FrancophonIA/ELRC3.0 huggingface dataset:
English: Four (2.5%) patients in the tocilizumab arm and two (1.2%) patients in the adalimumab arm experienced CTC grade 3 or 4 neutrophil count decreases.
Danish: Fire (2,5 %) patienter i tocilizumab-armen og to (1,2 %) patienter i adalimumab-armen oplevede et fald i neutrofiltal af CTC grad 3 eller 4.
English: In Study II, in patients with an inadequate response to MTX, inhibition of structural joint damage was assessed radiographically and expressed as change in modified Sharp score and its components, the erosion score and joint space narrowing score.
Danish: I studie II, som var på patienter, der havde utilstrækkeligt respons på MTX, blev hæmningen af strukturel ledbeskadigelse vurderet radiografisk.
English: The most common ISRs were injection site erythema, swelling, hematoma, pain and pruritis.
Danish: De mest almindelige reaktioner på injektionsstedet var erythem, pruritus, smerte og hævelse.
English: As there are many co-morbid conditions that may effect laboratory values in sJIA or pJIA, the decision to discontinue tocilizumab for a laboratory abnormality should be based upon the medical assessment of the individual patient.
Danish: Da der ved sJIA eller pJIA er mange komorbide tilstande, som kan påvirke laboratorieværdierne, skal beslutningen om at seponere tocilizumab på grund af en laboratorieanormalitet baseres på en medicinsk vurdering af den enkelte patient.
English: RA and GCA patients demonstrate a comparable (to healthy subjects) decrease of absolute neutrophil counts following RoActemra administration (see section 4.8).
Danish: Reumatoid artrit og GCA patienter udviste et lignende fald i det absolutte neutrofilocyttal efter administration af RoActemrasom raske forsøgspersoner (se pkt.
English: Peripheral oedema Hypersensitivity reaction, Injection site reaction
Danish: Perifert ødem, overfølsomhedsreaktioner, reaktioner på administrationsst edet
English: For subcutaneous administration, the effective t1/2 is up to 13 days for 162 mg every week and 5 days for 162 mg every other week in patients with RA at steady-state.
Danish: Ved subkutan administration er den effektive t1/2 ved steady-state op til 13 dage for 162 mg ugentligt og 5 dage for 162 mg hver anden uge hos patienter med RA.
English: Step 3.
Danish: Trin 3.
English: Keep the pre-filled syringes in the outer carton to protect it from light and keep them dry.
Danish: Opbevar de fyldte injektionssprøjter i æsken for at beskytte dem mod lys og holde dem tørre.
English: In GCA patients, the central volume of distribution was 4.09 L, the peripheral volume of distribution was 3.37 L, resulting in a volume of distribution at steady state of 7.46 L.
Danish: Hos GCA-patienter var det centrale fordelingsvolumen 4,09 L, og det perifere fordelingsvolumen 3,37 L, hvilket resulterede i et fordelingsvolumen ved steady-state på 7,46 L.
English: The efficacy of RoActemra in alleviating the signs and symptoms of RA was assessed in five randomised, double-blind, multi-centre studies.
Danish: RoActemras virkning på reduktion af symptomerne på reumatoid artrit blev undersøgt i fem randomiserede, dobbeltblindede multicenterstudier.
English: *τ = 2 week or 1 week for the two SC regimens
Danish: *τ = 2 uger eller 1 uge for de to subkutane regimer
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 400 mg/20 mL
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 400 mg/20 ml
English: Four (2.5%) patients in the RoActemra arm and two (1.2%) patients in the adalimumab arm experienced CTC grade 3 or 4 neutrophil count decreases.
Danish: Fire (2,5 %) patienter i RoActemra-armen og to (1,2 %) patienter i adalimumab-armen oplevede et fald i neutrofiltal af CTC grad 3 eller 4.
English: After IV dosing, approximately 90% of the steady-state was reached by week 8 for both the 12 mg/kg (BW < 30 kg) and 8 mg/kg Q2W (BW ≥ 30 kg) regimens.
Danish: Efter intravenøs dosering, var ca. 90 % af steady-state opnået ved uge 8 for både 12 mg/kg (legemsvægt < 30 kg) og 8 mg/kg (legemsvægt ≥ 30 kg), ved doseringsregimer på hver 2. uge.
