FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, it is recommended to administer strong P-gp inhibitors (including but not limited to ritonavir, cyclosporine A, ketoconazole, itraconazole, erythromycin, verapamil, quinidine, tacrolimus, nelfinavir, saquinavir, and amiodarone) using staggered dosing, preferably 6 hours or 12 hours apart from GIOTRIF (see section 4.2).
Maltese: Għalhekk, hu rakkomandat li tagħti inibituri qawwija ta' P-gp (li jinkludu, iżda mhumiex limitati għal ritonavir, cyclosporine A, ketoconazole, itraconazole, erythromycin, verapamil, quinidine, tacrolimus, nelfinavir, saquinavir, u amiodarone) billi jintuża dożaġġ imqassam fuq perjodi ta' ħin, preferibbilment wara 6 jew 12-il siegħa wara GIOTRIF (ara sezzjoni 4.2).
English: Overdose in 2 healthy adolescents involving the ingestion of 360 mg each of afatinib (as part of a mixed drug ingestion) was associated with adverse events of nausea, vomiting, asthenia, dizziness, headache, abdominal pain and elevated amylase (< 1.5 times ULN).
Maltese: Doża eċċessiva f'2 adolexxenti b'saħħithom li kienet tinvolvi l-inġestjoni ta' 360 mg kull wieħed ta' afatinib (bħala parti minn inġestjoni ta' mediċina mħallta) ġiet assoċjata ma' avvenimenti avversi ta' dardir, rimettar, astenja, sturdament, uġigħ ta' ras, uġigħ addominali u livell għoli ta' amylase (< 1.5 darbiet tal-ULN).
English: The total systemic exposure (AUC0-24) in male and female rats was in the range or less than that observed in patients (1.3 times and 0.51 times, respectively).
Maltese: L-esponiment sistemiku totali (AUC0-24) fil-firien irġiel u nisa kien fil-medda jew inqas minn dak osservat fil-pazjenti (1.3 drabi u 0.51 darbiet, rispettivament).
English: Table 7: PFS and OS efficacy results of GIOTRIF vs pemetrexed/cisplatin (LUX-Lung 3) gemcitabine/cisplatin (LUX-Lung 6) in the pre-defined EGFR mutation subgroups Del 19 and L858R (Independent review)
Maltese: Ir-riżultati tal-effikaċja tal-PFS u OS ta' GIOTRIF vs. pemetrexed/cisplatin (LUX-Lung 3) u gemcitabine/cisplatin (LUX-Lung 6) fis-sottogruppi b'mutazzjonijiet tal-EGFR iddefiniti minn qabel Del 19 u L858R (Evalwazzjoni indipendenti).
English: Grade 2 (> 2.5 to 5.0 times upper limit of normal (ULN)) ALT elevations occurred in < 8% of patients treated with this medicinal product.
Maltese: Żidiet fil-livell ta' ALT ta' Grad 2 (> 2.5 sa 5.0 darbiet ogħla mil-limitu ta' fuq tan-normal (ULN) seħħew f'< 8% tal-pazjenti kkurati b'dan il-prodott mediċinali.
English: Exposure to afatinib in subjects with renal impairment was compared to healthy volunteers following a single dose of 40 mg GIOTRIF.
Maltese: L-esponiment għal afatinib f'individwi b'indeboliment tal-kliewi tqabbel ma' voluntiera b'saħħithom wara doża waħda ta' 40 mg GIOTRIF.
English: ILD-like adverse reactions were reported in 0.7% of afatinib treated patients.
Maltese: Reazzjonijiet avversi li jixbħu l-ILD kienu rrappurtati f'0.7% ta' pazjenti kkurati b'afatinib.
English: The most frequent ADRs were diarrhoea and skin related adverse events (see section 4.4) as well as stomatitis and paronychia (see also Table 3, 4 and 5).
Maltese: L-iktar ADRs frekwenti kienu avvenimenti avversi relatati mad-dijarea u l-ġilda (ara sezzjoni 4.4) kif ukoll stomatite u paronikija (ara wkoll Tabelli 3, 4 u 5).
English: Patients had a tumour sample with an EGFR mutation categorised as either exon 19 deletion (58%) or exon 21 L858R substitutions (42%).
