FrancophonIA/ELRC3.0 huggingface dataset:
English: AVAGLIM tablets contain lactose and therefore should not be administered to patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose
Maltese: Il-pilloli AVAGLIM fihom il-lattosju u għalhekk m'għandhomx jingħataw lil pazjenti bi problemi rari u ereditarji ta' intolleranza galattosja, ta' defiċjenza Lapp lactase jew ta' assorbiment ħażin ta' glukosju-galattosju.
English: If ALT levels remain >3X the upper limit of normal, therapy should be discontinued.
Maltese: ALT jibqgħu >3X tal-limitu ta' fuq tan-normal, it-terapija għandha titwaqqaf.
English: For dose-related adverse reactions the frequency category reflects the higher dose of rosiglitazone.
Maltese: Għar-reazzjonijiet mhux mixtieqa relatati mad-doża lkategorija ta' frekwenza tirrifletti l-ogħla doża tar-rosiglitazone.
English: In addition, rosiglitazone inhibited ovarian oestradiol and progesterone synthesis and lowered plasma levels of these hormones resulting in effects on oestrus/menstrual cycles and fertility (see section 4.4).
Maltese: Barra minn hekk, rosiglitazone jostakola s-sintesi ta' l-estradjol ta' l-ovarju u l-progesterone u baxxa l-livelli fil-plażma ta' dawn l-ormoni biex b'hekk wassal għal effetti fuq iċ-ċikli oestrus/menstruwali u fertilità (ara sezzjoni 4.4).
English: See ‘Conditions you need to look out for' in Section 4.
Maltese: Ara ‘Kundizzjonijiet li hemm bżonn toqgħod attent għalihom' f'Sezzjoni 4.
English: Studies on embryofoetal development and pre-and postnatal development revealed eye malformations, skeletal anomalies, abortions, and an increased foetal death rate.
Maltese: Studji dwar l-iżvilupp embrijofetali u żviluppi ta' qabel u wara t-twelid urew formazzjoni difettuża fl-għajnejn, anomaliji skeletriċi, aborti, u żjieda ta' mwiet tal-fetu.
English: Administration of rosiglitazone with food resulted in no change in overall exposure (AUC), although a small decrease in Cmax (approximately 20-28%) and a delay in tmax (approximately 1.75 h) were observed compared to dosing in the fasted state.
Maltese: It-teħid ta' rosiglitazone ma' l-ikel ma rriżulta f'ebda bidla fl-esponiment ġenerali (AUC), għalkemm ġew osservati tnaqqis żgħir fis- Cmax (bejn wieħed u ieħor 20-28%) u dewmien fit- tmax (bejn wieħed u ieħor 1.75 s) meta mqabbla ma' teħid ta' dożi fi stat ta' sawm.
English: Absolute bioavailability of rosiglitazone following both a 4 and an 8 mg oral dose is approximately 99%.
Maltese: Il- bijodisponibilta` assoluta ta' rosiglitazone wara dożi orali ta' 4 u anke 8 mg hi bejn wieħed u ieħor ta' 99%.
English: Extrapancreatic effects include an improvement in insulin sensitivity of peripheral tissue and a reduction in hepatic uptake of insulin.
Maltese: Effetti extra-pankreatiċi jinkludu titjib fis-sensittivita` għall-insulina ta' tessuti periferali u tnaqqis ta' insulina li tgħaddi fil-fwied.
English: • allergic reactions, inflammation of blood vessels (allergic vasculitis)
Maltese: • reazzjonijiet allerġiċi, infjammazzjoni ta' l-arterji tad-demm (vaskulite allerġika)
English: Glimepiride binds with a high exchange rate to a beta cell membrane protein which is associated with the ATP-sensitive potassium channel but which differs from the usual sulphonylurea binding site.
Maltese: Glimepiride teħel b'rata ta' bdil mgħaġġel ma' proteina ta' membrana ta' ċellula beta li hi assoċjata mal-kanal tal-potassju sensittiv għal ATP iżda li tiddifferixxi mis-sit normali li fih jeħlu ssulphonylureas.
English: Very rare Very rare
Maltese: Rari ħafna
English: Table 3 presents adverse reactions by system organ class and by frequency category based on experience with glimepiride and other sulphonylureas.
Maltese: Tagħrif minn provi kliniċi u tagħrif ta' wara t-tqegħid fis-suq F'tabella 3 huma ppreżentati reazzjonijiet mhux mixtieqa b'sistema ta' klassi ta' organu u skond ilkategorija ta' frekwenza bbażata fuq l-esperjenza b'glimepiride u sulphonylureas oħra.
