FrancophonIA/ELRC3.0 huggingface dataset:
English: Elevations of ALT/AST > 5 x ULN were observed in 0.7% of RoActemra monotherapy patients and 1.4% of RoActemra plus DMARD patients, the majority of whom were discontinued permanently from RoActemra treatment.
Danish: Der blev set stigninger af ALAT/ASAT til > 5 gange øvre normalgrænse hos 0,7 % af de patienter, der fik RoActemra monoterapi, og hos 1,4 % af de patienter, der fik RoActemra plus DMARD.
English: • In RA, GCA, pJIA and sJIA, ALT/AST should be monitored every 4 to 8 weeks for the first 6 months of treatment followed by every 12 weeks thereafter.
Danish: • Hos patienter med reumatoid artrit, GCA, pJIA og sJIA bør ALAT/ASAT-værdier kontrolleres hver 4. til 8. uge i de første 6 måneder af behandlingen og derefter hver 12. uge.
English: Renal impairment: No formal study of the effect of renal impairment on the pharmacokinetics of tocilizumab has been conducted.
Danish: Nedsat nyref unktion: Der er ikke gennemført kliniske studier om virkningen af nedsat nyrefunktion på tocilizumabs farmakokinetik.
English: During routine laboratory monitoring in the RoActemra 12 month controlled clinical trial, 34% of patients experienced sustained elevations in total cholesterol > 6.2 mmol/L (240 mg/dL), with 15% experiencing a sustained increase in LDL to ≥ 4.1 mmol/L (160 mg/dL) in the RoActemra subcutaneous weekly group.
Danish: Under rutinemæssig laboratoriekontrol i det 12 måneders kontrollerede kliniske RoActemra studie, oplevede 34% af patienterne vedvarende stigninger i samlet kolesterol > 6,2 mmol/l (240 mg/dl), hvor 15% oplevede en vedvarende stigning i LDL op til ≥ 4,1 mmol/l (160 mg/dl) i den gruppe, der fik ugentlig RoActemra subkutant.
English: If a sJIA patient misses a subcutaneous weekly injection of RoActemra within 7 days of the scheduled dose, he/she should be instructed to take the missed dose on the next scheduled day.
Danish: Hvis en sJIA patient glemmer en subkutan ugentligt injektion med RoActemra inden for 7 dage af den planlagte dosis, skal han/hun instrueres i at tage den manglende dosis på næste planlagte dag.
English: GCA (SC)
Danish: Middelværdi (SD)
English: Each vial contains 400 mg of tocilizumab* in 20 mL (20 mg/mL).
Danish: Hver hætteglas indeholder 400 mg tocilizumab* i 20 ml (20 mg/ml).
English: Keep the pre-filled pen in the outer carton in order to protect from light and moisture.
Danish: Opbevar den fyldte pen i den ydre karton for at beskytte mod lys og fugt.
English: When compared to the adult RA population, events of nasopharyngitis, headache, nausea, and decreased neutrophil count were more frequently reported in the pJIA population.
Danish: Følgende bivirkninger var hyppigere hos pJIA-populationen sammenlignet med voksne med reumatoid artrit: nasopharyngitis, hovedpine, kvalme og nedsat antal neutrofilocytter.
English: > 1 to 3 x ULN Modify the dose of the concomitant MTX if appropriate For persistent increases in this range, interrupt RoActemra until ALT/AST have normalized.
Danish: Modificer dosis af samtidig MTX, hvis det er hensigtsmæssigt Ved vedvarende stigning stop behandlingen med RoActemra, indtil ALAT/ASAT er normaliseret
English: These may affect 1 in 10 patients or more
Danish: Forekommer hos flere end 1 ud af 10 patienter
English: • Do not try to re-cap your syringe.
Danish: • Sæt ikke kanylehætten tilbage på injektionssprøjten.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER Hætteglas
English: In healthy subjects administered RoActemra in doses from 2 to 28 mg/kg intravenously and 81 to 162 mg subcutaneously, absolute neutrophil counts decreased to their lowest 2 to 5 days following administration.
Danish: I GCA-studiet WA28119 blev der observeret samme hurtige fald i CRP og ESR sammen med lette stigninger i middelcelle hæmoglobinkoncentrationen (MCHC).Hos raske forsøgspersoner, som fik RoActemra i doser fra 2 til 28 mg/kg intravenøst og 81 til 162 mg subkutant, faldt det absolutte neutrofilocyttal til det laveste niveau 2-5 dage efter administrationen.
