FrancophonIA/ELRC3.0 huggingface dataset:
English: • 2 pre-filled pens (0.8 mL sterile solution), each in a blister, with 2 alcohol pads.
Maltese: • 2 pinen mimlija għal-lest (0.8 mL ta' soluzzjoni sterili) kull waħda f'folja, b'żewġ imsielaħ bl alkoħol.
English: NAME OF THE MEDICINAL PRODUCT Cyltezo 40 mg solution for injection in pre-filled syringe Cyltezo 40 mg solution for injection in pre-filled pen
Maltese: IL-PRODOTT MEDIĊINALI Cyltezo 40 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest adalimumab
English: • 1 pre-filled syringe (0.8 mL sterile solution) in a blister, with 2 alcohol pads.
Maltese: • 2 siringi mimlija għal-lest (0.8 mL ta' soluzzjoni sterili) kull waħda f'folja, b'żewġ imsielaħ blalkoħol.
English: • Discard Cyltezo pre-filled syringe into “sharps” container.
Maltese: • Armi l-pinna Cyltezo kollha f'kontenitur maħsub apposta għal oġġetti bil-ponta.
English: Assessments in SpondyloArthritis international Society Bath Ankylosing Spondylitis Disease Activity Index Ankylosing Spondylitis Disease Activity Score high sensitivity C-Reactive Protein (mg/L) Spondyloarthritis Research Consortium of Canada
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu.
English: • angioedema (localised swelling of the skin); • lichenoid skin reaction (itchy reddish-purple skin rash).
Maltese: • reazzjonijiet allerġiċi (li jinkludu allerġija assoċjata mal-istaġuni);
English: Ísland Vistor hf.
Maltese: Vistor hf.
English: County Wicklow Ireland
Maltese: County Wicklow l-Irlanda
English: 14 tablets 28 tablets 30 tablets 50 tablets 56 tablets 84 tablets 90 tablets 98 tablets
Maltese: 14-il pillola 28 pillola 30 pillola 50 pillola 56 pillola 84 pillola 90 pillola 98 pillola
English: Tablet
Maltese: Pilloli
English: EU/1/00/151/001 EU/1/00/151/002
Maltese: EU/1/00/151/015
English: Takeda GmbH Tel: 0800 825 3325 medinfo@takeda.de
Maltese: De uts chland Takeda GmbH Tel: 0800 825 3325 medinfo@takeda.de
English: Aluminium/aluminium blisters, packs of 14, 28, 30, 50, 56, 84, 90 and 98 tablets.
Maltese: Aluminju/Folja tal-aluminju pakketti ta' 14, 28, 30, 50, 56, 84, 90 u 98 pillola.
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: 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: Date of first authorisation: 11/10/2000 Date of latest renewal: 31/08/2010
Maltese: Data tal-aħħar tiġdid: 31/08/2010
English: See section 2 “Glustin contains lactose monohydrate”.
Maltese: Ara sezzjoni 2 “Glustin 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: 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: Takeda Nederland bv Tel: +31 23 56 68 777
Maltese: Ne de rland Takeda Nederland bv Tel: +31 23 56 68 777
English: Takeda UK Ltd Tel: +44 (0)1628 537 900
Maltese: Unite d Kingdom Takeda UK Ltd Tel: +44 (0)1628 537 900
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: Takeda Belgium Tél/Tel: +32 2 464 06 11 Takeda-belgium@takeda.com
Maltese: +32 2 464 06 11 takeda-belgium@takeda.com
English: Other medicines and Glustin
Maltese: Mediċini oħra u Glustin
English: Each tablet contains 76.34 mg of lactose monohydrate (see section 4.4).
Maltese: Kull pillola fiha 76.34 mg ta' lactose monohydrate (ara sezzjoni 4.4).
English: Takeda Pharmaceuticals Slovakia s.r.o.
Maltese: Slove nská re publika Takeda Pharmaceuticals Slovakia s.r.o.
English: Glustin contains pioglitazone.
