FrancophonIA/ELRC3.0 huggingface dataset:
English: It can also be used in patients who do not have this abnormal reading on the ECG, if they have unstable angina (a severe type of chest pain) or have had a ‘non-Q-wave' myocardial infarction.
Maltese: Jista' jintuża wkoll f'pazjenti li m'għandhomx dan il-qari anormali fuq l-ECG, jekk ikollhom anġina instabbli (tip serju ta' wġigħ fis-sider) jew kellhom infart mijokardijaku ‘non-Qwave'.
English: The standard dose of Clopidogrel Teva Pharma B.V. is one 75-mg tablet once a day, taken with or without food.
Maltese: Id-doża standard ta' Clopidogrel Teva Pharma B.V. hija pillola ta' 75mg darba kuljum, li tittieħed malikel jew mhux mal-ikel.
English: • patients who have a condition known as ‘acute coronary syndrome', when it should be given with aspirin (another medicine that prevents blood clots), including patients who have had a stent inserted (a short tube placed in an artery to prevent it closing up).
Maltese: • pazjenti b'kundizzjoni magħrufa bħala ‘sindromu koronarju akut', meta għandu jingħata malaspirina (mediċina oħra li tipprevjeni l-formazzjoni ta' emboli tad-demm), inkluż f'pazjenti li tkun iddaħħlitilhom stent (tubu qasir imqiegħed f'arterja biex ma jħallihiex tingħalaq). Clopidogrel Teva Pharma B.V. jista' jintuża f'pazjenti li jkollhom attakk tal-qalb b'‘elevazzjoni tas-segment ST' (qari anormali fuq ECG jew elettrokardjogramma) meta t-tabib jaħseb li għandhom jibbenefikaw mittrattament.
English: What is Clopidogrel Teva Pharma B.V.?
Maltese: Kif jaħdem Clopidogrel Teva Pharma B.V.?
English: Packaging size
Maltese: Daqs talpakkett
English: Gastrointestinal symptomsi,§
Maltese: Sintomi gastrointestinalii,§
English: Dysuria Polyuria*,f
Maltese: Disurja Poliurja*,f
English: АстраЗенека България ЕООД Тел.
Maltese: България АстраЗенека България ЕООД
English: Elderly patients (≥ 65 years)
Maltese: Pazjenti akbar fl-età (≥ 65 sena)
English: − film-coating: polyvinyl alcohol (E1203), macrogol 3350 (E1520(iii)), talc (E553b), titanium dioxide (E171), iron oxides (E172).
Maltese: − kisja b'rita: polyvinyl alcohol (E1203), macrogol 3350 (E1520(iii)), talc (E553b), titanium dioxide (E171), iron oxides (E172).
English: • Lactic acidosis.
Maltese: • Aċidożi lattika.
English: INFORMATION IN BRAILLE xigduo 5 mg/1,000 mg
Maltese: INFORMAZZJONI BIL-BRAILLE xigduo 5 mg/1,000 mg
English: − tablet core: hydroxypropyl cellulose (E463), microcrystalline cellulose (E460(i)), magnesium stearate (E470b), sodium starch glycolate.
Maltese: − qalba tal-pillola: hydroxypropyl cellulose (E463), microcrystalline cellulose (E460(i)), magnesium stearate (E470b), sodium starch glycolate.
English: INFORMATION IN BRAILLE xigduo 5 mg/850 mg
Maltese: INFORMAZZJONI BIL-BRAILLE xigduo 5 mg/850 mg
English: Urticaria§ Erythema Pruritus§
Maltese: Meta jitqiesu n-nuqqas ta' sejbiet ta'
English: Mean percent change from baseline for dapagliflozin 10 mg versus placebo, respectively, was: total cholesterol 2.5% versus 0.0%; HDL cholesterol 6.0% versus 2.7%; LDL cholesterol 2.9% versus -1.0%; triglycerides -2.7% versus -0.7%.
Maltese: kolesterol totali 2.5% kontra 0.0%; kolesterol HDL 6.0% kontra 2.7%; kolesterol LDL 2.9% kontra -1.0%; trigliċeridi -2.7% kontra -0.7%. k ara sezzjoni 4.4
English: After administration of a 50 mg [14C]-dapagliflozin dose, 96% was recovered, 75% in urine and 21% in feces.
