FrancophonIA/ELRC3.0 huggingface dataset:
English: The estimated mean difference for nintedanib compared with placebo was -6.12 (95% CI: -10.57, -1.67; p=0.0071).
Danish: Den estimerede middelforskel for nintedanib sammenlignet med placebo var -6,12 (95 % CI: -10,57; -1,67; p=0,0071).
English: Ofev 100 mg soft capsules EU/1/14/979/001
Danish: Ofev 100 mg bløde kapsler EU/1/14/979/001
English: Group 2 received steady state treatment of 801 mg pirfenidone three times a day and had a PK profiling before and after at least 7 days of co-treatment with 150 mg nintedanib twice daily (N=17 patients treated).
Danish: Gruppe 2 fik steady state-behandling med 801 mg pirfenidon 3 gange dagligt og havde en farmakokinetisk profilering før og efter mindst 7 dages samtidig behandling med 150 mg nintedanib to gange dagligt (N=17
English: PopPK analyses indicated moderate effects on exposure to nintedanib depending on age, body weight, and race (see below).
Danish: PopPK-analyser indikerede, at alder, legemsvægt og race havde moderate virkninger på eksponeringen for nintedanib (se nedenfor).
English: In volunteers with moderate hepatic impairment (Child Pugh B), exposure was 7.6-fold higher based on Cmax (90% CI 4.4 - 13.2) and 8.7-fold higher (90% CI 5.7 - 13.1) based on AUC, respectively, compared to healthy volunteers.
Danish: Hos frivillige med moderat nedsat leverfunktion (Child Pugh B) var eksponeringen henholdsvis 7,6 gange højere baseret på Cmax (90 %-CI 4,4-13,2) og 8,7 gange højere (90 %-CI 5,7-13,1) baseret på AUC end hos raske frivillige.
English: Nausea and vomiting were frequently reported gastrointestinal adverse reactions (see section 4.8).
Danish: Kvalme og opkastning var hyppigt indberettede gastrointestinale bivirkninger (se pkt.
English: The following medicines are examples that may lower the levels of nintedanib in your blood and thus may reduce the effectiveness of Ofev: - an antibiotic used to treat tuberculosis (rifampicin) - medicines to treat seizures (carbamazepine, phenytoin) - a herbal medicine to treat depression (St. John's Wort)
Danish: Følgende lægemidler kan nedsætte blodets indhold af nintedanib og kan derfor nedsætte virkningen af Ofev: - et antibiotikum, der bruges til behandling af tuberkulose (rifampicin) - lægemidler, der bruges til behandling af krampeanfald (carbamazepin, phenytoin) - et naturlægemiddel til behandling af depression (perikon).
English: In group 1, the adjusted geometric mean ratios (90% confidence interval (CI)) were 93% (57% - 151%) and 96% (70% - 131%) for Cmax and AUC0-tz of nintedanib, respectively (n=12 for intraindividual comparison).
Danish: I gruppe 1 var de justerede geometriske gennemsnitsratioer (90 % konfidensinterval (CI)) hhv. 93 % (57 % - 151 %) og 96 % (70 % - 131 %) for Cmax og AUC0-tz for nintedanib (N=12 for intraindividuel sammenligning).
English: The analysis of time to death resulted in a HR of 0.70 (95% CI 0.43, 1.12; p=0.1399).
Danish: Analysen af tid til død resulterede i en hazard ratio (HR) på 0,70 (95 % CI 0,43-1,12; p=0,1399).
English: The frequency of patients with at least 1 adjudicated exacerbation occurring within 52 weeks was lower in the nintedanib group (1.9% of patients) than in the placebo group (5.7% of patients).
Danish: Andelen af patienter med mindst 1 vurderet eksacerbation, der forekom inden for 52 uger, var lavere i nintedanib-gruppen (1,9 % af patienterne) end i placebogruppen (5,7 % af patienterne).
English: The estimated hazard ratio of nintedanib versus placebo was 0.16 (95% CI 0.04, 0.71; p=0.0054).
Danish: Den estimerede hazard ratio for nintedanib versus placebo var 0,16 (95 % CI 0,04-0,71; p=0,0054).
English: In a dedicated single dose phase I study and compared to healthy subjects, exposure to nintedanib based on Cmax and AUC was 2.2-fold higher in volunteers with mild hepatic impairment (Child Pugh A; 90% CI 1.3 - 3.7 for Cmax and 1.2 - 3.8 for AUC, respectively).
