FrancophonIA/ELRC3.0 huggingface dataset:
English: Surgery and operations
Maltese: Kirurġija u operazzjonijiet
English: st study, 4.2% for the combination therapy versus 27.9% for glimepiride plus metformin versus 2.9% for dapagliflozin plus metformin; for the 2
Maltese: el studju, 4.2 % għatterapija kombinata kontra 27.9 % għal glimepiride u metformin kontra 2.9 % għal dapagliflozin u metformin; għat-2
English: Metformin increases the transport capacity of specific types of membrane glucose transporters (GLUT-1 and GLUT-4).
Maltese: Metformin iżid il-kapaċità tat-trasport ta' tipi speċifiċi ta' trasportaturi tal-glucose talmembrana (GLUT-1 u GLUT-4).
English: (when used with SU)
Maltese: (meta jintuża ma' SU)
English: Following an oral dose, the apparent terminal elimination half-life is approximately 6.5 hours.
Maltese: Wara doża orali, il-half-life ta' eliminazzjoni terminali apparenti hija madwar 6.5 sigħat.
English: Difference from dapagliflozin + metformin (adjusted mean (95% CI)
Maltese: Differenza minn dapagliflozin + metformin (medja aġġustata (95% CI)
English: The metabolism of dapagliflozin is primarily via glucuronide conjugation mediated by uridine diphosphate (UDP) glucuronosyltransferase 1A9 (UGT1A9).
Maltese: Il-metaboliżmu ta' dapagliflozin jiġi medjat primarjament permezz ta' konjugazzjoni tal-glucuronide medjata minn uridine diphosphate (UDP) glucuronosyltransferase 1A9 (UGT1A9).
English: Placebo + saxagliptin 5 mg + metformin (N=160)
Maltese: Plaċebo + saxagliptin 5 mg + metformin (N=160)
English: Saxagliptin: Elderly patients (65-80 years) had about 60% higher saxagliptin AUC than young patients (18-40 years).
Maltese: Pazjenti anzjani (65-80 sena) kellhom madwar 60 % AUC ogħla ta' saxagliptin minn pazjenti iżgħar fl-età (18-40 sena).
English: The other ingredients are: o tablet core: carmellose sodium (E466) (see section 2 ‘Sodium content'); cellulose, microcrystalline (E460i); crospovidone (E1202); hypromellose (E464); lactose (see section 2 ‘Qtrilmet contains lactose'); magnesium stearate (E470b); silica, dental type (E551).
Maltese: - Is-sustanzi mhux attivi l-oħra huma: o qalba tal-pillola: carmellose sodium (E466) (ara sezzjoni 2 “Kontenut ta' sodium”); cellulose microcrystalline (E460i); crospovidone (E1202); hypromellose (E464), lactose (ara sezzjoni 2 “Qtrilmet fih lactose”); magnesium stearate (E470b); silica, tip dentali (E551).
English: Metformin stimulates intracellular glycogen synthesis by acting on glycogen synthase.
Maltese: Metformin jistimula sinteżi tal-glycogen intraċellulari billi jaġixxi fuq synthase ta' glycogen.
English: A clinically relevant effect with other inducers (e.g. carbamazepine, phenytoin and phenobarbital) is not expected.
Maltese: Mhux mistenni effett klinikament rilevanti ma' indutturi oħra (eż. carbamazepine, phenytoin u phenobarbital).
English: Necrotising fasciitis of the perineum (Fournier's gangrene)
Maltese: Faxxite nekrotizzanti tal-perinew (gangrene ta' Fournier)
English: Adverse reaction reported for saxagliptin.
Maltese: Reazzjoni avversa rrappurtata għal saxagliptin.
English: C-saxagliptin, 24%, 36% and 75% of the dose was excreted in the urine as saxagliptin, its active metabolite, and total radioactivity, respectively.
Maltese: C-saxagliptin, 24 %, 36 % u 75 % tad-doża ġew eliminati fl-awrina bħala saxagliptin, il-metabolit attiv tiegħu, u r-radjuattività totali, rispettivament.