English: • body aches, fever, chills
Danish: • ondt i kroppen, feber, kulderystelser
English: • Wipe the injection site with an alcohol pad in a circular motion and let it air dry to reduce the chance of getting an infection.
Danish: • Rens stedet med en spritserviet ved at tørre huden af i en cirkulær bevægelse.
English: Ask your healthcare provider any questions you may have.
Danish: Spørg lægen eller sundhedspersonalet, hvis der er noget, du er i tvivl om
English: For study I (SC-I), patients were required to be >18 years of age with moderate to severe active RA diagnosed according to ACR criteria who had at least 4 tender and 4 swollen joints at baseline.
Danish: I studie I (SC-I) skulle patienterne være >18 år gamle og have moderat til svær aktiv RA diagnosticeret i overensstemmelse med ACR-kriterier og med mindst 4 ømme og 4 hævede led ved baseline.
English: • RoActemra is used to treat children with sJIA.
Danish: • RoActemra anvendes til at behandle børn med aktiv systemisk juvenil idiopatisk artrit (sJIA).
English: Paediatric population sJIA Patients
Danish: Pædiatrisk population sJIA-patienter
English: In general, the adverse drug reactions in patients with sJIA were similar in type to those seen in RA patients (see Undesirable Effects section above).
Danish: Generelt var bivirkningerne hos patienter med sJIA svarende til dem set hos patienter med reumatoid artrit (se punktet ”Bivirkninger” ovenfor).
English: Maintain dose.
Danish: Fortsæt med samme dosis
English: *τ = 2 week or 3 week for the two SC regimens
Danish: *τ = 2 eller 3 uger for de to subkutane regimer
English: • difficulty with breathing, chest tightness or light-headedness
Danish: • problemer ved at trække vejret, trykken for brystet og svimmelhed
English: 4 vials of 4 mL
Danish: 4 hætteglas á 4 ml
English: • Do not reuse the same pre-filled pen.
Danish: • Sæt ikke hætten på den brugte pen igen.
English: Treatment should be initiated by healthcare professionals experienced in the diagnosis and treatment of RA, sJIA, pJIA and / or GCA.
Danish: Behandling bør påbegyndes af speciallæger med erfaring i diagnostik og behandling af reumatoid artrit, sJIA, pJIA og/eller GCA.
English: Eligible patients received RoActemra dosed according to body weight (BW), with patients weighing
Danish: Egnede patienter fik doseret RoActemra i forhold til kropsvægt.
English: Dose interruptions of tocilizumab for the following laboratory abnormalities are recommended in sJIA patients in the tables below.
Danish: Afbrydelser i doseringen af tocilizumab på grund af laboratorieanormaliteter anbefales hos patienter med sJIA som angivet i tabellerne nedenfor.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE LABEL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER Etiket på fyldt injektionssprøjte
English: The proportion of patients achieving a DAS28 clinical remission (DAS28 < 2.6) was significantly higher in patients receiving RoActemra (28-34%) compared to 1-12% of control patients at 24 weeks.
Danish: Efter 24 uger var der signifikant flere patienter i RoActemra-gruppen (28-34 %), som opnåede DAS28 klinisk remission DAS28 (DAS28 < 2,6), sammenlignet med gruppen af kontrolpatienter (1-12 %).
English: NAME OF THE MEDICINAL PRODUCT RoActemra 20 mg/mL concentrate for solution for infusion.
Danish: LÆGEMIDLETS NAVN RoActemra 20 mg/ml, koncentrat til infusionsvæske, opløsning
English: After SC dosing, approximately 90% of the steady-state was reached by week 12 for both the 162 mg QW and Q2W regimens.
Danish: Efter subkutan dosering, var ca. 90 % af steady-state opnået ved uge 12 for både doseringsregimet 162 mg hver uge og doseringsregimet 162 mg hver 2. uge.
English: *τ = 1 week or 2 weeks for the two SC regimens
Danish: AUCτ* *τ = 1 uge eller 2 uger for de to subkutane regimer
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 80 mg/4 mL
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 80 mg/4 ml
English: For storage conditions of the diluted medicinal product see section 6.3.
Danish: Opbevaringsforhold efter fortynding af lægemidlet, se pkt.
English: In RA and GCA patients, assessment of lipid parameters should be performed 4 to 8 weeks following initiation of RoActemra therapy.
