FrancophonIA/ELRC3.0 huggingface dataset:
English: Switching data: Following administration of 75 mg clopidogrel once daily for 10 days, 40 healthy subjects were switched to prasugrel 10 mg once daily with or without a loading dose of 60 mg.
Danish: Data om behandlingsskift: Efter administration af 75 mg clopidogrel én gang daglig i 10 dage, blev 40 raske forsøgspersoner skiftet til prasugrel 10 mg én gang daglig med eller uden en loading-dosis på 60 mg. Der blev observeret den samme eller højere hæmning af trombocytaggregeringen med prasugrel.
English: Also contact your doctor immediately if you notice any of the following:
Danish: Du skal også omgående kontakte din læge, hvis du oplever noget af følgende:
English: Although bleeding was increased with prasugrel, an analysis of the composite endpoint of death from any cause, nonfatal myocardial infarction, nonfatal stroke, and non-CABG-related TIMI major haemorrhage favoured Efient compared to clopidogrel (Hazard ratio, 0.87; 95% CI, 0.79 to 0.95; p = 0.004).
Danish: I en analyse af det endepunkt, der kombinerer død uanset årsag, ikke-letalt myokardieinfarkt, ikkeletalt slagtilfælde og ikke-CABG-relateret TIMI større blødning gav Efient bedre resultater end clopidogrel (risikoforhold 0,87, 95%, CI 0,79 til 0,95, p = 0.004), selvom der var øget blødning med prasugrel.
English: No dose adjustment is necessary in subjects with mild to moderate hepatic impairment (Child Pugh class A and B) (see section 5.2).
Danish: Der er ikke nødvendigt at justere dosis hos patienter med mild til moderat nedsat leverfunktion (Child Pugh-klasse A og B) (se pkt.
English: Common side effects (may affect up to 1 in 10 people)
Danish: Almindelige bivirkninger (sker for op til 1 ud af 10 patienter)
English: NAME OF THE MEDICINAL PRODUCT Efient 10 mg film-coated tablets.
Danish: LÆGEMIDLETS NAVN Efient 10 mg filmovertrukne tabletter.
English: Nonfatal MI
Danish: Ikke-letalt MI
English: Because of the potential for increased risk of bleeding, chronic NSAIDs (including COX-2 inhibitors) and Efient should be coadministered with caution (see section 4.4).
Danish: På grund af muligheden for øget blødningsrisiko bør kombinationen af vedvarende behandling med NSAIDs (inklusive COX-2 hæmmere) og Efient administreres med forsigtighed (se pkt.
English: In a study in subjects with stable atherosclerosis, the mean AUC of the active metabolite in patients ≥75 years old taking 5 mg prasugrel was approximately half that in patients < 65 years old taking 10 mg prasugrel, and the antiplatelet effect of 5 mg was reduced but was non-inferior compared to 10 mg.
Danish: I et studie med patienter med stabil aterosklerose var det gennemsnitlige AUC for den aktive metabolit omtrent halvt så stort hos patienter ≥75 år, der fik 5 mg prasugrel, som hos patienter < 65 år, der fik 10 mg prasugrel.
English: • Blood in stools
Danish: • Blod i afføringen
English: Rates of major bleeding were similar in patients treated with 5 mg prasugrel and those treated with 75 mg clopidogrel.
Danish: Andelen af større blødning var ens hos patienter behandlet med 5 mg prasugrel og 75 mg clopidogrel.
English: Tablet Core:
Danish: Tabletkerne:
English: Uncommon side effects (may affect up to 1 in 100 people)
Danish: Ikke almindelige bivirkninger (sker for op til 1 ud af 100 patienter)
English: • Low haemoglobin or red blood cell count (anaemia)
Danish: • Lav hæmoglobinværdi eller antal røde blodlegemer (blodmangel)
English: (see sections 4.2, 4.8 and 5.1).
Danish: 4.4, 4.8, 5.1 og 5.2).
English: Nonfatal stroke
Danish: Ikke-letalt slagtilfælde
English: No dose adjustment is necessary for patients with renal impairment, including patients with end stage renal disease (see section 5.2).
Danish: Det er ikke nødvendigt at justere dosis hos patienter med nedsat nyrefunktion, herunder patienter med nyresygdom i slutstadiet (se pkt.
