FrancophonIA/ELRC3.0 huggingface dataset:
English: • Importance of evaluating liver function tests (LFTs), TSH and signs/symptoms of irARs before each treatment.
Danish: • Vigtigheden af at evaluere leverfunktionstests, TSH og tegn/symptomer på immunrelaterede bivirkninger før hver behandling.
English: • Reminder to distribute the Patient Information Brochure, and to educate patients/caregivers about symptoms of irARs and of the need to report them immediately to the physician.
Danish: • En påmindelse om at udlevere informationsbrochurer til patienterne og at oplyse patienter/plejere om symptomerne på immunrelaterede bivirkninger og nødvendigheden af straks at rapportere dem til lægen.
English: • Information that ipilimumab can cause serious side effects in many parts of the body that can lead to death and require early intervention, as outlined in the guidelines for the management of immunerelated adverse reactions in section 4.4 of the SmPC.
Danish: • Information om at ipilimumab kan forårsage alvorlige bivirkninger i mange dele af kroppen, som kan medføre død og derfor kræver tidlig intervention, som angivet i retningslinjerne for behandling af immunrelaterede bivirkninger i pkt.
English: • Description of the main symptoms of irARs and the importance of notifying their treating physician immediately if symptoms occur, persist or worsen.
Danish: • Beskrivelse af de vigtigste symptomer på immunrelaterede bivirkninger og vigtigheden af straks at fortælle det til lægen, hvis symptomer opstår, vedvarer eller forværres.
English: Key elements for the Patient Information Brochure and Alert Card:
Danish: Væsentlige punkter i informationsbrochuren til patienterne og i patient informationskortet:
English: • The importance of carrying the detachable wallet-sized Patient Alert Card at all times to show it at all medical visits to healthcare professionals other than the prescriber (e.g. emergency healthcare professionals).
Danish: • Vigtigheden af altid af have det aftagelige patient informationskort på sig for at kunne vise det ved alle besøg hos ikke-ordinerende læger og sundhedspersonale (f.eks. sundhedspersonalet på skadestuen).
English: Conditions or restrictions with regard to the safe and effective use of medicinal product to be implemented by the member states
Danish: Betingelser eller begrænsninger med hensyn til en sikker og effektiv anvendelse af lægemidlet
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Danish: Medlemslandene skal sikre, at alle betingelser eller begrænsninger mht. sikker og effektiv anvendelse af nedenstående beskrevne lægemidler implementeres:
English: • Patient Information Brochures including Alert Cards
Danish: • Informationsbrochure til patienter inklusiv patient informationskort
English: The National Competent Authority shall agree the format and content of the above material with the Marketing Authorisation Holder prior to launch of the product in its territory.
Danish: Forud for markedsføring af lægemidlet i hver medlemsstat skal den kompetente nationale myndighed blive enig med indehaveren af markedsføringstilladelsen om indholdet og udformningen af ovenstående materiale.
English: Conditions or restrictions with regard to the safe and effective use of the medicinal product to be implemented by the member states
Danish: ANNEX Betingelser eller begrænsninger med hensyn til en sikker og effektiv anvendelse af lægemidlet som skal implementeres af medlemslandene
English: • List of important immune-related adverse reactions (irARs) and their symptoms, as outlined in section 4.4 of the Summary of Product Characteristics (SmPC): o Inflammation of the gastrointestinal tract, such as colitis, which can lead to bowel perforation o Inflammation of the liver, such as hepatitis, which can lead to liver failure o Inflammation of the skin that can lead to severe skin reaction (toxic epidermal necrolysis) o Inflammation of the nerves that can lead to neuropathy o Inflammation of the endocrine system.
Danish: 4.4 i produktresumeet (SmPC): o Inflammation i mave-tarmkanalen, f.eks. colitis, som kan medføre perforation af tarmen o Leverbetændelse, f.eks. hepatitis, som kan medføre leversvigt o Inflammation i huden, som kan medføre alvorlige hudreaktioner (toksisk epidermal nekrolyse) o Nervebetændelse, som kan medføre neuropati o Inflammation i det endokrine system, herunder binyrerne, hypofysen eller skjoldbruskkirtlerne o Øjeninflammation o Andre immun-relaterede bivirkninger (f.eks. pneumonitis, glomerulonephritis, multiorgansvigt…) o Alvorlige infusionsreaktioner
English: • Placeholder including the weblink of the Package Leaflet on the EMA website
Danish: • Link til indlægssedlen på EMA's hjemmeside (link anføres her).
