FrancophonIA/ELRC3.0 huggingface dataset:
English: Dapagliflozin: In subjects with mild or moderate hepatic impairment (Child-Pugh classes A and B), mean Cmax and AUC of dapagliflozin were up to 12 % and 36 % higher, respectively, compared to healthy matched control subjects.
Maltese: F'individwi b'indeboliment ħafif jew moderat tal-fwied (Child-Pugh klassijiet A u B), is-Cmax u AUC medji ta' dapagliflozin kienu sa 12 % u 36 % ogħla, rispettivament, meta mqabbla ma' individwi f'saħħtihom ta' kontroll korrispondenti.
English: Post-marketing reports of rash have been described in the DPP-4 inhibitor class.
Maltese: Rapporti ta' wara t-tqegħid fis-suq ta' raxx ġew deskritii fil-klassi tal-inibitur ta' DPP-4.
English: Serum creatinine was further evaluated in those patients with events related to decreased renal function, and most observed increases in creatinine were ≤ 0.5 mg/dl from baseline.
Maltese: Il-kreatinina tas-serum kienet evalwata aktar f'dawk il-pazjenti relatati ma' tnaqqis fil-funzjoni tal-kliewi, u l-aktar osservazzjonijiet osservati fil-kreatinina kienu ≤ 0.5 mg/dl millinja bażi.
English: Glycaemic control should be assessed when it is used concomitantly with a potent CYP3A4/5 inducer (see section 4.5).
Maltese: Il-kontroll gliċemiku għandu jkun valutat meta huwa użat b'mod konkomitanti ma' induċitur CYP3A4/5 qawwi (ara sezzjoni 4.5).
English: Anaphylactic reactions including anaphylactic shock
Maltese: Reazzjonijiet anafilattiċi inkluż xokk anafilattiku
English: Adverse events of genital infection were reported in 3.0 % in the saxagliptin plus dapagliflozin plus metformin group, 0.9 % of saxagliptin plus metformin group and 5.9 % of subjects in the dapagliflozin plus metformin group.
Maltese: Avvenimenti avversi ta' infezzjoni ġenitali kienu rrapportati fi 3.0 % fil-grupp ta' saxagliptin kif ukoll dapagliflozin kif ukoll metformin, 0.9% tal-grupp saxagliptin kif ukoll metformin u 5.9% tal-individwi fil-grupp dapagliflozin kif ukoll metformin.
English: The AUC values of 5-OH-saxagliptin were also increased.
Maltese: Il-valuri tal-AUC ta' 5-OH-saxagliptin żdiedu wkoll.
English: Baseline (mean)
Maltese: Linja bażi (medja)
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 sever tal-fwied (Child-Pugh klassi C) is-Cmax u AUC medji ta' dapagliflozin kienu ta' 40 % u 67 % ogħla minn kontrolli korrispondenti f'saħħithom, rispettivament.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of dapagliflozin/metabolites in milk, as well as pharmacologically-mediated effects in breast-feeding offspring (see section 5.3).
Maltese: Data farmakodinamika/tossikoloġika disponibbli fl-annimali uriet l-eliminazzjoni ta' dapagliflozin/metaboliti fil-ħalib, kif ukoll effetti medjati b'mod farmakoloġiku fit-treddigħ tal-frieħ (ara sezzjoni 5.3).
English: Vulvovaginitis, balanitis and related genital infection include the following preferred terms: vulvovaginal mycotic infection, balanoposthitis, genital infection fungal, vaginal infection, and vulvovaginitis.
Maltese: Vulvovaginitis, balanitis u infezzjonijiet ġenitali relatati jinkludu t-termini preferuti: infezzjoni vulvo-vaġinali mikotika, balanopostite, infezzjoni ġenitali fungali, infezzjoni vaġinali, u vulvovaġinite.
English: Saxagliptin assessment of vascular outcomes recorded in patients with diabetes mellitus - thrombolysis in myocardial infarction (SAVOR) study
Maltese: Valutazzjoni ta' saxagliptin ta' riżultati vaskulari irreġistrata f'pazjenti bid-dijabete mellitus - tromboliżi fi studju tal-infart mijokardijaku (SAVOR).
