FrancophonIA/ELRC3.0 huggingface dataset:
English: Saxagliptin also resulted in a significantly lower proportion of patients with hypoglycaemia, 3% (19 events in 13 subjects) vs. 36.3% (750 events in 156 patients) for glipizide.
Maltese: Saxaglitin irriżulta wkoll f' proporzjon sinifikanti anqas ta' pazjenti b'ipogliċemija, 3% (19-il avveniment f' 13-il persuna) vs. 36.3% (750-il avveniment f' 156 pazjent) għall-glipizide.
English: Onglyza contains lactose
Maltese: Onglyza fih lactose.
English: In patients with GFR < 45 mL/min, the recommended dose is 2.5 mg once daily.
Maltese: F'pazjenti b'GFR < 45 mL/min, id-doża rakkomandata hija 2.5 mg darba kuljum.
English: Diarrhoea
Maltese: Dislipidemija
English: Do not take Onglyza
Maltese: Tieħux Onglyza
English: 7.9 -0.7 (morning)
Maltese: -0.7 (filgħodu)
English: The average renal clearance of saxagliptin (~230 ml/min) was greater than the average estimated glomerular filtration rate (~120 ml/min), suggesting some active renal excretion.
Maltese: Il-medja tat-tneħħija ta' saxagliptin mill-kliewi (~230 mL/min) kienet akbar mir-rata tal-filtrazzjoni mill-glomeruli medja stmata (~120 mL/min), li tindika xi eskrezzjoni attiva permezz tal-kliewi.
English: The HbA1c change for the saxagliptin group (n=244) compared to placebo (n=124) was -0.4% at Week 52.
Maltese: Il-bidla fl-HbA1c għall-grupp fuq sxagliptin (n=244) imqabbel mal-plaċebo (n=124) kien -0.4% f'Ġimgħa 52.
English: Saxagliptin (n=250) provided significant improvements in HbA1c, FPG, and PPG compared to titration to a higher dose of glibenclamide (n=264).
Maltese: Saxagliptin (n=250) ġab titjib sinifikanti fl-HbA1c, FPG, u PPG mqabbel ma żieda bil-mod għal doża aktar għolja ta' glibenclamide (n=264).
English: A 12-week, multi-centre, randomised, double-blind, placebo-controlled study was conducted to evaluate the treatment effect of saxagliptin 2.5 mg once daily compared with placebo in 170 patients (85 patients on saxagliptin and 85 on placebo) with type 2 diabetes (HbA1c 7.0-11%) and renal impairment (moderate [n=90]; severe [n=41]; or ESRD [n=39]).
Maltese: Sar studju ta' 12-il ġimgħa, f'ħafna ċentri, randomizzati, double-blind u kkontrollat bi plaċebo sabiex jevalwa l-effett tal-kura ta' saxagliptin 2.5 mg darba kuljum imqabbel ma' plaċebo f'170 pazjent (85 pazjent fuq saxagliptin u 85 pazjent fuq plaċebo) b'dijabete tat-tip 2 (HbA1c 7.0-11 %) u indeboliment renali (moderat [n=90]; qawwi [n=41]; jew ESRD [n=39]).
English: This may be used to treat inflammation in different body parts and organs.
Maltese: Din tista tintuża għal kura ta' infjammazzjoni f'partijiet u organi differenti tal-ġisem.
English: Immunocompromised patients
Maltese: Pazjenti b'immunita kompromessa
English: Saxagliptin (n=186) provided significant improvements in HbA1c, FPG, and PPG compared to placebo (n=175).
Maltese: Saxagliptin (n=186) tejjeb b'mod sinifikanti l-HbA1c, FPG, u PPG mqabbel ma plaċebo (n=175).
English: Saxagliptin with a thiazolidinedione
Maltese: Saxagliptin ma' thiazolidinedione
English: 14 film-coated tablets 28 film-coated tablets 30x1 film-coated tablets 56 film-coated tablets 90x1 film-coated tablets 98 film-coated tablets
Maltese: 14-il pillola miksija b'rita 28 pillola miksija b'rita 30x1 pillola miksija b'rita 56 pillola miksija b'rita 90x1 pillola miksija b'rita 98 pillola miksija b'rita
English: Saxagliptin add-on to metformin compared with SU add-on to metformin A 52-week study was conducted to evaluate the efficacy and safety of saxagliptin 5 mg in combination with metformin (428 patients) compared with a sulphonylurea (glipizide, 5 mg titrated as needed to 20 mg, mean dose of 15 mg) in combination with metformin (430 patients) in 858 patients with inadequate glycaemic control (HbA1c 6.5%-10%) on metformin alone.
