FrancophonIA/ELRC3.0 huggingface dataset:
English: - film-coating: polyvinyl alcohol (E1203), macrogol 3350, titanium dioxide (E171), talc (E553b), yellow iron oxide (E172), red iron oxide (E172).
Maltese: Is-sustanzi l-oħra huma: - qalba tal-pillola: microcrystalline cellulose (E460i), croscarmellose sodium (E468), anhydrous lactose (ara sezzjoni 2 ‘Qtern fih il-lactose'), magnesium stearate (E470b), silica tat-tip dentali (E551). - kisja tar-rita: polyvinyl alcohol (E1203), macrogol 3350, titanium dioxide (E171), talc (E553b), yellow iron oxide (E172), red iron oxide (E172). - linka ta' stampar: shellac, indigo carmine aluminium lake (E132).
English: CALENDAR BLISTERS
Maltese: FOLJI B'KALENDARJU
English: Saxagliptin: Race was not identified as a statistically significant covariate on the apparent clearance of saxagliptin and its metabolite.
Maltese: Ir-razza ma kinitx identifikata bħala kovarjanti statistikament sinifikattivi fuq it-tneħħija apparenti ta' saxagliptin u l-metabolit tiegħu.
English: The absolute oral bioavailability of dapagliflozin following the administration of a 10 mg dose is 78 %.
Maltese: Il-bijodisponibilità assoluta tal-għoti mill-ħalq ta' dapagliflozin wara l-għoti ta' doża tal-10 mg hija ta' 78 %.
English: The formation of dapagliflozin 3-O-glucuronide is mediated by UGT1A9, an enzyme present in the liver and kidney, and CYP-mediated metabolism was a minor clearance pathway in humans.
Maltese: Il-formazzjoni ta' dapagliflozin 3-O-glucuronide hija medjata minn UGT1A9, enzimu li jinstab fil-fwied u l-kliewi, u lmetaboliżmu medjat minn-CYP kien mogħdija ta' eliminazzjoni minuri fil-bnedmin.
English: When considering the cases of tumours occurring in the different organ systems, the relative risk associated with dapagliflozin was above 1 for some tumours (bladder, prostate, breast) and below 1 for others (e.g. blood and lymphatic, ovary, renal tract), not resulting in an overall increased tumour risk associated with dapagliflozin.
Maltese: Meta jitqiesu l-każi ta' tumuri li jseħħu fis-sistemi differenti tal-organi, ir-riskju relattiv assoċjat ma' dapagliflozin kien 'il fuq minn 1 għal xi tumuri (bużżieqa tal-awrina, prostata, sider) u taħt 1 għal oħrajn (eż. demm u limfatiku, ovarji, apparat talkliewi), u ma rriżultawx f'riskju miżjud ta' tumur assoċjat ma' dapagliflozin.
English: Saxagliptin produced reversible skin lesions (scabs, ulcerations and necrosis) in extremities (tail, digits, scrotum and/or nose) in cynomolgus monkeys.
Maltese: Saxagliptin ipproduċa leżjonijiet tal-ġilda riversibbli (qxur, ulċerazzjonijiet u nekrożi) fl-estremitajiet (denb, swaba', skrotu u/jew imnieħer) fix-xadini tat- tip cynomolgus.
English: The proportion of patients achieving HbA1c < 7.0 % at Week 24 in the add-on therapy with dapagliflozin to saxagliptin plus metformin trial was higher in the dapagliflozin plus saxagliptin plus metformin group 38.0 % (95 % CI [30.9, 45.1]) compared to the placebo plus saxagliptin plus metformin group 12.4 % (95 % CI [7.0, 17.9]).
Maltese: Il-proporzjon ta' pazjenti li laħqu HbA1c < 7.0 % fil-Ġimgħa 24 fit-terapija ta' żieda għall-prova ta' dapagliflozin għal saxagliptin kif ukoll metformin kien ogħla fil-grupp ta' dapagliflozin kif ukoll saxagliptin kif ukoll metformin 38.0% (95 % CI [30.9, 45.1]) meta mqabbel mal-grupp ta' placebo kif ukoll saxagliptin kif ukoll metformin 12.4% (95 % CI
English: Additional developmental toxicity was limited to dose-related reductions in pup body weights, and observed only at doses ≥ 15 mg/kg/day (pup exposures ≥ 29 times the human values at the MRHD).
