FrancophonIA/ELRC3.0 huggingface dataset:
English: The study population had an average age of 62 years; the average duration of diabetes was 9.5 years.
Maltese: Il-popolazzjoni ta' studju kellha età medja ta' 62 sena; it-tul medju ta' dijabete kien 9.5 sena.
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 fil-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: 30-44 Maximum daily dose is 1,000 mg.
Maltese: Doża massima ta' kuljum hi 1,000 mg.
English: 56 tablets
Maltese: 56 pillola
English: Glucocorticoids (given by systemic and local routes), beta-2-agonists, and diuretics have intrinsic hyperglycaemic activity.
Maltese: Glukokortikojdi (mogħtija permezz ta' rotta sistemika u lokali), agonisti-beta-2, u dijuretiċi għandhom attività ipergliċemika intrinsika.
English: Takeda UAB Tel: +370 521 09 070 Lt-info@takeda.com
Maltese: Tel: +370 521 09 070 lt-info@takeda.com
English: Proportional increases of the plasma concentration were observed for doses from 2-60 mg.
Maltese: Żieda proporzjonali filkonċentrazzjoni fil-plażma kienet osservata f'dozi minn 2-60 mg.
English: Takeda Polska Sp. z o.o.
Maltese: Takeda Italia S.p.A.
English: 28 tablets
Maltese: 28 pillola
English: Reproductive system and breast disorders erectile dysfunction common
Maltese: Disturbi fis-sistema riproduttiva u fis-sider disfunzjoni erettili komuni
English: In patients at increased risk of further progression of renal impairment and in the elderly, renal function should be assessed more frequently, e.g every 3-6 months.
Maltese: F'pazjenti b'riskju akbar ta' aktar progressjoni ta' indeboliment renali u fl anzjani, il-funzjoni renali għandha tkun evalwata b'mod aktar frekwenti, eż. kull 3-6 xhur.
English: Almost all subjects (95%) were receiving cardiovascular medicinal products (beta blockers, ACE inhibitors, angiotensin II antagonists, calcium channel blockers, nitrates, diuretics, acetylsalicylic acid, statins, fibrates).
Maltese: Kważi l individwi kollha (95%) kienu qed jirċievu prodotti mediċinali kardjovaskulari (imblokkaturi tar riċetturi beta, inibituri ACE, antagonisti ta' angiotensin II, imblokkaturi tal-kanali tal-kalċju, nitrati,
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 < 1/1000); rari ħafna (< 1/10,000); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: There is no induction of the main inducible P450 isoenzymes 1A, 2C8/9, and 3A4 in man.
Maltese: P450, 1A, 2C8/9 u 3A4.
English: FOR CALENDARISED PACKS: Mon. 1
Maltese: GĦALL-PAKETTI B'KALENDARJU T 1 T 2
English: Metformin stimulates intracellular glycogen synthesis by acting on glycogen synthase.
Maltese: Metformin jistimola s-sintesi intraċellolari ta' glycogen billi jaħdem fuq glycogen synthase.
English: Thu. 2
Maltese: EL 1 EL 2
English: Risk of lactic acidosis
Maltese: Riskju ta' aċidożi lattika
English: Glubrava 15 mg/850 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Glubrava 15 mg/850 mg
English: In one year clinical trials, pioglitazone consistently gave a statistically significant reduction in the albumin/creatinine ratio compared to baseline.
Maltese: Fi provi kliniċi ta' sena, pioglitazone b'mod konsistenti wassal għal tnaqqis statistikament sinifikanti fil-proporzjon ta' albumin/krejatinina meta mqabbel mal-linja bażi.
English: Uncommon inflammation of the sinuses (sinusitis) gas difficulty sleeping (insomnia)
Maltese: Mhux komuni infjammazzjoni tas-sinus (sinusite) gass - diffikultà fl-irqad (insonnja)
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 ematokrit (tnaqqis relattiv ta' 4.1%) waqt terapija b'pioglitazone, konsistenti ma' emodiluzzjoni.
English: 50 tablets
Maltese: 50 pillola
English: What Glubrava contains The active substances are pioglitazone and metformin hydrochloride.
Maltese: Is-sustanzi attivi huma pioglitazone u metformin idrokloridu.
English: Metformin is contraindicated in patients with GFR < 30 mL/min and should be temporarily discontinued in the presence of conditions that alter renal function, see section 4.3.