Maltese: Saxagliptin miżjud ma' metformin mqabbel ma' SU miżjud ma' metformin Studju ta' 52 ġimgħa kien kondott sabiex tiġi evalwata l-effikaċja u s-sigurta ta' saxagliptin 5 mg meta jingħata flimkien ma metformin (428 pazjent) mqabbel ma sulphonylurea (glipizide, 5 mg miżjud skont il-bżonn sa 20 mg, doża medja ta' 15 mg) flimkien ma' metformin (430 pazjent) f' 858 pazjent b' kontroll taz-zokkor mhux xieraq (HbA1c 6.5%-10%) fuq metformin waħdu.
English: • Study CV181040: add-on to SU (n=250)
Maltese: • Studju CV181040: miżjud ma SU 1 (n=250)
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-galactose, nuqqas ta' lactase totali jew malassorbiment tal-glucose-galactose m'għandhomx jieħdu din il-mediċina.
English: Saxagliptin add-on to thiazolidinedione therapy
Maltese: Saxagliptin miżjud ma' terapija ta' thiazolidinedione
English: This is an antibiotic used to treat infections such as tuberculosis.
Maltese: Dan huwa antibijotiku li jintuża għal kura ta' infezzjonijiet bħal tuberkulosi.
English: Using CYP3A4 inducers like carbamazepine, dexamethasone, phenobarbital, phenytoin, and rifampicin may reduce the glycaemic lowering effect of Onglyza (see section 4.5).
Maltese: L-Użu ta' indutturi qawwija ta' CYP 3A4 bħal carbamażepine, dexamethasone, phenobarbital, phenytoin u rifampiċin jistgħu jnaqqsu l-effett ta' Onglyza li jbaxxi iz-zokkor fid-demm (ara sezzjoni 4.5).
English: • 2.5 mg tablets are available in pack sizes of 14, 28, or 98 film-coated tablets in non-perforated calendar blisters and 30x1 or 90x1 film-coated tablets in perforated unit dose blisters.
Maltese: • Il-pilloli ta' 2.5 mg jiġu f' daqsijiet tal-pakkett ta'14, 28, jew 98-il pillola miksija b'rita ġo folji bil-kalendarju mhux imtaqqbin u 30x1 jew 90x1 pillola miksija b'rita ġo folji mtaqqbin madwar kull doża.
English: Saxagliptin as monotherapy
Maltese: Saxagliptin bħala monoterapija
English: Decreased lymphocyte counts were reported in 0.5% of Onglyza treated patients and 0.4% of placebotreated patients.
Maltese: Ġew irrapportati għadd ta' limfoċiti mnaqqsa f'0.5% tal-pazjenti kkurati b'Onglyza u 0.4% talpazjenti kkurati bi plaċebo.
English: Mean HbA1c change is the difference between the saxagliptin+dapagliflozin+metformin and dapagliflozin+metformin groups (p< 0.0001).
Maltese: Tibdil fil-medja HbA1c hija d-differenza bejn il-gruppi ta' saxagliptin+metformin u metformin waħdu (p<0.0001).
English: • Study CV181039: initial combination with metformin Overall population (n=306) Baseline HbA1c ≥ 10% stratum (n=107)
Maltese: • Studju CV181039: taħlita tal-bidu ma metformin Popolazzjoni totali (n=306) Linja bażi
English: Adverse reactions reported in ≥ 5% of patients treated with saxagliptin 5 mg and more commonly than in patients treated with placebo or that were reported in ≥ 2% of patients treated with saxagliptin 5 mg and ≥ 1% more frequently compared to placebo from the pooled analysis of five studies of glycaemic control, plus an additional active-controlled study of initial combination with metformin are shown in Table 1.
