FrancophonIA/ELRC3.0 huggingface dataset:
English: 27.0 vs. 8.0 HR 0.60; p=0.0062
Maltese: HR 0.60; p=0.0062
English: The efficacy results are provided in Figure 1, Tables 6 and 7.
Maltese: Ir-riżultati tal-effikaċja huma mogħtija fil-Figura 1, Tabelli 6 u 7.
English: The respective total systemic exposure (AUC) was either slightly above (2.2 times in rats) or below (0.3 times in rabbits) compared with levels in patients.
Maltese: L-esponiment sistemiku totali rispettiv (AUC) kien jew ftit ogħla (2.2 darbiet fil-firien) jew taħt (0.3 darbiet fil-fniek) meta mqabbel mal-livelli fil-pazjenti.
English: The acquisition of a secondary T790M mutation is a major mechanism of acquired resistance to afatinib and gene dosage of the T790M-containing allele correlates with the degree of resistance in vitro.
Maltese: L-akkwiżizzjoni ta' mutazzjoni T790M sekondarja hija mekkaniżmu maġġuri ta' reżistenza akkwistata għal afatinib u dożaġġ tal-ġene tal-allele li fihom T790M jikkorelata mal-grad ta' reżistenza in vitro.
English: Boehringer Ingelheim RCV GmbH & Co KG Eesti Filiaal
Maltese: Boehringer Ingelheim RCV GmbH & Co
English: Patients with severe skin reactions may also require temporary interruption of therapy, dose reduction (see section 4.2), additional therapeutic intervention, and referral to a specialist with expertise in managing these dermatologic effects.
Maltese: Pazjenti b'reazzjonijiet severi tal-ġilda jistgħu wkoll ikunu jeħtieġu interruzzjoni temporanja tat-terapija, tnaqqis fid-doża (ara sezzjoni 4.2), intervent terapewtiku addizzjonali, u riferiment għand speċjalista b'kompetenza fl-immaniġġjar ta' dawn l-effetti dermatoloġiċi.
English: Smoking history, alcohol consumption (limited data), or presence of liver metastases had no significant impact on the pharmacokinetics of afatinib.
Maltese: Storja medika ta' tipjip, konsum ta' alkoħol (dejta limitata), jew il-preżenza ta' metastasi tal-fwied, ma kellhom l-ebda impatt sinifikanti fuq il-farmakokinetika ta' afatinib.
English: values presented for GIOTRIF vs. erlotinib, p-value based on logistic regression b p-value for time to deterioration based on stratified log-rank test c p-values were not adjusted for multiplicity
Maltese: valuri ppreżentati għal GIOTRIF vs. erlotinib, valur p fuq il-bażi ta' rigressjoni loġistika valur p għaż-żmien sad-deterjorament fuq il-bażi ta' test stratifikat ta' log-rank il-valuri p ma kinux aġġustati għall-multipliċità
English: One film-coated tablet contains 235 mg lactose (as monohydrate).
Maltese: Pillola waħda miksija b'rita fiha 235 mg ta' lactose (bħala monohydrate).
English: Hazard Ratio (HR) (95%CI) p-value
Maltese: Proporzjon ta' Periklu (HR) (95%CI) valur p
English: Liver function test abnormalities (including elevated ALT and AST) were observed in patients receiving GIOTRIF 40 mg.
Maltese: Ġew osservati anormalitajiet fit-test tal-funzjoni tal-fwied (li jinkludu livelli għoljin ta' ALT u AST) f'pazjenti li kienu qed jirċievu GIOTRIF 40 mg.
English: One film-coated tablet contains 118 mg lactose (as monohydrate).
Maltese: Pillola waħda miksija b'rita fiha 118 mg ta' lactose (bħala monohydrate).
English: One film-coated tablet contains 176 mg lactose (as monohydrate).
Maltese: Pillola waħda miksija b'rita fiha 176 mg ta' lactose (bħala monohydrate).
English: Rhinorrhoea
Maltese: OĦRAJN
English: • Inflammation of the lungs (uncommon, may affect up to 1 in 100 people) called “interstitial lung disease”.
Maltese: • Infjammazzjoni tal-pulmun (tista' taffettwa sa 1 minn kull 100 persuna) imsejħa “mard interstizjali tal-pulmun”.
