FrancophonIA/ELRC3.0 huggingface dataset:
English: Significant reduction in DAS28 from baseline (mean improvement) of 3.1-3.4 were observed in tocilizumab-treated patients compared to control patients (1.3-2.1).
Danish: Signifikant reduktion i DAS28 fra baseline (middel-forbedring) på 3,1 - 3,4 blev observeret hos de patienter, der blev behandlet med tocilizumab sammenlignet med kontrolpatienterne (1,3-2,1).
English: Serious hypersensitivity reactions have been reported in association with infusion of RoActemra (see section 4.8).
Danish: Der er indberetninger om alvorlige overfølsomhedssreaktioner i forbindelse med infusion af RoActemra (se pkt.
English: • If following insertion of the needle, you cannot press down the plunger, you must dispose of the pre-filled syringe in a puncture resistant container and use a new pre-filled syringe (starting again at Step 2).
Danish: • Hvis du ikke kan trykke injektionssprøjtens stempel ned efter at kanylen er stukket i ind huden, skal du bortskaffe den fyldte injektionssprøjte i en affaldsbeholder til skarpe genstande og en ny fyldt injektionssprøjte skal anvendes (gå tilbage til trin 2).
English: In the 52-week open-label SC Study (WA28118), neutrophil count decrease to below 1 × 109/L occurred in 23.5% of patients treated with RoActemra SC. Decreases in platelet counts to below 100 ×
Danish: I det 52-ugers åbne subkutane studie (WA28118) blev der observeret et fald i neutrofiltal til under 1 × 109/l hos 23,5 % af patienterne behandlet med subkutan RoActemra.
English: No dose adjustment is required in patients with mild renal impairment.
Danish: Dosisjustering er ikke nødvendig hos patienter med let nyreinsufficiens.
English: The mean change from baseline at week 104 in total Sharp-Genant score was significantly lower for patients randomised to tocilizumab 8 mg/kg plus MTX (p<0.0001) compared with patients who were randomised to placebo plus MTX.
Danish: Den gennemsnitlige ændring i total Sharp-Genant score fra baseline i uge 104 var signifikant lavere hos patienter randomiseret til tocilizumab 8 mg/kg plus MTX (p < 0,0001) sammenlignet med patienter, som blev randomiseret til placebo plus MTX.
English: A statistically significant superior treatment effect was seen in favour of RoActemra over adalimumab in control of disease activity from baseline to week 24 for the primary endpoint of change in DAS28 and for all secondary endpoints (Table 7).
Danish: Der blev vist en statistisk signifikant bedre behandlingseffekt af RoActemra sammenlignet med adalimumab i kontrol af sygdomsaktivitet fra baseline til uge 24, for det primære endepunkt, der var ændring i DAS28, samt for alle sekundære endepunkter (tabel 7).
English: During routine laboratory monitoring in the 12 week controlled phase, a decrease in neutrophil counts below 1 x 109/l occurred in 7% of patients in the tocilizumab group, and no decreases in the placebo group.
Danish: Under rutinemæssig laboratoriekontrol i den kontrollerede 12 ugers fase forekom der et fald i neutrofilocyttal til under 1 x 109/l hos 7 % af patienterne i tocilizumab-gruppen og hos ingen i placebogruppen.
English: • Then keep the syringe in position and let go of the pinch of skin.
Danish: • Hold injektionssprøjten i den position og slip hudfolden.
English: Tocilizumab has been shown to inhibit sIL-6R and mIL-6R-mediated signalling.
Danish: Det er vist, at tocilizumab hæmmer sIL-6R og mIL-6R-medieret signalering.
English: The mean change from baseline at week 104 in total Sharp-Genant score was significantly lower for patients randomised to RoActemra 8 mg/kg plus MTX (p<0.0001) compared with patients who were randomised to placebo plus MTX.
Danish: Den gennemsnitlige ændring i total Sharp-Genant score fra baseline i uge 104 var signifikant lavere hos patienter randomiseret til RoActemra 8 mg/kg plus MTX (p < 0,0001) sammenlignet med patienter, som blev randomiseret til placebo plus MTX.
English: After removing the pre-filled syringe from the refrigerator the pre-filled syringe should be allowed to reach room temperature (18°C to 28°C) by waiting for 25 to 30 minutes, before injecting RoActemra .
