FrancophonIA/ELRC3.0 huggingface dataset:
English: Two single-arm, open-label clinical studies, AURAex (Phase 2 Extension cohort, (n=201)) and AURA2 (n=210) were conducted in patients with EGFR T790M mutation-positive lung cancer who have progressed on one or more prior systemic therapies, including an EGFR TKI.
Maltese: Pazjenti b'NSCLC pożittivi għal T790M ikkurati minn qabel - AURAex u AURA2 Twettqu żewġ studji kliniċi b'tikketta mikxufa, b'fergħa waħda, AURAex (koorti tal-Estensjoni ta' Fażi 2, (n=201)) u AURA2 (n=210) f'pazjenti b'kanċer tal-pulmun pożittivi għall-mutazzjoni T790M ta' EGFR li kellhom progressjoni fuq terapija sistemika waħda jew aktar preċedenti, inkluż EGFR TKI. Il-pazjenti kollha kienu mitluba li jkollhom NSCLC pożittiv għall-mutazzjoni T790M ta' EGFR identifikat minn test tal-mutazzjoni ta' EGFR ta' cobas imwettaq f'laboratorju ċentrali qabel il-kura.
English: Patients with clinically important abnormalities in rhythm and conduction as measured by resting electrocardiogram (ECG) (e.g. QTc interval greater than 470 ms) were excluded from these studies.
Maltese: Il-pazjenti b'anormalitajiet klinikament importanti fir-ritmu u l-konduzzjoni kif imkejla minn elettrokardjogramma fi stat ta' mistrieħ (electrocardiogram, ECG) (eż. intervall QTc ta' iktar minn 470 ms) ġew esklużi minn dawn l-istudji.
English: AstraZeneca AB SE-151 85 Södertälje Sweden
Maltese: AstraZeneca AB Gärtunavägen SE-151 85
English: The safety and efficacy of TAGRISSO in children or adolescents aged less than 18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' TAGRISSO fit-tfal u l-adolexxenti li għandhom inqas minn 18-il sena ma ġewx determinati s'issa.
English: Each 40mg film-coated tablet contains 40mg of osimertinib.
Maltese: Kull pillolata' 40 mg miksija b'ritafiha 40mg ta' osimertinib.
English: In these studies, patients who were treated with TAGRISSO daily doses of 160 mg and 240 mg experienced an increase in the frequency and severity of a number of typical EGFR TKI-induced AEs (primarily diarrhoea and skin rash) compared to the 80 mg dose.
Maltese: F'dawn l-istudji, il-pazjenti li kienu kkurati b'dożi ta' kuljum ta' TAGRISSO ta' 160 mg u 240 mg esperjenzaw żieda fil-frekwenza u fis-severità f'numru ta' AEs tipiċi indotti mill-EGFR TKI (primarjament dijarea u raxx tal-ġilda) meta mqabbel ma' doża ta' 80 mg.
English: Information on other ingredients in this medicine This medicine contains less than 1 mmol sodium (23 mg) per 40 mg or 80 mg tablet, that is to say essentially “sodium-free”.
Maltese: Informazzjoni dwar sustanzi mhux attivi oħra f'din il-mediċina Din il-mediċina fiha inqas minn 1 mmol sodiun (23 mg) għal kull pillola ta' 40 mg jew 80 mg, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: Estimated
Maltese: Dispnea
English: In a clinical pharmacokinetic study in patients, co-administration with 200 mg itraconazole twice daily (a strong CYP3A4 inhibitor) had no clinically significant effect on the exposure of osimertinib (area under the curve (AUC) increased by 24% and Cmax decreased by 20%).
Maltese: Fi studju kliniku farmakokinetiku fuq il-pazjenti, mogħti flimkien ma' 200 mg itraconazole darbtejn kuljum (inibitur qawwi ta' CYP3A4) ma kellu l-ebda effett klinikament sinifikanti fuq l-espożizzjoni ta' osimertinib (l-erja taħt il-kurva (AUC) żdiedet b'24% (90% CI 15, 35) u s-Cmax naqas b'20% (90% CI -27, -13).
