FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended dose The dose for RA and GCA adults is 162 mg (the content of 1 pre-filled syringe) given once a week.
Danish: Dosis for voksne med leddegigt og GCA er 162 mg (indholdet i en fyldt injektionssprøjte), 1 gang om ugen.
English: Events of diverticular perforations as complications of diverticulitis have been reported uncommonly in patients treated with RoActemra (see section 4.8).
Danish: Tilfælde af divertikulære perforationer, som komplikation til diverticulitis, er blevet indberettet med frekvensen ”ikke almindelige” hos patienter behandlet med RoActemra (se pkt.
English: Following 1 year of treatment with tocilizumab plus MTX, 85% of patients (n=348) had no progression of structural joint damage, as defined by a change in the Total Sharp Score of zero or less, compared with 67% of placebo plus MTX-treated patients (n=290) (p ≤ 0.001).
Danish: Efter 1 års behandling med tocilizumab plus MTX havde 85 % af patienterne (n = 348) ingen progression af strukturel ledskade, defineret som ændring i det totale Sharp score på nul eller mindre,
English: In the double-blind controlled studies, 774 patients received tocilizumab 4 mg/kg in combination with MTX, 1870 patients received tocilizumab 8 mg/kg in combination with MTX or other DMARDs and 288 patients received tocilizumab 8 mg/kg monotherapy.
Danish: I de dobbeltblindede, kontrollerede studier fik 774 patienter tocilizumab 4 mg/kg i kombination med MTX, 1.870 patienter fik tocilizumab 8 mg/kg i kombination med MTX eller andre DMARDs, og 288 patienter fik tocilizumab 8 mg/kg som monoterapi.
English: Children with sJIA (aged 2 and over)
Danish: Børn med sJIA (2 år og ældre)
English: In Study IV, RoActemra was administered intravenously every 4 weeks in combination with other DMARDs vs. placebo and other DMARDs.
Danish: I studie IV blev RoActemra givet intravenøst hver 4. uge i kombination med andre DMARDs vs. placebo plus andre DMARDs.
English: Record your Injection
Danish: Hold regnskab med dine indsprøjtninger
English: Do not remove the green cap while allowing your RoACTEMRA pre-filled pen to reach room temperature.
Danish: Den grønne hætte skal blive på den fyldte RoActemra-pen under opvarmningen til stuetemperatur.
English: In clinical studies with tocilizumab, rapid decreases in CRP, erythrocyte sedimentation rate (ESR), serum amyloid A (SAA) and fibrinogen were observed.
Danish: I de kliniske studier med tocilizumab er der set et hurtigt fald i CRP, erytrocytsedimentationsreaktionen (ESR), serumamyloid A (SAA) og fibrinogen.
English: • injection site reactions
Danish: • reaktioner ved injektionsstedet
English: In the 6-month controlled trials adverse events associated with infusion (selected events occurring during or within 24 hours of infusion) were reported by 6.9% of patients in the tocilizumab 8 mg/kg plus DMARD group and 5.1% of patients in the placebo plus DMARD group.
Danish: I de 6-måneders kontrollerede studier blev der indberettet uønskede hændelser i forbindelse med infusion (udvalgte hændelser, som indtraf under eller inden for 24 timer efter infusionen) hos 6,9 % af patienterne, der fik tocilizumab 8 mg/kg plus DMARD, og hos 5,1 % af patienterne, der fik placebo plus DMARD.
English: As there are many co-morbid conditions that may effect laboratory values in 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 pJIA er mange samtidige sygdomme, 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: In patients treated with tocilizumab 8 mg/kg, significant improvements were noted on all individual components of the ACR response including: tender and swollen joint counts; patients and physician global assessment; disability index scores; pain assessment and CRP compared to patients receiving placebo plus MTX or other DMARDs in all studies.
Danish: Sammenlignet med de patienter, som fik placebo plus MTX eller andre DMARDs, blev der i alle studier hos de patienter, som blev behandlet med tocilizumab 8 mg/kg, set signifikante bedringer af alle individuelle komponenter af AC-responser, herunder: Antal ømme og hævede led, patienternes og lægernes globale vurdering, disability index score, vurdering af smerter og CRP.
