FrancophonIA/ELRC3.0 huggingface dataset:
English: However, the marketing authorisation holder shall submit periodic safety update reports for this medicinal product if the product is included in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Maltese: Madankollu, id-detentur tal-awtorizzazzjoni fis-suq għandu jissottometti rapporti perjodiċi ta' aġġornament tas-sigurta' għal dan il-prodott mediċinali jekk ilprodott jiġi inkluż fil-lista ta 'dati ta' referenza tal-Unjoni (lista EURD) previsti taħt l-Artikolu 107c (7) tad-Direttiva 2001/83/EC u pubblikata fuq il-web-portal tal-mediċini tal-Ewropa.
English: Actavis Export Int. Ltd., Malta.
Maltese: Ltd., Malta.
English: UNIQUE IDENTIFIER - 2D BARCODE
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D 2D barcode li jinkludi l-identifikatur uniku.
English: Musculoskeletal and connective tissue disorders fracture bone4
Maltese: Disturbi muskoluskeletrali u tal-connective tissue
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
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: Contents of the pack and other information
Maltese: Kontentut tal-pakkett u informazzjoni oħra
English: Sun.
Maltese: Int.
English: - The active substance is pioglitazone.
Maltese: - Is-sustanza attiva hi pioglitazone.
English: This is similar to that seen in a sulphonylurea active comparator group.
Maltese: Dan huwa simili għal dak osservat fi grupp attiv ta' paragun b'sulphonylurea.
English: Hypersensitivity and allergic reactions1
Maltese: Disturbi fis-sistema immuni sensittività eċċessiva u reazzjonijiet allerġiċi1
English: Glidipion 15 mg, 30 mg and 45 mg tablets Glidipion 15 mg tablets
Maltese: Glidipion 15 mg, 30 mg u 45 mg pilloli Glidipion 15 mg pilloli
English: Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland
Maltese: Reykjavíkurvegi 76-78 220
English: Glidipion contains pioglitazone.
Maltese: Glidipion fih pioglitazone.
English: Similar changes were seen in metformin (haemoglobin 3-4% and haematocrit 3.6-4.1% relative reductions) and to a lesser extent sulphonylurea and insulin (haemoglobin 1-2% and haematocrit 1-3.2% relative reductions) treated patients in comparative controlled trials with pioglitazone.
Maltese: Tibdiliet simili dehru fi provi kkontrollati komparattivi b'pioglitazone f'pazjenti kkurati b'metformin (tnaqqis relattiv flemoglobina 3 - 4% u fl-ematokrita 3.6 - 4.1%) u mhux daqstant b'sulphonylurea u bl-insulina (tnaqqis relattiv fl-emoglobina 1 - 2 % u fl-ematokrita 1 - 3.2%).
English: The Prescriber Guide should highlight the following:
Maltese: Pioglitazone huwa kontra-indikat f'pazjenti bi:
English: Each tablet contains 75.54 mg of lactose monohydrate (see section 4.4).
Maltese: Kull pillola fiha 75.54 mg ta' lactose monohydrate (ara sezzjoni 4.4).
English: The mean plasma elimination half-life of unchanged pioglitazone in man is 5 to 6 hours and for its total active metabolites 16 to 23 hours.
Maltese: Il-half-life medja ta' eliminazzjoni mill plażma ta' pioglitazone mhux mibdul fil-bniedem hija 5 sa 6 sigħat u għall-metaboliti attivi kollhatiegħu, 16 sa 23 siegħa.
English: Common (may affect up to 1 in 10 people) - respiratory infection - abnormal vision - weight gain - numbness
Maltese: Komuni (jista' jaffetwa minn 1 sa 10 nies) - infezzjoni respiratorja - vista mhux normali - żieda fil-piż - tnemnim
English: Each tablet contains 37.77 mg of lactose monohydrate (see section 4.4).
Maltese: Kull pillola fiha 37.77 mg ta' lactose monohydrate (ara sezzjoni 4.4).
English: Pioglitazone undergoes extensive hepatic metabolism by hydroxylation of aliphatic methylene groups.
Maltese: Pioglitazone jgħaddi minn metaboliżmu estensiv fil-fwied permezz ta' idroksilazzjoni tal-gruppi ta' aliphatic methylene.
