FrancophonIA/ELRC3.0 huggingface dataset:
English: At week 12, a significantly higher proportion of patients in Study HS-II experienced a clinically relevant decrease in HS-related skin pain (see table 21).
Maltese: esperjenzaw tnaqqis klinikament rilevanti fl-uġigħ fil-ġilda relatati ma' HS (ara t-tabella 21).
English: Hyrimoz 40 mg solution for injection in a single-use pre-filled syringe Hyrimoz is supplied in a single-use clear type I glass syringe with a rubber stopper and a stainless steel needle with an automatic needle guard with finger flange, rubber needle cap and plastic plunger, containing 0.8 ml solution.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Hyrimoz 40 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Hyrimoz jiġi fornut f'siringa tal-ħġieġ tat-tip I ċar li tintuża darba biss b'tapp tal-gomma u labra tal istainless steel bil-kappa awtomatika bi flanġ għas-suba', protezzjoni tal-labra tal-gomma u planġer tal-plastik, li fiha 0.8 ml ta' soluzzjoni.
English: Hyrimoz is used to treat rheumatoid arthritis in adults.
Maltese: Hyrimoz jintuża biex jikkura artrite rewmatika fl-adulti.
English: Multipack cartons contain 6 (3 packs of 2) pre-filled pens of Hyrimoz.
Maltese: Il-kartuni tal-pakkett multiplu fihom 6 (3 pakketti ta' 2) pinen mimlijin għal-lest ta' Hyrimoz.
English: • For a more comfortable injection, take your pen out of the refrigerator 15 to 30 minutes before injecting Hyrimoz to allow it to reach room temperature.
Maltese: • Għal injezzjoni aktar komda, oħroġ il-pinna mill-friġġ 15 sa 30 minuta qabel tinjetta Hyrimoz sabiex tħalliha tilħaq temperatura normali.
English: 115 45 (39.1) NEc
Maltese: NA 9.5 % 41.5 %
English: • that Hyrimoz treatment may increase the potential risks of o infections, including tuberculosis o cancer o nervous system problems o vaccinations
Maltese: o infezzjonijiet, inkluż tuberkulosi o kanċer o problemi fis-sistema nervuża o tilqim
English: Figure A: Hyrimoz SensoReady pen parts
Maltese: Figura I: żomm is-siringa
English: Hyrimoz dose for paediatric patients with plaque psoriasis Patient weight
Maltese: Tabella 3. Doża ta' Hyrimoz għal pazjenti pedjatriċi bil-psorjasi tal-plakka
English: Hyrimoz in combination with methotrexate, is indicated for:
Maltese: Hyrimoz, flimkien ma' methotrexate, huwa indikat għall-:
English: Vertigo and visual impairment may occur following administration of Hyrimoz (see section 4.8).
Maltese: Jista' jkun hemm vertigo u indeboliment fil-vista wara li tingħata Hyrimoz (ara sezzjoni 4.8).
English: Your Hyrimoz single-use pre-filled SensoReady pen
Maltese: Il-kura b'Hyrimoz tista' tirriżulta fil-formazzjoni ta'anti-korpi awtoimmuni.
English: Hyrimoz is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1).
Maltese: Hyrimoz huwa indikat għall-kura ta' artrite attiva relatata mal-entesite f'pazjenti, ta' 6 snin jew akbar, li kellhom rispons inadegwat għal, jew li ma jittollerawx, terapija konvenzjonali (ara sezzjoni 5.1).
English: Hyrimoz dose for patients with polyarticular juvenile idiopathic arthritis
Maltese: Tfal, adolexxenti u adulti bl-artrite idjopatika poliartikulari taż-żgħażagħ
English: Hyrimoz is supplied in a single-use clear type I glass syringe with a stainless steel needle with a needle guard with finger flange, rubber needle cap and plastic plunger rod, containing 0.8 ml of solution.
Maltese: Is-sirigna ġol-pinna hija magħmula minn ħġieġ tat-tip I b'labra talistainless steel, u protezzjoni tal-labra ta' ġewwa tal-gomma, u tapp tal-gomma li fiha 0.8 ml ta' soluzzjoni.