English: • Healthcare Professional FAQ Brochure
Danish: • Informationsbrochure til læger og sundhedspersonale
English: It is not known if it is safe and effective in these patients.
Danish: Det vides ikke, om det er sikkert og effektivt hos disse patienter.
English: It is also normal to see small air bubbles.
Danish: Det er også normalt at se små luftbobler.
English: General supportive measures should be employed.
Danish: Generelle understøttende foranstaltninger bør iværksættes.
English: Time(days) since Randomization
Danish: Tid (dage) siden randomisering
English: Administer every 3 months
Danish: Administreres hver 3. måned
English: The release of the active substance starts as early as day 1 and lasts for as long as 18 months.
Danish: Frigivelsen af det aktive stof starter så tidligt som dag 1 og varer så længe som 18 måneder.
English: Place on a clean surface.
Danish: Anbring på en ren overflade.
English: Date of first authorisation: 05 December 2014 Date of latest renewal:
Danish: Dato for første markedsføringstilladelse: 05. december 2014 Dato for seneste fornyelse:
English: The needle is secure when a “click” sound is heard.
Danish: Kanylen er sikker, når der høres et “klik”.
English: > 3½ months up to 4 months
Danish: > 3½ måneder op til 4 måneder
English: Proceed to the next step immediately after shaking.
Danish: Gå videre til næste trin straks efter omrystning.
English: Week 19 to Week 24, inclusive
Danish: Uge 19 til uge 24, begge inklusive
English: Check suspension
Danish: Kontrollér suspensionen
English: 1 month after day 8
Danish: 1 måned efter dag 8
English: Body mass index (BMI)/body weight
Danish: Body mass index (BMI)/kropsvægt
English: If the last dose of TREVICTA was
Danish: Hvis den sidste dosis af TREVICTA var
English: The difference is not likely to be of clinical relevance.
Danish: Det er ikke sandsynligt, at forskellen har klinisk relevans.
English: If patient weighs: Less than 90 kg pink hub
Danish: Hvis patienten vejer: Mindre end 90 kg pink muffe
English: There was a significant difference (p < 0.0001) between the two treatment groups in the time to relapse in favour of TREVICTA.
Danish: Der var en signifikant forskel (p < 0,0001) mellem de to behandlingsgrupper i tid til recidiv til fordel for TREVICTA.
English: logrank test, p-value<0.0001
Danish: Logrank-test, p-værdi < 0,0001
English: The suspension should appear uniform and milky white in colour.
Danish: Suspensionen bør være ensartet og mælkeagtig hvid i farve.
English: For both studies, the primary outcome was based on relapse.
Danish: I begge forsøg var det primære resultat baseret på recidiv.
English: Incomplete administration
Danish: Ufuldstændig administration
English: None of these events were serious or led to discontinuation.
Danish: Ingen af bivirkningerne var alvorlige eller førte til seponering.
English: Significant weight gain may be bad for your health.
Danish: Betydelig vægtstigning kan påvirke dit helbred negativt.
English: The primary efficacy variable was time to first relapse.
Danish: Den primære effektvariabel var tid til første recidiv.
English: The following terms and frequencies are applied: 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); and not known (cannot be estimated from the available data).
Danish: Følgende termer og hyppigheder anvendes: 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) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Do not administer by any other route.
Danish: Må ikke administreres ad nogen anden vej.
English: > 9 months
Danish: > 9 måneder
English: The efficacy results were consistent across population subgroups (gender, age, and race) in both studies.
Danish: Der var overensstemmelse mellem effektresultaterne på tværs af befolkningsundergrupper (køn, alder og race) i begge forsøg.
English: Recommended re-initiation regimen after missing 4 months to 9 months of TREVICTA
Danish: Anbefalet genopstartsregime efter 4 til 9 måneders manglende behandling med TREVICTA
English: 4 months to 9 months
Danish: 4 måneder til 9 måneder
English: Regardless of patient weight: yellow hub
Danish: Uanset patientens vægt: gul muffe
English: Depending on your symptoms, your doctor may increase or decrease the amount of medicine you receive at the time of your next scheduled injection.
Danish: Afhængigt af dine symptomer kan lægen øge eller reducere den mængde af medicin, du får på tidspunktet for din planlagte indsprøjtning.
English: TREVICTA can help alleviate the symptoms of your disease and reduce the chance of your symptoms coming back.
