FrancophonIA/ELRC3.0 huggingface dataset:
English: - If you have recently undergone major surgery or suffered from any form of serious physical trauma such as a bone fracture or road traffic accident.
Danish: - hvis du for nyligt har fået foretaget en større operation eller oplevet nogen form for alvorligt fysisk traume, såsom knoglebrud eller færdselsuheld.
English: • You suffer from impaired kidney function or require dialysis.
Danish: • du har nedsat nyrefunktion eller kræver dialyse.
English: Your treatment with Kengrexal will be supervised by a doctor experienced in caring for patients with heart disease.
Danish: Din behandling med Kengrexal overvåges af en læge med erfaring i pleje af hjertepatienter.
English: Frequency categories are defined according to the following conventions: Very common
Danish: Hyppighedskategorierne er defineret i henhold til følgende konvention: Meget almindelig (≥1/10),
English: 48155 Münster GERMANY
Danish: 48155 Münster Tyskland
English: 48155 Münster Germany
Danish: 48155 Münster TYSKLAND
English: Significant reductions in death/MI/IDR/ST and ST observed in the cangrelor group at 48 hours were maintained at 30 days (Table 4).
Danish: Signifikante reduktioner i dødsfald/MI/IDR/ST observeret i cangrelorgruppen efter 48 timer blev opretholdt efter 30 dage (tabel 4).
English: This medicinal product contains 52.2 mg sorbitol in each vial.
Danish: Dette lægemiddel indeholder 52,2 mg sorbitol i hvert hætteglas.
English: Mix the bag thoroughly.
Danish: Bland posen grundigt.
English: The safety and efficacy of cangrelor in children aged less than 18 years has not been established.
Danish: Cangrelors sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
English: Ecchymosis (petechiae, purpura)
Danish: Ekkymose (petekkier, purpura)
English: Female fertility was not affected at any dose.
Danish: Fertilitet hos hunner var ikke påvirket ved nogen dosis.
English: b In CHAMPION PHOENIX, GUSTO Mild was defined as other bleeding requiring intervention but not requiring blood transfusion or causing haemodynamic compromise.
Danish: b I CHAMPION PHOENIX blev GUSTO Mild defineret som anden blødning, der kræver indgreb, men ikke kræver blodtransfusion eller forårsager hæmodynamisk kompromis.
English: • 4 micrograms per kilogram body weight per minute by infusion (drip), for at least 2 hours.
Danish: • 4 mikrogram pr. kilogram legemsvægt pr. minut ved infusion (drop) i mindst 2 timer.
English: The active substance is cangrelor.
Danish: - Aktivt stof: cangrelor.
English: OR = odds ratio; CI = confidence interval; IDR = ischaemia-driven revascularisation; MI = myocardial infarction; mITT = modified intent-to-treat; ST = stent thrombosis.
Danish: OR = odds ratio, CI = konfidensinterval; IDR = revaskularisering af iskæmisk hjertesygdom, MI = myokardieinfarkt, mITT = modificeret intent-to-treat; ST = stenttrombose.
English: The half-life of Kengrexal is three to six minutes, independent of dose.
Danish: Kengrexals halveringstid er 3-6 minutter, uafhængigt af dosis.
English: • 30 micrograms per kilogram body weight by injection, followed immediately by
Danish: • 30 mikrogram pr. kilogram legemsvægt ved injektion straks efterfulgt
English: Transfusion and GUSTO severe/life-threatening bleeding rates were similar.
Danish: Forekomst af transfusion og svær/livstruende GUSTO-blødning var tilsvarende.
English: Kengrexal is not recommended for children and adolescents under 18 years.
Danish: Kengrexal bør ikke anvendes til børn og unge under 18 år.
English: Tell your doctor if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen, hvis du tager anden medicin, for nylig har taget anden medicin eller planlægger at tage anden medicin.
English: Sodium hydroxide
Danish: Natriumhydroxid
English: • bleeding from the penis, ear or pre-existing skin tumours.
