FrancophonIA/ELRC3.0 huggingface dataset:
English: At Week 48 when added to sitagliptin (with or without metformin), the adjusted mean change from baseline for dapagliflozin 10 mg and placebo was -0.30% and 0.38%, respectively.
Maltese: Fil-Ġimgħa 48, meta miżjud ma' sitagliptin (bi jew mingħajr metformin), it-tibdil medju aġġustat mil-linja bażi għal dapagliflozin 10 mg u plaċebo kien ta' -0.30% u 0.38%, rispettivament.
English: Experience in NYHA class I-II is limited, and there is no experience in clinical studies with dapagliflozin in NYHA class III-IV.
Maltese: Esperjenza fl-NYHA ta' klassi I-II hija limitata, u m'hemmx esperjenza fl-istudji kliniċi b'dapagliflozin fl-NYHA ta' klassi III-IV.
English: Haematocrit values >55% were reported in 1.3% of the subjects treated with dapagliflozin 10 mg versus 0.4% of placebo subjects.
Maltese: Valuri tal-ematokrit >55% ġew irrapportati f'1.3% tal-individwi kkurati b'10 mg dapagliflozin meta mqabbel ma' 0.4% tal-individwi fuq plaċebo h
English: Elderly patients are more likely to have impaired renal function, and/or to be treated with anti-hypertensive medicinal products that may cause changes in renal function such as angiotensin-converting enzyme inhibitors (ACE-I) and angiotensin II type 1 receptor blockers (ARB).
Maltese: Pazjenti anzjani jkollhom probabilità akbar li jkollhom funzjoni renali indebolita, u jew li jkunu se jiġu ikkurati bi prodotti mediċinali għall-pressjoni għolja jistgħu jikkawżaw bidliet fil-funzjoni renali bħal inibituri tal-angiotensin-converting enzyme (ACE-I) u inblukkaturi tar-riċettur tat-tip 1 għal angiotensin II (ARB).
English: Film-coating
Maltese: Żieda fil-kreatinina
English: Other side effects when taking Forxiga:
Maltese: Effetti sekondarji oħra meta tkun qed tieħu Forxiga:
English: Dapagliflozin as an add-on with either metformin, glimepiride, metformin and a sulphonylurea, sitagliptin (with or without metformin) or insulin resulted in statistically significant reductions in HbA1c at 24 weeks compared with subjects receiving placebo (p < 0.0001; Tables 4, 5 and 6).
Maltese: Dapagliflozin miżjud ma' metformin, glimepiride, metformin u sulphonylurea, sitagliptin (bi jew mingħajr metformin) jew insulina wassal għal tnaqqis statistikament sinifikanti fl-Hb1Ac f'ġimgħa 24 meta mqabbel ma' individwi li kienu fuq plaċebo (p < 0.0001; Tabelli 4, 5 u 6).
English: Results of 24-week placebo-controlled studies of dapagliflozin in add-on combination with sulphonylurea (glimepiride) or metformin and a sulphonylurea
Maltese: Riżultati ta' studji kkontrollati bil-plaċebo fuq 24 ġimgħa b'dapagliflozin f'taħlita miżjud ma' sulphonylurea (gliperamide) jew metformin u sulphonylurea
English: 0.00d
Maltese: *,b,d
English: 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 epatiku ħafif jew moderat (Klassijiet Child-Pugh A u B) is-Cmax u AUC medji ta' dapagliflozin kienu sa' 12% u 36% ogħla, rispettivament, meta mqabbla ma' individwi b'saħħithom imqabbla għall-kontroll.
English: HbA1c (%) Baseline (mean) Change from baselinec Difference from placeboc
Maltese: HbA1c (%) Linja bażi (medja) Bidla mil-linja bażi c
English: In subjects ≥ 65 years of age, a higher proportion of subjects treated with dapagliflozin had adverse reactions related to volume depletion (see section 4.8).