Maltese: Metformin huwa kontraindikat f'pazjenti b'GFR <30 mL/min u għandu jitwaqqaf temporanjament fil-preżenza ta' kundizzjonijiet li jibdlu l-funzjoni renali, ara sezzjoni 4.3).
English: 14 tablets
Maltese: 14-il pillola
English: Avoid excessive alcohol intake while taking Glubrava since this may increase the risk of lactic acidosis (see section “Risk of lactic acidosis”).
Maltese: Evita konsum eċċessiv ta' alkoħol waqt li tkun qed tieħu Glubrava peress li dan jista' jżid ir-riskju ta' aċidożi lattika (ara s-sezzjoni “Riskju ta' aċidożi lattika”).
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: 98 tablets
Maltese: 98 pillola
English: Pioglitazone undergoes extensive hepatic metabolism by hydroxylation of aliphatic methylene groups.
Maltese: Pioglitazone jgħaddi minn metaboliżmu epatiku estensiv permeżż ta' idroksilazzjoni tal-gruppi ta' aliphatic methylene.
English: It is assumed that the pharmacokinetics of metformin absorption is non-linear.
Maltese: Huwa preżunt li lfarmakokinetika ta' assorbiment ta' metformin mhix lineari.
English: Takeda Pharma AB Tel: +46 8 731 28 00 infosweden@takeda.com
Maltese: Tel: +46 8 731 28 00 infosweden@takeda.com
English: Medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors, such as ibuprofen and celecoxib).
Maltese: Mediċini użati biex jittrattaw l-uġigħ u l-infjammazzjoni (NSAID u inibituri ta' COX-2, bħal ibuprofen u celecoxib).
English: Cationic medicinal products that are eliminated by renal tubular secretion (e.g. cimetidine) may interact with metformin by competing for common renal tubular transport systems.
Maltese: Prodotti mediċinali katijoniċi li huma eliminati permezz ta' sekrezzjoni tubolari renali (e.ż. cimetidine) jistgħu jinteraġixxu ma' metformin billi jikkompetu għal sistemi komuni ta' trasport tubolari renali.
English: Glubrava combines two antihyperglycaemic active substances with complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes mellitus: pioglitazone, a member of the thiazolidinedione class and metformin hydrochloride, a member of the biguanide class.
Maltese: Glubrava jikkombina żewġ sustanzi attivi anti-ipergliċemiċi b'mekkaniżmi t'azzjoni li jikkumplimentaw lil xulxin biex itejbu l-kontroll gliċemiku f'pazjenti b'dijabete mellitus tat-tip 2: pioglitazone, membru tal-klassi thiazolidinedione u metformin idrokloridu, membru tal-klassi biguanide.
English: Glubrava with alcohol
Maltese: Glubrava ma' alkoħol
English: 7 In active comparator controlled trials oedema was reported in 6.3% of patients treated with metformin and pioglitazone, whereas the addition of sulphonylurea to metformin treatment resulted in oedema in 2.2% of patients.
Maltese: 7Fi provi attivi kkontrollati ta' paragun, edima kienet irrappurtata f'6.3% tal-pazjenti kkurati b'metformin u pioglitazone , filwaqt li ż-żieda ta' sulphonylurea ma' kura b'metformin wasslet għalledima f'2.2% tal-pazjenti.
English: The recommended dose of Glubrava is 30 mg/day pioglitazone plus 1,700 mg/day of metformin hydrochloride (this dose is achievable with one tablet of Glubrava 15 mg/850 mg, taken twice a day).
Maltese: Id-doża rakkomandata ta' Glubrava hija ta' pioglitazone 30 mg/kuljum flimkien ma' metformin idrokloridu 1,700 mg/kuljum (din id-doża tintlaħaq minn pillola waħda ta' Glubrava 15 mg/850 mg, darbtejn kuljum).
English: 90 tablets
Maltese: 90 pillola
English: Other:
Maltese: Manifattur:
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: rifampicin (induttur taċ-ċitokromju P450 2C8) huwa rrappurtat li jżid jew inaqqas, rispettivament, il konċentrazzjoni fil-plażma ta' pioglitazone (ara sezzjoni 4.5).
English: However, in the case of metformin, in the fed state the mean AUC and Cmax were lower (13% and 28% respectively).
