FrancophonIA/ELRC3.0 huggingface dataset:
English: Following a 60 mg loading dose of prasugrel, inhibition of ADP-induced platelet aggregation occurs at 15 minutes with 5 µM ADP and 30 minutes with 20 µM ADP.
Danish: Efter en loading-dosis på 60 mg prasugrel forekommer en hæmning af ADP-induceret trombocytaggregering efter 15 minutter med 5µM ADP og efter 30 minutter med 20 µM.
English: • Low blood platelet count
Danish: • Lavt antal blodplader
English: Rifampicin (600 mg daily), a potent inducer of CYP3A and CYP2B6, and an inducer of CYP2C9, CYP2C19, and CYP2C8, did not significantly change the pharmacokinetics of prasugrel.
Danish: Rifampicin (600 mg daglig), en potent induktor af CYP3A og CYP2B6 samt en induktor af CYP2C9, CYP2C19 og CYP2C8, ændrede ikke signifikant prasugrels farmakokinetik.
English: Vascular Disorders Haematoma Respiratory, thoracic and mediastinal disorders
Danish: Vaskulære sygdomme Blodansamling Luftveje, thorax og mediastinum
English: History of stroke or transient ischaemic attack (TIA).
Danish: Tidligere tilfælde af slagtilfælde eller transitorisk iskæmisk attak (TIA).
English: • Bleeding after surgery
Danish: • Blødning efter en operation
English: d Life-threatening bleeding is a subset of TIMI major bleeding and includes the types indented below.
Danish: d Livstruende blødning hører under TIMI større blødning og inkluderer de typer, der er anført nedenfor.
English: • Periodic Safety Update Reports
Danish: Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: Mean steady-state inhibition of platelet aggregation was 74% and 69% respectively for 5 µM ADP and 20 µM ADP, and was achieved following 3 to 5 days of administration of the 10 mg prasugrel maintenance dose preceded by a 60 mg loading dose.
Danish: Den gennemsnitlige steady state-hæmning af trombocytaggregeringen var henholdsvis 74 % og 69 % for 5µM og 20 µM ADP og blev nået efter 3 til 5 dages administration af en vedligeholdelsesdosis på 10 mg prasugrel med en forudgående loading-dosis på 60 mg .
English: A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLERE ANSVARLIGE FOR BATCHFRIGIVELSE
English: Patients randomised to receive prasugrel (60 mg loading dose followed by 10 mg once daily) or clopidogrel (300 mg loading dose followed by 75 mg once daily) were treated for a median of 14.5 months (maximum of 15 months with a minimum of 6 months follow-up).
Danish: De patienter, som var randomiseret til at få prasugrel (60 mg loading-dosis efterfulgt af 10 mg én gang daglig) eller clopidogrel (300 mg loading-dosis efterfulgt af 75 mg én gang daglig), blev behandlet i 14,5 måneder i gennemsnit (maksimum på 15 måneder med et minimum på 6 måneders opfølgning).
English: For patients with active bleeding for whom reversal of the pharmacological effects of Efient is required, platelet transfusion may be appropriate.
Danish: Hvis det er nødvendigt at ophæve Efients farmakologiske virkning hos patienter med aktiv blødning, kan transfusion af blodplader,være hensigtsmæssig.
English: Patients < 60 kg Non-CABG-related TIMI major or minor bleeding rates:
Danish: Patienter < 60 kg Andelen af ikke-CABG-relaterede større eller mindre blødning (TIMI):
English: Therefore, CYP3A inhibitors such as azol antifungals, HIV protease inhibitors, clarithromycin, telithromycin, verapamil, diltiazem, indinavir, ciprofloxacin, and grapefruit juice are not anticipated to have a significant effect on the pharmacokinetics of the active metabolite.
Danish: CYP3A-hæmmere såsom azolsvampemidler, HIV-proteasehæmmere, clarithromycin, telithromycin, verapamil, diltiazem, indinavir, ciprofloxacin og grapefrugtjuice forventes ikke at have en signifikant virkning på denaktive metabolits farmakokinetik.
English: As in the < 75 years old and ≥60 kg patients treated with 10 mg prasugrel, there was no difference between 5 mg prasugrel and 75 mg clopidogrel in CV outcomes.
