FrancophonIA/ELRC3.0 huggingface dataset:
English: In another study it was shown that administering clopidogrel and omeprazole 12 hours apart did not prevent their interaction that is likely to be driven by the inhibitory effect of omeprazole on CYP2C19.
Maltese: Fi studju ieħor deher li l-amministrazzjoni ta' clopidogrel u omeprazole 12-il siegħa il-bogħod minn xulxin ma jipprevjenux interazzjoni tagħhom li x'aktarx li tiġi mill-effett inibitorju ta' omeprazole fuq CYP2C19.
English: Clopidogrel has been evaluated for safety in more than 42,000 patients who have participated in clinical studies, including over 9,000 patients treated for 1 year or more.
Maltese: Clopidogrel ġie evalwat għas-sigurtà f'iktar minn 42,000 pazjent li pparteċipaw fi studji kliniċi, inklużi iktar minn 9,000 pazjent li kienu kkurati bih għal sena jew iktar.
English: The PSUR submission schedule for Clopidogrel Teva Generics B.V. should follow the PSURs submission schedule for the reference medicinal product.
Maltese: Minbarra l-esperjenza tal-istudji kliniċi, reazzjonijiet avversi ġew ukoll irrapportati b'mod spontanju.
English: NAME OF THE MEDICINAL PRODUCT Clopidogrel Teva Generics B.V. 75 mg film-coated tablets
Maltese: IL-PRODOTT MEDIĊINALI Clopidogrel Teva Generics B.V. 75 mg pilloli miksija b'rita
English: You have been prescribed Clopidogrel Teva Generics B.V. to help prevent blood clots and reduce the risk of these severe events because: - You have a condition of hardening of arteries (also known as atherosclerosis), and - You have previously experienced a heart attack, stroke or have a condition known as peripheral arterial disease, or - You have experienced a severe type of chest pain known as ‘unstable angina' or ‘myocardial infarction' (heart attack).
Maltese: - Għandek kundizzjoni fejn l-arterji tiegħek qegħdin jibbiesu (magħrufa wkoll bħala aterosklerożi), u - Kellek attakk tal-qalb, puplesija jew kundizzjoni magħrufa bħala mard periferali arterjali, jew - Kellek uġigħ sever f'sidrek magħruf bħala anġina mhux stabbli jew infart mijokardijaku (attakk ta' qalb).
English: NAME OF THE MEDICINAL PRODUCT Clopidogrel Teva Generics B.V. 75 mg film-coated tablets Clopidogrel
Maltese: TAL-PRODOTT MEDIĊINALI Clopidogrel Teva Generics B.V. 75 mg pillola miksija b'rita Clopidogrel
English: This was consistent across subgroups of patients defined by baseline characteristics, and type of fibrinolytic or heparin therapy.
Maltese: Dan kien konsistenti fil-firxa ta' sottogruppi ta' pazjenti migbura skont linja bażi ta' karatteristiċi u t-tip ta' terapija fibrinolitika jew bil-heparin.
English: In the intention to treat analysis, 939 events were observed in the clopidogrel group and 1,020 events with ASA (relative risk reduction (RRR) 8.7%, [95% CI: 0.2 to 16.4]; p = 0.045), which corresponds, for every 1,000 patients treated for 2 years, to 10 [CI: 0 to 20] additional patients being prevented from experiencing a new ischaemic event.
Maltese: Fl-analiżi ta' l-intenzjoni tal-kura, ġew osservati 939 avveniment fil-grupp ta' clopidogrel u 1 020 avveniment b'ASA (tnaqqis tar-riskju relattiv (RRR) ta' 8.7%, [95% CI: minn 0.2 għal 16.4]; p = 0.
English: Since clopidogrel is metabolised to its active metabolite partly by CYP2C19, use of medicinal products that inhibit the activity of this enzyme would be expected to result in reduced drug levels of the active metabolite of clopidogrel.
Maltese: Peress li parti mill-metaboliżmu ta' clopidogrel għall-metabolit attiv tiegħu jsir minn CYP2C19, huwa mistenni li l-użu tal-prodotti mediċinali li jinibixxu l-attività ta' din l-enzima jwasslu għal tnaqqis fillivell tal-metabolit attiv ta' clopidogrel.
