FrancophonIA/ELRC3.0 huggingface dataset:
English: Takeda Ireland Limited, Bray Business Park, Kilruddery, County Wicklow, Ireland Delpharm Novara S.r.l., Via Crosa, 86, I-28065 Cerano (NO), Italy Lilly S.A., Avda.
Maltese: Takeda Ireland Limited, Bray Business Park, Kilruddery, County Wicklow, L-Irlanda Delpharm Novara S.r.l., Via Crosa, 86, I-28065 Cerano (NO), L-Italja Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spanja
English: Takeda Pharma A/S Dybendal Alle 10 2630 Taastrup Denmark
Maltese: Takeda Pharma A/S Dybendal Alle 10 2630Taastrup Id-Danimarka
English: EU/1/06/354/001 14 tablets EU/1/06/354/002 28 tablets EU/1/06/354/003 30 tablets EU/1/06/354/004 50 tablets EU/1/06/354/005 56 tablets EU/1/06/354/006 60 tablets EU/1/06/354/007 90 tablets EU/1/06/354/008 98 tablets EU/1/06/354/010 112 tablets EU/1/06/354/009 180 tablets EU/1/06/354/012 60 x 1 tablets
Maltese: EU/1/06/354/001 14-il pillola EU/1/06/354/002 28 pillola EU/1/06/354/003 30 pillola EU/1/06/354/004 50 pillola EU/1/06/354/005 56 pillola EU/1/06/354/006 60 pillola EU/1/06/354/007 90 pillola EU/1/06/354/008 98 pillola EU/1/06/354/010 112 pillola EU/1/06/354/009 180 pillola EU/1/06/354/012 60 x 1 pillola
English: Microcrystalline cellulose Povidone (K30) Croscarmellose sodium Magnesium stearate
Maltese: Povidone (K30) Croscarmellose sodium Magnesium stearate
English: Maximum daily dose is 1,000 mg.
Maltese: Doża massima ta' kuljum hi 1,000 mg.
English: (ACE) inhibitors and angiotensin II receptor antagonists)
Maltese: (ACE) u antagonisti tar-riċetturi ta' angiotensin II)
English: common common alanine aminotransferase increased9
Maltese: komuni komuni żieda fl-aminotrasferasi alanine9
English: - The other ingredients are microcrystalline cellulose, povidone (K30), croscarmellose sodium magnesium stearate, hypromellose, macrogol 8000, talc and titanium dioxide (E171).
Maltese: − Is-sustanzi l-oħra huma mikrokristallina ċellulosi, povidone (K 30), croscarmellose sodium magnesium stearate, ipromellosi, macrogol 8000, talc u titanium dioxide (E171).
English: - The active substances are pioglitazone and metformin hydrochloride.
Maltese: − Is-sustanzi attivi pioglitazone u metformin hydrochloride.
English: They are supplied in aluminium/aluminium blisters in packs of 14, 28, 30, 50, 56, 60, 90, 98, 112, 180, multipacks of 196 (2 packs of 98) tablets or in aluminium/aluminium perforated unit dose blisters in packs of 60 x 1 tablets.
Maltese: Huma jiġu f'pakketti tal-aluminju/aluminju b'folji ta' 14, 28, 30, 50, 56, 60, 90, 98, 112, 180, pakketti multipli ta' 196 (2 pakketti ta' 98) pillola jew f'pakketti ta' folji pperforati ta' doża waħda ta' aluminju/aluminju ta' 60 x 1 pillola.
English: Multipack of 196 (2 packs of 98) tablets and aluminium/aluminium perforated unit dose blisters in pack of 60 x 1 tablets.
Maltese: Pakketti multipli ta' 196 (2 pakketti ta' 98) u folji tal-aluminju/aluminju perforati ta' doża waħda ta' 60 x 1 pillola.
English: Other medicines and Competact
Maltese: Mediċini oħra u Competact
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, dijuretiċi, acetylsalicylic acid, statins, fibrates).
English: Gastrointestinal disorders4
Maltese: Disturbi gastro-intestinali4
English: The fixed dose combination tablet of pioglitazone 15 mg/metformin 850 mg BID (N=201), pioglitazone 15 mg BID (N=189), and metformin 850 mg BID (N=210) were evaluated in type 2 diabetes mellitus patients with mean baseline HbA1c of 9.5% in a randomised double-blind, parallel-group study.