Danish: I et specifikt fase 1-enkeltdosisstudie I var eksponeringen for nintedanib baseret på Cmax og AUC 2,2 gange højere hos frivillige med let nedsat leverfunktion (Child Pugh A) end hos raske frivillige (90 %-CI hhv. 1,3-3,7 for Cmax og 1,2-3,8 for AUC).
English: Do not take more than the recommended dose of two Ofev 100 mg capsules per day if your daily dose was reduced to 200 mg per day.
Danish: Du må ikke tage mere end den højest anbefalede dosis på to Ofev 100 mg bløde kapsler om dagen, hvis din daglige dosis er nedsat til 200 mg pr. dag.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu og på Lægemiddelstyrelsens hjemmeside http://www.laegemiddelstyrelsen.dk.
English: Concomitant treatment with nintedanib and pirfenidone has been investigated in an exploratory openlabel, randomised trial of nintedanib 150 mg twice daily with add-on pirfenidone (titrated to 801 mg three times a day) compared to nintedanib 150 mg twice daily alone in 105 randomised patients for 12 weeks.
Danish: Samtidig behandling med nintedanib og pirfenidon er undersøgt i et eksploratorisk, åbent, randomiseret studie med nintedanib 150 mg to gange dagligt med tillægsbehandling med pirfenidon (titreret til 801 mg tre gange dagligt) sammenlignet med nintedanib 150 mg to gange dagligt alene hos 105 randomiserede patienter i 12 uger.
English: Additional data from the phase IV INJOURNEY trial with Ofev 150 mg twice daily and add-on pirfenidone:
Danish: Yderligere data fra fase 4 INJOURNEY-studiet med Ofev 150 mg to gange dagligt og tillægsbehandling med pirfenidon:
English: D-55216 Ingelheim am Rhein Germany
Danish: D-55216 Ingelheim am Rhein Tyskland
English: Nintedanib and its metabolites, the free acid moiety BIBF 1202 and its glucuronide BIBF 1202 glucuronide, did not inhibit or induce CYP enzymes in preclinical studies (see section 5.2).
Danish: Nintedanib og dets metabolitter, den frie syre-del BIBF 1202 og dens glukuronid BIBF 1202-glukuronid, hverken hæmmede eller inducerede CYP-enzymer i prækliniske studier (se pkt.
English: INFORMATION IN BRAILLE Ofev 100 mg
Danish: INFORMATION I BRAILLESKRIFT Ofev 100 mg
English: Women of childbearing potential / Contraception
Danish: Fertile kvinder/prævention
English: Nintedanib may affect the way your wounds heal.
Danish: Nintedanib kan påvirke sårhelingen.
English: In INPULSIS-1, the increase from baseline in SGRQ total score at week 52 was comparable between nintedanib and placebo (difference between treatment groups: -0.05; 95% CI: -2.50, 2.40; p=0.9657).
Danish: I INPULSIS-1 var forbedringen fra baseline i den samlede SGRQ-score i uge 52 sammenlignelig mellem nintedanib og placebo (forskel mellem behandlingsgrupperne:-0,05; 95 % CI:-2,50-2,40; p=0,9657).
English: Patients with mild hepatic impairment (Child Pugh A) should be treated with a reduced dose of Ofev (see sections 4.2 and 5.2).
Danish: Patienter med let nedsat leverfunktion (Child Pugh A) bør behandles med en nedsat dosis Ofev (se pkt.
English: The safety and efficacy of Ofev has not been studied in patients with moderate (Child Pugh B) or severe (Child Pugh C) hepatic impairment.
Danish: Ofevs sikkerhed og virkning er ikke undersøgt hos patienter med moderat (Child Pugh B) eller svært (Child Pugh C) nedsat leverfunktion.
English: From subchronic and chronic toxicity studies, there is no evidence that female fertility in rats is impaired at a systemic exposure level comparable with that at the maximum recommended human dose (MRHD) of 150 mg twice daily (see section 5.3).
Danish: Subkroniske og kroniske toksicitetsstudier giver ikke evidens for, at fertiliteten hos hunrotter forringes ved en systemisk eksponering, der kan sammenlignes med eksponeringen ved den maksimale, anbefalede humane dosis (MRHD) på 150 mg to gange dagligt (se pkt.
