FrancophonIA/ELRC3.0 huggingface dataset:
English: • Do not hold or push on the plunger while inserting the needle into the skin.
Danish: • Hold ikke i injektionssprøjtens stempel, mens du stikker kanylen i huden.
English: For the 162 every other week dose, the predicted mean (±SD) steady-state AUC2week, Cmin, and Cmax of RoActemra were 3430 ± 2660 µg•h/mL, 5.7 ± 6.8 µg/mL, and 13.2 ± 8.8 µg/mL, respectively.
Danish: Ved dosering med 162 mg hver anden uge var det beregnede gennemsnitlige (±SD) steady-state AUC2uger, Cmin og Cmax for RoActemra henholdsvis 3.430 ± 2.660 µg•t/mL, 5,7 ± 6,8 µg/mL og 13,2 ± 8,8 µg/mL.
English: The linear clearance was estimated as a parameter in the population pharmacokinetic analysis and was 9.5 mL/h.
Danish: Den lineære clearance blev estimeret som en parameter i den populationsfarmakokinetiske analyse og var 9,5 ml/time.
English: RoActemra helps to reduce RA symptoms such as pain and swelling in your joints, and can also improve your performance of daily tasks.
Danish: RoActemra nedsætter symptomer på leddegigt, som f.eks. smerter og hævelse i dine led og kan medvirke til, at du nemmere kan udføre dine daglige opgaver.
English: Once the non-linear clearance pathway is saturated, at higher tocilizumab concentrations, clearance is mainly determined by the linear clearance.
Danish: Når den non-lineære clearance pathway først er mættet, ved højere koncentrationer af tocilizumab, bestemmes clearance hovedsageligt af den lineære clearance.
English: DAS28 < 2.6, n (%)
Danish: ACR20, n (%)
English: • Sterile cotton ball or gauze
Danish: • Sterilt vat eller gaze
English: Eleven (6.8%) patients in the tocilizumab arm and five (3.1%) patients in the adalimumab arm experienced ALT increases of CTC grade 2 or higher.
Danish: Elleve (6,8 %) patienter i tocilizumab-armen og fem (3,1 %) patienter i adalimumab-armen oplevede ALAT-stigning af CTC grad 2 eller højere.
English: Some side effects were seen more often: inflamed nose and throat, diarrhoea, lower white blood cell counts and higher liver enzymes.
Danish: Dog blev følgende bivirkninger set hyppigere: infektion i næse og hals, diarré, nedsat antal hvide blodlegemer og forhøjede leverenzymer.
English: Doses of 8 mg/kg of tocilizumab were given every four weeks as monotherapy.
Danish: Der blev givet doser på 8 mg/kg tocilizumab hver 4. uge som monoterapi.
English: Steady state was reached after 12 weeks for AUC, Cmin, and Cmax.
Danish: Steady-state for AUC, Cmin og Cmax blev nået efter 12 uger.
English: Haematological abnormalities
Danish: Hæmatologiske abnormaliteter
English: When compared to the adult RA population, patients with sJIA experienced a higher frequency of nasopharyngitis, decrease in neutrophil counts, hepatic transaminases increased, and diarrhea.
Danish: Sammenlignet med voksne med reumatoid artrit var følgende bivirkninger hyppigere hos sJIApopulationen: nasopharyngitis, fald i neutrofilocytter, forhøjede levertransaminaser og diarré.
English: MTX naïve, Early RA Study VII (WA19926), a 2 year study with the planned primary analysis at week 52 evaluated 1162
Danish: MTX-naive patienter med tidlig reumatoid artrit Studie VII (WA19926), et 2-årigt studie med planlagt primær analyse i uge 52, undersøgte 1.162 MTX-naive voksne patienter med moderat til svær, aktiv tidlig reumatoid artrit (gennemsnitlig sygdomsvarighed ≤ 6 måneder).
