FrancophonIA/ELRC3.0 huggingface dataset:
English: Restarting Antithrombotic Therapy
Danish: Genoptagelse af antitrombotisk behandling
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING FOLDING BOX
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON
English: Figure 1 - Reversal of dabigatran-induced clotting time prolongation determined by dTT in patients from the RE-VERSE AD study (N=487)
Danish: Figur 1 - Revertering af dabigatran-induceret forhøjede koagulationsparametre udtrykt som dTT hos patienter fra RE-VERSE AD-studiet (N=487)
English: Figure 5 - Reversal of dabigatran-induced clotting time prolongation determined by dTT in the representative group of healthy subjects (administration of idarucizumab or placebo at 0 h)
Danish: Figur 5 - Revertering af dabigatran-induceret forhøjede koagulationsparametre udtrykt som dTT i den repræsentative gruppe med raske frivillige (administration af idarucizumab eller placebo ved 0 t)
English: It will not reverse the effects of other anticoagulants.
Danish: Praxbind modvirker ikke virkningen af andre antikoagulantia.
English: Figure 2 - Reversal of dabigatran-induced clotting time prolongation determined by ECT in patients from the RE-VERSE AD study (N=487)
Danish: Figur 2 - Revertering af dabigatran-induceret forhøjede koagulationsparametre udtrykt som ECT hos patienter fra RE-VERSE AD-studiet (N=487)
English: Figure 6 - Reversal of dabigatran-induced clotting time prolongation determined by ECT in the representative group of healthy subjects (administration of idarucizumab or placebo at 0 h)
Danish: Figur 6 - Revertering af dabigatran-induceret forhøjede koagulationsparametre udtrykt som ECT i den repræsentative gruppe med raske frivillige (administration af idarucizumab eller placebo ved 0 t)
English: Idarucizumab binds specifically to dabigatran and reverses its anticoagulant effect.
Danish: Idarucizumab binder specifikt til dabigatran og modvirker dets antikoagulerende virkning.
English: This medicine will only remove dabigatran from your body.
Danish: Medicinen virker kun på dabigatran.
English: PHARMACEUTICAL FORM AND CONTENTS 2 vials of 50 mL solution for injection/infusion each
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 2 hætteglas a 50 ml injektions-/infusionsvæske, opløsning
English: Praxbind binds specifically to dabigatran and reverses its anticoagulant effect.
Danish: Praxbind, som er et humant antistof, binder specifikt til dabigatran og modvirker dets antikoagulerende virkning.
English: A pre-existing intravenous line may be used for administration of Praxbind.
Danish: Praxbind kan administreres via en forud anlagt intravenøs slange.
English: In a subgroup of 6 phase I subjects, idarucizumab was administered a second time, two months after the first administration.
Danish: Idarucizumab blev genadministreret to måneder efter den første administration til en subgruppe med 6 fase I-forsøgspersoner.
English: Renal impairment did not impact the reversal effect of idarucizumab (see section 5.2).
Danish: Nedsat nyrefunktion påvirkede ikke idarucizumabs antidotvirkning (se pkt.
English: NAME OF THE MEDICINAL PRODUCT Praxbind 2.5 g/50 mL solution for injection/infusion Idarucizumab
Danish: Praxbind 2,5 g/50 ml injektions-/infusionsvæske, opløsning idarucizumab
English: Praxbind contains sodium
Danish: Praxbind indeholder natrium og sorbitol, hvor advarsel er påkrævet
English: Clear to slightly opalescent, colourless to slightly yellow solution.
Danish: Injektions-/infusionsvæske, opløsning Klar til let opaliserende, farveløs til lys gullig opløsning.
English: After treatment with idarucizumab proteinuria has been observed.
Danish: Der er set proteinuri efter behandling med idarucizumab.
English: -1 Porcine circovirus type 2 ORF2 subunit antigen: ≥ 1,436 AU* per 0.2 ml * Antigenic units as determined in the in vitro potency test (antigenic mass assay).
