Country: Европска Унија
Језик: Енглески
Извор: EMA (European Medicines Agency)
Dabigatran etexilate mesilate
Boehringer Ingelheim International GmbH
B01AE07
dabigatran etexilate
Antithrombotic agents
Arthroplasty, Replacement; Venous Thromboembolism
Pradaxa 75 mgPrimary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery.Pradaxa 110 mgPrimary 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 (NVAF), with one or more risk factors, such as prior stroke or transient ischemic attack (TIA); age ≥ 75 years; heart failure (NYHA Class ≥ II); diabetes mellitus; hypertension.Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.Pradaxa 150 mgPrevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischemic attack (TIA); age ≥ 75 years; heart failure (NYHA Class ≥ II); diabetes mellitus; hypertension.Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.
Revision: 40
Authorised
2008-03-17
179 B. PACKAGE LEAFLET 180 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PRADAXA 75 MG HARD CAPSULES dabigatran etexilate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Pradaxa is and what it is used for 2. What you need to know before you take Pradaxa 3. How to take Pradaxa 4. Possible side effects 5. How to store Pradaxa 6. Contents of the pack and other information 1. WHAT PRADAXA IS AND WHAT IT IS USED FOR Pradaxa contains the active substance dabigatran etexilate and belongs to a group of medicines called anticoagulants. It works by blocking a substance in the body which is involved in blood clot formation. Pradaxa is used in adults to: - prevent the formation of blood clots in the veins after knee or hip replacement surgery. Pradaxa is used in children to: - treat blood clots and to prevent blood clots from reoccurring. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PRADAXA DO NOT TAKE PRADAXA - if you are allergic to dabigatran etexilate or any of the other ingredients of this medicine (listed in section 6). - if you have severely reduced kidney function. - if you are currently bleeding. - if you have a disease in an organ of the body that increases the risk of serious bleeding (e.g., stomach ulcer, injury or bleeding in the brain, recent surgery of the brain or eyes). - if you have an increased tendency to bleed. This may be inborn, of unknown cause or due to other medicines. - if you are taking medicines to prevent blood clotting (e.g. warfarin, rivaroxaban, apixaban or heparin), except when Прочитајте комплетан документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Pradaxa 75 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 75 mg of dabigatran etexilate (as mesilate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. Capsules with white, opaque cap and white, opaque body of size 2 (approx. 18 × 6 mm) filled with yellowish pellets. The cap is imprinted with the Boehringer Ingelheim company symbol, the body with “R75”. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Primary prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery. Treatment of VTE and prevention of recurrent VTE in paediatric patients from the time the child is able to swallow soft food to less than 18 years of age. For age appropriate dose forms, see section 4.2. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Pradaxa capsules can be used in adults and paediatric patients aged 8 years or older who are able to swallow the capsules whole. Pradaxa coated granules can be used in children aged less than 12 years as soon as the child is able to swallow soft food. When changing between the formulations, the prescribed dose may need to be altered. The dose stated in the relevant dosing table of a formulation should be prescribed based on the weight and age of the child. _PRIMARY PREVENTION OF VTE IN ORTHOPAEDIC SURGERY_ The recommended doses of dabigatran etexilate and the duration of therapy for primary prevention of VTE in orthopaedic surgery are shown in table 1. 3 TABLE 1: DOSE RECOMMENDATIONS AND DURATION OF THERAPY FOR PRIMARY PREVENTION OF VTE IN ORTHOPAEDIC SURGERY TREATMENT INITIATION ON THE DAY OF SURGERY 1-4 HOURS AFTER COMPLETED SURGERY MAINTENANCE DOSE STARTING ON THE FIRST DAY AFTER SURGERY DURATION OF MAINTENANCE DOSE Patients following elective knee replacement surgery single capsule of 110 mg dabigatran etexilate 220 mg dabigatran ete Прочитајте комплетан документ