FrancophonIA/ELRC3.0 huggingface dataset:
English: The red blood cells most likely represent a secondary compartment of distribution.
Maltese: Iċ-ċelloli ħomor tad-demm jirrappreżentaw wisq probabbli kompartiment sekondarju ta' distribuzzjoni.
English: Film coat
Maltese: Żieda fil-piż
English: If 3 to 6 months after starting Glubrava your sugar control is not improved, the medicine should be discontinued.
Maltese: Jekk 3 sa 6 xhur wara li tibda Glubrava il-kontroll taz-zokkor tiegħek ma jitjiebx, il-mediċina għandha titwaqqaf.
English: Suomi/Finland Takeda Oy
Maltese: Takeda Oy
English: 8 In active comparator controlled trials mean weight increase with pioglitazone given as monotherapy was 2-3 kg over one year.
Maltese: 8Fi 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: Taking into account the PRAC Assessment Report on the PSUR(s) for glimepiride / pioglitazone hydrochloride, metformin / pioglitazone, pioglitazone, the scientific conclusions of CHMP are as follows:
Maltese: Meta jiġi kkunsidrat ir-Rapport ta' Valutazzjoni tal-PRAC dwar il-PSURs għal glimepiride/pioglitazone hydrochloride, metformin / pioglitazone, pioglitazone, il-konklużjonijiet xjentifiċi tas-CHMP huma kif ġejjin:
English: Other medicines and Glubrava
Maltese: Mediċini oħra u Glubrava
English: These effects were independent of pioglitazone's effects on glycaemia and were statistically significantly different to glibenclamide.
Maltese: Dawn l-effetti kienu indipendenti mill-effetti ta' pioglitazone fuq il-gliċemija u kienu differenti b'mod statistikament sinifikanti minn dawk ta' glibenclamide.
English: The effect of pioglitazone (45 mg monotherapy vs. placebo) was studied in a small 18-week trial in type 2 diabetics.
Maltese: L-effett ta' pioglitazone (45 mg monoterapija vs. plaċebo) kien studjat fi prova żgħira ta' 18-il ġimgħa f'pazjenti bid-dijabete tat-tip 2.
English: These reactions include anaphylaxis, angioedema, and urticaria.
Maltese: Dawn ir-reazzjonijiet jinkludu anafilassi, anġjoedima u urtikarja.
English: If no adequate strength of Glubrava is available, individual monocomponents should be used instead of the fixed dose combination.
Maltese: Jekk ma tkunx disponibbli qawwa adegwata ta' Glubrava, għandhom jiġu użati monokomponenti individwali minflok il-kombinazzjoni ta' doża fissa.
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: Huwa rrappurtat li l-għoti ta' pioglitazone flimkien ma' rifampicin (induttur taċ-ċitokromju P450 2C8) twassal għal tnaqqis ta' 54% fl-AUC ta' pioglitazone.
English: Blood and lymphatic system disorders anaemia common
Maltese: Disturbi tad-demm u tassistema limfatika anemija komuni
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 bażi ta' HbA1c kien simili bejn il-gruppi ta' kura wara l-ewwel sena.
English: Each tablet contains 15 mg pioglitazone (as hydrochloride) and 850 mg metformin hydrochloride.
Maltese: Kull pillola fiha 15 mg ta' pioglitazone (bħala idrokloridu) u 850 mg metformin idrokloridu.
English: No increase in fracture rates was observed in men treated with pioglitazone (1.3%) versus comparator (1.5%).
Maltese: Ma kienux osservati żidiet fir-rati ta' fratturi fl-irġiel kkurati b'pioglitazone (1.3%) meta mqabbel mal-prodott ta' paragun (1.5%).
English: CARTON
Maltese: TIKKETTAR
English: Film-coated tablet (tablet).
Maltese: Ma ġewx identifikati metaboliti fil-bnedmin.
English: Fertility of male or female rats was unaffected by metformin when administered at doses as high as 600 mg/kg/day, which is approximately three times the maximum recommended human daily dose based on body surface area comparisons.