Maltese: It-tossiċità taliżvilupp addizzjonali kienet limitata għal tnaqqis relatat mad-doża fil-piż tal-ġisem tal-frieħ, u osservata biss f'dożi ≥ 15 mg/kg/jum (esponimenti tal-frieħ ≥ 29 darba tal-valuri tal-bnedmin flMRHD).
English: Dyslipidaemia
Maltese: Pożoloġija
English: Qtern, fixed dose combination of saxagliptin and dapagliflozin, is indicated in adults aged 18 years and older with type 2 diabetes mellitus: - to improve glycaemic control when metformin and/or sulphonylurea (SU) and one of the monocomponents of Qtern do not provide adequate glycaemic control, - when already being treated with the free combination of dapagliflozin and saxagliptin.
Maltese: Qtern, kombinazzjoni ta' doża fissa ta' saxagliptin u dapagliflozin, huwa indikat fl-adulti li għandhom minn 18-il sena 'il fuq b'dijabete mellitus tip 2: - biex itejjeb il-kontroll gliċemiku meta metformin u/jew sulphonylurea (SU) u wieħed mill komponenti ta' Qtern ma jipprovdux kontroll gliċemiku adegwat, - meta jkunu diġà qegħdin jiġu kkurati bil-kombinazzjoni libera ta' dapagliflozin u saxagliptin.
English: Saxagliptin: The in vitro protein binding of saxagliptin and its major metabolite in human serum is negligible.
Maltese: L-irbit tal-proteina in vitro ta' saxagliptin u l-metabolit maġġuri tiegħu fis-serum uman.
English: Efficacy parameter
Maltese: Parametru ta' effikaċja
English: The safety and efficacy of the 5 mg saxagliptin/10 mg dapagliflozin fixed-dose combination was evaluated in three phase 3, randomised, double-blind, active/placebo-controlled clinical trials in 1169 adult subjects with type 2 diabetes mellitus.
Maltese: Is-sigurtà u l-effikaċja tal-kombinazzjoni tad-doża fissa ta' saxagliptin tal-5 mg/dapagliflozin tal10 mg kienu evalwati fi tliet provi kliniċi tal-Fażi 3, randomizzati, double-blind, kontroll attiv/plaċebo f'1169 individwu adult bid-dijabete mellitus tat-tip 2.
English: Dapagliflozin: Dapagliflozin exposure increased proportional to the increment in dapagliflozin dose over the range of 0.1 to 500 mg and its pharmacokinetics did not change with time upon repeated daily dosing for up to 24 weeks.
Maltese: L-esponiment ta' dapagliflozin żdied b'mod proporzjonat maż-żieda fid-doża ta' dapagliflozin matul il-firxa ta' 0.1 sa 500 mg u l-farmakokinetiċi tiegħu ma nbidlux biż-żmien maddożaġġ ripetut ta' kuljum sa 24 ġimgħa.
English: Saxagliptin/dapagliflozin combination: Overall, the pharmacokinetics of saxagliptin and dapagliflozin were not affected in clinically relevant manner when administered as Qtern compared with independent doses of saxagliptin and dapagliflozin.
Maltese: B'mod ġenerali, il-farmakokinetiċi ta' saxagliptin u dapagliflozin ma kinux affetwati b'mod klinikament relevanti meta mogħtija bħala Qtern meta mqabbla ma' dożi indipendenti ta' saxagliptin u dapagliflozin.
English: Dapagliflozin may add to the diuretic effect of thiazide and loop diuretics and may increase the risk of dehydration and hypotension (see section 4.4).
Maltese: Dapagliflozin jista' jżid mal-effett dijuretiku ta' thiazide u dijureitiċi ta' tip loop u jista' jżid ir-riskju ta' deidrazzjoni u pressjoni baxxa (ara sezzjoni 4.4).
