FrancophonIA/ELRC3.0 huggingface dataset:
English: Haematocrit values > 55% were reported in 1.3% of the subjects treated with dapagliflozin 10 mg versus 0.4% of placebo subjects.
Maltese: Valuri tal-ematokrit >55% ġew irrapportati f'1.3% tal-individwi kkurati b'10 mg dapagliflozin meta mqabbel ma' 0.4% tal-individwi fuq plaċebo Il-kura fit-tul b'metformin ġiet assoċjata ma' tnaqqis fl-assorbiment tal-vitamina
English: Nephropathy
Maltese: Nefropatija
English: Following coadministration of dapagliflozin with mefenamic acid (an inhibitor of UGT1A9), a 55% increase in dapagliflozin systemic exposure was seen, but with no clinically meaningful effect on 24-hour urinary glucose excretion.
Maltese: Wara l-għoti ta' dapagliflozin flimkien ma' mefenamic acid (impeditur ta' UGT1A9), ġiet innotata żieda ta' 55% fl-esponiment sistemiku ta' dapagliflozin, imma mingħajr effett kliniku sinifikanti fuq it-tneħħija tal-glukożju fl-awrina f'24 siegħa.
English: HbA1c (%) Baseline (mean) Change from baseline
Maltese: HbA1c (%) Linja bażi (medja)
English: In type 1 diabetes mellitus studies, DKA was reported with common frequency.
Maltese: Fi studji tad-dijabete mellitus tat-tip 1, DKA ġiet irrappurtata bi frekwenza komuni.
English: In rats, dapagliflozin was neither embryolethal nor teratogenic at exposures up to 1,441 times the maximum recommended human dose.
Maltese: Fil-firien, dapagliflozin la kkawża l-mewt tal-embriju u lanqas kien teratoġeniku f'esponimenti sa 1,441 darba iktar mid-doża massima rrakkomandata għall-bnedmin.
English: Baseline (mean) Change from baseline Difference from dapagliflozin c
Maltese: Linja bażi (medja) Bidla mil-linja bażi Differenza minn dapagliflozin c
English: Combination therapy with prolonged-release exenatide In a 28-week, double-blind, active comparator-controlled study, the combination of dapagliflozin and prolonged-release exenatide (a GLP-1 receptor agonist) was compared to dapagliflozin alone and prolonged-release exenatide alone in subjects with inadequate glycaemic control on metformin alone (HbA1c ≥ 8% and ≤ 12%).
Maltese: Terapija kkombinata ma' exenatide li jerħi l-mediċina bil-mod Fi studju attiv ikkontrollat ta' paragun, double-blind, ta' 28 ġimgħa, il-kombinazzjoni ta' dapagliflozin u exenatide li jerħi l-mediċina bil-mod (agonist tar-riċettur GLP-1) tqabblet ma' dapagliflozin waħdu u exenatide li jerħi l-mediċina bil-mod waħdu f'individwi b'kontroll gliċemiku inadegwat fuq metformin waħdu (HbA1c ≥ 8% u ≤ 12%).
English: Effect of other medicinal products on dapagliflozin Interaction studies conducted in healthy subjects, using mainly a single-dose design, suggest that the pharmacokinetics of dapagliflozin are not altered by pioglitazone, sitagliptin, glimepiride, voglibose, hydrochlorothiazide, bumetanide, valsartan, or simvastatin.
Maltese: L-effett ta' prodotti mediċinali oħrajn fuq dapagliflozin Studji dwar l-interazzjoni li saru fuq individwi b'saħħithom, prinċipalment bl-użu ta' disinn ta' doża waħda, jissuġġerixxu li l-farmakokinetika ta' dapagliflozin ma titbiddilx b'pioglitazone, sitagliptin, glimepiride, voglibose, hydrochlorothiazide, bumetanide, valsartan, jew simvastatin.