Maltese: Glustin 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 ta' 3-4% fl-emoglobina u ta' 3.6-4.1% fl-ematokrita) u fi kwantità inqas b'sulphonylurea u bl-insulina (tnaqqis relattiv ta' 1-2% fl-emoglobina u ta' 1-3.2% fl-ematokrita).
English: common common common common common blood creatine phospho-kinase increased common increased lactic dehydro-genase uncommon alanine aminotransferase increased7
Maltese: żieda fil-creatine phosphokinase fid-demm żieda ta' lactic dehydrogenase mhux komuni żieda f'alanine aminotransferase7
English: Reproductive system and breast disorders erectile dysfunction common
Maltese: Disturbi fissistema riproduttiva u fis -s ide r disfunzjoni erettili
English: Ελλάδα
Maltese: Ös te rreich
English: Takeda Pharma A/S Dybendal Alle 10 DK-2630 Taastrup Denmark
Maltese: Takeda Pharma A/S Dybendal Alle 10
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: < 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: Glustin contains lactose monohydrate
Maltese: Glustin fih lactose monohydrate
English: Gastrointestinal disorders flatulence uncommon common
Maltese: Disturbi gastrointe s tinali gass mhux komuni
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-insulina; Kodiċi ATC:
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: Each tablet contains 92.87 mg of lactose monohydrate (see section 4.4).
Maltese: Kull pillola fiha 92.87 mg ta' lactose monhydrate (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: puplesija, intervent kardijaku perkutanju jew bypass bi graft tal-arterja koronarja, sindromu koronarju akut, mard koronarju arterjali, jew mard tal-arterji periferali miżduda.
English: Marketing authorisation holder
Maltese: KONDIZZJONIJIET U REKWIŻITI
English: Glustin 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 Glustin 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: The safety and efficacy of Glustin in children and adolescents under 18 years of age have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Glustin fit-tfal u adolexxenti taħt l-età ta' 18-il sena għadhom ma ġewx determinati s'issa.
English: Glustin 30 mg tablets
Maltese: Glustin 30 mg Pilloli
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 induċibbli prinċipali P450, 1A, 2C8/9 u 3A4.
English: OTHER
Maltese: E
English: - The active substance in Glustin is pioglitazone.
Maltese: Is-sustanza attiva ta' Glustin hi pioglitazone.
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: Glustin 30 mg tablets pioglitazone
Maltese: Glustin 30 mg pilloli pioglitazone
English: Blood and lymphatic system disorders anaemia common
Maltese: Disturbi taddemm u tassistema limfatika anemija
English: 4 A pooled analysis was conducted of adverse reactions of bone fractures from randomised, comparator controlled, double blind clinical trials in over 8,100 patients in the pioglitazone-treated groups and 7,400 in the comparator-treated groups of up to 3.5 years duration.
Maltese: 4Twettqet analiżi ta' tagħrif miġbur ta' rapporti ta' effetti mhux mixtieqa ta' fratturi fl-għadam minn provi kliniċi randomised, ikkontrollati b'paragun, u double blind b'aktar minn 8100 pazjent fil-gruppi kkurati b'pioglitazone u 7400 pazjent fil-gruppi kkurrati bi prodott paragun li damu sa 3.5 snin.
English: Pioglitazone appears to act via activation of specific nuclear receptors (peroxisome proliferator activated receptor gamma) leading to increased insulin sensitivity of liver, fat and skeletal muscle cells in animals.
Maltese: Pioglitazone jidher li jaħdem permezz ta' attivazzjoni ta' riċetturi nuklejari speċifiċi (peroxisome proliferator activated receptor gamma) li jwassal għal żieda fis-sensitività għall-insulina tal-fwied, xaħam u ċelloli tal-muskoli skeletrali fl-annimali.
English: 6 In active comparator controlled trials mean weight increase with pioglitazone given as monotherapy was 2-3 kg over one year.
Maltese: 6Fi 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: Fri.
