FrancophonIA/ELRC3.0 huggingface dataset:
English: Co-administration of multiple daily doses of 10 mg linagliptin with 850 mg metformin hydrochloride, an OCT substrate, had no relevant effect on the pharmacokinetics of metformin in healthy subjects.
Maltese: L-għoti flimkien ta' dożi multipli ta' kuljum ta' 10 mg ta' linagliptin ma' 850 mg ta' metformin hydrochloride, substrat ta' OCT, ma kellu l-ebda effett rilevanti fuq il-farmakokinetika ta' metformin f'persuni b'saħħithom.
English: Among patients who were using insulin at baseline, the incidence of severe hypoglycaemia was 4.4% in linagliptin-treated patients and 4.9% in placebo treated patients.
Maltese: Fost pazjenti li kienu qed jużaw l-insulina fil-linja bażi, l-inċidenza ta' ipogliċemija severa kienet ta' 4.4% f'pazjenti ttrattati b'linagliptin u 4.9% f'pazjenti ttrattati bil-plaċebo.
English: Caution should be exercised in patients with a history of pancreatitis.
Maltese: Għandu jkun hemm kawtela f'pazjenti bi storja medika ta' pankreatite.
English: Jentadueto 2.5 mg/1,000 mg film-coated tablets EU/1/12/780/015 (10 x 1 film-coated tablets) EU/1/12/780/016 (14 x 1 film-coated tablets) EU/1/12/780/017 (28 x 1 film-coated tablets) EU/1/12/780/018 (30 x 1 film-coated tablets) EU/1/12/780/019 (56 x 1 film-coated tablets) EU/1/12/780/020 (60 x 1 film-coated tablets) EU/1/12/780/021 (84 x 1 film-coated tablets) EU/1/12/780/022 (90 x 1 film-coated tablets) EU/1/12/780/023 (98 x 1 film-coated tablets) EU/1/12/780/024 (100 x 1 film-coated tablets) EU/1/12/780/025 (120 x 1 film-coated tablets) EU/1/12/780/026 (14 film-coated tablets, bottle) EU/1/12/780/027 (60 film-coated tablets, bottle) EU/1/12/780/028 (180 film-coated tablets, bottle) EU/1/12/780/032 (120 (2 x 60 x 1) film-coated tablets) EU/1/12/780/033 (180 (2 x 90 x 1) film-coated tablets) EU/1/12/780/034 (200 (2 x 100 x 1) film-coated tablets)
Maltese: Jentadueto 2.5 mg/1,000 mg pilloli miksija b'rita EU/1/12/780/015 (10 x 1 pilloli miksija b'rita) EU/1/12/780/016 (14-il pillola x 1 pillola miksija b'rita) EU/1/12/780/017 (28 x 1 pillola miksija b'rita) EU/1/12/780/018 (30 x 1 pillola miksija b'rita) EU/1/12/780/019 (56 x 1 pillola miksija b'rita) EU/1/12/780/020 (60 x 1 pillola miksija b'rita) EU/1/12/780/021 (84 x 1 pillola miksija b'rita) EU/1/12/780/022 (90 x 1 pillola miksija b'rita) EU/1/12/780/023 (98 x 1 pillola miksija b'rita) EU/1/12/780/024 (100 x 1 pillola miksija b'rita) EU/1/12/780/025 (120 x 1 pillola miksija b'rita) EU/1/12/780/026 (14-il pillola miksija b'rita, flixkun) EU/1/12/780/027 (60 pillola miksija b'rita, flixkun) EU/1/12/780/028 (180 pillola miksija b'rita, flixkun) EU/1/12/780/032 (120 (2 x 60 x 1) pillola miksija b'rita) EU/1/12/780/033 (180 (2 x 90 x 1) pillola miksija b'rita) EU/1/12/780/034 (200 ( 2 x 100 x 1) pillola miksija b'rita)
English: In the overall study observation period adjudicated acute pancreatitis was reported in 0.3% of patients treated with linagliptin and in 0.1% of patients treated with placebo.
Maltese: Fil-perjodu globali ta' osservazzjoni tal-istudju pankreatite akuta aġġudikata kienet irrappurtata f'0.3% tal-pazjenti ttrattati b'linagliptin u f'0.1% tal-pazjenti ttrattati bil-plaċebo.