English: After administration of a 50 mg [
Maltese: Wara l-amministrazzjoni ta' doża ta' 50 mg [
English: The proportion of subjects remaining in the study at Week 104 was 72.4% for the group treated with dapagliflozin 10 mg and 54.8% for the placebo group.
Maltese: Il-proporzjon tal-pazjenti li kienu baqgħu fl-istudju fil-ġimgħa 104 kien ta' 72.4% għall-grupp ittrattat b'10 mg dapagliflozin u ta' 54.8% għall-grupp tal-plaċebo.
English: Prolonged-release exenatide 2 mg QW
Maltese: Exenatide 2 mg li jerħi l-mediċina bilmod QW
English: Results at Week 52 (LOCF a) in an active-controlled study comparing dapagliflozin with glipizide as add-on to metformin
Maltese: Tabella 3. Riżultati fil-Ġimgħa 52 (LOCF a) fi studju kkontrollat attivament li jqabbel dapagliflozin ma' glipizide bħala żieda ma' metformin
English: Mean difference in change from baseline between combination and single active agent (95% CI)
Maltese: Differenza medja fil-bidla mil-linja bażi bejn ilkombinazzjoni u l-aġent attiv uniku (95% CI)
English: Xigduo 5 mg/850 mg film-coated tablets and Xigduo 5 mg/1,000 mg film-coated tablets are available in PVC/PCTFE/Alu blister.
Maltese: Xigduo5mg/850mg pilloli miksijin b'rita u Xigduo5mg/1,000mg pilloli miksijin b'rita jiġu f'folja talPVC/PCTFE/Alu.
English: In the dapagliflozin cardiovascular outcomes study, with a median exposure time of 48 months, events of DKA were reported in 27 patients in the dapagliflozin 10 mg group and 12 patients in the placebo group.
Maltese: Fl-istudju tal-eżiti kardjovaskulari b'dapagliflozin, bi żmien medjan ta' esponiment ta' 48 xahar, ġew irrappurtati avvenimenti ta' DKA f'27 pazjent fil-grupp ta' dapagliflozin 10 mg u 12-il pazjent fil-grupp ta' plaċebo.
English: For metformin, studies in animals have not shown reproductive toxicity (see section 5.3).
Maltese: Għal metformin, studji fl-annimali ma wrewx tossiċità riproduttiva (ara sezzjoni 5.3).
English: For the add-on to metformin study, HbA1c reductions were sustained through Week 102 (-0.78% and 0.02% adjusted mean change from baseline for dapagliflozin 10 mg and placebo, respectively).
Maltese: 78% u 0.02% mil-linja bażi għal 10 mg dapagliflozin u plaċebo, rispettivament).
English: These infections were more frequent in females (8.4% and 1.2% for dapagliflozin and placebo, respectively), and subjects with a prior history were more likely to have a recurrent infection.
Maltese: Dawn l-infezzjonijiet kienu aktar frekwenti fin nisa (8.4% u 1.2% għal dapagliflozin u plaċebo, rispettivament), u individwi li kellhom dawn linfezzjonijiet fil-passat kellhom aktar probabilità li jerġgħu jkollhom infezzjoni.
English: The pharmacokinetics of 5 mg dapagliflozin twice daily and 10 mg dapagliflozin once daily were compared in healthy subjects.
Maltese: Il-farmakokinetika ta' 5 mg dapagliflozin darbtejn kuljum u ta' 10 mg dapagliflozin darba kuljum ġew imqabblin f'individwi b'saħħithom.
English: Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 1,000 mg of metformin hydrochloride.
Maltese: Kull pillola fiha dapagliflozin propanediol monohydrate ekwivalenti għal 5 mg dapagliflozin u 1,000 mg ta' metformin hydrochloride.
English: Metformin may act via three mechanisms: - by reduction of hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis; - by modestly increasing insulin sensitivity, improving peripheral glucose uptake and utilisation in muscle; - by delaying intestinal glucose absorption.
