FrancophonIA/ELRC3.0 huggingface dataset:
English: Packs of 2 dose-dispenser cartridges and 2 alcohol wipes, a multipack containing 6 (3 packs of 2) dose-dispenser cartridges and 6 (3 packs of 2) alcohol wipes, and a multipack containing 10 (5 packs of 2) dose-dispenser cartridges and 10 (5 packs of 2) alcohol wipes are available.
Danish: Fås i pakninger a 2 kassetter til dosisdispenser og 2 alkoholservietter, en multipakning indeholdende 6 (3 pakninger a 2) kassetter til dosisdispenser og 6 (3 pakninger a 2) alkoholservietter, og en multipakning indeholdende 10 (5 pakninger a 2) kassetter til dosisdispenser og 10 (5 pakninger a 2) alkoholservietter.
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in pre-filled syringe 2 single-use pre-filled syringes with needle guard 2 alcohol wipes
Danish: Injektionsvæske, opløsning i fyldt sprøjte 2 fyldte engangssprøjter med kanylebeskyttelse 2 alkoholservietter
English: • increased gastrointestinal motility
Danish: • øget aktivitet i mave-tarm-kanalen
English: Setting up
Danish: Forberedelse
English: If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Danish: Spørg lægen, apotekspersonalet eller sundhedspersonalet, hvis du har yderligere spørgsmål til anvendelsen af denne medicin.
English: Rare angioneurotic oedema, sarcoidosis, serum sickness, panniculitis (including erythema nodosum), worsening of symptoms of dermatomyositis**
Danish: Ikke almindelig vaskulitis, lupus erythematosus, lægemiddeloverfølsomhed (inklusive anafylaktisk shock), allergiske lidelser, autoantistof positiv Sjælden angioødem, sarkoidose, serumsyge, panniculitis (inklusive erythema nodosum), forværrede symptomer på dermatomyositis** Det endokrine system Sjælden thyreoideasygdomme Metabolisme og ernæring Ikke almindelig elektrolytforstyrrelser, dyslipidæmi, appetitforstyrrelser, vægtændring Sjælden hæmosiderose
English: • The starting dose for adults with psoriatic arthritis is 400 mg given at weeks 0, 2 and 4.
Danish: • Startdosistil voksne med psoriasisartritis er 400 mg ved uge 0, 2 og 4.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton (for packs of 2 pre-filled syringes with needle guard and 2 alcohol wipes)
Danish: Ydre karton (for pakninger med 2 fyldte sprøjter med kanylebeskyttelse og 2 alkoholservietter)
English: • swollen lymph nodes
Danish: Sandoz GmbH
English: PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING Intermediate carton within Multipack of 10 (for 2 dose-dispenser cartridges and 2 alcohol wipes) (without bluebox)
Danish: Indre karton i multipakning med 10 (til 2 kassetter til dosisdispenser og 2 alkoholservietter) (uden blå boks)
English: Uncommo chills, influenza-like illness, altered temperature perception, night sweats, flushing
Danish: Ikke almindelig kuldegysninger, influenzalignende sygdom, ændret temperaturopfattelse, nattesved, rødmen Sjælden fistel (et hvilket som helst sted)
English: §§ Cimzia 400 mg every 2 weeks versus etanercept 50 mg twice weekly demonstrated superiority
Danish: Cimzia 400 mg hver 2. uge versus etanercept 50 mg to gange om ugen påviste overlegenhed (p < 0,05) ** Cimzia vs. placebo p < 0,001.
English: What Cimzia looks like and contents of the pack Cimzia is provided as a solution for injection in a ready to use dose-dispenser cartridge.
Danish: Cimzia leveres som en injektionsvæske, opløsning i en kassette til dosisdispenser, der er klar til brug.
English: Packs of 2 pre-filled syringes and 2 alcohol wipes, a multipack containing 6 (3 packs of 2) pre-filled syringes and 6 (3 packs of 2) alcohol wipes, and a multipack containing 10 (5 packs of 2) pre-filled syringes and 10 (5 packs of 2) alcohol wipes are available.
