FrancophonIA/ELRC3.0 huggingface dataset:
English: The studies showed that a first course of vaccination with Infanrix Penta led to the development of protective levels of antibodies.
Maltese: L-istudji wrew li l-ewwel kors ta' vaċċini b'Infanrix Penta wassal għall-iżvilupp ta' livelli protettivi ta' antikorpi.
English: Keratitis (0.12%)
Maltese: Keratite (0.12%)
English: Uncommon Hepatitis**
Maltese: Epatite**
English: *from the following studies: INTEREST, ISEL, INTACT 1&2, IDEAL 1&2, INVITE
Maltese: *mill-istudji li ġejjin: INTEREST, ISEL, INTACT 1&2, IDEAL 1&2, INVITE
English: Allergic reactions (1.1%), including angioedema and urticaria.
Maltese: Reazzjonijiet allerġiċi (1.1%), inkluż anġjodima u urtikarja.
English: 117 Allée des Parcs 69800 Saint-Priest France
Maltese: 117 Allée des Parcs 69800 Saint Priest Franza
English: 1China, Hong Kong, Indonesia, Japan, Malaysia, Philippines, Singapore, Taiwan and Thailand.
Maltese: 1Iċ-Ċina, Hong Kong, l-Indoneżja, il-Ġappun, il-Malasja, il-Filippini, Singapore, it-Tajwan u tTajlandja.
English: Each tablet contains 161.0 mg of lactose (as monohydrate).
Maltese: Kull pillola fiha 161.0 mg lactose (bħala monohydrate).
English: Gefitinib binds to serum albumin and alpha 1-acid glycoprotein.
Maltese: Gefit jitwaħħal ma' albumina tas-serum u mal-alpha 1 acid glycoprotein.
English: 35/551 (6%) of males are M+.
Maltese: 35/551 (6%) tal-irġiel huma M+.
English: 31110 Noáin (Navarra) Spain
Maltese: Noáin (Navarra)
English: Lactose monohydrate Microcrystalline cellulose (101) Crospovidone (Type A) Povidone (K30) Sodium laurilsulfate Magnesium stearate
Maltese: Qalba tal-pillola Lactose monohydrate Microcrystalline cellulose (101) Crospovidone (Tip A) Povidone (K30) Sodium laurilsulfate Magnesium stearate
English: The tablet coating contains polyvinyl alcohol (E1203), macrogol 4000 (E1521), talc (E553b), titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172).
Maltese: Il-kisja tal-pillola fiha polyvinyl alcohol (E1203), macrogol 4000 (E1521), talc (E553b), titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172).
English: FACT-L Functional assessment of cancer therapy-lung.
Maltese: FACT L Functional assessment of cancer therapy-lung (Valutazzjoni funzjonali ta' terapija kontra l-kanċer - pulmun)
English: N HR
Maltese: HR
English: 40/235 (17%) of females are M+.
Maltese: 40/235 (17%) tan-nisa huma M+.
English: What Gefitinib Mylan contains - The active substance is gefitinib.
Maltese: X'fih Gefitinib Mylan - Is-sustanza attiva hi gefitinib.
English: Values presented are for gefitinib versus carboplatin/paclitaxel.
Maltese: Il-valuri ppreżentati huma għal gefitinib versus carboplatin/paclitaxel.
English: The ORR according to investigator review was 70% and the median PFS was 9.7 months.
Maltese: L-ORR skont ir-reviżjoni tal investigatur kienet ta' 70% u l-PFS medjan kien ta' 9.7 xhur.
English: HR Hazard ratio (hazard ratios <1 favour gefitinib).
Maltese: HR Hazard ratio (hazard ratios <1 jiffavorixxu gefitinib).
English: INFORMATION IN BRAILLE gefitinib mylan 250 mg
Maltese: INFORMAZZJONI BIL-BRAILLE gefitinib mylan 250 mg
English: An increased risk of ILD on gefitinib relative to chemotherapy was seen predominantly during the first 4 weeks of treatment (adjusted OR 3.8; 95% CI 1.9 to 7.7); thereafter the relative risk was lower (adjusted OR 2.5; 95% CI 1.1 to 5.8).
