natgillin/translations-raw huggingface dataset:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Xarelto til Bayer HealthCare AG den 30. september 2008.
The European Commission granted a marketing authorisation valid throughout the European Union for Xarelto to Bayer HealthCare AG on 30 September 2008.
Den fuldstændige EPAR for Xarelto findes her.
The full EPAR for Xarelto can be found here.
EU- nummer EU/ 1/ 08/ 472/ 001 EU/ 1/ 08/ 472/ 002 EU/ 1/ 08/ 472/ 003 EU/ 1/ 08/ 472/ 004 EU/ 1/ 08/ 472/ 005 EU/ 1/ 08/ 472/ 006 EU/ 1/ 08/ 472/ 007 EU/ 1/ 08/ 472/ 008
EU/ 1/ 08/ 472/ 001 EU/ 1/ 08/ 472/ 002 EU/ 1/ 08/ 472/ 003 EU/ 1/ 08/ 472/ 004 EU/ 1/ 08/ 472/ 005 EU/ 1/ 08/ 472/ 006 EU/ 1/ 08/ 472/ 007 EU/ 1/ 08/ 472/ 008
Særnavn Xarelto Xarelto Xarelto Xarelto Xarelto Xarelto Xarelto Xarelto
Xarelto Xarelto Xarelto Xarelto Xarelto Xarelto Xarelto Xarelto
Styrke 10 mg 10 mg 10 mg 10 mg 10 mg 10 mg 10 mg 10 mg
10 mg 10 mg 10 mg 10 mg 10 mg 10 mg 10 mg 10 mg
Emballage blister (PVC/ PVDC/ alu) blister (PVC/ PVDC/ alu) blister (PVC/ PVDC/ alu) blister (PVC/ PVDC/ alu) blister (PP / alu) blister (PP / alu) blister (PP / alu) blister (PP / alu)
blister (PVC/ PVDC/ alu) blister (PVC/ PVDC/ alu) blister (PVC/ PVDC/ alu) blister (PVC/ PVDC/ alu) blister (PP / alu) blister (PP / alu) blister (PP / alu) blister (PP / alu)
Paknings- størrelse 5 tabletter 10 tabletter 30 tabletter 100 tabletter 5 tabletter 10 tabletter 30 tabletter 100 tabletter
5 tablets 10 tablets 30 tablets 100 tablets 5 tablets 10 tablets 30 tablets 100 tablets
4. 4.
Each film-coated tablet contains 27.9 mg lactose monohydrate, see section 4.4.
Lyserøde, runde, filmovertrukne tabletter mærket med et BAYER- kors på den ene side og ” 10 "samt en trekant på den anden side.
Light red, round tablets marked with the BAYER-cross on one side and "10" and a triangle on the other side.
Forebyggelse af venøs tromboemboli (VTE) hos voksne patienter, som gennemgår planlagt hofteleds - eller knæledsalloplastik.
Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery.
Første dosis skal tages 6- 10 timer efter indgrebet, forudsat er der er opnået hæmostase.
The initial dose should be taken 6 to 10 hours after surgery, provided that haemostasis has been established.
Behandlingens varighed afhænger af den enkelte patients risiko for at udvikle venøs tromboemboli, hvilket igen afhænger af, hvilken type ortopædkirurgiske indgreb, der er tale om. • Hos patienter, der gennemgår et større hofteindgreb, anbefales en behandlingsvarighed på 5 uger. • Hos patienter, der gennemgår et større knæindgreb, anbefales en behandlingsvarighed på 2 uger.
The duration of treatment depends on the individual risk of the patient for venous thromboembolism which is determined by the type of orthopaedic surgery. • For patients undergoing major hip surgery, a treatment duration of 5 weeks is recommended. • For patients undergoing major knee surgery, a treatment duration of 2 weeks is recommended.
Hvis patienten glemmer at tage en dosis af Xarelto, skal han/ hun tage denne dosis øjeblikkeligt, og fortsætte næste dag med den daglige dosis som før.
If a dose is missed the patient should take Xarelto immediately and then continue the following day with once daily intake as before.
Xarelto kan indtages med eller uden samtidig fødeindtagelse.
Xarelto can be taken with or without food.
Nedsat nyrefunktion Der kræves ingen dosisjustering hos patienter med let nedsat nyrefunktion (kreatinclearance 50- 80 ml/ min.) eller moderat nedsat nyrefunktion (kreatininclearance 30- 49 ml/ min.) (se pkt.
