FrancophonIA/ELRC3.0 huggingface dataset:
English: Long-term safety evaluations are ongoing.
Danish: Der pågår evalueringer af langtidssikkerheden.
English: Clean your hands
Danish: Vask hænder
English: Important Information:
Danish: Vigtig information:
English: • The injection may take up to 10 seconds.
Danish: • Indsprøjtningen kan tage op til 10 sekunder.
English: There is no data.
Danish: Der foreligger ingen data.
English: • Let the skin dry for approximately 10 seconds.
Danish: • Lad huden tørre i ca. 10 sekunder.
English: The interval between consecutive doses should be at least 8 hours.
Danish: Intervallet mellem de givne doser skal være mindst 8 timer.
English: The expiry date refers to the last day of that month.
Danish: Udløbsdatoen er den sidste dag i den angivne måned.
English: They are usually effective, but can have side effects if used at high doses for a long time.
Danish: De er normalt effektive, men kan have bivirkninger, hvis de gives i høje doser i lang tid.
English: • If you have persistent headaches.
Danish: • Hvis du har vedvarende hovedpine
English: Combination with TNF antagonists
Danish: Kombination med TNF-antagonister
English: Talk to your doctor if you are pregnant, may be pregnant, or intend to become pregnant.
Danish: Fortæl det til din læge, hvis du er gravid, måske er gravid eller planlægger at blive gravid.
English: MedDRA System Organ Class
Danish: MedDRA Systemorganklasse
English: These events were not treatment limiting.
Danish: Hændelserne var ikke behandlingsbegrænsende.
English: (below 30 kg and ≥30 kg).
Danish: (under 30 kg og ≥ 30 kg).
English: - modified Total Sharp Score
Danish: - modificeret total Sharp-score
English: Week 52
Danish: Uge 52
English: Cmax increased dose-proportionally.
Danish: Cmax øgedes dosisproportionalt.
English: • If you are opening the box for the first time, check to make sure that it is properly sealed.
Danish: • Hvis det er første gang du åbner æsken, skal du checke at den er korrekt forseglet.
English: The results from study VII are shown in Table 6.
Danish: Resultaterne fra studie VII vises i table 6.
English: A decrease to the lower limit of normal occurred in 15 patients at some point in the study.
Danish: Et fald til den nedre normalgrænse forekom hos 15 patienter på et eller andet tidspunkt i studiet.
English: This remained consistent following 2 years of treatment (83%; n=353).
Danish: Dette forblev konsistent efter 2 års behandling (83 %, n = 353).
English: Of these 3 patients, 1 subsequently withdrew from the study.
Danish: Ud af disse 3 patienter, var der 1 patient som efterfølgende udgik af studiet.
English: Higher scores signal improvement in both FACIT-Fatigue and EQ5D.
Danish: Højere score signalerer forbedring i både FACIT-fatigue og EQ5D.
English: GCA is often treated with medicines called steroids.
Danish: GCA behandles ofte med lægemidler, som kaldes steroider.
English: Multiplicity controlled using Bonferroni-Holm Procedure
Danish: Multiplicitet er kontrolleret ved brug af Bonferroni-Holm-procedure.
English: Study I AMBITION
Danish: Studie I AMBITION
English: • Wash your hands with soap and water.
Danish: • Vask hænder med sæbe og vand.
English: • If needed, you may cover the injection site with a small bandage.
Danish: • Hvis det er nødvendigt, kan du dække injektionsstedet med et lille plaster.
English: p-value(a)
Danish: p-værdi(a)
English: • if you have an active, severe infection.
Danish: • hvis du har en aktiv og alvorlig infektion.
English: This includes medicines obtained without a prescription.
Danish: Dette gælder også medicin, som er købt uden recept.
English: They will dilute the solution, set up the intravenous infusion and monitor you during and after the treatment.
Danish: De vil fortynde opløsningen, give den intravenøse infusion og overvåge dig under og efter behandlingen.
English: Study III OPTION
Danish: Studie III OPTION
English: Study IV TOWARD
Danish: Studie IV TOWARD
English: It is important to read, understand and follow these instructions so that you or your caregiver uses the RoActemra syringe correctly.
Danish: Det er vigtigt at læse, forstå og følge denne vejledning, så at du eller din hjælper bruger RoActemrainjektionssprøjten rigtigt.
English: Effects can include strokes and blindness.
Danish: Følgerne kan omfatte slagtilfælde og blindhed.
English: Therefore, no dose recommendations can be made.
Danish: Der kan derfor ikke gives dosisanbefalinger.
