Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DABIGATRAN ETEXILATE MESILATE
BOEHRINGER INGELHEIM (MALAYSIA) SDN. BHD.
DABIGATRAN ETEXILATE MESILATE
60Capsule Capsules; 30Capsule Capsules; 10Capsule Capsules
BOEHRINGER INGELHEIM PHARMA GMBH & CO.KG
PRADAXA ® HARD CAPSULE Dabigatran etexilate (75 mg, 110 mg, 150 mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What PRADAXA is used for 2. How PRADAXA works 3. Before you use PRADAXA 4. How to use PRADAXA 5. While you are using it 6. Side effects 7. Storage and Disposal of PRADAXA 8. Product Description 9. Manufacturer 10. Product Registration Holder 11. Date of revision 1. WHAT PRADAXA IS USED FOR 75 mg/ 110 mg: PRADAXA is used to prevent the formation of blood clots in the veins after knee or hip replacement surgery in adults. 110 mg/ 150 mg: PRADAXA is a medicine which is used to reduce the risk of brain or body vessel obstruction by blood clot formation in adult patients with an abnormal heart beat (atrial fibrillation) and additional risk factors. PRADAXA is a blood thinner medicine that lowers the risk of blood clot formation. PRADAXA is used to treat blood clots in the veins of your legs and lungs and to prevent blood clots from reoccurring in the vein of your legs and lungs. 2. HOW PRADAXA WORKS PRADAXA is a medicine which contains the active substance dabigatran etexilate. It works by blocking a substance in the body which is involved in blood clot formation. 3. BEFORE YOU USE PRADAXA - _When you must not use it _ • if you are allergic to dabigatran etexilate or any of the other ingredients of this medicine (listed in section 8). • 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. • if you have an increased tendency to bleed. This may be inborn, of unknown cause or due to other medicines. • if you have a severely reduced liver function or liver disease which could possibly cause death. • if you are taking oral ketoconazole or itraconazole, medicines to treat fungal infections. • if you are taking oral cyclosporine, a medicine to prevent organ rejection after transplantation. • if you are taking dronedarone, a medicine used to trea Baca dokumen lengkap
Proposed Package Insert – amendment clearly marked 1 LPI TITLE: Pradaxa LPI DATE: 07 Feb 2020 COUNTRY: Malaysia/ Brunei REFERENCES: CCDS 0266-23 dated 27 Sep 2019 (main reference). REASON FOR CHANGE: Additional new adverse reactions of ‘neutropenia’ and ‘agranulocytosis’ as per CCDS 0266-23 update under section 4.8. PRADAXA ® Abcd 1. NAME OF THE MEDICINAL PRODUCT PRADAXA 75 mg hard capsules PRADAXA 110 mg hard capsules PRADAXA 150 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 75 mg or 110 mg or 150 mg of dabigatran etexilate (as mesilate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule for oral use. 75 mg capsule: Consist of an imprinted hydroxypropylmethylcellulose (HPMC) capsule with white opaque cap and white opaque body of size 2 filled with yellowish pellets. The cap is imprinted with the Boehringer Ingelheim company symbol, the body with “R75”. The colour of the imprint is black. 110 mg capsule: Consist of an imprinted hydroxypropylmethylcellulose (HPMC) capsule with light blue opaque cap and light blue opaque body of size 1 filled with yellowish pellets. The cap is imprinted with the Boehringer Ingelheim company symbol, the body with “R110”. The colour of the imprint is black. 150 mg capsule: Consist of an imprinted hydroxypropylmethylcellulose (HPMC) capsule with light blue opaque cap and white opaque body of size 0 filled with yellowish pellets. The cap is imprinted with the Boehringer Ingelheim company symbol, the body with “R150”. The colour of the imprint is black. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 75mg capsule: Primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery. 110mg capsule: Primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery. Reduction of the risk of stroke and s Baca dokumen lengkap