English: The tablet should be dropped into the water without crushing it, and stirred occasionally for up to 15 min until it is broken up into very small particles.
Maltese: Itfa' l-pillola ġol-ilma mingħajr ma tfarrakha, u kultant ħawwad l-ilma għal sa 15-il minuta sakemm il-pillola tinqasam fi frak żgħir ħafna.
English: OS results based on primary OS analysis as of April 2016 at event rates of 109 (68.1%) and 117 (73.6%) in the GIOTRIF and gefitinib arms, respectively p-value for PFS/OS based on stratified log-rank test; p-value for Objective Response Rate based on stratified logistic regression
Maltese: Riżultati tal-OS ibbażati fuq analiżi tal-OS primarja minn April 2016 f'rati ta' każijiet ta' 109 (68.1%) u 117 (73.6%) fil-fergħat ta' GIOTRIF u gefitinib, rispettivament
English: Monitor patients with severe renal impairment (eGFR 15-29 mL/min/1.73m²) and adjust GIOTRIF dose if not tolerated.
Maltese: Immonitorja l-pazjenti b'indeboliment tal-kliewi sever (eGFR 1529 mL/min/1.73m²) u aġġusta d-doża ta' GIOTRIF jekk din ma tkunx ittollerata.
English: Food should not be consumed for at least 3 hours before and at least 1 hour after taking this medicinal product (see sections 4.5 and 5.2).
Maltese: M'għandux jiġi kkunsmat ikel għal mill-inqas 3 sigħat qabel u mill-inqas siegħa wara li pazjent jieħu dan il-prodott mediċinali (ara sezzjonijiet 4.5 u 5.2).
English: The T790M mutation is found in approximately 50% of patients' tumours upon disease progression on afatinib, for which T790M targeted EGFR TKIs may be considered as a next line treatment option.
Maltese: Il-mutazzjoni T790M tinstab f'madwar 50% tat-tumuri tal-pazjenti hekk kif tavvanza l-marda fuq afatinib, li għalihom jistgħu jiġu kkunsidrati TKIs tal-EGFR immirati għal T790M bħala l-għażla ta' kura li jmiss.
English: There was limited data available for moderate and severe hepatic impairment.
Maltese: Kien hemm dejta limitata disponibbli għal indeboliment moderat u sever tal-fwied.
English: Enzyme-catalyzed metabolic reactions play a negligible role for afatinib in vivo.
Maltese: Reazzjonijiet metaboliċi katalizzati mill-enzimi għandhom rwol negliġibbli għal afatinib in vivo.
English: Grade 1 or Grade 2
Maltese: Grad 1 jew Grad 2
English: In patients with tumours harbouring de-novo T790M mutations (N=14) the confirmed ORR was 14.3% and the median duration of response was 8.3 months.
Maltese: F'pazjenti b'tumuri li fihom mutazzjonijiet T790M de-novo (N=14) l-ORR ikkonfermata kienet ta' 14.
English: Dyspepsia
Maltese: Dispneja
English: Overall Survival (OS) Months (median) Hazard Ratio (HR) (95%CI) p-value
Maltese: Sopravivenza Totali (OS) Xhur (medjan) Proporzjon ta' Periklu (HR) (95%CI) valur p
English: Strong P-gp inducers (including but not limited to rifampicin, carbamazepine, phenytoin, phenobarbital or St. John's wort (Hypericum perforatum)) may decrease exposure to afatinib (see section 4.4).
Maltese: John's wort (Hypericum perforatum), jistgħu jnaqqsu l-esponiment għal afatinib (ara sezzjoni 4.4).
English: Dose adjustment for adverse reactions
Maltese: Sopravivenza ħielsa minn progressjoni
English: In patients with tumours harbouring exon 20 insertions (N=23) the confirmed ORR was 8.7% and the median duration of response was 7.1 months.
Maltese: F'pazjenti b'tumuri b'inserzjonijiet ta' exon 20 (N=23) l-ORR ikkonfermata kienet ta' 8.7% u t-tul medjan tar-rispons kien ta' 7.1 xhur.
English: INFORMATION IN BRAILLE GIOTRIF 50 mg
Maltese: INFORMAZZJONI BIL-BRAILLE GIOTRIF 50 mg
English: You should have antidiarrhoeal medicine available prior to taking GIOTRIF.