English: Tell your doctor immediately if you feel unwell.
Danish: Fortæl det omgående til din læge, hvis du føler dig utilpas.
English: • The Patient Information Packs (to be given to patients by healthcare professionals)
Danish: • Informationsmaterialet til patienten (skal gives til patienten af sundhedspersonalet)
English: No case of an overdose in the paediatric population has been observed.
Danish: Der er ikke observeret nogen tilfælde af overdosering hos den pædiatriske population.
English: Renal function should be monitored closely in these patients.
Danish: Nyrefunktionen bør overvåges omhyggeligt hos disse patienter.
English: Infections with neutropenia have been reported.
Danish: Infektioner med neutropeni er rapporteret.
English: When clinically indicated, other liver function tests including bilirubin should be considered.
Danish: Hvis det er klinisk indiceret, bør andre leverfunktionstests, herunder bilirubin, overvejes.
English: • You may not have received your full dose of RoACTEMRA.
Danish: • du måske ikke har fået hele dosis af RoActemra.
English: • The product may lessen signs and symptoms of acute infection delaying the diagnosis
Danish: • Produktet kan mindske tegn og symptomer på en akut infektion og derved forsinke diagnosen
English: During the open-label period of Study II, the improvement in physical function has been maintained for up to 2 years.
Danish: Under den åbne periode af studie II blev forbedringen af den fysiske funktionsevne opretholdt i op til 2 år.
English: There may be an increased risk of neutropenia in patients who have previously been treated with a TNF antagonist.
Danish: Der kan være øget risiko for neutropeni hos patienter, som tidligere er behandlet med en TNF-antagonist.
English: Efficacy results from Study WA28119
Danish: Effektresultater for studie WA28119
English: • increased bilirubin shown by blood tests
Danish: • forhøjet bilirubin vist ved blodprøver
English: Unopened vial: 30 months
Danish: Uåbnet hætteglas: 30 måneder.
English: The Patient's Global Assessment of disease activity was assessed on a 0-100mm Visual Analogue Scale (VAS).
Danish: Patientens globale vurdering af sygdomsaktivitet blev vurderet på en 0-100mm visuel analog skala (VAS).
English: The safety profile of RoActemra across these indications remains similar and undifferentiated.
Danish: RoActemras sikkerhedsprofil på tværs af disse indikationer forbliver ens og udifferentieret.
English: • Wash your hands well with soap and water.
Danish: • Vask hænderne grundigt med sæbe og vand.
English: In GCA patients, higher exposure was observed in patients with lower body weight.
Danish: Hos GCA-patienter blev højere eksponering observeret hos patienter med lavere kropsvægt.
English: • The product must not be given to patients with active or suspected infection
Danish: • Produktet skal ikke administreres til patienter med aktiv infektion eller mistanke om infektion
English: At week 52 and week 104 the co-primary endpoints were prevention of joint damage and improvement in physical function.
Danish: Ved uge 52 og uge 104 var de coprimære endepunkter forebyggelse af ledskader og forbedring af den fysiske funktionsevne.
English: If you feel dizzy, do not drive or use machines.
Danish: Hvis du føler dig svimmel, skal du lade være med at føre motorkøretøj og betjene maskiner.
English: Patient advice regarding early recognition and treatment to limit risk of a serious infection
Danish: Råd til patienter i forbindelse med tidlig påvisning og behandling af infektion med henblik på at begrænse risikoen for alvorlige infektioner
English: • Do not inject through clothing covering the skin
Danish: • Giv ikke indsprøjtningen gennem tøj, der dækker huden
English: • Risk of serious infections
Danish: • Risikoen for alvorlige infektioner
English: One event (angioedema) was considered serious and life-threatening, and the patient was discontinued from study treatment.
Danish: Én hændelse (angioødem) blev anset for alvorlig og livstruende, og patientens behandling med studiemedicinen blev afbrudt.
English: The total patient exposure was 184.4 patient years.
Danish: Den totale patienteksponering var 184,4 patientår.
English: In this study, ACR/EULAR remission (Boolean and Index) were also analysed as pre-specified exploratory endpoints, with higher responses observed in the tocilizumab groups.
Danish: I dette studie blev ACR/EULAR-remission (Boolean og Index) også analyseret som præspecificerede eksploratoriske endepunkter, og der blev observeret højere responser i tocilizumab-grupperne.
English: In addition to this leaflet, you will be given a Patient Alert Card, which contains important safety information that you need to be aware of before and during treatment with RoActemra.