English: In the all exposure population the overall rate of serious infections was 4.7 events per 100 pt years.
Danish: Blandt alle tocilizumab eksponerede patienter var den samlede hyppighed af alvorlige infektioner 4,7 hændelser pr. 100 patientår.
English: Available data suggest that clinical improvement is observed within 12 weeks of initiation of treatment with RoActemra.
Danish: Tilgængelige data indikerer, at klinisk bedring observeres inden for 12 uger efter påbegyndelse af RoActemra.
English: The types of ADRs in pJIA patients were similar to those seen in RA and sJIA patients, see section 4.8.
Danish: De bivirkninger, som ses hos pJIA-patienterne, svarede til dem, der er set hos reumatoid artrit- og sJIA-patienter, se pkt.
English: The PCS mean change from baseline to week 52 was higher (showing more improvement) in the RoActemra weekly and every other weekly dose groups [4.10, 2.76, respectively] than in the two placebo groups [placebo plus 26 weeks; -0.28, placebo plus 52 weeks; -1.49], although only the comparison between RoActemra weekly plus 26 weeks prednisone taper group and placebo plus 52 weeks prednisone taper group (5.59, 99% CI: 8.6, 10.32) showed a statistically significant difference (p=0.0024).
Danish: Den gennemsnitlige ændring i den fysiske komponent score fra baseline til uge 52 var højere (viste større forbedring) i dem, der fik RoActemra hver eller hver anden uge [henholdsvis 4,10; 2,76] end i de to placebo-grupper [placebo plus 26 uger; -0,28, placebo plus 52 uger; -1,49], selvom det kun var sammenligningen mellem gruppen af RoActemra ugentligt dosis plus 26 ugers nedtrapningsregime af prednison gruppen og placebo plus 52 ugers nedtrapningsregime af prednison (5,59, 99% konfidensinterval: 8,6, 10,32), der viste en statistisk signifikant forskel (p = 0,0024).
English: How to store RoActemra
Danish: Seponer RoActemra
English: RA and GCA
Danish: Reumatoid artrit og GCA
English: Statistically significant improvements in haemoglobin levels were observed with RoActemra compared with DMARDs (p< 0.0001) at week 24.
Danish: I uge 24 blev der set statistisk signifikante forbedringer i hæmoglobinkoncentrationerne efter behandling med RoActemra, sammenlignet med behandling med DMARDs (p < 0,0001).
English: The linear clearance was estimated as a parameter in the population pharmacokinetic analysis and was 6.25 mL/h.
Danish: Den lineære clearance blev estimeret som en parameter i den populationsfarmakokinetiske analyse og var 6,25 ml/time.
English: Evaluable patients had been treated with tocilizumab 8 mg/kg (12 mg/kg for patients < 30 kg) with or without additional high-dose corticosteroids for severe or life-threatening CRS; only the first episode of CRS was included in the analysis.
Danish: Egnede patienter blev behandlet med tocilizumab 8 mg/kg (12 mg/kg for patienter, der vejede mindre end 30 kg), med eller uden supplerende høj-dosis kortikosteroid for svær eller livstruende cytokinfrigivelsessyndrom.
English: A higher frequency of pJIA patients experienced ISRs following SC RoActemra injections compared to adult RA.
Danish: Der var en højere forekomst af patienter med pJIA, der oplevede reaktioner ved injektionsstedet efter subkutan injektion med RoActemra sammenlignet med voksne patienter med reumatoid artrit.
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in pre-filled pen, ACTPen® Multipack: 12 (3 packs of 4) pre-filled pens.
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Injektionsvæske, opløsning i en fyldt pen, ACTPen® Multipakning: 12 (3 pakker á 4) fyldte penne 162 mg/0,9 ml
English: Because RoActemra is given in one pre-filled pen, it is unlikely that you will receive too much.
Danish: Det er ikke sandsynligt, at du får for meget RoActemra, da det leveres i en fyldt pen.
English: In Studies II, III and V, RoActemra was administered intravenously every four weeks in combination with MTX vs. placebo and MTX.
