FrancophonIA/ELRC3.0 huggingface dataset:
English: Liver enzyme elevations and hyperbilirubinaemia
Maltese: Żidiet fl-enzimi tal-fwied u iperbilirubinimja
English: Active brain metastasis
Maltese: Metastasi attiva tal-moħħ
English: System Organ Class
Maltese: KG organizačná zložka
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: Unless there is an alternative cause established, Vargatef should be permanently discontinued (see section 4.2).
Maltese: Ħlief jekk ikun hemm kawża alternattiva stabbilita, Vargatef għandu jitwaqqaf b'mod permanenti (ara sezzjoni 4.2).
English: Treatment of patients with moderate (Child Pugh B) and severe (Child Pugh C) hepatic impairment with Vargatef is not recommended (see sections 4.4 and 5.2).
Maltese: Il-kura ta' pazjenti b'indeboliment moderat tal-fwied (Child Pugh B) u sever (Child Pugh Ċ) b'Vargatef mhuwiex rakkomandat (ara sezzjonijiet 4.4 u 5.2).
English: Nintedanib binds competitively to the adenosine triphosphate (ATP) binding pocket of these receptors and blocks the intracellular signalling which is crucial for the proliferation and survival of endothelial as well as perivascular cells (pericytes and vascular smooth muscle cells).
Maltese: Nintedanib jeħel b'mod kompetittiv mal- adenosine triphosphate (ATP) binding pocket ta' dawn ir-riċetturi u jimblokka s-senjalazzjoni intraċellulari li hi kruċjali għall-proliferazzjoni u sopravivenza ta' ċelluli endoteljali kif ukoll ċelluli perivaskulari (periċiti u ċelluli vaskulari tal-muskoli lixxi).
English: DCE-MRI effects were seen 24 - 48 h after the first intake of the medicinal product and were preserved or even increased after continuous treatment over several weeks.
Maltese: Effetti DCE-MRI ġew osservati 24-48 siegħa wara l-ewwel teħid tal-prodott mediċinali u kienu ppreservati jew saħansitra anki żdiedu wara kura kontinwa fuq perjodu ta' diversi ġimgħat.
English: Nintedanib is a triple angiokinase inhibitor blocking vascular endothelial growth factor receptors (VEGFR 1-3), platelet-derived growth factor receptors (PDGFR α and ß) and fibroblast growth factor receptors (FGFR 1-3) kinase activity.
Maltese: Nintedanib hu inibitur tal-angiokinase triplu li jimblokka l-attività tal-kinase tar-riċetturi tal-fattur tat-tkabbir endoteljali vaskulari (VEGFR 1-3), tar-riċetturi tal-fattur tat-tkabbir derivati mill-plejtlits (PDGFR α u ß) u tar-riċetturi tal-fattur tat-tkabbir fibroblast (FGFR 1-3) .
English: Peripheral neuropathy was reported in 16.5 % of patients in the placebo arm and in 19.1 % of patients in the nintedanib arm.
Maltese: Newropatija periferali ġiet irrappurtata f'16.5 % tal-pazjenti fil-parti tal-istudju dwar il-plaċebo u f'19.1 % tal-pazjenti fil-parti tal-istudju dwar nintedanib.
English: The following medicines may increase the blood levels of nintedanib, the active substance of Vargatef, and hence may increase the risk for side effects (see section 4): - Ketoconazole (used to treat fungal infections) - Erythromycin (used to treat bacterial infections) The following medicines may decrease the blood levels of nintedanib and thus may lead to reduction of the effectiveness of Vargatef: - Rifampicin (an antibiotic used to treat tuberculosis) - Carbamazepine, phenytoin (used to treat seizures) - St. John's Wort (a herbal medicine to treat depression)
Maltese: Il-mediċini li ġejjin jistgħu jżidu l-livelli ta' nintedanib fid-demm, is-sustanza attiva ta' Vargatef, u dan jista' jżid ir-riskju ta' effetti sekondarji (ara sezzjoni 4): - Ketoconazole (jintuża biex jikkura infezzjonijiet fungali) - Erythromycin (jintuża biex jikkura infezzjonijiet batterjali)
English: Diarrhoea ≥ grade 3 despite anti-diarrhoeal treatment
Maltese: Dijarea ta' ≥ grad 3 minkejja l-kura kontra d-dijarea
English: Patients with low body weight (< 65 kg), Asian and female patients have a higher risk of elevations in liver enzymes.