Maltese: Għandu jkollok mediċina kontra d-dijarea disponibbli qabel ma tieħu GIOTRIF.
English: • St. John's wort (Hypericum perforatum), a herbal medicine to treat depression.
Maltese: John's wort (Hypericum perforatum), mediċina li ġejja mill-ħxejjex għall-kura tad-dipressjoni.
English: INFORMATION IN BRAILLE GIOTRIF 20 mg
Maltese: INFORMAZZJONI BIL-BRAILLE GIOTRIF 20 mg
English: th percentile) and decreased by 22%
Maltese: th percentile) u naqas bi
English: Liver function test abnormalities
Maltese: Anormalitajiet fit-test tal-funzjoni tal-fwied
English: GIOTRIF 20 mg film-coated tablets One film-coated tablet contains 20 mg afatinib (as dimaleate).
Maltese: GIOTRIF 20 mg pilloli miksija b'rita Pillola waħda miksija b'rita fiha 20 mg ta' afatinib (bħala dimaleate).
English: The types of adverse reactions (ADRs) were generally associated with the EGFR inhibitory mode of action of afatinib.
Maltese: It-tipi ta' reazzjonijiet avversi (ADRs) kienu ġeneralment assoċjati mal-mod ta' azzjoni inibitorju ta' EGFR ta' afatinib.
English: INFORMATION IN BRAILLE GIOTRIF 30 mg
Maltese: INFORMAZZJONI BIL-BRAILLE GIOTRIF 30 mg
English: • Fever
Maltese: • Dardir
English: LIST OF EXCIPIENTS Contains lactose.
Maltese: Din il-mediċina fiha zokkor li jissejjaħ lactose.
English: LUX-Lung 7 is a randomised, global, open label Phase IIb trial investigating the efficacy and safety of GIOTRIF in patients with locally advanced or metastatic lung adenocarcinoma (stage IIIB or IV) with EGFR mutations in the first-line setting.
Maltese: IIb randomizzata, globali bit-tikketta mikxufa li tinvestiga leffikaċja u s-sigurtà ta' GIOTRIF f'pazjenti b'adenokarċinoma tal-pulmun lokalment avvanzata jew metastatika (fażi IIIB jew IV) b'mutazzjonijiet EGFR fl-ambjent tal-ewwel linja.
English: When assessing the EGFR mutation status of a patient, it is important that a well-validated and robust methodology is chosen to avoid false negative or false positive determinations.
Maltese: Meta jiġi evalwat l-istat ta' mutazzjoni ta' EGFR ta' pazjent, hu importanti li tintgħażel metodoloġija vvalidata tajjeb u robusta biex jiġu evitati determinazzjonijiet pożittivi foloz jew negattivi foloz.
English: This means preferably 6 hours (for P-gp inhibitors dosed twice daily) or 12 hours (for P-gp inhibitors dosed once daily) apart from GIOTRIF (see section 4.5).
Maltese: Dan ifisser preferibbilment wara 6 sigħat (għal inibituri ta' P-gp iddożati darbtejn kuljum) jew 12-il siegħa (għal inibituri ta' P-gp iddożati darba kuljum) wara GIOTRIF (ara sezzjoni 4.5).
English: Effects of P-gp and breast cancer resistance protein (BCRP) inhibitors on afatinib In vitro studies have demonstrated that afatinib is a substrate of P-gp and BCRP.
Maltese: Effetti ta' inibituri P-glikoproteina (P-gp) u proteina tar-reżistenza għall-kanċer tas-sider (BCRP) fuq afatinib
English: NCI Common Terminology Criteria for Adverse Events In case of diarrhoea, anti-diarrhoeal medicinal products (e.g. loperamide) should be taken immediately and continued for persistent diarrhoea until loose bowel movements cease.
Maltese: Kriterji ta' Terminoloġija Komuni għal Avvenimenti Avversi tal-Istitut Nazzjonali tal-Kanċer (NCI - National Cancer Institute) F'każ ta' dijarea, prodotti mediċinali kontra d-dijarea (eż. loperamide) għandhom jittieħdu immedjatament u jitkomplew għal dijarea persistenti, sakemm l-ippurgar maħlul jieqaf.
