FrancophonIA/ELRC3.0 huggingface dataset:
English: Difference from saxagliptin + metformin (adjusted mean (95 % CI)
Maltese: Differenza minn saxagliptin + metformin (medja aġġustata3) (95 % CI)
English: Fungal infection
Maltese: Infezzjoni fungali
English: The adverse reactions are listed by system organ class (SOC) and frequency.
Maltese: Ir-reazzjonijiet avversi huma elenkati permezz tas-sistema tal-klassifika tal-organi (SOC) u l-frekwenza.
English: Dapagliflozin: The metabolism of dapagliflozin is primarily via glucuronide conjugation mediated by UDP glucuronosyltransferase 1A9 (UGT1A9).
Maltese: Il-metaboliżmu ta' dapagliflozin huwa medjat prinċipalment permezz ta' konjugazzjoni glukuronajd b'UDP glucuronosyltransferase 1A9 (UGT1A9).
English: Manufacturer AstraZeneca AB Gärtunavägen SE-151 85 Södertälje Sweden
Maltese: Manifattur AstraZeneca AB Gärtunavägen SE-151 85 Södertälje L-Isvezja
English: Dapagliflozin: 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 induċa CYP1A2, CYP2B6 jew CYP3A4.
English: Use with potent CYP3A4 inducers
Maltese: Użu ma' induċituri CYP3A4 qawwija
English: Cardiovascular death, MI and stroke were observed with a hazard ratio of 0.77 (95 % CI: 0.54, 1.10).
Maltese: Il-mewt kardjovaskulari, l-MI u lpuplesija kienu osservati bi proporzjon ta' periklu ta' 0.77 (95 % CI: 0.54, 1.10).
English: Excipient with known effect Each tablet contains 40 mg of lactose (as anhydrous).
Maltese: Eċċipjent b'effett magħruf Kull pillola ta' fiha 40 mg ta' lactose (bħala anhydrous).
English: There is no experience in clinical trials with dapagliflozin in NYHA class III-IV.
Maltese: Ma hemmx esperjenza fi provi kliniċi b'dapagliflozin fil-NYHA klassi III-IV.
English: Dapagliflozin: Dapagliflozin did not meaningfully alter the pharmacokinetics of saxagliptin, metformin, pioglitazone, sitagliptin, glimepiride, voglibose, hydrochlorothiazide, bumetanide, valsartan, or simvastatin.
Maltese: Dapagliflozin ma biddilx b'mod sinifikattiv il-farmakokinetiċi ta' saxagliptin, metformin, pioglitazone, sitagliptin, glimepiride, voglibose, hydrochlorothiazide, bumetanide, valsartan, jew simvastatin.
English: Saxagliptin, through the selective inhibition of dipeptidyl peptidase-4 (DPP-4), enhances glucose-mediated insulin secretion (incretin effect).
Maltese: Saxagliptin, permezz ta' inibizzjoni selettiva ta' dipeptidyl peptidase4 (DPP-4), itejjeb is-sekrezzjoni tal-insulina medjata mill-glucose (effett inkretin).
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 qawwi ħafna (Ki: 1.3 nM), selettiv, riversibbli u kompetittiv ta' DPP-4, enzimu responsabbli għat-tkissir tal-ormoni tal-inkretin.
English: HbA1c change from baseline at week 24 excluding data after rescue for randomised subjects - studies MB102129 and CV181168
Maltese: Bidla f'HbA1c mil-linja bażi fil-ġimgħa 24 bl-esklużjoni tad-data wara s-salvataġġ ta' individwi randomizzati-studji MB102129 u CV181168
English: Urosepsis and pyelonephritis
Maltese: Urosepsis u pjelonefrite
English: Qtern 5 mg/10 mg tablets are available in aluminium blisters in pack sizes of 14, 28, or 98 film-coated tablets in calendar blisters and 30 film-coated tablets in blister.
Maltese: Il-pilloli Qtern tal-5 mg/10 mg huma disponibbli f'folji tal-aluminju f'daqsijiet tal-pakketti ta' 14, 28 jew 98 pillola miksija b'rita f'folji b'kalendarju u 30 pillola miksija b'rita f'folja.
English: Saxagliptin: 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 inibixxu CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, jew 3A4, u lanqas induċew CYP1A2, 2B6, 2C9, jew 3A4.
English: The recommended dose is one 5 mg saxagliptin/10 mg dapagliflozin tablet once daily (see sections 4.5 and 4.8).
