FrancophonIA/ELRC3.0 huggingface dataset:
English: Change from baseline (adjusted mean (95% Confidence interval [CI])
Maltese: Linja bażi (medja) Bidla mil-linja bażi (medja aġġustata (95 % Intervall ta' kunfidenza [CI])
English: Following a 5 mg single oral dose of saxagliptin to healthy subjects, the mean plasma AUC values for saxagliptin and its major metabolite were 78 ng·h/ml and 214 ng·h/ml, respectively.
Maltese: Wara doża orali waħda ta' 5 mg ta' saxagliptin f'individwi b'saħħithom, il-medja tal-valuri ta' l-AUC fil-plażma għal saxagliptin u l-metabolu ewlieni tiegħu kienu 78 ng h/mL u 214 ng h/mL, rispettivament.
English: Use with potent CYP3A4 inducers
Maltese: Użu ma indutturii qawwija ta' CYP 3A4
English: The percent of subjects with reported on-treatment events of major hypoglycaemia (defined as an event that required assistance of another person) was higher in the saxagliptin group than in the placebo group (2.1% and 1.6%, respectively).
Maltese: Il-perċentwal ta' individwi b'avvenimenti waqt il-kura rrapportati ta' ipoġliċemija maġġuri (definit bħala avveniment li ħtieġ l-assistenza ta' persuna oħra) kien ogħla fil-grupp ta' saxagliptin milli fil-grupp tal-plaċebo (2.1% u 1.6%, rispettivament).
English: Hypertriglyceridaemia
Maltese: Wedel Il-Ġermanja
English: Saxagliptin in combination with a fixed, intermediate dose of a sulphonylurea (glibenclamide 7.5 mg) was compared to titration to a higher dose of glibenclamide (approximately 92% of patients in the placebo plus glibenclamide group were uptitrated to a final total daily dose of 15 mg).
Maltese: Saxagliptin imħallat ma' doża fissa intermedja ta' sulphonylurea (glibenclamide 7.5 mg) kien imqabbel ma' żieda bil-mod fid-doża ta' glibenclamide (madwar 92% tal-pazjenti fil-grupp fuq plaċebo ma' glibenclamide kienu miżjuda għal doża totali finali ta' 15 mg kuljum).
English: Concomitant administration of saxagliptin with the moderate inhibitor of CYP3A4/5 diltiazem, increased the Cmax and AUC of saxagliptin by 63% and 2.1-fold, respectively, and the corresponding values for the active metabolite were decreased by 44% and 34%, respectively.
Maltese: Meta saxagliptin ittieħed flimkien ma' inibitur moderat ta' CYP3A4/5 diltiazem, kien hemm żidiet fisCmax u l-AUC ta' saxagliptin b'63% u 2.1-il darba aktar, rispettivament, u l-valuri li jikkorrespondu għal metabolu attiv kienu mnaqqsa b'44% u 34%, rispettivament..
English: Saxagliptin produced gastrointestinal toxicity in dogs, including bloody/mucoid faeces and enteropathy at higher doses with a NOEL 4 and 2 times the human exposure for saxagliptin and the major metabolite, respectively, at RHD.
Maltese: Saxagliptin produċa tossiċita gastrointestinali fil-klieb inkluż ippurgar imdemmi/b'tisfija u enteropatija b'dożi aktar għolja b'NOEL ta' 4 u 2 darbiet l-esponiment fil-bniedem għal saxagliptin u l-metabolu ewlieni, rispettivament, bl-RHD.
English: Immune related findings of minimal, nonprogressive, lymphoid hyperplasia in spleen, lymph nodes and bone marrow with no adverse sequelae have been reported in all species tested at exposures starting from 7 times the RHD.
Maltese: Sejbit minimi u mhux progressivi relatati mal-immunita ta' iperplasja limfatika fil-milsa, nodi limfatiċi u l-mudullun, l-ebda effetti avversi ta' wara ma kienu rrapportati fl- ispeċi kollha ttestjati b'esponimenti li jibdew minn 7 darbiet l-RHD.
