXA

Download educational resources regarding Pradaxa (dabigatran etexilate) and it's use to prevent AF related PRADAXA Summary of Product Characteristics.

Appropriate Use Guide An easy to use guide that will answer your questions on how to prescribe PRADAXA (based on the EMEA approved Prescriber Guide).

PRADAXA Summary of Product Characteristics Summary of Product Characteristics approved by the European Medicines Agency (EMA) and as in force for the EU.

The materials listed below have been developed to provide you with practical and relevant information on the use of PRADAXA.

It provides guidance for patients on how to minimize the risk of bleeding that is inherent during treatment with any anticoagulant and directs the patient to sources of further information. In cases of emergency it is important to know if a patient is using an anticoagulant. The card also contains individual patient information and PRADAXA information for healthcare professionals, which the patient can use to inform other healthcare professionals regarding their PRADAXA treatment should this be necessary. Patient Alert Card The patient alert card contains information for both the patient and other healthcare professionals.

Prescriber Guide for the Stroke Prevention in Atrial Fibrillation (SPAF) Provides practical information about using PRADAXA in SPAF and helps you tailor the use of PRADAXA to the specific requirements of your patients in the treatment of SPAF.

To request a hard copy, please contact your local Boehringer Ingelheim PRADAXA sales representative. You are welcome to download these materials for your personal use, subject to our terms of use.

Emergency bleeding management guide This document includes important safety information for patients on PRADAXA presenting in emergency and surgery situations.

Prescriber Guide for the Primary Prevention of Venous Thromboembolic Events (VTE) Provides practical information about using PRADAXA in VTE and helps you tailor the use of PRADAXA to the specific requirements of your patients in the treatment of VTE.

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Positive CHMP opinion for Pradaxa in treatment of deep vein

1/17/2014
05:30 | Author: Jeremy Rodriguez

Summary of product characteristics emea
Positive CHMP opinion for Pradaxa in treatment of deep vein

Pradaxa is already approved for stroke prevention in patients with atrial. Pradaxa European Summary of Product Characteristics, 2014. 5.

Media & PR Julia Meyer-Kleinmann Binger Strasse 173 55216 Ingelheim am Rhein GERMANY.

Respect, equal opportunities and reconciling career and family form the foundation of the mutual cooperation. This includes worldwide involvement in social projects, such as the initiative "Making more Health" and caring for the employees. In everything it does, the company focuses on environmental protection and sustainability. Taking social responsibility is an important element of the corporate culture at Boehringer Ingelheim.

"With Pradaxa we aim to offer physicians and patients a new, simple treatment option that is as effective as warfarin, the current standard of care, while providing a favourable overall safety profile.".

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