Danish: I studierne II, III og V blev RoActemra givet intravenøst hver 4. uge i kombination med MTX vs. placebo plus MTX.
English: Step 6.
Danish: Trin 6.
English: Similarly the proportion of patients achieving a DAS 28 remission (DAS28 < 2.6) was significantly higher (31% vs. 16% respectively) in patients receiving RoActemra 8 mg/kg plus DMARD than in patients receiving RoActemra 4 mg/kg plus DMARD (p< 0.0001).
Danish: Antallet af patienter, som opnåede DAS 28-remission (DAS28 < 2,6), var også signifikant højere hos de patienter, som fik RoActemra 8 mg/kg plus DMARD, end hos de patienter, som fik RoActemra 4 mg/kg plus DMARD (31 % vs. 16 %, p < 0,0001).
English: ADA + Placebo (IV) N = 162
Danish: Adalimumab + placebo (intravenøs) N = 162
English: PHARMACEUTICAL FORM Solution for injection in pre-filled pen (ACTPen).
Danish: Injektionsvæske, opløsning i en fyldt pen (ACTPen).
English: This is an inflammatory disease that causes pain and swelling in one or more joints.
Danish: pJIA er en inflammations (betændelseslignende)-sygdom, som forårsager smerte og hævelse i et eller flere led.
English: In Studies II, III and V, tocilizumab was administered intravenously every four weeks in combination with MTX vs. placebo and MTX.
Danish: I studierne II, III og V blev tocilizumab givet intravenøst hver 4. uge i kombination med MTX vs. placebo plus MTX.
English: A 52-week, open-label, multicenter, PK-PD and safety study was conducted in paediatric patients with pJIA, aged 1 to 17 years old, to determine the appropriate subcutaneous dose of RoActemra that achieved comparable PK/PD and safety profiles to the IV regimen.
Danish: Et 52-ugers, åbent, multicenter, farmakokinetisk/farmakodynamisk og sikkerhedsstudie blev gennemført hos pædiatriske patienter med pJIA i alderen 1-17 år.
English: If the needle is not covered, carefully place the pre-filled pen into the sharps container to avoid any injury with the needle.
Danish: Hvis nålen ikke er dækket, skal du forsigtigt smide den fyldte pen i kanylebeholderen for at undgå nålestikskader.
English: 4 vials of 20 mL
Danish: 4 hætteglas á 20 ml
English: The treatment will be prescribed and started by healthcare professionals experienced in the diagnosis and treatment of RA, sJIA, pJIA or GCA.
Danish: Behandlingen vil blive ordineret og igangsat af sundhedspersonale, som har erfaring i diagnosticering og behandling af leddegigt, sJIA, pJIA og GCA.
English: Doses of 8 mg/kg tocilizumab or placebo were given every four weeks in combination with stable DMARDs.
Danish: Der blev givet doser på 8 mg/kg tocilizumab eller placebo hver 4. uge i kombination med stabil dosis DMARDs.
English: In paediatric patients with sJIA, the central volume of distribution was 1.87 L, the peripheral volume of distribution was 2.14 L resulting in a volume of distribution at steady state of 4.01 L
Danish: Hos pædiatriske patienter med sJIA var det centrale fordelingsvolumen 1,87 l og det perifere fordelingsvolumen 2,14 l. Det resulterede i et fordelingsvolumen ved steady-state på 4,01 l.
English: Step 4.
Danish: Trin 4.
English: These may affect up to 1 in every 100 patients
Danish: Forekommer hos op til 1 ud af 100 patienter
English: Pharmacokinetic parameters of tocilizumab did not change with time.
Danish: Tocilizumabs farmakokinetiske parametre ændrede sig ikke med tiden.
English: Patients in the adalimumab arm received an adalimumab SC injection (40 mg) q2w plus an IV placebo infusion q4w.
Danish: Patienterne i adalimumab-armen fik en subkutan injektion med adalimumab (40 mg) hver 2. uge plus en intravenøs infusion med placebo hver 4. uge.
English: Each pre-filled pen contains 162 mg tocilizumab in 0.9 mL.
Danish: Hver fyldt pen indeholder 162 mg tocilizumab i 0,9 ml.
