FrancophonIA/ELRC3.0 huggingface dataset:
English: Acknowledging the relationship between QTc prolongation (and the connected risks) and exposure, the Applicant proposed for this re-examination a contraindication in CYP2D6 poor metabolisers or in those patients with unknown CYP2D6 metaboliser status, and for concomitant use with drugs that are known strong CYP2D6 or CYP3A4 inhibitors.
Maltese: Filwaqt li rrikonoxxa r-relazzjoni bejn it-titwil tal-QTc (u r-riskji marbuta) u lesponiment, l-Applikant ippropona għal din l-eżaminazzjoni mill-ġdid kontraindikazzjoni f'metabolizzaturi batuti ta' CYP2D6 jew f'dawk il-pazjenti bi status ta' metabolizzatur CYP2D6 mhux magħruf, u għal użu konkomitanti ma' mediċini li huma inibituri qawwija magħrufa ta' CYP2D6 jew CYP3A4.
English: The overall nonclinical safety pharmacology data point to a risk of QT prolongation (hERG blockade, APD prolongation in dog Purkinje fibres).
Maltese: Id-dejta dwar is-sigurtà farmakoloġika mhux klinika globali tindika riskju ta' titwil tal-QT (ibblukkar ta' hERG, titwil ta' APD fil-fibri Purkinje tal-klieb ventrikulari).
English: Iloperidone is also associated with a clinically significant body weight increase.
Maltese: Iloperidone huwa assoċjat ma' żieda fil-piż tal-ġisem klinikament sinifikanti.
English: Compared to other antipsychotics, Fanaptum has a late onset of action.
Maltese: Meta mqabbel ma' antipsikotiċi oħra, Fanaptum għandu bidu ta' azzjoni tard.
English: Iloperidone lacks any significant affinity for cardiac sodium and/or calcium channels at therapeutic plasma concentrations.
Maltese: Iloperidone għandu nuqqas ta' affinità sinifikanti għas-sodju kardijaku u/jew kanali kardijaċi b'konċentrazzjonijiet fil-plażma terapewtiċi.
English: In this study, the PANSS reduction with Iloperidone 24 mg differed in a statistically significant manner from placebo at Week 4 but the magnitude of the effect was modest with a reduction of approximately 5 points on the PANNS-T scale compared to placebo.
Maltese: F'dan l-istudju, it-tnaqqis fil-PANSS b'Iloperidone 24 mg kien differenti b'mod statistikament sinifikanti mill-plaċebo f'Ġimgħa 4 iżda d-daqs tal-effett kien modest bi tnaqqis ta' madwar 5 punti fuq l-iskala PANNS-T meta mqabbel mal-plaċebo.
English: The arrhythmogenicity of Iloperidone is mechanistically related to its selective inhibition of cardiac potassium channels leading to delayed repolarization which is seen in the characteristic action potential prolongations in ventricular dog Purkinje fibres.
Maltese: L-aritmoġeniċità ta' Iloperidone hija mekkanistikament relatata mal-inibizzjoni selettiva tiegħu ta' kanali tal-potassju kardijaċi li twassal għal polarizzazzjoni mill-ġdid imdewma li tidher fl-azzjoni karatteristika ta' titwil potenzjali fil-fibri Purkinje tal-klieb ventrikulari.
English: • Considering all available non-clinical and clinical data (including the thorough QTc study, the overall clinical program and the cases of cardiac-related/sudden unexplained death in clinical trials and post-marketing), Iloperidone has a substantial and exposure-dependent arrhythmogenic potential.
Maltese: • Meta tiġi kkunsidrata d-dejta mhux klinika u klinika disponibbli kollha (inkluż l-istudju fil-fond dwar il-QTc, il-programm kliniku globali u l-każijiet ta' mewt mhux spjegata assoċjata malqalb/f'daqqa fil-provi kliniċi u wara t-tqegħid fis-suq), Iloperidone għandu potenzjal aritmoġeniku sostanzjali u dipendenti fuq l-esponiment.