Maltese: Ir-reazzjonijiet avversi rrappurtati f' >5% tal-pazjenti kkurati b'saxagliptin 5 mg huwa aktar komuni minn pazjenti kkurati bi plaċebo u li kienu rrapportati f' >2% tal-pazjenti kkurati b'saxagliptin 5 mg u >1% aktar frekwenti mqabbla ma' plaċebo mill-analiżi miġbura ta' ħames studji ta' kontroll gliċemiku, kif ukoll studju kkontrollat b'mod attiv ta' kombinazzjoni inizjali ma' metformin qed jidhru f'Tabella 1.
English: p=0.0059 compared to placebo.
Maltese: p<0.0001 mqabbel mal- plaċebo. p=0.0059 mqabbel mal- plaċebo.
English: Saxagliptin add-on to dapagliflozin plus metformin therapy A 24-week randomised, double-blind, placebo-controlled study conducted in patients with type 2 diabetes mellitus compared saxagliptin 5 mg with placebo as add-on therapy in individuals with HbA1c 7-10.5% treated with dapagliflozin (a SGLT2-inhibtor) and metformin.
Maltese: Saxagliptin miżjud ma' terapija ta' dapagliflozin u metformin Sar studju ta' 24 ġimgħa, randomizzat, double-blind, ikkontrollat bi plaċebo f'pazjenti b'dijabete mellitus tat-Tip 2 meta mqabbel ma' saxagliptin 5 mg bi plaċebo bħala terapija miżjuda f'individwi b' HbA1c 7-10.5 % ikkurati bi dapagliflozin (inibitur ta' SGLT2) u metformin.
English: Saxagliptin (n=127) provided significant improvements in HbA1c and PPG compared with the placebo (n=128).
Maltese: Saxagliptin (n=127) ipprovda titjib sinifikanti fil-HbA1c u filPPG meta mqabbel mal-plaċebo (n=128).
English: Postmarketing reports of rash have been described in the DPP4 inhibitor class.
Maltese: Rapporti ta' wara tqegħid fis-suq, dwar raxx, kienu deskritti għal klassi ta' inibituri DPP4.
English: Saxagliptin was rapidly absorbed after oral administration in the fasted state, with maximum plasma concentrations (Cmax) of saxagliptin and its major metabolite attained within 2 and 4 hours (Tmax), respectively.
Maltese: Saxagliptin kien assorbit malajr wara li ingħata b'mod orali fi stat sawmi, bl-ogħla konċentrazzjonijiet fil-plażma (Cmax) ta' saxagliptin u l-metabolu ewlieni jinkisbu fi żmien 2 u 4 sigħat (Tmax), rispettivament.
English: Nausea†
Maltese: Prurite†
English: Placebo-corrected mean change in HbA1c (%) at Week 24 (95% CI)
Maltese: Tibdil medju ta' HbA1c ikkoreġut bilplaċebo (%) fl24 Ġimgħa (95% CI)
English: In cynomolgus monkeys saxagliptin produced reversible skin lesions (scabs, ulcerations and necrosis) in extremities (tail, digits, scrotum and/or nose) at doses ≥ 3 mg/kg/day.
Maltese: F'xadini cynomolgus saxagliptin ikkawża feriti fil-ġilda riversibbli (qxur, ulċeri u nekrosi) flestremitajiet (denb, swaba, skrotu u/jew imnieħer) b'dożi ta' >3 mg/Kg/kuljum.
English: In a pooled analysis of 1,681 patients with type 2 diabetes including 882 patients treated with Onglyza 5 mg, randomised in five double-blind, placebo-controlled clinical safety and efficacy studies conducted to evaluate the effects of saxagliptin on glycaemic control, the overall incidence of adverse events in patients treated with saxagliptin 5 mg was similar to placebo.
Maltese: F'analiżi kollettiva ta' 1,681 pazjenti b'dijabete tip 2 inkluż 882 pazjent ikkurati b'Onglyza 5 mg, randomizzati f'ħames studji kliniċi tas-sigurtà u l-effikaċja, ikkontrollati bi plaċebo, double-blind imwettqa biex jevalwaw l-effetti ta' saxagliptin fuq il-kontroll gliċemiku, l-inċidenza globali talkażijiet avversi f'pazjenti kkurati b'saxagliptin 5 mg kien jixbah lill tal-plaċebo.
