FrancophonIA/ELRC3.0 huggingface dataset:
English: No clinically significant hypersensitivity reactions associated with tocilizumab and requiring treatment discontinuation were reported.
Danish: Der blev ikke rapporteret klinisk signifikante overfølsomhedsreaktioner, der krævede seponering af tocilizumab.
English: The mean LDL increase from baseline was 0.64 mmol/L (25 mg/dL) for patients in the tocilizumab arm and 0.19 mmol/L (7 mg/dL) for patients in the adalimumab arm.
Danish: Den gennemsnitlige stigning i LDL fra baseline var 0,64 mmol/l (25 mg/dl) for patienter i tocilizumab-armen og 0,19 mmol/l (7 mg/dl) for patienter i adalimumab-armen.
English: Therefore, tocilizumab doses exceeding 800 mg per infusion are not recommended (see section 4.2).
Danish: Tocilizumabdoser over 800 mg per infusion anbefales derfor ikke (se pkt 4.2).
English: • warfarin or phenprocoumon, used as a blood thinning agents
Danish: • warfarin eller phenprocoumon, som bruges til at fortynde blodet (forebygge blodpropper)
English: Side effects in children and adolescents with sJIA or pJIA are generally similar to those in adults.
Danish: Bivirkninger hos børn og unge med sJIA eller pJIA Generelt svarer bivirkningerne hos sJIA- eller pJIA-patienter til de typer af bivirkninger, som ses hos voksne patienter.
English: In general, the adverse drug reactions observed during or within 24 hours of an infusion were similar in nature to those seen in RA and sJIA patients, see section 4.8.
Danish: Generelt svarede de bivirkninger, der blev set under eller inden for 24 timer efter en infusion, til dem, der blev set hos reumatoid artrit-patienter og hos sJIA-patienter, se pkt.
English: The rate of infection/serious infection events was balanced between the RoActemra weekly group (200.2/9.7 events per 100 patient years) vs. placebo plus 26 weeks prednisone taper (156.0/4.2 events per 100 patient years) and placebo plus 52 weeks taper (210.2/12.5 events per 100 patient years) groups.
Danish: Infektionshyppigheden/alvorlige infektionshændelser var afbalanceret mellem gruppen, der fik RoActemra på ugentlig basis (200,2/9,7 hændelser pr. 100 patientår) versus placebo plus 26 ugers nedtrappende prednison-dosis (156,0/4,2 hændelser pr. 100 patientår) og placebo plus 52 ugers nedtrappende dosis (210,2/12,5 hændelser pr. 100 patientår) grupper.
English: The mean LDL increase from baseline was 0.64 mmol/L (25 mg/dL) for patients in the RoActemra arm and 0.19 mmol/L (7 mg/dL) for patients in the adalimumab arm.
Danish: Den gennemsnitlige stigning i LDL fra baseline var 0,64 mmol/L (25 mg/dL) for patienter i RoActemra-armen og 0,19 mmol/L (7 mg/dL) for patienter i adalimumab-armen.
English: *τ = 4 weeks for IV regimens
Danish: *τ = 4 uger for intravenøse regimer
English: Yes (N = 27)
Danish: Ja (n = 27)
English: Mean (SD) * p<0.0001 ** p<0.005 (threshold for significance for primary and key secondary tests of superiority) ***Descriptive p value <0.005 ****Flare: recurrence of GCA signs or symptoms and/or ESR ≥30 mm/h - Increase in the prednisone dose required Remission: absence of flare and normalization of the CRP Sustained remission: remission from week 12 to week 52 -Patients must adhere to the protocol-defined prednisone taper ¹ analysis of the time (in days) between clinical remission and first disease flare 2 p-values are determined using a Van Elteren analysis for non-parametric data § statistical analyses has not been performed
Danish: * p<0.0001 **p<0.005 (tærskel for signifikans for primære og vigtige sekundære tests af superioritet) ***Beskrivende p værdi <0.005 ****Flare: genopblussen af tegn eller symptomer på GCA og/eller ESR ≥30 mm/t - Kræver stigning i prednison dosis Remission: udeblivelse af flare og normalisering af CRP
English: • Continue to pinch the skin while you keep the pre-filled pen in place.
