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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Food does not affect the bioavailability of dabigatran etexilate but delays the time to peak plasma concentrations by 2 hours.
Pradaxa 75 mg hard capsules
Other patients at increased risk of bleeding. Pradaxa mg twice daily vs. Metabolism and excretion of dabigatran were studied zpc a single intravenous dose of radiolabeled dabigatran in healthy male subjects. The ECT can provide a direct measure of the activity of direct thrombin inhibitors. The primary outcome adjudicated major bleeding according to ISTH criteria occurred in 5 1.
In the clinical studies mucosal bleedings e. Back to top Boehringer Ingelheim Limited contact details. The capsules should be swallowed whole with water. You are encouraged to report negative side effects of prescription drugs to the FDA.
Pradaxa 150 mg hard capsules
Patients were followed-up for 2 years. When excessive dabigatran exposure is identified in patients epc high risk of bleeding, a reduced dose of mg taken as one mg capsule twice daily is recommended. Date of first authorisation: To bookmark a medicine you must sign up and log in. On subsequent days absorption of dabigatran is rapid with peak plasma concentrations attained 2 hours after dabigstran product administration.
Healthcare professionals are asked to report any suspected adverse reactions via:. Pradaxa should not be used during pregnancy unless clearly necessary.
Posaconazole also inhibits P-gp to some extent but has not been clinically studied. Respiratory, thoracic and mediastinal disorders. In vitro interaction studies did not show any inhibition or induction of the dabivatran isoenzymes of cytochrome P The main measure of effectiveness for these four studies was based on the number of patients who had blood clots forming in the veins DVT or lungs PEor who died from cardiovascular causes during the treatment period.
Show table of contents Hide table of contents 1. For further information, see the summary of product characteristics also part of the EPAR. You are therefore advised to be selective about which sections or pages you wish to print.
Pradaxa treatment should not dahigatran discontinued without medical advice. This should be considered in advance of any procedures. Keep the bottle tightly closed.
Pradaxa mg hard capsules – Summary of Product Characteristics (SmPC) – (eMC)
It was demonstrated in a further study that slow and delayed absorption is usually only present on the day of surgery. Interactions with anticoagulants and antiplatelet aggregation medicinal products. Reporting suspected adverse reactions after authorisation of the medicinal product is important.
The most commonly reported events are bleedings occurring in approximately Transporter interactions P-gp inhibitors Concomitant use contraindicated see dabigatrqn 4.
Pradaxa doses beyond those recommended, expose the patient to increased risk of bleeding. Quinidine Quinidine was given as mg dose every 2nd hour up to a total dose of 1, mg. When taking Pradaxa capsules out of the blister pack, the following instructions should be followed:.
The aPTT test is widely available and provides an approximate indication of the anticoagulation intensity achieved with dabigatran. Active ingredient dabigatran etexilate mesilate.