FrancophonIA/ELRC3.0 huggingface dataset:
English: In vivo assessment of interactions
Maltese: Evalwazzjoni in vivo ta' interazzjonijiet tal-mediċina
English: Multiple daily doses of 5 mg linagliptin did not alter the pharmacokinetics of S(-) or R(+) warfarin, a CYP2C9 substrate, administered in a single dose.
Maltese: Dożi multipli ta' kuljum ta' 5 mg ta' linagliptin ma bidlux il-farmakokinetika ta' S(-) jew R(+) warfarin, ssubstrat ta' CYP2C9, li jingħata f'doża waħda.
English: Lactic acidosis
Maltese: Aċidożi lattika
English: Cardiovascular and renal outcomes by treatment group in the CARMELINA study Linagliptin 5mg
Maltese: Tabella 4 Riżultati kardjovaskulari u renali skont il-grupp ta' trattament fl-istudju CARMELINA Linagliptin 5mg
English: Jentadueto is available in perforated unit dose blisters with 10 x 1, 14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 84 x 1, 90 x 1, 98 x 1, 100 x 1 and 120 x 1 film-coated tablets and multipacks containing 120 x 1 (2 packs of 60 x 1), 180 x 1 (2 packs of 90 x 1) and 200 x 1 (2 packs of 100 x 1) film-coated tablets.
Maltese: Jentadueto hu disponibbli f'folji perforati ta' doża waħda b'10 x 1, 14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 84 x 1, 90 x 1, 98 x 1, 100 x 1 u 120 x 1 pillola miksija b'rita u pakketti multipli li fihom 120 x 1 (2 pakketti ta' 60 x 1), 180 x 1 (2 pakketti ta' 90 x 1) u 200 x 1 (2 pakketti ta' 100 x 1) pillola miksija b'rita.
English: When linagliptin and metformin were administered in combination with a sulphonylurea, hypoglycaemia was the most frequently reported adverse event (linagliptin plus metformin plus sulphonylurea 23.9% and 16.0% in placebo plus metformin plus sulphonylurea).
Maltese: Meta linagliptin u metformin ngħataw flimkien ma' sulphonylurea, ipogliċemija kienet l-avveniment avvers irrappurtat l-aktar frekwentament (linagliptin flimkien ma' metformin u sulphonylurea 23.9% u 16.0% għal plaċebo flimkien ma' metformin u sulphonylurea).
English: • a significant reduction of the absolute risk of any diabetes-related mortality: metformin 7.5 events/1,000 patient-years, diet alone 12.7 events/1,000 patient-years, p=0.017,
Maltese: • tnaqqis sinifikanti tar-riskju assolut ta' kwalunkwe mortalità assoċjata mad-dijabete: metformin 7.5 avvenimenti/1,000 sena ta' pazjenti, dieta waħidha 12.7 avvenimenti/1,000 sena ta' pazjenti, p=0.017,
English: Linagliptin as add-on to metformin therapy
Maltese: Linagliptin flimkien ma' metformin
English: Animal studies with metformin do not indicate harmful effects with respect to reproductive toxicity (see section 5.3).
Maltese: Studji f'annimali ma urewx effetti tossiċi diretti jew indiretti fuq is-sistema riproduttiva (ara sezzjoni 5.3).
English: Metformin is contraindicated in patients with GFR<30 ml/min and should be temporarily discontinued in the presence of conditions that alter renal function, see section 4.3).
Maltese: Metformin huwa kontraindikat f'pazjenti b'GFR <30 mL/min u għandu jitwaqqaf temporanjament filpreżenza ta' kundizzjonijiet li jibdlu l-funzjoni renali, ara sezzjoni 4.3).
English: Liver, kidneys, stomach, reproductive organs, thymus, spleen, and lymph nodes were target organs of toxicity in Cynomolgus monkeys at more than 450 times human exposure.
Maltese: Il-fwied, il-kliewi, l-istonku, l-organi riproduttivi, it-timu, il-milsa, u l-għoqod tal-limfa kienu organi fil-mira ta' tossiċità f'xadini Cynomolgus f'iktar minn 450 darba tal-esponiment uman.
