FrancophonIA/ELRC3.0 huggingface dataset:
English: Treated bleeds ABR (95% CI) % reduction (RR), p-value
Danish: Behandlede blødningsepisoder Årlig blødingsrate (95 % konfidensinterval) % reduktion (rate ratio), p-værdi
English: ● To calculate the volume to be administered divide calculated dose 120 mg by 150 mg/mL: 120 mg of emicizumab ÷ 150 mg/mL = 0.8 mL of 150 mg/mL Hemlibra concentration to be injected.
Danish: ● For at beregne den volumen, der skal gives, divideres den beregnede dosis på 120 mg med 150 mg/ml: 120 mg emicizumab ÷ 150 mg/ml = 0,8 ml Hemlibra i en koncentration på 150 mg/ml, der skal injiceres.
English: Index Utility Score Adjusted mean
Danish: Index utility score (IUS) Justeret gennemsnit Forskel i justeret gennemsnit (95 % konfidensinterval)
English: ● For injection amount up to 1 mL use a 1 mL LDS
Danish: ● Til injektioner op til 1 ml bruges en 1 ml sprøjte uden dødvolumen.
English: General disorders and administration site conditions
Danish: Reaktioner på administrationsstedet
English: ● Keep the vials, needles and syringes out of the sight and reach of children.
Danish: ● Opbevar hætteglas, nåle og sprøjter utilgængeligt for børn.
English: Transfer Needle
Danish: ● Vatrondeller
English: ● Throw away the cap into a sharps disposal container.
Danish: ● Smid hætten i affaldsbeholderen til skarpe genstande.
English: What Hemlibra is and what it is used for What you need to know before you use Hemlibra How to use Hemlibra
Danish: Det skal du vide, før du begynder at bruge Hemlibra Sådan skal du bruge Hemlibra Bivirkninger
English: Instructions for Use Hemlibra Injection
Danish: Til subkutan injektion
English: Previous FVIII Prophylaxis (N = 48)
Danish: Arm D noninterventionsstudiet: Tidligere FVIII-profylakse (N = 48)
English: ● Remove the syringe from the vial adapter by twisting anticlockwise and gently pulling.
Danish: ● Fjern sprøjten fra hætteglasadapteren ved at dreje den mod uret og trække forsigtigt.
English: cMedian ABR (IQR) bN = 59
Danish: bN = 59
English: Musculoskeletal and connective tissue disorders
Danish: Blod- og lymfesystem
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1271/004
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/18/1271/004
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1271/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/18/1271/002
English: Instructions for Use Hemlibra Injection Single-Dose Vial(s)
Danish: Brugsanvisning Hemlibra Injektion Enkeltdosis-hætteglas
English: Arm A: 1.5 mg/kg Hemlibra weekly
Danish: Arm B: ingen profylakse Arm A: 1,5 mg/kg Hemlibra ugentligt
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1271/003
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/18/1271/003
English: How to store Hemlibra
Danish: Dosis af Hemlibra
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1271/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/18/1271/001
English: ● Do not recap the injection needle with the cap.
Danish: ● Sæt ikke hætten tilbage på injektionsnålen.
English: Keeping a record
Danish: Hold regnskab
English: ● Throw away any used caps, vial(s), needles and syringes in a sharps or puncture-proof container.
Danish: ● Smid brugte hætter, hætteglas, nåle og sprøjter i affaldsbeholderen til skarpe genstande.
English: Posology
Danish: Stempel
English: Throw away any used syringes and needles.
Danish: Smid alle brugte sprøjter og nåle ud, som foreskrevet.
English: Paediatric patients (age < 12 years old, or 12 to 17 years old weighing < 40 kg) with haemophilia A with factor VIII inhibitors (Study BH29992 - HAVEN 2)
Danish: Kliniske studier hos pædiatriske patienter Pædiatriske patienter (alder < 12 år eller 12-17 år, vægt < 40 kg) med hæmofili A og faktor VIII
English: 50 mg/5 ml
Danish: 50 mg/5 ml Oral suspension
English: 240 ml (10 mg/ml) 1 bottle + 1 syringe + 1 adapter
Danish: 1 flaske + 1 sprøjte + 1 adapter
English: Strength Pharmaceutical form Route of administration
Danish: Styrke Lægemiddelform Administration Emballage Indhold (Koncentration)
English: Age over 65 years
Danish: Alder over 65 år
English: Wait 30 minutes for medication to warm.
Danish: Vent 30 minutter, så lægemidlet kan varme op.