English: Immune System Disorders
Maltese: Disfunzjoni erettili
English: 5 Oedema was reported in 6-9% of patients treated with pioglitazone over one year in controlled clinical trials.
Maltese: Edima kienet irrappurtata bejn 6-9% tal-pazjenti kkurati bil-pioglitazone fuq medda ta' sena fi provi kliniċi kkontrollati.
English: Interaction studies have shown that pioglitazone has no relevant effect on either the pharmacokinetics or pharmacodynamics of digoxin, warfarin, phenprocoumon and metformin.
Maltese: Studji dwar interazzjoni wrew li pioglitazone m'għandu l-ebda effett relevanti la fuq ilfarmakokinetika u lanqas fuq il-farmakodinamika ta' digoxin, warfarin, phenprocoumon u metformin.
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 kinux jinħtieġu twaqqif tal-kura.
English: Each tablet contains 113.31 mg of lactose monohydrate (see section 4.4).
Maltese: Kull pillola fiha 113.31 mg ta' lactose monohydrate (ara sezzjoni 4.4).
English: In the 3.5 year cardiovascular risk PROactive study, 44/870 (5.1%; 1.0 fractures per 100 patient years) of pioglitazone-treated female patients experienced fractures compared to 23/905 (2.5%; 0.5 fractures per 100 patient years) of female patients treated with comparator.
Maltese: Fl-istudju PROactive dwar ir-riskju kardjovaskulari li dam 3.5 snin, 44/870 (5.1%; 1.0 fratturi kull 100 sena ta' pazjent) tal-pazjenti nisa kkurati b'pioglitazone kellhom fratturi meta mqabbel ma' 23/905 (2.5%; 0.5 fratturi kull 100 sena ta' pazjent) tal-pazjenti nisa kkurati bi prodott paragun.
English: Aluminium/aluminium blisters, packs of 14, 28, 30, 50, 56, 84, 90, 98 and 100 tablets.
Maltese: Il-pilloli huma disponibbli f'pakketti bil-folji tal-aluminium ta' 14, 28, 30, 50, 56, 84, 90, 98 jew 100 pillola.
English: At two years, glycaemic control (defined as HbA1c < 8.0%) was sustained in 69% of patients treated with pioglitazone, compared with 50% of patients on gliclazide.
Maltese: Wara sentejn, il-kontroll gliċemiku (definit bħala HbA1c < 8.0%) inżamm f'69% tal-pazjenti kkurati b'pioglitazone, meta mqabbla ma' 50% tal-pazjenti fuq gliclazide.
English: The tablets are supplied in aluminium blister packs of 14, 28, 30, 50, 56, 84, 90, 98 and 100 tablets.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Aluminju/Folja tal-aluminju, pakketti ta' 14, 28, 30, 50, 56, 84, 90, 98, u 100 pillola.
English: Glidipion 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 Glidipion 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: Studies in man suggest no induction of the main inducible cytochrome P450, 1A, 2C8/9 and 3A4.
Maltese: Studji fil-bniedem jissuġġerixxu li m'hemm l-ebda induzzjoni taċ-ċitokromu prinċipali induċibbli P450, 1A, 2C8/9 u 3A4.
English: There is no induction of the main inducible P450 isoenzymes 1A, 2C8/9, and 3A4 in man.
Maltese: M'hemm l-ebda induzzjoni tal-isoenzimi prinċipali induċibbli ta' P450 1A, 2C8/9, u 3A4 fil-bniedem.
English: Adverse reactions reported in excess (> 0.5%) of placebo and as more than an isolated case in patients receiving pioglitazone in double-blind studies are listed below as MedDRA preferred term by system organ class and absolute frequency.
Maltese: Reazzjonijiet avversi rrappurtati aktar (> 0.5%) minn bil-plaċebo u f'aktar minn każ iżolat f'pazjenti li qed jirċievu pioglitazone fi studji double-blind huma mniżżla hawn taħt bis-sistema ta' terminu ppreferut MedDRA permeżż tas-sistema tal-klassifika tal-organi u frekwenza assoluta.
English: To be eligible patients had to have had one or more of the following: myocardial infarction, stroke, percutaneous cardiac intervention or coronary artery bypass graft, acute coronary syndrome, coronary artery disease, or peripheral arterial obstructive disease.