Maltese: Żieda fir-riskju ta' ILD b'gefitinib metamqabbel mal-kimoterapija dehret l-aktar fl-ewwel erba' ġimgħat ta' kura (OR aġġustat 3.8; 95% CI 1.9 sa 7.7); minn hemm ‘il quddiem ir-riskju relattiv kien anqas (OR aġġustat 2.5; 95 % CI 1.1 sa 5.8).
English: Frequencies of occurrence of undesirable effects are defined as: 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: Il-frekwenzi ta' kif iseħħu l-effetti mhux mixtieqa huma definiti bħala: komuni ħafna (>1/10); komuni (≥1/100 sa <1/10); mhux komuni (>1/1,000 sa <1/100); rari (>1/10,000 sa <1/1000); rari ħafna (<1/10,000), mhux magħrufa (ma tistax tiġi stmata minn data disponibbli).
English: LSC Lung cancer subscale.
Maltese: Lung cancer subscale (Sottoskala tal-kanċer tal-pulmun)
English: Liver function test abnormalities (including increases in alanine aminotransferase, aspartate aminotransferase, bilirubin) have been observed, uncommonly presenting as hepatitis (see section 4.8).
Maltese: Ġew osservati abnormalitajiet fit-test tal-funzjoni tal-fwied (inkluż żidiet fl-alanine aminotransferase, aspartate aminotransferase, bilirubin) liippreżentaw ruħhom b'mod mhux komuni bħala epatite (ara sezzjoni 4.8).
English: HR Hazard ratio (hazard ratios <1 favour gefitinib)
Maltese: HR Hazard ratio (hazard ratios <1 jiffavorixxu gefitinib)
English: Approximately 8% of patients had a severe ADR (common toxicity criteria, (CTC) grade 3 or 4).
Maltese: Madwar 8% tal-pazjenti kellhom ADR qawwi (kriterji ta' tossiċità komuni (CTC, common toxicity criteria) grad 3 jew 4).
English: Primary endpoint overall survivala,b,c
Maltese: Sopravivenza totali talendpoint primarjua,b,c
English: Gefitinib Mylan contains the active substance gefitinib which blocks a protein called ‘epidermal growth factor receptor' (EGFR).
Maltese: Gefitinib Mylan fih is-sustanza attiva gefitinib li tibblokka proteina msejħa ‘riċettur tal-fattur tattkabbir epidermali' (EGFR, epidermal growth factor receptor).
English: Primary endpoint Progression free survival (PFS) a,b
Maltese: Sopravivenza mingħajr progressjoni (PFS, Progression Free Survival) talendpoint primarjua,b
English: HR 0.68 [0.58 to 0.81] 6.6 m vs 5.8 m p<0.0001
Maltese: HR 0.68 [0.58 sa 0.81] 6.6 m vs 5.8 m p<0.0001
English: Bullous conditions including Toxic epidermal necrolysis, Stevens Johnson syndrome and erythema multiforme.
Maltese: Kundizzjonijiet fejn joħorġu l-imsiemer inkluż nekroliżi tossika tal-ġilda, sindrome ta' Stevens Johnson u eritema multiforme.
English: QoL
Maltese: Tqala
English: Overall survivala,b
Maltese: Sopravivenza totalia,b
English: The objective response rate (ORR) in those patients who were tumour and ctDNA mutation positive was 77% (95% CI: 66% to 86%) and in those who were tumour only mutation positive 60% (95% CI: 44% to 74%).
Maltese: Ir-rata oġġettiva ta' rispons (ORR - objective response rate) f'dawk il-pazjenti li kienu pożittivi għal mutazzjoni tat-tumur u tas-ctDNA kienet ta' 77% (95% CI: 66% sa 86%) u f'dawk li kienu pożittivi għal mutazzjoni tattumur biss kienet 60% (95% CI: 44% sa 74%).
English: - The other ingredients are lactose monohydrate, microcrystalline cellulose (101), crospovidone (type A), povidone (K30), sodium laurilsulfate, magnesium stearate in the tablet core.
