FrancophonIA/ELRC3.0 huggingface dataset:
English: In the studies, a significantly higher proportion of patients treated with upadacitinib 15 mg achieved low disease activity (DAS28-CRP ≤3.2) and clinical remission (DAS28-CRP <2.6) compared to placebo, MTX or adalimumab (Table 4).
Danish: I studierne opnåede en signifikant højere andel af de patienter, der blev behandlet med upadacitinib 15 mg, lav sygdomsaktivitet (DAS28-CRP ≤ 3,2) og klinisk remission (DAS28-CRP < 2,6) sammenholdt med placebo, MTX eller adalimumab (tabel 4).
English: Creatine phosphokinase
Danish: Kreatininfosfokinase
English: Blood CPK increased ALT increased AST increased Weight increased * URTI includes: acute sinusitis, laryngitis, nasopharyngitis, oropharyngeal pain, pharyngitis, pharyngotonsillitis, rhinitis, sinusitis, tonsillitis, viral upper respiratory tract infection ** Herpes simplex includes oral herpes
Danish: Vægtøgning * Infektion i de øvre luftveje omfatter: akut sinuitis, laryngitis, nasofaryngitis, orofaryngeale smerter, faryngitis, faryngotonsillitis, rhinitis, sinuitis, tonsillitis, virusinfektion i de øvre luftveje ** Herpes simplex omfatter oral herpes
English: In a clinical study, rosuvastatin and atorvastatin AUC were decreased by 33% and 23%, respectively, and rosuvastatin Cmax was decreased by 23% following the administration of multiple 30 mg once daily doses of upadacitinib to healthy subjects.
Danish: I et klinisk studie faldt AUC for rosuvastatin og atorvastatin hos raske forsøgspersoner med hhv. 33 % og 23 %, og rosuvastatins Cmax faldt med 23 % efter administration af multiple doser upadacitinib på 30 mg én gang dagligt.
English: HDPE bottles with desiccant and polypropylene cap in carton containing 30 prolonged-release tablets.
Danish: HDPE-beholdere med tørremiddel og polypropylenlåg i æske med 30 depottabletter.
English: If hepatitis B virus DNA is detected while receiving upadacitinib, a liver specialist should be consulted.
Danish: Hvis der identificeres hepatitis B-virus DNA under behandling med upadacitinib, bør en hepatolog tages med på råd.
English: • Core tablet: microcrystalline cellulose, mannitol, tartaric acid, hypromellose, silica colloidal anhydrous, magnesium stearate.
Danish: • Tabletkerne: mikrokrystallinsk cellulose, mannitol, vinsyre, hypromellose, vandfri kolloid silica, magnesiumstearat.
English: • Risk of serious and opportunistic infections including TB o Language on the risk of infections during treatment with upadacitinib o Details on how to reduce the risk of infection with specific clinical measures (what laboratory parameters should be used to initiate upadacitinib, screening for TB, and getting patients immunised as per local guidelines, and interruption of upadacitinib if an infection develops) o Language on avoidance of live vaccines (i.e., Zostavax) prior to and during upadacitinib treatment o Details to advise patients on signs/symptoms of infection to be aware of, so that patients can seek medical attention quickly.
Danish: • Risiko for alvorlige og opportunistiske infektioner, herunder TB o En tekst om risikoen for infektioner under behandling med upadacitinib o Oplysninger om, hvordan man reducerer risikoen for infektion med specifikke kliniske forholdsregler (hvilke laboratorieparametre, der skal bruges til at initiere upadacitinib, screening for TB, immunisering af patienter i henhold til lokale retningslinier og afbrydelse af upadacitinib, hvis der udvikles en infektion) o En tekst om at undgå levende vacciner (dvs. Zostavax) før og under upadacitinibbehandling o Oplysninger for at rådgive patienter om tegn/symptomer på infektion og at være opmærksom på dette, så patienterne hurtigt kan søge lægehjælp.
English: What you need to know before you take RINVOQ 3.
Danish: Det skal du vide, før du begynder at tage RINVOQ 3.
English: Upadacitinib should not be given to patients with active TB (see section 4.3).
Danish: Upadacitinib bør ikke gives til patienter med aktiv TB (se pkt.
