FrancophonIA/ELRC3.0 huggingface dataset:
English: Use of alternative methods to monitor glycaemic control is advised.
Maltese: Huwa rakkomandat użu ta' metodi alternattivi biex jiġi mmonitorjat il-kontroll gliċemiku.
English: Data from the saxagliptin and dapagliflozin plus metformin treatment arms of the three individual studies included in the pooled analysis, 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: Data mill-fergħat ta' trattament ta' saxagliptin u dapagliflozin u metformin tat-tliet studji individwali inklużi fl-analiżi miġbura, uriet xejriet ta' żidiet perċentwali medji mil-linja bażi (mqarrbin għall-eqreb għaxar) fil-kolesterol totali (Total C), (li jvarjaw minn 0.4% sa 3.8%), LDL-C (li jvarjaw minn 2.1% sa 6.9%), u HDL-C (li jvarjaw minn 2.3% sa 5.2%) flimkien ma' tnaqqis perċentwali medju fit-trigliċeridi (li jvarjaw minn -3.0% sa -10.
English: The proportion of patients achieving HbA1c < 7% at week 24 for add-on therapy with saxagliptin 5 mg to dapagliflozin 10 mg plus metformin trial was higher in the saxagliptin 5 mg and dapagliflozin 10 mg plus metformin group 35.3% (95% CI [28.2, 42.2]) compared to the placebo plus dapagliflozin 10 mg plus metformin group 23.1% (95% CI [16.9, 29.3]).
Maltese: Il-proporzjon ta' pazjenti li kisbu HbA1c < 7.0% f'ġimgħa 24 fit-terapija miżjuda mal-prova ta' saxagliptin 5 mg ma' dapagliflozin 10 mg u metformin kien ogħla fil-grupp ta' dapagliflozin 10 mg u saxagliptin 5 mg u metformin 35.3% (95% CI [28.2, 42.2]) meta mqabbel mal-grupp ta' plaċebo u dapagliflozin 10 mg u metformin 23.1% (95% CI [16.9, 29.3]).
English: Possible signs of losing too much fluid from your body are listed in section 4; medicines that may change the amount of metformin in your blood, especially if you have reduced kidney function (such as verapamil, dolutegravir, ranolazine, trimethoprime, vandetanib, isavuconazole, crizotinib or olaparib); if you are using medicines containing any of the following active substances: o beta-2 agonists - used to treat asthma, o carbamazepine, phenobarbital or phenytoin - medicines for preventing fits (seizure) or some types of long-term pain, o cimetidine - used to treat stomach problems, o corticosteroids such as dexamethasone - used to treat inflammation in diseases like asthma and arthritis, o diltiazem - used to treat angina (chest pain) and lower blood pressure, o ketoconazole tablets - used to treat Cushing's syndrome (when the body produces an excess of cortisol), o rifampicin - an antibiotic used to treat infections such as tuberculosis, o non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and celecoxib (a
Maltese: Is-sinjali possibbli ta' telf ta' wisq fluwidu minn ġismek huma elenkati fis-sezzjoni 4. mediċini li jistgħu jibdlu l-ammont ta' metformin fid-demm tiegħek, speċjalment jekk għandek funzjoni tal-kliewi mnaqqsa (bħal verapamil, dolutegravir, ranolazine, trimethoprime, vandetanib, isavuconazole, crizotinib jew olaparib). jekk qed tuża mediċini li fihom xi waħda mis-sustanzi attivi li ġejjin: o agonisti ta' beta-2 - użati biex jittrattaw l-ażma. o carbamazepine, phenobarbital jew phenytoin - mediċini għall-prevenzjoni tal-aċċessjonijiet (puplesija) jew xi tipi ta' uġigħ fit-tul. o cimetidine - użat biex jittratta problemi tal-istonku.
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 5 mg and dapagliflozin 10 mg added concurrently to metformin, versus saxagliptin 5 mg (DPP-4 inhibitor) or dapagliflozin 10 mg (SGLT2 inhibitor) added to metformin.