English: Qtrilmet contains lactose
Maltese: Qtrilmet fih lactose
English: This medicinal product is contraindicated in patients with GFR < 30 mL/min (see sections 4.3, 4.4, 4.8 and 5.2).
Maltese: Dan il-prodott mediċinali huwa kontraindikat f'pazjenti b'GFR < 30 mL/min (ara sezzjonijiet 4.3, 4.4, 4.8 u 5.2).
English: Difference from saxagliptin + metformin (adjusted mean (95% CI)
Maltese: Differenza minn saxagliptin + metformin (medja aġġustata (95% CI)
English: Frequency categories were defined according to very common (≥ 1/10), common (≥ 1/100 to ˂ 1/10), uncommon (≥ 1/1,000 to ˂ 1/100), rare ( 1/10,000 to < 1/1,000), very rare ( 1/100,000 to < 1/10,000) and not known (cannot be estimated from the available data).
Maltese: Ilkategoriji tal-frekwenza huma definiti skont komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa ˂ 1/10), mhux komuni (≥ 1/1,000 sa ˂ 1/100), rari ( 1/10,000 sa < 1/1,000), rari ħafna ( 1/100,000 sa < 1/10,000) u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Poly(vinyl alcohol) (E1203) Titanium dioxide (E171)
Maltese: Poly(vinyl alcohol) (E1203)
English: Glucocorticoids (given by systemic and local routes), beta-2 agonists, and diuretics have intrinsic hyperglycaemic activity.
Maltese: Glukokortikojdi (mogħtija minn rotot sistemiċi u lokali), agonisti tal-beta-2, u dijuretiċi għandhom attività ipergliċemika intrinsika.
English: See package leaflet for further information.
Maltese: Sorsi oħra ta᾽ informazzjoni
English: Gastrointestinal symptoms
Maltese: Sintomi gastrointestin ali
English: Dapagliflozin: Dapagliflozin is approximately 91% protein bound.
Maltese: Dapagliflozin huwa madwar 91% imwaħħal mal-proteina.
English: There was a numerical imbalance in non-CV death, with more events on saxagliptin (1.8%) than placebo (1.4%) [HR = 1.27; (95% CI 1.00, 1.62); P = 0.051].
Maltese: Kien hemm żbilanċ numeriku fil-mewt mhux CV, b'aktar avvenimenti fuq saxagliptin (1.8%) milli plaċebo (1.4%) [HR = 1.27; (95% CI 1.00, 1.62); P = 0.051].
English: The adverse reactions associated with Qtrilmet are presented in Table 1.
Maltese: Ir-reazzjonijiet avversi assoċjati ma' Qtrilmet huma ppreżentati f'Tabella 1.
English: Modified-release tablet (tablet).
Maltese: Pillola b'rilaxx modifikat (pillola).
English: Additional analysis did not indicate a differential effect among NYHA classes.
Maltese: Analiżi addizzjonali ma indikatx effett differenzjali fost il-klassifiki ta' NYHA.
English: Each tablet contains 48 mg of lactose (as anhydrous).
Maltese: Kull pillola fiha 48 mg ta' lactose (bħala anidruż).
English: Proportion of patients achieving HbA1c < 7%
Maltese: Proporzjon ta' pazjenti li kisbu HbA1c < 7%
English: Experience in NYHA class I-II is limited in dapagliflozin.
Maltese: L-esperjenza fil-klassi I-II ta' NYHA hija limitata f'dapagliflozin.
English: Polyuria includes the following preferred terms: polyuria, and pollakiuria.
Maltese: Polijurja tinkludi t-termini ppreferuti li ġejjin: polijurja, u pollakjurja.
English: 14 modified-release tablets 28 modified-release tablets 56 modified-release tablets 60 modified-release tablets 196 modified-release tablets
Maltese: 14-il pillola b'rilaxx modifikat 28 pillola b'rilaxx modifikat 56 pillola b'rilaxx modifikat 60 pillola b'rilaxx modifikat 196 pillola b'rilaxx modifikat
English: Saxagliptin The metabolism of saxagliptin is primarily mediated by cytochrome P450 3A4/5 (CYP3A4/5).