Maltese: Metformin jista' jaġixxi permezz ta' tliet mekkaniżmi: - bit-tnaqqis tal-produzzjoni tal-glukożju fil-fwied billi jimpedixxi l-glukoneoġenesi u l-glikoġenoliżi; - billi jżid bi ftit is-sensittività għall-insulina, u b'hekk itejjeb it-teħid u l-użu periferiku tal-glukożju fil-muskoli; - billi jittardja l-assorbiment intestinali tal-glukożju.
English: HbA1c (%) Baseline (mean) Change from baseline Difference from placebo b
Maltese: HbA1c (%) Linja bażi (medja) Bidla mil-linja bażi Differenza mill-plaċebo b
English: Elderly patients are more likely to have impaired renal function, and/or to be treated with anti-hypertensive medicinal products that may cause changes in renal function such as angiotensin-converting enzyme inhibitors (ACE-I) and angiotensin II type 1 receptor blockers (ARB).
Maltese: Pazjenti akbar fl-età għandhom iktar ċans li jbatu minn indeboliment renali, u/jew li jiġu kkurati bi prodotti mediċinali ta' kontra l-pressjoni għolja li jistgħu jikkaġunaw bidliet fil-funzjoni tal-kliewi bħalma huma impedituri ta' enzimi li jikkonvertu angiotensin (ACE-I) u sustanzi li jimblokkaw ir-riċetturi angiotensin II ta' tip 1 (ARB).
English: Cationic substances that are eliminated by renal tubular secretion (e.g. cimetidine) may interact with metformin by competing for common renal tubular transport systems.
Maltese: Sustanzi katajoniċi li jiġu eliminati permezz ta' tnixxija mit-tubuli tal-kliewi (eż. cimetidine) jistgħu jinteraġixxu ma' metformin billi jikkompetu għal sistemi komuni ta' trasport tubulari renali.
English: In a study with add-on insulin therapy, higher rates of hypoglycaemia were observed (see section 4.5).
Maltese: Fi studju b'terapija ta' żieda bl-insulina, ġew osservati rati ogħla ta' ipogliċemija (ara sezzjoni 4.5).
English: Treatment with dapagliflozin 10 mg in combination with metformin (up to 2,000 mg per day) provided significant improvements in HbA1c compared to the individual components (Table 7), and led to greater reductions in FPG (compared to the individual components) and body weight (compared to metformin).
Maltese: Il-kura b'dapagliflozin 10 mg f'kombinazzoni ma' metmorfin (sa 2,000 mg kuljum) ipprovdiet titjib sinifikanti fl-HbA1c meta mqabbel mal-komponenti individwali (Tabella 7), u wasslet għal tnaqqis ikbar fl-FPG (meta mqabbel mal-komponenti individwali) u fil-piż tal-ġisem (meta mqabbel ma' metmorfin).
English: Alcohol intoxication is associated with an increased risk of lactic acidosis, particularly in the case of fasting, malnutrition or hepatic impairment due to the metformin active substance of this medicinal product (see section 4.4).
Maltese: Intossikazzjoni bl-alkoħol hija assoċjata ma' riskju akbar ta' aċidożi lattika, b'mod partikulari f'każijiet ta' sawm, malnutrizzjoni jew indeboliment epatiku minħabba s-sustanza attiva metformin li hemm f'dan ilprodott mediċinali (ara sezzjoni 4.4).
English: Urinary uric acid excretion was also increased transiently (for 3-7 days) and accompanied by a sustained reduction in serum uric acid concentration.
Maltese: It-tneħħija tal-uric acid mal-awrina żdiedet ukoll b'mod temporanju (għal 3-7 ijiem) u kienet imsieħba minn tnaqqis sostnut fil-konċentrazzjoni tal-uric acid fis-serum.
English: In an analysis of 5 placebo-controlled dapagliflozin add-on to metformin studies, the safety results were similar to that of the pre-specified pooled analysis of 13 placebo-controlled dapagliflozin studies (see Dapagliflozin, Summary of the safety profile below).