Maltese: Wara l-amministrazzjoni ta' doża ta' 50 mg [14C]-dapagliflozin, 96% kien irkuprat, 75% fl-awrina u 21% fl-ippurgar.
English: Renal clearance of metformin is > 400 ml/min, indicating that metformin is eliminated by glomerular filtration and tubular secretion.
Maltese: L-eliminazzjoni renali ta' metformin hija ta' > 400 ml/min, li turi li metformin jiġi eliminat b'filtrazzjoni glomerulari u bi tnixxija tubulari.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 16 January, 2014
Maltese: 16 ta' Jannar 2014
English: Αλέκτωρ Φαρµακευτική Λτδ Τηλ: +357 22490305
Maltese: Τηλ: +357 22490305
English: Difference from placebod
Maltese: Differenza minn Plaċeboc
English: In in vitro studies, dapagliflozin neither inhibited cytochrome P450 (CYP) 1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP3A4, nor induced CYP1A2, CYP2B6 or CYP3A4.
Maltese: CYP2C9, CYP2C19, CYP2D6, CYP3A4, u lanqas induċa CYP1A2, CYP2B6 or CYP3A4.
English: • Prior to initiation of treatment and at least yearly thereafter (see sections 4.2, 4.8, 5.1 and 5.2)
Maltese: • Qabel ma tinbeda l-kura u mill-inqas darba kull sena wara dan (ara sezzjonijiet 4.2, 4.8, 5.1 u 5.2)
English: Combinations not studied Dapagliflozin has not been studied in combination with glucagon-like peptide 1 (GLP-1) analogues.
Maltese: Dapagliflozin għadu ma ġiex studjat f'kombinazzjoni ma' analogi ta' glucagon-like peptide 1 (GLP-1).
English: Vulvovaginitis, balanitis and related genital infections Vulvovaginitis, balanitis and related genital infections were reported in 5.5% and 0.6% of subjects who received dapagliflozin 10 mg and placebo, respectively.
Maltese: Vulvovaginitis, balanite u infezzjonijiet ġenitali relatati Ġew irrapportati vulvovaġinite, balanite u infezzjonijiet ġenitali relatati f'5.5% u f'0.6% tal-pazjenti li rċevew 10 mg dapagliflozin u plaċebo, rispettivament.
English: Urinary tract infections were more frequently reported for dapagliflozin compared with placebo (4.7% versus 3.5%, respectively; see section 4.4).
Maltese: L-infezzjonijiet fil-passaġġ urinarju ġew irrapportati b'mod aktar frekwenti għal dapagliflozin meta mqabbel ma' plaċebo (4.7% kontra 3.5%, rispettivament; ara sezzjoni 4.4).
English: Vulvovaginitis, balanitis and related genital infections*,b,c
Maltese: Vulvovaginite, balanite u infezzjonijiet ġenitali relatati*,b,c Infezzjoni fil passaġġ urinarju*,b,d
English: Vulvovaginitis, 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: bAra s-subsezzjoni korrispondenti hawn taħt għal iktar informazzjoni. cVulvovaginite, balanite u infezzjonijiet ġenitali relatati jinkludu, eż. it-termini ppreferuti predefiniti: infezzjoni mikotika vulvovaġinali, infezzjoni vaġinali, balanite, infezzjoni fungali ġenitali, kandidjażi vulvovaġinali, vulvovaginite, balanite candida, kandidjażi ġenitali, infezzjoni ġenitali, infezzjoni ġenitali fl-irġiel, infezzjoni fil-pene, vulvite, vaginite batterjali, axxessi vulvali.
English: Blood creatinine increased**,b
Maltese: Żieda tal kreatinina fid demm**,b
English: The hazard ratio comparing dapagliflozin to comparator was 0.79 (95% Confidence interval [CI]: 0.58, 1.07), indicating that in this analysis dapagliflozin is not associated with an increase in cardiovascular risk in patients with type 2 diabetes mellitus.
Maltese: 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: Frequency categories are defined according to the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare
Maltese: Il-kategoriji tal-frekwenza huma definiti skont il-konvenzjoni li ġejja: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Polyuria includes the preferred terms: pollakiuria, polyuria, urine output increased.
Maltese: f Poliurja tinkludi t-termini ppreferuti: pollakurja, poliurja, żieda fil-produzzjoni tal-awrina.