Maltese: Biex ikunu eliġibbli, il-pazjenti ried ikollhom waħda jew aktar minn dawn li ġejjin: infart mijokardijaku, puplesija, intervent kardijaku perkutanju jew bypass bi graft tal-arterja koronarja, sindromu koronarju akut, mard koronarju arterjali, jew mard tal-arterji periferali misduda.
English: Neoplasms benign, malignant and unspecified (including cysts and polyps)
Maltese: Neoplasmi beninni, malinni u mhux speċifikati (inklużi ċesti u polipi)
English: Uncommon (may affect up to 1 in 100 people) - inflammation of the sinuses (sinusitis) - difficulty sleeping (insomnia)
Maltese: Mhux komuni (jista' jaffetwa minn 1 sa 10 nies) sinusite problema biex torqod (insonnja)
English: Blood and lymphatic system disorders anaemia common
Maltese: Disturbi taddemm u tas-sistema limfatika anemija
English: Pharmacotherapeutic group: Drugs used in diabetes, blood glucose lowering drugs, excl. insulins; ATC code: A10BG03.
Maltese: Mediċini li jittieħdu fid-dijabete, mediċini li jbaxxu l-glucose fiddemm, minbarra l-insulini; kodiċi ATC:
English: Ear and labyrinth disorders vertigo uncommon
Maltese: Disturbi filwidnejn u fis-sistema labirintika Vertigo mhux
English: No dose adjustment is necessary in patients with impaired renal function (creatinine clearance > 4 ml/min) (see section 5.2).
Maltese: L-ebda aġġustament fid-doża ma huwa neċessarju f'pazjenti b'indeboliment renali (tneħħijja ta'creatinine> 4 ml/min) (ara sezzjoni 5.2).
English: The oedema rates for comparator groups (sulphonylurea, metformin) were 2-5%.
Maltese: Ir-rati ta' edima għall-gruppi komparati (sulphonylurea , metformin) kienu bejn 25 %.
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 Glidipion 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' Glidipion billi tirreferi għall-kalendarju stampat fuq il-folja.
English: Interactions with substances metabolised by these enzymes, e.g. oral contraceptives, cyclosporin, calcium channel blockers, and HMGCoA reductase inhibitors are not to be expected.
Maltese: Mhumiex mistennija interazzjonijiet ma' sustanzi metabolizzati minn dawn l-enżimi, e.ż. kontraċettivi li jittieħdu mill-ħalq, cyclosporin, imblokkaturi tal-kanali tal-kalċju, u inibituri ta' HMGCoA reductase.
English: In comparator groups, addition of sulphonylurea to metformin resulted in a mean weight gain of 1.3 kg and addition of metformin to a sulphonylurea a mean weight loss of 1.0 kg.
Maltese: Fi gruppi ta' paragun, iż-żieda ta' sulphonylurea ma' metformin wasslet għall-żieda medja filpiż ta' 1.3 kg u ż-żieda ta' metformin ma' sulphonylurea għal telf medju fil-piż ta' 1.0 kg.
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
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: In a two-year study of combination therapy comparing pioglitazone with gliclazide when added to metformin, glycaemic control measured as mean change from baseline in HbA1c was similar between treatment groups after one year.
Maltese: Fi studju ta' sentejn b'terapija kombinata li qabbel pioglitazone ma' gliclazide meta miżjud ma' metformin, il-kontroll gliċemiku mkejjel bħala it-tibdil medju mill-linja bażika ta' HbA1c kien simili bejn il-gruppi ta' kura wara lewwel sena.
English: These effects were independent of pioglitazone's effects on glycaemia and were statistically significant different to glibenclamide.
Maltese: Dawn l-effetti kienu indipendenti mill-effetti ta' pioglitazone fuq il-gliċemija u kienu differenti b'mod statistikament sinifikanti minn dawk ta' glibenclamide.
English: • Additional risk minimisation measures
Maltese: • Aktar attivitajiet ta' minimizzazzjoni tar-riskju
English: The European Medicines Agency has waived the obligation to submit the results of studies with pioglitazone in all subsets of the paediatric population in Type 2 Diabetes Mellitus.
Maltese: L-Aġenzija Ewropea għall-Mediċini neħħiet l-obbligu li r-riżultati ta' studji jiġu ppreżentati bi Pioglitazone fis-sottogruppi kollha tal-popolazzjoni pedjatrika b'Tip 2 Diabetes Mellitus.