Danish: • blødning fra penis, ørerne eller eksisterende hudtumorer.
English: Administration of 600 mg clopidogrel immediately after the cessation of the cangrelor infusion results in the anticipated full pharmacodynamic effect.
Danish: Administration af 600 mg clopidogrel straks efter seponering af cangrelorinfusionen medfører hele den forventede farmakodynamiske virkning.
English: Patients with hereditary fructose intolerance (HFI) must not be given this medicine unless strictly necessary.
Danish: Bør ikke anvendes til patienter med hereditær fructoseintolerans (HFI) medmindre det er strengt nødvendigt.
English: Do not use this medicine after the expiry date which is stated on the label and carton after ‘EXP'.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på etiketten og kartonen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Kengrexal contains sodium and sorbitol
Danish: Kengrexal indeholder natrium og sorbitol
English: No pharmacokinetic or pharmacodynamic interaction with cangrelor was observed in an interaction study with aspirin, heparin, or nitroglycerin.
Danish: Der blev ikke observeret nogen farmakokinetisk eller farmakodynamisk interaktion med cangrelor i et interaktionsstudie med aspirin, heparin eller nitroglycerin.
English: The other ingredients are mannitol, sorbitol and sodium hydroxide for pH-adjustment.
Danish: - Øvrige indholdsstoffer: mannitol, sorbitol og natriumhydroxid til justering af pH.
English: Acetylsalicylic acid, heparin, nitrogycerin
Danish: Acetylsalicylsyre, heparin, nitroglycerin
English: The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: The pharmacokinetics of cangrelor are not affected by gender, age, or renal or hepatic status.
Danish: Cangrelors farmakokinetik påvirkes ikke af køn, alder eller nyre- eller leverstatus.
English: Oral P2Y12 agents (clopidogrel, prasugrel, ticagrelor)
Danish: Orale P2Y12-midler (clopidogrel, prasugrel, ticagrelor)
English: Platelets are very small cells in the blood that can clump together and help the blood to clot.
Danish: Blodplader er meget små blodlegemer, der kan klumpe sammen og hjælpe blodet med at størkne.
English: Kengrexal is a white to off-white freeze-dried powder.
Danish: Kengrexal er et hvidt til offwhite frysetørret pulver.
English: Allergic reaction is a rare side effect of treatment with Kengrexal (may affect up to 1 in 1,000 people) but may be potentially serious.
Danish: En allergisk reaktion er en sjælden bivirkning ved behandling med Kengrexal (kan forekomme hos op til 1 ud af 1.000 personer), men kan være alvorlig.
English: • Allergic reaction (a rash, itching, throat tightening/swelling, swelling of the tongue or lips, difficulty breathing).
Danish: • Allergisk reaktion (hududslæt, kløe, spænding i/hævelse af hals, hævelse af tunge eller læber, åndedrætsbesvær).
English: An analysis of non-coronary artery bypass grafting (CABG)-related bleeding is presented in Table 2.
Danish: En analyse af ikke-koronar bypasskirurgi- (CABG) relateret blødning er vist i Tabel 2.
English: Cangrelor is deactivated rapidly in the plasma by dephosphorylation to form its primary metabolite, a nucleoside.
Danish: Cangrelor deaktiveres hurtig i plasma ved dephosphorylering, hvorved dets primære metabolit, et nukleosid, dannes.
English: Further analysis of GUSTO mild bleeding revealed that a large proportion of mild bleeding events were ecchymosis, oozing and <5 cm haematoma.
Danish: Yderligere analyse af let GUSTO-blødning viste, at en stor andel af de lette blødningshændelser var ekkymose, sivning og <5 cm hæmatom.
English: Kengrexal should be administered by a physician experienced in either acute coronary care or in coronary intervention procedures and is intended for specialised use in an acute and hospital setting.
Danish: Kengrexal skal administreres af en læge med erfaring i enten akut koronar pleje eller koronare interventionsprocedurer og er beregnet til anvendelse i særlige akutte tilfælde eller i særlige tilfælde på hospitalet.