Maltese: OĦRA
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 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. D.
English: Hepatic impairment Pioglitazone should not be used in patients with hepatic impairment (see sections 4.3 and 4.4).
Maltese: Indeboliment epatiku Pioglitazone m'għandux jintuża f'pazjenti b'indeboliment epatiku (ara sezzjonijiet 4.3 u 4.4).
English: Glustin 45 mg tablets pioglitazone
Maltese: Glustin 45 mg pioglitazone
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 għall-żieda statistikament sinifikanti fil-livell ta' LDL kolesterol meta mqabbel mal-plaċebo, filwaqt li tnaqqis kien osservat b'metformin u gliclazide.
English: Environmental Risk Assessment (ERA) No environmental impact is anticipated from the clinical use of pioglitazone
Maltese: Valutazzjoni tar-Riskju Ambjentali (ERA) L-ebda impatt ambjentali ma huwa antiċipat mill-użu kliniku ta' pioglitazone.
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: 3Fi 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: Sun.
Maltese: Kft.
English: Neoplasms benign, malignant and unspecified (including cysts and polyps)
Maltese: Ne oplażmi beninni, malinni u dawk mhux s pe ċifikati (inklużi ċesti u polipi)
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 miżjuda ta' l-enżimi tal-fwied fil-linja bażika (ALT > 2.5 x l-għola limitu tan-normal) jew b'xi evidenza oħra ta' mard tal-fwied.
English: EU/1/00/151/009 14 tablets EU/1/00/151/010 28 tablets EU/1/00/151/020 30 tablets EU/1/00/151/011 50 tablets EU/1/00/151/012 56 tablets EU/1/00/151/021 84 tablets EU/1/00/151/022 90 tablets EU/1/00/151/013 98 tablets
Maltese: EU/1/00/151/009 14-il pillola EU/1/00/151/010 28 pillola EU/1/00/151/020 30 pillola EU/1/00/151/011 50 pillola EU/1/00/151/012 56 pillola EU/1/00/151/021 84 pillola EU/1/00/151/022 90 pillola EU/1/00/151/013 98 pillola
English: 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 kontra-indikazzjonijiet 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-għola 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-għola 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: EU/1/00/151/008 14 tablets EU/1/00/151/004 28 tablets EU/1/00/151/017 30 tablets EU/1/00/151/005 50 tablets EU/1/00/151/024 56 tablets EU/1/00/151/018 84 tablets EU/1/00/151/019 90 tablets EU/1/00/151/006 98 tablets
Maltese: EU/1/00/151/008 14-il pillola EU/1/00/151/004 28 pillola EU/1/00/151/017 30 pillola EU/1/00/151/005 50 pillola EU/1/00/151/024 56 pillola EU/1/00/151/018 84 pillola EU/1/00/151/019 90 pillola EU/1/00/151/006 98 pillola
English: EU/1/00/151/007 14 tablets EU/1/00/151/001 28 tablets EU/1/00/151/014 30 tablets EU/1/00/151/002 50 tablets EU/1/00/151/023 56 tablets EU/1/00/151/015 84 tablets EU/1/00/151/016 90 tablets EU/1/00/151/003 98 tablets
Maltese: EU/1/00/151/007 14-il pillola EU/1/00/151/001 28 pillola EU/1/00/151/014 30 pillola EU/1/00/151/002 50 pillola EU/1/00/151/023 56 pillola EU/1/00/151/015 84 pillola EU/1/00/151/016 90 pillola EU/1/00/151/003 98 pillola
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 fl-akutezza viżiva ġew irrappurtati b'thiazolidinediones, inkluż pioglitazone.
English: Deutschland
Maltese: Ísland
English: Each Glustin 45 mg tablet contains 45 mg of pioglitazone (as hydrochloride).
Maltese: Kull pillola Glustin 45 mg fiha 45 mg ta' pioglitazone (bħala hydrochloride).
English: Each Glustin 30 mg tablet contains 30 mg of pioglitazone (as hydrochloride).