English: Following a single 50 mg dose of C-saxagliptin, 24%, 36%, and 75% of the dose was excreted in the urine as saxagliptin, its major metabolite, and total radioactivity respectively.
Maltese: C-saxagliptin, 24%, 36%, U 75% tad-doża kienet eskretata fl-awrina bħala saxagliptin, il-metabolu ewlieni tiegħu u radjuattività totali rispettivament.
English: A total of 4,148 patients with type 2 diabetes, including 3,021 patients treated with, saxagliptin were randomised in 6 double-blind, controlled clinical safety and efficacy studies conducted to evaluate the effects of saxagliptin on glycaemic control.
Maltese: Total ta' 4,148 pazjent b'dijabete tat-tip 2, inklużi 3,021 pazjent ikkurat b'saxagliptin, kienu randomizzati f'6 studji kliniċi ikkontrollati, double-blind li saru sabiex jiġu evalwati l-effetti ta' saxagliptin fuq il-kontroll gliċemiku.
English: In the confirmatory full analysis set, mean reductions were -0.4% and -0.6% respectively for saxagliptin and sitagliptin, with median reductions of -0.5% for both groups.
Maltese: Fis-set ta' analiżi sħiħa kkonfermata, tnaqqis fil-medja kienu0.4% u -0.6% rispettivment għall-saxagliptin u sitagliptin, b' tnaqqis medju ta' -0.5% għaż-żewġ gruppi.
English: The HbA1c change for saxagliptin 5 mg plus metformin (n=31) compared to placebo plus metformin (n=15) was -0.8% at Week 102.
Maltese: Il-bidla fl- HbA1c għal saxagliptin 5 mg ma' metformin (n=31) imqabbel mal-plaċebo ma' metformin (n=15) kienet -0.8% f'Ġimgħa 102.
English: • in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations).
Maltese: • f'kombinazzjoni ma' prodotti mediċinali oħra għall-kura tad-dijabete, inkluż mal-insulina, meta dawn ma jiksbux kontroll xieraq taz-zokkor fid-demm (ara sezzjonijiet 4.4, 4.5 u 5.1 għal dejta disponibbli dwar taħlitiet differenti).
English: • 5 mg film-coated tablets are pink, biconvex, round.
Maltese: • Il-pilloli ta' 5 mg miksija b'rita huma roża, konvessi miż-żewġ naħat, tondi.
English: The increased risk of overall and major hypoglycaemia was primarily observed in subjects with A1C <7% at baseline.
Maltese: Ir-riskju miżjud ta' ipogliċemija ġenerali u maġġuri kien primarjament osservat f'individwi b'A1C <7% fil-linja bażi.
English: Mechanism of action and pharmacodynamic effects Saxagliptin is a highly potent (Ki: 1.3 nM), selective, reversible, competitive, DPP4 inhibitor.
Maltese: Saxagliptin huwa inibitur qawwi ħafna (Ki: 1.3 Nm), silettiv, riversibli u kompetittiv ta' DPP4.
English: Onglyza must not be used in patients who have had any serious hypersensitivity reaction to a dipeptidyl peptidase-4 (DPP4) inhibitor (see section 4.3).
Maltese: Onglyza ma jistax jintuża f'pazjenti li kellhom kwalunkwe reazzjoni ta' sensittività eċċessiva serja għal inibitur ta' dipeptidyl peptidase-4 (DPP4) (ara sezzjoni 4.3).
English: Placebo group had uptitration of glibenclamide from 7.5 to 15 mg total daily dose.
Maltese: Grupp tal-plaċebo b'żieda fid-doża totali kuljum ta' glibenclamide minn 7.5 għal 15 mg.
English: The rise in insulin from pancreatic beta-cells and the decrease in glucagon from pancreatic alpha-cells were associated with lower fasting glucose concentrations and reduced glucose excursion following an oral glucose load or a meal.
Maltese: Iż-żieda fl-insulina minn ċelluli beta tal-frixa u tnaqqis fil-glucagon miċ-ċelluli alfa tal-frixa kienu assoċjati ma' konċentrazzjonijiet ta' glucose aktar baxxi u tnaqqis fl-eskursjoni ta' glucose wara tagħbija orali ta' glucose jew ikla.