Maltese: F'individwi ta' ≥ 65 sena, proporzjon ogħla ta' individwi ikkurati b'dapagliflozin kellhom reazzjonijiet avversi relatati ma' nuqqas tal-volum (ara sezzjoni 4.8).
English: At Week 208, adjusted mean change from baseline in HbA1c was -0.10% for dapagliflozin and 0.20% for glipizide.
Maltese: Fil-Ġimgħa 208, it-tibdil medju aġġustat mil-linja bażi f'HbA1c kien ta' -0.10% għal dapagliflozin u ta' 0.20% għal glipizide.
English: NAME OF THE MEDICINAL PRODUCT Forxiga 10 mg tablets dapagliflozin
Maltese: Forxiga 10 mg pilloli 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 dijuretiċi loop u jista' jżid ir-riskju ta' deidrazzjoni u pressjoni baxxa (ara sezzjoni 4.4).
English: For the add-on to metformin study, HbA1c reductions were sustained through Week 102 (-0.78% and 0.02% adjusted mean change from baseline for 10 mg and placebo, respectively).
Maltese: Għall-istudju miżjud ma' metformin, tnaqqis fl-Hb1Ac kien sostnut sa' Ġimgħa 102 (-0.78% u 0.02% bidla aġġustata mil-linja bażi għal dapagliflozin 10 mg u plaċebo, rispettivament).
English: In an add-on to insulin study, episodes of major hypoglycaemia were reported in 0.5% and 1.0% of subjects treated with dapagliflozin 10 mg plus insulin at Weeks 24 and 104, respectively, and in 0.5% of subjects treated with placebo plus insulin groups at Weeks 24 and 104.
Maltese: Fi studju fejn ġie miżjud mal-insulina, ġew irrapportati episodji ta' ipogliċemija maġġuri f'0.5% u f'1.0% tas-suġġetti kkurati b'dapagliflozin 10 mg miżjud mal-insulina f'Ġimgħa 24 u 104 rispettivament u f'0.5% tas-suġġetti kkurati ma' gruppi ta' plaċebo miżjud mal-insulina f'Ġimgħat 24 u 104.
English: Urinary uric acid excretion was also increased transiently (for 3-7 days) and accompanied by a sustained reduction in serum uric acid concentration.
Maltese: Eskrezzjoni ta' uric acid mal-awrina żdiedet ukoll b'mod transitorju (għal 3-7 ijiem) u kienet akkumpanjata bi tnaqqis tal-konċentrazzjoni ta' uric acid fis-serum.
English: Glycaemic control
Maltese: Kontroll gliċemiku
English: For studies of dapagliflozin in monotherapy, as add-on to metformin or as add-on to sitagliptin (with or without metformin), the frequency of minor episodes of hypoglycaemia was similar (< 5%) between treatment groups, including placebo up to 102 weeks of treatment.
Maltese: Għal studji ta' dapagliflozin f'monoterapija, bħala sustanza miżjuda ma' metformin jew bħala sustanza miżjuda ma' sitagliptin (bi jew mingħajr metformin), il-frekwenza ta' episodji minuri ta' ipogliċemija kienet simili (< 5%) bejn il-gruppi ta' kura, inkluż il-plaċebo sa 102 ġimgħat ta' kura.
English: There were no clinically relevant differences in systemic exposures between White, Black or Asian races.
Maltese: Ma kienx hemm differenzi ta' rilevanza klinika bejn l-esponimenti sistemiċi fir-razzez Bojod, Suwed jew Ażjatiċi.
English: Dapagliflozin 3-O-glucuronide or other metabolites do not contribute to the glucose-lowering effects.
Maltese: Dapagliflozin 3-O-glucuronide jew il-metaboli l-oħra ma jikkontribwixxux għall-effetti biex jitbaxxa l-glukows.
