FrancophonIA/ELRC3.0 huggingface dataset:
English: A dose relationship was observed with CPK elevations ≥ 5 x ULN of normal reported in 1.5 %, 0.8 % and 0.6 % of patients at 16 weeks in the 4 mg, 2 mg and placebo groups, respectively.
Danish: En dosisrelateret sammenhæng blev observeret i forbindelse med stigning i kreatinkinase til ≥ 5 x ULN, som blev rapporteret hos 1,5 %, 0,8 % og 0,6 % af patienterne efter 16 uger i henholdsvis 4 mg-gruppen, 2 mg-gruppen og placebogruppen.
English: Physical function response and health-related outcomes Treatment with Olumiant 4 mg, alone or in combination with cDMARDs, resulted in a significant improvement in physical function compared to all comparators (placebo, MTX, adalimumab), as measured by HAQ-DI, at 12, 24 and 52 weeks.
Danish: Respons i fysisk funktion og helbredsrelaterede resultater Behandling med Olumiant 4 mg alene eller i kombination med cDMARDs resulterede i en signifikant forbedring i fysisk funktion ved uge 12, 24 og 52, sammenlignet med alle komparatorer (placebo, MTX, adalimumab), målt ved HAQ-DI.
English: Treatment with Olumiant 4 mg, alone or in combination with cDMARDs, resulted in a significant improvement in pain compared to all comparators (placebo, MTX, adalimumab), as measured on a 0-100 visual analogue scale, at 12 weeks.
Danish: Behandling med Olumiant 4 mg alene eller i kombination med cDMARDs resulterede i en signifikant reduktion af smerter i uge 12, sammenlignet med alle komparatorer (placebo, MTX, adalimumab), målt på en visuel analog skala fra 0-100.
English: Immunoglobulins
Danish: Immunglobuliner
English: Hypertriglyceridaemiac
Danish: Hypertriglyceridæmic
English: The recommended dose is 2 mg once daily in patients taking Organic Anion Transporter 3 (OAT3) inhibitors with a strong inhibition potential, such as probenecid (see section 4.5).
Danish: Derfor er den anbefalede dosis 2 mg én gang daglig hos patienter, der tager potente OAT3-hæmmere som f.eks. probenecid (se pkt.
English: In clinical trials, there were no confirmed cases of rhabdomyolysis.
Danish: Der var ingen bekræftede tilfælde af rabdomyolyse i kliniske studier.
English: In treatment-naïve patients, combination with methotrexate resulted in increased frequency of hepatic transaminase elevations compared with baricitinib monotherapy (see section 4.8).
Danish: Hos tidligere ubehandlede patienter resulterede kombination med methotrexat i en øget hyppighed af forhøjede leveraminotransferaser sammenlignet med monoterapi med baricitinib (se pkt.
English: Screening for viral hepatitis should be performed in accordance with clinical guidelines before starting therapy with Olumiant.
Danish: Før opstart af behandling med Olumiant bør der udføres screening for viral hepatitis i overensstemmelse med kliniske retningslinjer.
English: Dose dependent increases in blood lipid parameters were reported in patients treated with baricitinib compared to placebo (see section 4.8).
Danish: Sammenlignet med placebo blev der rapporteret dosisafhængige stigninger i blodlipidparametre hos patienter, der blev behandlet med baricitinib (se pkt.
English: Laboratory monitoring
Danish: Laboratorieanalyse Handling
English: No special requirements for disposal.
Danish: 6.6 Regler for bortskaffelse Ingen særlige forholdsregler ved bortskaffelse.
English: Herpes zoster, Herpes simplexb Gastroenteritis Urinary tract infections Pneumonia
Danish: Infektioner i øvre luftvejea Herpes zoster Herpes simplexb
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTONS FOR 4 MG FILM-COATED TABLETS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTONER TIL 4 MG FILMOVERTRUKNE TABLETTER
English: Lymphocytes
Danish: Lymfocytter
English: Renal elimination is the principal mechanism for baricitinib's clearance through glomerular filtration and active secretion via OAT3, Pgp, BCRP and MATE2-K.
Danish: Renal elimination gennem glomerulær filtration og aktiv udskillelse via OAT3, Pgp, BCRP og MATE2-K er hovedmekanismen bag baricitinibs clearance.