Maltese: Id-doża rakkomandata hi ta' pillola waħda 5mg saxagliptin /10mg dapagliflozin darba kuljum (ara sezzjonijiet 4.5 u 4.8).
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: Il-valuri tal-medja ġeometrika fi stadju fiss ta' dapagliflozin Cmax u AUCτ wara li jingħataw dożi tal-10 mg ta' dapagliflozin darba kuljum kienu 158 ng/ml u 628 ng h/ml, rispettivament.
English: AstraZeneca A.E. Τηλ: +30 2 106871500
Maltese: Τηλ: +30 2 106871500
English: Placebo + dapagliflozin 10 mg + metformin
Maltese: Plaċebo + dapagliflozin tal-10 mg + metformin
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-attività inibitorja tal-plażma DPP-4 fuq intervall ta' doża ma kinux influwenzati minn rifampicin (ara sezzjoni 4.4).
English: The modest lowering effects on BP were consistent over time and a similar number of subjects had systolic BP < 130 mmHg or diastolic BP < 80 mmHg at Week 24 across the treatment groups.
Maltese: L-effetti modesti li jbaxxu l-BP kienu konsistenti maż-żmien u numru simili ta' individwi kellhom BP sistolika < 130 mmHg jew BP dijastolika < 80 mmHg fil-Ġimgħa 24 matul il-gruppi ta' kura.
English: However, renal function and risk of volume depletion should be taken into account in elderly patients (≥ 65 years).
Maltese: Madankollu, il-funzjoni tal-kliewi u r-riskju ta' tnaqqis fil-volum għandhom jittieħdu in kunsiderazzjoni f'pazjenti anzjani (≥ 65 sena).
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: Każijiet rari ta' ketoaċidożi dijabetika (DKA), inkluż każijiet ta' theddida għall-ħajja u fatali, ġew irrapportati f'pazjenti kkurati b'inibituri SGLT2, inkluż dapagliflozin.
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: Termini ppreferuti rrapportati fi provi kliniċi ta' dapagliflozin inkludew f'ordni skont il-frekwenza: raxx, raxx ġeneralizzat, raxx pruritiku, raxx makulari, raxx makulo-papulari, raxx pustulari, raxx vexxikulari, u raxx eretematuż.
English: Pack sizes of 14, 28, and 98 film-coated tablets in calendar blisters Pack size of 30 film-coated tablets in blisters
Maltese: Daqsijiet tal-pakketti ta' 14, 28 u 98 pillola miksija b'rita f'folji b'kalendarju Daqs tal-pakketti ta' 30 pillola miksijin b'rita f'folji
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 ħafif (Child-Pugh klassi A), moderat (Child-Pugh klassi B), jew sever (Child-Pugh klassi C) tal-fwied l-esponimenti għal saxagliptin kienu ta' 1.1-, 1.4- u 1.8darbiet aktar, rispettivament,u l-esponimenti għal BMS-510849 (metabolit ta' saxagliptin) kienu ta' 22 %, 7 % u 33 % aktar baxxi, rispettivament, minn dawk osservati f'individwi f'saħħithom.
English: Effect of saxagliptin or dapagliflozin on other medicinal products Saxagliptin: Saxagliptin did not meaningfully alter the pharmacokinetics of 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 b'mod sinifikanti l-farmakokinetiċi ta' metformin, glibenclamide (substrat CYP2C9), pioglitazone [substrat CYP2C8 (ewlieni) u CYP3A4 (minuri)], digoxin (substrat P-gp), simvastatin (substrat CYP3A4), il-komponenti attivi ta' kontraċettiv kombinat li jittieħed mill-ħalq (ethinylestradiol u norgestimate), diltiazem jew ketoconazole.
English: This medicinal product should not be used in patients with moderate to severe renal impairment (patients with creatinine clearance [CrCl] < 60 ml/min or estimated glomerular filtration rate [eGFR] < 60 ml/min/1.73 m2, see sections 4.4, 4.8, 5.1 and 5.2).
Maltese: Dan il-prodott mediċinali ma għandux jintuża f'pazjenti b'indeboliment tal-kliewi moderat sa qawwi (pazjenti bi tneħħija tal-krejatinina [CrCl] < 60 ml/min jew rata stmata ta' filtrazzjoni glomerulari [eGFR] < 60 ml/min/1.73 m2, ara sezzjonijiet 4.4, 4.8, 5.1 u 5.2).