English: The majority of events were considered non-serious, mild or moderate in intensity, and resolved.
Maltese: Il-maġġoranza tal-avvenimenti kienu meqjusa mhux serji, ħfief jew moderati fl-intensità, u solvuti.
English: Dapagliflozin 10 mg add to saxagliptin 5 mg + metformin
Maltese: Dapagliflozin tal-10 mg miżjud ma' saxagliptin tal-5 mg + metformin
English: In rabbits, the effects of saxagliptin were limited to minor skeletal variations observed only at maternally toxic doses (NOEL 158 and 224 times the human exposure for saxagliptin and the major metabolite, respectively at RHD).
Maltese: Fil-fniek, leffetti ta' saxagliptin kien limitat għal varjazzjonijiet skeletrali minuri osservati biss f'dożi tossiċi maternali (NOEL 158 u 224 darba l-esponiment tal-bnedmin ta' saxagliptin u l-metabolit maġġuri, rispettivament tal-RHD).
English: Another secondary endpoint, all-cause mortality, occurred at a rate of 5.1 % in the saxagliptin group and 4.6 % in the placebo group.
Maltese: Punt ta' tmiem sekondarju ieħor, il-mortalità b'kull kawża, seħħ b'rata ta' 5.1 % fil-grupp ta' saxagliptin u 4.6 % fil-grupp tal-plaċebo.
English: Joint pain, which may be severe, has been reported in post-marketing reports for DPP-4 inhibitors (see section 4.8).
Maltese: L-uġigħ fil-ġogi, li jista' jkun sever, ġie rrapportat f'rapporti wara t-tqegħid fis-suq għall-inibituri ta' DPP-4 (ara sezzjoni 4.8).
English: The requirements for submission of periodic safety update reports 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: Ir-rekwiżiti tar-rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tadDirettiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: The mean steady-state volume of distribution of dapagliflozin was 118 l.
Maltese: Il-volum medju fi stadju fiss taddistribuzzjoni ta' dapagliflozin kien 118 l.
English: Saxagliptin/dapagliflozin combination: Events related to volume depletion (hypotension, dehydration, and hypovolemia) were reflective of the adverse events with dapagliflozin and were reported in two subjects (0.4 %) in the saxagliptin plus dapagliflozin plus metformin group (serious adverse event [SAE] of syncope and an AE of urine output decreased), and 3 subjects (0.9 %) in the dapagliflozin plus metformin group (2 AEs of syncope and 1 of hypotension).
Maltese: Kombinament saxagliptin/dapagliflozin: Avvenimenti relatati mat-tnaqqis fil-volum (pressjoni baxxa, deidrazzjoni, u ipovolemja) kienu jirriflettu dawn l-avvenimenti avversi b'dapagliflozin u kienu rrapportati f'żewġ individwi (0.4%) fil-grupp ta' saxagliptin kif ukoll dapagliflozin kif ukoll metformin (avveniment avvers serju [SAE] tas-sinkope u AE ta' tnaqqis fil-produzzjoni tal-awrina), u 3 individwi (0.9%) fil-grupp ta' dapagliflozin kif ukoll metformin (2 AEs ta' sinkope u 1 ta' pressjoni baxxa).
English: Summary of the safety profile of saxagliptin plus dapagliflozin The combination of saxagliptin 5 mg and dapagliflozin 10 mg in 1169 adults with type 2 diabetes mellitus (T2DM) and inadequate glycaemic control on metformin has been evaluated in three Phase 3, randomised, double-blind, active/placebo-control, parallel group, multi-centre clinical trials for up to 52 weeks (see section 5.1).