Maltese: - Is-sustanzi mhux attivi l-oħra huma lactose monohydrate, microcrystalline cellulose (101), crospovidone (Tip A), povidone (K30), sodium laurilsulfate, magnesium stearate fil-qalba talpillola.
English: a Values presented are for gefitinib versus docetaxel.
Maltese: Il-valuri ppreżentati huma għal gefitinib versus docetaxel.
English: • Inflammation of the pancreas.
Maltese: • Infjammazzjoni tal-pankreas.
English: In the pooled dataset from the ISEL, INTEREST and IPASS phase III clinical trials (2462 gefitinib-treated patients), the most frequently reported adverse drug reactions (ADRs), occurring in more than 20% of the patients, are diarrhoea and skin reactions (including rash, acne, dry skin and pruritus).
Maltese: III, ISEL, INTEREST u IPASS (2462 pazjent ikkurati b'gefitinib) l-aktar reazzjonijiet avversi (ADRs) li ġew irrappurtati l-aktar spiss, f'aktar minn 20% talpazjenti huma dijarea u reazzjonijiet fil-ġilda (inkluż raxx, ponot, ġilda xotta u ħakk).
English: • Gastrointestinal perforation.
Maltese: • Perforazzjoni gastro intestinali.
English: The dispersion can also be administered through a naso-gastric or gastrostomy tube.
Maltese: Id-dispersjoni tista' tiġi amministrata ukoll minn tubu naso-gastriku jew tal-gastrostomija.
English: Pre-treatment with rifampicin (a potent CYP3A4 inducer) in healthy volunteers reduced mean gefitinib AUC by 83% (see section 4.4).
Maltese: Kura minn qabel b'rifampiċina (induttur qawwi ta' CYP3A4) f'voluntiera b'saħħithom naqqset l-AUC medja ta' gefitinib bi 83% (ara sezzjoni 4.4).
English: These data are similar to those reported in the IPASS study.
Maltese: Din id-dejta hija simili għal dikirrapportata fl-istudju IPASS.
English: N Objective response rates and 95% CI for difference between treatmentsa
Maltese: Rati oġġettivi tarrispons u CI ta' 95% għad-differenza bejn it-trattamentia
English: 47/716 (7%) of ever smokers are M+.
Maltese: 47/716 (7%) ta' dawk li ġieli pejpu huma M+.
English: Table 5 - Efficacy outcomes for gefitinib versus docetaxel from the INTEREST study Population
Maltese: Tabella 5 - Riżultati tal-effikaċja għal gefitinib versus docetaxel mill-istudju INTEREST Popolazzjoni
English: It was shown that following daily administration of 250 mg gefitinib, time to steady-state, total plasma clearance (CmaxSS) and steady-state exposure (AUC24SS) were similar for the groups with normal and moderately impaired hepatic function.
Maltese: Sar magħruf li wara amministrazzjoni ta' gefitinib 250 mg kuljum, iż-żmien li ħadet biex stabbilizzat ruħa, l-eliminazzjoni totali mill-plasma (CmaxSS) u l-esponiment fi stat fiss (AUC24SS) kienu simili għal gruppi ta' pazjenti b'indeboliment tal-funzjoni tal-fwied moderat jew normali.
English: Concomitant medicinal products that induce CYP3A4 (e.g. phenytoin, carbamazepine, rifampicin, barbiturates or St John's wort, Hypericum perforatum) should be avoided.
Maltese: Prodotti mediċinali li jingħataw flimkien u li jinduċu CYP3A4 (eż phenytoin, carbamażepine, rifampiċina, barbiturati u St.
English: Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to the clinical exposure levels and with possible relevance to clinical use were as follows: - Corneal epithelia atrophy and corneal translucencies - Renal papillary necrosis - Hepatocellular necrosis and eosinophilic sinusoidal macrophage infiltration.
