FrancophonIA/ELRC3.0 huggingface dataset:
English: RINVOQ may be used as monotherapy or in combination with methotrexate.
Danish: RINVOQ kan anvendes som monoterapi eller i kombination med methotrexat.
English: Detailed and updated information on this product is available by scanning the QR code included below or on the outer carton with a smart phone.
Danish: Du kan også finde detaljerede og opdaterede oplysninger om dette lægemiddel ved at scanne den QRkode, der er angivet nedenfor eller på den ydre æske, ved brug af en smartphone.
English: Elevations were observed at 2 to 4 weeks of treatment and remained stable with longer-term treatment.
Danish: De forhøjede værdier sås efter 2-4 ugers behandling og forblev på et stabilt niveau ved længerevarende behandling.
English: • you have had a herpes zoster infection (shingles), because RINVOQ may allow it to come back.
Danish: • hvis du har haft en herpes zoster infektion (helvedesild), da RINVOQ kan få den til at komme tilbage.
English: Patients who develop adverse reactions should receive appropriate treatment.
Danish: Patienter, der udvikler bivirkninger, bør have relevant behandling.
English: Prior to initiating upadacitinib, it is recommended that patients be brought up to date with all immunisations, including prophylactic zoster vaccinations, in agreement with current immunisation guidelines.
Danish: Inden behandling med upadacitinib anbefales det, at patienterne bringes ajour med immuniseringer, herunder profylaktisk zoster-vaccination, i henhold til gældende immuniseringsretningslinjer.
English: Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with upadacitinib.
Danish: Patienterne bør overvåges tæt for udvikling af tegn og symptomer på infektion under og efter behandling med upadacitinib.
English: Treatment should be temporarily interrupted if drug-induced liver injury is suspected
Danish: Behandlingen bør afbrydes midlertidigt, hvis der er mistanke om lægemiddelinduceret leverskade
English: There are limited data in patients aged 75 years and older.
Danish: Der foreligger kun begrænsede data om patienter i alderen 75 år og derover.
English: The patient information pack should contain:
Danish: Patientinformationspakken skal indeholde:
English: RINVOQ contains the active substance upadacitinib.
Danish: RINVOQ indeholder det aktive stof upadacitinib.
English: • Active tuberculosis (TB) or active serious infections (see section 4.4).
Danish: • Aktiv tuberkulose (TB) eller aktive alvorlige infektioner (se pkt.
English: Talk to your doctor if you develop a new lesion or any change in the appearance of an area on the skin.
Danish: Tal med lægen, hvis du udvikler en ny læsion eller oplever en ændring af et hudområdes udseende.
English: Upadacitinib was teratogenic in both rats and rabbits.
Danish: Upadacitinib var teratogent hos både rotter og kaniner.
English: No dose adjustment is required in patients aged 65 years and older.
Danish: Dosisjustering er ikke nødvendigt hos patienter i alderen 65 år eller derover.
English: Upadacitinib has no relevant effects on plasma exposures of ethinylestradiol, levonorgestrel, methotrexate, or medicinal products that are substrates for metabolism by CYP1A2, CYP2B6, CYP2C9, CYP2C19, or CYP2D6.
Danish: Upadacitinib har ingen relevant indvirkning på plasmaeksponeringen af ethinylestradiol, levonorgestrel, methotrexat eller lægemidler, der er substrater for metabolisering via CYP1A2, CYP2B6, CYP2C9, CYP2C19 eller CYP2D6.
English: The JAK family of enzymes contains four members, JAK1, JAK2, JAK3 and TYK2 which work in pairs to phosphorylate and activate signal transducers and activators of transcription (STATs).
Danish: Familien af JAK-enzymer har fire medlemmer, JAK1, JAK2, JAK3 og TYK2, der samarbejder parvis for at fosforylere og aktivere signaltransducere og transkriptionsaktivatorer (STAT'er).
English: The proportion of patients with no radiographic progression (mTSS change ≤ 0) was significantly higher with upadacitinib 15 mg in both studies.