Maltese: Il-pazjenti kellhom kampjun ta' tumur b'mutazzjoni EGFR kategorizzata jew bħala tneħħija ta' exon 19 (58%) jew bħala sostituzzjonijiet ta' exon 21 L858R (42%).
English: Animal studies with afatinib did not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Maltese: Studji f'annimali b'afatinib ma urewx effetti diretti jew indiretti tossiċi fuq is-sistema riproduttiva (ara sezzjoni 5.3).
English: Table 1: Dose adjustment information for adverse reactions
Maltese: Tabella 1: Informazzjoni dwar aġġustament fid-doża għal reazzjonijiet avversi
English: Grade 2 (prolonged c or intolerable) or
Maltese: Grad 2 (imtawwal ċ jew intollerabbli) jew
English: OTHER
Maltese: OS
English: Afatinib may increase the bioavailability of orally administered BCRP substrates (including but not limited to rosuvastatin and sulfasalazine).
Maltese: Afatinib jista' jżid il-bijodisponibilità ta' substrati ta' BCRP li jingħataw mill-ħalq (li jinkludu, iżda mhumiex limitati għal, rosuvastatin u sulfasalazine).
English: Symptomatic adverse reactions (e.g. severe/persistent diarrhoea or skin related adverse reactions) may be successfully managed by treatment interruption and dose reductions or treatment discontinuation of GIOTRIF as outlined in Table 1 (see sections 4.4 and 4.8).
Maltese: Reazzjonijiet avversi sintomatiċi (eż. dijarea severa/persistenti jew reazzjonijiet avversi relatati malġilda) jistgħu jiġu mmaniġġjati b'suċċess permezz ta' interruzzjoni tal-kura u tnaqqis fid-doża jew it-twaqqif tal-kura b'GIOTRIF kif deskritt fil-qosor f'Tabella 1 (ara sezzjonijiet 4.4 u 4.8).
English: At the time of the analysis, 14 Nov 2013, 176 patients (76.5%) in the afatinib arm and 70 patients (60.9%) in the chemotherapy arm experienced an event contributing to the PFS analysis, i.e. disease progression as determined by central independent review or death.
Maltese: Fi żmien l-analiżi, l-14 ta' Novembru 2013, 176 pazjent (76.5%) fil-grupp tal-istudju b'afatinib u 70 pazjent (60.9%) fil-grupp tal-istudju bil-kimoterapija esperjenzaw episodju li kkontribwixxa għall-analiżi tal-PFS, jiġifieri progressjoni tal-marka kif iddeterminata permezz ta' evalwazzjoni indipendenti ċentrali jew mewt.
English: It works by blocking the activity of a group of proteins called the ErbB family (including EGFR [epidermal growth factor receptor or ErbB1], HER2 [ErbB2], ErbB3 and ErbB4).
Maltese: Jaħdem billi jimblokka l-attività ta' grupp ta' proteini msejħa l-familja ErbB (li tinkludi EGFR [riċettur ta' fattur tat-tkabbir epidermali jew ErbB1], HER2 [ErbB2], ErbB3 u ErbB4).
English: The adverse reactions observed at these doses were primarily dermatological (rash/acne) and gastrointestinal events (especially diarrhoea).
Maltese: Ir-reazzjonijiet avversi osservati f'dawn id-dożi kienu primarjament avvenimenti dermatoloġiċi (raxx/akne) u gastrointestinali (speċjalment dijarea).
English: Efficacy was similarly high in the group of patients who had received prior chemotherapy (N=68; ORR 57.4%; median PFS by independent review 8 months).
Maltese: L-effikaċja kienet għolja b'mod simili fil-grupp ta' pazjenti li kienu rċivew kimoterapija fil-passat (N =68; ORR 57.4%; PFS medjan minn evalwazzjoni indipendenti 8 xhur).
English: Table 9: Efficacy results of GIOTRIF vs. gefitinib (LUX-Lung 7) based on primary analysis as of August
Maltese: Tabella 9: Riżultati tal-effikaċja ta' GIOTRIF vs. gefitinib (LUX-Lung 7) abbażi ta' analiżi primarja minn Awwissu 2015.
English: Very common ADRs in GIOTRIF-treated patients occurring in at least 10% of patients in trial LUX-Lung 8 are summarised by National Cancer Institute-Common Toxicity Criteria (NCI-CTC) Grade in Table 5.
