natgillin/translations-raw huggingface dataset:
Pradaxa bør anvendes med forsigtighed til patienter, der har en øget risiko for blødning, eller som har et øget mængde af lægemidlet i blodet, f. eks. som følge af moderat nedsat nyrefunktion.
Pradaxa should be used with caution in patients at risk of bleeding or who could have high blood levels of the medicine, such as those who have moderate problems with their kidneys.
Patienter med en kropsvægt på mindre end 50 kg eller mere end 110 kg bør følges nøje for tegn på blødninger eller anæmi (lavt antal røde blodlegemer).
Patients weighing less than 50 kg or more than 110 kg should be closely monitored for signs of bleeding or anaemia (low red blood cell counts).
Patienter, der får udskiftet en hofte eller et knæ, har en større risiko for at danne blodpropper i blodårerne.
Patients undergoing hip or knee replacement surgery are at a high risk of blood clots forming in the veins.
Disse blodpropper, der omfatter dyb venetrombose, kan være farlige, hvis de føres til en anden del af kroppen, f. eks. lungerne eller hjernen.
These clots, which include deep vein thrombosis (DVT), can be dangerous if they move to another part of the body such as the lungs or the brain.
Det aktive stof i Pradaxa, dabigatran- etexilat, er et såkaldt prodrug for dabigatran.
The active substance in Pradaxa, dabigatran etexilate, is a ‘ prodrug ’ of dabigatran.
Det 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. blokerer et stof, der hedder trombin, som spiller en central rolle i blodkoaguleringsprocessen, og reducerer dermed risikoen for dannelse af blodpropper i blodårerne.
Reproduction is authorised provided the source is acknowledged.
Virkningerne af Pradaxa blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
The effects of Pradaxa were first tested in experimental models before being studied in humans.
Virkningen af Pradaxa blev undersøgt i to hovedundersøgelser, hvor Pradaxa (enten 220 mg eller 150 mg pr. dag) blev sammenlignet med enoxaparin, der er et andet blodfortyndende stof.
The effectiveness of Pradaxa was studied in two main studies, both of which compared Pradaxa (either 220 or 150 mg a day) with enoxaparin (another anticoagulant).
I begge undersøgelser var det primære parameter for virkning antallet af patienter, der dannede blodpropper i blodårerne, eller som døde uanset årsag i løbet af behandlingsperioden.
In both studies, the main measure of effectiveness was the number of patients who formed blood clots in the veins or who died of any cause during the treatment period.
I de fleste tilfælde blev blodpropdannelsen opdaget ved at skanne blodårerne eller ved at se efter tegn på blodpropper i lungerne.
In most cases, blood clot formation was detected using scans of the veins or by looking for signs of blood clots in the lungs.
Pradaxa var i begge undersøgelser lige så effektiv som enoxaparin til at forhindre dannelsen af blodpropper eller død.
In both studies, Pradaxa was as effective as enoxaparin in preventing the formation of blood clots or death.
I undersøgelsen af patienter, der havde fået nyt knæ, blev der opdaget blodpropper hos 182 (36%) af de 503 patienter, der fik 220 mg Pradaxa, sammenlignet med 192 (38%) af de 512, der fik enoxaparin.
In the study of patients undergoing knee replacement, blood clots were detected in 182 (36%) of the 503 patients taking the 220-mg dose of Pradaxa, compared with 192 (38%) of the 512 receiving enoxaparin.
Der var kun én patient, der døde i hver gruppe (mindre end 1%).
There was only one death in each group (less than 1%).
I undersøgelsen af patienter, der havde fået ny hofte, blev der opdaget blodpropper hos 50 (6%) af de 880 patienter, der fik 220 mg Pradaxa, sammenlignet med 60 (7%) af de 897, der fik enoxaparin.
After hip replacement, blood clots were detected in 50 (6%) of the 880 patients taking 220 mg Pradaxa, compared with 60 (7%) of the 897 receiving enoxaparin.
Tre patienter i Pradaxa- gruppen døde (mindre end 1%), men to af disse dødsfald var ikke relateret til blodpropper.
Three patients in the Pradaxa group died (less than 1%), but two of these deaths were unrelated to blood clots.
