FrancophonIA/ELRC3.0 huggingface dataset:
English: Adverse reactions are classified according to frequency and System Organ Class.
Danish: Bivirkningerne er klassificeret i henhold til deres hyppighed samt systemorganklasse.
English: Effects of Possia on other medicinal products
Danish: Indvirkning af Possia på andre lægemidler
English: No information is available concerning treatment of patients on renal dialysis and therefore Possia is not recommended in these patients.
Danish: Der foreligger ingen oplysninger om behandling af patienter i dialyse, og Possia anbefales derfor ikke til disse patienter.
English: Hyperuricaemia a
Danish: Hyperurikæmi a
English: • A similar effect on other statins metabolised by CYP3A4 cannot be excluded.
Danish: • En sammenlignelig virkning på andre statiner, der metaboliseres af CYP3A4, kan ikke udelukkes.
English: This suggests it is appropriate to treat patients with ticagrelor for up to 12 months (see section 4.2).
Danish: Dette indikerer, at det er hensigtsmæssigt at behandle patienter med ticagrelor i op til 12 måneder (se pkt.
English: In the event of overdose, observe for these potential adverse reactions and consider ECG monitoring
Danish: Vær i tilfælde af overdosis opmærksom på disse potentielle bivirkninger, og overvej EKGmonitorering.
English: The mechanism for uterine tumors is likely hormonal imbalance which can lead to tumors in rats.
Danish: De uterine tumorers mekanisme er sandsynligvis hormonforstyrrelser, som kan føre til tumorer hos rotter.
English: Do not stop taking Possia without talking to your doctor.
Danish: Du må ikke holde op med at tage Possia uden først at have talt med din læge.
English: Effects of other medicinal products on Possia
Danish: Andre lægemidlers indvirkning på Possia
English: • Allergic reaction - a rash, itching, or a swollen face or swollen lips/tongue may be signs of an allergic reaction (see section 2: What you need to know before you take Possia).
Danish: • Allergisk reaktion - udslæt, kløe eller hævelser i ansigt eller hævede læber eller tunge kan være tegn på en allergisk reaktion (se punkt 2: Det skal du vide, før du begynder at tage Possia)
English: Patients should be advised to inform physicians and dentists that they are taking Possia before any surgery is scheduled and before any new medicinal product is taken.
Danish: Patienterne skal rådes til at oplyse læger og tandlæger om, at de tager Possia, før planlægning af kirurgi, og før de begynder at anvende ny medicin.
English: If a patient reports new, prolonged or worsened dyspnoea this should be investigated fully and if not tolerated, treatment with Possia
Danish: Hvis en patient rapporterer ny, langvarig eller forværret dyspnø, skal dette undersøges fuldt ud, og hvis dyspnøen ikke tolereres, skal behandling med Possia stoppes.
English: As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report
Danish: I overensstemmelse med CHMP-retningslinjerne for risikostyringsprogrammer for lægemidler til mennesker skal den opdaterede RMP fremsendes samtidig med den næste periodiske sikkerhedsopdateringsrapport (PSUR).
English: Thus, the carcinogenicity findings are considered unlikely to be relevant for humans.
Danish: Derfor synes de karcinogene fund ikke relevante for mennesker.
English: Similar increases in AUC and Cmax were observed for all atorvastatin acid metabolites.
Danish: Der blev observeret lignende forøgelser af AUC og Cmax for alle atorvastatinsyremetabolitter.
English: • Feeling dizzy or like the room is spinning
Danish: • Fornemmelse af at være rundtosset, eller at rummet drejer rundt
English: The primary route of elimination for the active metabolite is most likely via biliary secretion.
Danish: Den primære eliminationsvej for den aktive metabolit er mest sandsynligt via galdesekretion.
English: Södertälje Sweden
Danish: Södertälje Sverige
English: Therefore, the use of Possia in patients at known increased risk for bleeding should be balanced against the benefit in terms of prevention of atherothrombotic events.
Danish: Derfor skal brugen af Possia hos patienter med kendt øget risiko for blødning afvejes mod fordelene ved forebyggelse af aterotrombotiske hændelser.
