FrancophonIA/ELRC3.0 huggingface dataset:
English: Erivedge can cause bones to stop growing and lead to premature onset of puberty (before age 8 years in girls or age 9 years in boys).
Maltese: Erivedge jista' jwaqqaf l-għadam milli jkompli jikber u jwassal għal bidu prematur tal-pubertà (qabel l-età ta' 8 snin fil-bniet jew l-età ta' 9 snin fis-subien).
English: NE = not estimable * Efficacy-evaluable patient population is defined as all enrolled patients who received any amount of Erivedge and for whom the independent pathologist's interpretation of archival tissue or baseline biopsy was consistent with BCC.
Maltese: NE = ma jistax jiġi stmat * Popolazzjoni ta' pazjenti li l-effikaċja tagħhom setgħet tiġi evalwata hija ddefinita bħala l-pazjenti kollha li daħlu fl-istudju li rċevew kwalunkwe ammont ta' Erivedge u li għalihom l-interpretazzjoni tal-patologu indipendenti ta' tessut arkivjat jew bijopsija fil-linja bażi kienet konsistenti ma' BCC.
English: Patients were treated with oral daily dosing of Erivedge at 150mg.
Maltese: Il-pazjenti kienu ttrattati b'dożaġġ orali kuljum ta' Erivedge 150 mg.
English: There are limited data in older people.
Maltese: Hemm data limitata f'persuni akbar fl-età.
English: The full EPAR for Actrapid can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: EPAR summary for the public human insulin
Maltese: Sommarju tal-EPAR għall-pubbliku insulina umana
English: Actrapid is a solution for injection that contains the active substance human insulin.
Maltese: Actrapid huwa soluzzjoni għall-injezzjoni li fiha s-sustanza attiva insulina umana.
English: This is a summary of the European public assessment report (EPAR) for Actrapid.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Actrapid.
English: The active substance in Actrapid, human insulin, is produced by a method known as ‘recombinant technology': the insulin is made by a yeast that has received a gene (DNA), which makes it able to produce insulin.
Maltese: Is-sustanza attiva f'Actrapid, l-insulina tal-bniedem, hi prodotta b'metodu magħruf bħala ‘teknoloġija rekombinanti': l-insulina hi magħmula minn ħmira li tkun irċeviet ġene (DNA), biex b'hekk tkun tista' tipproduċi l-insulina.
English: Actrapid is given 30 minutes before a meal.
Maltese: Actrapid jingħata 30 minuta qabel l-ikel.
English: It is available as vials, cartridges (Penfill) or prefilled pens (NovoLet, InnoLet or FlexPen).
Maltese: Jiġi fi fjali, stoċċijiet (Penfill), jew pinen mimlija minn qabel (NovoLet, InnoLet jew FlexPen).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Actrapid on 7 October 2002.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Actrapid valida fl-Unjoni Ewropea kollha fis-7 ta' Ottubru 2002.
English: Actrapid is given by injection under the skin in the thigh, the abdominal wall (at the front of the waist), the deltoid region (shoulder) or the gluteal region (buttocks).
Maltese: Actrapid jingħata bħala injezzjoni taħt il-ġilda, normalment fil-koxxa, fl-addome (fil-parti ta' quddiem tal-qadd), fil-parti tal-glutei (il-warrani), jew fil-parti deltojde (l-ispalla).
English: Actrapid may also be given intravenously (into a vein) but only by a doctor or a nurse.
Maltese: Actrapid jista' jingħata fil-vina, iżda minn tabib jew infermier biss.
English: What is the risk associated with Actrapid?
Maltese: X'inhu r-riskju assoċjat ma' Actrapid?
English: The most common side effect with Actrapid (seen in more than 1 patient in 10) is hypoglycaemia (low blood glucose levels).
Maltese: L-iktar effett sekondarju komuni b'Actrapid (li deher f'iktar minn pazjent 1 minn kull 10) hija lipogliċemija (livelli baxxi ta' glukożju fid-demm).
English: Actrapid is a replacement insulin that is very similar to the insulin made by the pancreas.
Maltese: Actrapid huwa insulina ta' sostituzzjoni li hija simili għall-insulina magħmula mill-frixa.
English: How has Actrapid been studied?
Maltese: Kif ġie studjat Actrapid?
English: Actrapid has been studied in patients with type 1 diabetes, when the pancreas cannot produce insulin (two studies involving 1,954 patients), and type 2 diabetes, when the body is unable to use insulin effectively (one study involving 182 patients).