English: Jentadueto 2.5 mg/850 mg film-coated tablets Each tablet contains 2.5 mg of linagliptin and 850 mg of metformin hydrochloride.
Maltese: Kull Jentadueto 2.5 mg/850 mg pillola miksija b'rita fiha 2.5 mg ta' linagliptin u 850 mg ta' metformin hydrochloride.
English: Linagliptin is a P-glycoprotein substrate, and inhibits P-glycoprotein mediated transport of digoxin with low potency.
Maltese: Linagliptin u l-metabolit ewlieni tiegħu ma wrewx potenzjal ġenotossiku.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu.
English: In addition the pharmacokinetic characteristics of linagliptin were found to be similar in dedicated phase I studies in Japanese, Chinese and Caucasian healthy subjects and African American type 2 diabetes patients.
Maltese: linagliptin kienu simili fl-istudji ddedikati ta' fażi I fuq persuni Ġappuniżi, Ċiniżi u Kawkasi b'saħħithom, u pazjenti Afrikani Amerikani li kellhom dijabete ta' tip 2.
English: Linagliptin as add-on therapy in elderly (age ≥ 70 years) with type 2 diabetes The efficacy and safety of linagliptin in elderly (age ≥ 70 years) with type 2 diabetes was evaluated in a double-blind study of 24 weeks duration.
Maltese: L-effikaċja u s-sigurtà ta' linagliptin fl-anzjani (età ta' ≥ 70 sena) b'dijabete ta' tip 2 ġew evalwati fi studju double blind li dam 24 ġimgħa.
English: Infections and infestations Nasopharyngitis uncommon
Maltese: Disturbi gastro-intestinali
English: Dehydration may lead to kidney problems, which can put you at risk for lactic acidosis (see 'Warnings and precautions').
Maltese: Id-deidrazzjoni tista' twassal għal problemi tal-kliewi li jistgħu jpoġġuk f'riskju ta' aċidożi lattika (ara “Twissijiet u prekawzjonijiet”).
English: No other additive toxicity caused by the combination of linagliptin and metformin was observed at AUC exposure levels up to 2 and 23 times human exposure, respectively.
Maltese: Ma ġiet osservata l-ebda tossiċità addizzjonali oħra kkawżata mill-kombinazzjoni ta' linagliptin u metformin f'livelli ta' esponiment tal-AUC sa darbtejn u 23 darba tal-esponiment fil-bniedem, rispettivament.
English: This is an antibiotic used to treat infections such as tuberculosis.
Maltese: Dan hu antibijotiku li jintuża għall-kura ta' infezzjonijiet bħal tuberkulosi.
English: • in patients already being treated with the combination of linagliptin and metformin as separate tablets.
Maltese: • f'pazjenti li diġà qegħdin jiġu kkurati bil-kombinazzjoni ta' linagliptin u metformin bħala pilloli separati.
English: Jentadueto 2.5 mg/1,000 mg are oval, biconvex light pink film-coated tablets (tablets).
Maltese: Jentadueto 2.5 mg/1,000 mg huma pillola (pilloli) miksija b'rita, ovali, bikonvessi, ta' lewn roża ċar.