Maltese: Pazjenti b'piż tal-ġisem baxx (< 65 kg), pazjenti Asjatiċi u nisa, għandhom riskju ogħla ta' żidiet fl-enzimi tal-fwied.
English: Diarrhoea, Vomiting, Nausea, Abdominal pain
Maltese: Dijarea, Rimettar, Nawseja, Uġigħ addominali
English: Supportive care for nausea and vomiting may include medicinal products with anti-emetic properties, e.g. glucocorticoids, anti-histamines or 5-HT3 receptor antagonists and adequate hydration.
Maltese: Kura ta' appoġġ għal nawseja u rimettar jistgħu jinkludu prodotti mediċinali bi propjetajiet kontra r-rimettar, eż. glukokortikojdi, antistamini jew antagonisti tar-riċetturi 5-HT3 u idratazzjoni adegwata.
English: Cases of pulmonary embolism have been reported.
Maltese: Ġew irrappurtati każijiet ta' emboliżmu pulmonari.
English: Decreased appetite, Electrolyte imbalance
Maltese: Tnaqqis fl-aptit, Żbilanċ fl-elettroliti
English: th
Maltese: JEW
English: Diarrhoea should be treated at first signs with adequate hydration and anti-diarrhoeal medicinal products, for example loperamide, and may require interruption, dose reduction or discontinuation of therapy with Vargatef (see section 4.2).
Maltese: Id-dijarea għandha tiġi kkurata mal-ewwel sinjali b'idratazzjoni adegwata u prodotti mediċinali kontra d-dijarea, pereżempju, loperamide, u tista' tkun teħtieġ interruzzjoni, tnaqqis fid-doża jew it-twaqqif tat-terapija b'Vargatef (ara sezzjoni 4.2).
English: In a post-hoc analysis in adenocarcinoma patients having progressed and entered the trial ≥ 9 months since start of their first-line therapy the difference did not reach statistical significance (HR for OS: 0.89, 95 % CI 0.66 - 1.19).
Maltese: F'analiżi post-hoc f'pazjenti b'adenokarċinoma li pprogressaw u daħlu fil-prova ≥ 9 xhur mill-bidu tat-terapija primarja tagħhom, id-differenza ma laħqitx sinifikanza statistika (HR għal OS: 0.89, 95 % CI 0.66-1.19).
English: Febrile neutropenia, Abscesses, Sepsis
Maltese: Newtropenija bid-deni, Axxessi, Sepsis
English: The safety, efficacy, and pharmacokinetics of nintedanib have not been studied in patients with severe renal impairment (< 30 ml/min creatinine clearance).
Maltese: Is-sigurtà, 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 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' ester cleavage.
English: In the overall population, 16.0 % of the patients had disease stage < IIIB/IV, 22.4 %, had disease stage IIIB and 61.6 % had disease stage IV. 9.2 % of the patients entered the trial with locally recurrent disease stage as had been evaluated at baseline.
Maltese: Fil-popolazzjoni globali, 16.0 % tal-pazjenti kellhom stadju tal-marda ta' < IIIB/IV, 22.4 %, kellhom stadju tal-marda ta' IIIB u 61.6 % kellhom stadju tal-marda ta' IV.
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: A multipack containing 120 capsules (2 boxes of 60 capsules each, bundled together by a wrapping foil).
Maltese: - Pakkett multiplu li fih 120 kapsula (2 kaxxi ta' 60 kapsula kull waħda, marbutin ma' xulxin permezz ta' wrapping foil).