English: You may receive acetylsalicylic acid (ASA) while you are treated with Kengrexal or another type of anti-platelet medicine (e.g., clopidogrel) before and after you are treated with Kengrexal.
Danish: Du kan få acetylsalicylsyre (ASA), når du behandles med Kengrexal eller en anden type trombocytfunktionshæmmende medicin (f.eks. clopidogrel), før og efter du behandles med Kengrexal.
English: - If you are allergic to cangrelor or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for cangrelor eller et af de øvrige indholdsstoffer i Kengrexal (angivet i punkt 6).
English: Ensure that the contents of the vial are fully dissolved and the reconstituted material is a clear, colourless to pale yellow solution.
Danish: Kontrollér, at hætteglassets indhold er helt opløst, og at det rekonstituerede materiale er en klar, farveløs til lysegul opløsning.
English: Although most bleeding associated with the use of cangrelor occurs at the site of arterial puncture, haemorrhage can occur at any site.
Danish: Selvom de fleste blødningstilfælde associeret med brugen af cangrelor forekommer på det arterielle punktursted, kan blødning forekomme på ethvert sted.
English: Kengrexal is only for use in adults.
Danish: Kengrexal er kun beregnet til voksne.
English: The pharmacokinetic/pharmacodynamic (PK/PD) effect of cangrelor is maintained consistently for the duration of the infusion.
Danish: Cangrelors farmakokinetiske/farmakodynamiske (PK/PD) virkning opretholdes konstant under hele infusionen.
English: Tell your doctor if you are taking other medicines that may increase the risk of side effects such as bleeding including blood thinners (anticoagulants e.g. warfarin).
Danish: Fortæl det til lægen, hvis du tager anden medicin, der kan øge risikoen for bivirkninger, såsom blødning, herunder blodfortyndende midler (antikoagulantia, f.eks. warfarin).
English: The effect of Kengrexal wears off quickly and it is unlikely to affect your ability to drive or to use machines.
Danish: Kengrexals virkning aftager hurtigt, og det vil sandsynligvis ikke påvirke din evne til at køre bil og betjene maskiner.
English: In CHAMPION PHOENIX, cangrelor significantly reduced (relative risk reduction 22%; absolute risk reduction 1.2%) the primary composite endpoint of all-cause mortality, MI, IDR, and ST compared to clopidogrel at 48 hours (Table 3).
Danish: I CHAMPION PHOENIX reducerede cangrelor signifikant (RRR (relativ risikoreduktion 22 %, absolut risikoreduktion 1,2 %) det primære kombinerede endepunkt for mortalitet af alle årsager, MI, IDR og ST sammenlignet med clopidogrel efter 48 timer (tabel 3).
English: • Active bleeding or increased risk of bleeding, because of impaired haemostasis and/or irreversible coagulation disorders or due to recent major surgery/trauma or uncontrolled severe hypertension.
Danish: • Aktiv blødning eller øget blødningsrisiko på grund af nedsat hæmostase og/eller irreversible koagulationssygdomme eller på grund af nylig større operation/traume eller ubehandlet svær hypertension.
English: Sodium hydroxide (for pH-adjustment)
Danish: Natriumhydroxid (til justering af pH)
English: Table 2: Non-CABG-related bleeding GUSTO bleeding, n (%) CHAMPION pooled
Danish: Tabel 2: Ikke-CABG-relateret blødning GUSTO-blødning, n (%) CHAMPION sammenlagt
English: This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodiumfree'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. hætteglas, dvs. det er i det væsentlige natrium-frit.
English: No baseline demographic factor altered the relative risk of bleeding with cangrelor.
Danish: Ingen demografisk baselinefaktor ændrede cangrelors relative risiko for blødning.
English: Cangrelor has a half-life of three to six minutes.
Danish: Cangrelor har en halveringstid på 3-6 minutter.
English: In clinical trials, the maximum accidental overdose was 10 times (bolus) or 3.5 times the infusion dose normally administered and bleeding was the most frequently observed adverse event.