Danish: Når den fyldte injektionssprøjte er taget ud af køleskabet, skal den ligge i mindst 25-30 minutter for at blive opvarmet til stuetemperatur (18°C til 28°C) inden RoActemra injiceres.
English: Anaphylaxis (fatal)1,
Danish: Anafylaksi (dødelig) 1,2,3
English: RoActemra helps to reduce symptoms such as pain and swelling in your joints and can also improve your performance of daily tasks.
Danish: RoActemra nedsætter symptomer som f.eks. smerter og hævelse i dine led og kan medvirke til, at du nemmere kan udføre dine daglige opgaver.
English: Missed dose
Danish: Manglende dosering
English: At Week 52, the mean change in HAQ-DI was -0.58 in the tocilizumab 8 mg/kg plus MTX group compared with -0.39 in the placebo + MTX group.
Danish: Ved uge 52 var den gennemsnitlige ændring i HAQ-DI -0,58 i tocilizumab 8 mg/kg plus MTX gruppen sammenlignet med -0,39 i placebo plus MTX gruppen.
English: Administration of RoActemra should be interrupted if a patient develops a serious infection until the infection is controlled (see section 4.8).
Danish: Hvis en patient får en alvorlig infektion, skal behandlingen med RoActemra stoppes, indtil infektionen er under kontrol (se pkt.
English: What you need to know before you use RoActemra
Danish: Det skal du vide, før du begynder at tage RoActemra
English: Do not use this medicine after the expiry date which is stated on the pre-filled syringe label and carton (EXP).
Danish: Brug ikke lægemidlet efter den udløbsdato, som står på etiketten på den fyldte injektionssprøjte og den ydre karton.
English: Concentrate for solution for infusion 80 mg/4 mL
Danish: Koncentrat til infusionsvæske, opløsning 80 mg/4 ml
English: Population pharmacokinetic analyses did not detect any effect of MTX, non-steroidal antiinflammatory drugs (NSAIDs) or corticosteroids on RoActemra clearance in RA patients.
Danish: Farmakokinetiske populationsanalyser har ikke påvist, at MTX, non-steroide anti-inflammatoriske lægemidler (NSAID) eller kortikosteroider påvirker clearance af RoActemra i reumatoid artrit patienter.
English: Due to lack of clinical experience, RoActemra is not recommended for use with other biological medicines for the treatment of RA or GCA.
Danish: På grund af manglende klinisk erfaring, bør RoActemra ikke bruges sammen med andre biologiske lægemidler til behandling af leddegigt og GCA.
English: Subcutaneous
Danish: Subkutan
English: Studies I-V enrolled patients ≥ 18 years of age with active RA diagnosed according to the American College of Rheumatology (ACR) criteria and who had at least eight tender and six swollen joints at baseline.
Danish: Studie I-V inkluderede patienter ≥ 18 år med aktiv reumatoid artrit, som var diagnosticerede i henhold til American College of Rheumatology (ACR)kriterierne, og som havde mindst otte ømme led og seks hævede led ved baseline.
English: Doses exceeding 800 mg per infusion are not recommended in CRS patients.
Danish: Det kan ikke anbefales at give højere doser end 800 mg pr. infusion hos patienter med cytokinfrigivelsessyndrom.
English: During routine laboratory monitoring in the intravenous RoActemra study WA19977 3.4% and 10.4% of patients experienced a post-baseline elevation of their LDL-cholesterol value to ≥ 130 mg/dL and total cholesterol value to ≥ 200 mg/dL at any time during the study treatment, respectively.
Danish: Under rutinemæssig laboratoriekontrol i studie WA19977 med intravenøs RoActemra oplevede 3,4 % og 10,4 % af patienterne en stigning i forhold til baseline i henholdsvis LDL-kolesterol til værdier på ≥ 130 mg/dl og totalkolesterol til værdier på ≥ 200 mg/dl på et hvilket som helst tidspunkt under studiebehandlingen.
English: • the medicine is any color besides colorless to yellowish
Danish: • medicinen ikke er farveløs eller svagt gullig
English: Your doctor will have to decide if they can still be given RoActemra.
Danish: Lægen skal beslutte, om barnet alligevel kan få RoActemra.