Danish: Andelen af patienter uden radiografisk progression (mTSS-ændring ≤ 0) var signifikant højere ved behandling med upadacitinib 15 mg i begge studier.
English: The risk of malignancies, including lymphoma is increased in patients with rheumatoid arthritis.
Danish: Risikoen for maligniteter, herunder lymfom, er forhøjet hos patienter med reumatoid artritis.
English: Following oral administration of upadacitinib prolonged-release formulation, upadacitinib is absorbed with a median Tmax of 2 to 4 hours.
Danish: Efter oral administration af upadacitinib-depotformulering absorberes upadacitinib med en median Tmax på 2-4 timer.
English: If you are a woman of child-bearing potential, you must use effective contraception to avoid becoming pregnant while taking RINVOQ and for at least 4 weeks after your last dose of RINVOQ.
Danish: Hvis du er en kvinde, der kan blive gravid, skal du anvende sikker prævention for at undgå at blive gravid, mens du tager RINVOQ og i mindst 4 uger efter din sidste dosis RINVOQ.
English: Risk factors that should be considered in determining the patient's risk for DVT/PE include older age, obesity, a medical history of DVT/PE, patients undergoing major surgery, and prolonged immobilisation.
Danish: Risikofaktorer, der bør overvejes ved vurdering af patientens risiko for DVT / PE, omfatter alder, fedme, en anamnese af DVT / PE, patienter, der gennemgår større kirurgiske indgreb, og langvarig immobilisering.
English: To listen to or request a copy of this leaflet in <Braille>, <large print> or <audio>, please contact the local representative of the Marketing Authorisation Holder.
Danish: Hvis du ønsker at rekvirere denne indlægsseddel som <lydfil> eller <i brailleskrift> eller < stor skrift (magnaprint)>, kan du kontakte den lokale repræsentant for indehaveren af markedsføringstilladelsen.
English: Rheumatoid arthritis patients have an increased risk for cardiovascular disorders.
Danish: Reumatoid artritis patienter har en øget risiko for hjerte-kar-sygdomme.
English: JAK1 is important in inflammatory cytokine signals while JAK2 is important for red blood cell maturation and JAK3 signals play a role in immune surveillance and lymphocyte function.
Danish: JAK1 har betydning for de inflammatoriske cytokinsignaler, mens JAK2 har betydning for modningen af røde blodlegemer, og JAK3-signaler har betydning for immunovervågningen og lymfocytfunktionen.
English: Inhibition of progression of structural joint damage was assessed using the modified Total Sharp Score (mTSS) and its components, the erosion score and joint space narrowing score, at weeks 24/26 and week 48 in SELECT-EARLY and SELECT-COMPARE.
Danish: Hæmning af progressionen af strukturelle ledskader blev vurderet ved hjælp af modificeret total Sharp-score (mTSS) og dennes komponenter, erosions-score og score for ledspalteforsnævring i uge 24/26 og uge 48 i SELECT-EARLY og SELECT-COMPARE.
English: By reducing the activity of this enzyme, RINVOQ can help to reduce pain, stiffness and swelling in your joints, reduce tiredness and it can slow down damage to the bone and cartilage in your joints.
Danish: Ved at reducere aktiviteten af dette enzym kan RINVOQ mindske træthed og forekomsten af ledsmerter, -stivhed og -hævelse, og det kan forsinke skadevirkningerne på knogler og brusk i dine led.
English: Most elevations > 5 x ULN were transient and did not require treatment discontinuation.
Danish: De fleste tilfælde af forhøjet kreatininfosfokinase > 5 x ULN var forbigående og krævede ikke seponering af behandlingen.
English: If you have moderate to severe active rheumatoid arthritis, you may first be given other medicines, one of which will usually be methotrexate.
Danish: Hvis du har moderat til svært aktiv leddegigt, kan det være, du først får andre lægemidler, hvoraf det ene typisk vil være methotrexat.