English: Jentadueto 2.5 mg/850 mg film-coated tablets EU/1/12/780/001 (10 x 1 film-coated tablets) EU/1/12/780/002 (14 x 1 film-coated tablets) EU/1/12/780/003 (28 x 1 film-coated tablets) EU/1/12/780/004 (30 x 1 film-coated tablets) EU/1/12/780/005 (56 x 1 film-coated tablets) EU/1/12/780/006 (60 x 1 film-coated tablets) EU/1/12/780/007 (84 x 1 film-coated tablets) EU/1/12/780/008 (90 x 1 film-coated tablets) EU/1/12/780/009 (98 x 1 film-coated tablets) EU/1/12/780/010 (100 x 1 film-coated tablets) EU/1/12/780/011 (120 x 1 film-coated tablets) EU/1/12/780/012 (14 film-coated tablets, bottle) EU/1/12/780/013 (60 film-coated tablets, bottle) EU/1/12/780/014 (180 film-coated tablets, bottle) EU/1/12/780/029 (120 (2 x 60 x 1) film-coated tablets) EU/1/12/780/030 (180 (2 x 90 x 1) film-coated tablets) EU/1/12/780/031 (200 (2 x 100 x 1) film-coated tablets)
Maltese: Jentadueto 2.5 mg/850 mg pilloli miksija b'rita EU/1/12/780/001 (10 x 1 pilloli miksija b'rita) EU/1/12/780/002 (14-il pillola x 1 pillola miksija b'rita) EU/1/12/780/003 (28 x 1 pillola miksija b'rita) EU/1/12/780/004 (30 x 1 pillola miksija b'rita) EU/1/12/780/005 (56 x 1 pillola miksija b'rita) EU/1/12/780/006 (60 x 1 pillola miksija b'rita) EU/1/12/780/007 (84 x 1 pillola miksija b'rita) EU/1/12/780/008 (90 x 1 pillola miksija b'rita) EU/1/12/780/009 (98 x 1 pillola miksija b'rita) EU/1/12/780/010 (100 x 1 pillola miksija b'rita) EU/1/12/780/011 (120 x 1 pillola miksija b'rita) EU/1/12/780/012 (14-il pillola miksija b'rita, flixkun) EU/1/12/780/013 (60 pillola miksija b'rita, flixkun) EU/1/12/780/014
English: Surgery
Maltese: Treddigħ
English: PHARMACEUTICAL FORM AND CONTENTS Multipack comprising 2 packs, each containing 60 x 1 film-coated tablets Multipack comprising 2 packs, each containing 90 x 1 film-coated tablets Multipack comprising 2 packs, each containing 100 x 1 film-coated tablets
Maltese: U KONTENUT Pakkett multiplu li fih 2 pakketti, li kull wieħed fih 60 x 1 pillola miksija b'rita Pakkett multiplu li fih 2 pakketti, li kull wieħed fih 90 x 1 pillola miksija b'rita Pakkett multiplu li fih 2 pakketti, li kull wieħed fih 100 x 1 pillola miksija b'rita
English: EU/1/12/780/001 10 x 1 film-coated tablets EU/1/12/780/002 14 x 1 film-coated tablets EU/1/12/780/003 28 x 1 film-coated tablets EU/1/12/780/004 30 x 1 film-coated tablets EU/1/12/780/005 56 x 1 film-coated tablets EU/1/12/780/006 60 x 1 film-coated tablets EU/1/12/780/007 84 x 1 film-coated tablets EU/1/12/780/008 90 x 1 film-coated tablets EU/1/12/780/009 98 x 1 film-coated tablets EU/1/12/780/010 100 x 1 film-coated tablets EU/1/12/780/011 120 x 1 film-coated tablets
Maltese: EU/1/12/780/001 10 x 1 pilloli miksija b'rita EU/1/12/780/002 14 x 1 pillola miksija b'rita EU/1/12/780/003 28 x 1 pillola miksija b'rita EU/1/12/780/004 30 x 1 pillola miksija b'rita EU/1/12/780/005 56 x 1 pillola miksija b'rita EU/1/12/780/006 60 x 1 pillola miksija b'rita EU/1/12/780/007 84 x 1 pillola miksija b'rita EU/1/12/780/008 90 x 1 pillola miksija b'rita EU/1/12/780/009 98 x 1 pillola miksija b'rita EU/1/12/780/010 100 x 1 pillola miksija b'rita EU/1/12/780/011 120 x 1 pillola miksija b'rita
English: Co-administration with other potent inducers of P-glycoprotein and CYP3A4, such as carbamazepine, phenobarbital and phenytoin has not been studied.
Maltese: L-għoti flimkien ma' indutturi qawwija oħrajn ta' P-glikoproteina u CYP3A4, bħal carbamazepine, phenobarbital u phenytoin ma ġiex studjat.
English: Plasma AUC of linagliptin increased approximately 33% following 5 mg doses at steady-state compared to the first dose.
Maltese: L-AUC fil-plażma ta' linagliptin żdiedet b'madwar 33% wara dożi ta' 5 mg fl-istat fiss meta mqabbla mal-ewwel doża.