Maltese: Il-fertilità fil-ferien maskili jew femminili ma kienitx effettwata bil-metforminmeta ingħatat f'dożi għolja sa 600 mg/kg/jum, li hi bejn wieħed u ieħor tliet darbiet tad-doża massima ta' kuljum fl-umani rrakkomandata bbażata fuq tqabbil tal-erja superfiċje tal-ġisem.
English: Tabulated list of adverse reactions
Maltese: Lista f'forma tabulari ta' reazzjonijiet avversi
English: The following statements reflect the information available on the individual active substances (pioglitazone and metformin).
Maltese: Id-dikjarazzjonijiet li ġejjin jirriflettu l-informazzjoni disponibbli dwar is-sustanzi attivi individwali (pioglitazone u metformin).
English: Patients with hepatic impairment
Maltese: Pazjenti b'indeboliment epatiku
English: Patients receiving pioglitazone had a mean reduction in HbA1c of 0.45% compared with those continuing on insulin alone, and a reduction of insulin dose in the pioglitazone treated group.
Maltese: Pazjenti li kienu qed jirċievu pioglitazone kellhom tnaqqis medju f'HbA1c ta' 0.45% meta mqabbel ma dawk li komplew b'insulina waħedha, u tnaqqis fid-doża ta' l-insulina fil-grupp ikkurat b'pioglitazone.
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-ogħla limitu tan-normal, it-terapija għandha titwaqqaf.
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, ACE inhibitors, angiotensin II receptor antagonists and diuretics, especially loop diuretics.
Maltese: NSAIDs, inklużi inibituri selettivi ta' cyclo-oxygenase (COX) II, inibituri ta' ACE,
English: This can lead to a risk of hyperglycaemia (high blood sugar level): - rifampicin (to treat tuberculosis and other infections) - glucocorticoids (to treat allergies and inflammation) - beta-2-agonists (to treat asthma) - medicines which increase urine production (diuretics, to treat high blood pressure)
Maltese: - rifampicin (biex jikkura t-tuberkulożi u infezzjonijiet oħra) - glukokortikojdi (biex jikkuraw allerġiji u infjammazzjoni) - agonisti tat-tip beta-2 (biex jikkuraw l-ażżma)
English: Available toxicological data in animals have shown excretion of pioglitazone and metformin in the milk of lactating rats (see section 5.3).
Maltese: Dejta tossikoloġika fl-annimali uriet li kien hemm eliminazzjoni ta' poiglitazone u metformin fil-ħalib ta' firien li qed ireddgħu (ara sezzjoni 5.3).
English: Eye disorders visual disturbance3
Maltese: Disturbi fl-għajnejn disturbi viżivi3
English: This has been shown at therapeutic doses in controlled, medium-term or long-term clinical studies: metformin reduces total cholesterol, LDLc and triglyceride levels.
Maltese: tul ta' żmien medju jew twil: metformin naqqas il-livelli ta' kolesterol totali, LDLc u triglyceride.
English: Glubrava is contraindicated during breast-feeding (see section 4.3).
Maltese: IGlubrava hu kontraindikat waqt it-treddigħ (ara sezzjoni 4.3).
English: The prospective randomised (UKPDS) study has established the long-term benefit of intensive blood glucose control in type 2 diabetes mellitus.
Maltese: L-istudju prospettiv każwali (UKPDS) stabbilixxa l-benefiċċju fit-tul ta' kontroll intensiv ta' glukożju fid-demm f'dijabete mellitus tat-tip 2.
English: Nervous system disorders hypo-aesthesia common common insomnia uncommon uncommon headache common taste disturbance common common
Maltese: Disturbi fis-sistema ne rvuża ipoesteżija komuni komuni insonnja mhux komuni mhux komuni uġigħ ta' ras komuni disturbi fit-togħma komuni komuni
English: In vitro studies have shown no evidence that pioglitazone inhibits any subtype of cytochrome P450.
Maltese: Studji in vitro ma wrew l-ebda evidenza li pioglitazone jinibixxi xi sottotip taċ-ċitokromju P450.