Renal impairment No dose adjustment is necessary in patients with mild renal impairment (creatinine clearance 50 - 80 ml/ min) or moderate renal impairment (creatinine clearance 30 - 49 ml/ min) (see section 5.2).
Xarelto skal derfor anvendes med forsigtighed hos disse patienter.
Limited clinical data for patients with severe renal impairment (creatinine clearance 15 - 29 ml/ min) indicate that rivaroxaban plasma concentrations are significantly increased in this patient population, therefore, Xarelto is to be used with caution in these patients.
4. 4 og 5. 2).
Use is not recommended in patients with creatinine clearance < 15 ml/ min (see sections 4.4 and 5.2).
4. 3 og 5. 2).
Hepatic impairment Xarelto is contraindicated in patients with hepatic disease associated with coagulopathy and clinically relevant bleeding risk (see sections 4.3 and 5.2).
Xarelto kan anvendes med forsigtighed hos cirrosepatienter med moderat nedsat leverfunktion (Child Pugh B), hvis det ikke er forbundet med koagulationsdefekt (se pkt.
Xarelto may be used with caution in cirrhotic patients with moderate hepatic impairment (Child Pugh B) if it is not associated with coagulopathy (see sections 4.4 and 5.2).
Der kræves ingen dosisjustering hos patienter med andre leversygdomme.
2 No dose adjustment is necessary in patients with other hepatic diseases.
Patienter over 65 år Ingen dosisjustering.
Patients above 65 years No dose adjustment.
Legemsvægt Ingen dosisjustering.
Body weight No dose adjustment.
Køn Ingen dosisjustering.
Gender No dose adjustment.
Børn og unge Xarelto bør ikke anvendes til børn eller unge under 18 år på grund af manglende dokumentation for lægemidlets sikkerhed og virkning.
Children and adolescents Xarelto is not recommended for use in children or adolescents below 18 years of age due to a lack of data on safety and efficacy.
Klinisk signifikant, aktiv blødning.
Clinically significant active bleeding.
5. 2).
Hepatic disease associated with coagulopathy and clinically relevant bleeding risk (see section 5.2).
Blødningsrisiko Flere patientgrupper har, som beskrevet nedenfor, øget risiko for blødning.
Haemorrhagic risk Several sub-groups of patients, as detailed below, are at increased risk of bleeding.
Disse patienter skal kontrolleres omhyggeligt for tegn på blødningskomplikationer, når behandlingen er påbegyndt.
These patients are to be carefully monitored for signs of bleeding complications after initiation of treatment.
Nedsat nyrefunktion Hos patienter med svært nedsat nyrefunktion (kreatininclearance < 30 ml/ min.) kan plasmakoncentrationerne af rivaroxaban være signifikant forhøjet, hvilket kan medføre en øget blødningsrisiko.
Renal impairment In patients with severe renal impairment (creatinine clearance < 30 ml/ min) rivaroxaban plasma levels may be significantly increased which may lead to an increased bleeding risk.
Xarelto bør ikke anvendes til patienter med en kreatininclearance på < 15 ml/ min.
Use is not recommended in patients with creatinine clearance < 15 ml/ min.
4. 2 og 5. 2).
Xarelto is to be used with caution in patients with creatinine clearance 15 - 29 ml/ min (see sections 4.2 and 5.2).
4. 5).
Xarelto is to be used with caution in patients with moderate renal impairment (creatinine clearance 30 - 49 ml/ min) concomitantly receiving other medicinal products which increase rivaroxaban plasma concentrations (see section 4.5).
Nedsat leverfunktion Hos cirrosepatienter med moderat nedsat leverfunktion (klassificeret som Child Pugh B) kan plasmaniveauerne for rivaroxaban være betydeligt øgede, hvilket kan medføre en øget blødningsrisiko.
Hepatic impairment In cirrhotic patients with moderate hepatic impairment (classified as Child Pugh B), rivaroxaban plasma levels may be significantly increased which may lead to an increased bleeding risk.
Xarelto er kontraindiceret til patienter med leversygdom, der er forbundet med koagulationsdefekt og en klinisk relevant blødningsrisiko.
Xarelto is contraindicated in patients with hepatic disease associated with coagulopathy and clinically relevant bleeding risk.
