FrancophonIA/ELRC3.0 huggingface dataset:
English: The population mean exposure to nintedanib was 33 - 50% higher in Chinese, Taiwanese, and Indian patients and 16% higher in Japanese patients while it was 16 - 22% lower in Koreans compared to Caucasians (body weight corrected).
Maltese: L-esponiment medju tal-popolazzjoni għal nintedanib kien 33 - 50% ogħla f'pazjenti Ċiniżi, Tajwaniżi, u Indjani u 16% ogħla f'pazjenti Ġappuniżi, filwaqt li kien 16 - 22% aktar baxx fil-Koreani meta mqabbel mal-Kawkasi (piż tal-ġisem ikkoreġut).
English: Time to progression (≥ 10% absolute decline of FVC % predicted or death) In both INPULSIS trials, the risk of progression was statistically significantly reduced for patients treated with nintedanib compared with placebo.
Maltese: Żmien għall-progressjoni (tnaqqis assolut ta' ≥ 10% fl-FVC % imbassar jew mewt) Fiż-żewġ provi INPULSIS, ir-riskju ta' progressjoni tnaqqas b'mod statistikament sinifikanti għal pazjenti kkurati b'nintedanib meta mqabbel mal-plaċebo.
English: Subjects with severe hepatic impairment (Child Pugh C) have not been studied.
Maltese: Individwi b'indeboliment tal-fwied sever (Child Pugh C) ma ġewx studjati.
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.
Maltese: Is-sigurtà u l-effikaċja ta' Ofev ma ġewx studjati f'pazjenti b'indeboliment moderat (Child Pugh B) jew sever (Child Pugh Ċ) tal-fwied.
English: 5.1 Pharmacodynamic properties
Maltese: .1 Proprjetajiet farmakodinamiċi
English: FVC responder analysis
Maltese: Informazzjoni għall-pazjent
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
Maltese: Ofev 100 mg kapsuli rotob huma disponibbli fid-daqsijiet tal-pakkett li ġejjin: - 30 x 1 kapsuli rotob f'folji tad-doża tal-unità erforati tal-Aluminju/aluminju - 60 x 1 kapsuli rotob f'folji tad-doża tal-unità perforati tal-Aluminju/aluminju
English: Based on these results, there is no evidence of a relevant pharmacokinetic drug-drug interaction between nintedanib and pirfenidone when administered in combination (see section 4.4).
Maltese: Abbażi ta' dawn ir-riżultati, m'hemmx evidenza ta' interazzjoni farmakokinetika rilevanti bejn mediċina u oħra bejn nintedanib u pirfenidone meta jingħataw flimkien (ara sezzjoni 4.4).
English: Patients with a recent history of myocardial infarction or stroke were excluded from the INPULSIS trials.
Maltese: Pazjenti bi storja medika riċenti ta' infart mijokardijaku jew puplesija ġew esklużi mill-provi INPULSIS.
English: Your doctor may reduce your recommended dose to two times 100 mg per day (a total of 200 mg per day).
Maltese: It-tabib tiegħek jista' jnaqqas id-doża rakkomandata tiegħek għal 100 mg darbtejn kuljum (total ta' 200 mg kuljum).
English: Given the similarity in safety profiles for both medicinal products, additive adverse events, including gastrointestinal and hepatic adverse events, may be expected.
Maltese: Minħabba x-xebh fil-profili ta' sigurtà għaż-żewġ prodotti mediċinali, jistgħu jkunu mistennija avvenimenti avversi addittivi, inklużi avvenimenti avversi gastrointestinali u epatiċi.
English: Ofev should only be initiated at least 4 weeks after abdominal surgery.
Maltese: Ofev għandu jinbeda biss mill-inqas 4 ġimgħat wara operazzjoni addominali.
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)
Maltese: Il-mediċini li ġejjin huma eżempji li jistgħu jnaqqsu l-livelli ta' nintedanib fid-demm u għalhekk jistgħu jnaqqsu l -effikaċja ta' Ofev: - antibijotiku li jintuża biex jikkura t-tuberkulożi (rifampicin) - mediċini li jintużaw biex jikkuraw aċċessjonijiet (carbamazepine, phenytoin) - mediċina li ġejja mill-ħxejjex għall-kura tad-depressjoni (St. John's Wort)
English: Nintedanib inhibits proliferation, migration and fibroblast to myofibroblast transformation of human lung fibroblasts from patients with IPF.