Maltese: Total ta' 534 pazjent adult b'dijabete mellitus tat-tip 2 u b'kontroll gliċemiku inadegwat fuq metformin biss (HbA1c ≥ 8% u ≤ 12%), ipparteċipaw f'din il-prova ta' 24 ġimgħa, randomizzata, double-blind, b'superjorità kkontrollata b'kumparatur attiv biex tqabbel il-kombinazzjoni ta' saxagliptin 5 mg u dapagliflozin 10 mg miżjuda b'mod konkurrenti ma' metformin, kontra saxagliptin 5 mg (inibitur ta' DPP-4) jew dapagliflozin 10 mg (inibitur ta' SGLT2) miżjuda ma' metformin.
English: At week 52, adjusted mean changes from baseline in HbA1c in the saxagliptin and dapagliflozin plus metformin and placebo and dapagliflozin plus metformin groups were -0.38% (95% CI: -0.53, -0.22) and 0.05% (95% CI: -0.11, 0.20), respectively.
Maltese: F'ġimgħa 52, il-bidliet medji aġġustati millinja bażi fl-HbA1c fil-gruppi ta' saxagliptin u dapagliflozin u metformin u plaċebo u dapagliflozin u metformin kienu -0.38% (95% CI: -0.53, -0.22) u 0.05% (95% CI: -0.
English: Other side effects when taking Qtrilmet include:
Maltese: Effetti sekondarji oħra meta tieħu Qtrilmet jinkludu:
English: 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 tas-sigurtà miġbura, l-infezzjonijiet fl-apparat tal-awrina (UTIs) kienu bbilanċjati fost it3 gruppi ta' trattament: 5.7 % fil-grupp ta' saxagliptin u dapagliflozin u metformin, 7.4 % fil-grupp ta' saxagliptin u metformin, u 5.6 % fil-grupp ta' dapagliflozin u metformin.
English: A 52-week randomised, double-blind, active-controlled, parallel-group study with a blinded 104-week extension compared once daily saxagliptin 5 mg and dapagliflozin 10 mg plus metformin to glimepiride (a sulphonylurea) up-titrated 1-6 mg plus placebo with metformin in T2DM patients with inadequate glycaemic control (HbA1c ≥ 7.5% and ≤ 10.5%) on metformin alone.
Maltese: Studju ta' 52 ġimgħa, randomizzat, double-blind, ikkontrollat b'mod attiv, ta' grupp parallel b'estensjoni blinded ta' 104 ġimgħat qabbel saxagliptin 5 mg u dapagliflozin 10 mg u metformin darba kuljumma' glimepiride (sulphonylurea) titrat 'il fuq 1-6 mg u plaċebo ma' metformin f'pazjenti T2DM b'kontroll gliċemiku inadegwat (HbA1c ≥ 7.5% u ≤ 10.
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 tal-fwied ħafif jew moderat (Child-Pugh klassijiet A u B) is-Cmax u l-AUC medji ta' dapagliflozin kienu sa 12 % u 36 % ogħla, rispettivament, meta mqabbel ma' individwi ta' kontroll imqabbla b'saħħithom.
English: Consideration of such etiology is recommended if a patient presents with megaloblastic anaemia.
Maltese: Hija rakkomandata kunsiderazzjoni ta' etjoloġija bħal din jekk pazjent ikollu anemija megaloblastika.
English: Some medicinal products can adversely affect renal function which may increase the risk of lactic acidosis, e.g. NSAIDs, including selective cyclo-oxygenase (COX) II inhibitors, ACE inhibitors, angiotensin II receptor antagonists and diuretics, especially loop diuretics.
Maltese: NSAIDs, inkluż inibituri selettivi ta' cyclo-oxygenase (COX) II, inibituri ta' ACE, antagonisti tar-riċettur tal-anġjotensina
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 konkomitanti ta' saxagliptin u indutturi ta' CYP3A4/5, minbarra rifampicin (bħal carbamazepine, dexamethasone, phenobarbital, u phenytoin) ma ġiex studjat u jista' jirriżulta f'konċentrazzjoni mnaqqsa ta' saxagliptin fil-plażma u konċentrazzjoni miżjuda tal-metabolit maġġuri tiegħu.