Danish: Fås i pakninger a 2 fyldte sprøjter og 2 alkoholservietter, en multipakning indeholdende 6 (3 pakninger a 2) fyldte sprøjter og 6 (3 pakninger a 2) alkoholservietter, og en multipakning indeholdende 10 (5 pakninger a 2) fyldte sprøjter og 10 (5 pakninger a 2) alkoholservietter.
English: Major Clinical
Danish: Medicin hoveddel
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Multipack of 10 (5 packs of 2 pre-filled syringes and 2 alcohol wipes) (with bluebox)
Danish: Karton Multipakning med 10 (5 pakninger a 2 fyldte sprøjter og 2 alkoholservietter) (med Blå Boks)
English: PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING Intermediate carton within Multipack of 10 (for 2 pre-filled pens and 2 alcohol wipes) (without bluebox)
Danish: Indre karton i multipakning med 10 (til 2 fyldte penne og 2 alkoholservietter) (uden blå boks)
English: • vertigo (dizziness)
Danish: • følelse/fornemmelse af at snurre rundt (vertigo)
English: PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING Intermediate carton within Multipack of 10 (for 2 pre-filled syringes and 2 alcohol wipes) (without bluebox)
Danish: Indre karton i multipakning med 10 (til 2 fyldte sprøjter og 2 alkoholservietter) (uden blå boks)
English: • numbness
Danish: • hoste
English: Hepatic impairment
Danish: Ankyloserende spondylitis
English: You should not do both.
Danish: Du skal ikke gøre begge dele.
English: All studies included long-term extensions for up to 5 years.
Danish: Alle studier omfattede længerevarende forlængelsesfaser i op til 5 år.
English: Table 4: Response and remission
Danish: Tabel 4: Respons og remission
English: • with underlying conditions that may predispose them to infection.
Danish: • med underliggende tilstande, der kan prædisponere dem for infektion.
English: If you become pregnant during this time, you must talk to your doctor straight away.
Danish: Hvis du bliver gravid i dette tidsrum, skal du tale med lægen med det samme.
English: There was no change in the LDL/HDL ratio.
Danish: Der var ingen ændring i LDL/HDL-ratioen.
English: The clinical data are currently limited and long-term studies are ongoing.
Danish: De kliniske data er p.t. begrænsede, og langtidsstudier er i gang.
English: • Do not take a double dose to make up for a forgotten tablet.
Danish: • Du må ikke tage en dobbeltdosis som erstatning for den glemte tablet.
English: Proportion of patients with no radiographic progressiond
Danish: Andel af patienter uden radiografisk progressiond
English: RINVOQ is to be taken orally once daily with or without food and may be taken at any time of the day.
Danish: RINVOQ er til oral anvendelse og skal tages én gang dagligt med eller uden mad og kan tages når som helst på dagen.
English: Table 5: Radiographic changes
Danish: Tabel 5: Radiografiske forandringer
English: Opportunistic infections (excluding tuberculosis)
Danish: Opportunistiske infektioner (bortset fra tuberkulose)
English: Approximately 97% of drug-related material in milk was parent drug.
Danish: Ca. 97 % af det lægemiddelrelaterede materiale i mælk var moderstof.
English: Each calendar blister contains 7 tablets.
Danish: Hver kalenderblister indeholder 7 tabletter.
English: Campoverde di Aprilia (LT) ITALY
Danish: Campoverde di Aprilia (LT)
English: • you have had tuberculosis or have been in close contact with someone with tuberculosis.
Danish: • hvis du har haft tuberkulose eller har været i tæt kontakt med nogen, der har tuberkulose.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology.
Danish: Non-kliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi.
English: Clinical Response:
Danish: Klinisk respons:
English: These effects can ease your normal daily activities and so improve your quality of life.
Danish: Lægemidlet kan derfor gøre det lettere for dig at udføre hverdagens aktiviteter og dermed forbedre din helbredsrelaterede livskvalitet.
English: Most of the herpes zoster events involved a single dermatome and were non-serious.
Danish: De fleste tilfælde af herpes zoster omfattede et enkelt dermatom og var ikke alvorlige.
English: Pregnancy RINVOQ must not be used during pregnancy.