Maltese: Sommarju tal-profil tas-sigurtà ta' saxagliptin kif ukoll dapagliflozin Il-kombinament ta' saxagliptin tal-5 mg u dapagliflozin tal-10 mg f'1169 adult bid-dijabete mellitus tat-tip 2 (T2DM) u l-kontroll inadegwat gliċemiku fuq metformin kien evalwat ma' tliet provi kliniċi tal-Fażi 3, randomizzati, double-blind, kontroll attiv/plaċebo-, grupp parallel, multi-ċentri sa 52 ġimgħa (ara sezzjoni 5.1).
English: Dapagliflozin: In the 21-study active- and placebo-controlled pool, the overall proportion of subjects with malignant or unspecified tumours was similar between those treated with dapagliflozin (1.50 %) and placebo/comparator (1.50 %), and there was no carcinogenicity or mutagenicity signal in animal data (see section 5.3).
Maltese: Fil-ġabra ta' 21 studju attiv u kkontrollat mill-plaċebo, il-proporzjon globali talindividwi b'tumuri malinni jew li mhumiex speċifikati kien simili bejn dawk ikkurati b'dapagliflozin (1.50 %) u l-plaċebo/komparatur (1.50 %), u ma kienx hemm sinjal ta' karċinoġeniċità jew mutaġeniċità fid-data tal-annimali (ara sezzjoni 5.3).
English: Immunocompromised patients, such as patients who have undergone organ transplantation or patients diagnosed with human immunodeficiency syndrome have not been studied in the saxagliptin clinical programme.
Maltese: Pazjenti immunokompromessi, bħall-pazjenti li kellhom trapjant tal-organi jew pazjenti dijanjostikati bilvirus tal-immunodefiċjenza umana ma ġewx studjati fil-programm kliniku ta' saxagliptin.
English: Mechanism of action for dapagliflozin
Maltese: Dapagliflozin:
English: Light brown to brown, biconvex, 0.8 cm round, film-coated tablet, with “5/10” printed on one side, and “1122” printed on the other side, in blue ink.
Maltese: Pillola miksija b'rita, kannella ċara għal kannella, tonda u mżaqqa miż-żewġ naħat, tonda ta' 0.8 cm, b'"5/10" stampata fuq naħa waħda, u "1122" stampata fuq in-naħa l-oħra, b'linka blu.
English: The adverse reactions of Qtern are presented in table 1 based on the summarized data from the saxagliptin/dapagliflozin combination clinical trials pooled safety data.
Maltese: Ir-reazzjonijiet avversi ta' Qtern li huma preżentati f'tabella 1 huma bbażati fuq id-data miġbura filqosor tal-provi kliniċi b'kombinament ta' saxagliptin/dapagliflozin.
English: A total of 534 adult patients with type 2 diabetes mellitus and inadequate glycaemic control on metformin alone (HbA1c ≥ 8 % and ≤ 12 %), participated in this 24-week randomised, double-blind, active comparator-controlled superiority trial to compare the combination of saxagliptin and dapagliflozin added concurrently to metformin, versus saxagliptin (DPP-4 inhibitor) or dapagliflozin (SGLT2 inhibitor) added to metformin.
Maltese: Total ta' 534 pazjent adult bid-dijabete mellitus tat-tip 2 u kontroll gliċemiku inadegwat b'metformin biss (HbA1c ≥ 8 % u ≤ 12 %), ipparteċipa f'din il-prova ta' superjorità kkontrollata b'komparatur attiv, randomizzata, double-blind, ta' 24-ġimgħa sabiex iqabbel il-kombinament ta' saxagliptin u dapagliflozin miżjuda flimkien ma' metformin, kontra saxagliptin (inibitur ta' DPP-4) jew dapagliflozin (inibitur ta' SGLT-2) mizjuda ma' metformin.
English: In patients with normal renal function or mild renal impairment (baseline eGFR ≥ 60 ml/min/1.73m2), events related to decreased renal function were reported in 1.3 % and 0.8 % of patients who received dapagliflozin 10 mg and placebo, respectively.