English: 2 An increased incidence of heart failure has been observed when rosiglitazone was added to treatment regimens with a sulphonylurea (either as dual or triple therapy), and appeared higher with 8 mg rosiglitazone compared to 4 mg rosiglitazone (total daily dose).
Maltese: 2Inċidenza miżjuda ta' waqfien tal-qalb ġiet osservata meta rosiglitazone ġie miżjud ma' sistemi ta' trattament b'sulphonylurea (b'terapija doppja jew trippla), u deher li kienet ogħla b'8 mg rosiglitazone meta mqabbla ma 4 mg rosiglitazone (doża sħiħa ta' kuljum).
English: Single oral doses of glimepiride in 14 healthy adult subjects had no clinically significant effect on the steady-state pharmacokinetics of rosiglitazone.
Maltese: Dożi singoli orali ta' glimepiride f'14-il suġġett adulti u f'saħħithom ma kellhom ebda effett sinifikanti kliniku fuq il-farmakokinetiċi steady-state ta' rosiglitazone.
English: The dose of your
Maltese: DATA TA' META JISKADI
English: What Avaglim contains
Maltese: X'fih Avaglim
English: Pregnancy and breast-feeding
Maltese: • nervożità, palpitazzjonijiet
English: Consistent with the mechanism of action, rosiglitazone reduced insulin resistance and improved pancreatic ß-cell function.
Maltese: Waqt li konsistenti fil-mekkaniżmu ta' azzjoni, rosiglitazone naqqas ir-reżistenza għall-insulina u tejjeb il-funzjoni biċ-ċellula ß fil-pankreas.
English: The minimum effective oral dose is approximately 0.6 mg.
Maltese: Id-doża minima effettiva li tittieħed mill-ħalq hi bejn wieħed u ieħor 0.6 mg.
English: Thiazolidinediones act primarily by reducing insulin resistance and sulphonylureas act primarily by stimulating release of insulin from functioning pancreatic β-cells.
Maltese: Thiazolidinediones jaġixxu primarjament billi jnaqqsu r-reżistenza ta' l-insulina u sulphonylureas billi jistimulaw ir-rilaxx ta' l-insulina minn ċelluli β tal-pankreas li jiffunzjonaw.
English: Reproduction toxicology findings may be related to the pharmacodynamic action of glimepiride.
Maltese: Sejbiet dwar tossikoloġija riproduttiva jistgħu ikunu relatati ma' l-azzjoni farmakodinamika ta' glimepiride.
English: If hypoglycaemic symptoms occur, the patient should revert to concomitant therapy and adjust the glimepiride dose as appropriate.
Maltese: Meta klinikament xieraq, tista' tiġi kkunsidrata bidla diretta minn terapija bi glimepiride għal dik b'AVAGLIM.
English: You must look out for certain symptoms while you are taking Avaglim, to reduce the risk of any problems.
Maltese: Għandek toqgħod attent għal ċerti sintomi waqt li tkun qed tieħu Avaglim, biex tnaqqas ir-riskju ta' xi problemi.
English: Pink, rounded triangular tablet with “gsk” debossed on one side and “4/4” on the other side.
Maltese: Pillola roża, triangolari u magħmula fit-tond li għandha minqux “gsk” fuq naħa waħda u “4/4” fuq innaħa l-oħra.
English: NAME OF THE MEDICINAL PRODUCT AVAGLIM 8 mg/4 mg film-coated tablets.
Maltese: AVAGLIM pilloli ta' 8 mg/4 mg miksijin b'rita.
English: Due to the potential for decreased renal function the initiation and maintenance of therapy with AVAGLIM in elderly patients should be under close medical supervision due to an increased susceptibility to hypoglycaemia (see section 4.4).
Maltese: Minħabba l-possibilta` ta' tnaqqis fil-funzjonament tal-kliewi fil-bidu u fil-kontinwazjoni ta' terapija b'AVAGLIM f'pazjenti anzjani għandhom jibqgħu taħt sorveljanza medika b'attenzjoni kbira minħabba żjieda fis-suxxettibilta` għal ipogliċemija (ara sezzjoni 4.4).
English: AVAGLIM is indicated in the treatment of type 2 diabetes mellitus patients who are unable to achieve sufficient glycaemic control on optimal dosage of sulphonylurea monotherapy, and for whom metformin is inappropriate because of contraindication or intolerance.