English: In studies conducted in healthy subjects, neither the pharmacokinetics of saxagliptin nor its major metabolite, were meaningfully altered by metformin, glibenclamide, pioglitazone, digoxin, simvastatin, omeprazole, antacids or famotidine.
Maltese: Fi studji kliniċi li saru f'individwi b'saħħithom, la l-farmakokinetika ta' saxagliptin u lanqas il-metabolit ewlieni tiegħu, ma kienu mibdula b'mod sinifikanti b'metformin, glibenclamide, pioglitazone, digoxin, simvastatin, omeprazole, antaċidi, jew famotidine.
English: The safety and efficacy of saxagliptin as triple oral therapy in combination with metformin and a thiazolidinedione have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' saxagliptin bħala terapija orali trippla, mħallta ma metformin u thiazolidinedione ma ġewx determinati s'issa.
English: There appeared to be no difference in percentage responders: 37.9% (saxagliptin) and 38.2% (glimepiride) achieved the primary endpoint.
Maltese: Jidher li ma kien hemm ebda differenza f'dawk li wieġbu perċentwali: 37.9% (saxagliptin) u 38.2% (glimepiride) laħqu l-punt ta' tmiem primarju.
English: There was no statistically significant difference compared to placebo.
Maltese: Ma kien hemm l-ebda differenza statistikament sinifikanti meta mqabbel ma' plaċebo.
English: Effects on fertility were observed in male and female rats at high doses producing overt signs of toxicity (see section 5.3).
Maltese: Effetti fuq il-fertilita kienu osservati filfirien maskili u femminili b' dożi għolja li produċew sinjali ta' tossiċita (ara sezzjoni 5.3).
English: Discontinuation of therapy due to adverse events was higher in patients who received saxagliptin 5 mg as compared to placebo (3.3% as compared to 1.8%).
Maltese: Twaqqif tat-terapija minħabba każijiet avversi kien ogħla f'pazjenti li rċevew saxagliptin 5 mg meta mqabbel mal-plaċebo (3.3% meta mqabbel ma' 1.8%).
English: Saxagliptin monotherapy
Maltese: Saxagliptin monoterapija
English: Onglyza contains less than 1 mmol sodium (23 mg) per dose, i.e. is essentially ‘sodium-free'.
Maltese: Onglyza fih anqas minn 1 mmol ta' sodium (23 mg) għal kull doża, jiġifieri essenzjalment huwa “mingħajr sodium”.
English: The in vitro protein binding of saxagliptin and its major metabolite in human serum is negligible.
Maltese: L-irbit in vitro mal- proteini ta' saxagliptin u l-metabolu ewlieni fis-serum uman huwa negliġibli.
English: When used as add-on to insulin (with or without metformin), the overall incidence of reported hypoglycaemia was 18.4% for Onglyza 5 mg and 19.9% for placebo.
Maltese: Meta jintuża bħala kura addizzjonali mal-insulina (b'metformin jew mingħajru), il-frekwenza globali tal-każijiet ipogliċemiċi rrapportati kienet 18.4% għal Onglyza 5 mg u 19.9% għal plaċebo.
English: The Cmax and AUC of saxagliptin and its major metabolite increased proportionally to the saxagliptin dose.
Maltese: Is- Cmax u l-AUC ta saxagliptin u l-metabolu ewlieni tiegħu żdiedu proporzjonalment mad-doża ta' saxagliptin.
English: They have “5” printed on one side and “4215” printed on the other side, in blue ink.
Maltese: Għandom “5” ittimbrata fuq naħa u “4215” ittimbrata fuq in-naħa l-oħra, b'linka blu.
English: Concomitant administration of saxagliptin with the potent CYP3A4/5 inducer rifampicin, reduced Cmax and AUC of saxagliptin by 53% and 76%, respectively.
Maltese: Meta saxagliptin ittieħed flimkien ma induttur qawwi ta' CYP3A4/5 rifampiċin, kien hemm tnaqqis fis-Cmax u l-AUC ta' saxagliptin b'53% u 76%, rispettivament.
