FrancophonIA/ELRC3.0 huggingface dataset:
English: Full analysis set (FAS) using last observation carried forward (LOCF) prior to glycaemic rescue therapy Up to 4 mg glimepiride Mean adjusted for baseline value Not evaluated for statistical significance as a part of the sequential confirmatory testing procedure LOCF, values after antihypertensive rescue censored * p-value <0.0001 for non-inferiority, and p-value = 0.0153 for superiority ** p-value <0.0001
Maltese: Mhux evalwat għal sinifikat ta' statistika bħala riżultat ta' proċedura ta' ttestjar konfermatorju sekwenzjali LOCF, valuri wara salvataġġ minn pressjoni għolja ċċensurati * valur p < 0.0001 għal nuqqas ta' inferjorità, u valur p = 0.0153 għal superjorità ** valur p < 0.0001
English: 1 (97.5% CI) Patients (%) achieving HbA1c <7% with baseline HbA1c ≥7% Body Weight (kg) Baseline (mean) Change from baseline Difference from glimepiride
Maltese: (97.5% CI) Pazjenti (%) li jiksbu HbA1c < 7% b'linja bażi
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: The double-blind, placebo-controlled EMPA-REG OUTCOME study compared pooled doses of empagliflozin 10 mg and 25 mg with placebo as adjunct to standard care therapy in patients with type 2 diabetes and established cardiovascular disease.
Maltese: L-istudju double-blind, ikkontrollat bi plaċebo EMPA-REG OUTCOME qabbel dożi miġburin ta' empagliflozin 10 mg u 25 mg ma' plaċebo bħala terapija addizzjonali għat-terapija ta' trattament standard f'pazjenti b'dijabete tip 2 u b'mard kardjovaskulari stabbilit.
English: HbA1c (%) at week 12 Baseline (mean) Change from baseline Difference from placebo (95% CI) 24 hour SBP at week 12 Baseline (mean) Change from baseline Difference from placebo (95% CI) 24 hour DBP at week 12 Baseline (mean) Change from baseline Difference from placebo (95% CI) Full analysis set (FAS) LOCF, values after taking antidiabetic rescue therapy censored Mean adjusted for baseline HbA1c, baseline eGFR, geographical region and number of antihypertensive medicinal products LOCF, values after taking antidiabetic rescue therapy or changing antihypertensive rescue therapy censored Mean adjusted for baseline SBP, baseline HbA1c, baseline eGFR, geographical region and number of antihypertensive medicinal products Mean adjusted for baseline DBP, baseline HbA1c, baseline eGFR, geographical region and number of antihypertensive medicinal products * p-value <0.0001 ** p-value <0.001
Maltese: Il-medja aġġustata għal SBP tal-linja bażi, HbA1c tal-linja bażi, eGFR tal-linja bażi, ir-reġjun ġeografiku u numru ta' prodotti mediċinali kontra l-pressjoni għolja 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 * valur p < 0.0001 ** valur p < 0.001
English: NAME OF THE MEDICINAL PRODUCT Synjardy 12.5 mg/1,000 mg tablets empagliflozin/metformin HCL
Maltese: Synjardy 12.5 mg/1,000 mg pilloli empagliflozin/metformin HCL
English: Synjardy 12.5 mg/850 mg film-coated tablets
Maltese: Synjardy 12.5 mg/850 mg pilloli miksijin b'rita
English: • medicines which increase urine production (diuretic), as Synjardy may increase the risk of losing too much fluid.
Maltese: • mediċini li jżidu l-produzzjoni tal-awrina (dijuretiċi), bħal Synjardy jistgħu jżidu r-riskju li titlef wisq fluwidu.
English: Metformin increases the transport capacity of all types of membrane glucose transporters (GLUTs) known to date.
Maltese: Metformin iżid il-kapaċità ta' trasport tat-tipi kollha ta' trasporaturi tal-glukosju fil-membrani (GLUTs) magħrufin sal-lum.
English: As expected from the mechanism of action, increased urination (as assessed by PT search including pollakiuria, polyuria, nocturia) was observed at higher frequencies in metformin-treated patients who received empagliflozin 10 mg (3.0%) and empagliflozin 25 mg (2.9%) compared to placebo (1.4%) as add-on to metformin therapy.