Maltese: AVAGLIM hu indikat biss fit-trattament ta' pazjenti bid-dijabete mellitus tip 2 li ma jistgħux jiksbu kontroll gliċemiku biżżejjed bl-aħjar dożaġġ ta' monoterapija b'sulphonylurea, u li għalihom metformin mhux adattat minħabba kontraindikazzjoni jew nuqqas ta' tolleranza.
English: 6 Cross-allergenicity with sulphonylureas, sulphonamides or related substances is possible.
Maltese: 6 Allerġeniċita` minn waħda għall-oħra b'sulphonylureas, sulphonamides jew sustanzi relatati hi possibbli.
English: Within each system organ class, adverse reactions are presented in the table by decreasing frequency for the rosiglitazone monotherapy treatment regimen.
Maltese: F'kull sistema ta' klassi ta' organu, effetti mhux mixtieqa għal monoterapija b'rosiglitazone huma ppreżentati fit-tabella f'ordni ta' tnaqqis fil-frekwenza.
English: Pharmacovigilance Plan or risk minimisation activities
Maltese: Sistema ta' farmakoviġilanza
English: Rare congestive heart failure/pulmonary oedema
Maltese: Mard tal-qalb b'waqfien tal-qalb konġestiva /edema pulmonari
English: In their entirety, the available data on the risk of cardiac ischaemia are
Maltese: Ma' tulhom kollha, l-informazzjoni disponibbli fuq ir-riskju ta' iskemja kardijaka m'hijiex konklussiva.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/06/349/001-004
Maltese: NUMRU(I) TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/06/349/001-004
English: In a bioequivalence study under fasted conditions, the AUC and Cmax of rosiglitazone and the AUC of glimepiride following a single dose of a 4 mg/4 mg combination tablet were bioequivalent to concomitant administration of rosiglitazone 4 mg and glimepiride 4 mg.
Maltese: Fi studju ta' bijoekwivalenza f'kondizzjonijiet ta' sawm, l-AUC u Cmax ta' rosiglitazone u l-AUC ta' glimepiride wara doża waħda ta' pillola 4 mg/4 mg kombinata kienu bijoekwivalenti għal teħid konkomitanti ta' rosiglitazone 4 mg u glimepiride 4 mg.
English: In clinical studies in volunteers rosiglitazone has been administered at single oral doses of up to 20 mg and was well
Maltese: Fi studji kliniċi fuq voluntieri rosiglitazone ingħata f'dożi individwali mill-ħalq sa 20 mg u baqa' tollerat tajjeb.
English: The usual starting dose is one combined tablet (4 mg rosiglitazone and 4 mg glimepiride), taken once
Maltese: Id-doża tal-bidu tas-soltu hija pillola waħda kombinata (4mg rosiglitazone u 4mg glimepiride), li tittieħed darba kuljum.
English: The clinical trial program in support of this fixed dose combination only compared rosiglitazone and glimepiride to glimepiride monotherapy and not to monotherapy with other sulphonylureas.
Maltese: Il-programm ta' prova klinika b'appoġġ għal din il-kombinazzjoni ta' doża fissa qabbel biss rosiglitazone u glimepiride ma' monoterapija bi glimepiride u mhux ma monoterapija ma sulphonylureas oħra.
English: Don't take Avaglim.
Maltese: Ieqaf ieħu Avaglim.
English: Some medicines used to treat high blood pressure (such as beta-blockers, clonidine, guanethidine or reserpine) may make you less aware of the warning signs of low blood sugar (sweating; fast irregular
Maltese: Xi mediċini li jintużaw biex jikkuraw il-pressjoni għolja (bħal beta-blockers, clonidine, guanethidine jew reserpine) jistgħu jagħmluk anqas attent għal sinjali ta' twissija li z-zokkor fid-demm baxx (għaraq; taħbit mgħaġġel u rregolari tal-qalb).
English: − an Acute Coronary Syndrome (unstable angina, NSTEMI and STEMI) (see section 4.4)
Maltese: Għandu jiġi kkunsidrat il-monitoraġġ b'attenzjoni tal-kontroll gliċemiku (ara sezzjoni 4.4).
English: The starting dose is 4 mg/day rosiglitazone plus 4 mg/day glimepiride (given as one tablet AVAGLIM
Maltese: Id-doża tal-bidu hi 4 mg/kuljum rosiglitazone u 4 mg/kuljum glimepiride (mogħtija bħala pillola AVAGLIM waħda ta' 4 mg/4 mg).
English: Patients receiving AVAGLIM may be at risk of dose-related hypoglycaemia (see section 4.8).