English: The total clearance of tocilizumab was concentrationdependent and is the sum of the linear and non-linear clearance.
Danish: Den totale clearance for tocilizumab var koncentrationsafhængig og er summen af den lineære og den non-lineære clearance.
English: Cmean (µg/mL)
Danish: Cgennemsnit (µg/mL)
English: In RA patients the central volume of distribution was 3.72 L, the peripheral volume of distribution was 3.35 L resulting in a volume of distribution at steady state of 7.07 L.
Danish: Hos patienter med reumatoid artrit, var det centrale fordelingsvolumen 3,72 l og det perifere fordelingsvolumen 3,35 l. Det resulterede i et fordelingsvolumen ved steady-state på 7,07 l.
English: • adults with severe, active and progressive rheumatoid arthritis (RA), who have not had previous treatment with methotrexate..
Danish: • til behandling af svær, aktiv og progressiv reumatoid artrit (RA) hos voksne patienter, som ikke tidligere har været i behandling med MTX
English: • The other ingredients are L-Histidine, L-Histidine monohydrochloride monohydrate, LArginine, L-Arginine hydrochloride, L-Methionine, Polysorbate 80 and Water for injections.
Danish: • Øvrige indholdsstoffer: L-histidin, L-histidinmonohydrochloridmonohydrat, L-arginin, L
English: However, if you are worried, talk to your doctor or nurse.
Danish: Hvis du er i tvivl, skal du tale med din læge eller sundhedspersonalet.
English: • If a dose is missed by more than 7 days, or you are not sure when to inject RoActemra, call the doctor or pharmacist.
Danish: • Hvis en dosis glemmes med en uge eller mere, eller du er usikker på, hvornår du/dit barn skal tage næste indsprøjtning, skal du kontakte lægen.
English: Since RoActemra is given by a doctor or nurse, it is unlikely that you will miss a dose.
Danish: Det er ikke sandsynligt, at du glemmer en dosis RoActemra, da du får det af en læge eller sygeplejerske.
English: NAME OF THE MEDICINAL PRODUCT RoActemra 162 mg solution for injection in pre-filled syringe.
Danish: LÆGEMIDLETS NAVN RoActemra 162 mg injektionsvæske, opløsning i en fyldt injektionssprøjte.
English: The pharmacokinetic parameters of RoActemra did not change with time.
Danish: RoActemras farmakokinetiske parametre ændrede sig ikke med tiden.
English: Clinically significant hypersensitivity reactions associated with RoActemra and requiring treatment discontinuation were reported in a total of 56 out of 4,009 patients (1.4%) treated with RoActemra during the controlled and open label clinical studies.
Danish: I de kontrollerede og åbne kliniske studier blev der i forbindelse med RoActemra indberettet klinisk signifikante overfølsomhedsreaktioner, som krævede afbrydelse af behandlingen, hos 56 ud af 4.009 patienter
English: Tell your doctor if you are taking any other medicines, or have recently taken any.
Danish: Brug af anden medicin sammen med RoActemra Fortæl altid lægen, hvis du tager anden medicin eller har gjort det for nylig.
English: Hepatic impairment: No formal study of the effect of hepatic impairment on the pharmacokinetics of tocilizumab has been conducted.
Danish: Nedsat leverfunktion: Der er ikke gennemført formelle studier om virkningen af nedsat leverfunktion på tocilizumabs farmakokinetik.
English: • If the patient weighs less than 30 kg: the dose is 162 mg (the content of 1 pre-filled syringe), once every 3 weeks
Danish: • Mindre end 30 kg: Dosis er 162 mg (indholdet i en forfyldt sprøjte) 1 gang hver tredje uge
English: Visually check the syringe
Danish: Check den fyldte injektionssprøjte
English: If following insertion of the needle, you cannot depress the plunger, you must dispose of the pre-filled syringe in a puncture resistant container and use a new pre-filled syringe.
Danish: Hvis injektionssprøjtens stempel ikke kan trykkes ned efter at kanylen er stukket ind i huden, skal den fyldte injektionssprøjte bortskaffes i en affaldsbeholder til skarpe genstande og en ny fyldt injektionssprøjte skal anvendes.
English: • RoActemra is used to treat children with pJIA.
Danish: • RoActemra anvendes til at behandle børn med aktiv polyartikulær juvenil idiopatisk artrit (pJIA).