Maltese: F'analiżi ta' 5 studji kkontrollati bi plaċebo dwar dapagliflozin miżjud ma' metformin, ir-riżultati ta' sigurtà kienu simili għal dawk tal-analiżi miġbura speċifikata minn qabel ta' 13-il studju dwar dapagliflozin kkontrollati bi plaċebo (ara Dapagliflozin, Sommarju tal-profil ta' sigurtà hawn taħt).
English: The proportion of subjects remaining in the study at Week 104 and Week 208 was 56.2% and 39.7% for the group treated with dapagliflozin and 50.0% and 34.6% for the group treated with glipizide.
Maltese: Il-proporzjon ta' pazjenti li kien baqa' fl-istudju fil-Ġimgħa 104 u fil-Ġimgħa 208 kien ta' 56.2% u 39.7% għall-grupp ikkurat b'dapagliflozin u ta' 50.0% u 34.6% għall-grupp ikkurat bi glipizide.
English: Xigduo combination tablets are considered to be bioequivalent to coadministration of corresponding doses of dapagliflozin and metformin hydrochloride administered together as individual tablets.
Maltese: Il-pilloli kombinati Xigduo huma kkunsidrati bijoekwivalenti għall-amministrazzjoni konġunta ta' dożi korrispondenti ta' dapagliflozin u metformin hydrochloride mogħtija flimkien bħala pilloli individwali.
English: Medicinal products that can acutely impair renal function (such as antihypertensives, diuretics and non-steroidal 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 antiinfjammatorji nonsterojdali
English: In patients with decreased renal function (based on measured creatinine clearance), the plasma and blood half-life of metformin is prolonged and the renal clearance is decreased in proportion to the decrease in creatinine clearance, leading to increased levels of metformin in plasma.
Maltese: F'pazjenti b'funzjoni renali mnaqqsa (abbażi tal-kejl tal-eliminazzjoni tal-kreatinina), il-half-life ta' metformin fil-plażma u fid-demm titwal u l-eliminazzjoni renali tonqos b'mod proporzjonat ma' kemm tonqos l-eliminazzjoni tal-kreatinina, u hekk twassal għal livelli ogħla ta' metformin fil-plażma.
English: In the dapagliflozin cardiovascular outcomes study, the number of patients with serious adverse events of genital infections were few and balanced: 2 patients in each of the dapagliflozin and placebo groups.
Maltese: Fl-istudju tal-eżiti kardjovaskulari b'dapagliflozin, in-numru ta' pazjenti b'avvenimenti avversi serji ta' infezzjonijiet ġenitali kienu ftit u bbilanċjati: 2 pazjenti f'kull wieħed mill-gruppi ta' dapagliflozin u plaċebo.
English: Of the 27 patients with DKA events in the dapagliflozin group, 22 had concomitant insulin treatment at the time of the event.
Maltese: Mis-27 pazjent b'avvenimenti ta' DKA fil-grupp ta' dapagliflozin, 22 kellhom kura bl-insulina konkomitanti meta seħħ lavveniment.
English: Thirst
Maltese: Tqala
English: Dapagliflozin does not impair normal endogenous glucose production in response to hypoglycaemia.
Maltese: Dapagliflozin ma jxekkilx il-produzzjoni endoġena normali tal-glukożju bħala rispons għall-ipogliċemija.
English: Of 17,160 randomised patients, 6,974 (40.6%) had established cardiovascular disease and 10,186 (59.4%) did not have established cardiovascular disease.
Maltese: Minn 17,160 pazjent randomizzat, 6,974 (40.6%) kellhom marda kardjovaskulari stabbilita u 10,186 (59.4%) ma kellhomx marda kardjovaskulari stabbilita. 8,582 pazjent ġew randomizzati għal dapagliflozin 10 mg u 8,578 għal plaċebo, u ġew segwiti għal medjan ta' 4.2 snin.
