FrancophonIA/ELRC3.0 huggingface dataset:
English: • Decreased levels of testosterone, a male sex hormone.
Maltese: • Tnaqqis fil-livelli ta' testosterone, ormon sesswali tal-irġiel.
English: • Clarithromycin, telithromycin, erythromycin, antibiotics used to treat bacterial infections.
Maltese: • Clarithromycin, telithromycin, erythromycin, antibijotiċi użati għat-trattament ta' infezzjonijiet batteriċi.
English: Crizotinib is an inhibitor of P-glycoprotein (P-gp) in vitro.
Maltese: Crizotinib huwa inibitur tal-P-glycoprotein (P-gp) in vitro.
English: Capsule shell: gelatin, titanium dioxide (E171), and red iron oxide (E172).
Maltese: Qoxra tal-kapsula: gelatin, titanium dioxide (E171), u red iron oxide (E172).
English: Adverse reactions reported in crizotinib clinical studies (N=1722) System organ class
Maltese: Tabella 3. Reazzjonijiet avversi rrappurtati fi studji kliniċi (N=1722) fejn pazjenti ngħataw crizotinib Sistema tal-klassifika tal-organi
English: • Atazanavir, ritonavir, cobicistat, used to treat HIV infections/AIDS.
Maltese: • Atazanavir, ritonavir, cobicistat, użati għat-trattament ta' infezzjonijiet tal-HIV/AIDS.
English: Printing ink: shellac, propylene glycol, potassium hydroxide, and black iron oxide (E172).
Maltese: Linka tal-istampar: shellac, propylene glycol, potassium hydroxide, u black iron oxide (E172).
English: Neutropeniaa (22%) Anaemiab (15%) Leukopeniac (15%)
Maltese: Newtropenijaa (22%) Anemijab (15%) Lewkopenijac (15%)
English: b. Anaemia (Anaemia, Haemoglobin decreased, Hypochromic anaemia).
Maltese: b. Anemija (Anemija, Tnaqqis fl-emoglobina, Anemija ipokromika).
English: Dizzinessf (26%) Bradycardiag (13%)
Maltese: Sturdamentf (26%) Bradikardijag (13%)
English: Oedemap (47%) Fatigue (30%)
Maltese: Edimap (47%) Għeja (30%)
English: g. Bradycardia (Bradycardia, Heart rate decreased, Sinus bradycardia).
Maltese: g. Bradikardija (Bradikardija, Nuqqas fir-rata ta' taħbit tal-qalb, Bradikardija tas-sinus).
English: • Procainamide, used to treat cardiac arrhythmia.
Maltese: • Procainamide, li jintuża għat-trattament ta' arritmija kardijaka.
English: * PFS, Objective Response Rate and Duration of Response are based on the data cutoff date of 30 March 2012;
Maltese: * PFS, ir-Rata ta' Rispons Oġġettiv u d-Dewmien tar-Rispons huma bbażati fuq id-data tal-għeluq għad-dejta tat-30 ta' Marzu 2012;
English: (Cyprus Branch) Τηλ: + 357 22 817690
Maltese: Τηλ: + 357 22 817690
English: e. Per data cutoff date 30 November 2013.
Maltese: Skont id-data tal-għeluq għad-dejta: 30 ta' Novembru 2013.
English: Each carton contains 60 hard capsules.
Maltese: Kull kartuna fiha 60 kapsula iebsa.
English: e. Estimated using the Kaplan-Meier method.
Maltese: Stima bl-użu tal-metodu Kaplan-Meier.
English: XALKORI dose modification - haematological toxicitiesa,b CTCAEc Grade
Maltese: Modifika fid-doża ta' XALKORI - tossiċitajiet ematoloġiċia,b Grad tas-CTCAEc
English: Date of latest renewal: 29 July 2016
Maltese: Data tal-ewwel awtorizzazzjoni: 23 ta' Ottubru 2012 Data tal-aħħar tiġdid: 29 ta' Lulju 2016
English: f. Based on the stratified Cochran-Mantel-Haenszel test (2-sided).
Maltese: Ibbażat fuq it-test stratifikat ta' Cochran-Mantel-Haenszel (2-sided).