English: Women should use appropriate contraceptive measures to avoid pregnancy while taking this medicine.
Danish: Kvinder skal anvende en sikker præventionsform for at undgå graviditet mens de tager denne medicin.
English: This is because Possia can affect the way some medicines work and some medicines
Danish: Det skyldes, at Possia kan påvirke virkningen af nogle lægemidler, og at nogle lægemidler kan påvirke Possia.
English: The result appeared early (absolute risk reduction [ARR] 0.6% and Relative Risk Reduction [RRR] of 12% at 30 days), with a constant treatment effect over the entire 12 month period, yielding ARR 1.9% per year with RRR of 16%.
Danish: Resultatet viste sig tidligt (absolut risikoreduktion [ARR] på 0,6 % og relativ risikoreduktion [RRR] på 12 % efter 30 dage) med en konstant behandlingseffekt gennem hele den 12 måneders periode, hvilket gav en ARR på 1,9 % pr. år med en RRR på 16 %.
English: Recoveries of ticagrelor and the active metabolite in urine were both less than 1% of the dose.
Danish: Genfinding af ticagrelor og den aktive metabolit i urin var begge mindre end 1 % af dosen.
English: Ticagrelor is well tolerated in single doses up to 900 mg. Gastrointestinal toxicity was dose-limiting in a single ascending dose study.
Danish: Ticagrelor er veltolereret i enkeltdoser på op til 900 mg. Gastrointestinal toksicitet var dosisbegrænsende i en studie, der undersøgte en enkelt stigende dosis.
English: • You have asthma or other lung problem or breathing difficulties.
Danish: • hvis du har astma eller andre lungesygdomme eller åndedrætsbesvær.
English: If clinically indicated, Possia should be used with caution in the following patient groups:
Danish: Hvis Possia er klinisk indiceret, skal det bruges med forsigtighed hos følgende patientgrupper:
English: Following oral administration of ticagrelor 90 mg under fasted conditions, Cmax is 529 ng/ml and AUC is 3451 ng*h/ml.
Danish: Efter oral administration af ticagrelor 90 mg i fastende tilstand er Cmax 529 ng/ml og AUC 3451 ng*h/ml.
English: - sudden confusion, difficulty speaking or understanding others - sudden difficulty in walking or loss of balance or co-ordination - suddenly feeling dizzy or sudden severe headache with no known cause These are signs of a kind of stroke caused by bleeding into the brain.
Danish: - pludselig opstået konfusion, problemer med at tale eller forstå andre - pludseligt opståede balance- eller koordinationsproblemer eller vanskeligheder med at gå - pludselig opstået svimmelhed eller pludselig svær hovedpine uden kendt årsag Ovenstående er tegn på en form for slagtilfælde, der skyldes en blødning i hjernen.
English: • ‘oral anticoagulants' often referred to as 'blood thinners' which include warfarin.
Danish: • "Orale antikoagulantia", ofte kaldet "blodfortyndende medicin", som omfatter warfarin.
English: Ask your doctor or pharmacist for advice before taking any medicine, if you are pregnant or breast
Danish: Spørg din læge eller apoteket til råds, før du tager nogen form for medicin, hvis du er gravid eller ammer.
English: Frequency categories are defined according to the following conventions: Very common (≥1/10), Common (≥1/100 to 1/10), Uncommon (≥1/1,000 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: Hyppigheden er opdelt i følgende kategorier: Meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: • The starting dose is two tablets at the same time (loading dose of 180 mg).
Danish: • Startdosis er to tabletter samtidig (mætningsdosis på 180 mg).
English: • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
Danish: • senest 60 dage efter en vigtig milepæl er nået (lægemiddelovervågning eller risikominimering)
English: • You have had a stroke caused by bleeding in the brain.
Danish: • hvis du har haft et slagtilfælde, der skyldtes en blødning i hjernen.
English: Possia contains the active substance called ticagrelor.
Danish: Possia indeholder et aktivt stof, der hedder ticagrelor.