English: A single-dose, open-label study was conducted to evaluate the pharmacokinetics of a 10 mg oral dose of saxagliptin in subjects with varying degrees of chronic renal impairment compared to subjects with normal renal function.
Maltese: Studju b'doża waħda open label sar sabiex tiġi evalwata il-farmakokinetika ta' doża orali ta' 10 mg ta' saxagliptin f'individwi b'gradi varji ta' indeboliment renali kroniku meta mqabbel ma' individwi b'funzjoni renali normali.
English: Table 2 Key efficacy results of Onglyza 5 mg per day in placebo-controlled monotherapy trials and in add-on combination therapy trials
Maltese: Tabella 2 Riżultati ta' l-effikaċja ta' Onglyza 5 mg kuljum fi provi ta' monoterapija ikkontrollati bil-plaċebo u fi provi ta' terapija mħallta u miżjuda
English: Another secondary endpoint, all-cause mortality, occurred at a rate of 5.1% in the saxagliptin group and 4.6% in the placebo group (see Table 4).
Maltese: Punt ta' tmiem sekondarju ieħor, il-mortalità minn kull kawża, seħħet b'rata ta' 5.1% fil-grupp ta' saxagliptin u 4.6% fil-grupp tal-plaċebo (ara Tabella 4).
English: Onglyza 5 mg film-coated tablets Each tablet contains 5 mg saxagliptin (as hydrochloride).
Maltese: Onglyza 5 mg pilloli miksija b'rita Kull pillola fiha 5 mg saxagliptin (bħala hydrochloride).
English: Improvements in HbA1c, PPG, and FPG following treatment with saxagliptin 5 mg plus metformin were sustained up to Week 102.
Maltese: Titjib fl- HbA1c, PPG u FPG wara kura b' saxagliptin 5 mg ma metformin inżamm sa' Ġimgħa 102.
English: Pack sizes of 14, 28, 56 and 98 film-coated tablets in non-perforated calendar blisters.
Maltese: Daqsijiet ta' pakketti ta' 14, 28, 56 u 98 pilloli miksija b'rita ġo folji, bil-kalendarju, mhux imtaqqbin.
English: In subjects with mild renal impairment, the mean AUC values of saxagliptin and its major metabolite were 1.2- and 1.7- fold higher, respectively, than mean AUC values in subjects with normal renal function.
Maltese: F'individwi b' indeboliment renali ħafif, il-medja tal-valuri AUC ta' saxagliptin u l-metabolu ewlieni tiegħu kienu 1.2- u 1.7- il darba aktar, rispettivament, mill-medja tal-valuri AUC f'individwi b' funzjoni renali normali.
English: The reduction in FPG was slightly less in the saxagliptin-group and there were more discontinuations (3.5% vs. 1.2%) due to lack of efficacy based on FPG criteria during the first 24 weeks of the study.
Maltese: It-tnaqqis fl-FPG kien ftit anqas filgrupp ta' saxagliptin u kien hemm aktar twaqqif (3.5% vs. 1.2%) minħabba nuqqas ta' effikaċja bbażata fuq kriterja ta' FPG waqt l-ewwel 24 ġimgħa ta'l-istudju.
English: Similar HbA1c reductions versus placebo were achieved for patients receiving saxagliptin 5 mg add-on to insulin regardless of metformin use (−0.4% for both subgroups).
Maltese: Tnaqqis simili fl-HbA1c kontra l-plaċebo inkiseb f'pazjenti li kienu qed jirċievu saxagliptin 5 mg miżjud mal-insulina irrispettivament jekk kienux qed jużaw metformin (-0.4% għaż-żewġ sottogruppi).
English: Food had relatively modest effects on the pharmacokinetics of saxagliptin in healthy subjects.
Maltese: L-ikel kellu effetti relattivament żgħar fuq il-farmakokinetika ta' saxagliptin f'individwi b'saħħithom.
English: The HbA1c change for saxagliptin 5 mg (n=56) compared to uptitrated glibenclamide plus placebo (n=27) was -0.7% at Week 76.
Maltese: Il-bidla fl- HbA1c għal saxagliptin 5 mg (n=56) imqabbel ma glibenclamide miżjud bilmod flimkien ma plaċebo (n=27) kienet -0.7% f'Ġimgħa 76.