Maltese: Iżda, fil-każ ta' metformin, l-medja ta' AUC u Cmax kienu inqas (13% u 28%
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: 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: In controlled clinical trials, maximum metformin plasma levels (Cmax) did not exceed 4 µg/mL, even at maximum doses.
Maltese: Fi provi kliniċi kkontrollati, il-livelli massimi fil-plażma ta' metformin (Cmax) ma qabżux 4 µg/mL, lanqas fl-ogħla dożi.
English: 60 tablets
Maltese: 60 pillola
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 kellhom ikollhom wieħed jew aktar minn dawn li ġejjin: infart mijokardijaku, puplesijja, intervent kardijaku perkutanju jew bypass graft tal-arterja koronarja, sindrome koronarju akut, marda ta' l-arterji koronarji, jew marda ostruttiva ta' l-arterji periferali.
English: NAME OF THE MEDICINAL PRODUCT Glubrava 15 mg/850 mg tablets pioglitazone/metformin hydrochloride
Maltese: Pilloli Glubrava 15 mg/850 mg pioglitazone/metformin idrokloridu
English: Pioglitazone and metformin combination
Maltese: pioglitazone u l-metabolita
English: A study conducted in seven normal healthy volunteers showed that cimetidine, administered as 400 mg twice daily, increased metformin systemic exposure (AUC) by 50% and Cmax by 81%.
Maltese: Studju li twettaq f'seba' voluntiera normali u b'saħħithom wera li cimetidine, mogħti bħala 400 mg darbtejn kuljum, żied l-espożizzjoni sistemika ta' metformin (AUC) b'50% u Cmax b'81%.
English: Studies in man suggest no induction of the main inducible cytochrome P450, 1A, 2C8/9 and 3A4.
Maltese: M'hemm l-ebda induzzjoni tal-isożimi prinċipali ta' P450 induċibbli 1A, 2C8/9, u 3A4 fil-bniedem.
English: As metformin is excreted via the kidney, and elderly patients have a tendency to decreased renal function, elderly patients taking Glubrava should have their renal function monitored regularly (see sections 4.3 and 4.4).
Maltese: Minħabba li metformin jiġi eliminat mill-kliewi, u pazjenti anzjani għandhom tendenza ta' funzjoni renali mnaqqsa, pazjenti anzjani li qed jieħdu Glubrava għandu jkollhom il-funzjoni renali tagħhom sorveljat b'mod regolari (ara sezzjonijiet 4.3 u 4.4).
English: Diagnostic laboratory findings are decreased blood pH (< 7.35), increased plasma lactate levels (> 5 mmol/L) and an increased anion gap and lactate/pyruvate ratio.
Maltese: Sejbiet dijanjostiċi tal-laboratorju huma tnaqqis fil-pH tad-demm (< 7.35), żieda fil-livelli ta' lactate fil-plażma (>5 mmol/L) u żieda fl-anion gap u l-proporzjon ta' lactate/pyruvate.
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 kienux jinħtieġu l-waqfien tal-kura.
English: In the 3.5 year 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 ta' 3.5 snin, 44/870 (5.1%; fratturawaħda ghal kull 100 sena ta' pazjenti) talpazjenti nisa kkurati b'pioglitazone kellhom esperjenza ta' fratturi meta mqabbel ma' 23/905 (2.5%; 0.5 fratturi għal kull 100 sena ta' pazjenti) tal-pazjenti nisa kkurati bi prodott paragun.
English: Luxe mbourg/Luxemburg Takeda Belgium Tél/Tel: +32 2 464 06 11 Takeda-belgium@takeda.com
Maltese: +32 2 464 06 11 takeda-belgium@takeda.com
English: At the usual metformin doses and dosing schedules, steady state plasma concentrations are reached within 24-48 h and are generally less than 1 µg/mL.
Maltese: F'dożi u programmi ta' dożaġġ normali ta' metformin, konċentrazzjonijiet fil-plażma fi stat fiss jintlaħqu f'madwar 24-48 siegħa u ġeneralment huma inqas minn 1 µg/mL.
English: Other risk factors for lactic acidosis are excessive alcohol intake, hepatic insufficiency, inadequately controlled diabetes, ketosis, prolonged fasting and any conditions associated with hypoxia, as well as concomitant use of medicinal products that may cause lactic acidosis (see sections 4.3 and 4.5).