English: During post-marketing experience with saxagliptin, including spontaneous reports and clinical trials, the following adverse reactions have been reported with the use of saxagliptin: serious hypersensitivity reactions, including anaphylactic reaction, anaphylactic shock, and angioedema.
Maltese: Waqt l-esperjenza ta' wara t-tqegħid fis-suq ta' saxagliptin, inkluż rapporti spontanji u provi kliniċi, ir-reazzjonijiet avversi li ġejjin ġew irraportati bl-użu ta' saxagliptin: reazzjonijiet serji ta' sensittività eċċessiva, inkluż reazzjoni anafilattika, xokk anafilattiku, u anġjoedima.
English: Arthralgia, back pain, myalgia
Maltese: Artralġja, uġigħ fiddahar, mijalġja
English: LRM = Longitudinal repeated measures (using values prior to rescue).
Maltese: LRM = Miżuri ripetuti lonġitudinali (bl-użu ta' valuri qabel is-salvataġġ).
English: Experience in NYHA class I-II is limited in dapagliflozin.
Maltese: I-II hija limitata f'dapagliflozin.
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: L-eliminazzjoni tal-glucose fl-awrina fi stadju-fiss ta' 24-siegħa kien dipendenti ħafna fuq il-funzjoni tal-kliewi u 85, 52, 18 u 11 g ta' glucose/jum kien eliminat minn individwi bid-dijabete mellitus tat-tip 2 u funzjoni normali tal-kliewi jew indeboliment ħafif, moderat jew sever tal-kliewi, rispettivament.
English: Dapagliflozin, a selective inhibitor of sodium-glucose co-transporter 2 (SGLT2), inhibits renal glucose reabsorption independently of insulin.
Maltese: Dapagliflozin, inibitur selettiv tal-ko-trasportatur tas-sodium glucose 2 (SGLT-2), jinibixxi l-assorbiment mill-ġdid tal-glucose fil-kliewi indipendentament mill-insulina.
English: The pooled safety analysis comprised 3 treatment groups: saxagliptin plus dapagliflozin plus metformin (492 subjects), saxagliptin plus metformin (336 subjects), and dapagliflozin plus metformin (341 subjects).
Maltese: L-analiżi tas-sigurtà miġbura kienet tikkonsisti minn 3 gruppi ta' kura: saxagliptin kif ukoll dapagliflozin kif ukoll metformin (492 individwi), saxagliptin kif ukoll metformin (336 individwi), u dapagliflozin kif ukoll metformin (341 individwu).
English: n = number of subjects with non-missing baseline and a Week 24 value.
Maltese: n = in-numru ta' individwi b'linja bażi mhux nieqsa u valur tal-Ġimgħa 24.
English: Using CYP3A4 inducers like carbamazepine, dexamethasone, phenobarbital, phenytoin, and rifampicin may reduce the glycaemic lowering effect of Qtern.
Maltese: L-użu ta' induċituri CYP3A4 bħal carbamazepine, dexamethasone, phenobarbital, phenytoin, u rifampicin jista' jnaqqas l-effett ta' tnaqqis gliċemiku ta' Qtern.
English: Dapagliflozin: Following coadministration of dapagliflozin with rifampicin (an inducer of various active transporters and drug-metabolising enzymes) a 22 % decrease in dapagliflozin systemic exposure (AUC) was observed, but with no clinically meaningful effect on 24-hour urinary glucose excretion.
Maltese: Wara l-għoti ta' dapagliflozin flimkien ma' rifampicin (induċitur ta' trasportaturi varji attivi u enzimi metabolanti-fil-mediċina) tnaqqis ta' 22 % fl-esponiment sistemiku ta' dapagliflozin (AUC) kien osservat, imma mingħajr effett klinikament sinifikattiv fuq l-eliminazzjoni tal-glucose fl-awrina ta' 24-siegħa.
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1, or 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).
Maltese: Sensittività eċċessiva għas-sustanzi attivi jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fissezzjoni 6.1, jew storja ta' reazzjoni ta' sensittività eċċessiva serja, inkluż reazzjoni anafilattika, xokk anafilattiku, u anġjoedema, għal kull inibitur ta' dipeptidyl peptidase-4 (DPP-4) jew għal kwalunkwe inibitur tal-ko-trasportatur tas-sodium-glucose 2 (SGLT2) (ara sezzjonijiet 4.4, 4.8 u 6.1).