English: Serious drug-induced liver injury, including acute liver failure, hepatitis and jaundice, have been observed with RoActemra (see section 4.8).
Danish: Der er observeret alvorlige tilfælde af lægemiddelinducerede leverskader, herunder akut leversvigt, hepatitis og gulsot, hos patienter behandlet med RoActemra (se pkt.
English: There is no experience with the use of RoActemra with TNF antagonists or other biological treatments for RA, sJIA or pJIA patients.
Danish: Der er ingen erfaring med anvendelse af RoActemra sammen med TNF-antagonister eller andre biologiske behandlinger hos patienter med reumatoid artrit eller sJIA- og pJIA-patienter.
English: Patients in the RoActemra arm received an intravenous (IV) infusion of RoActemra (8 mg/kg) every 4 weeks (q4w) and a subcutaneous (SC) placebo injection every 2 weeks (q2w).
Danish: Patienterne i RoActemra-armen fik en intravenøs infusion af RoActemra (8 mg/kg) hver 4. uge og en subkutan placebo-injektion hver 2. uge.
English: Infusion related reaction events in sJIA patients included but were not limited to rash, urticaria, diarrhoea, epigastric discomfort, arthralgia and headache pJIA Patients
Danish: Infusionsreaktioner i sJIA patienter inkluderede, men var ikke begrænset til udslæt, nældefeber, diarré, epigastrisk ubehag, artralgi og hovedpine.
English: Hypercholesterolae mia*
Danish: Hyperkolesterolæmi*
English: Figure C
Danish: Figur C
English: For persistent increases > 3 x ULN (confirmed by repeat testing, see 4.4.
Danish: Seponer behandlingen med RoActemra ved fortsat stigning til > 3 gange øvre normalgrænse (bekræftet ved gentagen testning, se pkt.
English: RoActemra has not been studied in patients with moderate to severe renal impairment (see section 5.2).
Danish: RoActemra er ikke undersøgt hos patienter med moderat til svær nyreinsufficiens (se pkt.
English: Reduction of tocilizumab dose due to laboratory abnormalities has not been studied in sJIA patients.
Danish: Reduktion af tocilizumab-dosis på grund af laboratorieanormaliteter er ikke blevet undersøgt hos patienter med sJIA.
English: Figure L
Danish: Figur L
English: Talk to your doctor, pharmacist or nurse before using RoActemra.
Danish: Kontakt lægen eller sundhedspersonalet, før du får RoActemra.
English: Once the non-linear clearance pathway is saturated, at higher RoActemra concentrations, clearance is mainly determined by the linear clearance.
Danish: Når den non-lineære clearance pathway først er mættet, ved højere koncentrationer af RoActemra, bestemmes clearance hovedsageligt af den lineære clearance.
English: *humanised IgG1 monoclonal antibody against the human interleukin-6 (IL-6) receptor produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.
Danish: *humaniseret IgG1 monoklonalt antistof mod den humane interleukin-6 (IL-6) receptor.
English: • calcium channel blockers (e.g. amlodipine), used to treat raised blood pressure
Danish: • calciumantagonist, f. eks. amlodipin, som bruges til at nedsætte blodtrykket
English: In these patients, RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.
Danish: Hos disse patienter kan RoActemra anvendes som monoterapi i tilfælde af intolerans over for MTX, eller hvor fortsat behandling med MTX er uhensigtsmæssig.
English: Fatal anaphylaxis has been reported after marketing authorisation during treatment with tocilizumab (see section 4.4).
Danish: Efter markedsføringstilladelse er letal anafylaksi rapporteret under behandling med tocilizumab (se pkt.
English: Significant reduction in DAS28 from baseline (mean improvement) of 3.1-3.4 were observed in RoActemra-treated patients compared to control patients (1.3-2.1).
Danish: Signifikant reduktion i DAS28 fra baseline (middel-forbedring) på 3,1 - 3,4 blev observeret hos de patienter, der blev behandlet med RoActemra sammenlignet med kontrolpatienterne (1,3-2,1).
English: • fluid retention (oedema) in the lower legs, weight increase
Danish: • væskeophobning (ødem) i benene, vægtøgning
English: • If you experience allergic reactions such as chest tightness, wheezing, severe dizziness or lightheadedness, swelling of the lips, tongue, face or skin itching, hives or rash during or after the injection, then tell your doctor immediately.