English: Non-Coronary Artery Bypass Graft (CABG) related bleeding In TRITON, the frequency of patients experiencing a non-CABG related bleeding event is shown in Table 1.
Danish: Frekvensen af patienter, som i TRITON fik en ikke-CABG-relateret blødning, er vist i tabel 1.
English: The most common site of spontaneous bleeding was the gastrointestinal tract (1.7% rate with prasugrel and 1.3% rate with clopidogrel); the most frequent site of provoked bleeding was the arterial puncture site (1.3% rate with prasugrel and 1.2% with clopidogrel).
Danish: Det mest hyppige sted for provokeret blødning var det arterielle indstikssted (1,3% med prasugrel og 1,2% med clopidogrel).
English: Limited data are available in children with sickle cell anaemia (see section 5.1).
Danish: Tilgængelige data vedrørende børn med seglcelleanæmi er begrænsede (se pkt.
English: Safety in patients with acute coronary syndrome undergoing PCI was evaluated in one clopidogrelcontrolled study (TRITON) in which 6741 patients were treated with prasugrel (60 mg loading dose and 10 mg once daily maintenance dose) for a median of 14.5 months (5802 patients were treated for over 6 months, 4136 patients were treated for more than 1 year).
Danish: I forsøget blev 6741 patienter behandlet med prasugrel (60 mg loading-dosis og 10 mg én gang daglig som vedligeholdelsesdosis) i gennemsnitlig 14,5 måneder (5802 patienter blev behandlet i mere end 6 måneder, 4136 patienter blev behandlet i mere end 1 år).
English: There is limited therapeutic experience in patients with mild and moderate hepatic dysfunction (see section 4.4).
Danish: Der er begrænset terapeutisk erfaring hos patienter med mild til moderat hepatisk leverinsufficiens (se pkt.
English: • A copy of the SPC
Danish: • bør indeholde en kopi af produktresumeet
English: Your doctor should prescribe a daily dose of 5 mg of Efient if you weigh less than 60 kg - renal (kidney) disease or moderate liver problems - taking certain types of medicines (see ‘Taking other medicines' below) - planned surgery (including some dental procedures) in the next seven days.
Danish: - du for nylig har haft eller har gentagen blødning fra maven eller tarmen (f.eks. mavesår eller polypper i tyktarmen), - du vejer mindre end 60 kg. Din læge bør ordinere en daglig dosis på 5 mg Efient, hvis din vægt er under 60 kg, - du har en nyresygdom eller moderate leverproblemer, - du tager visse typer medicin (se ”Brug af anden medicin” nedenunder), - der er planlagt et kirurgisk indgreb (herunder visse tandoperationer) inden for de næste 7 dage.
English: eClinically overt bleeding associated with a fall in haemoglobin of ≥3 g/dL but <5 g/dL.
Danish: eKlinisk åbenbar blødning relateret til et fald i hæmoglobin på ≥3 g/dl, men <5 g/dl.
English: Therapeutic experience with prasugrel is limited in patients with renal impairment (including ESRD) and in patients with moderate hepatic impairment.
Danish: Den terapeutiske erfaring med prasugrel til patienter med nedsat nyrefunktion (herunder ERSD/ terminal nyreinsufficiens) og til patienter med moderat nedsat leverfunktion er begrænset.
English: Gastrointestinal haemorrhage
Danish: Mave-tarmkanalen Gastrointestinal blødning
English: • A rash, itching, or a swollen face, swollen lips/tongue, or shortness of breath.
Danish: • Udslæt, kløe, hævelser i ansigtet, opsvulmede læber/tunge eller stakåndethed.
English: In a 30-day study (ACCOAST) in 4033 patients with NSTEMI with elevated troponin who were scheduled for coronary angiography followed by PCI within 2 to 48 hours after randomization, subjects who received prasugrel 30 mg loading dose on average 4 hours prior to coronary angiography followed by a 30 mg loading dose at the time of PCI (n=2037) had an increased risk of non-CABG peri-procedural bleeding and no additional benefit compared to patients receiving a 60 mg loading dose at the time of PCI (n=1996).
