FrancophonIA/ELRC3.0 huggingface dataset:
English: Number of Deaths or Progressions, n (%) Median PFS [months]
Maltese: Numru ta' Mwiet jew Progressjonijiet, n (%) PFS medjan [xhur]
English: th percentile) and increased by 13 % for a 76-year old patient (95
Maltese: th percentile) u żdiedet bi 13 %għal pazjent ta' 76 sena (95
English: INFORMATION IN BRAILLE Vargatef 150 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Vargatef 150 mg
English: Capsule content:Triglyceridesmedium-chain, hard fat, soya lecithin(E322)
Maltese: Kontenut tal-kapsula: Triglycerides medium-chain, xaħam iebes, soya lecithin (E322) Qoxra tal-kapsula:
English: INFORMATION IN BRAILLE Vargatef 100 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Vargatef 100 mg
English: Progression free survival (PFS)* - primary analysis Patients, n
Maltese: Sopravivenza ħielsa minn progressjoni (PFS)* - analiżi primarja Pazjenti, n
English: Observed adverse events were consistent with the known safety profile of nintedanib, i.e. increased liver enzymes and gastrointestinal symptoms.
Maltese: L-avvenimenti avversi osservati kienu konsistenti mal-profil tas-sigurtà magħruf ta' nintedanib, i.e. żieda fl-enzimi tal-fwied u sintomi gastrointestinali.
English: The HR for these patients for PFS and OS was 1.24 (95 % CI: 0.68, 2.28) and 1.09 (95 % CI: 0.70, 1.70), respectively.
Maltese: L-HR għal dawn il-pazjenti għal PFS u OS kien 1.24 (95 % CI: 0.68, 2.28) u 1.09 (95 % CI: 0.70, 1.70), rispettivament.
English: Aspartate aminotransferase (AST) increased,
Maltese: Aspartate aminotransferase;
English: Nintedanib is predominantly eliminated via biliary/faecal excretion (> 90 %).
Maltese: Nintedanib jiġi eliminat b'mod predominanti permezz ta' tneħħija mill-bila/ippurgar (> 90 %).
English: Vargatef 100 mg soft capsules EU/1/14/954/001
Maltese: Vargatef 100 mg kapsuli rotob EU/1/14/954/001
English: Exposure increased in patients with hepatic impairment (Child Pugh A, Child Pugh B; see section 5.2).
Maltese: L-esponiment żdied f'pazjenti b'indeboliment tal-fwied (Child Pugh A, Child Pugh B ; ara sezzjoni 5.2).
English: Neutropenia and sepsis
Maltese: Newtropenija u sepsis
English: The trial included 658 patients (50.1 %) with adenocarcinoma, 555 patients (42.2 %) with squamous cell carcinoma, and 101 patients (7.7 %) with other tumour histologies.
Maltese: Il-prova kienet tinkludi 658 pazjent (50.1 %) b'adenokarċinoma, 555 pazjent (42.2 %) b'karċinoma taċ-ċelluli skwamużi, u 101 pazjent (7.7 %) b'istoloġiji oħrajn ta' tumuri.
English: * CTCAE: Common Terminology Criteria for Adverse Events
Maltese: Kriterji tat-Terminoloġija Komuni għal Avvenimenti Avversi
English: Total plasma clearance after intravenous infusion was high (CL: 1390 mL/min, 28.8 % gCV).
Maltese: It-tneħħija totali mill-plażma wara infużjoni ġol-vini kienet għolja (CL: 1,390 ml/min, 28.8 % gCV).
English: Perforation Pancreatitis
Maltese: Perforazzjoni Pankreatite
English: The disease stage was determined at the time of diagnosis using Union Internationale Contre le Cancer (UICC) / American Joint Committee on Cancer (AJCC) Edition 6 or Edition 7.
Maltese: L-istadju tal-marda ġie stabbilit meta saret id -dijanjosi bl-użu ta' Union Internationale Contre le Cancer (UICC)/American Joint Committee on Cancer ( AJCC) Edizzjoni 6 jew Edizzjoni 7.