English: Taste disturbance§
Maltese: Disturb fit
English: Add-on combination
Maltese: Kombinazzjoni miżjuda
English: Analysis of the results for overweight patients treated with metformin after failure of diet alone showed: - a significant reduction of the absolute risk of any diabetes-related complication in the metformin group (29.8 events/1,000 patient-years) versus diet alone (43.3 events/1,000 patient-years), p=0.0023, and versus the combined sulphonylurea and insulin monotherapy groups (40.1 events/1,000 patient-years), p=0.0034; - a significant reduction of the absolute risk of any diabetes-related mortality: metformin 7.5 events/1,000 patient-years, diet alone 12.7 events/1,000 patient-years, p=0.017; - a significant reduction of the absolute risk of overall mortality: metformin 13.5 events/1,000 patient-years versus diet alone 20.6 events/1,000 patient-years, (p=0.011), and versus the combined sulphonylurea and insulin monotherapy groups 18.9 events/1,000 patient-years (p=0.021); - a significant reduction in the absolute risk of myocardial infarction: metformin 11 events/1,000 patient-years, diet alone 18 events/1,000 patient-years, (p=0.01).
Maltese: - tnaqqis sinifikanti fir-riskju assolut ta' kwalunkwe kumplikazzjoni relatata mad-dijabete fil-grupp ta' metformin (29.8 avveniment/1,000 sena ta' pazjent) meta mqabbel mad-dieta weħidha (43.3 avveniment/1,000 sena ta' pazjent), p=0.0023, u meta mqabbel mal-gruppi tal-monoterapija ta' sulphonylurea flimkien mal-insulina (40.1 avveniment/1,000 sena ta' pazjent), p=0.0034; - tnaqqis sinifikanti fir-riskju assolut ta' kwalunkwe mewt relatata mad-dijabete: metformin 7.5 avvenimenti/1,000 sena ta' pazjent, dieta weħidha 12.7-il avveniment/1,000 sena ta' pazjent, p=0.017; - tnaqqis sinifikanti fir-riskju assolut ta' mortalità b'mod ġenerali: metformin 13.5-il avveniment/1,000 sena ta' pazjent imqabbel mad-dieta weħidha 20.6 avveniment/1,000 sena ta' pazjent, (p=0.011), u mqabbel mal-gruppi tal-monoterapija b'sulphonylurea flimkien mal-insulina 18.9-il avveniment/1,000 sena ta' pazjent (p=0.021); - tnaqqis sinifikanti fir-riskju assolut ta' infart mijokardijaku: metformin 11-il avveniment/1,000 sena ta' pazjent, dieta weħidha 18-il avveniment/1,000 sena ta' pazjent, (p=0.01).
English: EU/1/13/900/012 Xigduo 5 mg/1000 mg 196 (2 x 98) tablets (multipack)
Maltese: EU/1/13/900/012 Xigduo 5mg/1000mg 196 (2x98) pillola (pakkett multiplu)
English: Nocturia** Renal impairment**,b
Maltese: Nokturja** Indeboliment fil-kliewi**,b
English: Geometric mean steady-state dapagliflozin Cmax and AUCτ values following once daily 10 mg doses of dapagliflozin were 158 ng/ml and 628 ng h/ml, respectively.
Maltese: Il-valuri Cmax u AUCτ medji ġeometriċi ta' dapagliflozin fi stat fiss wara dożi ta' 10 mg dapagliflozin darba kuljum kienu ta' 158 ng/ml u 628 ng h/ml, rispettivament.
English: Pruritus genital**
Maltese: Stitikezza**
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% talpazjenti kellhom storja ta' mard kardjovaskulari (minbarra l-pressjoni għolja) fil-linja bażi u 67.9%
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'pazjenti ta' ≥ 65 sena, ġew irrappurtati reazzjonijiet avversi relatati ma' indeboliment jew insuffiċjenza renali fi 7.7% tal-individwi ttrattati b'dapagliflozin u f'3.8% tal-individwi ttrattati bi plaċebo (ara sezzjoni 4.4).
English: • For renal function approaching moderate renal impairment, at least 2 to 4 times per year.
Maltese: • Għal funzjoni renali li toqrob lejn indeboliment renali moderat, mill-inqas darbtejn sa 4 darbiet fis-sena.
English: PHARMACEUTICAL FORM AND CONTENTS 98 film-coated tablets.