I begge undersøgelser sås der en tendens til, at 220 mg- dosen var mere effektiv end 150 mg- dosen.
In both studies, the 220-mg dose showed a trend towards being more effective than the 150-mg dose.
Den hyppigste bivirkning ved Pradaxa (som optræder hos flere end 1 ud af 10 patienter) er blødning.
The most common side effect with Pradaxa (seen in more than 1 patient in 10) is bleeding.
Den fuldstændige liste over de indberettede bivirkninger ved Pradaxa fremgår af indlægssedlen.
For the full list of all side effects reported with Pradaxa, see the Package Leaflet.
Pradaxa bør ikke anvendes til patienter, der kan være overfølsomme (allergiske) over for dabigatran - etexilat eller andre af indholdsstofferne.
Pradaxa should not be used in people who may be hypersensitive (allergic) to dabigatran etexilate or any of the other ingredients.
Det bør ikke anvendes til patienter, der har svært nedsat nyrefunktion, aktiv signifikant blødning, vævsskade, der kan føre til blødning, problemer med blodets størkningsevne (uanset om det er en medfødt tendens, skyldes ukendte årsager eller anvendelsen af anden medicin) eller nedsat leverfunktion, der kan være livstruende.
It should not be used in patients who have severe problems with their kidneys, active significant bleeding, tissue damage that could lead to bleeding, problems with the blood clotting process (this may be inborn, of unknown cause or due to other medicines), or liver problems that could be life-threatening.
Pradaxa bør heller ikke anvendes til patienter, der tager quinidin, der er et lægemiddel, som regulerer hjerterytmen.
Pradaxa should also not be used in patients taking quinidine (another medicine used to regulate the heart rhythm).
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Pradaxa er større end risiciene ved primær forebyggelse af venøse tromboemboliske hændelser hos voksne patienter, der har fået elektiv total hoftealloplastik (hofteledsudskiftning) eller total knæalloplastik (knæledsudskiftning).
The Committee for Medicinal Products for Human Use (CHMP) decided that Pradaxa’ s benefits are greater than its risks for primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Pradaxa.
The Committee recommended that Pradaxa be given marketing authorisation.
Andre oplysninger om Pradaxa:
Other information about Pradaxa:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Pradaxa til Boehringer Ingelheim International GmbH den 18. marts 2008.
The European Commission granted a marketing authorisation valid throughout the European Union for Pradaxa to Boehringer Ingelheim International GmbH on 18 March 2008.
Den fuldstændige EPAR for Pradaxa findes her.
The full EPAR for Pradaxa can be found here.
EU- nummer EU/ 1/ 08/ 442/ 001 EU/ 1/ 08/ 442/ 002 EU/ 1/ 08/ 442/ 003 EU/ 1/ 08/ 442/ 004 EU/ 1/ 08/ 442/ 005 EU/ 1/ 08/ 442/ 006 EU/ 1/ 08/ 442/ 007 EU/ 1/ 08/ 442/ 008
EU/ 1/ 08/ 442/ 001 EU/ 1/ 08/ 442/ 002 EU/ 1/ 08/ 442/ 003 EU/ 1/ 08/ 442/ 004 EU/ 1/ 08/ 442/ 005 EU/ 1/ 08/ 442/ 006 EU/ 1/ 08/ 442/ 007 EU/ 1/ 08/ 442/ 008
Særnavn Pradaxa Pradaxa Pradaxa Pradaxa Pradaxa Pradaxa Pradaxa Pradaxa
Pradaxa Pradaxa Pradaxa Pradaxa Pradaxa Pradaxa Pradaxa Pradaxa
Styrke 75 mg 75 mg 75 mg 75 mg 110 mg 110 mg 110 mg 110 mg
75 mg 75 mg 75 mg 75 mg 110 mg 110 mg 110 mg 110 mg
Lægemiddelform Kapsel, hård Kapsel, hård Kapsel, hård Kapsel, hård Kapsel, hård Kapsel, hård Kapsel, hård Kapsel, hård
Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard Capsule, hard
Indgivelsesvej Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Emballage blister (Alu/ alu) blister (Alu/ alu) blister (Alu/ alu) beholder (PP) blister (Alu/ alu) blister (Alu/ alu) blister (Alu/ alu) beholder (PP)
blister (Alu/ alu) blister (Alu/ alu) blister (Alu/ alu) bottle (PP) blister (Alu/ alu) blister (Alu/ alu) blister (Alu/ alu) bottle (PP)
Paknings- størrelse 10 x 1 kapsler 30 x 1 kapsler 60 x 1 kapsler 60 kapsler 10 x 1 kapsler 30 x 1 kapsler 60 x 1 kapsler 60 kapsler
10 x 1 capsules 30 x 1 capsules 60 x 1 capsules 60 capsules 10 x 1 capsules 30 x 1 capsules 60 x 1 capsules 60 capsules
Hjælpestoffer:
Each hard capsule contains 75 mg of dabigatran etexilate (as mesilate) Excipients:
Én hård kapsel indeholder 2 mikrogram sunset yellow FCF (E 110)
Each hard capsule contains 2 micrograms sunset yellow (E110)
Kapsler med tryk, lyseblå, uigennemsigtig top og flødefarvet, uigennemsigtig bund, størrelse 2 og indeholdende gullige pellets.
