FrancophonIA/ELRC3.0 huggingface dataset:
English: Almost all subjects (95%) were receiving cardiovascular medicinal products (beta blockers, ACE inhibitors, angiotensin II antagonists, calcium channel blockers, nitrates, diuretics, aspirin, statins, fibrates).
Maltese: Kważi ssoġġetti kollha (95%) kienu qed jirċievu prodotti mediċinali kardjovaskulari (imblokkaturi beta, inibituri ACE, antagonisti ta' angiotensin II, imblokkaturi tal-kanali tal-kalċju, nitrati, dijuretiċi, aspirina, statins, fibrates).
English: NAME OF THE MARKETING AUTHORISATION HOLDER Vaia S.A. (logo)
Maltese: FIS-SUQ Vaia S.A. (logo)
English: Cases of bladder cancer were reported more frequently in a meta-analysis of controlled clinical trials with pioglitazone (19 cases from 12506 patients, 0.15%) than in control groups (7 cases from 10212 patients, 0.07%) HR=2.64 (95% CI 1.11-6.31, P=0.029).
Maltese: Każijiet ta' kanċer tal-bużżieqa tal-awrina kienu rrappurtati b'mod aktar frekwenti f'meta-analiżi ta' provi kliniċi kkontrollati b'pioglitazone (19-il każ minn 12,506 pazjent, 0.15%) milli fil-gruppi ta' kontroll (7 każijiet minn 10,212 pazjent, 0.07%) HR = 2.64 (95% CI 1.11-6.31, p = 0.029).
English: Renal impairment
Maltese: Iindeboliment renali
English: Each tablet contains 36.866 mg of lactose monohydrate (see section 4.4).
Maltese: Kull pillola fiha 36.866 mg ta' lactose monohydrate (ara sezzjoni 4.4).
English: Eye disorders visual disturbance1
Maltese: Disturbi flgħajnejn disturbi viżwali1
English: LIST OF EXCIPIENTS Contains lactose monohydrate.
Maltese: LISTA TA' SUSTANZI MHUX ATTIVI Fiha lactose monohydrate.
English: Steady state pharmacokinetics are similar in patients age 65 and over and young subjects.
Maltese: Il-farmakokinetika fi stat stabbli ta' pazjenti b'età ta' 65 sena jew aktar hija simili għal dik f'pazjenti żgħar.
English: Pioglitazone undergoes extensive hepatic metabolism by hydroxylation of aliphatic methylene groups.
Maltese: Pioglitazone jgħaddi minn metaboliżmu epatiku estensiv permezz ta' idroksilazzjoni tal-gruppi ta' aliphatic methylene.
English: common (affects 1 to 10 users in 100) - headache - dizziness - joint pain - impotence - back pain - shortness of breath - small reduction in red blood cell count - flatulence uncommon (affects 1 to 10 users in 1,000) - sugar in urine, proteins in urine - increase in enzymes - spinning sensation (vertigo) - sweating - tiredness - increased appetite
Maltese: komuni (bejn 1 sa 10 minn 100) - uġigħ ta' ras - sturdament - uġigħ fil-ġogi - impotenza - uġigħ fid-dahar - qtugħ ta' nifs - tnaqqis żgħir fl-għadd taċ-ċelloli ħomor tad-demm - gass mhux komuni (bejn 1 sa 10 f'kull 1,000) - zokkor fl-awrina, proteina fl-awrina - żieda fl-enżimi - vertigo - tgħoroq - għejja - żieda fl-aptit
English: The study population had an average age of 62 years; the average duration of diabetes was 9.5 years.
Maltese: Il-popolazzjoni taħt studju kellha età medja ta' 62 sena; it-tul medju tad-dijabete kienet ta' 9.5 snin.
English: Each tablet contains 73.731 mg of lactose monohydrate (see section 4.4).
Maltese: Kull pillola fiha 73.731 mg ta' lactose monohydrate (ara sezzjoni 4.4).
English: There is no induction of the main inducible P450 isoenzymes 1A, 2C8/9, and 3A4 in man.