English: LOCF: Last observation (prior to or on the date of the first insulin up-titration, if needed) carried forward All randomised subjects who took at least one dose of double-blind study medicinal product during the shortterm double-blind period Least squares mean adjusted for baseline value and presence of oral glucose-lowering medicinal product p-value < 0.0001 versus placebo + insulin ± oral glucose-lowering medicinal product p-value < 0.05 versus placebo + insulin ± oral glucose-lowering medicinal product Up-titration of insulin regimens (including short-acting, intermediate, and basal insulin) was only allowed if subjects met pre-defined FPG criteria.
Maltese: L-individwi kollha magħżula b'mod każwali li ħadu mill-inqas doża waħda ta' prodott mediċinali ta' studju doubleblind matul il-perjodu double-blind ta' terminu qasir Il-medja tal-inqas kwadri aġġustata għall-valur tal-linja bażi u l-preżenza ta' prodott mediċinali orali li jbaxxi lglukożju valur-p < 0.0001 kontra plaċebo + insulina ± prodott mediċinali orali li jbaxxi l-glukożju valur-p < 0.05 kontra plaċebo + insulina ± prodott mediċinali orali li jbaxxi l-glukożju Żieda fid-dożi tal-insulina (inkluż insulina li taħdem għal żmien qasir, intermedja jew bażali) kienet permessa biss jekk il-pazjenti kienu jissodisfaw il-kriterji FPG definiti minn qabel Ħamsin fil-mija tal-pazjenti kienu fuq monoterapija bl-insulina fil-linja bażi; 50 % kienu fuq prodott jew żewġ prodotti mediċinali orali li jbaxxu l-glukożju miżjuda mal-insulina:
English: In the separate dapagliflozin add-on to metformin pooled analysis, 623 subjects were treated with dapagliflozin 10 mg as add-on to metformin and 523 were treated with placebo plus metformin.
Maltese: Fl-analiżi miġbura separata dwar dapagliflozin bħala żieda ma' metformin, 623 individwu ġew ittrattati b'10 mg dapagliflozin bħala żieda ma' metformin u 523 ġew ittrattati bi plaċebo ma' metformin.
English: The table shows adverse reactions identified from up to 24-week (short-term) data regardless of glycaemic rescue, except those marked with §, for which adverse reaction and frequency categories are based on information from the metformin Summary of Product Characteristics available in the European Union.
Maltese: It-tabella turi reazzjonijiet avversi identifikati minn dejta sa 24 ġimgħa (perjodu qasir) irrispettivament missalvataġġ gliċemiku, ħlief dawk immarkati b'§, li għalihom il-kategoriji tar-reazzjonijiet avversi u tal-frekwenza huma bbażati fuq informazzjoni mis-Sommarju tal-Karatterisiċi tal-prodott ta' metformin disponibbli fl-Unjoni Ewropea.
English: Treatment with dapagliflozin plus metformin at all doses produced clinically relevant and statistically significant improvements in HbA1c and fasting plasma glucose (FPG) compared with control.
Maltese: Il-kura b'dapagliflozin flimkien ma' metformin fid-dożi kollha pproduċiet titjib klinikament rilevanti u statistikament sinifikanti f'HbA1c u fil-glukożju fil-plażma waqt is-sawm (FPG) meta mqabbla mal-kontroll.
English: • if you have uncontrolled diabetes, with, for example severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below) or ketoacidosis.
Maltese: • jekk għandek dijabete mhux ikkontrollata, b'pereżempju, ipergliċemija severa (glucose għoli fiddemm), dardir, rimettar, dijarea, telf mgħaġġel fil-piż, aċidożi lattika (ara "Riskju ta' aċidożi lattika" hawn taħt) jew ketoaċidożi.
English: The reductions in HbA1c observed at Week 24 were sustained in the add-on combination studies.