Danish: Som hos patienter < 75 år og ≥60 kg, som blev behandlet med 10 mg prasugrel, var der ingen forskel i de kardiovaskulære resultater mellem 5 mg prasugrel og 75 mg clopidogrel.
English: Patients ≥ 75 years old Non-CABG-related TIMI major or minor bleeding rates:
Danish: Patienter ≥ 75 år Andelen af ikke-CABG-relaterede større eller mindre blødninger (TIMI):
English: Daily co-administration of ranitidine (an H2 blocker) or lansoprazole (a proton pump inhibitor) did not change the prasugrel active metabolite's AUC and Tmax, but decreased the Cmax by 14% and 29%, respectively.
Danish: Daglig samtidig administration af ranitidin (en H2-blokker) eller lansoprazol (en protonpumpehæmmer) ændrede ikke AUC og Tmax for prasugrels aktive metabolit, men formindskede Cmax med henholdsvis 14 % og 29 %.
English: If this has happened to you, tell your doctor immediately.
Danish: Fortæl det omgående til din læge, hvis det sker for dig.
English: Eli Lilly Hrvatska d.o.o.
Danish: Hrvatska Eli Lilly Hrvatska d.o.o.
English: Patients taking Efient should also take ASA daily (75 mg to 325 mg).
Danish: De patienter, som tager Efient, bør også tage ASA daglig (75 mg til 325 mg).
English: Rare side effects (may affect up to 1 in 1,000 people)
Danish: Sjældne bivirkninger (sker for op til 1 ud af 1.000 patienter)
English: In patients with acute coronary syndrome (ACS) who are managed with PCI, premature discontinuation of any antiplatelet agent, including Efient, could result in an increased risk of thrombosis, myocardial infarction or death due to the patient's underlying disease.
Danish: Hos patienter med akut koronarsyndrom (AKS), som gennemgår PCI, kan for tidlig seponering af enhver trombocytfunktionshæmmer inklusive Efient, resultere i en øget risiko for trombose, myokardieinfarkt eller død som følge af patientens tilgrundliggende sygdom.
English: EU/1/08/503/001 - 007, 015 Efient 10 mg: EU/1/08/503/008 - 014, 016
Danish: Efient 10 mg: EU/1/08/503/008 - 014, 016
English: Requiring inotropes
Danish: Inotrop-behandling påkrævet
English: Patients also received ASA (75 mg to 325 mg once daily).
Danish: Patienterne fik også ASA (75 mg til 325 mg én gang daglig).
English: Skin and subcutaneous tissue disorders
Danish: Hud og subkutane væv Udslæt Ekkymose
English: Switching directly to prasugrel 60 mg loading dose resulted in the most rapid onset of higher platelet inhibition.
Danish: Skiftet direkte til prasugrel 60 mg loading-dosis gav den hurtigste indtræden af højere trombocythæmning.
English: Efient, which contains the active substance prasugrel, belongs to a group of medicines called antiplatelet agents.
Danish: Efient indeholder det aktive stof prasugrel og tilhører en medicingruppe, som kaldes blodfortyndende medicin.
English: • Allergic reaction (rash, itching, swollen lips/tongue, or shortness of breath)
Danish: • Allergisk reaktion (udslæt, kløe, opsvulmede læber/tunge eller stakåndethed)
English: Beyond 7 days after drug discontinuation, the observed rates of CABG-related bleeding were similar between treatment groups (see section 4.4).
Danish: Ved CABG senere end 7 dage efter seponering var de observerede hyppigheder af CABG-relateret blødning ens mellem behandlingsgrupperne (se pkt.
English: Ketoconazole (400 mg daily), a selective and potent inhibitor of CYP3A4 and CYP3A5, did not affect prasugrel-mediated inhibition of platelet aggregation or the prasugrel active metabolite's AUC and Tmax, but decreased the Cmax by 34% to 46%.
Danish: Ketoconazol (400 mg daglig), en selektiv og potent hæmmer af CYP3A4 og CYP3A5, påvirkede ikke den prasugrelmedierede hæmning af trombocytaggregering eller AUC og Tmax for prasugrels aktive metabolit, men formindskede Cmax med 34 % til 46 %.
English: Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Danish: I prækliniske studier blev der kun iagttaget virkninger ved doser, der anses for at overstige den maksimale humane eksponering i væsentlig grad.