Danish: Hos patienter med reumatoid artrit og GCA bør lipidparametrene vurderes 4 til 8 uger efter, at behandlingen med RoActemra er påbegyndt.
English: EXP 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: Clear to opalescent, colourless to pale yellow solution.
Danish: Klar til opaliserende, farveløs til lysegul opløsning.
English: Vigilance for the timely detection of serious infection is recommended for patients receiving immunosuppressive agents such as RoActemra for moderate to severe RA or GCA as signs and symptoms of acute inflammation may be lessened, due to suppression of the acute phase reactants.
Danish: De patienter, som får immunsuppresive midler, som RoActemra, for moderat til svær reumatoid artrit eller GCA, skal overvåges for at opdage alvorlige infektioner i tide, da symptomer på akut inflammation kan mindskes på grund af suppression af akutfasereaktionen.
English: • Do not touch the syringe trigger fingers as this may damage the syringe
Danish: • Rør ikke ved injektionssprøjtens aktiveringsknap, da det kan beskadige injektionssprøjten
English: Check the liquid in the RoACTEMRA pre-filled pen (See Figure C).
Danish: Check at væsken i den fyldte RoActemra-pen (se figur C) er klar og farveløs til svagt gullig.
English: Dose adjustments due to laboratory abnormalities (see section 4.4).
Danish: Dosisjustering på grund af laboratorieanormaliteter (se pkt.
English: Injection into muscle could result in an uncomfortable injection.
Danish: Hvis du kommer til at give indsprøjtningen i muskelvæv, kan det være ubehageligt.
English: All ISRs reported were non-serious Grade 1 events, and none of the ISRs required patient withdrawal from treatment or dose interruption.
Danish: Alle reaktioner ved injektionsstedet blev rapporteret som ikke-alvorlige grad 1 bivirkninger og ingen krævede seponering af behandlingen eller afbrydelse af doseringen.
English: These are common: they may affect up to 1 in every 10 users
Danish: Disse er almindelige og forekommer hos op til 1 ud af 10 patienter
English: Available non-clinical data do not suggest an effect on fertility under tocilizumab treatment.
Danish: De foreliggende non-kliniske data tyder ikke på en virkning på fertiliteten under behandling med tocilizumab.
English: The recommended posology in patients above 1 year of age is subcutaneous 162 mg once every week in patients weighing greater than or equal to 30 kg or subcutaneous 162 mg once every 2 weeks in patients weighing less than 30 kg.
Danish: Den anbefalede dosis for patienter over 1 år er 162 mg sukutant én gang hver uge for patienter, som vejer 30 kg eller mere, eller 162 mg subkutant én gang hver 2. uge for patienter, som vejer mindre end 30 kg.
English: The safety observed in the tocilizumab arm was consistent with the known safety profile of RoActemra and no new or unexpected adverse drug reactions were observed (see Table 1).
Danish: Sikkerheden observeret i tocilizumab-armen var konsistent med den kendte sikkkerhedsprofil for RoActemra og ingen nye eller uventede bivirkninger blev observeret (se tabel 1).
English: What you need to know before you are given RoActemra
Danish: Det skal du vide, før du begynder at få RoActemra
English: DAS28 ≤ 3.2, n (%) ACR20 response, n (%) ACR50 response, n (%) ACR70 response, n (%)
Danish: DAS28 < 2,6, n (%) DAS28 ≤ 3,2, n (%) ACR20-respons, n (%) ACR50-respons, n (%) ACR70-respons, n (%) p-værdien er justeret for lokalisering og varighed af reumatoid artrit for alle endepunkter og desuden for baseline-værdier for alle kontinuerlige endepunkter.
English: If you are given more RoActemra than you should Since RoActemra is given by a doctor or nurse, it is unlikely that you will be given too much.
Danish: Det er ikke sandsynligt, at du får for meget RoActemra, da du får det af en læge eller sygeplejerske.
English: In patients with elevated ALT or AST above 5x ULN treatment is not recommended.
Danish: Behandlingen bør ikke anvendes til patienter med forhøjet ALAT eller ASAT, der er > 5 x øvre normalgrænse.
English: The proportion of patients achieving a DAS28 clinical remission (DAS28 < 2.6) was significantly higher in patients receiving tocilizumab (28-34%) compared to 1-12% of control patients at 24 weeks.