English: This medicinal product has not been studied in severe renal impairment (GFR < 30 mL/min) or end-stage renal disease (ESRD).
Maltese: Dan il-prodott mediċinali ma ġiex studjat f'indeboliment sever tal-kliewi (GFR < 30 mL/min) jew b'marda tal-kliewi fl-aħħar stadju (ESRD, end-stage renal disease).
English: Adverse reactions were reported in ≥ 2% of subjects with any of the mono-components, and ≥ 1% more than placebo, but not in the pooled safety analysis.
Maltese: Ir-reazzjonijiet avversi ġew irrappurtati fi ≥ 2% tal-individwi bi kwalunkwe wieħed mill-monokomponenti, u ≥ 1% aktar mill-plaċebo, iżda mhux fl-analiżi tas-sigurtà miġbura.
English: In the pooled safety analysis, 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: Fl-analiżi tas-sigurtà miġbura, l-avvenimenti relatati ma' tnaqqis fil-volum (pressjoni baxxa, deidratazzjoni u ipovolemija) kienu jirriflettu l-avvenimenti avversi b'dapagliflozin u ġew irrappurtati f'żewġ individwi (0.4%) fil-grupp ta' saxagliptin u dapagliflozin u metformin (avveniment avvers serju [SAE] ta' sinkope u AE ta' tnaqqis fl-output tal-awrina), u 3 individwi (0.9%) fil-grupp ta' dapagliflozin u metformin (2 AEs ta' sinkope u 1 ta' pressjoni baxxa).
English: Metformin/saxagliptin/dapagliflozin combination: In the pooled safety analysis for Qtrilmet, 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 għal Qtrilmet, l-inċidenza ta' avvenimenti avversi relatati ma' funzjoni tal-kliewi mnaqqsa kienet 2.0 % individwi filgrupp ta' saxagliptin u dapagliflozin u metformin, 1.8 % individwi fil-grupp ta' saxagliptin u metformin, u 0.6 % individwi fil-grupp ta' dapagliflozin u metformin.
English: The group with saxagliptin 5 mg sequentially added to dapagliflozin 10 mg 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 2).
Maltese: Il-grupp b'saxagliptin 5 mg sekwenzjalment miżjud ma' dapagliflozin 10 mg u metformin kiseb tnaqqis akbar statistikament sinifikanti (valur p < 0.0001) fl-HbA1c kontra l-grupp bil-plaċebo sekwenzjalment miżjud mal-grupp ta' dapagliflozin u metformin wara 24 ġimgħa (ara Tabella 4).
English: Use with medicinal products known to cause hypoglycaemia Saxagliptin and dapagliflozin can individually increase the risk of hypoglycaemia when combined with insulin or an insulin secretagogue.
Maltese: Użu ma' prodotti mediċinali magħrufa li jikkawżaw ipogliċemija Dapagliflozin u saxagliptin jistgħu individwalment iżidu r-riskju ta' ipogliċemija meta jiġu kombinati ma' insulina jew sekretagog tal-insulina.
English: Each tablet contains a fixed dose of metformin, saxagliptin and dapagliflozin (see section 2).
Maltese: Kull pillola fiha doża fissa ta' metformin, saxagliptin u dapagliflozin (ara sezzjoni 2).
English: Immune related findings of minimal, nonprogressive, lymphoid hyperplasia in spleen, lymph nodes and bone marrow with no adverse sequelae have been reported in all species tested at exposures starting from 7 times the RHD.
Maltese: Ġew irrappurtati sejbiet relatati mas-sistema immuni ta' iperpasija minimali, mhux progressiva, tallimfojde fil-milsa, limfonodi u mudullun b'sekwenzi mhux avversi fl-ispeċi kollha ttestjati b'esponimenti li jibdew minn 7 darbiet tal-RHD.
English: Cardiovascular death, MI, and stroke were observed with a hazard ratio of 0.77 (95% CI: 0.54, 1.10).