English: The steady state volume of distribution of ticagrelor is 87.5 l. Ticagrelor and the active metabolite is extensively bound to human plasma protein (>99.0%).
Danish: Steady state-distributionsvolumen for ticagrelor er 87,5 l. Ticagrelor og den aktive metabolit er i udstrakt grad bundet til humant plasmaprotein (>99,0 %).
English: • Diarrhoea or indigestion
Danish: • Diarré eller fordøjelsesbesvær
English: Round, biconvex, yellow tablets marked with ‘90' above ‘T' on one side and plain on the other.
Danish: Runde, bikonvekse, gule tabletter præget med "90" over "T" på den ene side og glat på den anden.
English: Absorption of ticagrelor is rapid with a median tmax of approximately 1.5 hours.
Danish: Absorptionen af ticagrelor er hurtig med en gennemsnitlig tmax på ca. 1,5 time.
English: AstraZeneca AB Gärtunavägen SE-151 85 Södertälje Sweden or
Danish: AstraZeneca AB Gärtunavägen SE-151 85 Södertälje Sverige eller
English: The mean t1/2 was approximately 7 hours for ticagrelor and 8.5 hours for the active metabolite.
Danish: Den gennemsnitlige t1/2 var ca. 7 timer for ticagrelor og 8,5 timer for den aktive metabolit.
English: Studies in rats and rabbits have shown reproductive toxicity, with slightly reduced maternal body weight gain and reduced neonatal viability and birth weight, with delayed growth.
Danish: Studier med rotter og kaniner har vist reproduktionstoksicitet med let nedsat øgning af moderens legemsvægt, reduceret neonatal levedygtighed og fødselsvægt samt forsinket vækst.
English: Gastrointestinal irritation was observed in several animal species at clinical relevant exposure levels (see section 4.8).
Danish: Der blev observeret gastrointestinal irritation hos flere dyrearter ved klinisk relevante eksponeringsniveauer (se pkt.
English: No evidence of clinically significant adverse interactions with these medicinal products was observed.
Danish: Der er ikke observeret evidens for klinisk signifikante uønskede interaktioner med disse lægemidler.
English: There is currently no known antidote to reverse the effects of Possia, and Possia is not expected to be dialysable (see section 4.4).
Danish: Der er p.t. ingen kendt antidot til at reversere Possias virkning, og Possia forventes ikke at være dialyserbart (se pkt.
English: The MAH must ensure that the system of pharmacovigilance presented in Module 1.8.1 of the Marketing Authorisation, is in place and functioning before and whilst the medicinal product is
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at det lægemiddelovervågningssystem,som er beskrevet i modul 1.8.1 i markedsføringstilladelsen, er på plads og fungerer, før og under markedsføringen af lægemidlet.
English: Also tell your doctor that because you are taking Possia, you may have an increased risk of bleeding if your doctor gives you fibrinolytics, often called ‘clot dissolvers', such as streptokinase or alteplase.
Danish: Fortæl også din læge, at fordi du tager Possia, kan du have en øget blødningsrisiko, hvis lægen giver dig fibrinolytika, som er medicin der kan opløse blodpropper, såsom streptokinase eller alteplase.
English: Treating 54 ACS patients with ticagrelor instead of clopidogrel will prevent 1 atherothrombotic event; treating 91 will prevent 1 CV death (see Figure 1 and Table 3).
Danish: Ved at behandle 54 AKS-patienter med ticagrelor i stedet for clopidogrel forebygges 1 aterotrombotisk hændelse; ved at behandle 91 patienter forebygges 1 kardiovaskulært dødsfald (se figur 1 og tabel 3).
English: Higher exposures to ticagrelor and the active metabolite were observed in women compared to men.
Danish: Der sås højere eksponeringer for ticagrelor og den aktive metabolit hos kvinder sammenlignet med mænd.
English: It is usually mild to moderate in intensity and often resolves without need for treatment discontinuation.
Danish: Dyspnøen er i reglen af mild til moderat styrke og forsvinder ofte uden behov for seponering af behandlingen.