English: There is no clinical experience of pioglitazone in triple combination with other oral antidiabetic medicinal products.
Maltese: M'hemmx esperjenza klinika ta' pioglitazone f'taħlita trippla ma' prodotti mediċinali oħra antidijabetiċi orali.
English: In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained (see section 4.4).
Maltese: Fid-dawl ta' riskji potenzjali marbuta ma' terapija fit-tul, it-tobba għandhom jikkonfermaw f'evalwazzjonijiet ta' rutina sussegwenti li lbenefiċċju ta' pioglitazone hu mmantenut (ara sezzjoni 4.4).
English: Fri. 2
Maltese: Ħ 1 Ħ 2
English: After initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in HbA1c).
Maltese: Wara bidu tat-terapija b'pioglitazone, il-pazjenti għandhom jiġu eżaminati mill-ġdid wara 3 sa 6 xhur sabiex tiġi evalwata s-suffiċjenza tar-rispons għat-trattament (eż. tnaqqis fl-HbA1c).
English: Common weight gain headache respiratory infection abnormal vision joint pain impotence blood in urine reduction in blood count (anaemia) numbness taste disturbance
Maltese: Komuni żieda fil-piż uġigħ ta' ras infezzjoni respiratorja vista mhux normali uġigħ fil-ġogi impotenza demm fl-awrina tnaqqis fil-għadd tad-demm (anemija)
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
English: Skin and subcutaneous tissue disorders erythema very rare very rare pruritis very rare very rare urticaria very rare very rare
Maltese: Disturbi fil-ġilda u fittessuti ta' taħt il-ġilda eritima rari ħafna rari ħafna prurite rari ħafna rari ħafna urtikarja rari ħafna rari ħafna
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 (proliferatur ta' peroxisome ta' riċettur gamma attivat) li jwassal għal żieda fis-sensittività għall-insulina f'ċelloli tal-fwied, xaħam u tal-muskoli skeletrali fl-annimali.
English: In most clinical trials, reduced total plasma triglycerides and free fatty acids, and increased HDL-cholesterol levels were observed as compared to placebo, with small, but not clinically significant increases in LDL-cholesterol levels.
Maltese: Fil-biċċa l-kbira tal-provi kliniċi, kienu osservati tnaqqis fit-triġliċeridi totali fil-plażma u fl-aċidi grassi ħielsa, u żieda fil-livelli ta' HDL-kolesterol meta mqabbel mal-plaċebo, b'żiediet żgħar, iżda mhux ta' rilevanza klinika fil-livelli ta' LDL-kolesterol.
English: Intravascular administration of iodinated contrast agents (see section 4.4) Breast-feeding (see section 4.6)
Maltese: Għotja intravaskulari ta' aġenti ta' kuntrast ijodinati (ara sezzjoni 4.4)
English: Glubrava 15 mg/850 mg film-coated tablets
Maltese: Glubrava 15 mg/850 mg pilloli miksija b'rita
English: In PROactive, a cardiovascular outcome study, 5,238 patients with type 2 diabetes mellitus and pre-existing major macrovascular disease were randomised to pioglitazone or placebo in addition to existing antidiabetic and cardiovascular therapy, for up to 3.5 years.
Maltese: Fi PROactive, studju dwar l-effett kardjovaskulari, 5,238 pazjent b'dijabete mellitus tat-tip 2 u b'marda makrovaskulari maġġuri eżistenti minn qabel kienu każwali għal pioglitazone jew plaċebo flimkien ma' terapija antidijabetika u kardjovaskulari eżistenti, sa 3.5 snin.
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: (< 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: Plasma protein binding is negligible.
Maltese: Twaħħil mal-proteini fil-plażma hija ftit li xejn.
English: Musculoskeletal and connective tissue disorders bone fracture6
Maltese: Disturbi muskoluskeletrali u tat-tessuti konne ttivi ksur ta' għadam6
English: Although the study failed regarding its primary endpoint, which was a composite of all-cause mortality, non-fatal myocardial infarction, stroke, acute coronary syndrome, major leg amputation, coronary revascularisation and leg revascularisation, the results suggest that there are no long-term cardiovascular concerns regarding use of pioglitazone.
