FrancophonIA/ELRC3.0 huggingface dataset:
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), very rare (<1/10,000) or 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), rari ħafna (<1/10,000) jew mhux magħrufa (ma tistax tittieħed stima mid-data disponibbli).
English: NAME OF THE MEDICINAL PRODUCT Trajenta 5 mg tablets
Maltese: Trajenta 5 mg pilloli
English: The observed difference in HbA1c over placebo was0.72% after 52 weeks.
Maltese: Id-differenza osservata f'HbA1c fuq il-plaċebo kienet ta' -0.72% wara 52 ġimgħa.
English: Linagliptin as add-on to insulin therapy
Maltese: Linagliptin bħala terapija addizzjonali ma' insulina
English: Pharmacotherapeutic group: Drugs used in diabetes, dipeptidyl peptidase 4 (DPP-4) inhibitors, ATC code: A10BH05
Maltese: Mediċini li jintużaw għal trattament tad-dijabete, impedituri ta' dipeptidyl peptidase 4 (DPP-4), Kodiċi ATC:
English: When linagliptin was added to a sulphonylurea (on a background of metformin), the incidence of hypoglycaemia was increased over that of placebo (see section 4.8).
Maltese: Meta linagliptin żdied ma' sulphonylurea (fuq sfond ta' metformin), l-inċidenza ta' ipogliċemija żdiedet meta mqabbla ma' plaċebo (ara sezzjoni 4.8).
English: Adverse reaction observed in combination with insulin
Maltese: Reazzjoni avversa osservata f'kombinazzjoni mal-insulina
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 limfatiċi kienu organi fil-mira ta' tossiċità f'xadini Cynomolgus f'iktar minn 450 darba l-esponiment uman.
English: Ritonavir: 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: Ritonavir: l-għoti flimkien ta' doża waħda orali ta' 5 mg ta' linagliptin u dożi orali multipli ta' 200 mg ta' ritonavir, impeditur potenti ta' P-glycoprotein u CYP3A4, żiedu l-AUC u s-Cmax ta' linagliptin b'madwar id-doppju u t-tripplu, rispettivament.
English: Trajenta contains the active substance linagliptin which belongs to a group of medicines called “oral anti-diabetics”.
Maltese: Trajenta fih is-sustanza attiva linagliptin li tappartjeni għal grupp ta' mediċini msejħa “anti-dijabetiċi orali”.
English: After a median follow up of 6.25 years, linagliptin did not increase the risk of major adverse cardiovascular events (see table 3) as compared to glimepiride.
Maltese: Wara segwitu medjan ta' 6.25 sena, linagliptin ma żiedx ir-riskju ta' avvenimenti avversi kardjovaskulari maġġuri (ara tabella 3) meta mqabbel ma' glimepiride.
English: This was achieved with a stable insulin dose (40.1 IU).
Maltese: Dan inkiseb b'doża stabbli ta' insulina (40.1 IU).
English: In the pooled analysis of the placebo-controlled trials, the overall incidence of adverse events in patients treated with placebo was similar to linagliptin 5 mg (63.4% versus 59.1%).
Maltese: Fl-analiżi miġbura tal-provi bi plaċebo bħala kontroll, l-inċidenza totali ta' każijiet avversi f'pazjenti ttrattati bi plaċebo kienet simili għal linagliptin 5 mg (63.4% kontra 59.1%).
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 flesponiment ta' madwar 1.7 darbiet meta mqabbla mal-kontroll.
English: Trajenta 5 mg film-coated tablets Linagliptin
Maltese: Trajenta 5 mg pilloli miksija b'rita Linagliptin
English: Oral contraceptives: co-administration with 5 mg linagliptin did not alter the steady-state pharmacokinetics of levonorgestrel or ethinylestradiol.
Maltese: Kontraċettivi orali: l-għoti flimkien ma' 5 mg ta' linagliptin ma biddilx il-farmakokinetika fl-istat fiss ta' levonorgestrel jew ethinylestradiol.
English: In addition patients with T2DM and severe renal impairment (<30 ml/min) were compared to T2DM patients with normal renal function.