English: Pharmacokinetics and pharmacodynamics of prasugrel have not been evaluated in a paediatric population (see section 4.2).
Danish: Pædiatrisk population: Prasugrels farmakokinetik og farmakodynamik er ikke evalueret hos en pædiatrisk population (se pkt
English: Pharmacokinetics and pharmacodynamics of prasugrel in patients with severe hepatic impairment have not been studied.
Danish: Prasugrels farmakokinetik og farmakodynamik hos patienter med svært nedsat leverfunktion er ikke undersøgt.
English: Because of the potential for increased risk of bleeding, warfarin (or other coumarin derivatives) and prasugrel should be co-administered with caution (see section 4.4).
Danish: På grund af muligheden for øget blødningsrisiko bør kombinationen warfarin (eller andre kumarinderivater) og prasugrel administreres med forsigtighed (se pkt 4.4).
English: For patients who received their thienopyridine within 3 days prior to CABG, the frequencies of TIMI major or minor bleeding were 26.7% (12 of 45 patients) in the prasugrel group, compared with 5.0% (3 of 60 patients) in the clopidogrel group.
Danish: For de patienter, som fik deres thienopyridin indenfor 3 dage før CABG, var hyppighederne af TIMI større eller mindre blødninger 26,7 % (12 af 45 patienter) i prasugrelgruppen sammenlignet med 5,0 % (3 af 60 patienter) i clopidogrelgruppen.
English: INFORMATION IN BRAILLE Efient 10 mg
Danish: INFORMATION I BRAILLESKRIFT Efient 10 mg
English: Pharmacokinetics in special Populations
Danish: Farmakodynamik hos Særlige Grupper
English: No data are available on the reversal of the pharmacological effect of prasugrel; however, if prompt correction of prolonged bleeding time is required, platelet transfusion and/or other blood products may be considered.
Danish: Hvis der er behov for hurtig korrektion af forlænget blødningstid, kan transfusion med blodplader og/eller andre blodprodukter dog overvejes.
English: Specifically, prasugrel did not significantly reduce the frequency of the composite endpoint of cardiovascular (CV) death, myocardial infarction (MI), stroke, urgent revascularization (UR), or glycoprotein (GP) IIb/IIIa inhibitor bailout through 7 days from randomization in subjects receiving prasugrel prior to coronary angiography compared to patients receiving the full loading dose of prasugrel at the time of PCI, and the rate of the key safety objective for all TIMI major bleeding (CABG and non-CABG events) through 7 days from randomization in all treated subjects was significantly higher in subjects receiving prasugrel prior to coronary angiography versus patients receiving the full loading dose of prasugrel at the time of PCI.
Danish: Specifikt reducerede prasugrel ikke signifikant hyppigheden af det sammensatte endepunkt kardiovaskulær (CV) død, myokardieinfarkt (MI), apopleksi, akut revaskularisering (UR) eller glykoprotein (GP) IIb/IIIa-inhibitor som redningsbehandling indenfor 7 dage efter randomisering hos patienter, der fik prasugrel før koronarangiografi sammenlignet med patienter, som fik den fulde prasugrel-loadingdosis på tidspunktet for PCI, og hyppigheden af det væsentlige sikkerhedsmål for alle TIMI større blødninger (CABG- og non-CABG-hændelser) indenfor 7 dage efter randomisering for alle behandlede patienter var signifikant højere hos de patienter, som fik prasugrel før koronarangiografi i forhold til de patienter, som fik den fulde prasugrel-loadingdosis på tidspunktet for PCI.
English: • Blood in urine
Danish: • Blod i urinen
English: In a study of 276 ACS patients managed with PCI, switching from an initial loading dose of 600 mg clopidogrel or placebo administered upon presentation to the hospital prior to coronary angiography to a 60 mg loading dose of prasugrel administered at the time of percutaneous coronary intervention, resulted in a similar increased inhibition of platelet aggregation for the 72 hour duration of the study.
Danish: I et studie, hvor 276 AKS-patienter, der undergik PCI, blev skiftet fra en initial loadingdosis på 600 mg clopidogrel eller placebo, indgivet ved ankomst til hospitalet før koronarangiografi, til en 60 mg loading-dosis prasugrel, indgivet på tidspunktet for perkutan koronar intervention (PCI), resulterede dette i en tilsvarende øget hæmning af trombocytaggregationen i de 72 timer, som studiet varede.