English: Tel.: +(48) 22 345 93 00
Maltese: Teva Pharmaceuticals Polska Sp. z o.o. Tel.: +(48) 22 345 93 00
English: As with other antiplatelet agents, clopidogrel should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery or other pathological conditions and in patients receiving treatment with ASA, heparin, glycoprotein IIb/IIIa inhibitors or non-steroidal anti-inflammatory drugs (NSAIDs) including Cox-2 inhibitors.
Maltese: Bħal fil-każ ta' sustanzi oħra kontra l-plejtlets, clopidogrel għandu jintuża b'kawtela f'pazjenti li jista' jkollhom riskju ta' iktar dmija minn trawma, operazzjoni jew kundizzjonijiet patoloġiċi oħra u pazjenti li jkunu qed jirċievu l-kura b'ASA, heparin, inibituri ta' glycoprotein IIb/IIIa jew mediċini kontra l-infjammazzjoni li m'humiex sterojdi (NSAIDs) li jinkludu l-inibituri ta' Cox-2.
English: • Hypersensitivity to the active substance or to any of the excipients.
Maltese: • Sensittività eċċessiva għas-sustanza attiva jew għal xi sustanzi mhux attivi.
English: Do not take Clopidogrel Teva Generics B.V.
Maltese: X'fih Clopidogrel Teva Generics B.V.
English: The most common side effect (affects 1 to 10 patients in 100) reported with Clopidogrel Teva Generics B.V. is bleeding.
Maltese: L-iżjed effett komuni (jaffettwa minn 1 sa 10 pazjenti minn kull 100) irrappurtat b'Clopidogrel Teva Generics B.V. hija l-fsada.
English: Important information about some of the ingredients of Clopidogrel Teva Generics B.V. Clopidogrel Teva Generics B.V. contains hydrogenated castor oil which may cause stomach upset and diarrhoea.
Maltese: Ma ġiex osservat effett fuq l-enzimi metabolizzanti tal-fwied fi bnedmin li kienu qed jingħataw clopidogrel b'doża terapewtika.
English: Acetylsalicylic acid (ASA): ASA did not modify the clopidogrel-mediated inhibition of ADP-induced platelet aggregation, but clopidogrel potentiated the effect of ASA on collagen-induced platelet aggregation.
Maltese: It-teħid flimkien ma' heparin ma kellu l-ebda effett fuq l-inibizzjoni tal-aggregazzjoni tal-plejtlets indott minn clopidogrel.
English: HOW TO TAKE CLOPIDOGREL TEVA GENERICS B.V.
Maltese: QABEL MA TIEĦU CLOPIDOGREL TEVA GENERICS B.V.
English: BEFORE YOU TAKE CLOPIDOGREL TEVA GENERICS B.V.
Maltese: Meta tieqaf tieħu Clopidogrel Teva Generics B.V.
English: Common side effects (affects 1 to 10 patients in 100): Diarrhoea, abdominal pain, indigestion or heartburn.
Maltese: Effetti sekondarji komuni (jaffettwaw minn 1 sa 10 pazjenti minn kull 100):
English: Other medicinal products:
Maltese: Farmakoġenetika:
English: The results obtained in populations with different characteristics (e.g. unstable angina or non-Q-wave MI, low to high risk levels, diabetes, need for revascularisation, age, gender, etc.) were consistent with the results of the primary analysis.
Maltese: Ir-riżultati f'popolazzjonijiet b'karatteristiċi differenti (eż. anġina instabbli jew MI ta' mewġa mhux Q, minn livelli baxxa sa għolja ta' riskju, dijabete, il-bżonn ta' revaskularizzazzjoni, eta`, sess eċċ.) kienu konsistenti mar-riżultati tal-analiżi primarja.
English: The relative difference in antiplatelet response between genotype groups varies across studies depending on the method used to evaluate response, but is typically greater than 30%.
Maltese: Id-differenza relattiva fir-rispons kontra l-plejtlits bejn il-gruppi ta' ġenotipi jvarja minn studju għal ieħor skont ilmetodu użat biex jiġi evalwat ir-rispons, iżda ġeneralment huwa iżjed minn 30 %.
English: Other concomitant therapy:
Maltese: Meta tieħu mediċini oħra:
English: What Clopidogrel Teva Generics B.V. contains - The active substance is clopidogrel.
Maltese: Is-sustanza attiva hi clopidogrel.
English: If you have experienced severe chest pain (unstable angina or heart attack), you may be prescribed clopidogrel in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever.