Maltese: Reazzjonijiet avversi mhux osservati fi studji kliniċi, iżda osservati fl-annimali, fil-livelli ta' esponiment simili għal livelli ta' esponiment kliniku u ta' relevanza potenzjali għall-użu kliniku kienu kif ġej: - Atrofija epiteljali tal-kornea u transluċenti tal-kornea - Nekrosi papillari renali - Nekrosi epatoċellulari u infiltrazzjoni eosinofilika u sinusojdali tal-makrofaġi.
English: 117 Allée des Parcs 69800 Saint-Priest
Maltese: 69800 Saint Priest
English: Gefitinib Mylan contains sodium
Maltese: Gefitinib Mylan fih is-sodium
English: Tablet core
Maltese: Ġieli pejpu
English: Gefitinib total plasma clearance is approximately 500 ml/min and the mean terminal half-life is 41 hours in cancer patients.
Maltese: L-eliminazzjoni totali ta' gefitinib mill-plasma hija ta' madwar 500 mL/min u l-medja tal-half-life terminali hija ta' 41 siegħa f'pazjenti bil-kanċer.
English: Plasma concentrations were not increased in patients with elevated aspartate transaminase (AST), alkaline phosphatase or bilirubin due to liver metastases (see section 5.2).
Maltese: Konċentrazzjonijiet fil-plasma ma żdidux f'pazjenti li kellhom aspartate transaminase (AST), alkaline phosphatase jew bilirubin elevati minħabba metastasi fil-fwied (ara sezzjoni 5.2).
English: Figures 1 and 2 - Efficacy outcomes in subgroups of non-Asian patients in the INTEREST study (N patients = Number of patients randomised)
Maltese: Figuri 1 u 2 - Riżultati tal-effikaċja fis-sottogruppi ta' pazjenti mhux-Asjatiċi fl-istudju INTEREST (N pazjenti = Numru ta' pazjenti li ntgħażlu b'mod arbitrarju)
English: Numbers in square brackets are 96% confidence interval for overall survival
Maltese: Numri fil-parentesi kwadri huma 96% intervall ta' fiduċja
English: • Protein in your urine (shown in a urine test).
Maltese: • Proteina fl-awrina (tidher f'test tal-awrina).
English: - Proton-pump inhibitors, H2-antagonists and antacids (for ulcers, indigestion, heartburn and to reduce acids in the stomach).
Maltese: - Inibituri proton-pump, antagonisti tal-H2 u anti-aċidi (għal ulċeri, indiġestjoni, ħruq ta' stonku u biex inaqqsu l-aċidi fl-istonku).
English: Uncommon Pancreatitis Gastrointestinal perforation
Maltese: Pankreatite Perforazzjoni gastro intestinali
English: It comes in PVC/PVDC/Aluminium blisters in packs of 30 film-coated tablets or in PVC/PVDC/Aluminium perforated unit dose blisters in packs of 30x1 film-coated tablets.
Maltese: Dawn jiġu f'folji tal-PVC/PVDC/Aluminju f'pakketti ta' 30 pillola miksija b'rita jew f'folji mtaqqba b'doża waħda tal-PVC/PVDC/Aluminju f'pakketti ta' 30×1 pillola miksija b'rita.
English: Progression free survivala,b
Maltese: Sopravivenza mingħajr progressjonia,b
English: The results of an in vitro phototoxicity study demonstrated that gefitinib may have phototoxicity potential.
Maltese: Ir-riżultati ta' studju fototossiku in vitro wrew li gefitinib jista' jkollu potenzjal fototossiku.
English: HR 0.82 [0.70 to 0.96] 18.9 m vs. 17.2 m a b
Maltese: 82 [0.70 sa 0.96] 18.9 m vs.
English: Interstitial lung disease (ILD) which may be acute in onset, has been observed in 1.3% of patients receiving gefitinib, and some cases have been fatal (see section 4.8).
Maltese: Mard interstizjali tal-pulmun (ILD) li fil-bidu jista' jkun akut, kien osservat f'1.3% tal-pazjenti li kienu qed jirċievu gefitinib, u xi każijiet kienu fatali (ara sezzjoni 4.8).
English: Numbers in square brackets are 95% confidence intervals for HR Number of patients randomised.