Imprinted capsules with light blue, opaque cap and cream-coloured, opaque body of size 2 filled with yellowish pellets.
Boehringer Ingelheims logo er trykt på hætten, ” R75 ” på bunden.
The cap is imprinted with the Boehringer Ingelheim company symbol, the body with “ R75”.
Primær forebyggelse af venøs tromboemboli hos voksne patienter ved elektiv total hofte - eller knæalloplastik.
Primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery.
Forebyggelse af venøs tromboemboli (VTE) hos patienter efter elektiv knæalloplastik:
Prevention of Venous Thromboembolism (VTE) in patients following elective knee replacement surgery:
Den anbefalede dosis af Pradaxa er 220 mg én gang dagligt i form af 2 kapsler à 110 mg.
The recommended dose of Pradaxa is 220 mg once daily taken as 2 capsules of 110 mg.
Efterfølgende gives 2 kapsler én gang dagligt i 10 dage i alt.
Treatment should be initiated orally within 1 – 4 hours of completed surgery with a single capsule and continuing with 2 capsules once daily thereafter for a total of 10 days.
Forebyggelse af venøs tromboemboli (VTE) hos patienter efter elektiv hoftealloplastik:
Prevention of Venous Thromboembolism (VTE) in patients following elective hip replacement surgery:
Efterfølgende gives 2 kapsler én gang dagligt i 28- 35 dage i alt.
Treatment should be initiated orally within 1 – 4 hours of completed surgery with a single capsule and continuing with 2 capsules once daily thereafter for a total of 28-35 days.
Specielle patientpopulationer:
Special patient populations:
4. 3).
Treatment with Pradaxa in patients with severe renal impairment (creatinine clearance < 30 ml/ min) is contraindicated (see section 4.3).
2 Der er begrænset klinisk erfaring hos patienter med moderat nedsat nyrefunktion (kreatinin clearance 30- 50 ml/ min).
2 In patients with moderate renal impairment (creatinine clearance 30-50 ml/ min), there is limited clinical experience.
4. 4 og 5. 1).
The recommended dose is 150 mg taken once daily as 2 capsules of 75 mg (see section 4.4 and 5.1).
Efterfølgende gives 2 kapsler dagligt i 10 dage i alt.
After knee replacement surgery treatment should be initiated orally within 1 – 4 hours of completed surgery with a single capsule and continuing with 2 capsules once daily thereafter for a total of 10 days.
Efterfølgende gives 2 kapsler dagligt i 28- 35 dage i alt.
After hip replacement surgery treatment should be initiated orally within 1 – 4 hours of completed surgery with a single capsule and continuing with 2 capsules once daily thereafter for a total of 28-35 days.
Efter hoftealloplastik bør behandlingen påbegyndes 1- 4 timer efter afsluttet operation med én enkel kapsel oralt og efterfølgende med 2 kapsler dagligt i 28- 35 dage i alt.