Maltese: Kif mistenni mill-mekkaniżmu ta' azzjoni, żieda fil-mogħdija tal-awrina (kif ivvalutata mit-tfittxija ta' PT inkluż pollakijurja, polijurja u nokturja) kienet osservata bi frekwenza ogħla f'pazjenti kkurati b'metformin li ngħataw empagliflozin 10 mg (3.0%) u empagliflozin 25 mg (2.9%) meta mqabbla ma' plaċebo (1.4%) bħala terapija aġġuntiva ma' metformin.
English: Therefore the effect was attenuated at week 94, with an adjusted mean (SE) improvement in HbA1c of 0.08% (0.02) in the placebo group, 0.50% (0.02) and 0.55% (0.02) in the empagliflozin 10 and 25 mg groups.
Maltese: Għalhekk, l-effett naqas f'Ġimgħa 94, b'titjib fil-medja aġġustata (SE) fl-HbA1c ta' 0.08% (0.02) fil-grupp tal-plaċebo, u 0.50% (0.02) u 0.55% (0.02) fil-gruppi ta' empagliflozin 10 u 25 mg.
English: Brownish yellow, oval, biconvex film coated tablets debossed with “S5” and the Boehringer Ingelheim logo on one side and “1000” on the other side (tablet length: 21.1 mm, tablet width: 9.7 mm).
Maltese: Pilloli ovali, ta' lewn isfar fil-kannella, mżaqqa fuq żewġ naħat, miksija b'rita, imnaqqxa b'“S5” u l-logo ta' Boehringer Ingelheim fuq naħa waħda u “1000” fuq in-naħa l-oħra (tul tal-pillola: 21.1 mm, wisa' tal-pillola: 9.7 mm).
English: NAME OF THE MEDICINAL PRODUCT Synjardy 5 mg/850 mg tablets empagliflozin/metformin HCL
Maltese: Synjardy 5 mg/850 mg pilloli empagliflozin/metformin HCL
English: The inter-subject and residual variabilities for empagliflozin oral clearance were 39.1% and 35.8%, respectively.
Maltese: Il-varjabilitajiet bejn individwu u ieħor u dawk residwali għat-tneħħija orali ta' empagliflozin kienu 39.1% u 35.8% rispettivament.
English: How to take Synjardy
Maltese: X'fih Synjardy
English: For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the population studied, see sections 4.4, 4.5 and 5.1.
Maltese: Għal riżultati ta' studju fir-rigward tal-kombinazzjonijiet, l-effetti fuq il-kontroll gliċemiku u lavvenimenti kardjovaskulari u l-popolazzjonijiet studjati, ara s-sezzjonijiet 4.4, 4.5 u 5
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) in metformin-treated patients who received empagliflozin was low: 0.6% for empagliflozin 10 mg, 0.3% for empagliflozin 25 mg and 0.1% for placebo.
Maltese: Il-frekwenza globali ta' żvojtjar ta' volum (li jinkludi t-termini determinati minn qabel ta' pressjoni tad-demm (ambulatorja) mnaqqsa, pressjoni tad-demm sistolika mnaqqsa, deidratazzjoni, pressjoni baxxa, ipovolemja, pressjoni baxxa meta tqum minn pożizzjoni ta' serħan u sinkope) f'pazjenti kkurati b'metformin li ngħataw empagliflozin kienet baxxa: 0.6% għal empagliflozin 10 mg, 0.3% għal empagliflozin 25 mg u 0.1% għal plaċebo.
English: Diabetic ketoacidosis
Maltese: Ketoaċidosi dijabetika
English: • Disease which may cause tissue hypoxia (especially acute disease, or worsening of chronic disease) such as: decompensated heart failure, respiratory failure, recent myocardial infarction,
Maltese: • Marda li tista' tikkawża nuqqas ta' ossiġnu fit-tessuti (b'mod speċjali marda akuta, jew aggravament ta' marda kronika) bħal: insuffiċjenza kardijaka mhux kumpensata, insuffiċjenza respiratorja, infart mijokardijaku reċenti, u xokk.
English: After an oral dose of metformin, tmax is reached in 2.5 hours.
Maltese: Wara doża orali ta' metformin, tmax jintlaħaq f'2.5 siegħat.
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-metodu ta' azzjoni ta' dawn it-tumuri jiddependi fuq il-predisposizzjoni naturali tal-ġurdien raġel għal patoloġija tal-kliewi u rotta tal-kliewi li ma tirriflettix il-bniedem.
English: • muscle cramps
Maltese: • għatx
English: The frequency of hypoglycaemia depended on the background therapy in the respective studies and was similar for empagliflozin and placebo as add-on to metformin, as add-on to linagliptin and metformin, for the combination of empagliflozin with metformin in drug-naïve patients compared to those treated with empagliflozin and metformin as individual components, and as adjunct to standard care therapy.