English: In randomised, controlled, double-blind clinical trials (including developmental and postmarketing experience), over 17,000 patients with type 2 diabetes have been treated with Onglyza.
Maltese: Fi provi klini double-blind, ikkontrollati, randomizzati (inkluż esperjenza tal-iżvilupp u ta' wara t-tqegħid fis-suq), aktar minn 17,000 pazjent b'dijabete tip 2 ġew ikkurati b'Onglyza.
English: Saxagliptin and dapagliflozin add-on to metformin therapy A total of 534 adult patients with type 2 diabetes mellitus and inadequate glycaemic control on metformin alone (HbA1c 8%-12%), participated in this 24-week randomised, double-blind, active comparator-controlled trial to compare the combination of saxagliptin and dapagliflozin added concurrently to metformin, versus saxagliptin or dapagliflozin added to metformin.
Maltese: Saxagliptin u dapagliflozin miżjudin ma' terapija ta' metformin Total ta' 534 pazjent adult b'dijabete mellitus tat-Tip 2 u li ma kellhomx kontroll xieraq taz-zokkor fid-demm b'metformin waħdu (HbA1c 8 %-12 %), ipparteċipaw f'din il-prova ta' 24 ġimgħa, randomizzata, double-blind, ikkontrollata b'komparatur attiv sabiex titqabbel it-taħlita ta' saxagliptinu u dapagliflozin miżjuda fl-istess ħin ma' metformin, kontra saxagliptin jew dapagliflozin miżjud ma' metformin.
English: A lower proportion of patients in the saxagliptin group (1.1%) compared to the glimepiride group (15.3%) experienced a confirmed or severe hypoglycaemic event.
Maltese: Proporzjon iżgħar ta' pazjenti fil-grupp ta' saxagliptin (1.1%) meta mqabbel mal-grupp ta' glimepiride (15.
English: The effect on HbA1c observed at Week 24 was sustained at Week 52.
Maltese: L-effett fuq HbA1c osservat wara Ġimgħa 24 kien sostnut f'Ġimgħa 52.
English: One component of the secondary composite endpoint, hospitalisation for heart failure, occurred at a greater rate in the saxagliptin group (3.5%) compared with the placebo group (2.8%), with nominal statistical significance favouring placebo [HR = 1.27; (95% CI 1.07, 1.51); P = 0.007].
Maltese: Komponent wieħed tal-punt ta' tmiem kompost sekondarju, rikoveru l-isptar għal kollass tal-qalb, seħħ b'rata akbar fil-grupp ta' saxagliptin (3.5%) meta mqabbel mal-grupp tal-plaċebo (2.8%), b'sinifikat statistiku nominali li jiffavorixxi plaċebo [HR = 1.27; (95% CI 1.07, 1.51); P = 0.007]. Fatturi klinikament relevanti ta' riskju relattiv miżjud bil-kura ta' saxagliptin ma setgħux jiġu identifikati b'mod definittiv.
English: The mean plasma terminal half-life (t1/2) values for saxagliptin and its major metabolite are 2.5 hours and 3.1 hours respectively, and the mean t1/2 value for plasma DPP4 inhibition was 26.9 hours.
Maltese: Il-medja tal-valuri tal-half-life terminali fil-plażma (t½) għal saxagliptin u l -metabolu ewlieni tiegħu kienu 2.5 sigħat u 3.1 sigħat rispettivament, u l-valur medju t½ għall-inibizzjoni ta' DPP4 fil-plażma kien 26.
English: • Common, (may affect 1 to 10 users in 100): infection of the upper chest or lungs, infection of the urinary tract, inflamed stomach or gut usually caused by an infection (gastroenteritis), infection of the sinuses with a feeling of pain and fullness behind your cheeks and eyes (sinusitis), inflamed nose or throat (nasopharyngitis) (signs of this may include a cold or a sore throat), headache, muscle pain (myalgia), vomiting, inflammation of the stomach (gastritis), stomach ache and indigestion (dyspepsia).