English: What Vargatef looks like and contents of the pack Vargatef 150 mg soft capsules (capsules) are brown-coloured, opaque, oblong capsules imprinted on one side in black with the Boehringer Ingelheim company symbol and the figure “150”.
Maltese: Vargatef 150 mg kapsuli rotob (kapsuli) huma kapsuli ta' kulur kannella, opaki, oblungi, stampati fuq naħa waħda bl-iswed bis-simbolu tal-kumpanija Boehringer Ingelheim u n-numru “150”.
English: Unless there is an alternative cause established, Vargatef should be permanently discontinued (see also section 4.4).
Maltese: Ħlief jekk ikun hemm kawża alternattiva stabbilita, Vargatef għandu jitwaqqaf b'mod permanenti (ara wkoll sezzjoni 4.4).
English: The rates of sepsis (1.3 %) and febrile neutropenia (7.5 %) were increased under treatment with nintedanib as compared to the placebo arm.
Maltese: Ir-rati ta' sepsis (1.3 %) u newtropenija bid-deni (7.5 %) żdiedu bil-kura b'nintedanib meta mqabbla mal-parti tal-istudju dwar il-plaċebo.
English: For patients with tumour of adenocarcinoma histology, 15.8 % had disease stage < IIIB/IV, 15.2 %, had disease stage IIIB and 69.0 % had disease stage IV. 5.8 % of the adenocarcinoma patients entered the trial with locally recurrent disease stage as had been evaluated at baseline.
Maltese: Għal pazjenti li kellhom istoloġija ta' tumur b'adenokarċinoma, 15.8 % kellhom stadju tal-marda ta' < IIIB/IV, 15.2 %, kellhom stadju tal-marda ta' IIIB u 69.0 % kellhom stadju tal-marda ta' IV.
English: Your doctor may reduce your recommended dose to 300 mg per day (two capsules of 150 mg).
Maltese: It-tabib tiegħek jista' jnaqqas id-doża rakkomandata tiegħek għal 300 mg kuljum (żewġ kapsuli ta' 150 mg).
English: For information about special populations, recommended measures and dosing adjustments in case of liver enzyme and bilirubin elevations, see sections 4.4 and 4.2, respectively.
Maltese: Għal informazzjoni dwar popolazzjonijiet speċjali, miżuri rakkomandati u aġġustamenti fid-dożaġġ f'każ ta' żidiet fl-enzimi tal-fwied u fil-bilirubina, ara sezzjonijiet 4.4 u 4.2, rispettivament.
English: The recommended dose of nintedanib is 200 mg twice daily administered approximately 12 hours apart, on days 2 to 21 of a standard 21 day docetaxel treatment cycle.
Maltese: Id-doża rakkomandata ta' nintedanib hi ta' 200 mg darbtejn kuljum mogħtija f'intervall ta' madwar 12-il siegħa, f'jiem 2 sa 21 ta' ċiklu ta' kura standard ta' 21 jum ta' docetaxel.
English: Elevation of AST and/or ALT values to > 3 x ULN in conjunction with an increase of total bilirubin to ≥ 2 x ULN and ALKP < 2 x ULN
Maltese: Żidiet fil-valuri ta' AST u/jew ALT għal > 3 x ULN flimkien ma' żieda fil-bilirubina totali għal ≥ 2 x ULN u ALKP < 2 x ULN
English: Perforation
Maltese: Manifattur
English: The safety, efficacy and pharmacokinetics of nintedanib have not been investigated in patients with severe hepatic impairment (Child Pugh C).
Maltese: Is-sigurtà, l-effikaċja u l-farmakokinetika ta' nintedanib ma ġewx investigati f'pazjenti b'indeboliment tal-fwied sever (Child Pugh Ċ).
English: The recommended dose is four capsules per day (this is a total of 400 mg nintedanib per day).