English: Of those, three - B202, 3000, and 3005 - failed to show superiority over placebo according to their pre-specified primary endpoints and analysis plans, and two3004 and 3101 - met their pre-specified criteria for superiority over placebo.
Maltese: Minn dawn, tlieta - B202, 3000, u 3005 - naqsu milli juru superjorità fuq il-plaċebo skont l-end-points primarji speċifikati minn qabel u l-pjanijiet ta' analiżi tagħhom, u tnejn - 3004 u 3101 - issodisfaw il-kriterji speċifikati minn qabel tagħhom għal superjorità fuq il-plaċebo.
English: Iloperidone is associated with extrapyramidal effects, but to a modest degree.
Maltese: Iloperidone huwa assoċjat ma' fatturi ekstrapiramidali, iżda għal grad modest.
English: • Furthermore, Iloperidone has a modest efficacy.
Maltese: • Barra minn hekk, Iloperidone għandu effikaċja modesta.
English: In reviewing the results of the thorough QTc study, out of 94 patients exposed to Iloperidone at different doses without metabolic inhibition in the Secondary QTc population 43 and 2 patients respectively developed a prolongation of the QTcF of more than 30 and 60 msec.
Maltese: Fir-reviżjoni tar-riżultati tal-istudju fil-fond dwar il-QTc, minn 94 pazjent esposti għal Iloperidone b'dożi differenti mingħajr inibizzjoni metabolika fil-popolazzjoni tal-QTc Sekondarja 43 u 2 pazjenti rispettivament żviluppaw titwil tal-QTcF ta' aktar minn 30 u 60 msec.
English: Very little detailed information is available from the post-marketing setting.
Maltese: Hemm vera ftit informazzjoni dettaljata disponibbli mill-ambjent ta' wara t-tqegħid fis-suq.
English: Iloperidone has a high affinity to the hERG channels and causes QTc exposure-dependent prolongation.
Maltese: Iloperidone għandu affinità għolja għall-kanali ta' hERG u jikkawża titwil tal-QTc dipendenti fuq lesponiment.
English: At least one fatal case could possibly have been preceded by ventricular arrhythmia and Torsades de Pointes.
Maltese: Tal-inqas każ fatali wieħed jaf ġie ppreċedut minn aritmija ventrikulari u Torsades de Pointes.
English: Unfortunately, the CYP2D6 genotype was not known in the patients that died during the clinical studies or post-marketing.
Maltese: Sfortunatament, il-ġenotip CYP2D6 ma kienx magħruf fil-pazjenti li mietu waqt l-istudji kliniċi jew wara t-tqegħid fis-suq.
English: It is currently unknown if Iloperidone can be safely administered with weak and/or moderate inhibitors of CYP2D6 and/or CYP3A4 given the likely variability of the efficiency of minor metabolic pathways.
Maltese: Attwalment mhuwiex magħruf jekk Iloperidone jistax jingħata b'mod sigur ma' inibituri dgħajfa u/jew moderati ta' CYP2D6 u/jew CYP3A4 minħabba l-varjabbiltà probabbli tal-effiċjenza ta' passaġġi metaboliċi minuri.
English: No QT prolongation was observed in the in vivo dog studies.
Maltese: Ma ġie osservat l-ebda titwil tal-QT fi studji in vivo fuq il-klieb.
English: Furthermore, as the metabolism of iloperidone relies heavily on CYP3A4 and CYP2D6, this creates the potential of increased exposure to the drug as a consequence of drug-drug interactions and genetic polymorphisms.
Maltese: Barra minn hekk, peress li l-metaboliżmu ta' iloperidone jiddependi ħafna fuq CYP3A4 u CYP2D6, dan joħloq il-potenzjal ta' esponiment akbar għall-mediċina bħala konsegwenza ta' interazzjonijiet mediċinali u polimorfiżmi ġenetiċi.
English: This indicates that Iloperidone could cause QT prolongation.
Maltese: Dan jindika li Iloperidone jista' jikkawża titwil tal-QT.
