FrancophonIA/ELRC3.0 huggingface dataset:
English: In the subgroup of patients with HR ≥ 75 bpm and on the recommended target dose of beta-blocker, no statistically significant benefit was observed on the primary composite endpoint (hazard ratio: 0.97, 95%CI [0.74;1.28]) and other secondary endpoints, including hospitalisation for worsening heart failure (hazard ratio: 0.79, 95% CI [0.56;1.10]) or death from heart failure (hazard ratio: 0.69, 95% CI [0.31;1.53]).
Maltese: Fis-subgrupp ta' pazjenti b'HR ≥ 75 bpm u fuq id-doża fil-mira rakkomandata ta' beta-blocker, ma ġie osservat ebda benefiċċju statistikament sinifikanti fuq l-endpoint kompost primarju (proporzjon ta' periklu: 0.97, 95%CI
English: Tel.: + 48 (0) 22 594 90 00
Maltese: Servier Polska SP. Z O.O. Tel.: + 48 (0) 22 594 90 00
English: Ivabradine can interact also with the retinal current Ih which closely resembles cardiac If.
Maltese: Ivabradine jista' jkollu interazzjoni ma' kurrent IH retinali li jixbaħ ħafna lil If kardijaku.
English: - Non cardiovascular QT prolonging medicinal products (e.g. pimozide, ziprasidone, sertindole,
Maltese: - bepridil (kura għal angina pectoris) - xi mediċini għall-kura ta' ansjetà, skiżofrenija jew psikożi oħra (bħal pimozide, ziprasidone,
English: thoracic and mediastinal disorders
Maltese: Disturbi respiratorji, toraċiċi u medjastinali
English: There is no evidence of risk of (excessive) bradycardia on return to sinus rhythm when pharmacological cardioversion is initiated in patients treated with ivabradine.
Maltese: Mhemmx evidenza ta' riskju ta' bradikardija (eċċessiva) mar-ritorn għal sinus rhythm meta lkardjoverżjoni farmakoloġika tinbeda f'pazjenti li qed jieħdu ivabradine.
English: Ivabradine must not be initiated in patients with a pre-treatment resting heart rate below 70 beats per minute (see section 4.3).
Maltese: Ivabradine m'għandux jinbeda f'pazjenti li qabel il-kura jkollhom rata tat-taħbit tal-qalb waqt il-mistrieħ ta' inqas minn 70 taħbita fil-minuta (ara sezzjoni 4.3).
English: Bradycardia was reported by 3.3% of patients particularly within the first 2 to 3 months of treatment initiation.
Maltese: Bradikardija ġiet irrapportata minn 3.3% tal-pazjenti l-aktar fl-ewwel 2 sa 3 xhur mill-bidu tal-kura. 0.5% tal-pazjenti kellhom bradikardija qawwija taħt jew daqs 40 bpm.
English: After two weeks of treatment, the dose can be increased to 7.5 mg twice daily if resting heart rate is persistently above 60 bpm or decreased to 2.5 mg twice daily (one half 5 mg tablet twice daily) if resting heart rate is persistently below 50 bpm or in case of symptoms related to bradycardia such as dizziness, fatigue or hypotension.
Maltese: F'pazjenti ta' 'l fuq minn 75 sena, doża mnaqqsa għandha tiġi kkunsidrata fil-bidu tal-kura (2.5 mg darbtejn kuljum i.e. nofs pillola ta' 5 mg darbtejn kuljum) qabel ma d-doża tiżdied bil-qies jekk ikun hemm bżonn.
English: Ivabradine is not effective in the treatment or prevention of cardiac arrhythmias and likely loses its efficacy when a tachyarrhythmia occurs (eg.
Maltese: Ivabradine m'huwiex effikaċi fil-kura jew prevenzjoni ta' arritmiji kardijaċi u bl-istess mod jitlef leffikaċja tiegħu meta sseħħ taki-arritmija (eż. takikardija ventrikulari jew supraventrikulari).
English: If heart rate is between 50 and 60 bpm, the dose of 5 mg twice daily should be maintained.