English: • You are allergic (hypersensitive) to ticagrelor or any of the other ingredients of Possia (listed in section 6).
Danish: • hvis du er allergisk over for ticagrelor eller et af de øvrige indholdsstoffer i Possia (angivet i punkt 6).
English: These increases are not considered clinically significant.
Danish: Disse forøgelser betragtes ikke som klinisk signifikante.
English: Within these subgroups renal-related serious adverse events and adverse events leading to discontinuation of study drug were similar between treatment groups.
Danish: Inden for disse undergrupper lignede de alvorlige nyrerelaterede bivirkninger og hændelser, der førte til ophør med forsøgsmedicinen, hinanden behandlingsgrupperne imellem.
English: Treatment is recommended for up to 12 months unless discontinuation of Possia is clinically indicated (see section 5.1).
Danish: Det anbefales at behandle i op til 12 måneder, medmindre seponering af Possia er klinisk indiceret (se pkt.
English: There were no adverse clinical consequences associated with this imbalance (including pacemaker insertions) in this population of patients.
Danish: Der var ingen uønskede kliniske konsekvenser forbundet med denne ubalance (herunder anlæggelse af pacemaker) hos denne patientpopulation.
English: A patient who misses a dose of Possia should take only one 90 mg tablet (their next dose) at its scheduled time.
Danish: En patient, der springer en dosis Possia over, må kun tage én 90 mg tablet (næste dosis) på det planlagte doseringstidspunkt.
English: Medicinal products metabolised by CYP2C9
Danish: Lægemidler der metaboliseres af CYP2C9
English: • You are bleeding now or have bled recently inside your body, such as bleeding in your stomach or gut from an ulcer.
Danish: • hvis du bløder nu eller for nylig har haft en blødning i kroppen som f.eks. blødning i maven eller tarmene fra et sår.
English: Blood creatinine increased
Danish: Forhøjet blod-kreatinin
English: Overall outcome of bleeding rates in the PLATO study are shown in Table 2.
Danish: Blødning Det samlede resultat af blødningshyppigheder i PLATO-studiet er vist i tabel 2.
English: • Patients with a propensity to bleed (e.g. due to recent trauma, recent surgery, coagulation disorders, active or recent gastrointestinal bleeding).
Danish: • Patienter med blødningstendens (f.eks. som følge af nyligt traume, nylig operation, koagulationsforstyrrelser, aktiv eller nylig gastrointestinal blødning).
English: Combined efficacy and safety composite
Danish: Kombineret virknings- og sikkerhedsprofil
English: Dyspnoea was reported by 13.8% of patients treated with Possia and by 7.8% of patients treated with clopidogrel.
Danish: Dyspnø blev indberettet af 13,8 % af de patienter, der blev behandlet med Possia og af 7,8 % af de patienter, der blev behandlet med clopidogrel.
English: Exploratory analyses suggest a possible association with ASA dose such that reduced efficacy was observed with ticagrelor with increasing ASA doses.
Danish: Eksplorative analyser tyder på en mulig forbindelse med ASA-dosis, således at der blev observeret reduceret effekt af ticagrelor med øgede ASA-doser.
English: In particular, tell your doctor or pharmacist if you are taking any of the following medicines that increase your risk of bleeding:
Danish: Det er især vigtigt, at du fortæller din læge eller apotekspersonalet, hvis du tager et eller flere af følgende lægemidler, der kan øge din risiko for blødning:
English: Switching from clopidogrel to ticagrelor results in an absolute IPA increase of 26.4% and switching from ticagrelor to clopidogrel results in an absolute IPA decrease of 24.5%.
Danish: Et skift fra clopidogrel til ticagrelor resulterer i en absolut IPA-stigning på 26,4 %, og et skift fra ticagrelor til clopidogrel resulterer i en absolut IPA-reduktion på 24,5 %.
English: Tabulated summary of adverse reactions The following adverse reactions have been identified following studies with Possia (Table 1).