Danish: TREVICTA kan hjælpe med at lindre symptomerne på din sygdom og nedsætte risikoen for, at dine symptomer vender tilbage.
English: The injection should be administered as soon as possible and then resume the 3-monthly injection schedule.
Danish: Injektionen skal administreres hurtigst muligt, og derefter genoptages tidsplanen med tremåneders injektion.
English: Use the recommended re-initiation regimen shown in the table below.
Danish: Brug det anbefalede genopstartsregime vist i nedenstående tabel.
English: If you have moderate or severe kidney problems this medicine should not be used.
Danish: Hvis du har moderate eller alvorlige nyreproblemer, må du ikke bruge dette lægemiddel.
English: Cardiovascular monitoring should commence immediately and should include continuous electrocardiographic monitoring for possible arrhythmias.
Danish: Kardiovaskulær monitorering skal straks iværksættes og skal omfatte kontinuerlig elektrokardiografisk monitorering for mulige arytmier.
English: TREVICTA with alcohol Alcohol should be avoided.
Danish: Brug af TREVICTA sammen med alkohol Alkohol skal undgås.
English: The data presented in this paragraph are based on a population pharmacokinetic analysis.
Danish: Oplysningerne i dette afsnit er baseret på en populationsfarmakokinetisk analyse.
English: (See sections 4.2 and 5.2).
Danish: 4.2 og 5.2).
English: Therefore, patients should be advised not to drive or operate machines until their individual susceptibility to TREVICTA is known.
Danish: Patienterne bør derfor advares om, at de ikke må føre motorkøretøj eller betjene maskiner, før deres individuelle følsomhed over for TREVICTA kendes.
English: TREVICTA should not be used during pregnancy unless clearly necessary.
Danish: TREVICTA må ikke anvendes under graviditeten, medmindre det er absolut nødvendigt.
English: If the patient remains symptomatic, they should be managed according to clinical practice.
Danish: Hvis en patient forbliver symptomatisk, skal denne behandles i henhold til klinisk praksis.
English: Week number after last TREVICTA dose Week 12 to Week 18, inclusive
Danish: Ugenumer efter sidste dosis TREVICTA Uge 12 til uge 18, begge inklusive
English: The European Medicines Agency has waived the obligation to submit the results of studies with TREVICTA in all subsets of the paediatric population in schizophrenia.
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med TREVICTA i alle undergrupper af den pædiatriske population ved skizofreni.
English: Patients should be informed to seek urgent medical care in case that priapism has not been resolved within 4 hours.
Danish: Patienter bør informeres om øjeblikkeligt at søge læge, hvis priapismen ikke er forsvundet inden for 4 timer.
English: The pharmacological activity of the (+)- and (-)-paliperidone enantiomers are qualitatively and quantitatively similar.
Danish: Den farmakologiske aktivitet af (+)- og (-)-paliperidon-enantiomererne er kvalitativt og kvantitativt ens.
English: The study was terminated on the basis of a pre-planned interim analysis conducted when 283 subjects had been randomised and 42 relapse events had been observed.
Danish: Forsøget blev afbrudt på baggrund af en planlagt interimanalyse, der blev foretaget efter randomisering af 283 forsøgspersoner og observering af 42 tilfælde af recidiv.
English: Intraoperative floppy iris syndrome
Danish: Intraoperativt floppy iris-syndrom
English: Elderly Your doctor will determine your dose of this medicine if your kidney function is reduced.
Danish: Ældre Din læge vil bestemme din dosis af dette lægemiddel, hvis din nyrefunktion er nedsat.
English: (See Information intended for medical or health care professionals).
Danish: (Se Oplysninger til læger og sundhedspersonale).
English: Very common side effects: may affect more than 1 in 10 people • difficulty falling or staying asleep.
Danish: Meget almindelige bivirkninger: forekommer hos mere end 1 ud af 10 personer • problemer med at falde i søvn eller sove igennem.
English: TREVICTA contains a racemic mixture of (+)- and (-)-paliperidone.
Danish: TREVICTA indeholder en racemisk blanding af (+)- og (-)-paliperidon.
English: However, elderly patients with dementia, who are treated with other similar types of medicine, may have an increased risk of stroke or death (see section 4).
Danish: Ældre patienter med demens, som behandles med andre lignende typer medicin, kan dog have en øget risiko for at få et slagtilfælde eller dø (se afsnit 4).