English: Multiple daily doses of linagliptin had a minimal effect on the steady-state pharmacokinetics of simvastatin, a sensitive CYP3A4 substrate, in healthy subjects.
Maltese: Dożi multipli ta' kuljum ta' linagliptin kellhom effett minimu fuq l-istat fiss tal-farmakokinetika ta' simvastatin, substrat sensittiv ta' CYP3A4, f'persuni b'saħħithom.
English: Diarrhoea common
Maltese: Dijarea komuni
English: In moderate renal impairment, a moderate increase in exposure of about 1.7 fold was observed compared with control.
Maltese: F'pazjenti b'indeboliment moderat tal-kliewi, ġiet osservata żieda moderata fl-esponiment ta' madwar 1.7 darbiet meta mqabbla mal-kontroll.
English: A paediatric Phase 2 study examined the pharmacokinetics and pharmacodynamics of 1 mg and 5 mg linagliptin in children and adolescents ≥10 to <18 years of age with type 2 diabetes mellitus.
Maltese: Studju pedjatriku ta' Fażi 2 eżamina l-farmakokinetika u l-farmakodinamika ta' 1 mg u 5 mg linagliptin fi tfal u adolexxenti b'età ta' ≥ 10 snin sa < 18-il sena b'dijabete mellitus tat-tip 2.
English: • a significant reduction of the absolute risk of any diabetes-related complication in the metformin group (29.8 events/1,000 patient-years) versus diet alone (43.3 events/1,000 patient-years), p=0.0023, and versus the combined sulphonylurea and insulin monotherapy groups (40.1 events/1,000 patient-years), p=0.0034,
Maltese: • tnaqqis sinifikanti tar-riskju assolut ta' kwalunkwe kumplikazzjoni assoċjata mad-dijabete fil-grupp ta' metformin (29.8 avvenimenti/1,000 sena ta' pazjenti) versus id-dieta waħidha (43.3 avvenimenti/1,000 sena ta' pazjenti), p=0.0023, u versus il-gruppi kombinati ta' sulphonylurea u insulina mogħtija waħidhom (40.1/1,000 sena ta' pazjenti), p=0.0034,
English: Hypoglycaemia may occur when Jentadueto is administered together with sulphonylurea (≥ 1 case per 10 patients).
Maltese: L-ipogliċemija tista' sseħħ meta Jentadueto jingħata flimkien ma' sulphonylurea (≥ 1 każ kull 10 pazjenti).
English: When linagliptin and metformin were administered in combination with insulin, hypoglycaemia was the most frequently reported adverse event, but occurred at comparable rate when placebo and metformin were combined with insulin (linagliptin plus metformin plus insulin 29.5% and 30.9% in the placebo plus metformin plus insulin group) with a low rate of severe (requiring assistance) episodes (1.5% and 0.9%).
Maltese: Meta linagliptin u metformin ingħataw flimkien mal-insulina, ipogliċemija kienet l-avveniment avvers irrapportat l-aktar frekwentament, iżda seħħet b'rata komparabbli meta l-plaċebo u metformin ingħataw flimkien mal-insulina (linagliptin flimkien ma' metformin u insulina 29.5% u 30.9% filgrupp tal-plaċebo flimkien ma' metformin u insulina) b'rata baxxa ta' episodji severi (li jeħtieġu assistenza) (1.5% u 0.9%).
English: For the entire treatment period (median time on treatment 5.9 years) the rate of patients with moderate or severe hypoglycaemia was 6.5% on linagliptin versus 30.9% on glimepiride, severe hypoglycaemia occurred in 0.3% of patients on linagliptin versus 2.2% on glimepiride.
Maltese: Għall-perjodu kollu ta' trattament (żmien medjan bit-trattament 5.9 snin) ir-rata ta' pazjenti b'ipogliċemija moderata jew severa kienet ta' 6.5% fuq linagliptin kontra 30.9% fuq glimepiride, ipogliċemija severa seħħet f'0.3% tal-pazjenti fuq linagliptin kontra 2.2% fuq glimepiride.