English: Vargatef 150 mg soft capsules EU/1/14/954/004
Maltese: Vargatef 150 mg kapsuli rotob EU/1/14/954/004
English: Each capsule contains 1.8 mg of soya lecithin.
Maltese: Kull kapsula fiha 1.8 mg ta' soya lecithin.
English: For the interaction potential of nintedanib with this transporter, see section 4.5.
Maltese: Għall-potenzjal ta' interazzjoni ta' nintedanib ma' dan it-trasportatur, ara sezzjoni 4.5.
English: Each capsule contains 1.2 mg of soya lecithin.
Maltese: Kull kapsula fiha 1.2 mg ta' soya lecithin.
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 fil-free acid moiety BIBF 1202.
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: AST / ALT and bilirubin elevations
Maltese: Żidiet f'AST/ALT u bilirubina
English: Co-administration of nintedanib with docetaxel (75 mg/m²) did not alter the pharmacokinetics of either medicinal product to a relevant extent.
Maltese: L-għoti ta' nintedanib ma' docetaxel (75 mg/m²) ma bidilx il-farmakokinetika tal-ebda wieħed mill-prodotti mediċinali sa grad rilevanti.
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors, ATC code: L01XE31
Maltese: Aġenti antineoplastiċi, inibituri tal-protein kinase, Kodiċi ATC:
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: Aluminium/aluminium blisters containing 10 capsules each.
Maltese: Folji tal-aluminju/aluminju li fihom 10 kapsuli kull waħda.
English: The following terms are used to rank the ADRs by frequency: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Maltese: It-termini li ġejjin jintużaw biex jikklassifikaw l-ADRs skont il-frekwenza: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: No QT prolongation was observed for nintedanib in the clinical trial program (see section 5.1).
Maltese: L-ebda titwil tal-QT ma ġie osservat għal nintedanib fil-programm ta' provi kliniċi (ara sezzjoni 5.1).
English: Overall survival analysis in the overall population did not reach statistical significance (HR 0.94; 95 % CI: 0.83 - 1.05).
Maltese: L-analiżi ta' sopravivenza globali fil-popolazzjoni globali ta' pazjenti ma laħqitx sinifikanza statistika (HR 0.94; 95 % CI: 0.83-1.05).
English: AUCτ,ss decreased by 16 % for a 45-year old patient (5
Maltese: L-AUCτ,ss naqset b'16 %għal pazjent ta' 45 sena (5
English: In the clinical trial LUME-Lung 1 (see section 5.1), the majority of patients had mild to moderate diarrhoea.
Maltese: Fil-prova klinika LUME-Lung 1 (ara sezzjoni 5.1), il-maġġoranza tal-pazjenti kellhom dijarea minn ħafifa sa moderata.
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 8.7fold 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: PHARMACEUTICAL FORM AND CONTENTS Multipack: 120 (2 packs of 60 x1) soft capsules.
Maltese: U KONTENUT Pakkett multiplu: 120 (2 pakketti ta' 60 x 1) kapsula ratba.
English: In a dedicated single dose phase I trial 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 prova ddedikata 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: The addition of nintedanib to docetaxel led to a statistically significant reduction in the risk of progression or death by 21 % for the overall population (hazard ratio (HR) 0.79; 95 % confidence interval (CI): 0.68 - 0.92; p = 0.0019) as determined by the Independent Review Committee.
Maltese: Iż-żieda ta' nintedanib ma' docetaxel wassal għal tnaqqis statistikament sinifikanti fir-riskju ta' progressjoni jew mewt b'21 %għall-popolazzjoni globali ( proporzjon ta' periklu (HR) 0.79; 95 % ta' intervall ta' kunfidenza (CI): 0.68-0.92; p = 0.0019) kif stabbilit mill-Independent Review Committee.
English: Efficacy in the pivotal phase 3 trial LUME-Lung 1
Maltese: Effikaċja fil-prova ta' Fażi 3 ta' importanza kbira, LUME-Lung 1
English: In the pivotal trial 1199.13, 85 patients (12.9 % of the patients with adenocarcinoma histology) were ≥ 70 years of age (median age: 72 years, range: 70 - 80 years) (see section 5.1).