Maltese: Mhemm l-ebda induzzjoni tal-isożimi prinċipali ta' P450 induċibbli 1A, 2C8/9, u 3A4 fil-bniedem.
English: Each tablet contains 110.596 mg of lactose monohydrate (see section 4.4).
Maltese: 596 mg ta' lactose monohydrate (ara sezzjoni 4.4).
English: Musculoskeletal and connective tissue disorders fracture bone4
Maltese: Disturbi muskoluskeletrali u talconnective tissue ksur ta' għadam4
English: Sepioglin contains pioglitazone.
Maltese: Sepioglin fih pioglitazone.
English: - hypersensitivity to the active substance or to any of the excipients - cardiac failure or history of cardiac failure (NYHA stages I to IV) - hepatic impairment - diabetic ketoacidosis - current bladder cancer or a history of bladder cancer - uninvestigated macroscopic haematuria
Maltese: - sensittività eċċessiva għas-sustanza attiva jew għal xi sustanzi mhux attivi - insuffiċjenza kardijaka jew passat ta' insuffiċjenza kardijaka (NYHA stadju I sa IV) - indeboliment epatiku - ketoaċidożi dijabetika - kanċer tal-bużżieqa attwali jew storja ta' kanċer tal-bużżieqa - ematurja makroskopika mhux mistħarrga
English: The tablets are supplied in PA/Aluminium/PVC/Aluminium blister packs of 14, 28, 30, 50, 56, 90 or 98 tablets.
Maltese: Il-pilloli huma disponibbli f'pakketti bil-folji talPA/Aluminju/PVC/Aluminju ta' 14, 28, 30, 50, 56, 90 jew 98 pillola.
English: DATE OF REVISION OF THE TEXT
Maltese: B'KALENDARJU)
English: Respiratory, thoracic and mediastinal disorders dyspnoea common
Maltese: Disturbi respiratorji, toraċiċi u medjastinali
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 jeħtieġu lwaqfien tal-kura.
English: 1, 28 Octovriou str., Ag. Varvara 123 51 Athens, Greece.
Maltese: Varvara 123 51 Ateni, il-Greċja.
English: Studies in man suggest no induction of the main inducible cytochrome P450, 1A, 2C8/9 and 3A4.
Maltese: Studji fil-bniedem jissuġġerixxu li mhemm l-ebda induzzjoni taċ-ċitokromju prinċipali induċibbli P450, 1A, 2C8/9 u 3A4.
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%; 0.5fractures 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 esperjenza ta' fratturi meta mqabbel ma' 23/905 (2.5%; 0.5 fratturi kull 100 sena ta' pazjent) tal-pazjenti nisa kkurati bi prodott paragun.
English: INFORMATION IN BRAILLE Sepioglin 30 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Sepioglin 30 mg
English: Reproductive system and breast disorders erectile dysfunction common
Maltese: Disturbi fissistema riproduttiva u fis-sider disfunzjoni erettili
English: INFORMATION IN BRAILLE Sepioglin 45 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Sepioglin 45 mg
English: The safety and efficacy of piogliatazone in children and adolescents under 18 years of age have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' pioglitazone f'pazjenti taħt l-età ta' 18-il sena, ma ġewx stabiliti.
English: 1, 28 Octovriou str., Ag. Varvara 123 51 Athens, Greece
Maltese: Varvara 123 51 Ateni, il-Greċja
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 fi kwantità inqas b'sulphonylurea u bl-insulina (tnaqqis relattiv fl-emoglobina 1 - 2% u fl-ematokrita 1 - 3.2 %).
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: 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: What Sepioglin looks like and contents of the pack Sepioglin 45 mg tablets are white, round, flat tablets, with “45” embossed on one side and a diameter of approximately 8.0 mm.
Maltese: Il-pilloli ta' Sepioglin 45 mg huma bojod, tondi, ċatti, immarkati b'‘45' imqabbeż fuq naħa waħda u b'dijametru ta' madwar 8.0 mm.
English: INFORMATION IN BRAILLE Sepioglin 15 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Sepioglin 15 mg
English: The active substance is pioglitazone.
