FrancophonIA/ELRC3.0 huggingface dataset:
English: There is limited experience in clinical trials in patients with hepatic impairment.
Maltese: Hemm esperjenza limitata fi provi kliniċi f'pazjenti b'indeboliment epatiku.
English: Placebo + insulin ± oral glucose-lowering medicinal products2
Maltese: Plaċebo + insulina ± prodotti mediċinali orali li jbaxxu l-glukows b
English: Fifty-two percent (52%) had mild renal impairment and 11% had moderate renal impairment.
Maltese: Tnejn u ħamsin fil-mija (52%) kellhom indeboliment renali ħafif u 11% kellhom indeboliment renali moderat.
English: Urinary tract infections were more frequently reported for dapagliflozin 10 mg compared to placebo (4.7% versus 3.5%, respectively; see section 4.4).
Maltese: L-infezzjonijiet fil-passaġġ tal-awrina kollha rrappurtati f'individwi b'dapagliflozin 10 mg meta mqabbel mal-plaċebo (4.7% kontra 3.5%, rispettivament, ara sezzjoni 4.4).
English: At 52, 104 and 208 weeks, a significantly lower proportion of subjects in the group treated with dapagliflozin (3.5%, 4.3% and 5.0%, respectively) experienced at least one event of hypoglycaemia compared to the group treated with glipizide (40.8%, 47.0% and 50.0%, respectively).
Maltese: Fil-ġimgħat 52, 104 u 208, proporzjon inqas b'mod sinifikanti fil-grupp ikkurat b'dapagliflozin (3.5%, 4.3% u 5.0%, rispettivament) kellu mill-anqas episodju wieħed ta' ipogliċemija meta mqabbel malgrupp fuq kura bi glipizide (40.8%, 47% u 50.0% rispettivament).
English: Once-daily treatment with dapagliflozin resulted in statistically significant (p < 0.0001) reductions in HbA1c compared to placebo (Table 2).
Maltese: Kura ta' darba kuljum b'dapagliflozin wasslet għal tnaqqis statistikament sinifikanti (p < 0.0001) fl-HbA1c meta mqabbel mal-plaċebo (Tabella 2).
English: The hazard ratio comparing dapagliflozin to comparator was 0.79 (95% Confidence interval [CI]: 0.58, 1.07), indicating that in this analysis Forxiga is not associated with an increase in cardiovascular risk in patients with type 2 diabetes mellitus.
Maltese: Il-proporzjon ta' riskju li jqabbel lil dapagliflozin ma' prodott ta' paragun kien ta' 0.79 (95% Intervall ta' fiduċja [CI]: 0.58, 1.07), li jindika li f'din l-analiżi dapagliflozin mhuwiex assoċjat ma' żieda fir-riskju kardjovaskulari f'pazjenti b'dijabete (diabetes mellitus) tat-tip 2.
English: In interaction studies conducted in healthy subjects, using mainly a single-dose design, dapagliflozin did not alter the pharmacokinetics of metformin, pioglitazone, sitagliptin, glimepiride, 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: Effett ta' dapagliflozin fuq prodotti mediċinali oħra Fi studji ta' interazzjoni li saru f'individwi b'saħħithom, l-aktar permezz ta' mudell b'doża waħda, dapagliflozin ma bidilx il-farmakokinetika ta' metformin, pioglitazone, sitagliptin, glimepiride, hydrochlorothiazide, bumetanide, valsartan, digoxin (sottostrat ta' P-gp) jew warfarin (S-warfarin, sottostrat ta' CYP2C9), jew l-effetti kontra l-koagulazzjoni ta' warfarina hekk kif imkejjel mill-INR.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of dapagliflozin/metabolites in milk, as well as pharmacologically-mediated effects in nursing offspring (see section 5.3).