Maltese: Mewt kardjovaskulari, MI, u puplesija ġew osservati bi proporzjon ta' periklu ta' 0.77 (95% CI: 0.54,
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha inqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment “mingħajr sodium”.
English: Qtrilmet 1,000 mg/2.5 mg/5 mg tablets metformin HCl/saxagliptin/dapagliflozin
Maltese: Qtrilmet 1,000 mg/2.5 mg/5 mg pilloli metformin HCl/saxagliptin/dapagliflozin
English: If Fournier's gangrene is suspected, Qtrilmet should be discontinued and prompt treatment (including antibiotics and surgical debridement) should be instituted.
Maltese: Jekk tiġi suspettata gangrene ta' Fournier, Qtrilmet għandu jitwaqqaf u għandu jinbeda trattament minnufih (li jinkludi antibijotiċi u debridement kirurġiku).
English: Saxagliptin: Race was not identified as a statistically significant covariate on the apparent clearance of saxagliptin and its metabolite.
Maltese: Ir-razza ma ġietx identifikata bħala kovarjat statistikament sinifikanti fuq it-tneħħija apparenti ta' saxagliptin u l-metabolit tiegħu.
English: Of the 1,169 subjects treated in the pooled safety data from the 3 clinical trials, 1,007 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-1,169 individwu ttrattati fid-data tas-sigurtà miġbura mit-3 provi kliniċi, 1,007 individwi (86.1%) kellhom < 65 sena, 162 individwu (13.9%) kellhom ≥ 65 sena u 9 individwi (0.8%) kellhom ≥ 75 sena.Ġeneralment, l-avvenimenti avversi l-aktar komuni li ġew irrappurtati f'≥ 65 sena kienu simili għal < 65 sena.
English: Qtrilmet 850 mg/2.5 mg/5 mg modified-release tablets Qtrilmet 1,000 mg/2.5 mg/5 mg modified-release tablets
Maltese: Qtrilmet 850 mg/2.5 mg/5 mg pilloli b'rilaxx modifikat Qtrilmet 1,000 mg/2.5 mg/5 mg pilloli b'rilaxx modifikat
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-seru uman huwa negliġibbli.
English: The adjusted percent of subjects with HbA1c < 7.0% at week 52 was 29.3% in the saxagliptin and dapagliflozin plus metformin group and 13.1% in the placebo and dapagliflozin plus metformin group.
Maltese: Il-perċentwal aġġustat ta' individwi b'HbA1c < 7.0% f'ġimgħa 52 kien 29.3 % fil-grupp ta' saxagliptin u dapagliflozin u metformin u 13.1 % fil-grupp ta' plaċebo u dapagliflozin u metformin.
English: HbA1c subgroup analysis by baseline HbA1c at week 24 in randomised subjects
Maltese: Tabella 3. Analiżi tas-sottogrupp ta' HbA1c skont HbA1c fil-linja bażi f'Ġimgħa 24 f'individwi randomizzati
English: In the study of concomitant addition of saxagliptin and dapagliflozin, 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 and 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 ta' żieda konkomitanti ta' saxagliptin u dapagliflozin, il-bidla medja aġġustata fil-piż talġisem f'ġimgħa 24 (minbarra data wara salvataġġ) kienet −2.05 kg (95% CI [−2.52, −1.58]) fil-grupp ta' saxagliptin 5 mg u dapagliflozin 10 mg u metformin u −2.39 kg (95% CI [−2.87, −1.91]) fil-grupp ta' dapagliflozin 10 mg u metformin, filwaqt li l-grupp ta' saxagliptin 5 mg u metformin ma kellu lebda bidla (0.00 kg) (95% CI [−0.
English: The mean duration of T2DM when entering the study was 7.6 years, mean baseline HbA1c of 8.2%.
Maltese: Id-durata medja ta' T2DM mad-dħul fl-istudju kienet 7.6 snin, HbA1c fil-linja bażi medja ta' 8.2 %.
English: The prospective randomised (UKPDS) study has established the long-term benefit of intensive blood glucose control in type 2 diabetes.