Maltese: F'pazjenti b'funzjoni normali talkliewi jew b'indeboliment ħafif tal-kliewi (eGFR tal-linja bażi ≥ 60 ml/min/1.73m2), avvenimenti relatati mat-tnaqqis tal-funzjoni tal-kliewi kienu rrapportati f'1.3% u 0.8% tal-pazjenti li rċevew dapagliflozin tal-10 mg u plaċebo, rispettivament.
English: Qtern should not be used in patients with moderate to severe renal impairment (patients with CrCl < 60 ml/min or eGFR < 60 ml/min/1.73 m2).
Maltese: Qtern ma għandux jintuża f'pazjenti b'indeboliment sever tal-kliewi (pazjenti b'CrCl < 60 ml/min jew eGFR < 60 ml/min/1.73 m2).
English: Dapagliflozin: The mean plasma terminal half-life (t1/2) for dapagliflozin was 12.9 hours following a single oral dose of dapagliflozin 10 mg to healthy subjects.
Maltese: Il-half-life medja terminali fil-plażma (t1/2) ta' dapagliflozin kienet ta' 12.9 sigħat wara doża waħda ta' dapagliflozin tal-10 mg mogħtija mill-ħalq lil individwi f'saħħithom.
English: Effect of other medicinal products on saxagliptin or dapagliflozin Saxagliptin: Concomitant administration of saxagliptin with the moderate inhibitor of CYP3A4/5 diltiazem, increased the Cmax and AUC of saxagliptin by 63 % and 2.1-fold, respectively, and the corresponding values for the active metabolite were decreased by 44 % and 34 %, respectively.
Maltese: L-għoti konkomitanti ta' saxagliptin mal-inibitur moderat ta' diltiazem CYP3A4/5 , żied il-Cmax u AUC ta' saxagliptin b'63 % u 2.1-drabi, rispettivament, u l-valuri korrispondenti talmetabolit attiv tnaqqsu b'44 % u 34 %, rispettivament.
English: Dapagliflozin dosed to maternal rats from gestation day 6 through postnatal day 21, and pups were indirectly exposed in utero and throughout lactation.
Maltese: Dapagliflozin dożat lil firien materni mis-6 jum ta' ġestazzjoni sal-21 jum ta' wara t-twelid, u l-frieħ kienu esposti indirettament in in utero u matul it-treddigħ.
English: Saxagliptin/dapagliflozin combination: Cardiovascular (CV) events that were adjudicated and confirmed as CV events were reported in a total of 1.0 % of subjects in the saxagliptin plus dapagliflozin plus metformin group, 0.6 % in the saxagliptin plus metformin group, and 0.9 % in the dapagliflozin plus metformin group.
Maltese: Kombinament saxagliptin/dapagliflozin: Avvenimenti kardjovaskulari (CV) li kienu aġġudikati u kkonfermati bħala avvenimenti CV kienu rrapportati f'total ta' 1.0% tal-individwi fil-grupp ta' saxagliptin kif ukoll dapagliflozin kif ukoll metformin, 0.6% fil-grupp ta' saxagliptin kif ukoll metformin, u 0.9% fil-grupp ta' dapagliflozin kif ukoll metformin.
English: Polyuria includes the following preferred terms: polyuria, and pollakiuria.
Maltese: Poliurja tinkludi t-termini preferuti li ġejjin: poliurja u pollakurja.
English: Adverse reactions were reported in ≥ 2 % of subjects with either mono-component and ≥ 1 % more than placebo, but not in the pooled analysis.
Maltese: Ir-reazzjonijiet avversi kienu rrapportati f'≥2 % tal-individwi bi kwalunkwe mono-komponent u ≥ 1 % aktar minn plaċebo, iżda mhux fl-analiżi miġbura.
English: The proportion of patients achieving HbA1c < 7 % at week 24 for add-on therapy with saxagliptin to dapagliflozin plus metformin trial was higher in the saxagliptin plus dapagliflozin plus metformin group 35.3 % (95 % CI [28.2, 42.2]) compared to the placebo plus dapagliflozin plus metformin group 23.1 % (95 % CI [16.9, 29.3]).