Maltese: Ukoll, pazjenti b'T2DM u indeboliment sever tal-kliewi (<30 ml/min), tqabblu ma' pazjenti b'T2DM b'funzjoni normali tal-kliewi.
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-il 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 pilloli miksija b'rita 100 x 1 pillola miksija b'rita 120 x 1 pillola miksija b'rita
English: The clinical trials before marketing authorisation 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: Sulphonylureas: co-administration of multiple oral doses of 5 mg linagliptin and a single oral dose of 1.75 mg glibenclamide (glyburide) resulted in clinically not relevant reduction of 14% of both AUC and Cmax of glibenclamide.
Maltese: Sulphonylureas: l-għoti flimkien ta' dożi multipli orali ta' 5 mg ta' linagliptin u doża orali waħda ta' 1.75 mg ta' glibenclamide (glyburide) irriżulta fi tnaqqis klinikament mhux rilevanti ta' 14% kemm tal-AUC kif ukoll tas-Cmax ta' glibenclamide.
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 fil-plażma ta' linagliptin.
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-espożizzjoni umana nkiseb għal tossiċità embriju-fetali fil-fniek, u għal tossiċità materna l-NOAEL kien ta' 2.1 darbiet tal-esponiment uman.
English: Linagliptin is a weak competitive and a weak to moderate mechanism-based inhibitor of CYP isozyme CYP3A4, but does not inhibit other CYP isozymes.
Maltese: Linagliptin hu impeditur kompettitiv dgħajjef u impeditur minn dgħajjef sa moderat ibbażat fuq mekkaniżmu ta' isożima CYP CYP3A4, iżda ma jimpedixxix isożimi oħrajn ta' CYP.
English: A risk to the breast-fed child cannot be excluded.
Maltese: Ir-riskju gћat-tarbija li tkun qed terda' mhux eskluż.
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: Following administration of a supratherapeutic dose of 10 mg linagliptin concomitantly with 40 mg of simvastatin daily for 6 days, the plasma AUC of simvastatin was increased by 34%, and the plasma Cmax by 10%.
Maltese: Wara l-għoti ta' doża supraterapewtika ta' 10 mg ta' linagliptin fl-istess ħin ma' 40 mg ta' simvastatin kuljum għal 6 ijiem, l-AUC ta' simvastatin fil-plażma żdied b'34%, u s-Cmax tal-plażma b'10%.
English: There were also 1,238 patients with mild renal impairment, and 143 patients with moderate renal impairment on linagliptin.
Maltese: Kien hemm ukoll 1,238 pazjent b'indeboliment ħafif tal-kliewi, u 143 pazjent fuq linagliptin b'indeboliment moderat tal-kliewi.
English: At high concentrations, where DPP-4 is fully saturated, 70-80% of linagliptin was bound to other plasma proteins than DPP-4, hence 30-20% were unbound in plasma.
Maltese: F'konċentrazzjonijiet għolja, fejn DPP-4 ikun saturat għal kollox, 70-80% ta' linagliptin weħel ma' proteini oħra fil-plażma li mhumiex DPP-4, u għaldaqstant 30-20% ma kinux imwaħħlin fil-plażma.
English: A statistically significant greater proportion of patients with a baseline HbA1c ≥7.0% and treated with linagliptin 5 mg achieved a target HbA1c of <7% compared to placebo.
Maltese: Proporzjon statistikament ferm ikbar ta' pazjenti b'HbA1c tal-linja bażi ≥ 7.0% u kkurati b'linagliptin 5 mg kisbu HbA1c fil-mira ta' < 7% meta mqabbel ma' plaċebo.
English: Of these, 4.0% were mild and 0.9% were moderate and 0.1% were classified as severe in intensity.
Maltese: Minn dawn, 4.0% kienu ħfief u 0.9% kienu moderati u 0.1% kienu kklassifikati bħala severi fl-intensità tagħhom.
English: A dose reduction of the sulphonylurea or insulin may be considered (see section 4.2).
Maltese: Tnaqqis fid-doża ta' sulphonylurea jew insulina, tista' tiġi kkunsidrata (ara sezzjoni 4.2).
English: During controlled clinical trials in healthy subjects, single doses of up to 600 mg linagliptin (equivalent to 120 times the recommended dose) were generally well tolerated.