English: The maximum reported dose of 120 mg/day for four days, then 180 mg/day for seven days was not associated with any symptoms.
Maltese: Id-doża massima rrappurtata ta' 120 mg/kuljum għal erbat ijiem, u wara 180 mg/kuljum għal sebat ijiem, ma kienet assoċjata ma' l-ebda sintomi.
English: Uncommon (may affect up to 1 in 100 people) - sugar in urine, proteins in urine - increase in enzymes - spinning sensation (vertigo) - sweating - tiredness - increased appetite
Maltese: Mhux komuni (jista' jaffetwa minn 1 sa 100 nies) - zokkor fl-awrina, proteini fl-awrina - żieda fl-enzimi - tħoss l-art iddur bik (vertigo) - għaraq - għeja - Żieda fl-aptit
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jwettaq l-attivitajiet u intervenzjonijiet ta' farmakoviġilanza ddettaljati fil-Pjan tal-immaniġġjar tar-riskju pprezentat f' Modul 1.8.2 tal-awtorizzzazzjoni għat-tqegħid fis-suq u kwalunkwe aġġornamenti sussegwenti tal-RMP.
English: 3 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: Glidipion 30 mg tablets
Maltese: Glidipion 30 mg pilloli
English: EU/1/12/756/019 [14 tablets] EU/1/12/756/020 [28 tablets] EU/1/12/756/021 [30 tablets] EU/1/12/756/022 [50 tablets] EU/1/12/756/023 [56 tablets] EU/1/12/756/024 [84 tablets] EU/1/12/756/025 [90 tablets] EU/1/12/756/026 [98 tablets] EU/1/12/756/027 [100 tablets]
Maltese: EU/1/12/756/019 [14 pilloli] EU/1/12/756/020 [28 pilloli] EU/1/12/756/021 [30 pilloli] EU/1/12/756/022 [50 pilloli] EU/1/12/756/023 [56 pilloli] EU/1/12/756/024 [84 pilloli] EU/1/12/756/025 [90 pilloli] EU/1/12/756/026 [98 pilloli] EU/1/12/756/027 [100 pilloli]
English: Glidipion 45 mg tablets
Maltese: Glidipion 45 mg pilloli
English: In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained (see section 4.4).
Maltese: Fid-dawl ta' riskji potenzjali ma' terapija fit-tul, ittobba għandhom jikkonfermaw mir-reviżjonijiet sussegwenti ta' rutina li l-benefiċċju ta' pioglitazone ikompli (ara sezzjoni 4.4).
English: OTHER (FOR CALENDARISED PACKS SIZES OF 14, 28, 56, 84 AND 98 TABLETS ONLY)
Maltese: OĦRAJN (GĦAL PAKKETI BIL-KALENDARJU DAQSIJIET TA' 14, 28, 56, 84 U 98 PILLOLI BISS
English: common
Maltese: Combination
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: Each tablet contains 15 mg, 30 mg or 45 mg of pioglitazone (as hydrochloride).
Maltese: Kull pillola fiha 15mg, 30mg jew 45mg ta' pioglitazone (bħala hydrochloride).
English: EU/1/12/756/001 [14 tablets] EU/1/12/756/002 [28 tablets] EU/1/12/756/003 [30 tablets] EU/1/12/756/004 [50 tablets] EU/1/12/756/005 [56 tablets] EU/1/12/756/006 [84 tablets] EU/1/12/756/007 [90 tablets] EU/1/12/756/008 [98 tablets] EU/1/12/756/009 [100 tablets]
Maltese: EU/1/12/756/001 [14 pilloli] EU/1/12/756/002 [28 pilloli] EU/1/12/756/003 [30 pilloli] EU/1/12/756/004 [50 pilloli] EU/1/12/756/005 [56 pilloli] EU/1/12/756/006 [84 pilloli] EU/1/12/756/007 [90 pilloli] EU/1/12/756/008 [98 pilloli] EU/1/12/756/009 [100 pilloli]
English: Glidipion 30 mg tablets are white, round, flat, bevelled, 7 mm in diameter and engraved with ‘TZ30' on one side.
Maltese: Glidipion 30 mg huma pilloli bojod, tondi, bbuzzati b'dijametru ta' 7 mm u immarkati b'‘TZ30' fuq naħa waħda.