English: In conclusion, Iloperidone has a substantial arrhythmogenic potential, which becomes obvious if all available non-clinical and clinical data (including the thorough QTc study, the overall clinical program and also the cases of cardiac-related/sudden unexplained death in clinical trials and post-marketing) are taken into account.
Maltese: Bħala konklużjoni, Iloperidone għandu potenzjal aritmoġeniku sostanzjali, li jsir ovvju jekk tiġi kkunsidrata d-dejta mhux klinika u klinika disponibbli kollha (inkluż l-istudju fil-fond dwar il-QTc, ilprogramm kliniku globali u anki l-każijiet ta' mewt mhux spjegata assoċjata mal-qalb/f'daqqa fil-provi kliniċi u wara t-tqegħid fis-suq).
English: The CHMP is of the opinion that pursuant to Article 12 of Regulation (EC) No 726/2004, the safety of the above mentioned medicinal product is not properly or sufficiently demonstrated.
Maltese: Is-CHMP huwa tal-fehma li skont l-Artikolu 12 tar-Regolament (KE) Nru 726/2004, is-sigurtà tal-prodott mediċinali msemmi hawn fuq ma ntwerietx kif xieraq jew biżżejjed.
English: Continued, long-term efficacy after stabilisation with Fanaptum has been studied and demonstrated in Study 2301, in which patients continuing on Fanaptum had a significantly lower rate of relapses or impending relapses compared to patients switched to placebo.
Maltese: Fi Studju 2301, ġiet studjata u murija effikaċja fit-tul kontinwa wara l-istabilizzazzjoni b'Fanaptum, li fih il-pazjenti li komplew fuq Fanaptum kellhom rata konsiderevolment aktar baxxa ta' rikaduti jew rikaduti imminenti meta mqabbla ma' pazjenti li qalbu għall-plaċebo. Madankollu, peress li mit-tfassil tiegħu, listudju dwar it-twaqqif randomizzat għandu jinkludi dawk li rrispondew biss jiġifieri, il-popolazzjoni tiżdied, id-daqs tal-effett jista' jiġi derivat biss mill-istudji f'perjodu qasir.
English: However, Study 3004 also included patients with schizoaffective disorder and efficacy was not demonstrated in the schizophrenia subgroup.
Maltese: Madankollu, Studju 3004 inkluda wkoll pazjenti b'disturbi skiżoaffettiv u l-effikaċja ma ntweritx fis-sottogrupp ta' skiżofrenja.
English: There were 6 cases of sudden deaths or deaths due to cardiac AE in the clinical trials.
Maltese: Kien hemm 6 każijiet ta' mwiet f'daqqa jew imwiet minħabba AE kardijaku fil-provi kliniċi.
English: The Applicant argued that the apparent difference between Fanaptum and risperidone could be partially due to a greater number of patients on Fanaptum discontinuing early due to lack of efficacy during titration.
Maltese: L-Applikant argumenta li d-differenza apparenti bejn Fanaptum u risperidone tista' tkun parzjalment minħabba numru akbar ta' pazjenti fuq Fanaptum li jwaqqfu l-kura kmieni minħabba nuqqas ta' effikaċja waqt it-titrazzjoni.
English: As mentioned for the one related to Efficacy, the indirect comparison for Akathisia proposed by the Applicant does not fulfil the methodological standards of systematic reviews (for instance, comprehensive search strategy, transparent and replicable inclusion criteria), and this limits the reliability of the conclusions that can be drawn from it.
Maltese: Kif imsemmi għal dak relatat mal-Effikaċja, it-tqabbil indirett għall-Akatiżija propost mill-Applikant ma jissodisfax l-istandards metodoloġiċi ta' reviżjonijiet sistematiċi (pereżempju, strateġija ta' tfittxija komprensiva, kriterji ta' inklużjoni trasparenti u replikabbli), u dan jillimita l-affidabbiltà talkonklużjonijiet li jistgħu jinsiltu minnu.