English: In all studies, more patients treated with upadacitinib 15 mg achieved ACR20, ACR50, and ACR70 responses at 12 weeks compared to placebo, MTX, or adalimumab (Table 4).
Danish: I alle studier havde flere upadacitinib 15 mg-behandlede patienter opnået ACR20-, ACR50- og ACR70-respons efter 12 uger sammenholdt med placebo, MTX eller adalimumab (tabel 4).
English: • medicines to treat tuberculosis (such as rifampicin)
Danish: • medicin til behandling af tuberkulose (f.eks. rifampicin)
English: Cases of bacterial meningitis have been reported in patients receiving upadacitinib.
Danish: Der er rapporteret om tilfælde af bakteriel meningitis hos patienter i behandling med upadacitinib.
English: 8017 JV Zwolle NETHERLANDS
Danish: 8017 JV Zwolle
English: Treatment should be interrupted if ANC is < 1,000 cells/mm3 and may be restarted once ANC returns above this value
Danish: Behandlingen bør afbrydes, hvis ANC er < 1.000 celler/mm3, og kan genoptages, når ANC igen ligger over denne værdi
English: Treatment should be interrupted if ALC is < 500 cells/mm3 and may be restarted once ALC returns above this value
Danish: Behandlingen bør afbrydes, hvis ALC er < 500 celler/mm3, og kan genoptages, når ALC igen ligger over denne værdi
English: Tel: +420 233 098 111
Danish: Sími: +420 233 098 111
English: Pack size: 1 bottle (30 prolonged-release tablets) or 3 bottles (90 prolonged-release tablets).
Danish: Pakningsstørrelser: 1 beholder (30 depottabletter) eller 3 beholdere (90 depottabletter).
English: Modified Total Sharps Score, mean change from baseline
Danish: Modificeret total Sharp-score, gennemsnitlig ændring ift.
English: Turn the cap over and place the cutting tool near the edge of the foil seal.
Danish: Vend låget om, og anbring skæret ved kanten af folieforseglingen.
English: Treatment with upadacitinib was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein (LDL) cholesterol, and high-density lipoprotein (HDL) cholesterol (see section 4.8).
Danish: Behandling med upadacitinib var forbundet med forhøjede lipidparametre, herunder total kolesterol, lavdensitetslipoproteinkolesterol (LDL-kolesterol) og højdensitetslipoproteinkolesterol (HDLkolesterol) (se pkt.
English: Patients should be monitored for changes in disease activity if upadacitinib is co-administered with strong CYP3A4 inducers.
Danish: Patienterne bør overvåges for ændringer i sygdomsaktivitet, hvis upadacitinib administreres samtidig med stærke CYP3A4-inducere.
English: What you need to know before you take RINVOQ Do not take RINVOQ
Danish: Det skal du vide, før du begynder at tage RINVOQ Tag ikke RINVOQ
English: Therefore, upadacitinib plasma exposures can be affected by medicinal products that strongly inhibit or induce CYP3A4.
Danish: Derfor kan upadacitinibs plasmaeksponering påvirkes af lægemidler, der er stærke hæmmere eller stærke inducere af CYP3A4.
English: Foil Cutting Tool - on the cap of the bottle
Danish: Skær til åbning af folien - på beholderens låg
English: Tell your doctor if you get a painful skin rash with blisters as these can be signs of shingles
Danish: Sig det til lægen, hvis du oplever smertefulde hududslæt med blærer, da det kan være tegn på helvedesild
English: The pharmacologic activity of upadacitinib is attributed to the parent molecule.
Danish: Upadacitinibs farmakologiske aktivitet tilskrives modermolekylet.
English: • Risk of herpes zoster o Language on the risk of herpes zoster during treatment with upadacitinib o Details to advise patients on signs/symptoms of infection to be aware of, so that patients can seek medical attention quickly.
Danish: • Risiko for herpes zoster o En tekst om risikoen for herpes zoster under behandling med upadacitinib o Oplysninger for at rådgive patienter om tegn/symptomer på infektion og at være opmærksom på dette, så patienter hurtigt kan søge lægehjælp.
English: The effect of these lipid parameter elevations on cardiovascular morbidity and mortality has not been determined (see section 4.2 for monitoring guidance).
Danish: Effekten af forhøjede lipidparametre på kardiovaskulær morbiditet og mortalitet er ikke fastlagt (se pkt.