English: The Guide for healthcare professionals shall contain the following key elements:
Danish: Oplysningsfolderen til sundhedspersonser skal omfatte følgende centrale punkter:
English: Janus Kinases (JAKs) are intracellular enzymes that transmit cytokine or growth factor signals involved in a broad range of cellular processes including inflammatory responses, hematopoiesis and immune surveillance.
Danish: Janus-kinaser (JAK'er) er intracellulære enzymer, der overfører cytokin- eller vækstfaktorsignaler, som indgår i en lang række cellulære processer, herunder inflammatorisk respons, hæmatopoiese og immunovervågning.
English: The tablets are provided in blisters or bottles.
Danish: Tabletterne fås i blisterpakninger eller beholdere.
English: How to take RINVOQ Always take this medicine exactly as your doctor or pharmacist has told you.
Danish: Sådan skal du tage RINVOQ Tag altid lægemidlet nøjagtigt efter lægens eller apotekspersonalets anvisning.
English: • Language for HCPs to inform patients of the importance of the PAC
Danish: • En tekst til sundhedspersoner om, at informere patienter om vigtigheden af PK
English: • throat and nose infections
Danish: • Infektion i svælg og næse
English: Upadacitinib is 52% bound to plasma proteins.
Danish: Upadacitinibs bindingsgrad til plasmaproteiner er 52 %.
English: When you have taken your tablet, put the cap back on and close the bottle.
Danish: Når du har taget din tablet, skal du sætte låget tilbage på plads og skrue det godt fast.
English: Patients treated with upadacitinib should have risk factors (e.g., hypertension, hyperlipidaemia) managed as part of usual standard of care.
Danish: Patienter, der behandles med upadacitinib, bør have risikofaktorer (f.eks hypertension, hyperlidæmi) håndteret som en del af deres standardbehandling.
English: Upadacitinib partitions similarly between plasma and blood cellular components, as indicated by the blood to plasma ratio of 1.0.
Danish: Upadacitinib fordeler sig ligeligt mellem plasma- og blodcellekomponenter, jf. en blod/plasma-ratio på 1,0.
English: Patients should be managed according to international clinical guidelines for hyperlipidaemia
Danish: Patienterne bør behandles i henhold til de internationale kliniske retningslinjer for hyperlipidæmi
English: Treatment with upadacitinib should be initiated and supervised by physicians experienced in the diagnosis and treatment of rheumatoid arthritis.
Danish: Behandling med upadacitinib bør iværksættes og overvåges af en læge med erfaring i diagnosticering og behandling af reumatoid artritis.
English: Prior to launch of RINVOQ in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Danish: Inden RINVOQ lanceres i de enkelte medlemsstater, skal indehaveren af markedsføringstilladelsen (MAH) indgå en aftale med den nationale kompetente myndighed om indholdet og formatet af informationsmaterialet, herunder kommunikationsmedier, distributionsmåder og lignende.
English: Package leaflet: Information for the patient RINVOQ 15 mg prolonged-release tablets upadacitinib This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til patienten RINVOQ 15 mg depottabletter upadacitinib Dette lægemiddel er underlagt supplerende overvågning.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of upadacitinib in milk (see section 5.3).
Danish: Tilgængelige farmakodynamiske/toksikologiske data fra dyr har vist udskillelse af upadacitinib i mælk (se pkt.
English: In a human radiolabeled study, unchanged upadacitinib accounted for 79% of the total radioactivity in plasma while the main metabolite (product of monooxidation followed by glucuronidation) accounted for 13% of the total plasma radioactivity.
Danish: I et klinisk studie med radioaktiv mærkning stod uomdannet upadacitinib for 79 % af den samlede radioaktivitet i plasma, mens hovedmetabolitten (produkt af monooxidering efterfulgt af glukoronidering) stod for 13 % af den samlede radioaktivitet i plasma.
English: Consultation with a physician with expertise in the treatment of TB is recommended to aid in the decision about whether initiating anti-TB therapy is appropriate for an individual patient.
