FrancophonIA/ELRC3.0 huggingface dataset:
English: Potent P-gp inducers (e.g. rifampicin, carbamazepine, phenytoin, and St. John's Wort) may decrease exposure to nintedanib.
Maltese: Indutturi potenti ta' P-gp (eż. rifampicin, carbamazepine, phenytoin, u St.
English: AUCτ,ss increased by 25% for a 50 kg patient (5
Maltese: L-AUCτ,ss żdiedet b'25% għal pazjent ta' 50 kg (5
English: Liver enzyme elevations (see section 4.4) were reported in 13.6% of nintedanib treated patients.
Maltese: Żidiet fl-enzimi tal-fwied (ara sezzjoni 4.4) kienu rrappurtati fi 13.6% tal-pazjenti kkurati b'nintedanib.
English: 10% threshold Number (%) of FVC responders
Maltese: valur p livell limitu ta' 10% Numru (%) ta' rispons talFVC
English: Observed adverse reactions were consistent with the known safety profile of nintedanib, i.e. increased liver enzymes and gastrointestinal symptoms.
Maltese: Irreazzjonijiet avversi osservati kienu konsistenti mal-profil tas-sigurtà magħruf ta' nintedanib, i.e. żieda fl-enzimi tal-fwied u sintomi gastrointestinali.
English: The terminal half-life of nintedanib was between 10 and 15 h (gCV % approximately 50%).
Maltese: Il-half-life terminali ta' nintedanib kienet bejn 10 u 15-il siegħa (gCV % madwar 50%).
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).
Maltese: Fil-provi INPULSIS (ara sezzjoni 5.1), id-dijarea kienet ir-reazzjoni avversa gastrointestinali rrappurtata l-aktar komuni f'62.4% kontra 18.4% tal-pazjenti kkurati b'Ofev u plaċebo, rispettivament (ara sezzjoni 4.8).
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).
Maltese: Fi grupp 1, il-proporzjonijiet ġeometriċi medji aġġustati (intervall ta' kunfidenza (CIconfidence interval) ta' 90%) kienu 93% (57%-151%) u 96% (70%-131%) għal Cmax u AUC0-tz ta' nintedanib, rispettivament (n=12 għal paragun intraindividwali).
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).
Maltese: F'INPULSIS-1, iż-żieda mil-linja bażi fil-punteġġ totali SGRQ f'ġimgħa 52 kienet paragunabbli bejn nintedanib u plaċebo (id-differenza bejn il-gruppi ta' kura: -0.05; 95% CI -2.50, 2.40; p=0.9657).
English: Reproduction toxicity
Maltese: Tossiċità fir-riproduzzjoni
English: The event was reported to be of severe intensity in 3.3% of nintedanib treated patients.
Maltese: L-avveniment kien irrappurtat bħala ta' intensità severa fi 3.3% ta' pazjenti kkurati b'nintedanib.
English: Number of analysed patients
Maltese: Numru ta' pazjenti analizzati
English: Dose proportionality was shown by increase of nintedanib exposure (dose range 50 - 450 mg once daily and 150 - 300 mg twice daily).
Maltese: Il-proporzjonalit à tad-doża ntweriet biż-żieda tal-esponiment ta' nintedanib (medda tad-doża 50 - 450 mg darba kuljum u 150 - 300 mg darbtejn kuljum).
English: Gastrointestinal Disorder
Maltese: Disturbi gastrointestinali
English: The estimated difference between the treatment groups was 0.131 L/year (95% CI 0.027, 0.235).
Maltese: Iddifferenza stmata bejn il-gruppi ta' kura kienet ta' 0.131 L/sena (95% CI 0.027, 0.235).
English: Genotoxicity studies indicated no mutagenic potential for nintedanib.
Maltese: Studji ġenotossiċi ma indikaw l-ebda potenzjal mutaġeniku għal nintedanib.
English: Printing ink shellac glaze iron oxide black (E172) propylene glycol (E1520)
Maltese: Linka tal-istampar: shellac glaze iron oxide black (E172) propylene glycol (E1520)
English: Tel: +420 234 655 111
Maltese: s r.o. Tel: +420 234 655 111
English: 55216 Ingelheim am Rhein Germany
Maltese: 55216 Ingelheim am Rhein Il-Ġermanja
English: Ofev is indicated in adults for the treatment of idiopathic pulmonary fibrosis (IPF).
Maltese: Ofev huwa indikat fl-adulti għall-kura tal-fibrożi pulmonarja idjopatika (IPF).