Danish: Efter 24 uger var der signifikant flere patienter i tocilizumab-gruppen (28-34 %), som opnåede DAS28 klinisk remission DAS28 (DAS28 < 2,6), sammenlignet med gruppen af kontrolpatienter (1-12 %).
English: Vigilance for the timely detection of serious infection is recommended for patients receiving biological treatments for moderate to severe RA, sJIA or pJIA as signs and symptoms of acute inflammation may be lessened, associated with suppression of the acute phase reaction.
Danish: De patienter, som får biologisk behandling for moderat til svær reumatoid artrit, sJIA eller pJIA, skal overvåges for at opdage alvorlige infektioner i tide, da symptomer på akut inflammation kan mindskes i forbindelse med suppression af akutfasereaktionen.
English: Leave a gap of at least 3 months after your last treatment before you start breast-feeding.
Danish: Du må ikke begynde at amme igen, før der er gået mindst 3 måneder, efter behandlingen med RoActemra er ophørt.
English: In RA clinical studies with RoActemra, rapid decreases in CRP, erythrocyte sedimentation rate (ESR), serum amyloid A (SAA) and fibrinogen were observed.
Danish: I reumatoid artrit-kliniske studier med RoActemra er der set et hurtigt fald i CRP, erytrocytsedimentationsreaktionen (ESR), serumamyloid A (SAA) og fibrinogen.
English: This medicine contains 26.55 mg sodium per maximum dose of 1200 mg. Take this into account if you are on a low-sodium diet.
Danish: Dette lægemiddel indeholder 1,17 mmol (eller 26,55 mg) natrium pr. maksimumdosis på 1200 mg.
English: JIA ACR90 Response
Danish: JIA-ACR90-respons
English: Allow the syringe to adjust to room temperature
Danish: Lad injektionssprøjten opnå stuetemperatur
English: JIA ACR50 Response
Danish: JIA-ACR50-respons
English: Decrease in neutrophil count sJIA
Danish: Fald i neutrofilocytter sJIA
English: HR (99% CI) Time to first GCA flare¹ (Tocilizumab groups vs Placebo+52)
Danish: Tid til første GCA flare¹ (Tocilizumab grupper vs Placebo+52)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PRE-FILLED PEN CARTON
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE FYLDT PEN KARTON
English: Treatment should be initiated by healthcare professionals experienced in the diagnosis and treatment of RA and/or GCA.
Danish: Behandling bør påbegyndes af speciallæger med erfaring i diagnostik og behandling af reumatoid artrit og/eller GCA.
English: Clinically significant hypersensitivity reactions associated with tocilizumab and requiring treatment discontinuation were reported in a total of 56 out of 4,009 patients (1.4%) treated with tocilizumab during the controlled and open label clinical studies.
Danish: I de kontrollerede og åbne kliniske studier blev der i forbindelse med tocilizumab indberettet klinisk signifikante overfølsomhedsreaktioner, som krævede afbrydelse af behandlingen, hos 56 ud af 4.009 patienter (1,4 %).
English: Study WA28119 was a randomized, multi-center, double-blind placebo-controlled Phase III superiority study conducted to assess the efficacy and safety of RoActemra in patients with GCA.
Danish: Effekten og sikkerheden af RoActemra, hos patienter med GCA, blev undersøgt ved WA28119, et randomiseret, multi-center, dobbeltblindet placebo-kontrolleret fase III-superioritetssstudie.
English: The incidence of infections leading to dose interruptions was also numerically higher in patients weighing <30 kg treated with 10 mg/kg tocilizumab (21.4%)
Danish: Hyppigheden af infektioner, der medførte dosisafbrydelse, var ligeledes numerisk højere hos patienter, der vejede <30 kg og fik 10 mg/kg tocilizumab (21,4%), sammenlignet med patienter, der vejede ≥30 kg og fik 8 mg/kg tocilizumab (7,6%).
English: The pharmacokinetics of tocilizumab were determined using a population pharmacokinetic analysis on a database composed of 140 sJIA patients treated with 8 mg/kg IV every 2 weeks (patients with a body weight ≥ 30 kg ) 12 mg/kg IV every 2 weeks (patients with a body weight < 30 kg), 162 mg SC every week (patients weighing ≥ 30 kg), 162 mg SC every 10 days or every 2 weeks (patients weighing below 30 kg).