English: Based on a clinical pharmacokinetic study in patients at 80 mg, food does not alter osimertinib bioavailability to a clinically meaningful extent.
Maltese: Abbażi ta' studji kliniku farmakokinetiku f'pazjenti b'80 mg, l-ikel ma jibdilx il-bijodisponibbiltà ta' osimertinib sa punt klinikament sinifikanti.
English: Patients presenting with signs and symptoms suggestive of keratitis such as acute or worsening: eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain and/or red eye should be referred promptly to an ophthalmology specialist (see section 4.2 Table 1).
Maltese: Il-pazjenti li jkollhom sinjali u sintomi li jissuġġerixxu l-keratite bħal akuta jew iggravar: infjammazzjoni fl-għajnejn, dmugħ, sensittività ħafifa, vista mċajpra, uġigħ fl-għajnejn u/jew għajnejn ħomor għandhom jiġu rreferuti minnufih għal speċjalista tal-oftalmoloġija (ara sezzjoni 4.2 Tabella 1).
English: Population PK analysis indicated that body weight was a significant covariate with a less than 20% change in osimertinib AUCss expected across a body weight range of 88 kg to 43 kg respectively (95% to 5% quantiles) when compared to the AUCss for the median body weight of 61 kg.
Maltese: Analiżi tal-PK tal-popolazzjoni indikat li l-piż tal-ġisem kien kovarjat sinifikanti b'bidla ta' inqas minn 20 % fl-AUCss ta' osimertinib mistenija f'medda ta' piż tal-ġisem ta' 88 kg sa 43kg rispettivament (quantiles ta' 95% sa 5%) meta mqabbel mal-AUCss għallpiż medjan tal-ġisem ta' 61 kg.
English: See ‘Serious side effects' in section 4 for more information.
Maltese: Ara 'Effetti sekondarji serji' fis-sezzjoni 4 għal iktar informazzjoni.
English: • you have a history of eye problems.
Maltese: • ikollok tqaxxir sever tal-ġildatiegħek.
English: Active substances whose plasma concentrations may be altered by TAGRISSO Based on in vitro studies, osimertinib is a competitive inhibitor of BCRP transporters.
Maltese: Sustanzi attivi li l-konċentrazzjonijiet fil-plażma tagħhom jistgħu jinbidlu b'TAGRISSO Abbażi ta' studji in vitro, osimertinib huwa inibitur kompetittiv tat-trasportaturi ta' BCRP.
English: The primary efficacy end-point was progression-free survival (PFS) as assessed by investigator.
Maltese: L-eżitu primarju tal-effikaċja kien sopravivenza mingħajr progressjoni (PFS, progression-free survival) kif ivvalutat mill-investigatur.
English: St. John's Wort should not be used together with TAGRISSO (see section 4.5).
Maltese: John's Wort ma għandux jintuża flimkien ma' TAGRISSO (ara sezzjoni 4.5).
English: In vivo oral administration of osimertinib lead to tumour shrinkage in both EGFRm and T790M NSCLC xenograft and transgenic mouse lung tumour models.
Maltese: Listatus tal-mutazzjoni T790M ukoll ġiet ivvalutata b'mod retrospettiv bl-użu ta' ctDNA estratta millkampjun tal-plażma li ttieħed waqt l-iskrinjar.
English: Lymphocytes decreased
Maltese: Indeboliment tal-kliewi
English: Al/Al perforated unit dose blisters.
Maltese: • Stotmatite -infjamazzjoni tar-ritainterna tal-ħalq.
English: TAGRISSO 40 mg film-coated tablets TAGRISSO 80 mg film-coated tablets osimertinib
Maltese: TAGRISSO 40 mg pilloli miksijin b'rita TAGRISSO 80 mg pilloli miksijin b'rita osimertinib
English: Your doctor will decide with you whether you should carry on taking TAGRISSO.
Maltese: M'hemm ebda kura speċifika fil-każ ta' doża eċċessiva ta' TAGRISSO.