Maltese: Nintedanib jinibixxi l-proliferazzjoni, il-migrazzjoni u ttrasformazzjoni minn fibroblast għal mijofibroblast tal-fibroblasti tal-pulmun tal-bniedem minn pazjenti bl-IPF.
English: In both INPULSIS trials, the proportion of FVC responders, defined as patients with an absolute decline in FVC % predicted no greater than 5% (a threshold indicative of the increasing risk of mortality in IPF), was significantly higher in the nintedanib group as compared to placebo.
Maltese: Fiż-żewġ provi INPULSIS, il-proporzjon ta' rispons tal-FVC, iddefinit bħala pazjenti bi tnaqqis assolut fil-% FVC li kien imbassar li se jkun mhux aktar minn 5% (livell limitu indikattiv tar-riskju miżjud ta' mortalità fl-IPF), kien ferm ogħla fil-grupp ikkurat b'nintedanib meta mqabbel mal-plaċebo.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: Patients ≥75 years may be more likely to require dose reduction to manage adverse effects (see section 5.2).
Maltese: Pazjenti li jkollhom ≥ 75 sena huma aktar probabbli li jkunu jeħtieġu tnaqqis fid-doża biex jimmaniġġjaw l-effetti avversi (ara sezzjoni 5.2).
English: Do not store Ofev above 25°C.
Maltese: Taħżinx Ofev f'temperatura 'l fuq minn 25°C.
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).
Maltese: L/sena, N=84) milli fil-parti tal-istudju bi plaċebo (-0.190 L/sena, N=83).
English: Diarrhoea led to dose reduction in 10.7% of the patients and to discontinuation of nintedanib in 4.4% of the patients in clinical trials.
Maltese: Id-dijarea wasslet għal tnaqqis fid-doża f'10.7% talpazjenti u għal twaqqif ta' nintedanib f'4.4% tal-pazjenti fil-provi kliniċi.
English: Based on results of a Population PK (PopPK) analysis in patients with IPF and non small cell lung cancer (NSCLC) (N=1,191) and descriptive investigations, exposure to nintedanib was not influenced by sex (body weight corrected), mild and moderate renal impairment (estimated by creatinine clearance), alcohol consumption, or P-gp genotype.
Maltese: Ibbażat fuq ir-riżultati ta' analiżi tal-PK tal-Popolazzjoni (PopPK) f'pazjenti bl-IPF u kanċer ta' ċelluli mhux żgħar tal-pulmun (NSCLC) (N=1,191) u investigazzjonijiet deskrittivi, l-esponiment għal nintedanib ma ġiex influwenzat mis-sess tal-persuna (piż tal-ġisem ikkoreġut), indeboliment ħafif u moderat tal-kliewi (stmat mit-tneħħija tal-krejatinina), il-konsum ta' alkoħol, u l-ġenotip P-gp. Lanaliżijiet PopPK indikaw effetti moderati fuq l-esponiment għal nintedanib li jiddependu fuq l-età, ilpiż tal-ġisem, u r-razza (ara taħt).
English: The in vitro protein binding of nintedanib in human plasma was high, with a bound fraction of 97.8%.
Maltese: Il-twaħħil ta' nintedanib mal-proteini in vitro fil-plażma tal-bniedem kien għoli, bi frazzjoni mwaħħla ta' 97.8%.
English: Patients with FVC baseline < 50% predicted or carbon monoxide diffusing capacity (DLCO, corrected for haemoglobin) < 30% predicted at baseline were excluded from the trials.
Maltese: Pazjenti b'FVC fil-linja bażi mbassar ta' < 50% jew DLCO ikkoreġut għall-emoglobina ta' < 30% imbassar fil-linja bażi, ġew esklużi mill-provi.
English: Group 1 received a single dose of 150 mg nintedanib before and after uptitration to 801 mg pirfenidone three times a day at steady state (N=20 patients treated).
Maltese: Grupp 1 irċieva doża waħda ta' 150 mg nintedanib qabel u wara żieda għal 801 mg pirfenidone tliet darbiet kuljum fi stat fiss (N=20 pazjent ittrattati).
English: Ofev 150 mg soft capsules nintedanib
Maltese: Ofev 150 mg kapsuli nintedanib
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.
