Transcription of 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
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2. QUALITATIVE AND QUANTITATIVE COMPOSITION
PRADAXA NZ DS v04 1 NEW ZEALAND DATASHEET 1. PRODUCT NAME PRADAXA 75 mg hard capsules PRADAXA 110 mg hard capsules PRADAXA 150 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION PRADAXA 75 mg hard capsules Each hard capsule contains 75 mg dabigatran etexilate (as mesilate) PRADAXA 110 mg hard capsules Each hard capsule contains 110 mg dabigatran etexilate (as mesilate) PRADAXA 150 mg hard capsules Each hard capsule contains 150 mg dabigatran etexilate (as mesilate) For full list of excipients, see section 3. PHARMACEUTICAL FORM Hard capsule PRADAXA 75 mg hard capsules Capsules with white, opaque cap and white, opaque body of size 2 filled with yellowish pellets. The cap is imprinted in black ink with the Boehringer Ingelheim company symbol, the body with R75 . PRADAXA 110 mg hard capsules Capsules with light blue, opaque cap and light blue, opaque body of size 1 filled with yellowish pellets.
The presence of the following factors may increase the risk of bleeding: e.g. age ≥75 years, moderate renal impairment (CrCl 30-50 ml/min), concomitant treatment with strong P-gp inhibitors
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