FrancophonIA/ELRC3.0 huggingface dataset:
English: SPECIAL STORAGE CONDITIONS Store in the original package in order to protect from air and moisture.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i den originale yderpakning for at beskytte mod luft og fugt.
English: At a very high dose (> 240 times the recommended daily human maintenance dose on a mg/m2 basis) that caused effects on maternal body weight and/or food consumption, there was a slight decrease in offspring body weight (relative to controls).
Danish: Ved en meget høj dosis (> 240 gange den anbefalede daglige humane vedligeholdelsesdosis på basis af mg/m2), som påvirkede moderens kropsvægt og/eller fødeindtagelse, var der et let fald i afkommets legemsvægt (i forhold til kontroller).
English: Prasugrel was associated with a 50% reduction in stent thrombosis through the 15 month follow-up period.
Danish: Prasugrel var forbundet med en reduktion på 50 % i stenttrombose i løbet af opfølgningsperiodens 15 måneder.
English: Efient is available in packs of 14, 28, 30, 56, 84, 90 and 98 tablets.
Danish: Efient findes i pakninger med 14, 28, 30, 56, 84, 90 og 98 tabletter.
English: Table 1: Incidence of Non-CABG related bleedinga (% Patients)
Danish: Tabel 1: Incidencen af ikke CABG-relateret blødninga (% patienter)
English: The increase in liver tumours with prasugrel administration in mice is not considered a relevant human risk.
Danish: Stigningen i levertumorer ved administration af prasugrel til mus betragtes ikke som en relevant human risiko.
English: Weight
Danish: Vægt
English: • If you have had allergic reactions (hypersensitivity) to clopidogrel or any other anti-platelet agent please tell your doctor before starting treatment with Efient.
Danish: • Hvis du har haft allergiske reaktioner (overfølsomhed) over for clopidogrel eller andre blodfortyndende midler, skal du fortælle det til din læge, inden du påbegynder behandling med Efient.
English: a Centrally adjudicated events defined by the Thrombolysis in Myocardial Infarction (TIMI) Study Group criteria.
Danish: a Hændelser, der er bedømt centralt og defineret efter Thrombolysis in Myocardial Infarction (TIMI) Study Grou-p kriterierne.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om at du er gravid eller planlægger at bliver gravid, skal du spørge din læge eller apotekspersonalet til råds, før du tager dette lægemiddel.
English: Patients ≥60 kg and age <75 years
Danish: Patienter ≥ 60 kg og < 75 år
English: Film-coated tablet (tablet).
Danish: Filmovertrukne tabletter (tabletter).
English: Likewise, prasugrel did not significantly alter the effect of heparin on measures of coagulation.
Danish: Ligeledes ændrede prasugrel ikke signifikant virkningen af heparin på koagulationsmålinger.
English: The reduction in stent thrombosis with Efient was observed both early and beyond 30 days for both bare metal and drug eluting stents.
Danish: Reduktionen af stenttrombose med Efient blev observeret både tidligt og efter 30 dage for både rene metalstents og medicingivende stents.
English: Morphine and other opioids
Danish: Morfin og andre opioider
English: In the All ACS population, analysis of each of the secondary endpoints showed a significant benefit (p < 0.001) for prasugrel versus clopidogrel.
Danish: I den totale AKS-population viste en analyse af hvert af de sekundære endepunkter en signifikant fordel (p < 0.001) ved prasugrel sammenlignet med clopidogrel.
English: Animal studies do not indicate direct harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Danish: Dyreforsøg indikerer ikke direkte skadelige virkninger på drægtighed, embryoets/fostrets udvikling, fødslen eller den postnatale udvikling (se pkt.
English: Primary Individual Outcome Events
Danish: Individuelle primære endepunktshændelser
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeat-dose toxicity, genotoxicity, carcinogenic potential, or toxicity to reproduction.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogenicitet samt reproduktions- og udviklingstoksicitet.
English: If you weigh less than 60 kg or are more than 75 years of age, the dose is 5 mg Efient per day.
Danish: Hvis du vejer mindre end 60 kg eller er over 75 år, er daglig dosis 5 mg Efient.
English: You may also have had one or more stents placed to keep open a blocked or narrowed artery supplying blood to the heart.
Danish: Du har måske også fået en eller flere stents indsat for at holde en blokeret eller forsnævret blodåre, som forsyner hjertet med blod, åben.
English: • with a propensity to bleed (e.g. due to recent trauma, recent surgery, recent or recurrent gastrointestinal bleeding, or active peptic ulcer disease)
Danish: • med en tendens til at bløde (f.eks. på grund af nyligt traume, nylig kirurgi, nylig eller tilbagevendende gastrointestinal blødning eller aktiv mavesårssygdom).
