FrancophonIA/ELRC3.0 huggingface dataset:
English: Urinary 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: • How to measure ketones, how to interpret the results and what to do in case of hyperketonaemia/DKA (contact HCP immediately if BHB > 0.6 mmol/L with symptoms or if BHB > 1.5 mmol/L with or without symptoms)
Maltese: • Kif jitkejlu l-“ketones”, kif jiġu interpretati r-riżultati u x'għandu jsir f'każ ta' iperketonemija/DKA (ikkuntattja HCP immedjatament jekk BHB ikun > 0.6 mmol/L bissintomi jew jekk BHB ikun > 1.5 mmol/L bi jew mingħajr sintomi)
English: Edistride is indicated in adults for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise - as monotherapy when metformin is considered inappropriate due to intolerance.
Maltese: Edistride huwa indikat f'adulti għall-kura ta' dijabete mellitus tat-tip 2 mhux ikkontrollata biżżejjed bħala żieda mad-dieta u mal-eżerċizzju - bħala monoterapija meta metformin huwa meqjus mhux xieraq minħabba nuqqas ta' tolleranza.
English: (95% CI) Subjects (%) achieving: HbA1c < 7% (LOCF) Adjusted for baseline Body weight (kg) (LOCF) Baseline (mean) Change from baseline Difference from placebo c
Maltese: (95% CI) (%) tal-individwi li kisbu: HbA1c < 7% Aġġustat għal-linja bażi Piż tal-ġisem (kg) Linja bażi (medja) Bidla mil-linja bażi Differenza minn plaċebo c
English: • necrotising fasciitis of the perineum or Fournier's gangrene, a serious soft tissue infection of the genitals or the area between the genitals and the anus, seen very rarely.
Maltese: • faxxite nekrotizzanti tal-perinew jew kankrena ta' Fournier, infezzjoni tat-tessut artab serja tal-ġenitali jew tal-parti bejn il-ġenitali u l-anus, li tidher f'każijiet rari ħafna.
English: - At blood ketone readings over 3.0 mmol/L (or urine ketones reading +++) you probably have diabetic ketoacidosis, go to the emergency department without delay and stop taking Edistride.
Maltese: - Għal qari tal-“ketone” fid-demm aktar minn 3.0 mmol/L (jew qari tal-“ketone” fl-awrina +++) probabbli għandek ketoaċidożi dijabetika, mur f'dipartiment tal-emerġenza mingħajr dewmien u ieqaf ħu Edistride.
English: In type 1 diabetes mellitus studies with dapagliflozin, DKA was reported with common frequency.
Maltese: Fi studji tad-dijabete mellitus tat-tip 1 b'dapagliflozin, DKA ġiet irrappurtata bi frekwenza komuni.
English: In the dapagliflozin cardiovascular outcomes study with 17,160 type 2 diabetes mellitus patients and a median exposure time of 48 months, a total of 6 cases of Fournier's gangrene were reported, one in the dapagliflozin-treated group and 5 in the placebo group.
Maltese: Fl-istudju tal-eżiti kardjovaskulari b'dapagliflozin bi 17,160 pazjent bid-dijabete mellitus tat-tip 2 u żmien ta' esponiment medjan ta' 48 xahar, ġie rrapportat total ta' 6 każijiet ta' kankrena ta' Fournier, wieħed fil-grupp ikkurat b'dapagliflozin u 5 fil-grupp ikkurat bi plaċebo.
English: In subjects with moderate renal impairment (GFR < 60 mL/min), 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 (GFR < 60 mL/min), proporzjon ogħla ta' individwi ikkurati b'dapagliflozin kellhom reazzjonijiet avversi ta' żieda talkrejatinina, phosphorous, ormon tal-paratirojde (PTH) u pressjoni baxxa, meta mqabbla mal-plaċebo.
English: Infections and infestations
Maltese: Infezzjonijiet u infestazzjonij iet
English: The treatment benefit of dapagliflozin over placebo was observed both in patients with and without established cardiovascular disease, with and without heart failure at baseline, and was consistent across key subgroups, including age, gender, renal function (eGFR) and region.