Maltese: Jekk irrata tal-qalb tkun bejn 50 u 60 bpm, għandha tinżamm id-doża ta' 5 mg darbtejn kuljum.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One film-coated tablet contains 5 mg ivabradine (equivalent to 5.39 mg ivabradine as hydrochloride)
Maltese: - Is-sustanza attiva hi ivabradine (bħala hydrochloride) Corlentor 5 mg: pillola waħda miksija b'rita fiha 5 mg ivabradine (ekwivalenti għal 5.390 mg ivabradine hydrochloride)
English: itraconazole), macrolide antibiotics (such as josamycin, clarithromycin, telithromycin or erythromycin given orally), medicines to treat HIV infections (such as nelfinavir, ritonavir) or nefazodone (medicine to treat depression) or diltiazem, verapamil (used for high blood pressure or angina pectoris); - if you are a woman able to have children and not using reliable contraception; - if you are pregnant or trying to become pregnant; - if you are breast-feeding.
Maltese: (mediċina għall-kura tad-dipressjoni) jew diltiazem, verapamil (użat għall-pressjoni tad-demm għolja jew anġina pectoris); - jekk inti mara li jista' jkollha t-tfal u ma tużax kontraċettivi affidabbli; - jekk int tqila jew qed tipprova toħroġ tqila;
English: Corlentor (ivabradine) is a heart medicine used to treat: - Symptomatic stable angina pectoris (which causes chest pain) in adult patients whose heart rate is over or equal to 70 beats per minute.
Maltese: - Anġina pectoris sintomatika stabbli (li tikkaġuna uġigħ fis-sider) f'adulti li r-rata tat-taħbit tal-qalb tagħhom hija 70 taħbita jew aktar fil-minuta.
English: (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, erythromycin per os,
Maltese: - erythromycin ġol-vini (antibijotiku)
English: Palpitations and cardiac extra beats, feeling sick (nausea), constipation, diarrhoea, abdominal pain, spinning sensation (vertigo), difficulty breathing (dyspnoea), muscle cramps, changes in laboratory parameters : high blood levels of uric acid, an excess of eosinophils (a type of white blood cell) and elevated creatinine in blood (a breakdown product of muscle), skin rash, angioedema (such as swollen face, tongue or throat, difficulty in breathing or swallowing), low blood pressure, fainting, feeling of tiredness, feeling of weakness, abnormal ECG heart tracing, double vision, impaired vision.
Maltese: anġjoedema (bħal nefħa fil-wiċċ, ilsien jew griżmejn, diffikultà fit-teħid tan-nifs jew biex tibla'), pressjoni tad-demm baxxa, ħass ħażin, sensazzjoni ta' għeja, sensazzjoni ta' dgħufija, intraċċar mhux normali tal-qalb b'ECG, vista doppja, indeboliment fil-vista.
English: Dizziness, possibly related to bradycardia
Maltese: Mhux komuni* Astenja, possibbilment relatata ma' bradikardija
English: The maintenance dose should not exceed 7.5 mg twice daily.
Maltese: Id-doża ta' manteniment ma għandhiex taqbeż 7.5 mg darbtejn kuljum.
English: It usually appears between 40 and 50 years of age.
Maltese: Dan jiġri l aktar fl-età ta' bejn l-40 u l-50 sena.
English: Ivabradine does not influence intracardiac conduction, contractility (no negative inotropic effect) or ventricular repolarisation: - in clinical electrophysiology studies, ivabradine had no effect on atrioventricular or intraventricular conduction times or corrected QT intervals; - in patients with left ventricular dysfunction (left ventricular ejection fraction (LVEF) between 30
Maltese: Ivabradine m'għandux effett fuq il-ħin biex jgħaddi l-istimulu intrakardijaku, fuq il-kontrazzjoni (l-ebda effett negattiv inotropiku) u lanqas fuq ir-ripolarizzazzjoni ventrikulari:
English: Concomitant use with precautions - Moderate CYP3A4 inhibitors: the concomitant use of ivabradine with other moderate CYP3A4 inhibitors (e.g. fluconazole) may be considered at the starting dose of 2.5 mg twice daily and if resting heart rate is above 70 bpm, with monitoring of heart rate.
Maltese: L-użu ta' ivabradine flimkien ma' impedituri ta' CYP3A4 moderati (eż.fluconazole) jista' jiġi kkunsidrat b'doża tal-bidu ta' 2.5 mg darbtejn kuljum u jekk ir-rata tat taħbit tal-qalb mistrieħa hija ogħla minn 70 bpm, hemm bżonn li l-pazjent ikun taħt monitoraġġ minħabba ir-rata tat-taħbit tal-qalb.
