FrancophonIA/ELRC3.0 huggingface dataset:
English: Microscopic evidence of the effects of exaggerated pharmacology on the kidney observed in some species included tubular dilatation, and tubular and pelvic mineralisation at approximately 4-times the clinical AUC exposure of empagliflozin associated with the 25 mg dose.
Maltese: farmakoloġija esaġerata fuq il-kliewi li ġiet osservata f'xi speċi kienet tinkludi twessigħ tubulari, u mineralizzazzjoni tubulari u pelvika f'madwar 4 darbiet l-esponiment ta' AUC kliniku ta' empagliflozin marbuta mad-doża ta' 25 mg.
English: Interstitial cell tumours in the testes were observed with a higher incidence in rats at 300 mg/kg/day and above, but not at 100 mg/kg/day which corresponds to approximately 18-times the maximal clinical exposure to empagliflozin.
Maltese: Inċidenza ogħla ta' tumuri fiċ-ċelluli interstizjali fit-testikoli kienet osservata filfirien f'doża ta' 300 mg/kg/jum u iżjed, iżda mhux f'doża ta' 100 mg/kg/jum li tikkorrispondi għal madwar 18-il darba l-esponiment kliniku massimu ta' empagliflozin.
English: A total of 11,250 patients with type 2 diabetes were treated in 10 double-blind, placebo- and active-controlled clinical studies, of which 7,015 received empagliflozin (empagliflozin 10 mg: 3021 patients; empagliflozin 25 mg: 3994 patients).
Maltese: B'kollox 11,250 pazjent b'dijabete ta' tip 2 kienu trattati f'10 studji kliniċi double-blind, ikkontrollati bi plaċebo u b'mod attiv, li minnhom 7,015 ħadu empagliflozin (empagliflozin 10 mg: 3,021-il pazjent; empagliflozin 25 mg: 3,994 pazjent).
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Ir-rekwiżiti tar-rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tadDirettiva 2001/83/KE u kwalunke aġġornament sussegwenti ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: Risk for volume depletion
Maltese: Riskju ta' żvojtar tal-volum
English: Therapy
Maltese: Monoterapija
English: Each tablet contains 10 mg or 25 mg empagliflozin.
Maltese: - Kull pillola fiha 10 mg jew 25 mg empagliflozin.
English: Boehringer Ingelheim RCV GmbH & Co KG Magyarországi Fióktelepe Tel: +36 1 299 89 00
Maltese: KG Magyarországi Fióktelepe Tel: +36 1 299 89 00
English: HbA1c (%) at week 18 Baseline (mean) Change from baseline1 Difference from placebo1
Maltese: HbA1c (%) f'Ġimgħa 18 Linja bażi (medja) Bidla mil-linja bażi1
English: Add-on to insulin therapy
Maltese: Terapija aġġuntiva mal-insulina
English: Jardiance 25 mg film-coated tablets
Maltese: Jardiance 25 mg pilloli Empagliflozin
English: • unusual thirst
Maltese: Tqala u treddigħ
English: The efficacy and safety of empagliflozin was evaluated in a double-blind, placebo controlled study of 12 weeks duration in patients with type 2 diabetes and high blood pressure on different antidiabetic and up to 2 antihypertensive therapies.
Maltese: L-effikaċja u s-sigurtà ta' empagliflozin ġew evalwati fi studju double blind, ikkontrollat bi plaċebo għal perijodu ta' 12-il ġimgħa f'pazjenti b'dijabete ta' tip 2 u pressjoni tad-demm għolja fuq antidijabetiku differenti u sa 2 terapiji li jaġixxu kontra l-pressjoni għolja.
English: Following administration of an oral [14C]-empagliflozin solution to healthy volunteers, approximately 96% of the drug-related radioactivity was eliminated in faeces (41%) or urine (54%).
Maltese: Wara l-għoti ta' doża orali ta' soluzzjoni ta' [14C] empagliflozin lil voluntiera b'saħħithom, madwar 96% tar-radjuattività marbuta mal-mediċina ġiet eliminata fl-ippurgar (41%) jew fl-awrina (54%).