Maltese: Dejta farmakokinetika/tossikoloġika li hemm mill-annimali wrew li l-eskrezzjoni ta' dapagliflozin/metaboli fil-ħalib, kif ukoll effetti medjati b'mod farmakoloġiku fil-wild li kienu qed ireddgħu (ara sezzjoni 5.3).
English: Combination of a single dose of dapagliflozin 20 mg and simvastatin (a CYP3A4 substrate) resulted in a 19% increase in AUC of simvastatin and 31% increase in AUC of simvastatin acid.
Maltese: Taħlita ta' doża waħda ta' dapagliflozin 20 mg u simvastatin (sottostrat ta' CYP3A4) wasslet għal żieda ta' 19% fl-AUC ta' simvastatin u 31% żieda fl-AUC ta; aċidu ta' simvastatin.
English: Very common Common*
Maltese: Komuni ħafna Komuni*
English: INFORMATION IN BRAILLE Forxiga 10 mg
Maltese: Forxiga 10 mg
English: The absolute oral bioavailability of dapagliflozin following the administration of a 10 mg dose is 78%.
Maltese: Il-bijodisponibilità orali assoluta ta' dapagliflozin wara l-għotja ta' doża ta' 10 mg hija 78%.
English: 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: Fi stat fiss (20 mg dapagliflozin darba kuljum għal 7 ijiem), individwi b'dijabete mellitus tat-tip 2 u indeboliment renali ħafif, moderat jew sever (hekk kif determinat mill-clearance mill-plażma ta' iohexol) kellu esponimenti sistemiċi medji ta' dapagliflozin ta' 32%, 60% u 87% ogħla, rispettivament, minn dawk l-individwi b'dijabete mellitus tat-tip 2 u funzjoni renali normali.
English: Reproductive and developmental toxicity
Maltese: Tossiċità riproduttiva u tal-iżvilupp
English: Forxiga contains lactose
Maltese: Forxiga fih lactose
English: cVulvovaginitis, balanitis and related genital infections includes, e.g. the predefined preferred terms: vulvovaginal mycotic infection, vaginal infection, balanitis, genital infection fungal, vulvovaginal candidiasis, vulvovaginitis, balanitis candida, genital candidiasis, genital infection, genital infection male, penile infection, vulvitis, vaginitis bacterial, vulval abscess.
Maltese: Vulvovaġinite, balanite u infezzjonijiet relatati jinkludu, eż. iżda mhumiex limitati, għat-termini preferiti definiti minn qabel, infezzjoni mikotika vulvovaġinali, infezzjoni fil-vaġina, balanite, infezzjoni ġenitali tal-fungu, kandidijasi vulvovaġinali, vulvovaġinite, balanite kandida, kandidijasi ġenitali, infezzjoni ġenitali, infezzjoni ġenital fl-irġiel, infezzjoni tal-pene, vulvite, vaginite batterika, axxess fil-vulva.
English: Dapagliflozin does not inhibit other glucose transporters important for glucose transport into peripheral tissues and is > 1,400 times more selective for SGLT2 versus SGLT1, the major transporter in the gut responsible for glucose absorption.
Maltese: Dapagliflozin ma jikkawżax inibizzjoni ta' trasportaturi oħra ta' glukows importanti għat-trasport ta' glukows fit-tessuti periferali u huwa > 1400 darba aktar selettiv għal SGLT2 milli għal SGLT1, ittrasportatur ewlieni fl-imsaren risponsabbli għal-assorbiment tal-glukows.
English: • Forxiga 5 mg film-coated tablets are yellow and round with diameter of 0.7 cm.
Maltese: • Forxiga 5 mg pilloli miksijin b'rita huma sofor u tondi b'dijametru ta' 0.7 cm.
English: Treatment with dapagliflozin 10 mg as a monotherapy or as an add-on to either metformin, glimepiride, metformin and a sulphonylurea, sitagliptin (with or without metformin) or insulin resulted in statistically significant reductions in fasting plasma glucose (-1.90 to -1.20 mmol/l [-34.2 to -21.7 mg/dl]) compared to placebo (-0.33 to 0.21 mmol/l [-6.0 to 3.8 mg/dl]).