Maltese: 13, 85 pazjent (12.9 %tal-pazjenti b'istoloġija ta' adenokarċinoma) kellhom ≥ 70 sena (età medjana: 72 sena, medda: 70 - 80 sena) (ara sezzjoni 5.1).
English: OS analysis and follow-up PFS-analysis performed when 1121 death cases had been observed in the overall ITT population (535 events in adenocarcinoma patients).
Maltese: ***Analiżi OS u analiżi follow-up PFS imwettqa meta 1,121 każ ta' mewt ġew osservati fil-popolazzjoni ITT globali (535 avveniment f'pazjenti b'adenokarċinoma).
English: Table 3 provides a summary of the adverse reactions by System Organ Class (SOC).
Maltese: Tabella 3 tipprovdi sommarju tar-reazzjonijiet avversi skont is-Sistema tal-Klassifika tal-Organi (SOC).
English: Figure 1: Kaplan-Meier curve for overall survival for patients with adenocarcinoma tumour histology by treatment group in trial LUME-Lung 1
Maltese: Figura 1: Kurva ta' Kaplan-Meier għas-sopravivenza globali għal pazjenti b'istoloġija ta' tumuri adenokarċinoma skont il-grupp ta' kura fil-prova LUME-Lung 1
English: Median OS improved by 3 months (nintedanib: 10.9 months; placebo: 7.9 months).
Maltese: 9 xhur; plaċebo: 7.9 xhur).
English: Vargatef capsules contain the active substance nintedanib.
Maltese: Il-kapsuli Vargatef fihom is-sustanza attiva nintedanib.
English: In case of specific elevations of aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) values to > 3 x upper limit normal (ULN) in conjunction with an increase of total bilirubin to ≥ 2 x ULN and alkaline phosphatase (ALKP) < 2 x ULN (see Table 2) treatment with Vargatef should be interrupted.
Maltese: Fil-każ ta' żidiet speċifiċi tal-valuri ta' aspartate aminotransferase (AST) / alanine aminotransferase (ALT) għal > 3 x tal-limitu normali ta' fuq (ULN) flimkien ma' żieda totali tal-bilirubin għal ≥ 2 x ULN u alkaline phosphatase (ALKP) < 2 x ULN (ara Tabella 2) il-kura b'Vargatef għandha titwaqqaf.
English: A statistically significant improvement in OS favouring treatment with nintedanib plus docetaxel was demonstrated in patients with adenocarcinoma with a 17 % reduction in the risk of death (HR 0.83, p = 0.0359) and a median OS improvement of 2.3 months (10.3 versus 12.6 months, Figure 1).
Maltese: Titjib statistikament sinifikanti fl-OS li jiffavorixxi l-kura b'nintedanib flimkien ma' docetaxel intwera f'pazjenti b'adenokarċinoma bi tnaqqis ta' 17 % fir-riskju ta' mewt (HR 0.83, p = 0.0359) u medjan ta' titjib fl-OS ta' 2.3 xhur (10.3 kontra 12.6 xhur, Figura 1).
English: Treatment of these patients with nintedanib in combination with docetaxel reduced the risk of death by 25 %, compared with placebo plus docetaxel (HR 0.75; 95 % CI: 0.60 - 0.92; p = 0.0073).
Maltese: Il-kura ta' dawn il-pazjenti b'nintedanib flimkien ma' docetaxel naqqset ir-riskju ta' mewt b'25 %, meta mqabbla ma' plaċebo flimkien ma' docetaxel (HR 0.75; 95 % CI: 0.60-0.92; p = 0.0073).
English: Hyperbilirubinaemia, Gammaglutamyltransferase (GGT) increased
Maltese: Iperbilirubinemija, Żieda fil-Gamma-glutamy ltransferase (GGT)
English: Pack-sizes: 60 or 120 capsules, or multipack of 120 (2 x 60) capsules (2 cartons of 60 capsules each,
Maltese: Daqs tal-pakkett: 60 jew 120 kapsula, jew pakkett multiplu ta' 120 (2 x 60) kapsula (2 kartuniet ta'
English: The proportion of adenocarcinoma patients with stage < IIIB/IV at diagnosis was small and balanced across treatment arms (placebo: 54 patients (16.1 %); nintedanib: 50 patients, (15.5 %)).