Maltese: Fatturi oħra ta' riskju għal aċidożi lattika huma konsum eċċessiv ta' alkoħol, insuffiċjenza epatika, dijabete ikkontrollata b'mod mhux adegwat, ketożi, sawm fit-tul u kwalunkwe kundizzjoni assoċjata ma' nuqqas ta' ossiġnu fit-tessuti, kif ukoll l-użu fl-istess waqt ta' prodotti mediċinali li jistgħu jikkawżaw aċidożi lattika (ara sezzjonijiet 4.3 u 4.5).
English: Glubrava 15 mg/850 mg film-coated tablets pioglitazone/metformin hydrochloride
Maltese: Glubrava 15 mg/850 mg pilloli miksija b'rita pioglitazone/metformin idrokloridu
English: Similar changes were seen in metformin (haemoglobin 3-4% and haematocrit 3.6-4.1% 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 ta' 3-4 % u fl-ematokrita ta' 3.6-4.1%).
English: Decreased renal function in elderly patients is frequent and asymptomatic.
Maltese: Funzjoni renali mnaqqsa f'pazjenti anzjani hija frekwenti u bla sintomi.
English: Takeda Italia S.p.A. Tel: +39 06 502601
Maltese: Tel: +39 06 502601
English: The safety and efficacy of Glubrava in children and adolescents under 18 years of age have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Glubrava fit-tfal u adolexxenti taħt l-età ta' 18-il sena ma ġewx determinati s'issa.
English: Following administration of a dose of 850 mg, a 40% lower plasma peak concentration, a 25% decrease in AUC and a 35 min prolongation of time to peak plasma concentration was observed.
Maltese: Wara għoti ta' doża ta' 850 mg, kienu osservati tnaqqis ta' 40% fl-ogħla konċentrazzjoni fil-plażma, tnaqqis ta'25% fl-AUC u dewmien b'35 min sal-ħin beix tintlaħaq l-ogħla konċentrazzjoni fil-plażma.
English: Pioglitazone did not cause statistically significant increases in LDL-cholesterol levels compared with placebo, whilst reductions where 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: 6 A pooled analysis was conducted of adverse event reports 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: 6Twettqet analiżi ta' tagħrif miġbur ta' rapporti ta' avvennimenti avversi ta' fratturi tal-għadam minn provi kliniċi każwali, ikkontrollati b'paragun, u doppju għomja f'aktar minn 8,100 pazjent fil-gruppi kkurati b'pioglitazone u 7,400 pazjent fil-gruppi kkurati bi prodott paragun li damu sa 3.5 snin.
English: Pioglitazone or placebo was added to existing antidiabetic and cardiovascular therapy for up to 3.5 years.
Maltese: Pioglitazone jew plaċebo kienu miżjuda mat-terapija antidijabetika u kardjovaskulari eżistenti sa 3.5 snin.
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Maltese: TAL-UŻU SIGUR U EFFETTIV TAL-PRODOTT MEDIĊINALI
English: Glubrava should not be used in patients with hepatic impairment (see sections 4.3 and 4.4).
Maltese: Glubrava m'għandux jintuża f'pazjenti b'indeboliment epatiku (ara sezzjonijiet 4.3 u 4.4).
English: How to take Glubrava
Maltese: X'fih Glubrava
English: The maximum daily dose of metformin should preferably be divided into 2-3 daily doses.
Maltese: Id-doża massima ta' kuljum ta' metformin preferibbilment għandha tinqasam fi 2-3 dożi kuljum.
English: 4 Gastrointestinal disorders occur most frequently during initiation of therapy and resolve spontaneously in most cases.
Maltese: 4Disturbi gastro-intestinali jsseħħu l-aktar waqt il-bidu tat-terapija u f'ħafna każijiet jiġu riżolti spontanjament.
English: Fluid retention and cardiac failure
Maltese: Żamma ta' fluwidu u insuffiċjenza kardijaka
English: not known not known liver function tests abnormal5
Maltese: mhux magħruf mhux magħruf anormalitajiet fit-testijiet tal-funzjoni tal-fwied5
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 monoterapija 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: This can lead to a risk of hypoglycaemia (low blood sugar): - gemfibrozil (to lower high cholesterol level) - angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor antagonists (to treat high blood pressure) - cimetidine (to reduce stomach acid)
Maltese: Dan jista' jwassal għal riskju ta' ipogliċemija (zokkor baxx fid-demm): - gemfibrizol (biex ibaxxi livell għoli tal-kolesterol) - inibituri tal-enzima li tikkonverti lil angiotensin (ACE - angiotensin-converting enzyme) u antagonisti tar-riċetturi ta' angiotensin II (biex jikkuraw pressjoni għolja)
English: In an animal model of familial adenomatous polyposis (FAP), treatment with two other thiazolidinediones increased tumour multiplicity in the colon.