Maltese: Kura b'dapagliflozin 10 mg bħala monoterapija jew miżjud ma' metformin, glimipiride, metformin u sulphonylurea, sitagliptin (bi jew mingħajr metformin) jew insulina wasslet għal tnaqqis statistikament sinifikanti tal-glukows fil-plażma fi stat sajjem (-1.90 għal -1.20 mmol/l [34.2 għal -21.7 mg/dl]) imqabbel mal-plaċebo (-0.33 għal 0.21 mmol/l [-6.0 għal 3.8 mg/dl]).
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 epatiku sever (klassi Child-Pugh C) il-medja Cmax u AUC ta' dapagliflozin kienu 40% u 67% ogħla minn kontrolli b'saħħithom imqabbla, rispettivament.
English: • changes in laboratory blood tests (for example creatinine or urea)
Maltese: • bidliet fit-testijiet tad-demm tal-laboratorju (kreatinina jew urea)
English: The increase in simvastatin and simvastatin acid exposures are not considered clinically relevant.
Maltese: Iż-żieda ta' esponimenti ta' simvastatin u aċidu ta' simvastatin mhumiex meqjusa klinikament rilevanti.
English: Dapagliflozin exposure is increased in patients with severe hepatic impairment (see sections 4.2 and 5.2).
Maltese: L-esponiment għal dapagliflozin jiżdied f'pazjenti b'indeboliment epatiku sever (ara sezzjonijiet 4.2 u 5.2).
English: Dapagliflozin 10 mg as an add-on to metformin, glimepiride, metformin and a sulphonylurea, sitagliptin (with or without metformin) or insulin resulted in statistically significant body weight reduction at 24 weeks (p < 0.0001, Tables 4 and 5).
Maltese: Dapagliflozin 10 mg miżjud ma' metformin, glimepiride, metformin u sulphonylurea, sitagliptin (bi jew mingħajr metformin) jew insulina wassal għal tnaqqis statistikament sinifikanti tal-piż tal-ġisem wara 24 ġimgħa (p < 0.0001, Tabelli 4 u 5).
English: Mean duration of diabetes ranged from 1.4 to 16.9 years.
Maltese: Il-medja tat-tul tad-dijabete kienet bejn 1.4 sa' 16.9 snin.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference 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) tad-Direttiva 2001/83/KE u kwalunke aġġornament sussegwenti ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: • Forxiga 10 mg film-coated tablets are yellow and diamond-shaped approximately 1.1 x 0.8 cm diagonally.
Maltese: • Forxiga 10 mg pilloli miksijin b'rita huma sofor u b'forma ta' djamant madwar 1.1 x 0.8 cm mid-dijagonali.
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-pazjenti kellhom storja ta' mard kardjovaskulari (minbarra l-pressjoni għolja) fil-linja bażi u 67.9% kellhom pressjoni għolja.
English: Dapagliflozin is extensively metabolised, primarily to yield dapagliflozin 3-O-glucuronide, which is an inactive metabolite.
Maltese: Dapagliflozin jiġi metabolizzat b'mod estensiv, l-aktar biex jagħti dapagliflozin 3-O-glucuronide, li huwa metabolu mhux attiv.
English: At Weeks 24 and 104, minor episodes of hypoglycaemia were reported, respectively, in 40.3% and 53.1% of subjects who received dapagliflozin 10 mg plus insulin and in 34.0% and 41.6% of the subjects who received placebo plus insulin.
Maltese: F'Ġimgħat 24 u 104, ġew irrapportati episodji minuri ta' ipogliċemija, rispettivament, f'40.3% u 53.1% tas-suġġetti li rċievew dapagliflozin 10 mg flimkien mal-insulina u f'34.0% u f'41.6% tassuġġetti li rċievew plaċebo flimkien mal-insulina.