English: 2.5 vs. 2.4 HR 0.99; p=0.8690
Maltese: HR 0.99; p=0.8690
English: Cough
Maltese: Sess
English: INFORMATION IN BRAILLE GIOTRIF 40 mg
Maltese: INFORMAZZJONI BIL-BRAILLE GIOTRIF 40 mg
English: When the strong P-gp and BCRP inhibitor ritonavir (200 mg twice a day for 3 days) was administered 1 hour before a single dose of 20 mg GIOTRIF, exposure to afatinib increased by 48% (area under the curve (AUC0-∞)) and 39% (maximum plasma concentration (Cmax)).
Maltese: Meta l-inibitur qawwi ta' P-gp u BCRP ritonavir (200 mg darbtejn kuljum għal 3 ijiem) ingħata siegħa qabel doża waħda ta' 20 mg ta' GIOTRIF, l-esponiment għal afatinib żdied b'48% (erja taħt il-kurva (AUC0-∞)) u 39%
English: Female gender, lower body weight, and underlying renal impairment Higher exposure to afatinib has been observed in female patients, patients with lower body weight and those with underlying renal impairment (see section 5.2).
Maltese: Sess femminili, piż baxx tal-ġisem, u indeboliment tal-kliewi diġà eżistenti Esponiment ogħla għal afatinib ġie osservat f'pazjenti nisa, pazjenti b'piż baxx tal-ġisem u dawk b'indeboliment tal-kliewi diġà eżistenti (ara sezzjoni 5.2).
English: Overall Survival (OS) Months (median) Hazard Ratio (HR) (95%CI) p-value p-value for PFS/OS based on stratified log-rank test; p-value for Objective Response Rate based on logistic regression CR=complete response; PR=partial response
Maltese: Proporzjon ta' Periklu (HR) (95%CI) valur p il-valur p għal PFS/OS ibbażat fuq test tal-log-rank stratifikat; il-valur p għar-Rata ta' Rispons Oġġettiv ibbażat fuq rigressjoni loġistika
English: The primary endpoint was PFS as assessed by central independent review; secondary endpoints included OS and ORR.
Maltese: Ir-riżultat aħħari primarju kienet sopravivenza ħielsa mill-progressjoni kif ivvalutata minn evalwazzjoni indipendenti ċentrali; ir-riżultati aħħarin sekondarji kienu OS u ORR.
English: Early intervention (such as emollients, antibiotics) of dermatologic reactions can facilitate continuous GIOTRIF treatment.
Maltese: Intervent bikri (bħal emoljenti u antibijotiċi) għal reazzjonijiet dermatoloġiċi, jista' jiffaċilita kura kontinwa b'GIOTRIF.
English: Grade 2 ALT elevations occurred in 1% and Grade 3 elevations occurred in 0.8% of patients treated with GIOTRIF (see section 4.4).
Maltese: Żidiet fl-ALT ta' Grad 2 seħħew f'1% u żidiet tal-Grad 3 seħħew f'0.8% tal-pazjenti kkurati b' GIOTRIF (ara sezzjoni 4.4).
English: Co-administration of a high-fat meal with GIOTRIF resulted in a significant decrease of exposure to afatinib by about 50% in regard to Cmax and 39% in regard to AUC0-∞.
Maltese: L-għoti ta' ikla b'ammont għoli ta' xaħam flimkien ma' GIOTRIF irriżultat fi tnaqqis sinifikanti tal-esponiment għal afatinib b'madwar 50% fir-rigward tas-Cmax u 39% fir-rigward tal-AUC0-∞.
English: The dispersion can also be administered through a gastric tube.
Maltese: Id-dispersjoni tista' tingħata wkoll permezz ta' tubu gastriku.
English: In LUX-Lung-3 Grade 3 ALT/AST elevations were about 3.5 fold higher in patients with abnormal baseline liver tests.
Maltese: F'LUX-Lung 3 iż-żidiet ta' ALT/AST tal-Grad 3 kienu ta' madwar 3.5 darbiet ogħla f'pazjenti b'testijiet anormali tal-fwied fil-linja bażi.
English: Patients with severe diarrhoea may require interruption and dose reduction or discontinuation of therapy with GIOTRIF (see section 4.2).
Maltese: Pazjenti b'dijarea severa jistgħu jkunu jeħtieġu l-interruzzjoni u tnaqqis tad-doża, jew it-twaqqif tat-terapija b'GIOTRIF (ara sezzjoni 4.2).