English: Adalimumab showed statistically significantly greater improvement in the HAQ-S total score and the SF-36 Physical Component Score (PCS) from baseline to week 12 compared to placebo.
Maltese: Punteġġ Kompetenti Fisiku (PCS) tal-SF-36 mill-linja bażi sa ġimgħa 12 meta mqabbel mal-plaċebo.
English: The interpretation of data may be impacted due to methodological limitations of the study, including small sample size and non-randomized design.
Maltese: Linterpretazzjoni tad-data jista' jkollha impatt minħabba limitazzjonijiet metodoloġiċi tal-istudju, inkluż daqs tal-kampjun żgħir u disinn mhux randomizzat.
English: A loading dose of 160 mg adalimumab on week 0 followed by 80 mg adalimumab on week 2 achieves serum adalimumab trough concentrations of approximately 12 µg / ml during the induction period.
Maltese: Doża kbira ta' 160 mg adalimumab f'ġimgħa 0 segwita b'80 mg Hyrimoz f'ġimgħa 2 tilħaq konċentrazzjonijiet minimali tas-seru f'adalimumab ta' bejn wieħed u ieħor 12 µg / ml matul il-perijodu tal-bidu.
English: Hyrimoz is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.
Maltese: Hyrimoz huwa intenzjonat għall-kura ta' psorjasi tal-plakka moderata sa severa fl-adulti.
English: The recommended Hyrimoz dose regimen for adult patients with hidradenitis suppurativa (HS) is 160 mg initially at Day 1 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), followed by 80 mg two weeks later at Day 15 (given as two 40 mg injections in one day).
Maltese: Ir-reġimen tad-doża ta' Hyrimoz rrakkomandata għal pazjenti adulti bi suppurativa hidradenitis (HS) hija 160 mg inizjalment f'Jum 1 (mogħtija bħala erba' injezzjonijiet ta' 40 mg f'ġurnata waħda jew bħala żewġ injezzjonijiet ta' 40 mg kuljum għal jumejn konsekuttivi), segwiti minn 80 mg żewġ ġimgħat wara f'Jum 15 (mogħtija bħala żewġ injezzjonijiet ta' 40 mg f'ġurnata waħda).
English: Hyrimoz is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and / or MRI, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs.
Maltese: Hyrimoz huwa indikat għall-kura ta' uveite pedjatrika anterjuri kronika mhux infettiva f'pazjenti minn sentejn li kellhom rispons inadegwat għal jew li mhumiex tolleranti għat-terapija konvenzjonali, jew li fihom it-terapija konvenzjonali mhix adattata.
English: Children, adolescents and adults with polyarticular juvenile idiopathic arthritis Children, adolescents and adults from 2 years of age weighing 30 kg or more The recommended dose of Hyrimoz is 40 mg every other week.
Maltese: Tfal, adolexxenti u adulti b'artrite relatata mal-entesite Tfal, adolexxenti u adulti minn sitt snin 'il fuq li jiżnu 30 kg jew aktar
English: Hyrimoz contains sodium
Maltese: Kif jidher Hyrimoz u l-kontenut tal-pakkett
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: • Rapporti perjodiċi aġġornati dwar is-sigurtà Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq ilportal elettroniku Ewropew tal-mediċini.
English: Hyrimoz dose for paediatric patients with Crohn's disease
Maltese: Doża ta' Hyrimoz għal pazjenti pedjatriċi bil-marda Crohn (Crohn's Disease) Piż tal-pazjent
English: 40 mg adalimumab every week week 26
Maltese: 40 mg adalimumab kull ġimgħa ġimgħa 26
English: • facial oedema (swelling) associated with allergic reactions;
Maltese: • edima fil-wiċċ (nefħa) assoċjata ma reazzjonijiet allerġiċi;
English: Clinical remission and clinical response (defined as reduction in PCDAI score of at least 15 points from Baseline) rates are presented in table 26.
Maltese: PCDAI ta' mill-inqas 15-il punt mill-linja bażi) huma ppreżentati f'tabella 26.