Maltese: Il-pillola b'doża kombinata fissa ta' pioglitazone 15 mg/metformin 850 mg BID (N = 201), pioglitazone 15 mg BID (N = 189), u metformin 850 mg BID (N = 210) kienu evalwati fi studju każwali doppju agħmi, u b'grupp parallelu, f'pazjenti b'dijabete mellitus tat-tip 2 b'medja ta' HbA1c fil-linja bażi ta' 9.5 %.
English: Risk related to metformin
Maltese: Riskju relatat ma' metformin
English: Competact with alcohol
Maltese: Competact ma' alkoħol
English: The safety and efficacy of Competact in children and adolescents under 18 years of age have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Competact fit-tfal u adolexxenti taħt l-età ta' 18-il sena ma ġewx determinati s'issa.
English: Multipack: 196 (2 packs of 98) film-coated tablets.
Maltese: Pakkett multiplu: 196 (2 pakketti ta' 98) pillola miksija b'rita.
English: EU/1/06/354/001 EU/1/06/354/002 EU/1/06/354/003 EU/1/06/354/004 EU/1/06/354/005 EU/1/06/354/006 EU/1/06/354/007 EU/1/06/354/008 EU/1/06/354/009 EU/1/06/354/010 EU/1/06/354/011 EU/1/06/354/012
Maltese: EU/1/06/354/006 EU/1/06/354/007 EU/1/06/354/008 EU/1/06/354/009 EU/1/06/354/010
English: - a significant reduction of the absolute risk of any diabetes-related complication in the metformin group (29.8 events/1,000 patient-years) versus diet alone (43.3 events/1,000 patient-years), p=0.0023, and versus the combined sulphonylurea and insulin monotherapy groups (40.1 events/1,000 patient-years), p=0.0034 - a significant reduction of the absolute risk of any diabetes-related mortality: metformin 7.5 events/1,000 patient-years, diet alone 12.7 events/1,000 patient-years, p=0.017 - a significant reduction of the absolute risk of overall mortality: metformin 13.5 events/1,000 patient-years versus diet alone 20.6 events/1,000 patient-years, (p=0.011), and versus the combined sulphonylurea and insulin monotherapy groups 18.9 events/1,000 patient-years (p=0.021)
Maltese: - tnaqqis sinifikanti tar-riskju assolut ta' kull kumplikazzjoni relatata ma' dijabete fil-grupp b'metformin (29.8 episodju/1,000 pazjent-snin) kontra l-grupp b'dieta biss (43.3 episodju/1,000 pazjent-snin), p = 0.0023, u kontra l-gruppi ta' monoterapija b'sulphonylurea u b'insulina kombinati (40.1 episodju/1,000 pazjent-snin), p = 0.0034 - tnaqqis sinifikanti fir-riskju assolut ta' kull mortalità relatata ma' dijabete: metformin 7.5 episodji/1,000 pazjent-snin, dieta biss 12.7 episodji/1,000 pazjent-snin, p = 0.
English: Frequency of adverse reactions Pioglitazone Metformin Competact
Maltese: Pioglitazone Metformin Competact
English: Small clinical trials have not revealed metformin to have malformative effects.
Maltese: Provi kliniċi żgħar ma wrewx li metformin għandu effetti malformattivi.
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: Date of first authorisation: 28/07/2006 Date of latest renewal: 25/04/2016
Maltese: Data tal-aħħar tiġdid: 25/04/2016
English: Competact contains pioglitazone and metformin.
Maltese: Competact fih pioglitazon u metformin.
English: Via Crosa, 86
Maltese: Delpharm Novara S.r.l. Via Crosa, 86
English: Immune System Disorders hypersensitivity and allergic reactions1
Maltese: Disturbi fis-sistema immuni sensittività eċċessiva u reazzjonijiet allerġiċi1 mhux magħruf mhux magħruf
English: Renal function
Maltese: Fuzjoni renali
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: As metformin is excreted via the kidney, and elderly patients have a tendency to decreased renal function, elderly patients taking Competact 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 Competact għandu jkollhom il-funzjoni renali tagħhom sorveljat b'mod regolari (ara sezzjonijiet 4.3 u 4.4).
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 % fil-grupp ta' taħlita kontra -0.96 % fil-grupp ta' pioglitazone (p < 0.0001) u -0.99 % fil-grupp ta' metformin (p < 0.0001).
English: Thu. 1
Maltese: T 1
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 orali, cyclosporin, imblokkaturi tal-kanali tal-kalċju, u inibituri ta' HMGCoA reductase.