English: 5 Mean adjusted for baseline DBP, baseline HbA1c, baseline eGFR, geographical region and number of antihypertensive medicinal products * p-value <0.0001
Maltese: Il-medja aġġustata għal DBP tal-linja bażi, HbA1c tal-linja bażi, eGFR tal-linja bażi, ir-reġjun ġeografiku u numru ta' prodotti mediċinali kontra l-pressjoni għolja
English: Add-on combination therapy
Maltese: Terapija ta' kombinazzjoni
English: Inhibition of OATP1B1/1B3 transporters by co-administration with rifampicin resulted in a 75% increase in Cmax and a 35% increase in AUC of empagliflozin.
Maltese: L-impediment ta t-trasportaturi OATPB1/1B3 bl-għoti konġunt ma' rifampicin irriżulta f'żieda ta' 75%
English: Based on the population pharmacokinetic analysis, the apparent terminal elimination half-life of empagliflozin was estimated to be 12.4 hours and apparent oral clearance was 10.6 l/hour.
Maltese: Abbażi tal-analiżi farmakokinetika tal-popolazzjoni, il-half-life tal-eliminazzjoni terminali apparenti ta' empagliflozin kienet stmata li hi ta' 12.4 sigħat u t-tneħħija orali apparenti kienet ta' 10.6 l/siegħa.
English: Jardiance 10 mg film-coated tablets
Maltese: Jardiance 10 mg pilloli Empagliflozin
English: In a juvenile toxicity study in the rat, when empagliflozin was administered from postnatal day 21 until postnatal day 90, non-adverse, minimal to mild renal tubular and pelvic dilation in juvenile rats was seen only at 100 mg/kg/day, which approximates 11-times the maximum clinical dose of 25 mg.
Maltese: Fi studju dwar it-tossiċità fil-friegħ fil-firien, meta empagliflozin ngħata minn jum 21 wara t-twelid sa jum 90 wara t-twelid, dilatazzjoni tubulari tal-kliewi u pelvika mhux avversa, minn minima għal ħafifa fil-friegħ tal-firien seħħet biss f'doża ta' 100 mg/kg/jum, li hija madwar 11-il darba d-doża klinika massima ta' 25 mg.
English: Empagliflozin 24 months data, as add on to metformin in comparison to glimepiride In a study comparing the efficacy and safety of empagliflozin 25 mg versus glimepiride (up to 4 mg per day) in patients with inadequate glycaemic control on metformin alone, treatment with empagliflozin daily resulted in superior reduction in HbA1c (Table 4), and a clinically meaningful reduction in FPG, compared to glimepiride.
Maltese: f'pazjenti b'kontroll gliċemiku inadegwat li qegħdin fuq metformin biss, it-trattament b'empagliflozin kuljum irriżulta fi tnaqqis superjuri f'HbA1c (Tabella 4), u tnaqqis klinikament validu fil-FPG, meta mqabbel ma' glimepiride.
English: Empagliflozin should be discontinued when eGFR is persistently below 45 ml/min/1.73 m2 or CrCl persistently below 45 ml/min.
Maltese: Empagliflozin għandu jitwaqqaf f'pazjenti li jkollhom eGFR b'mod persistenti taħt 45 mL/min/1.73 m2 jew CrCl b'mod persistenti taħt 45 ml/min.
English: Empagliflozin
Maltese: Pożoloġija
English: Body mass index had no clinically relevant effect on the pharmacokinetics of empagliflozin based on the population pharmacokinetic analysis.
Maltese: Il-ġeneru sesswali ma kellu l-ebda effett klinikament rilevanti fuq il-farmakokinetiċi ta' empagliflozin abbażi ta' analiżi farmakokinetika tal-popolazzjoni.
English: *p-value <0.0001
Maltese: 0005 # valur p = 0.0040
English: Complicated urinary tract infection (e.g. pyelonephritis or urosepsis) occurred at a similar frequency in patients treated with empagliflozin compared to placebo.