Maltese: It-tnaqqis fl-HbA1c osservat fil-ġimgħa 24 kien sostnut fl-istudji dwar kombinazzjonijiet miżjuda.
English: Xigduo 5 mg/850 mg film-coated tablets dapagliflozin/metformin hydrochloride
Maltese: Xigduo 5 mg/850 mg pilloli miksijin b'rita dapagliflozin/metformin hydrochloride
English: Possible signs of losing too much fluid from your body are listed at the top of section 4.
Maltese: Is-sinjali possibbli ta' telf eċċessiv ta' fluwidu mill-ġisem huma elenkati fil-bidu tas-sezzjoni 4.
English: You should stop taking this medicine if you become pregnant, since it is not recommended during the second and third trimesters (the last six months) of pregnancy.
Maltese: Għandek twaqqaf din il-mediċina jekk tinqabad tqila, peress li mhijiex rakkomandata waqt it-tieni u t-tielet trimestru (l-aħħar sitt xhur) tat-tqala.
English: Approximately 70 g of glucose was excreted in the urine per day (corresponding to 280 kcal/day) at a dapagliflozin dose of 10 mg/day in subjects with type 2 diabetes mellitus for 12 weeks.
Maltese: Bejn wieħed u ieħor tneħħew 70 g ta' glukożju mal-awrina kuljum (korrispondenti għal 280 kcal kuljum) b'doża ta' 10 mg dapagliflozin kuljum f'pazjenti bid-dijabete (diabetes mellitus) tat-tip 2 għal 12-il ġimgħa.
English: Analyses exclude measurements post rescue therapy and post premature discontinuation of study medicinal product.
Maltese: L-analiżijiet jeskludu kejliet wara t-terapija ta' salvataġġ u wara twaqqif prematur tal-prodott mediċinali talistudju.
English: If Fournier's gangrene is suspected, Xigduo should be discontinued and prompt treatment (including antibiotics and surgical debridement) should be instituted.
Maltese: Jekk tiġi suspettata kankrena ta' Fournier, Xigduo għandu jitwaqqaf u għandha tinbeda kura minnufih (li tinkludi antibijotiċi u tneħħija kirurġika).
English: There have been no therapeutic clinical trials conducted with Xigduo tablets.
Maltese: Ma saret ebda prova klinika terapewtika bil-pilloli Xigduo.
English: The maximum daily dose of metformin should preferably be divided into 2-3 daily doses.
Maltese: Preferibbilment, id-doża massima ta' kuljum ta' metformin għandha tiġi diviża fi 2-3 dożi ta' kuljum.
English: The glycaemic efficacy of dapagliflozin is dependent on renal function, and efficacy is reduced in patients who have moderate renal impairment and is likely absent in patients with severe renal impairment.
Maltese: L-effikaċja gliċemika ta' dapagliflozin tiddependi mill-funzjoni renali, u l-effikaċja tonqos f'pazjenti li jkollhom indeboliment renali moderat u aktarx li tkun assenti f'pazjenti b'indeboliment renali sever.
English: Nocturia
Maltese: • stitikezza
English: Maximum total daily dose is 10 mg.
Maltese: Id-doża totali massima ta' kuljum hija 10 mg.
English: Xigduo 5 mg/850 mg film-coated tablets
Maltese: Xigduo 5 mg/850 mg pilloli miksijin b'rita
English: Method of administration
Maltese: Treatment Group
English: Dapagliflozin exposure increased proportional to the increment in dapagliflozin dose over the range of 0.1 to 500 mg and its pharmacokinetics did not change with time upon repeated daily dosing for up to 24 weeks.
Maltese: L-esponiment ta' dapagliflozin żdied b'mod proporzjonat għaż-żieda fid-doża ta' dapagliflozin fuq medda ta' 0.1 sa 500 mg u l-faramakokinetika tiegħu ma nbidlitx maż-żmien wara dożi ripetuti ta' kuljum sa 24 ġimgħa.