Danish: • Hvis du oplever allergiske reaktioner som f.eks. trykken for brystet, hvæsende vejrtrækning, svær svimmelhed eller omtågethed, hævede læber, tunge eller ansigt, hudklæe, nældefeber eller udslæt under eller efter indsprøjtningen, skal du omgående fortælle det til din læge.
English: The types of adverse drug reactions in the tocilizumab arm were consistent with the known safety profile of tocilizumab and adverse drug reactions were reported at a similar frequency compared with Table 1.
Danish: Bivirkninger i tocilizumab-armen var i overensstemmelse med den kendte sikkerhedsprofil for tocilizumab, og bivirkningerne blev rapporteret med frekvenser, der er sammenlignelige med tabel 1.
English: During the 6-month controlled clinical trials, the overall rate of gastrointestinal perforation was 0.26 events per 100 patient years with RoActemra therapy.
Danish: Under de 6-måneders kontrollerede kliniske studier var den samlede hyppighed af gastrointestinal perforation 0,26 hændelser pr. 100 patientår for RoActemra-behandling.
English: It is important to remain under your healthcare provider's care while using RoActemra.
Danish: Det er vigtigt, at du holder kontakt med lægen eller sygeplejersken mens du bruger RoActemra.
English: The types of adverse drug reactions in the RoActemra arm were consistent with the known safety profile of RoActemra and adverse drug reactions were reported at a similar frequency compared with Table 1.
Danish: Bivirkninger i RoActemra-armen var i overensstemmelse med den kendte sikkerhedsprofil for RoActemra, og bivirkningerne blev rapporteret med frekvenser, der er sammenlignelige med Tabel 1.
English: RA The recommended posology is subcutaneous 162 mg once every week.
Danish: Reumatoid artrit Den anbefalede dosis er 162 mg subkutant, én gang ugentligt.
English: Your doctor will perform blood tests before you are given RoActemra, and during your treatment, to determine if you have a low white blood cell count, low platelet count or high liver enzymes.
Danish: Før og under din behandling med RoActemra, vil lægen tage blodprøver for at undersøge, om du har et lavt antal hvide blodlegemer eller blodplader, eller om du har forhøjede leverenzymer.
English: Events of cholesterol increased were less frequently reported in the sJIA population than in the adult RA population.
Danish: Forhøjet kolesterol var mindre hyppig hos sJIA-populationen end hos voksne med reumatoid artrit.
English: Due to lack of clinical experience, RoActemra is not recommended for use with other biological medicines for the treatment of RA, sJIA, pJIA or GCA.
Danish: På grund af manglende klinisk erfaring, bør RoActemra ikke bruges sammen med andre biologiske lægemidler til behandling af leddegigt, sJIA, pJIA og GCA.
English: • Throw away used syringes in a puncture-resistant container or sharps container.
Danish: • Smid den brugte injektionssprøjte i en affaldsbeholder til skarpe genstande.
English: RoActemra 162mg SC weekly + 26 weeks prednisone taper N=100
Danish: RoActemra 162mg SC ugentligt + 26 ugers nedtrapningsregime af prednison N=100
English: Once removed from the refrigerator, RoActemra must be administered within 8 hours and should not be kept above 30°C.
Danish: Når RoActemra er taget ud af køleskabet, skal den anvendes inden for 8 timer og må ikke opbevares ved mere end 30°C.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 162 mg/0.9 mL
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 162 mg/0,9 ml
English: RoActemra 162 mg SC every other weekly + 26 weeks prednisone taper N=49
Danish: RoActemra 162 mg SC hver anden uge + 26 ugers nedtrapningsregime af prednison N=49
English: Cytokine Release Syndrome (CRS) (adults and paediatrics) The recommended posology for treatment of CRS given as a 60-minute intravenous infusion is 8 mg/kg in patients weighing greater than or equal to 30 kg or 12 mg/kg in patients weighing less than 30 kg. RoActemra can be given alone or in combination with corticosteroids.
Danish: Cytokinfrigivelsessyndrom (voksne og pædiariske patienter) Den anbefalede dosering til behandling af cytokinfrigivelsessyndrom er 8 mg/kg for patienter, der vejer 30 kg eller mere og 12 mg/kg for patienter, der vejer mindre end 30 kg, givet som en 60 minutters intravenøs infusion.