English: Elevations of ALT/AST > 5 x ULN were observed in 0.7% of RoActemra monotherapy patients and 1.4% of RoActemra plus DMARD patients, the majority of whom were discontinued permanently from tocilizumab treatment.
Danish: Der blev set stigninger af ALAT/ASAT til > 5 gange øvre normalgrænse hos 0,7 % af de patienter, der fik tocilizumab monoterapi, og hos 1,4 % af de patienter, der fik RoActemra plus DMARD.
English: Placebo + MTX, but endpoint was exploratory (not included in the hierarchy of statistical testing and has therefore not been controlled for multiplicity)
Danish: ***p≤0,0001; **p<0,001; *p<0, 05; ‡p < 0,05 versus placebo + MTX, men endepunkterne var eksploratoriske (ikke inkluderet i hierarkiet af statistiske test og er derfor ikke kontrolleret for multiplicitet).
English: The dose is 12 mg for every kg of body weight if you weigh less than 30 kg. RoActemra can be given alone or in combination with corticosteroids.
Danish: Dosis er 12 mg pr. kg kropsvægt, hvis du vejer mindre end 30 kg.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PRE-FILLED PEN CARTON (WITHOUT BLUE BOX) - Multipack
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE FYLDT PEN KARTON (UDEN BLÅ BOKS) - MULTIPAKNING
English: Tocilizumab administered to cynomolgus monkeys during early gestation, was observed to have no direct or indirect harmful effect on pregnancy or embryonal-foetal development.
Danish: Der blev ikke set direkte eller indirekte skadelig virkning på graviditet eller embryonal-føtal udvikling efter indgift af tocilizumab til cynomolgusaber i den tidlige graviditet.
English: Hepatic transaminase elevations
Danish: Stigninger i leveraminotransferaser
English: If a pJIA patient misses a subcutaneous injection of RoActemra within 7 days of the scheduled dose, he/she should take the missed dose as soon as they remember and take the next dose at the regular scheduled time.
Danish: Hvis en pJIA patient glemmer en subkutan injektion med RoActemra inden for 7 dage af den planlagte dosering, skal han/hun instrueres i hurtigst muligt at tage den manglende dosis og at tage næste dosis til planlagt tid.
English: ANC < 0.5
Danish: Absolut neutrofilocyttal 0,5
English: Keep the vial in the outer carton in order to protect from light.
Danish: Opbevar hætteglassene i den ydre karton for at beskytte mod lys.
English: Patients should be instructed to contact their healthcare professional immediately when any symptoms suggesting infection appear, in order to assure rapid evaluation and appropriate treatment.
Danish: For at sikre hurtig undersøgelse og passende behandling skal patienterne informeres om omgående at kontakte sundhedspersonalet, hvis de får symptomer, som tyder på en infektion.
English: In RA, GCA, pJIA and sJIA patients, ALT/AST should be monitored every 4 to 8 weeks for the first 6 months of treatment followed by every 12 weeks thereafter.
Danish: Hos patienter med reumatoid artrit, GCA, pJIA og sJIA bør ALAT/ASAT-værdier kontrolleres hver 4. til 8. uge i de første 6 måneder af behandlingen og derefter hver 12. uge.
English: If a patient misses a subcutaneous once every 2 week injection of RoActemra within 7 days of the scheduled dose, he/she should be instructed to take the missed dose immediately and the next dose on the next scheduled day.
Danish: Hvis patienten glemmer en subkutan injektion med RoActemra, som skal tages én gang hver 2. uge, inden for 7 dage af den planlagte dosis, skal han/hun instrueres i at tage den manglende dosis med det samme og tage den næste dosis på den næste planlagte dag.
English: • If the patient weighs less than 30 kg: the dose is 162 mg (the content of 1 pre-filled syringe) once every 2 weeks
Danish: • Mindre end 30 kg: Dosis er 162 mg (indholdet i en forfyldt sprøjte) 1 gang hver anden uge
English: During routine laboratory monitoring in the RoActemra 6 month controlled clinical trial SC-I, 19% of patients experienced sustained elevations in total cholesterol > 6.2 mmol/L (240 mg/dl), with 9% experiencing a sustained increase in LDL to ≥ 4.1 mmol/L(160 mg/dL) on the subcutaneous weekly dose.