English: dUrinary tract infection includes the following preferred terms, listed in order of frequency reported: urinary tract infection, cystitis, Escherichia urinary tract infection, genitourinary tract infection, pyelonephritis, trigonitis, urethritis, kidney infection and prostatitis.
Maltese: Infezzjoni tal-passaġġ urinarju tinkludi t-termini ppreferuti li ġejjin, elenkati f'ordni skont il-frekwenza rrapportata: infezzjoni fil-passaġġ urinarju, ċistite, infezzjoni tal-passaġġ urinarju b'Escherichia, infezzjoni talpassaġġ ġenitourinarju, pajelonefrite, trigonite, uretrite, infezzjoni tal-kliewi u prostatite.
English: In patients with normal renal function or mild renal impairment (baseline eGFR ≥ 60 mL/min/1.73m2) this grouping of reactions were reported in 1.3% and 0.8% of patients who received dapagliflozin 10 mg and placebo, respectively.
Maltese: F'pazjenti b'funzjoni renali normali jew b'indeboliment renali ħafif (eGFR tal-linja bażi ≥ 60 mL/min/1.73m2) dan irraggruppament ta' reazzjonijiet ġie rrapportat f'1.3% u 0.8% tal-pazjenti li rċevew dapagliflozin 10 mg u plaċebo, rispettivament.
English: Cardiovascular episodes were adjudicated by an independent adjudication committee.
Maltese: L-episodji kardjovaskulari ġew iġġudikati minn kumitat aġġudikanti indipendenti.
English: NAME OF THE MEDICINAL PRODUCT Forxiga 5 mg tablets dapagliflozin
Maltese: Forxiga 5 mg pilloli dapagliflozin
English: There is no clinically meaningful increase in exposure based on age alone in subjects up to 70 years old.
Maltese: M'hemmx żieda klinikament rilevanti fl-esponiment ibbażat fuq l-età biss f'individwi li għandhom sa' 70 sena.
English: AstraZeneca d.o.o.
Maltese: AstraZeneca Oy
English: This grouping of reactions was reported in 3.2% and 1.8% of patients who received dapagliflozin 10 mg and placebo, respectively.
Maltese: Dan ir-raggruppament ta' reazzjonijiet ġie rrapportat fi 3.2% u f'1.8% tal-pazjenti li rċevew dapagliflozin 10 mg u plaċebo, rispettivament.
English: At Week 12 for both studies, dapagliflozin 10 mg plus usual antidiabetic treatment provided improvement in HbA1c and decreased the placebo-corrected systolic blood pressure on average by 3.1 and 4.3 mmHg, respectively.
Maltese: F'Ġimgħa 12 għaż-żewġ studji, dapagliflozin 10 mg flimkien ma' kura antidijabetika normali ta titjib f'HbA1c u naqqas ilpressjoni tad-demm sistolika kkoreġuta bi plaċebo bħala medja bi 3.1 u 4.3 mmHg, rispettivament.
English: The proportion of subjects remaining in the study at Week 104 and Week 208 was 56.2% and 39.7% for the group treated with dapagliflozin and 50.0% and 34.6% for the group treated with glipizide.
Maltese: Il-proporzjon ta' suġġetti li baqgħu fl-istudju fil-Ġimgħa 104 u fil-Ġimgħa 208 kien ta' 56.2% u 39.7% għall-grupp ikkurat b'dapagliflozin u 50.0% u 34.6% għall-grupp ikkurat b'glipizide.
English: In subjects with moderate renal impairment (patients with CrCl < 60 ml/min or eGFR < 60 ml/min/1.73 m2), a higher proportion of subjects treated with dapagliflozin had adverse reactions of increase in creatinine, phosphorus, parathyroid hormone (PTH) and hypotension, compared with placebo.
Maltese: F'individwi b'indeboliment renali moderat (pazjenti b'CrCl < 60 ml/min jew eGFR < 60 ml/min/1.73 m2), proporzjon ogħla ta' individwi ikkurati b'dapagliflozin kellhom reazzjonijiet avversi ta' żieda tal-krejatinina, phosphorous, ormon tal-paratirojde (PTH) u pressjoni baxxa, meta mqabbla mal-plaċebo.