4. 2, 4. 3 og 5. 2).
Xarelto may be used with caution in cirrhotic patients with moderate hepatic impairment (Child Pugh B) if it is not associated with coagulopathy (see sections 4.2, 4.3 and 5.2).
3 Interaktion med andre lægemidler Xarelto bør ikke anvendes til patienter, som får samtidig systemisk behandling med azolantimykotika (som f. eks. ketoconazol, itraconazol, voriconazol og posaconazol) eller HIV- proteasehæmmere (f. eks. ritonavir).
Interaction with other medicinal products The use of Xarelto is not recommended in patients receiving concomitant systemic treatment with azole-antimycotics (such as ketoconazole, itraconazole, voriconazole and posaconazole) or HIV protease inhibitors (e. g. ritonavir).
Disse aktive stoffer er stærke hæmmere af både CYP3A4 og P- gp, og kan derfor øge rivaroxabans plasmakoncentrationer til et klinisk relevant niveau, hvilket kan resultere i en øget blødningsrisiko (se pkt.
These active substances are strong inhibitors of both CYP3A4 and P-gp and therefore may increase rivaroxaban plasma concentrations to a clinically relevant degree which may lead to an increased bleeding risk (see section 4.5).
Fluconazol forventes at have en mindre indvirkning på eksponeringen af rivaroxaban, og kan gives samtidigt med forsigtighed.
3 Fluconazole is expected to have less effect on rivaroxaban exposure and can be co-administered with caution.
4. 5).
Care is to be taken if patients are treated concomitantly with medicinal products affecting haemostasis such as non-steroidal anti-inflammatory drugs (NSAIDs), acetylsalicylic acid, platelet aggregation inhibitors or other antithrombotic agents (see section 4.5).
Andre risikofaktorer for blødning Rivaroxaban skal som andre antitrombotika anvendes med forsigtighed hos patienter med øget blødningsrisiko, f. eks. i tilfælde af: • medfødte eller erhvervede blødningsforstyrrelser • ukontrolleret, svær arteriel hypertension • aktiv ulcerativ gastrointestinal sygdom • nylige gastrointestinale ulcerationer • vaskulær retinopati • nylig intrakraniel eller intracerebral blødning • intraspinale eller intracerebrale vaskulære abnormaliteter • nylig hjerne -, spinal - eller øjenkirurgi
Other haemorrhagic risk factors Rivaroxaban, like other antithrombotic agents, is to be used with caution in patients with an increased bleeding risk such as: • congenital or acquired bleeding disorders • uncontrolled severe arterial hypertension • active ulcerative gastrointestinal disease • recent gastrointestinal ulcerations • vascular retinopathy • recent intracranial or intracerebral haemorrhage • intraspinal or intracerebral vascular abnormalities • recent brain, spinal or ophthalmological surgery.
Hoftebrudskirurgi Rivaroxaban er ikke undersøgt i kliniske studier hos patienter, som har fået foretaget hoftebrudskirurgi.
Hip fracture surgery Rivaroxaban has not been studied in clinical trials in patients undergoing hip fracture surgery to evaluate efficacy and safety in these patients.
Effekt og sikkerhed hos disse patienter kan ikke vurderes, og Rivaroxaban bør derfor ikke anvendes til disse patienter.
Therefore, rivaroxaban is not recommended in these patients.
Spinal - / epiduralanæstesi eller - punktur Når der anvendes neuraksial anæstesi (spinal - / epiduralanæstesi) eller spinal - / epiduralpunktur, har patienter, som får behandling med antitrombotika til forebyggelse af tromboemboliske komplikationer, risiko for at udvikle epiduralt eller spinalt hæmatom, hvilket kan føre til langvarig eller permanent lammelse.
Spinal/ epidural anaesthesia or puncture When neuraxial anaesthesia (spinal/ epidural anaesthesia) or spinal/ epidural puncture is employed, patients treated with antithrombotic agents for prevention of thromboembolic complications are at risk of developing an epidural or spinal haematoma which can result in long-term or permanent paralysis.
Risikoen kan også stige ved traumatisk eller gentagen epidural - eller spinalpunktur.
The risk may also be increased by traumatic or repeated epidural or spinal puncture.
Patienten skal overvåges hyppigt for symptomer på neurologisk svækkelse (f. eks. følelsesløshed eller svaghed i benene og afførings - eller vandladningsforstyrrelser).