Maltese: Actrapid ġie studjat f'pazjenti b'dijabete tat-tip 1 li jkollhom il-frixa (pancreaas) li ma tkunx tista' tipproduċi insulina (żewġ studji li involvew 1910 pazjent), u f'dawk b'dijabete tat-tip 2 fejn il-ġisem ma jkunx jista' juża l-insulina b'mod effikaċi (studju wieħed li kien jinvolvi 182 pazjent).
English: The studies compared Actrapid with another replacement insulin called insulin aspart over six months by measuring the level of glycosylated haemoglobin (HbA1c), which is the percentage of haemoglobin in the blood that has glucose attached.
Maltese: L-istudji qabblu Actrapid ma' insulina sostituttiva oħra msejħa insulin aspart fuq medda ta' sitt xhur billi kejlu l-livell tal-emoglobina glikosilata (HbA1c), li hija l-persentaġġ tal-emoglobina fid-demm li magħha jeħel ilglukożju.
English: Actrapid is a fast-acting insulin and may be used with intermediate or long-acting insulins.
Maltese: Actrapid huwa insulina li taġixxi malajr u jista' jintuża ma' insulini intermedjarji jew li jaġixxu fit-tul.
English: Why has Actrapid been approved?
Maltese: Għaliex ġie approvat Actrapid?
English: Other information about Actrapid
Maltese: Kif jintuża Actrapid?
English: What is Actrapid?
Maltese: X'inhu Actrapid?
English: The CHMP decided that Actrapid's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Actrapid huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: HbA1c levels remained fairly steady over the six months of treatment with Actrapid.
Maltese: Il-livelli tal-HbA1c baqgħu ġeneralment fejn kienu wara sitt xhur ta' kura b'Actrapid.
English: For the full description of all side effects reported with Actrapid, see the package leaflet.
Maltese: Għal deskrizzjoni sħiħa tal-effetti sekondarji kollha irrapportati b'Actrapid, ara l-fuljett ta' tagħrif.
English: Bottle (HDPE) 1,000 ml Pack of 6 bottles
Maltese: 1,000 ml Pakkett ta' 6 fliexken
English: Bottle (HDPE) 1,000 ml 1 bottle 24 hours
Maltese: 1,000 ml flixkun 24 siegħa
English: Target species
Maltese: Baqar u klieb
English: Bottle (HDPE) 250 ml
Maltese: 250 ml flixkun 24 siegħa
English: Packaging Content Package size
Maltese: Klieb: Mhux Applikabbli
English: 15 mg Coated tablets Dogs
Maltese: 50 mg/ml Soluzzjoni għall injezzjoni
English: IFUM rate % (CI)
Maltese: Rata IFUM % (CI)
English: Allergic reactions (1.1%), including angioedema and urticaria
Maltese: Reazzjonijiet allerġiċi (1.1%), inkluż anġjodima u urtikarja
English: *from the following studies: INTEREST, ISEL, INTACT 1&2, IDEAL 1&2, INVITE
Maltese: INTEREST, ISEL, INTACT 1 u 2, IDEAL 1 u 2, INVITE
English: 6.2 v. 7.3 Overall
Maltese: 7.3 Overall
English: Tablet coating Hypromellose (E464) Macrogol 300
Maltese: Kisja tal-pillola Hypromellose (E464) Macrogol 300
English: Each tablet contains 163.5 mg of lactose (as monohydrate).
Maltese: Kull pillola fiha 163.5 mg lactose (bħala monohydrate).
English: Unadjusted analysis PP population for clinical factors ITT population for biomarker factors
Maltese: Unadjusted analysis PP population for clinical factors
English: This may take up to 20 minutes.
Maltese: Din tista' tieħu madwar 20 minuta.
English: 6.1List of excipients
Maltese: 6.1 Lista ta' eċċipjenti
English: Table 1 Adverse reactions
Maltese: Tabella 1 Reazzjonijiet Avversi
English: 40/235 (17%) of females are M+ 35/551 (6%) of males are M+
Maltese: 40/235 (17%) tan-nisa huma M+ 35/551 (6%) tal-irġiel huma M+
English: PVC/Aluminium perforated blister containing 10 tablets or PVC/Aluminium non-perforated blister containing 10 tablets.
Maltese: Strixxa tal-PVC/Aluminju mtaqqba li fiha 10 pilloli jew strixxa tal-PVC/Aluminju mhux imtaqqba li fiha 10 pilloli.