Danish: • Bliv ved med at klemme om hudfolden, mens du holder pennen i den rigtige position.
English: • If you weigh 30 kg or more, the dose is 8 mg for every kilogram of body weight The dose is calculated based on your body weight at each administration.
Danish: • Hvis du/barnet vejer 30 kg eller mere, er dosis 8 mg pr. kg kropsvægt Dosis beregnes ved hver administration på baggrund af din/barnets vægt.
English: Laboratory Value (cells x 109/ l )
Danish: Laboratorieværdi (celler x 10 9/l )
English: • benzodiazepines (e.g. temazepam), used to relieve anxiety.
Danish: • benzodiazepin, f.eks. temazepam, som bruges til at behandle angst.
English: Do not use the syringe if the expiration date has passed.
Danish: Brug ikke injektionssprøjten, hvis udløbsdatoen er overskredet.
English: Hepatic transaminases increased, Weight increased, Total bilirubin increased*
Danish: Forhøjede leveraminotransf eraser, vægtøgning, øget total-bilirubin*
English: Pinching the skin is important to ensure that you inject under the skin (into fatty tissue) but not any deeper (into muscle).
Danish: Det er vigtigt at klemme hudfolden fast sammen for at sikre, at du sprøjter medicinen ind under huden (i fedtvæv) og ikke dybere (i muskelvæv).
English: • phenytoin, used to treat convulsions
Danish: • phenytoin, som bruges til at behandle kramper
English: RoActemra monotherapy should not be used for the treatment of acute relapses (see 4.4).
Danish: RoActemra monoterapi skal ikke anvendes til behandling af akutte tilbagefald (se pkt.
English: If you cannot start the injection you should ask for help from a caregiver or contact your healthcare provider.
Danish: Hvis du ikke kan starte indsprøjtningen, skal du bede nogen om hjælp eller kontakte sundhedspersonalet.
English: Not included in the box:
Danish: • Fyldt injektionssprøjte Ikke inkluderet i æsken:
English: Most of the patients in the RA and GCA studies population pharmacokinetic analysis had normal renal function or mild renal impairment.
Danish: De fleste patienter i reumatoid artrit og GCA studierne havde udfra populationsfarmakokinetiske analyse havde normal eller let nedsat nyrefunktion.
English: RoActemra binds specifically to both soluble and membrane-bound IL-6 receptors (sIL-6R and mIL-6R).
Danish: RoActemra bindes specifikt til både opløselige og membranbundne IL-6 receptorer (sIL-6R og mIL6R).
English: • Do not remove the needle-cap until you are ready to inject
Danish: • Fjern ikke hætten over kanylen, før du er klar til at give indsprøjtningen
English: The adjusted mean change in the pain VAS after 40 weeks of tocilizumab treatment was 32.4 mm on a 0-100 mm scale compared to a reduction of 22.3 mm for placebo patients (highly statistically significant; p=0.0076).
Danish: Den justerede gennemsnitlige ændring i smerte-VAS efter 40 ugers tocilizumab-behandling på en 0-100 mm skala var 32,4 mm sammenlignet med en reduktion på 22,3 mm for placebo-behandlede patienter (høj statistisk signifikans, p=0,0076).
English: Of these 52 patients, 37 (71%) were naive to RoActemra and 15 (29%) had been receiving RoActemra IV and switched to RoActemra SC at baseline.
Danish: Ud af disse 52 patienter var 37 patienter (71 %) RoActemra naive, mens 15 (29 %) blev skiftet fra intravenøs til subkutan RoActerma ved baseline.
English: RoActemra treatment must not be initiated in patients with active infections (see section 4.3).
Danish: Behandling med RoActemra skal ikke påbegyndes hos patienter med aktive infektioner (se pkt.
English: The concentration-dependent non-linear clearance plays a major role at low RoActemra concentrations.
Danish: Den koncentrationsafhængige non-lineære clearance spiller en væsentlig rolle ved lave koncentrationer af RoActemra.
English: Inhibition of joint structural damage was shown with significantly less radiographic progression in patients receiving RoActemra compared to control (Table 6).
Danish: Der blev vist hæmning af strukturel ledbeskadigelse med signifikant mindre radiografisk progression hos de patienter, som fik RoActemra, sammenlignet med kontrolgruppen (tabel 6).