English: In the monotherapy study the rate of serious infections was 3.6 events per 100 patient years of exposure in the tocilizumab 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 tocilizumabgruppen og 1,5 hændelser pr. 100 patientår i MTX-gruppen.
English: Events of diverticular perforations as complications of diverticulitis have been reported uncommonly with RoActemra in RA patients (see section 4.8).
Danish: Tilfælde af divertikulære perforationer, som komplikation til diverticulitis, er blevet indberettet med frekvensen ”ikke almindelige” i forbindelse med RoActemra-behandling hos RA-patienter (se pkt.
English: During routine laboratory monitoring in the tocilizumab all exposure population, a decrease in neutrophil count below 1 × 109/L occurred in 3.7% of patients.
Danish: Under rutinemæssig laboratoriekontrol blandt alle tocilizumab-eksponerede patienter forekom der et fald i neutrofilocyttal til under 1 × 109/l hos 3,7 % af patienterne.
English: The treatment will be prescribed and started by healthcare professionals experienced in the diagnosis and treatment of RA or GCA.
Danish: Behandlingen vil blive ordineret og igangsat af sundhedspersonale, som har erfaring i diagnosticering og behandling af leddegigt og GCA.
English: • Nurse Information Pack
Danish: • Informationsmateriale til sygeplejersken
English: If you have any concerns or questions about your syringe, contact your healthcare provider or pharmacist for assistance.
Danish: Hvis der er noget du er usikker på, eller du har spørgsmål vedrørende injektionssprøjten, skal du kontakte lægen, sundhedspersonalet eller apoteket.
English: Keep the RoACTEMRA pre-filled pen and disposal container out of the reach of children.
Danish: Opbevar fyldte RoActemra-penne og kanylebeholder utilgængeligt for børn.
English: • children and adolescents, aged 2 years and over, with active polyarticular juvenile idiopathic arthritis (pJIA).
Danish: • børn og unge med aktiv polyartikulær juvenil idiopatisk artrit (pJIA) som er 2 år eller ældre.
English: After subcutaneous administration, the effective t1/2 of RoActemra in pJIA patients is up to 10 days for patients < 30 kg (162 mg SC Q3W) and up to 7 days for patients >= 30 kg (162 mg SC Q2W) during a dosing interval at steady state.
Danish: Efter subkutan administration er den effektive t½ af RoActemra op til 10 dage hos pJIA-patienter < 30 kg (162 mg subkutant hver 3. uge) og op til 7 dage for pJIA-patienter ≥ 30 kg (162 mg subkutant hver 2. uge) under et doseringsinterval ved steady-state.
English: Children and adolescents with pJIA (aged 2 and over)
Danish: Børn og unge med pJIA (2 år og ældre)
English: During the double-blind controlled period, the incidence of indirect bilirubin greater than the upper limit of normal, collected as a routine laboratory parameter, is 6.2% in patients treated with 8 mg/kg tocilizumab + DMARD.
Danish: I den dobbeltblindede, kontrollerede periode var forekomsten af indirekte bilirubin højere end den øvre grænse af normalområdet, indsamlet som en rutinemæssig laboratorieparameter, 6,2 % hos patienter behandlet med 8 mg tocilizumab/kg + DMARD.
English: All patients should be up-to-date with all their vaccinations before they start treatment with RoActemra.
Danish: Alle patienter bør forud for påbegyndelse af RoActemra-behandling bringes ajour med alle vaccinationer.
English: The mean change in Patient's global VAS from baseline at week 52 was lower (showing greater improvement) in the RoActemra weekly and every other weekly dose groups [-19.0, -25.3, respectively] than in both placebo groups [placebo plus 26 weeks -3.4, placebo plus 52 weeks -7.2], although only the RoActemra every other weekly plus 26 weeks prednisone taper group showed a statistically significant difference compared to placebo [placebo plus 26 weeks taper p=0.0059, and placebo plus 52 weeks taper p=0.0081].