Danish: Udover denne indlægsseddel får du udleveret et patientkort, som indeholder vigtige oplysninger om sikkerhed, som du skal være opmærksom på, før og under behandlingen med RoActemra.
English: Study II LITHE
Danish: Studie II LITHE
English: Signs of serious infections:
Danish: Tegn på alvorlige infektioner:
English: • Patient alert card - to address the risk of getting infections which can become serious if not treated.
Danish: • Patientkort - til at gøre opmærksom på risikoen for at få infektioner, som kan blive alvorlige, hvis de ikke behandles.
English: RoActemra can reduce your body's ability to respond to infections and may make an existing infection worse or increase the chance of getting a new infection.
Danish: RoActemra kan nedsætte kroppens evne til at bekæmpe infektioner og kan forværre en eksisterende infektion eller øge risikoen for at få en ny infektion.
English: Infusion related reactions pJIA1, sJIA2
Danish: Infusionsreaktioner pJIA1, sJIA2
English: The accumulation ratio was higher for Cmin (2.49), which was expected based on the non-linear clearance contribution at lower concentrations.
Danish: Akkumulationsratioen var højere for Cmin (2,49), hvilket var forventet på grund af bidraget fra den non-lineære clearance ved lavere koncentrationer.
English: In addition, some previous infections may reappear.
Danish: Desuden skal der gøres opmærksom på, at tidligere infektioner kan blusse op igen.
English: Call your healthcare provider for help.
Danish: Kontakt sundhedspersonalet for at få hjælp.
English: • red swollen areas in the mouth
Danish: • røde hævede (betændte) områder i munden
English: Carcinogenicity studies were not performed because IgG1 monoclonal antibodies are not deemed to have intrinsic carcinogenic potential.
Danish: Der er ikke udført studier for carcinogenicitet, da IgG1-monoklonale antistoffer ikke anses for at have carcinogent potentiale.
English: • adults with a disease of the arteries called giant cell arteritis (GCA), caused by inflammation of the body's largest arteries, especially those that supply blood to the head and neck.
Danish: • voksne med en sygdom i arterierne kaldet GCA, forårsaget af betændelse (inflammation) i kroppens største arterier, især dem, der leverer blod til hoved og halsen.
English: • ciclosporin, used to suppress your immune system during organ transplants
Danish: • ciclosporin, som bruges til at dæmpe immunsystemet i forbindelse med organtransplantation
English: Based upon the chronic nature of GCA, treatment beyond 52 weeks should be guided by disease activity, physician discretion, and patient choice.
Danish: Baseret på GCA's kroniske karakter skal behandling efter 52 uger styres af sygdomsaktivitet, lægens skøn og patientens valg.
English: Twist and pull off the green cap with the other hand (See Figure E).
Danish: Drej og træk den grønne hætte af med den anden hånd (se figur E).
English: Ninety three percent (93%; n=271) of patients had no progression between week 52 and week 104.
Danish: 93 % af patienterne (n = 271) havde ingen progression mellem uge 52 og uge 104.
English: Immunomodulatory medicinal products may increase the risk of malignancy.
Danish: Immunomodulerende lægemidler kan muligvis øge risikoen for malignitet.
English: Before you use the RoACTEMRA pre-filled pen for the first time, make sure your healthcare provider shows you the right way to use it.
Danish: Inden du bruger den fyldte RoActemra-pen første gang, skal du sikre dig at sundhedspersonalet har vist dig hvordan den bruges korrekt.
English: The first injection should be performed under the supervision of a qualified health care professional.
Danish: Den første injektion skal foretages under overvågning af kvalificeret sundhedspersonale.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Danish: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er) Indehaveren af markedsføringstilladelsen skal fremsende PSUR'er for dette lægemiddel i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for lægemidler.
English: Glucocorticoids should be given according to medical judgement and practice guidelines.
Danish: Glukokortikoider skal gives i henhold til medicinsk vurdering og kliniske retningslinjer.
English: (cells x 109/ L )
Danish: (celler x 109/l )
English: • simvastatin or atorvastatin, used to reduce cholesterol levels
Danish: • simvastatin eller atorvastin, som bruges til at nedsætte kolesterolniveauet
English: Week 24
Danish: Uge 24
English: The nonlinear part of RoActemra elimination leads to an increase in exposure that is more than dose-proportional.
Danish: Den ikke-lineære del af RoActemra-elimination fører til en øget eksponering, som er mere end proportional med dosis.
English: This is important to ensure that the syringe and medicine are safe to use.
Danish: Dette er vigtigt for at sikre, at det er sikkert at bruge injektionssprøjten og medicinen.
