FrancophonIA/ELRC3.0 huggingface dataset:
English: • Highly active relapsing multiple sclerosis associated with rapidly evolving disability, in patients for whom no alternative treatments are available.
Maltese: • Sklerożi multipla li tirkadi attiva ħafna assoċjata ma' diżabbiltà li tevolvi b'mod rapidu, f'pazjenti li għalihom l-ebda kura alternattiva mhija disponibbli.
English: • Relief of pain in patients with advanced prostate cancer;
Maltese: • Serħan mill-uġigħ f'pazjenti b'kanċer tal-prostata avvanzat;
English: The CHMP also agreed that Novantrone should no longer be approved for the treatment of acute lymphocytic leukaemia (a cancer of a different type of white blood cells) and liver cancer.
Maltese: Is-CHMP qabel ukoll li Novantrone ma għandux jiġi iżjed approvat għall-kura ta' lewkimja limfoċitika akuta (kanċer ta' tip differenti ta' ċelloli bojod tad-demm) u kanċer tal-fwied.
English: This has led to divergences across Member States in the medicine's authorised uses, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets.
Maltese: Dan wassal għal diverġenzi fost lIstati Membri fl-użi awtorizzati tal-mediċina, kif jidher fid-differenzi fis-sommarji tal-karatteristiċi talprodott (SmPCs), fit-tikkettar u fil-fuljetti ta' tagħrif.
English: Patients will receive a guide to the risks and an alert card describing the signs and symptoms to watch out for.
Maltese: Il-pazjenti se jirċievu gwida għar-riskji u kard ta' twissija li tiddeskrivi s-sinjali u s-sintomi li wieħed għandu joqgħod attent għalihom.
English: As part of this plan, the company will provide educational materials about the use of Novantrone in patients with multiple sclerosis.
Maltese: Bħala parti minn dan il-pjan, il-kumpanija se tipprovdi materjali edukattivi dwar l-użu ta' Novantrone f'pazjenti bi sklerożi multipla.
English: Absolute bioavailability is greater than 80%.
Maltese: Il-bijodisponibilità assoluta hija aktar minn 80 %.
English: 14 tablets 28 tablets 30 tablets 56 tablets 60 tablets 90 tablets 98 tablets
Maltese: 14-il pillola 28 pillola 30 pillola 56 pillola 60 pillola 90 pillola 98 pillola
English: Lactose monohydrate Hydroxypropylcellulose (E463) Croscarmellose sodium Magnesium stearate (E572)
Maltese: Lactose monohydrate Hydroxypropyl cellulose (E463) Croscarmellose sodium Magnesium stearate (E572)
English: Steady state is achieved after 4-7 days of dosing.
Maltese: Stat stabbli jintlaħaq wara 4 - 7 ijiem ta' dożaġġ.
English: Contains also lactose monohydrate.
Maltese: Pioglitazone Krka fih lactose monohydrate
English: Date of first authorisation: 21 March 2012 Date of latest renewal: DD month YYYY
Maltese: Data tal-ewwel awtorizzazzjoni: 21 ta' Marzu 2012 Data tal-aħħar tiġdid: JJ xahar SSSS
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: - The other ingredients are lactose monohydrate, hydroxypropylcellulose (E463), croscarmellose sodium, magnesium stearate (E572).
Maltese: - Is-sustanzi l-oħra huma lactose monohydrate, hydroxypropyl cellulose (E463), croscarmellose sodium, u magnesium stearate (E572).
English: Blister packs (OPA/Al/PVC-Al foil): 14, 28, 30, 56, 60, 90 and 98 tablets in a box.
Maltese: Pakketti ta' folji (folja ta' OPA/Al/PVA - Al) pakketti ta' 14, 28, 30, 56, 60, 90 u 98 pillola f'kaxxa.
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 wieħed mill-eċċipjenti elenkati 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: 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 1 f'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 1 f'100) - zokkor fl-awrina, proteina fl-awrina - żieda fl-enżimi - vertigo - tgħoroq - għejja - żieda fl-aptit
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: 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 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: Excipient with known effect: Each tablet contains 88.83 mg of lactose (see section 4.4).
Maltese: Kull pillola fiha 88.83 mg ta' lactose (ara sezzjoni 4.4).
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 għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott jekk il-prodott huwa inkluż fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: Excipient with known effect: Each tablet contains 264.68 mg of lactose (see section 4.4).
Maltese: Eċċipjent b'effett magħruf Kull pillola fiha 264.68 mg ta' lactose (ara sezzjoni 4.4).