English: Add-on therapy with saxagliptin in patients inadequately controlled on dapagliflozin plus metformin A 24-week randomised, double-blind, placebo-controlled study conducted on patients with type 2 diabetes mellitus and inadequate glycaemic control (HbA1c ≥ 7 % and ≤ 10.5 %) on metformin and dapagliflozin alone, compared the sequential addition of 5 mg saxagliptin to 10 mg dapagliflozin and metformin, to the addition of placebo to 10 mg dapagliflozin and metformin, 153 patients were randomised into the saxagliptin added to dapagliflozin plus metformin treatment group, and 162 patients were randomised into the placebo added to dapagliflozin plus metformin treatment group.
Maltese: %) fuq metformin u dapagliflozin waħedhom, qabbel iż-żieda sekwenzjali ta' saxagliptin tal-5 mg ma' dapagliflozin tal10 mg u metformin, 153 pazjent kienu randomizzati fil-grupp ta' kura ta' saxagliptin miżjud ma' dapagliflozin kif ukoll metformin, u 162 pazjent kienu randomizzati fil-grupp ta' kura ta' plaċebo miżjud ma' dapagliflozin kif ukoll metformin.
English: The coadministration of saxagliptin and CYP3A4/5 inducers, other than rifampicin (such as carbamazepine, dexamethasone, phenobarbital and phenytoin) has not been studied and may result in decreased plasma concentration of saxagliptin and increased concentration of its major metabolite.
Maltese: L-għoti ta' saxagliptin flimkien mal-induċituri CYP3A4/5, ħlief għal rifampicin (bħal carbamazepine, dexamethasone, phenobarbital u phenytoin) ma ġiex studjat u jista' jirriżulta f'konċentrazzjoni tal-plażma mnaqqsa ta' saxagliptin u konċentrazzjoni miżjuda tal-metabolit ewlieni tiegħu.
English: Film-coating
Maltese: Tnaqqis filvolum
English: Qtern 5 mg/10 mg film-coated tablets are light brown to brown, biconvex, round, film-coated tablets, with “5/10” printed on one side, and “1122” printed on the other side, in blue ink.
Maltese: Il-pilloli Qtern tal-5 mg/10 mg miksijin b'rita huma kannella ċar għal kannella, tondi u mżaqqa miżżewġ naħat, b'tondjatura ta' 0.8 cm, pilloli miksijin b'rita, b'"5/10" stampata fuq naħa waħda, u "1122" stampata fuq in-naħa l-oħra, b'linka blu.
English: They included adverse events of gastric neoplasm, pancreatic cancer with hepatic metastases, and invasive ductal breast carcinoma in the saxagliptin plus dapagliflozin plus metformin group.
Maltese: Dawn inkludew avvenimenti avversi ta' neoplażma gastrika, kanċer panreatiku b'metastasi fil-fwied, u karċinoma invasiva tal-kanal tas-sider fil-grupp ta' saxagliptin kif ukoll dapagliflozin kif ukoll metformin.
English: Dapagliflozin: There were no clinically relevant differences in systemic exposures between White, Black or Asian races.
Maltese: Ma kienx hemm differenzi klinikament relevanti fl-esponimenti sistemiċi bejn ir-razzez Bojod, Suwed jew Asjatiċi.
English: Qtern contains lactose
Maltese: Twissijiet u prekawzjonijiet
English: Placebo + saxagliptin 5 mg + metformin (N=160)
Maltese: Plaċebo + saxagliptin tal-5 mg + metformin
English: One component of the secondary composite endpoint, hospitalisation for heart failure, occurred at a greater rate in the saxagliptin group (3.5 %) compared with the placebo group (2.8 %), with nominal statistical significance favouring placebo [HR=1.27; (95 % CI 1.07, 1.51); P=0.007].
Maltese: Komponent wieħed tal-punt aħħari kompożit sekondarju, id-dħul fl-isptar għall-insuffiċjenza tal-qalb, seħħ f'rata akbar fil-grupp ta' saxagliptin (3.5 %) meta mqabbel mal-grupp ta' plaċebo (2.8 %), b'sinifikat statistiku nominali li jiffavorixxi plaċebo [HR=1.27; (95 % CI 1.07, 1.51); P=0.007]. Fatturi klinikament relevanti li jbassru żieda fir-riskju relattiv mal-lura b'saxagliptin ma setgħux jiġu identifikati b'mod definittiv.