Maltese: Waqt il-provi kliniċi kkontrollati f'pazjenti b'saħħithom, dożi waħidhom ta' sa 600 mg ta' linagliptin (ekwivalenti għal 120 darba tad-doża rrakkomandata) kienu ġeneralment ittollerati tajjeb.
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 vs +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 f'pazjenti li ngħataw glimepiride (-1.39 vs +1.29 kg).
English: Digoxin: co-administration of multiple daily doses of 5 mg linagliptin with multiple doses of 0.25 mg digoxin had no effect on the pharmacokinetics of digoxin in healthy volunteers.
Maltese: Digoxin: l-għoti flimkien ta' dożi multipli ta' kuljum ta' 5 mg ta' linagliptin ma' dożi multipli ta' 0.25 mg ta' digoxin ma kellu l-ebda effett fuq il-farmakokinetika ta' digoxin f'voluntiera b'saħħithom.
English: Pancreatitis was reported more often in patients randomized to linagliptin (7 events in 6,580 patients receiving linagliptin versus 2 events in 4,383 patients receiving placebo).
Maltese: Il-pankreatite ġiet irrappurtata iktar ta' spiss f'pazjenti li ntgħażlu b'mod każwali għal linagliptin (7 każijiet f'6,580 pazjent li rċivew linagliptin kontra 2 każijiet f'4,383 pazjent li rċivew plaċebo).
English: Metformin: co-administration of multiple three times daily doses of 850 mg metformin with 10 mg linagliptin once daily did not clinical meaningfully alter the pharmacokinetics of linagliptin in healthy volunteers.
Maltese: Metformin: l-għoti flimkien ta' dożi multipli ta' 850 mg ta' metformin tliet darbiet kuljum ma' 10 mg ta' linagliptin darba kuljum ma biddlux klinikament il-farmakokinetika ta' linagliptin b'mod sinifikanti f'voluntiera b'saħħithom.
English: Sulphonylureas: the steady-state pharmacokinetics of 5 mg linagliptin was not changed by concomitant administration of a single 1.75 mg dose glibenclamide (glyburide).
Maltese: Sulphonylureas: il-farmakokinetika fl-istat fiss ta' 5 mg ta' linagliptin ma nbidlitx bl-għoti fl-istess ħin ta' doża waħda ta' 1.75 mg ta' glibenclamide (glyburide).
English: Adverse reactions classified by system organ class and MedDRA preferred terms reported in patients who received 5 mg linagliptin in double-blind studies as monotherapy or as add-on therapy are presented in the table below (see table 1).
Maltese: Ir-reazzjonijiet avversi kklassifikati skont is-sistema tal-organi u t-termini ppreferuti MedDRA rrappurtati f'pazjenti li rċivew 5 mg ta' linagliptin fi studji double-blind bħala monoterapija jew bħala terapija addizzjonali huma ppreżentati fit-tabella t'hawn taħt (ara tabella 1).
English: Therefore, clinically relevant interactions would not be expected with other Pglycoprotein/CYP3A4 inhibitors.
Maltese: Għalhekk, interazzjonijiet klinikament rilevanti mhux se jkunu mistennija ma' impedituri oħrajn ta' P-glikoproteina/CYP3A4.
English: Metformin: co-administration of multiple daily doses of 10 mg linagliptin with 850 mg metformin, an OCT substrate, had no relevant effect on the pharmacokinetics of metformin in healthy volunteers.
Maltese: Metformin: l-għoti flimkien ta' dożi multipli ta' kuljum ta' 10 mg ta' linagliptin ma' 850 mg ta' metformin, substrat ta' OCT, ma kellu l-ebda effett rilevanti fuq il-farmakokinetika ta' metformin f'voluntiera b'saħħithom.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Maltese: Informazzjoni ddettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: A multiple-dose, open-label study was conducted to evaluate the pharmacokinetics of linagliptin (5 mg dose) in patients with varying degrees of chronic renal insufficiency compared to normal healthy control subjects.
