FrancophonIA/ELRC3.0 huggingface dataset:
English: The physician's global assessment of disease activity, as measured on a 0-100 mm scale, showed a greater reduction in disease activity for tocilizumab compared to placebo (adjusted mean changes of -45.2 mm vs -35.2 mm, p=0.0031).
Danish: Lægernes globale vurdering af sygdomsaktivitet, målt på en 0-100 mm skala, viste en større reduktion i sygdomsaktivitet for tocilizumab sammenlignet med placebo (justerede gennemsnitlige ændringer på -45,2 mm versus -35,2 mm; p=0,0031).
English: Sustained remission (Tocilizumab groups vs Placebo+52) Responders at Week 52, n (%) Unadjusted difference in proportions (99.5% CI)
Danish: Vigtigste sekundære endepunkt Vedvarende remission (Tocilizumab grupper vs Placebo+52) Respondenter ved uge 52, n (%) Ikke justeret forskel i proportioner (99.5% konfidensinterval)
English: Steady state was reached after 12 weeks for AUC and Cmin, and after 10 weeks for Cmax.
Danish: Steadystate for AUC og Cmin blev nået efter 12 uger og efter 10 uger for Cmax.
English: Patients should inform their doctor immediately if they experience signs and symptoms of liver toxicity including tiredness, abdominal pain and jaundice.
Danish: Patienterne skal gøres opmærksom på at kontakte lægen straks, hvis de oplever nogen tegn og symptomer på levertoksicitet inklusive træthed, mavesmerter og gulsot.
English: Pack sizes of 1 and 4 vials.
Danish: Pakningsstørrelser af 1 og 4 hætteglas.
English: As recommended for other biological treatments, RA, sJIA and pJIA patients should be screened for latent tuberculosis (TB) infection prior to starting RoActemra therapy.
Danish: Som det er anbefalet for andre biologiske behandlinger, skal RA-, sJIA- og pJIA-patienter undersøges for latent tuberkulose, før behandlingen med RoActemra påbegyndes.
English: A “click” sound indicates the start of the injection.
Danish: Når du hører en klik-lyd, er indsprøjtningen gået i gang.
English: TCZ SC 162 mg every week + DMARD N=558
Danish: Tocilizumab SC 162 mg ugentligt + DMARD N = 558
English: If the plunger is not fully depressed the needle shield will not extend to cover the needle when it is removed.
Danish: Hvis stemplet ikke er skubbet helt i bund, vil beskyttelseshylsteret ikke glide frem og dække kanylen, når den trækkes ud.
English: The frequency category was estimated as the upper limit of the 95% confidence interval calculated on the basis of the total number of patients exposed to TCZ in clinical trials.
Danish: Hyppighedskategorien for bivirkninger, som kun er indberettet efter markedsføringen, er defineret som den øvre grænse af 95% konfidensintervallet beregnet på basis af det totale antal patienter behandlet med tocilizumab i kliniske studier.
English: L-Histidine monohydrochloride monohydrate L-Arginine
Danish: L-Histidinmonohydrochloridmonohydrat L-Arginin
English: These ISRs occurred in a 44% of patients ≥30 kg compared to 14.8% of patients below 30 kg.
Danish: Hos patienterne på ≥ 30 kg oplevede 44 % reaktioner på injektionsstedet sammenlignet med 14,8 % af dem under 30 kg.
English: RoActemra has been shown to slow the damage to the cartilage and bone of the joints caused by the disease and to improve your ability to do normal daily activities.
Danish: RoActemra er vist at kunne forsinke skaden på brusk og knogler i leddene, som sygdommen forårsager, samt forbedre din evne til at udføre normale daglige aktiviteter.
English: The addition of potentially hepatotoxic drugs (e.g. MTX) to tocilizumab monotherapy resulted in increased frequency of these elevations.
Danish: Tillæg af potentielt hepatotoksiske lægemidler (f.eks. MTX) til tocilizumab monoterapi medførte en øget hyppighed af disse stigninger.
English: The majority (67%) of patients were MTX-naïve.
Danish: De fleste patienter (67 %) havde ikke tidligere fået MTX.
English: Therefore, RoActemra doses exceeding 800 mg per infusion are not recommended (see section 4.2).