English: The indirect comparison for efficacy proposed by the Applicant does not fulfil the methodological standards of systematic reviews (for instance, comprehensive search strategy, transparent and replicable inclusion criteria), and this limits the reliability of the conclusions that can be drawn from it.
Maltese: It-tqabbil indirett għall-effikaċja propost mill-Applikant ma jissodisfax l-istandards metodoloġiċi ta' reviżjonijiet sistematiċi (pereżempju, strateġija ta' tfittxija komprensiva, kriterji ta' inklużjoni trasparenti u replikabbli), u dan jillimita l-affidabbiltà tal-konklużjonijiet li jistgħu jinsiltu minnu.
English: The efficacy of daily doses lower than 24 mg was insufficiently characterised.
Maltese: L-effikaċja ta' dożi ta' kuljum inqas minn 24 mg ma ġietx ikkaratterizzata biżżejjed.
English: For example, the proposal to perform ECGs at the estimated Tmax could miss the actual Tmax due to intrinsic or extrinsic factors, leading to an underestimation of the QTcF prolongation.
Maltese: Pereżempju, il-proposta li jsiru ECGs bit-Tmax stmata jistgħu jitilfu t-Tmax attwali minħabba fatturi intrinsiċi jew estrinsiċi, li jwassal għal sottovalutazzjoni tattitwil tal-QTcF.
English: In consideration of the complex causal chain linking the exposure to Iloperidone to events such as Torsade de Pointes, including unknown and stochastic elements and elements subject to an unpredictable variability, it is considered that the risk minimization measures proposed would not adequately address in clinical practice the risk identified.
Maltese: Fid-dawl tal-katina kawżali kumplessa li torbot l-esponiment għal Iloperidone ma' avvenimenti bħal Torsade de Pointes, inklużi elementi mhux magħrufa u stokastiċi u elementi soġġetti għal varjabbiltà mhux prevvista, jiġi kkunsidrat li l-miżuri tal-imminimizzar tar-riskju proposti ma jindirizzawx b'mod adegwat ir-riskju identifikat fil-prattika klinika.
English: Physicochemical and biological aspects relevant to the uniform clinical performance of the product have been investigated and are controlled in a satisfactory way.
Maltese: L-aspetti fiżikokimiċi u bijoloġiċi rilevanti għall-prestazzjoni klinika uniformi tal-prodott ġew investigati u huma kkontrollati b'mod sodisfaċenti.
English: Teva Pharmaceuticals Polska Sp. z o.o.
Maltese: Teva Pharmaceuticals Polska Sp. z o.o. Tel.:
English: This check may be repeated at intervals.
Maltese: Dan ilkontroll jista' jkun ripetut f'intervalli.
English: - The other ingredients are lactose monohydrate, hydroxypropylcellulose, carmellose calcium and magnesium stearate.
Maltese: - Is-sustanzi l-oħra huma lactose monohydrate, hyprolose, carmellose calcium u magnesium stearate.
English: Frequencies are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi huma definiti bħala: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa< 1/1,000); rari ħafna (< 1/10,000); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Pioglitazone Actavis 15 mg, 30 mg and 45 mg tablets Pioglitazone Actavis 15 mg tablets
Maltese: Pioglitazone Actavis 15 mg, 30 mg and 45 mg pilloli Pioglitazone Actavis 15 mg pilloli
English: Pioglitazone Actavis contains pioglitazone.
Maltese: Pioglitazone Actavis fih pioglitazone.
English: EU/1/12/755/001 EU/1/12/755/002 EU/1/12/755/003 EU/1/12/755/004 EU/1/12/755/005 EU/1/12/755/006 EU/1/12/755/007
Maltese: EU/1/12/755/001 EU/1/12/755/002 EU/1/12/755/003 EU/1/12/755/004
English: The reports of oedema were generally mild to moderate and usually did not require discontinuation of treatment.
Maltese: Ir-rapporti ta' edima ġeneralment kienu ħfief għal moderati u normalment ma kienux jeħtieġu twaqqif tal-kura.