Maltese: Għalkemm l-istudju falla rigward il-mira primarja tiegħu, li kienet komposta minn mortalità millkawżi kollha, infart mijokardijaku mhux fatali, puplesija, sindrome koronarju akut, amputazzjoni maġġuri tas-sieq, vaskularizazzjoni koronarja mill-ġdid u vaskularizazzjoni tas-sieq mill-ġdid, ir riżultati jissuġġerixxu li ma hemm l-ebda riskji kardjovakulari fit-tul bl-użu ta' pioglitazone.
English: Total plasma concentration of pioglitazone is unchanged, but with an increased volume of distribution.
Maltese: Il-konċentrazzjoni totali fil-plażma ta' pioglitazone ma nbidlitx, iżda b'volum ta' distribuzzjoni miżjud.
English: These findings were observed across species at plasma concentrations ≤4 times the clinical exposure.
Maltese: Dawn is-sejbiet kienu osservati fi speċi differenti b'konċentrazzjonijiet fil-plażma ≤ 4 darbiet l espożizzjoni klinika.
English: Metformin increases the transport capacity of specific types of membrane glucose transporters (GLUT-1 and GLUT-4).
Maltese: Metformin iżid il-kapaċità ta' trasport ta' tipi speċifiċi ta' trasportaturi tal-membrana ta' glukożju
English: Acute conditions with the potential to alter renal function such as: - Dehydration - Severe infection - Shock
Maltese: Kondizzjonijiet akuti b'potenzjal li jbiddlu l-funzjoni renali bħal: - Deidratazzjoni - Infezzjoni severa - Xokk
English: 2 Long term treatment of metformin has been associated with a decrease of vitamin B12 absorption with decrease of serum levels.
Maltese: B12 bi tnaqqis tallivelli fis-serum.
English: In controlled clinical trials the incidence of reports of heart failure with pioglitazone treatment was the same as in placebo, metformin and sulphonylurea treatment groups, but was increased when used in combination therapy with insulin.
Maltese: Fi provi kliniċi kkontrollati, l-inċidenza ta' rapporti ta' insuffiċjenza tal-qalb b'kura b'pioglitazone kienet l-istess bħall-gruppi ta' kura bil-plaċebo, metformin u sulphonylurea, iżda kienet miżjuda meta wżata f'terapija kombinata ma' insulina.
English: Renal and urinary disorders haematuria common
Maltese: Disturbi fil-kliewi u fissistema urinarja ematurja komuni
English: HOMA analysis shows that pioglitazone improves beta cell function as well as increasing insulin sensitivity.
Maltese: HOMA juri li pioglitazone itejjeb il-funzjoni taċ-ċellola beta kif ukoll iżid is-sensittività għallinsulina.
English: Glubrava contains pioglitazone and metformin which are anti-diabetic medicines, used to control blood sugar level.
Maltese: Glubrava fih pioglitazon u metformin li huma mediċini anti-dijabetiċi , użati għall-kontroll taż-żokkor fid-demm.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Takeda (logo)
Maltese: Takeda (logo) DATA TA' SKADENZA
English: Clinical trials have been conducted with Glubrava tablets and co-administered pioglitazone and metformin (see section 5.1).
Maltese: Twettqu provi kliniċi kemm b'pilloli Glubrava kif ukoll bi pioglitazone u metformin mogħtija fl-istess waqt (ara Sezzjoni 5.1).
English: Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis) Diabetic pre-coma
Maltese: Intossikazzjoni akuta ta' alkoħol, alkoħoliżmu - Kull tip ta' aċidożi metabolika akuta (bħal aċidożi lattika, ketoaċidożi dijabetika)
English: Metabolism and nutrition disorders Vitamin B12 absorption decreased2
Maltese: Dis turbi fil-me tabolizmu u n-nutrizzjoni nuqqas ta' assorbiment talVitamina B122
English: The maximum reported dose of 120 mg/day for four days, then 180 mg/day for seven days was not associated with any symptoms.