English: 55216 Ingelheim am Rhein Germany
Danish: 55216 Ingelheim am Rhein Tyskland
English: Capsule content triglycerides, medium-chain hard fat lecithin (soya) (E322)
Danish: Kapselindhold triglycerider, mellemkædede hårdfedt lecithin (soja ) (E322)
English: Time to event analysis of the adjudicated exacerbation events using pooled data yielded a hazard ratio (HR) of 0.32 (95% CI 0.16, 0.65; p=0.0010).
Danish: Analysen af tid til hændelse af de vurderede eksacerbationer, baseret på de samlede data, resulterede i en hazard ratio (HR) på 0,32 (95 % CI 0,16-0,65; p=0,0010).
English: The primary endpoint, rate of decline in FVC over 52 weeks was lower in the nintedanib arm (-0.060 L/year, N=84) than the placebo arm (-0.190 L/year, N=83).
Danish: Det primære endepunkt, hastigheden af forværring i FVC i løbet af 52 uger, var lavere i nintedanibgruppen (-0,060 l/år, N=84) end i placebogruppen (-0,190 l/år, N=83).
English: INFORMATION IN BRAILLE Ofev 150 mg
Danish: INFORMATION I BRAILLESKRIFT Ofev 150 mg
English: Subjects with severe hepatic impairment (Child Pugh C) have not been studied.
Danish: Der er ikke udført studier hos personer med svært nedsat leverfunktion (Child Pugh C).
English: See Table 5 for individual and pooled study results.
Danish: Se Tabel 5 for individuelle og samlede studieresultater.
English: Your doctor will decide when to resume your treatment with this medicine.
Danish: Din læge afgør, hvornår din behandling med dette lægemiddel skal genoptages, - hvis du har for højt blodtryk,
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer box
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Karton
English: Other medicines and Ofev
Danish: Brug af anden medicin sammen med Ofev
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors, ATC code: L01XE31
Danish: Farmakoterapeutisk klassifikation: Andre midler med virkning på respirationssystemet, ATC-kode: L01XE31
English: Age
Danish: Alder
English: In the pooled analysis of the INPULSIS trials, the estimated mean change from baseline to week 52 in SGRQ total score was smaller in the nintedanib group (3.53) than in the placebo group (4.96), with a difference between the treatment groups of -1.43 (95% CI: -3.09, 0.23; p=0.0923).
Danish: I INPULSIS-studiernes samlede analyse var den estimerede middelændring fra baseline i den samlede SGRO-score i uge 52 mindre i nintedanib-gruppen (3,53) end i placebogruppen (4,96) med en forskel mellem behandlingsgrupperne på -1,43 (95 % CI:-3,09-0,23; p=0,0923).
English: 10% threshold Number (%) of FVC responders
Danish: 10 % tærskelværdi Antal (%)
English: Do not store Ofev above 25°C.
Danish: Ofev må ikke opbevares ved temperaturer over 25 °C.
English: Supportive evidence from the phase II trial (1199.30) Ofev 150 mg twice daily results Additional evidence of efficacy is provided by the randomised, double-blind, placebo-controlled, dose finding phase II trial including a nintedanib 150 mg twice daily dose group.
Danish: Understøttende evidens fra resultaterne fra fase-II-studiet (1199.30) Ofev 150 mg to gange dagligt Yderligere evidens for effekt ses i det randomiserede, dobbeltblindede, placebokontrollerede fase-IIdosisbestemmelsesstudie, der inkluderede en gruppe, der fik nintedanib i en dosis på 150 mg to gange dagligt.
English: In the INPULSIS trials (see section 5.1), diarrhoea was the most frequent gastro-intestinal adverse reaction reported in 62.4% versus 18.4% of patients treated with Ofev and placebo, respectively (see section 4.8).
Danish: 5.1) blev diarré indberettet som den hyppigste gastrointestinale bivirkning og blev rapporteret hos 62,4 % af de patienter, der blev behandlet med Ofev, versus hos 18,4 % i placebogruppen (se pkt.
English: Do not take more than the recommended dose of two Ofev 150 mg capsules per day.
Danish: Du må ikke tage mere end den anbefalede dosis på to Ofev 150 mg kapsler pr. dag.
English: Only a minor extent of the biotransformation of nintedanib consisted of CYP pathways.