English: Pioglitazone Actavis tablets contain lactose monohydrate and therefore should not be administered to patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
Maltese: Il-pilloli Pioglitazone Actavis fihom lactose monohydrate u għalhekk m'għandhomx jingħataw lil pazjenti bi problemi ereditarji rari ta' intolleranza għall-galactose, defiċjenza Lapp lactase jew assorbiment ħażin ta' glucose-galactose.
English: The oedema rates for comparator groups (sulphonylurea, metformin) were 2-5%.
Maltese: Ir-rati ta' edema għall-gruppi ta' paragun (b'sulphonylurea, metformin) kienu ta' 2-5%.
English: Each tablet contains 15 mg, 30 mg or 45 mg of pioglitazone (as hydrochloride).
Maltese: Kull pillola fiha 15 mg, 30 mg jew 45 mg ta' pioglitazone (bħala hydrochloride).
English: In patients on insulin with no pioglitazone the incidence of heart failure was 8.2% in those ≥65 years compared to 4.0% in patients less than 65 years.
Maltese: F'pazjenti fuq linsulina mingħajr pioglitazone l-inċidenża ta'insuffiċjenza tal-qalb kienet 8.2% f'dawk ≥ 65 sena meta mqabbla ma' 4.0% f'pazjenti li għandhom inqas minn 65 sena.
English: Oedema was reported in 6-9% of patients treated with pioglitazone over one year in controlled clinical trials.
Maltese: Edima kienet irrappurtata f'6-9% tal-pazjenti kkurati b'pioglitazone fuq medda ta' sena fi provi kliniċi kkontrollati.
English: For the 14, 28, 56, 84 and 98 tablets pack sizes, you can check the day on which you last took a tablet of Pioglitazone Actavis by referring to the calendar printed on the blister.
Maltese: Għall-pakketti ta' 14, 28, 56, 84 u 98 pakkett pilloli, tista' tiċċekkja l-ġurnata li fiha ħadt l-aħħar ilpillola ta' Pioglitazone Actavis billi tirreferi għall-kalendarju stampat fuq il-folja.
English: Pioglitazone Actavis 30 mg tablets are white, round, flat, bevelled, 7 mm in diameter and engraved with ‘TZ30' on one side.
Maltese: Pioglitazone Actavis 30 mg huma pilloli bojod, tondi, bbuzzati b'dijametru ta' 7 mm u immarkati b'‘TZ30' fuq naħa waħda
English: as triple oral therapy in combination with - metformin and a sulphonylurea, in adult patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy.
Maltese: bħala terapija orali trippla flimkien ma' metformin u sulphonylurea, f'pazjenti adulti (speċjalment pazjenti b'piż eċċessiv) b'kontroll gliċemiku insuffiċjenti minkejja terapija orali doppja.
English: Other medicines and Pioglitazone Actavis
Maltese: Mediċini oħra u Pioglitazone Actavis
English: What Pioglitazone Actavis looks like and contents of the pack Pioglitazone Actavis 15 mg tablets are white, round, flat, bevelled, 5.5 mm in diameter and engraved with ‘TZ15' on one side.
Maltese: Id-Dehra ta' Pioglitazone Actavis u l-kontenuti tal-pakkett Pioglitazone Actavis 15 mg huma pilloli bojod, tondi, bbuzzati b'dijametru ta' 5.5 mm u immarkati b'‘TZ15' fuq naħa waħda
English: Pioglitazone Actavis 30 mg tablets
Maltese: Pioglitazone Actavis 30 mg pilloli
English: Immune System Disorders Hypersensitivity and allergic reactions not known not known not known not known not known
Maltese: Disturbi fis-sistema immuni sensittività eċċessiva u reazzjonijiet allerġiċi 1
English: Wed. Thu.
Maltese: T TL E Ħ Ġ S
English: In controlled clinical trials the incidence of reports of heart failure with pioglitazone treatment was the same as in placebo, metformin and sulphonylurea treatment groups, but was increased when used in combination therapy with insulin.