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 98 pillola miksija b'rita.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - PART OF MULTIPACK - WITH BLUE BOX
Maltese: KARTUNA TA' BARRA - PARTI MINN PAKKETT MULTIPLU - BIL-KAXXA BLU
English: Treatment with dapagliflozin as an add-on to either metformin alone (dapagliflozin 10 mg QD or dapagliflozin 5 mg BID) or metformin plus sitagliptin, sulphonylurea 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 with placebo (-0.58 to 0.18 mmol/l [-10.4 to 3.3 mg/dl]) at Week 16 (5 mg BID) or Week 24.
Maltese: Il-kura b'dapagliflozin bħala żieda jew ma' metformin waħdu (10 mg dapagliflozin QD jew 5 mg dapagliflozin BID) jew ma' metformin flimkien ma' sitagliptin, sulphonylurea jew mal-insulina rriżultat fi tnaqqis statistikament sinifikanti fil-glukożju fil-plażma waqt is-sawm (-1.90 sa -1.20 mmol/l [-34.2 sa21.7 mg/dl]) imqabbel ma' plaċebo (-0.58 sa 0.18 mmol/l [-10.4 sa 3.3 mg/dl]) fil-ġimgħa 16 (5 mg BID)
English: This medicinal product must not be used in patients with moderate to severe renal impairment (patients with creatinine clearance [CrCl] < 60 ml/min or estimated glomerular filtration rate [eGFR] < 60 ml/min/1.73 m2, see sections 4.3, 4.4, 4.8, 5.1 and 5.2).
Maltese: Dan il-prodott mediċinali ma għandux jintuża f'pazjenti b'indeboliment renali moderat sa sever (pazjenti bit-tneħħija tal kreatinina [CrCl] < 60 ml/min jew b'rata stmata ta' filtrazzjoni fil-glomeruli [eGFR] ta' < 60 ml/min/1.73 m2, ara sezzjonijiet 4.3, 4.4, 4.8, 5.1 u 5.2).
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), pazjenti bid-dijabete (diabetes mellitus) tat-tip 2 u b'indeboliment renali ħafif, moderat jew sever (kif iddeterminat mill-eliminazzjoni ta' iohexol millplażma) kellhom esponimenti sistemiċi medji ta' dapagliflozin ta' 32%, 60% u 87% ogħla, rispettivament,
English: The mean total systemic clearance of dapagliflozin administered intravenously was 207 ml/min.
Maltese: L-eliminazzjoni sistemika totali medja ta' dapagliflozin amministrat ġol-vini kienet ta' 207 ml/min.
English: As an add-on therapy to metformin in an active-controlled non-inferiority study, dapagliflozin resulted in a statistically significant body weight change compared with glipizide of -4.65 kg at 52 weeks (p < 0.0001, Table 2) that was sustained at 104 and 208 weeks (-5.06 kg and -4.38 kg, respectively).
Maltese: 4.65 kg fil-ġimgħa 52 (p < 0.0001, Tabella 2) li kienet sostnuta sal-ġimgħat 104 u 208 (-5.06 kg u -4.38 kg rispettivament).
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: Ġew irrapportati reazzjonijiet relatati ma' tnaqqis fil-volum (inklużi, rapporti ta' idratazzjoni, ipovolemija jew pressjoni baxxa) f'1.1% u 0.7% tal-pazjenti li rċevew 10 mg dapagliflozin u plaċebo, rispettivament; reazzjonijiet serji seħħew f'< 0.2% tal-pazjenti mqassmin bejn 10 mg dapagliflozin u plaċebo (ara sezzjoni
English: PHARMACEUTICAL FORM AND CONTENTS Multipack: 196 (2 packs of 98) film-coated tablets
Maltese: Pakkett multiplu: 196 (2 pakketti ta' 98) pilloli miksijin b'rita
English: *,b,d
Maltese: h,§
English: The mean steady-state volume of distribution of dapagliflozin was 118 l.
Maltese: Il-volum medju ta' distribuzzjoni fi stat fiss ta' dapagliflozin kien ta' 118 l.
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% placebo).
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: The pack sizes are 14, 28, 56 and 60 film-coated tablets in non-perforated blisters, 60x1 film-coated tablets in perforated unit dose blisters and multipack containing 196 (2 packs of 98) film-coated tablets in non-perforated blisters.