English: Respiratory, thoracic, mediastinal disorders
Danish: Luftveje, thorax og mediastinum
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTONS FOR 2 MG FILM-COATED TABLETS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTONER TIL 2 MG FILMOVERTRUKNE TABLETTER
English: Treatment should be interrupted if Hb < 8 g/dL and may be restarted once Hb return above this value
Danish: Behandlingen bør afbrydes ved Hb < 4,96 mmol/l og kan genoptages, når Hb igen er over denne værdi.
English: However, in clinical studies, treatment was interrupted in response to ANC
Danish: I kliniske studier blev behandlingen dog afbrudt, hvis ANC faldt til < 1 x 109 celler/l.
English: Elevations were observed at 12 weeks and remained stable thereafter at a higher value than baseline including in the long-term extension study.
Danish: Stigningerne blev observeret over de første 12 uger, og niveauerne forblev herefter stabile ved en højere værdi end ved baseline.
English: - If you have any further questions, ask your doctor, or pharmacist or nurse.
Danish: Er du i tvivl, så spørg lægen eller apotekspersonalet.
English: 2 Patients who had an inadequate response to MTX (+/- other cDMARDs); biologic-naïve 3 Patients who had an inadequate response or were intolerant to ≥ 1 cDMARDs; biologic- naïve 4 Patients who had an inadequate response or were intolerant to ≥ 1 bDMARDs; including at least one TNF inhibitor
Danish: 4Patienter, der havde et utilstrækkeligt respons på eller ikke tålte ≥ 1 bDMARD, herunder mindst én TNF-hæmmer.
English: The pattern and incidence of increases in platelet counts remained stable at a higher value than baseline over time including in the long term extension study.
Danish: Mønsteret på og incidensen af stigning i trombocyttal forblev stabilt - med et højere neutrofiltal end ved baseline - over tid, herunder i det længerevarende forlængelsesstudie.
English: If you take more Olumiant than you should
Danish: Hvis du har taget for meget Olumiant
English: Abbreviations: ADA = adalimumab; MTX = methotrexate; OLU = Olumiant; PBO = Placebo a Placebo data at week 52 derived using linear extrapolation b No progression defined as mTSS change ≤ 0.
Danish: Forkortelser: ADA = adalimumab, MTX = methotrexat, OLU = Olumiant, PBO = placebo.
English: Olumiant may be used as monotherapy or in combination with methotrexate (see sections 4.4, 4.5 and 5.1 for available data on different combinations).
Danish: 4.4, 4.5 og 5.1 for forhåndenværende data om forskellige kombinationer).
English: • poly (vinyl alcohol)
Danish: • polyvinylalkohol
English: Tell your doctor if you get persistent cough, fever, night sweats and weight loss during Olumiant treatment as these can be signs of tuberculosis - have had a herpes infection (shingles), because Olumiant may allow it to come back.
Danish: Fortæl lægen, hvis du får vedvarende hoste, feber, nattesved eller vægttab under behandlingen med Olumiant, da disse kan være tegn på tuberkulose.
English: In vitro, baricitinib is a substrate for organic anionic transporter (OAT)3, P-glycoprotein (Pgp), breast cancer resistance protein (BCRP) and multidrug and toxic extrusion protein (MATE)2-K.
Danish: In vitro er baricitinib substrat for organisk anion-transportør (OAT) 3, P-glykoprotein (Pgp), brystcancerresistensprotein (BCRP) og multidrug and toxic extrusion protein (MATE) 2-K. I et klinisk farmakologisk studie resulterede dosering af probenecid (en OAT3-hæmmer) i omtrent en fordobling af AUC(0-∞) uden ændring i tmax eller Cmax af baricitinib.
English: In addition, for both study RA-BEACON and RA-BUILD, onset of efficacy was faster and the effect size was generally larger for the 4 mg dose groups compared to 2 mg.
Danish: Derudover indtrådte virkningen hurtigere, og størrelsen af effekt var generelt højere i 4 mg dosis-gruppen sammenlignet med 2 mg dosis-gruppen for både studie RA-BEACON og RA-BUILD.
English: • Olumiant 2 mg QD
Danish: • Olumiant 2 mg daglig
English: Olumiant 2 mg film-coated tablets Each film-coated tablet contains 2 mg baricitinib.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Olumiant 2 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder 2 mg baricitinib.