English: The prevalent metabolic reaction for nintedanib is hydrolytic cleavage by esterases resulting in the free acid moiety BIBF 1202.
Maltese: Ir-reazzjoni metabolika prevalenti għal nintedanib hu cleavage idrolitiku minn esterases li jirriżulta filfree acid moiety BIBF 1202.
English: 5% threshold Number (%) of FVC responders
Maltese: Numru ta' pazjenti analizzati livell limitu ta' 5% Numru (%) ta' rispons talFVC
English: The estimated hazard ratio of nintedanib versus placebo was 0.16 (95% CI 0.04, 0.71; p=0.0054).
Maltese: Il-proporzjon ta' periklu stmat ta' nintedanib versus plaċebo kien 0.16 (95% CI 0.04, 0.71; p=0.0054).
English: Comparison vs placebo
Maltese: Paragun vs plaċebo Differenza
English: Ofev 150 mg soft capsules
Maltese: Ofev 150 mg kapsuli rotob
English: Post-marketing bleeding events include but are not limited to gastrointestinal, respiratory and central nervous organ systems, with the most frequent being gastrointestinal.
Maltese: Avvenimenti ta' fsada wara t-tqegħid fis-suq jinkludu, iżda mhumiex limitati għas-sistemi tal-organi gastrointestinali, respiratorji u nervużi ċentrali, bl-aktar frekwenti li huma gastrointestinali.
English: Other medicines and Ofev
Maltese: Mediċini oħra u Ofev
English: No evidence of QT prolongation was observed for nintedanib in the clinical trial programme (Section 5.1).
Maltese: L-ebda evidenza tat-titwil tal-QT ma ġie osservat għal nintedanib fil-programm ta' provi kliniċi (Sezzjoni 5.1).
English: The analysis of time to death resulted in a HR of 0.70 (95% CI 0.43, 1.12; p=0.1399).
Maltese: L-analiżi taż-żmien sal-mewt irriżultat f'HR ta' 0.70 (95% CI 0.43, 1.12; p=0.1399).
English: Boehringer Ingelheim RCV GmbH & Co KG Viena - Sucursala Bucuresti Tel: +40 21 302 2800
Maltese: KG Viena - Sucursala Bucuresti Tel: +40 21 302 2800
English: Nintedanib binds competitively to the adenosine triphosphate (ATP) binding pocket of these receptors and blocks the intracellular signalling.
Maltese: Nintedanib jeħel b'mod kompetittiv mal-adenosine triphosphate (ATP) binding pocket ta' dawn ir-riċetturi u jimblokka s-senjalazzjoni intraċellulari.
English: Elevations of liver enzymes (ALT, AST, blood alkaline phosphatase (ALKP), gamma-glutamyltransferase (GGT)) and bilirubin were reversible upon dose reduction or interruption in the majority of cases.
Maltese: Żidiet fl-enzimi tal-fwied (ALT, AST, alkaline phosphatase fid-demm (ALKP), gammaglutamyltransferase (GGT)) u l-bilirubina kienu riversibbli mat-tnaqqis jew l-interruzzjoni tad-doża fil-maġġoranza tal-każijiet.
English: s r.o.
Maltese: U L-UŻU C.
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).
Maltese: Fi studju ddedikat tal-fażi I b'doża waħda u meta mqabbel ma' dak ta' individwi b'saħħithom, l-esponiment għal nintedanib abbażi ta' Cmax u AUC kien 2.2 drabi ogħla f'voluntiera b'indeboliment tal-fwied ħafif (Child Pugh A; 90% CI 1.3 - 3.7 għal Cmax u 1.2 - 3.8 għal AUC, rispettivament).
English: Hyperbilirubinaemia, Blood alkaline phosphatase (ALKP) increased
Maltese: Suffejra (iperbilirubinemija), Żieda fl-alkaline phosphatase (ALKP) fid-demm
English: Placebo Ofev 150 mg twice daily
Maltese: Plaċebo Ofev 150 mg darbtejn kuljum
English: The clinical efficacy of nintedanib has been studied in patients with IPF in two phase III, randomised, double-blind, placebo-controlled studies with identical design (INPULSIS-1 (1199.32) and INPULSIS-2 (1199.34)).
Maltese: L-effikaċja klinika ta' nintedanib ġiet studjata f'pazjenti bl-IPF f'żewġ studji tal-Fażi III, randomizzati, double-blind, ikkontrollati bi plaċebo b'disinn identiku (INPULSIS-1 (1199.