Maltese: Id-doża massima rrappurtata ta' 120 mg/kuljum għal erbat ijiem, u wara 180 mg/kuljum għal sebat ijiem ma kienet assoċjat ma' l-ebda sintomi.
English: Post-marketing reports of new-onset or worsening diabetic macular oedema with decreased visual acuity have been reported with thiazolidinediones, including pioglitazone.
Maltese: Disturbi fl-għajnejn Rapporti ta' wara t-tqegħid fis-suq ta' żvilupp jew irkadar ta' edima makulari dijabetika bi tnaqqis fl akutezza viżiva kienu rrappurtati b'thiazolidinediones, inkluż pioglitazone.
English: Gas trointe s tinal dis orders4 abdominal pain very common very common diarrhoea very common very common flatulence uncommon loss of appetite very common very common nausea very common very common vomiting very common very common
Maltese: Reazzjonijiet avversi rrappurtati fi studji doppju għomja u esperjenza ta' wara l-kummerċ huma mniżżla hawn taħt bis-sistema ta' terminu MedDRA ppreferut permeżż tas-sistema tal-klassifika talorgani u frekwenza assoluta.
English: If you have reduced kidney function, your doctor may prescribe a lower dose, which may need to be given as separate tablets of pioglitazone and metformin.
Maltese: jippreskrivi doża aktar baxxa, li għandha mnejn ikun meħtieġ li tingħata bħala pilloli separati ta' pioglitazone u metformin.
English: The risk of fractures should be considered in the long term care of patients treated with pioglitazone (see section 4.8).
Maltese: Ir-riskju ta' fratturi għandu jiġi kkunsidrat fil-kura fit-tul ta' pazjenti kkurati b'pioglitazone (ara sezzjoni 4.8).
English: Kaplan-Meier analysis showed shorter time to treatment failure in patients treated with gliclazide, compared with pioglitazone.
Maltese: Analiżi Kaplan-Meier wriet ħin iqsar għall-falliment tal-kura f'pazjenti kkurati b'gliclazide, meta mqabbel ma' pioglitazone.
English: PHARMACEUTICAL PARTICULARS
Maltese: EFFETTIV TAL-PRODOTT MEDIĊINALI
English: Post marketing cases of peripheral oedema and cardiac failure have also been reported in patients with concomitant use of pioglitazone and nonsteroidal anti-inflammatory drugs, including selective COX-2 inhibitors.
Maltese: Wara li l-prodott tqiegħed fis-suq każijiet ta' edema periferali u insuffiċjenza kardijaka kienu rrappurtati wkoll f'pazjenti b'użu konkomitanti ta' pioglitazone u mediċini anti-infjammatorji mhux sterojdi, li jinkludu inibituri selettivi COX-2.
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 fissensitività għall-insulina.
English: Symptoms of lactic acidosis include: vomiting stomach ache (abdominal pain) muscle cramps a general feeling of not being well with severe tiredness difficulty in breathing reduced body temperature and heartbeat
Maltese: rimettar uġigħ fl-istonku (uġigħ addominali) bugħawwieġ fil-muskoli sensazzjoni ġenerali li ma tiflaħx flimkien ma' għeja severa diffikultà biex tieħu n-nifs temperatura tal-ġisem u taħbit tal-qalb imnaqqsa
English: Medicinal products that can acutely impair renal function (such as antihypertensives, diuretics and nonsteroidal anti-inflammatory drugs (NSAIDs)) should be initiated with caution in metformin treated patients.
Maltese: Prodotti mediċinali li jistgħu jfixklu l-funzjoni renali b'mod akut (bħal sustanzi kontra l-pressjoni għolja, dijuretiċi u mediċini anti-infjammatorji mhux sterojdi (NSAIDs, nonsteroidal antiinflammatory drugs)) għandhom jinbdew b'kawtela f'pazjenti ttrattati b'metformin.
English: In toxicology studies, plasma volume expansion with haemodilution, anaemia, and reversible eccentric cardiac hypertrophy was consistently apparent after repeated dosing of mice, rats, dogs, and monkeys.