English: In some cases (e.g. if you are elderly), your doctor may prescribe half the dose i.e., one half 5 mg tablet of Corlentor 5 mg (corresponding to 2.5 mg ivabradine) in the morning and one half 5 mg tablet in the evening.
Maltese: F'xi każijiet (eż. jekk inti anzjan), it-tabib tiegħek jista' jordnalek nofs id-doża, jiġifieri nofs pillola ta' 5 mg ta' Corlentor 5 mg (li tikkorrispondi għal 2.5 mg ta' ivabradine) filgħodu u nofs pillola ta'
English: When treatment modifications are made in chronic heart failure patients treated with ivabradine blood pressure should be monitored at an appropriate interval (see section 4.8).
Maltese: Meta jsiru modifiki tal-kura f'pazjenti b'insuffiċjenza kronika tal-qalb ikkurati b'ivabradine, il-pressjoni tad-demm tagħhom għandha tiġi mmonitorjata f'intervall xieraq (ara sezzjoni 4.8).
English: In the SHIFT trial more patients experienced episodes of increased blood pressure while treated with ivabradine (7.1%) compared to patients treated with placebo (6.1%).
Maltese: Fil-prova SHIFT kien hemm numru akbar ta' pazjenti li esperjenzaw episodji ta' żieda fil-pressjoni taddemm waqt li kienu qed jingħataw kura b'ivabradine (7.1%) meta mqabbel mal-pazjenti li ngħataw kura bi plaċebo (6.1%).
English: Luminous phenomena (phosphenes)
Maltese: - rifampicin (antibijotiku)
English: Corlentor mainly works by reducing the heart rate by a few beats per minute.
Maltese: Corlentor jaħdem billi jnaqqas ir-rata tat-taħbit tal-qalb bi ftit taħbit fil-minuta.
English: In this study, the antianginal and anti-ischaemic benefits of ivabradine were confirmed in patients aged 65 years or more.
Maltese: F'dan listudju, il-benefiċċji ta' ivabradine kontra l-anġina u kontra l-iskemija ġew ikkonfermati f'pazjenti ta' 65
English: Efficacy was confirmed with 7.5 mg twice daily.
Maltese: L-effikaċja ġiet ikkonfermata b'doża ta' 7.5 mg darbtejn kuljum.
English: No data are available in patients with creatinine clearance below 15 ml/min.
Maltese: Mhemmx informazzjoni dwar pazjenti li għandhom tneħħija tal-krejatinina ta' inqas minn 15 mL/min.
English: Corlentor contains lactose
Maltese: Jekk tieħu Corlentor aktar milli suppost
English: Constipation Diarrhoea Abdominal pain*
Maltese: Is-sustanza attiva prinċipali ffurmata fil-metaboliżmu hi d-derivattiv
English: No dose adjustment is required in patients with renal insufficiency and creatinine clearance above 15 ml/min (see section 5.2).
Maltese: Mhemmx bżonn ta' aġġustar tad-doża f'pazjenti li jbatu minn insuffiċjenza renali u minn tneħħija tal krejatinina ta' iktar minn 15 mL/min (ara sezzjoni 5.2).
English: Concomitant use not recommended
Maltese: Użu konkomittanti bi prekawzjoni
English: High exposures to ivabradine that may occur when ivabradine is given in combination with strong CYP3A4 inhibitors may result in an excessive decrease in heart rate although this risk is reduced with moderate CYP3A4 inhibitors (see sections 4.3, 4.4 and 4.5).
Maltese: Bil-maqlub impedituri u mediċini li jġiegħlu iċ-CYP3A4 jaħdem iżjed qawwi jistgħu jaffetwaw sostanzjalment il-konċentrazzjonijiet tal-plażma ta' ivabradine (ara sezzjoni 4.5).
English: The concomitant use of ivabradine with these medicinal products is contraindicated (see section 4.3).
Maltese: L-użu flimkien ta' ivabradine ma' dawn il-prodotti mediċinali huwa kontraindikat (ara sezzjoni 4.3).
English: Do not take Corlentor if you are able to become pregnant unless you use reliable contraceptive measures (see “Do not take Corlentor”).
Maltese: Tiħux Corlentor jekk tista' tinqabad tqila ħlief jekk qed tuża miżuri ta' kontraċezzjoni affidabbli (ara “Tiħux Corlentor”).
English: Fertility Studies in rats have shown no effect on fertility in males and females (see section 5.3).
Maltese: Fertilità Studji fuq firien ma urew ebda effett fuq il-fertilità fl-irġiel u fin-nisa (ara sezzjoni 5.3).