English: MARKETING AUTHORISATION NUMBER(S) XALKORI 200 mg hard capsules EU/1/12/793/001
Maltese: XALKORI 200 mg kapsuli ibsin EU/1/12/793/001
English: The antitumour efficacy of crizotinib was dose-dependent and correlated to pharmacodynamic inhibition of phosphorylation of ALK fusion proteins (including EML4-ALK and NPM-ALK) in tumours in vivo.
Maltese: L-effikaċja ta' crizotinib kontra t-tumuri kienet dipendenti fuq id-doża u korrelatata mal-inibizzjoni farmakodinamika tal-fosforilazzjoni ta' proteini ta' fużjoni ta' ALK (inklużi EML4-ALK u NPM-ALK) f'tumuri in vivo.
English: The adverse reactions listed in Table 3 are presented by system organ class and frequency categories, defined using the following convention: 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: Ir-reazzjonijiet avversi elenkati f'Tabella 3 huma ppreżentati skont is-sistema tal-klassifika tal-organi u l-kategoriji tal-frekwenza huma definiti bil-konvenzjoni li ġejja: komuni ħafna (1/10); komuni (1/100 sa<1/10), mhux komuni (1/1,000 sa <1/100), rari (1/10,000 sa <1/1,000), rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: p. Oedema (Face oedema, Generalised oedema, Local swelling, Localised oedema, Oedema, Oedema peripheral, Periorbital oedema).
Maltese: Edima (Edima fil-wiċċ, Edima ġeneralizzata, Nefħa lokali, Edima lokalizzata, Edima, Edima periferali, Edima periorbitali).
English: Therefore, the concomitant use of strong CYP3A inhibitors (including but not limited to atazanavir, ritonavir, cobicistat, itraconazole, ketoconazole, posaconazole, voriconazole, clarithromycin, telithromycin, and erythromycin) should be avoided.
Maltese: Għalhekk, għandu jiġi evitat l-użu konkomitanti ta' inibituri qawwijin ta' CYP3A ((inkluż iżda mhux limitat għal atazanavir, ritonavir, cobicistat, itraconazole, ketoconazole, posaconazole, voriconazole, clarithromycin, telithromycin, u erythromycin).
English: The most common findings concerned slit lamp biomicroscopy (21.1%), fundoscopy (15.8%) and visual acuity (13.2%).
Maltese: L-iktar sejbiet komuni kienu jikkonċernaw bijomikroskopija slit lamp (21.1%), fundoskopija (15.8%) u akutezza viżwali (13.2%).
English: Abbreviations: CI=confidence interval; HR=hazard ratio; IRR=independent radiology review; N/n=number of patients; PFS=progression-free survival; OS=overall survival.
Maltese: HR = proporzjon ta' periklu, IRR=reviżjoni radjoloġika indipendenti; N/n=numru ta' pazjenti; PFS=sopravivenza bla progressjoni; OS=sopravivenza globali.
English: Secondary endpoints included time to tumour response (TTR), duration of response (DR), PFS, and OS.
Maltese: Punti tat-tmiem sekondarji inkludew żmien sar-rispons tat-tumur (TTR), kemm idum r-rispons (DR), PFS, u OS.
English: XALKORI 200 mg: each capsule contains 200 mg crizotinib XALKORI 250 mg: each capsule contains 250 mg crizotinib
Maltese: XALKORI 200 mg: kull kapsula fiha 200 mg crizotinib XALKORI 250 mg: kull kapsula fiha 250 mg crizotinib
English: a. Per data cutoff dates 01 June 2011 (Study 1001) and 15 February 2012 (Study 1005).
Maltese: Skont id-dati tal-għeluq għad-dejta: 1 ta' Ġunju 2011 (Studju 1001) u 15 ta' Frar 2012 (Studju 1005).
English: 44% (95% CI: 32, 55) for pemetrexed/carboplatin (p-value <0.0001 compared with crizotinib).
Maltese: 44% (95% CI: 32, 55) għal pemetrexed/carboplatin (valur p <0.
English: Patients with mild (60≤ CLcr <90 mL/min) and moderate (30≤ CLcr <60 mL/min) renal impairment were enrolled in single-arm Studies 1001 and 1005.