English: SELECT COMPARE MTX-IR
Danish: SELECT COMPARE MTX-UR
English: Tel: +386 (1)32 08 060
Danish: Sími: +386 (1)32 08 060
English: Tel: +34 91 384 09 10
Danish: Sími: +34 91 384 09 10
English: Treatment with upadacitinib was associated with an increased incidence of liver enzyme elevation compared to placebo.
Danish: Behandling med upadacitinib var forbundet med øget forekomst af forhøjede leverenzymer, sammenholdt med placebo.
English: SELECT MONO MTX-IR
Danish: SELECT MONO MTX-UR
English: Table 6: Mean change from baseline in HAQ-DIa,b Study
Danish: baseline i HAQ-DIa,b Studie
English: Upadacitinib is a selective and reversible JAK inhibitor.
Danish: Upadacitinib er en selektiv og reversibel JAK-hæmmer.
English: • Risk of foetal malformation o Language on teratogenicity of upadacitinib in animals o Details on how to reduce the risk of exposure during pregnancy for women of childbearing potential based on the following: upadacitinib is contraindicated during pregnancy, women of childbearing potential should be advised to use effective contraception both during treatment and for 4 weeks after the final dose of upadacitinib treatment, and to advise patients to inform their HCP immediately if they think they could be pregnant or if pregnancy is confirmed.
Danish: • Risiko for fostermisdannelser o En tekst om teratogenicitet hos dyr med upadacitinib o Oplysninger om, hvordan man reducerer risikoen for eksponering under graviditet for kvinder i den fødedygtige alder, baseret på følgende: upadacitinib er kontraindiceret under graviditet, kvinder i den fødedygtige alder skal rådes til at bruge sikker prævention både under behandlingen og i 4 uger efter den sidste dosis af updacitinib-behandlingen og til at rådgive patienter om straks at informere deres behandlende sundhedspersonale, ved mistanke om graviditet, eller hvis graviditet er bekræftet.
English: Upadacitinib AUC was 28% and 24% higher in subjects with mild and moderate hepatic impairment, respectively, compared to subjects with normal liver function.
Danish: AUC for upadacitinib var 28 % og 24 % højere hos patienter med hhv. let og moderat nedsat leverfunktion, sammenholdt med patienter med normal leverfunktion.
English: The use of upadacitinib has not been studied in subjects with end stage renal disease.
Danish: Brugen af upadacitinib er ikke undersøgt hos forsøgspersoner med nyresygdom i slutstadie.
English: In clinical studies, treatment was interrupted in response to ANC < 1,000 cells/mm3 (see section 4.2).
Danish: I kliniske studier blev behandlingen afbrudt på grund af et absolut neutrofiltal på < 1.000 celler/mm3 (se pkt.
English: c SELECT-EARLY, SELECT-NEXT, SELECT-COMPARE, SELECT-BEYOND d SELECT-MONOTHERAPY e SELECT-EARLY f SELECT-COMPARE g multiplicity controlled p≤0.001 upadacitinib vs placebo or MTX comparison h nominal p≤0.001 upadacitinib vs placebo or MTX comparison i nominal p≤0.01 upadacitinib vs adalimumab comparison
Danish: c SELECT-EARLY, SELECT-NEXT, SELECT-COMPARE, SELECT-BEYOND d SELECT-MONOTHERAPY e SELECT-EARLY f SELECT-COMPARE g multiplicitetskontrolleret ≤ 0,001 upadacitinib vs. placebo eller MTX-sammenligning h nominel p ≤ 0,001 upadacitinib vs. placebo eller MTX-sammenligning i nominel p ≤ 0,01 upadacitinib vs. adalimumab-sammenligning
English: NMSCs have been reported in patients treated with upadacitinib.
Danish: Der er rapporteret om NMSC hos patienter i behandling med upadacitinib.