English: In the phase 3 clinical trial (TRITON) key exclusion criteria included an increased risk of bleeding; anaemia; thrombocytopaenia; a history of pathological intracranial findings.
Danish: I det kliniske fase 3-studie (TRITON) omfattede hovedeksklusionskriterierne en øget risiko for blødning, anæmi, trombocytopeni og tidligere patologiske intrakranielle fund.
English: Prasugrel-mediated inhibition of platelet aggregation exhibits low between-subject (9%) and within-subject (12%) variability with both 5 µM and 20 µM ADP.
Danish: Prasugrelmedieret hæmning af trombocytaggregering viser lav varians imellem forsøgspersonerne (9 %) og hos forsøgspersonerne (12 %) med både 5 µM og 20 µM ADP.
English: The mean exposure (AUC) of the active metabolite of prasugrel is approximately 30 to 40% higher in healthy subjects and patients with a body weight of < 60 kg compared to those weighing ≥ 60 kg. Prasugrel should be used with caution in patients with a body weight of < 60 kg due to the potential risk of bleeding in this population (see section 4.4).
Danish: Den gennemsnitlige eksponering (AUC) af prasugrels aktive metabolit er ca. 30 til 40 % højere hos raske forsøgspersoner og patienter med en legemsvægt på < 60 kg sammenlignet med dem, som vejer ≥ 60 kg. Prasugrel bør anvendes med forsigtighed til patienter med legemsvægt < 60 kg på grund af den potentielle blødningsrisiko hos denne gruppe (se pkt.
English: The efficacy of prasugrel was independent of the ASA dose (75 mg to 325 mg once daily).
Danish: Virkningen af prasugrel var uafhængig af den indgivne ASA dosis (75 mg til 325 mg én gang daglig).
English: Higher inhibition of platelet aggregation was observed in patients switched to prasugrel 10 mg compared with those treated with clopidogrel 150 mg.
Danish: Der blev observeret højere hæmning af trombocytaggregering hos de patienter, som blev skiftet til 10 mg prasugrel, sammenlignet med dem, som blev behandlet med 150 mg clopidogrel.
English: Primary Composite Outcome Events
Danish: Hændelser i det primære sammensatte endepunkt
English: Efient is unlikely to affect your ability to drive or use machines.
Danish: Trafik- og arbejdssikkerhed Det er usandsynligt, at Efient påvirker evnen til at køre eller betjene maskiner.
English: Contusion
Danish: Kontusion
English: EU/1/08/503/008 14 film-coated tablets EU/1/08/503/009 28 film-coated tablets EU/1/08/503/010 30x1 film-coated tablet EU/1/08/503/011 56 film-coated tablets EU/1/08/503/012 84 film-coated tablets EU/1/08/503/013 90x1 film-coated tablet EU/1/08/503/014 98 film-coated tablets EU/1/08/503/016 30 film-coated tablets
Danish: EU/1/08/503/008 14 filmovertrukne tabletter EU/1/08/503/009 28 filmovertrukne tabletter EU/1/08/503/010 30x1 filmovertrukken tablet EU/1/08/503/011 56 filmovertrukne tabletter EU/1/08/503/012 84 filmovertrukne tabletter EU/1/08/503/013 90x1 filmovertrukken tablet EU/1/08/503/014 98 filmovertrukne tabletter EU/1/08/503/016 30 filmovertrukne tabletter
English: Event
Danish: Hændelser
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not take Efient.
Danish: Efient bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp Lactase deficiency) eller glucose/galactose malabsorption.
English: • Bleeding in the stomach or bowels
Danish: • Blødning i mave eller tarm
English: INFORMATION IN BRAILLE Efient 5 mg
Danish: INFORMATION I BRAILLESKRIFT Efient 5 mg
English: EU/1/08/503/001 14 film-coated tablets EU/1/08/503/002 28 film-coated tablets EU/1/08/503/003 30x1 film-coated tablet EU/1/08/503/004 56 film-coated tablets EU/1/08/503/005 84 film-coated tablets EU/1/08/503/006 90x1 film-coated tablet EU/1/08/503/007 98 film-coated tablets EU/1/08/503/015 30 film-coated tablets
Danish: EU/1/08/503/001 14 filmovertrukne tabletter EU/1/08/503/002 28 filmovertrukne tabletter EU/1/08/503/003 30x1 filmovertrukken tablet EU/1/08/503/004 56 filmovertrukne tabletter EU/1/08/503/005 84 filmovertrukne tabletter EU/1/08/503/006 90x1 filmovertrukken tablet EU/1/08/503/007 98 filmovertrukne tabletter EU/1/08/503/015 30 filmovertrukne tabletter
English: o Severe haemorrhagic events are more frequent in patients ≥ 75 years of age (including fatal events) or those weighing < 60 kg o Treatment with prasugrel is generally not recommended for patients of ≥ 75 years of age.