English: The safety and efficacy of this medicinal product in children and adolescents aged 0 to < 18 years have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' dan il-prodott mediċinali fit-tfal u adolexxenti minn età 0 sa < 18-il sena ma ġewx determinati s'issa.
English: Saxagliptin/dapagliflozin combination: In the pooled safety analysis, the incidence of adverse events related to decreased renal function was 2.0 % subjects in the saxagliptin plus dapagliflozin plus metformin group, 1.8 % subjects in the saxagliptin plus metformin group, and 0.6 % subjects in the dapagliflozin plus metformin group.
Maltese: Fl-analiżi tas-sigurtà miġbura, l-inċidenza ta' avvenimenti avversi relatati ma' tnaqqis fil-funzjoni tal-kliewi kienet 2.0 % tal-individwi fil-grupp ta' saxagliptin kif ukoll dapagliflozin kif ukoll metformin, 1.8 % tal-individwi fil-grupp saxagliptin kif ukoll metformin, u 0.6 % tal-individwi fil-grupp dapagliflozin kif ukoll metformin.
English: The safety profile of the combined use of saxagliptin plus dapagliflozin in these trials for up to 52 weeks was comparable to the safety profiles for the mono-components.
Maltese: Ilprofil tas-sigurtà tal-użu kombinat ta' saxagliptin kif ukoll dapagliflozin f'dawn il-provi sa 52 ġimgħa kien komparabbli mal-profili tas-sigurtà tal-mono-komponenti.
English: Dapagliflozin: In interaction studies conducted in healthy subjects, using mainly a single-dose design, dapagliflozin did not alter the pharmacokinetics of metformin, pioglitazone [a CYP2C8 (major) and CYP3A4 (minor) substrate], sitagliptin, glimepiride (a CYP2C9 substrate), hydrochlorothiazide, bumetanide, valsartan, digoxin (a P-gp substrate) or warfarin (S-warfarin, a CYP2C9 substrate), or the anticoagulatory effects of warfarin as measured by INR.
Maltese: (minuri)], sitagliptin, glimepiride (substrat CYP2C9) hydrochlorothiazide, bumetanide, valsartan, digoxin (substrat P-gp) jew warfarin (S-warfarin, substrat CYP2C9), jew l-effetti antikoagulatorji ta' warfarin kif imkejla mill-INR.
English: Fournier's gangrene has to be treated immediately.
Maltese: Il-kankrena ta' Fournier għandha tiġi kkurata immedjatament.
English: UNIQUE IDENTIFIER HUMAN READABLE DATA
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: The majority of the genital infection adverse events were reported in females (84 % of subjects with a genital infection), were mild or moderate in intensity, of single occurrence, and most patients continued on therapy.
Maltese: Il-maġġoranza tal-avvenimenti avversi tal-infezzjoni ġenitali kienu rrapportati fin-nisa (84% tal-individwi b'infezzjoni ġenitali) kienu ħfief jew moderati fl-intensità, ta' okkorrenza waħda u ħafna mill-pazjenti komplew bit-terapija.
English: - rash
Maltese: OĦRAJN
English: Saxagliptin/dapagliflozin combination: In the pooled safety analysis, urinary tract infections (UTIs) were balanced across the 3 treatment groups: 5.7 % in the saxagliptin plus dapagliflozin plus metformin group, 7.4 % in the saxagliptin plus metformin group and 5.6 % in the dapagliflozin plus metformin group.
Maltese: Fl-analiżi dwar is-sigurtà miġbura, l-infezzjonijiet fl-apparat tal-awrina (UTIs) kienu bbilanċjati madwar it-3 gruppi ta' kura: 5.7 % fil-grupp saxagliptin kif ukoll dapagliflozin kif ukoll metformin, 7.4 % fil-grupp kif ukoll metformin u 5.6 % fil-grupp dapagliflozin kif ukoll metformin.
