FrancophonIA/ELRC3.0 huggingface dataset:
English: The most serious ADRs were serious infections, complications of diverticulitis, and hypersensitivity reactions.
Danish: De alvorligste bivirkninger var svære infektioner, komplikationer med diverticulitis, og overfølsomhedsreaktioner.
English: Always use this medicine exactly as your doctor, pharmacist or nurse has told you.
Danish: .Brug altid medicinen præcis som lægen, apotekspersonalet eller sundhedspersonalet har vist dig.
English: • 1 RoACTEMRA pre-filled pen
Danish: • 1 fyldt RoActemra-pen
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
Danish: SÆRLIG ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN
English: In this case you will get training on how to inject RoActemra yourself.
Danish: I dette tilfælde vil du blive oplært i at give dig selv indsprøjtningen med RoActemra.
English: The steady-state profile following the RoActemra weekly dose was almost flat, with very little fluctuations between trough and peak values, while there were substantial fluctuations for the RoActemra every other weekly dose.
Danish: Steady-state-profilen for ugentlig dosis RoActemra var næsten flad, med meget små udsving mellem trough og peak værdier, mens der var væsentlige udsving for RoActemra dosis administreret hver anden uge.
English: • Package leaflet (with instructions for use for SC)
Danish: • Indlægsseddel (med brugsanvisning for subkutan anvendelse)
English: RoActemra is indicated for the treatment of Giant Cell Arteritis (GCA) in adult patients.
Danish: RoActemra er indiceret til behandling af kæmpecelle arteritis (Giant Cell Arteritis, GCA) hos voksne patienter.
English: • Put the used pre-filled pen into your sharps container (see “How do I dispose of used pre-filled pens?”)
Danish: • Læg den brugte pen i kanylebeholderen (se “Hvordan kommer jeg af med den brugte pen?”)
English: Stevens-JohnsonSyndrome3
Danish: Stevens-JohnsonSyndrom3
English: Patients presenting with symptoms potentially indicative of complicated diverticulitis, such as abdominal pain, haemorrhage and/or unexplained change in bowel habits with fever should be evaluated promptly for early identification of diverticulitis which can be associated with gastrointestinal perforation.
Danish: Patienter med symptomer, som kan tyde på kompliceret diverticulitis som f.eks. abdominale smerter, blødning og/eller uforklarlig ændring af afføringsmønster med feber, bør undersøges omgående med henblik på tidlig identificering af diverticulitis, som kan være ledsaget af gastrointestinal perforation.
English: • Watch the purple indicator until it stops moving to be sure the full dose of medication is injected.
Danish: • Hold øje med den lilla indikator indtil den holder op med at bevæge sig, så du er sikker på at hele dosis er givet.
English: • Serious hypersensitivity reactions and their management
Danish: • Alvorlige overfølsomhedsreaktioner og deres håndtering
English: Study III evaluated 623 patients who had an inadequate clinical response to MTX.
Danish: Studie III undersøgte 623 patienter, som ikke havde et tilstrækkeligt klinisk respons på MTX.
English: • The outer area of the upper arms may also be used only if the injection is being given by a caregiver.
Danish: • Ydersiden af overarmen kan også anvendes, hvis indsprøjtningen gives af en anden.
English: RoActemra will be given to you as a drip into a vein, by a doctor or a nurse.
Danish: Du vil få RoActemra som et drop i en vene af en læge eller en sygeplejerske.
English: Approximately one-third of the patients in the GCA study had moderate renal impairment at baseline (estimated creatinine clearance of 30-59 mL/min).
Danish: Ca. en tredjedel af patienterne i GCA-studiet havde moderat nedsat nyrefunktion ved baseline (estimeret creatininclearance på 30-59 mL/min).
English: A change in dose should only be based on a consistent change in the patient's body weight over time.
Danish: Ændring af dosis bør kun ske på baggrund af en konsistent ændring af patientens kropsvægt over tid.
English: The tocilizumab 8 mg/kg + MTX group also showed statistically significant results across the key secondary endpoints.