English: The proportion of subjects remaining in the study at Week 104 was 72.4% for the group treated with dapagliflozin 10 mg and 54.8% for the placebo group.
Maltese: Il-proporzjon ta' suġġetti li baqgħu fl-istudju f'Ġimgħa 104 kien ta' 72.4% għall-grupp ikkurat b'dapagliflozin 10 mg u 54.8% għall-grupp talplaċebo.
English: In a pre-specified pooled analysis of 13 placebo-controlled studies, treatment with dapagliflozin 10 mg resulted in a systolic blood pressure change from baseline of -3.7 mmHg and diastolic blood pressure of -1.8 mmHg versus -0.5 mmHg systolic and -0.5 mmHg diastolic blood pressure for placebo group at Week 24.
Maltese: F'analiżi miġbura speċifikata minn qabel ta' 13-il studju kkontrollat bi plaċebo, il-kura b'10 mg dapagliflozin irriżultat f'bidla ta' -3.7 mmHg fil-pressjoni sistolika tad-demm mil-linja bażi u ta'1.8 mmHg fil-pressjoni dijastolika tad-demm kontra -0.5 mmHg fil-pressjoni sistolika tad-demm u0.5 mmHg fil-pressjoni dijastolika għall-grupp tal-plaċebo fil-ġimgħa 24.
English: Limited data from clinical trials suggest that DKA occurs with common frequency when patients with type 1 diabetes are treated with SGLT2 inhibitors.
Maltese: Data limitata mill-provi kliniċi tissuġġerixxi li d-DKA sseħħ bi frekwenza komuni meta pazjenti bid-dijabete tat-tip 1 huma kkurati b'inibituri SGLT2.
English: In combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations).
Maltese: Flimkien ma' prodotti mediċinali oħra li jbaxxu l-glukows inkluża l-insulina, meta dawn, flimkien mad-dieta u l-eżerċizzju , ma jipprovdux kontroll gliċemiku xieraq (ara sezzjonijiet 4.4, 4.5 u 5.1 għad-dejta disponibbli fuq it-taħlit differenti).
English: ≥ 0.2% of subjects and ≥ 0.1% more and at least 3 more subjects treated with dapagliflozin 10 mg compared to placebo.
Maltese: Irrapportati f'≥ 2% tal-individwi u ≥ 1 % aktar u għallinqas 3 individwi aktar ikkurati b'10 mg dapagliflozin meta mqabbel ma' plaċebo.
English: Dapagliflozin did not show any toxicity in healthy subjects at single oral doses up to 500 mg (50 times the maximum recommended human dose).
Maltese: Dapagliflozin ma wera l-ebda tossiċità f'individwi b'saħħithom b'doża waħda orali sa' 500 mg (50 darba l-ogħla doża rakkomandata fil-bniedem).
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 tiġi medjata permezz ta' UGT1A9, enzima li tinsab fil-fwied u l-kliewi, u metaboliżmu medjat mil-metaboliżmu CYP kien mezz ta' tneħħija minura fil-bnedmin.
English: Elevated haematocrit
Maltese: TAL-PRODOTT MEDIĊINALI
English: Improvement in homeostasis model assessment for beta cell function (HOMA beta-cell) has been observed in clinical studies with Forxiga.
Maltese: Titjib fl-istima tal-mudell tal-omejostasi għall-funzjoni taċ-ċelluli beta (HOMO ċelluli-beta) deher fi studji kliniċi b'Forxiga.
English: Adverse drug reactions related to increased creatinine were grouped (e.g. decreased renal creatinine clearance, renal impairment, increased blood creatinine and decreased glomerular filtration rate).