Maltese: Is-sustanza attiva hija pioglitazone.
English: Pharmacotherapeutic group: Drugs used in diabetes, blood glucose lowering drugs, excl. insulins; ATC code: A10BG03.
Maltese: Mediċini li jittiehdu fid-djabete, mediċini li jbaxxu l-glucose fiddemm; minbarra l-insulina; kodiċi ATC:
English: as monotherapy - in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance as dual oral therapy in combination with - metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin - a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea.
Maltese: bħala monoterapija - F'pazjenti adulti(speċjalment pażjenti b'piż żejjed) li mhumiex ikkontrollati sew minn dieta u eżerċizzju li għalihom metformin mhux adattat minħabbla kontraindikazzjonijiet jew intolleranza bħala terapija doppja mill-ħalq f'taħlita ma' - metformin, f'pazjenti adulti (speċjalment pażjenti b'piż żejjed) b'kontroll gliċemiku insuffiċjenti minkejja monoterpija b'metformin fl-ogħla doża ttollerata - mediċina tat-tip sulphonylurea, f'pazjenti adulti li wrew intolleranza għal metformin jew li għalihom metformin huwa kontra-indikat, b'kontroll gliċemiku insuffiċjenti minkejja monoterpija b'mediċina tat-tip sulphonylurea fl-ogħla doża ttollerata bħala terapija trippla mill-ħalq f'taħlita ma' - metformin u mediċina tat-tip sulphonylurea, f'pazjenti adulti (speċjalment pażjenti b'piż żejjed) b'kontroll gliċemiku insuffiċjenti minkejja terapija doppja mill-ħalq.
English: What Sepioglin looks like and contents of the pack Sepioglin 30 mg tablets are white, round, flat tablets, with a break line on one side, “30” embossed on the other side and a diameter of approximately 7.0 mm.
Maltese: Il-pilloli ta' Sepioglin 30 mg huma bojod, tondi, ċatti, immarkati b'‘30' imqabbeż fuq naħa waħda u b'dijametru ta' madwar 7.0 mm.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropeja dwar il-Mediċini http://www.ema.europa.eu
English: HydroxypropylcelluloseLactose monohydrate Magnesium stearate
Maltese: FARMAĊEWTIKU 6.1 Lista ta' sustanzi mhux attivi Carmellose calcium Hydroxypropylcellulose Lactose monohydrate Magnesium stearate
English: common (affects 1 to 10 users in 100) - respiratory infection - abnormal vision - weight gain - numbness uncommon (affects 1 to 10 users in 1,000) - inflammation of the sinuses (sinusitis) - difficulty sleeping (insomnia)
Maltese: komuni (bejn 1 sa 10 minn 100) - infezzjoni respiratorja - vista mhux normali - żieda fil-piż - tirżiħ mhux komuni (bejn 1 sa 10 minn 1,000) - sinusite - insonnja mhux magħrufa (frekwenza ma tistax tiġi stmata mit-droga disponibbli) - żieda fl-enżimi tal-fwied
English: What Sepioglin looks like and contents of the pack Sepioglin 15 mg tablets are white, round, flat tablets, with “15” embossed on one side and a diameter of approximately 5.5 mm.
Maltese: Il-pilloli ta' Sepioglin 15 mg huma bojod, tondi, ċatti, immarkati b'‘15' imqabbeż fuq naħa waħda u b'dijametru ta' madwar 5.5 mm.
English: 5 In active comparator controlled trials mean weight increase with pioglitazone given as monotherapy was 2-3 kg over one year.
Maltese: 5Fi 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: In PROactive, a cardiovascular outcome study, 5238 patients with type 2 diabetes mellitus and preexisting 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 randomised għal pioglitazone jew plaċebo li kienu miżjuda ma' terapija anti-dijabetika u kardjovaskulari eżistenti, sa 3.5 snin.
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'għandhiex tinbeda f'pazjenti b'livelli miżjuda tal-enżimi tal-fwied fil-linja bażika (ALT > 2.5 X l-ogħla limitu tan-normal) jew b'xi evidenza oħra ta' mard tal-fwied.