Danish: I et 30-dages studie (ACCOAST) med 4.033 patienter, som havde NSTEMI med forhøjet troponin, og hvor koronarangiografi efterfulgt af PCI var planlagt indenfor 2 til 48 timer efter randomisering, havde de patienter, som fik en 30 mg loadingdosis gennemsnitligt 4 timer før koronarangiografi efterfulgt af en 30 mg loadingdosis på tidspunktet for PCI (n=2.037), en øget risiko for non-CABG-blødning i forbindelse med indgrebet og ingen yderligere fordele sammenlignet med de patienter, som fik en 60 mg loadingdosis på tidspunktet for PCI (n=1.996).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 25 February 2009
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Pregnancy and breast-feeding
Danish: Graviditet, amning
English: e ICH=intracranial haemorrhage.
Danish: e ICH=intrakraniel blødning.
English: * ICH=intracranial haemorrhage.
Danish: *ICH=intrakraniel blødning.
English: Each tablet contains 2.7 mg lactose.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver tablet indeholder 2,7 mg lactose.
English: There is limited therapeutic experience in patients with renal impairment (see section 4.4).
Danish: Der er begrænset terapeutisk erfaring hos patienter med nedsat nyrefunktion (se pkt.
English: Bleeding Risk Associated with Timing of Loading Dose in NSTEMI In a clinical trial of NSTEMI patients (the ACCOAST study), where patients were scheduled to undergo coronary angiography within 2 to 48 hours after randomization, a prasugrel loading dose given on average 4 hours prior to coronary angiography increased the risk of major and minor peri-procedural bleeding compared with a prasugrel loading dose at the time of PCI.
Danish: Blødningsrisiko forbundet med tidspunktet for loadingdosis for NSTEMI-patienter I et klinisk studie med NSTEMI-patienter (ACCOAST-studiet), hvor koronarangiografi var planlagt udført indenfor 2 til 48 timer efter randomisering, øgede indgivelse af en prasugrel-loadingdosis gennemsnitlig 4 timer før koronarangiografi risikoen for større eller mindre blødninger i forbindelse med indgrebet sammenlignet med indgivelse af prasugrel-loadingdosis på tidspunktet for PCI.
English: The 10 mg maintenance dose is not recommended.
Danish: 10 mg som vedligeholdelsesdosis bør ikke anvendes.
English: including oral anticoagulants, clopidogrel, non-steroidal anti-inflammatory drugs (NSAIDs), and fibrinolytics.
Danish: • ved samtidig administration af lægemidler, som kan øge blødningsrisikoen, herunder orale antikoagulantia, clopidogrel, non-steroide antiinflammatoriske lægemidler (NSAIDs) og fibrinolytika.
English: If prescribed, a lower maintenance dose of 5 mg should be used; the 10 mg maintenance dose is not recommended (see sections 4.2 and 4.8).
Danish: Hvis det ordineres, bør der anvendes en mindre vedligeholdelsesdosis på 5 mg. 10 mg vedligeholdelsesdosis frarådes (se pkt.
English: <75 years (N=7180)**
Danish: <75 år (N=7.180)**
English: <75 years (N=11672)*
Danish: <75år (N=11.672)*
English: 9.0% (1.0% fatal)
Danish: 9,0% (1,0% dødelige)
English: Each tablet contains 2.1 mg lactose.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver tablet indeholder 2,1 mg lactose.
English: Efient 10 mg film-coated tablets Efient 5 mg film-coated tablets Prasugrel
Danish: Efient 10 mg filmovertrukne tabletter Efient 5 mg filmovertrukne tabletter Prasugrel
English: Marketing Authorisation Holder Daiichi Sankyo Europe GmbH Zielstattstrasse 48
Danish: Indehaver af markedsføringstilladelsen Daiichi Sankyo Europe GmbH Zielstattstrasse 48
English: The educational material should include:
Danish: Undervisningsmaterialet:
English: Tell your doctor promptly if you notice any of the following:
Danish: Fortæl det omgående til din læge, hvis du oplever noget af følgende:
English: Eli Lilly Norge A.S. Tlf: +47 22 88 18 00
Danish: Tlf: +47 22 88 18 00
English: c Any intracranial haemorrhage or any clinically overt bleeding associated with a fall in haemoglobin ≥5 g/dL.
Danish: c Enhver intrakraniel blødning eller enhver klinisk tydelig blødning, der er forbundet med et fald i hæmoglobin ≥ 5 g/dl.