Danish: Nintedanibs biotransformation omfatter kun i mindre grad CYP-metaboliseringsveje.
English: Frequency of patients with ≥ 10% absolute decline of FVC % predicted or death over 52 weeks and time to progression in trials INPULSIS-1, INPULSIS-2, and their pooled data - treated set
Danish: Hyppighed af patienter med et fald ≥ 10 % i FVC % forventet eller død i 52 uger og tid til progression i studierne INPULSIS-1 og INPULSIS-2 samt deres samlede data - treated set
English: In case of persisting severe symptoms therapy with Ofev should be discontinued.
Danish: Ved vedvarende, alvorlige symptomer bør Ofev seponeres.
English: If coadministered with Ofev, potent P-gp inhibitors (e.g. ketoconazole, erythromycin or cyclosporine) may increase exposure to nintedanib.
Danish: Potente P-gp-hæmmere (f.eks. ketoconazol, erythromycin og ciclosporin) kan, hvis de administreres sammen med Ofev, øge eksponeringen for nintedanib.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/979/003
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/14/979/003
English: Ofev contains soya lecithin If you are allergic to soya or peanut, do not take this medicine (see section 2).
Danish: Du må ikke tage dette lægemiddel, hvis du er allergisk over for soja eller jordnødder (se afsnit 2).
English: No dedicated studies investigating the effect of nintedanib on wound healing were performed.
Danish: Der er ikke udført målrettede studier til undersøgelse af nintedanibs indvirkning på sårheling.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/979/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/14/979/001
English: Table 5:
Danish: Tabel 5:
English: See Table 3 for individual and pooled study results.
Danish: Se Tabel 3 for individuelle og samlede studieresultater.
English: Very common side effects (may affect more than 1 in 10 people) - Feeling sick (nausea) - Pain in the lower body (abdomen) - Abnormal liver test results.
Danish: Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 patienter) - Kvalme - Mavesmerter - Unormale resultater af prøver for leverfunktionen
English: In rats, embryo-foetal lethality and teratogenic effects were observed at exposure levels below human exposure at the MRHD of 150 mg twice daily.
Danish: Hos rotter blev der observeret embryoføtal letalitet og teratogene virkninger ved eksponeringsniveauer, der var lavere end eksponeringen hos mennesker ved en dosis på 150 mg to gange dagligt (MRHD).
English: What you need to know before you take Ofev
Danish: Det skal du vide, før du begynder at tage Ofev
English: In case of interruptions due to aspartate aminotransferase (AST) or alanine aminotransferase (ALT) elevations > 3x upper limit of normal (ULN), once transaminases have returned to baseline values, treatment with Ofev may be reintroduced at a reduced dose (100 mg twice daily) which subsequently may be increased to the full dose (150 mg twice daily) (see sections 4.4 and 4.8).
Danish: Hvis behandlingen afbrydes på grund af forhøjet aspartataminotransferase (ASAT) eller alaninaminotransferase (ALAT) til > 3 x øvre grænse for normalværdien (ULN), kan behandlingen med Ofev påbegyndes igen ved en reduceret dosis (100 mg to gange dagligt), når aminotransferase-værdierne er vendt tilbage til baseline.
English: In the pooled analysis of the INPULSIS trials, a numerically lower risk of first acute exacerbation was observed in patients receiving nintedanib compared to placebo.
Danish: I INPULSIS-studiernes samlede analyse blev en numerisk lavere risiko for den første akutte eksacerbation observeret hos patienter, der fik nintedanib, sammenlignet med placebo.
English: Hyperbilirubinaemia, Blood alkaline phosphatase (ALKP) increased
Danish: Leverskade forårsaget af lægemidlet Hyperbilirubinæmi Forhøjet basisk fosfatase (ALKP) i blodet
English: Based on preclinical investigations there is no evidence for impairment of male fertility (see section 5.3).
Danish: Prækliniske undersøgelser har ikke givet evidens for nedsættelse af fertiliteten hos hanner (se pkt.
English: See Table 2 for individual and pooled study results.
Danish: Se Tabel 2 for individuelle og samlede studieresultater.
English: Patients ≥75 years may be more likely to require dose reduction to manage adverse effects (see section 5.2).