English: In clinical studies with RoActemra, rapid decreases in CRP, erythrocyte sedimentation rate (ESR), serum amyloid A (SAA) and fibrinogen were observed.
Danish: I kliniske studier med RoActemra er der set et hurtigt fald i CRP, erytrocyt-sedimentationsreaktionen (ESR), serumamyloid A (SAA) og fibrinogen.
English: Mild renal impairment (creatinine clearance based on Cockcroft-Gault < 80 mL/min and ≥ 50 mL/min) did not impact the pharmacokinetics of tocilizumab.
Danish: Let nedsat nyrefunktion (creatininclearance < 80 ml/min og ≥ 50 ml/min iht.
English: Patients were required to be >18 years of age with active RA diagnosed according to ACR criteria who had at least 8 tender and 6 swollen joints at baseline.
Danish: Patienterne skulle være >18 år gamle og have aktiv RA diagnosticeret i overensstemmelse med ACR-kriterier med mindst 8 ømme og 6 hævede led ved baseline.
English: In RA and GCA patients, neutrophils and platelets should be monitored 4 to 8 weeks after start of therapy and thereafter according to standard clinical practice.
Danish: Hos patienter med reumatoid artrit og GCA bør neutrofilocyt- og trombocyttallet kontrolleres 4 til 8 uger efter behandlingens start og derefter i henhold til standardpraksis.
English: Modify the dose of the concomitant MTX if appropriate Interrupt RoActemra dosing until < 3x ULN and follow recommendations above for >1 to 3x ULN
Danish: Modificer dosis af samtidig MTX, hvis det er hensigtsmæssigt Afbryd behandlingen med RoActemra, indtil værdierne er faldet til under 3 gange øvre normalgrænse, og følg anbefalingerne for > 1 til 3 gange øvre normalgrænse ovenfor
English: Doses of 8 mg/kg RoActemra or placebo were given every four weeks in combination with stable DMARDs.
Danish: Der blev givet doser på 8 mg/kg RoActemra eller placebo hver 4. uge i kombination med stabil dosis DMARDs.
English: Interrupt RoActemra dosing until < 3 x ULN and follow recommendations above for > 1 to 3 x ULN
Danish: Afbryd behandlingen med RoActemra, indtil værdierne er faldet < 3 gange øvre normalgrænse, og følg anbefalingerne ovenfor for > 1 til 3 gange øvre normalgrænse
English: In clinical trials, RoActemra has not been studied in patients during an episode of active MAS.
Danish: RoActemra er ikke blevet undersøgt i kliniske studier hos patienter under en episode med aktiv makrofagaktiveringssyndrom
English: In Study IV, tocilizumab was administered intravenously every 4 weeks in combination with other DMARDs vs. placebo and other DMARDs.
Danish: I studie IV blev tocilizumab givet intravenøst hver 4. uge i kombination med andre DMARDs vs. placebo plus andre DMARDs.
English: After IV dosing, approximately 90% of the steady-state was reached by week 12 for the 10 mg/kg (BW < 30 kg), and by week 16 for the 8 mg/kg (BW ≥ 30 kg) dose.
Danish: Efter intravenøs dosering var ca. 90 % af steady-state opnået ved uge 12 for en dosis på 10 mg/kg (legemsvægt < 30 kg) og ved uge 16 for en dosis på 8 mg/kg (legemsvægt ≥ 30 kg).
English: In the 52-week open-label SC Study (WA28118), 23.4% and 35.4% of patients experienced a post baseline elevation of their LDL-cholesterol value to ≥130 mg/dL and total cholesterol value to ≥200
Danish: I det 52-ugers åbne subkutane studie (WA28118) oplevede henholdsvis 23,4 % og 35,4 % af patienterne en stigning i forhold til baseline af deres LDL-kolesterol værdier til ≥ 130 mg/dl og total kolesterol værdier til ≥ 200 mg/dl på et hvilket som helst tidspunkt under deres behandling.
English: Dose interruptions of tocilizumab for the following laboratory abnormalities are recommended in pJIA patients in the tables below.