Danish: -1 Porcint circovirus type 2 ORF2 subunit antigen: ≥ 1,436 AU* per 0.2 ml * Antigen-enheder målt ved in vitro potency test (antigenic mass assay).
English: Target species
Danish: Dyrearter , som lægemidlet er beregnet til
English: Content Package size
Danish: Emballage Emballage Pakningsstør relse
English: The subgroups in these studies were too small to draw reliable conclusions.
Danish: Undergrupperne i disse studier var for små til pålidelige konklusioner.
English: Then take the next capsule at the usual time.
Danish: Tag derefter næste kapsel til sædvanlig tid.
English: OS is based on a median follow up of approximately 63 months.
Danish: OS er baseret på en median opfølgning på cirka 63 måneder.
English: Effect on other transport proteins
Danish: Virkning på andre transportproteiner
English: d. Updated based on final OS analysis.
Danish: d. Er opdateret baseret på endelig analyse af OS.
English: Tell your doctor about the missed dose at your next visit.
Danish: Fortæl lægen om den glemte dosis ved næste besøg.
English: Monitor heart rate and blood pressure regularly.
Danish: Monitorer hjertefrekvens og blodtryk regelmæssigt.
English: • Take the capsules at about the same time each day.
Danish: • Tag kapslerne på nogenlunde samme tid hver dag.
English: The final wording used on the educational material should be in line with the approved product information.
Danish: Den endelige ordlyd i undervisningsmaterialet skal være i overensstemmelse med den godkendte produktinformation.
English: Both men and women should seek advice on fertility preservation before treatment.
Danish: Både mænd og kvinder bør søge råd om fertilitetsbevarelse før behandling.
English: The educational pack should contain the following:
Danish: Undervisningsmaterialet skal indeholde følgende:
English: No adverse drug reactions were reported with an absolute difference of ≥15%.
Danish: Ingen bivirkninger blev rapporteret med en absolut difference på ≥15%.
English: • Take the capsule once in the morning and once in the evening.
Danish: • Tag 1 kapsel om morgenen og 1 kapsel om aftenen.
English: If you are not able to take the medicine as your doctor prescribed, or you feel you do not need it anymore, contact your doctor right away.
Danish: Hvis du ikke er i stand til at tage medicinen, som lægen har anvist, eller du føler, at du ikke behøver den mere, skal du straks kontakte lægen.
English: If the combination is needed, then close clinical monitoring should be exercised.
Danish: Hvis kombinationen er nødvendig, bør dette ske under tæt klinisk monitorering.
English: Correct electrolytes as necessary.
Danish: Korriger elektrolytter efter behov.
English: • You can take the capsules with or without food always avoiding grapefruit.
Danish: • Du kan tage kapslerne med eller uden mad, men undgå altid grapefrugt.
English: Secondary endpoints included time to tumour response (TTR), duration of response (DR), PFS, and OS.
Danish: Sekundære effektmål inkluderede tid til respons (TTR), varighed af respons (DR), PFS og OS.
English: XALKORI with food and drink
Danish: Brug af XALKORI sammen med mad og drikke
English: These cases generally occurred within 3 months after the initiation of treatment.
Danish: Generelt opstod disse tilfælde inden for 3 måneder efter behandlingsstart.
English: Supportive care should include the use of antiemetic medicinal products.
Danish: Støttende behandling bør omfatte brug af antiemetiske lægemidler.
English: Of note, the effectiveness of concomitant administration of oral contraceptives may be reduced.
Danish: Bemærk at effekten af samtidig administreret oral kontraception kan være reduceret.
English: With twice daily dosing, steady state was achieved within 15 days.
Danish: Med 2 daglige doseringer opnås steady state indenfor 15 dage.
English: This medicinal product should not be used during pregnancy unless the clinical condition of the mother requires treatment.
Danish: Dette lægemiddel må ikke anvendes under graviditet, med mindre moderens kliniske tilstand nødvendiggør behandling.