Maltese: ADRs komuni ħafna f'pazjenti kkurati b'GIOTRIF li seħħew mill-inqas f'10% tal-pazjenti fil-prova LUX-Lung 8 huma mogħtija fil-qosor mill-Grad tal-Kriterji ta' Tossiċità Komuni tan-National Cancer Institute (NCI-CTC) fit-Tabella 5.
English: Pre-treatment with rifampicin (600 mg once daily for 7 days), a potent inducer of P-gp, decreased the plasma exposure to afatinib by 34% (AUC0-∞) and 22% (Cmax) after administration of a single dose of 40 mg GIOTRIF.
Maltese: Kura minn qabel b'rifampicin (600 mg darba kuljum għal 7 ijiem), induttur qawwi ta' P-gp, naqqas l-esponiment tal-plażma għal afatinib b'34% (AUC0-∞) u 22% (Cmax) wara l-għoti ta' doża waħda ta' 40 mg ta' GIOTRIF.
English: Table 5: Very common ADRs in trial LUX-Lung 8* GIOTRIF (40 mg/day)
Maltese: Tabella 4: ADRs komuni ħafna fil-prova LUX-Lung 7 GIOTRIF (40 mg/jum)
English: Adjustments to the starting dose are not necessary in patients with mild (eGFR 60-89 mL/min/1.73m²), moderate (eGFR 30-59 mL/min/1.73m²) or severe (eGFR 15-29 mL/min/1.73m²) renal impairment.
Maltese: Aġġustamenti fid-doża tal-bidu mhumiex meħtieġa f'pazjenti b'indeboliment talkliewi ħafif (eGFR 60-89 mL/min/1.73m²), moderat (eGFR 30-59 mL/min/1.73m²) jew sever (eGFR 15-29 mL/min/1.73m²).
English: Diarrhoea, including severe diarrhoea, has been reported during treatment with GIOTRIF (see section 4.8).
Maltese: Dijarea, inkluża dijarea severa, ġiet irrappurtata waqt il-kura b'GIOTRIF (ara sezzjoni 4.8).
English: Patients with rare hereditary conditions of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-galactose, nuqqas totali ta' lactase jew malassorbiment tal-glucose-galactose m'għandhomx jieħdu dan il-prodott mediċinali.
English: • Adult patients with locally advanced or metastatic NSCLC of squamous histology progressing on or after platinum-based chemotherapy (see section 5.1).
Maltese: • Pazjenti adulti b'NSCLC lokalment avvanzat jew metastatiku b' istoloġija skwamuża li javvanza mal- jew wara l-kimoterapija bbażata fuq il-platinu (ara sezzjoni 5.1).
English: Based on this trial and population pharmacokinetic analysis of data derived from clinical trials in various tumour types, it is concluded, that adjustments to the starting dose in patients with mild (eGFR 60-89 mL/min/1.73m²), moderate (eGFR 30-59 mL/min/1.73m²), or severe (eGFR 15-29 mL/min/1.73m²) renal impairment are not necessary, but patients with severe impairment should be monitored (see “Population pharmacokinetic analysis in special populations” below and section 4.2).
Maltese: Abbażi ta' din il-prova u tal-analiżi tad-dejta farmakokinetika tal-popolazzjoni minn provi kliniċi f'tipi ta' tumuri varji, ġie konkluż, li m'hemmx bżonn ta' aġġustament fid-doża tal-bidu f'pazjenti b'indeboliment tal-kliewi ħafif (eGFR 60-89 mL/min/1.73m²), moderat (eGFR 3059 mL/min/1.73m²), jew sever (eGFR 15-29 mL/min/1.73m²), iżda pazjenti b'indeboliment sever għandhom jiġu mmonitorjati (ara “Analiżi farmakokinetika tal-popolazzjoni f'popolazzjonijiet speċjali” hawn taħt u sezzjoni 4.2).
English: Exposure to afatinib is not significantly changed in patients with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment (see section 5.2).
Maltese: Esponiment għal afatinib ma jinbidilx b'mod sinifikanti f'pazjenti b'indeboliment ħafif (Child Pugh A) jew moderat (Child Pugh B) tal-fwied (ara sezzjoni 5.2).