Danish: Tocilizumab 8 mg/kg + MTX-gruppen viste også statistisk signifikante resultater på tværs af de sekundære hovedendepunkter.
English: You will find detailed “Instructions for administration” at the end of this leaflet.
Danish: Du finder en detaljeret brugsvejledning i slutningen af denne indlægsseddel.
English: Two hundred and fifty one (251) patients with new-onset or relapsing GCA were enrolled and assigned to one of four treatment arms.
Danish: 251 patienter med nyopstået eller recidiverende GCA blev inkluderet og tildelt til en af fire behandlingsarme.
English: Preparing for a RoACTEMRA Injection Find a comfortable space with a clean, flat, working surface.
Danish: Gør klar til RoActemra-indsprøjtning Find et godt sted med en ren, plan arbejdsflade.
English: No adverse reactions were observed.
Danish: Der blev ikke observeret bivirkninger.
English: An additional analyses of JIA ACR responses, considering observed data at Week 40, regardless of flare status, showed that by Week 40, 95.1% of patients who had received continuous TCZ therapy, had achieved JIA ACR30 or higher.
Danish: En supplerende analyse af JIA-ACR-responser, hvor uge 40-data blev taget i betragtning uanset flare-status, viste, at ved uge 40 havde 95,1 % af patienterne, som havde fået kontinuerlig tocilizumab-behandling, opnået en JIA-ACR30 eller højere.
English: The non-clinical safety profile of RoActemra in the cynomolgus monkey does not suggest a difference between intravenous and subcutaneous routes of administration.
Danish: Den ikke-kliniske sikkerhedsprofil for RoActemra i cynomolgusaber tyder ikke på, at der er forskel på intravenøs og subkutan administration.
English: • Place the pre-filled pen on a clean, flat surface and let the pre-filled pen warm up for 45 minutes to allow it to reach room temperature.
Danish: • Læg den fyldte pen på en ren, plan flade og lad den ligge i 45 minutter, så den får stuetemperatur.
English: • headache, dizziness, high blood pressure
Danish: • hovedpine, svimmelhed, højt blodtryk
English: Treatment with a murine analogue did not exert toxicity in juvenile mice.
Danish: Behandling med en murin analog førte ikke til toksicitet hos unge mus.
English: Dose modify concomitant DMARDs (RA) or immunomodulatory agents (GCA) if appropriate.
Danish: Modificer dosis af samtidig DMARDs (reumatoid artrit) eller immunmodulerende midler (GCA), hvis det er hensigtsmæssigt
English: One patient in the 10 mg/kg < 30kg group developed positive anti-tocilizumab antibodies without developing a hypersensitivity reaction and subsequently withdrew from the study.
Danish: Én patient i 10 mg/kg <30 kg-gruppen blev testet positiv for anti-tocilizumab-antistoffer uden at udvikle en overfølsomhedsreaktion og udgik efterfølgende af studiet.
English: • You should use a different place each time you give yourself an injection, at least three centimeters from the area you used for your previous injection.
Danish: • Du skal vælge et nyt sted, hver gang du giver dig selv en indsprøjtning - mindst 3 cm fra hvor du sidst gav indsprøjtningen.
English: For SF-36, the mean change from baseline at week 24 in the mental component score was 6.22 for the subcutaneous arm and 6.54 for the intravenous arm, and for the physical component score was also similar with 9.49 for the subcutaneous arm and 9.65 for the intravenous arm.
Danish: I SF-36 var den gennemsnitlige ændring fra baseline ved uge 24 i den mentale komponent 6,22 for den subkutane arm og 6,54 for den intravenøse arm; den fysiske komponent var også sammenlignelig med 9,49 for den subkutane arm og 9,65 for den intravenøse arm.
English: The following information is intended for healthcare professionals only:
Danish: Følgende oplysninger er tiltænkt læger og sundhedspersonale:
English: Do not repeat the injection with another pre-filled pen.
Danish: Du skal ikke gentage injektionen med en anden fyldt pen.
English: The primary endpoint was the proportion of patients achieving DAS28 remission (DAS28 < 2.6) at week 24.