English: There is no difference in exposure among Chinese, Japanese, and Korean subjects.
Danish: Dette skyldtes især højere eksponering hos asiater < 60 kg. Der er ingen forskel i eksponering blandt kinesiske, japanske og koreanske forsøgspersoner.
English: Patients ≥ 75 years of age have greater sensitivity to bleeding and higher exposure to the active metabolite of prasugrel (see sections 4.4, 4.8, 5.1 and 5.2).
Danish: Patienter ≥ 75 år har større følsomhed overfor blødning og højere eksponering for den aktive metabolit af prasugrel (se pkt.
English: 2.0% (0.1% fatal) a
Danish: 2,0% (0,1% dødelige) a
English: 10.1% (0% fatal)
Danish: 10,1% (0% dødelige)
English: In UA/NSTEMI patients, where coronary angiography is performed within 48 hours after admission, the loading dose should only be given at the time of PCI (see sections 4.4, 4.8 and 5.1).
Danish: Loadingdosis skal derfor indgives på tidspunktet for PCI hos UA/NSTEMI-patienter, hvor koronarangiografi udføres indenfor 48 timer efter indlæggelse (se pkt 4.2, 4.8 og 5.1).
English: Thrombocytopaenia Thrombotic thrombocytopaenic purpura (TTP) -see section 4.4
Danish: Trombocytopeni Trombotisk trombocytopenisk purpura (TTP)se pkt.
English: Bleeding Risk Associated with Timing of Loading Dose in NSTEMI In a clinical study of NSTEMI patients (the ACCOAST study), where patients were scheduled to undergo coronary angiography within 2 to 48 hours after randomization, patients given a 30 mg loading dose on average 4 hours prior to coronary angiography followed by a 30 mg loading dose at the time of PCI had an increased risk of non-CABG peri-procedural bleeding and no additional benefit compared to patients receiving a 60 mg loading dose at the time of PCI (see sections 4.2 and 4.4).
Danish: Blødningsrisiko forbundet med tidspunktet for loadingdosis for NSTEMI-patienter I et klinisk studie med NSTEMI-patienter (ACCOAST-studiet), hvor koronarangiografi var planlagt udført indenfor 2 til 48 timer efter randomisering, havde de patienter, som fik en 30 mg loadingdosis gennemsnitlig 4 timer før koronarangiografi efterfulgt af en 30 mg loadingdosis på tidspunktet for PCI, en øget risiko for non-CABG blødning i forbindelse med indgrebet og ingen yderligere fordele sammenlignet med de patienter, som fik en 60 mg loadingdosis på tidspunktet for PCI (se pkt.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF 5 mg FILM-COATED TABLETS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIPS BLISTERKORT TIL 5 mg FILMOVERTRUKNE TABLETTER
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF 10 mg FILM-COATED TABLETS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIPS BLISTERKORT TIL 10 mg FILMOVERTRUKNE TABLETTER
English: In these patients the 10 mg maintenance dose is not recommended.
Danish: 10 mg vedligeholdelsesdosis frarådes til disse patienter.
English: 2.2% (0.2% fatal) a
Danish: 2,2% (0,2% dødelige) a
English: ≥75 years (N=2060)**
Danish: ≥75 år (N=2.060)**
English: NAME OF THE MEDICINAL PRODUCT Efient 5 mg film-coated tablets prasugrel
Danish: LÆGEMIDLETS NAVN Efient 5 mg filmovertrukne tabletter prasugrel
English: Platelet aggregation gradually returned to baseline values after treatment in 7 to 9 days after administration of a single 60 mg loading dose of prasugrel and in 5 days following discontinuation of maintenance dosing at steady-state.
Danish: I løbet af 7 til 9 dage efter administration af en enkelt loadingdosis på 60 mg prasugrel og i løbet af 5 dage efter seponering af vedligeholdelsesdosis ved steady state vendte trombocytaggregationen gradvist tilbage til baselineværdierne.
English: Tabulated summary of adverse reactions
Danish: Resumé af bivirkninger i tabelform
English: f Clinically overt bleeding associated with a fall in haemoglobin of ≥3 g/dL but <5 g/dL.
Danish: f Klinisk tydelig blødning, der er forbundet med et fald i hæmoglobin ≥3 g/d,l men <5 g/dl.