English: Jentadueto 2.5 mg/1,000 mg film-coated tablets Each tablet contains 2.5 mg of linagliptin and 1,000 mg of metformin hydrochloride.
Maltese: Kull Jentadueto 2.5 mg/1,000 mg pillola miksija b'rita fiha 2.5 mg ta' linagliptin u 1,000 mg ta' metformin hydrochloride.
English: Linagliptin added to metformin provided significant improvements in HbA1c, (-0.64% change compared to placebo), from a mean baseline HbA1c of 8%.
Maltese: Linagliptin miżjud ma' metformin ipprovda titjib sinifikanti f'HbA1c, (bidla ta' -0.64% meta mqabbel mal-plaċebo), minn medja ta' HbA1c fil-linja bażi ta' 8%.
English: EU/1/12/780/015 10 x 1 film-coated tablets EU/1/12/780/016 14 x 1 film-coated tablets EU/1/12/780/017 28 x 1 film-coated tablets EU/1/12/780/018 30 x 1 film-coated tablets EU/1/12/780/019 56 x 1 film-coated tablets EU/1/12/780/020 60 x 1 film-coated tablets EU/1/12/780/021 84 x 1 film-coated tablets EU/1/12/780/022 90 x 1 film-coated tablets EU/1/12/780/023 98 x 1 film-coated tablets EU/1/12/780/024 100 x 1 film-coated tablets EU/1/12/780/025 120 x 1 film-coated tablets
Maltese: EU/1/12/780/015 10 x 1 pilloli miksija b'rita EU/1/12/780/016 14 x1 pillola miksija b'rita EU/1/12/780/017 28 x 1 pillola miksija b'rita EU/1/12/780/018 30 x 1 pillola miksija b'rita EU/1/12/780/019 56 x 1 pillola miksija b'rita EU/1/12/780/020 60 x 1 pillola miksija b'rita EU/1/12/780/021 84 x 1 pillola miksija b'rita EU/1/12/780/022 90 x 1 pillola miksija b'rita EU/1/12/780/023 98 x 1 pillola miksija b'rita EU/1/12/780/024 100 x 1 pillola miksija b'rita EU/1/12/780/025 120 x 1 pillola miksija b'rita
English: Effects of other medicinal products on linagliptin Clinical data described below suggest that the risk for clinically meaningful interactions by coadministered medicinal products is low.
Maltese: L-effetti ta' prodotti mediċinali oħrajn fuq linagliptin Dejta klinika deskritta hawn taħt tissuġġerixxi li hemm riskju żgħir għal interazzjonijiet klinikament sinifikanti minn prodotti mediċinali mogħtija flimkien miegħu.
English: Therefore, clinically relevant interactions would not be expected with other P-glycoprotein/CYP3A4 inhibitors.
Maltese: Għalhekk, interazzjonijiet klinikament rilevanti mhux se jkunu mistennija ma' impedituri oħrajn ta' P-glikoproteina/CYP3A4
English: Biotransformation Following a [
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I)
English: Management
Maltese: Terapija
English: Linagliptin also showed significant improvements in fasting plasma glucose (FPG) by -21.1 mg/dl and 2-hour postprandial glucose (PPG) by -67.1 mg/dl compared to placebo, as well as a greater portion of patients achieving a target HbA1c of < 7.0% (28.3% on linagliptin versus 11.4% on placebo).
Maltese: Linagliptin wera wkoll titjib sinifikanti fil-livell tal-glucose fil-plażma fl-istat sajjem (FPG) b'-21.1 mg/dl u fil-livell tal-glucose sagħtejn wara l-ikel (PPG) b'-67.1 mg/dl meta mqabbel ma' plaċebo, kif ukoll porzjon akbar ta' pazjenti li kisbu mira ta' HbA1c ta' < 7.0% (28.3% fuq linagliptin versus 11.4% fuq plaċebo).
English: The NOAEL for fertility, early embryonic development and teratogenicity in rats was set at > 900 times the human exposure.
Maltese: L-NOAEL għal fertilità, żvilupp bikri embrijoniku u teratoġeniċità fil-firien ġie deċiż li jkun ta' > 900 darba tal-esponiment uman.