English: 10 x 1 film-coated tablets 14 x 1 film-coated tablets 28 x 1 film-coated tablets 30 x 1 film-coated tablets 56 x 1 film-coated tablets 60 x 1 film-coated tablets 84 x 1 film-coated tablets 90 x 1 film-coated tablets 98 x 1 film-coated tablets 100 x 1 film-coated tablets 120 x 1 film-coated tablets
Maltese: 10 x 1 pilloli miksija b'rita 14 x 1 pillola miksija b'rita 28 x 1 pillola miksija b'rita 30 x 1 pillola miksija b'rita 56 x 1 pillola miksija b'rita 60 x 1 pillola miksija b'rita 84 x 1 pillola miksija b'rita 90 x 1 pillola miksija b'rita 98 x 1 pillola miksija b'rita 100 x 1 pillola miksija b'rita 120 x 1 pillola miksija b'rita
English: Jentadueto is not recommended in patients with hepatic impairment due to the active substance metformin (see sections 4.3 and 5.2).
Maltese: Jentadueto mhuwiex irrakkomandat f'pazjenti b'indeboliment tal-fwied minħabba s-sustanza attiva metformin (ara sezzjonijiet 4.3 u 5.2).
English: After repeated doses of 500 mg twice daily for 7 days in paediatric patients the peak plasma concentration (Cmax) and systemic exposure (AUC0-t) were reduced by approximately 33% and 40%, respectively compared to diabetic adults who received repeated doses of 500 mg twice daily for 14 days.
Maltese: Wara dożi ripetuti ta' 500 mg darbtejn kuljum għal 7 ijiem f'pazjenti pedjatriċi, il-konċentrazzjoni massima fil-plażma (Cmax) u l-esponiment sistemiku (AUC0-t) tnaqqsu b'madwar 33% u 40%, rispettivament meta mqabbla ma' persuni adulti dijabetiċi li rċivew dożi ripetuti ta' 500 mg darbtejn kuljum għal 14-il jum.
English: Alcohol
Maltese: Alkoħol
English: A NOAEL of 78 times human exposure was derived for embryo-fetal toxicity in rabbits, and for maternal toxicity the NOAEL was 2.1 times human exposure.
Maltese: NOAEL ta' 78 darba tal-esponiment uman inkiseb għal tossiċità embrijufetali fil-fniek, u għal tossiċità materna l-NOAEL kien ta' 2.1 darbiet tal-esponiment uman.
English: Co-administration of a single 5 mg oral dose of linagliptin and multiple 200 mg oral doses of ritonavir, a potent inhibitor of P-glycoprotein and CYP3A4, increased the AUC and Cmax of linagliptin approximately twofold and threefold, respectively.
Maltese: L-għoti flimkien ta' doża waħda orali ta' 5 mg ta' linagliptin u dożi orali multipli ta' 200 mg ta' ritonavir, impetitur potenti ta' P-glikoproteina u CYP3A4, żiedu l-AUC u s-Cmax ta' linagliptin b'madwar id-doppju u triplu, rispettivament.
English: Further symptoms are reduced body temperature and heartbeat.
Maltese: Sintomi oħrajn huma tnaqqis fit-temperatura tal-ġisem u fit-taħbit tal-qalb.
English: Some patients have experienced inflammation of the pancreas (pancreatitis; frequency rare, may affect up to 1 in 1000 people).
Maltese: Xi pazjenti kellhom infjammazzjoni tal-frixa (pankreatite; frekwenza rari, tista' taffettwa sa persuna 1 minn kull 1,000).
English: A dose reduction of the sulphonylurea or insulin may be considered (see section 4.2).
Maltese: Tnaqqis fid-doża tas-sulphonylurea jew ta' insulina tista' tiġi kkunsidrata (ara sezzjoni 4.2).
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), or very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi huma definiti bħala komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000), jew rari ħafna (< 1/10,000) u mhux magħrufa (ma tistax tittieħed stima mid-data disponibbli).
English: Avoid excessive alcohol intake while taking Jentadueto since this may increase the risk of lactic acidosis (see section ‘Warnings and precautions').