English: 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-medja tal-half-life (t1/2) terminali fil-plażma ta' dapagliflozin kienet 12.9 sigħat wara doża waħda ta' dapagliflozin 10 mg f'individwi b'saħħithom.
English: Minor episodes of hypoglycaemia were reported in 12.8% of subjects who received dapagliflozin 10 mg plus metformin and a sulphonylurea and in 3.7% of subjects who received placebo plus metformin and a sulphonylurea.
Maltese: Ġew irrappurtati episodji minuri ta' ipogliċemija fi 12.8% talpazjenti li rċevew dapagliflozin 10 mg flimkien ma' metformin u sulphonylurea u fi 3.7% tal-pazjenti li rċevew plaċebo flimkien ma' metformin u sulphonylurea.
English: It belongs to a group of medicines called “oral anti-diabetics”.
Maltese: Tagħmel parti minn grupp ta' mediċini li jissejħu “anti-dijabetiċi orali”.
English: In an add-on to glimepiride study, at weeks 24 and 48, minor episodes of hypoglycaemia were reported more frequently in the group treated with dapagliflozin 10 mg plus glimepiride (6.0% and 7.9%, respectively) than in the placebo plus glimepiride group (2.1% and 2.1%, respectively).
Maltese: Fi studju fejn ġie miżjud glimepiride, fil-ġimgħat 24 u 48, episodji minuri ta' ipogliċemija kienu rrappurtati b'mod aktar frekwenti fil-grupp ikkurat b'dapagliflozin 10 mg ma' glimepiride (6.0% u 7.9% rispettivament) milli fil-grupp bi plaċebo ma' glimepiride (2.1% u 2.1% rispettivament).
English: Yellow, biconvex, 0.7 cm diameter round, film-coated tablets with “5” engraved on one side and “1427” engraved on the other side.
Maltese: Pilloli sofor, konvessi miż-żewġ naħat, tondi b'dijametru ta' 0.7 cm, miksijin b'rita b'“5” imnaqqax fuq naħa u “1427” imnaqqax fuq in-naħa l-oħra.
English: Volume depletion b,e
Maltese: Jonqos ilvolum b,e
English: Reactions related to volume depletion (including, reports of dehydration, hypovolaemia or hypotension) were reported in 1.1% and 0.7% of subjects who received dapagliflozin 10 mg and placebo, respectively; serious reactions occurred in < 0.2% of subjects balanced between dapagliflozin 10 mg and placebo (see section 4.4).
Maltese: Reazzjonijiet relatati mat-tnaqqis tal-volum (inklużi rapporti ta' deidratazzjoni, ipovolumja jew pressjoni baxxa) kienu rrappurtati f'1.1% u 0.7% tal-individwi li rċievew dapagliflozin 10 mg u lplaċebo, rispettivament; reazzjonijiet serji seħħew f'< 0.2% tal-individwi u kienu bilanċati bejn dapagliflozin 10 mg u l-plaċebo (ara sezzjoni 4.4).
English: In a pre-specified pooled analysis of 13 placebo-controlled studies, 2,360 subjects were treated with dapagliflozin 10 mg and 2,295 were treated with placebo.
Maltese: F'analiżi kollettiva speċifikata minn qabel ta' 13-il studju kontrollat bil-plaċebo, 2,360 individwu kienu kkurati b'dapagliflozin 10 mg u 2,295 kienu kkurati bi plaċebo.
English: If renal function falls below CrCl < 60 ml/min or eGFR < 60 ml/min/1.73 m2, dapagliflozin treatment should be discontinued.
Maltese: Jekk il-funzjoni renali taqa' taħt CrCl < 60 ml/min jew eGFR < 60 ml/min/1.73 m2, kura b'dapagliflozin għandha titwaqqaf.
English: The reductions in HbA1c observed at Week 24 were sustained in add-on combination studies (glimepiride and insulin) with 48-week data (glimepiride) and up to 104-week data (insulin).