Maltese: Il-proporzjon ta' pazjenti b'adenokarċinoma bi stadju < IIIB/IV meta saret id-dijanjosi kien żgħir u bbilanċjat fil-partijiet tal-kura (plaċebo: 54 pazjent (16.1 %); nintedanib: 50 pazjent, (15.5
English: CTCAE* Adverse reaction
Maltese: CTCAE* Reazzjoni avversa
English: Vomiting ≥ grade 2
Maltese: Rimettar ta' ≥ grad 2
English: Patients were randomized (1:1) to receive nintedanib 200 mg orally twice daily in combination with 75 mg/m of intravenous docetaxel every 21 days (n = 655) or placebo orally twice daily in combination with 75 mg/m2 of docetaxel every 21 days (n = 659).
Maltese: Il-pazjenti ntgħażlu b'mod każwali (1:1) biex jirċievu nintedanib 200 mg mill-ħalq darbtejn kuljum flimkien ma' 75 mg/m ta' docetaxel ġol-vini kull 21 jum (n = 655) jew plaċebo mill-ħalq darbtejn kuljum flimkien ma' 75 mg/m ta' docetaxel kull 21 jum (n = 659).
English: PHARMACEUTICAL FORM AND CONTENTS 60 x 1 soft capsule
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 60 x 1 kapsula ratba
English: OR
Maltese: JIS
English: PHARMACEUTICAL FORM AND CONTENTS 60 x 1 soft capsule.
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 60 x 1 kapsula ratba.
English: This result was confirmed in the follow-up PFS analysis (HR 0.85, 95 % CI: 0.75 - 0.96; p = 0.0070) which included all events collected at the time of the final OS analysis.
Maltese: Dan ir-riżultat ġie kkonfermat fl-analiżi PFS follow-up (HR 0.85, 95 % CI: 0.75-0.96; p = 0.0070) li kienet tinkludi l-avvenimenti kollha miġbura fil-ħin tal-analiżi OS finali.
English: Patients should be closely monitored for thromboembolic events.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati mill-qrib għal avvenimenti tromboemboliċi.
English: Elevation of liver enzymes (ALT, AST, ALKP, gammaglutamyltransferase (GGT)) and bilirubin were reversible upon dose reduction or interruption in the majority of cases.
Maltese: Żidiet fl-enzimi tal-fwied (ALT, AST, ALKP, gamma-glutamyltransferase (GGT)) u l-bilirubina kienu riversibbli mat-tnaqqis jew l-interruzzjoni tad-doża fil-maġġoranza tal-każijiet.
English: The efficacy of nintedanib has not been investigated in patients with moderate hepatic impairment (Child Pugh B).
Maltese: L-effikaċja ta' nintedanib ma ġietx investigata f'pazjenti b'indeboliment tal-fwied moderat (Child Pugh B).
English: Capsule shell: Gelatin, glycerol (85 %), titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172)
Maltese: Gelatin, glycerol (85 %), titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172)
English: Dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) measurements showed an anti-angiogenic effect of nintedanib in humans.
Maltese: Kejl ta' Dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) wera effett antianġjoġeniku ta' nintedanib fil-bnedmin.
English: Post-marketing bleeding events include but are not limited to gastrointestinal, respiratory and central nervous system organs, with the most frequent being respiratory.
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 huma respiratorji.
English: Other medicines and Vargatef
Maltese: Mediċini oħra u Vargatef
English: AND/OR
Maltese: U/JEW
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 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: 55216 Ingelheim am Rhein GERMANY
Maltese: 55216 Ingelheim am Rhein Il-Ġermanja
English: Post-marketing bleeding events include but are not limited to gastrointestinal, respiratory and central nervous system organs, with the most frequent being respiratory (see also section 4.4).
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 huma respiratorji (ara wkoll sezzjoni 4.4).