English: Reporting the frequency of patients with all causality AEs Includes Paronychia, Nail infection, Nail bed infection Includes Stomatitis, Aphthous stomatitis, Mucosal inflammation, Mouth ulceration, Oral mucosa erosion, Mucosal erosion, Mucosal ulceration Includes group of rash preferred terms Includes Acne, Acne pustular, Dermatitis acneiform
Maltese: Disturbi gastro-intestinali Dijarea Stomatite Nawsja Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda Raxx Dermatite qisha akne * Rapportar tal-frekwenza ta' pazjenti b'AEs ta' kawżalità kollha Jinkludi Paronikija, Infezzjoni tad-dwiefer, Infezzjoni fit-tessuti ta' taħt id-dwiefer Jinkudi Stomatite, Stomatite aftuża, Infjammazzjoni tal-mukuża, Ulċeri fil-ħalq, Erożjoni tal-mukuża tal-ħalq, Erożjoni tal-mukuża, Ulċeri fil-mukuża Jinkludi grupp ta' termini preferuti għal raxx Jinkludi Akne, Akne pustulari, Dermatite akneiformi
English: Rash/acne has been reported in patients treated with this medicinal product (see section 4.8).
Maltese: Raxx/akne ġew irrappurtati f'pazjenti kkurati b'dan il-prodott mediċinali (ara sezzjoni 4.8).
English: NAME OF THE MEDICINAL PRODUCT GIOTRIF 20 mg tablets afatinib
Maltese: TAL-PRODOTT MEDIĊINALI GIOTRIF 20 mg pilloli afatinib
English: Covalent adducts to proteins were the major circulating metabolites of afatinib.
Maltese: Adducts kovalenti għal proteini kienu l-metaboliti ta' afatinib li jiċċirkolaw fil-maġġoranza.
English: NAME OF THE MEDICINAL PRODUCT GIOTRIF 30 mg tablets afatinib
Maltese: TAL-PRODOTT MEDIĊINALI GIOTRIF 30 mg pilloli afatinib
English: Gender Female patients had a 15% higher plasma exposure (AUCτ,ss, body weight corrected) than male patients.
Maltese: Pazjenti nisa kellhom esponiment fil-plażma li kien 15% ogħla (AUCτ,ss, piż tal-ġisem ikkoreġut) minn dak ta' pazjenti rġiel.
English: GIOTRIF contains lactose
Maltese: GIOTRIF fih il-lactose
English: Following administration of an oral solution of 15 mg afatinib, 85.4% of the dose was recovered in the faeces and 4.3% in urine.
Maltese: 4% tad-doża ġiet irkuprata fl-ippurgar u 4.3% fl-awrina.
English: What you need to know before you take GIOTRIF 3.
Maltese: X'għandek tkun taf qabel ma tieħu GIOTRIF 3.
English: NAME OF THE MEDICINAL PRODUCT GIOTRIF 50 mg tablets afatinib
Maltese: TAL-PRODOTT MEDIĊINALI GIOTRIF 50 mg pilloli afatinib
English: GIOTRIF 50 mg film-coated tablets One film-coated tablet contains 50 mg afatinib (as dimaleate).
Maltese: GIOTRIF 50 mg pilloli miksija b'rita Pillola waħda miksija b'rita fiha 50 mg ta' afatinib (bħala dimaleate).
English: NAME OF THE MEDICINAL PRODUCT GIOTRIF 40 mg tablets afatinib
Maltese: TAL-PRODOTT MEDIĊINALI GIOTRIF 40 mg pilloli afatinib
English: The highest dose of afatinib studied in a limited number of patients in Phase I clinical trials was 160 mg once daily for 3 days and 100 mg once daily for 2 weeks.
Maltese: L-ogħla doża ta' afatinib studjata f'numru limitat ta' pazjenti fil-provi kliniċi ta' Fażi I kienet ta' 160 mg darba kuljum għal 3 ijiem u 100 mg darba kuljum għal ġimagħtejn.
English: GIOTRIF 20 mg film-coated tablets EU/1/13/879/001
Maltese: GIOTRIF 20 mg pilloli miksija b'rita EU/1/13/879/001 (7 pillola) EU/1/13/879/002 (14 pillola) EU/1/13/879/003 (28 pillola)
English: Dark blue, oval, biconvex film-coated tablet debossed with the code “T50” on one side and the Boehringer Ingelheim company logo on the other.