Maltese: Evita konsum eċċessiv ta' alkoħol waqt li tkun qed tieħu Jentadueto peress li dan jista' jżid ir-riskju ta' aċidożi lattika (ara s-sezzjoni “Twissijiet u prekawzjonijiet”).
English: GFR should be assessed before treatment initiation and regularly thereafter, see section 4.2.
Maltese: Il-GFR għandha tiġi evalwata qabel jinbeda t-trattament u b'mod regolari wara dan, ara sezzjoni 4.2.
English: Single dose study: after single doses of metformin hydrochloride 500 mg, paediatric patients have shown a similar pharmacokinetic profile to that observed in healthy adults.
Maltese: Studju dwar dożi waħidhom: wara dożi waħidhom ta' metformin hydrochloride 500 mg, pazjenti pedjatriċi wrew profil farmakokinetiku simili għal dak li ġie osservat f'persuni adulti b'saħħithom.
English: Pack sizes of 14, 60 and 180 film-coated tablets.
Maltese: Daqs tal-pakketti ta' 14, 60 u 180 pillola miksija b'rita.
English: - High-Density PolyEthylene (HDPE) bottle with plastic screw cap and a seal liner (aluminiumpolyester foil laminate) and a silica gel desiccant.
Maltese: - Flixkun tal-High-Density PolyEthylene (HDPE) b'għatu bil-kamin tal-plastik u kisja siġillanti minn ġewwa (laminat tal-fojl tal-aluminium-polyester) u dessikant tas-silica gel.
English: C] linagliptin dose to healthy subjects, approximately 85% of the administered radioactivity was eliminated in faeces (80%) or urine (5%) within 4 days of dosing.
Maltese: C] lil persuni b'saħħithom, madwar 85% tar-radjuattività mogħtija ġiet eliminata fl-ippurgar (80%) jew fl-awrina (5%) fi żmien 4 ijiem mid-dożaġġ.
English: Renal clearance of metformin hydrochloride is > 400 ml/min, indicating that metformin hydrochloride is eliminated by glomerular filtration and tubular secretion.
Maltese: It-tneħħija ta' metformin hydrochloride mill-kliewi hi ta' > 400 ml/min, u dan jindika li metformin hydrochloride jitneħħa permezz ta' filtrazzjoni glomerulari u tnixxija tubulari.
English: Multiple co-administration of 5 mg linagliptin with rifampicin, a potent inductor of P-glycoprotein and CYP3A4, resulted in a 39.6% and 43.8% decreased linagliptin steady-state AUC and Cmax respectively, and about 30% decreased DPP-4 inhibition at trough.
Maltese: L-għoti flimkien multiplu ta' 5 mg ta' linagliptin ma' rifampicin, induttur potenti ta' P-glikoproteina u CYP3A4, irriżulta fi tnaqqis ta' 39.6% u 43.8% fl-AUC u fis-Cmax ta' linagliptin fl-istat fiss rispettivament, u tnaqqis ta' madwar 30% fl-inibizzjoni ta' DPP-4 fl-iktar livell baxx.
English: * PY=patient years ** Test on non-inferiority to demonstrate that the upper bound of the 95% CI for the hazard ratio is less than 1.3
Maltese: * PY=snin ta' pazjent ** Test fuq nuqqas ta' inferjorità biex juri li l-ogħla limitu ta' CI ta' 95% għall-proporzjon ta' periklu huwa inqas minn 1.3
English: Diagnostic laboratory findings are decreased blood pH (<7.35), increased plasma lactate levels (>5 mmol/l) and an increased anion gap and lactate/pyruvate ratio.
Maltese: Sejbiet dijanjostiċi tal-laboratorju huma tnaqqis fil-pH tad-demm (< 7.35), żieda fil-livelli ta' lactate fil-plażma (>5 mmol/l) u żieda fl-anion gap u l-proporzjon ta' lactate/pyruvate.
English: s r.o.
Maltese: U L-UŻU
English: Absolute bioavailability of a 500 mg or 850 mg metformin hydrochloride tablet is approximately 50-60% in healthy subjects.