Maltese: Id-doża rakkomandata hi ta' erba' kapsuli kuljum (dan huwa total ta' 400 mg nintedanib kuljum ).
English: Diarrhoea was the most frequently reported gastro-intestinal adverse reaction and appeared in close temporal relationship with the administration of docetaxel (see section 4.8).
Maltese: Id-dijarea kienet ir-reazzjoni avversa gastrointestinali li ġie rrappurtat bl-aktar mod frekwenti u deher f'relazzjoni temporali mill-qrib mal-għoti ta' docetaxel (ara sezzjoni 4.8).
English: Sepsis and febrile neutropenia have been reported as subsequent complications of neutropenia.
Maltese: Sepsis u newtropenija bid-deni ġew irrappurtati bħala kumplikazzjonijiet sussegwenti ta' newtropenija.
English: Randomization was stratified according to Eastern Cooperative Oncology Group (ECOG) status (0 versus 1), bevacizumab pretreatment (yes versus no), brain metastasis (yes versus no) and tumour histology (squamous versus non-squamous tumour histology).
Maltese: L-għażla b'mod każwali ġiet stratifikata skont l-istat tal-Koperattiva tal-Grupp tal-Onkoloġija tal-Lvant (ECOG) (0 kontra 1), kura minn qabel bi bevacizumab (iva kontra le), metastasi tal-moħħ (iva kontra le) u istoloġija tat-tumur (istoloġija tat-tumur skawmuża kontra mhux skawmuża).
English: After treatment interruption and recovery of transaminase-values to ≤ 2.5 x ULN in conjunction with bilirubin to normal, dose reduction from 200 mg twice daily to 150 mg twice daily and - if a 2
Maltese: Wara interruzzjoni tal-kura u l-irkupru tal-valuri ta' transaminase għal ≤ 2.5 x ULN, flimkien ma' livell normali ta' bilirubina, tnaqqis fid-doża minn 200 mg darbtejn kuljum għal 150 mg darbtejn kuljum u - jekk it-tieni tnaqqis fid-doża jiġi kkunsidrat li hu meħtieġ - minn 150 mg darbtejn kuljum għal 100 mg darbtejn kuljum.
English: Since the effect of nintedanib on the metabolism and efficacy of contraceptives has not been investigated, barrier methods should be applied as a second form of contraception, to avoid pregnancy.
Maltese: Billi l-effett ta' nintedanib fuq il-metaboliżmu u l-effikaċja tal-kontraċettivi ma ġiex investigat, metodi barriera għandu jiġi applikati bħala t-tieni forma ta' kontraċezzjoni, biex tiġi evitata t-tqala.
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 glucuronide tiegħu, ma inibixxewx jew ma induċewx enzimi ta' CYP fi studji prekliniċi (ara sezzjoni 5.2).
English: Venous thromboembolism Hypertension
Maltese: Tromboemboliżmu venuż
English: Each soft capsule contains100 mg nintedanib (as esilate).
Maltese: Kull kapsula ratba fiha 100 mg ta' nintedanib (bħala esilate).
English: ° Adjusted mean of best-% change from baseline and p-value generated from an ANOVA model adjusting for baseline ECOG PS (0 versus 1), brain metastases at baseline (yes versus no) and prior treatment with bevacizumab (yes versus no).
Maltese: ° Medja aġġustata tal-aħjar bidla f'% mil-linja bażi u valur p iġġenerata minn mudell ANOVA li jaġġusta għal ECOG PS fil-linja bażi (0 kontra 1), metastasijiet tal-moħħ fil-linja bażi (iva kontra le) u kura fil-passat b'bevacizumab (iva kontra le).
English: Тел: +359 2 958 79 98
Maltese: Tel: +353 1 295 9620
English: Patients with recent pulmonary bleeding (> 2.5 ml of red blood) as well as patients with centrally located tumours with radiographic evidence of local invasion of major blood vessels or radiographic evidence of cavitary or necrotic tumours have been excluded from clinical trials.