English: Do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard or not intact.
Danish: Giv ikke indsprøjtningen i en skønhedsplet, ar, blåt mærke eller et område, hvor huden er øm, rød, hård eller hvor huden ikke er intakt.
English: RA and GCA Dose adjustments due to laboratory abnormalities (see section 4.4).
Danish: Reumatoid artrit og GCA Dosisjustering på grund af laboratorieanormaliteter (se pkt.
English: Patients in the tocilizumab arm received an intravenous (IV) infusion of tocilizumab (8 mg/kg) every 4 weeks (q4w) and a subcutaneous (SC) placebo injection every 2 weeks (q2w).
Danish: Patienterne i tocilizumab-armen fik en intravenøs infusion af tocilizumab (8 mg/kg) hver 4. uge og en subkutan placebo-injektion hver 2. uge.
English: The half life of tocilizumab in sJIA patients is up to 16 days for the two body weight categories (8 mg/kg for body weight ≥ 30 kg or 12 mg/kg for body weight < 30 kg) at week 12.
Danish: Ved uge 12 er tocilizumabs halveringstid hos sJIA-patienter op til 16 dage for de to vægtkategorier (8 mg/kg for legemsvægt ≥ 30 kg eller 12 mg/kg for legemsvægt < 30 kg).
English: The most commonly reported Adverse Drug Reactions (ADRs) were upper respiratory tract infections, nasopharyngitis, headache, hypertension and increased ALT.
Danish: De hyppigst indberettede bivirkninger var øvre luftvejsinfektioner, nasopharyngitis, hovedpine, hypertension og forhøjet ALAT.
English: In SC-II, a total of 434 patients treated with RoActemra 162mg every other week were tested for antiRoActemra antibodies in the 6 month controlled period.
Danish: I SC-II-studiet blev ialt 434 patienter behandlet med RoActemra 162 mg hver anden uge testet for anti-RoActemra-antistoffer i den 6-måneders kontrollerede periode.
English: Before you use RoActemra, your doctor may do a blood test to measure your liver function.
Danish: Lægen vil måske tage en blodprøve for at undersøge din leverfunktion.
English: Very rare side effects:
Danish: Meget sjældne bivirkninger:
English: During the 6-month controlled clinical trials, the overall rate of gastrointestinal perforation was 0.26 events per 100 patient years with tocilizumab therapy.
Danish: Under de 6-måneders kontrollerede kliniske studier var den samlede hyppighed af gastrointestinal perforation 0,26 hændelser pr. 100 patientår for tocilizumab-behandling.
English: Doses of 8 mg/kg of RoActemra were given every four weeks as monotherapy.
Danish: Der blev givet doser på 8 mg/kg RoActemra hver 4. uge som monoterapi.
English: Headache, Dizziness
Danish: Hovedpine, svimmelhed
English: Numerically greater responses compared with MTX alone were observed in the tocilizumab 8 mg/kg monotherapy group in all secondary endpoints, including radiographic endpoints.
Danish: Det observerede respons var numerisk højere i tocilizumab 8 mg/kg monoterapi-gruppen for alle sekundære endepunkter, herunder de radiografiske endepunkter, sammenlignet med MTX-monoterapi-gruppen.
English: Tell your doctor if you are taking any other medicines (or your child is, if they are the patient), or have recently taken any.
Danish: Brug af anden medicin sammen med RoActemra Fortæl altid lægen, hvis du (eller dit barn) tager anden medicin eller har gjort det for nylig.
English: Рош България ЕООД Тел: +359 2 818 44 44
Danish: Тел: +359 2 818 44 44
English: During routine laboratory monitoring in the RoActemra 12 month controlled clinical trial, one patient (1%, 1/100) in the RoActemra subcutaneous weekly group had a single transient occurence of decrease in platelet count to <100 × 103 / μL without associated bleeding events.
Danish: Under rutinemæssig laboratoriekontrol i det 12 måneders kontrollerede kliniske RoActemra studie, havde en patient (1%, 1/100) i RoActemra subkutan en gang ugentlig et kortvarig fald i trombocytter til <100 × 103/μl uden forbundne blødninger.
English: Reduction of tocilizumab dosing frequency due to laboratory abnormalities has not been studied in sJIA or pJIA patients.