English: In a cardiovascular and renal safety study (CARMELINA) with median observation period of 2.2 years, adjudicated acute pancreatitis was reported in 0.3% of patients treated with linagliptin and in 0.1% of patients treated with placebo.
Maltese: Fi studju dwar is-sigurtà kardjovaskulari u renali (CARMELINA) b'perjodu medjan ta' osservazzjoni ta' 2.2 snin, kienet irrappurtata pankreatite akuta aġġudikata f'0.3% tal-pazjenti ttrattati b'linagliptin u f'0.1% tal-pazjenti ttrattati bi plaċebo.
English: OTHER
Maltese: II.
English: The steady-state pharmacokinetics of 5 mg linagliptin were not changed by concomitant administration of a single 1.75 mg dose glibenclamide (glyburide).
Maltese: Il-farmakokinetika fl-istat fiss ta' 5 mg ta' linagliptin ma nbidlitx mill-għoti fl-istess ħin ta' doża waħda ta' 1.75 mg ta' glibenclamide (glyburide).
English: if you have uncontrolled diabetes, with, for example, severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below) or ketoacidosis.
Maltese: - jekk għandek dijabete mhux ikkontrollata, b'pereżempju, ipergliċemija severa (glucose għoli fid-demm), dardir, rimettar, dijarea, telf mgħaġġel fil-piż, aċidożi lattika (ara "Riskju ta' aċidożi lattika" hawn taħt) jew ketoaċidożi.
English: Among patients who were using sulfonylurea at baseline, the incidence of severe hypoglycaemia was 2.0% in linagliptin-treated patients and 1.7% in placebo treated patients.
Maltese: Fost pazjenti li kienu qed jużaw sulfonylurea fil-linja bażi, l-inċidenza ta' ipogliċemija severa kienet ta' 2.0% f'pazjenti ttrattati b'linagliptin u 1.7% f'pazjenti ttrattati bil-plaċebo.
English: Metformin accumulation occurs at acute worsening of renal function and increases the risk of lactic acidosis.
Maltese: Akkumulazzjoni ta' metformin isseħħ ma' aggravar akut tal-funzjoni renali u żżid ir-riskju ta' aċidożi lattika.
English: Bioequivalence studies in healthy subjects demonstrated that the Jentadueto (linagliptin/metformin hydrochloride) combination tablets are bioequivalent to co-administration of linagliptin and metformin hydrochloride as individual tablets.
Maltese: Studji dwar il-bijoekwivalenza f'persuni b'saħħithom urew li l-pilloli kombinati ta' Jentadueto (linagliptin/metformin hydrochloride) huma bijoekwivalenti għall-għoti flimkien ta' linagliptin u metformin hydrochloride bħala pilloli individwali.
English: When linagliptin was added to a sulphonylurea on a background of metformin, the incidence of hypoglycaemia was increased over that of placebo.
Maltese: Meta linagliptin żdied ma' sulphonylurea fuq sfond ta' metformin, l-inċidenza ta' ipogliċemija żdiedet fuq dik tal-plaċebo.
English: You should not exceed the maximum recommended daily dose of 5 mg linagliptin and 2,000 mg metformin hydrochloride.
Maltese: M'għandekx taqbeż id-doża massima rrakkomandata ta' kuljum ta' 5 mg ta' linagliptin u 2,000 mg ta' metformin hydrochloride.
English: Linagliptin in combination with metformin plus insulin provided significant improvements in HbA1c in this subgroup with -0.68% (CI: -0.78; -0,57) adjusted mean change from baseline (mean baseline HbA1c 8.28%) compared to placebo in combination with metformin plus insulin.
Maltese: 68% (CI: -0.78; -0.57) ta' bidla medja aġġustata mil-linja bażi (medja tal-linja bażi ta' HbA1c 8.28%) meta mqabbla mal-plaċebo flimkien ma' metformin flimkien mal-insulina.
English: The overall incidence of adverse events and serious adverse events in patients receiving linagliptin was similar to that in patients receiving placebo.
Maltese: L-inċidenza globali ta' avvenimenti avversi u avvenimenti avversi serji f'pazjenti li kienu qed jirċievu linagliptin kienet simili għal dik f'pazjenti li kienu qed jirċievu plaċebo.
