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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Pradaxa 150 mg hard capsules

Name of the medicinal product 2. The health information contained in this Website is provided for educational purposes only dabigstran is not intended to replace discussions with a healthcare professional. Injury, poisoning and procedural complications. These affect P-gp either as inhibitor or as inducer. Caution should be exercised when interpreting these tests. Finland France Germany Greece Italy. Clearance of dabigatran in patients with renal insufficiency may take longer see section 5.

Irrespective of therapy, the highest absolute risk of MI was seen in the following subgroups, with similar relative risk: Protease inhibitors such as ritonavir Concomitant use not recommended e.

Dabigatran, the active moiety dabigatrran dabigatran etexilate mesilate, is persistent in the environment. No further increase in bioavailability was observed after another 7 days.

Pradaxa 75 mg hard capsules

For all other countries click here. Pradaxa should be stopped before elective surgery. In general, it can be assumed that these measures of anti-coagulant activity may reflect dabigatran levels and can provide guidance for the assessment of bleeding risk, i.

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This may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities.

The study in patients with non-valvular atrial fibrillation showed that the proportion of patients who had a stroke or other problems caused by blood clots each year was dahigatran 1.

A total of 2, patients were randomized and 2, patients were treated. Please review those sites’ privacy policies and terms of use to understand how your information will be processed. The duration of therapy should be individualised after careful assessment of the treatment benefit against the risk for bleeding see section 4. The dabigatran AUC and C max were increased by about 1.

After removal of a catheter, an interval of at least 2 hours should elapse before the administration of the first dose of Pradaxa. In phase I studies the exposure AUC of dabigatran after the oral administration of Pradaxa is approximately 2. Fertility No human data available.

Skin and spf tissue disorder. Close observation for signs of bleeding is recommended in patients concomitantly treated with NSAIDs see section 4. Patients at high surgical mortality risk and with intrinsic risk factors for thromboembolic dabogatran. After multiple doses of ticagrelor 90 mg b.

When taking a hard capsule out of the bottle, the following instructions should be observed: Patients who have atrial fibrillation are also at risk of blood clots which can travel to the brain and cause a stroke.

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

No treatment experience is available for this subpopulation of patients, and therefore the use of Pradaxa is not recommended in this population. At the end of the follow-up VTE events in patients treated with dabigatran etexilate was 6.

The aPTT slc is widely available and provides an approximate indication of the anticoagulation intensity achieved with dabigatran. The half-life was independent of dose.

The table 11 shows bleeding events broken down to major and any bleeding in the pivotal study testing the prevention of thromboembolic stroke and systemic embolism in patients with atrial fibrillation. Although low in frequency in clinical trials, major spx severe bleeding may occur and, regardless of location, may lead to disabling, life-threatening or even fatal outcomes. 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.

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.

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