Danish: • bør fremhæve at: o Alvorlige hæmoragiske hændelser er mere hyppige hos patienterne ≥ 75 år (inklusive letale hændelser) eller med vægt < 60 kg. o Patienter ≥ 75 år bør normalt ikke behandles med prasugrel.
English: No dosage adjustment is necessary for patients with renal impairment, including patients with end stage renal disease (ESRD).
Danish: Det er ikke nødvendigt at justere dosis hos patienter med nedsat nyrefunktion, herunder patienter med nyresygdom i slutstadiet (ESRD).
English: Effects of other medicinal products on Efient
Danish: Virkninger af andre lægemdiler på Efient:
English: Concomitant administration with chronic NSAIDs has not been studied.
Danish: Administration af Efient samtidig med vedvarende behandling med NSAIDs er ikke undersøgt.
English: Other medicines and Efient
Danish: Brug af anden medicin sammen med Efient
English: No dose adjustment is necessary for patients with mild to moderate impaired hepatic function (Child Pugh Class A and B).
Danish: Det er ikke nødvendigt at justere dosis hos patienter med mild til moderat nedsat leverfunktion (Child Pugh-klasse A og B).
English: Efient 5 mg film-coated tablets.
Danish: Efient 5 mg filmovertrukne tabletter.
English: For further information please refer to section 5.1.
Danish: For yderligere information henvises til pkt.
English: Aluminium foil blisters in cartons of 14, 28, 30, 30 (x1), 56, 84, 90 (x1) and 98 tablets.
Danish: Blisterpakninger af aluminiumsfolie i æske med 14, 28, 30, 30 (x1), 56, 84, 90 (x1) og 98 tabletter Ikke alle pakningsstørrelser er nødvendigvis markedsført.
English: Do not stop taking Efient without consulting your doctor; if you stop taking Efient too soon, your risk of a heart attack may be higher.
Danish: Hvis du stopper for tidligt med at tage Efient, kan du have højere risiko for at få et hjerteanfald.
English: - If you have ever had a stroke or a transient ischaemic attack (TIA).
Danish: - Hvis du på et tidligere tidspunkt har haft et slagtilfælde eller et forbigående tilfælde af sammentrækning af blodårer (iskæmisk tilfælde/TIA).
English: cLife-threatening is a subset of TIMI Major bleeding and includes the types indented below.
Danish: cLivstruende er en undergruppe af TIMI større blødning og inkluderer de indrykkede typer nedenunder.
English: This is due to an increase in exposure to the active metabolite of prasugrel, and an increased risk of bleeding in patients with body weight < 60 kg when given a 10 mg once daily dose compared with patients ≥ 60 kg (see sections 4.4, 4.8 and 5.2).
Danish: Dette skyldes en forøget eksponering for den aktive metabolit af prasugrel og en øget blødningsrisiko hos patienter med legemsvægt < 60 kg, når der gives en dosis på 10 mg én gang daglig sammenlignet med patienter ≥ 60 kg(se pkt.
English: What Efient is and what it is used for What you need to know before you take Efient How to take Efient
Danish: Virkning og anvendelse Det skal du vide, før du begynder at tage Efient Sådan skal du tage Efient Bivirkninger
English: Contact your doctor immediately if you notice any of the following:
Danish: Kontakt din læge omgående, hvis du oplever noget af følgende:
English: Primary Composite Outcome Events Cardiovascular (CV) death, non fatal MI, or non fatal stroke
Danish: Primære sammensatte endepunktshændelser Kardiovaskulær (CV) død, ikke-letal MI eller ikke letalt slagtilfælde
English: Iron oxide red (E172) {only Efient 10 mg} Iron oxide yellow (E172) Talc
Danish: Rød jernoxid (E172) {kun for Efient 10 mg} Gul jernoxid (E172)
English: • with body weight < 60 kg (see sections 4.2 and 4.8).