Maltese: Il-frekwenza ta' ipogliċemija kienet tiddependi fuq it-terapija fl-isfond fl-istudji rispettivi u kienet simili għal empagliflozin u plaċebo bħala terapija aġġuntiva ma' metformin, bħala terapija aġġuntiva għal linagliptin u metformin, għall-kombinazzjoni ta' empagliflozin ma' metformin f'pazjenti li qatt ma ngħataw kura qabel mqabbla ma' dawk ikkurati b'empagliflozin u metformin bħala komponenti individwali, u bħala żieda ma' terapija ta' kura standard.
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 fil-firien 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-espożizzjoni klinika massima ta' empagliflozin.
English: Comparison vs. met (95% CI)
Maltese: HR 0.65, CI ta' 95%
English: A total of 12245 patients with type 2 diabetes were treated in clinical studies to evaluate the safety of empagliflozin as add-on to metformin, of which 8199 patients were treated with empagliflozin as add-on to metformin either alone or in addition to a sulfonylurea, pioglitazone, or insulin.
Maltese: Total ta' 12,245 pazjent b'dijabete ta' tip 2 kienu kkurati fl-istudji kliniċi sabiex tiġi evalwata s-sigurtà ta' empagliflozin bħala terapija aġġuntiva ma' metformin, li minnhom 8,199 pazjent kienu kkurati b'empagliflozin bħala terapija aġġuntiva ma' metformin jew waħdu jew flimkien ma' sulfonylurea, pioglitazone, jew insulina.
English: The results of bioequivalence studies in healthy subjects demonstrated that Synjardy (empagliflozin/metformin hydrochloride) 5 mg/850 mg, 5 mg/1,000 mg, 12.5 mg/850 mg, and 12.5 mg/1,000 mg combination tablets are bioequivalent to co-administration of corresponding doses of empagliflozin and metformin as individual tablets.
Maltese: Ir-riżultati tal-istudji tal-bijoekwivalenza f'individwi b'saħħthom urew li Synjardy (empagliflozin/metformin hydrochloride) 5 mg/850 mg, 5 mg/1,000 mg, 12.5 mg/850 mg, u 12.5 mg/1,000 mg pilloli kombinati huma bijoekwivalenti għall-għoti flimkien ta' dożi korrispondenti ta' empagliflozin u metformin bħala pilloli individwali.
English: Synjardy 5 mg/1,000 mg film-coated tablets EU/1/15/1003/010
Maltese: Synjardy 5 mg/1,000 mg pilloli miksijin b'rita EU/1/15/1003/010
English: NAME OF THE MEDICINAL PRODUCT Synjardy 5 mg/1,000 mg tablets empagliflozin/metformin HCL
Maltese: Synjardy 5 mg/1,000 mg pilloli empagliflozin/metformin HCL
English: Glycaemic efficacy and cardiovascular outcomes have been assessed in a total of 10,366 patients with type 2 diabetes who were treated in 9 double-blind, placebo or active-controlled clinical studies of at least 24 weeks duration, of which 2950 patients received empagliflozin 10 mg and 3701 received empagliflozin 25 mg as add-on to metformin therapy.
Maltese: L-effikaċja gliċemika u r-riżultati kardjovaskulari ġew ivvalutati b'kollox f'10,366 pazjent b'dijabete ta' tip 2 li kienu kkurati f' 9 studji kliniċi double blind, ikkontrollati bi plaċebo jew b'mod attiv li damu tal-anqas 24 ġimgħa, li minnhom 2,950 pazjent ingħataw empagliflozin 10 mg u 3,701 pazjent ngħataw empagliflozin 25 mg bħala terapija aġġuntiva ma' metformin.
English: Glucocorticoids (given by systemic and local routes), beta 2 agonists, and diuretics have intrinsic hyperglycaemic activity.
Maltese: Glukokortikojdi (li jingħataw permezz ta' rotot sistemiċi u lokali) agonisti beta-2, u dijuretiċi, għandhom attività iperglikemika intrinsika.
English: Mean percent increases from baseline for empagliflozin 10 mg and 25 mg versus placebo, respectively, were total cholesterol 5.0% and 5.2% versus 3.7%; HDL-cholesterol 4.6% and 2.7% versus -0.5%; LDL-cholesterol 9.1% and 8.7% versus 7.8%; triglycerides 5.4% and 10.8% versus 12.1%.