Maltese: Infezzjoni kkomplikata tal-passaġġ urinarju (eż. pijelonefrite jew urosepsis) ġiet osservata bi frekwenza simili f'pazjenti trattati b'empagliflozin meta mqabbla ma' plaċebo.
English: Table 4: Efficacy results at 104 week in an active controlled study comparing empagliflozin to glimepiride as add on to metformina
Maltese: Tabella 4: Riżultati ta' effikaċja wara 104 ġimgħat fi studju kontrollat b'mod attiv li qabbel empagliflozin ma' glimepiride bħala terapija addizzjonali għal metformina
English: 2856 patients received empagliflozin 10 mg and 3,738 patients received empagliflozin 25 mg for at least 24 weeks and 601 or 881 patients for at least 76 weeks, either alone or in combination with metformin, a sulphonylurea, pioglitazone, DPP-4 inhibitors, or insulin.
Maltese: 25 mg għal tal-anqas 24 ġimgħa u 601 jew 881 pazjent għal tal-anqas 76 ġimgħa, jew waħdu jew flimkien ma' metformin, sulphonylurea, pioglitazone, impedituri ta' DPP-4, jew insulina.
English: Body Mass Index
Maltese: Sistema talklassifika talorgani
English: 2 Not evaluated for statistical significance as a result of the sequential confirmatory testing procedure
Maltese: 2 Mhux evalwat għal sinifikat ta' statistika bħala riżultat ta' proċedura ta' ttestjar konfermatorju sekwenzjali
English: Empagliflozin as add on to metformin, sulphonylurea, pioglitazone Empagliflozin as add-on to metformin, metformin and a sulphonylurea, or pioglitazone with or without metformin resulted in statistically significant (p<0.0001) reductions in HbA1c and body weight compared to placebo (Table 3).
Maltese: Empagliflozin bħala terapija addizzjonali għal metformin, sulphonylurea, pioglitazone Empagliflozin bħala terapija aġġuntiva għal metformin, metformin u sulphonylurea, jew pioglitazone bi jew mingħajr metformin irriżulta fi tnaqqis statistikament sinifikanti (p<0.
English: Pharmacotherapeutic group: Drugs used in diabetes, Other blood glucose lowering drugs, excl. insulins, ATC code: A10BX12
Maltese: Mediċini użati fid-dijabete, Mediċini oħra li jbaxxu l-glukosju fiddemm, li jeskludu insulini, Kodiċi ATC:
English: Round, pale yellow, biconvex, bevel-edged film-coated tablet debossed with “S10” on one side and the Boehringer Ingelheim logo on the other (tablet diameter: 9.1 mm).
Maltese: Pillola tonda, ta' lewn safrani ċar, mżaqqa fuq żewġ naħat, bi truf imċannfrin, miksija b'rita, imnaqqxa b'"S10" fuq naħa waħda u l-logo ta' Boehringer Ingelheim fuq in-naħa l-oħra (dijametru tal-pillola: 9.1 mm).
English: Peak plasma levels of empagliflozin were roughly 20% higher in subjects with mild and severe renal impairment as compared to subjects with normal renal function.
Maltese: Livelli għolja ta' empagliflozin fil-plażma kienu madwar 20% ogħla f'individwi b'indeboliment tal-kliewi ħafif għal sever meta mqabbla ma' pazjenti b'funzjoni tal-kliewi normali.
English: During the initial 18 weeks and the last 12 weeks, the insulin dose was kept stable, but was adjusted to achieve pre-prandial glucose levels <100 mg/dl [5.5 mmol/l], and post-prandial glucose levels <140 mg/dl [7.8 mmol/l] between Weeks 19 and 40.
Maltese: <100 mg/dl [5.5 mmol/l], u livelli ta' glukosju ta' wara l-ikla <140 mg/dl [7.8 mmol/l] bejn Ġimgħat 19 u 40.