English: HAQ-DI Minimum Clinically Important Difference (decrease in HAQ-DI score of ≥ 0.30): Week 12 60 % 81 %*** 77 %*** 46 % 68 %*** 64 %*** 44 % 60 %*** 56 %** 35 % 48 %* 54 %*** Week 24 66 % 77 %* 74 % 37 % 67 %***† 60 %*** 37 % 58 %*** 55 %*** 24 % 41 %*** 44 %*** Week 52 53 % 65 %* 67 %**
Danish: HAQ-DI - mindste klinisk relevante forskel (fald i HAQ-DI-scoren på ≥ 0,30): Uge 12 60 % 81 %*** 77 %*** 46 % 68 %*** 64 %*** 44 % 60 %*** 56 %** 35 % 48 %* 54 %*** Uge 24 66 % 77 %* 74 % 37 % 67 %***† 60 %*** 37 % 58 %*** 55 %*** 24 % 41 %*** 44 %*** Uge 52 53 % 65 %* 67 %**
English: Venous Thromboembolism
Danish: Venøs tromboembolisme
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 2 mg baricitinib
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 2 mg baricitinib.
English: Olumiant 4 mg film-coated tablets
Danish: Olumiant 4 mg filmovertrukne tabletter
English: Immune disorders
Danish: Immunsystemet
English: Anti-TB therapy should be considered prior to initiation of Olumiant in patients with previously untreated latent TB.
Danish: Hos patienter med tidligere ubehandlet latent TB bør TB-behandling overvejes før indledning af behandling med Olumiant.
English: Week 12 6 % 14 %* 20 %*** 2 % 8 %*** 7 %*** 1 % 9 %*** 9 %*** 2 % 2 % 5 % Week 24 10 % 22 %** 23 %*** 3 % 16 %*** 14 %*** 4 % 17 %*** 15 %*** 2 % 5 % 9 %** Week 52 13 % 25 %** 30 %***
Danish: Uge 12 6 % 14 %* 20 %*** 2 % 8 %*** 7 %*** 1 % 9 %*** 9 %*** 2 % 2 % 5 % Uge 24 10 % 22 %** 23 %*** 3 % 16 %*** 14 %*** 4 % 17 %*** 15 %*** 2 % 5 % 9 %** Uge 52 13 % 25 %** 30 %***
English: Olumiant 2 mg film-coated tablets Olumiant 4 mg film-coated tablets
Danish: Olumiant 2 mg filmovertrukne tabletter Olumiant 4 mg filmovertrukne tabletter
English: Joint Space Narrowing Score, mean change from baseline:
Danish: Score for afsmalnet ledspalte - gennemsnitlig ændring i forhold til baseline:
English: What you need to know before you take Olumiant
Danish: Det skal du vide, før du begynder at tage Olumiant Sådan skal du tage Olumiant Bivirkninger
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 4 mg baricitinib
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 4 mg baricitinib.
English: Blood fat:
Danish: Fedt i blodet
English: Creatine phosphokinase (CPK)
Danish: Kreatinkinase (CK)
English: • Olumiant 4 mg QD
Danish: • Olumiant 4 mg daglig
English: Tell your doctor or pharmacist if you are taking, have recently taken, or might take, any other medicines.
Danish: Brug af anden medicin sammen med Olumiant Fortæl lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: Tablet cores
Danish: Tabletkerne
English: Olumiant 2 mg film-coated tablets
Danish: Olumiant 2 mg filmovertrukne tabletter
English: Week 12 59 % 79 %*** 77 %*** 40 % 70 %***† 61 %*** 39 % 66 %*** 62 %*** 27 % 49 %*** 55 %*** Week 24 62 % 77 %** 78 %*** 37 % 74 %***† 66 %*** 42 % 61 %*** 65 %*** 27 % 45 %*** 46 %*** Week 52 56 % 73 %*** 73 %***
Danish: Uge 12 59 % 79 %*** 77 %*** 40 % 70 %***† 61 %*** 39 % 66 %*** 62 %*** 27 % 49 %*** 55 %*** Uge 24 62 % 77 %** 78 %*** 37 % 74 %***† 66 %*** 42 % 61 %*** 65 %*** 27 % 45 %*** 46 %*** Uge 52 56 % 73 %*** 73 %***
English: Mon. Tue.
Danish: Ma. Ti.
English: Since dedicated interaction studies have not been conducted, caution should be used when leflunomide or teriflunomide are given concomitantly with baricitinib.
Danish: Der skal udvises forsigtighed, når leflunomid eller teriflunomid gives samtidig med baricitinib, eftersom der ikke er udført specifikke interaktionsstudier.