Maltese: LDL-kolesterol 9.1% u 8.7% meta mqabbla ma' 7.8%; trigliċeridi 5.4% u 10.
English: • if you have had a diabetic pre-coma;
Maltese: • jekk kellek prekoma dijabetika;
English: Empagliflozin twice daily versus once daily as add on to metformin therapy The efficacy and safety of empagliflozin twice daily versus once daily (daily dose of 10 mg and 25 mg) as add-on therapy in patients with in sufficient glycemic control on metformin monotherapy was evaluated in a double blind placebo-controlled study of 16 weeks duration.
Maltese: Empagliflozin darbtejn kuljum kontra darba kuljum bħala terapija addizzjonali ma' metformin L-effikaċja u s-sigurtà ta' empagliflozin darbtejn kuljum kontra darba kuljum (doża ta' kuljum ta' 10 mg u 25 mg) bħala terapija addizzjonali f'pazjenti b'kontroll gliċemiku suffiċjenti fuq monoterapija b'metformin ġew evalwati fi studju double blind ikkontrollat bi plaċebo li dam 16-il ġimgħa.
English: • a significant reduction of the absolute risk of overall mortality: metformin 13.5 events/1,000 patient-years versus diet alone 20.6 events/1,000 patient-years, (p=0.011), and versus the combined sulphonylurea and insulin monotherapy groups 18.9 events/1,000 patient-years (p=0.021),
Maltese: • tnaqqis sinifikanti tar-riskju assolut ta' kwalunkwe kumplikazzjoni relatata mad-dijabete fil-grupp ikkurat b'metformin (29.8 avveniment/1,000 sena ta' pazjenti) versus kura b'dieta biss (43.3 avveniment/1,000 sena ta' pazjenti), p = 0.0023, u kontra l-gruppi kkurati b'monoterapija kombinata ta' sulphonylurea u insulina (40.1 avveniment/1,000 sena ta' pazjenti), p = 0.0034,
English: Age did not have a clinically meaningful impact 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: Overall exposure (AUCss) of empagliflozin over a 24-hour period with empagliflozin 5 mg administered twice daily was similar to empagliflozin 10 mg administered once daily.
Maltese: L-espożizzjoni globali (AUCss) ta' empagliflozin fuq perjodu ta' 24 siegħa b' empagliflozin 5 mg mogħti darbtejn kuljum kienet simili għal empagliflozin 10 mg mogħti darba kuljum.
English: Synjardy 5 mg/850 mg film-coated tablets
Maltese: Synjardy 5 mg/850 mg pilloli miksijin b'rita
English: • feeling sick (nausea), vomiting
Maltese: • tħossok ma tiflaħx (nawseja), rimettar
English: Multipack comprising 2 packs, each containing 100 x 1 film-coated tablets.
Maltese: Pakkett multiplu li fih 2 pakketti, kull wieħed fih 100 x 1 pillola miksija b'rita.
English: • in muscle, by increasing insulin sensitivity, improving peripheral glucose uptake and utilization,
Maltese: • fil-muskoli, billi jżid is-sensittività għall-insulina, itejjeb it-teħid u l-użu tal-glukosju periferali,
English: This is a rare but serious and potentially life-threatening event that requires urgent surgical intervention and antibiotic treatment.
Maltese: Dan huwa avveniment rari iżda serju u potenzjalment ta' periklu għall-ħajja li jeħtieġ intervent kirurġiku urġenti u trattament antibijotiku.
English: PHARMACEUTICAL FORM AND CONTENTS Multipack comprising 2 packs, each containing 60 x 1 film-coated tablets.
Maltese: U KONTENUT Pakkett multiplu li fih 2 pakketti, kull wieħed fih 60 x 1 pillola miksija b'rita.
English: • other medicines that lower the amount of sugar in your blood such as insulin or a “sulphonylurea” medicine.
Maltese: • mediċini oħra li jnaqqsu l-ammont ta' zokkor fid-demm tiegħek bħall-insulina jew mediċina ta' tip “sulphonylurea”.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS - INCLUDING THE BLUE BOX12.5 mg/1,000 mg
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA TIKKETTA TA' BARRA FUQ IL-PAKKETTI MULTIPLI - INKLUŻA L-KAXXA BLU12.5 mg/1,000 mg
English: Avoid excessive alcohol intake while taking Synjardy since this may increase the risk of lactic acidosis (see section ‘Warnings and precautions').
Maltese: Evita konsum eċċessiv ta' alkoħol waqt li tkun qed tieħu Synjardy peress li dan jista' jżid ir-riskju ta' aċidożi lattika (ara s-sezzjoni “Twissijiet u prekawzjonijiet”).