Danish: Tocilizumabs farmakokinetik blev bestemt ved en populationsfarmakokinetisk analyse af en database, som omfattede 140 sJIA-patienter behandlet med 8 mg/kg intravenøst hver 2. uge (patienter med en legemsvægt ≥ 30 kg), 12 mg/kg intravenøst hver 2. uge (patienter med en legemsvægt < 30 kg), 162 mg subkutant hver uge (patienter med en legemsvægt ≥ 30 kg), 162 mg subkutant hver 10. dag eller hver 2. uge (patienter med en legemsvægt < 30 kg).
English: After dilution, RoActemra for RA, sJIA, pJIA, and CRS patients should be administered as an intravenous infusion over 1 hour.
Danish: Efter fortynding skal RoActemra gives som intravenøs infusion over 1 time til patienter med reumatoid artrit, sJIA, pJIA og cytokinfrigivelsessyndrom.
English: JIA ACR30 Response
Danish: JIA-ACR30-respons
English: A colourless to slightly yellowish solution.
Danish: En farveløs til svagt gullig opløsning.
English: - Joint space narrowing - p≤ 0.0001, TCZ vs. PBO + MTX - p< 0.005, TCZ vs. PBO + MTX
Danish: JSN - Ledspalteforsnævring * - p ≤ 0,0001, tocilizumab vs. placebo + MTX ** - p < 0,005, tocilizumab vs. placebo + MTX
English: During routine laboratory monitoring in the Roactemra 12 month controlled clinical trial, a decrease in neutrophil count below 1 × 109/L occurred in 4% of patients in the RoActemra subcutaneous weekly group.
Danish: Under rutinemæssig laboratoriekontrol i det 12 måneders kontrollerede kliniske Roactemra studie, blev der observeret et fald under 1 × 109/l i netrofilocyttal hos 4% af patientgruppen der fik ugentlig subkutan RoActemra dosering.
English: If the needle is not covered proceed carefully, and place the syringe into the puncture resistant container to avoid injury with the needle.
Danish: Hvis kanylen ikke dækkes, skal du være forsigtig når du lægger injektionssprøjten i affaldsbeholderen til skarpe genstande for at undgå at nogen stikker sig på kanylen.
English: The pre-filled syringe should not be shaken.
Danish: Den fyldte injektionssprøjte må ikke rystes.
English: • mouth ulceration, stomach pain
Danish: • sår i munden, mavesmerter
English: The recommended posology in patients above 2 years of age is 8 mg/kg once every 2 weeks in patients weighing greater than or equal to 30 kg or 12 mg/kg once every 2 weeks in patients weighing less than 30 kg.
Danish: Den anbefalede dosis for patienter over 2 år er 8 mg/kg én gang hver 2. uge for patienter, som vejer 30 kg eller mere, og 12 mg/kg én gang hver 2. uge for patienter, som vejer mindre end 30 kg.
English: The syringe should not be shaken.
Danish: Injektionssprøjten må ikke rystes.
English: • RoActemra is used to treat adults and children aged 2 years and over with severe or lifethreatening cytokine release syndrome (CRS), a side-effect in patients treated with chimeric antigen receptor (CAR) T-cell therapies used to treat certain types of cancer.
Danish: • RoActemra anvendes til at behandle voksne og børn som er 2 år eller ældre med svær eller livstruende cytokinfrigivelsessyndrom.
English: • diverticulitis (fever, nausea, diarrhoea, constipation, stomach pain)
Danish: • Betændelse i udposning i mave-tarmkanalen (som viser sig ved feber, kvalme, diarré,
English: The pre-filled pen requires a firm injection site to properly activate.
Danish: Det er nødvendigt at hudfolden er fast for at den fyldte pen kan udløse indsprøjtningen.
English: 0.9 mL solution in a pre-filled syringe (type I glass) with a staked-in needle.
Danish: 0,9 ml opløsning i en fyldt injektionssprøjte (type I-glas) med indbygget kanyle, samlet som en fyldt injektionssprøjte.
English: JIA ACR70 Response
Danish: JIA-ACR70-respons
English: In patients who develop an ANC < 0.5 x 109/L or a platelet count < 50 x 103/μL, continued treatment is not recommended.