English: - if your resting heart rate before treatment is too slow (below 70 beats per minute); - if you are suffering from cardiogenic shock (a heart condition treated in hospital); - if you suffer from a heart rhythm disorder; - if you are having a heart attack; - if you suffer from very low blood pressure; - if you suffer from unstable angina (a severe form in which chest pain occurs very frequently and with or without exertion); - if you have heart failure which has recently become worse; - if your heart beat is exclusively imposed by your pacemaker; - if you suffer from severe liver problems; - if you are already taking medicines for the treatment of fungal infections (such as ketoconazole,
Maltese: - jekk tbati minn anġina mhux stabbli (tant qawwija li l-uġigħ fis-sider ikun spiss ħafna anke meta mhemmx eżerċizzju fiżiku); - jekk tbati minn insuffiċjenza tal-qalb li dan l-aħħar marret għall-agħar; - jekk it-taħbita ta' qalbek hija imposta esklussivament mill-pacemaker tiegħek;
English: possibly related to bradycardia
Maltese: Telqa, possibbilment relatata ma' bradikardija
English: In dogs given ivabradine (doses of 2, 7 or 24 mg/kg/day) for one year, reversible changes in retinal function were observed but were not associated with any damage to ocular structures.
Maltese: Fi klieb li ngħataw ivabradine (dożi ta' 2, 7 jew 24 mg/kg/jum) għal sena, ġie osservat tibdil riversibbli fil-funzjoni retinali iżda ma kellu x'jaqsam ma' ebda bidla fl-istrutturi ta' l-għajnejn.
English: Therefore, ivabradine is contra-indicated during pregnancy (see section 4.3).
Maltese: Għaldaqstant, ivabradine mhuwiex indikat sabiex jintuża waqt tqala (ara sezzjoni 4.3).
English: It is available as tablets (5 mg, 10 mg, 15 mg and 20 mg).
Maltese: Jiġi f'pilloli (5 mg, 10 mg, 15 mg u 20 mg).
English: The full EPAR for Axura 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 memantine hydrochloride
Maltese: Sommarju tal-EPAR għall-pubbliku memantina idroklorika
English: Axura was compared with placebo (a dummy treatment) over 24 to 28 weeks.
Maltese: Axura tqabbel ma' plaċebo (trattament finta) tul 24 sa 28 ġimgħa.
English: The first study involved 252 patients with moderately severe to severe disease, while the other two involved a total of 873 patients with mild to moderate disease.
Maltese: L-ewwel studju involva 252 pazjent bil-marda ta' Alzheimer moderata sa gravi, mentri t-tnejn l-oħra b'kollox involvew 873 pazjent bil-marda fi stadju minn ħafif sa moderat.
English: The active substance in Axura, memantine hydrochloride, is an antidementia medicine.
Maltese: Is-sustanza attiva f'Axura, il-memantina kloridrat, hija mediċina kontra d-dimenzja.
English: The most common side effects with Axura (seen in between 1 and 10 patients in 100) are somnolence (sleepiness), dizziness, hypertension (high blood pressure), dyspnoea (difficulty breathing), constipation, headache and drug hypersensitivity (allergy to the medicine).
Maltese: L-effetti sekondarji l-iktar komuni bl-użu ta' Axura (li dehru f'bejn 1 u 10 pazjenti minn kull 100) huma somnolenza, sturdament, ipertensjoni (pressjoni għolja tad-demm), dispnea (diffikultà fit-teħid tannifs), stitikezza, uġigħ ta' ras u ipersensittività għall-mediċina.
English: This summary was last updated in 11-2011.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'11-2011.
English: This is a summary of the European public assessment report (EPAR) for Axura.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Axura.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Axura on 17 May 2002.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Axura fis-17 ta' Mejju 2002.
English: Axura is a medicine that contains the active substance memantine hydrochloride.
Maltese: Axura huwa mediċina li fih is-sustanza attiva memantina kloridrat.
English: Why has Axura been approved?
Maltese: Għaliex ġie approvat Axura?
English: Axura has been studied in three main studies including a total of 1,125 patients with Alzheimer's disease, some of whom had taken other medicines for their disease in the past.
Maltese: Axura ġie studjat fi tliet studji prinċipali li b'kollox ħadu sehem fihom 1,125 pazjent bil-marda ta' Alzheimer.