English: • Swallow the tablet whole with water.
Maltese: • Ibla' l-pillola sħiħa mal-ilma.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS - INCLUDING THE BLUE BOX12.5 mg/850 mg
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA TIKKETTA TA' BARRA FUQ IL-PAKKETTI MULTIPLI - INKLUŻA L-KAXXA BLU12.5 mg/850 mg
English: Synjardy 5 mg/850 mg film-coated tablets and Synjardy 5 mg/1,000 mg film-coated tablets Tablet core
Maltese: Synjardy 5 mg/850 mg pilloli miksijin b'rita u Synjardy 5 mg/1,000 mg pilloli miksijin b'rita Qalba tal-pillola
English: Treatment with empagliflozin once daily resulted in statistically significant improvement in HbA1c, and 24 hour mean systolic and diastolic blood pressure as determined by ambulatory blood pressure monitoring (Table 10).
Maltese: Trattament b'empagliflozin darba kuljum irriżulta f'titjib statistikament sinifikanti f'HbA1c, u l-pressjoni tad-demm sistolika u dijastolika medja fuq 24 siegħa kif stabbilit b'monitoraġġ ambulatorju tal-pressjoni tad-demm (Tabella 10).
English: Synjardy 5 mg/1,000 mg film-coated tablets are brownish yellow, oval, biconvex.
Maltese: Synjardy 5 mg/1,000 mg pilloli miksijin b'rita huma ovali, ta' lewn isfar fil-kannella, mżaqqa fuq żewġ naħat.
English: The difference in frequency was less pronounced in male patients.
Maltese: Id-differenza fil-frekwenza kienet inqas evidenti fl-irġiel.
English: Body mass index had no clinically relevant effect on the pharmacokinetics of empagliflozin based on the population pharmacokinetic analysis.
Maltese: L-indiċi tal-piż tal-ġisem ma kellu l-ebda effett klinikament rilevanti fuq il-farmakokinetiċi ta' empagliflozin abbażi ta' analiżi farmakokinetika tal-popolazzjoni.
English: Co-medication with known inducers of UGT enzymes should be avoided due to a potential risk of decreased efficacy.
Maltese: L-għoti flimkien ma' indutturi tal-enzimi UGT għandu jiġi evitat minħabba r-riskju potenzjali ta' tnaqqis fl-effikaċja.
English: Pharmacotherapeutic group: Drugs used in diabetes, combinations of oral blood glucose lowering drugs, ATC code: A10BD20
Maltese: Mediċini li jintużaw kontra d-dijabete, kombinazzjonijiet ta' mediċini orali li jbaxxu l-livelli tal-glucose fid-demm, Kodiċi ATC:
English: Severe infections may lead to kidney problems, which can put you at risk for lactic acidosis (see 'Warnings and precautions');
Maltese: Infezzjonijiet severi jistgħu jwasslu għal problemi tal-kliewi, li jistgħu jpoġġuk f'riskju ta' aċidożi lattika (ara “Twissijiet u prekawzjonijiet”);
English: As expected, empagliflozin 5 mg administered twice daily compared with 10 mg empagliflozin once daily resulted in lower Cmax and higher trough plasma empagliflozin concentrations (Cmin).
Maltese: Kif mistenni, empagliflozin 5 mg mogħti darbtejn kuljum imqabbel ma' empagliflozin 10 mg darba kuljum irriżulta fi tnaqqis fl-Cmax u konċentrazzjonijiet iktar baxxi ta' empagliflozin fil-plażma (Cmin).
English: Synjardy 12.5 mg/850 mg film-coated tablets Each tablet contains 12.5 mg empagliflozin and 850 mg metformin hydrochloride.
Maltese: Kull Synjardy 12.5 mg/850 mg pillola miksija b'rita fiha 12.5 mg empagliflozin u 850 mg metformin hydrochloride.
English: Synjardy 12.5 mg/1,000 mg film-coated tablets Each tablet contains 12.5 mg empagliflozin and 1,000 mg metformin hydrochloride.
Maltese: Kull Synjardy 12.5 mg/1,000 mg pillola miksija b'rita fiha 12.5 mg empagliflozin u 1,000 mg metformin hydrochloride.
English: Synjardy 5 mg/1,000 mg film-coated tablets Each tablet contains 5 mg empagliflozin and 1,000 mg metformin hydrochloride.