English: It is especially important to mention the following: - gemfibrozil (used to lower cholesterol) - rifampicin (used to treat tuberculosis and other infections) - cimetidine (used to reduce stomach acid) - glucocorticoids (used to treat inflammation) - beta-2-agonists (used to treat asthma) - medicines which increase urine production (diuretics) - medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors, such as ibuprofen and celecoxib) - certain medicines for the treatment of high blood pressure (angiotensin-converting enzyme
Maltese: Huwa importanti ħafna li wieħed isemmi dan li ġej: - gemfibrizol (użat biex ibaxxi l-kolesterol) - rifampicin (użat biex jikkura it-tuberkulożi u nfezzjonijiet oħra) - cimetidine (użat biex tnaqqas l-aċidu fl-istonku) - glukokortikojdi (użati biex jikkuraw infjammazzjoni) - agonisti tat-tip beta-2 (użati biex jikkuraw l-ażżma) - mediċini li jżidu l-produzzjoni tal-awrina (dijuretiċi) - mediċini użati biex jittrattaw l-uġigħ u l-infjammazzjoni (NSAID u inibituri ta' COX-2, bħal ibuprofen u celecoxib)
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: 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: kontroll (7 każijiet minn 10,212 pazjent, 0.07 %) HR = 2.64 (95 % CI 1.11-6.31, p = 0.029).
English: 60 x 1 tablets
Maltese: 112 pillola 180 pillola 60 x 1 pillola
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: The recommended dose of Competact is 30 mg/day pioglitazone plus 1,700 mg/day of metformin hydrochloride (this dose is achievable with one tablet of Competact 15 mg/850 mg, taken twice a day).
Maltese: Id-doża rakkomandata ta' Competact hija ta' pioglitazone 30 mg/kuljum flimkien ma' metformin idrokloridu 1,700 mg/kuljum (din id-doża tintlaħaq minn pillola waħda ta' Competact 15 mg/850 mg, darbtejn kuljum).
English: Pioglitazone and metformin combination
Maltese: pioglitazone u metformin
English: Competact 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: Competact 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: Thu. 2
Maltese: T 2
English: Hepatic impairment
Maltese: Infezzjoni severa
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: 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: Avoid excessive alcohol intake while taking Competact 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 Competact peress li dan jista' jżid ir-riskju ta' aċidożi lattika (ara s-sezzjoni “Riskju ta' aċidożi lattika”).
English: Fri.
Maltese: tqala.
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 ta'
English: Some medicinal products that can adversely affect renal function which may increase the risk of lactic acidosis, e.g. NSAIDS, including selective cyclo-oxygenase (COX) II inhibitors, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists and diuretics, especially loop diuretics.
Maltese: NSAIDs, inklużi inibituri selettivi ta' cyclo-oxygenase (COX) II, inibituri talenzima li tikkonverti angiotensin (ACE, angiotensin-converting enzyme), antagonisti tar-riċetturi ta'
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: No animal studies have been conducted with the combined products in Competact.
Maltese: Ma sarux studji fuq l-annimali bil-prodotti kombinati Competact.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL (WITH BLUE BOX) MULTIPACKS ONLY (2 x 98 TABLETS)
Maltese: TIKKETTA TA' BARRA (BIL-KAXXA BLU) PAKKETTI MULTIPLI BISS (2 x 98 PILLOLA)
English: At the initiation of the treatment abdominal pain, diarrhoea, loss of appetite, nausea and vomiting may occur, these reactions are very common but usually disappear spontaneously in most cases.
Maltese: Fil-bidu tal-kura jista' jkun hemm uġigħ addominali, dijarea, nuqqas t'aptit, dardir u rimettar, dawn ir-reazzjonijiet huma komuni ħafna imma normalment jintemmu b'mod spontanju fil-biċċa l-kbira ta' każijiet.
English: Vitamin B12 absorption decreased2
Maltese: B12 fid-demm
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: 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 stabbli jintlaħqu f'madwar 24-48 siegħa u ġeneralment huma inqas minn 1 µg/mL.
English: Competact 15 mg/850 mg tablets pioglitazone/metformin hydrochloride
Maltese: Competact 15 mg/850 mg pilloli miksija b'rita pioglitazone/metformin idrokloridu
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 għall-edima f'2.2 % tal-pazjenti.
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-għola dożi.