After hip replacement surgery treatment should be initiated orally within 1 – 4 hours of completed surgery with a single capsule and continuing with 2 capsules once daily thereafter for a total of 28-35 days.
Patienter med forhøjede levertal defineret som > 2 gange øvre normalgrænse var udelukket fra de kliniske forsøg.
Patients with elevated liver enzymes > 2 upper limit of normal (ULN) were excluded in clinical trials.
4. 4 og 5. 2).
Therefore the use of Pradaxa is not recommended in this population (see sections 4.4 and 5.2).
4. 4.).
ALT should be measured as part of the standard pre-operative evaluation (see section 4.4).
4. 4).
Given the available clinical and kinetic data no adjustment is necessary (see section 5.2) but close clinical surveillance is recommended (see section 4.4).
Post- operative patienter med en forøget risiko for blødning:
Post-surgical patients with an increased risk for bleeding:
4. 4 og 5. 1)
Patients at risk for bleeding or patients at risk of overexposure, notably patients with moderate renal impairment (creatinine clearance 30 – 50 ml/ min), should be treated with caution (see sections 4.4 and 5.1).
Pradaxa bør ikke anvendes til patienter under 18 år pga. manglende dokumentation for sikkerhed og virkning.
Pradaxa is not recommended for use in patients below 18 years due to lack of data on safety and efficacy.
Samtidig brug af Pradaxa med amiodaron:
Concomitant use of Pradaxa with Amiodarone:
4. 5).
Dosing should be reduced to 150 mg Pradaxa daily in patients who received concomitantly dabigatran etexilate and amiodarone (see section 4.5).
3 Skift fra Pradaxa til parenteral antikoagulant:
Switching from Pradaxa treatment to parenteral anticoagulant:
4. 5).
It is recommended to wait 24 hours after the last dose before switching from Pradaxa to a parenteral anticoagulant (see section 4.5).
Skift fra en parenteral antikoagulant til Pradaxa:
3 Switching from parenteral anticoagulants treatment to Pradaxa:
4. 5).
No data are available, therefore it is not recommended to start the administration of Pradaxa before the next scheduled dose of the parenteral anticoagulant would have been due (see section 4.5).
Pradaxa bør ikke tygges, men synkes hele med vand og med eller uden mad.
Pradaxa should be swallowed as a whole with water, with or without food.
4. 5)
• Hypersensitivity to the active substance or to any of the excipients • Patients with severe renal impairment (CrCl < 30 ml/ min) • Active clinically significant bleeding • Organic lesion at risk of bleeding • Spontaneous or pharmacological impairment of haemostasis • Hepatic impairment or liver disease expected to have any impact on survival • Concomitant treatment with quinidine (see section 4.5)
Patienter med forhøjede levertal defineret som > 2 gange øvre normalgrænse var udelukket fra de to kontrollerede kliniske forsøg.
Patients with elevated liver enzymes > 2 ULN were excluded in controlled clinical trials.
Pradaxa anbefales derfor ikke til denne population.
Therefore the use of Pradaxa is not recommended in this population.
Der bør indgå en ALAT - bestemmelse som en del af den normale præ- operative evaluering.
ALT should be measured as part of the standard pre- operative evaluation.
Blødningsrisiko:
Haemorrhagic risk:
Sygdomme med øget risiko for blødning, f. eks. medfødt eller erhvervet koagulationssygdom, trombocytopeni eller funktionelle trombocytdefekter, aktiv gastrointestinal ulceration, bakteriel endokardit, nyligt foretaget biopsi eller større traume, nylig intrakraniel blødning eller operation i hjerne, ryg eller øjne.
Close clinical surveillance (looking for signs of bleeding or anaemia) is recommended throughout the treatment period, especially in the following situations that may increase the hemorrhagic risk: diseases associated with an increased risk of bleeding, such as congenital or acquired coagulation disorders, thrombocytopenia or functional platelet defects, active ulcerative gastrointestinal disease, recent biopsy or major trauma, recent intracranial haemorrhage or brain, spinal or ophthalmic surgery, bacterial endocarditis.
Der ses en øget eksponering af dabigatran hos patienter med moderat nedsat nyrefunktion.
Patients with moderate renal impairment have an increased exposure to dabigatran.