English: - Common (may affect up to 1 in 10 people): a metallic taste (taste disturbance).
Maltese: - Komuni (jistgħu jaffettwaw sa persuna 1 minn kull 10): togħma metallika (disturb fit-togħma).
English: The unbound concentrations, which are usually less than 1% at the therapeutic dose of linagliptin, were increased 4-5-fold after co-administration with ritonavir.
Maltese: Il-konċentrazzjonijiet mhux imwaħħla, li normalment ikunu inqas minn 1% fid-doża terapewtika ta' linagliptin, żdiedu b'4-5-darbiet wara l-għoti flimkien ma' ritanovir.
English: After a median follow up of 2.2 years, linagliptin, when added to standard of care, did not increase the risk of major adverse cardiovascular events or renal outcome events.
Maltese: Wara segwitu medjan ta' 2.2 snin, linagliptin, meta miżjud ma' kura standard, ma żiedx ir-riskju ta' avvenimenti kardjovaskulari avversi maġġuri jew avvenimenti b'riżultat tal-kliewi.
English: Co-administration of multiple three-times-daily doses of 850 mg metformin hydrochloride with 10 mg linagliptin once daily did not clinical meaningfully alter the pharmacokinetics of linagliptin in healthy subjects.
Maltese: L-għoti flimkien ta' dożi multipli tliet darbiet kuljum ta' 850 mg ta' metformin hydrochloride ma' 10 mg ta' linagliptin darba kuljum ma bidlux b'mod klinikament sinifikanti l-farmakokinetika ta' linagliptin f'persuni b'saħħithom.
English: If no adequate strength of Jentadueto is available, individual monocomponents should be used instead of the fixed dose combination.
Maltese: Jekk ma tkunx disponibbli qawwa adegwata ta' Jentadueto, għandhom jiġu użati monokomponenti individwali minflok il-kombinazzjoni ta' doża fissa.
English: Metformin hydrochloride is excreted unchanged in the urine.
Maltese: Metformin hydrochloride jitneħħa mhux mibdul fl-awrina.
English: In the CARMELINA study, bullous pemphigoid was reported in 0.2% of patients on treatment with linagliptin and in no patient on placebo.
Maltese: Fl-istudju CARMELINA, pemfigojd bulluża kienet irrappurtata f'0.2% tal-pazjenti ttrattati b'linagliptin u fl-ebda pazjent ittrattat bil-plaċebo.
English: Patients inadequately controlled on dual combination therapy with insulin and the maximal tolerated dose of metformin
Maltese: Pazjenti li mhumiex ikkontrollati b'mod adegwat fuq terapija kombinata doppja b'insulina u bid-doża massima ttollerata ta' metformin
English: The safety of linagliptin 2.5 mg twice daily (or its bioequivalent of 5 mg once daily) in combination with metformin has been evaluated in over 6800 patients with type 2 diabetes mellitus.
Maltese: Is-sigurtà ta' linagliptin 2.5 mg darbtejn kuljum (jew il-bijoekwivalenti tiegħu ta' 5 mg darba kuljum) flimkien ma' metformin ġiet evalwata f'aktar minn 6,800 pazjent b'dijabete mellitus ta' tip 2.
English: Adverse reactions reported in all clinical trials with the linagliptin+metformin combination or the use of the monocomponents (linagliptin or metformin) in clinical trials or from post-marketing experience are shown below according to system organ class.
Maltese: Reazzjonijiet avversi rrappurtati fil-provi kliniċi kollha bil-kombinazzjoni ta' linagliptin+metformin jew bl-użu tal-komponenti waħedhom (linagliptin jew metformin) fi provi kliniċi jew mill-esperjenza ta' wara t-tqegħid fis-suq qed jintwerew hawn taħt skont is-sistema tal-klassifika tal-organi.
English: INSTRUCTIONS ON USE
Maltese: Darbtejn Kuljum
English: NAME OF THE MEDICINAL PRODUCT Jentadueto 2.5 mg/850 mg film-coated tablets Linagliptin/metformin hydrochloride
Maltese: Jentadueto 2.5 mg/850 mg pilloli miksija b'rita Linagliptin/metformin hydrochloride
English: Oval, biconvex, light orange, film-coated tablet of 19.2 mm x 9.4 mm debossed with "D2/850" on one side and the company logo on the other.