Maltese: Il-proporzjon ta' pazjenti li laħqu HbA1c < 7 % fil-ġimgħa 24 għall-prova ta' terapija miżjuda b'saxagliptin għal dapagliflozin kif ukoll metformin kien ogħla filgrupp saxagliptin kif ukoll dapagliflozin kif ukoll metformin 35.3% (95 % CI [28.2, 42.2]) meta mqabbel mal-grupp ta' placebo kif ukoll saxagliptin kif ukoll metformin 23.1% (95 % [16.9, 29.3]).
English: Saxagliptin: The Cmax and AUC of saxagliptin and its major metabolite increased proportionally to the saxagliptin dose.
Maltese: Is-Cmax u AUC ta' saxagliptin u l-metabolit maġġuri żdiedu b'mod proporzjonat maddoża ta' saxagliptin.
English: The major active metabolite of saxagliptin, 5-OH-saxagliptin, is also a selective, reversible, competitive DPP-4 inhibitor, half as potent as saxagliptin.
Maltese: Il-metabolit attiv maġġuri ta' saxagliptin, 5-OH-saxagliptin, huwa inibitur ta' DPP-4 selettiv, riversibbli, u kompetittiv, b'nofs il-qawwa ta' saxagliptin.
English: Interactions with other oral anti-diabetic or cardiovascular medicinal products Saxagliptin: Saxagliptin did not meaningfully alter the pharmacokinetics of dapagliflozin, metformin, glibenclamide, pioglitazone, digoxin, diltiazem or simvastatin.
Maltese: Interazzjonijiet ma' prodotti mediċinali anti-dijabetiċi oħrajn li jittieħdu mill-ħalq jew kardjovaskulari Saxagliptin: Saxagliptin ma biddilx b'mod sinifikattiv il-farmakokinetiċi ta' dapagliflozin, metformin, glibenclamide, pioglitazone, digoxin, diltiazem jew simvastatin.
English: Add-on therapy with dapagliflozin in patients inadequately controlled on saxagliptin plus metformin A 24-week randomised, double-blind, placebo-controlled study compared the sequential addition of 10 mg dapagliflozin to 5 mg saxagliptin and metformin to the addition of placebo to 5 mg saxagliptin (DPP-4 inhibitor) and metformin in patients with type 2 diabetes mellitus and inadequate glycaemic control (HbA1c ≥ 7% and ≤ 10.5%).
Maltese: Studju ta' 24-ġimgħa randomizzat, double-blind, ikkontrollat minn plaċebo qabbel iż-żieda sekwenzjali ta' dapagliflozin tal-10 mg ma' saxagliptin tal-5 mg u metformin maż-żieda tal-plaċebo ma' saxagliptin tal-5 mg (inibitur ta' DPP-4) u metformin f'pazjenti bid-dijabete mellitus tat-tip 2 u kontroll gliċemiku inadegwat (HbA1c ≥ 7% u ≤ 10.
English: In the concomitant study, the adjusted mean change from baseline in body weight at Week 24 (excluding data after rescue) was −2.05 kg (95 % CI [−2.52, −1.58]) in the saxagliptin 5 mg plus dapagliflozin 10 mg plus metformin group and −2.39 kg (95 % CI [−2.87, −1.91]) in the dapagliflozin 10 mg plus metformin group, while the saxagliptin 5 mg plus metformin group had no change (0.00 kg) (95 % CI [−0.48, 0.49]).
Maltese: Fl-istudju konkomitanti, il-bidla medja aġġustata mil-linja bażi fil-piż tal-ġisem fil-Ġimgħa 24 (blesklużjoni tad-data wara s-salvataġġ) kienet −2.05 kg (95 % CI [−2.52, −1.58]) fil-grupp ta' saxagliptin tal-5 mg kif ukoll dapagliflozin tal-10 mg kif ukoll metformin u −2.39 kg (95 % CI [−2.87,
English: There were no clinically relevant differences observed in saxagliptin pharmacokinetics between males and females.
Maltese: Ma kienx hemm differenzi klinikament relevanti osservati fil-farmakokinetiċi ta' saxagliptin bejn lirġiel u n-nisa.