English: Key outcome measures
Danish: Vigtige resultater
English: AbbVie AB Tel: +46 (0)8 684 44 600
Danish: AbbVie AB Sími: +46 (0)8 684 44 600
English: Multipack: 84 (3 packs of 28) prolonged-release tablets
Danish: Multipakning: 84 depottabletter (3 pakker af 28)
English: • Risk of MACE o Language on the increased risk of MACE in RA patients and the need to consider typical CV risk factors (e.g., hypertension, hyperlipidaemia) when treating RA patients o Language on the risk of MACE during treatment with upadacitinib o Language on the risk of hyperlipidaemia during upadacitinib therapy o Details on monitoring of lipid levels and management of elevated lipid levels per clinical guidelines
Danish: • Risiko for MACE-hændelser o En tekst om den øgede risiko for MACE hos RA patienter og behovet for at overveje typiske CV-risikofaktorer (f.eks hypertension, hyperlipidæmi) ved behandling af RApatienter o En tekst om risikoen for MACE under behandling med upadacitinib o Tekst om risikoen for hyperlipidæmi under behandling med upadacitinib o Oplysninger om overvågning af lipidniveauer og håndtering af forhøjede lipidniveauer i henhold til kliniske retningslinjer
English: RINVOQ is available in packs containing 28 or 98 prolonged-release tablets and in multipacks of 84 comprising 3 cartons, each containing 28 prolonged-release tablets.
Danish: RINVOQ fås i pakninger med 28 eller 98 depottabletter og i multipakninger med 84 depottabletter fordelt i 3 æsker, der hver indeholder 28 depottabletter.
English: No dose adjustment is required in patients with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment (see section 5.2).
Danish: Dosisjustering er ikke nødvendigt hos patienter med let (Child Pugh A) eller moderat (Child Pugh B) nedsat leverfunktion (se pkt.
English: • you have an infection (fever, sweating, or chills, shortness of breath, warm, red, or painful skin or sores on your body, feeling tired, cough, burning sensation when you pass urine or passing urine more often than normal, severe headache with stiff neck), or if you have ever had an infection that keeps coming back - RINVOQ can reduce your body's ability to fight infections and so may worsen an infection that you already have, or make it more likely for you to get a new infection
Danish: • hvis du har en infektion (feber, svedtendens eller kulderystelser, åndenød, varmefølelse, rød eller øm hud eller sår på kroppen, træthed, hoste, brændende fornemmelse ved vandladning eller hyppigere vandladning end normalt, svær hovedpine med nakkestivhed), eller hvis du har haft en infektion, der bliver ved at komme tilbage.
English: Tel.: +48 22 372 78 00
Danish: Tlf.: +48 22 372 78 00
English: If you forget to take RINVOQ
Danish: Hvis du har glemt at tage RINVOQ
English: Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), was reported in clinical studies (see section 4.8).
Danish: I kliniske studier er der rapporteret om virus-reaktivering, herunder tilfælde af herpesvirusreaktivering (f.eks. herpes zoster) (se pkt.
English: SELECT NEXT csDMARD-IR
Danish: SELECT NEXT csDMARD-UR
English: Do not use this medicine after the expiry date which is stated on the blister label and carton after ‘EXP'.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på blisterpakningen etiketten og æsken efter EXP. Der er ingen særlige krav vedrørende opbevaringstemperaturer for dette lægemiddel.
English: AbbVie GmbH Tel: +43 1 20589-0
Danish: AbbVie GmbH Sími: +43 1 20589-0
English: RINVOQ is available in bottles with desiccant containing 30 prolonged-release tablets, each pack contains 1 bottle (30 tablet pack) or 3 bottles (90 tablet pack).
Danish: RINVOQ fås i beholdere (med tørremiddel), der indeholder 30 depottabletter, idet en pakning enten indeholder 1 beholder (pakning med 30 tabletter) eller 3 beholdere (pakning med 90 tabletter).
English: Upadacitinib Cmax was similar in subjects with normal and impaired renal function.
Danish: Cmax for upadacitinib var den samme hos patienter med normal og nedsat nyrefunktion.
English: • low white blood cell counts shown in blood tests
Danish: • Lavt antal hvide blodlegemer (påvises i blodprøver)
English: AbbVie Limited Tel: +353 (0)1 4287900
Danish: AbbVie Limited Sími: +353 (0)1 4287900
English: Upadacitinib Cmax was unchanged in subjects with mild hepatic impairment and 43% higher in subjects with moderate hepatic impairment compared to subjects with normal liver function.
Danish: Cmax for upadacitinib var uændret hos patienter med let nedsat leverfunktion og 43 % højere hos patienter med moderat nedsat leverfunktion sammenholdt med patienter med normal leverfunktion.