English: If you take more Xigduo tablets than you should, you may experience lactic acidosis.
Maltese: Jekk tieħu aktar pilloli ta' Xigduo minn kemm suppost, tista' taqbdek aċidożi lattika.
English: Adjusted least squares means (LS Means) and treatment group difference(s) in the change from baseline values at Week 28 are modelled using a mixed model with repeated measures (MMRM) including treatment, region, baseline HbA1c stratum (< 9.0% or ≥ 9.0%), week, and treatment by week interaction as fixed factors, and baseline value as a covariate.
Maltese: LS) u differenza/differenzi fil-grupp ta' kura fil-bidla mill-valuri fillinja bażi fit-28 Ġimgħa huma mmudellati permezz ta' mudell imħallat b'kejliet ripetuti (MMRM) inklużi lkura, ir-reġjun, l-istrat HbA1c fil-linja bażi (< 9.0% or ≥ 9.0%), il-ġimgħa, u l-kura skont l-interazzjoni talġimgħa bħala fatturi fissi, u valur fil-linja bażi bħala kovarjant.
English: Following an oral dose, the apparent terminal elimination half-life is approximately 6.5 hours.
Maltese: Wara doża orali, il-half-life ta' eliminazzjoni terminali apparenti hija madwar 6 sigħat u nofs.
English: • in patients already being treated with the combination of dapagliflozin and metformin as separate tablets.
Maltese: • f'pazjenti li diġà qegħdin jiġu kkurati bil-kombinazzjoni ta' dapagliflozin u metformin bħala pilloli separati.
English: Some medicinal products 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,
Maltese: NSAIDs, inklużi inibituri selettivi ta' cyclo-oxygenase (COX) II, inibituri ta' ACE, antagonisti tar-riċetturi ta' angiotensin II u dijuretiċi, speċjalment dijuretiċi loop.
English: • dizziness
Maltese: Bijotrasformazzjoni
English: Excipient(s) with known effect: Xigduo contains less than 1 mmol sodium (23 mg) per dose, i.e. is essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha inqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri hija essenzjalment “mingħajr sodium”.
English: Use of alternative methods to monitor glycaemic control is advised.
Maltese: Huwa rrakkomandat l-użu ta' metodi alternattivi biex timmonitorja l-kontroll gliċemiku.
English: The following statements reflect the preclinical safety data of the individual active substances of Xigduo.
Maltese: Id-dikjarazzjonijiet li ġejjin jirriflettu l-informazzjoni disponibbli dwar is-sustanzi attivi individwali.
English: The safety and efficacy of Xigduo in children and adolescents aged 0 to < 18 years have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' Xigduo fit-tfal u l-adolexxenti minn età ta' 0 sa < 18-il sena ma ġewx determinati s'issa.
English: After an oral dose of metformin, tmax is reached in 2.5 h. Absolute bioavailability of a 500 mg or 850 mg metformin tablet is approximately 50-60% in healthy subjects.
Maltese: Il-bijodisponibbiltà assoluta ta' pillola ta' metformin ta' 500 mg jew ta' 850 mg hija bejn wieħed u ieħor 50-60% f'individwi b'saħħithom.
English: There is no clinically meaningful increase in exposure based on age alone in subjects up to 70 years old.
Maltese: Ma hemmx żieda klinikament sinifikanti fl-esponiment ibbażat fuq l-età weħidha f'individwi sa 70 sena.
English: Results of one 28-week trial of dapagliflozin and prolonged-release exenatide versus dapagliflozin alone and prolonged-release exenatide alone, in combination with metformin (intent to treat patients)
Maltese: Riżultati ta' prova waħda ta' 28 ġimgħa ta' dapagliflozin u exenatide li jerħi l-mediċina bil-mod meta mqabbla ma' dapagliflozin waħdu u exenatide li jerħi l-mediċina bil-mod waħdu, f'kombinazzjoni ma' metformin (intenzjoni li jikkura l-pazjenti)