Maltese: Pazjenti li jkunu jieħdu AVAGLIM jistgħu ikunu f'riskju ta' ipogliċemija relatata mad-dożi (ara sezzjoni 4.8).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/06/349/005-008
Maltese: NUMRU(I) TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/06/349/005-008
English: Once glycaemic control is stable at these doses, AVAGLIM may be introduced at a starting dose of 4 mg rosiglitazone/4 mg glimepiride
Maltese: Darba li kontroll gliċemiku jkun stabbli b'dawn id-dożi, AVAGLIM jista' jinbeda b'doża inizjali ta' 4 mg rosiglitazone/4 mg glimepiride darba kuljum.
English: AVAGLIM may be used to substitute concomitant sulphonylurea and rosiglitazone in established dual oral therapy providing the patient has achieved at least half-maximum dose of sulphonylurea.
Maltese: AVAGLIM jista' jintuża minflok sulphonylurea u rosiglitazone flimkien f'terapija stabbilita orali doppja basta li l-pazjent ikun kiseb għall-inqas id-doża ta' nofs massimu tas- sulphonylurea.
English: No clinically significant reductions in glimepiride AUC and Cmax were observed after repeat doses of rosiglitazone for eight days in healthy adult
Maltese: Ebda tnaqqis sinifikanti kliniku ta' AUC u Cmax ma ġie osservat wara dożi ripetuti ta' rosiglitazone għal tmint ijiem f'suġġetti adulti f'saħħithom.
English: Frequency of adverse reaction by treatment regimen Rosiglitazone monotherapy Rosiglitazone with sulphonylurea
Maltese: Frekwenza ta' reazzjonijiet avversi skond it-terapija Monoterapija bir
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 4 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the
Maltese: L-MAH jikkommetti li jwettaq l-istudji u attivitajiet oħra ta' farmakoviġilanza ddettaljati fil-Pjan ta' Farmakoviġilanza, kif miftiehem f'verżjoni 4 tal-Pjan għall-Immaniġġjar tar-Riskju (RMP) ippreżentat f'Module 1.8.2 ta' l-Applikazzjoni għat-Tqegħid fis-Suq u kull aġġornament ta' l-RMP li ġie wara iffissat mis-CHMP.
English: The incidence of all adverse events relating to liver and biliary systems was < 1.5% in any treatment group and similar to placebo.
Maltese: L-inċidenza tal-każi avversi kollha relatati ma sistemi tal-fwied u biljari kienet <1.5% f'kull grupp trattat u l-istess għall-plaċebo.
English: There have been rare reports of hepatocellular dysfunction during post-marketing experience with rosiglitazone (see section 4.8).
Maltese: Monitoraġġ tal-funzjoni tal-fwied Kien hemm rapporti rari ta' funzjonament epatoċellulari ħażin wara l-esperjenza tat-tqegħid fis-suq ta' rosiglitazone (ara sezzjoni 4.8).
English: These may be signs of liver problems:
Maltese: Id-detentur ta' l-awtorizzazzjoni għat-tqegħid fis-suq:
English: If risk factors for hypoglycaemia are present (including renal insufficiency, low body weight, malnourishment, co-administration with certain other medicinal products (see section 4.5) or if the patient's life-style changes) it may be necessary to revert to concomitant therapy and down titrate the glimepiride dose.
Maltese: Jekk hemm preżenti fatturi ta' riskju għal ipogliċemija (inklużi insuffiċjenza tal-kliewi, piż baxx tal-ġisem, nuqqas ta' nutriment, teħid fl-istess ħin ta' prodotti mediċinali oħra (ara sezzjoni 4.5) jew jekk jinbidel l-istil tal-ħajja tal-pazjent) jista' jkun hemm bżonn li wieħed jerga' jdur għal terapija konkomitanti u b'doża ta' glimepiride li tiżdied jew titnaqqas ftit ftit.
English: Both rosiglitazone and glimepiride have been detected in the milk of experimental animals.
Maltese: Kemm rosiglitazone u kemm glimepiride instabu fil-ħalib ta' annimali f'esperimentazzjoni.
English: Elderly
Maltese: Lott
English: A study comparing AVAGLIM to monotherapy rosiglitazone or glimepiride demonstrated incremental benefit in control of glycaemia of the fixed-dose combination over monotherapy.
Maltese: Studju li jqabbel AVAGLIM ma' monoterapija b'rosiglitazone jew glimepiride wera benefiċċju ikbar fil-kontroll ta' gliċemija tal-kombinazzjoni b'doża fissa fuq monoterapija.