Maltese: Il-benefiċċju tal-kura ta' dapagliflozin fuq plaċebo kien osservat kemm f'pazjenti bi u mingħajr marda kardjovaskulari stabbilita, bi u mingħajr insuffiċjenza tal-qalb fil-linja bażi, u kien konsistenti fost issottogruppi ewlenin, inkluż l-età, is-sess, il-funzjoni renali (eGFR) u r-reġjun.
English: Edistride5mg tablets are available in aluminium blisters in pack sizes of 14, 28 or 98film-coated tablets in non-perforated calendar blisters and 30x1 or 90x1 film-coated tablets in perforated unit dose blisters.
Maltese: Il-pilloli Edistride 5 mg jiġu ġo folji tal-aluminju f'daqsijiet ta' pakketti ta' 14, 28 jew 98 pilloli miksijin b'rita ġo folji mhux imtaqqbin tal-kalendarju u 30x1 jew 90x1 pilloli miksijin b'rita ġo folji imtaqqbin b'doża individwali.
English: • if you have “type 1 diabetes” - the type that usually starts when you are young, and your body does not produce any insulin.
Maltese: • jekk għandek “dijabete tat-tip 1” - it-tip li normalment tibda meta tkun żgħir, u ġismek ma jipproduċix insulina.
English: During treatment with dapagliflozin:
Maltese: Waqt il-kura b'dapagliflozin:
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 4) 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 4) li ġie sostnut wara 104 u 208 ġimgħat (-5.06 kg u4.
English: Edistride should not be initiated in patients with a GFR < 60 mL/min and should be discontinued at GFR persistently below 45 mL/min.
Maltese: Edistride m'għandux jinbeda f'pazjenti b'GFR < 60 ml/min u għandu jitwaqqaf f'GFR li b'mod persistenti tkun taħt 45 mL/min.
English: Edistride is indicated in adults for the treatment of insufficiently controlled type 1 diabetes mellitus as an adjunct to insulin in patients with BMI ≥ 27 kg/m2, when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy.
Maltese: Edistride huwa indikat f'adulti għall-kura ta' dijabete mellitus tat-tip 1 mhux ikkontrollata biżżejjed bħala żieda mal-insulina f'pazjenti b'BMI ≥ 27 kg/m2, meta l-insulina waħidha ma tipprovdix kontroll gliċemiku xieraq minkejja l-aħjar terapija bl-insulina.
English: Fourteen double-blind, randomised, controlled clinical studies were conducted with 7,056 subjects with type 2 diabetes to evaluate the glycaemic efficacy and safety of Edistride; 4,737 subjects in these studies were treated with dapagliflozin.
Maltese: Erbatax-il studju kliniku double-blind, randomised, ikkontrollati twettqu b' 7,056 individwu b'dijabete mellitus tat-tip 2 sabiex ikunu evalwati s-sigurtà u l-effikaċja gliċemika ta' Edistride; 4,737 individwu f'dawn l-istudji kienu kkurati b'dapagliflozin.
English: Sodium-glucose co-transporter 2 (SGLT2) inhibitors should be used with caution in patients with increased risk of diabetic ketoacidosis (DKA).
Maltese: L-inibituri tal-ko-trasportatur 2 ta' sodium-glucose (SGLT2) għandhom jintużaw b'kawtela f'pazjenti b'riskju miżjud ta' ketoaċidożi dijabetika (DKA).
English: OUTER CARTON 5 mg
Maltese: KARTUNA TA' BARRA 5 mg
English: Additional risk minimisation measures
Maltese: Sustained eGFR decrease
English: Dapagliflozin 10 mg demonstrated superiority versus placebo in preventing the composite of hospitalisation for heart failure or cardiovascular death (Figure 1).
Maltese: Dapagliflozin 10 mg wera superjorità kontra plaċebo fil-prevenzjoni tal-kompost ta' dħul fl-isptar għal insuffiċjenza tal-qalb jew mewt kardjovaskulari (Figura 1).
English: - At blood ketone readings over 1.5 to 3.0 mmol/L (or urine ketones reading ++) you may be developing diabetic ketoacidosis, seek medical advice immediately and stop taking Edistride.
Maltese: - Għal qari tal-“ketone” fid-demm aktar minn 1.5 sa 3.0 mmol/L (jew qari tal-“ketone” flawrina ++) jaf qed tiżviluppa ketoaċidożi dijabetika, fittex parir mediku immedjatament u ieqaf ħu Edistride.