Danish: Under rutinemæssig laboratoriekontrol blandt alle RoActemra-eksponerede patienter i det 6-måneders kontrollerede kliniske studie SC-I fik 19% af patienterne vedvarende stigninger i total-kolesterol til > 6,2 mmol/l (240 mg/dl), og 9% fik vedvarende stigning i LDL til ≥4,1 mmol/l (160 mg/dl) ved ugentlig subkutant dosering.
English: RoActemra is not to be used in pregnancy unless clearly necessary.
Danish: RoActemra bør kun på tvingende indikation anvendes til gravide.
English: If the pre-filled pen is not used within 3 minutes of the cap removal, the pre-filled pen should be disposed of in the sharps container and a new pre-filled pen should be used.
Danish: Hvis den fyldte pen ikke bruges inden for 3 minutter efter hætten er fjernet, skal den fyldte pen smides i kanylebeholderen, og en ny fyldt pen tages i brug.
English: In the 6-month controlled trials decreases in neutrophil counts below 1 x 109/ l occurred in 3.4% of patients on tocilizumab 8 mg/kg plus DMARDs compared to < 0.1% of patients on placebo plus DMARDs.
Danish: I de 6-måneders kontrollerede studier forekom der fald i neutrofilocyttal til under 1 x 109/l hos 3,4 % af de patienter, som fik tocilizumab 8 mg/kg plus DMARDs, sammenlignet med < 0,1 % af de patienter, som fik placebo plus DMARDs.
English: Discontinue RoActemra
Danish: Stop behandlingen med RoActemra
English: HR (99% CI)
Danish: Hazard ratio (99% konfidensinterval)
English: Doses of 4 or 8 mg/kg of tocilizumab or placebo were given every four weeks as blinded therapy for 52 weeks in combination with stable MTX (10 mg to 25 mg weekly).
Danish: Der blev givet doser på 4 eller 8 mg tocilizumab/kg eller placebo som blindet behandling hver 4. uge i 52 uger i kombination med stabil dosis MTX (10-25 mg ugentligt).
English: Cmax (µg/mL)
Danish: Cmax (µg/mL) Cmin (µg/mL)
English: RoActemra 162 mg solution for injection in pre-filled syringe Tocilizumab
Danish: RoActemra 162 mg injektionsvæske, opløsning i en fyldt injektionssprøjte Tocilizumab
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PRE-FILLED PEN CARTON (WITH BLUE BOX) - Multipack
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE FYLDT PEN KARTON (MED BLÅ BOKS) - MULTIPAKNING
English: In RoActemra-treated patients, decreases in the levels of CRP to within normal ranges were seen as early as week 2, with decreases maintained while on treatment.
Danish: Der blev allerede i uge 2 set fald i CRP-koncentrationerne indenfor referenceintervallet hos de patienter, som blev behandlet med RoActemra.
English: RoActemra is supplied in a single use pre-filled syringe fitted into a needle safety device.
Danish: RoActemra leveres i fyldt injektionssprøjte til éngangsbrug.
English: • Place the syringe on a clean flat surface and allow the syringe to come to room temperature (18°C - 28°C) for about 25-30 minutes to warm up.
Danish: Lad injektionssprøjten ligge i ca. 25-30 minutter for at den opnår stuetemperatur (18 ºC - 28 ºC).
English: ANC > 1
Danish: Absolut neutrofilocyttal > 1
English: In the 6-month controlled trials decreases in neutrophil counts below 1 x 109/ L occurred in 3.4% of patients on RoActemra 8 mg/kg plus DMARDs compared to < 0.1% of patients on placebo plus DMARDs.
Danish: I de 6-måneders kontrollerede studier forekom der fald i neutrofilocyttal til under 1 x 109/l hos 3,4 % af de patienter, som fik RoActemra 8 mg/kg plus DMARDs, sammenlignet med < 0,1 % af de patienter, som fik placebo plus DMARDs.
English: RoActemra should be diluted to a final volume of 100 mL with sterile, non-pyrogenic sodium chloride 9 mg/mL (0.9%) solution for injection using aseptic technique.
Danish: Patienter med reumatoid artrit samt sJIA-, pJIA- og cytokinfrigivelsessyndrom-patienter ≥ 30 kg RoActemra skal fortyndes til et slutvolumen på 100 ml med steril, pyrogenfri natriumchlorid 9 mg/ml (0,9 %) injektionsvæske ved hjælp af aseptisk teknik.