English: The frequency of ADRs in sJIA patients can be found in Table 2.
Danish: Frekvensen af bivirkninger hos sJIA-patienter kan ses i tabel 2.
English: Population pharmacokinetic analyses did not detect any effect of MTX, non-steroidal antiinflammatory drugs (NSAIDs) or corticosteroids on tocilizumab clearance.
Danish: Populationsfarmakokinetisk analyse har ikke påvist effekt af MTX, non-steroide antiinflammatoriske midler (NSAIDs) eller kortikosteroider på tocilizumabs clearance.
English: • If any patient has recently been vaccinated, or is planning a vaccination, tell your doctor.
Danish: • Hvis du er blevet vaccineret for nylig eller planlægger at blive det, skal du fortælle det til lægen.
English: 162 mg every other weekly
Danish: 162 mg hver anden uge
English: Tocilizumab AUC, Cmin and Cmax increased with increase of body weight.
Danish: AUC, Cmin og Cmax for tocilizumab steg med øget legemsvægt.
English: The safety profile of intravenous RoActemra in pJIA has been studied in 188 patients from 2 to 17 years of age.
Danish: Sikkerhedsprofilen af intravenøs RoActermra hos pJIA-patienter er blevet undersøgt hos 188 patienter i alderen 2 til17 år.
English: This medicine is subject to restricted medical prescription by your doctor.
Danish: Dette lægemiddel må kun udleveres efter ordination på recept udstedt af en begrænset lægegruppe
English: Disodium phosphate dodecahydrate Sodium dihydrogen phosphate dihydrate Water for injections
Danish: Dinatriumphosphatdodecahydrat Natriumdihydrogenphosphatdihydrat Vand til injektionsvæsker
English: • Do not leave the pre-filled pen unattended.
Danish: • Efterlad aldrig en fyldt pen uden opsyn.
English: The safety of tocilizumab in CRS has been evaluated in a retrospective analysis of data from clinical trials, where 51 patients were treated with intravenous tocilizumab 8 mg/kg (12 mg/kg for patients less than 30 kg) with or without additional high-dose corticosteroids for severe or life-threatening CAR Tcell-induced CRS.
Danish: Sikkerheden af tocilizumab hos patienter med cytokinfrigivelsessyndrom er undersøgt i en retrospektiv analyse af data fra kliniske forsøg, hvor 51 patienter blev behandlet med intravenøs tocilizumab 8 mg/kg (12 mg/kg for patienter vejende mindre end 30 kg) med eller uden supplerende behandling med høj-dosis kortikosteroid for svær eller livstruende CAR T-celle-induceret cytokinfrigivelsessyndrom.
English: The safety of subcutaneous RoActemra in RA includes a double-blind, controlled, multicenter study, SC-I. SC-I was a non-inferiority study that compared the efficacy and safety of RoActemra162 mg administered every week versus 8 mg/kg intravenous in 1262 patients with RA.
Danish: Vurderingen af sikkerheden ved subkutan RoActemra hos reumatoid artrit-patienter inkluderer et dobbeltblindet, kontrolleret, multicenter-studie, SC-I. SC-I var et non-inferiority studie med 1262 reumatoid artrit-patienter, der sammenlignede effekt og sikkerhed af RoActemra 162 mg administreret ugentligt versus 8 mg/kg administreret intravenøst.
English: • Infusion rate
Danish: • Infusionshastighed
English: The primary endpoint in the study was the difference in the proportion of patients who achieved an ACR20 response at week 24.
Danish: Det primære endpunkt i studiet var forskellen i andelen af patienter, der oplevede ACR20-respons ved uge 24.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION RoActemra 20 mg/mL sterile concentrate
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) RoActemra 20 mg/ml sterilt koncentrat
English: • Write the date, time, and specific part of your body where you injected yourself.
Danish: • Skriv ned dato og tidspunkt for hvornår du gav indsprøjtningen og det præcise indsprøjtningssted.
English: • low counts for white blood cells, red blood cells and platelets in blood tests.
Danish: • Lavt antal hvide blodlegemer, røde blodlegemer og blodplader vist ved blodprøver.