English: Week 12 15 % 21 % 34 %*** 7 % 24 %*** 21 %*** 7 % 21 %*** 22 %*** 4 % 13 %** 12 %** Week 24 23 % 36 %** 39 %*** 10 % 32 %*** 34 %*** 10 % 29 %*** 32 %*** 7 % 11 % 17 %** Week 52 27 % 36 % 45 %***
Danish: Uge 12 15 % 21 % 34 %*** 7 % 24 %*** 21 %*** 7 % 21 %*** 22 %*** 4 % 13 %** 12 %** Uge 24 23 % 36 %** 39 %*** 10 % 32 %*** 34 %*** 10 % 29 %*** 32 %*** 7 % 11 % 17 %** Uge 52 27 % 36 % 45 %***
English: Week 12 33 % 55 %*** 60 %*** 17 % 45 %***†† 35 %*** 13 % 33 %*** 34 %*** 8 % 20 %** 28 %*** Week 24 43 % 60 %** 63 %*** 19 % 51 %*** 45 %*** 21 % 41 %*** 44 %*** 13 % 23 %* 29 %*** Week 52 38 % 57 %*** 62 %***
Danish: Uge 12 33 % 55 %*** 60 %*** 17 % 45 %***†† 35 %*** 13 % 33 %*** 34 %*** 8 % 20 %** 28 %*** Uge 24 43 % 60 %** 63 %*** 19 % 51 %*** 45 %*** 21 % 41 %*** 44 %*** 13 % 23 %* 29 %*** Uge 52 38 % 57 %*** 62 %***
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS CALENDAR BLISTERS NON-PERFORATED FOR 4 MG FILM-COATED TABLETS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP IKKE-PERFOREREDE KALENDEREBLISTERE TIL 4 MG FILMOVERTRUKNE TABLETTER
English: What Olumiant looks like and contents of the pack Olumiant 2 mg film-coated tablets are light pink, oblong tablets, with “Lilly” on one side and “2” on the other.
Danish: Olumiant 2 mg filmovertrukne tabletter er svagt pink, aflange tabletter med “Lilly” på den ene side og “2” på den anden.
English: Tell your doctor or seek medical help immediately if you get the following symptoms, which may be signs of shingles (herpes zoster): - painful skin rash with blisters and fever
Danish: Infektion som f.eks. helvedesild; kan forekomme hos op til 1 ud af 10 behandlede: Fortæl det straks til lægen, eller søg omgående lægehjælp, hvis du får følgende symptomer, som kan være tegn på helvedesild (herpes zoster): - smertefuldt hududslæt med blærer og feber
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS CALENDAR BLISTERS NON-PERFORATED FOR 2 MG FILM-COATED TABLETS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP IKKE-PERFOREREDE KALENDER-BLISTERE TIL 2 MG FILMOVERTRUKNE TABLETTER
English: Week 12 30 % 47 %*** 56 %*** 14 % 44 %***†† 35 %*** 17 % 36 %*** 39 %*** 9 % 24 %*** 32 %*** Week 24 38 % 57 %*** 60 %*** 19 % 52 %*** 48 %*** 24 % 46 %*** 52 %*** 11 % 20 %* 33 %*** Week 52 38 % 57 %*** 63 %***
Danish: Uge 12 30 % 47 %*** 56 %*** 14 % 44 %***†† 35 %*** 17 % 36 %*** 39 %*** 9 % 24 %*** 32 %*** Uge 24 38 % 57 %*** 60 %*** 19 % 52 %*** 48 %*** 24 % 46 %*** 52 %*** 11 % 20 %* 33 %*** Uge 52 38 % 57 %*** 63 %***
English: Elevations of CPK were observed at 4 weeks and remained stable at a higher value than baseline thereafter including in the long-term extension study.
Danish: Stigning i CK blev observeret over de første 4 uger, hvorefter CK forblev stabilt ved en højere værdi end ved baseline.