Maltese: Studju dwar dożi multipli, open label, sar biex jevalwa l-farmakokinetika ta' linagliptin (doża ta' 5 mg) f'pazjenti bi gradi varji ta' insuffiċjenza kronika tal-kliewi meta mqabbla ma' persuni b'saħħithom normali bħala kontroll.
English: Hypoglycaemia (frequency: very common, may affect more than 1 in 10 people) is an identified side effect when Trajenta is taken together with metformin and a sulphonylurea.
Maltese: L-ipogliċemija (frekwenza: komuni ħafna, tista' taffettwa iktar minn persuna 1 minn 10) hu effett sekondarju identifikat meta Trajenta jittieħed flimkien ma' metformin u sulphonylurea.
English: The most frequently reported adverse reaction was “hypoglycaemia” observed under the triple combination, linagliptin plus metformin plus sulphonylurea 14.8% versus 7.6% in placebo.
Maltese: L-iktar reazzjoni avversa rrappurtata b'mod frekwenti kienet “ipogliċemija” osservata bil-kumbinazzjoni tripla, linagliptin flimkien ma' metformin flimkien ma' sulphonylurea 14.8% vs. 7.6% fil-plaċebo.
English: BMI had no clinically relevant effect on the pharmacokinetics of linagliptin based on a population pharmacokinetic analysis of Phase I and Phase
Maltese: Il-BMI ma kellu l-ebda effett klinikament rilevanti fuq il-farmakokinetika ta' linagliptin abbażi ta' analiżi farmakokinetika talpopolazzjoni ta' dejta minn Fażi I u Fażi
English: Older subjects (65 to 80, oldest patient was 78 years) had comparable plasma concentrations of linagliptin compared to younger subjects.
Maltese: II. Persuni aktar anzjani (65 sa 80 sena, l-ixjeħ pazjent kellu 78 sena) kellhom konċentrazzjonijiet ta' linagliptin fil-plażma li kienu komparabbli ma' dawk ta' persuni iżgħar.
English: - monotherapy with short-term duration of up to 4 weeks - monotherapy with ≥ 12 week duration - add-on to metformin - add-on to metformin + sulphonylurea - add on to metformin and empagliflozin - add-on to insulin with or without metformin
Maltese: - monoterapija b'tul ta' żmien qasir ta' sa 4 ġimgħat - monoterapija b'tul ta' żmien ta' ≥ 12-il ġimgħa - terapija addizzjonali ma' metformin - terapija addizzjonali ma' metformin + sulphonylurea - terapija addizzjonali ma' metformin + empagliflozin - terapija addizzjonali ma' insulina bi jew mingħajr metformin
English: Discontinuation of therapy due to adverse events was higher in patients who received placebo as compared to linagliptin 5 mg (4.3% versus 3.4%).
Maltese: It-twaqqif tat-terapija minħabba każijiet avversi kienet ogħla f'pazjenti li rċivew plaċebo meta mqabbla ma' linagliptin 5 mg (4.3% kontra 3.4%).
English: There was a significant difference in reduction in HbA1c between Asian patients (0.8%) and White patients (0.5%) in the pooled studies.
Maltese: Kien hemm differenza sinifikanti fit-tnaqqis f'HbA1c bejn pazjenti Ażjatiċi (0.8%) u pazjenti ta' razza Bajda (0.5%) fl-istudji miġbura.
English: Linagliptin as add-on to a combination of metformin and empagliflozin therapy In patients inadequately controlled with metformin and empagliflozin (10 mg (n=247) or 25 mg (n=217)), 24-weeks treatment with add-on therapy of linagliptin 5 mg provided adjusted mean HbA1c reductions from baseline by -0.53% (significant difference to add-on placebo -0.32% (95% CI -0.52, -0.13) and -0.58% (significant difference to add-on placebo -0.47% (95% CI -0.66; -0.28), respectively.
Maltese: Linagliptin bħala terapija addizzjonali ma' terapija ta' kombinament ta' metformin u empagliflozin F'pazjenti li ma kinux ikkontrollati b'mod adegwat b'metformin u b'empagliflozin (10 mg (n = 247) jew 25 mg (n = 217)), kura ta' 24 ġimgħa b'terapija addizzjonali ta' linagliptin 5 mg irriżulta fi tnaqqis medju fl-HbA1c aġġustat mil-linja bażi b'-0.