English: This is consistent with population pharmacokinetic data derived from clinical trials in various tumour types (see “Population pharmacokinetic analysis in special populations” below).
Maltese: Dan huwa konsistenti mad-dejta farmakokinetika tal-popolazzjoni miksuba minn provi kliniċi f'diversi tipi ta' tumuri (ara “Analiżi farmakokinetika tal-popolazzjoni f'popolazzjonijiet speċjali” hawn taħt).
English: Subjects with moderate renal impairment (n=8; eGFR 30-59 mL/min/1.73m², according to the Modification of Diet in Renal Disease [MDRD] formula) had an exposure of 101% (Cmax) and 122% (AUC0-tz) in comparison to their healthy controls.
Maltese: Individwi b'indeboliment tal-kliewi moderat (n=8; eGFR 30-59 mL/min/1.73m², skont il-formula talModifikazzjoni tad-Dieta f'Mard tal-Kliewi [MDRD, Modification of Diet in Renal Disease]) kellhom esponiment ta' 101% (Cmax) u 122% (AUC0-tz) meta mqabbla mal-kontrolli b'saħħithom tagħhom.
English: Left ventricular function
Maltese: Funzjoni ventrikulari tax-xellug
English: In patients treated with afatinib for more than 6 months a terminal half-life of 344 h was estimated.
Maltese: F'pazjenti kkurati b'afatinib għal aktar minn 6 xhur, ġie stmat half-life terminali ta' 344 siegħa.
English: ILD-like adverse reactions were reported in 0.7% of patients treated with GIOTRIF across all clinical trials (including 0.5% of patients with CTCAE Grade ≥ 3 ILD-like adverse reactions).
Maltese: Reazzjonijiet avversi li jixbhu lil ILD ġew irrappurtati f'0.7% tal-pazjent ikkurati b'GIOTRIF fil-provi kliniċi kollha (inkluż 0.5% tal-pazjenti b'reazzjonijiet avversi ta' Grad ≥ 3 CTCAE li jixbhu lil ILD).
English: Renal impairment/ Renal failure
Maltese: Indeboliment tal-kliewi/ Insuffiċjenza tal-kliewi
English: In the pre-defined subgroup of common mutations (combined Del 19 and L858R) for GIOTRIF and chemotherapy, the median PFS was 13.6 months vs. 6.9 months (HR 0.48; 95% CI 0.35-0.66; p<0.0001; N=307) in LUX-Lung 3, and 11.0 months vs. 5.6 months (HR 0.24; 95% CI 0.17-0.35; p<0.0001; N=324) in LUX-Lung 6, respectively.
Maltese: Fis-sottogrupp predefinit ta' mutazzjonijiet komuni (Del 19 u L858R ikkombinati) għal GIOTRIF u kimoterapija, il-PFS medjan kien ta' 13.6 xhur meta mqabbel ma' 6.9 xhur (HR 0.48; 95% CI 0.35-0.66; p<0.0001;
English: Other potential mechanisms of resistance to afatinib have been suggested preclinically and MET gene amplification has been observed clinically.
Maltese: Mekkaniżmi ta' reżistenza potenzjali oħrajn għal afatinib ġew issuġġeruti preklinikament u amplifikazzjoni tal-ġene MET ġiet osservata klinikament.
English: Cmax and AUC0-∞ values increased slightly more than proportionally in the dose range from 20 mg to 50 mg GIOTRIF.
Maltese: Il-medja tal-valuri tas-Cmax u tal-AUC0-∞ żdiedet ftit aktar minn dik proporzjonali fil-medda tad-doża minn 20 mg sa 50 mg ta' GIOTRIF.
English: The parent compound afatinib accounted for 88% of the recovered dose.
Maltese: Il-kompost ġenitur ta' afatinib kien jammonta għal 88% tad-doża rkuprata.
English: Thus, steady state plasma concentrations of afatinib were achieved within 8 days of multiple dosing of afatinib resulting in an accumulation of 2.77-fold (AUC0-∞) and 2.11-fold (Cmax).
Maltese: B'hekk, il-konċentrazzjonijiet ta' afatinib fil-plażma fl-istat fiss inkisbu fi żmien 8 ijiem ta' dożaġġ multiplu ta' afatinib li rriżultaw f'akkumulazzjoni ta' 2.77 drabi (AUC0-∞) u 2.11 drabi (Cmax).