Der findes begrænsede mængder data for patienter < 50 kg og ældre patienter (se pkt.
Limited data is available in patients < 50 kg and the elderly (see sections 4.2 and 5.2).
4. 2)
In these situations, Pradaxa should be used with caution and a close clinical surveillance (looking for signs of bleeding or anemia) is required throughout the treatment period (see section 4.2).
4. 9).
When severe bleedings occur treatment must be discontinued and the source of bleeding investigated (see section 4.9).
4. 5).
Agents that may enhance the risk of haemorrhage should not be administered concomitantly or should be administered with caution with Pradaxa (see section 4.5).
Patienter med høj risiko for død i forbindelse med operation, og hvor væsentlige risikofaktorer for udvikling af VTE er til stede:
Patients at high surgical mortality risk and with intrinsic risk factors for thromboembolic events:
4 Der er begrænsede data for dabigatrans virkning og sikkerhed i disse patienter, og der bør udvises forsigtighed ved behandling.
There are limited efficacy and safety data for dabigatran available in these patients and therefore they should be treated with caution.
Spinalanæstesi/ epiduralanæstesi/ lumbalpunktur:
4 Spinal anaesthesia/ epidural anaesthesia/ lumbar puncture:
Hvis dabigatran gives samtidigt med spinal - / epiduralanæstesi eller spinalpunktur til patienter, der har fået gennemført større ortopædiske operationer, kan man ikke udelukke epiduralt eller spinalt hæmatom, der kan medføre langvarig eller permanent lammelse.
In patients undergoing major orthopaedic surgery, epidural or spinal haematomas that may result in long- term or permanent paralysis cannot be excluded with the concurrent use of dabigatran and spinal/ epidural anaesthesia or spinal puncture.
Risikoen for disse sjældne hændelser er muligvis højere i forbindelse med post- operativt brug af epidural katetre eller samtidig brug af andre lægemidler, der påvirker hæmostasen.
The risk of these rare events may be higher with postoperative use of indwelling epidural catheters or the concomitant use of other medicinal products affecting haemostasis.
Derfor frarådes det at anvende Pradaxa hos patienter, der får anæstesi via postoperativt indlagt epiduralkateter.
Therefore the use of Pradaxa is not recommended in patients undergoing anaesthesia with post-operative indwelling epidural catheters.
Den første dosis Pradaxa bør tidligst gives 2 timer efter, at kateteret er fjernet.
Administration of the first dose of Pradaxa should occur a minimum of two hours after the catheter is removed.
Disse patienter kræver en tæt observation af neurologiske tegn og symptomer.
These patients require frequent observation for neurological signs and symptoms.
Hoftefraktur- kirurgi:
Hip fracture surgery:
Farvestoffer:
Colorants:
Der er kun udført interaktionsforsøg hos voksne.
Interaction studies have only been performed in adults.
Antikoagulanter og trombocythæmmere:
Anticoagulants and platelet aggregation agents:
Ufraktionerede hepariner og heparinderivater, lavmolekylære hepariner (LMWH), fondaparinux, desirudin, trombolytika, GPIIb/ IIIa- receptor antagonister, clopidogrel, ticlopidin, dextran, sulfinpyrazon og vitamin- Kantagonister.
The following treatments are not recommended concomitantly with Pradaxa: unfractionated heparins and heparin derivatives, low molecular weight heparins (LMWH), fondaparinux, desirudin, thrombolytic agents, GPIIb/ IIIa receptor antagonists, clopidogrel, ticlopidine, dextran, sulfinpyrazone and vitamin K antagonists.
4. 2 og 4. 4).
It should be noted that unfractionated heparin can be administered at doses necessary to maintain a patent central venous or arterial catheter (see sections 4.2 and 4.4).
Interaktioner knyttet til dabigatran- etexilats og dabigatrans metaboliske profil:
Interactions linked to dabigatran etexilate and dabigatran metabolic profile:
Dabigatran- etexilat og dabigatran metaboliseres ikke via cytokrom P450- systemet og har ingen virkning in vitro på humane cytokrom P450- enzymer.
Dabigatran etexilate and dabigatran are not metabolised by the cytochrome P450 system and have no in vitro effects on human cytochrome P450 enzymes.