Danish: I kliniske studier var den maksimale tilfældige dosis 10 gange (bolus) eller 3,5 gange den normalt administrerede infusionsdosis, og blødning var den hyppigst observerede bivirkning.
English: No clinically relevant interruption of P2Y12 inhibition was observed in phase III studies when 600 mg clopidogrel was administered immediately after discontinuation of the cangrelor infusion.
Danish: Der er ikke observeret klinisk relevant afbrydelse af P2Y12-hæmning i fase III-studier, når 600 mg clopidogrel blev administreret straks efter seponering af cangrelorinfusionen.
English: Moderate
Danish: Moderat
English: These included cases of anaphylactic reactions/shock and angioedema (see section 4.8).
Danish: Disse omfattede tilfælde af anafylaktiske reaktioner/shock og angioødem (se pkt.
English: The GUSTO bleeding scale was measured in the CHAMPION (PHOENIX, PLATFORM, and PCI) clinical trials.
Danish: GUSTO-blødningsskalaen blev målt i de kliniske CHAMPION-studier (PHOENIX, PLATFORM og PCI).
English: Blood creatinine increased
Danish: Forhøjet blodkreatinin
English: Effects on fertility, ability to produce a pregnancy with female partner(s), sperm morphology and sperm motility were observed in the male rat fertility study when cangrelor was administered at human equivalent doses equal to 1.8 fold the recommended PCI dose.
Danish: Der sås virkninger på fertilitet, evnen til at forårsage graviditet hos kvindelig(e) partner(e), morfologien og bevægeligheden af sperma i fertilitetsstudiet med hanrotter, når cangrelor blev administreret ved human-ækvivalente doser svarende til 1,8 gange den anbefalede PCI-dosis.
English: Mild w/o ecchymosis, oozing and haematoma <5 cm 707 (5.6) Patients with any transfusion
Danish: Mild u/ekkymose, udsivning og hæmatom <5 cm 707 (5,6) Patienter med enhver transfusion
English: Table 1: Adverse reactions for cangrelor in CHAMPION pooled studies within 48 hours System organ class
Danish: Tabel 1: Bivirkninger ved cangrelor i sammenlagte CHAMPION-studier i løbet af 48 timer Organsystemklasse
English: Cangrelor binds selectively and reversibly to the P2Y12 receptor to prevent further signalling and platelet activation.
Danish: Cangrelor binder selektivt og reversibelt til P2Y12-receptoren for at forhindre yderligere signalering og trombocytaktivering.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Kengrexal in one or more subsets of the paediatric population in the prevention of non-site specific embolism and thrombosis, for the treatment of thrombosis in paediatric patients undergoing diagnostic and / or therapeutic percutaneous vascular procedures.
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Kengrexal i en eller flere undergrupper af den pædiatriske population ved forebyggelse af ikkestedspecifik embolisme og trombose, til behandling af trombose hos pædiatriske patienter, som får diagnostiske og/eller terapeutiske perkutane vaskulære procedurer (se pkt.
English: Fructose intolerance
Danish: Fruktoseintolerans
English: Chiesi Bulgaria EOOD Teл.
Danish: Chiesi Bulgaria EOOD
English: A pharmacodynamic interaction study has been conducted with cangrelor and prasugrel, which demonstrated that cangrelor and prasugrel can be administered concomitantly.
Danish: Der er gennemført et farmakodynamisk interaktionsstudie med cangrelor og prasugrel, der påviste, at cangrelor og prasugrel kan administreres samtidig.
English: • balloon-like swelling in an artery or wall of the heart, which involves only a few layers of the vessel walls,
Danish: • ballonlignende hævelse i en arterie eller hjertevæg, der kun involverer få lag af karvæggene,
English: Kengrexal is intended for intravenous use, only after reconstitution and dilution.
Danish: Kengrexal er beregnet til intravenøs anvendelse, kun efter rekonstitution og fortynding.