English: Weight decreased 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 Includes Pruritus, Pruritus generalised Includes Dry skin, Skin chapped Based on post-marketing experience Includes Nail disorder, Onycholysis, Nail toxicity, Onychoclasis, Ingrowing nail, Nail pitting, Onychomadesis, Nail discoloration, Nail dystrophy, Nail ridging, and Onychogryphosis
Maltese: Jinkludu Paronikija, Infezzjoni fid-dwiefer, Infezzjoni fil-bażi tad-difer Jinkludu Stomatite, Stomatite aftuża, Infjammazzjoni tal-mukuża, Ulċerazzjoni fil-ħalq, Erożjoni tal-mukuża orali, Erożjoni tal-mukuża, Ulċerazzjoni tal-mukuża Jinkludu grupp ta' termini ppreferuti għal raxx Jinkludu Akne, Akne pustulari, Dermatite qisha akne Jinkludu Ħakk, Ħakk ġeneralizzat Jinkludu Ġilda xotta, Ġilda maqsuma Fuq il-bażi tal-esperjenza ta' wara t-tqegħid fis-suq Jinkludu Disturbi fid-dwiefer, Onikolisi, Tossiċità tad-dwiefer, Onikoklasi, Dwiefer jikbru 'l ġewwa, Dwiefer jitħaffru, Onikomadesi, Bidla fil-kulur tad-dwiefer, Distrofija tad-dwiefer, Xfarijiet fid dwiefer u Onikogrifosi
English: Very common
Maltese: Kwalunke Grad
English: Metabolism and nutrition disorders Decreased appetite
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Nuqqas ta' aptit
English: Stomatitis
Maltese: Kwalunkwe
English: Odds Ratio (OR) (95%CI) p-value
Maltese: Proporzjon tal-Odds (OR) (95%CI) valur p
English: Effects of P-gp inducers on afatinib
Maltese: L-effetti ta' indutturi ta' P-gp fuq afatinib
English: Rare side effects (may affect up to 1 in 1,000 people):
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa 1 minn 1,000 persuna):
English: GIOTRIF 30, 40 and 50 mg film-coated tablets Hypromellose (E464)
Maltese: GIOTRIF 30, 40 u 50 mg pilloli miksija b'rita Hypromellose 2910 (E464) Macrogol 400
English: Bullous, blistering and exfoliative skin conditions have been reported including rare cases suggestive of Stevens-Johnson syndrome and toxic epidermal necrolysis although in these cases there were potential alternative aetiologies (see section 4.4).
Maltese: Kundizzjonijiet tal-ġilda li jkunu bullużi, bl-infafet u bit-tqaxxir ġew irrappurtati, li jinkludu każijiet rari li jissuġġerixxu s-sindrome ta' Stevens-Johnson u nekroliżi epidermali tossika, għalkemm f'dawn il-każijiet kien hemm etjoloġiji alternattivi potenzjali (ara sezzjoni 4.4).
English: Based on population pharmacokinetic data derived from clinical trials in various tumour types, an average decrease of 26% in AUCτ,ss was observed when food was consumed within 3 hours before or 1 hour after taking GIOTRIF.
Maltese: Ibbażat fuq dejta farmakokinetika tal-popolazzjoni miksuba minn provi kliniċi fuq tipi differenti ta' tumuri, tnaqqis medju ta' 26% fl-AUCτ,ss ġie osservat meta l-ikel ġie kkunsmat fi żmien 3 sigħat qabel jew siegħa wara li ttieħed GIOTRIF.
English: How to store GIOTRIF 6.
Maltese: Kif taħżen GIOTRIF 6.
English: Months (median)
Maltese: Xhur (medjan)
English: In patients with an ejection fraction below the institution's lower limit of normal, cardiac consultation as well as treatment interruption or discontinuation should be considered.
Maltese: F'pazjenti b'porzjon ta' tfigħ 'il barra taħt il-limitu t'isfel tan-normal tal-istituzzjoni, konsultazzjoni kardijaka kif ukoll l-interruzzjoni jew it-twaqqif tal-kura għandhom jiġu kkunsidrati.
English: Randomisation was stratified according to EGFR mutation status (Del 19; L858R) and presence of brain metastases (yes; no).