English: Not known (frequency cannot be estimated from available data):
Danish: Ikke kendt (hyppigheden kan ikke estimeres ud fra forhåndenværende data):
English: • Wash your hands with soap and water, then dry them completely.
Danish: • Vask hænder med sæbe og vand, og tør dem helt.
English: • It is normal to see an air bubble.
Danish: • Det er normalt at se en luftboble.
English: Maintenance Dose Starting at Week 4
Danish: Vedligeholdelsesdosis startende ved uge 4
English: • It is normal to see one or more bubbles in the medication.
Danish: • Det er normalt at se en eller flere bobler i lægemidlet.
English: The primary non-responders were excluded from the studies and therefore these patients were not further evaluated.
Danish: De primære ikke-responderende blev ekskluderet fra studierne, og derfor blev disse patienter ikke yderligere undersøgt.
English: • Select a different site each time you inject at least 2.5 centimetres away from a previous site.
Danish: • Vælg et forskelligt sted hver gang du injicerer, mindst 2,5 cm væk fra et tidligere sted.
English: > 32 weeks
Danish: > 32 uger
English: In order to improve traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Danish: For at forbedre sporbarheden af biologiske lægemidler skal navnet og batchnummeret for det administrerede præparat registreres tydeligt.
English: RA study III also had a primary endpoint of changes in quality of life.
Danish: RA-studie III havde også et primært endepunkt med ændringer i livskvalitet.
English: Improvement in quality of life was measured up to week 156 (36 months) and improvement was maintained through that time.
Danish: Forbedring af livskvalitet blev målt op til uge 156 (36 måneder), og forbedringen blev opretholdt gennem hele
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 10 November 2017
Danish: Dato for første markedsføringstilladelse: 10 november 2017
English: Results from the overall UC-II study population are shown in Table 28.
Danish: Resultater fra den samlede UC-II studiepopulation er vist i tabel 28.
English: 14 weeks
Danish: 14 uger
English: It is very important that you tell your doctor if you have ever had tuberculosis, or if you have been in close contact with someone who has had tuberculosis.
Danish: Det er meget vigtigt at informere lægen, hvis du nogensinde har haft tuberkulose, eller hvis du har været i tæt kontakt med nogen, som havde tuberkulose.
English: Ps Study IV Efficacy Results at 16, 26 and 52 Weeks
Danish: Ps studie IV Virkningsresultater ved 16, 26 og 52 uger
English: Mean exposure in all adalimumab population was 762 days.
Danish: Den gennemsnitlige eksponering med adalimumab i populationen var 762 dage.
English: Always take the outer carton of the medicine with you, even if it is empty.
Danish: Tag altid den ydre karton eller hætteglasset fra medicinen med, også selvom den er tom.
English: The interpretation of data may be impacted due to methodological limitations of the study, including small sample size and non-randomized design.
Danish: Fortolkningen af data kan være påvirket af studiets metodologiske begrænsninger, inklusive lille prøvegruppe og ikkerandomiseret design.
English: If these medicines do not work well enough, you will be
Danish: Hvis disse lægemidler ikke virker godt nok, vil
English: ASAS 20 ASAS 5/6
Danish: ASAS 5/6
English: Assessment of SpondyloArthritis international Society Baseline is defined as open label baseline when patients have active disease.
Danish: Assessment of SpondyloArthritis international Society Baseline er defineret som åben periode baseline, når patienterne har aktiv sygdom.
English: The decision to stop using Cyltezo should be discussed with your doctor.
Danish: Beslutningen om at stoppe med at bruge Cyltezo skal diskuteres med din læge.
English: 95 % confidence intervals for the differences in change scores between methotrexate and adalimumab.
Danish: 95 % Konfidensintervaller for forskellen i ændring af score mellem methotrexat og adalimumab.
English: • In some patients the body may fail to produce enough of the blood cells to fight off infections or help you to stop bleeding.
Danish: • Hos nogle patienter vil kroppen ikke producere tilstrækkeligt af de blodlegemer, som hjælper med at bekæmpe infektioner eller stoppe blødninger.
English: Of those receiving corticosteroids at baseline
Danish: Af dem som fik kortikosteroider ved baseline
English: The primary endpoint was ‘time to treatment failure'.
Danish: Det primære endepunkt var ‘tid til behandlingssvigt'.
English: • DO NOT attempt to self-inject until you are sure that you understand how to prepare and give the
Danish: • Du MÅ IKKE forsøge at injicere dig selv, før du er sikker på, at du forstår hvordan injektionen
English: • If you have a severe infection, including tuberculosis (see “Warnings and precautions”).
Danish: • hvis du har en alvorlig infektion, herunder tuberkulose (se ”Advarsler og forsigtighedsregler”).