Maltese: Numri fil-parentesi kwadri huma 95% intervalli ta' kunfidenza għal HR.
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘ sodium-free'.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull pillola, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: Interstitial lung disease (1.3%), often severe (CTC grade 3-4).
Maltese: Mard interstizjali tal-pulmun (1.3%), bosta drabi qawwi (CTC grad 3 - 4).
English: Data from non-clinical (in vitro) studies indicate that gefitinib has the potential to inhibit the cardiac action potential repolarization process (e.g. QT interval).
Maltese: Dejta minn studji mhux kliniċi (in vitro) indikat li gefitinib għandu potenzjal li jinibixxi l-proċess ta' ripolarizzazzjoni tal-potenzjal tal-azzjoni kardijaku (eżempju intervall QT).
English: Primary endpoint overall survivala,b
Maltese: Sopravivenza totali talendpoint primarjua,b
English: Tablet coating Polyvinyl alcohol (E1203) Macrogol 4000 (E1521) Talc (E553b) Titanium dioxide (E171) Red iron oxide (E172) Yellow iron oxide (E172)
Maltese: Kisja tal-pillola Polyvinyl alcohol (E1203) Macrogol 4000 (E1521) Talc (E553b)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1321/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/18/1321/001
English: Pre-treated patients
Maltese: TAL-PRODOTT MEDIĊINALI
English: • Red and sore eyelids.
Maltese: - Żomm dan il-fuljett.
English: Adverse reactions have been assigned to the frequency categories in Table 1 where possible based on the incidence of comparable adverse reactions reports in a pooled dataset from the ISEL, INTEREST and IPASS phase III clinical trials (2462 gefitinib-treated patients).
Maltese: Reazzjonijiet avversi kienu assenjati skont il-kategoriji talfrekwenza f'Tabella 1 fejn possibbli bbażati fuq l-inċidenza ta' rapporti ta' avvenimenti avversi komparabbli miġbura f'sett ta' dejta minn provi kliniċi ta' fażi III ISEL, INTEREST u IPASS (2462 pazjent ikkurat b'gefitinib).
English: In a Japanese pharmacoepidemiological case control study in 3,159 patients with NSCLC receiving gefitinib or chemotherapy who were followed up for 12 weeks, the following risk factors for developing ILD (irrespective of whether the patient received gefitinib or chemotherapy) were identified: smoking, poor performance status (PS≥ 2), CT scan evidence of reduced normal lung (≤ 50%), recent diagnosis of NSCLC (< 6 months), pre-existing ILD, older age (≥ 55 years old) and concurrent cardiac disease.
Maltese: Fi studju farmakoepidemjoloġiku Ġappuniż ta' kontroll tal-każ (case control) fi 3,159 pazjent b'NSCLC li kienu qed jirċievu gefitinib jew kimoterapija u li ġew segwiti għal 12-il ġimgħa, ġew identifikati l-fatturi ta' riskju li ġejjin għall-iżvilupp ta' ILD (irrispettivament minn jekk il-pazjent kienx qed jirċievi gefitinib jew kimoterapija): tipjip, status ta' prestazzjoni dgħajfa (PS≥2), evidenza b'CT scan ta' tiċkin ta' pulmun normali (<50%), dijanjosi reċenti ta' NSCLC (<6 xhur), ILD pre eżistenti, età akbar (≥55 sena), u mard tal-qalb fl-istess ħin.
English: Gefitinib Mylan contains lactose
Maltese: Gefitinib Mylan fih il-lactose
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Gefitinib Mylan fih il-lactose Pazjenti bi problemi ereditarji rari ta' intolleranza għal galactose, defiċjenza ta' lactose totali jew malassorbiment ta' glucose-galactose m'għandhomx jieħdu dan ilprodott mediċinali.
English: In that study ctDNA derived from serum, not plasma was used for EGFR mutation analysis using the EGFR Mutation Test Kit (DxS) (N= 86).