Maltese: Il-bijotrasformazzjoni ta' saxagliptin tiġi medjata primarjament miċ-ċitokromu P450 3A4/5 (CYP3A4/5).
English: Saxagliptin did not meaningfully alter the pharmacokinetics of dapagliflozin, metformin, glibenclamide (a CYP2C9 substrate), pioglitazone (a CYP2C8 [major] and CYP3A4 [minor] substrate), digoxin (a P-gp substrate), simvastatin (a CYP3A4 substrate), the active components of a combined oral contraceptive (ethinylestradiol and norgestimate), diltiazem or ketoconazole.
Maltese: Saxagliptin ma biddilx sinifikament il-farmakokinetika ta' dapagliflozin, metformin, glibenclamide (substrat ta' CYP2C9), pioglitazone (substrat ta' CYP2C8 [maġġuri] u CYP3A4 [minuri]), digoxin (substrat ta' P-gp), simvastatin (substrat ta' CYP3A4), il-komponenti attivi ta' kontraċettiv orali kkombinat (ethinylestradiol u norgestimate), diltiazem jew ketoconazole.
English: The mean steady-state volume of distribution of dapagliflozin was 118 L.
Maltese: Il-volum fi stat fiss ta' distribuzzjoni ta' dapagliflozin kien ta' 118 L.
English: Adverse reaction reported for metformin.
Maltese: Reazzjoni avversa rrappurtata għal metformin.
English: The absolute oral bioavailability of dapagliflozin following the administration of a 10 mg dose is 78%.
Maltese: Il-bijodisponibbiltà orali assoluta ta' dapagliflozin wara l-għoti ta' doża ta' 10 mg hija 78 %.
English: In in vitro studies, dapagliflozin neither inhibited cytochrome P450 (CYP) 1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP3A4, nor induced CYP1A2, CYP2B6 or CYP3A4.
Maltese: Fi studji in vitro, dapagliflozin la inibixxa ċ-ċitokromu P450 (CYP) 1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP3A4, u lanqas indotta CYP1A2, CYP2B6 jew CYP3A4.
English: In in vitro studies, saxagliptin and its major metabolite neither inhibited CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, or 3A4, nor induced CYP1A2, 2B6, 2C9 or 3A4.
Maltese: Fi studji in vitro, saxagliptin u l-metabolit maġġuri tiegħu la inibixxa CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, jew 3A4, u lanqas indotta CYP1A2, 2B6, 2C9 jew 3A4.
English: A meta-analysis of cardiovascular events in the clinical program was performed.
Maltese: Saret metaanaliżi ta' avveniment kardjovaskulari fil-programm kliniku.
English: PVC/PCTFE/alu blister Do not store above 30°C.
Maltese: Folja PVC/PCTFE/alu Taħżinx f'temperatura 'l fuq minn 30°C.
English: PVC/PCTFE/alu blister:
Maltese: Folja PVC/PCTFE/alu:
English: Geometric mean steady-state dapagliflozin Cmax and AUCτ values following once daily 10 mg doses of dapagliflozin were 158 ng/mL and 628 ng h/mL, respectively.
Maltese: Ilvaluri ta' Cmax u AUCτ ta' dapagliflozin fi stat fiss medju ġeometriċi wara dożi ta' darba kuljum ta' 10 mg ta' dapagliflozin kienu 158 ng/mL u 628 ng h/mL, rispettivament.
English: The mean age was 55.1 years and 54.4% of patients were female.
Maltese: L-età medja kienet 55.1 snin u 54.4% tal-pazjenti kienu nisa.
English: In the clinical program, 34.4% of subjects had a history of cardiovascular disease (excluding hypertension) at baseline and 67.9% had hypertension.
Maltese: Fil-programm kliniku, 34.4 % tal-individwi kellhom storja ta' marda kardjovaskulari (minbarra ipertensjoni) fil-linja bażi u 67.9 % kellhom ipertensjoni.