English: Nausea and vomiting were frequently reported gastrointestinal adverse reactions (see section 4.8).
Maltese: Nawseja u rimettar kienu reazzjonijiet avversi gastrointestinali li ġew irrappurtati ta' spiss (ara sezzjoni 4.8).
English: Metabolism and nutrition disorders
Maltese: Disturbi filmetaboliżmu u nnutrizzjoni
English: For the interaction potential of nintedanib with this transporter, see section 4.5.
Maltese: Għall-potenzjal ta' interazzjoni ta' nintedanib ma' dan ittrasportatur, ara sezzjoni 4.5.
English: In a dedicated pharmacokinetic study, concomitant treatment of nintedanib with pirfenidone was investigated in patients with IPF.
Maltese: Fi studju farmakokinetiku ddedikat, it-trattament konkomitanti ta' nintedanib flimkien ma' pirfenidone kien investigat f'pazjenti b'IPF.
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors, ATC code: L01XE31
Maltese: Sustanzi antineoplastiċi, inibituri tal-kinase tal-proteini, Kodiċi ATC:
English: Urinary excretion of the unchanged active substance within 48 h was about 0.05% of the dose (31.5% gCV) after oral and about 1.4% of the dose (24.2% gCV) after intravenous administration; the renal clearance was 20 mL/min (32.6% gCV).
Maltese: It-tneħħija fl-awrina tas-sustanza attiva mhux mibdula fi żmien 48 siegħa kienet ta' madwar 0.05% tad-doża (31.5% gCV) wara l-għoti orali u madwar 1.4% tad-doża (24.2% gCV) wara l-għoti ġol-vini; it-tneħħija mill-kliewi kienet ta' 20 mL/min (32.6% gCV).
English: Summary of ADRs per frequency category Frequency System Organ Class
Maltese: Tabella 1: Sommarju ta' ADRs skont il-kategorija ta' frekwenza Frekwenza
English: Arterial thromboembolic events were infrequently reported: in 0.7% of patients in the placebo and 2.5% in the nintedanib treated group.
Maltese: Avvenimenti tromboemboliċi arterjali ġew irrapportati b'mod mhux frekwenti: f'0.7% talpazjenti fil-grupp tal-kura bil-plaċebo u f'2.5% fil-grupp tal-kura b'nintedanib.
English: Nintedanib inhibits the activation of FGFR and PDGFR signalling cascades which are critically involved in proliferation, migration and differentiation of lung fibroblasts/myofibroblasts, the hallmark cells in the pathology of IPF.
Maltese: Nintedanib jinibixxi l-attivazzjoni tal-kaskati tas-sinjalazzjoni FGFR u PDGFR li huma involuti b'mod kritiku fil-proliferazzjoni, il-migrazzjoni u d-differenzjazzjoni tal-fibroblasti/mijofibroblasti talpulmun, iċ-ċelluli hallmark fil-patoloġija tal-IPF.
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.
Maltese: F'voluntiera b'indeboliment tal-fwied moderat (Child Pugh B), l-esponiment kien 7.6 drabi ogħla fuq il-bażi ta' Cmax (90% CI 4.4 - 13.2) u 8.7 drabi ogħla (90% CI 5.7 - 13.1) fuq il-bażi ta' AUC, rispettivament, meta mqabbel ma' dak ta' voluntiera b'saħħithom.
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
Maltese: - 30 x 1 kapsuli rotob f'folji tad-doża tal-unità perforati tal-Aluminju/aluminju - 60 x 1 kapsuli rotob f'folji tad-doża tal-unità perforati tal-Aluminju/aluminju
English: Nintedanib is a small molecule tyrosine kinase inhibitor including the receptors platelet-derived growth factor receptor (PDGFR) α and β, fibroblast growth factor receptor (FGFR) 1-3, and VEGFR 1-3.
Maltese: Nintedanib hu inibitur ta' tyrosine kinase ta' molekuli żgħar inklużi r-riċettur tal-fattur tat-tkabbir derivat mill-plejtlits (PDGFR) α u ß u tar-riċettur tal-fattur tat-tkabbir fibroblast (FGFR) 1-3, u VEGFR 1-3.
English: Ofev 100 mg soft capsules
Maltese: Ofev 100 mg kapsuli rotob
English: Accumulation upon multiple administrations was 1.04-fold for Cmax and 1.38-fold for AUCτ.