NSAID:
NSAIDs:
Ved samtidig indtagelse af Pradaxa og diclofenac var plasmaniveau for begge lægemidler uændret, hvilket tyder på at der ikke er nogen farmakokinetisk interaktion mellem dabigatran- etexilat og diclofenac.
When Pradaxa was coadministered with diclofenac, the plasma exposure of both medicinal products remained unchanged indicating a lack of a pharmacokinetic interaction between dabigatran etexilate and diclofenac.
4. 4).
However, due to the risk of haemorrhage, notably with NSAIDs with elimination half-lives > 12 hours, close observation for signs of bleeding is recommended (see section 4.4).
5 Transporter- interaktioner:
Transporter interactions:
Amiodaron hæmmer efflukstransporteren P- glykoprotein, og dabigatran- etexilat er et substrat af denne transporter.
Amiodarone is an inhibitor of the efflux transporter P-glycoprotein and dabigatran etexilate a substrate of this transporter.
Ved samtidig indgift af Pradaxa og amiodaron forblev absorptionsgraden og absorptionshastigheden af amiodaron og dets aktive metabolit DEA praktisk taget uændret.
When Pradaxa was coadministered with amiodarone, the extent and rate of absorption of amiodarone and its active metabolite DEA were essentially unchanged.
60% og 50%.
The dabigatran AUC and Cmax were increased by about 60% and 50%, respectively.
I lyset af den lange halveringstid for amiodaron kan lægemiddelinteraktion forekomme i flere uger efter ophør med amiodaron.
In view of the long half-life of amiodarone the potential for drug interaction may exist for weeks after discontinuation of amiodarone.
4. 2).
5 Dosing should be reduced to 150 mg Pradaxa daily in patients who received concomitantly dabigatran etexilate and amiodarone (see section 4.2).
P- glycoprotein- hæmmere:
P- glycoprotein inhibitors:
Der bør udvises særlig opmærksomhed ved samtidig brug af stærke P- glycoprotein- hæmmere som, verapamil, clarithromycin og lignende produkter.
Caution should be exercised with strong P- glycoprotein inhibitors like verapamil, clarithromycin, and others.
4. 3).
The P- glycoprotein inhibitor quinidine is contraindicated (see section 4.3).
P- glycoprotein- induktorer:
P- glycoprotein inducers:
Kraftige P- glycoprotein- induktorer såsom rifampicin eller Perikum (prikbladet perikum eller Hypericum perforatum) kan måske reducere den systemiske eksponering af dabigatran.
Potent P- glycoprotein inducers such as rifampicin or St John’ s wort (Hypericum perforatum), may reduce the systemic exposure of dabigatran.
Der bør udvises særlig opmærksomhed ved samtidig behandling med disse lægemidler.
Caution is advised when co-administering these medicinal products.
I et forsøg med 24 raske forsøgspersoner, hvor Pradaxa blev givet samtidigt med digoxin, så man ingen ændringer i eksponeringen af digoxin og ingen klinisk relevante ændringer i eksponeringen af dabigatran.
In a study performed with 24 healthy subjects, when Pradaxa was coadministered with digoxin, no changes on digoxin and no clinical relevant changes on dabigatran exposure have been observed.
Gastrisk pH:
Gastric pH:
30%.
When Pradaxa was coadministered with pantoprazole, a decrease in the dabigatran area under the plasma concentration - time curve of approximately 30% was observed.
Pantoprazol og andre protonpumpehæmmere blev givet sammen med Pradaxa i kliniske forsøg, og der så man ingen påvirkning af blødning eller effekt.
Pantoprazole and other proton- pump inhibitors were co-administered with Pradaxa in clinical trials and no effects on bleeding or efficacy were observed.
Samtidig indtagelse af ranitidin og Pradaxa havde ingen klinisk relevant virkning på omfanget af dabigatran- absorptionen.
Ranitidine administration together with Pradaxa had no clinically relevant effect on the extent of absorption of dabigatran.
Der foreligger ikke tilstrækkelige data om brugen af Pradaxa hos gravide kvinder.
There are no adequate data from the use of Pradaxa in pregnant women.