Maltese: F'dak l-istudju, intuża ctDNA miksub minn serum, mhux mill-plasma għal analiżi tal-mutazzjoni ta' EGFR permezz ta' Kitt ta' Test ta' Mutazzjoni ta' EGFR (DxS) (N=86).
English: There are no data on concomitant treatment with an inhibitor of CYP2D6 but potent inhibitors of this enzyme might cause increased plasma concentrations of gefitinib in CYP2D6 extensive metabolisers by about 2-fold (see section 5.2).
Maltese: Ma hemmx dejta ta' meta jingħata flimkien ma' inibituri ta' CYP2D6, iżda inibituri qawwija ta' din lenzima jistgħu jżidu l-konċentrazzjonijiet ta' gefitinib fil-plasma ta' metabolizzaturi estensivi ta' CYP2D6, b'madwar darbtejn (ara sezzjoni 5.2).
English: In the IPASS trial, gefitinib demonstrated superior PFS, ORR, QoL and symptom relief with no significant difference in overall survival compared to carboplatin/paclitaxel in previously untreated patients, with locally advanced or metastatic NSCLC, whose tumours harboured activating mutations of the EGFR tyrosine kinase.
Maltese: Fil-provi IPASS, gefitinib wera PFS, ORR, QoL u serħan mis-sintomi superjuri bl-ebda differenza sinifikanti fis-sopravivenza totali meta mqabbel ma' carboplatin/paclitaxel f'pazjenti li ma kinux ikkurati minn qabel, b'NSCLC lokalment avvanzat jew metastatiku, li t-tumuri kienu jattivaw mutazzjonijiet ta' EGFR tyrosine kinase.
English: Concomitant administration of gefitinib with ranitidine at a dose that caused sustained elevations in gastric pH ≥ 5 resulted in a reduced mean gefitinib AUC by 47% in healthy volunteers (see section 4.4 and 5.2).
Maltese: Meta gefitinib jingħata ma' ranitidine f'doża li tikkawża elevazzjoni sostnuta tal-pH gastriku ta' ≥5 dan irriżulta fi tnaqqis tal-AUC medja ta' gefitinib ta' 47 % f'voluntiera b'saħħithom (ara sezzjoni 4.4 u 5.2).
English: In a phase III open-label clinical trial (IPASS) in 1217 patients comparing gefitinib to carboplatin/paclitaxel doublet chemotherapy as first-line treatment in selected patients with advanced NSCLC in Asia, the incidence of ILD-type events was 2.6% on the gefitinib treatment arm versus 1.4% on the carboplatin/paclitaxel treatment arm.
Maltese: III open label (IPASS) f'1217-il pazjent fejn gefitinib tqabbel ma' kimoterapija doppja b'carboplatin/paclitaxel bħala l-ewwel kura f'għażla ta' pazjenti b'NSCLC avvanzata fl-Asja, l-inċidenza ta' avvenimenti tat-tip ILD kienet ta' 2.6% fil-fergħa tal-kura b'gefitinib meta mqabbel ma' 1.4% fil-fergħa tal-kura b'carboplatin/paclitaxel.
English: EGFR mutation status and clinical characteristics Clinical characteristics of never smoker, adenocarcinoma histology, and female gender have been shown to be independent predictors of positive EGFR mutation status in a multivariate analysis of 786 Caucasian patients from gefitinib studies* (see Table 7).
Maltese: Stat ta' mutazzjoni tal-EGFR u karatteristiċi kliniċi Karatteristiċi kliniċi ta' min qatt ma pejjep, istoloġija ta' adenokarċinoma u ġeneru femminili, urew li huma fatturi indipendenti li jbassru l-istatus pożittiv ta' mutazzjoni ta' EGFR f'analiżi multivarjanti ta' 786 pazjent Kawkasu minn studji b'gefitinib* (ara Tabella 7).
English: In a post-marketing surveillance study in Japan (3350 patients) the reported rate of ILD-type events in patients receiving gefitinib was 5.8%.
Maltese: Fi studju ta' sorveljanza ta' wara t-tqegħid fis-suq fil-Ġappun (3350 pazjent) ir-rata rrappurtata ta' avvenimenti tat-tip ILD f'pazjenti li ngħataw gefitinib kienet ta' 5.8%.