Danish: Det primære endepunkt var andelen af patienter, som opnåede DAS28-remission (DAS28< 2,6) i uge 24.
English: The comparator group was weekly MTX (dose titrated from 7.5 mg to a maximum of 20 mg weekly over an eight week period).
Danish: Sammenligningsgruppen fik MTX ugentligt (dosistitrering fra 7,5 mg til højst 20 mg ugentligt over en 8-ugers periode).
English: In the tocilizumab all exposure population, 11 patients (5.9%) experienced infusion reactions during the infusion and 38 patients (20.2%) experienced an event within 24 hours of an infusion.
Danish: Blandt alle tocilizumab-eksponerede patienter oplevede 11 patienter (5,9 %) infusionsreaktioner under infusionen, og 38 patienter (20,2%) oplevede en hændelse inden for 24 timer efter en infusion.
English: Impaired lung function may increase the risk for developing infections.
Danish: Nedsat lungefunktion kan øge risikoen for at udvikle infektioner.
English: A more than dose-proportional increase in the AUC and Cmin was observed for doses of 4 and 8 mg/kg every 4 weeks.
Danish: Der blev set en mere end dosisproportional stigning i AUC og Cmax efter doser på 4 og 8 mg/kg hver 4. uge.
English: The usual dose of RoActemra is 8 mg per kg of body weight.
Danish: Den normale dosis RoActemra er 8 mg pr. kg kropsvægt.
English: In the open label extension phase (Part II), the overall rate of infections remained similar at 306.6 per 100 patient years.
Danish: I den åbne forlængelsesfase (del II) forblev den samlede infektionshyppighed konstant på 306,6 per 100 patientår.
English: Talk to your doctor if you have any questions about giving yourself or a child patient you look after an injection.
Danish: Kontakt lægen, hvis du har spørgsmål til hvordan du giver dig selv eller et barn du passer en indsprøjtning.
English: Dispose of the syringe and do not use if:
Danish: Lad være med at bruge injektionssprøjten og smid den ud, hvis:
English: • Recommendations for dose interruptions in sJIA and pJIA patients
Danish: • Anbefalinger vedrørende afbrydelse af dosering hos sJIA- og pJIA-patienter
English: • If the Window area is not filled by the purple indicator then:
Danish: • Hvis vinduet ikke er fyldt af den lilla indikator, kan det betyde at:
English: Symptoms include headache, fatigue and jaw pain.
Danish: Symptomer omfatter hovedpine, træthed og smerter i kæben.
English: Quality of Life Outcomes
Danish: Resultater for livskvalitet
English: The efficacy of tocilizumab for the treatment of active sJIA was assessed in a 12 week randomised, double blind, placebo-controlled, parallel group, two arm study.
Danish: Tocilizumabs virkning ved behandling af aktiv sJIA blev undersøgt i et 12 ugers randomiseret dobbeltblindet, placebokontrolleret, parallelgruppe, to-armet studie.
English: • Do not warm up the syringe in any other way.
Danish: • Injektionssprøjten må ikke opvarmes på andre måder.
English: - to address the risk of allergic reactions.
Danish: - til at gøre opmærksom på risikoen for at få overfølsomhedsreaktioner.
English: It may also be helpful to write any questions or concerns about the injection so you can ask your healthcare provider.
Danish: Det kan også være en god idé at notere eventuelle spørgsmål, der kunne være opstået i forbindelse med indsprøjtningen, så du husker at spørge lægen.
English: Response Rate
Danish: Respons-rate
English: The primary endpoint was the proportion of patients with a JIA ACR30 flare at week 40 relative to week 16.
Danish: Det primære endepunkt var andel af patienter med JIA-ACR30-flare ved uge 40 i forhold til uge 16.
English: Eighty five percent (64/75) of tocilizumab treated patients and 24.3% (9/37) of placebo treated patients achieved this endpoint.
Danish: 85 % (64/75) af patienterne behandlet med tocilizumab og 24,3 % (9/37) af patienterne behandlet med placebo nåede dette endepunkt.
English: • The active substance is tocilizumab.
