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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At doses that were toxic to the mothers 5- to fold the plasma exposure level in patientsa decrease in foetal body weight and viability along with an increase in foetal variations were observed in rats and rabbits.

Pradaxa 75 mg hard capsules

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. When taking Pradaxa capsules out of the blister pack, the following instructions should be followed: The dose of mg twice daily, reduces significantly the risk of ischemic and haemorrhagic stroke, vascular death, ICH and total bleeding compared dzbigatran warfarin. Concomitant use contraindicated see section 4. Respiratory, thoracic and mediastinal disorders.

Concomitant administration of a loading dose of mg ticagrelor and mg dabigatran etexilate in steady state increased the dabigatran AUC ,ss and C max,ss by 1. Special populations Renal insufficiency In phase I studies the exposure AUC of dabigatran after the oral administration of Pradaxa is approximately 2.

Pradaxa 150 mg hard capsules

The risk of spinal or epidural haematoma may be increased in cases of traumatic or repeated puncture and by the prolonged use of epidural catheters.

There is a clear correlation between plasma dabigatran concentration and degree of anticoagulant effect based on phase II studies. Pradaxa must not be used in patients who have severely reduced kidney function, who are currently bleeding significantly or who have a condition putting them at significant risk of major bleeding.

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Therefore treatment is not recommended. No further dabigatrqn in bioavailability was observed after another 7 days. Biotransformation Metabolism and excretion of dabigatran were studied following a single intravenous dose of radiolabeled dabigatran in healthy male subjects. Traces of other metabolites were only detectable with highly sensitive analytical methods.

Pradaxa 75 mg hard capsules – Summary of Product Characteristics (SmPC) – (eMC)

The European Commission granted a marketing authorisation valid throughout the European Union for Pradaxa on 18 March Known bleeding complications such as compartment syndrome and acute renal failure due to hypoperfusion have been reported for Pradaxa.

Pradaxa treatment should not be discontinued without medical advice. Dose adjustment should be decided at the discretion of the physician, following assessment of the potential dabiigatran and risk to an individual patient see table 1 above.

The concomitant use of antiplatelets ASA or clopidogrel approximately doubles MBE rates with both dabigatran and warfarin. The capsules should be swallowed whole with water.

To email a medicine you must sign up and log in. The rates of outcome events including, major bleed and other bleeding events were consistent with those seen in RE-LY. All symptomatic treatment should be given according to the physician’s judgement. The first study involved a total of 2, patients who dabigatrsn had dabigattan knee replacement operation, and the second involved a total of 3, patients who had had a hip replacement.

Bleeding can occur at any site during therapy with Pradaxa. Use of platelet aggregation inhibitors such as clopidogrel and acetylsalicylic acid ASA or non steroidal antiinflammatory drugs NSAIDas well as the presence of esophagitis, gastritis or gastroesophageal reflux increase the risk of GI bleeding.

After oral administration of Pradaxa in healthy volunteers, the pharmacokinetic profile of dabigatran in plasma is characterized by a rapid increase in plasma concentrations with C max attained within 0.

Pradaxa | European Medicines Agency

Pradaxa should be restarted after the invasive procedure or surgical intervention as soon as possible provided the clinical situation allows and adequate haemostasis has been established. The concomitant use of LMWHs, such as enoxaparin and dabigatran etexilate has not been specifically investigated. Metabolism and excretion of dabigatran were studied following a single intravenous dose of radiolabeled dabigatran in healthy male subjects.

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Concomitant use sp see section 4. Risk factors Table 2 summarises factors which may increase the haemorrhagic risk. This risk of bleeding should be weighed against the urgency of dabigtaran.

Pradaxa should be temporarily discontinued. Itraconazole, cyclosporine Based on in vitro results a similar effect as with ketoconazole may be expected.

Number of patients treated with Pradaxa. This staggered intake is the recommended administration for start of ticagrelor with a loading dose. In case of an overdose suspicion, coagulation tests can help to determine a bleeding risk see sections 4.

A phase II study examined dabigatran etexilate and warfarin in a total of patients with recent mechanical valve replacement surgery i. Dabigatran inhibits free thrombin, fibrin-bound thrombin and thrombin-induced platelet aggregation.

Table 3 shows coagulation test thresholds at trough that may be associated with an increased risk of bleeding see section 5. Consideration should also be given to administration of platelet concentrates in cases where thrombocytopenia is present or long acting antiplatelet medicinal products have been used.

Polypropylene bottle with a screw cap containing 60 hard capsules. Respiratory, thoracic and mediastinal disorders. Elimination Plasma concentrations of dabigatran showed a biexponential decline with a mean terminal half-life of 11 hours in healthy elderly subjects. The capsules can be taken with or without food. Pradaxa was as effective as enoxaparin in preventing the formation of blood clots or death. In the early post-operative patients, major bleeding manifested predominantly as haemorrhagic pericardial effusions, specifically in patients who started dabigatran etexilate early i.

No new safety findings were observed. In addition, dabigatran AUC ,ss and C max,ss and the coagulation measures for dabigatran effect or the inhibition of platelet aggregation as measure of clopidogrel effect remained essentially unchanged comparing combined treatment and the respective mono-treatments.

Not all pack sizes may be marketed.