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: Definition
Maltese: Definizzjoni
English: Date of first authorisation: 24/06/2009 Date of latest renewal: 23/04/2014
Maltese: Data tal-ewwel awtorizzazzjoni: 24/06/2009 Data tal-aħħar tiġdid: 23/04/2014
English: 63/396 (16%) of patients with adenocarcinoma histology are M+ 12/390 (3%) of patients with non-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: HR Hazard ratio (hazard ratios <1 favour IRESSA)
Maltese: HR Hazard ratio (hazard ratios <1 jiffavurixxu IRESSA)
English: What IRESSA contains The active substance is gefitinib.
Maltese: Is-sustanza attiva hi gefitinib.
English: Five metabolites have been fully identified in excreta and 8 metabolites in plasma.
Maltese: Ħames metaboliti kienu identifikati kompletament fl-eskrezzjoni u 8 metaboliti fil-plasma.
English: ORR (%) Gefitinib v. Docetaxel
Maltese: ORR (%) Gefitinib v.
English: Lactose monohydrate Microcrystalline cellulose (E460) Croscarmellose sodium Povidone (K29-32) (E1201) Sodium laurilsulfate Magnesium stearate
Maltese: Qalba tal-pillola Lactose monohydrate Mycrocrystalline cellulose (E460) Croscarmellase sodium Povidone (K29-32) (E1201) Sodium laurilsulfate Magnesium stearate
English: Gefitinib binds to serum albumin and alpha 1-acid glycoprotein.
Maltese: Gefitinib jingħaqad ma' albumina tasserum u mal-alpha 1-acid glycoprotein.
English: An updated RMP shall be submitted:
Maltese: RMP aġġornat għandu jiġi ppreżentat:
English: PC: {number} SN: {number} NN: {number}
Maltese: M'hemmx dejta dwar l-użu ta' gefitinib f'nisa tqal.
English: China, Hong Kong, Indonesia, Japan, Malaysia, Philippines, Singapore, Taiwan and Thailand.
Maltese: Iċ-Ċina, Ħong Kong, l-Indonesja, il-Ġappun, il-Malasja, il-Filippini, Singapor, it-Tajwan u tTajlandja
English: AstraZeneca UK Limited Macclesfield Cheshire SK10 2NA United Kingdom
Maltese: AstraZeneca UK Limited Macclesfield Cheshire SK 10 2NA Ir-Renju Unit
English: Primary endpoint overall survival abc
Maltese: Sopravivenza Totali tal-endpoint primarju abc
English: The common EGFR activating mutations (Exon 19 deletions; L858R) have robust response data supporting sensitivity to gefitinib; for example a progression free survival HR (95% CI) of 0.489 (0.336, 0.710) for gefitinib vs. doublet chemotherapy [WJTOG3405].
Maltese: Il-mutazzjonijiet komuni li jattivaw l-EGFR (tħassir ta' Exon 19; L858R) għandhom dejta ta' rispons robusta li tappoġġja s-sensittività għal gefitinib; pereżempju HR ta' sopravivenza mingħajr progressjoni (95% CI) ta' 0.489 (0.336, 0.710) għal gefitinib vs. kimoterapija doppja [WJTOG3405].
English: 4 years.
Maltese: 4 snin
English: IRESSA contains sodium
Maltese: IRESSA fiha sodium
English: Other medicines and IRESSA
Maltese: Mediċini oħra u IRESSA
English: <2D barcode carrying the unique identifier included.>
Maltese: barcode 2D li jkollu l-identifikatur uniku inkluż.
English: These data are similar to those reported in the IPASS study.
Maltese: Din id-dejta hija simili għal dik irrapportata fl-istudju IPASS.
English: The metabolism of gefitinib is via the cytochrome P450 isoenzyme CYP3A4 (predominantly) and via CYP2D6.
Maltese: Il-metaboliżmu ta' gefitinib isir permezz ta' isoenżima P450 cytochrome CYP3A4 (predominanti) u permezz ta' CYP2D6.
English: In the INTEREST trial, the incidence of ILD type events was 1.4% (10) patients in the gefitinib group versus 1.1% (8) patients in the docetaxel group.
Maltese: Fil-provi INTEREST, l-inċidenza ta' avvenimenti ta' tip ILD kienet ta' 1.4% (10) pazjenti fil-grupp gefitinib versus 1.1 % (8) pazjenti fil-grupp docetaxel.
English: FACT-LFunctional assessment of cancer therapy-lung LCS Lung cancer subscale
Maltese: FACT-L Functional assessment of cancer therapy-lung (Valutazzjoni funzjonali ta' terapija kontra l-kanċerpulmun)
English: Values presented are for IRESSA versus carboplatin/paclitaxel.