English: • If the patient weighs 30 kg or more: the dose is 162 mg (the content of 1 pre-filled syringe) once every week
Danish: • 30 kg eller derover: Dosis er 162 mg (indholdet i en forfyldt sprøjte) 1 gang hver uge
English: What RoActemra is and what it is used for What you need to know before you use RoActemra How to use RoActemra
Danish: Det skal du vide, før du begynder at tage RoActemra Sådan skal du tage RoActemra Bivirkninger
English: The pharmacokinetics of tocilizumab were determined using a population pharmacokinetic analysis on a database composed of 3552 RA patients treated with a one-hour infusion of 4 or 8 mg/kg tocilizumab every 4 weeks for 24 weeks or with 162 mg tocilizumab given subcutaneously either once a week or every other week for 24 weeks.
Danish: Tocilizumabs farmakokinetik blev bestemt ved en populationsfarmakokinetisk analyse af en database, som omfattede -3.552 patienter med reumatoid artrit, som fik 4 eller 8 mg/kg tocilizumab som i.v.infusion over 1 time hver 4. uge i 24 uger eller 162 mg tocilizumab subkutant enten ugentligt eller hver anden uge i 24 uger.
English: If you miss your weekly or once every other weekly dose more than 7 days or are not sure when to inject RoActemra, call your doctor or pharmacist.
Danish: Hvis der er gået mere end en uge før du opdager, at du har glemt en dosis, eller du bliver usikker på, hvornår du skal tage næste indsprøjtning, skal du, uanset om du får RoActemra hver uge eller hver anden uge, kontakte lægen.
English: n (%)
Danish: n (%) Sekundære hovedendepunkter
English: For ALT or AST elevations > 3-5 x ULN, confirmed by repeat testing, RoActemra treatment should be interrupted.
Danish: Behandlingen med RoActemra bør stoppes, hvis stigningerne i ALAT eller ASAT bekræftes at være > 3-5 gange øvre normalgrænse ved en ny prøve.
English: In RA, pJIA and sJIA patients, ALT/AST should be monitored every 4 to 8 weeks for the first 6 months of treatment followed by every 12 weeks thereafter.
Danish: Hos patienter med reumatoid artrit, pJIA og sJIA bør ALAT/ASAT-værdier kontrolleres hver 4. til 8. uge i de første 6 måneder af behandlingen og derefter hver 12. uge.
English: 162 mg Q2W below 30 kg
Danish: 162 mg hver uge ≥ 30 kg 162 mg hver 2. uge, under 30 kg
English: With routine laboratory monitoring it was seen that approximately 24% of patients receiving RoActemra in clinical trials experienced sustained elevations in total cholesterol ≥ 6.2 mmol/ l, with 15% experiencing a sustained increase in LDL to ≥ 4.1 mmol/ l. Elevations in lipid parameters responded to treatment with lipid-lowering agents.
Danish: Rutinemæssig laboratoriekontrol afslørede, at ca. 24 % af de patienter, som fik RoActemra i de kliniske studier, fik vedvarende stigninger i total-kolesterol til ≥ 6,2 mmol/l, heraf fik 15 % vedvarende stigning i LDL til ≥ 4,1 mmol/l.
English: In patients not previously treated with RoActemra, initiation is not recommended in patients with an absolute neutrophil count (ANC) below 2 x 109/l.
Danish: Det anbefales ikke at påbegynde behandling hos patienter, som ikke tidligere er behandlet med RoActemra, og som har et absolut neutrofilocyttal under 2 x 109/l.
English: During the double-blind controlled period and with long-term exposure, the pattern and incidence of decreases in neutrophil counts remained consistent with what was seen in the 6-month controlled clinical trials.
Danish: I den dobbeltblindede, kontrollerede periode og ved langtidseksponering var mønstret og forekomsten af faldet i neutrofilocyttal i overensstemmelse med det, der blev set i de 6-måneders kontrollerede kliniske studier.
English: Withdraw a volume of sterile, non-pyrogenic sodium chloride 9 mg/mL (0.9%) solution for injection from a 50 mL infusion bag, equal to the volume of RoActemra concentrate required for the patients dose, under aseptic conditions.