Maltese: Il-bijodisponibilità assoluta ta' 500 mg jew 850 mg ta' pillola ta' metformin hydrochloride hi ta' madwar 50-60% f'persuni b'saħħithom.
English: Nausea common
Maltese: mhux komuni
English: - Keep this leaflet.
Maltese: Proporzjon ta' Periklu
English: Linagliptin 5 mg showed superiority over 1 mg with regard to trough DPP-4 inhibition (72% vs 32%, p=0.0050) and a numerically larger reduction with regard to adjusted mean change from baseline in HbA1c (-0.63% vs -0.48%, n.s.).
Maltese: Linagliptin 5 mg wera superjorità fuq 1 mg fir-rigward tal-inqas inibizzjoni ta' DPP-4 (72% vs 32%, p=0.0050) u tnaqqis numerikament akbar fir-rigward tal-bidla medja aġġustata mil-linja bażi f'HbA1c (-0.63% vs -0.
English: Bullous pemphigoid rare #
Maltese: Pemfigojd bulluża rari
English: One main metabolite with a relative exposure of 13.3% of linagliptin at steady-state was detected which was found to be pharmacologically inactive, and thus does not contribute to the plasma DPP-4 inhibitory activity of linagliptin.
Maltese: Metabolit ewlieni wieħed b'esponiment relattiv ta' 13.3% ta' linagliptin fl-istat fiss, ġie osservat u nstab li kien farmakoloġikament inattiv u għaldaqstant ma jikkontribwixxix għall-attività impeditorja ta' DPP-4 ta' linagliptin fil-plażma.
English: Plasma protein binding of linagliptin is concentration-dependent, decreasing from about 99% at 1 nmol/l to 75-89% at ≥ 30 nmol/l, reflecting saturation of binding to DPP-4 with increasing concentration of linagliptin At high concentrations, where DPP-4 is fully saturated, 70-80% of linagliptin was bound to other plasma proteins than DPP-4, hence 20-30% were unbound in plasma.
Maltese: F'konċentrazzjonijiet għolja, fejn DPP-4 ikun saturat b'mod sħiħ, 70-80% ta' linagliptin weħel ma' proteini oħra fil-plażma li mhumiex DPP-4, u għaldaqstant 20-30% ma kinux imwaħħlin fil-plażma.
English: NAME OF THE MEDICINAL PRODUCT Jentadueto 2.5 mg/1,000 mg tablets Linagliptin/metformin HCl
Maltese: Jentadueto 2.5 mg/1,000 mg tablets Linagliptin/metformin HCl
English: Number of Subjects (%)
Maltese: NUMRU(I)
English: - bronchodilators (β-sympathomimetics) for the treatment of bronchial asthma.
Maltese: -bronkodilaturi (β-simpatomimetiċi) għall-kura ta' ażżma tal-bronki.
English: • Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Maltese: • Sensittività eċċessiva għas-sustanzi attivi jew għal kwalunkwe sustanza mhux attiva elenkata elenkati fis-sezzjoni 6.1.
English: Because glibenclamide is primarily metabolised by CYP2C9, these data also support the conclusion that linagliptin is not a CYP2C9 inhibitor.
Maltese: Minħabba li glibenclamide jiġi mmetabolizzat prinċipalment minn CYP2C9, din id-dejta tkompli ssostni l-konklużjoni li linagliptin mhuwiex impeditur ta' CYP2C9.
English: • a significant reduction in the absolute risk of myocardial infarction: metformin 11 events/1,000 patient-years, diet alone 18 events/1,000 patient-years, (p=0.01).
Maltese: • tnaqqis sinifikanti tar-riskju assolut ta' infart mijokardijaku: metformin 11-il 11 avveniment/1,000 sena ta' pazjenti, dieta waħidha 18-il avveniment/1,000 sena ta' pazjenti, (p=0.01).
English: Following administration of a dose of 850 mg, a 40% lower plasma peak concentration, a 25% decrease in AUC (area under the curve) and a 35 minute prolongation of the time to peak plasma concentration were observed.