Danish: Afbrydelser i doseringen af tocilizumab på grund af laboratorieanormaliteter anbefales hos patienter med pJIA som angivet i tabellerne nedenfor.
English: • Place the needle-shield of the pre-filled pen against your pinched skin at a 90° angle (See
Danish: • Hold pennens nåleskjold mod hudfolden i en vinkel på 90° (se figur H).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 162 mg of tocilizumab in 0.9 mL.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver fyldt injektionssprøjte indeholder 162 mg tocilizumab i 0,9 ml.
English: • Keep out of the reach of children.
Danish: • Opbevar pennen utilgængeligt for børn.
English: In paediatric patients with pJIA, the central volume of distribution was 1.97 L, the peripheral volume of distribution was 2.03 L, resulting in a volume of distribution at steady state of 4.0 L.
Danish: Hos pædiatriske patienter med pJIA var det centrale fordelingsvolumen 1,97 l og det perifere fordelingsvolumen 2,03 l. Det resulterede i et fordelingsvolumen ved steady-state på 4,0 l.
English: • Do not hold the syringe by the plunger while removing the needle-cap.
Danish: • Hold ikke injektionssprøjten i stemplet, når du fjerner hætten fra kanylen.
English: (fatal)1, 2 ,3
Danish: Anafylaksi (dødelig)1,2,3
English: Similarly the proportion of patients achieving a DAS28 remission (DAS28 < 2.6) was significantly higher (31% vs. 16% respectively) in patients receiving tocilizumab 8 mg/kg plus DMARD than in patients receiving tocilizumab 4 mg/kg plus DMARD (p< 0.0001).
Danish: Antallet af patienter, som opnåede DAS28-remission (DAS28 < 2,6), var også signifikant højere hos de patienter, som fik tocilizumab 8 mg/kg plus DMARD, end hos de patienter, som fik tocilizumab 4 mg/kg plus DMARD (31 % vs. 16 %, p < 0,0001).
English: For study II (SC-II), patients were required to be > 18 years of age with moderate to severe active RA diagnosed according to ACR criteria who had at least 8 tender and 6 swollen joints at baseline.
Danish: I studie II (SC-II) skulle patienterne være >18 år gamle med moderat til svær aktiv RA diagnosticeret i overensstemmelse med ACR-kriterierne og have mindst 8 ømme og 6 hævede led ved baseline.
English: 1 vial of 10 mL
Danish: 1 hætteglas á 10 ml
English: The all exposure population includes all patients who received at least one dose of RoActemra either in the double-blind control period or open label extension phase in studies.
Danish: Populationen, alle eksponerede, omfatter alle patienter, der fik mindst én dosis RoActemra enten i den dobbeltblindede kontrolperiode eller i den åbne forlængelsesfase i studierne.
English: The recommended posology in patients above 2 years of age is 8 mg/kg once every 4 weeks in patients weighing greater than or equal to 30 kg or 10 mg/kg once every 4 weeks in patients weighing less than 30 kg.
Danish: Den anbefalede dosis for patienter over 2 år er 8 mg/kg én gang hver 4. uge hos patienter, der vejer 30 kg eller mere, og 10 mg/kg én gang hver 4. uge hos patienter, der vejer under 30 kg.
English: In RA patients, neutrophils and platelets should be monitored 4 to 8 weeks after start of therapy and thereafter according to standard clinical practice.
Danish: Hos patienter med reumatoid artrit bør neutrofilocyt- og trombocyttallet kontrolleres 4 til 8 uger efter behandlingens start og derefter i henhold til standardpraksis.
English: *τ = 2 weeks for IV regimens
Danish: *τ = 2 uger for intravenøse regimer
English: These may affect up to 1 in 10 patients
Danish: Forekommer hos op til 1 ud af 10 patienter
English: Comprehensive instructions for the administration of RoActemra in a pre-filled pen are given in the package leaflet.
Danish: Detaljeret vejledning i administration af RoActemra i fyldt pen gives i indlægssedlen.
English: Some side effects were seen more often: inflamed nose and throat, headache, feeling sick (nausea) and lower white blood cell counts.