Maltese: Reazzjonijiet avversi għall-mediċina relatati ma' żieda fil-kreatinina ġew raggruppati (eż. tnaqqis fleliminazzjoni tal-kreatinina mill-kliewi, indeboliment renali, żieda tal-kreatinina fid-demm u rata mnaqqsa ta' filtrazzjoni glomerulari).
English: Each Forxiga 10 mg film-coated tablet (tablet) contains dapagliflozin propanediol monohydrate equivalent to 10 mg dapagliflozin.
Maltese: Kull pillola fiha dapagliflozin propanediol monohydrate ekwivalenti għal 10 mg dapagliflozin.
English: In the extension period, HbA1c reductions were sustained through Week 102 (-0.61%, and -0.17% adjusted mean change from baseline for dapagliflozin 10 mg and placebo, respectively).
Maltese: Fil-perijodu estiż, tnaqqis tal-HbA1c kien sostnut f'Ġimgħa 102 (-0.61%, u -0.17% tal-bidla medja aġġustata mil-linja bażi għal dapagliflozin 10 mg u plaċebo, rispettivament).
English: 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 għal dapagliflozin żdied b'mod proporzjonali maż-żieda fid-doża ta' dapagliflozin fuq medda ta' 0.1 sa' 500 mg u l-farmakokinetika tiegħu ma nbidlitx maż-żmien wara dożi ripetuti kuljum għal mhux aktar minn 24 ġimgħa.
English: In a separate study of pre- and postnatal development, maternal rats were dosed from gestation day 6 through postnatal day 21, and pups were indirectly exposed in utero and throughout lactation.
Maltese: Fi studju separat tal-iżvilupp ta' qabel u wara t-twelid, firien materni ngħataw dożi minn jum 6 talġestazzjoni sa' jum 21 wara l-ħlas, u l-wild kienu esposti indirettament in utero u permezz tat-treddigħ.
English: In the placebo group there was a mean increase of 10.5 IU/day and 18.3 IU/day from baseline (mean average dose of 84 and 92 IU/day) at Weeks 48 and 104, respectively.
Maltese: IU/kuljum mil-linja bażi (doża medja ‘mean' ta' 84 u 92 IU/kuljum) f'Ġimgħat 48 u 104, rispettivament.
English: Each Forxiga 5 mg film-coated tablet (tablet) contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin.
Maltese: Kull pillola fiha dapagliflozin propanediol monohydrate ekwivalenti għal 5 mg dapagliflozin.
English: Dapagliflozin acts independently of insulin secretion and insulin action.
Maltese: Dapagliflozin jaħdem b'mod indipendenti mis-sekrezzjoni tal-insulina u l-azzjoni tal-insulina.
English: Tel: +385 1 4628 000
Maltese: AstraZeneca d.o.o. Tel: +385 1 4628 000
English: Diabetic ketoacidosis
Maltese: Ketoaċidożi dijabetika
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għallgalactose, nuqqas ta' Lapp lactase jew malassorbiment tal-glukows-galactose m'għandhomx jieħdu din il-mediċina.
English: The recommended dose is 10 mg dapagliflozin once daily for monotherapy and add-on combination therapy with other glucose-lowering medicinal products including insulin.
Maltese: Monoterapija u terapija miżjuda ma' terapija oħra Id-doża rakkomandata hija ta' 10 mg dapagliflozin darba kuljum għal monoterapija u bħala terapija miżjuda ma' prodotti mediċinali oħra li jbaxxu l-glukows inkluża l-insulina.
English: These infections were more frequent in females (8.4% and 1.2% for dapagliflozin and placebo, respectively), and subjects with a prior history were more likely to have a recurrent infection.
Maltese: Dawn l-infezzjonijiet kienu aktar frekwenti fin-nisa (8.4% u 1.2% għal dapagliflozin u plaċebo, rispettivament), u individwi li kellhom fil-passat kellhom aktar probabilità li tirkadilhom linfezzjoni.