English: • The recommended dose is one 80 mg tablet each day.
Maltese: • Id-doża rakkomandata hija ta' 80mg darba kuljum.
English: What TAGRISSO looks like and contents of the pack TAGRISSO 40 mg is supplied as beige, film-coated, round and biconvex tablets, marked with “AZ” and “40” on one side, and plain on the other.
Maltese: TAGRISSO 40 mg jiġi bħala pilloli ta' kulur kafellatte, miksijin b'rita, tondi u bikonvessi, immarkati b'“A” u “40” fuq naħa waħda, u xejn fuq in-naħa l-oħra.
English: In healthy volunteers administered an 80 mg tablet where gastric pH was elevated by dosing of omeprazole for 5 days, osimertinib exposure was not affected (AUC and Cmax increase by 7% and 2%, respectively) with the 90% CI for exposure ratio contained within the 80-125% limit.
Maltese: F'voluntiera b'saħħithom li ngħataw pillola ta' 80 mg fejn il-pH gastriku żdied bl-għoti ta' doża ta omeprazole għal 5 ijiem, l-espożizzjoni ta' osimertinib ma kinitx affettwata (żieda fl-AUC u sCmax b'7% u 2%, rispettivament) b'CI ta' 90% għal proporzjon ta' espożizzjoni fi ħdan il-limitu ta' 80
English: Older patients reported more Grade 3 or higher adverse reactions compared to younger patients (13.4% versus 9.3%).
Maltese: Pazjenti ikbar fl-età rrappurtaw iktar reazzjonijiet avversi ta' Grad 3 jew ogħla meta mqabbel ma' pazjenti iżgħar (13.4 % meta mqabbel ma' 9.3 %).
English: • Phenytoin, carbamazepine or phenobarbital -used for seizures or fits.
Maltese: • Phenytoin, carbamazepine jew phenobarbital -li jintużaw għal aċċessjonijiet jew puplesiji.
English: Compared with younger subjects (<65), more subjects ≥65 years old had reported adverse reactions that led to study drug dose modifications (interruptions or reductions) (13.4% versus 7.6%).
Maltese: Meta mqabbel ma' individwi iżgħar (<65), iktar individwi ≥65 sena kienu rrappurtaw reazzjonijiet avversi li wasslu għal modifiki fid-doża tal-mediċina tal-istudju (interruzzjonijiet jew tnaqqis) (13.4 % meta mqabbel ma' 7.6 %).
English: Based on a pharmacokinetic analysis of 134 patients with mild hepatic impairment, 8 patients with moderate hepatic impairment and 1216 patients with normal hepatic function osimertinib exposures were similar.
Maltese: Abbażi ta' analiżi farmakokinetika ta' 134 pazjent b'indeboliment tal-fwied ħafif, 8 pazjenti b'indeboliment tal-fwied moderat u 1216 pazjent b'funzjoni tal-fwied normali l-espożizzjonijiet għal osimertinib kienu simili.M'hemm lebda dejta disponibbli dwar pazjenti b'indeboliment tal-fwied sever (ara sezzjoni 4.2).
English: Fifty-four percent (54%) of patients had extra-thoracic visceral metastases, including 34% with CNS metastases (identified by CNS lesion site at baseline, medical history, and/or prior surgery, and/or prior radiotherapy to CNS metastases) and 23% with liver metastases.
Maltese: Erbgħa u ħamsin fil-mija (54 %) tal-pazjenti kellhom metastasi vixxerali estratoraċiċi, inkluż 34 % b'metastasi CNS (identifikati mis-sit ta' leżjoni CNS fil-linja bażi, storja medika, u /jew qabel il-kirurġija.
English: Dose adjustments
Maltese: Sopravivenza Globali
English: How to take TAGRISSO 4.
Maltese: Kif għandek tieħu TAGRISSO 4.
English: Renal impairment
Maltese: CTCAE kollha)
English: Serial ECGs were collected following a single dose and at steady-state to evaluate the effect of osimertinib on QTc intervals.