Danish: Den gennemsnitlige ændring i patientens globale VAS fra baseline i uge 52 var lavere (viste større forbedring) i grupperne,der fik RoActemra ugentligt og hver anden uge [henholdsvis -19,0;25,3] end i begge af placebo-grupperne [placebo plus 26 uger -3,4 Placebo plus 52 uger -7,2], selvom det kun var RoActemra administreret hver anden uge plus 26 ugers nedtrapningsregime af prednison, der viste en statistisk signifikant forskel i forhold til placebo [placebo plus 26 ugers nedtrapning p = 0,0059 og placebo plus 52 uger aftagende p = 0,0081] .
English: During the double-blind controlled period, the incidence of indirect bilirubin greater than the upper limit of normal, collected as a routine laboratory parameter, is 6.2% in patients treated with 8 mg/kg RoActemra + DMARD.
Danish: I den dobbeltblindede, kontrollerede periode var forekomsten af indirekte bilirubin højere end den øvre grænse af normalområdet, indsamlet som en rutinemæssig laboratorieparameter, 6,2 % hos patienter behandlet med 8 mg RoActemra/kg + DMARD.
English: Caution should be exercised when considering initiation of RoActemra treatment in patients with elevated ALT or AST > 1.5 x ULN.
Danish: Der skal udvises forsigtighed, hvis det overvejes at påbegynde behandling med RoActemra hos patienter med forhøjet ALAT eller ASAT dvs. hos patienter, som har værdier, der er >1,5 x øvre normalgrænse.
English: Eleven (6.8%) patients in the RoActemra arm and five (3.1%) patients in the adalimumab arm experienced ALT increases of CTC grade 2 or higher.
Danish: Elleve (6,8 %) patienter i RoActemra-armen og fem (3,1 %) patienter i adalimumab-armen oplevede ALAT-stigning af CTC grad 2 eller højere.
English: RoActemra 20 mg/mL concentrate for solution for infusion Tocilizumab
Danish: RoActemra 20 mg/ml koncentrat til infusionsvæske, opløsning Tocilizumab
English: ACR responses in study SC-I (% patients) at Week 24
Danish: ACR-responsrater i studie SC-1 ved uge 24 (% patienter)
English: The Physician Information pack should contain the following key elements:
Danish: Informationsmaterialet til lægen skal indeholde følgende nøgleelementer:
English: Thus, CYP450 expression may be reversed when potent cytokine inhibitory therapy, such as RoActemra, is introduced.
Danish: Supprimeringen af CYP450-ekspressionen kan derfor reverseres ved påbegyndelse af potent cytokinhæmmende behandling, som fx RoActemra.
English: Children with pJIA (aged 2 and over)
Danish: Børn med pJIA (2 år og ældre)
English: Step 2.
Danish: Trin 2.
English: Statistically significant improvements in HAQ-DI scores were observed in patients treated with RoActemra compared with patients treated with DMARDs.
Danish: Sammenlignet med de patienter, som fik DMARDs, blev der set statistisk signifikante forbedringer i HAQ-DI-scoren hos de patienter, som fik behandling med RoActemra.
English: If following pressing the activation button the purple indicator does not move, you must dispose of the pre-filled pen in a puncture resistant container.
Danish: Hvis den lilla indikator ikke flyttes ved tryk på aktiveringskappen , skal den fyldte pen bortskaffes i en affaldsbeholder til skarpe genstande.
English: Step 7.
Danish: Trin 7.
English: Clinically significant hypersensitivity reactions associated with RoActemra and requiring treatment discontinuation were reported in a total of 13 out of 3778 patients (0.3%) 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 13 ud af 3778 patienter (0,3%).
English: • Alcohol pad
Danish: • Spritservietter
English: The long-term exposure population includes all patients who received at least one dose of tocilizumab either in the double-blind control period or open label extension phase in the studies.