Maltese: Pazjenti b'indeboliment ħafif (60≤ CLcr <90 mL/min) u moderat (30≤ CLcr <60 mL/min) tal-kliewi ġew irreġistrati fi Studji 1001 u 1005 li kien fihom parti waħda biss.
English: Nausea (57%), diarrhoea (54%), vomiting (51%), and constipation (43%) were the most commonly reported all-causality gastrointestinal events.
Maltese: Dardir (57%), dijarea (54%), rimettar (51%), u stitikezza (43%) kienu l-aktar avvenimenti gastrointestinali mill-kawżalitajiet kollha rrappurtati b'mod komuni.
English: Patient-reported symptoms and global QOL were collected using the EORTC QLQ-C30 and its lung cancer module (EORTC QLQ-LC13).
Maltese: Sintomi rrapportati mill-pazjenti u QOL globali nġabru bl-użu tal-EORTC QLQ-C30 u l-modulu talkanċer tal-pulmun (EORTC QLQ-LC13).
English: • Pravastatin, used to reduce cholesterol levels.
Maltese: • Pravastatin, użat sabiex inaqqas il-livelli tal-kolesterol.
English: The results of an in vitro phototoxicity study demonstrated that crizotinib may have phototoxic potential.
Maltese: Ir-riżultati ta' studju in vitro tal-fototossiċità wera li crizotinib jista' jkollu potenzjal fototossiku.
English: Renal cyst
Maltese: Ċesta renali
English: There is no antidote for XALKORI.
Maltese: Ma hemmx antidotu għal XALKORI.
English: • Mefloquine, used for the prevention of malaria.
Maltese: • Mefloquine, użat għall-prevenzjoni tal-malarja.
English: • Ergot alkaloids (e.g., ergotamine, dihydroergotamine), used to treat migraine.
Maltese: • Alkalojdi tal-ergot (eż., ergotamine, dihydroergotamine), użati sabiex jittratta l-emigranja.
English: • Ciclosporin, sirolimus and tacrolimus used in transplant patients.
Maltese: • Ciclosporin, sirolimus u tacrolimus użati f'pazjenti għat-trapjanti.
English: In vitro, crizotinib did not inhibit the human hepatic uptake transport proteins organic anion transporting polypeptide (OATP)1B1 or OATP1B3 or the renal uptake transport proteins organic anion transporter (OAT)1 or OAT3 at clinically relevant concentrations.
Maltese: In vitro, crizotinib ma inibixxiex il-proteini ta' trasport tat-teħid epatiku tal-bniedem tal-anjoni organiċi tat-trasport tal-polypeptide (OATP)1B1 jew OATP1B3 jew il-proteini tat-trasport tat-teħid tal-kliewi tat-trasportatur anjoniku organiku (OAT)1 jew OAT3 f'konċentrazzjonijiet klinikament rilevanti.
English: Nervous system effects
Maltese: Effetti fuq is-sistema nervuża
English: Vomiting (51%) Diarrhoea (54%) Nausea (57%) Constipation (43%) Abdominal painj
Maltese: Rimettar (51%) Dijarea (54%) Dardir (57%) Stitikezza (43%) Uġigħ addominalij
English: m. Elevated transaminases (Alanine aminotransferase increased, Aspartate aminotransferase increased, Gamma-glutamyltransferase increased, Hepatic enzyme increased, Hepatic function abnormal, Liver function test abnormal, Transaminases increased).
Maltese: Żieda fit-transaminases (Żieda fl-alanine aminotransferase, Żieda fl-Aspartate aminotransferase, Żieda filgamma-glutamyltransferase, Żieda fl-enzimi epatiċi, Funzjoni tal-fwied anormali, Test tal-funzjoni tal-fwied b'riżultat anormali, Żieda fit-transaminases).
English: The active substance in XALKORI is crizotinib.
Maltese: Is-sustanza attiva f'XALKORI hi crizotinib.
English: All-causality Grade 3 or 4 Electrocardiogram QT prolonged was reported in 27 (1.6%) out of 1722 patients (see sections 4.2, 4.4, 4.5 and 5.2).