English: Duration of Corticosteroid Therapy During Screening in Study WA28119
Danish: Varighed af kortikosteroid-behandling under screening i WA28119 studiet
English: Secondary Endpoints
Danish: Sekundære endepunkter
English: FACIT-Fatigue change from baseline to week 52 scores were calculated for all groups.
Danish: FACIT-fatigue ændring fra baseline til uge 52 blev beregnet for alle grupper.
English: • If you have any kind of infection, short- or long-term, or if you often get infections.
Danish: • Hvis du har en infektion, uanset hvilken, herunder infektioner af kort eller lang varighed eller hvis du tit får infektioner.
English: In particular, there was no impairment of skeletal growth, immune function and sexual maturation.
Danish: Specielt var der ingen hæmning af knoglevækst, immunfunktion eller kønsmodning.
English: Possible serious side effects: tell a doctor straight away.
Danish: Mulige alvorlige bivirkninger, fortæl det straks til lægen.
English: Four patients were tested positive for IgE isotype (0.9%).
Danish: Fire patienter blev testet positive for IgE isotype (0,9%).
English: The percentage of patients achieving sustained remission at week 52, are shown in the Table 4.
Danish: Procentdelen af patienter, der opnåede vedvarende remission i uge 52, er vist i tabel 4.
English: Call your doctor and seek medical attention without delay if you think you might be developing an infection.
Danish: Kontakt lægen og søg straks lægehjælp, hvis du tror du er ved at udvikle en infektion.
English: Complications of diverticulitis
Danish: Komplikationer med diverticulitis
English: Component of a multipack, can't be sold separately.
Danish: Enkelte enheder fra en multipakning må ikke sælges seperat.
English: Laboratory Parameters
Danish: Laboratorieparametre
English: There are limited data available on overdose with RoActemra.
Danish: Der foreligger begrænsede data om overdosering med RoActemra.
English: If you are using medicines containing any of the following active substances, tell your doctor:
Danish: Hvis du/barnet bruger medicin, som indeholder et af følgende aktive stoffer, skal du fortælle det til lægen:
English: Time to onset was rapid (as early as week 2) and the magnitude of response continued to improve with duration of treatment.
Danish: Tiden til indtræden af virkning var hurtig (så tidlig som efter 2 uger), og responset blev bedre og bedre i takt med behandlingens varighed.
English: Allergic reactions during or after injection:
Danish: Allergiske reaktioner under og efter injektion:
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Danish: Læger og sundhedsspersonale anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem anført i Appendiks V.
English: This patient did not develop a hypersensitivity reaction or injection site reaction.
Danish: Patienten udviklede ikke en overfølsomhedsreaktion eller reaktion ved injektionsstedet.
English: One patient was tested positive for IgE isotype (0.2%).
Danish: En patient blev testet positiv for IgE isotype (0,2%).
English: IgG levels decrease during therapy.
Danish: IgG-niveauer falder under behandling.
English: Population pharmacokinetic analyses in any patient population tested so far indicate no relationship between apparent clearance and the presence of anti-drug antibodies.
Danish: Befolkningsfarmakokinetiske analyser i en hvilken som helst patientpopulation, der er testet indtil nu, indikerer ingen sammenhæng mellem tilsyneladende clearance og tilstedeværelsen af anti-lægemiddelantistoffer.
English: From a microbiological point of view, the prepared solution for infusion should be used immediately.
Danish: Fra et mikrobiologisk synspunkt bør den tilberedte infusionsvæske, opløsning anvendes omgående.
English: The dose should be calculated based on the patient's body weight at each administration.
Danish: Dosis bør beregnes ud fra patientens legemsvægt ved hver administration.
English: • Press the green Activation button to start the injection.
Danish: • Tryk på den grønne aktiveringsknap for at starte indsprøjtningen.
English: The green cap contains a loose fitting metal tube.
Danish: Den grønne hætte indeholder et løstsiddende metalrør.
English: In a separate analysis of the patients who received escape prednisone to treat GCA flare during the first 52 weeks, the cumulative prednisone dose varied greatly.
Danish: I en separat analyse af de patienter, der fik escapeprednison til behandling af GCA-flares i de første 52 uger, varierede den kumulative prednison-dosis meget.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Danish: Da der ikke er gennemført kompatabilitetsstudier, må dette lægemiddel ikke blandes med andre lægemidler.
English: Adding RoActemra to the treatment means that steroids can be used for a shorter time, while still controlling GCA.
Danish: Ved at tilføje RoActemra til behandlingen kan steroider bruges i kortere tid, mens man stadig kontrollerer GCAen.