English: RINVOQ 15 mg prolonged-release tablets upadacitinib
Danish: RINVOQ 15 mg depottabletter upadacitinib
English: Upadacitinib should be used with caution in patients receiving chronic treatment with strong CYP3A4 inhibitors.
Danish: Upadacitinib bør anvendes med forsigtighed hos patienter, der er i kronisk behandling med stærke CYP3A4-hæmmere.
English: Potential for other medicinal products to affect the pharmacokinetics of upadacitinib
Danish: Andre lægemidler, der kan påvirke upadacitinibs farmakokinetik
English: • General introductory language that the HCP measure contains important information to assist the discussion with patients when prescribing upadacitinib.
Danish: • En generel introduktion med vigtige oplysninger, som sundhedspersonen kan benytte under drøftelsen med patienten ved ordinering af upadacitinib.
English: • Low disease activity (DAS28-CRP)
Danish: • Lav sygdomsaktivitet (DAS28-CRP)
English: Serious and sometimes fatal infections have been reported in patients receiving upadacitinib.
Danish: Der er rapporteret om alvorlige infektioner, herunder tilfælde med dødelig udgang, hos patienter i behandling med upadacitinib.
English: How to puncture the foil
Danish: Sådan åbner du folien
English: Coadministration with CYP3A4 inducers
Danish: Samtidig administration af CYP3A4-inducere
English: Treatment should not be initiated in patients with an absolute lymphocyte count (ALC) that is < 500 cells/mm3, an absolute neutrophil count (ANC) that is < 1,000 cells/mm3 or who have haemoglobin (Hb) levels that are < 8 g/dL (see sections 4.4 and 4.8).
Danish: Behandling bør ikke indledes hos patienter med et absolut lymfocyttal (ALC) på < 500 celler/mm3, et absolut neutrofiltal (ANC) på < 1.000 celler/mm3 eller et hæmoglobinniveau (Hb) på < 8 g/dl (se pkt.
English: There are limited data on the use of upadacitinib in subjects with severe renal impairment (see section 5.2).
Danish: Der foreligger kun begrænsede data om anvendelse af upadacitinib hos patienter med svært nedsat nyrefunktion (se pkt.
English: The overall long-term rate of infections for the upadacitinib 15 mg group across all five Phase 3 clinical studies (2,630 patients) was 93.7 events per 100 patient-years.
Danish: Den samlede langsigtede forekomst af infektioner for de grupper, der fik upadacitinib 15 mg, i alle fem kliniske fase 3-studier (2.630 patienter), var 93,7 hændelser pr. 100 patientår.
English: Treatment should be interrupted if a patient develops a serious infection until the infection is controlled.
Danish: Hvis en patient udvikler en alvorlig infektion, bør behandlingen afbrydes, indtil infektionen er under kontrol.
English: On background csDMARDs
Danish: I baggrundsbehandling med csDMARD's
English: bDMARD-IRe
Danish: bDMARD-URe
English: Tablet contents:
Danish: Tabletkerne:
English: AbbVie Ltd Tel: +44 (0)1628 561090
Danish: AbbVie Ltd Sími: +44 (0)1628 561090
English: Treatment with upadacitinib was associated with a small, transient increase in mean ALC from baseline up to Week 36 which gradually returned to at or near baseline levels with continued treatment.
Danish: baseline frem til uge 36; ALC-værdien vendte gradvist tilbage til eller tæt på baseline-niveauet ved fortsat behandling.
English: Silica, colloidal anhydrous Magnesium stearate
Danish: Vandfri kolloid silica Magnesiumstearat
English: Adverse reactions System Organ Class
Danish: Tabel 2: Bivirkninger Systemorganklasse Meget almindelig
English: If clinical features of DVT/PE occur, upadacitinib treatment should be discontinued and patients should be evaluated promptly, followed by appropriate treatment.
Danish: Hvis der ses kliniske tegn på dyb venetrombose/lungeemboli, bør behandlingen med upadacitinib afbrydes, og patienten bør undersøges med det samme og have relevant behandling.
English: • Instructions for how to access digital HCP information
Danish: • Oplysning om, hvordan digitale oplysninger til sundhedspersoner tilgås.