Maltese: Pillola miksija b'rita, ovali, bikonvessa, ta' lewn blu skur, imnaqqxa bil-kodiċi “T50” fuq naħa waħda u l-Logo ta' Boehringer Ingelheim fuq in-naħa l-oħra.
English: Efficacy in EGFR-negative tumours has not been established.
Maltese: L-effikaċja fit-tumuri negattivi għal EGFR għandha ma ġietx stab-bilita.
English: GIOTRIF 30 mg film-coated tablets One film-coated tablet contains 30 mg afatinib (as dimaleate).
Maltese: GIOTRIF 30 mg pilloli miksija b'rita Pillola waħda miksija b'rita fiha 30 mg ta' afatinib (bħala dimaleate).
English: This medicinal product has not been studied in patients with severe (Child Pugh C) hepatic impairment.
Maltese: Dan il-prodott mediċinali ma ġiex studjat f'pazjenti b'indeboliment sever tal-fwied (Child Pugh Ċ).
English: Left ventricular dysfunction has been associated with HER2 inhibition.
Maltese: Disfunzjoni ventrikulari tax-xellug ġiet assoċjata ma' inibizzjoni ta' HER2.
English: GIOTRIF 20 mg film-coated tablets afatinib
Maltese: GIOTRIF 20 mg pilloli miksija b'rita afatinib
English: P-glycoprotein (P-gp) interactions Concomitant treatment with strong inducers of P-gp may decrease exposure to afatinib (see section 4.5).
Maltese: Kura fl-istess ħin ma' indutturi qawwija ta' P-gp tista' tnaqqas l-esponiment għal afatinib (ara sezzjoni 4.5).
English: Pregnancy and breast-feeding
Maltese: • Infjammazzjoni tal-frixa (pankreatite)
English: CTCAE
Maltese: Treddigħ
English: • if you have liver problems.
Maltese: • jekk għandek problemi tal-fwied.
English: Additionally, in various organs pharmacodynamically mediated atrophy of epithelia was observed in both species.
Maltese: Flimkien ma' dan, f'diversi organi medjati farmakodinamikament, ġiet osservata atrofija tal-epitelja fiż-żewġ speċi.
English: GIOTRIF 40 mg film-coated tablets One film-coated tablet contains 40 mg afatinib (as dimaleate).
Maltese: GIOTRIF 40 mg pilloli miksija b'rita Pillola waħda miksija b'rita fiha 40 mg ta' afatinib (bħala dimaleate).
English: • Verapamil, quinidine, amiodarone - used to treat heart conditions.
Maltese: • Verapamil, quinidine, amiodarone - li jintużaw biex jikkuraw kundizzjonijiet tal-qalb.
English: Similar to LUX-Lung 3, patients with previously untreated NSCLC were screened for EGFR mutations using TheraScreen
Maltese: Simili għal LUX-Lung 3, pazjenti b'NSCLC mhux ikkurata preċedentement ġew skrinjati għal mutazzjonijiet tal-EGFR bl-użu ta' TheraScreen
English: In cases of suspected overdose, GIOTRIF should be withheld and supportive care initiated.
Maltese: L-ommijiet għandhom jingħataw parir biex ma jreddgħux waqt li jkunu qed jirċievu dan il-prodott mediċinali.
English: Muscle spasms
Maltese: Spażmi tal-muskoli
English: GIOTRIF 30 mg film-coated tablets EU/1/13/879/004
Maltese: GIOTRIF 30 mg pilloli miksija b'rita EU/1/13/879/004 (7 pillola) EU/1/13/879/005 (14 pillola) EU/1/13/879/006 (28 pillola)
English: GIOTRIF treatment should be continued until disease progression or until no longer tolerated by the patient (see Table 1 below).
Maltese: Il-kura b'GIOTRIF għandha titkompla sakemm ikun hemm progressjoni tal-marda jew sa meta ma jiġix ittollerat iktar mill-pazjent (ara Tabella 1 hawn taħt).
English: Missed dose
Maltese: Tqala u treddigħ
English: Hypersensitivity to afatinib or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għal afatinib jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1.
English: • Nausea
Maltese: • St.