Danish: Bland opløsningen ved at vende posen forsigtigt for at undgå skumdannelse sJIA-patienter og patienter med cytokinfrigivelsessyndrom < 30 kg Et volumen, som svarer til det volumen RoActemra-koncentrat, som er nødvendig til patientens dosis, udtages under aseptiske forhold fra en 50 ml infusionspose, som indeholder steril, pyrogenfri natriumchlorid 9 mg/ml (0,9 %) injektionsvæske.
English: During the double-blind controlled period and with long-term exposure, the pattern and incidence of elevation in ALT/AST remained consistent with what was seen in the 6-month controlled clinical trials.
Danish: I den dobbeltblindede, kontrollerede periode og ved langtidseksponering var mønstret og forekomsten af stigninger af ALAT/ASAT i overensstemmelse med det, der blev set i de 6-måneders kontrollerede kliniske studier.
English: Treatment should be initiated by healthcare professionals experienced in the diagnosis and treatment of RA, sJIA, pJIA or CRS.
Danish: Behandling bør påbegyndes af speciallæger med erfaring i diagnostik og behandling af reumatoid artrit, sJIA, pJIA eller cytokinfrigivelsessyndrom.
English: Do not use if the medicine is cloudy or contains particles, is any colour besides colourless to slightly yellowish, or any part of the pre-filled pen appears to be damaged.
Danish: Brug ikke medicinen hvis den er uklar eller indeholder partikler, ikke er farveløs til svagt lysegul, eller én eller flere dele af den fyldte pen ser ud til at være beskadiget.
English: The decision to discontinue RoActemra in pJIA for a laboratory abnormality should be based on the medical assessment of the individual patient.
Danish: Seponer RoActemra Beslutningen om at seponere RoActemra på grund af en laboratorieanormalitet skal baseres på en medicinsk vurdering af den enkelte pJIA-patient
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PRE-FILLED SYRINGE CARTON (WITHOUT BLUE BOX) - Multipack
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE FYLDT INJEKTIONSSPRØJTE KARTON (UDEN BLÅ BOKS) - MULTIPAKNING
English: How to use RoActemra
Danish: Sådan skal du tage RoActemra
English: In the 6-month controlled trials decreases in platelet counts below 100 x 103/ μL occurred in 1.7% of patients on tocilizumab 8 mg/kg plus DMARDs compared to < 1% on placebo plus DMARDs.
Danish: I de 6-måneders kontrollerede studier blev der set fald i trombocyttal til under 100 x 103/μl hos 1,7 % af de patienter, der fik tocilizumab 8 mg/kg plus DMARDs, sammenlignet med < 1 % hos de patienter, der fik placebo plus DMARDs.
English: ≥30 kg (n=26) dosed with 162 mg of RoActemra every week (QW) and patients weighing below 30
Danish: 30 kg (n = 25) doseret 162 mg RoActemra hver 2. uge, mens patienter, der vejede under 30 kg (n = 27), fik doseret 162 mg RoActemra hver.
English: With routine laboratory monitoring it was seen that approximately 24% of patients receiving RoActemra in clinical trials experienced sustained elevations in total cholesterol ≥ 6.2 mmol/ l, with 15% experiencing a sustained increase in LDL to ≥ 4.1 mmol/ L. Elevations in lipid parameters responded to treatment with lipid-lowering agents.
Danish: Rutinemæssig laboratoriekontrol afslørede, at ca. 24 % af de patienter, som fik RoActemra i de kliniske studier, fik vedvarende stigninger i total-kolesterol til ≥ 6,2 mmol/L, heraf fik 15 % vedvarende stigning i LDL til ≥ 4,1 mmol/L.
English: Doses of 4 or 8 mg/kg of RoActemraor placebo were given every four weeks as blinded therapy for 52 weeks in combination with stable MTX (10 mg to 25 mg weekly).
Danish: Der blev givet doser på 4 eller 8 mg RoActemra/kg eller placebo som blindet behandling hver 4. uge i 52 uger i kombination med stabil dosis MTX (10-25 mg ugentligt).
English: After removing the cap the injection must be started within 3 minutes to prevent the medicine from drying out and blocking the needle.
Danish: Når kanylehætten er fjernet, skal injektionen påbegyndes inden for 3 minutter for at forhindre at medicinen tørrer ud og blokerer kanylen.
English: In general, the ADRs in pJIA and sJIA patients were similar in type to those seen in RA patients, see section 4.8.
Danish: Generelt svarede bivirkningerne hos pJIA- og sJIA-patienter til de typer af bivirkninger, som er set hos patienter med reumatoid artrit (se pkt.