English: Injecting medication that is cold can cause discomfort.
Danish: Hvis et koldt lægemiddel injiceres, kan det være ubehageligt.
English: Monoclonal antibodies are proteins that attach to a specific target.
Danish: Monoklonale antistoffer er proteiner, som binder sig til et specifikt mål.
English: • DO NOT remove cap until right before injection (step 6).
Danish: • Hætten MÅ IKKE fjernes indtil lige før injektionen (trin 6).
English: Cyltezo can also be given alone.
Danish: Cyltezo kan også anvendes alene.
English: The air bubble does not need to be removed prior to injection.
Danish: Det er ikke nødvendigt at fjerne luftboblen før injektionen.
English: Gather supplies onto clean, flat surface: a.
Danish: Placér materialerne på en ren, vandret overflade: a.
English: • Tell your doctor if you are a carrier of the hepatitis B virus (HBV), if you have an active HBV infection or if you think you might be at risk of contracting HBV.
Danish: • Fortæl lægen, hvis du er bærer af hepatitis B-virus (HBV), hvis du har en aktiv HBV-infektion, eller hvis du tror, du kan have risiko for at få HBV.
English: • Certain vaccines contain weakened but live forms of bacteria or viruses that cause diseases, and should not be given while receiving Cyltezo because they may cause infections.
Danish: • Visse vacciner indeholder svækkede, men levende former for bakterier eller vira, der kan forårsage sygdomme, og de bør ikke gives under Cyltezo-behandling da de kan forårsage infektioner.
English: In all situations described below, the benefit/risk balance of therapy should be very carefully considered.
Danish: I alle disse situationer beskrevet nedenfor skal benefit/risk-forholdet ved behandling tages meget nøje i
English: • Signs or symptoms of the safety concern and when to seek attention from a HCP
Danish: • Tegn og symptomer på sikkerhedsproblematik, og hvornår der skal søges hjælp fra læger eller
English: There is a window on each side of the pen through which you can see the Cyltezo solution inside the syringe.
Danish: Der er et vindue på hver side af pennen, hvor du kan se Cyltezo-opløsningen indeni sprøjten.
English: Clinical remission is Mayo score ≤ 2 with no subscore > 1;
Danish: Klinisk remission er Mayo-score ≤ 2 uden subscore > 1;
English: • On rare occasions, treatment with Cyltezo could result in lupus-like syndrome.
Danish: • I sjældne tilfælde kan behandling med Cyltezo resultere i lupus-lignende syndrom.
English: The predicted exposures indicate that in the absence of methotrexate, a loading dose may lead to an initial increase in systemic
Danish: De estimerede eksponeringer indikerer, at induktionsdosis i fravær af methotrexat kan føre til en initial stigning i systemisk
English: Some side effects observed with adalimumab may not have symptoms and may only be discovered through
Danish: Nogle bivirkninger, som er set med adalimumab, har ikke symptomer og kan kun opdages ved
English: None of these patients experienced rebound during the withdrawal period.
Danish: Ingen af disse patienter oplevede rebound-virkning i den behandlingsfri periode.
English: 117/276 patients from CD study I and 272/777 patients from CD studies II and III were followed through at least 3 years of open-label adalimumab therapy.
Danish: 117/276 patienter fra CD-studie I og 272/777 patienter fra CD-studie II og III blev fulgt gennem mindst 3 års åben adalimumab-behandling.
English: • According to a pregnancy study, there was no higher risk of birth defects when the mother had received adalimumab during pregnancy compared with mothers with the same disease who did not
Danish: • Der var i følge et graviditetsstudie ikke højere risiko for misdannelser, når moderen havde fået Cyltezo under graviditeten, ved sammenligning med mødre med samme sygdom, som ikke
English: Detailed information is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Du kan finde yderligere oplysninger på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: • Do not attempt to reuse a used Cyltezo pen.
Danish: • Forsøg ikke at genbruge en brugt Cyltezo-pen.
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator (2ºC - 8ºC).
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i køleskab (2 ºC - 8 ºC).
English: If you do not have all the supplies listed above, contact your pharmacist before proceeding.
Danish: Hvis du ikke har alle de ovenstående materialer, skal du kontakte apotekspersonalet, før du fortsætter.
English: • Do not touch this area again before injecting.
Danish: • Du må ikke røre ved dette område igen før injektionen.
English: • including cancer of the lymph system (lymphoma) and
Danish: • herunder kræft i lymfesystemet (lymfom) og
English: The potential risk with the combination of azathioprine or 6-mercaptopurine and Cyltezo should be carefully considered.
