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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Dabigatram explains how the Committee for Medicinal Products for Human Use CHMP assessed the medicine to reach its opinion in favour of granting a spf authorisation and its recommendations on the conditions of use for Pradaxa. Pradaxa is a medicine that contains the active substance dabigatran etexilate. It is available as capsules dabigqtran, and mg.
The capsules should be swallowed whole with water. For patients who have had a hip or knee replacement, treatment with Pradaxa should start with one mg capsule taken one to four hours after the end of the operation. 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. The start of the treatment should be delayed in patients who are still bleeding from the site of surgery.
If treatment is not started on the day of the operation, it should start at mg as two mg capsules once a day. A lower dose is used in patients with moderately reduced kidney function, in patients over 75 years of age, and in patients also taking amiodarone, quinidine or verapamil medicines used to treat heart problems.
For the prevention of stroke and blood clots in patients with non-valvular atrial fibrillation, Pradaxa is taken as one mg capsule twice a day and should be taken long term.
For the treatment and prevention of DVT and PE, Pradaxa is taken as one mg capsule twice a day, following treatment for at least five days with an injectable anticoagulant. All patients considered to be dpc increased risk of bleeding should be monitored closely and the dose of Pradaxa lowered at the discretion of the doctor.
In all patients, kidney function should also be assessed before starting treatment to exclude patients with severely reduced kidney function, and should be re-assessed during treatment if any worsening is suspected. When Pradaxa is used long term in patients with non-valvular atrial fibrillation, or when it is used in patients with DVT or PE, kidney function should be assessed at least once a year if their kidney function is mildly to moderately reduced or if they are over 75 years old.
Patients undergoing hip or knee replacement surgery are at a high risk of blood clots forming in their leg veins.
These clots, which include deep vein thrombosis DVTcan be dangerous if they move to another part of daigatran body such as the lungs. Patients who have atrial fibrillation are also at risk of blood clots which can travel to the brain and cause a stroke.
This means that it is converted into dabigatran in the body. Dabigatran is an anticoagulant, meaning that it prevents the blood from coagulating clotting. It blocks a substance called thrombin, which is central to the process wpc blood clotting. Two main studies have been performed to compare Pradaxa either or mg a day with enoxaparin another anticoagulant in patients who had undergone a hip or knee replacement. The first study involved a total of 2, patients who had had a knee replacement operation, and the second involved a total of 3, patients who had had a hip replacement.
In both studies, the main measure of effectiveness was based on the number of patients who had blood clots forming in the veins spx who died of any cause during the treatment period.
In most cases, blood clot formation was detected using scans of the veins or by looking for signs of blood clots in the lungs. A third main study compared Pradaxa mg and mg twice a day with warfarin another anticoagulant in around 18, adult patients with non-valvular atrial fibrillation who were considered to be at risk of stroke.
The patients were treated for one to three years and the main measure of effectiveness was based on the proportion of patients who had a stroke or a blood clot blocking blood vessels in other parts of the body each year. Two main studies in over 5, adult patients with symptoms of DVT or PE, and who were initially treated with an injectable anticoagulant, compared Pradaxa with warfarin.
Pradaxa mg hard capsules – Summary of Product Characteristics (SmPC) – (eMC)
Another two studies looked at the prevention of VTE or PE in around 4, adult patients with symptoms dabigattran recurring blood clots and who were on long-term treatment with anticoagulants. One of these prevention studies compared Pradaxa with warfarin and the other compared Pradaxa with placebo a dummy treatment. 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.
Pradaxa was as effective as enoxaparin in preventing the formation of blood clots or death. In the hip and knee studies, there was some evidence that the mg dose may be more effective than the mg dose. 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 around 1.
In the studies looking at treatment of VTE and PE, blood clots or blood-clot related death occurred in 2. In the first study looking at prevention of VTE and PE, blood clots or blood-clot related death occurred in 1. In the second prevention study, blood clots or dabigayran related death occurred in 0.
Pradaxa 75 mg hard capsules
The most common side effect with Pradaxa seen in more than one patient in 10 is bleeding. For the full list of all side effects reported with Pradaxa, see the package leaflet.
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.
It must not be used in patients taking any other anticoagulant medicine, except in specific situations such as when the anticoagulant medication is being switched. Pradaxa must also not be used in patients with serious liver problems or patients taking by mouth or injection dablgatran medicines ketoconazole and itraconazole used for fungal infectionsciclosporin a medicine used to reduce the activity of the immune system or dronedarone a medicine to treat a heart problem called atrial fibrillation.
For the full list of restrictions, see the package leaflet.
The CHMP considered that the benefits of the medicine outweigh its risk and recommended that it be given marketing authorisation. The CHMP noted that effect of Pradaxa in preventing the formation of blood clots patients who have undergone a hip or knee replacement is comparable to that of enoxaparin.
Pradaxa, which is taken by mouth, has the advantage of being more convenient for patients. The CHMP also noted that Pradaxa compared well with warfarin in reducing the risk of strokes in patients with atrial fibrillation without increasing the risk of major bleeding. Since certain patients are at increased risk of bleeding, a number of precautions were included in the prescribing information. However, the number of bleeding events was lower for Pradaxa than for warfarin.
Although the studies showed a small higher risk of heart problems with Pradaxa than with warfarin, the benefits of Pradaxa were still considered to outweigh its risks. A risk management plan has been developed to ensure that Pradaxa is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Pradaxa, including the appropriate precautions to be followed by healthcare professionals and patients.
In addition, the company that makes Pradaxa will provide an educational pack for all doctors who are expected to prescribe the medicine, to increase awareness of the risk of bleeding and provide guidance on how to manage it. Patients will also receive an alert card summarising key safety information on the medicine.
The European Commission granted a marketing authorisation valid throughout the European Union for Pradaxa on 18 March For more information about treatment with Pradaxa, read the package leaflet also part of the EPAR or contact your doctor or pharmacist. More detail is available in the summary of product characteristics. Primary prevention of venous thromboembolic events in adult patients who have undergone elective total-hip-replacement surgery or total-knee-replacement surgery.
Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more of the following risk factors:. Skip to main content. Veterinary regulatory Overview Research and development Marketing authorisation Post-authorisation. Table of contents Overview Authorisation details Product information Assessment history.
Expand all Collapse all. Pradaxa is used for the following: The medicine can only be obtained with a prescription. For further information, see the summary of product characteristics also part of the EPAR. Product details Name Pradaxa. D Ingelheim am Rhein Germany. You are therefore advised to be selective about which sections or pages you wish to print. Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more of the following risk factors: Changes since initial authorisation of medicine List item.
Initial marketing-authorisation documents List item. European Medicines Agency updates patient and prescriber information for Pradaxa. European Medicines Agency updates on safety of Pradaxa.
More information on Pradaxa. How useful was this page?
View all dabigqtran ratings. Leave this field blank. International non-proprietary name INN or common name. Arthroplasty, Replacement Venous Thromboembolism. Anatomical therapeutic chemical ATC code.
Boehringer Ingelheim International GmbH. Date of issue of marketing authorisation valid throughout the European Union.