English: At Week 52, the adjusted mean changes in body weight from baseline for dapagliflozin 5 mg relative to placebo were -2.56 kg and -3.50 kg, in the two studies, respectively.
Maltese: F'Ġimgħa 52, it-tibdil medju aġġustat fil-piż tal-ġisem mil-linja bażi għal dapagliflozin 5 mg relattiv għal plaċebo kien -2.56 kg u -3.50 kg, fiż-żewġ studji, rispettivament.
English: Fungal infection
Maltese: Infezzjoni fungali**
English: BLISTERS PERFORATED UNIT DOSE 5 mg
Maltese: B'DOŻA INDIVIDWALI 5 mg
English: Edistride10mg tablets are available in aluminium blisters in pack sizes of 14, 28 or 98film-coated tablets in non-perforated calendar blisters and 30x1 or 90x1 film-coated tablets in perforated unit dose blisters.
Maltese: Il-pilloli Edistride 10 mg jiġu ġo folji tal-aluminju f'daqsijiet ta' pakketti ta' 14, 28 jew 98 pilloli miksijin b'rita ġo folji mhux imtaqqbin tal-kalendarju u 30x1 jew 90x1 pilloli miksijin b'rita ġo folji imtaqqbin b'doża individwali.
English: Diabetic ketoacidosis was reported with common frequency.
Maltese: Ilketoaċidożi dijabetika ġiet irrappurtata bi frekwenza komuni.
English: Baseline (mean) Change from baseline Difference from dapagliflozin c
Maltese: Qabel tinbeda l-kura b'dapagliflozin:
English: Other side effects when taking Edistride:
Maltese: Effetti sekondarji oħra meta tkun qed tieħu Edistride:
English: • The other ingredients are: tablet core: microcrystalline cellulose (E460i), lactose (see section 2 ‘Edistride contains lactose'), crospovidone (E1202), silicon dioxide (E551), magnesium stearate (E470b).
Maltese: Kull pillola Edistride 10 mg miksija b'rita (pillola) fiha dapagliflozin propanediol monohydrate ekwivalenti għal 10 mg dapagliflozin Is-sustanzi l-oħra huma: - qalba tal-pillola: microcrystalline cellulose (E460i), lactose (ara sezzjoni 2 ‘Edistride fih lactose'), crospovidone (E1202), silicon dioxide (E551), magnesium stearate (E470b). - kisja tar-rita: polyvinyl alcohol (E1203), titanium dioxide (E171),macrogol 3350, talc (E553b), yellow iron oxide (E172).
English: Hypoglycaemia (when used with SU or insulin)
Maltese: Ipogliċemija (meta jintuża ma' SU jew insulina)
English: Type 1 diabetes: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Maltese: Dijabete tat-tip 1: Prodott mediċinali li jingħata b'riċetta ristretta tat-tabib (ara Anness I: Sommarju tal-Karatteristiċi tal-Prodott, sezzjoni 4.2).
English: The primary assessment of safety and tolerability was conducted in a pre-specified pooled analysis of 13 short-term (up to 24 weeks) placebo-controlled studies with 2,360 subjects treated with dapagliflozin 10 mg and 2,295 treated with placebo.
Maltese: Il-valutazzjoni primarja tas-sigurtà u t-tollerabbiltà saret f'analiżi kollettiva speċifikata minn qabel ta' 13-il studju ta' perjodu qasir (24 ġimgħa) ikkontrollat bil-plaċebo bi 2,360 individwu kkurati b'dapagliflozin 10 mg u 2,295 kkurati bi plaċebo.
English: A cardiovascular outcomes study (DECLARE) was conducted with dapagliflozin 10 mg compared with placebo in 17,160 patients with type 2 diabetes mellitus with or without established cardiovascular disease to evaluate the effect on cardiovascular and renal events.
Maltese: Sar studju tal-eżiti kardjovaskulari (DECLARE) b'dapagliflozin 10 mg imqabbel ma' plaċebo fi 17,160 pazjent b'djiabete mellitus tat-tip 2 bi jew mingħajr marda kardjovaskulari stabbilita biex jevalwa l-effett fuq avvenimenti kardjovaskulari u renali.
English: Improvement in homeostasis model assessment for beta cell function (HOMA beta-cell) has been observed in clinical studies with Edistride.