English: de la Industria 30 28108 Alcobendas (Madrid) Spain
Maltese: de la Industria 30 28108 Alcobendas (Madrid) Spanja
English: Takeda Pharmaceuticals Slovakia s.r.o.
Maltese: Slovenská republika Takeda Pharmaceuticals Slovakia s.r.o.
English: Carmellose calcium Hyprolose
Maltese: Carmellose calcium
English: Takeda GmbH Tel: 0800 825 3325 medinfo@takeda.de
Maltese: Deutschland Takeda GmbH Tel: 0800 825 3325 medinfo@takeda.de
English: Eli Lilly Holdings Limited atstovybė
Maltese: Eli Lilly Holdings Limited atstovybė Tel.
English: Actos contains pioglitazone.
Maltese: Actos fih pioglitazone.
English: 14 tablets 28 tablets 30 tablets 50 tablets 56 tablets 84 tablets 90 tablets 98 tablets 112 tablets 196 tablets
Maltese: 14-il pillola 28 pillola 30 pillola 50 pillola 56 pillola 84 pillola 90 pillola 98 pillola 112 pillola 196 pillola
English: Lilly Hungária Kft. Tel: +36 1 328 5100
Maltese: Magyarország Lilly Hungária Kft. Tel: + 36 1 328 5100
English: Takeda Pharma A/S Dybendal Alle 10 DK-2630 Taastrup Denmark
Maltese: Takeda Pharma A/S Dybendal Alle 10 DK-2630
English: See section 2 “Actos contains lactose monohydrate”.
Maltese: Ara sezzjoni 2 “Actos fih lactose monohydrate”.
English: Almost all subjects (95%) were receiving cardiovascular medicinal products (beta blockers, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II antagonists, calcium channel blockers, nitrates, diuretics, acetylsalicylic acid, statins, fibrates).
Maltese: Kważi s-soġġetti kollha (95%) kienu qed jirċievu prodotti mediċinali kardjovaskulari (imblokkaturi beta, inibituri tal-enzima li tikkonverti angiotensin (ACE, angiotensin-converting enzyme), antagonisti ta' angiotensin II, imblokkaturi tal-kanali tal-kalċju, nitrati, dijuretiċi, acetylsalicylic acid, statins, fibrates).
English: − The other ingredients are lactose monohydrate, hyprolose, carmellose calcium and magnesium stearate.
Maltese: - Is-sustanzi mhux attivi l-oħra huma lactose monohydrate, hyprolose, carmellose calcium u magnesium stearate.
English: Date of first authorisation: 13/10/2000 Date of latest renewal: 31/08/2010
Maltese: Data tal-aħħar tiġdid: 31/08/2010
English: Oy Eli Lilly Finland Ab Puh/Tel: +358 (0)9 8545250
Maltese: Suomi/Finland Oy Eli Lilly Finland Ab Puh/Tel: + 358 (0)9 8545250
English: Other medicines and Actos
Maltese: Mediċini oħra u Actos
English: Takeda UK Ltd Tel: +44 (0)1628 537 900
Maltese: United Kingdom Takeda UK Ltd Tel: +44 (0)1628 537 900
English: België/Belgique/Belgien
Maltese: België/Belgique/Belgien Takeda Belgium Tél/Tel:
English: Takeda Ireland Limited, Bray Business Park, Kilruddery, County Wicklow, Ireland.
Maltese: Takeda Ireland Limited, Bray Business Park, Kilruddery, County Wicklow, L-Irlanda. Lilly S.A, Avda. de la Industria 30, 28108 Alcobendas (Madrid), Spanja
English: Actos contains lactose monohydrate
Maltese: Actos fih lactose monohydrate
English: Proportional increases of the plasma concentration were observed for doses from 2-60 mg.
Maltese: Żieda proporzjonali fil-konċentrazzjoni fil-plażma kienet osservata f'dozi minn 2 - 60 mg.