English: This could be symptoms of serious liver problems - if you develop fever as this could be a symptom of febrile neutropenia or sepsis (see section 4) - if you experience severe pain in your stomach area, fever, chills, sickness, vomiting, or abdominal rigidity or bloating, as these could be symptoms of a hole in the wall of your gut (‘gastrointestinal perforation') - if you experience pain, swelling, reddening, warmth of a limb or if you experience chest pain and difficulty to breathe as these could be symptoms of a blood clot in one of your veins - if you have any major bleeding - if you experience 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 any side effect(s) you may get (see section 4) becomes serious
Maltese: Dawn jistgħu jkunu sintomi ta' problemi serji tal-fwied - jekk jitlagħlek id-deni, għax dan jista' jkun sintomu ta' newtropenija bid-deni jew sepsis (ara sezzjoni 4) - jekk ikollok uġigħ sever fiż-żona tal-istonku, deni, tertir, mard, nawseja, rimettar jew riġidità jew nefħa fiż-żaqq, għax dawn jistgħu jkunu sintomi ta' toqba fil-ħajt tal-imsaren tiegħek (‘perforazzjoni gastrointestinali') - jekk tħoss uġigħ, nefħa, ħmura, sħana fi driegħ/riġel, jew jekk tħoss uġigħ fis-sider u diffikultà biex tieħu n-nifs għax dawn jistgħu jkunu sintomi ta' embolu tad-demm f'waħda mill-vini tiegħek - jekk ikollok kwalunkwe ħruġ ta' demm maġġuri - jekk ikollok pressjoni jew uġigħ fis-sider, tipikament fuq in-naħa tax-xellug tal-ġisem, uġigħ fl-għonq, xedaq, spalla jew driegħ, rata mgħaġġla ta' taħbit tal-qalb, qtugħ ta' nifs, nawseja, rimettar, għax dawn jistgħu jkunu sintomi ta' attakk tal-qalb - jekk kwalunkwe effett(i) sekondarju(i) li jista' jkollok (ara sezzjoni 4) isir serju
English: Dose adjustments in 100 mg steps per day (i.e. a 50 mg reduction per dosing) based on individual safety and tolerability are recommended as described in Table 1 and Table 2.
Maltese: Aġġustamenti fid-doża f'ammonti ta' 100 mg kuljum (i.e. tnaqqis ta' 50 mg kull dożaġġ) ibbażati fuq is-sigurtà u t-tollerabilità individwali huma rakkomandati kif deskritt f'Tabella 1 u Tabella 2.
English: Pharmacokinetic/pharmacodynamic relationship(s) In exploratory pharmacokinetic adverse event analyses, higher exposure to nintedanib tended to be associated with liver enzyme elevations, but not with gastrointestinal adverse events.
Maltese: Relazzjoni(jiet) farmakokinetika(ċi)/farmakodinamika(ċi) F'analiżijiet farmakokinetiċi esploratorji dwar avvenimenti avversi, esponiment ogħla għal nintedanib kellu tendenza li jiġi assoċjat ma' żieda fl-enzimi tal-fwied, iżda mhux ma' avvenimenti avversi gastrointestinali.
English: Patients treated with Vargatef have an increased risk of venous thromboembolism including pulmonary embolism and deep vein thrombosis.
Maltese: Pazjenti kkurati b'Vargatef għandhom riskju miżjud ta' tromboemboliżmu venuż li jinkludi emboliżmu pulmonari u trombożi tal-vini profondi.
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: 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: Nintedanib reached maximum plasma concentrations approximately 2 - 4 hours after oral administration as soft gelatin capsule under fed conditions (range 0.5 - 8 hours).
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: SCS Boehringer Ingelheim Comm.V
Maltese: SCS Boehringer Ingelheim Comm.V Tél/Tel:
English: Drug-drug interactions between nintedanib and CYP substrates, CYP inhibitors, or CYP inducers are not expected, since nintedanib, BIBF 1202, and BIBF 1202 glucuronide did not inhibit or induce CYP enzymes in preclinical studies nor was nintedanib metabolized by CYP enzymes to a relevant extent.