Danish: Graviditet RINVOQ må ikke anvendes under graviditet.
English: • Swallow the tablet whole with water.
Danish: • Tabletten skal synkes hel sammen med vand.
English: It is unknown whether upadacitinib/metabolites are excreted in human milk.
Danish: Det er ukendt, om upadacitinib/metabolitter udskilles i human mælk.
English: 148 Pontina, km 52 SNC 04011 Campoverde di Aprilia (Latina) Italy
Danish: 148 Pontina, km 52 SNC 04011 Campoverde di Aprilia (Latina) Italien
English: • Radiographic progression (mTSS)
Danish: • Radiografisk progression (mTSS)
English: The following list of adverse reactions is based on experience from registrational clinical studies.
Danish: Den følgende liste over bivirkninger er baseret på erfaringer fra kliniske registreringsstudier.
English: • you have heart problems, high blood pressure, or high cholesterol
Danish: • hvis du har hjerteproblemer, forhøjet blodtryk eller højt kolesteroltal
English: The safety and efficacy of RINVOQ in children and adolescents aged 0 to less than 18 years have not yet been established.
Danish: Sikkerheden og virkningen ved RINVOQ hos børn og unge i alderen 0 til < 18 år er endnu ikke klarlagt.
English: Monitoring guidance
Danish: Monitoreringsvejledning
English: • who have resided or travelled in areas of endemic tuberculosis or endemic mycoses; or
Danish: • der har opholdt sig eller rejst i områder med endemisk tuberkulose eller endemiske mykoser,
English: • if you have active tuberculosis (TB)
Danish: • hvis du har aktiv tuberkulose (TB)
English: There are no or limited data on the use of upadacitinib in pregnant women.
Danish: Der foreligger ingen eller kun begrænsede data fra anvendelse af upadacitinib hos gravide kvinder.
English: • who have been exposed to tuberculosis
Danish: • der har været eksponeret for tuberkulose
English: Pharmacotherapeutic group: Immunosuppressants, selective immunosuppressants ATC code: not yet assigned
Danish: Farmakoterapeutisk klassifikation: Immunsuppressiva, selektive immunsuppressiva, ATC-kode: endnu ikke tildelt
English: As there is a higher incidence of infections in the elderly ≥ 75 years of age, caution should be used when treating this population.
Danish: Da der ses en højere forekomst af infektioner hos ældre i alderen ≥ 75 år, bør der udvises forsigtighed ved behandling af denne population.
English: Compared to adalimumab, significantly higher rates of low disease activity were achieved at week 12 in SELECT-COMPARE.
Danish: Sammenholdt med adalimumab blev der opnået signifikant højere forekomst af lav sygdomsaktivitet i uge 12 i SELECT-COMPARE.
English: The brochure also informs on steps which can be taken to reduce a patient's risk for key safety aspects of upadacitinib.
Danish: Folderen oplyser også om, hvilke forholdsregler der kan tages for at reducere en patients risiko, hvad angår centrale sikkerhedsmæssige aspekter ved upadacitinib.
English: The primary analysis for each of these studies included all randomised subjects who received at least 1 dose of study drug, and non-responder imputation was used for categorical endpoints.
Danish: Den primære analyse for hvert af disse studier omfattede alle randomiserede patienter, der fik mindst 1 dosis forsøgslægemiddel, og der blev anvendt imputering af ikke-respondere for de kategoriske endepunkter.
English: • Physical function (HAQ-DI)
Danish: • Fysisk funktionsevne (HAQ-DI)
English: The rate of serious infections remained stable with long-term exposure.
Danish: Forekomsten af alvorlige infektioner forblev stabil ved længerevarende eksponering.
English: Mean neutrophil counts decreased over 4 to 8 weeks.
Danish: Det gennemsnitlige neutrofiltal faldt i løbet af 4-8 uger.
English: The most common serious infection was pneumonia.
Danish: Den hyppigste alvorlige infektion var lungebetændelse.
English: Pneumonia Herpes zoster Herpes simplex** Oral candidiasis
Danish: Pneumoni Herpes zoster Herpes simplex** Oral candidiasis
English: • if you are pregnant (see section Pregnancy, breast-feeding and contraception)
Danish: • hvis du er gravid (se afsnittet Graviditet, amning og prævention).