English: Analysis of the results for overweight patients treated with metformin after failure of diet alone showed: a significant reduction of the absolute risk of any diabetes-related complication in the metformin group (29.8 events/1,000 patient-years) versus diet alone (43.3 events/1,000 patient-years), p = 0.0023, and versus the combined sulphonylurea and insulin monotherapy groups (40.1 events/1,000 patient-years), p = 0.0034; a significant reduction of the absolute risk of any diabetes-related mortality: metformin 7.5 events/1,000 patient-years, diet alone 12.7 events/1,000 patient-years, p = 0.017; 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); a significant reduction in the absolute risk of myocardial infarction: metformin 11 events/1,000 patient-years, diet alone 18 events/1,000 patient-years, (p = 0.01).
Maltese: Analiżi tar-riżultati għal pazjenti b'piż żejjed ittrattati b'metformin wara li ma rnexxietx id-dieta biss uriet: - tnaqqis sinifikanti tar-riskju assolut ta' kwalunkwe kumplikazzjoni relatata mad-dijabete fil-grupp ta' metformin (29.8 avvenimenti/1,000 sena ta' pazjent) kontra d-dieta biss (43.3 avvenimenti/1,000 sena ta' pazjent), p = 0.0023, u kontra l-gruppi kkombinati ta' sulphonylurea u monoterapija bl-insulina (40.1 avvenimenti/1,000 sena ta' pazjent), p = 0.0034; - tnaqqis sinifikanti tar-riskju assolut ta' kwalunkwe mortalità relatata mad-dijabete: metformin 7.5 avvenimenti/1,000 sena ta' pazjent, id-dieta biss 12.7 avvenimenti/1,000 sena ta' pazjent, p = 0.017; - tnaqqis sinifikanti tar-riskju assolut ta' mortalità globali: metformin 13.5 avvenimenti/1,000 sena ta' pazjent kontra d-dieta biss 20.
English: The study population included those ≥ 65 years (n = 8,561) and ≥ 75 years (n = 2,330), with normal or mild renal impairment (n = 13,916) as well as moderate (n = 2,240) or severe (n = 336) renal impairment.
Maltese: Ilpopolazzjoni tal-istudju kienet tinkludi dawk li kellhom ≥ 65 sena (n = 8,561) u ≥ 75 sena (n = 2,330), b'indeboliment tal-kliewi normali jew ħafif (n = 13,916) kif ukoll indeboliment tal-kliewi moderat (n = 2,240) jew sever (n = 336).
English: p-value < 0.0001. p-value = 0.0166.
Maltese: Medja tal-inqas kwadrata aġġustata għall-valur tal-linja bażi. valur p < 0.0001. valur p = 0.0166.
English: Possible signs of dehydration are listed in section 4.
Maltese: Is-sinjali possibbli ta' deidratazzjoni huma elenkati fis-sezzjoni 4.
English: Haematocrit values > 55% were reported in 1.3% of the subjects treated with dapagliflozin 10 mg versus 0.4% of placebo subjects.
Maltese: Valuri tal-ematokrit ta' > 55% ġew irrappurtati f'1.3 % tal-individwi ttrattati b'dapagliflozin 10 mg kontra 0.4 % tal-individwi bi plaċebo.
English: Saxagliptin is a highly potent (Ki: 1.3 nM), selective, reversible and competitive inhibitor of DPP-4, an enzyme responsible for the breakdown of incretin hormones.
Maltese: Saxagliptin huwa inibitur ta' DPP-4 qawwi ħafna (Ki: 1.3 nM), selettiv, riversibbli u kompetittiv, enzima responsabbli għat-tkissir ta' ormoni ta' incretin.
English: The mean age was 53.8 years and 49.8% of patients were female.
Maltese: L-età medja kienet 53.8 snin u 49.8 % tal-pazjenti kienu nisa.
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union references dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: PSURs għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: Pharmacotherapeutic group: Drugs used in diabetes, combinations of oral blood glucose lowering drugs, ATC code: A10BD25.
Maltese: Mediċini użati fid-dijabete, kombinazzjonijiet ta' mediċini li jbaxxu lglucose fid-demm orali, Kodiċi ATC : A10BD25.