Danish: • med legemsvægt < 60 kg (se pkt.
English: In patients ≥60 kg and age <75 years, non-CABG-related TIMI major or minor bleeding rates were 3.6% for prasugrel and 2.8% for clopidogrel; rates for fatal bleeding were 0.2% for prasugrel and 0.1% for clopidogrel.
Danish: Hos patienter ≥ 60 kg og < 75 år var andelen af ikke-CABG-relaterede TIMI større eller mindre blødning 3,6 % for prasugrel og 2,8 % for clopidogrel.
English: In clinical pharmacology studies, after adjusting for body weight, the AUC of the active metabolite was approximately 19% higher in Chinese, Japanese, and Korean subjects compared to that of Caucasians, predominantly related to higher exposure in Asian subjects < 60 kg.
Danish: I klinisk farmakologiske forsøg var AUC af den aktive metabolit efter justering for legemsvægt ca. 19 % højere hos kinesiske, japanske og koreanske forsøgspersoner sammenlignet med kaukasiere.
English: Efient contains lactose
Danish: Efient indeholder lactose.
English: • Coughing up blood
Danish: • Hoster blod op
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Daiichi Sankyo Europe GmbH
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Daiichi Sankyo Europe GmbH
English: • warfarin (an anti-coagulant),
Danish: • warfarin (forhindrer blodet i at størkne),
English: CV death, nonfatal MI, or nonfatal stroke CV death
Danish: CV død, ikke-letalt MI eller ikke-letalt slagtilfælde
English: Administration of the 60 mg prasugrel loading dose in the fasted state may provide most rapid onset of action (see section 5.2).
Danish: Administration af 60 mg prasugrel loading-dosis ved faste kan give den hurtigst indsættende virkning (se pkt.
English: • Subcutaneous haematoma (bleeding under the skin causing a swelling)
Danish: • Hæmatomer under huden (blødning under huden som forårsager hævelse)
English: The use of Efient in patients ≥ 75 years of age is generally not recommended.
Danish: Efient bør normalt ikke anvendes til patienter ≥ 75 år.
English: Reduced prasugrel efficacy has been seen in patients co-administered prasugrel and morphine (see section 4.5).
Danish: Der er set reduceret effekt af prasugrel hos patienter, hvor prasugrel og morfin er administreret samtidig (se pkt.
English: An allergic reaction may be recognised as a rash, itching, a swollen face, swollen lips or shortness of breath.
Danish: En allergisk reaktion kan kendes på hududslæt, kløe, hævelse af ansigtet, hævede læber eller stakåndethed.
English: Pharmacokinetics of prasugrel and its inhibition of platelet aggregation were similar in subjects with mild to moderate hepatic impairment compared to healthy subjects.
Danish: Prasugrels farmakokinetik og dets hæmning af trombocytaggregering var ens hos forsøgspersoner med mild til moderat nedsat leverfunktion sammenlignet med raske forsøgspersoner.
English: Prasugrel must not be used in patients with severe hepatic impairment (see section 4.
Danish: Prasugrel må ikke anvendes til patienter med svært nedsat leverfunktion (se pkt.
English: How to take Efient
Danish: Sådan skal du tage EFIENT
English: Table 2: Haemorrhagic and Non-haemorrhagic adverse reactions System Organ
Danish: Tabel 2: Hæmoragiske og non-hæmoragiske bivirkninger Organklasse
English: Your doctor should prescribe a daily dose of 5 mg as there is a greater risk of bleeding in patients older than 75 years - a recent serious injury - recent surgery (including some dental procedures) - recent or recurrent bleeding from the stomach or intestines (e.g. a stomach ulcer or colon polyps) - body weight of less than 60 kg.
Danish: Din læge bør ordinere en daglig dosis på 5 mg, da der er en større risiko for blødning hos patienter, der er ældre end 75 år, - du for nylig har haft en alvorlig kvæstelse, - du for nylig har fået foretaget et kirurgisk indgreb (herunder visse tandoperationer).
English: dICH=intracranial haemorrhage.
Danish: dICH=intrakraniel blødning.