English: Axura was also studied in three additional studies including a total of 1,186 patients with mild to severe disease.
Maltese: Axura ġie studjat ukoll fi tliet studji supplimentari li b'kollox fihom ħadu sehem 1,186 pazjent bil-marda fi stadju ħafif jew gravi.
English: Axura is also available as an oral solution, which is supplied with a pump that delivers 5 mg memantine hydrochloride with each activation.
Maltese: Axura jiġi f'soluzzjoni orali, li tingħata permezz ta' pompa li tagħti 5 mg ta' memantina kloridrat ma' kull attivazzjoni.
English: The main measures of effectiveness were the change in symptoms in three main areas: functional (the degree of disability), cognitive (the ability to think, learn and remember) and global (a combination of several areas including general function, cognitive symptoms, behaviour and the ability to carry out everyday activities).
Maltese: Il-kejl ewlieni tal-effikaċja kien il-bidla fis-sintomi fi tliet oqsma prinċipali: funzjonali (il-grad ta' diżabbiltà), konjittiv (il-kapaċità tal-ħsieb, it-tagħlim u l-memorja) u globali (kombinazzjoni ta' diversi oqsma inklużi l-funzjoni ġenerali, is-sintomi konjittivi, l-imġiba u lkapaċità li wieħed iwettaq l-attivitajiet ta' kuljum).
English: Axura is used to treat patients with moderate to severe Alzheimer's disease.
Maltese: Axura jintuża fit-trattament ta' pazjenti bil-marda ta' Alzheimer moderata jew gravi.
English: What is Axura?
Maltese: X'inhu Axura?
English: What is the risk associated with Axura?
Maltese: X'inhu r-riskju assoċjat ma' Axura?
English: Axura was more effective than placebo at controlling the symptoms of Alzheimer's disease.
Maltese: Axura kien iktar effikaċi mill-plaċebo fil-kontroll tas-sintomi tal-marda ta' Alzheimer.
English: In the study of moderately severe to severe disease, patients taking Axura had fewer symptoms than those taking placebo after 28 weeks, as measured on both global and functional scores.
Maltese: Fl-istudju fuq ilmarda fi stadju minn moderat sa gravi, wara 28 ġimgħa l-pazjenti li ngħataw Axura kellhom inqas sintomi (imkejla skont il-punteġġ globali u funzjonali) minn dawk li ngħataw il-plaċebo.
English: The CHMP decided that Axura's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Axura huma akbar mir-riskji tiegħu u għaldaqstant irrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: To prevent side effects, the dose of Axura is gradually increased over the first three weeks of treatment: during the first week, the dose is 5 mg; in the second week, it is 10 mg; and during the third week, it is 15 mg. From week four onwards, the recommended maintenance dose is 20 mg once a day.
Maltese: Biex jiġu evitati effetti sekondarji, id-doża ta' Axura tiżdied bil-mod il-mod matul l-ewwel tliet ġimgħat tat-trattament: fl-ewwel ġimgħa d-doża hija 5 mg; fit-tieni ġimgħa titla' għal 10 mg; u fit-tielet ġimgħa ssir 15 mg.
English: How has Axura been studied?
Maltese: Kif ġie studjat Axura?
English: Other information about Axura
Maltese: Kif jintuża Axura?
English: How does Axura work?
Maltese: Għal xiex jintuża Axura?
English: For the full list of all side effects reported with Axura, see the package leaflet.
Maltese: Għal-lista sħiħa ta' effetti sekondarji kollha rrapportati b'Axura, ara l-fuljett ta' tagħrif.
English: In the two studies of mild to moderate disease, patients on Axura had less severe symptoms after 24 weeks, as measured on the global and cognitive scores.
Maltese: Fiż-żewġ studji fejn il-marda kienet fi stadju ħafif sa moderat, wara 24 ġimgħa l-pazjenti li ngħataw Axura kellhom sintomi inqas gravi (imkejla skont il-punteġġ globali u konjittiv).
English: The dose may need to be reduced in patients who have moderate or severe problems with their kidneys.
Maltese: Jista' jenħtieġ li titnaqqas id-doża f'pazjenti li jkollhom problemi moderati jew gravi fil-kliewi.
English: Alzheimer's disease is a type of dementia (a brain disorder) that gradually affects memory, intellectual ability and behaviour.
Maltese: Il-marda ta' Alzheimer hija tip ta' dimenzja (diżordni fil-moħħ) li bil-mod il-mod taffettwa l-memorja, il-kapaċità intellettwali u l-imġiba.