Maltese: IV INJOURNEY b'Ofev 150 mg darbtejn kuljum u żieda ta' pirfenidone għal 12-il ġimgħa hija deskritta fis-sezzjoni 5.1.
English: Ofev 100 mg soft capsules nintedanib
Maltese: Ofev 100 mg kapsuli nintedanib
English: AUCτ,ss decreased by 16% for a 45-year old patient and increased by 13% for a 76-year old patient relative to a patient with the median age of 62 years.
Maltese: L-AUCτ,ss naqset b'16% għal pazjent ta' 45 sena u żdiedet bi 13% għal pazjent ta' 76 sena fir-rigward ta' pazjent ta' età medja ta' 62 sena.
English: Number at risk Patients with events, N (%) Comparison vs placebo p-value Hazard ratio 95% CI
Maltese: Numru f'riskju Pazjenti b'avvenimenti, N (%) 13 (6.4) 13 (4.2) 20 (9.1) Paragun vs plaċebo valur p Proporzjon ta' periklu 95% CI
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).
Maltese: Parti żgħira biss tal-bijotrasformazzjoni ta' nintedanib kienet tikkonsisti fil-passaġġi ta' CYP. Nintedanib u l-metaboliti tiegħu, il-free acid moiety BIBF 1202 u l-glucuronide BIBF 1202 tiegħu, ma inibixxewx jew ma induċewx enzimi ta' CYP fi studji prekliniċi (ara sezzjoni 5.2).
English: Each capsule contains 100 mg nintedanib (as esilate).
Maltese: Kull kapsula fiha 100 mg ta' nintedanib (bħala esilate)
English: Hepatic impairment
Maltese: Pankreatite Kolite
English: In case of renal impairment/failure, therapy adjustment should be considered (see section 4.2 Dose adjustments).
Maltese: F'każ ta' indeboliment/insuffiċjenza renali, għandu jiġi kkunsidrat aġġustament tat-terapija (ara sezzjoni 4.2 Aġġustamenti fid-doża).
English: Haemorrhage
Maltese: Pożoloġija
English: The safety and efficacy of Ofev in children aged 0-18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Ofev fit-tfal minn etá ta' 0-18-il sena għadhom ma ġewx determinati s'issa.
English: Diarrhoea led to permanent treatment discontinuation in 4.4% of patients; otherwise the events were managed by antidiarrhoeal therapy, dose reduction or treatment interruption (see section 4.4).
Maltese: Id-dijarea wasslet għal twaqqif tal-kura b'mod permanenti f'4.4% tal-pazjenti; inkella l-avvenimenti kienu mmaniġġjati b'kura kontra d-dijarea, tnaqqis fid-doża jew twaqqif tal-kura (ara sezzjoni 4.4).
English: Two pack-sizes of Ofev 150 mg capsules are available:
Maltese: Hemm żewġ daqsijiet ta' pakketti disponibbli ta' Ofev 150 mg kapsuli:
English: Talk to your doctor or pharmacist before taking Ofev, - if you have or ever had liver problems, - if you have or ever had problems with your kidney, - if you have or ever had bleeding problems, - if you take blood-thinning medicines (such as warfarin, phenprocoumon or heparin) to prevent blood clotting, - if you take pirfenidone as this may increase the risk of having diarrhoea, nausea, vomiting and liver problems, - if you have or ever had problems with your heart (for example a heart attack), - if you have recently had surgery.
Maltese: Kellem lit-tabib jew lill-ispiżjar tiegħek qabel tieħu Ofev, - jekk għandek jew qatt kellek problemi tal-fwied, - jekk għandek jew qatt kellek problemi fil-kliewi, - jekk għandek jew qatt kellek problemi ta' ħruġ ta' demm, - jekk tieħu mediċini biex traqqaq id-demm (bħal warfarin, phenprocoumon jew heparin) biex tipprevjeni emboli tad-demm, - jekk tieħu pirfenidone peress li dan jista' jżid ir-riskju li jkollok dijarea, dardir, rimettar u problemi tal-fwied, - jekk għandek jew qatt kellek problemi bil-qalb (pereżempju attakk tal-qalb), - jekk kellek operazzjoni riċenti.
English: While adverse events reflecting ischaemic heart disease were balanced between the nintedanib and placebo groups, a higher percentage of patients experienced myocardial infarctions in the nintedanib group (1.6%) compared to the placebo group (0.5%).