English: Fifty percent of objective tumour responses were achieved during the first 8 weeks of treatment.
Danish: 50% af de objektive tumorresponser blev nået i løbet af de første 8 behandlingsuger.
English: a. Per data cutoff date30 June 2018. b. Estimated using the Kaplan-Meier method.
Danish: a. Ved data cutoff den 30. juni 2018. b. Estimeret ved hjælp af Kaplan-Meier-metoden.
English: The median duration of treatment was 42 weeks.
Danish: Den mediane behandlingstid var 42 uger.
English: Dosing interruption and/or dose reduction may be required based on individual safety and tolerability.
Danish: Det kan være nødvendigt at pausere behandlingen eller reducere dosis ud fra individuel sikkerhed og tolerance.
English: The full effect of crizotinib on reduction of heart rate may not develop until several weeks after start of treatment.
Danish: Den fulde virkning af crizotinib med hensyn til nedsat hjertefrekvens vil muligvis først vise sig flere uger efter behandlingsstart.
English: There was a numerical improvement in overall survival (OS) in the patients treated with crizotinib, although this improvement was not statistically significant.
Danish: Der var en numerisk forbedring i den samlede overlevelse (OS) hos patienter, der blev behandlet med crizotinib, selvom denne forbedring ikke var statistisk signifikant.
English: You should immediately contact your doctor if you experience any of the following serious side effects (see also section 2 “What you need to know before you take XALKORI ”):
Danish: Kontakt straks lægen, hvis du får nogle af de følgende alvorlige bivirkninger (se også afsnit 2 ”Det skal du vide, før du begynder at tage XALKORI”):
English: Of the patients enrolled in these studies, the patients described below had received prior systemic therapy for locally advanced or metastatic disease.
Danish: Af de patienter, der var inkluderet i disse studier, havde de patienter, der er beskrevet nedenfor, tidligere fået systemisk behandling for lokalt fremskreden eller metastatisk sygdom.
English: It is important to take XALKORI every day, as long as your doctor prescribes it to you.
Danish: Det er vigtigt at tage XALKORI hver dag, ligeså længe som lægen har sagt.
English: QT prolongation can result in arrhythmias and is a risk factor for sudden death.
Danish: QT-forlængelse kan medføre arytmier og er en risikofaktor for pludselig død.
English: • If you have ever had any other lung problems.
Danish: • Hvis du på noget tidspunkt har haft andre lungeproblemer.
English: Dose modification is not required in cases of asymptomatic bradycardia.
Danish: Dosisjustering er ikke nødvendig i tilfælde med asymptomatisk bradykardi.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i benefit/risk-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: The median duration of treatment for these patients was 23 weeks.
Danish: Den mediane behandlingstid var 23 uger for disse patienter.
English: Body Weight and Gender
Danish: Kropsvægt og køn
English: Date of latest renewal: 29 July 2016
Danish: Dato for første markedsføringstilladelse: 23. oktober 2012 Dato for seneste fornyelse: 29. juli 2016
English: Do not take a double dose (two capsules at the same time) to make up for a forgotten capsule.
Danish: Du må ikke tage en dobbeltdosis (2 kapsler på samme tid) som erstatning for den glemte kapsel.
English: Non-adenocarcinoma histology
Danish: Non-adenokarcinom histologi
English: When assessing either ALK or ROS1 status of a patient, it is important that a well-validated and robust methodology is chosen to avoid false negative or false positive determinations.
Danish: Når en patients ALK- eller ROS1-status vurderes, er det vigtigt at vælge en velvalideret og solid metode for at undgå falsk negative eller falsk positive bestemmelser.
English: Crizotinib was not shown to be teratogenic in pregnant rats or rabbits.
Danish: Crizotinib var ikke teratogent i gravide rotter eller kaniner.
English: • If you have moderate or severe liver disease.
Danish: • Hvis du har haft moderat eller alvorlig leversygdom.