English: Linagliptin as add-on therapy in elderly (age ≥ 70 years) with type 2 diabetes The efficacy and safety of linagliptin in elderly (age ≥ 70years) with type 2 diabetes was evaluated in a double-blind study of 24 weeks duration.
Maltese: Linagliptin bħala terapija addizzjonali f'anzjani (età ta' ≥ 70 sena) b'dijabete ta' tip 2 L-effikaċja u s-sigurtà ta' linagliptin f'anzjani (età ta' ≥ 70 sena) b'dijabete ta' tip 2 ġew evalwati fi studju double blind li dam 24 ġimgħa.
English: The study included patients with renal insufficiency classified on the basis of creatinine clearance as mild (50 to <80 ml/min), moderate (30 to <50 ml/min), and severe (<30 ml/min), as well as patients with ESRD on hemodialysis.
Maltese: L-istudju kien jinkludi pazjenti b'insuffiċjenza tal-kliewi kklassifikati fuq il-bażi tat-tneħħija tal-krejatinina bħala ħafifa (50 sa <80 ml/min), moderata (30 sa <50 ml/min), u severa (<30 ml/min), kif ukoll pazjenti b'ESRD fuq l-emodijalisi.
English: Linagliptin provided significant improvements in HbA1c, (-0.57% change compared to placebo), from a mean baseline HbA1c of 8.09%.
Maltese: Linagliptin ipprovda titjib sinifikanti fl-HbA1c, (bidla ta' -0.57% meta mqabbel mal-plaċebo), minn medja ta' HbA1c fil-linja bażi ta' 8.09%.
English: Linagliptin 24 month data, as add-on to metformin in comparison with glimepiride In a study comparing the efficacy and safety of the addition of linagliptin 5 mg or glimepiride (mean dose 3 mg) in patients with inadequate glycaemic control on metformin monotherapy, mean reductions in HbA1c were -0.16% with linagliptin (mean baseline HbA1c 7.69%) and -0.36% with glimepiride (mean baseline HbA1c 7.69%.)
Maltese: Fi studju li qabbel l-effikaċja u s-sigurtà taż-żieda ta' linagliptin 5 mg jew glimepiride (doża medja ta' 3 mg) f'pazjenti b'kontroll gliċemiku inadegwat li kienu fuq terapija b'metformin mogħti waħdu, it-tnaqqis medju f'HbA1c kien ta' -0.16% b'linagliptin (medja tal-linja bażi ta' HbA1c ta' 7.69%) u -0.36% bi glimepiride (medja tal-linja bażi ta' HbA1c ta' 7.69%.) b'medja ta' differenza fittrattament ta' 0.20% (97.5% CI: 0.09, 0.299).
English: 8 mm diameter round, light red film-coated tablet debossed with "D5" on one side and the Boehringer Ingelheim logo on the other.
Maltese: Pillola tonda miksija b'rita b'dijametru ta' 8 mm ta' lewn aħmar ċar, imnaqqxa b'"D5" fuq naħa waħda u l-logo ta' Boehringer Ingelheim fuq in-naħa l-oħra.
English: There is no experience with doses above 600 mg in humans.
Maltese: M'hemmx esperjenza b'dożi ta' aktar minn 600 mg fil-bnedmin.
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.
Maltese: It-twaħħil mal-proteini fil-plażma ta' linagliptin jiddependi mill-konċentrazzjoni, u jonqos minn madwar 99% f'1 nmol/l għal 75-89% f'≥30 nmol/l, li jirrifletti saturazzjoni tat-twaħħil ma' DPP-4 maż-żieda fil-konċentrazzjoni ta' linagliptin.
English: This is an antibiotic used to treat infections such as tuberculosis.
Maltese: Dan hu antibijotiku jintuża għall-kura ta' infezzjonijiet bħal tuberkulosi.
English: Some patients experienced rash (frequency uncommon), hives (urticaria; frequency rare, may affect up to 1 in 1000 people), and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing (angioedema; frequency rare).