Danish: Det anbefales at rådføre sig med en speciallæge med erfaring i behandling af TB for at understøtte beslutningen om, hvorvidt det er relevant at iværksætte anti-TB-behandling hos den enkelte patient.
English: • Low disease activity (CDAI)
Danish: • Lav sygdomsaktivitet (CDAI)
English: If a patient becomes pregnant while taking upadacitinib the parents should be informed of the potential risk to the foetus.
Danish: Hvis en patient bliver gravid under behandling med upadacitinib, bør patienten informeres om den potentielle risiko for fostret.
English: Elevations in LDL cholesterol decreased to pre-treatment levels in response to statin therapy, although evidence is limited.
Danish: Det forhøjede LDL-kolesterol faldt til niveauet før behandling, som respons på statin-behandling, om end evidensen er begrænset.
English: Following single dose administration of [14C]-upadacitinib immediate-release solution, upadacitinib was eliminated predominantly as the unchanged parent substance in urine (24%) and faeces (38%).
Danish: Efter administration af en enkelt dosis [14C]-upadacitinib-opløsning til øjeblikkelig frigivelse blev upadacitinib fortrinsvis elimineret som uomdannet moderstof i urin (24 %) og fæces (38 %).
English: Microcrystalline cellulose Hypromellose Mannitol
Danish: Mikrokrystallinsk cellulose Hypromellose Mannitol
English: • cold sores (herpes simplex)
Danish: • Forkølelsessår (herpes simplex)
English: The objective of the programme is to increase awareness of HCPs and patients on the risks of serious and opportunistic infections including TB, herpes zoster, foetal malformation (pregnancy risk), MACE, and VTEs and how to manage these risks.
Danish: Målet med informationsmaterialet er at øge opmærksomheden hos sundhedspersonale og patienter om risikoen for alvorlige og opportunistiske infektioner, herunder tuberkulose, herpes zoster, fostermisdannelse (graviditetsrisiko), MACE og VTE, og hvordan man håndterer disse risici.
English: Prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury.
Danish: Det anbefales at undersøge årsagen til forhøjede leverenzymer hurtigt for at identificere potentielle tilfælde af lægemiddelinduceret leverskade.
English: The maximal inhibition was observed 1 hour after dosing which returned to near baseline by the end of dosing interval.
Danish: Den maksimale hæmning sås 1 time efter indgift og vendte tilbage til tæt på baseline ved udløbet af doseringsintervallet.
English: No dose adjustment is required in patients with mild or moderate renal impairment.
Danish: Dosisjustering er ikke nødvendigt hos patienter med let eller moderat nedsat nyrefunktion.
English: RINVOQ has no effect on the ability to drive and use machines.
Danish: RINVOQ påvirker ikke evnen til at føre motorkøretøj eller betjene maskiner.
English: It belongs to a group of medicines called Janus kinase inhibitors, which help reduce inflammation.
Danish: Det tilhører en gruppe af lægemidler, der kaldes Janus-kinase-hæmmere, som kan reducere inflammation (betændelsestilstande).
English: Interruption of dosing may be needed for management of laboratory abnormalities as described in Table 1.
Danish: Dosisafbrydelser kan være nødvendige for at behandle unormale laboratorieværdier, jf. tabel 1.
English: Upadacitinib metabolism is mediated by CYP3A4 with a potential minor contribution from CYP2D6.
Danish: Upadacitinibs metabolisering medieres af CYP3A4 med et muligt mindre bidrag fra CYP2D6.
English: Coadministration of upadacitinib with a high-fat meal had no clinically relevant effect on upadacitinib exposures (increased AUC by 29% and Cmax by 39%).
Danish: Administration af upadacitinib sammen med et fedtrigt måltid havde ingen klinisk relevant indvirkning på upadacitinibs eksponering (AUC øget med 29 % og Cmax med 39 %).