Maltese: Il-valuri preżentati huma għal IRESSA versus carboplatin/paclitaxel.
English: Pancreatitis Gastrointestinal perforation
Maltese: Pankreatite Perforazzjoni gastrointestinali
English: These data are consistent with the pre-planned exploratory Japanese subgroup analysis in IPASS (Goto 2012).
Maltese: Din id-dejta hija konsistenti ma' analiżi esploratorja ta' subgrupp Ġappuniż ppjanata minn qabel f'IPASS (Goto 2012).
English: Mean absolute bioavailability is 59% in cancer patients.
Maltese: Ilbijodisponibilità medja assoluta hija madwar 59% fil-pazjenti bil-kanċer.
English: HR 0.82 [0.70 to 0.96] 18.9 m vs. 17.2 m
Maltese: 82 [0.70 sa 0.96] [8.9 m vs 17.2 m]
English: Pharmacotherapeutic group: antineoplastic agents, protein kinase inhibitors; ATC code: L01XE02
Maltese: Kategorija farmakoterapewtika: aġenti antineoplastiċi, inibituri tal-proteina kinasi; Kodiċi ATC:
English: N FACT-L QoL improvement rate
Maltese: N FACT-L QoL rata ta' titjib
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 meta mqabbel 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: Interstitial lung disease (ILD)
Maltese: Mard interstizjali tal-pulmun (Interstitial lung disease - ILD)
English: IRESSA comes in blister packs of 30 tablets.
Maltese: IRESSA tiġi f'pakketti ta' folji ta' 30 pillola.
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: The ORR according to investigator review was 70% and the median PFS was 9.7 months.
Maltese: L-ORR skont ir-reviżjoni talinvestigatur kienet ta' 70% u l-PFS medjan kien ta' 9.7 xhur.
English: a Values presented are for IRESSA versus docetaxel.
Maltese: a Valuri ppreżentati huma għal IRESSA versus docetaxel.
English: Each tablet contains 3.86 mg of sodium.
Maltese: Kull pillola fiha 3.86 mg ta' sodium.
English: The role of CYP2D6 in the metabolic clearance of gefitinib has been evaluated in a clinical trial in healthy volunteers genotyped for CYP2D6 status.
Maltese: Il-funzjoni ta' CYP2D6 fl-eliminazzjoni metabolika ta' gefitinib ġiet evalwata fi prova klinika f'voluntiera b'saħħithom ġenotipati għal status CYP2D6.
English: Positive predictive value (9.5% of the overall population are EGFR mutation-positive (M+))
Maltese: Valur ta' tbassir pożittiv (9.5% talpopolazzjoni totali għandhom mutazzjoni-pożittiva tal-EGFR (M+))
English: Proportion of tumour M+ that are M+ by ctDNA
Maltese: Proporzjon ta' tumuri M+ li huma M+ minħabba ctDNA
English: Gefitinib response data is more sparse in patients whose tumours contain the less common mutations; the available data indicates that G719X, L861Q and S7681 are sensitising mutations; and T790M alone or exon 20 insertions alone are resistance mechanisms.
Maltese: Id-dejta ta' rispons ta' gefitinib hija iktar rari f'pazjenti li t-tumuri tagħhom fihom il-mutazzjonijiet inqas komuni; id-dejta disponibbli tindika li G719X, L861Q u S7681 huma mutazzjonijiet sensitizzanti; u T790M waħdu jew inserzjonijiet ta' Exon 20 waħidhom huma mekkaniżmi ta' reżistenza.
English: Children and adolescents IRESSA is not indicated in children and adolescents under 18 years.
Maltese: Tfal u adolexxenti IRESSA mhux indikat fi tfal u adolexxenti taħt it-18-il sena.
English: In one study a limited number of patients were treated weekly with doses from 1500 mg to 3500 mg.
Maltese: Fi studju wieħed numru limitat ta' pazjenti ġew ikkurati kull ġimgħa b'dożi minn 1500 mg sa 3500 mg.
English: Numbers in square brackets are 96% confidence interval for overall survival
Maltese: Numri fil-parentesi kwadri huma 96% intervall ta' fiduċja (confidence interval)
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 ta' rispons objettiv (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: Manufacturer AstraZeneca AB Gärtunavägen SE-151 85 Södertälje Sweden
Maltese: Manifattur AstraZeneca AB Gärtunavägen SE-151 85 Södertälje L-Iżvezja
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 dejta disponibbli)
English: Circulating Tumour DNA (ctDNA)
Maltese: DNA tat-Tumur Ċirkolanti (ctDNA)
English: Only robust, reliable and sensitive test(s) with demonstrated utility for the determination of EGFR mutation status of tumours or ctDNA should be used to avoid false negative or false positive determinations (see section 5.1).