Maltese: Titjib fl-istima talmudell tal-omejostasi għall-funzjoni taċ-ċelluli beta (HOMO ċelluli-beta) deher fi studji kliniċi b'Edistride.
English: Edistride 10 mg Tablets Type 2 diabetes: Medicinal product subject to medical prescription.
Maltese: Edistride 10 mg Pilloli Dijabete tat-tip 2: Prodott mediċinali li jingħata bir-riċetta tat-tabib.
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 5 and 6).
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 5 u 6).
English: Each tablet contains dapagliflozin propanediol monohydrate equivalent to 10 mg dapagliflozin.
Maltese: Kull pillola fiha dapagliflozin propanediol monohydrate ekwivalenti għal 10 mg dapagliflozin.
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 dawn l-infezzjonijiet fil-passat kellhom aktar probabilità li jerġgħu jkollhom infezzjoni.
English: Type 1 diabetes:
Maltese: Dijabete tat-tip 1:
English: In a 52-week, active-controlled non-inferiority study (with 52- and 104-week extension periods), Edistride 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), Edistride 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: In the dapagliflozin cardiovascular outcomes study, with a median exposure time of 48 months, events of DKA were reported in 27 patients in the dapagliflozin 10 mg group and 12 patients in the placebo group.
Maltese: Fl-istudju tal-eżiti kardjovaskulari b'dapagliflozin, bi żmien medjan ta' esponiment ta' 48 xahar, ġew irrappurtati avvenimenti ta' DKA f'27 pazjent fil-grupp ta' dapagliflozin 10 mg u 12-il pazjent filgrupp ta' plaċebo.
English: Treatment with dapagliflozin 10 mg in combination with metformin (up to 2000 mg per day) provided significant improvements in HbA1c compared to the individual components (Table 7), and led to greater reductions in fasting plasma glucose (FPG) (compared to the individual components) and body weight (compared to metformin).
Maltese: Il-kura b'dapagliflozin 10 mg f'kombinazzoni ma' metformin (sa 2000 mg kuljum) ipprovdiet titjib sinifikanti fl-HbA1c meta mqabbel mal-komponenti individwali (Tabella 7), u wasslet għal tnaqqis ikbar fil-glukows fil-plażma fi stat sajjem (FPG) (meta mqabbel mal-komponenti individwali) u fil-piż tal-ġisem (meta mqabbel ma' metformin).
English: Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin.
Maltese: Kull pillola fiha dapagliflozin propanediol monohydrate ekwivalenti għal 5 mg dapagliflozin.
English: Statistically significant reductions in body weight were demonstrated for dapagliflozin compared with placebo (Table 11).
Maltese: Tnaqqis statistikament sinifikanti fil-piż tal-ġisem intwera għal dapagliflozin meta mqabbel ma' plaċebo (Tabella 11).
English: In two placebo-controlled studies in subjects with type 1 diabetes mellitus, 548 subjects were treated with dapagliflozin 5 mg plus adjustable insulin and 532 were treated with placebo plus adjustable insulin.
Maltese: F'żewġ studji kkontrollati bi plaċebo f'individwi b'dijabete mellitus tat-tip 1, 548 individwu ġew ikkurati b'dapagliflozin 5 mg u insulina aġġustabbli u 532 ġew ikkurati bi plaċebo u insulina aġġustabbli.
English: b,i,k
Maltese: b,i,k volum b,e
English: EU/1/15/1052/008 98 film-coated tablets
Maltese: EU/1/15/1052/005 90 x 1 (doża waħda) pillola miksija b'rita
English: • The patients should be educated on the risk of DKA, emphasizing that DKA could occur even when blood glucose levels are below 14 mmol/L (250 mg/dL).
Maltese: • Il-pazjenti għandhom jiġu edukati dwar ir-riskju ta' DKA, billi jiġi enfasizzat li d-DKA tista' sseħħ anki meta l-livelli tal-glucose fid-demm ikunu inqas minn 14 mmol/L (250 mg/dL).
English: If well tolerated, the dose may be increased to 10 mg when indicated (see sections 4.1 of the 10 mg SmPC, 4.4 and 5.2).
Maltese: Jekk tkun tollerata sew, iddoża tista' tiżdied għal 10 mg, meta jiġi indikat (ara sezzjonijiet 4.1 tal-SmPC ta' 10 mg, 4.4 u 5.2).