Maltese: Xi pazjenti kellhom raxx (frekwenza mhux komuni), ħorriqija (urtikarja; frekwenza rari, tista' taffettwa sa persuna 1 minn 1,000), u nefħa tal-wiċċ, xufftejn, ilsien, u filgriżmejn li jistgħu jikkawżaw diffikultà biex tieħu n-nifs jew tibla' (anġjoedema; frekwenza rari).
English: Each film-coated tablet (tablet) contains 5 mg of linagliptin
Maltese: Kull pillola miksija b'rita (pillola) fiha 5 mg ta' linagliptin
English: Bullous pemphigoid
Maltese: Pemfigojd bulluża
English: Linagliptin and its main metabolite did not show a genotoxic potential.
Maltese: Linagliptin u l-metabolit ewlieni tiegħu ma wrewx potenzjal ġenotossiku.
English: * Based on post-marketing experience ** Based on lipase elevations >3xULN observed in clinical trials Based on Linagliptin cardiovascular and renal safety study (CARMELINA), see also below Adverse reaction observed in combination with metformin plus sulphonylurea
Maltese: * Ibbażat fuq esperjenza wara t-tqegħid fis-suq ** Ibbażat fuq żidiet fil-lipase >3xULN osservati fi provi kliniċi Ibbażat fuq l-Istudju dwar is-sigurtà kardjovaskulari u renali ta' linagliptin (CARMELINA), ara wkoll hawn taħt Reazzjoni avversa osservata f'kombinazzjoni ma' metformin u sulphonylurea
English: Linagliptin provided significant improvements in HbA1c, (-0.64% change compared to placebo), from a mean baseline HbA1c of 8%.
Maltese: Linagliptin ipprovda titjib sinifikanti fl-HbA1c, (bidla ta' -0.64% meta mqabbel mal-plaċebo), minn medja ta' HbA1c fil-linja bażi ta' 8%.
English: In rats effects on reproductive organs, thyroid and the lymphoid organs were seen at more than 1,500 times human exposure.
Maltese: Fil-firien, l-effetti fuq l-organi riproduttivi, it-tirojde u l-organi limfojdi ġew osservati f'livell ta' iktar minn 1,500 darba tal-esponiment uman.
English: • are taking an anti-diabetic medicine known as a ‘sulphonylurea'(e.g. glimepiride, glipizide), your doctor may want to reduce your dose of sulphonylurea when you take it together with Trajenta in order to avoid your blood sugar going too low.
Maltese: • qed tieħu mediċina kontra d-dijabete magħrufa bħala ‘sulphonylurea' (eż. glimepiride, glipizide), it-tabib għandu mnejn ikun jixtieq li jnaqqas id-doża ta' sulphonylurea meta teħodha flimkien ma' Trajenta sabiex tevita li l-livell ta' zokkor fid-demm tiegħek jinżel wisq.
English: Due to the impact of the background therapy on adverse reactions (e.g. on hypoglycaemias), adverse reactions were analysed based on the respective treatment regimens (monotherapy, add-on to metformin, add-on to meformin plus sulphonylurea, and add-on to insulin).
Maltese: Minħabba l-impatt tat-terapija fl-isfond fuq ir-reazzjonijiet avversi (eż. fuq ipogliċemiji), irreazzjonijiet avversi ġew analizzati skont il-korsijiet ta' trattament rispettivi (monoterapija, terapija addizzjonali ma' metformin u terapija addizzjonali ma' metformin flimkien ma' sulphonylurea u terapija addizzjonali ma' insulina).
English: • Severe and persistent pain in the abdomen (stomach area) which might reach through to your back, as well as nausea and vomiting, as it could be a sign of an inflamed pancreas
Maltese: • Uġigħ sever u persistenti fiż-żaqq (fiż-żona tal-istonku) li jista' jasal sa dahrek, kif ukoll nawsja u rimettar, għax jista' jkun sinjal ta' frixa infjammata (pankreatite).
English: In the placebo-controlled studies 4.9% of patients experienced “hypoglycaemia” as an adverse reaction under linagliptin.
Maltese: Fl-istudji bil-plaċebo bħala kontroll, 4.9% tal-pazjenti kellhom “ipogliċemija” bħala reazzjoni avversa taħt linagliptin.