English: An elevation in AST > 3 ULN occurred in 1% of patients in the RoActemra subcutaneous weekly group, compared to no patients in either of the placebo plus prednisone taper groups.
Danish: En stigning i ASAT > 3 øvre normal referencegrænse forekom hos 1% af patienterne, der fik ugentlig RoActemra subkutan sammenlignet med ingen patienter i nogen af grupperne, der fik placebo plus nedtrappende prednison-dosis.
English: When starting or stopping therapy with RoActemra, patients taking medicinal products which are individually adjusted and are metabolised via CYP450 3A4, 1A2 or 2C9 (e.g. methylprednisolone, dexamethasone, (with the possibility for oral glucocorticoid withdrawal syndrome), atorvastatin,
Danish: Når behandlingen med tocilizumab påbegyndes eller ophører, skal patienter, der tager lægemidler, som er individuelt justerede, og som metaboliseres via CYP450 3A4, 1A2 eller 2C9 (fx methylprednisolon eller dexamethason (med mulighed for oral glukokortikoid-seponeringssyndrom),
English: Decreases in neutrophil and platelet counts have occurred following treatment with tocilizumab 8 mg/kg in combination with MTX (see section 4.8).
Danish: Der er set fald i antallet af neutrofilocytter og trombocytter under behandling med tocilizumab 8 mg/kg i kombination med MTX (se pkt.
English: A significantly higher proportion of patients in the tocilizumab 8 mg/kg + MTX and tocilizumab monotherapy groups met the primary endpoint compared with MTX alone.
Danish: Der var en signifikant større andel af patienter i tocilizumab 8 mg/kg + MTX og tocilizumabmonoterapi-grupperne, som nåede det primære endepunkt, sammenlignet med MTX-monoterapigruppen.
English: • Pinching the skin is important to make sure that you inject under the skin (into fatty tissue) but not any deeper (into muscle).
Danish: • Det er også vigtigt at klemme fast om huden for at sikre, at indsprøjtningen gives under huden (i fedtvæv) og ikke dybere (i muskelvæv).
English: In sJIA and pJIA patients, neutrophils and platelets should be monitored at the time of the second administration and thereafter according to good clinical practice (see section 4.2).
Danish: Hos patienter med sJIA og pJIA bør neutrofilocyt- og trombocyttallet kontrolleres ved tidspunktet for 2. administration og derefter i henhold til god klinisk praksis (se pkt.
English: If either of these applies to you, tell a doctor.
Danish: Hvis noget af det ovenstående passer på dig, skal du fortælle det til lægen.
English: The recommended dose The dose for all adults is 162 mg (the content of 1 pre-filled pen) given once a week.
Danish: Den anbefalede dosis Dosis for alle voksne er 162 mg (indholdet i en fyldt pen), 1 gang om ugen.
English: Modify the dose of the concomitant MTX if appropriate Interrupt RoActemra dosing
Danish: Modificer dosis af samtidig MTX, hvis det er hensigtsmæssigt Afbryd behandlingen med RoActemra
English: Corticosteroid Tapering
Danish: Kortikosteroid-nedtrapning
English: OTHER SPECIAL WARNING(S), IF NECESSARY Allow the pre-filled pen to sit at room temperature outside the box for 45 minutes before use
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Opbevar pennen uden æske ved stuetemperatur i 45 minutter inden anvendelse
English: • if you or a child patient you look after are allergic to tocilizumab or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du eller dit barn eller det barn du passer er allergisk over for det aktive stof eller et af de øvrige indholdsstoffer, angivet i punkt 6.
English: In the tocilizumab group, the events included, but were not limited to rash, urticaria, diarrhea, epigastric discomfort, arthralgia and headache.
Danish: I tocilizumab-gruppen inkluderede bivirkningerne (men var ikke begrænsede til): Udslæt, urticaria, diarré, epigastrisk ubehag, artralgi og hovedpine.
English: When starting or stopping therapy with tocilizumab, patients taking medicinal products which are individually adjusted and are metabolised via CYP450 3A4, 1A2 or 2C9 (e.g. methylprednisolone, dexamethasone, (with the possibility for oral glucocorticoid withdrawal syndrome), atorvastatin, calcium channel blockers, theophylline, warfarin, phenprocoumon, phenytoin, ciclosporin, or benzodiazepines) should be monitored as doses may need to be increased to maintain therapeutic effect.