Maltese: Jekk ħassejt uġigħ qawwi f'sidrek (anġina mhux stabbli jew attakk tal-qalb), jista' jingħatalek clopidogrel flimkien ma' acetylsalicylic acid, sustanza inkorporata f'ħafna mediċini użati biex itaffu l-uġigħ u jnaqqsu d-deni.
English: The final study report should be submitted to the National Competent Authorities by December 2016.
Maltese: Ir-rapport finali tal-istudju għandu jkun ippreżentat lill-Awtoritajiet Nazzjonali Kompetenti sa Diċembru 2016.
English: A case-control study shall be performed to further investigate the possibility of an association between pholcodine use and NMBA-related anaphylactic reactions.
Maltese: Għandu jsir studju ta' kontroll tal-każ sabiex tiġi investigata aktar il-possibbiltà ta' rabta bejn l-użu tal-folkodina u reazzjonijiet anafilattiċi relatati mal-NMBAs.
English: National Competent Authorities, coordinated by the Reference Member State where applicable, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
Maltese: L-Awtoritajiet Nazzjonali Kompetenti, ikkoordinati mill-Istat Membru ta' Referenza fejn applikabbli, għandhom jiżguraw li l-kundizzjonijiet li ġejjin jiġu ssodisfati mid-Detenturi tal-Awtorizzazzjoni għat-Tqegħid fis-Suq:
English: Annex III Conditions of the marketing authorisation
Maltese: Anness III Kundizzjonijiet tal-awtorizzazzjoni għat-tqegħid fis-suq
English: A draft protocol should be submitted to CHMP for assessment and approval within 3 months of the Commission Decision.
Maltese: Abbozz ta' protokoll għandu jiġi ppreżentat lis-CHMP għall-evalwazzjoni u għall-approvazzjoni fi żmien tliet (3) xhur mid-Deċiżjoni tal-Kummissjoni.
English: 31-546, Krakow Poland
Maltese: 31-546, Krakow Il-Polonja
English: Balkanpharma Dupnitsa AD 3 Samokovsko Shosse Str., Dupnitsa 2600, Bulgaria
Maltese: Balkanpharma Dupnitsa AD 3 Samokovsko Shosse Str., Dupnitsa 2600, Il-Bulgarija
English: Teva Operations Poland Sp z.o.o.
Maltese: Teva Operations Poland Sp z.o.o. ul.
English: No data are available.
Maltese: M'hemmx dejta disponibbli.
English: Merckle GmbH Ludwig-Merckle Strasse 3 89143 Blaubeuren Germany
Maltese: Merckle GmbH Ludwig-Merckle Strasse 3 89143 Blaubeuren
English: България Тева Фармасютикълс България ЕООД
Maltese: Тева Фармасютикълс България ЕООД Teл.:
English: 14 tablets 28 tablets 30 tablets 50 tablets 56 tablets 84 tablets 90 tablets 98 tablets 112 tablets 196 tablets
Maltese: 14-il pillola 28 pillola 30 pillola 50 pillola 56 pillola 84 pillola 90 pillola 98 pillola 112-il pillola 196 pillola
English: Immune System Disorders hypersensitivity and allergic reactions1
Maltese: Disturbi fissistema immuni sensittività eċċessiva u reazzjonijiet allerġiċi1
English: Brampton Road, Hampden Park, Eastbourne, East Sussex - BN22 9AG United Kingdom
Maltese: Brampton Road, Hampden Park, Eastbourne, East Sussex - BN22 9AG Ir-Renju Unit
English: 2031GA Haarlem Netherlands
Maltese: 2031GA Haarlem The Netherlands
English: This check may be repeated at intervals.
Maltese: Dan il-kontroll jista' jkun ripetut f'intervalli.
English: Aluminium/aluminium blisters, packs of 14, 28, 30, 50, 56, 84, 90, 98, 112 and 196 tablets
Maltese: Folji tal-aluminju/aluminju, pakketti ta' 14, 28, 30, 50, 56, 84, 90, 98, 112 u 196 pillola.
English: Cases of bladder cancer were reported more frequently in a meta-analysis of controlled clinical trials with pioglitazone (19 cases from 12506 patients, 0.15%) than in control groups (7 cases from 10212 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 12506 pazjent, 0.15%) milli fil-gruppi ta' kontroll (7 każijiet minn 10212 pazjent, 0.07%) HR = 2.64 (95% CI 1.11-6.31, p = 0.029).