Maltese: Ir-randomizzazzjoni ġiet stratifikata skont l-istatus ta' mutazzjoni EGFR (Del 19; L858R) u l-preżenza ta' metastażi tal-moħħ (iva; le).
English: In vitro studies indicated that afatinib is a substrate and an inhibitor of the transporter BCRP.
Maltese: Studji in vitro indikaw li afatinib hu substat u inibitur tat-trasportatur ta' BCRP.
English: Patients were randomised (2:1) to receive GIOTRIF 40 mg once daily or up to 6 cycles of pemetrexed/cisplatin.
Maltese: Il-pazjenti ntgħażlu b'mod każwali (2:1) biex jirċievu GIOTRIF 40 mg darba kuljum jew sa 6 ċikli ta' pemetrexed/cisplatin.
English: In the first-line setting, the efficacy and safety of GIOTRIF in patients with EGFR mutation-positive locally advanced or metastatic NSCLC (stage IIIB or IV) were assessed in a global, randomised, multicentre, open-label trial.
Maltese: Fl-isfond primarju, l-effikaċja u s-sigurtà ta' GIOTRIF f'pazjenti b'NSCLC lokalment avvanzat jew metastatiku b'mutazzjoni pożittiva EGFR (stadju IIIB jew IV) ġew evalwati fi prova globali, multiċentrika u open-label, li fiha l-parteċipanti ntgħażlu b'mod każwali.
English: Among the patients randomised, 62% were female, the median age was 63 years, 16% of patients had brain metastases, the baseline ECOG performance status was 0 (31%) or 1 (69%), 57% were Asian and 43% were non-Asian.
Maltese: Fost il-pazjenti randomizzati, 62% kienu nisa, l-età medjana kienet ta' 63 sena, 16% tal-pazjenti kellhom metastażi tal-moħħ, l-istatus ta' prestazzjoni tal-ECOG tal-linja bażi kien 0 (31%) jew 1 (69%), 57% kienu Asjatiċi u 43% kienu mhux Asjatiċi.
English: GIOTRIF (40 mg/day) N=160
Maltese: GIOTRIF (40 mg/jum) N=392
English: In oral repeated-dose studies for up to 26 weeks in rats or 52 weeks in minipigs the main effects were identified in the skin (dermal changes, epithelial atrophy and folliculitis in rats), the gastrointestinal tract (diarrhoea, erosions in the stomach, epithelial atrophy in rats and minipigs) and the kidneys (papillary necrosis in rats).
Maltese: Fi studji b'dożi ripetuti orali għal sa 26 ġimgħa fil-firien jew 52 ġimgħa fil-minipigs, l-effetti ewlenin ġew identifikati fil-ġilda (tibdil dermali, atrofija epiteljali u follikulite fil-firien), fl-apparat gastrointestinali (dijarea, erożjonijiet fl-istonku, atrofija epiteljali fil-firien u fil-minipigs) u fil-kliewi (nekrożi papillari fil-firien).
English: 31.1 vs. 10.3 HR 0.46; p=0.0001
Maltese: HR 0.46; p=0.0001
English: The efficacy results are summarized in Figure 1 (LUX-Lung 3) and Tables 6 and 7 (LUX-Lung 3 and 6).
Maltese: Ir-riżultati tal-effikaċja huma mogħtija fil-qosor fil-Figura 1 (LUX-Lung 3) u fit-Tabelli 6 u 7 (LUX-Lung 3 u 6).
English: In patients treated with once daily GIOTRIF 40 mg, dose reductions due to ADRs occurred in 57% of the patients in the LUX-Lung 3 trial and in 25% of the patients in the LUX-Lung 8 trial.
Maltese: F'pazjenti kkurati darba kuljum b'GIOTRIF 40 mg, tnaqqis fid-doża minħabba ADRs seħħ f'57% tal-pazjenti fil-prova LUX-Lung 3 u f'25% tal-pazjenti fil-prova LUX-Lung 8.
English: • if you are female, have a low body weight of less than 50 kg or have kidney problems.
Maltese: • jekk inti mara, għandek piż baxx tal-ġisem ta' inqas minn 50 kg jew għandek problemi fil-kliewi.