English: Nervous system disorders hypo-aesthesia common common insomnia uncommon uncommon headache common taste disturbance common common
Maltese: Disturbi fis-sistema nervuża ipoesteżija komuni komuni insonnja mhux komuni mhux komuni uġigħ ta' ras komuni disturbi fit-togħma komuni komuni
English: recent myocardial infarction, shock - Hepatic impairment - Acute alcohol intoxication, alcoholism - Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis) - Diabetic pre-coma - Severe renal failure (GFR < 30 mL/min)
Maltese: - Intossikazzjoni akuta ta' alkoħol, alkoħoliżmu - Kull tip ta' aċidożi metabolika akuta (bħal aċidożi lattika, ketoaċidożi dijabetika)
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 %; ksur 1.0 għal kull 100 sena ta' pazjent) tal-pazjenti nisa kkurati b'pioglitazone kellhom esperjenza ta' fratturi meta mqabbel ma' 23/905 (2.5 %; 0.5 ksur għal kull mitt sena ta' pazjent) tal-pazjenti nisa kkurati bi prodott paragun.
English: How to take Competact
Maltese: Tiħux Competact :
English: not known not known liver function tests abnormal5
Maltese: mhux magħruf mhux magħruf anormalitajiet fit-testijiet tal-funzjoni talfwied5
English: Musculoskeletal and connective tissue disorders bone fracture6
Maltese: Disturbi muskolu-skeletrali u tat-tessuti konnettivi ksur ta' għadam6
English: Hepatobiliary disorders hepatitis5
Maltese: Pazjenti b'indeboliment epatiku
English: Lactic acidosis is a serious reaction which may occur very rarely (< 1/10,000) (see section 4.4) and other reactions such as bone fracture, weight increase and oedema may occur commonly (≥ 1/100 to < 1/10) (see section 4.4).
Maltese: Aċidożi lattika hi reazzjoni serja li tista' sseħħ b'mod rari ħafna (< 1/10,000) (ara sezzjoni 4.4) u reazzjonijiet oħra bħal fratturi tal-għadam, żieda fil-piż u edima jistgħu jseħħu b'mod komuni (≥ 1/100 sa < 1/10) (ara sezzjoni 4.4).
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: 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: FOR CALENDARISED PACKS: 7 Tablet blister
Maltese: Folja b'7 pilloli
English: 5 How to store Competact Contents of the pack and other information
Maltese: Kontenut tal-pakkett u informazzjoni oħra
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: 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' tneħħijja tubolari renali (e.ż. cimetidine) jistgħu jinteraġixxu ma' metformin billi jikkompetu għal sistemi komuni ta' trasport tubolari renali.
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 fl-emoglobina ta' 3-4 % u fl-ematokrita ta' 3.6-4.1 %).
English: As Competact contains metformin hydrochloride,it must be discontinued at the time of surgery under general, spinal or epidural anesthesia.
Maltese: Peress li Competact fih metgormin hydrochloride, dan għandu jitwaqqaf fi żmien il-kirurġija taħt anestesija ġenerali, spinali jew epidurali.
English: 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 (pilloli) huma 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 shown teratogenic effects but have shown foetotoxicity related to the pharmacologic action (see section 5.3).
Maltese: Studji fuq l-annimali ma wrewx effetti teratoġeniċi iżda wrew effett tossiku fuq il-fetu relatat mal-azzjoni farmakoloġika (ara sezzjoni 5.3).
English: 6 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: 6Twettqet analiżi ta' tagħrif miġbur ta' rapporti ta' reazzjonijiet 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: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (WITH BLUE BOX) (EXCLUDING MULTIPACKS)
Maltese: KARTUNA (BIL-KAXXA BLU) (MINBARRA PAKKETTI
English: Each tablet contains 15 mg of pioglitazone (as hydrochloride) and 850 mg of metformin hydrochloride.
Maltese: Kull pillola fiha 15 mg ta' pioglitazone (bħala idrokloridu) u 850 mg metformin idrokloridu.
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 għotja ta' doża ta' 850 mg, kienu osservati tnaqqis ta' 40 % fl-għola konċentrazzjoni fil-plażma, tnaqqis ta'25 % fl-AUC
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: (induttur taċ-ċitokromju P450 2C8) twassal għal tnaqqis ta' 54 % fl-AUC ta' pioglitazone.
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: Competact may cause a very rare (may affect up to 1 in 10,000), but very serious side effect called lactic acidosis (see section “Risk of lactic acidosis”).
Maltese: Competact jista' jikkawża effett sekondarju rari ħafna, (jista' jaffettwa sa persuna 1 minn kull 10,000 li qed jużawh), iżda serju ħafna li jissejjaħ aċidożi lattika (ara s-sezzjoni “Riskju ta' aċidożi lattika”).