Danish: Opsummering af bivirkninger i tabelform Der er identificeret følgende bivirkninger efter undersøgelser med Possia (tabel 1).
English: CYP2C19 and ABCB1 genotyping of 10,285 patients in PLATO provided associations of genotype groups with PLATO outcomes.
Danish: CYP2C19- og ABCB1-genotypebestemmelse af 10.285 patienter i PLATO muliggjorde en undersøgelse af sammenhæng mellem genotypegrupper og PLATO-resultater.
English: Lapses in therapy should also be avoided.
Danish: Afbrydelser af behandlingen skal også undgås.
English: • Inflamed stomach (gastritis)
Danish: • Mavekatar (gastritis)
English: When radiolabeled ticagrelor is administered, the mean recovery of radioactivity is approximately 84% (57.8% in faeces, 26.5% in urine).
Danish: Ved administration af radioaktivt mærket ticagrelor genfindes gennemsnitligt ca. 84 % af radioaktiviteten (57,8 % i fæces, 26,5 % i urin).
English: CYP3A4 is the major enzyme responsible for ticagrelor metabolism and the formation of the active metabolite and their interactions with other CYP3A substrates ranges from activation through to inhibition.
Danish: CYP3A4 er det vigtigste enzym ansvarligt for metaboliseringen af ticagrelor og dannelsen af den aktive metabolit, og deres interaktion med andre CYP3A-substrater spænder fra aktivering til hæmning.
English: If you stop taking Possia
Danish: Hvis du holder op med at tage Possia
English: In rats minor developmental anomalies were seen at a maternal toxic dose (safety margin of 5.1).
Danish: Der blev hos rotter set mindre udviklingsanomalier ved en for moderen toksisk dosis (sikkerhedsmargin på 5,1).
English: The Cmax of the active metabolite was unchanged and the AUC was decreased by 46%, respectively.
Danish: Cmax for den aktive metabolit var uændret, og AUC blev reduceret med 46 %.
English: To study the occurrence of ventricular pauses and other arrhythmic episodes during PLATO, investigators performed Holter monitoring in a subset of nearly 3000 patients, of whom approximately 2000 had recordings both in the acute phase of their ACS and after one month.
Danish: For at undersøge forekomsten af ventrikulære pauser og andre arytmiske episoder under PLATO udførte investigatorerne Holter-monitorering i en undergruppe på knap 3000 patienter, hvoraf ca. 2000 havde optagelser i såvel den akutte fase af deres AKS som efter én måned.
English: The higher incidence of dyspnoea with Possia is not associated with new or worsening heart or lung disease (see section 4.4).
Danish: Den højere incidens af dyspnø ved Possia er ikke forbundet med ny eller forværret hjerte- eller lungesygdom (se pkt.
English: If you forget to take Possia
Danish: Hvis du har glemt at tage Possia
English: In 2.2% of patients, investigators considered the dyspnoea causally related to treatment with Possia.
Danish: Hos 2,2 % af patienterne vurderede investigatorerne dyspnøen som kausalt relateret til behandlingen med Possia.
English: If a CABG procedure is planned, ticagrelor bleeding risk is increased compared to clopidogrel when discontinued within less than 96 hours prior to procedure.
Danish: Hvis der er planlagt en koronar bypass-operation, vil der være en øget blødningsrisiko med ticagrelor sammenlignet med clopidogrel, når behandlingen afbrydes mindre end 96 timer inden proceduren.
English: Patients received a 300 mg loading dose of clopidogrel (600 mg possible if having PCI) or 180 mg of ticagrelor.
Danish: Patienterne fik en mætningsdosis på 300 mg clopidogrel (evt. 600 mg, hvis de fik PCI) eller 180 mg ticagrelor.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Possia in all subsets of the paediatric population in the granted indication (see section 4.2 and 5.2).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om fremlæggelse af resultaterne af studier med Possia hos alle undergrupper af den pædiatriske population i den godkendte indikation (se pkt.
English: • unstable angina (angina or chest pain that is not well controlled).
Danish: • ustabil angina pectoris (hjertekrampe eller smerter i brystkassen, der ikke er velkontrolleret).