English: This group of events was reported in 3.2 % and 1.8 % of patients who received dapagliflozin 10 mg and placebo, respectively.
Maltese: Dan il-grupp ta' avvenimenti kien irrapportat fi 3.2% u1.8% talpazjenti li rċevew dapagliflozin tal-10 mg u plaċebo, rispettivament.
English: Possible signs of dehydration are listed at the top of section 4.
Maltese: Is-sinjali possibbli tad-deidrazzjoni huma elenkati fil-parti ta' fuq tassezzjoni 4.
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' mard kardjovaskulari (bl-esklużkoni tal-pressjoni għolja) fil-linja bażi u 67.9% kellhom pressjoni għolja.
English: See corresponding subsections below for events in the dapagliflozin programme.
Maltese: Ara s-subsezzjonijiet korrespondenti ta' hawn taħt għal episodji fil-programm ta' dapagliflozin.
English: Rash has been seen with both saxagliptin and dapagliflozin when given separately (see section 4).
Maltese: Ir-raxx ġie osservat kemm b'saxagliptin u dapagliflozin meta mogħtija separatament (ara sezzjoni 4).
English: The hazard ratio comparing dapagliflozin to comparator was 0.79 (95 % CI: 0.58, 1.07), indicating that in this analysis dapagliflozin is not associated with an increase in cardiovascular risk in patients with type 2 diabetes mellitus.
Maltese: Ilproporzjon ta' periklu li jqabbel dapagliflozin mal-komparatur kien ta' 0.79 (95 % CI: 0.58, 1.07), li jindika li f'din l-analiżi dapagliflozin mhuwiex assoċċjat ma' żieda fir-riskju kardjovaskulari f'pazjenti bid-dijabete mellitus tat-tip 2.
English: Concomitant administration of saxagliptin with the potent CYP3A4/5 inducer rifampicin reduced Cmax and AUC of saxagliptin by 53 % and 76 %, respectively.
Maltese: L-għoti konkomitanti ta' saxagliptin mal-induċitur qawwi rifampicin CYP3A4/5 naqqas il-Cmax u AUC ta' saxagliptin b'53 % u 76 %, rispettivament.
English: In patients with baseline eGFR ≥ 30 and < 60 ml/min/1.73m2 these events were reported in 18.5 % and 9.3 % of patients with dapagliflozin 10 mg or placebo.
Maltese: F'pazjenti b'eGFR tal-linja bażi ≥ 30 u < 60 ml/min/1.73m2, dawn l-avvenimenti ġew irrapportati fi 18.5 % u 9.3 % tal-pazjenti b'dapagliflozin 10 mg jew plaċebo).
English: Headache, dizziness
Maltese: dijarea, dispepsja
English: Forty-one point four percent (41.4 %) (95 % CI [34.5, 48.2]) of patients in the saxagliptin and dapagliflozin combination group achieved HbA1c levels of less than 7 % compared to 18.3 % (95 % CI [13.0, 23.5]) patients in the saxagliptin group and 22.2 % (95 % CI [16.1, 28.3]) patients in the dapagliflozin group.
Maltese: Wieħed u erbgħin punt erba' fil-mija (41.4 %) (95 % CI [34.5, 48.2]) ta' pazjenti fil-grupp ta' kombinament ta' saxagliptin u dapagliflozin laħqu livelli ta' HbA1c ta' anqas minn 7 % meta mqabbla ma' 18.3 % (95 % CI [13.0, 23.5]) ta' pazjenti fil-grupp ta' saxagliptin u 22.2 % (95 % CI [16.1, 28.3]) ta' pazjenti fil-grupp ta' dapagliflozin.
English: Proportion of patients achieving HbA1c < 7 %
Maltese: Proporzjon ta' pazjenti li jilħqu HbA1c < 7 %
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 > 55 % ġew irrapportati f'1.3 % tal-individwi kkurati b'dapagliflozin 10 mg meta mqabbla ma' 0.4 % tal-individwi bi plaċebo.
English: Therapeutic experience with Qtern in patients 65 years and older is limited, and very limited in patients 75 years and older.
Maltese: Esperjenza terapewtika bi Qtern f'pazjenti ta' 65 sena u akbar hija limitata, u limitata ħafna f'pazjenti ta' 75 sena u akbar.
English: Lipids
Maltese: Lipidi
English: Saxagliptin: The metabolism of saxagliptin is primarily mediated by cytochrome P450 3A4/5 (CYP3A4/5).