Maltese: Jentadueto 2.5 mg/850 mg pilloli miksija b'rita Pillola miksija b'rita, ovali, bikonvessa, ta' lewn oranġjo ċar, ta' 19.2 mm x 9.4 mm imnaqqxa b'"D2/850" fuq naħa waħda u l-logo tal-kumpanija fuq in-naħa l-oħra.
English: Rash uncommon
Maltese: Raxx mhux komuni
English: In the CARMELINA study, bullous pemphigoid was reported in 0.2% of patients treated with linagliptin and in no patient treated with placebo.
Maltese: Fl-istudju CARMELINA, pemfigojd bulluża kienet irrappurtata f'0.2% tal-pazjenti li kienu fuq trattament b'linagliptin u fl-ebda pazjent fuq il-plaċebo.
English: Hospitalization for heart failure (HHF)
Maltese: Rari: infafet (pemfigojd bulloża)
English: Frequency of adverse reaction
Maltese: Reazzjonijiet avversi oħra
English: Monitoring of renal function is necessary to aid in prevention of metformin-associated lactic acidosis, particularly in the elderly (see sections 4.3 and 4.4).
Maltese: Għal pazjenti b'insuffiċjenza tal-qalb akuta u mhux stabbli, Jentadueto mhuwiex rakkomandat (ara sezzjoni 4.3).
English: Therapy may be restarted no earlier than 48 hours following surgery or resumption of oral nutrition and provided that renal function has been re-evaluated and found to be stable.
Maltese: It-terapija tista' terġa' tinbeda mill-ġdid mhux qabel 48 siegħa wara l-kirurġija jew wara li tinbeda mill-ġdid nutrizzjoni orali u bil-patt li l-funzjoni renali tkun ġiet evalwata mill-ġdid u nstabet li hija stabbli.
English: Blister: Store in the original package in order to protect from moisture.
Maltese: Folja: Żommu fil-pakkett oriġinali sabiex tilqa' mill-umdita'.
English: The most effective method to remove lactate and metformin hydrochloride is haemodialysis.
Maltese: L-iktar metodu effettiv biex tneħħi lactate u metformin hydrochloride hi l-emodijalisi.
English: It is assumed that the pharmacokinetics of metformin hydrochloride absorption are non-linear.
Maltese: Hu ssoponut li l-farmakokinetika tal-assorbiment ta' metformin hydrochloride mhijiex lineari.
English: When linagliptin plus metformin hydrochloride is used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be required to reduce the risk of hypoglycaemia (see section 4.4).
Maltese: Meta linagliptin flimkien ma' metformin hydrochloride jintuża flimkien ma' sulphonylurea, doża iktar baxxa ta' sulphonylurea tista' tkun meħtieġa biex jitnaqqas ir-riskju ta' ipogliċemija (ara sezzjoni 4.4).
English: It is especially important to mention the following: - medicines which increase urine production (diuretics) - medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors, such as ibuprofen and celecoxib) - certain medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II
Maltese: Huwa importanti ħafna li wieħed isemmi dan li ġej: - mediċini li jżidu l-produzzjoni tal-awrina (dijuretiċi) - mediċini użati biex jittrattaw l-uġigħ u l-infjammazzjoni (NSAID u inibituri ta' COX-2, bħal ibuprofen u celecoxib) - ċerti mediċini għat-trattament ta' pressjoni għolja (inibituri ta' ACE u antagonisti tar-riċetturi ta'
English: Some patients have experienced allergic reactions (frequency rare), which may be serious, including wheezing and shortness of breath (bronchial hyperreactivity; frequency uncommon (may affect up to 1 in 100 people)).
Maltese: Waqt li kienu qed jieħdu Jentadueto xi pazjenti kellhom reazzjonijiet allerġiċi (frekwenza rari), li jistgħu jkunu serji, li jinkludu tħarħir u qtugħ ta' nifs (reattività eċċessiva tal-bronki; frekwenza mhux komuni (jistgħu jaffettwaw sa persuna 1 minn kull 100)).