Maltese: Ġie rrappurtat titwil tal-QT fuq lElettrokardjogramma ta' Grad 3 jew 4 minn kull kawżalità f'27 (1.6%) minn 1,722 pazjent (ara sezzjonijiet 4.2, 4.4, 4.5 u 5.2).
English: Limited data are available in this subgroup of patients (see sections 4.2 and 5.1).
Maltese: Dejta limitata hija disponibbli f'dan is-sottogrupp ta' pazjenti (ara sezzjonijiet 4.2 u 5.1).
English: In vitro studies indicated that crizotinib is a weak inhibitor of uridine diphosphate glucuronosyltransferase (UGT)1A1 and UGT2B7.
Maltese: Studji in vitro indikaw li crizotinib huwa inibitur dgħajjef ta' uridine diphosphate glucuronosyltransferase (UGT)1A1 u UGT2B7.
English: Visual effects
Maltese: Effetti viżivi
English: Hepatotoxicity
Maltese: Potassium hydroxide
English: Drug-induced ILD/pneumonitis should be considered in the differential diagnosis of patients with ILD-like conditions such as: pneumonitis, radiation pneumonitis, hypersensitivity pneumonitis, interstitial pneumonitis, pulmonary fibrosis, acute respiratory distress syndrome (ARDS), alveolitis, lung infiltration, pneumonia, pulmonary oedema, chronic obstructive pulmonary disease, pleural effusion, aspiration pneumonia, bronchitis, obliterative bronchiolitis, and bronchiectasis.
Maltese: L-ILD/pulmonite kkawżati mill-mediċini għandhom jiġu kkunsidrati fid-dijanjożi differenzjali tal-pazjenti li jkollhom kundizzjonijiet jixbħu lill-ILD bħal: pulmonite, pulmonite mirradjazzjoni, pulmonite minn sensittività eċċessiva, pulmonite interstizjali, fibrożi pulmonari, sindromu ta' diffikultà respiratorja akuta (ARDS), alveolite, infiltrazzjoni tal-pulmun, pulmonite, edima pulmonari, mard pulmonari ostruttiv kroniku, effużjoni plewrali, aspirazzjoni pulmonari, bronkite, bronkjolite obliterattiva, u bronkiekstasi.
English: Bradycardia has been reported during clinical studies; therefore, use crizotinib with caution due to the risk of excessive bradycardia when used in combination with other bradycardic agents (e.g., non-dihydropyridine calcium channel blockers such as verapamil and diltiazem, beta-blockers, clonidine, guanfacine, digoxin, mefloquine, anticholinesterases, pilocarpine) (see sections 4.2 and 4.4).
Maltese: Ġiet irrappurtata bradikardija matul l-istudji kliniċi; għalhekk, uża crizotinib b'attenzjoni minħabba rriskju ta' bradikardija eċċessiva meta użat flimkien ma' aġenti bradikardijaċi oħrajn (eż., imblokkaturi mhux dihydropyridine tal-kanali tal-kalċju bħal verapamil u diltiazem, imblokkaturi beta, clonidine, guanfacine, digoxin, mefloquine, anticholinesterases, pilocarpine) (ara sezzjonijiet 4.2 u 4.4).
English: According to an independent review committee (IRC) assessment of patients with ALK-positive NSCLC (N=1669), 20 (1.2%) patients had ILD/pneumonitis, including 10 (<1%) patients with fatal cases.
Maltese: Skond stima talkumitat indipendenti tal-evalwazzjoni (IRC) ta' pazjenti b'NSCLC pożittiv għall-ALK (N=1,699), 20 (1.2%) pazjent kellhom ILD/pulmonite, inklużi 10 (<1%) pazjenti b'każijiet fatali.
English: Elevated transaminasesm (32%)
Maltese: Żieda fittransaminasesm (32%)
English: • Medicines for high blood pressure called beta-blockers such as atenolol, propranolol, labetolol.
Maltese: • Mediċini għall-pressjoni għolja tad-demm imsejħa imblokkaturi beta bħal atenolol, propranolol, labetolol.