English: PA/alu/PVC/alu blister Pack size of 14, 28, 56, 60 and 196 modified-release tablets in blisters.
Maltese: Folja PA/alu/PVC/alu Daqs tal-pakkett ta' 14, 28, 56, 60 u 196 pillola b'rilaxx modifikat f'folji.
English: Qtrilmet is contraindicated in patients with: hypersensitivity to the active substances or to any of the excipients listed in section 6.1, history of a serious hypersensitivity reaction, including anaphylactic reaction, anaphylactic shock, and angioedema, to any dipeptidyl peptidase-4 (DPP-4) inhibitor or to any sodium-glucose co-transporter 2 (SGLT2) inhibitor (see sections 4.4, 4.8 and 6.1); any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis) (see sections 4.4 and 4.8); diabetic pre-coma (see section 4.4); severe renal failure (GFR < 30 mL/min) (see sections 4.2, 4.4 and 5.2); acute conditions with the potential to alter renal function such as: o dehydration, o severe infection, o shock; acute or chronic disease which may cause tissue hypoxia such as: o cardiac or respiratory failure, o recent myocardial infarction, o shock; hepatic impairment (see sections 4.2 and 5.2); acute alcohol intoxication, alcoholism (see section 4.5).
Maltese: Qtrilmet huwa kontraindikat f'pazjenti bi: - sensittività eċċessiva għas-sustanzi attivi jew għal kwalunkwe sustanza mhux attiva elenkata fissezzjoni 6.1, storja ta' reazzjoni ta' sensittività eċċessiva serja, inkluż reazzjoni anafilattika, xokk anafilattiku, u anġjoedema, għal xi inibitur ta' dipeptidyl peptidase-4 (DPP-4) jew xi inibitur talkotrasportatur 2 ta' sodium-glucose (SGLT2) (ara sezzjonijiet 4.4, 4.8 u 6.1). - kwalunkwe tip ta' aċidożi metabolika akuta (bħal aċidożi lattika, ketoaċidożi dijabetika) (ara sezzjonijiet 4.4 u 4.8). - prekoma dijabetika (ara sezzjoni 4.4). - insuffiċjenza severa tal-kliewi (GFR < 30 mL/min) (ara sezzjonijiet 4.2, 4.4 u 5.2). - kondizzjonijiet akuti bil-potenzjal li jibdlu l-funzjoni tal-kliewi bħal: o deidratazzjoni o infezzjoni severa o xokk - marda akuta jew kronika li tista' tikkawża ipoksija tat-tessut bħal: o insuffiċjenza kardijaka jew respiratorja o infart kardijaku riċenti o xokk - indeboliment tal-fwied (ara sezzjonijiet 4.2 u 5.2). - intossikazzjoni akuta tal-akoħol, alkoħoliżmu (ara sezzjoni 4.5).
English: Saxagliptin: In subjects with mild (Child-Pugh class A), moderate (Child-Pugh class B) or severe (Child-Pugh class C) hepatic impairment the exposures to saxagliptin were 1.1-, 1.4- and 1.8-fold higher, respectively, and the exposures to BMS-510849 (saxagliptin metabolite) were 22%, 7%, and 33% lower, respectively, than those observed in healthy subjects.
Maltese: F'individwi b'indeboliment tal-fwied ħafif (Child-Pugh klassi A), moderat (Child-Pugh klassi B) jew sever (Child-Pugh klassi C), l-esponimenti għal saxagliptin kienu 1.1, 1.4 u 1.8 darbiet ogħla, rispettivament, u l-esponimenti għal BMS-510849 (metabolit ta' saxagliptin) kienu 22 %, 7 %, u 33 % aktar baxxi, rispettivament, minn dawk osservati f'individwi b'saħħithom.
English: The mean age was 54.6 years and 52.7% of patients were female.
Maltese: L-età medja kienet 54.6 snin u 52.7% tal-pazjenti kienu nisa.
English: Metformin: Renal clearance of metformin is > 400 mL/min, indicating that metformin is eliminated by glomerular filtration and tubular secretion.