Maltese: Il-bijotrasformazzjoni ta' saxagliptin huwa medjat prinċipalment permezz taċċitokromu P450 3A4/5 (CYP3A4/5).
English: 14 film-coated tablets 28 film-coated tablets 98 film-coated tablets 30 film-coated tablets
Maltese: 14-il pillola miksija b'rita 28 pillola miksija b'rita 98 pillola miksija b'rita 30 pillola miksija b'rita
English: This medicinal product has not been studied in severe renal impairment (CrCl < 30 ml/min or eGFR < 30 ml/min/1.73 m2) or end-stage renal disease (ESRD).
Maltese: Dan il prodott mediċinali ma ġiex studjat f'indeboliment sever tal-kliewi (CrCl < 30 ml/min jew eGFR < 30 ml/min/1.73 m2) jew mard tal-kliewi fl- istadju-finali (ESRD).
English: Subjects with adverse events of renal impairment had lower mean eGFR values at baseline of 61.8 ml/min/1.73m2 compared to 93.6 ml/min/1.73m2 in the overall population.
Maltese: 73m2 meta mqabbla ma' 93.6 ml/min/1.73m2 fil-popolazzjoni ġenerali.
English: AstraZeneca AB Gärtunavägen SE-151 85 Södertälje Sweden
Maltese: AstraZeneca AB Gärtunavägen SE-151 85
English: Dapagliflozin: In the 13-study, short-term, placebo-controlled pool, reported terms referring to events related to decreased renal function were grouped (e.g. decreased renal creatinine clearance, renal impairment, increased blood creatinine and decreased glomerular filtration rate).
Maltese: Fil-ġabra kkontrollata mill-plaċebo minn 13-il studju, ta' perjodu qasir, inġabru termini rrapportati li jirreferu għal avvenimenti relatati mat-tnaqqis fil-funzjoni tal-kliewi (eż. tnaqqis fittneħħija tal-krejatinina tal-kliewi, indeboliment tal-kliewi, żieda fil-kreatinina tad-demm u tnaqqis firrata tal-filtrazzjoni glomerulari).
English: The change in mean eGFR from baseline at Week 24 was -1.17 ml/min/1.73m2 in the saxagliptin plus dapagliflozin plus metformin group, -0.46 ml/min/1.73 m 2 in saxagliptin plus metformin, and 0.81 ml/min/1.73m 2 in dapagliflozin plus metformin.
Maltese: Il-bidla f'eGFR medju mil-linja bażi f'Ġimgħa 24 kienet ta' -1.17 ml/min/1.73m2 fil-grupp ta' saxagliptin kif ukoll dapagliflozin kif ukoll metformin, -0.46 ml/min/1.73m 2 f'saxagliptin kif ukoll metformin, u
English: Dapagliflozin: A meta-analysis of cardiovascular events in the clinical program was performed.
Maltese: Ġiet imwettqa meta-analiżi ta' avvenimenti kardjovaskulari fil-programm kliniku.
English: Dapagliflozin: At steady-state (20 mg once-daily dapagliflozin for 7 days), subjects with type 2 diabetes mellitus and mild, moderate or severe renal impairment (as determined by iohexol plasma clearance) had mean systemic exposures of dapagliflozin of 32 %, 60 % and 87 % higher, respectively, than those of subjects with type 2 diabetes mellitus and normal renal function.
Maltese: Fl-istadju fiss (dapagliflożin tal-20 mg darba-kuljum għal 7 ijiem), l-individwi biddijabete mellitus tat-tip 2 u indeboliment ħafif, moderat jew sever tal-kliewi (kif determinat mittneħħija tal-plażma ta' iohexol) kellhom esponimenti sistemiċi medji ta' dapagliflozin ta' 32 %, 60 % u 87 % ogħla, rispettivament, minn dawk l-individwi bid-dijabete mellitus tat-tip 2 u funzjoni normali tal-kliewi.
English: Concomitant administration of saxagliptin with the potent inhibitor of CYP3A4/5 ketoconazole, increased the Cmax and AUC of saxagliptin by 62 % and 2.5-fold, respectively, and the corresponding values for the active metabolite were decreased by 95 % and 88 %, respectively.
Maltese: L-għoti konkomitanti ta' saxagliptin mal-inibitur qawwi ta' ketoconazole CYP3A4/5 , żied il-Cmax u AUC ta' saxagliptin b'62 % u 2.5-drabi, rispettivament, u l-valuri korrispondenti tal-metabolit attiv tnaqqsu b'95 % u 88 %, rispettivament.