English: The tests are to check that treatment with RINVOQ is not causing problems.
Danish: Blodprøverne er for at kontrollere, at behandling med RINVOQ ikke medfører problemer.
English: • you have recently had or plan to have a vaccination (immunisation) - this is because live vaccines are not recommended while using RINVOQ
Danish: • hvis du for nylig har fået eller planlægger at få en vaccination (immunisering), da levende vacciner ikke anbefales, mens du er i behandling med RINVOQ
English: • with chronic or recurrent infection
Danish: • med kronisk eller tilbagevendende infektion
English: No data are available on the response to vaccination with live or inactivated vaccines in patients receiving upadacitinib.
Danish: Der foreligger ingen data vedrørende responset på vaccination med levende eller inaktiverede vacciner hos patienter, der får upadacitinib.
English: There was a higher rate of serious infections in patients ≥ 75 years of age, although data are limited.
Danish: Der sås en højere forekomst af alvorlige infektioner hos patienter ≥ 75 år, om end dataene er begrænsede.
English: Patients 18 years of age and older were eligible to participate.
Danish: Patienter på 18 år eller derover var egnede til at deltage.
English: Evaluate at baseline and thereafter according to routine patient management.
Danish: Vurderes ved baseline og derefter i henhold til den rutinemæssige patientbehandling.
English: Immunomodulatory medicinal products may increase the risk of malignancies, including lymphoma.
Danish: Immunmodulerende lægemidler kan øge risikoen for maligniteter, herunder lymfom.
English: Adverse reactions were comparable to those seen at lower doses and no specific toxicities were identified.
Danish: Bivirkningerne var sammenlignelige med de bivirkninger, der ses ved lavere doser, og der blev ikke identificeret nogen specifikke toksiciteter.
English: Talk to your doctor if you notice any of the following side effects: Very common (may affect more than 1 in 10 people)
Danish: Tal med lægen, hvis du oplever en eller flere af følgende bivirkninger: Meget almindelige bivirkninger (kan forekomme hos mere end 1 ud af 10 patienter)
English: RINVOQ works by reducing the activity of an enzyme in the body called ‘Janus kinase'.
Danish: RINVOQ virker ved at reducere aktiviteten af et enzym i kroppen, der kaldes Janus-kinase.
English: Durable response rates were observed (with or without MTX), with ACR20/50/70 responses maintained for at least 1 year.
Danish: Der sås langvarigt respons (med eller uden MTX), idet ACR20/50/70-responset blev opretholdt i mindst 1 år.
English: Overall, both low disease activity and clinical remission rates were consistent across patient populations, with or without MTX.
Danish: Generelt var frekvensen for såvel lav sygdomsaktivitet som klinisk remission konsistent i alle patientpopulationer, med eller uden MTX.
English: Important to open
Danish: Vigtigt- åben her.
English: Periodic skin examination is recommended for patients who are at increased risk for skin cancer.
Danish: Regelmæssige hudundersøgelser anbefales hos patienter, der har forhøjet risiko for hudkræft.
English: • Elevations in plasma lipids and the need for monitoring and lipid lowering treatment
Danish: • Forhøjede plasmalipider og behovet for monitorering og lipidsænkende behandling
English: Approximately 34% of upadacitinib dose was excreted as metabolites.
Danish: Ca. 34 % af upadacitinib-dosen blev udskilt som metabolitter.
English: Approximately 90% of upadacitinib in the systemic circulation is eliminated within 24 hours of dosing (within the range of doses evaluated in clinical studies).
Danish: Ca. 90 % af upadacitinib i det systemiske kredsløb elimineres inden for 24 timer efter doseringen (inden for det dosisinterval, der er undersøgt i kliniske studier).
English: The same information is also available on the following URL: www.rinvoq.eu
Danish: Disse oplysninger er også tilgængelige via følgende URL: www.rinvoq.eu
English: • If you forget your dose for an entire day, just skip the missed dose and take only a single dose as usual the following day.
Danish: • Hvis du glemmer at tage en dosis en hel dag, skal du springe dosen over og nøjes med at tage den sædvanlige dosis dagen efter.
English: • you are at high risk of developing skin cancer, your doctor may recommend preventive measures such as regular skin examinations while taking RINVOQ.
Danish: • hvis du har høj risiko for at udvikle hudkræft; lægen kan anbefale forebyggende foranstaltninger som f.eks. regelmæssige hudundersøgelser, mens du tager RINVOQ.
English: Tablets should be swallowed whole and should not be split, crushed, or chewed.
Danish: Tabletterne skal synkes hele og må ikke deles, knuses eller tygges.
English: Do not split, crush, chew or break the tablet before swallowing as it may change how much medicine gets into your body.
Danish: Du må ikke dele, knuse, tygge eller knække tabletten, inden du sluger den, da det kan påvirke den mængde medicin, du får ind i kroppen.
English: • If you miss a dose, take it as soon as you remember.
Danish: • Hvis du glemmer at tage en dosis, skal du tage den, så snart du kommer i tanker om det.
English: 12 weeks after initiation of treatment and thereafter according to international clinical guidelines for hyperlipidaemia
Danish: 12 uger efter behandlingsstart og derefter i henhold til de internationale kliniske retningslinjer for hyperlipidæmi
English: This phosphorylation, in turn, modulates gene expression and cellular function.
Danish: Denne fosforylering modulerer igen genekspressionen og cellefunktionen.
English: SELECT BEYOND BIO-IR
Danish: SELECT BEYOND BIO-UR
English: UPA 15mg N 314 317 216 217 221 221 651 651 327 169 164 Week
Danish: UPA 15 mg N 314 317 216 217 221 221 651 651 327 169 164 Uge
English: The presence of at least 6 tender and 6 swollen joints and evidence of systemic inflammation based on elevation of hsCRP was required at baseline.
Danish: Tilstedeværelse af mindst 6 ømme og 6 hævede led og evidens for systemisk inflammation baseret på forhøjet hsCRP-værdi var påkrævet ved baseline.
English: Most cases of hepatic transaminase elevations were asymptomatic and transient.
Danish: De fleste tilfælde af forhøjede aminotransferaser var asymptomatiske og forbigående.
English: • Morning stiffness
Danish: • Morgenstivhed
English: Zwolle, 8017 JV, Netherlands
Danish: Zwolle, 8017 JV, Holland
English: Upadacitinib mean terminal elimination half-life ranged from 9 to 14 hours.
Danish: Upadacitinibs gennemsnitlige terminale eliminationshalveringstid var 9-14 timer.
English: ACR Response
Danish: ACR-respons
English: In vitro, upadacitinib is a substrate for the efflux transporters P-gp and BCRP.
Danish: In vitro er upadacitinib et substrat for efflukstransporterne P-gp og BCRP.
English: Consider the risks and benefits of treatment prior to initiating upadacitinib in patients:
Danish: Overvej risici og fordele inden iværksættelse af upadacitinib-behandling hos patienter:
English: The effect of upadacitinib on human fertility has not been evaluated.
Danish: Upadacitinibs indvirkning på menneskers fertilitet er ikke undersøgt.
English: Talk to your doctor or get medical help straight away if you get any signs of infection such as:
Danish: Tal med lægen eller søg læge med det samme, hvis du oplever symptomer på infektion, f.eks.:
English: Steady-state plasma concentrations are achieved within 4 days with minimal accumulation after multiple once-daily administrations.
Danish: Steady state-plasmakoncentrationen opnås inden for 4 dage med minimal akkumulering efter multiple doseringer én gang dagligt.
English: Upadacitinib was not carcinogenic in a 26-week carcinogenicity study in CByB6F1-Tg(HRAS)2Jic transgenic mice.
Danish: Upadacitinib var ikke karcinogent i et 26-ugers karcinogenicitetsstudie hos CByB6F1-Tg(HRAS)2Jic-transgene mus.
English: Some patients receiving RINVOQ have developed skin cancers
Danish: Nogle patienter i behandling med RINVOQ har udviklet hudkræft
English: In a pre-/postnatal development study in rats, there were no maternal effects, no effects on parturition, lactation or maternal behaviour and no effects on their offspring.