Maltese: Wara l-għoti ta' doża ta' 850 mg, ġie osservat tnaqqis ta' 40% fil-konċentrazzjoni massima fil-plażma, tnaqqis ta' 25% fl-AUC (żona taħt il-kurva) u titwil ta' 35 minuta fil-ħin biex intlaħqet il-konċentrazzjoni massima fil-plażma.
English: A slow increase in dose of metformin hydrochloride may also improve gastrointestinal tolerability.
Maltese: Żieda bil-mod fid-doża ta' metformin hydrochloride tista' wkoll ittejjeb it-tollerabilità gastrointestinali.
English: Maximum daily dose is 1000 mg.
Maltese: Doża massima ta' kuljum hi 1000 mg.
English: Linagliptin also showed significant improvements in patients achieving a target HbA1c of < 7.0% (31.2% on linagliptin versus 9.2% on placebo), and also for fasting plasma glucose (FPG) with -12.7 mg/dl reduction compared to placebo.
Maltese: Linagliptin wera wkoll titjib sinifikanti f'pazjenti li laħqu mira ta' HbA1c ta' < 7.0% (31.2% fuq linagliptin versus 9.2% fuq plaċebo), u wkoll għall-glucose fil-plażma fl-istat sajjem (FPG) bi tnaqqis ta' -12.7 mg/dl meta mqabbel mal-plaċebo.
English: The observed pharmacokinetic and pharmacodynamic responses were consistent with those found in adult subjects.
Maltese: Irrisponsi farmakokinetiċi u farmakodinamiċi osservati kienu konsistenti ma' dawk li nstabu f'individwi adulti.
English: After an oral dose, the non-absorbed fraction recovered in faeces was 20-30%.
Maltese: Wara doża orali, il-porzjon mhux assorbit irkuprat fl-ippurgar kien ta' 20-30%.
English: Patients treated with linagliptin exhibited a significant mean decrease from baseline in body weight compared to a significant weight gain in patients administered glimepiride (-1.39 versus +1.29 kg).
Maltese: Il-pazjenti ttrattati b'linagliptin urew tnaqqis medju sinifikanti mil-linja bażi fil-piż tal-ġisem meta mqabbel ma' żieda sinifikanti fil-piż ta' pazjenti li ngħataw glimepiride (-1.39 versus +1.29 kg).
English: GLP-1 and GIP increase insulin biosynthesis and secretion from pancreatic beta cells in the presence of normal and elevated blood glucose levels.
Maltese: GLP-1 u GIP iżidu l-bijosintesi tal-insulina u t-tnixxija miċ-ċelluli beta pankreatiċi fil-preżenza ta' livelli normali u għolja ta' glucose fid-demm.
English: Other medicines and Jentadueto
Maltese: Mediċini oħra u Jentadueto
English: Nervous system disorders Taste disturbance common
Maltese: Disturbi fis-sistema nervuża Disturb fit-togħma komuni
English: Metformin hydrochloride partitions into erythrocytes.
Maltese: Metformin hydrochloride jinqasam għal ġol-eritroċiti.
English: The clinical trials before marketing authorization have been performed up to a BMI equal to 40 kg/m
Maltese: Il-provi kliniċi ta' qabel l-awtorizzazzjoni għat-tqegħid fis-suq twettqu fuq BMI ekwivalenti għal sa 40 kg/m
English: These hormones are rapidly degraded by the enzyme DPP-4.
Maltese: Dawn l-ormoni malajr jiġu ddegradati mill-enzima DPP-4.
English: NAME OF THE MEDICINAL PRODUCT Jentadueto 2.5 mg/850 mg tablets Linagliptin/metformin HCl
Maltese: Jentadueto 2.5 mg/850 mg pilloli Linagliptin/metformin HCl
English: In the pooled analysis of the seven placebo-controlled trials, the overall incidence of adverse events in patients treated with placebo and metformin was comparable to that seen with linagliptin 2.5 mg and metformin (54.3 and 49.0%).
Maltese: Fl-analiżi miġbura tas-seba' provi bi plaċebo bħala kontroll, l-inċidenza globali ta' każijiet avversi f'pazjenti ttrattati bi plaċebo u metformin kienet simili għal dak li ġie osservat b'linagliptin 2.5 mg u metformin (54.3 u 49.0%).