English: Date of first authorisation: 26 March 2012 Date of latest renewal: 17 February 2017
Maltese: Data ta' l-ewwel awtorizzazzjoni: 26 ta' Marzu 2012
English: - The other ingredients are mannitol, carmellose calcium, hydroxypropylcellulose and magnesium stearate.
Maltese: - Is-sustanzi l-oħra huma mannitol, carmellose calcium, hydroxypropylcellulose u magnesium stearate.
English: - The active substance is pioglitazone.
Maltese: - Is-sustanza attiva hija pioglitazone.
English: Three of the six identified metabolites are active (M-II, M-III, and M-IV).
Maltese: Tlieta mis-sitt metaboliti identifikati huma attivi (M-II, M
English: Teva Norway AS Tlf: +47 66 77 55 90
Maltese: Tlf: +47 66 77 55 90
English: Teva Pharma, S.L.U.
Maltese: Teva Pharma, S.
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: 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: pioglitazone mhux mibdul fil-bniedem hija 5 sa 6 sigħat u għall-metaboliti attivi kollha tiegħu, 16 sa 23 siegħa.
English: The estimated volume of distribution in humans is 0.25 l/kg.
Maltese: Il-volum stmat ta' distribuzzjoni fil-bnedmin huwa ta' 0.25 l/kg.
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/creatinine meta mqabbel mal-linja bażika.
English: Pioglitazone Teva 15 mg tablets EU/1/12/757/001-010
Maltese: Pioglitazone Teva 15 mg pilloli EU/1/12/757/001-010
English: Pioglitazone Teva 30 mg tablets EU/1/12/757/011-020
Maltese: Pioglitazone Teva 30 mg pilloli EU/1/12/757/011-020
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 t-twaqqif tal-kura.
English: See section 4.2 for information on paediatric use.
Maltese: Ara sezzjoni 4.2 għall-aktar informazzjoni fuq l-użu pedjatriku.
English: The study population had an average age of 62 years; the average duration of diabetes was 9.5 years.
Maltese: Il popolazzjoni taħt studju kellha eta' medja ta' 62 sena; it-tul medju tad-dijabete kienet ta' 9.5 snin.
English: This is similar to that seen in a sulphonylurea active comparator group.
Maltese: Dan huwa simili għal dak sservat fi grupp attiv ta' paragun b'sulphonylurea.
English: Similar changes were seen in metformin (haemoglobin 3-4% and haematocrit 3.6-4.1% relative reductions) and to a lesser extent sulphonylurea and insulin (haemoglobin 1-2% and haematocrit 1-3.2% relative reductions) treated patients in comparative controlled trials with pioglitazone.
Maltese: Tibdiliet simili dehru fi provi kkontrollati komparattivi b'pioglitazone f'pazjenti kkurati b'metformin (tnaqqis relattiv fl-emoglobina 3 - 4% u fl-ematokrita 3.6 - 4.1%) u fi kwantità inqas b'sulphonylurea u bl-insulina (tnaqqis relattiv fl-emoglobina 1 - 2 % u fl-ematokrita 1 - 3.2%).
English: - The tablets are supplied in blisters in packs of 14, 28, 30, 50, 56, 84, 90, 98, 112 or 196 tablets.
Maltese: - Il-pilloli huma disponibbli f'folji f'pakketti ta' 14, 28, 30, 50, 56, 84, 90, 98 u 112 jew 196 pillola.
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: Pioglitazone Teva 45 mg tablets EU/1/12/757/021-030
Maltese: Pioglitazone Teva 45 mg pilloli EU/1/12/757/021-030
English: PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties
Maltese: FARMAKOLOĠIKU 5.1 Tagħrif farmakodinamiku
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: infart mijokardiku, puplesija, intervent kardijaku perkutanju jew bypass bi graft tal-arterja koronarja, sindromu koronarju akut, mard koronarju arterjali, jew mard tal-arterji periferali miżduda.
English: Pioglitazone Teva contains pioglitazone.
Maltese: Pioglitazone Teva fih is-sustanza attiva pioglitazone.
English: Investigations weight increased6 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: Fri.
Maltese: reductase.