Patients are to be frequently monitored for signs and symptoms of neurological impairment (e. g. numbness or weakness of the legs, bowel or bladder dysfunction).
Før der iværksættes et neuraksialt indgreb, skal lægen afveje de mulige fordele med risikoen hos de patienter, der får antikoagulantia, eller hos de patienter, der skal have antikoagulantia til tromboprofylakse.
Prior to neuraxial intervention the physician should consider the potential benefit versus the risk in anticoagulated patients or in patients to be anticoagulated for thromboprophylaxis.
Et eventuelt epiduralkateter må tidligst fjernes 18 timer efter den sidste indtagelse af rivaroxaban.
An epidural catheter is not to be removed earlier than 18 hours after the last administration of rivaroxaban.
Den næste dosis af rivaroxaban må tidligst gives 6 timer efter, at kateteret er fjernet.
The next rivaroxaban dose is to be administered not earlier than 6 hours after the removal of the catheter.
Hvis der forekommer traumatisk punktur, skal indtagelsen af rivaroxaban udskydes i 24 timer.
If traumatic puncture occurs the administration of rivaroxaban is to be delayed for 24 hours.
Interaktion med CYP3A4- induktorer Samtidig brug af rivaroxaban og stærke CYP3A4- induktorer (f. eks. rifampicin, phenytoin, carbamazepin, phenobarbital eller perikum (hypericum perforatum)) kan medføre nedsatte plasmakoncentrationer af rivaroxaban.
Interaction with CYP3A4 inducers The concomitant use of rivaroxaban with strong CYP3A4 inducers (e. g. rifampicin, phenytoin, carbamazepine, phenobarbital or St.
4. 5).
John’ s Wort) may lead to reduced rivaroxaban plasma concentrations.
Oplysninger om hjælpestofferne
Strong CYP3A4 inducers should be co-administered with caution (see section 4.5).
4 Xarelto indeholder lactose.
Information about excipients Xarelto contains lactose.
Derfor bør det ikke anvendes til patienter med arvelig galactoseintolerance, en særlig form for hereditær lactasemangel (Lapp Lactase Deficiency) eller glucose - / galactosemalabsorption.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
CYP3A4 - og P- gp- hæmmere Samtidig indtagelse af rivaroxaban og ketoconazol (400 mg én gang dagligt) eller ritonavir (600 mg to gange dagligt) førte til en stigning på 2, 6 gange/ 2, 5 gange i det gennemsnitlige AUC for rivaroxaban og en stigning på 1, 7 gange/ 1, 6 gange i den gennemsnitlige Cmax for rivaroxaban med en signifikant stigning i de farmakodynamiske effekter, som kan medføre øget risiko for blødning.
CYP3A4 and P-gp inhibitors Co-administration of rivaroxaban with ketoconazole (400 mg once a day [od]) or ritonavir (600 mg twice a day [bid]) led to a 2.6 fold / 2.5 fold increase in mean rivaroxaban AUC and a 1.7 fold / 1.6 fold increase in mean rivaroxaban Cmax, with significant increases in pharmacodynamic effects which may lead to an increased bleeding risk.
Xarelto bør derfor ikke anvendes til patienter, der får samtidig systemisk behandling med azolantimykotika som f. eks. ketoconazol, itraconazol, voriconazol og posaconazol eller HIV- proteasehæmmere.
Therefore, the use of Xarelto is not recommended in patients receiving concomitant systemic treatment with azole-antimycotics such as ketoconazole, 4 itraconazole, voriconazole and posaconazole or HIV protease inhibitors.
4. 4).
These active substances are strong inhibitors of both CYP3A4 and P-gp (see section 4.4).
Fluconazol forventes at have mindre effekt på eksponeringen af rivaroxaban, og kan gives samtidig med forsigtighed.
Fluconazole is expected to have less effect on rivaroxaban exposure and can be co-administered with caution.
Aktive stoffer, som er stærke hæmmere af kun én af rivaroxabans udskillelsesveje, enten CYP3A4 eller P- gp, forventes kun at øge plasmakoncentrationen af rivaroxaban i mindre udstræknng.
Active substances strongly inhibiting only one of the rivaroxaban elimination pathways, either CYP3A4 or P-gp, are expected to increase rivaroxaban plasma concentrations to a lesser extent.