Maltese: Synjardy 5 mg/1,000 mg pilloli miksijin b'rita Kull pillola fiha 5 mg empagliflozin u 1,000 mg metformin hydrochloride.
English: Animal studies with empagliflozin and metformin do not indicate direct or indirect harmful effects with respect to fertility (see section 5.3).
Maltese: Studji f'annimali b'empagliflozin u metformin ma urewx effetti diretti jew indiretti tossiċi fuq is-sistema riproduttiva (ara sezzjoni 5.3).
English: Multipack comprising 2 packs, each containing 90 x 1 film-coated tablets.
Maltese: Komponent ta' pakkett multiplu, ma jistax jinbiegħ separatament. 90 x 1 pillola miksija b'rita.
English: • genital yeast infection (thrush)
Maltese: • infezzjoni ġenitali kkawżata minn fungi (traxx)
English: In patients age 75 years and older, numerically lower reductions in HbA1c were observed with empagliflozin treatment.
Maltese: F'pazjenti li għandhom 75 sena u ikbar, kien osservat tnaqqis numerikament aktar baxx fl-HbA1c bil-kura b'empagliflozin.
English: HbA1c (%) Baseline (mean) Change from baseline Difference from placebo (97.5% CI)
Maltese: HbA1c (%) Linja bażi (medja) Bidla mil-linja bażi Differenza mill-plaċebo (97.5% CI)
English: C]-empagliflozin solution to healthy volunteers, the red blood cell partitioning was approximately 37% and plasma protein binding was
Maltese: C]-empagliflozin lil voluntiera b'saħħithom, it-tqassim ta' ċelluli ħomor tad-demm kien madwar 37% u t-twaħħil mal-proteini fil-plażma kien ta'
English: • necrotising fasciitis of the perineum or Fournier´s gangrene, a serious soft tissue infection of the genitals or the area between the genitals and the anus
Maltese: • fasciitis nekrotika tal-perineum jew kankrena ta' Fournier, infezzjoni serja tat-tessut artab tal ġenitali jew taż-żona bejn il-ġenitali u l-anus
English: For patients with acute and unstable heart failure, Synjardy is contraindicated due to the metformin component (see section 4.3).
Maltese: Għal pazjenti b'insuffiċjenza tal-qalb akuta u mhux stabbli, Synjardy mhuwiex rakkomandat minħabba l-komponent ta' metformin (ara sezzjoni 4.3).
English: Synjardy 12.5 mg/850 mg film-coated tablets and Synjardy 12.5 mg/1,000 mg film-coated tablets Tablet core
Maltese: Synjardy 12.5 mg/850 mg pilloli miksijin b'rita u Synjardy 12.5 mg/1,000 mg pilloli miksijin b'rita Qalba tal-pillola
English: The efficacy and safety of empagliflozin as add on to basal insulin with concomitant metformin therapy was evaluated in a double-blind, placebo-controlled trial of 78 weeks duration.
Maltese: L-effikaċja u s-sigurtà ta' empagliflozin bħala terapija addizzjonali ma' insulina bażali bi jew mingħajr terapija konkomitanti b'metformin ġew evalwati fi studju double blind ikkontrollat bi plaċebo li dam 78 ġimgħa.
English: EU/1/15/1003/001 10 film-coated tablets EU/1/15/1003/002 14 film-coated tablets EU/1/15/1003/003 30 film-coated tablets EU/1/15/1003/004 56 film-coated tablets EU/1/15/1003/005 60 film-coated tablets EU/1/15/1003/037 90 film-coated tablets EU/1/15/1003/006 100 film-coated tablets
Maltese: EU/1/15/1003/001 10 pilloli miksija b'rita EU/1/15/1003/002 14 pilloli miksija b'rita EU/1/15/1003/003 30 pilloli miksija b'rita EU/1/15/1003/004 56 pilloli miksija b'rita EU/1/15/1003/005 60 pilloli miksija b'rita EU/1/15/1003/037 90 pilloli miksija b'rita EU/1/15/1003/006 100 pilloli miksija b'rita
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS - INCLUDING THE BLUE BOX5 mg/850 mg
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA TIKKETTA TA' BARRA FUQ IL-PAKKETTI MULTIPLI - INKLUŻA L-KAXXA BLU5 mg/850 mg
English: Synjardy 12.5 mg/850 mg film-coated tablets are pinkish white, oval, biconvex.
Maltese: Synjardy 12.5 mg/850 mg pilloli miksijin b'rita huma ovali, ta' lewn abjad fir-roża, mżaqqa' fuq żewġ naħat.