English: The absorption of rosiglitazone is not affected by increases in gastric pH.
Maltese: L-assorbiment ta' rosiglitazone mhuwiex affettwat minn żjidiet fil-pH gastriku.
English: Although hormonal imbalance has been seen in preclinical studies (see section 5.3), no significant undesirable effects associated with menstrual disorders have been observed.
Maltese: Għalkemm deher żbilanċ ormonali fi studji pre-kliniċi (ara sezzjoni 5.3), ebda effetti sinifikanti mhux mixtieqa assoċjati ma' mard menstruwali ma ġew osservati.
English: Pharmacotherapeutic group: Combinations of oral blood glucose lowering drugs, ATC code: A10BD04
Maltese: Kombinazzjonijiet ta' mediċini li jittieħdu mill-ħalq u li jnaqqsu lglukosju fid-demm, Kodiċi ATC:
English: AVAGLIM combines two antidiabetic agents with complimentary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: rosiglitazone maleate, a member of the thiazolidinedione class and glimepiride, a member of the sulphonylurea class.
Maltese: Konsegwenza ta' mekkaniżmi differenti imma kumplementari ta' azzjoni, terapija doppja mill-ħalq b'rosiglitazone b'sulphonylurea jew metformin irriżultat f'effetti addittivi fil-kontroll gliċemiku f'pazjenti b'dijabete ta' tip 2.
English: 05 October 2012
Maltese: 5 ta' Ottubru 2012
English: The full European Public Assessment Report for Erbitux 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: Erbitux is an anticancer medicine which has been authorised in the European Union (EU) since 29 June 2004.
Maltese: Erbitux huwa mediċina kontra l-kanċer li ilha awtorizzata fl-Unjoni Ewropea (UE) mid29 ta' Ġunju 2004.
English: The applicant presented a re-analysis of the data from one main study involving 1,125 patients with advanced or metastatic non-small cell lung cancer with EGFR.
Maltese: L-applikant ippreżenta analiżi mill-ġdid tad-dejta minn studju prinċipali wieħed li involva 1,125 pazjent b'kanċer tal-pulmun ta' ċelloli mhux żgħar avvanzat jew metastatiku.
English: What was Erbitux expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża Erbitux?
English: The active substance in Erbitux, cetuximab, is a monoclonal antibody, a type of protein that has been designed to recognise and attach to EGFR, which can be found on the surface of some tumour cells.
Maltese: Is-sustanza attiva f'Erbitux, cetuximab, hija antikorp monoklonali, tip ta' proteina li ġiet iddisinjata sabiex tagħraf u teħel mal-EGFR, li jista' jinsab fuq il-wiċċ ta' xi ċelloli ta' tumuri.
English: Erbitux is used in patients whose tumour cells have a protein on their surface called epidermal growth factor receptor (EGFR) and contain a ‘wildtype' (non-mutated) gene called ‘KRAS'.
Maltese: Erbitux jintuża f'pazjenti li ċċelloli tat-tumur tagħhom ikollhom proteina fuq il-wiċċ imsejħa riċettur tal-fattur tat-tkabbir epidermiku (epidermal growth factor receptor, EGFR) u fihom ġene tat-'tip selvaġġ' (mhux mutat) imsejjaħ ‘KRAS'.
English: On 17 September 2012, Merck KGaA officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a change to the marketing authorisation for Erbitux, to extend its use in the treatment of non-small cell lung cancer.
Maltese: Fis-17 ta' Settembru 2012, Merck KGaA għarrfet uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għallUżu mill-Bniedem (CHMP) li hija tixtieq tirtira l-applikazzjoni tagħha għal bidla tal-awtorizzazzjoni għattqegħid fis-suq għal Erbitux, sabiex testendi l-użu tiegħu fil-kura ta' kanċer tal-pulmun ta' ċelloli mhux żgħar.
English: In cancer that is recurrent (has come back after previous treatment) or metastatic, Erbitux is used with a ‘platinum-based' anticancer medicine combination.
Maltese: F'kanċer li jkun reċediv (meta jerġa' lura wara kura preċedenti) jew metastatiku, Erbitux jintuża ma' taħlita ta' mediċini kontra l-kanċer abbażi tal-platinu.
English: In colorectal cancer it can be used in combination with chemotherapy (medicines to treat cancer) or on its own.
Maltese: F'kanċer kolorettali, jista' jintuża f'kombinazzjoni ma' kemoterapija (mediċini li jikkuraw il-kanċer) jew waħdu.