English: • Stomach pain, indigestion, heartburn
Maltese: • Uġigħ fl-istonku, indiġestjoni, qrusa fl-istonku
English: • if you develop diarrhoea.
Maltese: • jekk tiżviluppa dijarea.
English: Systemic exposure to afatinib is decreased by 50% (Cmax) and 39% (AUC0-∞), when administered with a high-fat meal compared to administration in the fasted state.
Maltese: L-esponiment sistemiku għal afatinib naqas b'50% (Cmax) u 39% (AUC0-∞), meta ngħata ma' ikla b'ħafna xaħam meta mqabbel mal-għoti fl-istat sajjem.
English: Hazard Ratio/ Odds Ratio (95%CI)
Maltese: Proporzjon ta' Periklu/Proporzjon ta' Probabbiltà (95% CI)
English: MedDRA Preferred Term Infections and infestations Paronychia Metabolism and nutrition disorders Decreased appetite Respiratory, thoracic and mediastinal disorders Epistaxis Gastrointestinal disorders Diarrhoea Stomatitis Cheilitis Skin and subcutaneous tissue disorders Rash Dermatitis acneiform Dry skin Pruritus Investigations Weight decreased
Maltese: Ibbażat fuq dejta disponibbli mill-provi kliniċi, m'hemm l-ebda suġġeriment li dan il-prodott mediċinali jikkawża reazzjoni avversa fuq il-kontrattilità kardijaka.
English: Each film-coated tablet contains 20 mg of afatinib (as dimaleate).
Maltese: Kull pillola miksija b'rita fiha 20 mg ta' afatinib (bħala dimaleate).
English: GIOTRIF 50 mg film-coated tablets EU/1/13/879/010
Maltese: GIOTRIF 50 mg pilloli miksija b'rita EU/1/13/879/010 (7 pillola) EU/1/13/879/011 (14 pillola) EU/1/13/879/012 (28 pillola)
English: GIOTRIF 40 mg film-coated tablets EU/1/13/879/007
Maltese: GIOTRIF 40 mg pilloli miksija b'rita EU/1/13/879/007 (7 pillola) EU/1/13/879/008 (14 pillola) EU/1/13/879/009 (28 pillola)
English: Among randomized patients, 65% were female, the median age was 58 years and all patients were of Asian ethnicity.
Maltese: Fost il-pazjenti magħżula b'mod każwali, 65% kienu nisa, l-età medjana kienet 58 sena u l-pazjenti kollha kellhom etniċità Ażjatika.
English: GIOTRIF 50 mg film-coated tablets afatinib
Maltese: GIOTRIF 50 mg pilloli miksija b'rita afatinib
English: Dark blue, round, biconvex and bevel-edged film-coated tablet debossed with the code “T30” on one side and the Boehringer Ingelheim company logo on the other.
Maltese: Pillola miksija b'rita, tonda, bikonvessa u b'tarf illixxat, ta' lewn blu skur, imnaqqxa bil-kodiċi “T30” fuq naħa waħda u l-Logo ta' Boehringer Ingelheim fuq in-naħa l-oħra.
English: th percentile) relative to a patient weighing 62 kg (median body weight of patients in the overall patient population).
Maltese: th percentile) meta mqabbel ma' pazjent li jiżen 62 kg (piż talġisem medjan tal-pazjenti fil-popolazzjoni globali ta' pazjenti).
English: White to yellowish, round, biconvex and bevel-edged film-coated tablet debossed with the code “T20” on one side and the Boehringer Ingelheim company logo on the other.
Maltese: Pillola miksija b'rita, tonda, bikonvessa u b'tarf illixxat, ta' lewn abjad sa safrani, imnaqqxa bil-kodiċi “T20” fuq naħa waħda u l-Logo ta' Boehringer Ingelheim fuq in-naħa l-oħra.
English: • if you have a history of lung inflammation (interstitial lung disease).
Maltese: • jekk għandek storja medika ta' infjammazzjoni tal-pulmun (mard interstizjali tal-pulmun).
English: There were no Grade 3 ALT/AST elevations in patients with abnormal baseline liver tests in LUX-Lung 8 (see section 4.8).
Maltese: Ma kien hemm l-ebda żidiet ta' ALT/AST tal-Grad 3 f'pazjenti b'testijiet tal-fwied fil-linja bażi mhux normali f'LUX-Lung 8 (ara sezzjoni 4.8).