English: EU/1/12/756/010 [14 tablets] EU/1/12/756/011 [28 tablets] EU/1/12/756/012 [30 tablets] EU/1/12/756/013 [50 tablets] EU/1/12/756/014 [56 tablets] EU/1/12/756/015 [84 tablets] EU/1/12/756/016 [90 tablets] EU/1/12/756/017 [98 tablets] EU/1/12/756/018 [100 tablets]
Maltese: EU/1/12/756/010 [14 pilloli] EU/1/12/756/011 [28 pilloli] EU/1/12/756/012 [30 pilloli] EU/1/12/756/013 [50 pilloli] EU/1/12/756/014 [56 pilloli] EU/1/12/756/015 [84 pilloli] EU/1/12/756/016 [90 pilloli] EU/1/12/756/017 [98 pilloli] EU/1/12/756/018 [100 pilloli]
English: Marketing Authorisation Holder Actavis Group PTC ehf.
Maltese: Deutschland Actavis Group PTC ehf.
English: Pioglitazone did not cause statistically significant increases in LDL cholesterol levels compared with placebo, whilst reductions were observed with metformin and gliclazide.
Maltese: Pioglitazone ma wassalx għal żieda statistikament sinifikanti fil-livell ta' LDL cholesterol meta mqabbel mal-plaċebo, filwaqt li tnaqqis kien osservat b'metformin u gliclazide.
English: Post-marketing reports of new-onset or worsening diabetic macular oedema with decreased visual acuity have been reported with thiazolidinediones, including pioglitazone.
Maltese: Rapporti ta' wara t-tqegħid fis-suq ta' żvilupp jew irkadar ta' edima makulari dijabetika bi tnaqqis flakutezza viżiva ġew irrappurtati b'thiazolidinediones, inkluż pioglitazone.
English: Glidipion 45 mg tablets are white, round, flat, bevelled, 8 mm in diameter and engraved with ‘TZ45' on one side.
Maltese: Glidipion 45 mg huma pilloli bojod, tondi, bbuzzati b'dijametru ta' 8 mm u immarkati b'‘TZ45' fuq naħa waħda
English: Tel: +4021 230 65 24
Maltese: Teva Pharmaceuticals S.R.L Tel: +4021 230 65 24
English: If ALT levels remain > 3 X the upper limit of normal, therapy should be discontinued.
Maltese: Jekk il-livelli ta' ALT jibqgħu > 3 X l-ogħla limitu tan-normal, it-terapija għandha titwaqqaf.
English: In PROactive, a cardiovascular outcome study, 5238 patients with type 2 diabetes mellitus and pre-existing major macrovascular disease were randomised to pioglitazone or placebo in addition to existing antidiabetic and cardiovascular therapy, for up to 3.5 years.
Maltese: Fi PROactive, studju dwar l-effett kardjovaskulari, 5238 pazjent b'dijabete mellitus tat-tip 2 u b'mard makrovaskulari maġġur li kien hemm minn qabel kienu randomizzati għal pioglitazone jew plaċebo li kienu miżjuda ma' terapija anti-dijabetika u kardjovaskulari eżistenti, sa 3.5 snin.
English: Glidipion 15 mg tablets
Maltese: Glidipion 15 mg pilloli
English: In clinical trials of up to two years duration, pioglitazone reduced total plasma triglycerides and free fatty acids, and increased HDL cholesterol levels, compared with placebo, metformin or gliclazide.
Maltese: Fi provi kliniċi li damu sa sentejn, pioglitazone naqqas it-triġliċeridi totali fil-plażma u l-fatty acids mhux marbuta, u żied l-livelli ta' HDL kolesterol, meta mqabbel mal-plaċebo, metformin jew gliclazide.
English: Co-administration of pioglitazone with sulphonylureas does not appear to affect the pharmacokinetics of the sulphonylurea.
Maltese: L-għotja ta' pioglitazone flimkien ma' mediċini tat-tip sulphonylureas ma tidhirx li taffettwa l-farmakokinetika tal-mediċini tat-tip sulphonylurea.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Maltese: Informazzjoni ddettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku ta' l-Aġenzija Ewropeja dwar ilMediċini http://www.ema.europa.eu/.
English: Therapy with pioglitazone should not be initiated in patients with increased baseline liver enzyme levels (ALT > 2.5 X upper limit of normal) or with any other evidence of liver disease.