English: In male and female rats, dapagliflozin showed no effects on fertility at any dose tested.
Maltese: Fil-firien ta' sess maskili u femminili, dapagliflozin ma wera l-ebda effetti fuq il-fertilità bi kwalunkwe doża li ġiet eżaminata.
English: Dyslipidaemiah
Maltese: FARMAĊEWTIKU
English: In a 52-week, active-controlled non-inferiority study (with 52- and 104-week extension periods), Forxiga was evaluated as add-on therapy to metformin compared with a sulphonylurea (glipizide) as add-on therapy to metformin in subjects with inadequate glycaemic control (HbA1c > 6.5% and ≤ 10%).
Maltese: Fi studju mhux inferjuri ta' 52-ġimgħa, kontrollat b'mod attiv (b'perjodi ta' estensjoni ta' 52 ġimgħa u ta' 104 ġimgħat), Forxiga kien evalwat bħala terapija add-on imqabbel ma' sulphonylurea (glipizide) miżjud ma' terapija b'metformin f'individwi b'kontroll gliċemiku mhux xieraq (HbA1c > 6.5% u ≤ 10 %).
English: Protein binding was not altered in various disease states (e.g. renal or hepatic impairment).
Maltese: L-irbit mal-proteini ma nbidilx f'sitwazzjonijiet varji ta'mard (eż. indeboliment renali jew epatiku).
English: Forxiga has not been studied in severe renal impairment (CrCl < 30 ml/min or eGFR < 30 ml/min/1.73 m2) or end-stage renal disease (ESRD).
Maltese: Forxiga mhux rakkomandat għall-użu f'pazjenti b'indeboliment renali moderat għal sever (pazjenti b'CrCl < 60 ml/min jew [eGFR] < 60 ml/min/1.73 m2).Forxiga ma ġiex studjat f'każijiet ta' indeboliment renali sever (CrCl < 30 ml/min jew eGFR < 30 ml/min/1.73 m2) jew mard renali fl-aħħar-stadju (ESRD).
English: • thirst
Maltese: • sturdament
English: Increased incidence or severity of renal pelvic dilatation was observed in adult offspring of treated dams, although only at the highest dose tested (associated maternal and pup dapagliflozin exposures were 1,415 times and 137 times, respectively, the human values at the maximum recommended human dose).
Maltese: Żieda fil-frekwenza jew fis-severità tad-dilatazzjoni renali pelvika dehret meta l-wild ta' firien femminili ttrattati saru adulti, għalkemm dan seħħ biss bl-ogħla dożi eżaminati (esponimenti materniċi u tal-wild għal dapagliflozin assoċjati kienu 1,415-il darba u 137-il darba, rispettivament, il-valuri filbniedem bl-ogħla doża rakkomandata).
English: Dapagliflozin and related metabolites are primarily eliminated via urinary excretion with less than 2% as unchanged dapagliflozin.
Maltese: Dapagliflozin u l-metaboli relatati jiġu eliminati fil-parti lkbira permezz ta' eskrezzjoni mal-awrina b'anqas minn 2% bħala dapagliflozin mhux mibdul.
English: Dapagliflozin was rapidly and well absorbed after oral administration.
Maltese: Dapagliflozin kien assorbit malajr u tajjeb wara assorbiment orali.
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-għotja ta'dapagliflozin flimkien ma' mefenamic acid (inibitur ta' UGT1A9), żieda ta' 55% flesponiment sistemiku ta' dapagliflozin deher, iżda ma' kienx hemm effett ta' sinifikat kliniku fuq leskrezzjoni tal-glukows mal-awrina fuq 24-siegħa.
English: Treatment with dapagliflozin 10 mg as an add-on to glimepiride resulted in statistically significant reductions in 2-hour post-prandial glucose at 24 weeks that were maintained up to Week 48.