Danish: Populationen, som blev eksponeret i lang tid, omfatter alle patienter, der fik mindst én dosis tocilizumab enten i den dobbeltblindede kontrolperiode eller i den åbne forlængelsesfase i studierne.
English: Patients should be advised to seek medical advice if signs/symptoms (e.g., persistent cough, wasting/weight loss, low grade (fever) suggestive of a tuberculosis infection occur during or after therapy with RoActemra.
Danish: Patienter skal tilrådes at søge læge, hvis de får symptomer (f.eks. vedvarende hoste, vægttab, let feber), som tyder på tuberkuloseinfektion, under eller efter behandling med RoActemra.
English: In Part 1, eligible patients ≥ 30 kg received tocilizumab at 8 mg/kg IV every 4 weeks for 4 doses.
Danish: I del I fik inkluderbare patienter, som vejede ≥30 kg, 8 mg/kg tocilizumab som infusion hver fjerde uge, i alt 4 doser.
English: TCZ + Placebo (SC) N = 163
Danish: Tocilizumab + placebo (subkutan) N = 163
English: Placebo + 26 weeks prednisone taper N=50
Danish: Placebo + 26 ugers nedtrapningsregime af prednison N=50
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
English: Excipients with known effects Each 80 mg vial contains 0.10 mmol (2.21 mg) sodium.
Danish: Hvert 80 mg hætteglas indeholder 0,10 mmol (2,21 mg) natrium.
English: • adults with moderate to severe active rheumatoid arthritis (RA), an autoimmune disease, if previous therapies did not work well enough.
Danish: • voksne patienter med moderat til svær aktiv leddegigt (en autoimmun sygdom), hos hvem tidligere behandling ikke har virket godt nok.
English: for patients weighing ≥ 30 kg respectively provide PK exposure and PD responses to support efficacy and safety outcomes similar to those achieved with the approved RoActemra IV regimens for pJIA.
Danish: 3 uge afhængig af en vægt ≥ 30 kg eller en vægt under 30 kg viste, at den farmakokinetiske eksponering og farmakodynamiske respons kunne supportere sammenlignelig virkning og sikkerhed med det godkendte intravenøse RoActemra behandlingsregime for pJIA.
English: Biologic Use
Danish: Tidligere biologisk behandling
English: If the needle cap is removed for more than 5 minutes, it may be more difficult to perform an injection as the medicine can dry out and block the needle.
Danish: Det kan være svært at give indsprøjtningen, hvis det er mere end 5 minutter siden den grønne hætte er fjernet, eftersom medicinen kan tørre ud og blokere kanylen.
English: Patients should be instructed to seek medical advice if signs/symptoms (e.g., persistent cough, wasting/weight loss, low grade fever) suggestive of a tuberculosis infection occur during or after therapy with RoActemra.
Danish: Patienter skal instrueres i at søge læge, hvis de får symptomer (f.eks. vedvarende hoste, vægttab, let feber), som tyder på tuberkuloseinfektion, under eller efter behandling med RoActemra.
English: The primary efficacy endpoint assessed by the proportion of patients achieving steroid free sustained remission at week 52 on RoActemra plus 26 weeks prednisone taper compared with placebo plus 26 weeks prednisone taper, was met (Table 4).
Danish: Det primære effekt-endepunkt vurderet ved andelen af patienter, der opnåede steroidfri vedvarende remission i uge 52 med RoActemra plus 26 ugers nedtrapningsregime af prednison sammenlignet med placebo ved 26 ugers nedtrapningsregime af prednison, blev nået (tabel 4).
English: Proportion of patients achieving a clinically relevant improvement in HAQ-DI at week 24 (change from baseline of ≥ 0.3 units) was higher for RoActemra subcutaneous every other week (58%) versus placebo
Danish: Andelen af patienter, som opnåede klinisk relevant forbedring i HAQ-DI ved uge 24 (ændring fra baseline på > 0,3 enheder), var højere hos den gruppe, som blev behandlet med subkutant RoActemra hver anden uge, (58%) sammenlignet med placebo (46,8%).