Maltese: Għandhom jintużaw biss test(ijiet) robusti, affidabbli u sensittivi, b'utilità murija għaddeterminazzjoni ta' status ta' mutazzjoni ta' EGFR ta' tumuri jew ctDNA, biex jiġu evitati determinazzjonijiet negattivi foloz jew pożittivi foloz (ara sezzjoni 5.1).
English: Plasma protein binding is approximately 90%.
Maltese: Ir-rabta mal-proteini tal-plasma hija ta' madwar 90%.
English: Bullous conditions including toxic epidermal necrolysis, Stevens Johnson syndrome and erythema multiforme Cutaneous vasculitis
Maltese: Kundizzjonijiet fejn joħorġu limsiemer inkluż nekroliżi tossika tal-ġilda, sindrome ta' Stevens Johnson u eritema multiforme Vaskulite tal-ġilda
English: Adverse reactions by system organ class and frequency Metabolism and nutrition disorders
Maltese: Reazzjonijiet avversi skont is-sistema tal-klassifika tal-organi u l-frekwenza Disturbi fil-metaboliżmu u n-nutrizzjoni
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 esponiment fi stat fiss(AUC24SS) kienu simili għal gruppi ta' pazjenti b'indeboliment tal-funzjoni tal-fwied moderat jew normali.
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 naqqas l-AUC medja ta' gefitinib bi 83 % (ara sezzjoni 4.4)
English: Gefitinib has been evaluated in a clinical trial conducted in 41 patients with solid tumours and normal hepatic function, or moderate or severe hepatic impairment (classified according to baseline Common Toxicity Criteria grades for AST, alkaline phosphatase and bilirubin) due to liver metastases.
Maltese: Gefitinib ġie evalwat fi prova klinika f'41 pazjent b'tumuri solidi u funzjoni tal-fwied normali, jew indeboliment tal-fwied moderat jew qawwi (klassifikat skont il-linja bażi, gradi ta' Common Toxicity Criteria għal AST, alkaline phosphatase u bilirubin) minħabba metastasi fil-fwied.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għal galactose, defiċjenza ta' lactose totali jew malassorbiment ta' glucose-galactose m'għandhomx jieħdu dan il-prodott mediċinali.
English: The results of an in vitro phototoxicity study demonstrated that gefitinib may have phototoxicity potential.
Maltese: Ir-riżultati ta' studju fototossiku, in vitro, wera li gefitinib jista' jkollu potenzjal fototossiku.
English: In the pooled dataset from the ISEL, INTEREST and IPASS phase III clinical trials (2462 IRESSA-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'IRESSA) l-aktar reazzjonijiet avversi (ADRs) li ġew irrappurtati l-aktar spiss, f'aktar minn 20% talpazjenti huma dijarrea u reazzjonijiet fil-ġilda (inkluż raxx, ponot, ġilda xotta u ħakk).
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: 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 interstizjalital-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: 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: a Values presented are for IRESSA versus placebo.
Maltese: a Valuri ppreżentati huma għal IRESSA versus plaċebo.
English: IRESSA 250 mg tablets gefitinib
Maltese: IRESSA pilloli ta' 250 mg gefitinib
English: Nail disorder Alopecia
Maltese: Disturbi fid-dwiefer Alopeċja
English: Antacids if taken regularly close in time to administration of gefitinib may have a similar effect (see sections 4.5 and 5.2).
Maltese: Jekk antaċidi jittieħdu regolarment qrib il-ħin li jittieħed gefitinib jista' jkollhom effett simili (ara sezzjoni 4.5 u 5.2).
English: In a trial in healthy volunteers where gastric pH was maintained above pH 5, gefitinib exposure was reduced by 47%, likely due to impaired solubility of gefitinib in the stomach (see sections 4.4 and 4.5).
Maltese: Minn provi b'voluntiera f'saħħithom, li fihom il-pH tal-istonku nżamm ogħla minn pH 5, l-esponiment għal gefitinib naqas b'47%, x'aktarx minħabba tnaqqis fis-solubilità ta' gefitinib fl-istonku (ara sezzjoni 4.4 u 4.5).
English: IRESSA contains lactose
Maltese: IRESSA fiha lactose
English: In the IPASS trial, IRESSA 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, IRESSA uriet PFS, ORR, QoL u serħan mis-sintomi superjuri bl-ebda differenza sinifikanti fis-sopravivenza totali meta mqabbla 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.