English: The NOAEL for developmental toxicityis associated with a maternal systemic exposure 19 times the human values at the MRHD.
Maltese: In-NOAEL għat-tossiċità tal-iżvilupp hija assoċjata ma' esponiment sistemiku matern ta' 19-il darba tal-valuri tal-bnedmin fl-MRHD).
English: If Fournier's gangrene is suspected, Qtern should be discontinued and prompt treatment (including antibiotics and surgical debridement) should be instituted.
Maltese: Jekk ikun hemm suspett ta' kankrena ta' Fournier, Qtern għandu jitwaqqaf u għandha tinbeda kura minnufih (li tinkludi antibijotiċi u tneħħija kirurġika).
English: Necrotising fasciitis of the perineum (Fournier's gangrene) Post-marketing cases of necrotising fasciitis of the perineum (also known as Fournier's gangrene) have been reported in female and male patients taking SGLT2 inhibitors.
Maltese: Faxxite nekrotizzanti tal-perinew (kankrena ta' Fournier) Ġew irrappurtati każijiet ta' wara t-tqegħid fis-suq ta' faxxite nekrotizzanti tal-perinew (magħrufa wkoll bħala kankrena ta' Fournier) f'pazjenti nisa u rġiel li kienu qed jieħdu inibituri ta' SGLT2.
English: After an oral glucose load, this produced in a 2- to 3-fold increase in circulating levels glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), decreased glucagon concentrations, and increased beta-cell responsiveness, resulting in higher insulin and C-peptide concentrations.
Maltese: Wara kwantità ta' glucose mill-ħalq, dan ipproduċa f'żieda ta' darbtejn sa tliet darbiet aktar f'livelli ta' ċirkolazzjoni ta' peptide-1 (GLP-1) li qisu glucagon u polypeptide insulinotropika li tiddependi mill-glucose (GIP), konċentrazzjonijiet imnaqqsa tal-glucagon, u żieda f'kemm juru rispons iċ-ċelloli beta, li jirriżulta f'konċentrazzjonijiet ogħla ta' insulina u C-peptide.
English: In the pooled safety data, urinary tract infections were frequently reported across the 3 treatment groups: 5.7 % in the saxagliptin plus dapagliflozin plus metformin group 7.4 % in the saxagliptin plus metformin group and 5.6 % in the dapagliflozin plus metformin group at 52 weeks (see section 4.8).
Maltese: Fid-data dwar is-sigurtà miġbura, l-infezzjonijiet fl-apparat tal-awrina kienu rrapportati b'mod frekwenti madwar it-3 gruppi ta' kura: 5.7 % fil-grupp saxagliptin kif ukoll dapagliflozin kif ukoll metformin, 7.4 % fil-grupp ta' saxagliptin kif ukoll metformin u 5.6 % fil-grupp dapagliflozin kif ukoll metformin wara 52 ġimgħa (ara sezzjoni 4.8).
English: The effect in HbA1c observed at Week 24 was sustained at Week 52.
Maltese: L-effett f'HbA1c osservat filĠimgħa 24 kien sostnut fil-Ġimgħa 52.
English: Saxagliptin: Saxagliptin was rapidly absorbed after oral administration in the fasted state, with maximum plasma concentrations (Cmax) of saxagliptin and its major metabolite attained within 2 and 4 hours (Tmax), respectively.
Maltese: Saxagliptin kien assorbit malajr wara li ngħata mill-ħalq fl-istat ta' sawm, b'konċentrazzjonijiet massimi ta' plażma (Cmax) ta' saxagliptin u l-metabolit maġġuri tiegħu milħuqa fi żmien sagħtejn sa' 4 sigħat (Tmax), rispettivament.
English: In a number of cases, the presentation of the condition was atypical with only moderately increased blood glucose values, below 14 mmol/litres (250 mg/dl).
Maltese: F'numru ta' każijiet, ilpreżentazzjoni tal-kundizzjoni kienet atipika b'żieda moderata biss tal-valuri tal-glucose fid-demm, taħt 14 mmol/l (250 mg/dl).