Maltese: Kull pillola Glustin 30 mg fiha 30 mg ta' pioglitazone (bħala hydrochloride).
English: Combination with metformin with sulphonylurea with metformin and sulphonylurea with insulin
Maltese: Ma' me tformin u sulphonylurea
English: Glustin 15 mg tablets
Maltese: Pilloli Glustin 15 mg Pilloli
English: Glustin 30 mg tablets are white to off-white, round, flat tablets marked “30” on one face, “AD4” on the other.
Maltese: Glustin 30 mg huma pilloli bojod għal abjad maħmuġ, tondi, ċatti u mmarkati b'‘30' fuq naħa waħda u b'‘AD4' fuq in-naħa l-oħra.
English: ANNEX III LABELLING AND PACKAGE LEAFLET
Maltese: B'KALENDARJU) GĦALL-PAKKETTI
English: - Glustin 45 mg tablets are white to off-white, round, flat tablets marked “45” on one face, “AD4” on the other.
Maltese: Glustin 45 mg huma pilloli bojod għal abjad maħmuġ, tondi, ċatti u mmarkati b'‘45' fuq naħa waħda u b'‘AD4' fuq in-naħa l-oħra.
English: Musculoskeletal and connective tissue disorders fracture bone4
Maltese: Disturbi muskoluskeletriċi u tatte s suti konne ttivi ksur ta' għadam4
English: België/Belgique/Belgien
Maltese: B e lgië/Belgique/Belgien Takeda Belgium Tél/Tel:
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: Glustin 15 mg tablets pioglitazone
Maltese: Glustin 15 mg pilloli pioglitazone
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 sulphonylurea ma tidhirx li taffettwa il-farmakokinetika tal- mediċini tat-tip sulphonylurea.
English: MARKETING AUTHORISATION NUMBER(S)
Maltese: B'KALENDARJU: T
English: Similar changes in body fat distribution on pioglitazone have been accompanied by an improvement in insulin sensitivity.
Maltese: Tibdiliet simili fid-distribuzzjoni tax-xaħam fil-ġisem b'pioglitazone saru flimkien ma' titjib fis-sensitività għall-insulina.
English: Package leaflet: Information for the patient Glustin 15 mg tablets
Maltese: INFORMAZZJONI BIL-BRAILLE Glustin 15 mg
English: - Glustin 15 mg tablets are white to off-white, round, convex tablets marked “15” on one face, “AD4” on the other.
Maltese: Il-pilloli huma bojod għal abjad maħmuġ, tondi, bbużżati miż-żewġ naħat u mmarkati b'‘15' fuq naħa waħda, ‘AD4' fuq in-naħa l-oħra.
English: Each Glustin 15 mg tablet contains 15 mg of pioglitazone (as hydrochloride).
Maltese: Kull pillola Glustin 15 mg fiha 15 mg ta' pioglitazone (bħala hydrochloride).
English: Co-administration of pioglitazone with rifampicin (an inducer of cytochrome P450 2C8) is reported to result in a 54% decrease in AUC of pioglitazone.
Maltese: Ħija rrappurtata li l-għotja ta' piogltazone flimkien ma' rifampicin (induttur taċ-ċitokromju P450 2C8) twassal għal tnaqqis ta' 54% fl-AUC ta' pioglitazone.
English: Glustin 45 mg tablets
Maltese: Glustin 45 mg pilloli pioglitazone
English: The other side effects that have been experienced by some patients taking Glustin are:
Maltese: Effetti sekondarji oħra li ġew esperjenzati minn uħud mill-pazjenti li jieħdu Glustin huma:
English: The European Medicines Agency has waived the obligation to submit the results of studies with Glustin in all subsets of the paediatric population in type 2 diabetes mellitus.
Maltese: L-Aġenzija Ewropea għall-Mediċini irrinunzjat għall-obbligu li jiġu ppreżentati riżultati tal-istudji b'Glustin f'kull sett tal-popolazzjoni pedjatrika f'diabetes mellitus tip 2.