Maltese: L-akkumulazzjoni wara għoti multiplu kienet ta' 1.04 drabi għas-Cmax u 1.38 drabi għall-AUCτ.
English: Based on a Cox's regression model.
Maltese: Ibbażat fuq mudell ta' rigressjoni ta' Cox.
English: In a dedicated study in renal cell cancer patients, QT/QTc measurements were recorded and showed that a single oral dose of 200 mg nintedanib as well as multiple oral doses of 200 mg nintedanib administered twice daily for 15 days did not prolong the QTcF interval.
Maltese: Fi studju ddedikat f'pazjenti b'kanċer taċ-ċelluli tal-kliewi, il-kejlijiet QT/QTc ġew irreġistrati u wrew li dożi orali waħedhom ta' 200 mg nintedanib kif ukoll dożi orali multipli ta' 200 mg nintedanib mogħtija darbtejn kuljum għal 15-il jum, ma tawlux l-intervall tal-QTcF.
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.
Maltese: Trattament konkomitanti b'nintedanib u pirfenidone ġie investigat fi prova esploratorja, open-label u randomised ta' nintedanib 150 mg darbtejn kuljum flimkien ma' żieda ta' pirfenidone (ittitrat għal 801 mg tliet darbiet kuljum) meta mqabbel ma' nintedanib 150 mg darbtejn kuljum waħdu f'105 pazjenti randomised għal 12-il ġimgħa.
English: Diarrhoea was reported in 62.4% of patients treated with nintedanib.
Maltese: Dijarea kienet irrappurtata f'62.4% tal-pazjenti kkurati b'nintedanib.
English: Thrombocytopenia
Maltese: Tromboċitopenija
English: Serious bleeding events occurred with low and similar frequencies in the 2 treatment groups (placebo: 1.4%; Ofev: 1.3%).
Maltese: Avvenimenti serji ta' fsada seħħew bi frekwenzi baxxi u simili fiż-żewġ gruppi tal-kura (plaċebo: 1.4%;
English: Since the effect of nintedanib on the metabolism and efficacy of hormonal contraceptives has not been investigated, barrier methods should be applied as a second form of contraception, to avoid pregnancy.
Maltese: Billi l-effett nintedanib fuq il-metaboliżmu u l-effikaċja tal-kontraċettivi ormonali ma ġiex investigat, metodi barriera għandhom jiġu applikati bħala t-tieni forma ta' kontraċezzjoni, biex tiġi evitata t-tqala.
English: In the INPULSIS trials, the frequency of patients with perforation was very low in both treatment groups: 0% placebo, 0.3% Ofev (involving two patients).
Maltese: Fil-provi INPULSIS, il-frekwenza ta' pazjenti b'perforazzjoni kienet baxxa ħafna fiż-żewġ gruppi ta' trattament: 0% plaċebo, 0.3% Ofev (li tinvolvi żewġ pazjenti).
English: Nintedanib reached maximum plasma concentrations approximately 2 - 4 h after oral administration as soft gelatine capsule under fed conditions (range 0.5 - 8 h).
Maltese: Nintedanib laħaq konċentrazzjonijiet massimi fil-plażma madwar 2 - 4 sigħat wara l-għoti mill-ħalq bħala kapsula ta' ġelatina ratba f'kundizzjonijiet fejn l-individwu jkun kiel (medda 0.5 - 8 sigħat).
English: Mean (SE) absolute changes from baseline in FVC at week 12 were −13.3 (17.4) mL in patients treated with nintedanib with add-on pirfenidone (n=48) compared to −40.9 (31.4) mL in patients treated with nintedanib alone (n=44).
Maltese: Bidliet assoluti medji (SE) mil-linja bażi f'FVC f'ġimgħa 12 kienu −13.3 (17.4) mL f'pazjenti ttrattati b'nintedanib flimkien ma' żieda ta' pirfenidone (n=48) meta mqabbel ma' −40.9 (31.4) mL f'pazjenti ttrattati b'nintedanib waħdu (n=44).
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).
Maltese: Grupp 2 irċieva trattament fi stat fiss ta' 801 mg pirfenidone tliet darbiet kuljum u kellu profil tal-PK qabel u wara mill-inqas 7 t'ijiem ta' trattament konġunt b'150 mg nintedanib darbtejn kuljum (N=17-il pazjent ittrattat).
English: Nintedanib, BIBF 1202, and BIBF 1202 glucuronide did not inhibit or induce CYP enzymes in preclinical studies, either.