Maltese: Fi provi kliniċi kkontrollati, l-inċidenza ta' rapporti ta' insuffiċjenza tal-qalb b'kura b'pioglitazone kienet l-istess bħall-gruppi ta' kura bil-plaċebo, metformin u sulphonylurea, iżda żdiedet meta ntuża f'terapija kkombinata ma' insulina.
English: EU/1/12/755/001 [14 tablets] EU/1/12/755/002 [28 tablets] EU/1/12/755/003 [30 tablets] EU/1/12/755/004 [50 tablets] EU/1/12/755/005 [56 tablets] EU/1/12/755/006 [84 tablets] EU/1/12/755/007 [90 tablets] EU/1/12/755/008 [98 tablets] EU/1/12/755/009 [100 tablets]
Maltese: EU/1/12/755/001 [14 pilloli] EU/1/12/755/002 [28 pilloli] EU/1/12/755/003 [30 pilloli] EU/1/12/755/004 [50 pilloli] EU/1/12/755/005 [56 pilloli] EU/1/12/755/006 [84 pilloli] EU/1/12/755/007 [90 pilloli] EU/1/12/755/008 [98 pilloli] EU/1/12/755/009 [100 pillola]
English: EU/1/12/755/019 [14 tablets] EU/1/12/755/020 [28 tablets] EU/1/12/755/021 [30 tablets] EU/1/12/755/022 [50 tablets] EU/1/12/755/023 [56 tablets] EU/1/12/755/024 [84 tablets] EU/1/12/755/025 [90 tablets] EU/1/12/755/026 [98 tablets] EU/1/12/755/027 [100 tablets]
Maltese: EU/1/12/755/019 [14 pilloli] EU/1/12/755/020 [28 pilloli] EU/1/12/755/021 [30 pilloli] EU/1/12/755/022 [50 pilloli] EU/1/12/755/023 [56 pilloli] EU/1/12/755/024 [84 pilloli] EU/1/12/755/025 [90 pilloli] EU/1/12/755/026 [98 pilloli] EU/1/12/755/027 [100 pillola]
English: Pioglitazone Actavis 30 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Pioglitazone Actavis 30 mg
English: Pioglitazone Actavis 45 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Pioglitazone Actavis 45 mg
English: A pooled analysis was conducted of adverse reactions of bone fractures from randomised, comparator controlled, double blind clinical trials in over 8100 patients in the pioglitazone-treated groups and 7400 in the comparator-treated groups of up to 3.5 years duration.
Maltese: Twettqet analiżi ta' tagħrif miġbur ta' rapporti ta' effetti mhux mixtieqa ta' fratturi fl-għadam minn provi kliniċi randomised, ikkontrollati b'paragun, u double blind b'aktar minn 8100 pazjent fil-gruppi kkurati b'pioglitazone u 7400 pazjent fil-gruppi kkurrati bi prodott paragun li damu sa 3.5 snin.
English: EU/1/12/755/010 [14 tablets] EU/1/12/755/011 [28 tablets] EU/1/12/755/012 [30 tablets] EU/1/12/755/013 [50 tablets] EU/1/12/755/014 [56 tablets] EU/1/12/755/015 [84 tablets] EU/1/12/755/016 [90 tablets] EU/1/12/755/017 [98 tablets] EU/1/12/755/018 [100 tablets]
Maltese: EU/1/12/755/010 [14 pilloli] EU/1/12/755/011 [28 pilloli] EU/1/12/755/012 [30 pilloli] EU/1/12/755/013 [50 pilloli] EU/1/12/755/014 [56 pilloli] EU/1/12/755/015 [84 pilloli] EU/1/12/755/016 [90 pilloli] EU/1/12/755/017 [98 pilloli] EU/1/12/755/018 [100 pillola]
English: Pioglitazone Actavis 30 mg tablets pioglitazone
Maltese: Pioglitazone Actavis 30 mg pilloli pioglitazone
English: Pioglitazone Actavis 45 mg tablets
Maltese: Pioglitazone Actavis 45 mg pilloli
English: The packs with 14, 28, 56, 84 and 98 tablets contain blisters with abbreviations for days of the week printed on the blister (Mon, Tue, Wed, Thu, Fri, Sat, Sun).
