País: Austrália
Língua: inglês
Origem: Department of Health (Therapeutic Goods Administration)
dabigatran etexilate mesilate, Quantity: 86.475 mg (Equivalent: dabigatran etexilate, Qty 75 mg)
Pharmacor Pty Ltd
Capsule, hard
Excipient Ingredients: purified water; hypromellose phthalate; tartaric acid; butylated hydroxytoluene; hyprolose; microcrystalline cellulose; dichloromethane; purified talc; isopropyl alcohol; macrogol 600; citric acid monohydrate; ethanol; povidone; titanium dioxide; polyvinyl alcohol; macrogol 3350; sodium bicarbonate; methacrylic acid copolymer; macrogol 8000; hypromellose; sunset yellow FCF
Oral
30, 10, 60
(S4) Prescription Only Medicine
Dabigatran is indicated for Prevention of venous thromboembolic events in adult patients who have undergone major orthopaedic surgery of the lower limb (elective total hip or knee replacement). Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and at least one additional risk factor for stroke. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and for the prevention of recurrent DVT and PE in adults.
Visual Identification: White to pale yellow pellets in HPMC capsule size "1" light cream opaque cap and body imprinted with "DAB" on cap and "75" on body in black ink; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2022-08-24
AKM DABIGATRAN _CAPSULES _ _ _ _dabigatran etexilate _ _ _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about AKM Dabigatran. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the expected benefits. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. This leaflet was last updated on the date at the end of this leaflet. More recent information may be available. The latest Consumer Medicine Information is available from your pharmacist, doctor or from www.medicines.org.au and may contain important information about the medicine and its use of which you should be aware. KEEP THIS INFORMATION WITH THE MEDICINE. You may need to read it again. WHAT AKM DABIGATRAN IS USED FOR AKM Dabigatran contains the active substance dabigatran etexilate (as dabigatran etexilate mesilate). After oral use, dabigatran etexilate is rapidly converted in the body to its active form dabigatran. It belongs to a group of medicines called anticoagulants. Some people refer to anticoagulant medicines as "blood thinners". Dabigatran works by inhibiting a specific protein in the blood, called thrombin. Thrombin contributes to the formation of blood clots. Dabigatran prevents the formation of blood clots. AKM Dabigatran has been prescribed to you for one of the following uses: • to prevent the formation of blood clots in the veins after knee or hip replacement surgery in adults • to reduce the risk of brain (stroke) and/or other body vessel obstruction by blood clot formation in adults with an abnormal heart beat rhythm called non-valvular atrial fibrillation • to treat blood clots in the veins of your legs and lungs and to prevent blood clots from re-occurring in the veins of your legs and/or lungs. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED Leia o documento completo
AKM Dabigatran Ver: 00 1 AUSTRALIAN PRODUCT INFORMATION- AKM DABIGATRAN CAPSULES (DABIGATRAN ETEXILATE MESILATE) 1. NAME OF THE MEDICINE: Dabigatran Etexilate Mesilate 2. QUALITATIVE AND QUANTITATIVE COMPOSITION AKM Dabigatran 75 mg Capsules Each capsule contains Dabigatran Etexilate Mesilate equivalent to Dabigatran Etexilate 75 mg AKM Dabigatran 110 mg Capsules Each capsule contains Dabigatran Etexilate Mesilate equivalent to Dabigatran Etexilate 110 mg AKM Dabigatran 150 mg Capsules Each capsule contains Dabigatran Etexilate Mesilate equivalent to Dabigatran Etexilate 150 mg List of excipients with known effect For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Capsules, Hard AKM Dabigatran 75 mg Capsules White to pale yellow pellets filled in HPMC capsule size ''1" light cream opaque cap and light cream opaque body imprinted with "75" on body and “DAB” on cap in black ink. AKM Dabigatran 110 mg Capsules White to pale yellow pellets filled in HPMC capsule size "0" light blue opaque cap and light blue opaque body imprinted with "110" on body and "DAB" on cap in black ink. AKM Dabigatran 150 mg Capsules White to pale yellow pellets filled in HPMC capsule size “0EL” light blue opaque cap and light cream opaque body imprinted with “150” on body and “DAB” on cap in black ink. AKM Dabigatran Ver: 00 2 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevention of venous thromboembolic events in adult patients who have undergone major orthopaedic surgery of the lower limb (elective total hip or knee replacement). (see Section 4.2 Dose and method of administration for details of treatment duration). Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and at least one additional risk factor for stroke. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and for the prevention of recurrent DVT and PE in adults. 4.2 DOSE AND METHOD OF ADMINISTRATION AKM Dabigatran capsules can be taken with or without foo Leia o documento completo