Maltese: Metformin L-istudju prospettiv randomizzat (UKPDS) stabbilixxa l-benefiċċju fit-tul ta' kontroll ta' glucose fiddemm intensiv f'dijabete tat-tip 2.
English: In patients at increased risk of further progression of renal impairment and in the elderly, renal function should be assessed more frequently, e.g. every 3-6 months.
Maltese: F'pazjenti b'riskju miżjud ta' progressjoni ulterjuri ta' indeboliment talkliewi u fl-anzjani, il-funzjoni tal-kliewi għandha tiġi vvalutata aktar ta' spiss, eż. kull 3-6 xhur.
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 bid-demm/bil-mukus u enteropatija b'dożi ogħla b'NOEL 4 u darbtejn l-esponiment fil-bniedem għal saxagliptin u lmetabolit maġġuri, rispettivament, bl-RHD.
English: Qtrilmet 850 mg/2.5 mg/5 mg modified-release tablets Qtrilmet 1,000 mg/2.5 mg/5 mg modified-release tablets metformin hydrochloride/saxagliptin/dapagliflozin
Maltese: Qtrilmet 850 mg/2.5 mg/5 mg pilloli b'rilaxx modifikat Qtrilmet 1,000 mg/2.5 mg/5 mg pilloli b'rilaxx modifikat metformin hydrochloride/saxagliptin/dapagliflozin
English: Gastrointestinal symptoms (subsumed terms included nausea, vomiting, diarrhoea, abdominal pain, and loss of appetite) occur most frequently during initiation of therapy and resolve spontaneously in most cases.
Maltese: Sintomi gastrointestinali (termini sottoskritti inkludew dardir, rimettar, dijarea, uġigħ addominali, u telf ta' aptit) iseħħu bl-aktar mod frekwenti waqt il-bidu tat-terapija u jiġu riżolti spontanjament f'ħafna mill-każijiet.
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: Tossiċità għall-iżvilupp addizzjonali ġiet limitata għal tnaqqis relatat mad-doża fil-piżijiet tal-ġisem tal-frieħ, u ġiet osservata biss bid-dożi ta' ≥ 15 mg/kg/jum (esponimenti fil-frieħ ta' ≥ 29 darbiet il-valuri tal-bniedem blMRHD).
English: Therapy with saxagliptin 5 mg and dapagliflozin 10 mg in patients inadequately controlled on metformin
Maltese: Terapija b'saxagliptin 5 mg u dapagliflozin 10 mg f'pazjenti kkontrollati b'mod inadegwat fuq metformin
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 2).
Maltese: Il-grupp b'dapagliflozin sekwenzjalment miżjud ma' saxagliptin u metformin kisbu tnaqqis akbar statistikament sinifikanti (valur p < 0.0001) fl-HbA1c kontra l-grupp bi plaċebo sekwenzjalment miżjud ma' saxagliptin u metformin wara 24 ġimgħa (ara Tabella 4).
English: Dapagliflozin: There were no clinically relevant differences in systemic exposures between White, Black or Asian races.
Maltese: Ma kien hemm l-ebda differenza klinikament rilevanti fl-esponimenti sistemiċi bejn razez Bojod, Suwed jew Asjatiċi.
English: Females had approximately 25% higher systemic-exposure values for saxagliptin, this difference is considered not clinically relevant.
Maltese: In-nisa kellhom valuri ta' esponiment sistemiku madwar 25 % ogħla għal saxagliptin, din id-differenza titqies bħala mhux klinikament rilevanti.
English: This medicinal product should not be used in patients with moderate to severe renal impairment (patients with GFR < 60 mL/min (see sections 4.4, 4.8, 5.1 and 5.2).
Maltese: Dan il-prodott mediċinali m'għandux jintuża f'pazjenti b'indeboliment tal-kliewi moderat sa sever (pazjenti b'GFR < 60 mL/min (ara sezzjonijiet 4.4, 4.8, 5.1 u 5.2).