Danish: Det er ikke nødvendigt at justere dosis på grundlag af patientens alder. Dosisreduktion med henblik på håndtering af bivirkninger kan hyppigere være nødvendig hos patienter ≥ 75 år (se pkt.
English: Summary of ADRs per frequency category Frequency System Organ Class
Danish: Tabel 1: Oversigt over bivirkninger efter hyppighedskategori Hyppighed
English: Nintedanib is a substrate of P-gp (see section 5.2).
Danish: Nintedanib er et substrat for P-gp (se pkt.
English: Additional data from the phase IV INJOURNEY trial with Ofev 150 mg twice daily and add-on pirfenidone for 12 weeks are described in section 5.1.
Danish: Yderligere data fra fase 4 INJOURNEY-studiet med Ofev 150 mg to gange dagligt og tillægsbehandling med pirfenidon i 12 uger er beskrevet i pkt.
English: Annual rate of decline in FVC (mL) in trials INPULSIS-1, INPULSIS-2 and their pooled data - treated set
Danish: Årlig grad af forværring i FVC (ml) i studierne INPULSIS-1 og INPULSIS-2 og deres samlede data - treated set
English: GERMANY
Danish: TYSKLAND
English: How to take Ofev
Danish: Sådan skal du tage Ofev
English: The recommended dose is one capsule of 150 mg twice daily (a total of 300 mg per day).
Danish: Den anbefalede dosis er en kapsel på 150 mg to gange dagligt (i alt 300 mg pr. dag).
English: INPULSIS-1 and INPULSIS-2 pooled
Danish: INPULSIS-1 og INPULSIS-2 samlet
English: Do not take more than the recommended dose of two Ofev 100 mg capsules per day.
Danish: Du må ikke tage mere end den anbefalede dosis på to Ofev 100 mg kapsler pr. dag.
English: Hypersensitivity to nintedanib, to peanut or soya, or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for nintedanib, jordnødder eller soja eller over for et eller flere af hjælpestofferne anført i pkt.
English: 5% threshold Number (%) of FVC responders
Danish: 5 % tærskelværdi Antal (%)
English: Nausea and vomiting
Danish: Kvalme og opkastning
English: Capsule shell gelatin glycerol (85%) titanium dioxide (E171) iron oxide red (E172) iron oxide yellow (E172)
Danish: Kapselskal gelatine glycerol (85 %) titandioxid (E171) jernoxid, rød (E172) jernoxid, gul (E172)
English: - 30 x 1 soft capsules in Aluminium/aluminium perforated unit dose blisters - 60 x 1 soft capsules in Aluminium/aluminium perforated unit dose blisters
Danish: - 30 x 1 bløde kapsler i aluminium/aluminiumsperforerede enkeltdosisblistere - 60 x 1 bløde kapsler i aluminium/aluminiumsperforerede enkeltdosisblistere
English: Two pack-sizes of Ofev 100 mg capsules are available:
Danish: Der fås to pakningsstørrelser med Ofev 100 mg kapsler:
English: Frequency of patients with acute IPF exacerbations over 52 weeks and time to first exacerbation analysis based on investigator-reported events in trials INPULSIS-1, INPULSIS-2, and their pooled data - treated set
Danish: Andel af patienter med akutte IPF-eksacerbationer i 52 uger og analyse af tid til første eksacerbation baseret på investigatorindberettede hændelser i studierne INPULSIS-1 og INPULSIS-2 og deres samlede data - treated set
English: Cases of renal impairment/failure, in some cases with fatal outcome, have been reported with nintedanib use (see section 4.8).
Danish: Der er rapporteret om tilfælde med nedsat nyrefunktion/-svigt, hvoraf nogle havde dødelig udgang, under behandling med nintedanib (se pkt.
English: - If you have any further questions, ask your doctor or pharmacist.
Danish: Er du i tvivl, så spørg lægen eller apotekspersonalet.
English: The recommended dose is one capsule of 100 mg twice daily (a total of 200 mg per day).
Danish: Den anbefalede dosis er en kapsel på 100 mg to gange dagligt (i alt 200 mg pr. dag).
English: Once transaminases have returned to baseline values, treatment with Ofev may be resumed at the full dose (150 mg twice daily) or reintroduced at a reduced dose (100 mg twice daily) which subsequently may be increased to the full dose (see section 4.2).