English: Unchanged crizotinib represented approximately 53% and 2.3% of the administered dose in faeces and urine, respectively.
Maltese: Crizotinib mhux mibdul irrappreżenta bejn wieħed u ieħor 53% u 2.3% tad-doża amministrata fl-ippurgar u lawrina, rispettivament.
English: • Inflammation of the oesophagus (swallowing tube).
Maltese: • Infjammazzjoni tal-esofagu (it-tubu minn fejn tibla').
English: i. Interstitial lung disease (Acute respiratory distress syndrome, Alveolitis, Interstitial lung disease, Pneumonitis).
Maltese: Mard interstizjali tal-pulmun (Sindromu ta' diffikultà respiratorja akuta, Alveolite, Mard interstizjali talpulmun, Pulmonite).
English: Titanium dioxide (E171) Red iron oxide (E172)
Maltese: Titanium dioxide (E171)
English: Intracranial Disease Control Rate (IC-DCR) at 12 weeks was 65% and 46% for crizotinib and chemotherapy-treated patients, respectively.
Maltese: (Intracranial Disease Control Rate (IC-DCR)) wara 12-il ġimgħa kienet ta' 65% u 46% għall-pazjenti ttrattati bi crizotinib u bil-kimoterapija, rispettivament.
English: Figure 3.
Maltese: Figura 3.
English: N=765a
Maltese: Studju 1005 N=765a
English: Any Grade interstitial lung disease (ILD)/pneumonitis
Maltese: Mard interstizjali tal-pulmun (ILD)/pulmonite ta' kwalunkwe Grad
English: Grade 3 or 4 leukopenia has been commonly (3%) reported (see section 4.8).
Maltese: Il-lewkopenija ta' Grad 3 jew 4 kienet irrappurtata b'mod komuni (3%) (ara sezzjoni 4.8).
English: The disease characteristics were 94% metastatic, 96% adenocarcinoma histology, and 13% with no prior systemic therapy for metastatic disease.
Maltese: Il-karatteristiċi tal-marda kienu 94% metastatika, 96% kienu kklassifikati bħala istoloġija ta' adenokarċinoma, u 13% mingħajr terapija sistemika minn qabel għal mard metastatiku.
English: In vitro studies indicated that clinical drug-drug interactions are unlikely to occur as a result of crizotinib-mediated inhibition of the metabolism of medicinal products that are substrates for CYP1A2, CYP2C8, CYP2C9, CYP2C19 or CYP2D6.
Maltese: L-istudji in vitro indikaw li mhuwiex probabbli li jseħħu interazzjonijiet kliniċi bejn li-mediċini minħabba l-inibizzjoni medjata minn crizotinib talmetaboliżmu ta' prodotti mediċinali li huma sustratti għal CYP1A2, CYP2C8, CYP2C9, CYP2C19 jew CYP2D6.
English: In studies in patients with ALK-positive advanced NSCLC (N=1669), the following adverse reactions were reported with an absolute difference of ≥10% in Asian patients (N=753) than in non-Asian patients (N=916): elevated transaminases, decreased appetite, neutropenia, and leukopenia.
Maltese: Fi studji f'pazjenti b'NSCLC avvanzat pożittiv għall-ALK (N=1669), ir-reazzjonijiet avversi li ġejjin ġew irrappurtati b'differenza assoluta ta' ≥10% f'pazjenti Asjatiċi (N=753) milli f'pazjenti mhux Asjatiċi (N=916): livelli għoljin ta' transaminases, tnaqqis fl-aptit, newtropenija, u lewkopenija.
English: Renal cystn (3%) Blood creatinine increasedo (8%)
Maltese: Ċesta fil-kliewin (3%) Żieda fil-kreatinina fid-demmo (8%)
English: Of 154 and 1063 ALK-positive NSCLC patients in single arm studies 1001 and 1005, 22 (14%) and 173 (16%) were 65 years or older, respectively.
Maltese: Mill-154 u 1,063 pazjent b'NSCLC pożittiv għall-ALK fi studji ta' fergħa waħda 1001 u 1005, 22 (14%) u 173 (16%) kellhom 65 sena jew aktar, rispettivament.