Maltese: Kura b'dapagliflozin 10 mg miżjud ma' glimipiride wasslet għal tnaqqis statistikament sinifikanti talglukows wara sagħtejn mill-ikel wara 24 ġimgħa li nżammu sa' Ġimgħa 48.
English: • genital infection (thrush) of your penis or vagina (signs may include irritation, itching, unusual discharge or odour)
Maltese: • infezzjoni ġenitali (traxx) tal-pene jew tal-vaġina (sinjali jistgħu jinkludu irritazzjoni, ħakk,
English: Results at Week 24 (LOCFa) of a placebo-controlled study of dapagliflozin as monotherapy
Maltese: a) ta' studju kontrollat bi plaċebo b'dapagliflozin bħala monoterapija
English: Haematocrit increasedg
Maltese: Ematokrit għoli
English: Add-on combination therapy
Maltese: Terapija miżjuda ma' terapija oħra
English: Forxiga is indicated in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control as:
Maltese: Forxiga huwa indikat f'adulti li għandhom aktar minn 18-il sena jew aktar b'dijabete mellitus tat-tip 2 sabiex itejjeb il-kontroll gliċemiku bħala:
English: Thirteen double-blind, randomised, controlled clinical trials were conducted with 6,362 subjects with type 2 diabetes to evaluate the efficacy and safety of Forxiga; 4,273 subjects in these studies were treated with dapagliflozin.
Maltese: Tlettax-il prova klinika double-blind, randomised, ikkontrollati twettqu b' 6,362 individwu b'dijabete mellitus tat-tip 2 sabiex ikunu evalwati s-sigurtà u l-effikaċja ta' Forxiga; 4,273 individwu f'dawn listudji kienu kkurati b'dapagliflozin.
English: In patients with severe hepatic impairment, a starting dose of 5 mg is recommended.
Maltese: F'pazjenti b'indeboliment epatiku sever, doża tal-bidu ta' 5 mg hija rakkomandata.
English: (95% CI) Subjects with mean daily insulin dose reduction of at least 10% (%) LOCF: Last observation (prior to or on the date of the first insulin up-titration, if needed) carried forward All randomised subjects who took at least one dose of double-blind study medicinal product during the short-term double-blind period Least squares mean adjusted for baseline value and presence of oral glucose-lowering medicinal product p-value < 0.0001 versus placebo + insulin ± oral glucose-lowering medicinal product p-value < 0.05 versus placebo + insulin ± oral glucose-lowering medicinal product Up-titration of insulin regimens (including short-acting, intermediate, and basal insulin) was only allowed if subjects met pre-defined FPG criteria.
Maltese: Medja tal-anqas kwadri aġġustata għall-valur tal-linja bażi u l-preżenza ta' prodott mediċinali li jbaxxi l-glukows valur-p < 0.0001 kontra plaċebo + insulina ± prodott mediċinali orali li jbaxxi l-glukows valur-p < 0.05 kontra plaċebo + insulina ± prodott mediċinali orali li jbaxxi l-glukows Żieda gradwali fir-reġimens tal-insulina (inklużi insulina li taħdem malajr, intermedja, u basali) kien permess biss jekk l-individwi laħqu kriterji FPG stabiliti minn qabel.
English: Post-prandial glucose
Maltese: Dieta u eżerċizzju
English: However, an increased exposure due to age-related decrease in renal function can be expected.
Maltese: Madankollu, żieda fl-esponiment minħabba tnaqqis fil-funzjoni renali relatata mal-età huwa mistenni.
English: MARKETING AUTHORISATION HOLDER AstraZeneca AB
Maltese: AstraZeneca AB
English: Diuretics
Maltese: Manifattur
English: AstraZeneca S.p.A. Tel: +39 02 9801 1
Maltese: Tel: +39 02 9801 1
English: The increased/decreased risk was not statistically significant in any of the organ systems.
Maltese: Iż-żieda/tnaqqis tar-riskju ma kienx statistikament sinifikanti fl-ebda sistema tal-organi.