English: The phase 3 TRITON study compared Efient (prasugrel) with clopidogrel, both co-administered with ASA and other standard therapy.
Danish: Fase 3 TRITON-undersøgelsen sammenlignede Efient (prasugrel) med clopidogrel, både administreret i kombination med ASA og anden standardterapi.
English: In patients with or without a history of TIA or stroke, the incidence of stroke in the phase 3 clinical trial was as follows (see section 4.4):
Danish: Hos patienter med eller uden tidligere tilfælde af TIA eller slagtilfælde var incidensen af slagtilfælde i det kliniske fase 3-forsøg som følger (se pkt.
English: Analysis of all cause death did not show any significant difference between prasugrel and clopidogrel in the All ACS population (2.76% vs 2.90%), in the UA/NSTEMI population (2.58% vs 2.41%), and in the STEMI population (3.28% vs 4.31%).
Danish: Analyse af alle dødsårsager viste ingen signifikant forskel mellem prasugrel og clopidogrel i den totale AKS-population (2,76% mod 2,90%), i UA/NSTEMI-populationen (2.58% mod 2.41%) og i STEMI-populationen (3.28% vs 4.31%).
English: Medicinal products that elevate gastric pH:
Danish: Lægemidler, som øger mavens pH:
English: If given together with Efient these medicines may increase the risk of bleeding.
Danish: Hvis disse lægemidler tages sammen med Efient, kan de øge risikoen for blødning.
English: All ACS population:
Danish: Total AKS population:
English: Overall, no new safety findings were identified for prasugrel as monotherapy in this patient population.
Danish: Overordnet blev der ikke identificeret ny sikkerhedsinformation for prasugrel monoterapi i denne patientgruppe.
English: The active metabolite is further metabolised to two inactive compounds by S-methylation or conjugation with cysteine.
Danish: Den aktive metabolit metaboliseres yderligere i to inaktive forbindelser ved Smethylering eller konjugering med cystein.
English: OTHER <MON, TUE, WED, THU, FRI, SAT, SUN>
Danish: ANDET MAN, TIR, ONS, TOR, FRE, LØR, SØN
English: 81379 Munich
Danish: 81379 München
English: 81366 Munich
Danish: 81366 München
English: Animal studies have shown excretion of prasugrel in breast milk.
Danish: Dyreforsøg har vist udskillelse af prasugrel i modermælk.
English: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10,000 to <1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Danish: sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Gender: In healthy subjects and patients, the pharmacokinetics of prasugrel are similar in men and women.
Danish: Køn: Hos raske forsøgspersoner og patienter er prasugrels farmakokinetik ens hos mænd og kvinder.
English: - If you have a medical condition that is currently causing bleeding, such as bleeding from your stomach or intestines.
Danish: - Hvis du har en sygdom, som kan forårsage blødning, f.eks. blødning fra din mave eller tarm.
English: A delayed and decreased exposure to oral P2Y12 inhibitors, including prasugrel and its active metabolite, has been observed in patients with acute coronary syndrome treated with morphine.
Danish: Der er observeret en forsinket og nedsat eksponering af oral P2Y12-inhibitorer, inklusiv prasugrel og dets aktive metabolit, hos patienter med akut koronarsyndrom behandlet med morfin.
English: This effect is likely to be of clinical concern only when prasugrel is co-administered with medicinal products for which CYP2B6 is the only metabolic pathway and have a narrow therapeutic window (e.g. cyclophosphamide, efavirenz).
Danish: Denne virkning er sandsynligvis kun af klinisk interesse, når prasugrel administreres samtidig med lægemidler, hvor CYP2B6 er den eneste metaboliske vej, og hvor det terapeutiske vindue er smalt (f.eks. cyclophosphamid, efavirenz).
English: Hypersensitivity including angioedema
Danish: Overfølsomhed, herunder angioødem
English: The absorption and metabolism of prasugrel are rapid, with peak plasma concentration (Cmax) of the active metabolite occurring in approximately 30 minutes.
Danish: Absorptionen og metabolismen af prasugrel er hurtig, og maksimal plasmakoncentration (Cmax) af den aktive metabolit nås på ca. 30 minutter.
English: Your doctor will also tell you to take acetylsalicylic acid- (s)he will tell you the exact dose to take (usually between 75 mg and 325 mg daily).
Danish: Din læge vil ligeledes sige, at du skal tage acetylsalicylsyre samt fortælle dig den nøjagtige dosis, du skal tage (sædvanligvis mellem 75 mg og 325 mg daglig).