Danish: Reduktion af doseringshyppighed af tocilizumab på grund af laboratorieanormaliteter er ikke blevet undersøgt hos patienter med sJIA eller pJIA.
English: • The front of your thigh or your abdomen except for the 2-inch (5cm) area around your navel are the recommended injection sites (See Figure D).
Danish: • Det anbefales at give indsprøjtningen i forsiden af låret eller i maven, bortset fra området omkring navlen, som der bør holdes 5 cm afstand til (se figur D).
English: In SC-I, a total of 625 patients treated with RoActemra 162mg weekly were tested for anti-RoActemra antibodies in the 6 month controlled period.
Danish: I SC-I-studiet blev ialt 625 patienter behandlet med RoActemra 162 mg ugentligt testet for antiRoActemra-antistoffer i den 6-måneders kontrollerede periode.
English: • Do not take the next dose until you have informed your doctor AND your doctor has told you to take the next dose if you have experienced any allergic reaction symptoms after RoActemra administration.
Danish: • Hvis du oplever allergiske reaktioner efter du har taget RoActemra, skal du ikke tage næste dosis, før du har kontaktet lægen OG lægen har sagt, at du skal tage næste dosis.
English: Concentrate for solution for infusion 400 mg/20 mL
Danish: Koncentrat til infusionsvæske, opløsning 400 mg/20 ml
English: 1 vial of 20 mL
Danish: 1 hætteglas á 20 ml
English: • eye infection (conjunctivitis)
Danish: • infektion i øjnene
English: When platelet count > 100 x 103/ μL resume RoActemra dosing every other week and increase to every week injection as clinically appropriate.
Danish: Når trombocyttallet er > 100 x 103/µl, genoptages behandlingen med RoActemra med dosering hver anden uge og øges til dosering hver uge efter et klinisk skøn
English: ACR20 Week 24 Weighted difference (95% CI) ACR50 Week 24 Weighted difference (95% CI) ACR70 Week 24 Weighted difference (95% CI)
Danish: Vægtet forskel (95% konfidensinterval) ACR70 uge 24
English: In a pooled analysis of studies II, III and IV, the proportion of patients achieving an ACR 20, 50 and 70 response was significantly higher (59% vs. 50%, 37% vs. 27%, 18% vs. 11%, respectively) in the tocilizumab 8 mg/kg plus DMARD vs. the tocilizumab 4 mg/kg plus DMARD group (p< 0.03).
Danish: I en samlet analyse af studierne II, III og IV var der signifikant flere patienter, som opnåede et ACR20-, ACR50- og ACR70-respons i den gruppe, som fik tocilizumab 8 mg/kg plus DMARD, sammenlignet med den gruppe, som fik tocilizumab 4 mg/kg plus DMARD (hhv. 59 % vs. 50 %, 37 % vs. 27 %, og 18 % vs. 11 %, p < 0,03).
English: Some side effects are seen more often in children and adolescents: inflamed nose and throat, headache, feeling sick (nausea) and lower white blood cell counts.
Danish: Dog blev følgende bivirkninger set hyppigere hos børn og unge: infektion (betændelse) i næse og hals, hovedpine, kvalme samt nedsat antal hvide blodlegemer.
English: • If it is not used within 5 minutes of cap removal, the syringe must be disposed of in the puncture resistant container or sharps container and a new syringe must be used.
Danish: • Hvis den ikke anvendes inden for 5 minutter efter at hætten er fjernet, skal injektionssprøjten smides i affaldsbeholderen for skarpe genstande, og en ny injektionssprøjte skal anvendes.
English: • Low platelet count Laboratory Value (cells x 103/µL)
Danish: • Lavt trombocyttal Laboratorieværdi (celler x 103/µl)
English: > 3 x ULN to 5x ULN
Danish: > 5 x øvre normalgrænse
English: In the monotherapy study the rate of serious infections was 3.6 events per 100 patient years of exposure in the RoActemra group and 1.5 events per 100 patient years of exposure in the MTX group.
Danish: I monoterapi-studiet var hyppigheden af alvorlige infektioner 3,6 hændelser pr. 100 patientår i RoActemra-gruppen og 1,5 hændelser pr. 100 patientår i MTX-gruppen.