Danish: Når aminotransferaseværdierne er vendt tilbage til baseline, kan behandlingen genoptages med den fulde dosis (150 mg to gange dagligt) eller reduceret dosis (100 mg to gange dagligt), som efterfølgende kan øges til den fulde dosis (se pkt.
English: Printing ink:
Danish: Printblæk:
English: BATCH NUMBER Lot
Danish: FREMSTILLERENS BATCHNUMMER Lot
English: Ofev 150 mg soft capsules
Danish: Ofev 150 mg bløde kapsler
English: Ofev 150 mg soft capsules are available in the following pack-sizes: - 30 x 1 soft capsules in Aluminium/aluminium perforated unit dose blisters - 60 x 1 soft capsules in Aluminium/aluminium perforated unit dose blisters
Danish: Ofev 150 mg bløde kapsler fås i følgende pakningsstørrelser: - 30 x 1 bløde kapsler i aluminium/aluminiumsperforerede enkeltdosisblistere - 60 x 1 bløde kapsler i aluminium/aluminiumsperforerede enkeltdosisblistere
English: Two pack-sizes of Ofev 150 mg capsules are available:
Danish: Der fås to pakningsstørrelser med Ofev 150 mg kapsler:
English: Each capsule contains 150 mg nintedanib (as esilate).
Danish: Hver kapsel indeholder 150 mg nintedanib (som esilat).
English: In the INPULSIS trials no increased risk of venous thromboembolism was observed in nintedanib treated patients.
Danish: Der blev ikke observeret øget risiko for venøs tromboemboli hos patienter, der blev behandlet med nintedanib, i INPULSIS-studierne.
English: Each capsule contains 100 mg nintedanib (as esilate).
Danish: Hver kapsel indeholder 100 mg nintedanib (som esilat).
English: Printing ink shellac glaze iron oxide black (E172) propylene glycol (E1520)
Danish: Printblæk shellac jernoxid, sort (E172) propylenglycol (E1520)
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including herbal medicines and medicines obtained without a prescription.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: Shellac glaze, iron oxide black (E172), propylene glycol (E1520)
Danish: Shellac, jernoxid, sort (E172), propylenglycol (E1520)
English: Table 2:
Danish: Tabel 2:
English: Based on the mechanism of action nintedanib may impair wound healing.
Danish: Som følge af virkningsmekanismen kan nintedanib hæmme sårhelingen.
English: Ofev 100 mg soft capsules are available in the following pack-sizes: - 30 x 1 soft capsules in Aluminium/aluminium perforated unit dose blisters - 60 x 1 soft capsules in Aluminium/aluminium perforated unit dose blisters
Danish: Ofev 100 mg bløde kapsler fås i følgende pakningsstørrelser: - 30 x 1 bløde kapsler i aluminium/aluminiumsperforerede enkeltdosisblistere - 60 x 1 bløde kapsler i aluminium/aluminiumsperforerede enkeltdosisblistere
English: Table 4:
Danish: Tabel 4:
English: All-cause mortality over 52 weeks in trials INPULSIS-1, INPULSIS-2, and their pooled data - treated set
Danish: Mortalitet (alle årsager) i 52 uger i studierne INPULSIS-1og INPULSIS-2 og deres samlede data - treated set
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Danish: Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (se bilag I: Produktresumé, pkt.
English: Ofev 100 mg soft capsules
Danish: Ofev 100 mg bløde kapsler
English: No evidence of QT prolongation was observed for nintedanib in the clinical trial programme (Section 5.1).
Danish: I det kliniske forsøgsprogram blev der ikke fundet evidens for, at nintedanib forlænger QT (pkt.
English: No increased frequency of impaired wound healing was observed in the INPULSIS trials.
Danish: Der blev ikke observeret øget risiko for forringet sårheling i INPULSIS-studierne.
English: Alanine aminotransferase (ALT) increased, Aspartate aminotransferase (AST) increased, Gamma glutamyl transferase (GGT) increased
Danish: Forhøjet alaninaminotransferase (ALAT)
English: Table 6:
Danish: Tabel 6:
English: Table 3:
Danish: Tabel 3:
English: Each 150 mg soft capsule contains 1.8 mg of soya lecithin.
Danish: Hver bløde kapsel indeholder 150 mg nintedanib (som esilat) Hjælpestof, som behandleren skal være opmærksom på Hver 150 mg bløde kapsel indeholder 1,8 mg sojalecithin.