English: AstraZeneca d.o.o.
Maltese: AstraZeneca S.p.A.
English: The increased/decreased risk was not statistically significant in any of the organ systems.
Maltese: Ir-riskju miżjud/imnaqqas ma kienx statistikament sinifikanti fi kwalunkwe sistema tal-organi.
English: The average renal clearance of saxagliptin (~230 ml/min) was greater than the average estimated glomerular filtration rate (~120 ml/min), suggesting some active renal excretion.
Maltese: filtrazzjoni glomerulari (~120 ml/min), li jissuġerixxi xi eliminazzjoni attiva fil-kliewi.
English: Use of DPP-4 inhibitors has been associated with a risk of developing acute pancreatitis.
Maltese: L-użu ta' inibituri ta' DPP-4 ġie assoċjat ma' riskju ta' iżvilupp ta' pankreatite akuta.
English: Saxagliptin/dapagliflozin combination: Of the 1169 subjects treated in the pooled safety data from the 3 clinical trials, 1007 subjects (86.1 %) were aged < 65 years, 162 subjects (13.9 %) were aged ≥ 65 years, and 9 subjects (0.8 %) were aged ≥ 75 years.
Maltese: Mill-1169 individwu kkurat fid-data tas-sigurtà miġbura mit3 provi kliniċi, 1007 individwi (86.1 %) kellhom < 65 sena, 162 individwu (13.9 %) kellhom ≥ 65 sena, u 9 individwi (0.8 %) kellhom ≥ 75 sena, Ġeneralment, l-aktar avvenimenti avversi rrapportati f'individwi ≥ 65 sena kienu simili għal dawk < 65 sena.
English: The mean total systemic clearance of dapagliflozin administered intravenously was 207 ml/min.
Maltese: It-tneħħija medja totali sistemika ta' dapagliflozin mogħtija mill-vina kienet ta' 207 ml/min.
English: Saxagliptin: The mean plasma terminal half-life (t1/2) values for saxagliptin and its major metabolite are 2.5 hours and 3.1 hours respectively, and the mean t1/2 value for plasma DPP-4 inhibition was 26.9 hours.
Maltese: Il-valuri medji tal-half-life terminali fil-plażma (t1/2) ta' saxagliptin u l-metabolit maġġuri tiegħu huma ta' 2.5 sigħat u 3.1 sigħat rispettivament, u l-valur t1/2 medju tal-inibizzjoni DPP-4 fil-plażma kien ta' 26.
English: Urinary uric acid excretion was also increased transiently (for 3-7 days) and accompanied by a sustained reduction in serum uric acid concentration.
Maltese: L-eliminazzjoni tal-uric acid fl-awrina żdied ukoll b'mod tranżitorju (għal 3-7 ijiem) u akkumpanjat minn tnaqqis sostnut filkonċentrazzjoni tal-uric acid tas-serum.
English: Dapagliflozin and saxagliptin exposure is increased in patients with severe hepatic impairment (see sections 4.2 and 5.2).
Maltese: L-esponiment ta' dapagliflozin u saxagliptin jiżdied f'pazjenti b'indeboliment sever tal-fwied (ara sezzjonijiet 4.2 u 5.2).
English: Saxagliptin/dapagliflozin combination: Data from the saxagliptin plus dapagliflozin plus metformin treatment arms of 3 Phase 3 trials, demonstrated trends of mean percent increases from baseline (rounded to the nearest tenth) in total cholesterol (Total C), (ranging from 0.4 % to 3.8 %), LDL-C (ranging from 2.1 % to 6.9 %) and HDL-C (ranging 2.3 % to 5.2 %) along with mean percent decreases from baseline in triglycerides (ranging from -3.0 % to -10.8 %).
Maltese: Dejta mill-fergħat ta' kura ta' 3 provi tal-Fażi 3 ta' saxagliptin kif ukoll dapagliflozin kif ukoll metformin, uriet xejriet ta' żidiet medji fil-perċentwal millinja bażi (aġġustat għall-eqreb għaxra) fil-kolesterol totali (C Totali), (li jvarja minn 0.4% sa 3.8%), LDL-C (li jvarja minn 2.1% sa 6.9%) u HDL-C (li jvarja minn 2.3% sa 5.2%) flimkien ma' tnaqqis medju mil-linja bażi fi triglycerides (li jvarja minn -3.0% sa -10.