English: - 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: - 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 Krka 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 Krka fihom lactose monohydrate u għalhekk m'għandhomx jingħataw lillpazjenti bi problemi ereditarji rari ta' intolleranza għall-galactose, defiċjenza Lapp lactase jew assorbiment ħażin ta' glucose-galactose.
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, eż. kontraċettivi mill-ħalq, cyclosporin, imblokkaturi tal-kanali tal-kalċju, u inibituri ta' HMGCoA reductase.
English: There was a small reduction in mean haemoglobin (4% relative reduction) and haematocrit (4.1% relative reduction) during therapy with pioglitazone, consistent with haemodilution.
Maltese: Kien hemm tnaqqis żgħir fil-medja ta' emoglobina (tnaqqis relattiv ta' 4 %) u ematokrita (tnaqqis relattiv ta' 4.1 %) waqt terapija b'pioglitazone, konsistenti ma' emodiluzzjoni.
English: Pioglitazone Krka contains pioglitazone.
Maltese: Pioglitazone Krka fih pioglitazone.
English: Excipient with known effect: Each tablet contains 176.46 mg of lactose (see section 4.4).
Maltese: Eċċipjent b'effett magħruf Kull pillola fiha 176.46 mg ta' lactose (ara sezzjoni 4.4).
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: Environmental Risk Assessment (ERA): no environmental impact is anticipated from the clinical use of pioglitazone.
Maltese: Rapport ta' Stima tar-Riskju Ambjentali (ERA): l-ebda impatt ambjentali huwa antiċipat mill-użu kliniku ta' pioglitazone.
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: 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: - The risk of heart failure and relevant risk minimisation advice.
Maltese: - Ir-riskju ta' falliment tal-qalb u r-rakkomandazzjonijiet dwar it-tnaqqis ta' riskju rilevanti.
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: The other side effects that have been experienced by some patients taking Pioglitazone Krka are:
Maltese: Effetti sekondarji oħra li ġew esperjenzati minn uħud mill-pazjenti li jieħdu Pioglitazone Krka huma:
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: Pioglitazone Krka 30 mg tablets
Maltese: Pioglitazone Krka 30 mg pilloli
English: Blood and lymphatic system disorders anaemia
Maltese: Disturbi tad-demm u tas-sistema limfatika anemija
English: Pioglitazone Krka 45 mg tablets
Maltese: Pioglitazone Krka 45 mg pilloli
English: A clinical trial of pioglitazone vs. gliclazide as monotherapy was extended to two years in order to assess time to treatment failure (defined as appearance of HbA1c ≥ 8.0% after the first six months of therapy).
Maltese: Prova klinika ta' pioglitazone vs. gliclazide bħala monterapija ġiet estiża għal sentejn sabiex jiġi studjat il-ħin sal-falliment tal-kura (definit bħala d-dehra ta' HbA1c ≥ 8.0 % wara l-ewwel sitt xhur ta' terapija).
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 ħielsa, u żied llivelli ta' HDL kolesterol, meta mqabbel mal-plaċebo, metformin jew gliclazide.
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA
English: Metabolism and nutrition disorders hypo-glycaemia uncommon very common common appetite increased uncommon
Maltese: Disturbi fil-metabolizmu u n-nutrizzjoni ipoglicemija mhux komuni komuni ħafna
English: Combination with sulphonylurea with metformin and sulphonylurea with insulin
Maltese: Taħlita ma' Sulphonylurea ma' metformin u sulphonylurea ma' insulina
English: Do not use this medicine after the expiry date which is stated on the packaging after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi skadenza li tidher fuq il- pakkett wara ‘EXP'.
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 każwali għal pioglitazone jew plaċebo li kienu miżjuda ma' terapija anti-dijabetika u kardjovaskulari eżistenti, sa 3.5 snin.
English: Pioglitazone Krka 30 mg tablets Pioglitazone
Maltese: Pioglitazone Krka 30 mg pilloli Pioglitazone
English: Pioglitazone Krka 15 mg tablets
Maltese: Pioglitazone Krka 15 mg pilloli
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 kombinata ma' insulina.
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 każwali, ikkontrollati b'paragun, u double blind b'aktar minn 8,100 pazjent fil-gruppi kkurati b'pioglitazone u 7400 pazjent fil-gruppi kkurrati bi prodott paragun li damu sa 3.5 snin.