Danish: • Aktiv stof: tocilizumab.
English: These injection site reactions (including erythema, pruritus, pain and haematoma) were mild to moderate in severity.
Danish: Disse reaktioner ved injektionsstedet (inklusive erythem, pruritus, smerter og hæmatom) var af ilet til moderat i sværhedsgrad.
English: RoActemra can be used alone following discontinuation of glucocorticoids.
Danish: RoActemra kan anvendes alene efter seponering af glukokortikoider.
English: Elderly No dose adjustment is required in elderly patients >65 years of age.
Danish: Ældre Dosisjustering er ikke nødvendig hos ældre patienter > 65 år.
English: Dose adjustments due to laboratory abnormalities (sJIA and pJIA)
Danish: Dosisjustering på grund af laboratorieanormaliteter (sJIA og pJIA)
English: Cases of liver failure resulting in liver transplantation have been reported.
Danish: Der er rapporteret tilfælde af leverskader som krævede levertransplantation.
English: There was no clear relationship between decreases in neutrophils below 1 x 109/L and the occurrence of serious infections.
Danish: Der var ingen klar sammenhæng mellem fald i neutrofilocytter til under 1 x 109/l og forekomsten af alvorlige infektion.
English: No correlation between antibody development and clinical response or adverse events was observed
Danish: Der blev ikke observeret nogen korrelation mellem antistofudvikling og klinisk respons eller bivirkninger.
English: Thirty patients (1.1%) developed neutralising antibodies.
Danish: 30 patienter (1,1 %) udviklede neutraliserende antistoffer.
English: Thereafter, neutrophils recovered towards baseline in a dose dependent manner.
Danish: Neutrofilocyttallet steg derefter til baselineværdier på en dosisafhængig måde.
English: Patients in studies I - V had a mean Disease Activity Score (DAS28) of 6.5-6.8 at baseline.
Danish: Patienterne i studierne I - V havde en gennemsnitlig Disease Activity Score (DAS28) på 6,5-6,8 ved baseline.
English: Approximately 90% of the steady-state (AUCτ) was reached by week 14 in the every other weekly and week 17 in the weekly dose groups.
Danish: Ca. 90% af steady-state (AUCτ) blev nået ved uge 14 ved hver anden uge dosisgruppe og uge 17 i den ugentlige dosis gruppe.
English: No patient developed positive antitocilizumab antibodies post baseline.
Danish: Ingen patienter udviklede positive anti-tocilizumab-antistoffer efter baseline.
English: If a child has a history of macrophage activation syndrome (activation and uncontrolled proliferation of specific blood cells), tell your doctor.
Danish: Hvis et barn tidligere har haft makrofag aktiveringssyndrom, (aktivering og ukontrolleret vækst af specifikke blodceller), skal du fortælle det til barnets læge.
English: • Never reattach the green cap after removal.
Danish: • Sæt aldrig den grønne hætte på igen efter den er fjernet.
English: • jaundice (yellow discoloration of skin or eyes)
Danish: • gulsot (gulfarvning af hud eller øjne)
English: ACR responses in placebo-/MTX-/DMARDs-controlled studies (% patients)
Danish: ACR-respons i placebo-/MTX-/DMARD-kontrollerede studier (% patienter)
English: The cumulative prednisone dose at week 52 was significantly lower in the two RoActemra dose groups compared to the two placebo groups (Table 3).
Danish: Den kumulative prednison-dosis ved uge 52 var signifikant lavere i de to RoActemra grupper sammenlignet med de to placebogrupper (tabel 3).
English: During the 6-month controlled trials, increases of lipid parameters such as total cholesterol, triglycerides, LDL cholesterol, and/or HDL cholesterol have been reported commonly.
Danish: Under de 6-måneders kontrollerede studier blev der hyppigt indberettet stigninger i lipidparametrene, såsom total-kolesterol, triglycerider, LDL-kolesterol og/eller HDL-kolesterol.
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt inden du begynder at tage dette lægemiddel, da den indeholder vigtige oplysninger.
English: • Check that the pre-filled pen box is not damaged.