English: SRI = serious recurrent ischaemia; RI = recurrent ischaemia; TIA = transient ischaemic attack; ATE = arterial thrombotic event.
Danish: SRI = alvorlig recidiverende iskæmi; RI = recidiverende iskæmi; TIA = transitorisk iskæmisk attak; ATE = arteriel trombotisk hændelse.
English: A weakly significant treatment interaction was observed with region whereby the HR for the primary endpoint favours ticagrelor in the rest of world but favours clopidogrel in North America, which represented approximately 10% of the overall population studied (interaction p-value=0.045).
Danish: Der sås en svagt signifikant behandlingsinteraktion i forhold til region, hvorved HR (hazard ratio) for det primære endepunkt falder ud til fordel for ticagrelor i resten af verden men ikke i Nordamerika, hvor udfaldet er til fordel for clopidogrel i Nordamerika, som udgjorde ca. 10 % af den samlede undersøgte population (interaktion-p-værdi = 0,045).
English: Reproductive system and breast disorders Vaginal bleeding (including metrorrhagia)
Danish: Blødning fra urinvejene Det reproduktive system og mammae Vaginal blødning (inklusive metroragi)
English: However, platelets can also form clots inside diseased blood vessels in the heart and brain.
Danish: Der kan dog også dannes blodpropper inde i et beskadiget blodkar i hjertet eller hjernen.
English: Patients of Asian descent have a 39% higher mean bioavailability compared to Caucasian patients.
Danish: Patienter af asiatisk afstamning havde en 39 % højere gennemsnitlig biotilgængelighed sammenlignet med kaukasiske patienter.
English: Possia has not been studied in patients with moderate or severe hepatic impairment.
Danish: Possia er ikke blevet undersøgt hos patienter med moderat eller svært nedsat leverfunktion.
English: Discontinuation of treatment due to non-procedural bleeding was more common for ticagrelor (2.9%) than for clopidogrel (1.2%; p<0.001).
Danish: Behandlingsophør som følge af ikke-procedurerelateret blødning var mere almindelig for ticagrelor (2,9 %) end for clopidogrel (1,2 %; p<0,001).
English: Similarly, when removing all procedure related bleeds, more bleeding occurred with ticagrelor than with clopidogrel (Table 2).
Danish: Ligeledes forekom der, når alle procedurerelaterede blødninger blev udelukket, flere blødninger med ticagrelor end med clopidogrel (tabel 2).
English: • Patients with concomitant administration of medicinal products that may increase the risk of bleeding (e.g. non-steroidal anti-inflammatory drugs (NSAIDs), oral anticoagulants and/or fibrinolytics) within 24 hours of Possia dosing.
Danish: • Patienter med samtidig administration af lægemidler, der kan øge blødningsrisikoen (f.eks. nonsteroide antiinflammatoriske stoffer (NSAID), orale antikoagulantia og/eller fibrinolytika) inden for 24 timer fra dosering af Possia.
English: The mean trough digoxin levels were increased about 30% with ticagrelor co-administration with some individual maximum increases to 2 fold.
Danish: De laveste gennemsnitlige digoxin-niveauer blev øget med omkring 30 % ved samtidig administration af ticagrelor med nogle enkeltstående maksimum-stigninger til det dobbelte.
English: Ticagrelor demonstrates linear pharmacokinetics and exposure to ticagrelor and the active metabolite (AR-C124910XX) are approximately dose proportional up to 1260 mg.
Danish: Ticagrelor udviste lineær farmakokinetik og eksponering for ticagrelor, og den aktive metabolit (AR-C124910XX) er omtrent dosisproportional op til 1260 mg.
English: • the clot can partly block the blood vessels to the heart - this reduces the blood flow to the heart and can cause chest pain which comes and goes (called ‘unstable angina').
Danish: • Blodproppen kan delvist blokere blodkar der fører til hjertet - dette reducerer hjertets blodforsyning og kan give forbigående smerter i brystet (kaldet ”ustabil angina pectoris”).