Maltese: Filwaqt li l-avvenimenti avversi li jirriflettu mard iskemiku tal-qalb kienu bbilanċjati bejn il-grupp tal-kura b'nintedanib u dak bi plaċebo, perċentwal ogħla ta' pazjenti esperjenzaw infart mijokardijaku fil-grupp tal-kura b'nintedanib (1.6%) meta mqabbel mal-grupp tal-kura bi plaċebo (0.5%).
English: In the INPULSIS trials, one patient was inadvertently exposed to a dose of 600 mg daily for a total of 21 days.
Maltese: Fil-provi INPULSIS, pazjent wieħed kellu esponiment aċċidentali għal doża ta' 600 mg kuljum għal total ta' 21 ġurnata.
English: The safety data provided in the following are based on the two Phase III, randomised, double-blind, placebo-controlled studies in 1,061 patients comparing treatment with nintedanib 150 mg twice daily to placebo for 52 weeks (INPULSIS-1 and INPULSIS-2) and based on data observed during the post-marketing period.
Maltese: Id-dejta tas-sigurtà mogħtija f'dan l-ġej hija bbażata fuq żewġ studji tal-Fażi III, randomizzati, double-blind, ikkontrollati bi plaċebo f'1,061 pazjent li jqabblu l-kura b'nintedanib 150 mg darbtejn kuljum ma' plaċebo għal 52 ġimgħa (INPULSIS-1 u INPULSIS-2) u bbażat fuq data osservata matul il-perjodu ta' wara t-tqegħid fis-suq.
English: The recommended dose is one capsule of 100 mg twice daily (a total of 200 mg per day).
Maltese: Id-doża rakkomandata hija kapsula waħda ta' 100 mg darbtejn kuljum (total ta' 200 mg kuljum).
English: Based on a PopPK model, an increase in nintedanib exposure of approximately 20 - 25% was observed in patients ≥ 75 years compared with patients under 65 years.
Maltese: Ibbażat fuq mudell PopPK, żieda fl-esponiment għal nintedanib ta' madwar 20-25% ġiet osservata f'pazjenti li kellhom ≥ 75 sena meta mqabbel ma' pazjenti li kellhom inqas minn 65 sena.
English: Effect on QT interval
Maltese: Intervall tal-QT
English: INPULSIS-1 and INPULSIS-2 pooled
Maltese: INPULSIS-1 u INPULSIS-2.
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
Maltese: Tabella 4: Frekwenza ta' pazjenti bi tnaqqis assolut ta' ≥ 10% fl-FVC % imbassar jew mewt fuq 52 ġimgħa u ż-żmien sal-progressjoni fil-provi INPULSIS-1, INPULSIS-2 u d-dejta raggruppata tagħhom - sett ikkurat
English: Based on these results, there is no evidence of a relevant pharmacokinetic drug-drug interaction between nintedanib and pirfenidone when administered in combination (see section 5.2).
Maltese: Abbażi ta' dawn ir-riżultati, m'hemmx evidenza ta' interazzjoni farmakokinetika rilevanti bejn mediċina u oħra bejn nintedanib u pirfenidone meta jingħataw flimkien (ara sezzjoni 5.2).
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu.
English: The safety and efficacy of nintedanib have not been investigated in patients with hepatic impairment classified as Child Pugh B and C. Treatment of patients with moderate (Child Pugh B) and severe (Child Pugh C) hepatic impairment with Ofev is not recommended (see section 5.2).
Maltese: Il-kura ta' pazjenti b'indeboliment moderat tal-fwied (Child Pugh B) u sever (Child Pugh Ċ) b'Ofev mhijiex rakkomandata (ara sezzjoni 5.2).
English: - Keep this leaflet.
Maltese: Proporzjon ta' periklu
English: Common side effects (may affect up to 1 in 10 people) - Vomiting - Loss of appetite - Weight loss - Bleeding - Rash - Headache
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa pazjent 1 minn kull 10) - Rimettar - Telf ta' aptit - Tnaqqis fil-piż - Fsada - Raxx - Uġigħ ta' ras
English: Each capsule contains 150 mg nintedanib (as esilate).
Maltese: Kull kapsula fiha 150 mg ta' nintedanib (bħala esilate).
English: Serious cases of diarrhoea leading to dehydration and electrolyte disturbances have been reported in the post-marketing.