English: Children and adolescents Gefitinib Mylan is not indicated in children and adolescents under 18 years.
Maltese: Tfal u adolexxenti Gefitinib Mylan mhux indikat fi tfal u adolexxenti taħt it-18-il sena.
English: Gefitinib shows no enzyme induction effects in animal studies and no significant inhibition (in vitro) of any other cytochrome P450 enzyme.
Maltese: Minn studji fuq annimali deher li gefitinib ma jżidx l-attività tal-enzimi u ma kienx hemm inibizzjoni sinifikanti talattività (in vitro) ta' xi enzimi cytochrome P450 oħra.
English: Table 4 - Quality of life outcomes for gefitinib versus carboplatin/paclitaxel from the IPASS study
Maltese: Tabella 4 - Riżultati tal-kwalità tal-ħajja għal gefitinib versus carboplatin/paclitaxel mill-istudju IPASS
English: - Herbal remedies containing St John's wort (Hypericum perforatum, used for depression and anxiety).
Maltese: John's wort (Hypericum perforatum, użat għad-dipressjoni u l-ansjetà).
English: Histology
Maltese: Istoloġija
English: A reduction in female fertility was observed in the rat at a dose of 20 mg/kg/day.
Maltese: Tnaqqis fil-fertilità kien osservat fil-firien nisa b'doża ta' 20 mg/kg/jum.
English: 63/396 (16%) of patients with adenocarcinoma histology are M+.
Maltese: 63/396 (16%) tal-pazjenti b'istoloġija ta' adenokarċinoma huma M+. 12/390 (3%) tal-pazjenti b'istoloġija ta' non-adenokarċinoma huma M+.
English: Gefitinib Mylan is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of EGFR-TK (see section 4.4).
Maltese: Gefitinib Mylan huwa indikat bħala monoterapija għall-kura ta' pazjenti adulti li għandhom kanċer talpulmun mhux ta' ċellula żgħira (NSCLC) lokalment avvanzat jew metastatiku u li għandu mutazzjonijiet attivanti ta' EGFR-TK (ara sezzjoni 4.4).
English: The dispersion should be drunk immediately after dispersion is complete (i.e. within 60 minutes).
Maltese: Id-dispersjoni għandha tinxtorob minnufih wara li d-dispersjoni tkun lesta (jiġifieri fi żmien 60 minuta).
English: Gefitinib Mylan 250 mg film-coated tablets gefitinib
Maltese: Gefitinib Mylan 250 mg pilloli gefitinib
English: When gefitinib was administered to rats during organogenesis, there were no effects on embryofoetal development at the highest dose (30 mg/kg/day).
Maltese: Meta gefitinib ġie amministrat fil-firien waqt organoġenesi, ma kien hemm lebda effett fuq l-iżvilupp embrijufetali bl-akbar doża (30 mg/kg/jum).
English: Gastrointestinal disorders
Maltese: Disturb gastro-intestinali
English: Very common Elevations in alanine aminotransferase, mainly mild to moderate.
Maltese: Komuni ħafna Żidiet ħfief jew moderati ta' alanine aminotransferase.
English: FACT-L QoL improvement ratea
Maltese: Sopravivenza mingħajr Progressjoni
English: Other medicines and Gefitinib Mylan
Maltese: Mediċini oħra u Gefitinib Mylan
English: • Fever.
Maltese: • Dardir.
English: What Gefitinib Mylan looks like and contents of the pack Gefitinib Mylan tablets are brown, round, biconvex film-coated tablets with approximately 11.1 mm x 5.6 mm of dimension and marked with “250” on one side and plain on the other.
Maltese: Kif jidher Gefitinib Mylan u l-kontenut tal-pakkett Pilloli ta' Gefitinib Mylan huma pillola miksija b'rita kannella, tondi, ibbuzzati fuq iż-żewġ naħat b'daqs ta' madwar 11.1 mm x 5.6 mm u mmarkati b'“250” fuq naħa waħda u xejn fuq in-naħa l-oħra.