English: Pioglitazone tablets contain lactose monohydrate and therefore should not be administered to patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption.
Maltese: Il-pilloli pioglitazone fihom lactose monohydrate u għalhekk m'għandhomx jingħataw lill-pazjenti bi problemi ereditarji rari ta' intolleranza għall-galactose, defiċjenza Lapp lactase jew assorbiment ħażin ta' glucose-galactose.
English: 2 Oedema was reported in 6-9% of patients treated with pioglitazone over one year in controlled clinical trials.
Maltese: 2 Edima kienet irrappurtata f'6 - 9 % tal-pazjenti kkurati b'pioglitazone fuq medda ta' sena fi provi kliniċi kkontrollati.
English: White, round, flat tablets, with a break line on one side, “30” embossed on the other side and a diameter of approximately 7.0 mm.
Maltese: Pilloli bojod, tondi, ċatti, b'linja ta' rottura fuq naħa waħda, immarkati b'‘30' imqabbeż fuq naħa waħda u b'dijametru ta' madwar 7.0 mm.
English: The European Medicines Agency has waived the obligation to submit the results of studies with pioglitazonein all subsets of the paediatric population in Type 2 Diabetes Mellitus.
Maltese: L-Aġenzija Ewropea għall-Mediċini neħħiet l-obbligu lir-riżultati ta' studji jieġu ippreżentati b'pioglitazone fis-sottogruppi kollha tal-popolazzjoni pedjatrika ta' Tip 2 Diabetes Mellitus.
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%) milli fil-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 permezz tas-sistema tal-klassifika tal-organi u frekwenza assoluta.
English: Investigations weight increased5 common common common common common blood creatine phospho-kinase increased common increased lactic dehydro-genase uncommon
Maltese: żieda fil-creatine phosphokinase fid-demm żieda ta' lactic dehydrogenase mhux komuni
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 fil-piż ta' 1.3 kg u żżieda ta' metformin ma' sulphonylurea għall-tnaqqis medju fil-piż ta' 1.0 kg.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 45 mg pioglitazone (as hydrochloride).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha 45 mg pioglitazone (bħala hydrochloride).
English: Sepioglin tablets contain lactose monohydrate and therefore should not be administered to patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption.
Maltese: Il-pilloli Sepioglin fihom lactose monohydrate u għalhekk m'għandhomx jingħataw lill-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' edima għall-gruppi ta' paragun (sulphonylurea, metformin) kienu ta' 25%.
English: Any macroscopic haematuria should be investigated before starting pioglitazone therapy.
Maltese: Kull ematurja makroskopiċi għandha tiġi investigata qabel ma tinbeda terapija b'pioglitazone.
English: Fractures were observed in 2.6% of women taking pioglitazone compared to 1.7% of women treated with a comparator.
Maltese: Fratturi kienu osservati f'2.6% ta' nisa li kienu qed jieħdu pioglitazone meta mqabbel ma' 1.7% tannisa kkurati bi prodott paragun.
English: No increase in fracture rates was observed in men treated with pioglitazone (1.3%) versus comparator (1.5%).
Maltese: Ma kinux osservati żidiet fir-rati ta' fratturi fl-irġiel kkurati b'pioglitazone (1.3%) meta mqabbel mal-prodott ta' paragun (1.5%).
English: The other side effects that have been experienced by some patients taking pioglitazone are:
Maltese: Effetti sekondarji oħra li ġew esperjenzati minn uħud mill-pazjenti li jieħdu pioglitazone huma:
English: White, round, flat tablets, with “15” embossed on one side and a diameter of approximately 5.5 mm..
Maltese: Pilloli bojod, ċatti, immarkati b'‘15' imqabbeż fuq naħa waħda u b'dijametru ta' madwar 5.5 mm..
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 għallżieda statistikament sinifikanti fil-livell ta' LDL cholesterol meta mqabbel mal-plaċebo, filwaqt li tnaqqis kien osservat b'metformin u gliclazide.
English: 4 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: 4Twettqet analiżi ta' ġabra 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: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 30 mg pioglitazone (as hydrochloride).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha 30 mg pioglitazone (bħala hydrochloride).