English: - If you have ever had a stroke, or a ‘mini-stroke' (also known as a transient ischaemic attack, TIA) caused by the temporary interruption of the blood supply to the brain.
Danish: - hvis du nogensinde har haft en hjerneblødning eller et slagtilfælde (kaldes også TIAtransistorisk iskæmisk attak eller apopleksi) på grund af en midlertidig afbrydelse af blodforsyningen til hjernen.
English: If bleeding occurs appropriate supportive measures should be taken, which may include stopping the medicinal product so platelet function can return.
Danish: I tilfælde af blødning skal der iværksættes passende understøttende behandling, der kan omfatte seponering af lægemidlet, så trombocytfunktionen kan genoprettes.
English: Effects on renal function
Danish: Virkninger på nyrefunktion
English: Anaphylactic reaction (anaphylactic shock), hypersensitivity
Danish: Anafylaktisk reaktion (anafylaktisk shock), overfølsomhed
English: In rabbits, cangrelor was associated with increased incidences of abortion and intrauterine losses, as well as foetal growth retardation at higher doses which may have been secondary to maternal toxicity.
Danish: Hos kaniner var cangrelor associeret med øgede forekomster af abort og intrauterine aborter samt væksthæmning hos fostre ved højere doser, der kan have været sekundært til maternel toksicitet.
English: In vitro inhibition of BCRP by the metabolite ARC-69712XX at clinically relevant concentrations has been observed.
Danish: Det er in vitro observeret, at metabolitten ARC-69712XX hæmmer BCRP ved klinisk relevante koncentrationer.
English: The bolus volume should be administered rapidly (<1 minute), from the diluted bag via manual intravenous push or pump.
Danish: Bolusinjektionen bør administreres hurtigt (<1 minut) fra den fortyndede pose ved manuel intravenøs hurtig injektion eller pumpe.
English: Patients can be transitioned from cangrelor to prasugrel when prasugrel is administered immediately following discontinuation of the cangrelor infusion or up to one hour before, optimally at 30 minutes before the end of the cangrelor infusion to limit recovery of platelet reactivity.
Danish: Patienter kan skifte fra cangrelor til prasugrel, når prasugrel administreres straks efter seponering af cangrelorinfusionen eller op til 1 time, optimalt 30 minutter, før cangrelorinfusionen er slut, for at begrænse genopretning af trombocytreaktiviteten.
English: Using Kengrexal reduces the risk that this procedure will cause a clot to form and block the blood vessels again.
Danish: Brug af Kengrexal reducerer risikoen for, at denne procedure forårsager, at der dannes en blodprop, der igen blokerer blodårerne.
English: Injury to the urinary tract was reversible following cessation of dosing in an investigative study in rats.
Danish: Skader på urinvejene var reversible efter seponering af dosis i et undersøgende studie med rotter.
English: Sometimes clots can form within a damaged blood vessel such as in an artery in the heart and this can be very dangerous as the clot can cut off the blood supply (a thrombotic event), causing a heart attack (myocardial infarction).
Danish: Der kan undertiden dannes blodpropper (størknet blod) i et beskadiget blodkar, f.eks. en blodåre i hjertet, og dette kan være meget farligt, idet blodproppen kan afskære blodforsyningen (trombotisk hændelse) og forårsage et hjertetilfælde (myokardieinfarkt).
English: Patients can be transitioned from cangrelor to ticagrelor without interruption of antiplatelet effect.
Danish: Patienter kan skifte fra cangrelor til ticagrelor uden afbrydelse af den trombocytfunktionshæmmende virkning.
English: Bleeding is a common side effect of treatment with Kengrexal (may affect up to 1 in 10 people).
Danish: Blødning er en almindelig bivirkning ved behandling med Kengrexal (kan forekomme hos op til 1 ud af 10 personer).
English: - If you have a medical condition that is currently causing bleeding such as bleeding from the stomach or intestines or you have a condition which makes you more prone to uncontrolled bleeding (impaired haemostasis or irreversible coagulation disorders).