Maltese: F'mudell tal-annimali ta' adenomatous polyposis familjali (FAP), kura b'żewġ thiazolidinediones oħra żiedet il-multipliċità tat-tumuri fil-musrana.
English: Pioglitazone was devoid of genotoxic potential in a comprehensive battery of in vivo and in vitro genotoxicity assays.
Maltese: Pioglitazone ma kellux potenzjal ġenotossiku f'sensiela kompluta ta' analiżi ġenotossika in vivo u in vitro.
English: There have been no formal interaction studies for Glubrava.
Maltese: Ma twettaq l-ebda studju formali ta' interazzjoni għal Glubrava.
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-aċidi grassi ħielsa, u żied l-livelli ta' HDL kolesterol, meta mqabbel mal-plaċebo, metformin jew gliclazide.
English: Therapy with Glubrava 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'Glubrava m'għandiex tinbeda f'pazjenti b'livelli ta' l-enżimi tal-fwied fil-linja bażika miżjuda (ALT > 2.5 x l-ogħla limitu tan-normal) jew b'xi evidenza oħra ta' mard tal-fwied.
English: In patients on insulin with no pioglitazone the incidence of heart failure was 8.2% in those ≥ 65 years compared to 4.0% in patients less than 65 years.
Maltese: F'pazjenti fuq l-insulina mingħajr pioglitazone l-inċidenża ta'insuffiċjenza tal-qalb kienet 8.2% f'dawk ≥ 65 sena meta mqabbla ma' 4.0% f'pazjenti li għandhom inqas minn 65 sena.
English: Metformin partitions into erythrocytes.
Maltese: Metformin jitqassam fl-eritroċiti.
English: Therapy may be restarted no earlier than 48 hours following surgery or resumption of oral nutrition and provided that renal function has been re-evaluated and found to be stable.
Maltese: 48 siegħa wara l-kirurġija jew wara li tinbeda mill-ġdid nutrizzjoni orali u bil-patt li l-funzjoni renali tkun ġiet evalwata mill-ġdid u nstabet li hija stabbli.
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: 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,
English: Renal clearance of metformin is > 400 mL/min, indicating that metformin is eliminated by glomerular filtration and tubular secretion.
Maltese: Tneħħijja renali ta' metformin hija > 400 mL/min, u b'hekk tindika li metformin jitneħħa permezz ta' filtrazzjoni glomerulari u tneħħijja tubolari.
English: After 24 weeks of treatment, the primary endpoint of mean change from baseline in HbA1c was -1.83% in the combination group versus -0.96% in the pioglitazone group (p< 0.0001) and -0.99% in the metformin group (p< 0.0001).
Maltese: Wara 24 ġimgħa ta' kura, il-mira primarja tal-bidla medja mil-linja bażi f'HbA1c kienet -1.83% filgrupp ta' taħlita kontra -0.96% fil-grupp ta' pioglitazone (p<0.
English: General disorders and administration site conditions oedema7
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata edima7
English: What Glubrava looks like and contents of the pack The film-coated tablets (tablets) are white to off white, oblong, convex, embossed '15 / 850' on one face and ‘4833M' on the other.
Maltese: Il-pilloli miksija b'rita huma (pilloli) bojod għal abjad maħmuġ, oblung, bbuzzati fuq iż-żewġ naħat u mmarkati b'‘15/850' fuq naħa u b'‘4833M' fuq in-naħa l-oħra.
English: Animal studies have not revealed teratogenic effects or do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Maltese: Studji fuq l-annimali ma wrewx effetti teratoġeniċi jew ma urewx effetti ta' ħsara diretti jew indiretti rigward effett tossiku fuq is-sitema riproduttiva (ara sezzjoni 5.3).
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu
English: After an oral dose, the non-absorbed fraction recovered in faeces was 20-30%.
Maltese: Wara doża orali, il-frazzjoni mhux assorbita miġbura mill-ħmieġ kienet ta' 20-30%.
English: Thu. 1
Maltese: TL 1 TL 2
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