F. eks. øgede clarithromycin (500 mg to gange dagligt), som betragtes som en stærk hæmmer af CYP3A4 og en svag til moderat hæmmer af P- gp, middel- AUC for rivaroxaban med en faktor 1, 5 og Cmax med en faktor 1. 4.
Clarithromycin (500 mg bid), for instance, considered as strong CYP3A4 inhibitor and moderate P-gp inhibitor, led to a 1.5 fold increase in mean rivaroxaban AUC and a 1.4 fold increase in Cmax.
Erythromycin (500 mg tre gange dagligt), som hæmmer CYP3A4 og P- gp i moderat grad, medførte en stigning på 1, 3 gange i det gennemsnitlige AUC og Cmax for rivaroxaban.
Erythromycin (500 mg three times a day [tid]), which inhibits CYP3A4 and P-gp moderately, led to a 1.3 fold increase in mean rivaroxaban AUC and Cmax.
Antikoagulantia Efter kombineret indtagelse af enoxaparin (enkeltdosis på 40 mg) og rivaroxaban (enkeltdosis på 10 mg) blev der observeret en additiv indvirkning på anti- faktor Xa- aktiviteten uden yderligere indvirkning på koagulationsparametrene (PT, aPTT).
Anticoagulants After combined administration of enoxaparin (40 mg single dose) with rivaroxaban (10 mg single dose) an additive effect on anti-Factor Xa activity was observed without any additional effects on clotting tests (PT, aPTT).
4. 4).
Due to the increased bleeding risk care is to be taken if patients are treated concomitantly with any other anticoagulants (see section 4.4).
NSAID' er/ trombocytaggregationshæmmere Der blev ikke observeret en klinisk relevant forlængelse af blødningstiden efter samtidig indtagelse af rivaroxaban og 500 mg naproxen.
NSAIDs/ platelet aggregation inhibitors No clinically relevant prolongation of bleeding time was observed after concomitant administration of rivaroxaban and 500 mg naproxen.
Der sås ingen farmakokinetisk interaktion ved brug af clopidogrel (initialdosis på 300 mg efterfulgt af en vedligeholdelsesdosis på 75 mg), men hos en undergruppe af patienter blev der observeret en relevant forlængelse af blødningstiden, som ikke var korreleret med trombocytaggregation, P- selektin eller GPIIb - / IIIa- receptorniveauerne.
Clopidogrel (300 mg loading dose followed by 75 mg maintenance dose) did not show a pharmacokinetic interaction but a relevant increase in bleeding time was observed in a subset of patients which was not correlated to platelet aggregation, P-selectin or GPIIb/ IIIa receptor levels.
4. 4).
Care is to be taken if patients are treated concomitantly with NSAIDs (including acetylsalicylic acid) and platelet aggregation inhibitors because these medicinal products typically increase the bleeding risk (see section 4.4).
50% i det gennemsnitlige AUC for rivaroxaban og parallelle reduktioner i dets farmakodynamiske effekter.
CYP3A4 inducers Co-administration of rivaroxaban with the strong CYP3A4 inducer rifampicin led to an approximate 50% decrease in mean rivaroxaban AUC, with parallel decreases in its pharmacodynamic effects.
Samtidig brug af rivaroxaban og andre stærke CYP3A4- induktorer (f. eks. phenytoin, carbamazepin, phenobarbital eller perikum (hypericum perforatum)) kan også medføre et fald i plasmakoncentrationerne af rivaroxaban.
The concomitant use of rivaroxaban with other strong CYP3A4 inducers (e. g. phenytoin, carbamazepine, phenobarbital or St.
Der skal udvises forsigtighed ved samtidig indtagelse af stærke CYP3A4- induktorer.
John’ s Wort) may also lead to reduced rivaroxaban plasma concentrations.
Anden samtidig behandling
Strong CYP3A4 inducers should be co-administered with caution.
5 Der blev ikke observeret nogen klinisk signifikante farmakokinetiske eller farmakodynamiske interaktioner, når rivaroxaban blev givet samtidigt med midazolam (substrat af CYP3A4), digoxin (substrat af P- gp) eller atorvastatin (substrat af CYP3A4 og P- gp), ranitidin (H2- receptorantagonist) eller antacidet aluminiumhydroxid/ magnesiumhydroxid.
Other concomitant therapies No clinically significant pharmacokinetic or pharmacodynamic interactions were observed when rivaroxaban was co-administered with midazolam (substrate of CYP3A4), digoxin (substrate of P-gp) or atorvastatin (substrate of CYP3A4 and P-gp).