Maltese: It-tnaqqis HbA1c li deher f'Ġimgħa 24 kien sostnut fl-istudji ta' kombinazzjoni miżjuda (glimepiride, u insulina) b'dejta minn 48-ġimgħa (glimepiride) u sa dejta ta' 104 ġimgħat (insulina).
English: They have “10” on one side and “1428” on the other side.
Maltese: Għandhom “10” fuq naħa u “1428” fuq in-naħa l-oħra.
English: Difference from glipizide + metforminc
Maltese: Differenza minn glipizide + metformin c
English: As an add-on therapy to metformin in an active-controlled non-inferiority study, dapagliflozin resulted in a statistically significant body weight reduction compared with glipizide of -4.65 kg at 52 weeks (p < 0.0001, Table 3) that was sustained at 104 and 208 weeks (-5.06 kg and -4.38 kg, respectively).
Maltese: Bħala terapija miżjuda ma' metformin fi studju ta' nuqqas ta' inferjorità ikkontrollat b'mod attiv, dapagliflozin irriżulta fi tnaqqis tal-piż tal-ġisem statistikament sinifikanti meta mqabbel ma' glipizide ta' -4.65 kg fi 52 ġimgħa (p < 0.0001, Tabella 3) li ġie sostnut wara 104 u 208 ġimgħat (-5.06 kg u4.
English: Therapeutic experience in patients 75 years and older is limited.
Maltese: Esperjenza terapewtika f'pazjenti li jkollhom 75 sena jew aktar hija limitata.
English: The mean total systemic clearance of dapagliflozin administered intravenously was 207 ml/min.
Maltese: Il-clearance medja totali sistemika ta' dapagliflozin mogħti minn ġol-vina kienet 207 ml/min.
English: These reactions were more common in patients with baseline eGFR ≥ 30 and < 60 mL/min/1.73m2 (18.5% dapagliflozin 10 mg vs 9.3%
Maltese: Dawn ir-reazzjonijiet kienu aktar komuni f'pazjenti b'eGFR tal-linja bażi ≥ 30 u < 60 mL/min/1.73m2 (18.5% dapagliflozin 10 mg vs 9.3% plaċebo).
English: In subjects ≥ 65 years of age, adverse reactions related to renal impairment or failure were reported in 7.7% of subjects treated with dapagliflozin and 3.8% of subjects treated with placebo (see section 4.4).
Maltese: F'individwi ta' ≥ 65 sena, reazzjonijiet avversi relatati mal-indeboliment jew insuffiċjenza renali kienu rrappurtati f'7.7% tal-individwi ikkurati b'dapagliflozin u 3.8% tal-individwi ikkurati bi plaċebo (ara sezzjoni 4.4).
English: Effect of other medicinal products on dapagliflozin Interaction studies conducted in healthy subjects, using mainly a single dose design, suggest that the pharmacokinetics of dapagliflozin are not altered by metformin, pioglitazone, sitagliptin, glimepiride, voglibose, hydrochlorothiazide, bumetanide, valsartan, or simvastatin.
Maltese: Effett ta' prodotti mediċinali oħra fuq dapagliflozin Studji dwar interazzjoni li saru f'individwi b'saħħithom, permezz ta' mudell b'doża waħda, jindikaw li l-farmakokinetika ta' dapagliflozin ma tiġix mibdula b'metformin, pioglitiazone, sitagliptin, glimepride, voglibose, hydrochlorothiazide, bumetanide, valsartan, jew simvastatin.
English: Glipizide + metformin
Maltese: Glipizide + metformin b
English: Rare cases of diabetic ketoacidosis (DKA), including life-threatening cases, have been reported in clinical trials and post-marketing in patients treated with SGLT2 inhibitors, including dapagliflozin.