Danish: Når behandling med tocilizumab påbegyndes eller seponeres, bør patienter der får lægemidler, der justeres individuelt og metaboliseres via CYP450 3A4, 1A2 eller 2C9 (fx methylprednisolon eller dexamethason, (med mulighed for oral glukokortikoid-seponeringssyndrom), atorvastatin, calciumantagonister, theophyllin, warfarin, phenprocoumon, phenytoin, ciclosporin og benzodiazepiner) monitoreres, da doserne måske skal øges for at opretholde terapeutisk effekt.
English: When platelet count is > 100 x 103/µl resume RoActemra
Danish: Når trombocyttallet er > 100 x 103/µl, genoptages behandlingen med RoActemra
English: Healthcare professionals should exercise caution when considering the use of RoActemra in patients with a history of recurring or chronic infections or with underlying conditions (e.g. diverticulitis, diabetes and interstitial lung disease which may predispose patients to infections.
Danish: Sundhedspersonalet skal udvise forsigtighed, hvis det overvejes at anvende RoActemra til patienter med tidligere recidiverende eller kroniske infektioner eller med underliggende sygdomme, som kan prædisponere patienterne for infektioner (f.eks. diverticulitis, diabetes og interstitiel lungesygdom).
English: In the open-label extension of Study II the inhibition of progression of structural joint damage in RoActemra plus MTX-treated patients was maintained in the second year of treatment.
Danish: I den åbne forlængelse af studie II blev hæmningen af strukturel ledskadeprogression hos patienter behandlet med RoActemra plus MTX opretholdt i det andet behandlingsår.
English: RoActemra subcutaneous weekly dose also showed a clinically meaningful decrease in the risk for flare compared to placebo plus 26 weeks prednisone in patients who entered the trial with relapsing GCA as well as those with new-onset disease (Table 4).
Danish: Ugentlig RoActemra subkutan viste også et klinisk signifikant fald i risikoen for flares sammenlignet med placebo plus 26 ugers prednison hos patienter, blev inkluderet i studiet med recidiverende GCA såvel som dem med ny tilkommet sygdom (tabel 4).
English: Increases in haemoglobin levels were observed, through RoActemra decreasing the IL-6 driven effects on hepcidin production to increase iron availability.
Danish: Der blev set stigninger i hæmoglobinkoncentrationen, fordi RoActemra nedsatte den af IL-6 medierede virkning på hepcidinproduktionen, hvorved tilgængeligheden af jern blev øget.
English: PBO + MTX
Danish: Placebo + MTX
English: Rheumatoid arthritis patients demonstrated a similar pattern of absolute neutrophil counts following tocilizumab administration (see section 4.8).
Danish: Reumatoid artrit patienter udviste et lignende mønster for det absolutte neutrofilocyttal efter administration af tocilizumab (se pkt.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Allow the syringe to sit at room temperature outside the box for 25 to 30 minutes before use
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Opbevar injektionssprøjten uden æske ved stuetemperatur i 25 til 30 minutter inden anvendelse
English: For the 162 mg every week dosing regimen, the steady-state Cavg was 51% higher in patients with body weight less than 60 kg compared to patients weighing between 60 to 100 kg. For the 162 mg every other week regimen, the steady-state Cavg was 129% higher in patients with body weight less than 60 kg compared to patients weighing between 60 to 100 kg.
Danish: For dosisregimet på 162 mg hver uge var steady-state Cgennemsnit 51% højere hos patienter med kropsvægt mindre end 60 kg sammenlignet med patienter, der vejede mellem 60 kg til 100 kg. For dosisregimet på 162 mg hver anden uge var steady-state Cgennemsnit 129% højere hos patienter med kropsvægt mindre end 60 kg sammenlignet med patienter, der vejede mellem 60 kg til 100 kg. Der er begrænset data for patienter over 100 kg (n = 7).
English: Approximately 20% of patients had received prior treatment with DMARDs other than MTX.
Danish: Omkring 20% af patienterne var tidligere behandlet med andre
English: • fever and chills
Danish: • feber og kulderystelser
English: Consistent with the effect on acute phase reactants, treatment with tocilizumab was associated with reduction in platelet count within the normal range.