Danish: RoActemra doser over 800 mg per infusion anbefales derfor ikke (se pkt 4.2).
English: The total content (0.9 mL) of the pre-filled syringe should be administered as a subcutaneous injection.
Danish: Alt indholdet (0,9 ml) i den fyldte injektionssprøjte skal administreres som subkutan injektion.
English: Roche Pharma AG Emil-Barell-Strasse 1 D-79639 Grenzach-Wyhlen Germany
Danish: Roche Pharma AG Emil-Barell-Strasse 1 D-79639 Grenzach-Wyhlen Tyskland
English: The safety profile of tocilizumab has been studied in 4 placebo-controlled studies (studies II, III, IV and V), 1 MTX-controlled study (study I) and their extension periods (see section 5.1).
Danish: Sikkerhedsprofilen af tocilizumab er blevet undersøgt i 4 placebokontrollerede studier (studierne II, III, IV og V), 1 MTX-kontrolleret studie (studie I) og i efterfølgende forlængelsesstudier (se pkt.
English: You should check with your doctor, pharmacist or nurse if you are not sure.
Danish: Spørg lægen, apotekspersonalet eller sundhedspersonalet, hvis du ikke er sikker.
English: Your doctor will have to decide if you can still be given RoActemra.
Danish: Lægen vil tage stilling til, om du stadig kan behandles med RoActemra.
English: In the open-label extension of Study II the inhibition of progression of structural joint damage in tocilizumab plus MTX-treated patients was maintained in the second year of treatment.
Danish: I den åbne forlængelse af studie II blev hæmningen af strukturel ledskadeprogression hos patienter behandlet med tocilizumab plus MTX opretholdt i det andet behandlingsår.
English: No (N = 58)
Danish: Nej (n = 58)
English: Patient advice regarding hypersensitivity reactions (also known as anaphylaxis, if severe)
Danish: Råd til patienter vedrørende allergiske reaktioner (kaldes i svære tilfælde også anafylaksi)
English: RoActemra has minor influence on the ability to drive and use machines (see section 4.8, dizziness).
Danish: RoActemra påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner (se pkt.
English: No (N = 55)
Danish: Nej (n = 55)
English: Such reactions may be more severe, and potentially fatal in patients who have experienced hypersensitivity reactions during previous infusions even if they have received premedication with steroids and antihistamines.
Danish: Sådanne reaktioner kan være mere alvorlige og muligvis letale hos patienter, som har oplevet overfølsomhedsreaktioner under tidligere infusioner, selv hvis de er præmedicineret med steroider og antihistaminer.
English: The addition of potentially hepatotoxic drugs (e.g. MTX) to RoActemra monotherapy resulted in increased frequency of these elevations.
Danish: Tillæg af potentielt hepatotoksiske lægemidler (f.eks. MTX) til RoActemra monoterapi medførte en øget hyppighed af disse stigninger.
English: In the 12 week controlled phase, the rate of all infections in the intravenous RoActemra group was 344.7 per 100 patient years and 287.0 per 100 patient years in the placebo group.
Danish: I den kontrollerede 12 ugers fase var hyppigheden af alle infektioner i intravenøs RoActemra-gruppen 344,7 per 100 patientår og i placebogruppen 287,0 per 100 patientår.
English: Radiographic Endpoints (mean change from baseline)
Danish: Radiografiske endepunkter (gennemsnitsændring fra baseline) Uge 52
English: The risk of malignancy is increased in patients with RA.
Danish: Risikoen for malignitet er forhøjet hos patienter med reumatoid artrit.
English: After week 52, all patients could receive open-label treatment with tocilizumab 8 mg/kg.
Danish: Efter uge 52 kunne alle patienterne få åben behandling med tocilizumab 8 mg/kg.
English: Caution should be exercised when considering initiation of RoActemra treatment in patients with a low platelet count (i.e. platelet count below 100 x 103/ μL).
Danish: Der skal udvises forsigtighed, hvis det overvejes at påbegynde behandling med RoActemra hos patienter med lavt trombocyttal (dvs. trombocyttal < 100 x 103/μl).
English: RoActemra subcutaneous injection is not recommended for use in children under 1 year of age.