Maltese: Id-daqsijiet tal-pakkett huma 14, 28, 56 u 60 pilloli miksijin b'rita f'folji mhux perforati, 60x1 pilloli miksijin b'rita f'folji ta' doża waħda perforati u pakkett multiplu li fih
English: (95% CI) Mean daily insulin dose (IU)1
Maltese: Doża medja ta' insulina kuljum (IU)1
English: However, the differences in exposure were not considered clinically meaningful.
Maltese: Madankollu, id differenzi fl-esponiment ma kinux meqjusin klinikament sinifikanti.
English: Metformin increases the transport capacity of specific types of membrane glucose transporters (GLUT-1 and GLUT-4).
Maltese: Metformin iżid il-kapaċità ta' trasport minn ġol-membrana ta' tipi speċifiċi ta' trasportaturi tal-glukożju (GLUT-1 u
English: If renal function falls below CrCl < 60 ml/min or eGFR < 60 ml/min/1.73 m2, treatment must be discontinued.
Maltese: Jekk il-funzjoni renali taqa' taħt CrCl < 60 ml/min jew eGFR ta' < 60 ml/min/1.73 m2, il-kura għandha titwaqqaf.
English: (95% CI) Subjects (%) achieving: HbA1c < 7% Adjusted for baseline
Maltese: Differenza minn Plaċeboc (95% CI) Individwi (%) li kisbu: HbA1c < 7%
English: NAME OF THE MEDICINAL PRODUCT Xigduo 5 mg/850 mg tablets dapagliflozin/metformin HCl
Maltese: Xigduo 5 mg/850 mg pilloli dapagliflozin/metformin HCl
English: SGLT2 is the predominant transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation.
Maltese: SGLT2 huwa t-trasportatur predominanti responsabbli għar-riassorbiment tal-glukożju mill-filtrat tal glomeruli lura fiċ-ċirkulazzjoni.
English: They have “5/850” on one side and “1067” on the other side.
Maltese: Għandhom “5/850” fuq naħa u “1067” fuq in-naħa l-oħra.
English: NAME OF THE MEDICINAL PRODUCT Xigduo 5 mg/1,000 mg tablets dapagliflozin/metformin HCl
Maltese: Xigduo 5 mg/1,000 mg pilloli dapagliflozin/metformin HCl
English: • in combination with other glucose-lowering medicinal products, including insulin, in patients inadequately controlled with metformin and these medicinal products (see sections 4.4, 4.5 and 5.1 for available data on different combinations)
Maltese: • f'kombinazzjoni ma' prodotti mediċinali oħra li jbaxxu l-glukożju, inkluża l-insulina, f'pazjenti mhux ikkontrollati adegwatament b'metformin u b'dawn il-prodotti mediċinali (ara sezzjonijiet 4.4, 4.5 u 5.1
English: In controlled clinical trials, maximum metformin plasma levels (Cmax) did not exceed 5 μg/ml, even at maximum doses.
Maltese: Fi provi kliniċi kkontrollati, il-livelli massimi ta' metformin filplażma (Cmax) ma qabżux l-5 μg/ml, anke b'dożi massimi.
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: Il-kombinazzjoni ta' doża waħda ta' 20 mg ta' dapagliflozin u simvastatin (sostrat ta' CYP3A4) irriżultat f'żieda ta' 19% fl-AUC ta'
English: Diagnostic laboratory findings are decreased blood pH, plasma lactate levels above 5 mmol/l, and an increased anion gap and lactate/pyruvate ratio.
Maltese: Sejbiet dijanjostiċi tal-laboratorju huma pH tad-demm imnaqqas, livelli tal-lactate fil-plażma ogħla minn 5 mmol/l, u żieda fl-anion gap u fil-proporzjon ta' lactate/pyruvate.