Maltese: Każijiet rari ta' ketoaċidożi dijabetika (DKA), inkluż każijiet ta' periklu għall-ħajja, ġew irrapportati fi provi kliniċi u wara t-tqegħid fis-suq f'pazjenti kkurati b'inibituri SGLT2, inkluż dapagliflozin.
English: Other medicines and Forxiga
Maltese: Mediċini oħra u Forxiga
English: If well tolerated, the dose may be increased to 10 mg (see sections 4.4 and 5.2).
Maltese: Jekk tkun tollerata sew, iddoża tista' tiżdied għal 10 mg (ara sezzjonijiet 4.4 u 5.2).
English: Renal function and risk of volume depletion should be taken into account (see sections 4.4 and 5.2).
Maltese: Il-funzjoni renali u r-riskju li jitbaxxa l-volum għandu jitqies (ara sezzjonijiet 4.4 u 5.2).
English: • Swallow the tablet whole with half a glass of water.
Maltese: • Ibla' l-pillola sħiħa ma' nofs tazza ilma.
English: (95% CI) Subjects (%) achieving: HbA1c < 7% Adjusted for baseline Body weight (kg) Baseline (mean) Change from baselinec Difference from placeboc
Maltese: (95% CI) Individwi (%) li kisbu: HbA1c < 7% Aġġustat għallinja bażi Piż tal-ġisem (kg) Linja bażi (medja)
English: • decrease in kidney function
Maltese: • tnaqqis fil-funzjoni tal-kliewi
English: Mean changes from baseline in haematocrit were 2.30% for dapagliflozin 10 mg versus -0.33% for placebo.
Maltese: Il-bidliet medji mil-linja bażi fl-ematokrit kienu 2.30% għal 10 mg dapagliflozin kontra -0.33% għal plaċebo.
English: • Prior to initiation of dapagliflozin and at least yearly, thereafter (see sections 4.2, 4.8, 5.1 and 5.2)
Maltese: • Qabel jinbeda dapagliflozin u mill-anqas kull sena, minn hemm-il quddiem (ara sezzjonijiet 4.2, 4.8, 5.1 u 5.2)
English: The mean steady-state volume of distribution of dapagliflozin was 118 l.
Maltese: Il-volum tad-distribuzzjoni medju fl-istat fiss ta' dapagliflozin kien 118 l.
English: Take the medicine pack with you.
Maltese: Ħu lpakkett tal-mediċina miegħek.
English: The most commonly reported adverse reaction related to renal function was increased serum creatinine.
Maltese: L-aktar reazzjoni avversa rrappurtata b'mod komuni relatata mal-funzjoni renali kienet żieda tal-krejatinina fis-serum.
English: How to store Forxiga
Maltese: X'fih Forxiga
English: Metabolism and nutrition
Maltese: Disturbi filmetaboliżmu u nnutrizzjoni
English: Rates of adverse events including dehydration or hypotension were similar to placebo, and there were no clinically meaningful dose-related changes in laboratory parameters, including serum electrolytes and biomarkers of renal function.
Maltese: Rati ta' każijiet avversi inklużi deidratazzjoni jew pressjoni baxxa kienu simili għal plaċebo, u ma kienx hemm bidliet ta' sinifikat kliniku relatati mad-doża fil-parametri tal-laboratorju, inklużi elettroliti fis-serum u bijomarkaturi talfunzjoni renali.
English: Difference from placeboc
Maltese: Differenza mill-Plaċebo c
English: At Week 104, adjusted mean change from baseline in HbA1c was -0.32% for dapagliflozin and -0.14% for glipizide.
Maltese: F'Ġimgħa 104, il-bidla medja aġġustata millinja bażi f'HbA1c kienet -0.32% għal dapagliflozin u -0.14% għal glipizide.