Danish: RoActemra subkutan injektion bør ikke anvendes til børn under 1 år.
English: The median doses for escape patients in the RoActemra weekly and every other weekly groups were 3129.75 mg and 3847 mg, respectively.
Danish: Mediandoserne til escape-patienter, der enten fik RoActemra ugentligt eller hver anden uge var henholdsvis 3129,75 mg og 3847 mg.
English: Following SC dosing in pJIA patients, the absorption half-life was around 2 days, and the bioavailability for the SC formulation in pJIA patients was 96%.
Danish: Efter subkutan dosering til pJIA-patienter var absorptionshalveringstiden omkring 2 dage, og biotilgængeligheden for den subkutane formulering hos pJIA-patienterne var 96 %.
English: RoActemra is used to improve the symptoms of pJIA and can be given in combination with methotrexate or alone.
Danish: RoActemra anvendes til at lindre symptomerne på pJIA og kan gives i kombination med methotrexat eller alene.
English: • The recommended injection sites are the front and middle of your thighs and the lower part of the abdomen below the navel (belly button) except for the five centimeter area directly around the navel.
Danish: • Det anbefales at give indsprøjtningen foran og midt på låret og i den nederste del af maven, under navlen, i ca. 5 cm afstand fra navlen (se Fig. B)
English: This study evaluated the efficacy of IV tocilizumab 4 or 8 mg/kg every 4 weeks/MTX combination therapy, IV tocilizumab 8 mg/kg monotherapy and MTX monotherapy in reducing the signs and symptoms and rate of progression of joint damage for 104 weeks.
Danish: Studiet undersøgte effekten af intravenøs tocilizumab 4 eller 8 mg/kg hver 4. uge /MTX-kombinationsbehandling, intravenøs tocilizumab-monoterapi 8 mg/kg og MTX-monoterapi med henblik på at nedsætte tegn og symptomer og progressionshastigheden af ledskader i 104 uger.
English: The overall clinical adverse event profile was similar between RoActemra and adalimumab.
Danish: Den overordnede kliniske bivirkningsprofil for RoActemra og adalimumab var sammenlignelig.
English: • Return any remaining pre-filled pens in the box to the refrigerator.
Danish: • Lad resterende fyldte penne blive i æsken og læg æsken tilbage i køleskabet.
English: Immune system disorders
Danish: Sygdomme i immunsystemet
English: • Hold your RoACTEMRA pre-filled pen with the green cap pointing down (See Figure C).
Danish: • Hold den fyldte RoActerma-pen med den grønne hætte nedad (se figur C).
English: • mouth or skin blisters
Danish: • blister i munden eller på huden
English: PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate).
Danish: Koncentrat til infusionsvæske, opløsning (sterilt koncentrat).
English: Forty (80%) of these patients had an increase in their haemoglobin to within the normal range at week 12, in comparison to 2 out of 29 (7%) of placebo treated patients with haemoglobin < LLN at baseline (p<0.0001).
Danish: Ved uge 12 havde 40 (80 %) af disse patienter en stigning i deres hæmoglobin til inden for normalområdet mod kun 2 ud af 29 (7 %) placebobehandlede patienter med hæmoglobin < nedre normalgrænse ved baseline (p < 0,0001).
English: Exploratory efficacy results showed that RoActemra SC improved all exploratory efficacy parameters including Juvenile Arthritis Disease Activity Score (JADAS)-71, for TCZ naïve patients and maintained all exploratory efficacy parameters for patients who switched from RoActemra IV to RoActemra SC treatment over the entire course of the study for patients in both body weight groups
Danish: Eksploratoriske effektresultater viste, at subkutan RoActemra øgede alle eksploratoriske effektparametre inklusiv Juvenile Arthiritis Disease Activity Score (JADAS) -71 hos RoActemra naive patienter og opretholdt alle eksploratoriske effektparametre hos patienter, som skiftede fra intravenøs til subkutan RoActemra behandling, under hele studieforløbet, hos patienter i begge vægtklasser
English: In clinical trials, tocilizumab has not been studied in patients during an episode of active MAS.