English: Patients ≥ 75 years in whom the benefit with prasugrel was more evident included those with diabetes, STEMI, higher risk of stent thrombosis, or recurrent events.
Danish: De patienter ≥ 75 år, hos hvem fordelen ved prasugrel var mest tydelig, omfattede dem med diabetes, STEMI, højere risiko for stenttromboser eller tilbagevendende hændelser.
English: No (N=13090)
Danish: Nej (N=13090)
English: The clinical relevance is unknown, but data indicate the potential for reduced prasugrel efficacy in patients coadministered prasugrel and morphine.
Danish: Den kliniske relevans er ukendt, men data indikerer en mulig reduceret effekt af prasugral hos patienter, hvor prasugrel og morfin administreres samtidig.
English: If you forget your dose for an entire day, just resume taking Efient at its usual dose the next day.
Danish: Hvis du glemmer din dosis en hel dag, så vent til næste dag og tag den sædvanlige dosis af Efient.
English: TRITON was a 13,608 patient, multicentre international, randomised, double blind, parallel group study.
Danish: TRITON var et internationalt multicenter, randomiseret, dobbeltblindt, parallelgruppeforsøg med 13.608 patienter.
English: Store in the original package in order to protect from air and moisture.
Danish: Opbevares i den originale yderpakning for at beskytte mod luft og fugt.
English: There was an increased incidence of tumours (hepatocellular adenomas) in mice exposed for 2 years to high doses (> 75 times human exposure), but this was considered secondary to prasugrel-induced enzyme-induction.
Danish: Der var en øget incidens af tumorer (hepatocellulære adenomer) hos mus eksponeret gennem 2 år med høje doser (< 75 gange human eksponering), men dette blev betragtet sekundært til prasugrelinduceret enzyminduktion.
English: Prasugrel is expected to have no or negligible influence on the ability to drive and use machines.
Danish: Prasugrel forventes ikke at have nogen eller ubetydelig indflydelse på evnen til at føre motorkøretøj og betjene maskiner.
English: Embryo-foetal developmental toxicology studies in rats and rabbits showed no evidence of malformations due to prasugrel.
Danish: Toksikologiforsøg på embryo-fosterudvikling hos rotter og kaniner viste ingen tegn på misdannelser på grund af prasugrel.
English: Approximately 40% of patients (in each of the treatment groups) received GPIIb/IIIa inhibitors in support of PCI (no information available regarding the type of GP IIb/IIIa inhibitor used).
Danish: Omkring 40 % af patienterne (i hver behandlingsgruppe) fik GPIIb/IIIa-inhibitorer til støtte for PCI (der er ingen tilgængelig infornmation om den anvendte type af GPIIb/IIIa-inhibitor).
English: In the phase 3 clinical trial these patients were at greater risk of bleeding, including fatal bleeding, compared to patients <75 years of age.
Danish: I det kliniske fase 3-forsøg havde disse patienter større risiko for blødning, herunder letal blødning, sammenlignet med patienter < 75 år.
English: Efient can be concomitantly administered with medicinal products metabolised by cytochrome P450 enzymes (including statins), or medicinal products that are inducers or inhibitors of cytochrome P450 enzymes.
Danish: Efient kan administreres samtidigt med lægemidler, som metaboliseres af cytokrom P450-enzymer (inklusive statiner), eller lægemidler, som inducerer eller inhiberer cytokrom P450-enzymer.
English: Pharmacotherapeutic group: Platelet aggregation inhibitors excluding heparin, ATC code: B01AC22.
Danish: Farmakoterapeutisk klassifikation: Trombocytfunktionshæmmende midler eksklusive heparin, ATCkode: B01AC22
English: Efient can also be concomitantly administered with ASA, heparin, digoxin, and medicinal products that elevate gastric pH, including proton pump inhibitors and H2 blockers.
Danish: Efient kan ligeledes administreres samtidigt med ASA, heparin, digoxin og lægemidler, som øger mavens pH, inklusive protonpumpehæmmere og H2-blokkere.
English: Other therapies, such as heparin and GPIIb/IIIa inhibitors, were administered at the discretion of the physician.
Danish: Andre behandlinger såsom heparin og GPIIb/IIIainhibitorer blev administreret som skønnet af lægen.
English: Non-CABG- related TIMI bleeding rates through 7 days for patients were as follows:
Danish: Hyppighederne for non-CABG-relateret TIMI-blødning indenfor 7 dage var følgende:
English: Acute Coronary Syndrome (ACS)
Danish: Akut Koronarsyndrom (AKS)
English: Prasugrel did not inhibit CYP2C9, as it did not affect the pharmacokinetics of S-warfarin.