Danish: Dog blev følgende bivirkninger set hyppigere: infektion i næse og hals, hovedpine, kvalme samt nedsat antal hvide blodlegemer.
English: In general, side effects in sJIA patients were of a similar type to those in adults with RA.
Danish: Generelt svarede bivirkningerne hos sJIA-patienter til de typer af bivirkninger, som ses hos voksne patienter med leddegigt.
English: uncommon (≥ 1/1,000 to < 1/100) rare, (≥1/10,000 to <1/1,000) or very rare (<1/10,000).
Danish: < 1/100), sjældne (≥1/10.000 til < 1/1.000) eller meget sjældne (<1/10.000).
English: The long-term exposure population includes all patients who received at least one dose of RoActemra either in the double-blind control period or open label extension phase in the studies.
Danish: Populationen, som blev eksponeret over lang tid, omfatter alle patienter, der fik mindst én dosis RoActemra enten i den dobbeltblindede kontrolperiode eller i den åbne forlængelsesfase i studierne.
English: Max
Danish: Min - Max
English: uncommon (≥ 1/1,000 to < 1/100), rare (>1/10,000 to <1/1,000) or very rare (<1/10,000).
Danish: < 1/100), sjældne (>1/10.000 til < 1/1.000) eller meget sjældne (<1/10.000).
English: Vigilance for the timely detection of serious infection is recommended for patients receiving immunosuppressive agents such as RoActemra 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, skal overvåges for at opdage alvorlige infektioner i tide, da symptomer på akut inflammation kan mindskes på grund af suppression af akutfasereaktionen.
English: The corresponding frequency category for each ADR is based on the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10) or uncommon (≥ 1/1,000
Danish: Følgende hyppighedskategorier er anvendt: Meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til
English: If you develop symptoms such as, but not limited to skin rash, itching, chills, swelling of face, lips, tongue or throat, chest pain, wheezing, difficulty breathing or swallowing or feeling dizzy or faint at any time while not at the clinic during or following an RoACTEMRA injection you should seek emergency care immediately.
Danish: Hvis du efter en indsprøjtning udvikler symptomer som fx udslæt, kløe, kulderystelser, hævelse af ansigt, læber, tunge eller svælg, brystsmerter, hvæsende vejrtrækning, vejrtræknings- eller synkebesvær eller svimmelhed, skal du straks søge lægehjælp.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 200 mg/10 mL
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 200 mg/10 ml
English: In sJIA, pJIA and RA patients, assessment of lipid parameters should be performed 4 to 8 weeks following initiation of RoActemra therapy.
Danish: Hos sJIA- og pJIA-patienter samt patienter med reumatoid artrit bør lipidparametrene vurderes 4 til 8 uger efter, at behandlingen med RoActemra er påbegyndt.
English: 1 vial of 4 mL
Danish: 1 hætteglas á 4 ml
English: In the open label extension phase (study WA18221), 13.2% and 27.7% of patients experienced a post baseline elevation of their LDL-cholesterol value to ≥ 130 mg/dL and total cholesterol value to ≥ 200
Danish: I den åbne forlængelsesfase (studie WA18221) oplevede 13,2 % og 27,7 % 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: • Throw away the needle-cap in the puncture resistant container or sharps container.
Danish: • Smid kanylehætte i affaldsbeholderen til skarpe genstande.
English: The linear clearance was estimated as a parameter in the population pharmacokinetic analysis and was 6.7 mL/h in GCA patients,
Danish: Den lineære clearance blev estimeret som et parameter i den populationsfarmakokinetiske-analyse og var 6,7 mL/time hos GCA-patienter,
English: For recommended modifications, including RoActemra discontinuation, based on transaminases levels see section 4.2.
Danish: 4.2 vedrørende de anbefalede dosisændringer samt sponering af behandling med RoActemra baseret på niveauerne af aminotransferaser.
English: 4 vials of 10 mL
Danish: 4 hætteglas á 10 ml
English: Hepatic transaminases increased pJIA
Danish: Forhøjede leveraminotransferaser pJIA
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in pre-filled pen, ACTPen® 4 pre-filled pens.
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Injektionsvæske, opløsning i en fyldt pen; ACTPen® 4 fyldte penne.