Danish: Tocilizumab er ikke blevet undersøgt i kliniske forsøg hos patienter under en episode med aktiv MAS.
English: Events of cholesterol increased were less frequently reported in the pJIA population than in the adult RA population.
Danish: Forhøjet kolesterol var mindre hyppig rapporteret hos pJIA-populationen end hos voksne med reumatoid artrit.
English: Do not touch the injection site again before giving the injection.
Danish: Rør ikke ved den rensede hud igen før indsprøjtningen er givet.
English: The excretion of RoActemra in milk has not been studied in animals.
Danish: Udskillelsen af RoActemra i mælk er ikke undersøgt i dyreforsøg.
English: Health related and quality of life outcomes
Danish: Effekten på sundhed og livskvalitet
English: The percent of patients achieving JIA ACR 30, 50, 70 and 90 responses are shown in Table 7.
Danish: Procentdelen af patienter, som opnåede JIA ACR30-, ACR50-, ACR70- og ACR90-respons vises i tabel 7:
English: The overall clinical adverse event profile was similar between tocilizumab and adalimumab.
Danish: Den overordnede kliniske bivirkningsprofil for tocilizumab og adalimumab var sammenlignelig.
English: Exploratory efficacy results showed that RoActemra SC improved median Juvenile Arthritis Disease Activity Score (JADAS)-71 for RoActemra naïve patients and maintained the median JADAS-71 for patients who switched from IV to SC RoActemra treatment over the entire course of the study for patients in both body weight groups (below 30 kg and ≥ 30 kg).
Danish: Eksploratoriske effektresultater viste, at subkutan RoActemra øgede den mediane Juvenile Arthiritis Disease Activity Score (JADAS) -71 hos RoActemra naive patienter og opretholdt den mediane JADAS-71 hos patienter, som skiftede fra intravenøs til subkutan behandling, under hele studieforløbet, hos patienter i begge vægtklasser (under 30 kg og ≥ 30 kg).
English: Patients in study SC-I had a mean Disease Activity Score (DAS28) at baseline of 6.6 and 6.7 on the subcutaneous and intravenous arms, respectively.
Danish: Patienterne i SC-I-studiet havde en gennemsnitlig sygdomsaktivitetsscore (DAS28) ved baseline på 6,6 og 6,7 i henholdsvis den subkutane og den intravenøse behandlingsarm.
English: • Look in the clear Window area.
Danish: • Kig på pennens vindue.
English: Of these 51 patients, 26 (51%) were naive to RoActemra and 25 (49%) had been receiving RoActemra IV and switched to RoActemra SC at baseline.
Danish: Ud af disse 51 patienter var 26 patienter (51 %) RoActemra naive, mens 25 (49 %) blev skiftet fra intravenøs til subkutan RoActerma ved baseline.
English: • Fatal Allergic Reactions (Anaphylaxis [fatal])
Danish: • Dødelig allergisk reaktion (anafylaksi ([dødelig])
English: Patients with sJIA must have a minimum body weight of 10 kg when receiving RoActemra subcutaneously (see section 4.2).
Danish: Patienter med sJIA skal have en kropsvægt på mindst 10 kg ved behandling med RoActemra subkutant (se pkt.
English: Interstitial Lung Disease
Danish: Interstitiel lungesygdom
English: • If you cannot remove the green cap you should ask a caregiver for help or contact your healthcare provider.
Danish: • Hvis du ikke kan få den grønne hætte af, skal du bede en anden om hjælp eller kontakte sundhedspersonalet.
English: Systemic Effects In the tocilizumab treated patients, 85% who had fever due to sJIA at baseline were free of fever (no temperature recording ≥ 37.5°C in the preceding 14 days) at week 12 versus 21% of placebo patients
Danish: Hos tocilizumab-behandlede patienter var 85 % af de patienter, som havde feber på grund af sJIA ved baseline, feberfri (ingen temperaturmåling ≥ 37,5 °C i de forudgående 14 dage) ved uge 12 versus kun 21 % af placebo-patienterne (p < 0,0001).
English: Concomitant administration of a single dose of 10 mg/kg tocilizumab with 10-25 mg MTX once weekly had no clinically significant effect on MTX exposure.