Danish: Fortsat behandling anbefales ikke hos patienter, som udvikler absolut neutrofilocyttal < 0,5 x 109/l eller trombocyttal < 50 x 103/μl.
English: During routine laboratory monitoring in the RoActemra 6 month controlled clinical trial SC-I, a decrease in neutrophil count below 1 × 109/L occurred in 2.9% of patients on the subcutaneous weekly dose.
Danish: Under rutinemæssig laboratoriekontrol blandt alle RoActemra-eksponerede patienter i det 6-måneders kontrollerede kliniske studie SC-I blev der observeret et fald i neutrofilocyttal til under 1 × 109/l hos 2,9 % af patienterne med ugentlig subkutan dosering.
English: Patients (treated with or without MTX) were randomised (tocilizumab:placebo = 2:1) to one of two treatment groups, 75 patients received tocilizumab infusions every two weeks, either 8 mg/kg for patients ≥ 30 kg or 12 mg/kg for patients < 30 kg and 37 patients were assigned to receiving placebo infusions every two weeks.
Danish: 75 patienter fik tocilizumab-infusioner hver 2. uge enten 8 mg/kg for patienter ≥ 30 kg eller 12 mg/kg for patienter < 30 kg, og 37 patienter fik placebo-infusioner hver 2. uge.
English: Patients demonstrate a comparable (to healthy subjects) decrease of absolute neutrophil counts following RoActemra administration (see section 4.8).
Danish: Patienterne udviste et lignende fald i det absolutte neutrofilocyttal efter administration af RoActemra som raske forsøgspersoner (se pkt.
English: Platelets During routine laboratory monitoring in the RoActemra 6 month clinical trial SC-I, none of the patients on the SC weekly dose had a decrease in platelet count to ≤50 × 103 / μL.
Danish: Ved en rutinemæssig laboratoriekontrol af det RoActemra kontrollerede kliniske studie SC-1, fremgik det at ingen patienter på den subkutane ugentlige dosis oplevede et fald i trombocytter til ≤50 × 103/μl.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 pre-filled pen contains 162 mg tocilizumab
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 fyldt pen indeholder 162 mg tocilizumab.
English: • children and adolescents, aged 1 year and over, with active systemic juvenile idiopathic arthritis (sJIA), an inflammatory disease that causes pain and swelling in one or more joints as well as fever and rash.
Danish: • børn og unge med aktiv systemisk juvenil idiopatisk artrit (sJIA) som er 1 år eller ældre.
English: RoActemra 162 mg solution for injection in pre-filled pen (ACTPen®) Tocilizumab
Danish: RoActemra, 162 mg injektionsvæske, opløsning i en fyldt pen (ACTPen Tocilizumab
English: These may affect up to 1 in every 10,000 patients
Danish: Forekommer hos op til 1 ud af 10.000 patienter
English: Available non-clinical data do not suggest an effect on fertility under RoActemra treatment.
Danish: Foreliggende ikke-kliniske data viser ingen tegn på, at fertiliteten påvirkes under behandling med RoActemra.
English: For the 162 mg every week dose, the predicted mean (±SD) steady-state AUC1week, Cmin and Cmax of RoActemra were 7970 ± 3432 µg•h/mL, 43.0 ± 19.8 µg/mL, and 49.8 ± 21.0 µg/mL, respectively.
Danish: Ved dosering med 162 mg ugentligt var det beregnede gennemsnitlige (±SD) steady-state AUC1uge, Cmin og Cmax for RoActemra henholdsvis 7.970 ± 3.432 µg•t/mL; 43,0 ± 19,8 µg/mL og 49,8 ± 21,0 µg/Ll.Akkumuleringsratio for AUC, Cmin og Cmax var henholdsvis 6,32; 6,30 og 5,27.
English: RoActemra has not been studied in patients with severe renal impairment (see section 5.2).
Danish: RoActemra er ikke undersøgt hos patienter med svær nedsat nyrefunktion (se pkt.
English: The linear clearance was estimated as a parameter in the population pharmacokinetic analysis and was 5.7 mL/h in paediatric patients with systemic juvenile idiopathic arthritis.
Danish: Den lineære clearance blev estimeret som en parameter i den populationsfarmakokinetiske analyse og var 5,7 ml/time hos pædiatriske patienter med sJIA.