English: Acute renal failure (<1%) Renal failure
Maltese: Indeboliment renali akut (<1%)
English: • St. John's wort (Hypericum perforatum), a herbal product used to treat depression.
Maltese: John's wort (Hypericum perforatum), prodott tal-ħxejjex użat sabiex jittratta d-depressjoni.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Pfizer Europe MA EEIG (as MAH logo)
Maltese: TAD-DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Pfizer Europe MA EEIG (bħala lowgo tal-MAH)
English: In clinical studies with crizotinib, events of gastrointestinal perforations were reported.
Maltese: Fi studji kliniċi bi crizotinib, ġew irrapportati episodji ta' perforazzjonijiet gastrointestinali.
English: d. PFS data from Study 1005 included 807 patients in the safety analysis population who were identified by the FISH assay (data cutoff date 15 February 2012).
Maltese: d. Id-dejta dwar il-PFS u l-OS mill-Istudju 1005 kienet tinkludi 807 pazjenti fil-popolazzjoni tal-analiżi dwar issigurtà li kienu identifikati bit-test ta' FISH (data tal-għeluq għad-dejta: 15 ta' Frar 2012).
English: In vitro, crizotinib is not an inhibitor of BSEP at clinically relevant concentrations.
Maltese: In vitro, crizotinib mhuwiex inibitur ta' BSEP f'konċentrazzjonijiet klinikament rilevanti.
English: The concurrent use of strong CYP3A inducers, including but not limited to carbamazepine, phenobarbital, phenytoin, rifampicin, and St. John's wort, should be avoided (see section 4.4).
Maltese: Għandu jiġi evitat l-użu konkomitanti ta' indutturi qawwijin ta' CYP3A, fosthom, iżda mhux limitati għal carbamazepine, phenobarbital, phenytoin, rifampicin, u l-fexfiex tar-raba' (St. John's wort) (ara sezzjoni 4.4).
English: e. ORRs were 47% (95% CI: 37, 58) for pemetrexed/cisplatin (p-value <0.0001 compared with crizotinib) and
Maltese: e. ORRs kienu 47% (95% CI: 37, 58) għal pemetrexed/cisplatin (valur p <0.
English: ALK and ROS1 testing
Maltese: Ittestjar tal-ALK u tal-ROS1
English: All-causality, all grade, vision disorder, most commonly visual impairment, photopsia, vision blurred, and vitreous floaters, was experienced by 1084 (63%) of 1722 patients treated with crizotinib.
Maltese: Ġie esperjenzat disturb fil-vista, f'kull kawżalità, f'kull grad, l-aktar komuni indeboliment tal-vista, fotopsija, vista mċajpra, u floaters vitrużi minn 1,084 (63%) minn 1,722 pazjent ittrattati b'crizotinib.
English: l. Gastrointestinal perforation (Gastrointestinal perforation, Intestinal perforation, Large intestine perforation).
Maltese: Perforazzjoni gastrointestinali (Perforazzjoni gastrointestinali, Perforazzjoni intestinali, Perforazzjoni tal-musrana l-kbira). m.
English: Crizotinib plasma concentrations may be increased in patients with severe renal impairment (CLcr <30 mL/min).
Maltese: Ilkonċentrazzjonijiet ta' crizotinib fil-plażma jistgħu jiżdiedu f'pazjenti b'indeboliment renali sever (CLcr <30 mL/min).
English: • Lung inflammation
Maltese: • Infjammazzjoni tal-pulmun
English: Drug-induced hepatotoxicity with fatal outcome occurred in 0.1% of 1722 patients treated with crizotinib across clinical trials.
Maltese: Kien hemm epatotossiċità indotta mill-mediċina b'eżitu fatali f'0.1% minn 1,722 pazjent ittrattati bi crizotinib fil-provi kliniċi.
English: HR (95% CI)b p-valuec
Maltese: HR (95% C
English: PVC-foil blisters containing 10 hard capsules.
Maltese: Folji tal-PVC/fojl li fihom 10 kapsuli ibsin.
English: • Irinotecan, a chemotherapy drug used to treat cancer of the colon and rectum.
Maltese: • Irinotecan, kemjoterapija użata għat-trattament tal-kanċer fil-kolon u fir-rektum.