Danish: Samtidig administration af en enkeltdosis tocilizumab på 10 mg/kg og MTX 10-25 mg én gang ugentlig havde ingen klinisk signifikant virkning på eksponeringen af MTX.
English: • If you see drops of blood at the injection site, you can press a sterile cotton ball or gauze over the injection site for approximately 10 seconds.
Danish: • Hvis der er dråber af blod ved injektionsstedet, kan du presse lidt vat eller gaze på i ca. 10
English: The developed model had the same structure as the population PK model developed earlier based on data from RA patients (see Table 8).
Danish: Den udviklede model havde samme struktur som den tidligere udviklede farmakinetiske-model baseret på data fra reumatoid artrit patienter (se tabel 8).
English: The t1/2 of tocilizumab was concentration-dependent.
Danish: Tocilizumabs halveringstid (t1/2) var koncentrationsafhængig.
English: A place to prepare your supplies: • Find a well-lit, clean, flat surface such as a table
Danish: • Vælg en godt oplyst, ren, flad overflade, fx et bord
English: Increases in haemoglobin levels were observed, through tocilizumab decreasing the IL-6 driven effects on hepcidin production to increase iron availability.
Danish: Der blev set stigninger i hæmoglobinkoncentrationen, fordi tocilizumab nedsatte den af IL-6 medierede virkning på hepcidinproduktionen, hvorved tilgængeligheden af jern blev øget.
English: Effects on endocrine active and reproductive system organs were not observed in a chronic cynomolgus monkey toxicity study and reproductive performance was not affected in IL-6 deficient mice.
Danish: I et kronisk toksicitetsstudie hos cynomolgusaber blev der ikke set virkninger på endokrint aktive organer og organer i det reproduktive system, og reproduktionsevnen var ikke påvirket hos IL-6-deficiente mus.
English: • Do not touch the needle or let it touch any surface.
Danish: • Rør ikke ved kanylen, og lad ikke kanylen røre ved noget.
English: Age, gender and ethnicity: Population pharmacokinetic analyses in RA patients, showed that age, gender and ethnic origin did not affect the pharmacokinetics of tocilizumab.
Danish: Alder, køn og etnicitet: Populationsfarmakokinetiske analyser af patienter med reumatoid artrit viste, at alder, køn og race ikke påvirkede tocilizumabs farmakokinetik.
English: Do not use RoActemra pre-filled pen if the box looks damaged.
Danish: Brug ikke de fyldte penne, hvis æsken ser beskadiget ud.
English: Such reactions may be more severe, and potentially fatal in patients who have experienced hypersensitivity reactions during previous treatment with RoActemra even if they have received premedication with steroids and antihistamines.
Danish: Sådanne reaktioner kan være mere alvorlige og muligvis dødelige hos patienter, som har oplevet overfølsomhedsreaktioner under tidligere behandlinger med RoActemra, selv hvis de er præmedicineret med steroider og antihistaminer.
English: Inhibition of joint structural damage was shown with significantly less radiographic progression in patients receiving tocilizumab compared to control (Table 4).
Danish: Der blev vist hæmning af strukturel ledbeskadigelse med signifikant mindre radiografisk progression hos de patienter, som fik tocilizumab, sammenlignet med kontrolgruppen (tabel 4).
English: Following SC dosing in sJIA patients, the absorption half-life was around 2 days, and the bioavailability for the SC formulation in sJIA patients was 95%.
Danish: Efter subkutan dosering til sJIA-patienter var absorptionshalveringstiden omkring 2 dage, og biotilgængeligheden for den subkutane formulering hos sJIA-patienterne var 95 %.
English: Pack size of 1 and 4 vials.
Danish: Pakningsstørrelser på 1 og 4 hætteglas.
English: This was not observed in either of the placebo plus prednisone taper groups.
Danish: Dette blev ikke observeret i nogen af grupperne, der fik placebo plus nedtrappende prednison-dosis.
English: The developed model had the same structure as the population PK model developed earlier based on data from RA patients (see Table 10).
Danish: Den udviklede model havde samme struktur som den tidligere udviklede farmakinetiske-model baseret på data fra reumatoid artrit patienter (se tabel 10).