Maltese: ECGs serjali nġabru wara doża unika u fi stat fiss biex jiġi evalwat l-effett ta' osimertinib fl-intervalli
English: • If your cancer has progressed while you were being treated with other protein kinase inhibitor medicines, it means that your cancer contains a gene defect called ‘T790M'.
Maltese: • Jekk il-kanċer tiegħek ipprogressa waqt li kont qed tiġi kkurat/a b'mediċini oħra tal-inbitur ta' protein kinase, dan ifisser li l-kanċer tiegħek fih difett fil-ġene msejjaħ ‘T790M'.
English: Early reductions in the median laboratory counts of leukocytes, lymphocytes, neutrophils and platelets have been observed in patients treated with TAGRISSO, which stabilised over time and then remained above the lower limit of normal.
Maltese: Ġie osservat tnaqqis bikri fil-għadd medjan tal-laboratorju tal-lewkoċiti, limfoċiti, newtrofili u plejtlits f'pazjenti kkurati b'TAGRISSO, li stabilizzew maż-żmien imbagħad baqgħu 'l fuq mil-limitu aktar baxx tan-normal.
English: Adverse events of leukopenia, lymphopenia, neutropenia and thrombocytopenia have been reported, most of which were mild or moderate in severity and did not lead to dose interruptions.
Maltese: Ġew irrappurtati avvenimenti avversi ta' lewkopenija, newtropenija u tromboċitopenija, li l-biċċa l-kbira minnhom kienu ħfief jew moderati fis-severità u ma wasslux għal interruzzjonijiet fid-doża.
English: All patients were required to have EGFR T790M mutation-positive NSCLC identified by the cobas EGFR mutation test performed in a central laboratory prior to randomisation.
Maltese: Il-pazjenti kollha kienu meħtieġa jieħdu NSCLC pożittiv għall-mutazzjoni EFGR T790M identifikat mit-test ta' mutazzjoni ta' EGFR ta' cobas li sar f'laboratorju ċentrali qabel ir-randomizzazzjoni.
English: Number of Deaths (% maturity)
Maltese: Numru ta' Mwiet (% maturità)
English: The C30 was assessed every 6 weeks before and after progression.
Maltese: Is-C30 ġie vvalutat kull 6 ġimgħat qabel u wara l-progressjoni.
English: TAGRISSO 40 mg film-coated tablets TAGRISSO 80 mg film-coated tablets
Maltese: TAGRISSO 40 mg pilloli miksijin b'rita TAGRISSO 80 mg pilloli miksijin b'rita
English: Patients received study therapy until intolerance to therapy, or the investigator determined that the patient was no longer experiencing clinical benefit.
Maltese: Il-pazjenti rċivew terapija talistudju sakemm ma ttollerawx it-terapija aktar, jew sakemm l-investigatur iddetermina li l-pazjent ma kienx għadu qed jesperjenza benefiċċju kliniku.
English: ORR and DoR results by investigator assessment were consistent with those reported via Blinded Independent Central Review (BICR); ORR by BICR assessment was 64.9% [95% CI: 59.0, 70.5] on osimertinib and 34.3 % [95% CI: 26.5, 42.8] on chemotherapy; DoR by BICR assessment was 11.2 months (95% CI: 8.3, NC) on osimertinib and 3.1 months (95% CI: 2.9, 4.3) on chemotherapy.
Maltese: 11.2 xhur (95 % CI: 8.3, NC) fuq osimertinib u 3.1 xhur (95 % CI: 2.9, 4.3) fuq il-kimoterapija.
English: TAGRISSO demonstrated a clinically meaningful and statistically significant improvement in PFS compared to EGFR TKI comparator (median 18.9 months and 10.2 months, respectively, HR=0.46, 95% CI: 0.37, 0.57; P<0.0001).
Maltese: Meta saret lanaliżi inizjali tas-sopravivenza globali (25 % maturità), HR ta' 0.63 iffavorixxa TAGRISSO (95% CI: 0.45, 0.88; P = 0.0068), li ma laħaqx sinifikanza statistika formali.