English: Jentadueto 2.5 mg/1,000 mg film-coated tablets also contains iron oxide red (E172).
Maltese: Jentadueto 2.5 mg/1,000 mg pilloli miksija b'rita fihom ukoll iron oxide red (E172).
English: The mean HbA1c at baseline was 8.0%.
Maltese: HbA1c medja fil-linja bażi kienet ta' 8.0%.
English: The renal composite endpoint was defined as renal death or sustained end stage renal disease or sustained decrease of 40% or more in eGFR.
Maltese: Il-punt finali kompost tal-kliewi kien definit bħala mewt tal-kliewi jew marda tal-kliewi fl-aħħar stadju sostnuta jew tnaqqis sostnut ta' 40% jew aktar fl-eGFR.
English: Metabolism and nutrition disorders Hypoglycaemia very common
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Ipogliċemija komuni ħafna
English: 83% of patients were taking metformin in combination with insulin in this trial.
Maltese: F'din il-prova 83% tal-pazjenti kienu qed jieħdu metformin flimkien mal-insulina.
English: In a pooled analysis of elderly (age ≥ 70 years) patients with type 2 diabetes (n=183) who were taking both metformin and basal insulin as background therapy, linagliptin in combination with metformin plus insulin provided significant improvements in HbA1c parameters with -0.81% (CI: -1.01; -0.61) adjusted mean change from baseline (mean baseline HbA1c 8.13%) compared to placebo in combination with metformin plus insulin.
Maltese: F'analiżi miġbura ta' pazjenti anzjani (età ta' ≥ 70 sena) b'dijabete ta' tip 2 (n=183) li kienu qed jieħdu kemm metformin u kif ukoll insulina bażali bħala terapija fl-isfond, linagliptin flimkien ma' metformin flimkien mal-insulina pprovdew titjib sinifikanti fil-parametri ta' HbA1c b'-0.81% (CI: -1.01; -0.61) ta' bidla medja aġġustata mil-linja bażi (medja tal-linja bażi ta' HbA1c 8.13%) meta mqabbla mal-plaċebo flimkien ma' metformin flimkien mal-insulina.
English: Approximately 19% of the population had eGFR ≥45 to <60 mL/min/1.73 m2, 28% of the population had eGFR ≥30 to <45 mL/min/1.73 m2) and 15%
Maltese: Madwar 19% talpopolazzjoni kellhom eGFR ta' ≥45 sa <60 mL/min/1.73 m2, 28% tal-popolazzjoni kellhom eGFR ta'
English: The study population included 2089 (35%) patients with cardiovascular disease and 1130 (19%) patients with renal impairment with an eGFR < 60ml/min/1.73m2 at baseline.
Maltese: Ilpopolazzjoni tal-istudju kienet tinkludi 2,089 (35%) pazjent b'mard kardjovaskulari u 1,130 (19%) pazjent b'indeboliment tal-kliewi b'eGFR < 60 ml/min/1.73m2 fil-linja bażi.
English: Major adverse cardiovascular events (MACE) and mortality by treatment group in the CAROLINA study
Maltese: Tabella 5 Avvenimenti avversi kardjovaskulari maġġuri (MACE - major adverse cardiovascular events) u mortalità skont il-grupp ta' trattament fl-istudju CAROLINA Linagliptin 5mg
English: Patients inadequately controlled on dual combination therapy with the maximal tolerated dose of metformin and a sulphonylurea
Maltese: Pazjenti li mhumiex ikkontrollati b'mod adegwat fuq terapija kombinata doppja bid-doża massima ttollerata ta' metformin u sulphonylurea
English: receptor antagonists) - medicines that may change the amount of metformin in your blood, especially if you have reduced kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine,
Maltese: angiotensin II) - mediċini li jistgħu jibdlu l-ammont ta' metformin fid-demm tiegħek, speċjalment jekk għandek funzjoni tal-kliewi mnaqqsa (bħal verapamil, rifampicin, cimetidine, dolutegravir, ranolazine,