English: bColumns 1 and 2, HbA1c analyzed using LOCF (see footnote d); Columns 3 and 4, HbA1c analyzed using LRM (see footnote e) cLeast squares mean adjusted for baseline value dLOCF: Last observation (prior to rescue for rescued subjects) carried forward LRM: Longitudinal repeated measures analysis *p-value < 0.0001 versus placebo + oral glucose-lowering medicinal product(s)
Maltese: Kolonni 1 u 2, HbA1c analizzat bl-użu tal- LOCF (ara n-nota tal-qiegħ d); Kolonni 3 u 4, HbA1c analizzat bl-użu talLRM (ara n-nota tal-qiegħ e) Medja tal-anqas kwadri aġġustata għall-valur tal-linja bażi LOCF: L-aħħar osservazzjoni (qabel is-salvataġġ għal individwi salvati) imressqa 'l quddiem LRM:
English: Combinations not studied Dapagliflozin has not been studied in combination with glucagon-like peptide 1 (GLP-1) analogues.
Maltese: Taħlit li ma ġiex studjat Dapagliflozin ma ġiex studjat f'taħlita ma' analogi tal-peptide 1 li jixbhu l-glucagon (GLP-1).
English: The SGLT2 is selectively expressed in the kidney with no expression detected in more than 70 other tissues including liver, skeletal muscle, adipose tissue, breast, bladder and brain.
Maltese: L-SGLT2 jiġi espress b'mod selettiv mill-kliewi bl-ebda espressjoni ma nstabet f'aktar min 70 tessuti oħra inklużi l-fwied, il-muskolu skeletrali, tessut adipose, sider, bużżieqa tal-awrina u l-moħħ.
English: Yellow, biconvex, approximately 1.1 x 0.8 cm diagonally diamond-shaped, film-coated tablets with “10” engraved on one side and “1428” engraved on the other side.
Maltese: Pilloli sofor, konvessi miż-żewġ naħat, madwar 1.1 x 08 cm mid-dijagonali b'forma ta' djamant, miksijin b'rita b'“10” imnaqqax fuq naħa u “1428” imnaqqax fuq in-naħa l-oħra.
English: The same recommendations for renal function apply to elderly patients as to all patients (see sections 4.2, 4.4, 4.8 and 5.1).
Maltese: L-istess rakkomandazzjonijiet għall-funzjoni renali japplikaw għall-pazjenti anzjani kif ukoll għall-pazjenti kollha (ara sezzjonijiet 4.2, 4.4, 4.8 u 5.1).
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-istat fiss ta' 24 siegħa tneħħija tal-glukows mill-awrina kien jiddependi ħafna fuq il-funzjoni renali u 85, 52, 18 u 11 g ta' glukows/jum kien imneħħi f'individwi b'dijabete mellitus tat-tip 2 u funzjoni renali normali, indeboliment renali ħafif, moderat jew sever, rispettivament.
English: However, the differences in exposure were not considered clinically meaningful.
Maltese: Dawn id-differenzi ma kienux meqjusa klinikament rilevanti.
English: In a pre-specified analysis of subjects with baseline HbA1c ≥ 9.0%, treatment with dapagliflozin 10 mg resulted in statistically significant reductions in HbA1c at Week 24 as a monotherapy (adjusted mean change from baseline: -2.04% and 0.19% for dapagliflozin 10 mg and placebo, respectively) and as an add-on to metformin (adjusted mean change from baseline: -1.32% and -0.53% for dapagliflozin and placebo, respectively).
Maltese: F'analiżi speċifikata minn qabel ta' individwi b'HbA1c ≥ 9% mal-linja bażi, kura b'dapagliflozin 10 mg wasslet għal tnaqqis statistikament sinifikanti fl-HbA1c f'Ġimgħa 24 bħala monoterapija (bidla medja aġġustata mil-linja bażi: -2.04% u 0.19% għal dapagliflozin 10 mg u plaċebo, rispettivament) u bħala terapija miżjud ma' metformin (bidla medja aġġustata mil-linja bażi: -1.32% u -0.53% għal dapagliflozin u plaċebo rispettivament).