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 bl'Pioglitazone fis-sottogruppi kollha tal-popolazzjoni pedjatrika ta' Tip 2 Diabetes Mellitus.
English: Ear and labyrinth disorders vertigo uncommon
Maltese: Disturbi filwidnejn u fissistema labirintika vertiġini mhux komuni
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 Krka 45 mg tablets Pioglitazone
Maltese: Pioglitazone Krka 45 mg pilloli Pioglitazone
English: What Pioglitazone Krka looks like and contents of the pack White to almost white round tablets with bevelled edges and with engraved "15" on one side of tablet (diameter 7.0 mm).
Maltese: Pilloli tondi u bojod għal kważi bojod bi truf imċandrin u intaljati bi “15” fuq naħa waħda (dijametru 7.0 mm).
English: Neoplasms benign, malignant and unspecified (including cysts and polyps) bladder cancer uncommon uncommon uncommon uncommon uncommon Respiratory, thoracic and mediastinal disorders dyspnoea common
Maltese: Neoplażmi bennini, malanni u dawk mhux speċifikati (inklużi ċesti u polipi) kanċer talbużżieqa mhux komuni mhux komuni mhux komuni mhux komuni mhux komuni
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 mqabbel mal-prodott ta' paragun (1.5 %).
English: 14 tablets: EU/1/11/723/015 28 tablets: EU/1/11/723/016 30 tablets: EU/1/11/723/017 56 tablets: EU/1/11/723/018 60 tablets: EU/1/11/723/019 90 tablets: EU/1/11/723/020 98 tablets: EU/1/11/723/021
Maltese: EU/1/11/723/019 90 pillola:
English: - Pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus in adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance (see section 4.4).
Maltese: - Pioglitazone huwa indikat ukoll għall-użu flimkien ma' insulina f'pazjenti adulti b'dijabete mellitus tat-tip 2 b'kontroll gliċemiku insuffiċjenti bl-insulina u li għalihom metformin mhux adattat minħabba kontraindikazzjonijiet jew intolleranza (ara sezzjoni 4.4).
English: United Kingdom Consilient Health (UK) Ltd. Tel: + 44 (0)2089562310
Maltese: Tel: + 44 (0)2089562310
English: When Pioglitazone Krka is taken in combination with other medicines used to treat diabetes (such as insulin, chlorpropamide, glibenclamide, gliclazide, tolbutamide) your doctor will tell you whether you need to take a smaller dose of your medicines.
Maltese: Meta Pioglitazone Krka jittieħed flimkien ma' mediċini oħra użati għall-kura tad-dijabete (bħal insulina, chlorpropamide, glibenclamide, gliclazide, tolbutamide), it-tabib tiegħek jgħidlek jekk għandekx bżonn tieħu doża inqas tal-mediċini tiegħek.
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 % tan-nisa kkurati bi prodott paragun.
English: These reactions include anaphylaxis, angioedema, and urticaria.
Maltese: Dawn ir-reazzjonijiet jinkludu anafilassi, anġjoedema u urtikarja.
English: Patients receiving pioglitazone had a mean reduction in HbA1c of 0.45% compared with those continuing on insulin alone, and a reduction of insulin dose in the pioglitazone treated group.
Maltese: Pazjenti li rċevew pioglitazone kellhom tnaqqis medju f'HbA1c ta' 0.45 % meta mqabbel ma' dawk li komplew fuq l-insulina biss, u fil-grupp ikkurat b'pioglitazone kien hemm tnaqqis fid-doża talinsulina.
English: 14 tablets: EU/1/11/723/001 28 tablets: EU/1/11/723/002 30 tablets: EU/1/11/723/003 56 tablets: EU/1/11/723/004 60 tablets: EU/1/11/723/005 90 tablets: EU/1/11/723/006 98 tablets: EU/1/11/723/007
Maltese: EU/1/11/723/001 28 pillola:
English: Other medicines and Pioglitazone Krka
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: Infections and infestations upper respiratory tract infection common common common common common bronchitis common sinusitis uncommon uncommon uncommon uncommon uncommon
Maltese: Infezzjonijiet u infestazzjonijiet Infezzjoni fil-passaġġ respiratorju ta' fuq bronkite sinusite mhux komuni mhux komuni mhux komuni mhux komuni mhux komuni
English: Pioglitazone Krka 15 mg tablets Pioglitazone
Maltese: Pioglitazone Krka 15 mg pilloli Pioglitazone
English: 14 tablets: EU/1/11/723/008 28 tablets: EU/1/11/723/009 30 tablets: EU/1/11/723/010 56 tablets: EU/1/11/723/011 60 tablets: EU/1/11/723/012 90 tablets: EU/1/11/723/013 98 tablets: EU/1/11/723/014
Maltese: EU/1/11/723/013 98 pillola:
English: Immune System Disorders Hypersensitivity and allergic reactions not known not known not known not known not known
Maltese: Disturbi fissistema immuni sensittività eċċessiva u reazzjonijiet allerġiċi1
English: concomitant administration may increase the risk of oedema.