Maltese: Terapija b'pioglitazone m'għandiex tinbeda f'pazjenti b'livelli għoljin ta' l-enżimi tal-fwied fuq il-linja bażika (ALT > 2.5 X l-ogħla limitu tan-normal) jew b'xi evidenza oħra ta' mard tal-fwied.
English: Although the study failed regarding its primary endpoint, which was a composite of all-cause mortality, non-fatal myocardial infarction, stroke, acute coronary syndrome, major leg amputation, coronary revascularisation and leg revascularisation, the results suggest that there are no long-term cardiovascular concerns regarding use of pioglitazone.
Maltese: Għalkemm l-istudju falla fil-mira primarja tiegħu, li kienet magħmula mill-kawżi kollha ta' mortalità, infart mijokariku mhux fatali, puplesija, sindromu koronarju akut, amputazzjoni maġġura tas-sieq, rivaskularizzazzjoni koronarja u rivaskularizzazzjoni tas-sieq, ir-riżultati ssuġġerixxew li m'hemmx periklu kardjovaskulari dwar l-użu ta' pioglitazone fit-tul.
English: Glidipion 30 mg tablets pioglitazone
Maltese: Glidipion 30 mg pilloli pioglitazone
English: In most clinical trials, reduced total plasma triglycerides and free fatty acids, and increased HDL-cholesterol levels were observed as compared to placebo, with small, but not clinically significant increases in LDL-cholesterol levels.
Maltese: Fil-biċċa l-kbira tal-provi kliniċi, kienu osservati tnaqqis fit-triġliċeridi totali fil-plażma u fil-fatty acids ħielsa, u żieda fil-livelli ta' HDL-kolesterol meta mqabbel malplaċebo, b'żiediet żgħar, iżda klinikament rilevanti fil-livelli ta' LDL-kolesterol.
English: • The risk of heart failure and relevant risk minimisation advice.
Maltese: • Ir-riskju ta' insuffiċjenza tal-qalb u parir rilevanti biex jitnaqqas ir-riskju.
English: Glidipion 45 mg tablets pioglitazone
Maltese: Glidipion 45 mg pilloli pioglitazone
English: Not known (frequency cannot be estimated from the available data) - increase in liver enzymes - allergic reactions
Maltese: Mhux magħrufa (frekwenza ma tistax tiġi stmata mid-dejta disponibbli) - żieda fl-enżimi tal-fwied - reazzjonijiet allergiċi
English: Glidipion 15 mg tablets pioglitazone
Maltese: Glidipion 15 mg pilloli pioglitazone
English: In toxicology studies, plasma volume expansion with haemodilution, anaemia, and reversible eccentric cardiac hypertrophy was consistently apparent after repeated dosing of mice, rats, dogs, and monkeys.
Maltese: Fi studji tossikoloġiċi, l-espansjoni tal-volum tal-plażma permeżz ta' emodiluzzjoni, anemija u ipertrofija kardijaka eċċentrika riversibbli instabet b'mod konsistenti wara dożaġġ ripetut fil-ġrieden, firien, klieb u xadini.
English: Pioglitazone and all active metabolites are extensively bound to plasma protein (> 99%).
Maltese: Pioglitazone u l-metaboliti attivi kollha huma marbuta b'mod estensiv mal-proteini fil-plażma (>99
English: These findings were observed across species at plasma concentrations ≤ 4 times the clinical exposure.
Maltese: Dawn is-sejbiet kienu osservati fi speċi differenti b'konċentrazzjonijiet fil-plażma < 4 darbiet lespożizzjoni klinika.
English: In an outcome study of patients with pre-existing major macrovascular disease, the incidence of serious heart failure was 1.6% higher with pioglitazone than with placebo, when added to therapy that included insulin.
Maltese: Fi studju dwar ir-riżultat f'pazjenti b'mard makrovaskulari maġġuri minn qabel, l-inċidenza ta' insuffiċjenza serja tal-qalb kienet 1.6% ogħla b'pioglitazone milli bil-plaċebo, meta miżjud ma' terapija li tinkludi insulina.
English: No increase in fracture rates was observed in men treated with pioglitazone (1.3%) versus comparator (1.5%).
Maltese: Ma kienux osservati żidiet fir-rati ta' fratturi fl-irġiel kkurati b'pioglitazone (1.3%) meta mqabbla mal-prodott ta' paragun (1.5%).