Maltese: Il-pakketti bi 14, 28, 56, 84 u 98 pillola fihom folji bil-ġranet tal-ġimgħa pprintjati fil-qosor fuq ilfolja (T, TL, E, Ħ, Ġ, S, Ħ).
English: Pioglitazone Actavis 15 mg tablets pioglitazone
Maltese: Pioglitazone Actavis 15 mg pilloli pioglitazone
English: Pioglitazone Actavis 45 mg tablets pioglitazone
Maltese: Pioglitazone Actavis 45 mg pilloli pioglitazone
English: The packs with 14, 28, 56, 84 and 98 tablets contain blisters with abbreviations for days of the week printed on the blister (Mon., Tue., Wed., Thu., Fri., Sat., Sun.).
Maltese: Il-pakketti ta' 14, 28, 56, 84 u 98 pilloli fihom folji bil-ġranet tal-ġimgħa stampati fil-qosor fuq il-folja (T, TL, E, Ħ, Ġ, S, Ħ).
English: In active comparator controlled trials mean weight increase with pioglitazone given as monotherapy was 2-3 kg over one year.
Maltese: Fi provi attivi kkontrollati ta' paragun, iż-żieda medja fil-piż bi pioglitazone mogħti bħala monoterapija kienet ta' 2 - 3 kg fuq medda ta' sena.
English: Pioglitazone Actavis 45 mg tablets The tablets are white, round, flat, bevelled, 8 mm in diameter and engraved with ‘TZ45' on one side.
Maltese: Pioglitazone Actavis 45 mg huma pilloli bojod, tondi, bbuzzati b'dijametru ta' 8 mm ut immarkati b'‘TZ45' fuq naħa waħda
English: Broken bones
Maltese: Mhux komuni
English: Pioglitazone Actavis 15 mg tablets
Maltese: Pioglitazone Actavis 15 mg pilloli
English: MARKETING AUTHORISATION NUMBER(S)
Maltese: DETENTUR(I)
English: Pioglitazone Actavis 15 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Pioglitazone Actavis 15 mg
English: Eye disorders
Maltese: Disfunzjoni erettili
English: Respiratory, thoracic and mediastinal disorders dyspnoea common
Maltese: Disturbi muskoluskeletrali u tal-connective tissue
English: Each tablet contains 30 mg pioglitazone (as hydrochloride).
Maltese: Kull pillola fiha 30 mg ta' pioglitazone (bħala hydrochloride).
English: How to take Pioglitazone Actavis
Maltese: Kif taħżen Pioglitazone Actavis
English: Co-administration of pioglitazone with rifampicin (an inducer of cytochrome P450 2C8)
Maltese: Sorveljanza xierqa tal-kontroll gliċemiku għandha tiġi kkunsidrata (ara sezzjoni 4.4).
English: Nervous system disorders hypo-aesthesia common common common common common headache common uncommon dizziness common insomnia uncommon uncommon uncommon uncommon uncommon
Maltese: Il-professjonisti dwar il-kura tas-saħħa huma mitluba jirrappurtaw kwalunkwe reazzjoni avversa suspettata permezz tas-sistema ta' rappurtar nazzjonali imniżżla f'Appendiċi V.
English: Pioglitazone Actavis may be used on its own in patients who are unable to take metformin, and where treatment with diet and exercise has failed to control blood sugar or may be added to other therapies (such as metformin, sulphonylurea or insulin) which have failed to provide sufficient control of blood sugar.
Maltese: Pioglitazone Actavis jista' jintuża waħdu f'pazjenti li ma jistgħux jieħdu metformin, u fejn trattament ma' dieta u eżercizzju naqas milli jikkontrolla z-zokkor fid-demm jew jista' jittieħed flimkien ma'terapiji oħra (bħal metformin, sulphonylurea jew insulina) li naqsu milli jipprovdu kontroll biżżejjed taz-zokkor fid-demm.