Maltese: • Komuni, (jistgħu jaffettwaw utent 1 sa 10 minn kull 100): infezzjoni tal-parti ta' fuq tas-sider jew tal-pulmun, infezzjoni ta' mnejn tgħaddi l-awrina, infjammazzjoni fl-istonku jew musrana, normalment ikkawżata minn infezzjoni (gastroenterite). infezzjoni tas-sinużite , b'sensazzjoni ta' uġigħ u ebusija wara ħaddejk u għajnejk (sinużite), infjammazzjoni ta' l-imnieħer jew griżmejn (nasofarinġite).
English: Improvements in HbA1c, PPG and FPG following treatment with saxagliptin 5 mg were sustained up to Week 76.
Maltese: Titjib fl- HbA1c, PPG u FPG wara kura b' saxagliptin 5 mg inżammu sa' Ġimgħa 76.
English: In addition, patients should be alerted to the risk of hypoglycaemia when Onglyza is used in combination with other antidiabetic medicinal products known to cause hypoglycaemia (e.g. insulin, sulphonylureas).
Maltese: Barra minn hekk, il-pazjenti għandhom jiġu mwissija bir-riskju ta' ipogliċemija meta Onglyza jintuża f'kombinazzjoni ma' prodotti mediċinali antidijabetiċi magħrufin li jikkawżaw ipogliċemija (eż. insulina, sulphonylureas).
English: CALENDAR BLISTERS (NON-PERFORATED) for Onglyza 2.5 mg tablets
Maltese: FOLJI (IMTAQQBIN) għal Onglyza 2.5 mg pilloli
English: The incidence of confirmed hypoglycaemia was uncommon for Onglyza 5 mg (0.8%) and placebo (0.7%).
Maltese: 1 % għal Onglyza 5 mg u 6.3% għal plaċebo.
English: Improvements in HbA1c, PPG and FPG following initial therapy with saxagliptin 5 mg plus metformin were sustained up to Week 76.
Maltese: Titjib fl- HbA1c, PPG u FPG wara kura fil-bidu b' saxagliptin 5 mg ma metformin inżammu sa' Ġimgħa 76.
English: Common Common Common
Maltese: Mhux komuni Mhux komuni
English: From a baseline mean absolute lymphocyte count of approximately 2,200 cells/μl, a mean decrease of approximately 100 cells/μl relative to placebo was observed in the placebo-controlled-pooled analysis.
Maltese: Minn għadd assolut tal-limfoċiti mal-linja bażi ta' madwar 2200 ċellula/µl , deher tnaqqis medju ta' 100 ċellula/µl meta mqabbel f'analiżi kollettiva ikkontrollat bil-plaċebo.
English: Saxagliptin add-on combination therapy with metformin and sulphonylurea A total of 257 patients with type 2 diabetes participated in a 24-week randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of saxagliptin (5 mg once daily) in combination with metformin plus sulphonylurea (SU) in patients with inadequate glycemic control (HbA1c ≥ 7% and ≤ 10%).
Maltese: Terapija ta' kombinazzjoni miżjuda ta' saxagliptin b'metformin u sulphonylurea Total ta' 257 pazjent b'dijabete tip 2 ħadu sehem fi studju ta' 24 ġimgħa, randomizzat, double-blind, ikkontrollat bi plaċebo sabiex jiġu evalwati l-effikaċja u s-sigurtà ta' saxagliptin (5 mg darba kuljum) f'kombinazzjoni ma' metformin flimkien ma' sulphonylurea (SU) f'pazjenti b'kontroll gliċemiku mhux adegwat (HbA1c ≥7% u ≤10%).
English: • Common: infection of the upper chest or lungs, infection of the urinary tract, inflamed stomach or gut usually caused by an infection (gastroenteritis), infection of the sinuses with a feeling of pain and fullness behind your cheeks and eyes (sinusitis), headache, vomiting, stomach ache and swelling of the hands, ankles or feet (peripheral oedema).