English: You should not stop using this medicine unless told to do so by your doctor.
Danish: Du bør ikke holde op med at bruge denne medicin, medmindre du får besked på det af lægen.
English: DO NOT divide dose into multiple injections.
Danish: Dosis MÅ IKKE opdeles i flere injektioner.
English: Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with TREVICTA and preventative measures undertaken.
Danish: Da patienter, der behandles med antipsykotika, ofte har erhvervede risikofaktorer for VTE, bør samtlige mulige risikofaktorer for VTE identificeres før og under behandlingen med TREVICTA, og forebyggende foranstaltninger sættes i værk.
English: The difference (95% CI) between the treatment groups was 1.2% (-2.7%, 5.1%), meeting non-inferiority criterion based on a margin of -10%.
Danish: Forskellen (95 % KI) mellem behandlingsgrupperne var 1,2 % (-2,7 %, 5,1 %), hvilket opfyldte kriteriet for non-inferioritet baseret på en grænse på -10 %.
English: The time to relapse of the placebo group (median 395 days) was significantly shorter than for the TREVICTA group (the median could not be estimated due to the low percentage of subjects with relapse [8.8%]).
Danish: Tid til recidiv for placebogruppen (median 395 dage) var signifikant kortere end for TREVICTA-gruppen (medianen kunne ikke estimeres på grund af den lave procentdel af forsøgspersoner med recidiv [8,8 %]).
English: 90 kg or more yellow hub
Danish: 90 kg eller derover gul muffe
English: Initiate TREVICTA at the following dose
Danish: Påbegyndes TREVICTA med følgende dosis
English: Caution is recommended if paliperidone is used in such patients.
Danish: Det anbefales at udvise forsigtighed, hvis paliperidon anvendes til sådanne patienter.
English: Among those treated with risperidone, the mortality was 4% compared with 3.1% for placebo.
Danish: Blandt dem, der blev behandlet med risperidon, var mortaliteten 4 % sammenlignet med 3,1 % for placebo.
English: Four metabolic pathways have been identified in vivo, none of which accounted for more than 10% of the dose: dealkylation, hydroxylation, dehydrogenation, and benzisoxazole scission.
Danish: Der er identificeret fire metaboliske processer in vivo, hvoraf ingen udgjorde mere end 10 % af dosis: nemlig dealkylering, hydroxylering, dehydrogenering og benzisoxazolspaltning.
English: TREVICTA should be administered within 5 minutes after shaking.
Danish: TREVICTA skal administreres inden for 5 minutter efter omrystning.
English: This interaction has not been studied with TREVICTA.
Danish: Denne interaktion er ikke undersøgt med TREVICTA.
English: No in vivo data are available and the clinical relevance is unknown.
Danish: Der foreligger ingen in vivo-data, og den kliniske relevans kendes ikke.
English: Information intended for medical or health care professionals
Danish: Oplysninger til læger og sundhedspersonale
English: Following administration of TREVICTA, the (+) and (-) enantiomers of paliperidone interconvert, reaching an AUC (+) to (-) ratio of approximately 1.7-1.8.
Danish: Efter administration af TREVICTA omdannes paliperidons (+)- og (-)-enantiomerer indbyrdes således, at der opnås et AUC (+) til (-)-forhold på ca. 1,7-1,8.
English: The release profile and dosing regimen of TREVICTA results in sustained therapeutic concentrations.
Danish: Frigivelsesprofilen og dosisregimet for TREVICTA resulterer i opretholdelse af terapeutiske koncentrationer.
English: Read complete instructions prior to use.
Danish: Læs alle anvisninger inden brug.
English: The safety and efficacy of TREVICTA in children and adolescents < 18 years of age have not been established.
Danish: TREVICTA's sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: However, in the event of an incompletely injected dose, the dose remaining in the syringe should not be re-injected and another dose should not be given since it is difficult to estimate the proportion of the dose actually administered.
Danish: I tilfælde af en ufuldstændigt injiceret dosis, må den tiloversblevne dosis ikke injiceres igen og en ny dosis må heller ikke administreres, da det er vanskeligt at estimere den faktiske injicerede dosis.
English: • are planning to have an operation on your eye, make sure you tell your eye doctor that you are taking this medicine.
Danish: • planlægger at blive opereret i øjet, skal du sørge for at informere øjenlægen om, at du bruger dette lægemiddel.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a 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, en vigtig milepæl
English: In general, recommended dosing of TREVICTA for elderly patients with normal renal function is the same as for younger adult patients with normal renal function.
