Country: Singapore
Language: English
Source: HSA (Health Sciences Authority)
Dabigatran etexilate mesilate 172.95mg eqv Dabigatran etexilate
BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.
B01AE07
150.00mg
CAPSULE
Dabigatran etexilate mesilate 172.95mg eqv Dabigatran etexilate 150.00mg
ORAL
Prescription Only
Boehringer Ingelheim Pharma GmbH & Co. KG (Ingelheim/Rhein site)
ACTIVE
2011-03-31
0266-10 (SG) 20140313 1 PRADAXA ® Abcd COMPOSITION 1 Capsule contains 86.48 mg, 126.83 mg or 172.95 mg of beta-alanine, N-[[2-[[[4(hexyloxy)carbonyl]amino]iminomethyl] phenyl]amino]methyl]-1-methyl-1H- benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methane-sulfonate, being the methane sulfonic acid salt (corresponding to dabigatran etexilate base form 75 mg, 110 mg or 150 mg) Excipients: Tartaric acid, acacia, hypromellose, dimethicone 350, talc, hydroxypropyl cellulose _HPMC capsule shell:_ Carragenan, potassium chloride, titanium dioxide, Sunset Yellow (E110), Indigo Carmin (E132), hypromellose. _Printing ink:_ Shellac, N-butyl alcohol, isopropyl alcohol, industrial methylated spirit, Iron oxide black (E172), purified water, propylene glycol DESCRIPTION 75 mg capsule: Consist of an imprinted hydroxypropylmethylcellulose (HPMC) capsule with light blue opaque cap and cream-coloured, 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 cream-coloured, 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 creamcoloured, opaque body of size 0 filled with yellowish pellet Read the complete document
1 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 75 mg capsule: Consist of an imprinted hydroxypropylmethylcellulose (HPMC) capsule with white opaque cap and white opaque body of size 2. 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. 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. 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. Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. 150mg capsule: Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. 4.2 DOSAGE AND ADMINISTRATION _PRIMARY Read the complete document