Maltese: Pioglitazone Fi studji dwar l-effett tossiku, l-espansjoni tal-volum tal-plażma permeżz ta' emodiluzzjoni, anemija u ipertrofija kardijaka eċċentrika riversibbli kienet apparenti b'mod konsistenti wara dożaġġ ripetut filġrieden, firien, klieb u xadini.
English: In this study in patients receiving pioglitazone and insulin, a higher percentage of patients with heart failure was observed in patients aged ≥ 65 years compared with those less than 65 years (9.7% compared to 4.0%).
Maltese: kien osservat persentaġġ ogħla ta' pazjenti b'insuffiċjenza tal-qalb f'pazjenti li għandhom ≥ 65 sena meta mqabbla ma'dawk iżgħar minn 65 sena (9.7% meta mqabbla ma'4.0%).
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
English: Hypoglycae mia
Maltese: Ipoġliċe mija
English: No increase in fracture rates was observed in men treated with pioglitazone (1.7%) versus comparator (2.1%).
Maltese: Ma kinietx osservata żieda fir-rata ta' fratturi f'irġiel ikkurati b'pioglitazone (1.7%) meta mqabbla ma' prodott paragun (2.1%).
English: Patients receiving pioglitazone in dual oral therapy with a sulphonylurea may be at risk for dose-related hypoglycaemia, and a reduction in the dose of the sulphonylurea may be necessary.
Maltese: Pazjenti li qed jirċievu pioglitazone f'terapija orali doppja ma' sulphonylurea jista jkunu f'riskju ta' ipogliċemija relatat mad-doża, u jista' jkun meħtieġ tnaqqis fid-doża tas-sulphonylurea.
English: He patobiliary dis orde rs hepatitis5
Maltese: Mhux magħrufa infjammazzjoni fil-fwied (epatite)
English: Following an oral dose, the apparent terminal elimination half-life is approximately 6.5 h. When renal function is impaired, renal clearance is decreased in proportion to that of creatinine and thus the elimination half-life is prolonged, leading to increased levels of metformin in plasma.
Maltese: Meta jkun hemm indeboliment tal-funzjoni renali, tneħħijja renali tonqos f'proporzjon ma' dik ta' krejatinina u b'hekk il-half-life ta' eliminazzjoni titwal, u twassal għall-livelli ogħla ta' metformin fil-plażma.
English: Alcohol intoxication is associated with an increased risk of lactic acidosis, particularly in case of fasting, malnutrition or hepatic impairment.
Maltese: Intossikazzjoni bl-alkoħol hija assoċjata ma' riskju akbar ta' aċidożi lattika, b'mod partikulari f'każijiet ta' sawm, malnutrizzjoni jew indeboliment epatiku.
English: if you have uncontrolled diabetes with, for example, severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see section “Risk of lactic acidosis”) or ketoacidosis.
Maltese: jekk tixrob wisq alkoħol (kemm kuljum kif ukoll darba kull tant). jekk għandek dijabete mhux ikkontrollata, b'pereżempju, ipergliċemija severa (glucose għoli fid-demm), dardir, rimettar, dijarea, telf mgħaġġel fil-piż, aċidożi lattika (ara s-sezzjoni "Riskju ta' aċidożi lattika") jew ketoaċidożi.
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-għoti ta' pioglitazone flimkien ma' gemfibrozil (inibitur taċ-ċitokromju P450 2C8) twassal għall-żieda ta' 3 darbiet fl-AUC ta' pioglitazone.
English: Tel.: +48 22 608 13 00
Maltese: Takeda Polska Sp. z o.o. Tel.: +48 22 608 13 00
English: Glubrava may cause a very rare (may affect up to 1 in 10,000), but very serious side effect called lactic acidosis (see section “Warnings and precautions”).
Maltese: Glubrava 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 “Twissijiet u prekawzjonijiet”).
English: There are limited amount of data from the use of metformin in pregnant women.
Maltese: Hemm dejta limitata dwar l-użu ta' metformin f'nisa tqal.