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: Ear and labyrinth disorders vertigo uncommon
Maltese: Disturbi filwidnejn u fissistema labirintika vertigo mhux komuni
English: OTHER (FOR CALENDARISED PACKS)
Maltese: OĦRAJN (GĦAL PAKKETTI KALENDARJI)
English: Pioglitazone Teva 15 mg tablets Pioglitazone Teva 30 mg tablets Pioglitazone Teva 45 mg tablets
Maltese: Pioglitazone Teva 15 mg pilloli Pioglitazone Teva 30 mg pilloli Pioglitazone Teva 45 mg pilloli
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: 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: This leaflet was last revised in {MM/YYYY}.
Maltese: DATA TA' META ĠIET RIVEDUTA
English: Steady state pharmacokinetics are similar in patients age 65 and over and young subjects.
Maltese: Anzjani Il-farmakokinetika fi stat stabbli ta' pazjenti b'eta' ta' 65 sena jew aktar hija simili għal dik f'pazjenti żgħar.
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, ilkonċentrazzjoni fil-plażma ta' pioglitazone (ara sezzjoni 4.5).
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: l-Aġenzija Ewropeja dwar il-Mediċini http://www.ema.europa.eu.
English: - metformin and a sulphonylurea, in adult patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy.
Maltese: - metformin u mediċina tat-tip sulphonylurea, f'pazjenti adulti (speċjalment pażjenti b'piż żejjed) b'kontroll gliċemiku insuffiċjenti minkejja terapija doppja mill-ħalq.
English: Do not use this medicine after the expiry date which is stated on the carton and the blister after “EXP”.
Maltese: Tużax din il- mediċina wara d-data ta' skadenza li tidher fuq il-kartuna u l-folja wara “EXP”.
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-sensittività għall-insulina tal-fwied, xaħam u ċelloli tal-muskoli skeletrali fl-annimali.
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 huwa antiċipat mill-użu kliniku ta' pioglitazone.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Maltese: 6.1 Lista ta' sustanzi mhux attivi
English: Pioglitazone should not be used in patients with hepatic impairment (see section 4.3 and 4.4).
Maltese: Pioglitazone m'għandux jintuża f'pazjenti b'indeboliment epatiku (ara sezzjoni 4.3 u 4.4).
English: Tablet
Maltese: KARTUNA
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: 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' kreatinina > 4 ml/min) (ara sezzjoni 5.2).
English: 5 Oedema was reported in 6-9% of patients treated with pioglitazone over one year in controlled clinical trials.
Maltese: Edima kienet irrappurtata f'6-9% tal-pazjenti kkurati b'pioglitazone fuq medda ta' sena fi provi kliniċi kkontrollati.
English: In comparator groups addition of sulphonylurea to metformin resulted in a mean weight gain of 1.3 kg and addition of metformin to a sulphonylurea a mean weight loss of 1.0 kg.
Maltese: Fi gruppi ta' paragun, iż-żieda ta' sulphonylurea ma' metformin wasslet għall-żieda medja fil-piż ta' 1.3 kg u ż-żieda ta' metformin ma' sulphonylurea għall-tnaqqis medju fil-piż ta' 1.0 kg.
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 sulphonylureas ma tidhirx li taffettwa il-farmakokinetika tal-mediċini tat-tip sulphonylurea.
English: - in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance 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 as triple oral therapy in combination with
Maltese: - 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 kombinat ma'
English: This is the diabetes that usually develops in adulthood.
Maltese: Din hija d-dijabete li ġeneralment tiżviluppa fi stat adult.
English: In a two-year study of combination therapy comparing pioglitazone with gliclazide when added to metformin, glycaemic control measured as mean change from baseline in HbA1c was similar between treatment groups after one year.
Maltese: Fi studju ta' sentejn b'terapija kombinata li qabbel pioglitazone ma' gliclazide meta miżjuda ma' metformin, il-kontroll gliċemiku mkejjel bħala it-tibdil medju mill-linja bażika ta' HbA1c kien simili bejn il-gruppi ta' kura wara lewwel sena.
English: Gastrointestinal disorders flatulence uncommon common
Maltese: Disturbi gastrointestinali gass mhux komuni
English: If ALT levels remain > 3 X the upper limit of normal, therapy should be discontinued.
Maltese: Jekk il-livelli ta' ALT jibqgħu > 3 X l-għola limitu tan-normal, it-terapija għandha titwaqqaf.