Maltese: Pazjenti bi ħruġ ta' demm pulmonari riċenti (> 2.5 ml ta' demm aħmar) kif ukoll pazjenti b'tumuri lokalizzati ċentralment b'evidenza radjografika ta' invażjoni lokali ta' vini/arterji maġġuri tad-demm jew evidenza radjografika ta' tumuri kavitarji jew nekrotiċi ġew esklużi mill-provi kliniċi.
English: After food intake, nintedanib exposure increased by approximately 20 % compared to administration under fasted conditions (CI: 95.3 - 152.5 %) and absorption was delayed (median tmax fasted: 2.00 hours; fed: 3.98 h).
Maltese: 3-152.5 %) u l-assorbiment ittardja (medjan tmax stat sajjem: 2.00 sagħtejn; ikel: 3.98 sigħat).
English: However, an increased frequency of arterial thromboembolic events was observed in patients with idiopathic pulmonary fibrosis (IPF) when treated with nintedanib monotherapy.
Maltese: Madankollu, żieda fil-frekwenza ta' avvenimenti tromboemboliċi arterjali ġiet osservata f'pazjenti b'fibrożi pulmonari idjopatika (IPF) meta kkurati b'nintedanib waħdu.
English: Logistic regression revealed a statistically significant association between nintedanib exposure and DCE-MRI response.
Maltese: Rigressjoni loġistika żvelat assoċjazzjoni statistikament sinifikanti bejn l-esponiment għal nintedanib u r-rispons DCE-MRI.
English: In case of specific changes in liver values (AST/ALT > 3 x ULN; total bilirubin ≥ 2 x ULN and ALKP < 2 x ULN) treatment with Vargatef should be interrupted.
Maltese: Fil-każ ta' tibdil speċifiku fil-valuri tal-fwied (AST/ALT ta' > 3 x ULN; bilirubina totali ta' ≥ 2 x ULN u ALKP ta' < 2 x ULN) il-kura b'Vargatef għandha tiġi interrotta.
English: Based on population pharmacokinetic (PK) analyses, no a priori dose adjustments of Vargatef are necessary (see section 5.2).
Maltese: Ibbażat fuq analiżi tal-farmakokinetika (PK) tal-popolazzjoni, l-ebda aġġustamenti fid-doża a priori ta' Vargatef mhuma meħtieġa (ara sezzjoni 5.2).
English: Printing ink
Maltese: , Pressjoni għolja
English: The recommended dose is two capsules per day (this is a total of 300 mg nintedanib per day).
Maltese: Id-doża rakkomandata hi ta' żewġ kapsuli kuljum (dan huwa total ta' 300 mg nintedanib kuljum).
English: What Vargatef contains The active substance is nintedanib.
Maltese: X'fih Vargatef Is-sustanza attiva hi nintedanib.
English: If you cannot tolerate the recommended dose of 300 mg per day because of side effects (see section 4), your doctor may reduce your recommended daily dose of Vargatef to 200 mg per day (two capsules of 100 mg).
Maltese: Jekk ma tistax tittollera d-doża rakkomandata ta' 300 mg kuljum minħabba l-effetti sekondarji (ara sezzjoni 4), it-tabib tiegħek jista' jnaqqas id-doża ta' kuljum ta' Vargatef għal 200 mg kuljum (żewġ kapsuli ta' 100 mg).
English: Glycerol (85 %) Titanium dioxide (E171)
Maltese: Glycerol (85 %) Titanium dioxide (E171) Iron oxide red (E172) Iron oxide yellow (E172)
English: Table 3 summarizes the frequencies of adverse drug reactions that were reported in the pivotal trial LUME-Lung 1 for patients with NSCLC of adenocarcinoma tumour histology (n = 320) or from the post-marketing period.