English: Onglyza 5 mg tablets saxagliptin
Maltese: Onglyza 5 mg pilloli saxagliptin
English: Onglyza is not a substitute for insulin in insulin-requiring patients.
Maltese: Onglyza mhuwiex sostitut għall-insulina f'pazjenti li jeħtieġu l-insulina.
English: The primary safety (noninferiority) and efficacy (superiority) endpoint was a composite endpoint consisting of the time-to-first occurrence of any of the following major adverse CV events (MACE): CV death, nonfatal myocardial infarction, or nonfatal ischaemic stroke.
Maltese: Il-punt ta' tmiem primarju tas-sigurtà (noninferjorità) u effikaċja (superjorità) kien punt ta' tmiem kompost magħmul mill-ħin għall-ewwel okkorrenza ta' kwalunkwe wieħed mill-avvenimenti CV avversi li ġejjin (MACE): mewta CV, infart mijokardijaku mhux fatali, jew puplesija iskemika mhux fatali.
English: The incidence of diarrhoea was 4.1% (36/882) in the saxagliptin 5 mg group and 6.1% (49/799) in the placebo group.
Maltese: L-inċidenza ta' ipogliċemija konfermata ma kinitx komuni għal Onglyza 5 mg (0.8%) u plaċebo (0.7%) L-inċidenza ta' dijarea kienet ta' 4.1% (36/882) fil-grupp ta' saxagliptin 5 mg u 6.1% (49/799) fil-grupp tal-plaċebo.
English: Rash is also noted as an adverse reaction for Onglyza (see section 4.8).
Maltese: Raxx huwa wkoll mniżżel bħala reazzjoni avversa għal Onglyza ( ara sezzjoni 4.8).
English: Hypoglycaemia
Maltese: Ipertrigliċeridemija
English: Onglyza 2.5 mg film-coated tablets Each tablet contains 2.5 mg saxagliptin (as hydrochloride).
Maltese: Onglyza 2.5 mg pilloli miksija b'rita Kull pillola fiha 2.5 mg saxagliptin (bħala hydrochloride).
English: Saxagliptin significantly decreased HbA1c compared with placebo; the HbA1c change for saxagliptin was -0.9% at Week 12 (HbA1c change of -0.4% for placebo).
Maltese: Saxagliptin naqqas b'mod sinifikanti lHbA1c meta mqabbel ma' plaċebo; it-tibdil fl-HbA1c għal saxagliptin kien -0.9% f'Ġimgħa 12 (tibdil fl-HbA1c ta' -0.4 % għall-plaċebo).
English: Treatment with saxagliptin 5 mg once daily produced clinically relevant and statistically significant improvements in haemoglobin A1c (HbA1c), fasting plasma glucose (FPG) and postprandial glucose (PPG) compared to placebo in monotherapy, in combination with metformin (initial or add-on therapy), in combination with a sulphonylurea, and in combination with a thiazolidinedione (see Table 2).
Maltese: Kura b'saxagliptin 5 mg darba kuljum produċiet titjib kliniku relevanti u statistikament sinifikanti fl-emoglobina A1c (HbA1c), glucose ta' waqt is-sawm (FPG), u glucose ta' wara l-ikel (PPG), imqabbla mal-plaċebo fil-monoterapija, meta mħallta ma metformin (fil-bidu jew terapija miżjuda), mħallta ma sulfonylurea u imħallta ma thiazolidinedione (ara Tabella 2).
English: The HbA1c change for saxagliptin 5 mg (n=82) compared to TZD plus placebo (n=53) was -0.9% at Week 76.
Maltese: Il-bidla fl- HbA1c għal saxagliptin 5 mg (n=82) imqabbel ma TZD flimkien mal-plaċebo (n=53) kienet -0.9% f'Ġimgħa 76.
English: Saxagliptin add-on to metformin compared with sitagliptin add-on to metformin An 18-week study was conducted to evaluate the efficacy and safety of saxagliptin 5 mg in combination with metformin (403 patients), compared with sitagliptin 100 mg in combination with metformin (398 patients) in 801 patients with inadequate glycaemic control on metformin alone.