English: Decrease in lymphocyte counts
Maltese: Indeboliment tal-kliewi
English: SAVOR was a CV outcome trial in 16,492 patients with HbA1c ≥ 6.5 % and < 12 % (12,959 with established CV disease; 3533 with multiple risk factors only) who were randomised to saxagliptin (n=8280) or placebo (n=8212) added to regional standards of care for HbA1c and CV risk factors.
Maltese: 3533 b'diversi fatturi ta' riskju biss) li kienu randomizzati għal saxagliptin (n=8280) jew plaċebo (n=8212) miżjuda ma' standards reġjonali ta' kura għall-fatturi ta' riskju HbA1c u CV.
English: Use with medicinal products known to cause hypoglycaemia If Qtern is used in combination with insulin secretagogue (sulphonylurea), a reduction in the dose of sulphonylurea may be required to minimize the risk of hypoglycaemia (see section 4.4).
Maltese: Jekk Qtern huwa użat f'kombinament ma' sekretagogu tal-insulina (sulphonylurea), tnaqqis fid-doża ta' sulphonylurea jista' jkun meħtieġ sabiex jiġi minimizzat ir-riskju ta' ipogliċemija (ara sezzjoni 4.8).
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Il-pazjenti bi problemi ereditarji rari ta' intolleranza tal-galactose, id-defiċjenza tal-lattażi Lapp, jew malassorbiment tal-glucose-galactose ma għandhomx jieħdu dan il-prodott mediċinali.
English: Qtern contains the active substances saxagliptin and dapagliflozin.
Maltese: Qtern fih is-sustanzi attivi saxagliptin u dapagliflozin.
English: Drug interactions:
Maltese: Interazzjonijiet ma' mediċini:
English: Use of alternative methods to monitor glycaemic control is advised.
Maltese: Huwa rrakkomandat l-użu ta'metodi alternattivi biex timmonitorja l-kontroll gliċemiku.
English: Change from baseline (adjusted mean (95 % Confidence interval [CI])
Maltese: Bidla mil-linja bażi (medja aġġustata3) (95 % Intervall ta' kunfidenza [CI])
English: Upper respiratory tract infection includes the following preferred terms: nasopharyngitis, influenza, upper respiratory tract infection, pharyngitis, rhinitis, sinusitis, pharyngitis bacterial, tonsillitis, acute tonsillitis, laryngitis, viral pharyngitis, and viral upper respiratory tract infection.
Maltese: L-infezzjoni fl-apparat respiratorju ta' fuq tinkludi t-termini ppreferuti li ġejjin: nażofarinġite, influwenza, infezzjoni fl-apparat respiratorju ta' fuq, farinġite, rinite, sinużite, farinġite batterjali, tonsillite, tonsillite akuta, larinġite, farinġite virali, u infezzjoni virali fl-apparat respiratorju ta' fuq.
English: It should also not be used in patients with end-stage renal disease (ESRD) (see section 4.4, 4.8, and 5.2).
Maltese: Lanqas ma għandu jintuża f'pazjenti b'mard tal-kliewi fil-fażi terminali (ESRD) (ara sezzjoni 4.4, 4.8, u 5.2).
English: Saxagliptin 5 mg added to dapagliflozin 10 mg + metformin
Maltese: Saxagliptin tal5 mg miżjud ma' dapagliflozin tal-10 mg + metformin
English: Urinary tract infection vulvovaginitis, balanitis and related genital infection gastroenteritis
Maltese: Infezzjoni fl-apparat tal-awrina vulvovaginitis, balanitis u infezzjoni tal-ġenitali relatata gastroenterite
English: The majority of patients in this study had a baseline HbA1c of > 8 % (see table 3).
Maltese: Il-maġġoranza tal-pazjenti f'dan l-istudju kellhom HbA1c tal-linja bażi ta' > 8 % (ara tabella 3).