English: Treatment with dapagliflozin 10 mg in combination with metformin (up to 2000 mg per day) provided significant improvements in HbA1c compared to the individual components (Table 8), and led to greater reductions in fasting plasma glucose (FPG) (compared to the individual components) and body weight (compared to metformin).
Maltese: Il-kura b'dapagliflozin 10 mg f'kombinazzoni ma' metformin (sa 2000 mg kuljum) ipprovdiet titjib sinifikanti fl-HbA1c meta mqabbel mal-komponenti individwali (Tabella 8), u wasslet għal tnaqqis ikbar fil-glukows fil-plażma fi stat sajjem (FPG) (meta mqabbel mal-komponenti individwali) u fil-piż tal-ġisem (meta mqabbel ma' metformin).
English: Mechanism of action Dapagliflozin is a highly potent (Ki: 0.55 nM), selective and reversible inhibitor of SGLT2.
Maltese: Mekkaniżmu ta' azzjoni Dapagliflozin huwa inibitur qawwi ħafna (Ki 0.55 nM), selettiv u riversibli ta' SGLT2.
English: EU/1/15/1052/004 30 x 1 (unit dose) film-coated tablets EU/1/15/1052/005 90 x 1 (unit dose) film-coated tablets
Maltese: EU/1/15/1052/001 14-il pillola miksija b'rita EU/1/15/1052/002 28 pillola miksija b'rita EU/1/15/1052/003 98 pillola miksija b'rita EU/1/15/1052/004 30 x 1 (doża waħda) pillola miksija b'rita
English: HbA1c (%) Baseline (mean) Change from baseline Difference from placebo c
Maltese: HbA1c (%) Linja bażi (medja) Bidla mil-Linja bażi Differenza mill-Plaċebo c
English: • If treated with dapagliflozin, glucose levels will not adequately reflect insulin needs, and DKA may occur in patients treated with dapagliflozin even if blood glucose levels are below 14 mmol/l (250 mg/dl).
Maltese: • Jekk tingħata kura b'dapagliflozin, il-livelli tal-glucose mhumiex ser jirriflettu b'mod adegwat il-ħtiġijiet tal-insulina, u DKA tista' sseħħ f'pazjenti kkurati b'dapagliflozin anki jekk il-livelli tal-glucose fid-demm ikunu inqas minn 14 mmol/l (250 mg/dl).
English: LOCF: 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: Analiżi lonġitudinali ta' kejl ripetut valur-p < 0.0001 kontra l-plaċebo + prodott(i) mediċinali ieħor/oħra li jbaxxu l-glukożju
English: At Week 24, treatment with dapagliflozin once daily provided statistically significant improvements in HbA1c compared with placebo (Table 11).
Maltese: F'Ġimgħa 24, il-kura b'dapagliflozin darba kuljum ipprovdiet titjib statistikament sinifikanti f'HbA1c meta mqabbel ma' plaċebo (Tabella 11).
English: • Talk with your doctor about the risk of diabetic ketoacidosis before you start to take Edistride.
Maltese: • Tkellem mat-tabib tiegħek dwar ir-riskju ta' ketoaċidożi dijabetika qabel tibda tieħu Edistride.
English: Following an 8-week lead-in period to optimise each patient's diabetes management (glycaemic control including hyperglycaemia and hypoglycaemia, diet and exercise patterns), a total of 1,646 patients with HbA1c ≥ 7.5% and ≤ 10.5% were randomised to 5 mg dapagliflozin once daily, 10 mg dapagliflozin once daily or placebo once daily.
Maltese: Wara l-bidu inizjali tal-mediċina ta' 8 ġimgħat biex tiġi ottimizzata l-ġestjoni tad-dijabete ta' kull pazjent (kontroll gliċemiku inkluż xejriet ta' ipergliċemija u ipogliċemija, dieta, u eżerċizzju), total ta' 1,646 pazjent b'HbA1c ≥ 7.5% u ≤ 10.
English: OUTER CARTON 10 mg
Maltese: KARTUNA TA' BARRA 10 mg
English: LOCF: last observation (prior to rescue for rescued patients) carried forward.