English: • Bleeding from a needle puncture site
Danish: • Blødning fra et kanyleindstikssted
English: NAME OF THE MEDICINAL PRODUCT Efient 10 mg film-coated tablets prasugrel
Danish: LÆGEMIDLETS NAVN Efient 10 mg filmovertrukne tabletter prasugrel
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF 10 mg FILM-COATED TABLETS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE TIL 10 mg FILMOVERTRUKNE TABLETTER
English: 3.0% (0.5% fatal)
Danish: 3,0% (0,5% dødelige)
English: • Fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice).
Danish: • Feber og blå mærker eller røde nålespidslignende pletter, evt. med samtidig uforklarlig, voldsom træthed, forvirring og gulfarvning af hud og øjne (gulsot) (se afsnit 2 ”Det skal du vide, før du begynder at tage Efient”).
English: 3.8% (0.2% fatal)
Danish: 3,8% (0,2% dødelige)
English: bAny intracranial haemorrhage or any clinically overt bleeding associated with a fall in haemoglobin ≥5 g/dL.
Danish: bEnhver intrakraniel blødning eller enhver klinisk åbenbar blødning relateret til et fald i hæmoglobin på ≥5 g/dl.
English: Although a pharmacodynamic interaction with ASA leading to an increased risk of bleeding is possible, the demonstration of the efficacy and safety of prasugrel comes from patients concomitantly treated with ASA.
Danish: Demonstrationen af prasugrels effekt og sikkerhed stammer fra patienter i samtidig behandling med ASA, selv om der er mulighed for en farmakodynamisk interaktion med ASA, som kan medføre en øget blødningsrisiko.
English: ≥75 years (N=1785)*
Danish: ≥75 år (N=1.785)*
English: Efient 5 mg: Each tablet contains 5 mg of prasugrel (as hydrochloride).
Danish: Efient 5 mg: Hver tablet indeholder 5 mg prasugrel (som hydrochlorid).
English: Efient 10 mg: Each tablet contains 10 mg of prasugrel (as hydrochloride).
Danish: Efient 10 mg: Hver tablet indeholder 10 mg prasugrel (som hydrochlorid).
English: Lactose monohydrate Hypromellose (E464) Titanium dioxide (E171) Triacetin (E1518)
Danish: Titandioxid (E171)
English: Because of the potential for increased risk of bleeding, warfarin and Efient should be co-administered with caution (see section 4.4).
Danish: På grund af muligheden for øget blødningsrisiko bør der udvises forsigtighed ved samtidig administration af warfarin og Efient (se pkt.
English: Patients ≥ 75 years were at increased risk of bleeding, including fatal (see sections 4.2, 4.4,
Danish: Patienter ≥ 75 år havde øget risiko for blødning, inklusive letale risici (se pkt.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF 5mg FILM-COATED TABLETS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE TIL 5 mg FILMOVERTRUKNE TABLETTER
English: Each tablet contains 10 mg prasugrel (as hydrochloride).
Danish: Hver tablet indeholder 10 mg prasugrel (som hydrochlorid).
English: Each tablet contains 5 mg prasugrel (as hydrochloride).
Danish: Hver tablet indeholder 5 mg prasugrel (som hydrochlorid).
English: It is rapidly hydrolysed in the intestine to a thiolactone, which is then converted to the active metabolite by a single step of cytochrome P450 metabolism, primarily by CYP3A4 and CYP2B6 and to a lesser extent by CYP2C9 and CYP2C19.
Danish: Det hydrolyseres hurtigt i tarmen til en thiolacton, som et enkelt trin af cytokrom P450-metabolismen derpå omdanner til den aktive metabolit.
English: (See sections 4.2, 4.4, and 4.8)
Danish: 4.2, 4.4 og 4.8).
English: 1.6% (0.2% fatal)
Danish: 1,6% (0,2% dødelige)
English: Efient 10 mg: The tablets are beige and double-arrow-shaped, with “10 MG” debossed on one side and “4759” on the other.
Danish: Efient 10 mg: Tabletterne er beige med form som en aflang sekskant, præget med ”10 MG” på den ene side og ”4759” på den anden.
English: Posology and method of administration
Danish: 4.2 Dosering og administration
English: Efient 5 mg: The tablets are yellow and double-arrow-shaped, with “5 MG” debossed on one side and “4760” on the other.
Danish: Efient 5 mg: Tabletterne er gule med form som en aflang sekskant, præget med ”5 MG” på den ene side og ”4760” på den anden.
English: 2.9% (0.1% fatal)
Danish: 2,9% (0,1% dødelige)
English: 6.9% (0.1% fatal)
Danish: 6,9% (0,1% dødelige)
English: 6.5% (0.3% fatal)
Danish: 6,5% (0,3% dødelige)
English: The maximum inhibition by prasugrel of ADP-induced platelet aggregation is 83% with 5 µM ADP and 79% with 20 µM ADP, in both cases with 89% of healthy subjects and patients with stable atherosclerosis achieving at least 50% inhibition of platelet aggregation by 1 hour.
Danish: Prasugels maksimale hæmning af ADP-induceret trombocytaggregering er 83 % med 5 µM ADP og 79 % med 20 µM ADP.
English: 3.3% (0.1% fatal)
Danish: 3,3% (0,1%dødelige)
English: Results of a pharmacodynamic/pharmacogenomic study in 720 Asian ACS PCI patients demonstrated that higher levels of platelet inhibition are achieved with prasugrel compared to clopidogrel, and that prasugrel 60-mg loading dose/10-mg maintenance dose is an appropriate dose regimen in Asian subjects who weigh at least 60 kg and are less than 75 years of age (see section 4.2).
Danish: Studiet viste endvidere, at 60 mg prasugrel loading-dosis/10 mg vedligeholdelsesdosis er en passende dosering til asiatiske patienter, som vejer mindst 60 kg, og som er yngre end 75 år (se pkt.
English: Increased frequency (3-fold) and severity of bleeding may occur in patients undergoing CABG surgery within 7 days of discontinuation of prasugrel (see section 4.8).
Danish: Hos de patienter, som gennemgår CABG-kirurgi indenfor 7 dage efter seponering af prasugrel (se pkt.
English: Therefore, Efient can be administered without regard to food; however, the administration of prasugrel loading dose in the fasted state may provide most rapid onset of action (see section 4.2).
Danish: Det er dog muligt, at administration af prasugrel loading-dosis under faste kan give den hurtigst indsættende virkning (se pkt.
English: Patients with a history of TIA or a history of ischaemic stroke more than 3 months prior to prasugrel therapy had no reduction in the primary composite endpoint.
Danish: Der var ingen reduktion i primære sammensatte endepunktshændelser for de patienter,som havde en sygehistorie med TIA eller en sygehistorie med iskæmisk slagtilfælde mere end 3 måneder før prasugrelbehandling.
English: 2.6% (0.3% fatal)
Danish: 2,6% (0,3% dødelige)
English: 4.2% (0.3% fatal)
Danish: 4,2% (0,3% dødelige)
English: 1.4% (0.1% fatal)
Danish: 1,4% (0,1% dødelige)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 5 mg prasugrel (as hydrochloride)
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 5 mg prasugrel (som hydrochlorid)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 10 mg prasugrel (as hydrochloride)
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 10 mg prasugrel (som hydrochlorid)
English: Of those patients, the rate of CABG-related TIMI major or minor bleeding was 14.1% for the prasugrel group and 4.5% in the clopidogrel group.
Danish: Af disse patienter var andelen af CABG-relaterede TIMI større eller mindre blødninger 14,1 % for prasugrelgruppen og 4,5 % i clopidogrelgruppen.Hos de forsøgspersoner, der blev behandlet med prasugrel, varede den højere risiko for blødningstilfælde i op til 7 dage efter den seneste dosis af forsøgsmedicin.
English: Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription, dietary supplements and herbal remedies.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: 2.2% (0.3% fatal)
Danish: 2,2% (0,3% dødelige)
English: The use of Efient in patients ≥75 years of age is generally not recommended and should only be undertaken with caution after a careful individual benefit/risk evaluation by the prescribing physician indicates that benefits in terms of prevention of ischaemic events outweigh the risk of serious bleedings.
Danish: Hvis behandling skønnes nødvendig til patienter i aldersgruppen ≥ 75 år, efter at den ordinerende læge har foretaget en omhyggelig individuel vurdering af fordele/risici (se pkt.
English: If you have been told by a doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Danish: Kontakt lægen, før du tager denne medicin, hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter.