FrancophonIA/ELRC3.0 huggingface dataset:
English: If these medicines do not work well enough, patients will be given Kromeya to treat their polyarticular juvenile idiopathic arthritis or enthesitis-related arthritis.
Danish: Hvis du ikke reagerer tilstrækkeligt godt på disse lægemidler, vil du få Kromeya til behandling af din polyartikulære juvenile idiopatiske artrit eller entesopatirelateret artrit.
English: Table 22 Maintenance of clinical remission and response (percent of patients)
Danish: Tabel 22 Vedligeholdelse af klinisk remission og respons (Procent af patienterne) Placebo
English: Exposure-response relationship in paediatric population On the basis of clinical trial data in patients with JIA (pJIA and ERA), an exposure-response relationship was established between plasma concentrations and PedACR 50 response.
Danish: Sammenhæng mellem eksponering og respons i den pædiatriske population Der er fundet en eksponerings-respons sammenhæng mellem plasmakoncentration og PedACR 50 respons på basis af data fra kliniske studier i patienter med JIA (pJIA og ERA).
English: What you need to know before your child uses Kromeya
Danish: Det skal du vide, før dit barn begynder at tage Kromeya
English: • Only use Kromeya Vial Kit if your healthcare professional has trained you how to use it correctly.
Danish: • Du må kun bruge Kromeya hætteglassæt, hvis lægen eller andet sundhedspersonale har vist dig, hvordan du skal bruge det korrekt.
English: Initial dose of 20 mg, followed by 20 mg given every other week starting one week after the initial dose
Danish: Startdosis på 20 mg, efterfulgt af 20 mg givet hver anden uge startende en uge efter den initiale dosis
English: PGA: Clear/minimal a, b a p<0.001 adalimumab vs. placebo b p<0.001 adalimumab vs. methotrexate c p<0.01 adalimumab vs. placebo d p<0.05 adalimumab vs. methotrexate
Danish: 79 (73,1) a, b a p<0,001 adalimumab versus placebo b p<0,001 adalimumab versus methotrexat c p<0,01 adalimumab versus placebo d p<0,05 adalimumab versus methotrexat
English: 4.1 Peel open the needle packaging to uncover the yellow syringe connector.
Danish: 4.1 Riv kanyleemballagen op, så den gule sprøjtekonnektor bliver tilgængelig.
English: Table 20: Paediatric plaque psoriasis efficacy results at 16 weeks MTX
Danish: Tabel 20: Effektresultater ved uge 16 for pædiatrisk plaque-psoriasis MTXa N=37
English: Pulmonary fibrosis
Danish: Lungefibrose1)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER HÆTTEGLASETIKET
English: In CD study I, 299 TNF-antagonist naive patients were randomised to one of four treatment groups; placebo at weeks 0 and 2, 160 mg adalimumab at week 0 and 80 mg at week 2, 80 mg at week 0 and 40 mg at week 2, and 40 mg at week 0 and 20 mg at week 2.
Danish: I CD-studie I blev 299 TNF-antagonist-naive patienter randomiseret til en af fire behandlingsgrupper: placebo i uge 0 og 2, 160 mg adalimumab i uge 0 og 80 mg i uge 2, 80 mg i uge 0 og 40 mg i uge 2, og 40 mg i uge 0 og 20 mg i uge 2.
English: Initial dose of 160 mg (as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days),
Danish: Startdosis på 160 mg (som fire 40 mg injektioner på én dag eller to 40 mg injektioner pr. dag i to på hinanden følgende
English: The recommended dose of Kromeya for patients with Crohn's disease from 6 to 17 years of age is based on body weight (Table 4).
Danish: Den anbefalede Kromeya-dosis til patienter med Crohns sygdom fra 6 til 17 år er baseret på legemsvægt (tabel 4).
English: The recommended Kromeya dose for patients with plaque psoriasis from 4 to 17 years of age is based on body weight (Table 3).
Danish: Den anbefalede Kromeya-dosis til patienter med plaque-psoriasis fra 4 til 17 år er baseret på legemsvægt (tabel 3).
English: In study UC-I, 390 TNF-antagonist naïve patients were randomised to receive either placebo at weeks 0 and 2, 160 mg adalimumab at week 0 followed by 80 mg at week 2, or 80 mg adalimumab at week 0 followed by 40 mg at week 2.
Danish: I studie UC-I blev 390 TNF-antagonist-naïve patienter randomiseret til at få enten placebo i uge 0 og 2, 160 mg adalimumab i uge 0 efterfulgt af 80 mg i uge 2, eller 80 mg adalimumab i uge 0 efterfulgt af 40 mg i uge 2.
English: Warning: Do not throw away the syringe or the vial in your household trash.
Danish: Advarsel: Du må ikke smide sprøjten eller hætteglasset i skraldespanden.
English: It is important that you tell your doctor if you have symptoms of infections, e.g. fever, wounds, feeling tired, dental problems (see “Warnings and precautions”).
Danish: Det er vigtigt, at du fortæller din læge, hvis du har symptomer på infektioner, f.eks. feber, sår, træthedsfornemmelse, tandproblemer (se ”Advarsler og forsigtighedsregler”).
English: • Throw away the needle cap.
Danish: • Smid kanylehætten ud.
English: Clinical response
Danish: Klinisk Respons
English: Table 10 Radiographic mean changes at week 52 in RA study V
Danish: Tabel 10 Gennemsnitlige radiografiske ændringer i uge 52 i RA-studie V
English: • Talk to your healthcare professional if you have any questions or concerns.
Danish: • Tal med lægen, hvis du har spørgsmål eller er i tvivl om noget.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu/.
English: It is important that you tell your doctor if your child has symptoms of infections, e.g. fever, wounds, feeling tired, dental problems (see “Warnings and precautions”).
Danish: Det er vigtigt, at du fortæller din læge, hvis dit barn har symptomer på infektioner, f.eks. feber, sår, træthedsfornemmelse, tandproblemer (se ”Advarsler og forsigtighedsregler”).
English: Fatal and life-threatening infections (including sepsis, opportunistic infections and TB), HBV reactivation and various malignancies (including leukaemia, lymphoma and HSTCL) have also been reported with use of adalimumab.
Danish: Ved brug af adalimumab er der også rapporteret om letale og livstruende infektioner (inklusive sepsis, opportunistiske infektioner og tuberkulose), HBV-reaktivering og forskellige maligniteter (inklusive leukæmi, lymfomer og hepatosplenisk T-celle-lymfom).
English: Initial dose of 20 mg, followed by 20 mg one week later.
Danish: Startdosis på 20 mg efterfulgt af 20 mg en uge senere.
English: Your healthcare provider should show you how to prepare and inject Kromeya properly using the pre-filled pen before you use it for the first time.
Danish: Din læge eller andet sundhedspersonale bør vise dig, hvordan du skal forberede og injicere Kromeya korrekt ved brug af den fyldte pen, inden du bruger den første gang.
English: Figure 1: Kaplan-Meier curves summarizing time to treatment failure in the paediatric uveitis study
Danish: Figur 1: Kaplan-Meier-kurver, opsummerende tid til behandlingssvigt i det pædiatriske uveitis studie
English: Refer to Storage information for -how to store your unused syringe(s).
Danish: Se under afsnittet Opbevaring, hvordan du skal opbevare ubrugte injektionssprøjter.
English: Table 9 ACR responses in placebo-controlled trials (percent of patients)
Danish: Tabel 9 ACR-respons i placebokontrollerede studier (Procent af patienter)
English: Adult Crohn's disease
Danish: Crohns sygdom hos voksne
English: • enthesitis-related arthritis,
Danish: • Entesopatirelateret artrit,
English: In controlled and open label adult and paediatric studies with adalimumab, serious infections (including fatal infections, which occurred rarely) have been reported, which include reports of tuberculosis (including miliary and extra-pulmonary locations) and invasive opportunistic infections (e.g. disseminated or extrapulmonary histoplasmosis, ,blastomycosis, coccidioidomycosis,
Danish: I kontrollerede og åbne studier med voksne og pædiatriske patienter med adalimumab blev der rapporteret alvorlige infektioner (herunder dødelige infektioner, som forekom sjældent), inklusive rapporter om tuberkulose (herunder miliærtuberkulose og ekstra-pulmonær tuberkulose) og invasive opportunistiske infektioner (f.eks. dissemineret eller ekstrapulmonal histoplasmose, blastomykose, kokcidioimykose, pneumocytis , candidiasis, aspergillose og listeriose).
English: ≥ 40 kg • 80 mg at week 0 and 40 mg at week 2
Danish: ≥ 40 kg • 80 mg i uge 0 og 40 mg i uge 2
English: Percent of patients achieving PASI75 response was calculated as centeradjusted rate b p<0.001, adalimumab vs. placebo
Danish: 506 (62,2)b a Procent af patienterne, som opnåede PASI 75-respons beregnet med justering for center variation b p<0,001, adalimumab versus Placebo
English: Very Common
Danish: Ikke almindelig
English: * p < 0.001 for adalimumab versus placebo pairwise comparisons of proportions ** p < 0.02 for adalimumab versus placebo pairwise comparisons of proportions a
Danish: * p<0,001 for adalimumab vs. placebo parvise sammenligninger af andelene ** p<0,02 for adalimumab vs. placebo parvise sammenligninger af andelene a Af dem, som fik kortikosteroider ved baseline
English: Table 7 ACR responses in placebo-controlled trials (percent of patients)
Danish: Tabel 7 ACR-respons i placebokontrollerede studie (Procent af patienter)
English: Kromeya is administered by injection under the skin (by subcutaneous injection).
Danish: Kromeya indgives ved injektion under huden (subkutan injektion).
English: • paediatric plaque psoriasis
Danish: • Pædiatrisk plaque plaque-psoriasis,
English: In patients with polyarticular JIA who were 2 to <4 years old or aged 4 and above weighing <15 kg dosed with adalimumab 24 mg/m2 , the mean trough steady-state serum adalimumab concentrations was 6.0 ± 6.1 µg/mL (101% CV) for adalimumab without concomitant methotrexate and 7.9 ± 5.6 µg/mL (71.2% CV) with concomitant methotrexate.
Danish: Hos patienter med polyartikulær JIA, som var 2-<4 år eller 4 år og derover med en vægt <15 kg, som blev doseret med adalimumab 24 mg/m2, var den gennemsnitlige 'dal'-steady state-serum-adalimumab 6,0 ± 6,1 µg/ml (101% CV) for adalimumab uden samtidig methotrexat og 7,9 ± 5,6 µg/ml (71,2% CV) med samtidig methotrexat.
English: Leucopaenia (including neutropaenia and agranulocytosis), anaemia
Danish: Blod og lymfesystem * Meget almindelig Leukopeni (inklusive neutropeni og agranulocytose), anæmi
English: 3.2 Hold the vial adapter, insert the syringe tip into it and screw to connect.
Danish: 3.2 Hold om hætteglasadapteren, indfør sprøjtespidsen i adapteren, og skru delene sammen.
English: 6.1 With the other hand, gently pinch a fold of cleaned skin and maintain it.
Danish: 6.1 Klem forsigtigt den rensede hud sammen med den anden hånd.
English: Failure N (%)
Danish: N Behandlingssvigt N (%)
English: In controlled Phase 3 trials of adalimumab in patients with polyarticular juvenile idiopathic arthritis who were 4 to 17 years and enthesitis-related arthritis who were 6 to 17 years, ALT elevations ≥ 3 x ULN occurred in 6.1% of adalimumab-treated patients and 1.3% of control-treated patients.
Danish: I kontrollerede fase 3-studier med adalimumab hos patienter med polyartikulær juvenil idiopatisk artrit i alderen fra 4 til 17 år og hos patienter med entesopatirelateret artrit i alderenfra 6 til 17 år forekom ALAT-stigninger ≥ 3 x ULN hos 6,1% af de adalimumab-behandlede patienter og hos 1,3 % af de kontrol-behandlede patienter.
English: Low dose 20/10 mg eow N = 95
Danish: Lav-dosis 20/10 mg hver anden uge N = 95
English: Kromeya is indicated for treatment of moderately to severely active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
Danish: Kromeya er indiceret til behandling af moderat til svær aktiv Crohns sygdom hos voksne patienter, som på trods af et fuldt og adækvat behandlingsforløb med glukokortikoid og/eller immunsuppressivum ikke har responderet tilfredsstillende, eller som er intolerante over for eller har kontraindikationer mod sådanne behandlinger.
English: Kromeya is also used to treat severe plaque psoriasis in children and adolescents adolescents aged 4 to 17 years for whom medicines applied to the skin and treatment with UV light have either not worked very well or are not suitable.
Danish: Kromeya bruges også til at behandle alvorlig plaque-psoriasis hos børn og unge i alderen 4 til 17 år, hos hvem lokal behandling og behandlinger med ultaviolet lys enten ikke har virket godt nok eller ikke er egnede.
English: Storage Information
Danish: Opbevaring
English: In controlled Phase 3 trials of adalimumab in patients with plaque psoriasis with a control period duration ranging from 12 to 24 weeks, ALT elevations ≥ 3 x ULN occurred in 1.8% of adalimumabtreated patients and 1.8% of control-treated patients.
Danish: I kontrollerede fase 3-studier af adalimumab hos patienter med plaque-psoriasis med en kontrolperiode på 12 til 24 uger forekom ALAT-stigninger ≥ 3 x ULN hos 1,8% af de adalimumab-behandlede patienter og hos 1,8% af de kontrol-behandlede patienter.
English: • Only use Kromeya pre-filled syringe if your healthcare professional has trained you on how to use the pre-filled syringe correctly.
Danish: • Du må kun bruge Kromeya fyldt injektionssprøjte, hvis din læge eller andet sundhedspersonale har vist dig, hvordan du skal bruge den fyldte injektionssprøjte korrekt.
English: Table 21 Maintenance of clinical remission and response (percent of patients)
Danish: Tabel 21 Vedligeholdelse af klinisk remission og respons (Procent af patienterne) Placebo
English: 3.1 Peel open the syringe packaging and grab the syringe by the barrel.
Danish: Sprøjte 3.1 Riv sprøjtens emballage op, og tag fat om sprøjtens rør.
English: You should record the date when the syringe is first removed from refrigerator, and the date after which it should be discarded.
Danish: Du skal registrere den dato, hvor injektionssprøjten først tages ud af køleskabet, og den dato efter hvilken, den skal kasseres.
English: Solution for injection 2 pre-filled pens 2 alcohol pads 6 pre-filled pens 6 alcohol pads
Danish: 2 fyldte penne 2 spritservietter 6 fyldte penne 6 spritservietter
English: Adalimumab 40 mg eow N=814 n (%)
Danish: Adalimumab 40 mg hver anden uge N=814 n (%)
English: • Hold the syringe upward and pull the needle cap straight off (Figure N).
Danish: • Hold sprøjten, så den peger opad, og træk kanylehætten lige af (figur N).
English: P=0.027, adalimumab 0.8 mg/kg versus MTX
Danish: PGA: clear/minimalc a MTX = methotrexat b P=0,027, adalimumab 0,8 mg/kg versus MTX c P=0,083, adalimumab 0,8 mg/kg versus MTX
English: When needed (for example when you are travelling), a single Kromeya pre-filled pen may be stored at room temperature (up to 25°C) for a maximum period of 14 days - be sure to protect it from light.
Danish: Hvis det er nødvendigt (f.eks. når du rejser), kan en enkelt Kromeya fyldt pen opbevares ved stuetemperatur (op til 25 °C) i en periode på højst 14 dage - vær sikker på at beskytte den mod lys.
English: Initial dose of 40 mg, followed by 40 mg given every other week starting one week after the initial dose
Danish: Startdosis på 40 mg, efterfulgt af 40 mg mg givet hver anden uge startende en uge efter den initiale dosis
English: Warning: Do not throw the vial away.
Danish: Advarsel: Du må ikke smide hætteglasset ud.
English: Kromeya is administered by subcutaneous injection.
Danish: Kromeya administeres ved subkutan injektion.
English: Kromeya 40 mg/0.8 mL solution for injection for paediatric use is supplied in a glass vial.
Danish: Kromeya 40 mg/0,8 ml injektionsvæske, opløsning til pædiatrisk brug leveres i et hætteglas.
English: Table 12 Radiographic mean changes at week 52 in RA study V
Danish: Tabel 12 Gennemsnitlige radiografiske ændringer i uge 52 i RA-studie V
English: Initial dose of 80 mg (as two 40 mg injections), followed by 40 mg every other week starting one week after the initial dose.
Danish: Startdosis på 80 mg (som to 40 mg injektioner), efterfulgt af 40 mg hver anden uge startende en uge efter startdosis.
English: Table 9 Radiographic mean changes over 12 months in RA study III
Danish: Tabel 9 Gennemsnitlige radiografiske ændringer gennem 12 måneder i RA-studie III
English: 2.8 Hold the vial and lift the packaging off. To ensure the adapter remains on top of the vial, hold the packaging by the outer rim.
Danish: For at sikre, at adapteren bliver på hætteglastoppen, skal du tage fat om emballagens yderkant.
English: Of the patients who lost adequate response after re-randomisation to placebo who then enrolled into the openlabel extension trial, 38% (25/66) and 55% (36/66) regained PASI 75 response after 12 and 24 weeks of re-treatment, respectively.
Danish: 38% (25/66) og 55% (36/66) af de patienter, som mistede tilstrækkeligt respons efter genrandomisering til placebo, og som derefter fortsatte i det åbne forlængelsesstudie, genvandt PASI 75-respons efter henholdsvis 12 og 24 ugers behandling.
English: If a faster response is required, your doctor may prescribe a first dose of 80 mg (two 40 mg injections in one day), followed by 40 mg two weeks later.
Danish: Hvis et hurtigere respons er nødvendigt, kan din læge ordinere en startdosis på 80 mg (to 40 mg injektioner på én dag) efterfulgt af 40 mg to uger senere.
English: Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, are inflammatory diseases of the spine.
Danish: Ankyloserende spondylitis og aksial spondyloartritis uden radiografiske tegn på ankyloserende spondylitis er inflammatoriske (betændelseslignende) sygdomme i rygsøjlen.
English: Kromeya can be used during breast-feeding.
Danish: Kromeya kan anvendes under amning.
English: In adult patients with uveitis, a loading dose of 80 mg adalimumab on week 0 followed by 40 mg adalimumab every other week starting at week 1, resulted in mean steady-state concentrations of approximately 8 to 10 µg/mL.
Danish: Hos voksne patienter med uveitis resulterede en startdosis på 80 mg adalimumab i uge 0 efterfulgt af 40 mg adalimumab hver anden uge fra uge 1 i en gennemsnitskoncentration på ca. 8-10 µg/ml ved steady state.
English: Kromeya 40 mg solution for injection in pre-filled syringe Kromeya 40 mg solution for injection in pre-filled pen
Danish: Kromeya 40 mg injektionsvæske, opløsning i fyldt injektionssprøjte Kromeya 40 mg injektionsvæske, opløsning i fyldt pen
English: Initial dose of 80 mg (as two 40 mg injections in one day), followed by 40 mg two weeks later.
Danish: Startdosis på 80 mg (som to 40 mg injektioner på én dag) efterfulgt af 40 mg to uger senere.
English: The recommended dose of Kromeya for patients with polyarticular juvenile idiopathic arthritis from 2 years of age is based on body weight (Table 1).
Danish: Den anbefalede Kromeya-dosis til patienter fra 2 år med polyartikulær juvenil idiopatisk artrit er baseret på legemsvægt (tabel 1).
English: Warning: Do not touch the syringe tip.
Danish: Advarsel: Du må ikke røre ved sprøjtens spids.
English: Kromeya is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1).
Danish: Kromeya er indiceret til behandling af aktiv entesopatirelateret artrit hos patienter fra 6 år, som har haft et utilstrækkeligt respons på, eller som er intolerante over for, konventionel behandling (se pkt.
English: In adult patients with ulcerative colitis, a loading dose of 160 mg adalimumab on week 0 followed by 80 mg adalimumab on week 2 achieves serum adalimumab trough concentrations of approximately 12 µg/mL during the induction period.
Danish: Hos voksne patienter med colitis ulcerosa gav en startdosis på 160 mg adalimumab i uge 0 efterfulgt af 80 mg adalimumab i uge 2 dal-serumkoncentrationer af adalimumab på omkring 12 µg/ml i induktionsperioden.
English: Immune system disorders* Common
Danish: Immunsystemet*
English: Kromeya is used to treat severe plaque psoriasis in children and adolescents aged 4 to 17 years for whom medicines applied to the skin and treatment with UV light have either not worked very well or are not suitable.
Danish: Kromeya bruges til at behandle alvorlig plaque-psoriasis hos børn og unge i alderen 4 til 17 år, hos hvem lokal behandling og behandlinger med ultaviolet lys enten ikke har virket godt nok eller ikke er egnede.
English: If you forget to give your child a Kromeya injection, you should inject the Kromeya dose as soon as you remember.
Danish: Hvis du glemmer at give dit barn en Kromeya injektion, bør du injicere den næste dosis af Kromeya, så snart du kommer i tanke om det. Fortsæt dernæst med at injicere dit barns næste dosis som planlagt på den oprindeligt fastlagte dag, som om du ikke havde glemt en dosis.
English: • facial oedema (swelling) associated with allergic reactions;
Danish: • ødem i ansigtet forbundet med allergiske reaktioner
English: Neurologic evaluation should be performed in patients with non-infectious intermediate uveitis prior to the initiation of Kromeya therapy and regularly during treatment to assess for preexisting or developing central demyelinating disorders.
Danish: Før initiering af Kromeya og regelmæssigt under behandlingen bør der foretages en neurologisk udredning for at vurdere allerede eksisterende eller udvikling af demyeliniserende sygdomme hos patienter med non-infektiøs intermediær uveitis.
English: The safety and efficacy of adalimumab were assessed in adult patients with non-infectious intermediate, posterior, and panuveitis, excluding patients with isolated anterior uveitis, in two randomised, double- masked, placebo-controlled studies (UV I and II).
Danish: Adalimumabs sikkerhed og effekt blev undersøgt i to randomiserede, dobbeltblinde, placebokontrollerede studier (UV I og UV II) hos voksne patienter med non-infektiøs intermediær, posterior og pan-uveitis; patienter med isoleret anterior uveitis blev ekskluderet.
English: CD study I and CD study II induction of remission and response rates are presented in Table 21.
Danish: Tabel 21 viser rater for induktion af remission og respons i CD-studie I og CD-studie II.
English: The safety and efficacy of adalimumab were assessed in over 1500 patients with moderately to severely active Crohn's disease (Crohn's Disease Activity Index (CDAI) ≥ 220 and ≤ 450) in randomised, double-blind, placebo-controlled studies.
Danish: Adalimumabs sikkerhed og virkning er undersøgt i randomiserede, dobbelt-blinde, placebokontrollerede studier med over 1.500 patienter med moderat til svær aktiv Crohns sygdom (Crohns sygdoms-aktivitetsindeks (CDAI)  220 og  450).
English: Once removed from the refrigerator for room temperature storage, your pre-filled pen must be used within 14 days or discarded, even if it is later returned to the refrigerator.
Danish: Når pennen er taget ud af køleskabet og har været opbevaret ved stuetemperatur, skal pennen bruges indenfor 14 dage eller kasseres, også selv om den lægges tilbage i køleskab.
English: Double blind 32 weeks Adalimumab
Danish: Resultater af effekt Dobbeltblindet 32 uger Adalimumab/M TX (N = 38)
English: Table 25 Paediatric CD study Discontinuation of corticosteroids or immunomodulators and fistula remission
Danish: Tabel 25 Pædiatrisk CD-studie Seponering af kortikosteroider eller immunmodulerende lægemidler og remisssion af fistler Standard-dosis 40/20 mg hver anden uge
English: When needed (for example when you are travelling), a single Kromeya pre-filled syringe may be stored at room temperature (up to 25°C) for a maximum period of 14 days - be sure to protect it from light.
Danish: Hvis det er nødvendigt (f.eks. når du rejser), kan en enkelt Kromeya fyldt injektionssprøjte opbevares ved stuetemperatur (op til 25 °C) i en periode på højst 14 dage - vær sikker på at beskytte den mod lys.
English: Table 13: Paediatric plaque psoriasis efficacy results at 16 weeks MTX
Danish: Tabel 13: Effektresultater ved uge 16 for pædiatrisk plaque-psoriasis
English: PEN LABEL
Danish: • blå mærker