FrancophonIA/ELRC3.0 huggingface dataset:
English: Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, oral/oesophageal candidiasis, and cryptococcosis were reported with upadacitinib.
Danish: Der er også rapporteret om opportunistiske infektioner ved anvendelse af upadacitinib, herunder tuberkulose, herpes zoster i flere dermatomer, oral/øsofageal candidiasis og cryptokokkose.
English: How to store RINVOQ 6.
Danish: Sådan skal du tage RINVOQ 4.
English: (DAS28-CRP) at week 24
Danish: (DAS28-CRP) i uge 24
English: (DAS28-CRP) at week 14
Danish: (DAS28-CRP) i uge 14
English: Table 3: Clinical trials summary Study name Population (n) Treatment arms
Danish: Tabel 3: Oversigt over kliniske studier Studietitel
English: • increased levels of cholesterol (a type of fat in the blood) as shown in tests
Danish: • Forhøjet kolesterol (en type fedtstof i blodet (påvises i blodprøver))
English: • increased levels of triglycerides (a type of fat in the blood) as shown in tests
Danish: • Forhøjede triglycerider (en type fedtstof i blodet (påvises i blodprøver))
English: ACR20 (% of patients)
Danish: ACR20 (%-del af patienterne)
English: (DAS28-CRP) at week 12
Danish: (DAS28-CRP) i uge 12
English: improvement; ADA = adalimumab; CDAI = Clinical Disease Activity Index; CR = Clinical Remission; CRP = C-Reactive Protein, DAS28 = Disease Activity Score 28 joints; IR = inadequate responder; LDA = Low Disease Activity; MTX = methotrexate; PBO = placebo; UPA= upadacitinib a SELECT-NEXT, SELECT-EARLY, SELECT-COMPARE, SELECT-BEYOND b SELECT-MONOTHERAPY c SELECT-EARLY d SELECT-COMPARE e multiplicity controlled p≤0.001upadacitinib vs placebo or MTX comparison f multiplicity controlled p≤0.01 upadacitinib vs placebo or MTX comparison g nominal p≤0.001 upadacitinib vs placebo or MTX comparison h nominal p≤0.001upadacitinib vs adalimumab comparison i nominal p≤0.01 upadacitinib vs adalimumab comparison j nominal p<0.05 upadacitinib vs adalimumab comparison k nominal p≤0.01 upadacitinib vs placebo or MTX comparison l nominal p<0.05 upadacitinib vs MTX comparison
Danish: ≥ 50 % eller ≥ 70 %); ADA = adalimumab; CDAI = klinisk sygdomsaktivitetsindeks; CR = klinisk remission; CRP = C-reaktivt protein, DAS28 = sygdomsaktivitetsscore for 28 led; UR = tilstrækkelige respondere; LDA = lav sygdomsaktivitet; MTX = methotrexat; PBO = placebo; UPA= upadacitinib a SELECT-NEXT, SELECT-EARLY, SELECT-COMPARE, SELECT-BEYOND b SELECT-MONOTHERAPY c SELECT-EARLY d SELECT-COMPARE e multiplicitetskontrolleret p ≤ 0,001 upadacitinib vs. placebo eller MTX-sammenligning f multiplicitetskontrolleret p ≤ 0,01 upadacitinib vs. placebo eller MTX-sammenligning g nominel p ≤ 0,001 upadacitinib vs. placebo eller MTX-sammenligning h nominel p ≤ 0,001 upadacitinib vs. adalimumab-sammenligning i nominel p ≤ 0,01 upadacitinib vs. adalimumab-sammenligning j nominal p ≤ 0,05 upadacitinib vs. adalimumab-sammenligning k nominel p ≤ 0,01 upadacitinib vs. placebo eller MTX-sammenligning l nominal p<0,05 upadacitinib vs. MTX sammenligning Note: Uge 48-data afledt fra analyse på FAS (Fulde analysesæt) af randomiseret gruppe ved anvendelse af Non-Responder Imputation
English: Upper respiratory tract infections (URTI)*
Danish: Infektioner i de øvre luftveje*
English: Across the Phase 3 studies, the efficacy seen with upadacitinib 15 mg QD was generally similar to that observed with upadacitinib 30 mg QD.
Danish: I alle fase 3-studierne var virkningen ved upadacitinib 15 mg én gang dagligt generelt sammenlignelig med virkningen ved upadacitinib 30 mg én gang dagligt.
English: Events of deep venous thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients receiving JAK inhibitors including upadacitinib.
Danish: Der er rapporteret om tilfælde af dyb venetrombose og lungeemboli hos patienter i behandling med JAK-hæmmere, herunder upadacitinib.
English: In MTX-controlled studies, for up to 12/14 weeks, ALT and AST elevations ≥ 3 x ULN in at least one measurement were observed in 0.8% and 0.4% of patients treated with upadacitinib 15 mg, compared to 1.9% and 0.9%, respectively, of patients treated with MTX.
Danish: I MTX-kontrollerede studier sås forhøjede ALAT- og ASAT-værdier på ≥ 3 x ULN over op til 12/14 uger i mindst én måling hos hhv. 0,8 % og 0,4 % af de patienter, der fik upadacitinib 15 mg, sammenholdt med hhv. 1,9 % og 0,9 % af de patienter, der fik MTX.
English: Dose interruption
Danish: Afbrydelse af behandlingen
English: Treatment should not be initiated, or should be temporarily interrupted, in patients with an ANC < 1 x 109 cells/L, ALC < 0.5 x 109 cells/L or haemoglobin < 8 g/dL observed during routine patient management (see section 4.2).
Danish: Behandlingen bør ikke påbegyndes eller bør afbrydes midlertidigt hos patienter, hvor der ved den rutinemæssige patientbehandling ses et ANC på < 1 x 109 celler/l, et ALC på < 0,5 x 109 celler/l eller et hæmoglobinniveau på < 8 g/dl (se pkt.
English: Uncommon (may affect up to 1 in 100 people)
Danish: Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 patienter)
English: • increased levels of liver enzymes, shown by blood tests (sign of liver problems)
Danish: • Forhøjede leverenzymer (påvises i blodprøver (tegn på leverproblemer))
English: PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING Bottle Label
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE Beholder etiket
English: ACR70 (% of patients)
Danish: ACR70 (%-del af patienterne)
English: Each prolonged-release tablet contains 15 mg of upadacitinib (as upadacitinib hemihydrate).
Danish: Hver depottablet indeholder 15 mg upadacitinib (som upadacitinibhemihydrat).
English: • Patient Alert Card (PAC)
Danish: • Patientkort (PK)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for 84 tablet multipack (with Blue Box)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre æske til multipakning med 84 tabletter (med blue box)
English: • Language to advise patients and their HCPs about the risk of live vaccinations when given during upadacitinib therapy o Description of targeted risks for awareness by the patient and for HCPs involved in their care including:
Danish: • En advarsel til patienter og sundhedspersoner om risikoen ved levende vacciner, hvis de gives under behandling med upadacitinib o Beskrivelse af udvalgte risici for at gøre patienter og sundhedspersoner opmærksomme på væsentlige bivirkninger, herunder:
English: The overall longterm rate of opportunistic infections for the upadacitinib 15 mg group across all five Phase 3 clinical studies was 0.6 events per 100 patient-years.
Danish: Den samlede langsigtede forekomst af opportunistiske infektioner for de grupper, der fik upadacitinib 15 mg, i alle fem kliniske fase 3studier, var 0,6 hændelser pr. 100 patientår.
English: 49 prolonged-release tablets.
Danish: 49 depottabletter.
English: RINVOQ 15 mg prolonged-release tablets
Danish: RINVOQ 15 mg depottabletter
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Blister Carton (Individual carton)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Blister karton (én blisterpakning)
English: Moreover, upadacitinib treated patients reported significant improvements in fatigue, as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue score (FACIT-F) compared to placebo.
Danish: FACIT-F-score (Functional Assessment of Chronic Illness Therapy-Fatigue), sammenholdt med placebo.
English: Push down to make a hole in the foil and move the cutting tool round the edge of the foil to continue cutting the foil.
Danish: Tryk skæret nedad, så der kommer hul på folien, og før det rundt langs hele foliekanten.
English: On background MTX
Danish: I baggrundsbehandling med MTX
English: 28 prolonged-release tablets
Danish: 28 depottabletter
English: Purple 14 x 8 mm, oblong biconvex prolonged-release tablets imprinted on one side with ‘a15'.
Danish: Lilla, aflange, bikonvekse depottabletter på 14 x 8 mm og præget med "a15" på den ene side.
English: Absolute Neutrophil Count (ANC) < 1 x 109 cells/L, Absolute Lymphocyte Count (ALC) < 0.5 x 109 cells/L and haemoglobin < 8 g/dL were reported in ≤1 % of patients in clinical trials (see section 4.8).
Danish: I kliniske studier sås et absolut neutrofiltal (ANC) på < 1 x 109 celler/l, et absolut lymfocyttal (ALC) på < 0,5 x 109 celler/l og et hæmoglobinniveau på < 8 g/dl hos ≤ 1 % af patienterne (se pkt.
English: Abbreviations: ACR20 (or 50) = American College of Rheumatology ≥20% (or ≥50%) improvement;
Danish: Forkortelser: ACR20 (eller 50) = forbedring iht.
English: In the clinical studies, upadacitinib treated patients reported significant improvements in patientreported quality of life, as measured by the Short Form (36) Health Survey (SF-36) Physical Component Score compared to placebo and MTX.
Danish: SF-36-scoren (Short Form (36) Health Survey Physical Component) sammenlignet med placebo og MTX.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Intermediate carton of 84 tablet multipack (without Blue Box)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Indre æske (i multipakning) med 84 tabletter (uden blue box)
English: 28 prolonged-release tablets.
Danish: 28 depottabletter.
English: ACR50 (% of patients)
Danish: ACR50 (%-del af patienterne)
English: • medicines to treat seizures or fits (such as phenytoin)
Danish: • medicin til behandling af krampeanfald (f.eks. phenytoin)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton of 98 tablets
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre æske med 98 tabletter
English: Upadacitinib should not be used in patients with severe (Child Pugh C) hepatic impairment (see section 4.3).
Danish: Upadacitinib bør ikke anvendes hos patienter med svært nedsat leverfunktion (Child Pugh C) (se pkt.
English: • increase in an enzyme called creatine kinase, shown by blood tests
Danish: • Forhøjet niveau af enzymet kreatinkinase (påvises i blodprøver)
English: Physical function response and health-related outcomes Treatment with upadacitinib 15 mg, alone or in combination with csDMARDs, resulted in a significantly greater improvement in physical function compared to all comparators as measured by HAQ-DI (see Table 6).
Danish: Behandling med upadacitinib 15 mg, alene eller i kombination med csDMARD's, gav en signifikant større forbedring af fysisk funktionsevne sammenholdt med alle komparatorer iht.
English: In placebo-controlled studies with background DMARDs, for up to 12/14 weeks, alanine transaminase (ALT) and aspartate transaminase (AST) elevations ≥ 3 x upper limit of normal (ULN) in at least one measurement were observed in 2.1% and 1.5% of patients treated with upadacitinib 15 mg, compared to 1.5% and 0.7%, respectively, of patients treated with placebo.
Danish: I placebo-kontrollerede studier, hvor patienterne fik baggrundsbehandling med DMARD's, sås forhøjet alaninaminotransferase (ALAT) og forhøjet aspartataminotransferase (ASAT) på ≥ 3 x ULN (øvre normalgrænse) over op til 12/14 uger i mindst én måling hos hhv. 2,1 % og 1,5 % af de patienter, der fik upadacitinib 15 mg, sammenholdt med hhv. 1,5 % og 0,7 % af de patienter, der fik placebo.
English: CPK elevations > 5 x upper limit of normal (ULN) were reported in 1.0% and 0.3% of patients over 12/14 weeks in the upadacitinib 15 mg and placebo groups, respectively.
Danish: Der blev rapporteret om forhøjet kreatininfosfokinase > 5 x ULN (øvre normalgrænse) efter 12/14 uger hos 1,0 % og 0,3 % af patienterne i hhv. upadacitinib 15 mg-gruppen og placebo-gruppen.
English: Upadacitinib should be used with caution in patients at high risk for DVT/PE.
Danish: Upadacitinib bør anvendes med forsigtighed hos patienter med høj risiko for dyb venetrombose/lungeemboli.
English: Do not chew, crush or break the tablet.
Danish: Tabletterne må ikke tygges, knuses eller deles.
English: 47h Abbreviations: ACR20 (or 50 or 70) = American College of Rheumatology ≥20% (or ≥50% or ≥70%)
Danish: Forkortelser: ACR20 (eller 50 eller 70) = forbedring iht.
English: Treatment with upadacitinib was associated with decreases from baseline in mean hsCRP levels as early as Week 1 which were maintained with continued treatment.
Danish: baseline allerede i uge 1; den nedsatte hsCRP-værdi forblev på det lave niveau ved fortsat behandling.
English: • Triglycerides ≥ 2.26 mmol/L (200 mg/dL): 25% vs. 15%, in the upadacitinib 15 mg and placebo groups, respectively
Danish: • Triglycerider ≥ 2,26 mmol/l (200 mg/dl): 25 % vs. 15 % hos hhv. upadacitinib 15 mg-gruppen og placebo-gruppen
English: In placebo-controlled studies with background DMARDs, for up to 12/14 weeks, decreases in neutrophil counts below 1,000 cells/mm3 in at least one measurement occurred in 1.1% and <0.1% of patients in the upadacitinib 15 mg and placebo groups, respectively.
Danish: I placebo-kontrollerede studier, hvor patienterne fik baggrundsbehandling med DMARD's, sås et neutrofiltal på < 1.000 celler/mm3 efter op til 12/14 uger ved mindst én måling hos 1,1 % og < 0,1 % af patienterne i hhv. upadacitinib 15 mg-gruppen og placebo-gruppen.
English: • HDL cholesterol ≥ 1.03 mmol/L (40 mg/dL): 89% vs. 61%, in the upadacitinib 15 mg and placebo groups, respectively
Danish: • HDL-kolesterol ≥ 1,03 mmol/l (40 mg/dl): 89 % vs. 61 % hos hhv. upadacitinib 15 mg-gruppen og placebo-gruppen
English: • weight gain
Danish: • Vægtøgning
English: Each prolonged-release tablet contains upadacitinib hemihydrate, equivalent to 15 mg of upadacitinib.
Danish: Hver depottablet indeholder upadacitinibhemihydrat, svarende til 15 mg upadacitinib.
English: SELECT-NEXT csDMARD-IRc
Danish: SELECT-NEXT csDMARD
English: • Total cholesterol ≥ 5.17 mmol/L (200 mg/dL): 62% vs. 31%, in the upadacitinib 15 mg and placebo groups, respectively
Danish: • Total kolesterol ≥ 5,17 mmol/l (200 mg/dl): 62 % vs. 31 % hos hhv. upadacitinib 15 mggruppen og placebo-gruppen
English: Store in original blister or bottle with the lid tightly closed to protect from moisture.
Danish: Opbevares i den originale blisterpakning eller beholder med tæt tillukket låg for at beskytte mod fugt.
English: Tartaric acid
Danish: Mave-tarm-kanalen
English: In placebo-controlled studies with background DMARDs, for up to 12/14 weeks, increases in CPK values were observed.
Danish: I placebo-kontrollerede studier, hvor patienterne fik baggrundsbehandling med DMARD's, sås forhøjet kreatininfosfokinase i løbet af op til 12/14 uger.
English: In MTX-controlled studies, there were no cases of opportunistic infection over 12/14 weeks in the upadacitinib 15 mg monotherapy group and 0.2% in the MTX group.
Danish: I MTX-kontrollerede studier var der ingen tilfælde af opportunistiske infektioner over 12/14 uger i den gruppe, der fik upadacitinib 15 mg som monoterapi, sammenholdt med 0,2 % i MTX-gruppen.
English: In placebo-controlled clinical studies with background DMARDs, the frequency of infection over 12/14 weeks in the upadacitinib 15 mg group was 27.4% compared to 20.9% in the placebo group.
Danish: I placebo-kontrollerede kliniske studier, hvor patienterne fik baggrundsbehandling med DMARD's, sås en infektionshyppighed over 12/14 uger på 27,4 % i de grupper, der fik upadacitinib 15 mg, sammenholdt med 20,9 % i placebo-gruppen.
English: Store in the original blister or bottle in order to protect from moisture.
Danish: Opbevares i den originale blisterpakning eller beholder for at beskytte mod fugt.
English: Coadministration with CYP3A4 inhibitors
Danish: Samtidig administration af CYP3A4-hæmmere
English: In MTX-controlled studies, the frequency of serious infection over 12/14 weeks in the upadacitinib 15 mg monotherapy group was 0.6% compared to 0.4% in the MTX group.
Danish: I MTX-kontrollerede studier var hyppigheden af alvorlige infektioner over 12/14 uger på 0,6 % i den gruppe, der fik upadacitinib 15 mg som monoterapi, sammenholdt med 0,4 % i MTX-gruppen.
English: • LDL cholesterol ≥ 3.36 mmol/L (130 mg/dL): 42% vs. 19%, in the upadacitinib 15 mg and placebo groups, respectively
Danish: • LDL-kolesterol ≥ 3,36 mmol/l (130 mg/dl): 42 % vs. 19 % hos hhv. upadacitinib 15 mggruppen og placebo-gruppen
English: In placebo-controlled clinical studies with background DMARDs, the frequency of opportunistic infections over 12/14 weeks in the upadacitinib 15 mg group was 0.5% compared to 0.3% in the placebo group.
Danish: I placebo-kontrollerede kliniske studier, hvor patienterne fik baggrundsbehandling med DMARD's, sås en forekomst af opportunistiske infektioner over 12/14 uger på 0,5 % i den gruppe, der fik upadacitinib 15 mg, sammenholdt med 0,3 % i placebo-gruppen.
English: In placebo-controlled clinical studies with background DMARDs, the frequency of serious infection over 12/14 weeks in the upadacitinib 15 mg group was 1.2% compared to 0.6% in the placebo group.
Danish: I placebo-kontrollerede kliniske studier, hvor patienterne fik baggrundsbehandling med DMARD's, sås en hyppighed af alvorlige infektioner over 12/14 uger på 1,2 % i de grupper, der fik upadacitinib 15 mg, sammenholdt med 0,6% i placebo-gruppen.
English: In methotrexate (MTX)-controlled studies, the frequency of infection over 12/14 weeks in the upadacitinib 15 mg monotherapy group was 19.5% compared to 24.0% in the MTX group.
Danish: I methotrexat (MTX)-kontrollerede studier sås en infektionshyppighed over 12/14 uger på 19,5 % i de grupper, der fik upadacitinib 15 mg som monoterapi, sammenholdt med 24,0 % i MTX-gruppen.
English: In a clinical study, coadministration of upadacitinib after multiple doses of rifampicin (strong CYP3A inducer) resulted in approximately 50% and 60% decreases in upadacitinib Cmax and AUC, respectively.
Danish: I et klinisk studie sås en reduktion i Cmax og AUC for upadacitinib på hhv. ca. 50 % og 60 % ved administration af upadacitinib efter indgift af flere doser rifampicin (en stærk CYP3A-inducer).
English: MTX-IRd
Danish: MTX-URd
English: Remove the cap from the bottle by pushing down and while still pushing, turn the cap anti-clockwise.
Danish: 1a Tag låget af beholderen ved at trykke det nedad og dreje det mod uret.
English: Each prolonged-release tablet contains upadacitinib hemihydrate, equivalent to 15 mg upadacitinib.
Danish: Hver depottablet indeholder upadacitinibhemihydrat, svarende til 15 mg upadacitinib
English: Store in the original bottle and keep the bottle tightly closed in order to protect from moisture.
Danish: Opbevares i den originale beholder, der skal holdes tæt tillukket for at beskytte mod fugt.
English: Abbreviations: ADA = adalimumab; IR = inadequate responder; MTX = methotrexate; PBO = placebo; UPA= upadacitinib a All placebo data at week 48 derived using linear extrapolation b SELECT-EARLY c SELECT-COMPARE
Danish: Forkortelser: ADA = adalimumab; UR = utilstrækkelige respondere; MTX = methotrexat; PBO = placebo; UPA= upadacitinib a Alle placebo-data for uge 48 er udledt ved lineær ekstrapolering b SELECT-EARLY c SELECT-COMPARE d Ingen progression defineret som mTSS-ændring ≤ 0 e nominel p ≤ 0,001 upadacitinib vs. placebo eller MTX-sammenligning f multiplicitetskontrolleret p ≤ 0,01 upadacitinib vs. placebo eller MTX-sammenligning g multiplicitetskontrolleret p ≤ 0,001 upadacitinib vs. placebo eller MTX-sammenligning
English: AbbVie B.V. Tel: +31 (0)88 322 2843
Danish: Sími: +31 (0)88 322 2843
English: • A reminder to use contraception, that upadacitinib is contraindicated during pregnancy, and to notify their HCPs if they become pregnant while taking upadacitinib o Description of signs/symptoms of deep venous thrombosis or pulmonary embolism which the patient needs to be aware of, so that they can seek attention from an HCP.
Danish: • En påmindelse om at bruge prævention og om, at upadacitinib er kontraindiceret under graviditet, samt om, at patienten skal kontakte egen læge, hvis der indtræffer graviditet under behandling med upadacitinib.
English: o Language on the risk of VTE during treatment with upadacitinib o Language on need for discontinuation of upadacitinib, evaluation, and appropriate treatment for VTE if clinical features of deep venous thrombosis or pulmonary embolism develop
Danish: • Risiko for VTE o Eksempler på risikofaktorer, der kan øge patientens risiko for VTE, og i hvilke der er behov for forsigtighed, når man bruger upadacitinib o Tekst om risiko for VTE under behandling med upadacitinib o En tekst om behov for seponering af upadacitinib, evaluering og passende behandling af VTE, hvis der udvikles kliniske tegn på dyb venøs trombose eller lungeemboli
English: Haematological abnormalities
Danish: Hæmatologiske anomalier
English: Rheumatoid arthritis is a disease that causes inflamed joints.
Danish: Leddegigt er en sygdom, hvor der opstår betændelsestilstand i leddene.
English: AbbVie Logistics B.V Zuiderzeelaan 53
Danish: AbbVie Logistics B.V.
English: - If you have any further questions, ask your doctor, pharmacist, or nurse.
Danish: - Spørg lægen, apotekspersonalet eller sygeplejersken, hvis der er mere, du vil vide.
English: Hypercholesterolaemia Hypertriglyceridaemia
Danish: Hypertriglyceridæmi
English: MTX-Naїve
Danish: MTX-URb
English: • shingles or painful skin rash with blisters (herpes zoster)
Danish: • Helvedesild (herpes zoster), der kan give smertefulde hududslæt med blærer
English: • infection of the lung (pneumonia), which may cause shortness of breath, fever, and a cough with mucus
Danish: • Lungebetændelse, der kan give åndenød, feber og hoste med slim Ovenstående er ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 patienter).
English: How to take RINVOQ
Danish: Hvis du har taget for meget RINVOQ
English: • The Summary of Product Characteristics
Danish: • Oplysning om, hvordan bivirkninger indberettes
English: Hepatic transaminase elevations
Danish: Forhøjede leveraminotransferaser
English: • Do not swallow the desiccant.
Danish: • Tørremidlet må ikke indtages.
English: 1 vial + 1 pre-filled syringe powder: 450 IU; solvent: 0.75 ml (600 IU/ml)
Danish: Pulver: 450 IE Solvens: 0,75 ml (600 IE/ml)
English: Subcutaneous use powder: vial (glass); solvent: vial (glass)
Danish: Subkutan anvendelse Pulver: hætteglas Solvens: hætteglas
English: Lorviqua is available as tablets (25 and 100 mg) and the recommended dose is 100 mg once a day.
Danish: Lorviqua fås som tabletter (25 mg og 100 mg), og den anbefalede dosis er 100 mg en gang dagligt.
English: Treatment may be stopped altogether if the patient develops severe side effects.
Danish: Behandlingen kan standses helt, hvis patienten udvikler svære bivirkninger.
English: If certain side effects develop the doctor may reduce the dose or interrupt treatment temporarily.
Danish: Hvis der opstår visse bivirkninger, kan lægen nedsætte dosis eller afbryde behandlingen midlertidigt.
English: Lorviqua has been given ‘conditional authorisation'.
Danish: Lorviqua har fået en "betinget godkendelse".
English: There is more evidence to come about the medicine, which the company is required to provide.
Danish: Det betyder, at der er flere videnskabelige beviser på vej om lægemidlet, som firmaet er blevet bedt om at fremlægge.
English: As for all medicines, data on the use of Lorviqua are continuously monitored.
Danish: Som for alle lægemidler er data vedrørende brug af Lorviqua løbende overvåget.
English: Treatment with Lorviqua should be started and supervised by a doctor who is experienced in using cancer medicines.
Danish: Behandlingen med Lorviqua bør indledes og overvåges af en læge med erfaring i anvendelse af kræftlægemidler.
English: The European Medicines Agency therefore decided that Lorviqua's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Lorviqua opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: It works by blocking the activity of ALK, thereby reducing the growth and spread of the cancer cells.
Danish: Det virker ved at blokere aktiviteten af ALK og reducerer derved kræftcellernes vækst og spredning.
English: Other information about Lorviqua
Danish: Andre oplysninger om Lorviqua
English: Lorviqua must not be used together with medicines known as ‘strong CYP3A4/5 inducers' because the combined medicines could have an effect on the liver.
Danish: Lorviqua må ikke anvendes sammen med lægemidler, der kaldes "stærke CYP3A4/5-inducere", fordi de kombinerede lægemidler kunne påvirke leveren.