Danish: Den potentielle risiko ved kombination af azathioprin eller 6-mercaptopurin med Cyltezo bør nøje overvejes.
English: The long halflife of adalimumab should be taken into consideration if a surgical procedure is planned.
Danish: Den lange halveringstid for adalimumab bør tages med i overvejelserne, når der planlægges et kirurgisk indgreb.
English: In some rare cases, especially if you are taking other medicines that suppress the immune system, reactivation of HBV infection can be life
Danish: I sjældne tilfælde, specielt hvis du tager anden medicin, der undertrykker immunsystemet, kan reaktivering af HBV-infektion blive livstruende.
English: If you accidentally inject Cyltezo more frequently than you should, call your doctor or pharmacist and explain that you have taken more.
Danish: Hvis du ved en fejltagelse injicerer Cyltezo hyppigere end du bør, skal du kontakte lægen eller apotekspersonalet og forklare, at du har taget mere.
English: • If you are over 65 years you may be more susceptible to infections while taking Cyltezo.
Danish: • Hvis du er over 65 år, kan du være mere modtagelig for infektioner, mens du tager Cyltezo.
English: • Select an area on the upper thighs or abdomen/belly (at least 5 centimetres away from navel).
Danish: • Vælg et område øverst på lårene eller på maven (mindst 5 cm fra navlen).
English: • Hold pen straight up from injection site (at a 90 degree angle).
Danish: • Hold pennen lige op fra injektionsstedet (med en 90 graders vinkel).
English: • Do not inject through clothes.
Danish: • Der må ikke injiceres gennem beklædning.
English: 5) Clean injection site
Danish: 5) Rens injektionsstedet
English: COPD, or you are a heavy smoker, you should discuss with your doctor whether treatment with a TNFα blocker is appropriate for you.
Danish: Hvis du har KOL, eller du ryger meget, bør du diskutere med din læge, om behandling med en TNFα-hæmmer er passende for dig.
English: • After proper training, the injection can be given by yourself or given by another person, for example, a
Danish: • Efter en korrekt træning, kan du give dig selv injektionen eller en anden person kan give dig den,
English: RA Study III a**
Danish: RA-studie III a**
English: The conduct and results of these tests should be recorded on your patient alert card.
Danish: Disse undersøgelser og resultaterne heraf bør registreres på dit patientkort.
English: • If you are allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for adalimumab eller et af de øvrige indholdsstoffer i Cyltezo (angivet i punkt 6).
English: In RA study V, structural joint damage was assessed radiographically and expressed as change in modified
Danish: I RA-studie V blev strukturel ledskade vurderet radiografisk og udtrykt som ændringer i modificeret
English: • If you receive Cyltezo during your pregnancy, your baby may have a higher risk for getting an
Danish: • Hvis du har fået Cyltezo, mens du var gravid, kan dit spædbarn have en højere risiko for at få en
English: • Remove needle from skin at the same angle you inserted it (45 degree angle).
Danish: • Fjern kanylen fra huden med den samme vinkel, som den blev indsat (45 graders vinkel).
English: If an alternate dose is required, other adalimumab products offering such an option should be used.
Danish: Hvis en anden dosis er nødvendig, bør der anvendes andre adalimumab-præparater, der giver sådan en mulighed.
English: • You will be instructed by your doctor, nurse or pharmacist on the technique of self-injection.
Danish: • Lægen, sygeplejersken eller apotekspersonalet vil instruere dig i selvinjektionsteknikken.
English: Hepatitis reactivation of hepatitis B autoimmune hepatitis
Danish: Hepatit, reaktivering af hepatitis B autoimmun hepatit
English: Adalimumab was studied in 9,506 patients in pivotal controlled and open-label trials for up to 60 months or more.
Danish: Adalimumab blev undersøgt hos 9.506 patienter i pivotale kontrollerede og åbne studier i op til 60 måneder eller mere.
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: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er) 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 den europæiske webportal for
English: Patients from studies UC-I and UC-II had the option to roll over into an open-label long-term extension study (UC III).
Danish: Patienter fra studie UC-I og UC-II havde mulighed for at indgå i et åbent langvarigt forlængelsesstudie (UC III).
English: Clinical remission results remained relatively constant irrespective of previous TNF-antagonist exposure.
Danish: Raterne for klinisk remission forblev forholdvis konstante uanset tidligere TNF-antagonist
English: Any unused medicinal product or waste material should be disposed of in accordance with local
Danish: Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: Patients must therefore be monitored closely for infections, including tuberculosis, before, during and after treatment with Cyltezo.