English: • Adalimumab 40 mg SC Q2W
Danish: • Adalimumab 40 mg s.c. hver anden uge
English: NAME OF THE MEDICINAL PRODUCT Olumiant 2 mg tablets baricitinib
Danish: LÆGEMIDLETS NAVN Olumiant 2 mg tabletter baricitinib
English: NAME OF THE MEDICINAL PRODUCT Olumiant 4 mg tablets baricitinib
Danish: LÆGEMIDLETS NAVN Olumiant 4 mg tabletter baricitinib
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS PERFORATED UNIT DOSE FOR 2 MG FILM-COATED TABLETS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP PERFOREREDE ENKELTDOSIS-BLISTERE TIL 2 MG FILMOVERTRUKNE TABLETTER
English: NAME OF THE MEDICINAL PRODUCT Olumiant 2 mg film-coated tablets baricitinib
Danish: LÆGEMIDLETS NAVN Olumiant 2 mg filmovertrukne tabletter baricitinib
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS PERFORATED UNIT DOSE FOR 4 MG FILM-COATED TABLETS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP PERFOREREDE ENKELTDOSIS-BLISTERE TIL 4 MG FILMOVERTRUKNE TABLETTER
English: NAME OF THE MEDICINAL PRODUCT Olumiant 4 mg film-coated tablets baricitinib
Danish: LÆGEMIDLETS NAVN Olumiant 4 mg filmovertrukne tabletter baricitinib
English: Fri.
Danish: Lø.
English: Week 12 7 % 14 %* 19 %*** 2 % 8 %*** 7 %** 2 % 10 %*** 9 %*** 2 % 3 % 6 % Week 24 11 % 21 %** 22 %** 4 % 16 %*** 12 %*** 4 % 15 %*** 15 %*** 3 % 5 % 9 %* Week 52 16 % 25 %* 28 %**
Danish: Uge 12 7 % 14 %* 19 %*** 2 % 8 %*** 7 %** 2 % 10 %*** 9 %*** 2 % 3 % 6 % Uge 24 11 % 21 %** 22 %** 4 % 16 %*** 12 %*** 4 % 15 %*** 15 %*** 3 % 5 % 9 %* Uge 52 16 % 25 %* 28 %**
English: Gastrointestinal disorders
Danish: Gastroenteritis
English: Sat.
Danish: Sø.
English: Week 12 16 % 31 %*** 34 %*** 5 % 19 %***† 13 %*** 3 % 18 %*** 18 %*** 2 % 13 %*** 11 %** Week 24 21 % 42 %*** 40 %*** 8 % 30 %***† 22 %*** 8 % 25 %*** 24 %*** 3 % 13 %*** 17 %*** Week 52 25 % 42 %*** 46 %***
Danish: Uge 12 16 % 31 %*** 34 %*** 5 % 19 %***† 13 %*** 3 % 18 %*** 18 %*** 2 % 13 %*** 11 %** Uge 24 21 % 42 %*** 40 %*** 8 % 30 %***† 22 %*** 8 % 25 %*** 24 %*** 3 % 13 %*** 17 %*** Uge 52 25 % 42 %*** 46 %***
English: Tell your doctor if you get painful skin rash with blisters during Olumiant treatment as these can be signs of shingles - have, or have previously had, hepatitis B or C - are due to have a vaccine.
Danish: Fortæl lægen, hvis du får et smertefuldt hududslæt med blærer under behandlingen med Olumiant, da dette kan være tegn på helvedesild.
English: Week 24 68 % 76 % 81 %** 70 % 81 %*** 83 %*** 74 % 72 % 80 % Week 52 66 % 69 % 80 %** 70 % 79 %** 81 %**
Danish: Uge 24 68 % 76 % 81 %** 70 % 81 %*** 83 %*** 74 % 72 % 80 % Uge 52 66 % 69 % 80 %** 70 % 79 %** 81 %** Forkortelser: ADA = adalimumab, MTX = methotrexat, OLU = Olumiant, PBO = placebo aPlacebo-data ved uge 52 udledt ved brug af lineær ekstrapolation bIngen progression defineret som mTSS-ændring ≤ 0 *p ≤ 0,05, **p ≤ 0,01, ***p ≤ 0,001 vs. placebo (vs. MTX for studie RA-BEGIN)
English: Information for Patients about OLUMIANT® (baricitinib)
Danish: Oplysninger til patienten om OLUMIANT®
English: Hepatic transaminases
Danish: Leveraminotransferaser
English: ‘Idiopathic' means that the cause of the disease is unknown.
Danish: “Idiopatisk” betyder, at sygdommens årsag er ukendt.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ofev on 15 January 2015.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Ofev den 15. januar 2015.
English: Ofev is available as capsules (100 and 150 mg).
Danish: Ofev fås som kapsler (100 og 150 mg).
English: This is a summary of the European public assessment report (EPAR) for Ofev.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Ofev.