English: Name and address of the manufacturers responsible for batch release
Danish: Navn og adresse på de fremstillere, der er ansvarlige for batchfrigivelse AbbVie S.r.l.
English: Other medicines and RINVOQ
Danish: Brug af anden medicin sammen med RINVOQ
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Inner carton of 49 tablets (for the 98 pack)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Indre æske med 49 tabletter (for 98 stk. pakningen)
English: Upadacitinib was not studied in patients with severe (Child-Pugh C) hepatic impairment.
Danish: Upadacitinib er ikke undersøgt hos patienter med svært nedsat leverfunktion (Child-Pugh C).
English: Upadacitinib AUC was 18%, 33%, and 44% higher in subjects with mild (estimated glomerular filtration rate 60 to 89 mL/min/1.73 m2), moderate (estimated glomerular filtration rate 30 to 59 mL/min/1.73 m2), and severe (estimated glomerular filtration rate 15 to 29 mL/min/1.73 m2) renal impairment, respectively, compared to subjects with normal renal function.
Danish: 2), moderat nedsat nyrefunktion (estimeret glomerulær filtrationshastighed 60-89 ml/min/1,73 m glomerulær filtrationshastighed 30-59 ml/min/1,73 m2) og svært nedsat nyrefunktion (estimeret glomerulær filtrationshastighed 15-29 ml/min/1,73 m2), sammenholdt med patienter med normal nyrefunktion.
English: AbbVie Deutschland GmbH & Co. KG Tel: 00800 222843 33 (gebührenfrei) Tel: +49 (0) 611 / 1720-0
Danish: KG Sími: 00800 222843 33 (gebührenfrei) Sími: +49 (0) 611 / 1720-0
English: • you have cancer - because your doctor will have to decide if you can still be given RINVOQ
Danish: • hvis du har kræft, da lægen så skal vurdere, om du er egnet til at få RINVOQ på trods af din kræftsygdom
English: 98 prolonged-release tablets.
Danish: 98 depottabletter.
English: QR code to be included For more information and support on taking RINVOQ go to www.rinvoq.eu
Danish: Du kan finde flere oplysninger om anvendelse af RINVOQ på www.rinvoq.eu
English: The overall long-term rate of serious infections for the upadacitinib 15 mg group across all five Phase 3 clinical studies was 3.8 events per 100 patient-years.
Danish: Den samlede langsigtede forekomst af alvorlige infektioner for de grupper, der fik upadacitinib 15 mg, i alle fem kliniske fase 3-studier, var 3,8 hændelser pr. 100 patientår.
English: If you stop taking RINVOQ
Danish: Hvis du holder op med at tage RINVOQ
English: Talk to your doctor or pharmacist before and during treatment with RINVOQ if:
Danish: Kontakt lægen eller apotekspersonalet, før du tager RINVOQ, eller mens du tager det:
English: In a clinical study, coadministration of upadacitinib with ketoconazole resulted in 70% and 75% increases in upadacitinib Cmax and AUC, respectively.
Danish: I et klinisk studie sås en stigning i Cmax og AUC for upadacitinib på hhv. 70 % og 75 % ved samtidig administration af upadacitinib og ketoconazol.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Bottle Carton (30 and 90 pack)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske med beholder(e) (30 og 90 tabletter)
English: Upadacitinib should be used with caution in patients with severe renal impairment.
Danish: Upadacitinib bør anvendes med forsigtighed hos patienter med svært nedsat nyrefunktion.
English: • The patient alert card shall contain the following key messages: o Contact details of the upadacitinib prescriber o Language that the PAC should be carried by the patient at any time and to share it with HCPs involved in their care (i.e., non-upadacitinib prescribers, emergency room HCPs, etc.) o Description of signs/symptoms of infections the patient needs to be aware of, so that they can seek attention from their HCP:
Danish: • Patientkortet skal indeholde følgende centrale punkter: o Kontaktoplysninger på den læge, der har ordineret upadacitinib o En tekst om, at patienterne altid skal have PK på sig, så de kan vise det til sundhedspersoner, som de behandles af (dvs. sundhedspersoner, der ikke har ordineret upadacitinib, sundhedspersoner på skadestuer osv.) o En beskrivelse af tegn/symptomer på infektioner, som patienterne skal være opmærksomme på, så de om nødvendigt kan kontakte egen læge: