FrancophonIA/ELRC3.0 huggingface dataset:
English: - The other ingredients are: tablet core: lactose monohydrate (see end of section 2 under ‘Jardiance contains lactose'), cellulose microcrystalline, hydroxypropylcellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate film-coating: hypromellose, titanium dioxide (E171), talc, macrogol (400), iron oxide yellow (E172)
Maltese: - Is-sustanzi l-oħra huma - il-qalba tal-pillola: lactose monohydrate (ara fl-aħħar ta' sezzjoni 2 taħt "Jardiance fih illactose"), cellulose microcrystalline, hydroxypropylcellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate - kisi tal-pillola: hypromellose, titanium dioxide (E171), talc, macrogol (400), iron oxide yellow (E172)
English: INFORMATION IN BRAILLE Jardiance 25 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Jardiance 25 mg
English: Systemic exposure of each metabolite was less than 10% of total drug-related material.
Maltese: L-esponiment sistemiku ta' kull metabolit kien inqas minn 10% tal-materjal kollu marbut mal-mediċina.
English: The frequency of reported nocturia was similar for placebo and empagliflozin (<1%).
Maltese: Il-frekwenza ta' nokturja rapportata kienet simili għal plaċebo u empagliflozin (<1%)
English: Urine glucose
Maltese: Glukosju fl-urina
English: Each tablet contains lactose monohydrate equivalent to 107.4 mg lactose anhydrous.
Maltese: Kull pillola fiha lactose monohydrate ekwivalenti għal 107.4 mg lactose anidru.
English: The tablets are 9.1 mm in diameter.
Maltese: Ilpilloli għandhom dijametru ta' 9.1 mm.
English: Insulin and insulin secretagogues
Maltese: Insulina u sekretagogi tal-insulina
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 May 2014
Maltese: Data tal-ewwel awtorizzazzjoni: 22 ta' Mejju 2014
English: Add-on to metformin and a sulphonylurea therapy Placebo
Maltese: Terapija aġġuntiva għal metformin u sulphonylurea Plaċebo
English: Empagliflozin is a reversible, highly potent (IC50 of 1.3 nmol) and selective competitive inhibitor of sodium-glucose co-transporter 2 (SGLT2).
Maltese: Empagliflozin huwa impeditur riversibbli, qawwi ħafna (IC50 ta' 1.3 nmol) kompettitiv u silettiv ta' kotrasportatur 2 ta' sodju-glukosju (SGLT2).
English: Experience in New York Heart Association (NYHA) class I-II is limited, and there is no experience in clinical studies with empagliflozin in NYHA class III-IV.
Maltese: I-II tan-New York Heart Association hija ristretta, u m'hemmx esperjenza fi studji kliniċi b'empagliflozin fi klassi III-IV ta' NYHA.
English: Empagliflozin does not inhibit UGT1A1, UGT1A3, UGT1A8, UGT1A9, or UGT2B7.
Maltese: Empagliflozin ma jimpedixxix UGT1A1, UGT1A3, UGT1A8, UGT1A9, jew UGT2B7.
English: Pack sizes of 7 x 1, 10 x 1, 14 x 1, 28 x 1, 30 x 1, 60 x 1, 70 x 1, 90 x 1, and 100 x 1 film-coated tablets.
Maltese: Id-daqsijiet tal-pakkett huma ta' 7 x 1, 10 x 1, 14 x 1, 28 x 1, 30 x 1, 60 x 1, 70 x 1, 90 x 1, u 100 x 1 ta' pilloli miksija b'rita.
English: Possible signs are listed in section 4, ‘Possible side effects' under ‘dehydration'.
Maltese: Sinjali possibbli huma elenkati f'sezzjoni 4, "Effetti sekondarji possibbli" taħt "deidratazzjoni".
English: Difference from placebo1 (95% CI)
Maltese: Differenza mill-plaċebo1 (95% CI)
English: • if you are 85 years old or older as you should not start taking Jardiance.
Maltese: • jekk għandek 85 sena jew aktar m'għandekx tibda tieħu Jardiance.
English: Interaction studies conducted in healthy volunteers suggest that the pharmacokinetics of empagliflozin were not influenced by co-administration with metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, warfarin, verapamil, ramipril, simvastatin, torasemide and hydrochlorothiazide.
Maltese: empagliflozin ma kinux influwenzati bl-għoti konġunt ta' metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, warfarin, verapamil, ramipril, simvastatin, torasemide u hydrochlorothiazide.
English: Pruritus (generalised)
Maltese: Folji (perforati)
English: (add-on to metformin: placebo +5.9 mg/dl, empagliflozin 10 mg: -46.0 mg/dl, empagliflozin 25 mg: -44.6 mg/dl, add-on to metformin and a sulphonylurea: placebo -2.3 mg/dl, empagliflozin 10 mg: -35.7 mg/dl, empagliflozin 25 mg: -36.6 mg/dl).
Maltese: 10 mg: -46.0 mg/dl, empagliflozin 25 mg: -44.6 mg mg/dl, terapija addizzjonali għal metformin u sulphonylurea: plaċebo -2.3 mg/dl, empagliflozin 10 mg: -35.7 mg/dl, empagliflozin 25 mg: -36.6 mg/dl).
English: Hypoglycaemia (when used with sulphonylurea or insulin)a
Maltese: sulphonylurea jew mal-insulina)a
English: In this analysis, AUC was estimated to be 5.82%, 10.4%, and 17.3% lower in subjects with BMI of 30, 35, and 45 kg/m2, respectively, compared to subjects with a body mass index of 25 kg/m2.
Maltese: F'din l-analiżi,l-AUC kien stmat li kien 5.82%, 10.4% u 17.3% inqas f'individwi b'BMI ta' 30, 35 u 45 kg/m2, rispettivament, meta mqabbla ma' individwi b'indiċi tal-piz tal-ġisem ta' 25 kg/m2.
English: Titanium dioxide (E171)
Maltese: Kisja tar-rita Hypromellose Titanium dioxide (E171) Talc
English: The steady state mean plasma AUC and Cmax were 1870 nmol.h and 259 nmol/l with empagliflozin 10 mg and 4740 nmol.h and 687 nmol/l with empagliflozin 25 mg once daily.
Maltese: 1870 nmol/l u 259 nmol/l b'empagliflozin 10 mg u 4740 nmol.h u 687 nmol/l b'empagliflozin 25 mg li jingħata darba kuljum.
English: Each tablet contains lactose monohydrate equivalent to 154.3 mg lactose anhydrous.
Maltese: Eċċipjent b'effett magħruf Kull pillola fiha lactose monohydrate ekwivalenti għal 154.3 mg lactose anidru.
English: The intensity (mild, moderate, severe) of urinary tract infection was similar in patients treated with empagliflozin and placebo.
Maltese: L-intensità (ħafifa, moderata, severa) ta' infezzjoni tal-passaġġ urinarju kienet simili f'pazjenti trattati b'empagliflozin u plaċebo.
English: Consistent with the half-life, up to 22% accumulation, with respect to plasma AUC, was observed at steady-state.
Maltese: B'mod konsistenti mal-half-life, sa 22% akkumulazjoni, firrigward ta' AUC tal-plażma, ġiet osservata fl-istadju fiss.
English: Česká republika Boehringer Ingelheim spol.
Maltese: Boehringer Ingelheim spol.
English: Effects of other medicinal products on empagliflozin In vitro data suggest that the primary route of metabolism of empagliflozin in humans is glucuronidation by uridine 5'-diphosphoglucuronosyltransferases UGT1A3, UGT1A8, UGT1A9, and UGT2B7.
Maltese: L-effetti ta' prodotti mediċinali oħrajn fuq empagliflozin Dejta in vitro tissuġerixxi li r-rotta prinċipali ta' metaboliżmu ta' empagliflozin fil-bniedem hi glukuronidazzjoni permezz ta' uridine 5'-diphosphoglucuronosyltransferases UGT1A3, UGT1A8, UGT1A9, u UGT2B7.
English: Empagliflozin should be discontinued when eGFR is persistently below 45 ml/min/1.73 m2 or CrCl persistently below 45 ml/min (see sections 4.4, 4.8, 5.1, and 5.2).
Maltese: Empagliflozin għandu jitwaqqaf f'pazjenti li jkollhom eGFR b'mod persistenti taħt 45 mL/min/1.73 m jew CrCl b'mod persistenti taħt 45 ml/min (ara sezzjonijiet 4.4, 4.8, 5.1, u 5.2).
English: No major metabolites of empagliflozin were detected in human plasma and the most abundant metabolites were three glucuronide conjugates (2-, 3-, and 6-O glucuronide).
Maltese: Ma ġewx osservati metaboliti prinċipali ta' empagliflozin fil-plażma tal-bniedem u l-aktar metaboliti abundanti kienu tliet konjugati ta' glucuronide (2-, 3-, u 6-O glucorinide).
English: *, b
Maltese: Dijabetika*, b
English: At week 18, empagliflozin provided statistically significant improvement in HbA1c (Table 6).
Maltese: F'ġimgħa 18, empagliflozin ġab titjib statistikament sinifikanti f'HbA1c (Tabella 6).
English: In patients aged 85 years and older, initiation of empagliflozin therapy is not recommended due to the limited therapeutic experience (see section 4.4).
Maltese: F'pazjenti li għandhom 85 sena jew aktar, mhux rakkomandat li tinbeda terapija b'empagliflozin minħabba lesperjenza terapewtika limitata (ara sezzjoni 4.4).
English: Improvement of surrogate markers of beta cell function including Homeostasis Model Assessment-β (HOMA-β) was noted.
Maltese: Kien innotat titjib fil-markaturi sostituti tal-funzjoni taċ-ċelluli beta li jinkludu l-Mudell Omeostatiku ta' Assessjar β (HOMA-βHomeostasis Model Assessment-B).
English: Therapeutic experience in patients aged 85 years and older is limited.
Maltese: L-esperjenza terapewtika f'pazjenti li għandhom 85 sena jew aktar hija limitata.
English: The adverse reactions are listed by absolute frequency.
Maltese: Ir-reazzjonijiet avversi huma elenkati skont il-frekwenza assoluta.
English: Co-administration of empagliflozin with probenecid, an inhibitor of UGT enzymes and OAT3, resulted in a 26% increase in peak empagliflozin plasma concentrations (Cmax) and a 53% increase in area under the concentration-time curve (AUC).
Maltese: L-għoti konġunt ta' empagliflozin ma' probenecid, impeditur ta' enzimi UGT u OAT3, irriżulta f'żieda ta' 26% fl-ogħla konċentrazzjonijiet ta' empagliflozin fil-plażma (Cmax) u żieda ta' 53% fl-erja ta' taħt il-kurva ta' konċentrazzjoni mal-ħin (AUC).
English: Boehringer Ingelheim Sp. z o.o.
Maltese: Boehringer Ingelheim Sp.zo.o.
English: 7 x 1 film-coated tablets 10 x 1 film-coated tablets 14 x 1 film-coated tablets 28 x 1 film-coated tablets 30 x 1 film-coated tablets 60 x 1 film-coated tablets 70 x 1 film-coated tablets 90 x 1 film-coated tablets 100 x 1 film-coated tablets
Maltese: 7 x 1 pilloli miksija b'rita 10 x 1 pilloli miksija b'rita 14 x 1 pilloli miksija b'rita 28 x 1 pillola miksija b'rita 30 x 1 pillola miksija b'rita 60 x 1 pillola miksija b'rita 70 x 1 pillola miksija b'rita 90 x 1 pillola miksija b'rita 100 x 1 pillola miksija b'rita
English: Empagliflozin daily resulted in a statistically significant reduction in body weight, systolic and diastolic blood pressure and a statistically significantly lower proportion of patients with hypoglycaemic events compared to glimepiride (2.5% for empagliflozin, 24.2% for glimepiride, p<0.0001).
Maltese: Empagliflozin kuljum irriżulta fi tnaqqis statistikament sinifikanti fil-piż tal ġisem, fil-pressjoni sistolika u dijastolika tad-demm u proporzjon statistikament sinifikanti aktar baxx f'pazjenti b'każijiet ipogliċemiċi meta mqabbla ma' glimepiride (2,5% għal empagliflozin, 24,2% għal glimepiride, p<0.0001).
English: The overall frequency of urinary tract infection reported as adverse event was similar in patients treated with empagliflozin 25 mg and placebo (7.6%) and higher in empagliflozin 10 mg (9.3%).
Maltese: Il-frekwenza globali ta' infezzjoni tal-passaġġ urinarju rapportata bħala avveniment avvers kienet simili f'pazjenti trattati b'empagliflozin 25 mg u plaċebo (7.6%) u ogħla f'pazjenti trattati b'empagliflozin 10 mg (9.3%).
English: No dose adjustment is required for patients with an eGFR ≥60 ml/min/1.73 m2 or CrCl ≥60 ml/min.
Maltese: ≥60 ml/min/1.73 m2 jew CrCl ≥60 ml/min.
English: Co-administration of digoxin, a P-gp substrate, with empagliflozin resulted in a 6% increase in AUC and 14% increase in Cmax of digoxin.
Maltese: Lgħoti fl-istess waqt ta' digoxin, sottostrat ta' P-gp, ma' empagliflozin irriżulta f'żieda ta' 6% fl-AUC u ta' 14% żieda f'Cmax ta' digoxin.
English: Add-on to pioglitazone +/- metformin therapy Placebo
Maltese: Terapija aġġuntiva għal pioglitazone +/- metformin
English: Insulin and insulin secretagogues, such as sulphonylureas, may increase the risk of hypoglycaemia.
Maltese: L-insulina u sekretagogi tal-insulina, bħal sulphonylureas, jistgħu jgħollu r-riskju ta' ipogliċemija.
English: • if you have “type 1 diabetes”.
Maltese: • jekk għandek "dijabete ta' tip 1".
English: What is type 2 diabetes?
Maltese: X'inhi d-dijabete ta' tip 2?
English: 2 Not evaluated for statistical significance as a result of the sequential confirmatory testing procedure 3 95% CI
Maltese: 2 Mhux evalwat għal sinifikat ta' statistika bħala riżultat ta' proċedura ta' ttestjar konfermatorju sekwenzjali 3 95% CI
English: Difference from placebo5
Maltese: Differenza mill-plaċebo1
English: In a pre-specified pooled analysis of 4 placebo controlled studies, treatment with empagliflozin resulted in body weight reduction (-0.24 kg for placebo, -2.04 kg for empagliflozin 10 mg and -2.26 kg for empagliflozin 25 mg) at week 24 that was maintained up to week 52 (-0.16 kg for placebo, -1.96 kg for empagliflozin 10 mg and -2.25 kg for empagliflozin 25 mg).
Maltese: F'analiżi ppuljata speċifikata minn qabel ta' 4 studji kkontrollati bi plaċebo, it-trattament b'empagliflozin irriżulta fi tnaqqis fil-piż tal-ġisem (-0.24 kg għal plaċebo, -2.04 kg għal empagliflozin 10 mg u -2.26 kg għal empagliflozin 25 mg) f'ġimgħa 24 li kienet miżmuma sa ġimgħa 52 (-0.16 kg għal plaċebo, -1.96 kg għal empagliflozin 10 mg u -2.25 kg għal empagliflozin 25 mg).
English: Difference from placebo2
Maltese: Differenza mill plaċebo
English: In patients 75 years and older, an increased risk for volume depletion should be taken into account (see sections 4.4 and 4.8).
Maltese: F'pazjenti li għandhom 75 sena u aktar, riskju ogħla għal żvojtar ta' volum għandu jiġi kkonsidrat (ara sezzjonijiet 4.4 u 4.8).
English: In a prespecified analysis of patients (N=201) with a baseline HbA1c ≥8.5%, treatment resulted in a reduction in HbA1c from baseline of -1.44% for empagliflozin 10 mg, -1.43% for empagliflozin 25 mg, -1.04% for sitagliptin, and an increase of 0.01% for placebo.
Maltese: F'analiżi speċifikata minn qabel ta' pazjenti (N=201) b'linja bażi ta' HbA1c ≥8.5%, it-trattament irriżulta fi tnaqqis f'HbA1c mil-linja bażi ta' -1.44 għal empagliflozin 10 mg, -1.43% għal empagliflozin 25 mg, -1.04% għal sitagliptin, u f'żieda ta' 0.01% għal plaċebo.
English: Treatment with empagliflozin resulted in a statistically significant (p<0.0001) reduction in HbA1c compared to placebo (Table 2) and a clinically meaningful decrease in FPG.
Maltese: 0001) f'HbA1c meta mqabbel ma' plaċebo (tabella 2) u tnaqqis klinikament validu fil-FBG.
English: How to take Jardiance
Maltese: Mediċini oħra u Jardiance
English: * p-value <0.0001 for non-inferiority, and p-value = 0.0153 for superiority ** p-value <0.0001
Maltese: 0001 ** valur p = 0.0003 *** valur p =0.
English: Patients with high baseline HbA1c >10%
Maltese: Pazjenti b'linja bażi għolja ta' HbA1c >10%
English: In subjects with mild, moderate, and severe hepatic impairment according to the Child-Pugh classification, AUC of empagliflozin increased approximately by 23%, 47%, and 75% and Cmax by approximately 4%, 23%, and 48%, respectively, compared to subjects with normal hepatic function.
Maltese: AUC ta' empagliflozin żdied b'madwar 23%, 47% u 75% u Cmax b'madwar 4%, 23% u 48%,
English: The maximum daily dose is 25 mg (see below and section 4.4).
Maltese: Id-doża massima hi ta' 25 mg (ara hawn taħt u sezzjoni 4.4).
English: Table 3: Efficacy results of 24 week placebo-controlled studiesa Add-on to metformin therapy Placebo
Maltese: Tabella 3: Riżultati ta' effikaċja fi studju ta' 24 ġimgħa kkontrollat bi plaċeboa Terapija aġġuntiva għal metformin Plaċebo
English: Slovenská republika Boehringer Ingelheim RCV GmbH & Co KG
Maltese: Slovenská republika Boehringer Ingelheim RCV GmbH & Co
English: Most toxicity was consistent with secondary pharmacology related to urinary glucose loss and electrolyte imbalances including decreased body weight and body fat, increased food consumption, diarrhoea, dehydration, decreased serum glucose and increases in other serum parameters reflective of increased protein metabolism and gluconeogenesis, urinary changes such as polyuria and glucosuria, and microscopic changes including mineralisation in kidney and some soft and vascular tissues.
Maltese: Il-maġġoranza tat-tossiċita kienet marbuta ma' farmakoloġija sekondarja relatata ma' telf ta' glukosju urinarju u żbilanċi fl-elettroliti li jinkludu tnaqqis fil-piż tal ġisem u fix-xaħam tal-ġisem, żieda fil-konsum tal-ikel, dijarea, deidratazzjoni, tnaqqis ta' glukosju fis serum u żidiet f'parametri oħra fis-serum li jirriflettu żieda fil-metaboliżmu ta' proteini u glukoneoġenesi, bidliet urinarji bħal polijurja u glukosurja, u bidliet mikroskopiċi li jinkludu mineralizzazzjoni fil-kliewi u xi tessuti rotob u vaskulari.
English: What you need to know before you take Jardiance 3.
Maltese: X'għandek tkun taf qabel ma tieħu Jardiance 3.
English: Table 1: Adverse reactions reported in placebo-controlled studies System organ class
Maltese: Tabella 1: Reazzjonijiet avversi rapportati fi studji bi plaċebo bħala kontroll.
English: Monotherapy and add-on combination
Maltese: Monoterapija u l-kombinazzjoni miżjuda
English: Vaginal moniliasis, vulvovaginitis, balanitis and other genital infection Vaginal moniliasis, vulvovaginitis, balanitis and other genital infections were reported more frequently in patients treated with empagliflozin (empagliflozin 10 mg: 4.1%, empagliflozin 25 mg: 3.7%) compared to placebo (0.9%).
Maltese: Monilijasi vaġinali, vulvovaġinite, balanite u infezzjoni ġenitali oħraa Monolijasi vaġinali, vulvovaġinite, balanite u infezzjonijiet ġenitali oħra kienu rapportati bi frekwenza akbar f'pazjenti trattati b'empagliflozin (empagliflozin 10 mg: 4.1%, empagliflozin 25 mg 3.7%) meta mqabbel ma' plaċebo (0.9%).
English: Possible signs of losing too much fluid from your body are listed in section 4 ‘Possible side effects'.
Maltese: Sinjali possibbli li tkun qed titlef ħafna fluwidu mill-ġisem tiegħek huma elenkati f'sezzjoni 4, 'Effetti sekondarji possibbli'.
English: Peak plasma levels of empagliflozin were similar in subjects with moderate renal impairment and kidney failure/ESRD compared to patients with normal renal function.
Maltese: Livelli għolja ta' empagliflozin fil-plażma kienu simili f'individwi b'indeboliment tal-kliewi moderat u falliment tal-kliewi/ESRD meta mqabbla ma' pazjenti b'funzjoni tal-kliewi normali.
English: Empagliflozin does not inhibit human uptake transporters such as OAT3, OATP1B1, and OATP1B3 in vitro at clinically relevant plasma concentrations and, as such, drug-drug interactions with substrates of these uptake transporters are considered unlikely.
Maltese: Empagliflozin ma jimpedixxix it-trasportaturi tat-teħid uman bħal OAT3, OATP1B1, u OATP1B3 in vitro f'konċentrazzjonijiet tal-plażma klinikament rilevanti u, bħala tali, interazzjonijiet bejn mediċina u oħra b'sottostrati ta' dawn it-trasportaturi tat-teħid huma kkonsidrati improbabbli.
English: Urinary tract infection
Maltese: Infezzjonijiet tal-passaġġ urinarju
English: In 5 placebo-controlled trials of 18 to 24 weeks duration, 2,971 patients were included of which 995 were treated with placebo and 1,976 with empagliflozin.
Maltese: F'5 provi li damu sejrin għal bejn 18-il ġimgħa sa 24 ġimgħat bil-plaċebo bħala kontroll, 2,971 pazjent kienu inklużi li minnhom 995 kienu trattati bi plaċebo u 1,976 b'empagliflozin.
English: Empagliflozin is a substrate of the human uptake transporters OAT3, OATP1B1, and OATP1B3, but not OAT1 and OCT2.
Maltese: OAT3 u OATP1B1/1B3,
English: (≥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 mfissra 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), mhux magħrufa (ma tistax tittieħed stima mid data disponibbli).
English: Empagliflozin does not inhibit other glucose transporters important for glucose transport into peripheral tissues and is 5000 times more selective for SGLT2 versus SGLT1, the major transporter responsible for glucose absorption in the gut.
Maltese: Empagliflozin ma jimpedixxix trasportaturi oħra talglukosju importanti għat-trasport ta' glukosju għal ġot-tessuti periferali u huwa 5,000 darba aktar silettiv għal SGLT2 kontra SGLT1, it-trasportatur ewlieni responsabbli għall-assorbiment ta' glukosju fl-imsaren.
English: Difference from glimepiride1 (97.5% CI) a Full analysis set (FAS) using last observation carried forward (LOCF) prior to glycaemic rescue therapy b Up to 4 mg glimepiride
Maltese: Differenza mill plaċebo1 (95% CI) * Sett ta' analiżi sħiħa (FAS - Full analysis set) fejn intużat l-aħħar osservazzjoni li ġiet imexxija 'l quddiem (LOCF - Last observation carried forward) qabel l-għoti ta' terapija għal salvataġġ gliċemiku.
English: The overall frequency of urinary tract infection reported as adverse event was similar in patients treated with empagliflozin 25 mg and placebo and higher in patients treated with empagliflozin 10 mg (see section 4.8).
Maltese: Il-frekwenza globali ta' infezzjoni tal-passaġġ urinarju rapportata bħala każ avvers kienet simili f'pazjenti trattati b'empagliflozin 25 mg u plaċebo u ogħla f'pazjenti trattati b'empagliflozin 10 mg (ara sezzjoni 4.8).
English: Table 6 Efficacy results at 18 and 78 weeks in a placebo-controlled study of empagliflozin as add on to basal insulin with or without metformin or a sulphonylureaa
Maltese: Tabella 6: Riżultati ta' effikaċja fit-18 u 78 ġimgħa fi studju kkontrollat bi plaċebo ta' empagliflozin bħala terapija aġġuntiva għal insulina bażali bi jew mingħajr metformin jew sulphonylureaa.
English: It is responsible, as the predominant transporter, for the reabsorption of glucose from the glomerular filtrate back into the circulation.
Maltese: Huwa responsabbli, bħala t-trasportatur predominanti, għar-riassorbiment ta' glukosju millfiltrat glomerulari lura għal ġoċ-ċirkolazzjoni.
English: Tel: +34 91 663 50 00
Maltese: Lilly S.A. Tel: +34 91 663 50 00
English: They have “S25” on one side and the Boehringer Ingelheim logo on the other side.
Maltese: "S25" fuq naħa waħda u l-logo ta' Boehringer Ingelheim fuq in-naħa l-oħra.
English: The overall frequency of volume depletion (including the predefined terms blood pressure (ambulatory) decreased, blood pressure systolic decreased, dehydration, hypotension, hypovolaemia, orthostatic hypotension, and syncope) was similar in patients treated with empagliflozin (empagliflozin 10 mg: 0.5%, empagliflozin 25 mg: 0.3%) and placebo (0.3%).
Maltese: Il-frekwenza globali ta' żvojtjar tal-volum (li jinkludi termini mfissra minn qabel ta' pressjoni taddemm (ambulatorja) mnaqqsa, pressjoni tad-demm sistolika mnaqqsa, dieidratazzjoni, pressjoni baxxa, ipovolemja, pressjoni baxxa meta tqum minn pożizzjoni ta' serħan u sinkope) kienet simili f'pazjenti trattati b'empagliflozin (empagliflozin 10 mg: 0.5%, empagliflozin 25 mg: 0.3%) u plaċebo
English: Each tablet contains 10 mg empagliflozin.
Maltese: Kull pillola fiha 10 mg empagliflozin.
English: There were no clinically relevant differences in empagliflozin pharmacokinetics between healthy volunteers and patients with type 2 diabetes.
Maltese: Ma kienx hemm differenzi klinikamenti rilevanti fil-farmakokinetiċi ta' empagliflozin bejn voluntieri b'saħħithom u pazjenti b'dijabete ta' tip 2.
English: Empagliflozin as add on to basal insulin
Maltese: Empagliflozin bħala terapija addizzjonali għal insulina bażali
English: Increased urination
Maltese: urina
English: In combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations).
Maltese: Flimkien ma' prodotti mediċinali oħra li jnaqqsu l-glukosju li jinkludu l-insulina, meta dawn, flimkien mad-dieta u l-eżerċizzju, ma jipprovdux kontroll gliċemiku adegwat (ara sezzjoni 4.4, 4.5 u 5.1 għal data disponibbli fuq kombinazzjonijiet differenti).
English: Patients (%) achieving HbA1c <7% with baseline HbA1c ≥7%2
Maltese: Pazjenti (%) li jiksbu HbA1c <7% b'linja bażi ta' HbA1c ≥7% f'ġimgħa
English: Treatment with empagliflozin as monotherapy and in combination with metformin, pioglitazone, a sulphonylurea, DPP-4 inhibitors, and insulin lead to clinically relevant improvements in HbA1c, fasting plasma glucose (FPG), body weight, and systolic and diastolic blood pressure.
Maltese: It-trattament ta' empagliflozin bħala monoterapija u f'limkien ma' metformin. pioglitazone, sulphonylurea, impedituri DPP-4, u insulina wasslu għal titjib klinikament rilevanti fl-HbA1c, il glukosju fil-plażma waqt sawm (FPG -Fasting Plasma Glucose), il-piż tal-ġisem u l-pressjoni tad demm sistolika u dijastolika.