English: The group with dapagliflozin sequentially added to saxagliptin and metformin achieved statistically significant (p-value < 0.0001) greater reductions in HbA1c versus the group with placebo sequentially added to saxagliptin plus metformin group at 24 weeks (see table 4).
Maltese: Il-grupp b'dapagliflozin miżjud b'mod sekwenzjali ma' saxagliptin u metformin laħaq żidiet akbar (pvalur < 0.0001) li huma statistikament sinifikanti f'HbA1c kontra l-grupp bi plaċebo miżjud b'mod sekwenzjali mal-grupp ta' saxagliptin kif ukoll metformin f'24 ġimgħa (ara tabella 4).
English: Interference with 1,5-anhydroglucitol (1,5-AG) assay Monitoring glycaemic control with 1,5-AG assay is not recommended as measurements of 1,5-AG are unreliable in assessing glycaemic control in patients taking SGLT2 inhibitors.
Maltese: Il-monitoraġġ tal-kontroll gliċemiku b'assaġġ ta' 1,5-AG mhuwiex irrakkomandat peress li r-riżultati mkejla ta' 1,5-AG mhumiex affidabbli fil-valutazzjoni tal-kontroll gliċemiku f'pazjenti li jieħdu inibituri SGLT2.
English: pruritus
Maltese: prurite
English: Effects on fertility were observed using saxagliptin in male and female rats at high doses producing overt signs of toxicity (see section 5.3).
Maltese: L-effetti fuq ilfertilità ġew osservati bl-użu ta' saxagliptin fil-firien irġiel u nisa f'dożi għoljin li jipproduċu sinjali ċari ta' tossiċità (ara sezzjoni 5.3).
English: • Prior to initiation of this medicinal product and at least yearly, thereafter (see sections 4.2, 4.8, 5.1 and 5.2).
Maltese: • Qabel il-bidu ta' dan il-prodott mediċinali u tal-anqas kull sena, 'il quddiem (ara sezzjonijiet 4.2, 4.8, 5.1 u 5.2).
English: This medicinal product is not recommended for use in patients at risk of volume depletion (e.g. receiving loop diuretics) (see section 4.5) or who are volume depleted, e.g. due to acute illness (such as acute gastrointestinal illness with nausea, vomiting or diarrhoea).
Maltese: Dan il-prodott mediċinali mhuwiex rakkomandat għall-użu f'pazjenti f'riskju ta' tnaqqis fil-volum (eż. dawk li qed jirċievu dijuretiċi ta' tip loop) (ara sezzjoni 4.5) jew li għandhom tnaqqis fil-volum, jiġifieri minħabba mard akut (bħall-mard gastrointestinali akut bid-dardir, bir-rimettar jew biddijarea).
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 jibblokka l-assorbiment mill-ġdid tal-glucose iffiltrat missegment S1 ta' tubulu tal-kliewi, effettivament ibaxxi l-glucose fid-demm b'mod dipendenti fuq ilglucose u b'mod indipendenti mill-insulina.
English: The primary safety (non-inferiority) and efficacy (superiority) endpoint was a composite endpoint consisting of the time-to-first occurrence of any of the following major adverse CV events (MACE): CV death, nonfatal myocardial infarction, or nonfatal ischemic stroke.
Maltese: Il-punt aħħari primarju tas-sigurtà (non-inferjorità) u effikaċja (superjorità) kien punt aħħari kompost li jikkonsisti fiż-żmien biex ikun-hemm-l-ewwel okkorrenza ta' kwalunkwe mill-avvenimenti CV avversi maġġuri li ġejjin (MACE):
English: Approximately 70 g of glucose was excreted in the urine per day (corresponding to 280 kcal/day) at a dapagliflozin dose of 10 mg/day in subjects with type 2 diabetes mellitus for 12 weeks.
Maltese: Bejn wieħed u ieħor 70 g ta' glucose kienu eliminati fl-awrina kuljum (jikkorrespondu għal 280 kcal/jum) b'doża ta' dapagliflozin ta' 10 mg/jum f'individwi bid-dijabete mellitus tat-tip 2 għal 12-il ġimgħa.