English: During routine laboratory monitoring in the RoActemra all exposure population, a decrease in neutrophil count below 1 × 109/L occurred in 15.4% of patients treated with SC RoActemra.
Danish: Under rutinemæssig laboratoriekontrol blandt alle RoActemra-eksponerede patienter blev der observeret et fald i neutrofiltal til under 1 × 109/L hos 15,4 % af patienterne behandlet med subkutan RoActemra.
English: RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.
Danish: RoActemra kan gives som monoterapi i tilfælde af intolerance over for MTX, eller hvor fortsat behandling med MTX er uhensigtsmæssig.
English: Clinical Efficacy
Danish: Klinisk virkning
English: Modify the dose of the concomitant MTX if appropriate For persistent increases in this range, reduce RoActemra dose to 4 mg/kg or interrupt RoActemra until alanine aminotransferase (ALT) or aspartate aminotransferase (AST) have normalised
Danish: Modificer dosis af samtidig MTX, hvis det er hensigtsmæssigt Ved vedvarende stigning nedsæt dosis af RoActemra til 4 mg/kg eller stop behandlingen med RoActemra indtil alaninaminotransferase (ALAT) eller aspartataminotransferase (ASAT) er normaliseret Påbegynd behandlingen igen med 4 mg/kg eller 8 mg/kg efter et klinisk skøn
English: What do I need to know to use my RoActemra pre-filled syringe safely?
Danish: Det skal du vide for at bruge din fyldte RoActemra-injektionssprøjte sikkert.
English: Major Clinical Response
Danish: Betydningsfuldt klinisk respons
English: • If you experience allergic reactions such as chest tightness, wheezing, severe dizziness or light-headedness, swelling of the lips or skin rash during or after the infusion, then tell your doctor immediately.
Danish: • Hvis du får allergiske reaktioner som f.eks. trykken for brystet, hvæsende vejrtrækning, svær svimmelhed eller omtågethed, hævede læber eller udslæt under eller efter infusionen, skal du omgående fortælle det til din læge.
English: Do not use the pre-filled pen if the expiration date has passed because it may not be safe to use.
Danish: Brug ikke de fyldte penne, hvis udløbsdatoen er overskredet af sikkerhedsmæssige grunde.
English: If you stop using RoActemra You should not stop using RoActemra without discussing with your doctor first.
Danish: Hvis du holder op med at få RoActemra Beslutningen om at stoppe behandlingen med RoActemra aftales med din læge.
English: For subcutaneous administration, the concentration-dependent apparent t 1/2 is up to 12 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 koncentrationsafhængige tilsyneladende t1/2 ved steady-state op til 12 dage for 162 mg ugentligt og 5 dage for 162 mg hver anden uge hos patienter med RA.
English: Do not touch the trigger fingers on the syringe as this may damage the syringe.
Danish: Rør ikke ved injektionssprøjtens aktiveringsknap, da det kan beskadige injektionssprøjten.
English: Following 1 year of treatment with RoActemra 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 RoActemra 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: For MCS, the mean change from baseline to week 52 for both RoActemra weekly and every other weekly dose groups [7.28, 6.12, respectively] were higher than the placebo plus 52 weeks prednisone taper group [2.84] (although the differences were not statistically significant [weekly p=0.0252 for weekly, p=0.1468 for every other weekly]) and similar to the placebo plus 26 weeks prednisone taper group [6.67].
Danish: For mental komponent score var den gennemsnitlige ændring fra baseline til uge 52 for både ugentlig dosis RoActemra, der fik RoActemra hver anden uge grupperne [henholdsvis 7,28; 6,12] højere end placebo plus 52 ugers aftagende prednison dosis gruppen [2,84] (selv om forskellene ikke var statistisk signifikante [p = 0,0252 for ugentligt, p = 0,1468 for hver anden uge]) og sammenlignelig med placebo plus 26 ugers aftagende prednison dosis gruppen [6,67].