Danish: I overensstemmelse med virkningen på akut fase reaktanter var behandlingen med tocilizumab ledsaget af et fald i trombocyttallet inden for referenceintervallet.
English: Of the 46 patients (1.6%) who developed anti-tocilizumab antibodies, 6 had an associated medically significant hypersensitivity reaction, of which 5 led to permanent discontinuation of treatment.
Danish: Af de 46 patienter (1,6 %), som udviklede anti-tocilizumab-antistoffer, havde 6 en ledsagende, klinisk signifikant overfølsomhedsreaktion, som hos 5 medførte permanent seponering af behandlingen.
English: Do not try to re-use the pre-filled pen.
Danish: Du må ikke forsøge at genbruge den fyldte pen.
English: In a study in RA patients, levels of simvastatin (CYP3A4) were decreased by 57% one week following a single dose of tocilizumab, to the level similar to, or slightly higher than, those observed in healthy subjects.
Danish: I et studie med RA-patienter faldt simvastatin-niveauet (CYP3A4) med 57% 1 uge efter en enkelt dosis tocilizumab, til et niveau svarende til, eller lidt højere end hvad der ses hos raske forsøgspersoner.
English: Not allowing the syringe to come to room temperature could result in an uncomfortable injection and it may be difficult to depress the plunger.
Danish: Hvis injektionssprøjten ikke har stuetemperatur, kan indsprøjtningen være ubehagelig, og det kan være svært at presse stemplet ned.
English: Signs and symptoms of liver toxicity These may affect up to 1 in every 1000 users
Danish: Tegn og symptomer på leverskader: Forekommer hos op til 1 ud af 1.000 patienter
English: Each 400 mg vial contains 0.39 mmol (8.85 mg) sodium.
Danish: Hvert 400 mg hætteglas indeholder 0,39 mmol (8,85 mg) natrium.
English: Yes (N = 23)
Danish: Ja (n = 23)
English: pJIA Patients
Danish: pJIA patienter
English: Lipid parameters
Danish: Lipidparametre
English: • 1 Alcohol pad
Danish: • 1 spritserviet
English: • Insert the needle all the way into the pinched skin at an angle between 45° to 90° with a quick,
Danish: • Stik kanylen i hudfolden i en vinkel på 45° til 90° med en hurtig, fast bevægelse (se Fig. E).
English: • inflammation of the liver (hepatitis), jaundice
Danish: • Leverbetændelse (hepatitis), gulsot
English: In study SC-I, the mean decrease in HAQ-DI from baseline to week 24 was 0.6 on both the subcutaneous and intravenous arms.
Danish: I SC-I-studiet var det gennemsnitlige fald i HAQ-DI fra baseline til uge 24 0,6 i såvel den subkutane som den intravenøse behandlingsarm.
English: In sJIA patients, the central volume of distribution was 1.87 L and the peripheral volume of distribution was 2.14 L resulting in a volume of distribution at a steady state of 4.01 L. The linear clearance estimated as a parameter in the population pharmacokinetic analysis, was 5.7 mL/h.
Danish: Hos sJIA-patienter var det centrale fordelingsvolumen 1,87 l og det perifere fordelingsvolumen 2,14 l, hvilket resulterede i et fordelingsvolumen ved steady-state på 4,01 l. Den linære clearence, estimeret som en parameter ved den populationsfarmakokinetiske analyse, var 5,7 ml/time.
English: Study SC-II evaluated patients with moderate to severe active RA who had an inadequate clinical response to their existing rheumatologic therapy, including one or more DMARD(s) where approximately 20% had a history of inadequate response to at least one TNF inhibitor.
Danish: SC-II-studiet undersøgte patienter med moderat til svær aktiv RA, som havde utilstrækkeligt klinisk respons på deres eksisterende reumatologiske behandling, inklusive én eller flere DMARDs og hvor omkring 20% tidligere havde oplevet utilstrækkeligt respons på mindst én TNF-hæmmer.
English: Children and adolescents RoActemra subcutaneous injection is not recommended for use in children under 18 years of age.
Danish: Børn og unge RoActemra subkutan injektion bør ikke anvendes til patienter under 18 år.