English: The absolute bioavailability of crizotinib was determined to be 43% following the administration of a single 250 mg oral dose.
Maltese: Il-bijodisponibilità assoluta ta' crizotinib ġiet determinata għal 43% wara l-amministrazzjoni ta' doża orali waħda ta' 250 mg.
English: Efficacy data from Studies 1001 and 1005 are provided in Table 6.
Maltese: Id-dejta dwar l-effikaċja mill-Istudji 1001 u 1005 huma pprovduti fit-Tabella 6.
English: Therefore, coadministration of crizotinib with CYP3A substrates with narrow therapeutic indices, including but not limited to alfentanil, cisapride, cyclosporine, ergot derivatives, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus should be avoided (see section 4.4).
Maltese: Għalhekk, għandha tiġi evitata l-amministrazzjoni konkomitanti ta' crizotinib ma' sustratti ta' CYP3A li għandhom indiċi terapewtiku strett, fosthom, iżda mhux limitati għal alfentanil, cisapride, cyclosporine, derivati mill-ergot, fentanyl, pimozide, quinidine, sirolimus, u tacrolimus (ara sezzjoni 4.4).
English: Crizotinib demonstrated potent and selective growth inhibitory activity and induced apoptosis in tumour cell lines exhibiting ALK fusion events (including echinoderm microtubule-associated protein-like 4 [EML4]-ALK and nucleophosmin [NPM]-ALK), ROS1 fusion events, or exhibiting amplification of the ALK or MET gene locus.
Maltese: Crizotinib wera attività inibitorja qawwija u selettiva tat-tkabbir u induċa apoptosi f'linji ta' ċelloli tattumuri li wrew avvenimenti ta' fużjoni ta' ALK (inklużi ekinodermi mikrotubuli-assoċjat mal-proteini simili 4 [EML4]-ALK u nucleophosmin [NPM]-ALK) u avvenimenti ta' fużjoni ta' ROS1, jew li wrew amplifikazzjoni tal-lokus tal-ġeni ta' ALK jew MET. Crizotinib wera effikaċja kontra t-tumuri, inkluża attività ċitoriduttiva markata kontra t-tumuri, fi ġrieden li ġarrbu xenografts ta' tumuri li esprimew proteini ta' fużjoni ta' ALK.
English: In vitro studies showed that crizotinib is a weak inhibitor of UGT1A1 and UGT2B7 (see section 4.5).
Maltese: Studji in vitro wrew li crizotinib huwa inibitur dgħajjef ta' UGT1A1 u UGT2B7 (ara sezzjoni 4.5).
English: Treatment with crizotinib should be used with caution in patients with hepatic impairment (see Table 2 and sections 4.4, 4.8 and 5.2).
Maltese: It-trattament bi crizotinib għandu jintuża b'kawtela f'pazjenti b'indeboliment epatiku (ara Tabella 2 u sezzjonijiet 4.4, 4.8 u 5.2).
English: • Phenytoin, carbamazepine or phenobarbital, anti-epileptics used to treat seizures or fits.
Maltese: • Phenytoin, carbamazepine jew phenobarbital, antiepilettiċi użati biex jitrattaw attakki ta'
English: For ALK-positive NSCLC patients in Studies 1001 (N=154) and 1005 (N=1063), the median duration of treatment was 57 and 45 weeks, respectively.
Maltese: Għal pazjenti b'NSCLC pożittiv għal ALK fi Studji 1001 (N=154) u 1005 (N=1063), it-tul medjan tattrattament kien ta' 57 u 45 ġimgħa, rispettivament.
English: Final OS analysis was not adjusted for the potentially confounding effects of crossover (154 [89%] patients received subsequent crizotinib treatment).
Maltese: Analiżi tal-OS finali ma ġietx aġġustata għall-effetti potenzjalment li jfixklu lil dak li jkun tal-crossover (154 [89%] pazjent rċevew trattament sussegwenti bi crizotinib).
English: Do not take XALKORI
Maltese: Tiħux XALKORI
English: INFORMATION IN BRAILLE XALKORI 250 mg
Maltese: XALKORI 250 mg