Maltese: Nintedanib, BIBF 1202 u l-glucuronide BIBF 1202 ukoll ma inibixxewx jew ma induċewx enzimi ta' CYP fi studji prekliniċi.
English: Diarrhoea
Maltese: Deidratazzjoni
English: In a sensitivity analysis which assumed that in patients with missing data at week 52 the FVC decline after the last observed value would be the same as in all placebo patients, the adjusted difference in the annual rate of decline between nintedanib and placebo was 113.9 mL/year (95% CI 69.2, 158.5) in INPULSIS-1 and 83.3 mL/year (95% CI 37.6, 129.0) in INPULSIS-2.
Maltese: F'analiżi dwar is-sensittività li assumiet li f'pazjenti b'dejta nieqsa f'ġimgħa 52, it-tnaqqis f'FVC wara l-aħħar valur osservat se jkun l-istess bħal dak fil-pazjenti kollha fuq plaċebo, id-differenza aġġustata fir-rata annwali ta' tnaqqis bejn nintedanib u l-plaċebo kienet ta' 113.9 mL/sena (95% CI 69.2, 158.5) f'INPULSIS-1 u 83.3 mL/sena (95% CI
English: Alanine aminotransferase (ALT) increased, Aspartate aminotransferase (AST) increased, Gamma glutamyl transferase (GGT) increased
Maltese: Żieda fl-aspartate aminotransferase (AST),
English: Aneurysms and artery dissections
Maltese: Anewriżmi u dissezzjonijiet tal-arterji
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
Maltese: Ofev 150 mg kapsuli rotob huma disponibbli fid-daqsijiet tal-pakkett li ġejjin: - 30 x 1 kapsuli rotob f'folji tad-doża tal-unità perforati tal-Aluminju/aluminju - 60 x 1 kapsuli rotob f'folji tad-doża tal-unità perforati tal-Aluminju/aluminju
English: Additional data from the phase IV INJOURNEY trial with Ofev 150 mg twice daily and add-on pirfenidone:
Maltese: IV INJOURNEY b'Ofev 150 mg darbtejn kuljum u żieda ta' pirfenidone:
English: Ofev contains the active substance nintedanib and it is used for the treatment of idiopathic pulmonary fibrosis (IPF) in adults.
Maltese: Ofev fih is-sustanza attiva nintedanib u jintuża għall-kura tal-fibrożi pulmonarja idjopatika (IPF) fladulti.
English: The safety, efficacy, and pharmacokinetics of nintedanib have not been studied in patients with severe renal impairment (<30 ml/min creatinine clearance).
Maltese: Issigurtà, l-effikaċja, u l-farmakokinetika ta' nintedanib ma ġewx studjati f'pazjenti b'indeboliment sever tal-kliewi (tneħħija tal-krejatinina ta' <30 mL/min).
English: In the pooled analysis, the HR was 0.60 indicating a 40% reduction in the risk of progression for patients treated with nintedanib compared with placebo.
Maltese: Fl-analiżi miġbura, l-HR kien ta' 0.60 li jindika tnaqqis ta' 40% fir-riskju ta' progressjoni għal pazjenti kkurati b'nintedanib meta mqabbel malplaċebo.
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).
Maltese: Flanaliżi miġbura tal-provi INPULSIS, il-bidla medja stmata mil-linja bażi f'ġimgħa 52 fil-punteġġ totali SGRQ kienet iżgħar fil-grupp ikkurat b'nintedanib (3.53) milli fil-grupp ikkurat bi plaċebo (4.96), b'differenza bejn il-gruppi ta' kura ta' -1.43 (95% CI: -3.09, 0.23; p=0.0923).
English: The age range covered by the analysis was 29 to 85 years; approximately 5% of the population were older than 75 years.
Maltese: Il-medda ta' età koperta mill-analiżi kienet ta' 29 sa 85 sena; madwar 5% tal-popolazzjoni kienu akbar minn 75 sena.
English: Nintedanib is preferentially distributed in plasma with a blood to plasma ratio of 0.869.
Maltese: Nintedanib jiġi ddistribwit b'mod preferenzjali fil-plażma bi proporzjon ta' demm għal plażma ta' 0.869.
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.
Maltese: Fil-firien, ġew osservati letalità embrijofetali u effetti teratoġeniċi f' livelli ta' esponiment taħt lesponiment uman fil-MRHD ta' 150 mg darbtejn kuljum.
English: Less than 1% of a single dose of nintedanib is excreted via the kidney (see section 5.2).