English: Upadacitinib should not be initiated in patients with an active, serious infection, including localised infections.
Danish: Behandling med upadacitinib bør ikke iværksættes hos patienter med en aktiv alvorlig infektion, herunder lokaliserede infektioner.
English: Upadacitinib had no relevant effect on atorvastatin Cmax or on plasma exposures of ortho-hydroxyatorvastatin (major active metabolite for atorvastatin).
Danish: Upadacitinib havde ingen relevant indvirkning på atorvastatins Cmax eller plasmaeksponeringen af ortho-hydroxyatorvastatin (væsentlig aktiv atorvastatin-metabolit).
English: Among patients in the controlled studies with baseline values below the specified limits, the following frequencies of patients were observed to shift to above the specified limits on at least one occasion during 12/14 weeks (including patients who had an isolated elevated value):
Danish: Blandt de patienter i de kontrollerede studier, der havde baselineværdier under de fastsatte grænser, sås følgende hyppighed af patienter, hvis værdier steg til over de fastsatte grænser ved mindst én måling i løbet af 12/14 uger (herunder patienter, der havde en isoleret forhøjet værdi):
English: Upadacitinib was teratogenic in rats and rabbits with effects in bones in rat foetuses and in the heart in rabbit foetuses when exposed in utero.
Danish: Upadacitinib var teratogent hos rotter og kaniner med indvirkning på knoglerne hos rottefostre og på hjertet hos kaninfostre ved eksponering in utero.
English: Your doctor will test you for tuberculosis before starting RINVOQ and may retest during treatment
Danish: Lægen vil teste dig for tuberkulose før behandling med RINVOQ og kan teste dig igen under behandlingen
English: Intrinsic factors
Danish: Indre faktorer
English: Tel: +39 06 928921
Danish: Sími: +39 06 928921
English: The decreases in neutrophil counts remained stable at a lower value than baseline over time including with extended therapy.
Danish: De nedsatte neutrofiltal forblev på et stabilt niveau med en lavere værdi end baseline-værdien over tid, også ved længerevarende behandling.
English: V.J.Salomone Pharma Limited Tel: +356 22983201
Danish: V.J.Salomone Pharma Limited Sími: +356 22983201
English: In human cellular assays, upadacitinib preferentially inhibits signalling by JAK1 or JAK1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK2.
Danish: I humane celleanalyser hæmmer upadacitinib fortrinsvis signalering via JAK1 eller JAK1/3 med funktionel selektivitet over for cytokinreceptorer, der signalerer via JAK2-par.
English: The efficacy and safety of upadacitinib 15 mg once daily was assessed in five Phase 3 randomised, double-blind, multicentre studies in patients with moderately to severely active rheumatoid arthritis and fulfilling the ACR/EULAR 2010 classification criteria (see Table 3).
Danish: Virkningen og sikkerheden ved upadacitinib 15 mg én gang dagligt blev undersøgt i fem randomiserede, dobbeltblindede fase 3-studier på flere centre hos patienter med moderat til svært aktiv reumatoid artritis, der opfyldte ACR/EULAR 2010-klassifikationskriterierne (se tabel 3).
English: No dose adjustment is recommended for CYP3A substrates or for rosuvastatin or atorvastatin when coadministered with upadacitinib.
Danish: Dosisjustering anbefales ikke for CYP3A-substrater eller for rosuvastatin eller atorvastatin, når upadacitinib administreres samtidigt.
English: You may get some of the side effects listed in section 4.
Danish: Du kan få nogle af de bivirkninger, der er angivet i pkt.
English: Following administration of upadacitinib to lactating rats, the concentrations of upadacitinib in milk over time generally paralleled those in plasma, with approximately 30-fold higher exposure in milk relative to maternal plasma.
Danish: Efter administration af upadacitinib hos diegivende rotter fulgte koncentrationen af upadacitinib i mælk over tid generelt en parallel kurve med koncentrationen i plasma, med ca. 30 gange højere eksponering i mælk end i maternelt plasma.