English: Assessment of ALK and ROS1 status
Danish: Vurdering af ALK- og ROS1-status
English: A decision to resume crizotinib should consider the potential benefit to the patient.
Danish: Ved en beslutning om at genoptage crizotinib-behandling skal man tage de mulige fordele for patienten i betragtning.
English: • Do not use this medicine after the expiry date which is stated on the bottle or blister foil and carton after “EXP”.
Danish: • Brug ikke lægemidlet efter den udløbsdato, der står på blisterkortet og æsken efter EXP.
English: • Decreased appetite.
Danish: • Nedsat appetit.
English: If a dose is missed, then it should be taken as soon as the patient remembers unless it is less than 6 hours until the next dose, in which case the patient should not take the missed dose.
Danish: Hvis en dosis glemmes, skal den tages så snart patienten kommer i tanke om det, med mindre der er under 6 timer til, at næste dosis skal indtages, i dette tilfælde springes den glemte dosis over.
English: It is not known whether crizotinib and its metabolites are excreted in human milk.
Danish: Det er ukendt, om crizotinib eller dets metabolitter udskilles i human mælk.
English: Treatment with XALKORI should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.
Danish: Behandlingen med XALKORI skal initieres og superviseres af en læge med erfaring i administration af lægemidler mod cancer.
English: The use of concomitant medicinal products associated with bradycardia should be carefully evaluated.
Danish: Samtidig brug af lægemidler, der er forbundet med bradykardi, bør evalueres nøje.
English: If you vomit after taking a dose of XALKORI, do not take an extra dose; just take your next dose at your regular time.
Danish: Hvis du kaster op efter at have taget en dosis XALKORI, må du ikke tage en ekstra dosis, du skal blot tage din næste dosis på det sædvanlige tidspunkt.
English: Coadministration with medicinal products that are substrates of transporters
Danish: Samtidig administration af lægemidler som er substrater for transportproteiner
English: Terms actually reported in the study up to the data cutoff date and contributing to the relevant adverse drug reaction are indicated in parentheses, as listed below.
Danish: Termer, som faktisk blev rapporteret i studiet op til opgørelsesdatoen for data og som bidrager til den relevante bivirkning, er angivet i parentes som anført nedenfor.
English: Re-treatment with crizotinib
Danish: Genbehandling med crizotinib
English: • Reduction in the number of white blood cells (including neutrophils) Tell your doctor right away if you experience fever or infection.
Danish: • Nedsat antal hvide blodlegemer (herunder neutrofile granulocytter) Fortæl straks lægen, hvis du får feber eller en infektion.
English: Uncommon side effects (may affect up to 1 in 100 people) • Hole (perforation) in stomach or intestine.
Danish: Ikke almindelige bivirkninger (kan forekomme hos 1 ud af 1.00 personer) • Hul (perforering) i maven eller tarmen.
English: Contraception in males and females
Danish: Antikonception i kvinder og mænd
English: Median times to onset for nausea and vomiting were 3 days, and these events declined in frequency after 3 weeks of treatment.
Danish: Mediantid indtil forekomst af kvalme og opkastning var 3 dage, og hyppigheden af disse tilfælde faldt efter 3 ugers behandling.
English: • Ciclosporin, sirolimus and tacrolimus used in transplant patients.
Danish: • Ciclosporin, sirolimus og tacrolimus til patienter, der er blevet transplanteret.
English: There were 6 complete responses and 32 partial responses for an ORR of 72% (95% CI: 58%, 83%).
Danish: Der var 6 med komplet respons og 32 med delvist respons ved en ORR på 72% (95% CI: 58%; 83%).
English: Other toxicities of potential concern to paediatric patients have not been evaluated in juvenile animals.
Danish: Der er ikke undersøgt andre potentielle problemer for pædiatriske patienter i unge dyr.
English: Of the 1084 patients who experienced vision disorder, 95% had events that were mild in severity.
Danish: Ud af de 1.084 patienter, der fik synsforstyrrelser, havde 95% hændelser, der var lette i sværhedsgrad.
English: Cases with fatal outcome, cases requiring hemodialysis and cases of grade 4 hyperkalemia were also observed.
Danish: Der blev ligeledes observeret tilfælde med dødelig udgang, tilfælde som krævede hæmolyse og tilfælde af hyperkaliæmi grad 4.
English: Grade 3 and 4 transaminase elevations were generally reversible upon dosing interruption.
Danish: Grad 3 og 4 aminotransferasestigninger var generelt reversible efter dosisafbrydelse.
English: Event terms that represent the same medical concept or condition were grouped together and reported as a single adverse drug reaction in Table 3.
Danish: Bivirkningstermer, som repræsenterer det samme medicinske koncept eller den samme medicinske tilstand, blev grupperet og rapporteret som en enkelt bivirkning i Skema 3.
English: Grade 3 or 4 alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevation with Grade ≤1 total bilirubin
Danish: Grad 3 eller 4 alanin-aminotransferase (ALAT)eller aspartat-aminotransferase (ASAT)-stigning med grad ≤ 1 total bilirubin
English: d. PFS data from Study 1005 included 807 patients in the safety analysis population who were identified by the FISH assay (data cutoff date 15 February 2012).
Danish: Data for PFS fra studie 1005 omfattede 807 patienter i populationen til sikkerhedsanalysen, hvor sygdommen blev fastslået med FISH-testen (opgørelsesdato for data var den 15. februar 2012).
English: Dysgeusia was also very commonly reported in these studies, and was primarily Grade 1 in severity.
Danish: Smagsforstyrrelser blev også hyppigt indberettet i disse studier, og var primært sværhedsgrad 1.
English: The primary efficacy endpoint in both studies was objective response rate (ORR) according to RECIST.
Danish: Det primære effektendepunkt i begge studier var objektiv responsrate (ORR) vurderet i overensstemmelse med RECIST.
English: Evaluate concomitant medicinal products known to cause bradycardia, as well as anti-hypertensive medicinal products
Danish: Vurder samtidigt administrerede lægemidler, der er kendt for at forårsage bradykardi, samt antihypertensive lægemidler
English: Hypophosphataemia (6%)
Danish: Hypofosfatæmi (6%)
English: Patients should be informed of the first signs of gastrointestinal perforations and be advised to consult rapidly in case of occurrence.
Danish: Patienterne bør informeres om tidlige tegn på gastrointestinal perforation og rådes til hurtigt at henvende sig, hvis disse tegn forekommer.
English: The results of an in vitro phototoxicity study demonstrated that crizotinib may have phototoxic potential.
Danish: Resultater fra et in vitro fototoksicitetsstudie viste at crizotinib kan have fototoksisk potentiale.
English: The absolute bioavailability of crizotinib was determined to be 43% following the administration of a single 250 mg oral dose.
Danish: Absolut biotilgængelighed af crizotinib er bestemt til 43% efter administration af en enkelt oral dosis på 250 mg.
English: Pregnant women, or patients becoming pregnant while receiving crizotinib, or treated male patients as partners of pregnant women, should be apprised of the potential hazard to the foetus.
Danish: Gravide kvinder eller patienter, der bliver gravide under behandling med crizotinib, eller mandlige patienter, der er partner med en gravid kvinde, skal oplyses om den potentielle risiko for fostret.
English: Close clinical surveillance is recommended when crizotinib is administered with these medicinal products.
Danish: Tæt klinisk overvågning anbefales, når crizotinib administreres samtidig med disse lægemidler.
English: The primary efficacy endpoint was ORR according to RECIST.
Danish: Det primære effektmål var ORR ifølge RECIST.
English: Study 1005
Danish: Studie 1005
English: Most events were mild to moderate in severity.
Danish: De fleste tilfælde var lette til moderate i sværhedsgrad.
English: • This medicine does not require any special storage conditions.
Danish: • Lægemidlet kræver ingen særlige forholdsregler vedrørende opbevaringen.