English: • Stevens-Johnson syndrome, which can appear as reddish target-like macules or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and be preceded by fever and flu-like symptoms.
Maltese: • Is-sindrometa'Stevens-Johnson, li jista' jidher bħala makuli ħomor qishom targitjew dbabar tondi ħafna drabi bi nfafet ċentrali fuq it-tronk, tqaxxir tal-ġilda, ulċeri fil-ħalq, fil-griżmejn, fl-imnieħer,
English: Previously untreated EGFR mutation positive locally advanced or metastatic NSCLC - FLAURA The efficacy and safety of TAGRISSO for the treatment of patients with EGFR mutation positive locally advanced, not amenable to curative surgery or radiotherapy, or metastatic NSCLC, who had not received previous systemic treatment for advanced disease, was demonstrated in a randomised, double-blind, active-controlled study (FLAURA).
Maltese: L-effikaċja u s-sigurtà ta' TAGRISSO għall-kura tal-pazjenti b'NSCLC pożittiv għall-muazzjoni EGFR lokament avvanzat, mhux suġġett għal kirurġija kurattiva jew radjoterapija, jew metastatiku, li ma rċivewx kura sistemika minn qabel għal marda avvanzata, intwerew fi studju randomizzat, doubleblind, ikkontrollat b'mod attiv (FLAURA).
English: A pharmacokinetic study in patients with renal impairment has not been conducted.
Maltese: Ma twettaqx studju farmakokinetiku f'pazjenti b'indeboliment tal-kliewi.
English: Secondary efficacy outcome measures included Duration of Response (DoR) and Progression-Free Survival (PFS).
Maltese: Il-metodi ta' kejl tal-eżitu taleffikaċja sekondarju inkludew id-Durata tar-Rispons (DoR) u s-Sopravivenza mingħajr Progressjoni (PFS).
English: What you need to know before you take TAGRISSO 3.
Maltese: X'għandek tkun taf qabel ma tieħu TAGRISSO 3.
English: • Bosentan - used for high blood pressure in the lungs.
Maltese: Mard tal-Pulmun Interstizjali u pulmonite. 5
English: Patient tumour tissue samples were required to have one of the two common EGFR mutations known to be associated with EGFR TKI sensitivity (Ex19del or L858R), as identified by local or central testing.
Maltese: Il-kampjuni tat-tessut tat-tumuri tal-pazjenti kienu meħtieġa li jkollhom waħda miż-żewġ mutazzjonijiet EGFR komuni magħrufa li huma assoċjati ma' sensittività għal EGFR TKI (Ex19del jew L858R), kif identifikat minn ittestjar lokali jew ċentrali.
English: Efficacy results from FLAURA by investigator assessment are summarised in Table 3, and the Kaplan-Meier curve for PFS is shown in Figure 1.
Maltese: Lebda differenza globali fl-effikaċja ma ġiet osservata bejn dawn l-individwi u individwi iżgħar.
English: Interstitial lung disease
Maltese: Mard tal-interstizju talpulmun
English: Patients taking concomitant medications with disposition dependent upon P-gp and with narrow therapeutic index (e.g. digoxin, dabigatran, aliskiren) should be closely monitored for signs of changed tolerability as a result of increased exposure of the concomitant medication whilst receiving TAGRISSO (see section 5.2).
Maltese: Il-pazjenti li jkunu qegħdin jieħdu mediċini konkomitanti b'dispożizzjoni li tiddependi fuq il-P-gp u b'indiċi terapewtiku dejjaq (eż. digoxin, dabigatran, aliskiren) għandhom jiġu ssorveljati mill-qrib għal sinjali ta' tibdil fit-tollerabbiltà bħala riżultat ta' żieda fl-espożizzjoni waqt li jkunu qegħdin jirċievu TAGRISSO (ara sezzjoni 5.2).