English: Metabolism and nutrition disorders hypo-glycaemia uncommon very common common appetite increased uncommon
Maltese: Disturbi filmetabolizmu u n-nutrizzjoni ipoglicemija mhux komuni komuni ħafna żieda fl-aptit mhux komuni
English: Contents of the pack and other information What Glustin contains
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih Glustin
English: Eye disorders visual disturbance2
Maltese: Disturbi fl għajne jn disturbi viżwali2
English: Blurred vision due to swelling (or fluid) at the back of the eye has also been reported in patients taking Glustin (frequency cannot be estimated from the available data).
Maltese: sinusite insonnja mhux magħrufa (frekwenza ma tistax tiġi stmata mid-dejta disponibbli)
English: If jaundice is observed, the medicinal product should be discontinued.
Maltese: Jekk tkun osservata s-suffejra, il-prodott mediċinali għandhu jitwaqqaf.
English: Takeda Pharma Kft. Tel: +361 2707030
Maltese: Tel: +361 2707030
English: Co-administration of pioglitazone with gemfibrozil (an inhibitor of cytochrome P450 2C8) is reported to result in a 3-fold increase in AUC of pioglitazone.
Maltese: Huwa rrappurtat li l-għotja ta' pioglitazone flimkien ma' gemfibrozil (inibitur taċ-ċitokromju P450 2C8) twassal għall-żieda ta' 3 darbiet fl-AUC ta' pioglitazone.
English: Infections and infestations upper respiratory tract infection common common common common common bronchitis common sinusitis uncommon uncommon uncommon uncommon uncommon
Maltese: Infezzjonijiet u infe s tazzjonijie t Infezzjoni filpassaġġ respiratorju ta' fuq bronkite sinusite mhux komuni mhux komuni mhux komuni mhux komuni mhux komuni
English: In vitro studies have shown no inhibition of any subtype of cytochrome P450.
Maltese: Studji in vitro wrew li m'hemmx induzzjoni ta' l-ebda sottotip ta' ċitokromju P450.
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: Ipogliċemija Bħala konsegwenza ta' żieda fis-sensittività għall-insulina, pazjenti li qed jirċievu pioglitazone f'terapija mill-ħalq doppja jew trippla 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: Nervous system disorders hypo-aesthesia common common common common common headache common uncommon dizziness common insomnia uncommon uncommon uncommon uncommon uncommon
Maltese: Il-professjonisti tal-kura tas-saħħa huma mitluba jirrappurtaw kwalunkwe reazzjoni avversa suspettata permezz tas-sistema ta' rappurtar nazzjonali mniżżla f'Appendiċi V.
English: 7 In clinical trials with pioglitazone the incidence of elevations of ALT greater than three times the upper limit of normal was equal to placebo but less than that seen in metformin or sulphonylurea comparator groups.
Maltese: 7Fi provi kliniċi b'pioglitazone l-inċidenża ta' elevazzjonijiet ta' ALT aktar minn tlett darbiet l-għola limitu tan-normal kienet daqs il-plaċebo iżda inqas minn dik li deheret fil-grupp ta' paragun b'metformin jew b'sulphonylurea.
English: 14 January 2013
Maltese: 14 ta' Jannar 2013
English: It was to be available as oral drops (100 microgram/ml).
Maltese: Kellha tiġi fi qtar orali (100 mikrogramma/ml).
English: • thyroid cancer.
Maltese: • kanċer tat-tirojde.
English: What is Levothyroxine Alapis?
Maltese: X'inhu Levothyroxine Alapis?
English: Member States', in this instance Belgium, Bulgaria, Cyprus, Germany, Greece, Malta, Portugal, Romania and United Kingdom).
Maltese: f'dan il-każ il-Belġju, il-Bulgarija, Ċipru, il-Ġermanja, il-Greċja, Malta, il-Portugall, ir-Rumanija u rRenju Unit).