Maltese: Interazzjonijiet bejn mediċina u oħra bejn nintedanib u substrati ta' CYP, inibituri ta' CYP, jew indutturi ta' CYP, mhumiex mistennija, billi nintedanib, BIBF 1202, u BIBF 1202 glucuronide ma jinibixxux jew jinduċu enzimi ta' CYP fi studji ta' qabel l-użu kliniku u nintedanib lanqas ma kien immetabolizzat minn enzimi ta' CYP għal grad rilevanti.
English: Nausea and vomiting, mostly of mild to moderate severity, were frequently reported gastrointestinal adverse reactions (see section 4.8).
Maltese: Nawseja u rimettar, l-aktar ta' severità minn ħafifa sa moderata, kienu reazzjonijiet avversi gastrointestinali li ġew irrappurtati ta' spiss (ara sezzjoni 4.8).
English: Only a weak inhibitory potential on OCT-1, BCRP, and P-gp was observed in vitro which is considered to be of low clinical relevance.
Maltese: Ġie osservat potenzjal inibitorju dgħajjef biss fuq OCT-1, BCRP, u P-gp in vitro, li hu kkunsidrat li hu ta' rilevanza klinika baxxa.
English: In the overall population, 72.7 % of the patients were male.
Maltese: Fl-popolazzjoni globali, 72.7 %tal-pazjenti kienu rġiel.
English: No. of patients at risk
Maltese: Numru ta' pazjenti f'riskju
English: Liver-related adverse reactions occurred in 42.8 % of nintedanib-treated patients.
Maltese: Reazzjonijiet avversi relatati mal-fwied seħħew fi 42.8 % tal-pazjenti kkurati b'nintedanib.
English: Summary of ADRs per frequency category
Maltese: Tabella 3: Sommarju ta' ADRs skont il-kategorija ta' frekwenza Sistema tal-Klassifika tal-Organi
English: Vargatef 150 mg soft capsules
Maltese: Vargatef 150 mg kapsuli rotob
English: Elevation of AST and/or ALT values to > 2.5 x ULN in conjunction with total bilirubin elevation to ≥ 1.5 x ULN
Maltese: Ż ieda tal-valuri ta' AST u/jew ALT għal > 2.5 x ULN flimkien ma' żieda fil-bilirubina totali għal ≥ 1.5 x ULN
English: AST: Aspartate aminotransferase; ALT: Alanine aminotransferase ALKP: Alkaline phosphatase; ULN: Upper limit normal
Maltese: Alanine aminotransferase ALKP: Alkaline phosphatase;
English: Vargatef 100 mg soft capsules
Maltese: Vargatef 100 mg kapsuli rotob
English: + Odds ratio and p-value were obtained from a logistic regression model adjusted for baseline ECOG Performance Score (0 versus 1).
Maltese: + Il-proporzjon ta' probabbiltà u l-valur p inkisbu minn mudell ta' rigressjoni loġistika aġġustat għal Punteġġ ta' Prestazzjoni ECOG fil-linja bażi (0 kontra 1).
English: In the clinical trial (LUME-Lung 1; see section 5.1) with Vargatef, the frequency of bleeding in both treatment arms was comparable (see section 4.8).
Maltese: Fil-prova klinika (LUME-Lung 1; ara sezzjoni 5.1) b'Vargatef, il-frekwenza ta' ħruġ ta' demm fiż-żewġ partijiet tal-kura kienet komparabbli (ara sezzjoni 4.8).
English: Exposure to nintedanib was not influenced by gender (body weight corrected), mild and moderate renal impairment (estimated by creatinine clearance), liver metastases, ECOG performance score, alcohol consumption, and P-gp genotype.
Maltese: 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), metastasi tal-fwied, il-punteġġ tal-prestazzjoni ECOG, il-konsum ta' alkoħol, u l-ġenotip P-gp.
English: Therapy with Vargatef should be permanently discontinued in patients who develop gastrointestinal perforation.
Maltese: It-terapija b'Vargatef għandha titwaqqaf b'mod permanenti f'pazjenti li jiżviluppaw perforazzjoni gastrointestinali.