English: Grade 3 (> 5.0 to 20.0 times ULN) elevations occurred in <4% of patients treated with GIOTRIF (see section 4.4).
Maltese: darba tal-ULN) seħħew f'< 4% tal-pazjenti kkurati b'GIOTRIF (ara sezzjoni 4.4).
English: Respiratory, thoracic and mediastinal disorders Rhinorrhoea
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Tinfaraġ
English: Figure 2: Kaplan-Meier Curve for OS by treatment group in LUX-Lung 8
Maltese: Figura 2: Kurva ta' Kaplan-Meier għal OS skont il-grupp ta' kura f'LUX-Lung 8
English: • Muscle spasms
Maltese: • Ġilda xotta
English: Patients were treated with GIOTRIF 40 mg (all three trials) or 50 mg (LUX-Lung 2) orally once daily.
Maltese: Il-pazjenti ġew ittrattati b'GIOTRIF 40 mg (it-tliet provi kollha) jew 50 mg (LUX-Lung 2) mill-ħalq darba kuljum.
English: One film-coated tablet contains 294 mg lactose (as monohydrate).
Maltese: Pillola waħda miksija b'rita fiha 294 mg ta' lactose (bħala monohydrate).
English: In three clinical trials of GIOTRIF with prospective tumour genotyping (Phase 3 trials LUX-Lung 3 and -6, and single arm Phase 2 trial LUX-Lung 2), an analysis was conducted of data from a total of 75 TKI-naïve patients with advanced (stage IIIb-IV) lung adenocarcinomas harbouring uncommon EGFR mutations, which were defined as all mutations other than Del 19 and L858R mutations.
Maltese: 2 bi grupp wieħed LUX-Lung 2), saret analiżi ta' data minn total ta' 75 pazjent li qatt ma ħadu TKI qabel b'adenokarċinomi avvanzati tal-pulmun (stadju IIIb-IV) b'mutazzjonijiet mhux komuni ta' EGFR, li kienu definiti bħala l-mutazzjonijiet kollha minbarra l-mutazzjonijiet Del 19 u L858R.
English: A dose escalation to a maximum of 50 mg/day may be considered in patients who tolerate a 40 mg/day starting dose (i.e. absence of diarrhoea, skin rash, stomatitis, and other adverse reactions with CTCAE Grade > 1) in the first cycle of treatment (21 days for EGFR mutation positive NSCLC and 28 days for squamous NSCLC).
Maltese: Żieda fid-doża sa massimu ta' 50 mg/jum tista' tiġi kkunsidrata f'pazjenti li jittolleraw doża tal-bidu ta' 40 mg/jum (i.e. assenza ta' dijarea, raxx tal-ġilda, stomatite u reazzjonijiet avversi oħrajn b'CTCAE ta' Grad > 1) fl-ewwel għal ċiklu ta' kura (21 jum għal NSCLC pożittiv għal mutazzjoni tal-EGFR u 28 jum għal NSCL skwamuż).
English: Interactions with drug uptake transport systems
Maltese: Interazzjonijiet ma' sistemi tat-trasport tal-mediċina
English: Bullous, blistering and exfoliative skin conditions have been reported including rare cases suggestive of Stevens-Johnson syndrome and toxic epidermal necrolysis.
Maltese: Kundizzjonijiet tal-ġilda li jkunu bullużi, bl-infafet u bit-tqaxxir ġew irrappurtati, li jinkludu każijiet rari li jissuġġerixxu s-sindrome ta' Stevens-Johnson u nekroliżi epidermali tossika.
English: GIOTRIF has not been studied in patients with eGFR <15 mL/min/1.73m² or on dialysis.
Maltese: GIOTRIF ma ġiex studjat f'pazjenti b'eGFR < 15 mL/min/1.73m² jew f'dawk il-pazjenti fuq dijaliżi.
English: In vitro binding of afatinib to human plasma proteins is approximately 95%.
Maltese: It-twaħħil in vitro ta' afatinib mal-proteini tal-plażma umana hu ta' madwar 95%.
English: The highest total systemic exposure (AUC0-24) in female rats was less than that observed in patients (0.23 times).
Maltese: L-ogħla esponiment sistemiku totali (AUC0-24) fil-firien nisa kien inqas minn dak osservat fil-pazjenti (0.23 darbiet).