English: Oval, pale yellow, biconvex film-coated tablet debossed with “S25” on one side and the Boehringer Ingelheim logo on the other (tablet length: 11.1 mm, tablet width: 5.6 mm).
Maltese: Pillola ovali, ta' lewn safrani ċar, mżaqqa fuq żewġ naħat, miksija b'rita, imnaqqxa b'"S25" fuq naħa waħda u l-logo ta' Boehringer Ingelheim fuq in-naħa l-oħra (dijametru tal-pillola: 5.6 mm).
English: It is important to tell your doctor:
Maltese: Huwa importanti li tgħid lit-tabib tiegħek:
English: What Jardiance contains - The active substance is empagliflozin.
Maltese: - Is-sustanza attiva hi empagliflozin
English: LIST OF EXCIPIENTS Contains lactose, see leaflet for further information.
Maltese: TA' EĊĊIPJENTI Fiha lactose, ara l-fuljett għal aktar informazzjoni.
English: Systemic exposure of empagliflozin increased in a dose-proportional manner.
Maltese: L-esponiment sistemiku ta' empagliflozin żdied f'manjiera proporzjonali maddoża.
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: 2 Mean adjusted for baseline HbA1c, baseline eGFR, geographical region and number of antihypertensive medicinal products 3 LOCF, values after taking antidiabetic rescue therapy or changing antihypertensive rescue therapy censored 4 Mean adjusted for baseline SBP, baseline HbA1c, baseline eGFR, geographical region and number of antihypertensive medicinal products
Maltese: 1 LOCF, valuri wara terapija ta' salvataġġ kontra d-dijabete ċċensurati 2 Il-medja aġġustata għal HbA1c tal-linja bażi, eGFR tal-linja bażi, ir-reġjun ġeografiku u numru ta' prodotti mediċinali kontra l-pressjoni għolja
English: The pharmacokinetics of empagliflozin have been extensively characterised in healthy volunteers and patients with type 2 diabetes.
Maltese: Il-farmakokinetiċi ta' empagliflozin kienu kkaratterizzati b'mod estensiv f'voluntiera b'saħħithom u pazjenti b'dijabete ta' tip 2.
English: Jardiance 10 mg film-coated tablets Jardiance 25 mg film-coated tablets empagliflozin
Maltese: Jardiance 10 mg pilloli miksija b'rita Jardiance 25 mg pilloli miksija b'rita empagliflozin
English: Urine laboratory assessments
Maltese: Valutazzjonijiet tal-urina fil-laboratorju
English: Boehringer Ingelheim Ltd. Tel: +44 1344 424 600
Maltese: Boehringer Ingelheim Zagreb d.o.o. Tel: +385 1 2444 600
English: Patients with renal impairment, 52 week placebo controlled data The efficacy and safety of empagliflozin as add on to antidiabetic therapy was evaluated in patients with renal impairment in a double-blind, placebo-controlled study for 52 weeks.
Maltese: L-effikaċja u s-sigurtà ta' empagliflozin bħala terapija addizzjonali għal terapija antidijabetika ġew evalwati f'pazjenti b'indeboliment tal-kliewi fi studju double blind ikkontrollat bi plaċebo li dam 52 ġimgħa.
English: Age did not have a clinically meaningful impact on the pharmacokinetics of empagliflozin based on the population pharmacokinetic analysis.
Maltese: L-età ma kellha l-ebda impatt validu fuq il-farmakokinetiċi ta' empagliflozin abbażi ta' analiżi farmakokinetika tal-popolazzjoni.
English: The mode of action for these tumours is dependent on the natural predisposition of the male mouse to renal pathology and a metabolic pathway not reflective of humans.
Maltese: Il-mod t'azzjoni ta' dawn it-tumuri huwa dipendenti fuq il-predisposizzjoni naturali tal ġurdien raġel għal patoloġija tal-kliewi u għal rotta tal-kliewi li mhix riflettiva għall-bniedem.