Danish: • Check at den fyldte pen ikke er beskadiget.
English: Limited information is available regarding switching patients from RoActemra intravenous formulation to RoActemra subcutaneous fixed dose formulation.
Danish: Der er begrænset information vedrørende skift af patienter fra den intravenøse RoActemraformulering til den subkutane formulering med fast dosis.
English: In the RoActemra subcutaneous weekly group, one patient (1.1%, 1/95) developed positive neutralizing anti-RoActemra antibodies, though not of the IgE isotype.
Danish: I den RoActemra subkutane ugentlige patientgruppe udviklede en patient (1,1%, 1/95) positive neutraliserende anti-RoActemra-antistoffer, men ikke af IgE-isotypen.
English: All efficacy comparisons vs Placebo + MTX.
Danish: Alle sammenligninger vedrørende effekt er versus placebo + MTX.
English: Infusion related reaction events in pJIA patients included but were not limited to headache, nausea and hypotension 2.
Danish: Infusionsreaktioner hos pJIA patienter inkluderede, men var ikke begrænset til hovedpine, kvalme og hypotension 2.
English: • The purple indicator will move along the Window area during the injection (See Figure K).
Danish: • Under indsprøjtningen vil den lilla indikator bevæge sig i vinduet (se figur K).
English: Resolution of CRS was defined as lack of fever and off vasopressors for at least 24 hours.
Danish: Ophør af cytokinfrigivelsessyndrom blev defineret som feberfri og ude af behandling med vasopressorer i mindst 24 timer.
English: The pharmacokinetics of RoActemra is characterized by nonlinear elimination which is a combination of linear clearance and Michaelis-Menten elimination.
Danish: RoActemras farmakokinetik er karakteriseret ved ikke-lineær eliminering, som er en kombination af lineær clearance og Michaelis-Menten elimination.
English: In this statistical analysis, patients who flared (and escaped to TCZ) during Part II or who withdrew, were classified as non-responders.
Danish: I den statistiske analyse blev patienter, der oplevede et flare (og som fik tocilizumab som escape-behandling) under del II, eller som udgik, klassificeret som ikke-respondenter.
English: No serious adverse reactions were observed in healthy volunteers who received a single dose up to 28 mg/kg, although dose limiting neutropenia was observed.
Danish: Der er ikke observeret alvorlige bivirkninger hos raske frivillige, som fik en enkeltdosis på op til 28 mg/kg, selvom der blev set dosisbegrænsende neutropeni.
English: In the SC Study 5.8% [3/52] developed positive neutralizing anti-tocilizumab antibodies without developing a serious or clinically significant hypersensitivity reaction.
Danish: I det subkutane studie udviklede 5,8 % (3/52) positive neutraliserende anti-tocilizumab-antistoffer uden at udvikle en alvorlig eller klinisk signifikant overfølsomhedsreaktion.
English: Additionally, proliferative lesions were not observed in a 6-month chronic toxicity study in cynomolgus monkeys or in IL-6 deficient mice.
Danish: Der blev desuden ikke observeret prolifererende læsioner i et 6-måneders kronisk toksicitetsstudie hos cynomolgusaber eller hos IL-6deficiente mus.
English: The recommended posology is subcutaneous 162 mg once every week in combination with a tapering course of glucocorticoids.
Danish: Den anbefalede dosis er 162 mg subkutant, én gang ugentligt i kombination med et nedtrapningsforløb af glukokortikoider.
English: Duration (days) Mean (SD)
Danish: Varighed (dage) Middelværdi (SD) Median
English: Physicians should be vigilant for symptoms potentially indicative of new-onset central demyelinating disorders.
Danish: Der bør udvises opmærksomhed på symptomer, som kan tyde på start af nye centrale demyeliserende sygdomme.
English: Stop breast-feeding if you are to be given RoActemra, and talk to your doctor.
Danish: Stop med at amme, hvis du skal i behandling med RoActemra og snak med din læge.
English: sJIA and pJIA Patients
Danish: sJIA og pJIA patienter
English: • Prevention of medical errors and injection/infusion reactions
Danish: • Forebyggelse af medicinske fejl og injektions/infusions-reaktioner
English: See package leaflet for further information.