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 assoċjat mal-ebda sintomi.
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%) milli fil-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 permezz tas-sistema tal-klassifika tal-organi u frekwenza assoluta.
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 bilplaċebo, meta miżjud ma' terapija li tinkludi insulina.
English: HOW TO TAKE SEPIOGLIN
Maltese: X'fih Sepioglin
English: HOMA analysis shows that pioglitazone improves beta cell function as well as increasing insulin sensitivity.
Maltese: HOMA turi li pioglitazone itejjeb il-funzjoni taċ-ċellola beta kif ukoll iżid is-sensittività għallinsulina.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 15 mg pioglitazone (as hydrochloride).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha 15 mg pioglitazone (bħala hydrochloride).
English: Gastrointestinal disorders flatulence Skin and subcutaneous tissue disorders sweating uncommon
Maltese: Disturbi gastrointestinali gass mhux
English: • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Maltese: • KUNDIZZJONIJIET JEW RESTRIZZJONIJIET RIGWARD L-UŻU SIGUR U EFFETTIV TAL-PRODOTT MEDIĊINALI
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 ssuġġerixxu li mhemmx periklu kardjovaskulari dwar l-użu ta' pioglitazone fit-tul.
English: Each tablet contains 15 mg of pioglitazone (as hydrochloride).
Maltese: Kull pillola fiha 15 mg ta' pioglitazone (bħala hydrochloride).
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: very common (affects more than 1 user in 10) - decreased blood sugar (hypoglycaemia)
Maltese: komuni hafna (aktar minn 1 f'kull 10) - tnaqqis taż-żokkor fid-demm (ipogliċemija)
English: Broken bones have been reported commonly (1 to 10 users in 100) in women patients taking pioglitazone.
Maltese: Ksur tal-għadam kien irrappurtat b'mod komuni (minn 1 sa 10 utenti f'100) f'nisa li jieħdu pioglitazone flimkien mal-insulina.
English: Important information about some of the ingredients of Sepioglin This medicine contains lSepiogline monohydrate.
Maltese: Tagħrif importanti dwar xi wħud mis-sustanzi ta' Sepioglin Din il-mediċina fiha lactose monohydrate.
English: Investigations weight increased5
Maltese: Investigazzjonijiet żieda fil-piż 5
English: 1, 28 Octovriou Str. Ag. Varvara EL-12351
Maltese: EL-123 51 Ateni, il-Greċja
English: Reproductive system and breast disorders erectile dysfunction General disorders and administration site conditions oedema very common fatigue uncommon
Maltese: Disturbi fissistema riproduttiva u fissider disfunzjoni erettili Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata edima
English: Environmental Risk Assessment: no environmental impact is anticipated from the clinical use of pioglitazone.
Maltese: Valutazzjoni tar-Riskju Ambjentali: l-ebda impatt ambjentali huwa antiċipat mill-użu kliniku ta' pioglitazone.
English: NAME OF THE MEDICINAL PRODUCT Sepioglin 45 mg tablets Pioglitazone
Maltese: Pilloli Sepioglin 45 mg Pioglitazone
English: White, round, flat tablets, with “45” embossed on one side and a diameter of approximately 8.0 mm.
Maltese: Pilloli bojod, tondi, ċatti u mmarkati b'‘45' imqabbeż fuq naħa waħda u b'dijametru ta' madwar 8.00 mm..
English: Heart failure has been experienced commonly (1 to 10 users in 100) in patients taking pioglitazone in combination with insulin.
Maltese: Insufficjenza tal-qalb kienet esperjenzata b'mod komuni (minn 1 sa 10 utenti f'100) f'pazjenti li jieħdu pioglitazone flimkien mal-insulina.
English: Bladder cancer has been experienced uncommonly (1 to 10 users in 1000) in patients taking pioglitazone.
Maltese: Kanċer tal-bużżieqa ġie esperjenzat b'mod mhux komuni (1 sa 10 utenti minn kull 1,000) f'pazjenti li qed jieħdu pioglitazone.