Maltese: It-tneħħija mill-kliewi ta' metformin hija > 400 mL/min, li tindika li metformin jiġi eliminat permezz ta' filtrazzjoni glomerulari u sekrezzjoni tubulari.
English: The difference in the adjusted mean change from baseline to week 52 between the treatment groups was -0.81% (95% CI: -1.06, -0.55).
Maltese: Id-differenza fil-bidla medja aġġustata millinja bażi sa ġimgħa 52 bejn il-gruppi ta' trattament kienet 0.81% (95% CI: -1.06, -0.55).
English: Dapagliflozin is a highly potent (Ki: 0.55 nM), selective and reversible inhibitor of sodium-glucose co-transporter 2 (SGLT2).
Maltese: Dapagliflozin huwa inibitur selettiv u riversibbli qawwi ħafna (Ki: 0.55 nM), ta' ko-trasportatur 2 ta' sodium-glucose (SGLT2).
English: Frequencies of all uncommon adverse reactions were based on the individual mono-components data.
Maltese: Il-frekwenzi tar-reazzjonijiet avversi mhux komuni kollha kienu bbażati fuq id-data tal-monokomponenti individwali.
English: gastritis
Maltese: gastrite
English: Dapagliflozin: Dapagliflozin is extensively metabolised, primarily to yield dapagliflozin 3-O-glucuronide, which is an inactive metabolite.
Maltese: Dapagliflozin jiġi metabolizzat b'mod estensiv, primarjament sabiex jagħti dapagliflozin 3-O-glucuronide, li huwa metabolit inattiv.
English: Difference in HbA1c effect
Maltese: Differenza fleffett ta' HbA1c
English: The adjusted percent difference at week 52 between the treatment groups was 16.8%.
Maltese: Id-differenza perċentwali aġġustata f'ġimgħa 52 bejn il-gruppi ta' trattament kienet 16.8 %.
English: PVC/PCTFE/alu blister
Maltese: Folja PVC/PCTFE/alu
English: Change from baseline (adjusted mean (95% Confidence interval [CI])
Maltese: Bidla mil-linja bażi (medja aġġustata (95% Intervall ta' fiduċja [CI])
English: The AUC values of 5-OH-saxagliptin were also increased.
Maltese: Il-valuri tal-AUC ta' 5-OH-saxagliptin ukoll żdiedu.
English: The pharmacokinetics of dapagliflozin were not meaningfully altered by saxagliptin, metformin, pioglitazone, sitagliptin, glimepiride, voglibose, hydrochlorothiazide, bumetanide, valsartan, or simvastatin.
Maltese: Il-farmakokinetika ta' dapagliflozin ma nbidlitx b'mod sinifikanti minn saxagliptin, metformin, pioglitazone, sitagliptin, glimepiride, voglibose, hydrochlorothiazide, bumetanide, valsartan, jew simvastatin.
English: Use with potent CYP3A4 inducers
Maltese: Użu ma' indutturi qawwija ta' CYP3A4
English: Experience in NYHA class III-IV is limited with saxagliptin.
Maltese: L-esperjenza fil-klassi III-IV ta' NYHA hija limitata.
English: LRM = Longitudinal repeated measures (using values prior to rescue).
Maltese: LRM = Miżuri ripetuti lonġitudinali (permezz ta' valuri qabel is-salvataġġ).
English: Preferred terms reported in dapagliflozin clinical trials included in order of frequency: rash, rash generalised, rash pruritic, rash macular, rash maculo-papular, rash pustular, rash vesicular, and rash erythematous.
Maltese: It-termini ppreferuti rrappurtati fil-provi kliniċi ta' dapagliflozin skont il-frekwenza inkludew: raxx, raxx ġeneralizzat, raxx pruritiku, raxx makulari, raxx makulopapulari, raxx pustulari, raxx vesikulari, u raxx eritematuż.
English: The steady-state 24-hour urinary glucose excretion was highly dependent on renal function and 85, 52, 18 and 11 g of glucose/day was excreted by subjects with type 2 diabetes mellitus and normal renal function or mild, moderate or severe renal impairment, respectively.