English: The recommended starting dose is 10 mg empagliflozin once daily for monotherapy and add-on combination therapy with other glucose-lowering medicinal products including insulin.
Maltese: Id-doża rakkomandata tal-bidu hi ta' 10 mg empagliflozin darba kuljum għal monoterapija u bħala terapija kombinata miżjuda ma' prodotti mediċinali oħra li jnaqqsu l-glukosju li jinkludu l-insulina.
English: They have “S10” on one side and the Boehringer Ingelheim logo on the other side.
Maltese: Għandhom "S10" fuq naħa waħda u l-logo ta' Boehringer Ingelheim fuq in-naħa l-oħra.
English: As a precautionary measure, it is preferable to avoid the use of Jardiance during pregnancy.
Maltese: Bћala miżura ta' prekawzjoni hu preferribli li Jardiance ma jintuzax fil-perijodu tat-tqala.
English: Administration of empagliflozin 25 mg after intake of a high-fat and high calorie meal resulted in slightly lower exposure; AUC decreased by approximately 16% and Cmax by approximately 37% compared to fasted condition.
Maltese: L-għoti ta' empagliflozin 25 mg wara teħid ta' ikla b'ħafna xaħam u ħafna kaloriji rriżulta f'esponiment ftit aktar baxx; l-AUC naqas b'madwar 16% u Cmax b'madwar 37% meta mqabbel mal-kondizzjoni tas sawm.
English: In a pre-specified pooled analysis of three phase 3 studies, treatment with open-label empagliflozin 25 mg in patients with severe hyperglycaemia (N=184, mean baseline HbA1c 11.15%) resulted in a clinically meaningful reduction in HbA1c from baseline of 3.27% at week 24; no placebo or empagliflozin 10 mg arms were included in these studies.
Maltese: F'analiżi ppuljata speċifikata minn qabel ta' 3 studji ta' tliet fażijiet, it-trattament b'empagliflozin 25 mg open-label f'pazjenti b'ipergliċemija severa (N=184, linja bażi medja ta' HbA1c 11.15%) irriżulta fi tnaqqis klinikament validu f'HbA1c mil-linja bażi ta' 3.27% fil-ġimgħa 24; ebda gruppi ta' plaċebo jew empagliflozin 10 mg ma kienu inklużi f'dawn l-istudji.
English: CLINICAL PARTICULARS
Maltese: KLASSIFIKAZZJONI ĠENERALI
English: In patients tolerating empagliflozin 10 mg once daily who have an eGFR ≥60 ml/min/1.73 m2 and need tighter glycaemic control, the dose can be increased to 25 mg once daily.
Maltese: F'pazjenti li jittoleraw empagliflozin 10 mg darba kuljum li għandhom eGFR ≥60 ml/min/1.73 m2u jeħtieġu kontroll gliċemiku aktar strett, id-doża tista' togħla għal 25 mg darba kuljum.
English: Each tablet contains 25 mg empagliflozin.
Maltese: Kull pillola fiha 25 mg ta' empagliflozin.
English: An increased frequency was noted when given as add-on to metformin and a sulfonylurea (empagliflozin 10 mg: 16.1%, empagliflozin 25 mg: 11.5%, placebo: 8.4%), and as add-on to insulin with or without metformin and with or without a sulphonylurea (empagliflozin 10 mg: 19.5%, empagliflozin 25 mg: 27.1%, placebo: 20.6% during initial 18 weeks treatment when insulin could not be adjusted; empagliflozin 10 mg: 36.1%, empagliflozin 25 mg: 34.8%, placebo 35.3% over the 78-week trial).
Maltese: 1%, plaċebo: 20.6 waqt l-ewwel 18-il ġimgħa ta' trattament meta l-insulina ma setgħetx tiġi aġġustata; empagliflozin 10 mg: 36.1%, empagliflozin 25 mg: 34.8%, plaċebo 35.3% fuq prova ta' 78 ġimgħa).