Danish: Prasugrel hæmmer ikke CYP2C9, eftersom det ikke påvirker S-warfarins farmakokinetik.
English: Prasugrel is an inhibitor of platelet activation and aggregation through the irreversible binding of its active metabolite to the P2Y12 class of ADP receptors on platelets.
Danish: Prasugrel er en inhibitor af trombocytaktivering og aggregering gennem den irreversible binding af dets aktive metabolit til P2Y12-klassen af ADP-receptorer på trombocytter.
English: Fatal Symptomatic ICHd
Danish: Dødelig Symptomatisk ICHd
English: An increased risk of bleeding is possible when Efient is co-administered with heparin.
Danish: Der er en mulig øget blødningsrisiko, når Efient administreres i kombination med heparin.
English: • Spontaneous bleeding from the eye, rectum, gums or in the abdomen around the internal organs
Danish: • Spontan blødning fra øjne, endetarm, tandkød eller i bughulen omkring de indre organer
English: You have been prescribed Efient because you have already had a heart attack or unstable angina and you have been treated with a procedure to open blocked arteries in the heart.
Danish: Efient er blevet ordineret til dig, fordi du allerede har haft et hjerteanfald eller ustabil hjertekrampe og fået en behandling for at åbne blokerede blodårer i hjertet.
English: Therefore, the use of Efient in patients at increased risk of bleeding should only be considered when the benefits in terms of prevention of ischaemic events are deemed to outweigh the risk of serious bleedings.
Danish: Brugen af Efient til patienter med øget risiko for blødning bør derfor kun overvejes, når fordelene i form af forebyggelse af iskæmiske tilfælde vurderes at opveje risikoen for alvorlige blødninger.
English: If you stop taking Efient
Danish: Hvis du holder op med at tage Efient
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Dette gælder også mulige bivirkninger, som ikke er medtaget i denne indlægsseddel.Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Table 2 summarises haemorrhagic and non-haemorrhagic adverse reactions in TRITON, or that were spontaneously reported, classified by frequency and system organ class.
Danish: Tabel 2 opsummerer hæmoragiske og non-hæmoragiske bivirkninger i TRITON samt spontane indberetninger, klassificeret efter hyppighed og organklasse.
English: Efient reduces the chances of you having a further heart attack or stroke or of dying from one of these atherothrombotic events.
Danish: Efient nedsætter risikoen for, at du får yderligere/hjerteanfald, et slagtilfælde eller dør af en af disse hændelser, som skyldes forkalkede blodårer.
English: The use of oral anticoagulants, non-study antiplatelet medicinal products and chronic NSAIDs was not allowed in TRITON.
Danish: Brug af orale antikoagulantia, antitrombosemidler uden for forsøget og vedvarende NSAIDs var ikke tilladt i TRITON.
English: Morphine and other opioids:
Danish: Morfin og andre opioider:
English: In the All ACS population, prasugrel was associated with a lower incidence of CV death, non-fatal MI, or non-fatal stroke compared to clopidogrel, regardless of baseline characteristics such as age, sex, body weight, geographical region, use of GPIIb/IIIa inhibitors, and stent type.
Danish: I den totale AKS-population var prasugrel forbundet med en lavere incidens af CV død, ikke-letale MI eller ikke-letale slagtilfælde sammenlignet med clopidogrel, uafhængigt af baseline-karakteristika såsom alder, køn, legemsvægt, geografisk region, brug af GPIIb/IIIa-inhibitorer og stenttype.
English: A 5 mg maintenance dose should be used.
Danish: Der bør anvendes en 5 mg vedligeholdelsesdosis.
English: Prasugrel has no clinically significant effect on the pharmacokinetics of digoxin.
Danish: Prasugrel har ingen klinisk signifikant virkning på digoxins farmakokinetik.
English: Approximately 98% of patients (in each of the treatment groups) received antithrombins (heparin, low molecular weight heparin, bivalirudin, or other agent) directly in support of PCI.
Danish: Omkring 98 % af patienterne (i hver af behandlingsgrupperne) fik antitrombiner (heparin, lavmolekylært heparin, bivalirudin eller andet stof) direkte til støtte for PCI.
English: More than 98% of subjects had ≥ 20% inhibition of platelet aggregation during maintenance dosing.
Danish: Mere end 98 % af forsøgspersonerne havde ≥ 20 % hæmning af trombocytaggregering under vedligeholdelsesdosering.
English: Efient may be administered with or without food.
Danish: Efient kan administreres med eller uden føde.