English: Dose reduction guidelines for haematological and non-haematological toxicities are provided in Tables 1 and 2.
Danish: Vejledning om dosisreduktion for hæmatologisk toksicitet og non-hæmatologisk toksicitet kan ses i skema 1 og 2.
English: • Mefloquine, used for the prevention of malaria.
Danish: • Mefloquin, til forebyggelse af malaria.
English: Treatment of children and adolescents with this medicine is not recommended.
Danish: Dette lægemiddel anbefales ikke til behandling af børn og teenagere.
English: Binding of crizotinib to human plasma proteins in vitro is 91% and is independent of medicinal product concentration.
Danish: In vitro-binding af crizotinib til human plasmaprotein er 91% og er ikke koncentrationsafhængig.
English: The MAH should ensure that, at launch and thereafter, all Healthcare Professionals who are expected to use and/or prescribe XALKORI are provided with an educational pack.
Danish: MAH skal ved markedsføring og herefter sørge for, at alt sundhedspersonale, hvor XALKORI forventes at blive anvendt og/eller ordineret, får udleveret opdateret undervisningsmateriale.
English: • Increased blood levels of creatinine (may indicate that kidneys are not functioning properly).
Danish: • Forhøjede niveauer af kreatinin i blodet (kan tyde på, at nyrerne ikke fungerer normalt).
English: • Visual effects (seeing flashes of light, blurred vision, or double vision, often beginning soon after starting treatment with XALKORI).
Danish: • Synsforstyrrelser (lysglimt, sløret syn eller dobbeltsyn, som almindeligvis begynder lige efter behandlingen med XALKORI er påbegyndt).
English: XALKORI may cause foetal harm when administered to a pregnant woman.
Danish: XALKORI kan forårsage fosterskade, når det gives til gravide kvinder.
English: • Stomach upset, including vomiting, diarrhoea, nausea.
Danish: • Ubehag i maven, herunder opkastning, diaré, kvalme.
English: XALKORI as monotherapy is indicated for:
Danish: XALKORI som monoterapi er indiceret til:
English: Crizotinib should be administered with caution in these patients and periodic monitoring of electrocardiograms (ECG), electrolytes and renal function is required.
Danish: Crizotinib skal administreres med forsigtighed hos disse patienter, og periodisk monitorering med elektrokardiogram (ekg), af elektrolytter og af nyrefunktion er påkrævet.
English: Crizotinib plasma concentrations may be increased in patients with severe renal impairment (CLcr <30 mL/min).
Danish: Plasmakoncentrationen af crizotinib kan være forhøjet hos patienter med svært nedsat nyrefunktion (CLcr < 30 ml/min).
English: XALKORI may slow or stop the growth of lung cancer.
Danish: XALKORI kan hæmme eller standse lungekræftens vækst.
English: Study 1001
Danish: Studie 1001
English: Symptoms may be similar to those from lung cancer.
Danish: Symptomer kan minde om symptomer på lungekræft.
English: Adequate contraceptive methods should be used during therapy, and for at least 90 days after completing therapy (see section 4.5).
Danish: Der bør anvendes sikker prævention under behandlingen og mindst 90 dage efter afslutning af behandlingen (se pkt.
English: The disease characteristics of the overall study population were metastatic disease in 98% of patients, 92% of patients' tumours were classified as adenocarcinoma histology, and 27% of patients had brain metastases.
Danish: Sygdomskarakteristika for den samlede studiepopulation var metastaserende sygdom hos 98% af patienterne, 92% af tumorerne var histologisk klassificeret som adenokarcinom, og 27% af patienterne havde hjernemetastaser.
English: a. Per data cutoff dates 01 June 2011 (Study 1001) and 15 February 2012 (Study 1005).
Danish: Ved opgørelsesdatoerne for data den 1. juni 2011 (studie 1001) og 15. februar 2015 (studie 1005).
English: ROS1-Positive Advanced NSCLC
Danish: ROS1-positiv fremskreden NSCLC