Rivaroxaban hverken hæmmer eller inducerer væsentlige CYP- isoformer såsom CYP3A4.
Rivaroxaban neither inhibits nor induces any major CYP isoforms like CYP3A4.
4. 2).
No clinically relevant interaction with food was observed (see section 4.2).
Laboratorieparametre Koagulationsparametrene (f. eks.
Laboratory parameters Clotting parameters (e. g.
5. 1).
PT, aPTT, HepTest) are affected as expected by the mode of action of rivaroxaban (see section 5.1).
Graviditet Der foreligger ikke tilstrækkelige data om brugen af rivaroxaban hos gravide kvinder.
Pregnancy There are no adequate data from the use of rivaroxaban in pregnant women.
Xarelto er kontraindiceret under graviditet på grund af den potentielle reproduktive toksicitet, den iboende risiko for blødning og evidens for, at rivaroxaban passerer placenta (se pkt.
5 risk of bleeding and the evidence that rivaroxaban passes the placenta, Xarelto is contraindicated during pregnancy (see section 4.3).
Amning Der foreligger ingen data om brugen af rivaroxaban hos kvinder, der ammer.
Lactation No data on the use of rivaroxaban in breast-feeding women are available.
Data fra dyreforsøg indikerer, at rivaroxaban udskilles i modermælken.
Data from animals indicate that rivaroxaban is secreted into milk.
Xarelto er derfor kontraindiceret under amning (se pkt.
Therefore Xarelto is contraindicated during breast-feeding (see section 4.3).
Det må besluttes enten at afbryde amningen eller at afbryde/ undgå behandlingen.
A decision must be made whether to discontinue breast-feeding or to discontinue/ abstain from therapy.
4. 8).
Syncope and dizziness have been reported in the post-operative setting and may affect the ability to drive and use machines, these adverse reactions have been reported to be uncommon (see section 4.8).
Sikkerheden ved rivaroxaban 10 mg er blevet evalueret i tre fase III- studier med 4. 571 patienter, som fik rivaroxaban og gennemgik større ortopædkirurgiske indgreb i underekstremiteterne (hofteledsalloplastik eller knæalloplastik), og som blev behandlet i op til 39 dage.
The safety of rivaroxaban 10 mg has been evaluated in three phase III studies including 4,571 patients exposed to rivaroxaban undergoing major orthopaedic surgery of the lower limbs (total hip replacement or total knee replacement) treated for up to 39 days.
14% af de behandlede patienter bivirkninger.
In total, about 14% of the treated patients experienced adverse reactions.
3, 3% og 1% af patienterne.
Bleedings or anaemia occurred in approximately 3.3% and 1% of patients, respectively.
Andre almindelige bivirkninger var kvalme, øget GGT og stigning i transaminaserne.
Other common adverse reactions were nausea, increased GGT and an increase in transaminases.
På grund af Xareltos virkningsmekanisme kan brugen af lægemidlet være forbundet med en øget risiko for okkult eller manifest blødning fra alle væv eller organer, hvilket kan medføre posthæmoragisk anæmi.
Due to the pharmacological mode of action, the use of Xarelto may be associated with an increased risk of occult or overt bleeding from any tissue or organ which may result in posthaemorrhagic anaemia.
Symptomerne og sværhedsgraden (herunder mulig fatal udgang) varierer i forhold til blødningens placering og graden eller omfanget af den.
The signs, symptoms, and severity (including possibly fatal outcome) will vary according to the location and degree or extent of the bleeding.
Risikoen for blødningen kan være øget hos visse patientgrupper, f. eks. hos patienter med ukontrolleret, svær arteriel hypertension og/ eller samtidig behandling med andre lægemidler, som påvirker hæmostasen (se Blødningsrisiko i pkt 4. 4).
The risk of bleedings may be increased in certain patient groups e. g. those patients with uncontrolled severe arterial hypertension and/ or on concomitant treatment with other medicinal products affecting haemostasis (see Haemorrhagic risk in section 4.4).
Hæmoragiske komplikationer kan optræde som svaghed, asteni, bleghed, svimmelhed, hovedpine eller uforklarlig hævelse.
Haemorrhagic complications may present as weakness, asthenia, paleness, dizziness, headache or unexplained swelling.