English: Do not use this medicine after the expiry date, which is stated on the blister and carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på blisteren og pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Yes (N=518)
Danish: Ja (N=518)
English: • Haematoma (bleeding under the skin at the site of an injection, or into a muscle, causing swelling)
Danish: • Hæmatom (blødning under huden på et injektionssted eller i en muskel, som forårsager hævelse)
English: It is unknown whether prasugrel is excreted in human breast milk.
Danish: Det vides ikke, om prasugrel udskilles i modermælk hos mennesker .
English: Contact your doctor or hospital straight away, as you may be at risk of excessive bleeding.
Danish: Kontakt din læge eller skadestuen øjeblikkelig på grund af den øgede blødningsrisiko.
English: Patients with STEMI within 12 hours of symptoms and planned for primary PCI could be randomised without knowledge of coronary anatomy.
Danish: Patienter med STEMI med symptomer indenfor 12 timer og planlagt til primær PCI kunne randomiseres uden der var kendskab til koronaranatomi.
English: Medicinal products metabolised by CYP2C9:
Danish: Lægemidler, som metaboliseres af CYP2C9:
English: In the phase 3 clinical trial, Efient was administered without regard to co-administration of a proton pump inhibitor or H2 blocker.
Danish: I det kliniske fase 3-forsøg blev Efient administreret uden hensyn til samtidig administration af en protonpumpehæmmer eller H2-blokker.
English: Efient showed superior efficacy compared to clopidogrel in reducing the primary composite outcome events as well as the pre-specified secondary outcome events, including stent thrombosis (see Table 3).
Danish: Sammenlignet med clopidogrel viste Efient større effekt i reduktion af det primære sammensatte endepunkt såvel som det præspecificerede sekundære endepunkt, inklusive stenttrombose (se tabel 3).
English: 14 film-coated tablets 28 film-coated tablets 30x1 film-coated tablet 56 film-coated tablets 84 film-coated tablets 90x1 film-coated tablet 98 film-coated tablets 30 film-coated tablets
Danish: 14 filmovertrukne tabletter 28 filmovertrukne tabletter 30x1 filmovertrukken tablet 56 filmovertrukne tabletter 84 filmovertrukne tabletter 90x1 filmovertrukken tablet 98 filmovertrukne tabletter 30 filmovertrukne tabletter
English: Tell your doctor if you become pregnant or are trying to become pregnant while you are taking Efient.
Danish: Fortæl det til din læge, hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, medens du tager Efient.
English: In an analysis of patients who survived an ischaemic event, prasugrel was associated with a reduction in the incidence of subsequent primary endpoint events (7.8% for prasugrel vs 11.9% for clopidogrel).
Danish: I en analyse af de patienter, som overlevede et iskæmisk tilfælde, blev prasugrel forbundet med en reduktion i incidensen af efterfølgende primære endepunktshændelser (7,8 % for prasugrel mod 11,9 % for clopidogrel).
English: If you then take Efient and experience allergic reactions that may be recognised as a rash, itching, a swollen face, swollen lips or shortness of breath you need to tell your doctor immediately.
Danish: Hvis du tager Efient og derefter får allergiske reaktioner, som kendetegnes ved udslæt, kløe, hævelser i ansigtet, opsvulmede læber eller stakåndethed, skal du omgående fortælle det til din læge.
English: Administration of the 60 mg prasugrel loading dose without concomitant use of proton pump inhibitors may provide most rapid onset of action.
Danish: Administration af 60 mg prasugrel loading-dosis uden samtidig brug af protonpumpehæmmere kan give den hurtigst indsættende virkning.
English: No compound-related tumours were observed in a 2-year rat study with prasugrel exposures ranging to greater than 75 times the recommended therapeutic exposures in humans (based on plasma exposures to the active and major circulating human metabolites).
Danish: Der blev ikke observeret nogen stofrelaterede tumorer i et 2-årigt rotteforsøg med eksponeringer af prasugrel, der rækker til mere end 75 gange den anbefalede terapeutiske eksponering hos mennesker (baseret på plasmaeksponeringer for den aktive og de vigtigste metabolitter i det humane kredsløb).
English: Inducers of cytochromes P450:
Danish: Induktorer af P450 cytokromer:
English: The MAH should provide educational material to all physicians who may be involved in treating patients with prasugrel.
Danish: Indehaveren af markedsføringstilladelsen bør give undervisningsmateriale til alle de læger, som kan blive inddraget i behandling af patienter med prasugrel.
English: Efient inhibits the clumping of platelets and so reduces the chance of a blood clot forming.
Danish: Efient hæmmer sammenklumpningen af blodpladerne, og dermed nedsættes muligheden for dannelse af en blodprop.
English: Inhibitors of CYP3A:
Danish: Hæmmere af CYP3A: