PRADAXA 110mg Hard capsule (2022)
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Περιεχόμενα
Name of the medicinal product
Pradaxa 110 mg hard capsules.
Qualitative and quantitative composition
Each hard capsule contains 110 mg of dabigatran etexilate (as mesilate). For the full list of excipients, see section 6.1.
Pharmaceutical form
Hard capsule. Capsules with light blue, opaque cap and light blue, opaque body of size 1 (approx. 19 7 mm) filled with yellowish pellets. The cap is imprinted with the Boehringer Ingelheim company symbol, ...
Therapeutic indications
Primary prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery. Prevention of stroke and systemic ...
Posology and method of administration
Posology Pradaxa capsules can be used in adults and paediatric patients aged 8 years or older who are able to swallow the capsules whole. Pradaxa coated granules can be used in children aged less than ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 Severe renal impairment (CrCL <30 mL/min) in adult patients eGFR <50 mL/min/1.73m² in paediatric patients Active ...
Special warnings and precautions for use
Haemorrhagic risk Dabigatran etexilate should be used with caution in conditions with an increased risk of bleeding or with concomitant use of medicinal products affecting haemostasis by inhibition of ...
Interaction with other medicinal products and other forms of interaction
Transporter interactions Dabigatran etexilate is a substrate for the efflux transporter P-gp. Concomitant administration of P-gp inhibitors (see table 9) is expected to result in increased dabigatran plasma ...
Pregnancy and lactation
Women of childbearing potential Women of childbearing potential should avoid pregnancy during treatment with Pradaxa. Pregnancy There is limited amount of data from the use of Pradaxa in pregnant women. ...
Effects on ability to drive and use machines
Dabigatran etexilate has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile Dabigatran etexilate has been evaluated in clinical trials overall in approximately 64,000 patients; thereof approximately 35,000 patients were treated with dabigatran etexilate. ...
Overdose
Dabigatran etexilate doses beyond those recommended expose the patient to increased risk of bleeding. In case of an overdose suspicion, coagulation tests can help to determine a bleeding risk (see sections ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> antithrombotic agents, direct thrombin inhibitors <b>ATC code:</b> B01AE07 Mechanism of action Dabigatran etexilate is a small molecule prodrug which does not exhibit ...
Pharmacokinetic properties
After oral administration, dabigatran etexilate is rapidly and completely converted to dabigatran, which is the active form in plasma. The cleavage of the prodrug dabigatran etexilate by esterase-catalysed ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity. Effects observed in the repeated dose toxicity studies ...
List of excipients
<u>Capsule content:</u> Tartaric acid Acacia Hypromellose Dimeticone 350 Talc Hydroxypropylcellulose <u>Capsule shell:</u> Carrageenan Potassium chloride Titanium dioxide Indigo carmine (E132) Hypromellose ...
Incompatibilities
Not applicable.
Shelf life
<u>Blister and bottle:</u> 3 years. Once the bottle is opened, the medicinal product must be used within 4 months.
Special precautions for storage
<u>Blister:</u> Store in the original package in order to protect from moisture. <u>Bottle:</u> Store in the original package in order to protect from moisture. Keep the bottle tightly closed.
Nature and contents of container
Perforated aluminium unit dose blisters of 10 1 hard capsules. Each carton contains 10, 30 or 60 hard capsules. Multipack containing 3 packs of 60 1 hard capsules (180 hard capsules). Each individual ...
Special precautions for disposal and other handling
When taking Pradaxa capsules out of the blister pack, the following instructions should be followed: One individual blister should be teared off from the blister card along the perforated line. The backing ...
Marketing authorization holder
Boehringer Ingelheim International GmbH, Binger Str. 173, 55216 Ingelheim am Rhein, Germany
Marketing authorization number(s)
EU/1/08/442/005 EU/1/08/442/006 EU/1/08/442/007 EU/1/08/442/008 EU/1/08/442/014 EU/1/08/442/015 EU/1/08/442/018
Date of first authorization / renewal of the authorization
Date of first authorisation: 18 March 2008 Date of latest renewal: 08 January 2018
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