Maltese: Tabella 3 turi fil-qosor il-frekwenzi tar-reazzjonijiet avversi tal-mediċina li ġew irrappurtati fil-prova importanti ħafna LUME-Lung 1 għal pazjenti b'NSCLC ta' istoloġija ta' tumur adenokarċinoma (n = 320) jew mill-perjodu ta' wara t-tqegħid fis-suq.
English: For recommended measures and dosing adjustments in case of diarrhoea, see sections 4.4 and 4.2, respectively.
Maltese: Għal miżuri rakkomandati u aġġustamenti fid-dożaġġ f'każ ta' dijarea, ara sezzjonijiet 4.4 u 4.2, rispettivament.
English: Population pharmocokinetic analysis in special populations The pharmacokinetic properties of nintedanib were similar in healthy volunteers, cancer patients, and patients of the target population.
Maltese: Il-proprjetajiet farmakokinetiċi ta' nintedanib kienu simili f'voluntiera b'saħħithom, pazjenti bil-kanċer, u pazjenti tal-popolazzjoni fil-mira.
English: The major route of elimination of drug related radioactivity after oral administration of [14C] nintedanib was via faecal/biliary excretion (93.4 % of dose, 2.61 % gCV).
Maltese: Ir-rotta ewlenija tal-eliminazzjoni tar-radjuattività assoċjata mal-mediċina wara l-għoti orali ta' [14C] nintedanib kienet permezz ta' tneħħija mal-ippurgar/biljari (93.4 % tad-doża, 2.61 % gCV) Il-kontribuzzjoni tat-tneħħija mill-kliewi għat-tneħħija totali kienet baxxa (0.649 % tad-doża, 26.3 % gCV).
English: Jaundice (hyperbilirubinaemia)
Maltese: Newtropenija (tinkludi newtropenija bid-deni)
English: One box contains 60 capsules (6 aluminium blisters of 10 capsules each).
Maltese: - Kaxxa waħda fiha 60 kapsula (6 folji tal-aluminju li fihom 10 kapsuli kull waħda).
English: Elevation of AST and/or ALT values to > 5 x ULN
Maltese: Ż ieda fil-valuri ta' AST u/jew ALT għal > 5 x ULN
English: Bleeding (see section 4.4)
Maltese: Ħruġ ta' demm (ara sezzjoni 4.4)
English: NAME OF THE MEDICINAL PRODUCT Vargatef 150 mg capsules Nintedanib
Maltese: Vargatef 150 mg kapsuli Nintedanib
English: The safety and efficacy of Vargatef in children aged 0-18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Vargatef fit-tfal minn etá ta' 0-18-il sena għadhom ma ġewx determinati s'issa.
English: Plasma levels of electrolytes should be monitored, if relevant gastrointestinal adverse events occur.
Maltese: Il-livelli tal-elettroliti fil-plażma għandhom jiġu mmonitorjati, jekk iseħħu avvenimenti avversi gastrointestinali rilevanti.
English: In trial 1199.13 (LUME-Lung 1), there was a higher frequency of SAEs in patients treated with nintedanib plus docetaxel with a body weight of less than 50 kg compared to patients with a weight ≥ 50 kg; however the number of patients with a body weight of less than 50 kg was small.
Maltese: 13 (LUME-Lung 1), kien hemm frekwenza ogħla ta' SAEs f'pazjenti kkurati b'nintedanib flimkien ma' docetaxel b'piż tal-ġisem ta' inqas minn 50 kg meta mqabbla ma' pazjenti b'piż tal-ġisem ta' ≥ 50 kg; madankollu, in-numru ta' pazjenti b'piż tal-ġisem ta' inqas minn 50 kg kien żgħir.
English: In rabbits, embryofoetal lethality was observed at an exposure approximately 8 times higher than at the MRHD.
Maltese: Fil-fniek, ġiet osservata letalità embrijofetali f'esponiment ta' madwar 8 darbiet ogħla milli fl-MRHD.
English: Five point eight percent (5.8 %) of the patients had stable brain metastasis at trial entry and 3.8 % had prior bevacizumab treatment.