English: Saxagliptin produced gastrointestinal toxicity in dogs, including bloody/mucoid faeces and enteropathy at higher doses with a NOEL 4 and 2 times the human exposure for saxagliptin and the major metabolite, respectively at RHD.
Maltese: Saxagliptin ipproduċa tossiċità gastrointestinali fil-klieb, inkluż ippurgar imdemmi/mukuż u enteropatija b'dożi ogħla b'NOEL 4 u darbtejn l-esponiment tal-bnedmin għal saxagliptin u lmetabolit ewlieni, rispettivament tal-RHD.
English: Lower limb amputations
Maltese: GĦAMLA KWALITATTIVA
English: Concomitant therapy with saxagliptin and dapagliflozin in patients inadequately controlled on metformin
Maltese: Terapija konkomitanti b'saxagliptin u dapagliflozin f'pazjenti kontrollati b'mod inadegwat fuq metformin
English: Dapagliflozin + Metformin Adjusted mean change from baseline
Maltese: Dapagliflozin + Metformin Bidla medja aġġustata millinja bażi
English: Evidence of sustained glucose excretion was seen in subjects with type 2 diabetes mellitus given dapagliflozin 10 mg/day for up to 2 years.
Maltese: Evidenza ta' eliminazzjoni tal-glucose sostnuta dehret f'individwi bid-dijabete mellitus tat-tip 2 li ngħataw dapagliflozin 10 mg/jum sa sentejn.
English: Saxagliptin + Metformin Adjusted mean change from baseline
Maltese: Saxagliptin + Metformin Bidla medja aġġustata millinja bażi
English: Following coadministration of dapagliflozin with mefenamic acid (an inhibitor of UGT1A9), a 55 % increase in dapagliflozin systemic exposure was seen, but with no clinically meaningful effect on 24-hour urinary glucose excretion.
Maltese: Wara l-għoti ta' dapagliflozin flimkien ma' aċidu mefenamic (inibitur ta' UGT1A9) dehret żieda ta' 55 % fl-esponiment sistemiku ta' dapagliflozin, imma mingħajr effett klinikament sinifikattiv fuq leliminazzjoni tal-glucose fl-awrina ta' 24-siegħa.
English: In rats, dapagliflozin was neither embryolethal nor teratogenic at exposures up to 1441 times the human values at the MRHD.
Maltese: Fil-firien, dapagliflozin la kien letali għall-embriju u lanqas teratoġeniku f'esponimenti sa 1441 drabi tal-valuri tal-bniedem tal-MRHD.
English: HbA1c subgroup analysis by baseline HbA1c at week 24 in randomised subjects
Maltese: Tabella 3. Analiżi tas-sottogrupp ta' HbA1c permezz tal-linja bażi ta' HbA1C fil-ġimgħa 24 f'individwi randomizzati
English: Pharmacotherapeutic group: Drugs used in diabetes, combinations of oral blood glucose lowering drugs, ATC code: A10BD21
Maltese: Mediċini użati għad-dijabete, kombinazzjonijiet ta' mediċini li jittieħdu mill-ħalq għall-glucose fid-demm, ATC kodiċi: A10BD21
English: If renal function falls below CrCl < 60 ml/min or eGFR < 60 ml/min/1.73 m2, Qtern treatment should be discontinued.
Maltese: Jekk il-funzjoni tal-kliewi taqa' taħt CrCl < 60 ml/min jew eGFR < 60 ml/min/1.73 m2, il-kura b'Qtern għandha titwaqqaf.
English: The increase in simvastatin and simvastatin acid exposures are not considered clinically relevant.
Maltese: Madankollu, id-differenti fl-esponiment ma kinux meqjusa klinikament sinfikanti.
English: The safety profile of the combined use of saxagliptin plus dapagliflozin plus metformin was comparable to the adverse reactions identified for the respective mono-components.
Maltese: Il-profil tas-sigurtà dwar l-użu kombinat ta' saxagliptin kif ukoll dapagliflozin kif ukoll metformin kien komparabbli marreazzjonijiet avversi indentifikati l-mono-komponenti rispettivi.