Danish: - hvis du har en medicinsk tilstand, der forårsager aktuel blødning, såsom blødning fra maven eller tarmene, eller hvis du har en tilstand, der gør dig mere tilbøjelig til ukontrolleret blødning (nedsat hæmostase eller irreversible koagulationssygdomme).
English: The most common adverse reactions with cangrelor include mild and moderate bleeding and dyspnoea.
Danish: De mest almindelige bivirkninger af cangrelor omfatter mild og moderat blødning samt dyspnø.
English: Coagulation time abnormal, prothrombin time prolonged.
Danish: Unormal koagulationstid, forlænget protrombintid.
English: At the discretion of the physician, the infusion may be continued for a total duration of four hours, see section 5.1.
Danish: Efter lægens skøn kan infusionen fortsættes i i alt 4 timer, se pkt.
English: Before administration, 5 mL reconstituted solution has to be withdrawn from each vial and must be diluted further with 250 mL sodium chloride 9 mg/mL (0.9%) solution for injection or glucose (5%) solution for injection.
Danish: Før administration skal 5 ml rekonstitueret opløsning trækkes op fra hvert hætteglas og fortyndes yderligere med 250 ml natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning, eller glucose (5 %) injektionsvæske, opløsning.
English: Cangrelor is rapidly distributed reaching Cmax within two minutes after administration of an intravenous bolus followed by infusion.
Danish: Cangrelor fordeles hurtigt og når Cmax i løbet af 2 minutter efter administration af en intravenøs bolus efterfulgt af infusion.
English: Platelet function is restored within 60 minutes of stopping infusion.
Danish: Trombocytfunktionen er genoprettet i løbet af 60 minutter efter standsning af infusionen.
English: Powder in 10 mL glass vials (Type 1) closed with a Flurotec coated butyl rubber stopper and sealed with crimped aluminium seal.
Danish: Pulver i 10 ml hætteglas af glas (type 1) lukket med en butylgummiprop beklædt med Flurotec og forseglet med krympeforsegling af aluminium.
English: Kengrexal should be administered via an intravenous line.
Danish: Kengrexal skal administreres via et intravenøst drop.
English: • infection of bleeding sites,
Danish: • infektion af steder, der bløder,
English: The primary clinical evidence for the efficacy of cangrelor is derived from CHAMPION PHOENIX, a randomised, double-blind study comparing cangrelor (n=5,472) to clopidogrel (n=5,470), both given in combination with aspirin and other standard therapy, including unfractionated heparin (78%), bivalirudin (23%), LMWH (14%) or fondaparinux (2.7%).
Danish: Den primære kliniske evidens for cangrelors virkning stammer fra CHAMPION PHOENIX, et randomiseret, dobbeltblindet studie, der sammenligner cangrelor (n=5.472) med clopidogrel (n=5.470), der begge gives i kombination med aspirin og anden standardbehandling, herunder ufraktioneret heparin (78 %), bivalirudin (23 %), lavmolekylært heparin (14 %) eller fondaparinux (2,7 %).
English: What you need to know before you use Kengrexal Do not use Kengrexal
Danish: Det skal du vide, før du begynder at få Kengrexal Du må ikke få Kengrexal
English: Following the intravenous administration of a 2 micrograms/kg/min infusion of [3H] cangrelor to healthy male volunteers, 93% of total radioactivity was recovered.
Danish: infusion af [3H] cangrelor til raske mandlige frivillige blev 93 % af den samlede radioaktivitet genvundet.
English: • dyspnoea (shortness of breath),
Danish: • kortåndethed (dyspnø),
English: Kengrexal has no or negligible influence on the ability to drive and use machines.
Danish: Kengrexal påvirker ikke eller kun i ubetydelig grad evnen til føre motorkøretøj og betjene maskiner.
English: 5.3 Preclinical safety data
Danish: 5.3 Non-kliniske sikkerhedsdata
English: If you get any side effects, talk to your doctor.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge.
English: Risk of bleeding
Danish: Blødningsrisiko