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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For the primary safety endpoint of major bleeding there was an interaction of treatment effect and age. Please see full Prescribing Information and Medication Guide. 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. Patients between spcc.

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Patients on Pradaxa who undergo surgery or daibgatran procedures are at increased risk for bleeding. If not otherwise specifically described, close clinical surveillance looking for signs of bleeding or anaemia is required when dabigatran is co-administered with strong P-gp inhibitors.

Pradaxa should be stopped before elective surgery. Concomitant administration of a loading dose of mg dabigatrwn and mg dabigatran etexilate in steady state increased the dabigatran AUC ,ss and C max,ss by 1. Changes since initial authorisation of medicine List item. They have not been studied and are therefore not recommended for concomitant treatment with Pradaxa.

When dabigatran etexilate mg was co-administered with oral verapamil, the C max and AUC of dabigatran were increased but the magnitude of this change differs depending on timing of administration and formulation of verapamil see sections 4.


Date of first authorisation: This may include current or recent gastrointestinal ulceration, presence dsbigatran 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.

In the clinical studies mucosal bleedings e.

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Quinidine was given as mg dose every 2nd hour up to a total dose of 1, mg. The relative risk of bleeding with dabigatarn compared to warfarin increased with age.

Ranitidine administration together with Pradaxa had no clinically relevant effect on the extent of absorption of dabigatran. Patients were randomized to dabigatran etexilate mg bid dual-therapy, dabigatran etexilate mg bid dual-therapy or warfarin triple-therapy.

A prospective, randomized, open-label, blinded endpoint PROBE study Phase IIIb to evaluate dual-therapy with dabigatran etexilate mg or mg bid plus clopidogrel or ticagrelor P2Y12 antagonist vs. A specific reversal agent for dabigatran, idarucizumab, is available in case of uncontrollable bleeding see Section 4.

After oral administration, dabigatran etexilate is rapidly and completely converted to dabigatran, which is the active form in plasma. Clearance of dabigatran by haemodialysis was investigated in 7 patients with end-stage renal disease ESRD without atrial fibrillation. In case of an overdose suspicion, coagulation tests can help to determine a bleeding risk see sections 4. Dabigatran etexilate is a small molecule prodrug which does not exhibit any pharmacological activity.

Pradaxa | European Medicines Agency

The point estimate for incidence of major VTE and VTE related mortality for the mg dose was slightly worse than enoxaparin table In this situation Pradaxa and these medicinal products should be taken at the same time.

Interactions with anticoagulants and antiplatelet aggregation medicinal products. Date of revision of the text. The use of fibrinolytic medicinal products 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 dzbigatran range.


There were no statistical differences in the individual components of the efficacy endpoints between dabigstran dabigatran etexilate dual-therapy groups and warfarin triple-therapy. Zpc clicking continue, you acknowledge that you are a U. Concomitant use of Pradaxa with mild to moderate P-glycoprotein P-gp inhibitors, i.

After switching from 3-day treatment of once daily 40 mg enoxaparin s. Carton containing 6 blister strips 60 x 1 in perforated aluminium unit dose white blisters. Tell your doctor if you are pregnant or plan to become pregnant. Carton containing 6 blister strips 60 x 1 in perforated aluminium unit dose white blisters.

Biotransformation Metabolism and excretion of dabigatran were studied dabigatrwn a single intravenous dose of radiolabeled dabigatran in healthy male subjects. Fertility No human data available.

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

This staggered intake is the daigatran administration for start of ticagrelor with a loading dose. Studies in animals have shown reproductive toxicity see section 5. Half-life is prolonged if renal function is impaired as shown in table Available in over 3, hospitals nationwide. There are limited efficacy and safety data for Pradaxa available in these patients and therefore they should be treated with caution.