English: Reproductive system and breast disorders erectile dysfunction common
Maltese: Disturbi fissistema riproduttiva u fissider disfunzjoni erettili komuni
English: FOR CALENDARISED PACKS:
Maltese: B'KALENDARJU:
English: Cases of bladder cancer were reported more frequently in a meta-analysis of controlled clinical trials with pioglitazone (19 cases from 12,506 patients, 0.15%) than in control groups (7 cases from 10,212 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: Takeda Belgium Tél/Tel: +32 2 464 06 11 takeda-belgium@takeda.com
Maltese: +32 2 464 06 11 takeda-belgium@takeda.com
English: Takeda (logo)
Maltese: FIS-SUQ Takeda (logo)
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: The tablets are supplied in blister packs of 14, 28, 30, 50, 56, 84, 90, 98, 112 or 196 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, 112 u 196 pillola.
English: Aluminium/aluminium blisters, packs of 14, 28, 30, 50, 56, 84, 90, 98, 112 and 196 tablets.
Maltese: Il-pilloli huma disponibbli f'pakketti bil-folji ta' 14, 28, 30, 50, 56, 84, 90, 98, 112 jew 196 pillola.
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 kollha tiegħu, 16 sa 23 siegħa.
English: Steady state pharmacokinetics are similar in patients age 65 and over and young subjects.
Maltese: Il-farmakokinetika fi stat stabbli ta' pazjenti b'eta' ta' 65 sena jew aktar hija simili għal dik f'pazjenti żgħar.
English: Lilly S.A. Tel: +34 (91) 663 50 00
Maltese: Tel: + 34 (91) 663 50 00
English: - hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - 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 kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1 - insuffiċjenza kardijaka jew passat ta' insuffiċjenza kardijaka (NYHA stadju I sa IV) - indeboliment epatiku - ketoaċidożi dijabetika - kancer tal-bużżieqa attwali jew storja ta' kancer tal-bużżieqa - ematurja makroskopika mhux mistħarrga
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 fl-emoglobina 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: The oedema rates for comparator groups (sulphonylurea, metformin) were 2-5%.
Maltese: Ir-rati ta' edima għall-gruppi ta' paragun (sulphonylurea, metformin) kienu ta' 2 - 5%.
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 il-farmakokinetika u lanqas fuq il-farmakodinamika ta' digoxin, warfarin, phenprocoumon u metformin.
English: Each tablet contains 114.51 mg of lactose monohydrate (see section 4.4).
Maltese: 51 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: M'hemm l-ebda induzzjoni tal-isożimi prinċipali ta' P450 induċibbli 1A, 2C8/9, u 3A4 fil-bniedem.
English: Actos tablets contain lactose monohydrate and therefore should not be administered to patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
Maltese: Il-pilloli Actos fihom lactose monohydrate u għalhekk m'għandhomx jingħataw lill-pazjenti bi problemi ereditarji rari ta' intolleranza għall-galactose, nuqqas totali ta' lactase jew malassorbiment tal-glucose-galactose.
English: Contains lactose monohydrate.
Maltese: Lactose monohydrate
English: common (may affect up to 1 in 10 people) - headache - dizziness - joint pain - impotence - back pain - shortness of breath - small reduction in red blood cell count - flatulence 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: komuni (jistgħu jaffettwaw sa persuna waħda minn kull 10) - 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 (jistgħu jaffettwaw sa persuna waħda minn kull 100) - zokkor fl-awrina, proteina fl-awrina - żieda fl-enżimi - vertigo - tgħoroq - għejja - żieda fl-aptit
English: Takeda Pharma A/S
Maltese: Takeda Pharma AB
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 (iddefinit bħala HbA1c < 8.0%) inżamm f'69% tal-pazjenti kkurati b'pioglitazone, meta mqabbla ma' 50% tal-pazjenti fuq gliclazide.
English: Ear and labyrinth disorders vertigo uncommon
Maltese: Disturbi filwidnejn u fissistema labirintika Vertigo mhux komuni
English: Concomitant administration of pioglitazone with gemfibrozil (an inhibitor of cytochrome P450 2C8) or with rifampicin (an inducer of cytochrome P450 2C8) is reported to increase or decrease, respectively, the plasma concentration of pioglitazone (see section 4.5).