Maltese: • Komuni: infezzjoni tal-parti ta' fuq tas-sider jew tal-pulmun, infezzjoni ta' mnejn tgħaddi lawrina, infjammazzjoni fl-istonku jew musrana, normalment ikkawżata minn infezzjoni (gastroenterite), infezzjoni tas-sinużite, b'sensazzjoni ta' uġigħ u ebusija wara ħaddejk u għajnejk (sinużite), uġigħ ta' ras, tirremetti, uġigħ fl-istonku u tneffiħ ta' l-idejn, ekiesi u riġlejn (edima periferali).
English: A total of 22% of the administered radioactivity was recovered in faeces representing the fraction of the saxagliptin dose excreted in bile and/or unabsorbed medicinal product from the gastrointestinal tract.
Maltese: Total ta' 22% tar-radjuattività li ngħatat kienet irkuprata fl-ippurgar u din kienet tirrappreżenta l-frazzjoni taddoża ta' saxagliptin eskretata fil-bajl u/jew prodott mediċinali li ma ġiex assorbit mill-passaġġ gastrointestinali.
English: Thus, changes in blood protein levels in various disease states (e.g. renal or hepatic impairment) are not expected to alter the disposition of saxagliptin.
Maltese: Għal daqstant tibdil fil-livell ta' proteini fid-demm fi stati varji ta' mard (eżempju Indeboliment renali jew epatiku) ma humiex mistennija li jbiddlu d-dispożizzjoni ta' saxagliptin.
English: Saxagliptin add-on to metformin therapy
Maltese: Terapija ta' saxagliptin miżjud ma' metformin
English: Reductions in HbA1c were seen across subgroups including gender, age, race, and baseline body mass index (BMI) and higher baseline HbA1c was associated with a greater adjusted mean change from baseline with saxagliptin.
Maltese: Tnaqqis fl-HbA1c dehru fissottogruppi li kienu jinkludu s-sess, l-età, razza, u l-indiċi tal-massa tal-ġisem mal-linja bażi (BMI).
English: Across clinical studies, the incidence of laboratory adverse events was similar in patients treated with saxagliptin 5 mg compared to patients treated with placebo.
Maltese: Fl-istudji kliniċi l-inċidenza ta' avvenimenti avversi tal-laboratorju kienu simili f'pazjenti kkurati b'saxagliptin 5 mg meta komparati ma' pazjenti kkurati bi plaċebo.
English: Some patients have had the following side effects while taking Onglyza and a thiazolidinedione:
Maltese: Xi pazjenti kellhom dawn l-effetti sekondarji waqt li kienu qed jieħdu Onglyza u thiazolidinedione:
English: Reductions in HbA1c from baseline to Week 24 were observed in all evaluated subgroups defined by baseline HbA1c, with greater reductions observed in patients with a baseline HbA1c ≥ 10% (see Table 2).
Maltese: Tnaqqis fl-HbA1c mill-linja bażi sa 24 ġimgħa kien osservat fis-sottogruppi kollha evalwati definiti bil-linja bażi
English: Onglyza 2.5 mg film-coated tablets Onglyza 5 mg film-coated tablets
Maltese: Onglyza 2.5 mg pilloli miksija b'rita Onglyza 5 mg pilloli miksija b'rita
English: It is not known if this medicine is safe and effective when used in children and adolescents under 18 years of age.
Maltese: Mhuwiex magħruf jekk din il-mediċina hijiex sigura u effettiva meta użata fi tfal u adolexxenti iżgħar minn 18-il sena.
English: Dyslipidaemia
Maltese: Dijarea
English: The incidence of confirmed hypoglycaemic events was somewhat higher in the saxagliptin group (9.4%) versus placebo group (4.7%) although the number of subjects with any hypoglycaemic event did not differ between the treatment groups.
Maltese: L-inċidenza ta' avvenimenti kkonfermati ta' ipogliċemija kien kemmxejn ogħla fil-grupp ta' saxagliptin (9.4 %) mqabbel mal-grupp tal-plaċebo (4.7 %) għalkemm in-numru ta' individwi b'avveniment ipogliċemiku ma kienx differenti bejn iżżewġ gruppi ta' kura.
English: Onglyza had no clinically meaningful effect on QTc interval or heart rate at oral doses up to 400 mg daily for 2 weeks (80 times the recommended dose).