English: EMA/268384/2015 EMEA/H/C/002692
Maltese: EMA/268384/2015
English: Imatinib medac is available as capsules (100 and 400 mg).
Maltese: Imatinib medac huwa disponibbli bħala kapsuli (100 mg u 400 mg).
English: • Adults with Ph+ CML in blast crisis;
Maltese: • Adulti b'PH+ CML fi stadju terminali;
English: The full EPAR for Imatinib medac 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: Imatinib medac is a ‘generic medicine'.
Maltese: Imatinib medac huwa ‘medeċina ġenerika'.
English: The active substance in Imatinib medac, imatinib, is a protein-tyrosine kinase inhibitor.
Maltese: Is-sustanza attiva f'Imatinib medac, imatinib, hija inibitur tat-tirosina kinażi.
English: This is a summary of the European public assessment report (EPAR) for Imatinib medac.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Imatinib medac.
English: Imatinib medac is used when the patients are ‘Philadelphia chromosome positive' (Ph+).
Maltese: Imatinib medac jintuża meta l-pazjenti jkunu ‘pożittivi għall-kromożoma ta' Filadelfja' (Ph+).
English: • Adults with advanced hypereosinophilic syndrome (HES) or chronic eosinophilic leukaemia (CEL), diseases in which eosinophils (another type of white blood cell) start growing out of control.
Maltese: • Adulti b'sindromu avvanzat ipereosinofiliku (HES) jew lewkimja kronika eosinofilika (CEL), mard fejn l-eosinofili (tip ieħor ta' ċelloli bojod fid-demm) jibdew jikbru mingħajr kontroll.
English: Other information about Imatinib medac
Maltese: Informazzjoni oħra dwar Imatinib medac
English: Imatinib medac is used to treat adults with MDS/MPD who have re-arrangements of the gene for platelet-derived growth factor receptor (PDGFR);
Maltese: MDS/MPD li kellhom arranġament mill-ġdid tal-ġene għar-riċettur tal-fattur tat-tkabbir derivat millpjastrini (PDGFR);
English: Imatinib medac is used to treat adults with HES or CEL who have a specific re-arrangement of two genes called FIP1L1 and PDGFRα;
Maltese: Imatinib medac jintuża għall-kura tal-adulti bl-HES jew bis-CEL li għandhom arranġament mill-ġdid speċifiku ta' żewġ ġeni msejħa FIP1L1 u PDGFRα;
English: This means that it blocks some specific enzymes known as tyrosine kinases.
Maltese: Dan ifisser li timblokka xi enzimi speċifiċi magħrufa bħala tirosina kinażi.
English: This means that Imatinib medac is similar to a ‘reference medicine' already authorised in the European Union (EU) called Glivec.
Maltese: Dan ifisser li Imatinib medac huwa simili għal ‘mediċina ta' referenza' li diġà hija awtorizzata fl-Unjoni Ewropea (UE) imsejħa Glivec.
English: Imatinib medac is an anticancer medicine that contains the active substance imatinib.
Maltese: Imatinib medac huwa mediċina kontra l-kanċer li fih is-sustanza attiva imatinib.
English: • Adults with dermatofibrosarcoma protuberans (DFSP), a type of cancer (sarcoma) in which cells in the tissue beneath the skin divide uncontrollably.
Maltese: • Adulti b'dermatofibrosarkoma protuberans (DFSP), tip ta' kanċer (sarkoma) li fih, iċ-ċelloli fittessut ta' taħt il-ġilda jinqasmu b'mod inkontrollabbli.
English: Because Imatinib medac is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Glivec.
Maltese: Minħabba li Imatinib medac huwa mediċina ġenerika, l-istudji fil-pazjenti kienu limitati għal testijiet biex tiġi stabbilita l-bijoekwivalenza tiegħu għall-mediċina ta' referenza, Glivec.
English: • Adults and children with Ph+ acute lymphoblastic leukaemia (ALL), a type of cancer in which lymphocytes (another type of white blood cell) multiply too quickly.
Maltese: • Adulti b'Ph+ lewkimja limfoblastika akuta (ALL), tip ta' kanċer fejn il-limfoċiti (tip ieħor ta' ċelloli bojod tad-demm) jirriproduċu ruħhom malajr ħafna.
English: Why is Imatinib medac approved?
Maltese: Għal xiex ġie approvat Imatinib medac?