English: Qtrilmet 850 mg/2.5 mg/5 mg tablets metformin HCl/saxagliptin/dapagliflozin
Maltese: Qtrilmet 850 mg/2.5 mg/5 mg pilloli metformin HCl/saxagliptin/dapagliflozin
English: A 24-week randomised, open-label, active-controlled, parallel-group study with a 28-week extension compared orally once daily saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without a sulphonylurea to titrated subcutaneous insulin glargine plus metformin with or without a sulphonylurea in T2DM patients with inadequate glycaemic control (HbA1c ≥ 8.0% and ≤ 12.0%).
Maltese: Studju ta' 24 ġimgħa, randomizzat, open-label, ikkontrollat b'mod attiv, ta' grupp parallel b'estensjonit ta' 28 ġimgħa qabbel saxagliptin 5 mg u dapagliflozin 10 mg u metformin oralment darba kuljum ma' jew mingħajr sulphonylurea ma' insulin glargine u metformin titrati taħt il-ġilda ma' jew mingħajr sulphonylurea f'pazjenti T2DM b'kontroll gliċemiku inadegwat (HbA1c ≥ 8.0% and ≤ 12.0%).
English: Alcohol intoxication is associated with an increased risk of lactic acidosis, particularly in the case of fasting, malnutrition or hepatic impairment due to the metformin active substance of this medicinal product (see section 4.4).
Maltese: Intossikazzjoni tal-alkoħol hija assoċjata ma' riskju miżjud ta' aċidożi lattika, partikolarment fil-każ ta' sawm, malnutrizzjoni jew indeboliment tal-fwied minħabba s-sustanza attiva metformin ta' dan ilprodott mediċinali (ara sezzjoni 4.4).
English: EXPIRY DATE
Maltese: FOLJI KALENDARJI
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 wkoll inibitur ta' DPP-4 selettiv, riversibbli, kompetittiv b'nofs il-qawwa ta' saxagliptin.
English: Like for all diabetic patients it is important to counsel patients on routine preventative foot care.
Maltese: Bħal għall-pazjenti dijabetiċi kollha huwa importanti li l-pazjenti jiġu kkonsultati dwar kura tas-saqajn preventiva ta' rutina.
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 ta' età ta' ≥ 65 sena, proporzjon ogħla ta' individwi ttrattati b'dapagliflozin kellhom reazzjonijiet avversi relatati ma' tnaqqis fil-volum u indeboliment jew insuffiċjenza tal-kliewi meta mqabbel mal-plaċebo (ara sezzjoni 4.8).
English: Saxagliptin: Across clinical studies in the saxagliptin programme a small decrease in absolute lymphocyte count was observed, approximately 100 cells/microL relative to placebo.
Maltese: Fl-istudji kliniċi fil-programm ta' saxagliptin, ġie osservat tnaqqis żgħir fl-għadd assolut tal-limfoċiti, madwar 100 ċellula/microl relattiv għall-plaċebo.
English: SAVOR was a CV outcome trial in 16,492 patients with HbA1c ≥ 6.5% and < 12% (12,959 with established CV disease; 3,533 with multiple risk factors only) who were randomised to saxagliptin (n=8,280) or placebo (n=8,212) added to regional standards of care for HbA1c and CV risk factors.
Maltese: 3,533 b'fatturi ta' riskju multipli biss) li ġew randomizzati għal saxagliptin (n=8,280) jew plaċebo (n=8,212) miżjud ma' standards reġjonali ta' kura għal HbA1c u fatturi ta' riskju ta' CV.
English: The difference in mean SBP between treatment groups was -3.6 mmHg (95% CI [-6.3, -1.0] p = 0.007).
Maltese: Id-differenza fis-SBP medja bejn il-gruppi ta' trattament kienet -3.6 mmHg (95% CI
English: Vulvovaginitis, balanitis and related genital infection include the following preferred terms: vulvovaginal mycotic infection, balanoposthitis, genital infection fungal, vaginal infection, and vulvovaginitis.
Maltese: Vulvovaġinite, balanite u infezzjoni ġenitali relatati tinkludi t-termini ppreferuti li ġejjin: infezzjoni mikotika vulvovaġinali, balanopostite, infezzjoni fungali ġenitali, infezzjoni vaġinali, u vulvovaġinite.