English: Excipient with known effect
Maltese: Evidenza mikroskopika fuq l-effetti ta'
English: The inter-subject and residual variabilities for empagliflozin oral clearance were 39.1% and 35.8%,
Maltese: Il-varjabilitajiet bejn individwu u ieħor u dawk residwali għat-tneħħija orali ta' empagliflozin kienu 39.1% u 35.8% rispettivament.
English: Jardiance is indicated in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults as:
Maltese: Jardiance huwa indikat fit-trattament ta' dijabete mellitus ta' tip 2 sabiex itejjeb il-kontroll gliċemiku fl-adulti bħala:
English: Empagliflozin exposure was similar with and without co-administration with verapamil, a P-gp inhibitor, indicating that inhibition of P-gp does not have any clinically relevant effect on empagliflozin.
Maltese: L-ebda effett bħal dan ma' ġie osservat f'esponiment sistemiku ekwivalenti għall-esponiment kliniku massimu ta' empagliflozin.
English: The safety and efficacy of empagliflozin in children and adolescents has not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' empagliflozin fit-tfal u adolexxenti ma ġewx determinati s'issa.
English: Empagliflozin did not increase the incidence of tumours in female mice at doses up to 1000 mg/kg/day, which corresponds to approximately 62-times the maximal clinical exposure to empagliflozin.
Maltese: Empagliflozin ma żiedx l-inċidenza ta' tumuri fi ġrieden nisa sa dożi ta' 1000 mg/kg/jum, li jikkorrispondi għal madwar 62 darba l-esponiment kliniku massimu ta' empagliflozin.
English: Talc
Maltese: KG
English: 12 phase 2 and 3 clinical studies involving 10,036 patients with type 2 diabetes, empagliflozin did not increase cardiovascular risk.
Maltese: F'metanaliżi prospettiva, speċifikata minn qabel ta' każijiet kardjovaskulari aġġudikati indipendentement minn 12-il studju kliniku ta' Fażi 2 u 3 li kienu jinvolvu 10,036 pazjent b'dijabete ta' tip 2, il-kura b'empagliflozin ma kinitx assoċjata ma' żieda fir-riskju kardjovaskulari.
English: Jardiance contains the active substance empagliflozin which works by blocking a protein in the kidneys called sodium-glucose co-transporter 2 (SGLT2).
Maltese: X'inhu Jardiance u għalxiex jintuża Jardiance fih is-sustanza attiva empagliflozin li taħdem billi timblokka proteina fil-kliewi li tissejjaħ kotrasportatur 2 tas-sodju-glukożju (SGLT2).
English: • Jardiance can be used without other medicines in patients who cannot take metformin (another diabetes medicine).
Maltese: • Jardiance jista' jintuża mingħajr mediċini oħra f'pazjenti li ma jistgħux jieħdu metformin (mediċina oħra tad-dijabete).
English: Interaction studies conducted in healthy volunteers suggest that empagliflozin had no clinically relevant effect on the pharmacokinetics of metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, simvastatin, warfarin, ramipril, digoxin, diuretics and oral contraceptives.
Maltese: linagliptin, simvastatin, warfarin, ramipril, digoxin, dijuretiċi u kontraċettivi orali. 4.6 Fertilità, tqala u treddigħ
English: Other side effects while taking Jardiance:
Maltese: Effetti sekondarji oħra waqt li qed tieħu Jardiance:
English: Therefore assessment of renal function is recommended as follows: - Prior to empagliflozin initiation and periodically during treatment, i.e. at least yearly (see sections 4.2, 5.1 and 5.2).
Maltese: - Qabel il-bidu ta' empagliflozin u kull tant żmien waqt it-trattament i.e tal-anqas darba fis-sena (ara sezzjonijiet 4.2, 5.1 u 5.2).
English: - Prior to initiation of any concomitant medicinal product that may have a negative impact on renal function.
Maltese: - Qabel il-bidu ta' kull prodott mediċinali li jingħata fl-istess waqt li jista' jkollu impatt negattiv fuq il-funzjoni tal-kliewi.
English: An increased frequency was noted when given as add-on to insulin with or without metformin and with or without a sulfonylurea (empagliflozin 10 mg: 0%, empagliflozin 25 mg: 1.3%, placebo: 0% during initial 18 weeks treatment when insulin could not be adjusted; empagliflozin 10 mg: 0%, empagliflozin 25 mg: 1.3%, placebo 0% over the 78-week trial).
Maltese: (empagliflozin 10 mg: 0%, empagliflozin 25 mg: 1.3%, plaċebo: 0% waqt l-ewwel 18-il ġimgħa ta' trattament meta l-insulina ma setgħetx tiġi aġġustata; empagliflozin 10 mg: 0%, empagliflozin 25 mg:
English: NAME OF THE MEDICINAL PRODUCT Jardiance 10 mg film-coated tablets Jardiance 25 mg film-coated tablets
Maltese: Jardiance 10 mg pilloli miksija b'rita Jardiance 25 mg pilloli miksija b'rita
English: NAME OF THE MARKETING AUTHORISATION HOLDER Boehringer Ingelheim
Maltese: Boehringer Ingelheim
English: Following administration of an oral [14C]-empagliflozin solution to healthy volunteers, the red blood cell partitioning was approximately 37% and plasma protein binding was
Maltese: Wara l-għoti ta' soluzzjoni orali ta' [14C]-empagliflozin lil voluntiera b'saħħithom, ittqassim ta' ċelluli ħomor tad-demm kien madwar 37% u t-twaħħil mal-proteini fil-plażma kien ta' 86%.
English: Therefore, a lower dose of insulin or an insulin secretagogue may be required to reduce the risk of hypoglycaemia when used in combination with empagliflozin (see sections 4.2 and 4.8).
Maltese: Għalhekk, doża iktar baxxa ta' insulina jew ta' sekretagog tal-insulina, għandha mnejn tkun meħtieġa biex jitnaqqas ir-riskju ta' ipogliċemija meta tintuża ma' empagliflozin (ara sezzjonijiet 4.2 u 4.8).
English: Patients who may be at higher risk of DKA include patients with a low beta-cell function reserve (e.g. type 2 diabetes patients with low C-peptide or latent autoimmune diabetes in adults (LADA) or patients with a history of pancreatitis), patients with conditions that lead to restricted food intake or severe dehydration, patients for whom insulin doses are reduced and patients with increased insulin requirements due to acute medical illness, surgery or alcohol abuse.
Maltese: Pazjenti li jistgħu jkunu f'riskju ogħla ta' DKA jinkludu pazjenti b'riżerva baxxa tal-funzjoni taċ-ċelloli beta (eż. pazjenti b'dijabete tata' Tip 2 b'għadd baxx ta' peptidi C jew dijabete awtoimmuni latenti fl-adulti (LADA, latent autoimmune diabetes in adults) jew pazjenti bi storja ta' pankreatite), pazjenti b'kundizzjonijiet li jistgħu jwasslu għal teħid limitat tal-ikel jew deidrazzjoni severa, pazjenti li d-dożi tal-insulina tagħhom jonqsu u pazjenti b'żieda fil-ħtiġijiet ta' insulina minħabba mard mediku akut, kirurġija jew abbuż ta' alkoħol.
English: • if you are taking other medicines that lower the amount of sugar in your blood such as insulin or a “sulphonylurea” medicine.
Maltese: • Jekk qed tieħu mediċini oħra li jnaqqsu l-ammont ta' zokkor fid-demm tiegħek bħall-insulina jew mediċina ta' tip "sulphonylurea".
English: Empagliflozin is a substrate of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP).
Maltese: Empagliflozin huwa sottostrat tat-trasportaturi tat-teħid uman OAT3, OATP1B1, u OATPiB3, imma mhux OAT1 u OCT2. Empagliflozin huwa sottostrat ta' P-glycoprotein (P-gp) u proteina ta' reżistenza għall-kanċer tas-sider (BCRP - breast cancer resistance protein).