English: A 52-week, open-label, multi-centre, PK/PD and safety study (WA28118) was conducted in paediatric patients with sJIA, aged 1 to 17 years, to determine the appropriate SC 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 (WA28118) blev gennemført hos pædiatriske patienter med sJIA i alderen 1-17 år.
English: In patients treated with RoActemra 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 RoActemra 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: The safety observed in the tocilizumab arm was consistent with the known safety profile of tocilizumab 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 tocilizumab og ingen nye eller uventede bivirkninger blev observeret (se tabel 1).
English: Statistically significant improvements in haemoglobin levels were observed with tocilizumab compared with DMARDs (p< 0.0001) at week 24.
Danish: I uge 24 blev der set statistisk signifikante forbedringer i hæmoglobinkoncentrationerne efter behandling med tocilizumab, sammenlignet med behandling med DMARDs (p < 0,0001).
English: Haematological abnormalities:
Danish: Hæmatologiske abnormiteter:
English: The efficacy of tocilizumab in alleviating the signs and symptoms of RA was assessed in five randomised, double-blind, multi-centre studies.
Danish: Tocilizumabs virkning på reduktion af symptomerne på reumatoid artrit blev undersøgt i fem randomiserede, dobbeltblindede multicenterstudier.
English: Available data with the IV formulation suggest that clinical improvement is observed within 12 weeks of initiation of treatment with RoActemra.
Danish: Tilgængelige data for intravenøs formulering indikerer, at der observeres en klinisk forbedring inden for 12 uger efter start af behanfdling med RoActemra.
English: Serious hypersensitivity reactions, including anaphylaxis have been reported in association with RoActemra (see section 4.8).
Danish: Der er indberetninger om alvorlige overfølsomhedssreaktioner, inklusive anafylaksi, i forbindelse med RoActemra (se pkt.
English: The data available so far does not suggest any effect on fertility from this treatment.
Danish: Tilgængelige data tyder ikke på, at frugtbarheden påvirkes under denne behandling.
English: During routine laboratory monitoring in the tocilizumab all exposure population, 1% of patients had a decrease in platelet count to ≤ 50 × 103/µL without associated bleeding events.
Danish: Under rutinemæssig laboratoriekontrol blandt alle tocilizumab-eksponerede patienter forekom der et fald i trombocytter til ≤50 × 103/µl uden ledsagende blødningsepisoder hos 1 % af patienterne.
English: During the withdrawal phase (Part II), the percentage of patients achieving JIA ACR 30, 50, and 70 responses at Week 40 relative to baseline are shown in Table 8.
Danish: Procentdelen af patienter, der opnåede JIA-ACR30-, ACR50- og ACR70-respons ved uge 40 i forhold til baseline i udtrædningsfasen (del II) er vist i tabel 8.
English: In the double-blind controlled studies, 774 patients received RoActemra 4 mg/kg in combination with MTX, 1870 patients received RoActemra 8 mg/kg in combination with MTX or other DMARDs and 288 patients received RoActemra 8 mg/kg monotherapy.
Danish: I de dobbeltblindede, kontrollerede studier fik 774 patienter RoActemra 4 mg/kg i kombination med MTX, 1.870 patienter fik RoActemra 8 mg/kg i kombination med MTX eller andre DMARDs, og 288 patienter fik RoActemra 8 mg/kg som monoterapi.
English: TCZ IV 8 mg/kg + DMARD
Danish: TCZ 8 mg/kg + DMARD
English: It is recommended that all patients particularly elderly patients, be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating RoActemra therapy.
Danish: Det anbefales at alle patienter, specielt ældre patienter, før påbegyndelse af RoActemra-behandling bringes ajour med alle immuniseringer i overensstemmelse med gældende retningslinjer for immunisering.