Maltese: Leskrezzjoni tal-glucose mill-awrina fi stat fiss ta' 24 siegħa kienet tiddependi ħafna fuq il-funzjoni talkliewi u 85, 52, 18 u 11 g ta' glucose/jum ġie eliminat minn individwi b'dijabete mellitus tat-tip 2 u funzjoni tal-kliewi normali jew indeboliment ħafif, moderat jew sever tal-kliewi, rispettivament.
English: Dapagliflozin blocks reabsorption of filtered glucose from the S1 segment of the renal tubule, effectively lowering blood glucose in a glucose dependent and insulin-independent manner.
Maltese: Dapagliflozin jimblokka l-assorbiment mill-ġdid ta' glucose filtrat mis segment S1 tat-tubulu renali, billi effettivament ibaxxi l-glucose fid-demm b'mod dipendenti fuq ilglucose u indipendenti mill-insulina.
English: PA/alu/PVC/alu blister:
Maltese: Folja PA/alu/PVC/alu:
English: Arthralgia back pain myalgia
Maltese: Artralġja uġigħ fiddahar mijalġija
English: HbA1c change from baseline at week 24 excluding data after rescue for randomised subjects - studies MB102129 and CV181168
Maltese: Bidla fl-HbA1c mil-linja bażi f'ġimgħa 24 li teskludi data wara salvataġġ għal individwi randomizzati - studji MB102129 u CV181168
English: Rare cases of diabetic ketoacidosis (DKA), including life-threatening and fatal cases, have been reported in patients treated with SGLT2 inhibitors, including dapagliflozin.
Maltese: Ġew irrappurati każijiet rari ta' ketoaċidożi dijabetika (DKA), inkluż każijiet ta' periklu għall-ħajja u fatali, f'pazjenti ttrattati b'inibituri ta' SGLT2, inkluż dapagliflozin.
English: Joint pain, which may be severe, has been reported in post-marketing reports for DPP-4 inhibitors (see section 4.8).
Maltese: Ġie rrappurtat uġigħ fil-ġogi, li jista' jkun sever f'rapporti ta' wara t-tqegħid fis-suq għal inibituri ta' DPP-4 (ara sezzjoni 4.8).
English: Beige, biconvex, 11 x 21 mm oval tablet, with 3005 debossed on one side.
Maltese: Pillola beige, bikonvessa, 11 x 21 mm ovali, bi 3005 imnaqqxa fuq naħa waħda.
English: In subjects with severe hepatic impairment (Child-Pugh class C) mean Cmax and AUC of dapagliflozin were 40% and 67% higher than matched healthy controls, respectively.
Maltese: F'individwi b'indeboliment tal-fwied sever (Child-Pugh klassi C) is-Cmax u l-AUC medji ta' dapagliflozin kienu 40 % u 67 % ogħla minn individwi ta' kontroll imqabbla b'saħħithom, rispettivament.
English: Dapagliflozin 10 mg added to saxagliptin 5 mg + metformin
Maltese: Dapagliflozin 10 mg miżjud ma' saxagliptin 5 mg + metformin
English: Metformin is excreted by the kidney, and moderate to severe renal insufficiency increases the risk of lactic acidosis (see section 4.4).
Maltese: Metformin jiġi eliminat mill-kliewi, u insuffiċjenza tal-kliewi moderata sa severa żżid ir-riskju ta' aċidożi lattika (ara sezzjoni 4.4).
English: Therapeutic experience in patients 65 years and older is limited, and very limited in patients 75 years and older.
Maltese: L-esperjenza terapewtika f'pazjenti ta' 65 sena u aktar hija limitata, u limitata ħafna f'pazjenti ta' 75 sena u aktar.
English: The exposure of the active metabolite and the plasma DPP-4 activity inhibition over a dose interval were not influenced by rifampicin (see section 4.4).
Maltese: L-esponiment tal-metabolit attiv u l-inibizzjoni tal-attività ta' DPP-4 fil-plażma matul intervall tad-doża ma ġewx influwenzati minn rifampicin (ara sezzjoni 4.4).