Maltese: Inqas minn 1% ta' doża waħda ta' nintedanib tiġi eliminata mill-kliewi (ara sezzjoni 5.2).
English: Therapy with Ofev should be permanently discontinued in patients who develop gastrointestinal perforation.
Maltese: It-terapija b'Ofev għandha titwaqqaf b'mod permanenti f'pazjenti li jiżviluppaw perforazzjoni gastrointestinali.
English: The below table provides a summary of the adverse reactions by MedDRA System Organ Class (SOC) and frequency category.
Maltese: It-tabella ta' hawn taħt tipprovdi sommarju tar-reazzjonijiet avversi skont is-Sistema tal-Klassifika talOrgani (SOC) MedDRA u l-kategorija ta' frekwenza.
English: Children and adolescents Ofev should not be taken by children and adolescents under 18 years of age.
Maltese: Tfal u adolexxenti Ofev ma għandux jittieħed minn tfal u adolexxenti taħt it-18-il sena.
English: Odds ratio
Maltese: Komuni ħafna
English: The deterioration of HRQoL was smaller in the nintedanib group; the difference between the treatment groups was statistically significant (-2.69; 95% CI: -4.95, -0.43; p=0.0197).
Maltese: Iddeterjorazzjoni tal-HRQoL kienet iżgħar fil-grupp ikkurat b'nintedanib; id-differenza bejn il-gruppi tal-kura kienet statistikament sinifikanti (-2.69; 95% CI: -4.95, -0.
English: Absorption and bioavailability are decreased by transporter effects and substantial first-pass metabolism.
Maltese: L-assorbiment u l-bijodisponibilità jonqsu bl-effetti tat-trasportaturi u l-metaboliżmu sostanzjali first-pass.
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).
Maltese: Fil-każ ta' interruzzjonijiet minħabba żidiet f'aspartate aminotransferase (AST) jew alanine aminotransferase (ALT) > 3x il-limitu ta' fuq tan-normal (ULN), meta t-transaminases jerġgħu lura għall-valuri tal-linja bażi, il-kura b'Ofev tista' titkompla bid-doża mnaqqsa (100 mg darbtejn kuljum) li wara tista' tiġi miżjuda għad-doża sħiħa (150 mg darbtejn kuljum) (ara sezzjonijiet 4.4 u 4.8).
English: The estimated mean difference for nintedanib compared with placebo was -6.12 (95% CI: -10.57, -1.67; p=0.0071).
Maltese: 12 (95% CI: -10.57, -1.67; p=0.0071).
English: Co-administration with the potent P-gp inhibitor ketoconazole increased exposure to nintedanib 1.61-fold based on AUC and 1.83-fold based on Cmax in a dedicated drug-drug interaction study.
Maltese: L-għoti flimkien mal-inibitur potenti ta' P-gp ketoconazole żied l-esponiment għal nintedanib b'1.61 darbiet ibbażat fuq l-AUC u 1.83 darbiet ibbażat fuq is-Cmax fi studju ddedikat dwar l-interazzjonijiet bejn mediċina u oħra.
English: The contribution of renal excretion to the total clearance was low (0.649% of dose, 26.3% gCV).
Maltese: Il-kontribuzzjoni tat-tneħħija mill-kliewi għattneħħija totali kienet baxxa (0.649% tad-doża, 26.
English: The recommended dose is one capsule of 150 mg twice daily (a total of 300 mg per day).
Maltese: Id-doża rakkomandata hija kapsula waħda ta' 150 mg darbtejn kuljum (total ta' 300 mg kuljum).
English: In vitro, CYP-dependent metabolism accounted for about 5% compared to about 25% ester cleavage.
Maltese: In vitro, il-metaboliżmu dipendenti fuq CYP ammonta għal madwar 5% meta mqabbel ma' madwar 25% ta' cleavage esters.
English: Boehringer Ingelheim RCV GmbH & Co KG Magyarországi Fióktelepe Tel: +36 1 299 8900
Maltese: KG Magyarországi Fióktelepe Tel: +36 1 299 8900
English: In preclinical disease models of lung fibrosis nintedanib exerts potent anti-fibrotic and anti-inflammatory activity.
Maltese: Fil-mudelli tal-mard prekliniċi tal-fibrożi tal-pulmun, nintedanib jeżerċita attività b'saħħitha antifibrotika u anti-infjammatorja.
English: Diarrhoea, Nausea, Abdominal pain
Maltese: Dijarea, Nawseja, Uġigħ addominali