English: Placebo + insulin ± oral glucose-lowering medicinal products2
Maltese: ± prodotti mediċinali orali li jbaxxu l-glukożju2
English: HbA1c (%) Baseline (mean) Change from baselinec Difference from glipizide + metforminc (95% CI)
Maltese: Differenza minn glipizide + metforminc (95% CI)
English: Vulvovaginal pruritus**
Maltese: Prurite vulvovaġinali
English: Haematocrit increasedg
Maltese: Żieda fl-ematokrit
English: In an add-on to insulin study up to 104 weeks, episodes of major hypoglycaemia were reported in 0.5% and 1.0% of subjects in 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 dwar żieda mal-insulina sa 104 ġimgħat, ġew irrapportati episodji maġġuri ta' ipogliċemija f'0.5% u 1.0% tal-individwi f'10 mg dapagliflozin flimkien mal-insulina fil-ġimgħat 24 u 104, rispettivament, u f'0.5% tal-individwi ttrattati bi gruppi ta' plaċebo flimkien mal-insulina fil-ġimgħat 24 u
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: It-tneħħija tal glukożju fl-awrina fl-istat fiss f'24 siegħa kienet tiddependi ħafna mill-funzjoni renali u 85, 52, 18 u 11 g ta' glukożju kuljum tneħħew minn pazjenti bid-dijabete (diabetes mellitus) tat-tip 2 u b'funzjoni renali normali jew b'indeboliment renali ħafif, moderat jew sever, rispettivament.
English: Results at Week 24 (LOCFa) in a placebo-controlled study of dapagliflozin in combination with insulin (alone or with oral glucose-lowering medicinal products, including metformin)
Maltese: Ir-riżultati fil-Ġimgħa 24 (LOCFa) fi studju kkontrollat bi plaċebo dwar dapagliflozin f'kombinazzjoni mal-insulina (weħidha jew ma' prodotti mediċinali orali li jbaxxu l-glukożju, inkluż metformin)
English: (95% CI) Abbreviations: QD: once daily; BID: twice daily Metformin ≥ 1500 mg/day;
Maltese: QD: darba kuljum; BID: darbtejn kuljum 1Metformin ≥ 1500 mg kuljum; 2Sitagliptin 100 mg kuljum aLOCF:
English: Mean changes from baseline in haematocrit were 2.30% for dapagliflozin 10 mg versus -0.33% for placebo.
Maltese: g Il-bidliet medji mil-linja bażi fl-ematokrit kienu 2.30% għal 10 mg dapagliflozin kontra -0.33% għal plaċebo.
English: Results at Week 52 (LOCFa) in an active-controlled study comparing dapagliflozin with glipizide as add-on to metformin
Maltese: Riżultati fil-Ġimgħa 52 (LOCFa) fi studju kkontrollat attivament li jqabbel dapagliflozin ma'
English: In subjects ≥ 65 years of age, adverse reactions of volume depletion, most commonly reported as hypotension, were reported in 1.7% and 0.8% of dapagliflozin-treated subjects and placebo-treated subjects, respectively (see section 4.4).
Maltese: F'pazjenti ta' ≥ 65 sena, ġew irrapportati reazzjonijiet avversi ta' tnaqqis fil-volum, irrapportati l-aktar bħala pressjoni tad-demm baxxa, f'1.7% u f'0.8% tal-individwi ttrattati b'dapagliflozin u ta' dawk ittrattati bi plaċebo, rispettivament (ara sezzjoni 4.4).
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 fl eliminazzjoni tal-kreatinina mill-kliewi, indeboliment renali, żieda tal-kreatinina fid-demm u rata mnaqqsa ta' filtrazzjoni glomerulari).
English: As this medicinal product contains metformin, the treatment must be discontinued 48 hours before elective surgery with general, spinal or epidural anaesthesia.
Maltese: Billi dan il-prodott mediċinali fih metformin, il-kura trid titwaqqaf 48 siegħa qabel kirurġija mhux obbligatorja b'anestesija ġenerali, spinali jew epidurali.
English: They have “5/1000” on one side and “1069” on the other side.
Maltese: Għandhom “5/1000” fuq naħa u “1069” fuq in-naħa l-oħra.
English: Package leaflet: Information for the patient Xigduo 5 mg/850 mg film-coated tablets Xigduo 5 mg/1,000 mg film-coated tablets dapagliflozin/metformin hydrochloride
Maltese: Xigduo 5 mg/850 mg pilloli miksijin b'rita Xigduo 5 mg/1,000 mg pilloli miksijin b'rita dapagliflozin/metformin hydrochloride
English: HbA1c analyzed using LRM (Longitudinal repeated measures analysis) Least squares mean adjusted for baseline value p-value < 0.0001 versus placebo + oral glucose-lowering medicinal product(s)
Maltese: Il-medja tal-inqas kwadri aġġustata għall-valur tal-linja bażi valur-p < 0.0001 kontra plaċebo + prodott(i) mediċinali orali li jbaxxi(u) l-glukożju