Maltese: Onglyza ma kellu ebda effett kliniku sinifikanti fuq l-intervall QTc jew ir-rata tal-qalb b'dożi ta' mhux aktar minn 400 mg kuljum għal ġimgħatejn (80 darba id-doża rakkomandata).
English: Improvements in HbA1c following treatment with saxagliptin 2.5 mg were sustained up to Week 52, however, the number of patients who completed 52 weeks without modification of other antihyperglycaemic treatment was low (26 subjects in the saxagliptin group versus 34 subjects in the placebo group).
Maltese: Titjib fl-HbA1c wara kura b'saxagliptin 2.5 mg kien sostnut sa Ġimgħa 52, madanakollu in-numru ta' pazjenti li spiċċaw 52 ġimgħa mingħajr modifikazzjoni oħra fil-kura b'mediċini li jbaxxu l-livell taz-zokkor fid-demm kien baxx (26 individwu fil-grupp ta' saxagliptin kontra 34 individwu fil-grupp tal-plaċebo).
English: Pack sizes of 14, 28, and 98 film-coated tablets in non-perforated calendar blisters.
Maltese: Daqsijiet ta' pakketti ta' 14, 28, u 98 pilloli miksija b'rita ġo folji, bil-kalendarju, mhux imtaqqbin.
English: After an oral glucose load, this DPP4 inhibition resulted in a 2- to 3-fold increase in circulating levels of active incretin hormones, including glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), decreased glucagon concentrations and increased glucose-dependent beta-cell responsiveness, which resulted in higher insulin and C-peptide concentrations.
Maltese: Wara li tittieħed tagħbija ta' glucose orali, din l-inibizzjoni DPP4 wasslet għal żiediet ta' 2- sa 3-il darba fil-livelli ta' ormoni inkretin li jiċċirkolaw, GLP-1 u GIP, konċentrazzjonijiet ta' glucagon li jitbaxxew, u żieda fir-rispons għall-ħruġ ta' insulina għallglucose, li twassal għal konċentrazzjonijiet ta' C-peptajd u insulina.
English: Clinical data described below suggest that the risk for clinically meaningful interactions with co-administered medicinal products is low.
Maltese: Dejta klinika spjegata hawn taħt tindika li r-riskju għal interazzjonijiet kliniċi ta' ċertu importanza meta jingħataw flimkien ma' prodotti mediċinali huwa baxx.
English: Some patients have had the following side effects while taking Onglyza and metformin and a sulphonylurea:
Maltese: Xi pazjenti kellhom dawn l-effetti sekondarji waqt li kienu qed jieħdu Onglyza u metformin u sulphonylurea:
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say it is essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol ta' sodium (23 mg) għal kull doża, jiġifieri essenzjalment hija “mingħajr sodium”.
English: In both studies, once-daily treatment with saxagliptin provided significant improvements in HbA1c (see Table 2).
Maltese: Fiż-żewġ studji, kura ta' darba kuljum b'saxagliptin ipprovdiet titjieb sinifikanti fl-HbA1c (ara Tabella 2).
English: The HbA1c change for saxagliptin 5 mg plus metformin (n=177) compared to metformin plus placebo (n=147) was -0.5% at Week 76.
Maltese: Il-bidla fl-HbA1c għal saxagliptin 5 mg ma' metformin (n=177) imqabbel ma' metformin flimkien mal-plaċebo (n=147) kienet -0.5% f'Ġimgħa 76.
English: BLISTERS (PERFORATED/NON-PERFORATED) for Onglyza 5 mg tablets
Maltese: FOLJI (IMTAQQBIN/MHUX IMTAQQBIN) għal Onglyza 5 mg pilloli
English: A1C was lower with saxagliptin compared to placebo in an exploratory analysis.
Maltese: A1C kien iktar baxx b'saxagliptin meta mqabbel ma' plaċebo f'analiżi esploratorja.
English: Each film-coated tablet contains 2.5 mg saxagliptin (as hydrochloride).
Maltese: Kull pillola miksija b'rita fiha 2.5 mg saxagliptin (bħala hydrochloride).
English: In postmarketing experience of saxagliptin, there have been spontaneously reported adverse reactions of acute pancreatitis.