English: In subjects ≥ 65 years of age, a higher proportion of subjects treated with dapagliflozin had adverse reactions related to volume depletion and renal impairment or failure compared with placebo (see section 4.8).
Maltese: F'individwi ≥ 65 sena, proporzjon ogħla ta' individwi kkurati b'dapagliflozin kellhom reazzjonijiet avversi relatati ma' tnaqqis fil-volum u indeboliment tal-kliewi jew insuffiċjenza meta mqabbel mal plaċebo (ara sezzjoni 4.8).
English: - Urinary tract infection, seen commonly (may affect up to 1 in 10 people).
Maltese: - Infezzjoni fl-apparat tal-awrina, komuni li tidher (tista' taffetwa sa persuna 1 minn kull 10).
English: Printing ink
Maltese: Jekk tinsa tieħu Qtern
English: Vulvovaginitis, balanitis and related genital infections Saxagliptin/dapagliflozin combination: The reported adverse events of vulvovaginitis, balanitis and related genital infections from pooled safety analysis were reflective of the safety profile of dapagliflozin.
Maltese: Vulvovaginitis, balanitis u infezzjonijiet ġenitali relatati Kombinament saxagliptin/dapagliflozin:
English: In studies conducted in healthy subjects, neither the pharmacokinetics of saxagliptin nor its major metabolite were meaningfully altered by metformin, glibenclamide, pioglitazone, digoxin, simvastatin, omeprazole, antacids or famotidine.
Maltese: Fi studji li twettqu f'individiwi f'saħħithom, la l-farmakokinetiċi ta' saxagliptin u lanqas il-metabolit ewlieni tiegħu ma tbiddlu b'mod sinfikattiv minn metformin, glibenclamide, pioglitazone, digoxin, simvastatin, omeprazole, antacids jew famotidine.
English: This decrease in mean absolute lymphocyte count was not associated with clinically relevant adverse reactions.
Maltese: Dan it-tnaqqis fl-għadd ta' limfoċiti assolut medju ma kienx assoċjat ma' reazzjonijiet avversi klinikament relevanti.
English: Qtern 5 mg/10 mg film-coated tablets
Maltese: Qtern 5 mg/10 mg pilloli miksijin b'rita
English: The group with saxagliptin sequentially added to dapagliflozin and metformin achieved statistically significant (p-value < 0.0001) greater reductions in HbA1c versus the group with placebo sequentially added to dapagliflozin plus metformin group at 24 weeks (see table 4).
Maltese: Il-grupp b'saxagliptin miżjud b'mod sekwenzjali ma' dapagliflozin u metformin laħaq żidiet akbar (pvalur < 0.0001) li huma statistikament sinifikanti f'HbA1c kontra l-grupp bi plaċebo miżjud b'mod sekwenzjali mal-grupp ta' saxagliptin kif ukoll metformin f'24 ġimgħa (ara tabella 4).
English: Saxagliptin: After a single dose of saxagliptin in subjects with mild, moderate or severe renal impairment (or ESRD) classified on the basis of creatinine clearance the mean AUC values of saxagliptin were 1.2-, and up to 2.1- and 4.5- fold higher, respectively, than AUC values in subjects with normal renal function.
Maltese: Wara doża waħda ta' saxagliptin f'individwi b'indeboliment ħafif, moderat, jew sever tal-kliewi (jew ERSD) abbażi tat-tneħħija tal-krejatinina il-valuri medji tal-AUC ta' saxagliptin kienu 1.2-, u sa 2.1- u 4.5- darbiet ogħla, rispettivament, mill-valuri tal-AUC f'individwi b'funzjoni normali tal-kliewi.
English: The saxagliptin and dapagliflozin group achieved significantly greater reductions in HbA1c versus either the saxagliptin group or dapagliflozin group at 24 weeks (see table 2).
Maltese: Il-grupp ta' saxagliptin u dapagliflozin laħaq tnaqqis akbar b'mod sinifikanti fl-HbA1c kontra jew ilgrupp ta' saxagliptin jew il-grupp ta' dapagliflozin f'24 ġimgħa (ara tabella 2).