English: Other information about Ofev
Danish: Andre oplysninger om Ofev
English: A risk management plan has been developed to ensure that Ofev is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Ofev anvendes så sikkert som muligt.
English: Because the number of patients with IPF is low, the disease is considered ‘rare', and Ofev was designated an ‘orphan medicine' (a medicine used in rare diseases) on 26 April 2013.
Danish: Da antallet af patienter med IPF er lavt, betragtes sygdommen som “sjælden”, og Ofev blev udpeget som “lægemiddel til sjældne sygdomme” den 26. april 2013.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Ofev's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Ofev overstiger risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: The recommended dose is 150 mg taken twice a day with food, approximately 12 hours apart.
Danish: Den anbefalede dosis er 150 mg to gange dagligt, der tages med et måltid med ca. 12 timers mellemrum.
English: What measures are being taken to ensure the safe and effective use of Ofev?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Ofev?
English: Ofev can only be obtained with a prescription, and treatment should be started by a doctor experienced in the diagnosis and treatment of IPF.
Danish: Ofev fås kun på recept, og behandlingen bør iværksættes af en læge med erfaring i diagnose og behandling af IPF.
English: Ofev has been compared with placebo (a dummy treatment) in two main studies involving a total of 1,066 patients with IPF.
Danish: Ofev er blevet sammenlignet med virkningsløs behandling (placebo) i to hovedundersøgelser, hvori der deltog i alt 1 066 patienter med IPF.
English: These enzymes are present in certain receptors (such as VEGF, FGF and PDGF receptors) in cells in the lungs, where they activate several processes involved in the generation of fibrous tissue seen in IPF.
Danish: Disse enzymer findes i visse receptorer (såsom VEGF-, FGF- og PDGF-receptorer) i cellerne i lungerne, hvor de aktiverer en række processer, der medvirker til dannelse af det fiberholdige væv, der ses ved IPF.
English: What is Ofev and what is it used for?
Danish: Hvad er Ofev, og hvad anvendes det til?
English: Ofev contains the active substance nintedanib.
Danish: Ofev indeholder det aktive stof nintedanib.
English: It is not intended to provide practical advice on how to use Ofev.
Danish: Det er ikke en praktisk vejledning i, hvordan Ofev bør anvendes.
English: The average FVC of patients before treatment was between 2600 and 2700 millilitre (ml).
Danish: Før behandling var patienternes gennemsnitlige FVC mellem 2600 og 2700 ml.
English: The full EPAR and risk management plan summary for Ofev can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Ofev findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Why is Ofev approved?
Danish: Hvorfor blev Ofev godkendt?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ofev, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Ofev, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: In the second study, the average decrease was 114 ml for Ofev compared with 207 ml for placebo.
Danish: I den anden undersøgelse var det gennemsnitlige fald 114 ml for Ofev, sammenholdt med 207 ml for placebo.
English: In patients who do not tolerate this dose, the dose should be reduced to 100 mg twice a day or treatment should be interrupted.
Danish: Hvis denne dosis ikke tåles, skal dosis nedsættes til 100 mg to gange dagligt, eller behandlingen afbrydes.
English: What are the risks associated with Ofev?
Danish: Hvilke risici er der forbundet med Ofev?
English: The CHMP considered that Ofev has been shown to be effective at slowing down the worsening of lung function in patients with IPF.
Danish: CHMP fandt, at Ofev var påvist at være effektivt til at bremse forværringen af lungefunktionen hos patienter med IPF.
English: Ofev must not be used in patients who are hypersensitive (allergic) to nintedanib, peanut or soya, or any of the other ingredients.
Danish: Ofev må ikke anvendes hos patienter, der er overfølsomme (allergiske) over for nintedanib eller andre af indholdsstofferne eller over for jordnødder eller soja.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Ofev can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Ofev findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: In both studies, the main measure of effectiveness was the decline in the functioning of the patients' lungs over the course of 1 year of treatment, measured by their forced vital capacity (FVC).
Danish: I begge undersøgelser blev virkningen hovedsagelig målt på forringelsen af patienternes lungefunktion i løbet af 1 års behandling, baseret på den forcerede vitalkapacitet (FVC).
English: By blocking these enzymes, nintedanib helps to reduce the formation of fibrous tissue in the lungs, thereby helping to prevent the symptoms of IPF from getting worse.
Danish: Ved at blokere disse enzymer nedsætter nintedanib dannelsen af fiberholdigt væv i lungerne, så symptomerne på IPF ikke bliver værre.