English: Median, Months (95% CI)
Maltese: Medjan, Xhur (95 % CI)
English: A pre-specified PFS subgroup based on CNS metastases status (identified by CNS lesion site at baseline, medical history, and/or prior surgery, and/or prior radiotherapy to CNS metastases) at study entry was performed in FLAURA and is shown in Figure 2.
Maltese: Twettaq sottogrupp ta' PFS speċifikat minn qabel ibbażat fuq l-istatus ta' metastasi ta' CNS (identifiakt minn sit ta' leżjoni ta' CNS fil-linja bażi, storja medika, u/jew qabel il-kirurġija, u/jew qabel ir-radjoterapija għal metastasi ta' CNS) mad-dħul fl-istudju f'FLAURA u kif jidher f'Figura 2.
English: 10 FILM-COATED TABLET BLISTERS (PERFORATED) 7 FILM-COATED TABLET BLISTERS (PERFORATED)
Maltese: FOLJIB'PILLOLI MIKSIJIN B'RITA(IMTAQQBIN) 7 FOLJI B'PILLOLI MIKSIJIN B'RITA (IMTAQQBIN)
English: • Dabigatran - used to prevent blood clots.
Maltese: • Dabigatran -użat biex jipprevjeni emboli tad-demm.
English: • Digoxin - used for irregular heart beat or other heart problems.
Maltese: • Digoxin -użat għal taħbit tal-qalb irregolari jew għal problemi oħrajntal-qalb.
English: Target organ Adverse reaction
Maltese: Effetti sekondarji oħra
English: Difference (95%CI) p-value p <0.001
Maltese: 32 95% CI (0.21, 0.49) P value <0.
English: TAGRISSO 80 mg film-coated tablets osimertinib
Maltese: TAGRISSO 80 mg pilloli miksijin b'rita osimertinib
English: It is recommended that concomitant use of strong CYP3A inducers (e.g. Phenytoin, rifampicin and carbamazepine) with TAGRISSO should be avoided.
Maltese: Huwa rrakkomandat li l-użu konkomitanti ta' indutturi qawwija ta' CYP3A (eż. Phenytoin, rifampicin u carbamazepine) ma' TAGRISSO jiġi evitat.
English: The efficacy and safety of TAGRISSO for the treatment of patients with locally advanced or metastatic T790M NSCLC whose disease has progressed on or after EGFR TKI therapy, was demonstrated in a randomised, open-label, active-controlled Phase 3 study (AURA3).
Maltese: Pazjenti-AURA3 b'NSCLC pożittiv għal T790M ikkurati minn qabel L-effikaċja u s-sigurtà ta' TAGRISSO għall-kura tal-pazjenti b'NSCLC T790M avvanzat lokalment jew metastatiku li l-marda tagħhom marret għall-agħar waqt jew wara t-terapija EGFR TKI, intwerew fi studju ta' Fażi 3 (AURA3), randomizzat, open-label, ikkontrollat b'mod attiv.
English: The main findings observed in repeat dose toxicity studies in rats and dogs comprised atrophic, inflammatory and/or degenerative changes affecting the epithelia of the cornea (accompanied by corneal translucencies and opacities in dogs at ophthalmology examination), GI tract (including tongue), skin, and male and female reproductive tracts with secondary changes in spleen.
Maltese: Is-sejbiet ewlenin fi studji dwar it-tossiċità b'dożi ripetuti fil-firien u l-klieb kienu jinkludu tibdil atropiku, infjammatorju u/jew diġenerattiv li jaffettwa l-epitelji tal-kornea (akkumpanjat minn transluċenti u opaċitajiet korneali fil-klieb fl-eżami tal-oftalmoloġija), l-apparat GI (inkluż l-ilsien), ilġilda, u l-apparat riproduttiv tar-raġel u l-mara b'tibdil sekondarju fil-milsa.
English: Safety findings in the single-arm Phase 2 AURAex and AURA2 studies were generally consistent with those observed in the AURA3 TAGRISSO arm. No additional or unexpected toxicity has been observed and adverse events have been aligned in type, severity and frequency.