Maltese: F'esperjenza ta' wara t-tqegħid fis-suq ta' saxagliptin kien hemm reazzjonijiet avversi irrappurtati b'mod spontanju ta' pankrejatite akuta.
English: The co-administration of saxagliptin and CYP3A4/5 inducers, other than rifampicin (such as carbamazepine, dexamethasone, phenobarbital and phenytoin) have not been studied and may result in decreased plasma concentration of saxagliptin and increased concentration of its major metabolite.
Maltese: L-għoti ta' saxagliptin flimkien ma' indutturi ta' CYP3A4/5 għajr rifampicin (bħal carbamazepine, dexamethasone, phenobarbital u phenytoin) ma ġiex studjat u dan jista' jwassal għal tnaqqis filkonċentrazzjonijiet fil-plażma ta' saxagliptin u żieda fil-konċentrazzjonijiet tal-metabolu ewlieni.
English: The dose should be reduced to 2.5 mg once daily in patients with moderate renal impairment that have GFR < 45 mL/min and in patients with severe renal impairment.
Maltese: Id-doża għandha titnaqqas għall-2.5 mg darba kuljum f'pazjenti b'indeboliment renali moderat li għandhom GFR < 45 mL/min u f'pazjenti b'indeboliment renali qawwi.
English: Onglyza 2.5 mg film-coated tablets Polyvinyl alcohol Macrogol 3350
Maltese: Onglyza 2.5 mg pilloli miksija b'rita Polyvinyl alcohol
English: There were 4,148 patients with type 2 diabetes, including 3,021 patients treated with Onglyza, randomised in six double-blind, controlled clinical safety and efficacy studies conducted to evaluate the effects of saxagliptin on glycaemic control.
Maltese: Kien hemm 4,148 pazjent b'dijabete tat-tip 2, inkluż 3,021 pazjent ikkurati b'Onglyza, f'6 studji kliniċi, randomizzati u ikkontrollati dwar is-sigurtà u l-effikaċja li saru sa biex jiġu evalwati l-effetti ta' saxagliptin fuq il-kontroll taz-zokkor fid-demm.
English: The reductions from baseline in HbA1c respectively for saxagliptin and sitagliptin in the primary per-protocol analysis were -0.5% (mean and median) and -0.6% (mean and median).
Maltese: It-tnaqqis mill-linja bażi fl' HbA1c għall-saxagliptin u sitagliptin fl' analiżi primarja skont il-protokol kienu -0.5% (medja u medjan) u0.
English: Primary composite endpoint: MACE Secondary composite endpoint: MACE plus All-cause mortality
Maltese: Punt ta' tmiem kompost sekondarju:
English: The incidence of adjudicated pancreatitis events was 0.3% in both Onglyza-treated patients and placebo-treated patients in the intent-to-treat population.
Maltese: L-inċidenza ta' episodji ta' pankreatite aġġudikata kienet ta' 0.3% kemm f'pazjenti kkurati b'Onglyza kif ukoll f'pazjenti kkurati bi plaċebo fil-popolazzjoni b'intenzjoni li tiġi kkurata.
English: • Uncommon (may affect 1 to 10 users in 1,000): joint pain (arthralgia) and difficulties in getting or maintaining an erection (erectile dysfunction).
Maltese: • Mhux komuni (jistgħu jaffettwaw utent 1 sa 10 minn kull 1,000): uġigħ fil-ġogi (artralġja) u diffikultajiet sabiex ikollok u żżomm erezzjoni (anormalita fl-erezzjoni).
English: Onglyza contains the active substance saxagliptin, which belongs to a group of medicines called ‘oral anti-diabetics'.
Maltese: Onglyza fih is-sustanza attiva saxagliptin, li tagħmel parti minn grupp ta' mediċini li jissejħu “mediċini orali kontra d-dijabete”.
English: Pruritus†
Maltese: Stitikezza†
English: Each film-coated tablet contains 5 mg saxagliptin (as hydrochloride).
Maltese: Kull pillola miksija b'rita fiha 5 mg saxagliptin (bħala hydrochloride).