Maltese: Każijiet serji ta' dijarea li jwasslu għal deidratazzjoni u disturbi fl-elettroliti ġew irrappurtati wara ttqegħid fis-suq.
English: In addition, similar effects were observed on other lung function endpoints e.g. change from baseline in FVC at week 52 and FVC responder analyses providing further substantiation of the effects of nintedanib on slowing disease progression.
Maltese: Barra minn hekk, effetti simili kienu osservati fuq punti aħħarin oħrajn tal-funzjoni tal-pulmun, eż. bidla mil-linja bażi fl-FVC f'ġimgħa 52 u analiżijiet tar-rispons tal-FVC li ssostanzjaw iżjed l-effetti ta' nintedanib fuq it-tnaqqis tal-progress tal-marda.
English: Also, tell your doctor if you had peptic ulcers or diverticular disease in the past, or are concomitantly treated with anti-inflammatory drugs (NSAIDs) (used to treat pain relief and swelling) or steroids (used for inflammation and allergies), as this may increase this risk; - if you have pain, swelling, reddening, warmth of a limb as this could be symptoms of a blood clot in one of your veins (a type of blood vessel); - if you have chest pressure or pain, typically on the left side of the body, pain in the neck, jaw, shoulder or arm, a fast heartbeat, shortness of breath, nausea, vomiting, as this could be symptoms of a heart attack; - if you have any major bleeding.
Maltese: (li jintużaw biex jittrattaw l-uġigħ u n-nefħa) jew sterojdi (li jintużaw għall-infjammazzjoni u lallerġiji), peress li dan jista' jżid dan ir-riskju; - jekk tħoss uġigħ, nefħa, ħmura, sħana fi driegħ/riġel, għax dawn jistgħu jkunu sintomi ta' embolu tad-demm f'waħda mill-vini tiegħek (tip ta' pajp tad-demm); - jekk ikollok għafis jew uġigħ fis-sider, normalment fuq in-naħa tax-xellug tal-ġisem, uġigħ flgħonq, ix-xedaq, l-ispalla jew driegħ, taħbit mgħaġġel tal-qalb, qtugħ ta' nifs, nawseja, rimettar, għaliex dawn jistgħu jkunu sintomi ta' attakk tal-qalb; - jekk ikollok kwalunkwe ħruġ ta' demm maġġuri.
English: QT interval
Maltese: Mhux komuni
English: Nintedanib exposure increased linearly with patient age, which may also result in a higher risk of developing liver enzyme elevations (see section 5.2).
Maltese: L-esponiment għal nintedanib żdied b'mod lineari mal-età tal-pazjent, li jista' jirriżulta wkoll f'riskju ogħla li jiżviluppaw żidiet fl-enzimi tal-fwied (ara sezzjoni 5.2).
English: In rabbits, embryo-foetal lethality and teratogenic effects were observed at an exposure approximately 3 times higher than at the MRHD but equivocal effects on the embryo-foetal development of the axial skeleton and the heart were noted already at an exposure below that at the MRHD of 150 mg twice daily.
Maltese: Fil-fniek, ġew osservati letalità embrijofetali u effetti teratoġeniċi f'esponiment ta' madwar 3 darbiet ogħla milli fl-MRHD, iżda ġew osservati effetti ekwivoċi fuq l-iżvilupp tal-iskeletru assjali u l-qalb tal-embriju u fetu diġà f'esponiment taħt l-MRHD ta' 150 mg darbtejn kuljum.
English: Annual rate of decline in FVC (mL) in trials INPULSIS-1, INPULSIS-2 and their pooled data - treated set
Maltese: Tabella 2: Rata annwali ta' tnaqqis fl-FVC (mL) fil-provi INPULSIS-1, INPULSIS-2 u ddejta raggruppata tagħhom - sett ikkurat
English: Ofev 150 mg twice daily
Maltese: Ofev 150 mg darbtejn kuljum
English: th percentile) and decreased by 19% for a 100 kg patient th percentile) relative to a patient with the median weight of 71.5 kg.
Maltese: th percentile) u naqset b'19% għal pazjent ta' 100 kg (95
English: Proportion of FVC responders at 52 weeks in trials INPULSIS-1, INPULSIS-2 and their pooled data - treated set
Maltese: Tabella 3: Proporzjon ta' rispons tal-FVC f'ġimgħat 52 fil-provi INPULSIS-1, INPULSIS-2 u d-dejta raggruppata tagħhom - sett ikkurat
English: In the pre-specified pooled analysis of survival data of the INPULSIS trials, overall mortality over 52 weeks was lower in the nintedanib group (5.5%) compared with the placebo group (7.8%).
