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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Metabolism and excretion of dabigatran were studied following a single intravenous dose of radiolabeled dabigatran in healthy male subjects. If surgery cannot dabiyatran delayed the risk of bleeding may be increased. Pradaxa should only be given if the benefit outweighs bleeding risks. Another two studies looked at the prevention of VTE or PE in around 4, adult patients with symptoms of recurring blood clots and who were on long-term treatment with anticoagulants.

Finland France Germany Greece Italy. Genitourological haemorrhage, including haematuria. No change in dabigatran exposure was seen dabivatran 12 subjects with moderate hepatic insufficiency Child Pugh B compared to 12 controls see sections 4. Mean on-therapy follow-up time was Concomitant use should be avoided. Substances influencing gastric pH. When rapid reversal of the anticoagulation effect is required the specific reversal agent Praxbind, idarucizumab to Pradaxa is available. Boehringer Ingelheim Pharmaceuticals, Inc.

View all 4 ratings. Pradaxa should be temporarily discontinued.

The CHMP considered that the benefits of the medicine outweigh its risk and recommended that it be given marketing authorisation. When excessive dabigatran exposure is identified in patients at high dabigxtran of bleeding, a reduced dose of mg taken as one mg capsule twice daily is recommended.

Posaconazole also inhibits P-gp to some extent but has not been clinically studied. Dabigatran etexilate has not been clinically studied together with tacrolimus. For the full list of excipients, see section 6.

Choose Pradaxa® (dabigatran etexilate) for AFib, DVT or PE

Concomitant use of Pradaxa with mild to moderate P – glycoprotein P – gp inhibitors, i. This is explained sabigatran completed dabigatran absorption after 2 hours.

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Dose reductions may be required in combination with some P-gp inhibitors see sections 4. This risk of bleeding should be weighed against the urgency of intervention.

Changes since initial authorisation of medicine List item. Capsules with light blue, opaque cap and white, opaque body of size 0 filled with yellowish pellets. Itraconazole, cyclosporine Based on in vitro results a similar effect as with ketoconazole may be expected.

Pradaxa 75 mg hard capsules

Concomitant use not recommended Tacrolimus Tacrolimus has been found in vitro to have a similar level of inhibitory effect on P-gp as that seen with itraconazole and cyclosporine. The clinical evidence for the efficacy of dabigatran etexilate is derived from the RE-LY study Randomized Evaluation of Long —term anticoagulant therapy a multi-centre, multi-national, randomized parallel group study of two blinded doses of dabigatran etexilate mg and mg twice daily compared to open-label warfarin in patients with atrial fibrillation at moderate to high risk of stroke and systemic embolism.

Pre-dosing of the probe inducer rifampicin at a dose of mg once daily for 7 days decreased total dabigatran peak and total exposure sp The intended therapy was 6 months dabigatran etexilate mg twice daily without need for monitoring.

The aPTT test is widely available and provides an approximate indication of the anticoagulation intensity achieved with dabigatran. The duration of treatment with fixed dose of dabigatran was Patients on Pradaxa who undergo surgery or invasive procedures are at increased risk for bleeding.

However, for patients with high risk of bleeding, a adbigatran reduction of Pradaxa to mg taken as one mg capsule twice daily should be considered see sections 4. The medicine can only be obtained with a prescription.

Based on dabigatran concentrations and clinical assessment, the dose was subsequently modified to a target dose of 2. A risk management plan has dwbigatran developed to ensure that Pradaxa is used as safely as possible. Biotransformation Metabolism and excretion of dabigatran were studied following a daabigatran intravenous dose of radiolabeled dabigatran in healthy male subjects. Analysis of first occurrence of ischemic or haemorrhagic strokes during the study period in RE-LY.

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Subjects randomized to mg Pradaxa twice daily had a significantly higher risk for major GI bleeds compared with warfarin hazard ratio 1.

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

Breast-feeding There are no clinical data of the effect of dabigatran on infants during breast-feeding. These are switching anticoagulant therapy see section 4. Skin and subcutaneous tissue disorder. Tabulated list of adverse reactions Table 8 shows the adverse reactions ranked under headings of System Organ Classes SOC and frequency using the following convention: Stroke occurred in 0. Treatment then continues with mg as two mg capsules once a day for 28 to 35 days after hip replacement and for 10 days after knee replacement.

Patients with gastritis, esophagitis or gastroesophageal reflux. Half-life of total dabigatran in healthy subjects and subjects with impaired renal function. P-gp inducers Concomitant use should be avoided. The European Medicines Agency has waived the obligation to submit the results of studies with Pradaxa in all subsets of the ddabigatran population in prevention of thromboembolic events for the granted indication see section 4.

Pradaxa 150 mg hard capsules

Therefore surgical interventions may require the temporary discontinuation of Pradaxa. The parenteral anticoagulant should be discontinued and Pradaxa should be started hours prior to the time that the next dose of the alternate therapy would be due, or at the time of discontinuation in case of continuous treatment e. Pantoprazole and other proton-pump inhibitors PPI were co-administered with Pradaxa in clinical trials, and concomitant PPI treatment did not appear to reduce the efficacy of Pradaxa.

For subjects with gastritis, esophagitis, or gastroesophageal reflux, a dose reduction may be considered due to the elevated risk of major gastro-intestinal bleeding see table 1 above and section 4.