Danish: Generelt er den anbefalede dosering af TREVICTA til ældre patienter med normal nyrefunktion den samme som til yngre voksne patienter med normal nyrefunktion.
English: • diabetes or worsening of diabetes, increased insulin (a hormone that controls blood sugar levels) in your blood
Danish: • diabetes eller forværring af diabetes, forhøjet insulin (et hormon, som styrer blodsukkerniveauet) i blodet
English: TREVICTA contains sodium
Danish: TREVICTA indeholder natrium
English: Hold the syringe upright and tap gently to make any air bubbles rise to the top.
Danish: Hold sprøjten opad og bank forsigtigt så eventuelle luftbobler stiger til toppen.
English: In this period, 305 symptomatically stable subjects were randomised to continue treatment with TREVICTA (n = 160) or placebo (n = 145) until relapse, early withdrawal, or the end of study.
Danish: I denne periode blev 305 symptomatisk stabile forsøgspersoner randomiseret til at fortsætte behandlingen med TREVICTA (n = 160) eller placebo (n = 145) indtil recidiv, tidlig udtrædelse eller afslutning af forsøg.
English: TREVICTA should be administered by a healthcare professional as a single injection.
Danish: TREVICTA skal administreres af sundhedspersonale som en enkelt injektion.
English: Dizziness, extreme tiredness and vision problems may occur during treatment with this medicine (see section 4).
Danish: Der kan forekomme svimmelhed, ekstrem træthed og synsproblemer under behandling med dette lægemiddel (se afsnit 4).
English: There were no potentially prolactin related adverse reactions among males in either group.
Danish: Der var ingen mulige prolaktinrelaterede bivirkninger blandt mænd i nogen af grupperne.
English: Unused needle should be discarded and not saved for future use.
Danish: Den ubrugte kanyle skal bortskaffes og må ikke gemmes til fremtidig brug.
English: Improvements in functioning, as measured by the Personal and Social Performance scale (PSP), which was observed during the open-label stabilisation phase were maintained during the double-blind phase for both treatment groups.
Danish: De funktionsforbedringer, som blev observeret i open-label stabiliseringsfasen og målt ved hjælp af skalaen Personal and Social Performance (PSP), blev opretholdt under den dobbeltblindede periode for begge behandlingsgrupper.
English: Care must be taken to avoid inadvertent injection of TREVICTA into a blood vessel.
Danish: Der skal udvises forsigtighed for at undgå utilsigtet injektion af TREVICTA i et blodkar.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: TREVICTA should be used with caution with medicines that increase the activity of the central nervous system (psychostimulants such as methylphenidate).
Danish: TREVICTA bør anvendes med forsigtighed sammen med lægemidler, der øger aktiviteten i centralnervesystemet (psykostimulanser som f.eks. methylphenidat).
English: Shake vigorously
Danish: Rystes kraftigt
English: The patient should be closely monitored and managed as clinically appropriate until the next scheduled 3-monthly injection of TREVICTA.
Danish: Patienten bør nøje overvåges og behandles på klinisk relevant måde inden den næste planlagte tremåneders injektion af TREVICTA.
English: Do not use this medicine in children and adolescents under 18 years of age.
Danish: Dette lægemiddel er ikke til personer under 18 år.
English: Subject-rated injection site pain based on a visual analogue scale was low and decreased in intensity over time.
Danish: Forsøgspersonernes evalueringer af smerter fra injektionsstedet baseret på en visuel analog skala var lav og faldt i intensitet over tid.
English: Missed doses If scheduled dose is missed and the time since last injection is
Danish: Oversprungne doser Hvis en planlagt dosis springes over, og tiden siden sidste injektion er
English: Therefore, you should not breast-feed when using this medicine.
Danish: Du må derfor ikke amme, når du bruger dette lægemiddel.
English: The contents of the pre-filled syringe should be inspected visually for foreign matter and discolouration prior to administration.
Danish: Indholdet af den fyldte injektionssprøjte skal inspiceres visuelt for fremmedlegemer og misfarvning forud for administration.
English: Potential for other medicines to affect TREVICTA
Danish: Andre lægemidlers potentiale for påvirkning af TREVICTA
English: Figure 1: Kaplan-Meier plot of time to relapse - Final analysis
Danish: Figur 1: Kaplan-Meier-afbildning af tid til recidiv - endelig analyse