Danish: I studier af den præ- og postnatale udvikling hos rotter sås ingen maternelle virkninger, ingen effekt på forløsningen, laktationen eller den maternelle adfærd og ingen effekt på afkommet.
English: Analyses of erosion and joint space narrowing scores were consistent with the overall scores.
Danish: Analyserne af erosions-score og score for ledspalteforsnævring var konsistente med de samlede scorer.
English: In case of an overdose, it is recommended that the patient be monitored for signs and symptoms of adverse reactions.
Danish: I tilfælde af overdosering anbefales det, at patienten monitoreres for tegn og symptomer på bivirkninger.
English: You and your doctor should decide if you will breast-feed or use RINVOQ.
Danish: Du og din læge skal beslutte, om du vil amme eller bruger RINVOQ.
English: • if you have a severe infection (such as pneumonia or bacterial skin infection)
Danish: • hvis du har en svær infektion (f.eks. lungebetændelse eller en bakterieinfektion i huden)
English: Titanium dioxide (E171) Iron oxide black (E172) Iron oxide red (E172)
Danish: Titandioxid (E171) Sort jernoxid (E172) Rød jernoxid (E172)
English: Inhibition of IL-6 induced STAT3 and IL-7 induced STAT5 phosphorylation
Danish: Hæmning af fosforyleringen af IL-6-induceret STAT3 og IL-7-induceret STAT5
English: RINVOQ is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs).
Danish: RINVOQ er indiceret til behandling af moderat til svær aktiv reumatoid artritis hos voksne patienter, der har udvist utilstrækkeligt respons på eller er intolerante over for et eller flere sygdomsmodificerende antireumatiske lægemidler (DMARD's).
English: The pattern and incidence of elevation in ALT/AST remained stable over time including in long term extension studies.
Danish: Mønsteret og incidensen for forhøjet ALAT/ASAT forblev på et stabilt niveau over tid, herunder i længerevarende forlængelsesstudier.
English: Do not stop taking RINVOQ unless your doctor tells you to stop taking it.
Danish: Stop ikke behandlingen med RINVOQ, medmindre lægen siger, du skal.
English: The recommended dose is one 15 mg tablet once a day.
Danish: Den anbefalede dosis er én 15 mg-tablet én gang dagligt.
English: • thrush in the mouth (white patches in the mouth)
Danish: • Trøske i munden (hvide belægninger i munden)
English: If these medicines do not work well enough, you will be given RINVOQ either alone or in combination with methotrexate to treat your rheumatoid arthritis.
Danish: Hvis disse lægemidler ikke har tilstrækkelig virkning, vil du få RINVOQ enten alene eller i kombination med methotrexat til behandling af din leddegigt.
English: Use of live, attenuated vaccines during or immediately prior to upadacitinib therapy is not recommended.
Danish: Anvendelse af levende, svækkede vacciner under eller umiddelbart inden behandling med upadacitinib anbefales ikke.
English: • Primary endpoint: clinical remission
Danish: • Primært endepunkt: klinisk remission
English: You should not use RINVOQ while breast-feeding as it is not known if this medicine passes into breast milk.
Danish: Du bør ikke anvende RINVOQ, mens du ammer, da man ikke ved, om lægemidlet udskilles i modermælk.
English: Combination with other potent immunosuppressants such as azathioprine, ciclosporin, tacrolimus, and biologic DMARDs or other Janus kinase (JAK) inhibitors has not been evaluated in clinical studies and is not recommended as a risk of additive immunosuppression cannot be excluded.
Danish: Kombination med andre potente immunsuppressiva som f.eks. azathioprin, ciclosporin og tacrolimus samt biologiske DMARD's eller andre Janus-kinase-hæmmere (JAK-hæmmere) er ikke undersøgt i kliniske studier og anbefales ikke, da en risiko for additiv immunsuppression ikke kan udelukkes.
English: Upadacitinib therapy should be interrupted if a patient develops a serious or opportunistic infection.
Danish: Behandlingen med upadacitinib bør afbrydes, hvis en patient udvikler en alvorlig eller opportunistisk infektion.