English: • Choose a different injection site for each new injection at least 1 inch (2.5cm) from the last area you injected.
Danish: • Giv indsprøjtningen et nyt sted hver gang, mindst 2,5 cm fra hvor du gav den sidst.
English: Thus, CYP450 expression may be reversed when potent cytokine inhibitory therapy, such as tocilizumab, is introduced.
Danish: Ekspression af CYP450 kan derfor reverteres, hvis der initieres behandling med potente cytokinhæmmere f.eks. tocilizumab.
English: • Do not rub the injection site.
Danish: • Massér ikke injektionsstedet.
English: Children and adolescents RoActemra is not recommended for use in children under 2 years of age.
Danish: Børn og unge RoActemra bør ikke anvendes til børn under 2 år.
English: DMARD - Disease modifying anti-rheumatic drug - p< 0.01, TCZ vs. PBO + MTX/DMARD - p< 0.0001, TCZ vs. PBO + MTX/DMARD
Danish: DMARD - Sygdomsmodificerende antireumatisk middel - p < 0,01, tocilizumab vs. placebo + MTX / DMARD - p < 0,0001, tocilizumab vs. placebo + MTX /DMARD
English: At week 24, a significant reduction in DAS28 from baseline (mean improvement) of 3.5 was observed on both treatment arms, and a comparable proportion of patients had achieved DAS28 clinical remission (DAS28 < 2.6) on the subcutaneous (38.4%) and IV (36.9%) arms.
Danish: Ved uge 24 sås en signifikant reduktion i DAS28 fra baseline (gennemsnitlig forbedring) på 3,5 i begge behandlingsarme og en sammenlignelig andel af patienter havde opnået DAS28 klinisk remission (DAS28 < 2,6) i den subkutane (38,4%) og intravenøse (36,9%) arm.
English: The safety of RoActemra has been studied in 4 placebo-controlled studies (studies II, III, IV and V), 1 MTX-controlled study (study I) and their extension periods (see section 5.1).
Danish: RoActemras sikkerhed er blevet undersøgt i 4 placebokontrollerede studier (studierne II, III, IV og V), 1 MTX-kontrolleret studie (studie I) og i efterfølgende forlængelsesstudier (se pkt.
English: RoActemra is used to improve the symptoms of sJIA and can be given in combination with methotrexate or alone.
Danish: RoActemra anvendes til at lindre symptomerne på sJIA og kan gives i kombination med methotrexat eller alene.
English: Neurological disorders
Danish: Neurologiske hændelser
English: Approximately half of the patients who developed an ANC < 1 x 109/ L did so within 8 weeks after starting therapy.
Danish: Ca. halvdelen af de patienter, som udviklede absolut neutrofilocyttal < 1 x 109/L, fik det indenfor 8 uger efter behandlingens start.
English: • the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more diseasemodifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists.
Danish: • til behandling af moderat til svær aktiv RA hos voksne patienter, som enten har haft utilstrækkelig respons på, eller som ikke har tolereret tidligere behandling med en eller flere af de sygdomsmodificerende antireumatiske lægemidler (DMARDs) eller tumornekrosefaktor(TNF)-antagonister.
English: For persistent increases in this range, reduce RoActemra dose frequency to every other week injection or interrupt RoActemra until alanine aminotransferase (ALT) or aspartate aminotransferase (AST) have normalised.
Danish: Ved vedvarende stigning i dette interval nedsæt doseringshyppighed af RoActemra til hver anden uge eller stop behandlingen med RoActemra indtil alaninaminotransferase (ALAT) eller aspartataminotransferase (ASAT) er normaliseret
English: • high blood fat (cholesterol) levels.
Danish: • højt indhold af fedt (kolesterol) i blodet.
English: If the pre-filled pen does not reach room temperature, this could cause your injection to feel uncomfortable and it could take longer to inject.
Danish: Hvis den fyldte pen ikke har stuetemperatur, kan indsprøjtningen tage længere tid og være ubehagelig.
English: • Hold the needle-shield of the syringe firmly with one hand and pull off the needle-cap with the other hand.
Danish: • Hold fast i injektionssprøjtens beskyttelseshylster med én hånd og træk kanylehætten af med den anden hånd (se Fig. D).