Maltese: AURA ta' Fażi 2, ġiet osservata tendenza konsistenti fir-riżultati tas-sigurtà u taleffikaċja.
English: AURA3 demonstrated a statistically significant improvement in PFS in the patients treated with TAGRISSO compared to chemotherapy.
Maltese: AURA3 wera titjib statistikament sinifikanti fil-PFS fil-pazjenti kkurati b'TAGRISSO meta mqabbel mal-kimoterapija.
English: In vitro studies have shown that osimertinib is not a substrate of OATP1B1 and OATP1B3.
Maltese: Studji in vitro wrew li osimertinib mhuwiex sottostrat ta' OATP1B1 u OATP1B3.
English: The full EPAR for Lusduna 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: It contains the active substance insulin glargine.
Maltese: Fiha ssustanza attiva insulina glargine.
English: In the second study, involving 531 patients with type 2 diabetes, the average reduction in HbA1c was from 8.3 to 7.2% with Lusduna and from 8.4 to 7.2% with Lantus.
Maltese: Fit-tieni studju, li fih ħadu sehem 531 pazjent bid-dijabete tat-tip 2, it-tnaqqis medju fl-HbA1c kien minn 8.3 għal 7.2% b'Lusduna u minn 8.4 għal 7.2% b'Lantus.
English: Lusduna is a ‘biosimilar medicine'.
Maltese: Lusduna huwa ‘mediċina bijosimili'.
English: This is a summary of the European public assessment report (EPAR) for Lusduna.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Lusduna.
English: Extensive laboratory studies comparing Lusduna with Lantus have shown that insulin glargine in Lusduna is highly similar to that in Lantus in terms of chemical structure, purity and biological activity.
Maltese: Studji estensivi fil-laboratorju li qabblu Lusduna ma' Lantus urew li insulina glargine f'Lusduna hija simili ħafna għal dik f'Lantus f'termini ta' struttura kimika, purità u attività bijoloġika.
English: Other information about Lusduna
Maltese: Informazzjoni oħra dwar Lusduna
English: Why is Lusduna approved?
Maltese: Għaliex ġie approvat Lusduna?
English: This means that Lusduna is highly similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU).
Maltese: Dan ifisser li Lusduna huwa simili għal mediċina bijoloġika (magħrufa wkoll bħala l-‘mediċina ta' referenza') li diġà hija awtorizzata fl-Unjoni Ewropea (UE).
English: Insulin glargine, the active substance in Lusduna, enters the bloodstream more slowly than human insulin after injection and so it works for longer.
Maltese: L-insulina glargine, is-sustanza attiva f'Lusduna, tidħol fil-fluss tad-demm aktar bil-mod mill-insulina umana u għalhekk taħdem aktar fit-tul.
English: In the first supportive study, involving 506 patients with type 1 diabetes, the average HbA1c score was reduced from 8.0 to 7.4% with both Lusduna and Lantus.
Maltese: Fl-ewwel studju ta' appoġġ, li fih ħadu sehem 506 pazjenti bid-dijabete tat-tip 1, il-punteġġ medju talHbA1c naqas minn 8.0 għal 7.4% kemm b'Lusduna kif ukoll b'Lantus.
English: What are the risks associated with Lusduna?
Maltese: X'inhuma r-riskji assoċjati ma' Lusduna?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements for biosimilar medicines, Lusduna has been shown to have a comparable quality, safety and effectiveness to Lantus.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija ddeċieda li, b'mod konformi mar-rekwiżiti tal-UE għal mediċini bijosimili, Lusduna wera li għandu profil ta' kwalità, sigurtà u effikaċja komparabbli għal Lantus.
English: The most common side effect with Lusduna (which may affect more than 1 in 10 people) is hypoglycaemia (low blood glucose).
Maltese: L-effett sekondarju l-aktar komuni b'Lusduna (li jista' jaffettwa aktar minn 1 minn kull 10) huwa ipogliċemija (glukożju baxx fid-demm).
English: Lusduna insulin glargine
Maltese: Sommarju tal-EPAR għall-pubbliku insulina glargine