English: The letter from the company notifying the Agency of the withdrawal of the application is available under the tab 'All documents'.
Maltese: L-ittra mill-kumpanija li tinnotifika lill-Aġenzija bl-irtirar tal-applikazzjoni hija disponibbli taħt it-tab 'All documents'.
English: In the study, patients were given cisplatin and vinorelbine (two chemotherapy medicines) with or without Erbitux.
Maltese: Fl-istudju, pazjenti ngħataw cisplatin u vinorelbine (żewġ mediċini ta' kemoterapija) bi jew mingħajr Erbitux.
English: The Committee was concerned that, although the re-analysis of the data indicated that there might be a beneficial effect on survival for patients whose tumour cells had high levels of EGFR, there were some concerns, particularly over the way that patients had been categorised into high or low EGFR level groups in the retrospective analysis, as well as the fact that the effect seen in patients with high EGFR levels in the main study had not been confirmed in another study.
Maltese: Il-Kumitat kien imħasseb li, għalkemm l-analiżi mill-ġdid tad-dejta indikat li jista' jkun hemm effett ta' benefiċċju fuq is-sopravivenza għall-pazjenti li ċ-ċelloli tat-tumur tagħhom kellhom livelli għoljin ta' EGFR, kien hemm xi tħassib, b'mod partikolari fuq il-mod li bih il-pazjenti ġew ikkategorizzati fi gruppi ta' livell ta' EGFR għoli jew baxx fl-analiżi retrospettiva, kif ukoll il-fatt li l-effett li deher f'pazjenti b'livelli ta' EGFR għoljin fl-istudju prinċipali ma ġiex ikkonfermat fi studju ieħor.
English: In locally advanced cancer (when the tumour has grown but has not spread), Erbitux is given in combination with radiotherapy (treatment with radiation).
Maltese: Fil-kanċer lokalment avvanzat (meta t-tumur ikun kiber iżda jkun għadu ma nfirixx), Erbitux jingħata flimkien marradjoterapija (kura b'radjazzjoni).
English: It is used to treat adults with colorectal cancer (a cancer of the large intestine) when the cancer is metastatic (has spread to other parts of the body).
Maltese: Jintuża biex jikkura adulti b'kanċer kolorettali (kanċer tal-musrana l-kbira) meta lkanċer ikun metastatiku (ikun infirex għal partijiet oħrajn tal-ġisem).
English: Multaq dronedarone
Maltese: Multaq dronedaron
English: The full EPAR for Multaq can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ għal Multaq jinsab fuq is-sit elettroniku tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Multaq contains the active substance dronedarone.
Maltese: Multaq fih is-sustanza attiva dronedaron.
English: This is a summary of the European public assessment report (EPAR) for Multaq.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Multaq.
English: The most common side effects with Multaq (seen in more than 1 patient in 10) are increased blood levels of creatinine (a breakdown product of muscle), a prolonged ‘QTc Bazett' (an alteration of the electrical activity of the heart) and congestive heart failure (a type of heart disease), but this side effect occurred at a similar rate in patients who took placebo in clinical studies.
Maltese: L-effetti sekondarji l-aktar komuni b'Multaq (li dehru f'aktar minn pazjent wieħed minn kull 10) huma żieda fil-livelli tad-demm ta' kreatinina (prodott ta' tkissir tal-muskoli), ‘QTc Bazett' imtawwal (alterazzjoni tal-attività elettrika tal-qalb) u insuffiċjenza kardijaka konġestiva (tip ta' mard tal-qalb), iżda dan l-effett sekondarju seħħ b'rata simili f'pazjenti li ħadu plaċebo fi studji kliniċi.
English: Multaq was less effective than amiodarone at maintaining normal rhythm: after a year, atrial fibrillation came back or treatment was stopped in 75% of the patients taking Multaq, compared with 59% of the patients receiving amiodarone.
Maltese: Multaq kien inqas effettiv minn amiodaron fiż-żamma tar-ritmu normali: wara sena, il-fibrillazzjoni atrijali reġgħet feġġet jew il-kura twaqqfet f'75% tal-pazjenti li jieħdu Multaq, meta mqabbla ma' 59% tal-pazjenti li jieħdu amiodaron.
English: This followed a review of data that became available since its authorisation including data from the PALLAS study.1
Maltese: Dan kien b'segwitu ta' rieżami ta' data li saret disponibbli mill-awtorizzazzjoni tiegħu inkluż data millistudju PALLAS 1.