Maltese: Saxagliptin miżjud ma' metfomin mqabbel ma' sitagliptin miżjud ma' metformin Studju ta' 18-il ġimgħa kien kondott sabiex tiġi evalwata l-effikaċja u s-sigurta ta' saxagliptin 5 mg meta jingħata flimkien ma' metformin (403 pazjenti), mqabbel ma' sitaglptin 100 mg flimkien ma' metformin (398 pazjent) f' 801-il pazjent b' kontroll taz-zokkor mhux xieraq fuq metformin waħdu.
English: Pack sizes of 14, 28, 56 and 98 film-coated tablets in non-perforated blisters.
Maltese: Daqsijiet ta' pakketti ta' 14, 28, 56 u 98 pilloli miksija b'rita ġo folji mhux imtaqqbin.
English: Onglyza 5 mg tablets are pink, biconvex, round, film-coated tablets, with “5” printed on one side and “4215” printed on the other side, in blue ink.
Maltese: Onglyza 5 mg pilloli huma roża, konvessi miż-żewġ naħat, tondi, pilloli miksija b'rita, b' “5” stampata fuq naħa u “4215” stampata fuq in-naħa l-oħra, b'linka blu.
English: Concomitant administration of saxagliptin with the potent inhibitor of CYP3A4/5 ketoconazole, increased the Cmax and AUC of saxagliptin by 62% and 2.5-fold, respectively, and the corresponding values for the active metabolite were decreased by 95% and 88%, respectively.
Maltese: Meta saxagliptin ittieħed flimkien ma inibitur qawwi ta' CYP3A4/5 ketoconazole, kien hemm żidiet fis-Cmax u l-AUC ta' saxagliptin b'62% u 2.5-il darba aktar, rispettivament, u l-valuri li jikkorrespondu għal metabolu attiv kienu mnaqqsa b'95% u 88%, rispettivament.
English: After 52 weeks, the saxagliptin and glipizide groups had similar mean reductions from baseline in HbA1c in the per-protocol analysis (-0.7% vs. -0.8%, respectively, mean baseline HbA1c of 7.5% for both groups).
Maltese: Wara 52 ġimgħa, il-gruppi ta' saxagliptin u glipizide, kellhom tnaqqis simili fil-medja mill-linja bażi fl' HbA1c skont l-analiżi tal-protokol (-0.7% vs. -0.8%, rispettivament, linja bażi medja HbA1c ta' 7.5% għaż-żewġ gruppi).
English: Onglyza 2.5 mg tablets saxagliptin
Maltese: Onglyza 2.5 mg pilloli saxagliptin
English: Onglyza 2.5 mg tablets are pale yellow to light yellow, biconvex, round, film-coated tablets, with “2.5” printed on one side and “4214” printed on the other side, in blue ink.
Maltese: Onglyza 2.5 mg pilloli sofor sa sofor ċari, konvessi miż-żewġ naħat, tondi, pilloli miksija b'rita, b' “2.5” stampata fuq naħa u “4214” stampata fuq in-naħa l-oħra, b'linka blu.
English: CALENDAR BLISTERS (NON-PERFORATED) for Onglyza 5 mg tablets
Maltese: FOLJI BIL- KALENDARJU (MHUX IMTAQQBIN) għal Onglyza 5 mg tablets
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 saxagliptin.
Maltese: Fi provi kliniċi randomizzati, ikkontrollati, double-blind (inkluż esperjenza tal-iżvilupp u ta' wara ttqegħid fis-suq), aktar minn 17,000 pazjent b'dijabete tip 2 ġew ikkurati b'saxagliptin.
English: The study included patients with renal impairment classified on the basis of creatinine clearance as mild (approximately GFR ≥ 45 to < 90 mL/min), moderate (approximately GFR ≥ 30 to < 45 mL/min), or severe (approximately GFR < 30 mL/min), as well as patients with ESRD on haemodialysis.
Maltese: L-istudju inkluda pazjenti b' indeboliment renali klassifikati fuq bażi ta' tneħħija ta' krejatinina bħala ħafif (GFR ta' madwar ≥ 45 sa < 90 mL/min), moderat (≥GFR ta' madwar ≥ 30 sa < 45 mL/min) jew qawwi (GFR ta' madwar < 30 mL/min) kif ukoll pazjenti b' ESRD fuq emodijalisi.