Maltese: INPULSIS, il-mortalità ġenerali fuq 52 ġimgħa kienet aktar baxxa fil-grupp ikkurat b'nintedanib (5.5%) milli fil-grupp ikkurat bi plaċebo (7.8%).
English: Printing ink:
Maltese: Pressjoni għolja,
English: The number of patients with acute IPF exacerbations over 52 weeks was lower in the nintedanib group (2.3%, N=86) compared to placebo (13.8%, N=87).
Maltese: In-numru ta' pazjent b'taħrix akut tal-IPF fuq 52 ġimgħa kien aktar baxx fil-grupp ikkurat b'nintedanib (2.3%, N=86) meta mqabbel mal-plaċebo (13.8%, N=87).
English: General toxicology
Maltese: Tossikoloġija ġenerali
English: Venous thromboembolism
Maltese: Tromboemboliżmu venuż
English: Hypersensitivity to nintedanib, to peanut or soya, or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għal nintedanib, karawett jew sojja, jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1.
English: Boehringer Ingelheim RCV GmbH & Co KG Eesti filiaal
Maltese: Boehringer Ingelheim RCV GmbH & Co
English: Cases of renal impairment/failure, in some cases with fatal outcome, have been reported with nintedanib use (see section 4.8).
Maltese: Każijiet ta' indeboliment/insuffiċjenza renali, f'xi każijiet b'riżultat fatali, ġew irrappurtati bl-użu ta' nintedanib (ara sezzjoni 4.8).
English: In view of the limited number of patients, this study detected only the most frequent adverse events and showed an increase in gastrointestinal adverse events and a trend toward increased hepatic adverse events.
Maltese: Minħabba n-numru limitat ta' pazjenti, dan l-istudju osserva biss l-aktar avvenimenti avversi frekwenti u wera żieda flavvenimenti avversi gastrointestinali u tendenza lejn żieda ta' avvenimenti avversi epatiċi.
English: Patients were randomized in a 3:2 ratio to treatment with Ofev 150 mg or placebo twice daily for 52 weeks.
Maltese: Il-pazjenti ntgħażlu b'mod każwali fi proporzjon ta' 3:2 għall-kura b'Ofev 150 mg jew plaċebo darbtejn kuljum għal 52 ġimgħa.
English: Systemic blood pressure should be measured periodically and as clinically indicated.
Maltese: Il-pressjoni tad-demm sistematika għandha titkejjel perjodikament u skont kif ikun indikat klinikament.
English: The primary endpoint was the percentage of patients with gastrointestinal adverse events from baseline to week 12.
Maltese: Il-punt aħħari primarju kien il-perċentwali ta' pazjenti b'avvenimenti avversi gastrointestinali mil-linja bażi sa ġimgħa 12.
English: In addition to symptomatic treatment if applicable, the management of adverse reactions to Ofev (see sections 4.4 and 4.8) could include dose reduction and temporary interruption until the specific adverse reaction has resolved to levels that allow continuation of therapy.
Maltese: Minbarra l-kura għas-sintomi jekk applikabbli, l-immaniġġjar tar-reazzjonijiet avversi ta' Ofev (ara sezzjonijiet 4.4 u 4.8) jista' jinkludi t-tnaqqis tad-doża u t-twaqqif temporanju sakemm ir-reazzjoni avversa speċifika tkun ittaffiet għal livelli li jippermettu l-kontinwazzjoni tat-terapija.
English: Ofev 150 mg soft capsules are brown-coloured, opaque, oblong soft-gelatin capsules imprinted on one side in black with the Boehringer Ingelheim company symbol and “150”.
Maltese: Ofev 150 mg kapsuli rotob huma kapsuli tal-ġelatina ratba ta' kulur kannella, opaki, oblungi, stampati fuq naħa waħda bl-iswed bis-simbolu tal-kumpanija Boehringer Ingelheim u n-numru “150”.
English: The same applies for nintedanib being a substrate of OCT-1.
Maltese: L-istess japplika għal nintedanib billi hu substrat ta' OCT-1.