Land: Israel
Språk: engelsk
Kilde: Ministry of Health
DABIGATRAN ETEXILATE AS MESILATE
BOEHRINGER INGELHEIM ISRAEL LTD.
B01AE07
CAPSULES
DABIGATRAN ETEXILATE AS MESILATE 110 MG
PER OS
Required
BOEHRINGER INGELHEIM PHARMA GMBH & CO.KG, GERMANY
DABIGATRAN ETEXILATE
DABIGATRAN ETEXILATE
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 nonvalvular atrial fibrillation.Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.
2015-02-28
Pradaxa 75 mg capsules Updated Patient Information Leaflet Boehringer Ingelheim June 2020 1 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is to be supplied by physician’s prescription only PRADAXA ® 75 MG CAPSULES ACTIVE INGREDIENT: Each capsule of PRADAXA 75 contains: 75 mg dabigatran etexilate (as mesilate) Inactive ingredients and allergens in the medicine - See section 6. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, ask your physician or the pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar. Patient information card: This card contains important safety information which you should know prior to beginning treatment with Pradaxa and during the treatment with Pradaxa. The card contains information intended for both the patient and the healthcare staff. It provides guidance for the patients on how to minimize the risk of bleeding resulting from treatment with any anticoagulant agent. In addition, the card contains personal details of the patient and information regarding Pradaxa for the healthcare staff. Present this card to any healthcare professional involved in your treatment. 1. WHAT IS THIS MEDICINE INTENDED FOR? Pradaxa contains the active ingredient dabigatran etexilate that belongs to a group of medicines called anticoagulants. Pradaxa is intended for prevention of thrombosis of the veins following elective knee replacement or hip replacement orthopedic surgeries in adults. THERAPEUTIC GROUP: Anticoagulants. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: You are sensitive (allergic) to the active ingredient or to any of the other ingredients that this medicine contains (for the list of inactive ingredients, see section 6). You suffer from severe renal impairment. You suffer from active read_full_document
Pradaxa 75 Prescribing Information Boehringer Ingelheim January 2022 1 PRADAXA 75 DABIGATRAN ETEXILATE 75 mg Hard Capsules PRESCRIBING INFORMATION The marketing of Pradaxa is subject to a risk management plan (RMP) including a “Patient safety information card”. The “Patient safety information card”, emphasizes important safety information that the patient should be aware of before and during treatment. Please explain to the patient the need to review the card before starting treatment. _Please provide patient safety information card (patient card) to each patient who is prescribed with _ _Pradaxa. Explain to the patient the implications of anticoagulant treatment including the need for _ _compliance. Please also explain the signs of bleeding and when to seek medical attention. _ _The patient card will inform physicians and dentists about the patient‘s anticoagulation treatment _ _and will contain emergency contact information. The patient should be instructed to carry the _ _patient alert card at all times and present it to every health care provider_. Pradaxa 75 Prescribing Information Boehringer Ingelheim January 2022 2 1. NAME OF THE MEDICINAL PRODUCT Pradaxa 75 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 x 6 mm ) filled with yellowish pellets. The cap is imprinted with the Boehringer Ingelheim company symbol, the body with “R7 5”. WARNING: DISCONTINUING PRADAXA IN PATIENTS WITHOUT ADEQUATE CONTINUOUS ANTICOAGULATION INCREASES RISK OF STROKE Discontinuing Pradaxa places patients at an increased risk of thrombotic events. If anticoagulation with Pradaxa must be discontinued for a reason other than pathological bleeding, consider coverage with another anticoagulant [see Special warnings and precautions for use (section 4.4)]. Pradaxa 75 Prescribing Information Boehr read_full_document