Maltese: Ħamsa punt tmienja fil-mija (5.8 %) tal-pazjenti kellhom metastasi stabbli tal-moħħ meta daħlu fil-prova u 3.8 % kellhom kura bi bevacizumab fil-passat.
English: Neutropenia, febrile neutropenia and sepsis
Maltese: Newtropenija, newtropenija bid-deni u sepsis
English: In preclinical in vivo experiments, BIBF 1202 did not show efficacy despite its activity at target receptors of the substance.
Maltese: F'esperimenti ta' qabel l-użu kliniku in vivo, BIBF 1202 ma weriex effikaċja minkejja l-attività tiegħu fir-riċetturi fil-mira tas-sustanza.
English: NAME OF THE MEDICINAL PRODUCT Vargatef 100 mg capsules Nintedanib
Maltese: Vargatef 100 mg kapsuli Nintedanib
English: Data on bio-/tumour markers from all clinical studies in the clinical program for nintedanib.
Maltese: 3. Dejta dwar il-bijomarkaturi/markaturi tat-tumuri mill-istudji kliniċi kollha fil-programm kliniku għal nintedanib.
English: What Vargatef looks like and contents of the pack Vargatef 100 mg soft capsules (capsules) are peach-coloured, opaque, oblong capsules imprinted on one side in black with the Boehringer Ingelheim company symbol and the figure “100”.
Maltese: Vargatef 100 mg kapsuli rotob (kapsuli) huma kapsuli ta' kulur il-ħawħ, opaki, oblungi, stampati fuq naħa waħda bl-iswed bis-simbolu tal-kumpanija Boehringer Ingelheim u n-numru “100”.
English: The safety, efficacy and pharmacokinetics of nintedanib have not been studied in patients with severe hepatic impairment (Child Pugh C).
Maltese: Is-sigurtà, l-effikaċja u l-farmakokinetika ta' nintedanib ma ġewx studjati f'pazjenti b'indeboliment sever tal-fwied (Child Pugh Ċ).
English: Brain metastasis
Maltese: Reazzjoni allerġika
English: In a drug-drug interaction study with the potent P-gp inducer rifampicin, exposure to nintedanib decreased to 50.3 % based on AUC and to 60.3 % based on Cmax upon co-administration with rifampicin compared to administration of nintedanib alone.
Maltese: Fi studju dwar l-interazzjonijiet bejn mediċina u oħra bl-induttur potenti ta' P-gp rifampicin, l-esponiment għal nintedanib naqas għal 50.3 % ibbażat fuq l-AUC u għal 60.3 %ibbażat fuq is-Cmax mal-għoti flimkien ma' rifampicin meta mqabbel mal-għoti ta' nintedanib waħdu.
English: wrapped in plastic foil).
Maltese: (mukożite, li tinkludi stomatite)
English: The efficacy and safety of Vargatef was investigated in 1314 adult patients with locally advanced, metastatic or recurrent NSCLC after one prior line of chemotherapy.
Maltese: L-effikaċja u s-sigurtà ta' Vargatef ġiet investigata f'1,314-il pazjent adult b'NSCLC lokalment avvanzat, metastatiku jew rikorrenti wara kors wieħed ta' kimoterapija fil-passat.
English: Increased liver enzyme values (alanine aminotransferase, aspartate aminotransferase, blood alkaline phosphatase) in the blood as seen from blood tests Hair loss (alopecia)
Maltese: Żieda f'alanine aminotransferase (ALT), Żieda f'aspartate aminotransferase (AST), Żieda f'alkaline phosphatase (ALKP) fid-demm
English: Population PK analyses indicated moderate effects on exposure to nintedanib depending on age, body weight, and race (see below).
Maltese: Analiżijiet PK tal-popolazzjoni indikaw effetti moderati fuq l-esponiment għal nintedanib skontl-età, il-piż tal-ġisem u r-razza (ara hawn taħt).