Maltese: Riskju possibbli wara trattament ta' perijodu qasir ma jistax jiġi eskluż.
English: Reproductive system and breast disorders erectile dysfunction common
Maltese: Disturbi fis-sistema riproduttiva u fis-sider impotenza Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata edima
English: Therapy with pioglitazone should not be initiated in patients with increased baseline liver enzyme levels (ALT > 2.5 times the upper limit of normal) or with any other evidence of liver disease.
Maltese: Terapija b'pioglitazone m'għandiex tinbeda f'pazjenti b'livelli miżjuda ta' l-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: As a consequence of increased insulin sensitivity, patients receiving pioglitazone in dual or triple oral therapy with a sulphonylurea or in dual therapy with insulin may be at risk for dose-related hypoglycaemia, and a reduction in the dose of the sulphonylurea or insulin may be necessary.
Maltese: Bħala konsegwenza ta' żieda fis-sensittività għall-insulina, pazjenti li qed jirċievu pioglitazone f'terapija mill-ħalq doppja jew tripla ma' mediċina tat-tip sulphonylurea jew f'terapija doppja mal-insulina jistgħu jkunu f'riskju ta' ipogliċemija relatat mad-doża, u tista' tkun neċessarja tnaqqis fid-doża tal-mediċina tat-tip sulphonylurea jew tal-insulina.
English: CARTON FOLDING BOX
Maltese: KARTUNA TAL-KAXXA LI TINTEWA
English: How to take Pioglitazone Krka
Maltese: Kif taħżen Pioglitazone Krka
English: Prior to distribution of the prescriber guide in each Member State, the MAH must agree the content and format of the educational material, together with a communication plan, with the national competent authority.
Maltese: Qabel id-distrubuzzjoni tal-gwida tat-tabib li jippreskrivi f'kull Stat Membru, id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq għandu jiftiehem dwar il-kontenut u l-format tal-materjal edukazzjonali, flimkien ma' pjan ta' kommunikazzjoni, mal-awtorità kompetenti nazzjonali.
English: In a placebo controlled trial, patients with inadequate glycaemic control despite a three month insulin optimisation period were randomised to pioglitazone or placebo for 12 months.
Maltese: Fi prova kkontrollata bil-plaċebo, pazjenti b'kontroll gliċemiku inadegwat minkejja perjodu ta' ottimizzazzjoni b'insulina ta' 3 xhur, kienu każwali għal pioglitazone jew plaċebo għal 12-il xahar.
English: No increase in fracture rates was observed in men treated with pioglitazone (1.7%) versus comparator (2.1%).
Maltese: Ma kinietx osservata żieda fir-rata ta' fratturi f'irġiel ikkurati b'pioglitazone (1.7 %) meta mqabbla ma' prodott paragun (2.1 %).
English: What Pioglitazone Krka looks like and contents of the pack White to almost white round tablets with bevelled edges and with engraved "45" on one side of tablet (diameter 10.0 mm).
Maltese: Pilloli tondi bojod għal kważi bojod bi truf imċanfrin u li fuq hemm intaljat “45” fuq naħa waħda talpillola (dijametru 10 mm).
English: common (may affect up to 1 in 10 people) - respiratory infection - abnormal vision - weight gain - numbness uncommon (may affect up to 1 in 100 people) - inflammation of the sinuses (sinusitis) - difficulty sleeping (insomnia)
Maltese: komuni (jistgħu jaffettwaw sa persuna 1 f'10) - infezzjoni respiratorja - vista mhux normali - żieda fil-piż - tirżiħ mhux komuni (jistgħu jaffettwaw sa persuna 1 f'100) - sinusite - insonnja mhux maghrufa (frekwenza ma tistax tiġi stmata mit-droga disponibbli) - żieda fl-enżimi tal-fwied - reazzjonijiet allerġiċi
English: This leaflet was last revised in <MM/YYYY>
Maltese: Deskrizzjoni ta' reazzjonijiet avversi magħżula