Maltese: L-għotja ta' pioglitazone flimkien ma' gemfibrozil (inibitur taċ-ċitokromju P450 2C8) jew ma' rifampicin (induttur taċ-ċitokromju P450 2C8) huwa rrappurtat li jżid jew inaqqas, rispettivament, il-konċentrazzjoni fil-plażma ta' pioglitazone (ara sezzjoni 4.5).
English: Actos 45 mg
Maltese: Pilloli Actos 45 mg
English: Actos 15 mg tablets Actos 30 mg tablets Actos 45 mg tablets
Maltese: Pilloli Actos 15 mg Pilloli Actos 30 mg Pilloli Actos 45 mg pioglitazone
English: Actos 30 mg
Maltese: Pilloli Actos 30 mg
English: Lactose monohydrate Magnesium stearate
Maltese: Magnesium stearate
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 mill-ħalq, cyclosporin, imblokkaturi tal-kanali tal-kalċju, u inibituri ta' HMGCoA reductase.
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 fid-demm, minbarra l-insulini; Kodiċi ATC:
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-ċitokromju prinċipali induċibbli P450, 1A, 2C8/9 u 3A4.
English: Actos 15 mg
Maltese: Pilloli Actos 15 mg
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 permeżż tas-sistema tal-klassifika tal-organi u frekwenza assoluta.
English: 5 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: Each tablet contains 76.34 mg of lactose monohydrate (see section 4.4).
Maltese: Eċċipjent b'effett magħruf Kull pillola fiha 76.34 mg ta' lactose monohydrate (ara sezzjoni 4.4).
English: On the basis of the scientific conclusions for glimepiride / pioglitazone hydrochloride, metformin / pioglitazone, pioglitazone the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing glimepiride / pioglitazone hydrochloride, metformin / pioglitazone, pioglitazone is unchanged subject to the proposed changes to the product information.
Maltese: Abbażi ta' konklużjonijiet xjentifiċi għal glimepiride/pioglitazone hydrochloride, metformin/pioglitazone, pioglitazone is-CHMP huwa tal-opinjoni li l-bilanċ bejn benefiċċju u riskju ta' prodotti mediċinali li fihom glimepiride/pioglitazone hydrochloride, metformin / pioglitazone, pioglitazone huwa mhux mibdul soġġett għall-bidliet proposti lill-informazzjoni tal-prodott.
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 eta' medja ta' 62 sena; it-tul medju tad-dijabete kienet ta' 9.5 snin.
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: Each tablet contains 92.87 mg of lactose monohydrate (see section 4.4).
Maltese: Eċċipjent b'effett magħruf Kull pillola fiha 92.87 mg ta' lactose monohydrate (ara sezzjoni 4.4).
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 mijokardiku, puplesija, intervent kardijaku perkutanju jew bypass bi graft tal-arterja koronarja, sindromu koronarju akut, mard koronarju arterjali, jew mard tal-arterji periferali miżduda.
English: Blood and lymphatic system disorders anaemia common
Maltese: Disturbi taddemm u tassistema limfatika anemija komuni
English: Combination with metformin with sulphonylurea with metformin and sulphonylurea with insulin
Maltese: Ma' metformin u sulphonylurea
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti biex jigu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunke aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: In the 3.5 year PROactive study, 44/870 (5.1%) of pioglitazone-treated female patients experienced fractures compared to 23/905 (2.5%) of female patients treated with comparator.
Maltese: Fl-istudju PROactive ta' 3.5 snin, 44/870 (5.1%) tal-pazjenti nisa kkurati b'pioglitazone kellhom esperjenza ta' fratturi meta mqabbel ma' 23/905 (2.5%) tal-pazjenti nisa kkurati bi prodott paragun.
English: B. PACKAGE LEAFLET
Maltese: GĦALL-PAKKETTI
English: Wed. Thu.
Maltese: T TL E Ħ G S Ħ
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-għola limitu tan-normal, it-terapija għandha titwaqqaf.