English: Table 5: Efficacy Results for Study VI (WA19924)
Danish: Effektresultater for studie VI (WA19924)
English: L-Histidine
Danish: L-Histidin
English: • if you or a child patient you look after have an active, severe infection.
Danish: • hvis du eller dit barn eller det barn du passer har en aktiv og alvorlig infektion.
English: The duration of glucocorticoid therapy during screening and before RoActemra (or placebo) was initiated, was similar in all 4 treatment groups (see Table 3).
Danish: Varigheden af glukokortikoid-behandling under screening og før RoActemra (eller placebo) behandling blev initieret, var ens i alle 4 behandlingsgrupper (se tabel 3).
English: The purpose of Part 2 was to describe the long-term safety and maintenance of efficacy after 52 weeks of RoActemra therapy, to explore the rate of relapse and the requirement for RoActemra therapy beyond 52 weeks, and to gain insight into the potential long-term steroid-sparing effect of RoActemra.
Danish: Formålet med del 2 var at beskrive den langsigtede sikkerhed og vedligeholdelse af effekt efter 52 uger med RoActemra-terapi for at undersøge tilbagefaldsraten og behovet for RoActemra-behandling ud over 52 uger, og for at få indsigt i den potentielle langsigtede steroid-besparende effekt af RoActemra.
English: • Hold the syringe comfortably in your hand.
Danish: • Hold injektionssprøjten roligt i din hånd.
English: A study in animals has shown an increased risk of spontaneous abortion/embryo-foetal death at a high dose (see section 5.3).
Danish: Et dyreforsøg har vist øget risiko for spontan abort/embryonal-føtal død efter høje doser (se pkt.
English: RoActemra can reduce pain and swelling in the arteries and veins in your head, neck and arms.
Danish: RoActemra kan reducere smerte og hævelse i arterierne og venerne i dit hoved, hals og arme.
English: RoActemra subcutaneous formulation is not intended for intravenous administration.
Danish: RoActemra subkutan formulering er ikke beregnet til intravenøs administration.
English: Allergic reactions during or after infusion:
Danish: Allergiske reaktion under eller efter infusion:
English: The efficacy of tocilizumab was assessed in a three-part study WA19977 including an open-label extension in children with active pJIA.
Danish: Tocilizumabs virkning blev vurderet i et tre-delt studie, WA19977, inklusive en åben forlængelse med børn med aktiv pJIA.
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 risk/benefit-forholdet, eller som følge af, en vigtig milepæl
English: • Hold the RoACTEMRA pre-filled pen firmly with one hand.
Danish: • Hold den fyldte RoActemra-pen fast med én hånd.
English: RoActemra should not be used during pregnancy unless clearly necessary.
Danish: RoActemra må ikke anvendes under graviditet, medmindre det er klart nødvendigt.
English: Lift the pre-filled pen straight off of the injection site at a 90° angle to remove the needle from the skin.
Danish: Løft pennen op fra injektionsstedet i en vinkel på 90° for at fjerne nålen fra huden.
English: It is very important to use RoActemra exactly as prescribed by the doctor.
Danish: Det er meget vigtigt, at du tager RoActemra præcis som lægen har foreskrevet.
English: You must press the plunger all the way down to ensure that you get the full dose of medication and to ensure the trigger fingers are completely pushed to the side.
Danish: Du skal presse stemplet helt i bund for at sikre, at du får den fulde dosis medicin og for at sikre, at udløserene er helt skubbet til siden.
English: You will need the following to give your injection: Included in the box:
Danish: Før du tager indsprøjtningen skal du bruge følgende : Inkluderet i æsken:
English: Reductions in corticosteroids continued, with 44 patients off oral corticosteroids at week 44, while maintaining JIA ACR responses.
Danish: Reduktion i kortikosteroid fortsatte, idet 44 patienter var stoppet med orale kortikosteroider i uge 44, samtidig med, at de opretholdt JIA ACRrespons.
English: These proportions were statistically significantly different (p=0.0024).
Danish: Denne forskel var statistisk signifikant (p=0,0024).
English: Exploratory Endpoints Week 24: ACR/EULAR Boolean Remission, n (%) ACR/EULAR Index Remission, n (%) Week 52: ACR/EULAR Boolean Remission, n (%) ACR/EULAR Index Remission, n (%)
Danish: Eksploratoriske endepunkter Uge 24: ACR/EULAR Boolean remission, n (%) ACR/EULAR Index remission, n (%) Uge 52: ACR/EULAR Boolean remission, n (%) ACR/EULAR Index remission, n (%)