Maltese: LOCF: l-aħħar osservazzjoni (qabel is-salvataġġ għall-pazjenti salvati) miġjuba minn qabel.
English: Patients using an insulin infusion pump have a higher risk of DKA and should be experienced with pump use, common trouble-shooting strategies when interruptions of insulin delivery via pump occur (issues with insertion site, clogged tubing, empty reservoir, etc.) and use of supplemental insulin injections with pen or syringe as needed in case of pump failure.
Maltese: Pazjenti li jużaw pompa tal-infużjoni tal-insulina għandhom riskju ogħla ta' DKA u għandu jkollhom esperjenza fl-użu tal-pompa, strateġiji komuni tas-soluzzjoni ta' problemi meta jseħħu interruzzjonijiet tal-għoti tal-insulina permezz tal-pompa (problemi bis-sit tal-inserzjoni, tubu msaddad, riżerva vojta, eċċ.) u l-użu ta' injezzjonijiet tal-insulina supplimentali b'pinna jew siringa kif meħtieġ f'każ li ma taħdimx il-pompa.
English: The risk of diabetic ketoacidosis must be considered in the event of non-specific symptoms such as nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue or sleepiness.
Maltese: Ir-riskju ta' ketoaċidożi dijabetika għandu jitqies fil-każ ta' sintomi mhux speċifiċi bħal dardir, rimettar, anorexja, uġigħ addominali, għatx eċċessiv, diffikultà biex tieħu nifs, konfużjoni, għeja mhux tas-soltu u ngħas.
English: BLISTERS PERFORATED UNIT DOSE 10 mg
Maltese: B'DOŻA INDIVIDWALI 10 mg
English: Dapagliflozin 10 mg demonstrated non-inferiority versus placebo for the composite of cardiovascular death, myocardial infarction or ischaemic stroke (one-sided p < 0.001).
Maltese: Avvenimenti kardjovaskulari avversi maġġuri Dapagliflozin 10 mg wera nuqqas ta' inferjorità kontra plaċebo għall-kompost ta' mewt kardjovaskulari, infart mijokardijaku jew puplesija iskemika (p minn naħa waħda < 0.001).
English: • Patients who insist on maintaining caloric restriction, carbohydrate restriction or ketogenic diet or who chronically under-dose insulin (e.g. in order to remain in a lipolytic state).
Maltese: • Pazjenti li jinsistu fuq li jżommu restrizzjoni kalorika, restrizzjoni tal-karboidrati jew dieta ketoġenika jew li kronikament jieħdu nuqqas ta' doża tal-insulina (eż. biex jibqgħu fi stat lipolitiku).
English: Clinical studies in type 1 diabetes mellitus
Maltese: Tabella 1 Stadju kliniku
English: • Your doctor will prescribe the strength that is right for you.
Maltese: • Pazjenti bi storja riċenti jew rikorrenti ta' DKA.
English: EU/1/15/1052/009 30 x 1 (unit dose) film-coated tablets EU/1/15/1052/010 90 x 1 (unit dose) film-coated tablets
Maltese: EU/1/15/1052/006 14-il pillola miksija b'rita EU/1/15/1052/007 28 pillola miksija b'rita EU/1/15/1052/008 98 pillola miksija b'rita EU/1/15/1052/009 30 x 1 (doża waħda) pillola miksija b'rita EU/1/15/1052/010 90 x 1 (doża waħda) pillola miksija b'rita
English: Fifty percent of subjects were on insulin monotherapy at baseline; 50% were on 1 or 2 oral glucose-lowering medicinal product(s) in addition to insulin: Of this latter group, 80% were on metformin alone, 12% were on metformin plus sulphonylurea therapy, and the rest were on other oral glucose-lowering medicinal products.
Maltese: Minn dan il-grupp tal-aħħar, 80% kienu fuq metformin waħdu, 12% kienu fuq metformin flimkien ma' terapija b'sulphonylurea, u l-oħrajn kienu fuq prodotti mediċinali orali li jbaxxu l-glukows.
English: • Correction of volume depletion prior to initiation of dapagliflozin is recommended in patients with this condition (see section 4.4).
Maltese: • Il-korrezzjoni tat-tnaqqis tal-volum qabel il-bidu ta' dapagliflozin hija rakkomandata f'pazjenti b'din il-kondizzjoni (ara sezzjoni 4.4).