Danish: Patienter skal derfor monitoreres nøje for infektioner, herunder tuberkulose, før, under og efter behandling med Cyltezo.
English: If you have
Danish: Du skal
English: The primary efficacy endpoint in both studies was ´time to treatment failure´.
Danish: Det primære virkningsendepunkt i begge studier var tid til behandlingssvigt.
English: You and your doctor should pay special attention to signs of infection while you are being treated with Cyltezo.
Danish: Du og din læge bør være særligt opmærksomme på tegn på infektion, mens du er i behandling med Cyltezo.
English: You should continue to inject Cyltezo for as long as your doctor has told you.
Danish: Du skal fortsætte med at injicere Cyltezo så længe, din læge har fortalt dig.
English: First read all the instructions carefully and then follow them step by step.
Danish: Læs først hele vejledningen nøje, og følg den trinvist.
English: Available data suggest that re-introduction of adalimumab after discontinuation for 70 days or longer resulted in the same magnitudes of clinical response and similar safety profile as before dose interruption.
Danish: Tilgængelige data tyder på, at genopstart af adalimumab efter seponering i 70 dage eller længere resulterede i et klinisk respons i samme størrelsesorden og med samme sikkerhedsprofil som før behandlingsafbrydelsen.
English: • Lift pen straight up from skin.
Danish: • Løft pennen lige op fra huden.
English: Assessments in SpondyloArthritis international Society Bath Ankylosing Spondylitis Disease Activity Index Ankylosing Spondylitis Disease Activity Score high sensitivity C-Reactive Protein (mg/L) Spondyloarthritis Research Consortium of Canada
Danish: Assessments of SpondyloArthritis international Society Bath Ankylosing Spondylitis Disease Activity Index Ankylosing Spondylitis Disease Activity Score høj følsomhed C-reaktivt protein (mg/l) Spondyloarthritis Research Consortium of Canada
English: Disease flare criteria were defined as a worsening of ≥ 30 % from baseline in ≥ 3 of 6 Paediatric ACR core criteria, ≥ 2 active joints, and improvement of > 30 % in no more than 1 of the 6 criteria.
Danish: Kriterier for opblussen af sygdommen var defineret som en forværring på ≥ 30 % i forhold til baseline af ≥ 3 ud af 6 pædiatrisk ACR-hovedkriterier, ≥ 2 aktive led og en forbedring på > 30 % i ikke mere end 1 af de 6 kriterier.
English: Detailed instructions on how to inject Cyltezo are provided in section 7 ‘Instructions for use'.
Danish: En detaljeret vejledning i, hvordan man injicerer Cyltezo findes i punkt 7 'Brugsanvisning'.
English: Your doctor should test you for HBV. Cyltezo can reactivate HBV infection in people who carry this virus.
Danish: Lægen vil teste dig for HBV. Cyltezo kan reaktivere HBV-infektion hos mennesker, der bærer denne virus.
English: • Cyltezo should only be used during a pregnancy if needed.
Danish: • Cyltezo bør kun anvendes under graviditet, hvis det er tydeligvis nødvendigt.
English: With current data it is not known if adalimumab treatment influences the risk for developing dysplasia or colon cancer.
Danish: Med de nuværende data er det ukendt, om behandling med adalimumab påvirker risikoen for udvikling af dysplasi eller coloncancer.
English: Concomitant stable doses of aminosalicylates, corticosteroids, and/or immunomodulatory agents were permitted and 80 % of patients continued to receive at least one of
Danish: Samtidige faste doser af aminosalicylater, kortikosteroider, og/eller immunmodulerende midler var tilladt, og 80 % af patienterne fortsatte med at
English: - Not applicable.
Danish: - Ikke relevant.
English: Vertigo and visual impairment may occur following administration of Cyltezo (see section 4.8).
Danish: Vertigo og svækket syn kan forekomme efter administration af Cyltezo, se pkt 4.8.
English: No other diseasemodifying anti-rheumatic drugs were allowed.
Danish: Ingen andre sygdomsmodificerende antireumatiske lægemidler blev tilladt.
English: After adjustment for weight differences, gender and age appeared to have a minimal effect on adalimumab clearance.
Danish: Efter justering for vægtforskelle viste køn og alder sig kun at have minimal virkning på clearance af adalimumab.
English: • Using your thumb, slowly push plunger down until all medication in syringe has been delivered.
Danish: • Med tommelfingeren trykkes stemplet langsomt ned, indtil alt lægemidlet i injektionssprøjten er blevet leveret.
English: • vertigo (sensation of the room spinning);
Danish: • vertigo (fornemmelse af at rummet snurrer rundt)