Danish: Se indlægssedlen for yderligere information.
English: Rash, Pruritus, Urticaria
Danish: Udslæt, pruritus, urticaria
English: At the start, your doctor or nurse may inject RoActemra (ACTPen®).
Danish: I starten vil lægen eller sygeplejersken måske give indsprøjtningen med RoActemra (ACTPen®).
English: An increased frequency of these elevations was observed when potentially hepatotoxic drugs (e.g. MTX) were used in combination with RoActemra.
Danish: Der blev set en øget hyppighed af disse stigninger, når der blev givet potentielt hepatotoksiske lægemidler (f.eks. MTX) i kombination med RoActemra.
English: Depending on your response, your doctor may decrease your dose to 4 mg/kg then increase back to 8 mg/kg when appropriate.
Danish: Afhængig af, hvordan du reagerer, vil din læge måske nedsætte dosis til 4 mg pr. kg og om nødvendigt hæve den igen til 8 mg pr. kg.
English: • Check the expiration date on the box and syringe (See Fig. A) to make sure that it has not passed (expired).
Danish: • Check udløbsdatoen på æsken og på injektionssprøjten (se Fig. A) for at sikre, at medicinen ikke er udløbet.
English: Viral reactivation (e.g. hepatitis B virus) has been reported with biologic therapies for RA.
Danish: Viral reaktivering (f.eks. hepatitis B virus) er blevet rapporteret ved behandling af reumatoid artrit med biologiske lægemidler.
English: The radiographic response of subcutaneous administered RoActemra was assessed in a double-blind, controlled, multicenter study in patients with active RA (SC-II).
Danish: Radiografisk respons på subkutant administreret RoActemra blev vurderet i et dobbelt-blindet, kontrolleret multicenter-studie med patienter med aktiv RA (SC-II).
English: - to address the risk that patients using RoActemra may develop serious hepatic injury.
Danish: - til at gøre opmærksom på risikoen for at patienter, som får RoActemra, kan udvikle alvorlige leverskader.
English: RoActemra normalises expression of these enzymes.
Danish: RoActemra normaliserer ekspressionen af disse enzymer.
English: Important: Do not touch the needle shield which is located at the tip of the pre-filled pen below the Window area (see Figure A), to avoid accidental needle stick injury.
Danish: Vigtigt: Rør ikke ved nåleskjoldet, der sidder på spidsen af pennen, under vinduet (se figur A), da du kan komme til at stikke dig ved en fejl.
English: The effects of tocilizumab on C-reactive protein (CRP), neutrophils and signs and symptoms of infection should be considered when evaluating a patient for a potential infection.
Danish: Der skal tages hensyn til virkningen af tocilizumab på C-reaktivt protein (CRP), neutrofilocytter og symptomer på infektion, når en patient skal evalueres for en potentiel infektion.
English: In Part II, patients were randomized to tocilizumab (same dose received in Part I) or placebo in a 1:1 ratio, stratified by concurrent MTX use and concurrent corticosteroid use.
Danish: I del II blev patienterne randomiseret til tocilizumab (samme dosis som i del I) eller placebo i forholdet 1:1, stratificeret efter samtidig brug af MTX og kortikosteroid.
English: • theophylline, used to treat asthma
Danish: • theophyllin, som bruges til at behandle astma
English: Side effects could occur at least up to 3 months after your last dose of RoActemra.
Danish: Der kan forekomme bivirkninger i op til 3 måneder efter, du har fået sidste dosis RoActemra.
English: pJIA patients < 30 kg
Danish: pJIA-patienter <30 kg
English: The MAH must agree the content and format of the educational material, together with a communication plan (including means of distribution), with the national competent authority prior to distribution of the educational material.
Danish: Indehaveren af markedsføringstilladelsen skal forud for distribution af undervisningspakken blive enig med den kompetente nationale myndighed om indholdet og formatet af undervisningsmaterialet samt om en kommunikationsplan (inklusiv distributionsmetoder).