English: A patient who develops a new infection during treatment with upadacitinib should undergo prompt and complete diagnostic testing appropriate for an immunocompromised patient; appropriate antimicrobial therapy should be initiated, the patient should be closely monitored, and upadacitinib therapy should be interrupted if the patient is not responding to antimicrobial therapy.
Danish: En patient, der udvikler en ny infektion under behandling med upadacitinib, bør med det samme underkastes komplet diagnostisk testning målrettet en immunkompromitteret patient; der bør iværksættes relevant antimikrobiel behandling, patienten bør overvåges tæt, og behandlingen med upadacitinib bør afbrydes, hvis patienten ikke udviser respons på antimikrobiel behandling.
English: Screening for viral hepatitis and monitoring for reactivation should be performed before starting and during therapy with upadacitinib.
Danish: Screening for viral hepatitis og overvågning for reaktivering bør ske hhv. før og under behandling med upadacitinib.
English: The MAH shall ensure that in each Member State where RINVOQ is marketed, all healthcare professionals and patients/carers who are expected to prescribe, dispense or use RINVOQ have access to/are provided with the following educational package:
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at alle sundhedspersoner og patienter, der forventes at skulle ordinere, dispensere eller anvende RINVOQ, i alle de medlemsstater, hvor RINVOQ markedsføres, har adgang til/får udleveret følgende informationsmateriale:
English: The European Medicines Agency has deferred the obligation to submit the results of studies with RINVOQ in one or more subsets of the paediatric population in chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, spondyloarthritis and juvenile idiopathic arthritis) (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med RINVOQ i en eller flere undergrupper af den pædiatriske population ved kronisk idiopatisk artritis (herunder reumatoid artritis, psoriasisartritis, spondyloartritis og juvenil idiopatisk artritis) (se pkt.
English: • Primary endpoint: low disease activity
Danish: • Primært endepunkt: lav sygdomsaktivitet
English: Lipid elevations
Danish: Forhøjede lipider
English: Week 24b/26c
Danish: Uge 24b/26c
English: If any of the above apply to you or you are not sure, talk to your doctor or pharmacist before taking RINVOQ.
Danish: Hvis noget af ovenstående gælder for dig, eller hvis du er i tvivl, skal du tale med lægen eller apotekspersonalet, før du tager RINVOQ.
English: • with a history of a serious or an opportunistic infection
Danish: • der tidligere har haft en alvorlig eller opportunistisk infektion
English: Age, sex, body weight, race, and ethnicity did not have a clinically meaningful effect on upadacitinib exposure.
Danish: Alder, køn, legemsvægt og etnisk oprindelse havde ingen relevant klinisk betydning for upadacitinibs eksponering.
English: ANNEX I 0BSUMMARY OF PRODUCT CHARACTERISTICS
Danish: BILAG I 0BPRODUKTRESUMÉ
English: In clinical trials, upadacitinib was administered without regard to meals (see section 4.2).
Danish: I kliniske studier blev upadacitinib administreret uden hensyn til måltider (se pkt.
English: Patients who were positive for hepatitis C antibody and hepatitis C virus RNA were excluded from clinical studies.
Danish: Patienter, der testede positive for hepatitis C-antistoffer og hepatitis C-virus RNA, blev ekskluderet fra kliniske studier.
English: • if you are allergic to upadacitinib or any of the other ingredients of this medicine (listed in section 6)
Danish: • hvis du er allergisk over for upadacitinib eller et af de øvrige indholdsstoffer i dette lægemiddel
English: Tel: +421 2 5050 0777
Danish: Sími: +421 2 5050 0777
English: • The active substance is upadacitinib.
Danish: • Aktivt stof: upadacitinib.
English: Treatment should be interrupted if Hb is < 8 g/dL and may be restarted once Hb returns above this value
Danish: Behandlingen bør afbrydes, hvis Hb er < 8 g/dl, og kan genoptages, når Hb igen ligger over denne værdi