FrancophonIA/ELRC3.0 huggingface dataset:
English: United Kingdom Aventis Pharma Ltd Epilim Chrono
Maltese: Aventis Pharma Ltd Epilim Chrono
English: Valpromide 300mg Tablet
Maltese: Valpromide 300mg Pillola
English: Pharma Gmbh Convulex Cr
Maltese: G.L. Pharma Gmbh Convulex Cr
English: Pharma Gmbh Epival Cr
Maltese: G.L. Pharma Gmbh Epival Cr
English: Sodium Valproate Ivax Sodium Valproate 200mg/5 Ml
Maltese: Sodium Valproate Ivax Sodium Valproate 200mg/5
English: Pharma Gmbh Convulex® Retard
Maltese: G.L. Pharma Gmbh Convulex® Retard
English: Pharma Gmbh Kонвулекс хроно
Maltese: G.L. Pharma Gmbh Kонвулекс хроно
English: Valproic Acid 87mg G, Sodium Valproate 200mg Tablet
Maltese: Valproic Acid 87mg G, Sodium Valproate 200mg Pillola
English: United Kingdom Aventis Pharma Ltd Depakote
Maltese: Aventis Pharma Ltd Depakote
English: Pharma Gmbh Convulex Retard
Maltese: G.L. Pharma Gmbh Convulex Retard
English: Valproate Semisodium 250mg Tablet
Maltese: Valproate Semisodium 250mg Pillola
English: United Kingdom Aventis Pharma Ltd Epilim
Maltese: Aventis Pharma Ltd Epilim
English: Pharma Gmbh конвулекс хроно
Maltese: Gmbh конвулекс хроно
English: Valproic Acid 217.75mg Sachet, Sodium Valproate 500.06mg Sachet
Maltese: Valproic Acid 217.75mg Qartas, Sodium Valproate 500.06mg Qartas
English: Depakine Chrono 300 Valproic Acid 87mg Tablet, Sodium
Maltese: Depakine Chrono 300 Valproic Acid 87mg Pillola, Sodium
English: Valproic Acid 72.61mg Sachet, Sodium Valproate 166.76mg Sachet
Maltese: Valproic Acid 72.61mg Qartas, Sodium Valproate 166.76mg Qartas
English: Sodium Valproate 150mg Capsule
Maltese: Sodium Valproate 150mg Kapsula
English: Sodium Valproate 300mg Suppository
Maltese: Sodium Valproate 300mg Suppositorju
English: Valproate Magnesium 500mg Tablet
Maltese: Valproate Magnesium 500mg Pillola
English: Valproate 200mg Tablet
Maltese: Valproate 200mg Pillola
English: Valproate Magnesium 200mg Tablet
Maltese: Valproate Magnesium 200mg Pillola
English: Pharma Gmbh конвулекс
Maltese: Gmbh конвулекс
English: Sodium Valproate Teva Sodium Valproate 200mg Tablet
Maltese: Sodium Valproate Teva Sodium Valproate 200mg Pillola
English: Valproic Acid 29.03mg Sachet, Sodium Valproate 66.66mg Sachet
Maltese: Valproic Acid 29.03mg Qartas, Sodium Valproate 66.66mg Qartas
English: Valproic Acid 145.14mg Sachet, Sodium Valproate 333.3mg Sachet
Maltese: Valproic Acid 145.14mg Qartas, Sodium Valproate 333.3mg Qartas
English: Austria sanofi-aventis GmbH Depakine Chrono
Maltese: L-Awstrija sanofi-aventis GmbH Depakine Chrono
English: Valproate Retard Eg Valproic Acid 87mg Tablet, Sodium
Maltese: Valproate Retard Eg Valproic Acid 87mg Pillola, Sodium
English: Valproate Semisodium 500mg Tablet
Maltese: Valproate Semisodium 500mg Pillola
English: ácido Valpróico Generis Valproic Acid 87mg Tablet, Sodium
Maltese: ácido Valpróico Generis Valproic Acid 87mg Pillola, Sodium
English: Valproate Retard Eg Valproic Acid 145mg Tablet, Sodium
Maltese: Valproate Retard Eg Valproic Acid 145mg Pillola, Sodium
English: Sodium Valproate 300mg Capsule
Maltese: Sodium Valproate 300mg Kapsula
English: ácido Valpróico Generis Valproic Acid 145mg Tablet, Sodium
Maltese: ácido Valpróico Generis Valproic Acid 145mg Pillola, Sodium
English: Sanofi-Aventis Aebe Depakine Chronosphere Valproic Acid 29.03mg Sachet, Sodium
Maltese: Sanofi-Aventis Aebe Depakine Chronosphere Valproic Acid 29.03mg Qartas, Sodium
English: Depakine Chronosphere Valproic Acid 217.75mg Sachet, Sodium
Maltese: Depakine Chronosphere Valproic Acid 217.75mg Qartas, Sodium
English: Sodium Valproate Teva Sodium Valproate 500mg Tablet
Maltese: Sodium Valproate Teva Sodium Valproate 500mg Pillola
English: Espa-Valept Retard Sodium Valproate 300mg Tablet
Maltese: Espa-Valept Retard Sodium Valproate 300mg Pillola
English: Epilim Chronosphere Valproic Acid 72.61mg Sachet, Sodium
Maltese: Epilim Chronosphere Valproic Acid 72.61mg Qartas, Sodium
English: Sodium Valproate 500mg Capsule
Maltese: Sodium Valproate 500mg Kapsula
English: Valproate Retard Mylan Sodium Valproate 300mg Tablet
Maltese: Valproate Retard Mylan Sodium Valproate 300mg Pillola
English: Valproate Retard Mylan Sodium Valproate 500mg Tablet
Maltese: Valproate Retard Mylan Sodium Valproate 500mg Pillola
English: Sanofi-Aventis Ireland Ltd. T/A SANOFI
Maltese: Sanofi-Aventis Ireland Ltd.
English: Epilim Chronosphere Valproic Acid 29.03mg Sachet, Sodium
Maltese: Epilim Chronosphere Valproic Acid 29.03mg Qartas, Sodium
English: Pharmaceuticals Uk
Maltese: Pharmaceuticals
English: Sanofi-Aventis Aebe Depakine Chronosphere Valproic Acid 72.61mg Sachet, Sodium
Maltese: Sanofi-Aventis Aebe Depakine Chronosphere Valproic Acid 72.61mg Qartas, Sodium
English: United Kingdom Aventis Pharma Ltd Epilim Chronosphere Valproic Acid 29.03mg Sachet, Sodium
Maltese: Aventis Pharma Ltd Epilim Chronosphere Valproic Acid 29.03mg Qartas, Sodium
English: United Kingdom Aventis Pharma Ltd Epilim Chronosphere Valproic Acid 217.75mg Sachet, Sodium
Maltese: Aventis Pharma Ltd Epilim Chronosphere Valproic Acid 217.75mg Qartas, Sodium
English: Depakine Chronosphere Valproic Acid 72.61mg Sachet, Sodium
Maltese: Depakine Chronosphere Valproic Acid 72.61mg Qartas, Sodium
English: United Kingdom Aventis Pharma Ltd Epilim Chronosphere Valproic Acid 72.61mg Sachet, Sodium
Maltese: Aventis Pharma Ltd Epilim Chronosphere Valproic Acid 72.61mg Qartas, Sodium
English: Austria sanofi-aventis GmbH Depakine
Maltese: L-Awstrija sanofi-aventis GmbH Depakine
English: Depakine Chronosphere Valproic Acid 29.03mg Sachet, Sodium
Maltese: Depakine Chronosphere Valproic Acid 29.03mg Qartas, Sodium
English: Oral Drops, Solution Oral Use
Maltese: Qtar Orali, Soluzzjoni
English: United Kingdom Aventis Pharma Ltd Epilim Chronosphere Valproic Acid 145.14mg Sachet, Sodium
Maltese: Aventis Pharma Ltd Epilim Chronosphere Valproic Acid 145.14mg Qartas, Sodium
English: Valproat 1 A Pharma Sodium Valproate 150mg Tablet
Maltese: Valproat 1 A Pharma Sodium Valproate 150mg Pillola
English: Depakine Chronosphere Valproic Acid 14.51mg Sachet, Sodium
Maltese: Depakine Chronosphere Valproic Acid 14.51mg Qartas, Sodium
English: Epilim Chronosphere Valproic Acid 145.14mg Sachet, Sodium
Maltese: Epilim Chronosphere Valproic Acid 145.14mg Qartas, Sodium
English: United Kingdom Aventis Pharma Ltd Epilim Chronosphere Valproic Acid 14.51mg Sachet, Sodium
Maltese: Aventis Pharma Ltd Epilim Chronosphere Valproic Acid 14.51mg Qartas, Sodium
English: Austria sanofi-aventis GmbH Depakine Chronosphere Valproic Acid 145.14mg Sachet, Sodium
Maltese: L-Awstrija sanofi-aventis GmbH Depakine Chronosphere Valproic Acid 145.14mg Qartas, Sodium
English: ácido Valpróico Sandoz Sodium Valproate 500mg Tablet
Maltese: ácido Valpróico Sandoz Sodium Valproate 500mg Pillola
English: Depakine Chronosphere Valproic Acid 145.14mg Sachet, Sodium
Maltese: Depakine Chronosphere Valproic Acid 145.14mg Qartas, Sodium
English: Acido Valproico Sandoz Sodium Valproate 500mg Tablet
Maltese: Acido Valproico Sandoz Sodium Valproate 500mg Pillola
English: ácido Valpróico Sandoz Sodium Valproate 300mg Tablet
Maltese: ácido Valpróico Sandoz Sodium Valproate 300mg Pillola
English: Valproat Neuraxpharm Sodium Valproate 150mg Units
Maltese: Valproat Neuraxpharm Sodium Valproate 150mg Unitajiet
English: G.L.
Maltese: L-Italja
English: Acido Valproico Sandoz Sodium Valproate 300mg Tablet
Maltese: Acido Valproico Sandoz Sodium Valproate 300mg Pillola
English: Austria sanofi-aventis GmbH Depakine Chronosphere Valproic Acid 14.51mg Sachet, Sodium
Maltese: L-Awstrija sanofi-aventis GmbH Depakine Chronosphere Valproic Acid 14.51mg Qartas, Sodium
English: Valproat Chrono Sandoz Sodium Valproate 500mg Tablet
Maltese: Valproat Chrono Sandoz Sodium Valproate 500mg Pillola
English: Valproát Chrono Sandoz Sodium Valproate 500mg Tablet
Maltese: Valproát Chrono Sandoz Sodium Valproate 500mg Pillola
English: Gastro-Resistant Capsule
Maltese: Kapsula Gastroreżistenti Użu Orali
English: Austria sanofi-aventis GmbH Depakine Chronosphere Valproic Acid 72.61mg Sachet, Sodium
Maltese: L-Awstrija sanofi-aventis GmbH Depakine Chronosphere Valproic Acid 72.61mg Qartas, Sodium
English: Valproat 1 A Pharma Sodium Valproate 300mg Tablet
Maltese: Valproat 1 A Pharma Sodium Valproate 300mg Pillola
English: Gastro-Resistant Capsule, Hard
Maltese: Kapsula Gastroreżistenti, Iebsa
English: Valproat 1 A Pharma Sodium Valproate 600mg Tablet
Maltese: Valproat 1 A Pharma Sodium Valproate 600mg Pillola
English: Valproat Chrono Sandoz Sodium Valproate 300mg Tablet
Maltese: Valproat Chrono Sandoz Sodium Valproate 300mg Pillola
English: Valproát Chrono Sandoz Sodium Valproate 300mg Tablet
Maltese: Valproát Chrono Sandoz Sodium Valproate 300mg Pillola
English: Valproat Neuraxpharm Sodium Valproate 600mg Units
Maltese: Valproat Neuraxpharm Sodium Valproate 600mg Unitajiet
English: Valproat 1 A Pharma Sodium Valproate 500mg Tablet
Maltese: Valproat 1 A Pharma Sodium Valproate 500mg Pillola
English: Sodium Valproate 1000mg Sachet
Maltese: Sodium Valproate 1000mg Qartas
English: Valproat Neuraxpharm Sodium Valproate 300mg Units
Maltese: Valproat Neuraxpharm Sodium Valproate 300mg Unitajiet
English: Valproat Neuraxpharm Sodium Valproate 500mg Units
Maltese: Valproat Neuraxpharm Sodium Valproate 500mg Unitajiet
English: Depakine Chrono 500 Valproic Acid 145.14mg Tablet, Sodium
Maltese: Valproic Acid 145.14mg Pillola, Sodium
English: Sanofi-Aventis Sro
Maltese: Sanofi-Aventis
English: Sanofi-Aventis Aebe Depakine Chronosphere Valproic Acid 290.27mg Sachet, Sodium
Maltese: Sanofi-Aventis Aebe Depakine Chronosphere Valproic Acid 290.
English: Valproic Acid 290.27mg Sachet, Sodium Valproate 666.6mg Sachet
Maltese: 27mg Qartas, Sodium Valproate 666.6mg Qartas
English: The full EPAR for Ucedane can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The initial daily dose of Ucedane should be 100 mg per kilogram body weight, but up to 250 mg/kg can be used if necessary.
Maltese: Id-doża inizjali ta' kuljum ta' Ucedane għandha tkun ta' 100 mg għal kull kilogramma piż tal-ġisem, iżda jekk ikun meħtieġ tista' tintuża doża sa 250 mg/kg.
English: Ucedane contains the active substance carglumic acid and is a ‘generic medicine'.
Maltese: Ucedane fih is-sustanza attiva carglumic acid u huwa "mediċina ġenerika".
English: This is a summary of the European public assessment report (EPAR) for Ucedane.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Ucedane.
English: Why is Ucedane approved?
Maltese: Għaliex ġie approvat Ucedane?
English: The active substance in Ucedane, carglumic acid, is very similar in structure to N-acetylglutamate, which activates an enzyme that breaks down ammonia.
Maltese: Issustanza attiva f'Ucedane, carglumic acid, għandha struttura simili ħafna għal ta' N-acetylglutamate, li tattiva enzima li tkisser l-ammonja.
English: Other information about Ucedane
Maltese: Informazzjoni oħra dwar Ucedane
English: What are the benefits and risks of Ucedane?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Ucedane?
English: For more information on generic medicines, see the question-and-answer document here.
Maltese: Għal aktar informazzjoni dwar il-mediċini ġeneriċi, ara d-dokument mistoqsijiet-u-tweġibiet hawn.
English: Because Ucedane is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Ucedane huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, ilbenefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: This means that Ucedane contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Carbaglu.
Maltese: Dan ifisser li Ucedane fih listess sustanza attiva u jaħdem bl-istess mod ta' "mediċina ta' referenza" diġà awtorizzata fl-Unjoni Europea (UE) li jisimha Carbaglu.
English: What measures are being taken to ensure the safe and effective use of Ucedane?
Maltese: X'miżuri qegħdin jitteħdu biex jiġi żgurat l-użu sigur u effettiv ta' Ucedane?
English: Studies on the benefits and risks of the active substance in the approved use have already been carried out with the reference medicine, Carbaglu, and do not need to be repeated for Ucedane.
Maltese: Diġà saru studji dwar il-benefiċċji u r-riskji tas-sustanza attiva fl-użu approvat bil-mediċina ta' referenza, Carbaglu, u ma għandhomx għalfejn jiġu ripetuti għal Ucedane.
English: Ucedane is a medicine used for the treatment of hyperammonaemia (high blood levels of ammonia) in patients with N-acetylglutamate synthase (NAGS) deficiency.
Maltese: L-EPAR sħiħ tal-mediċina ta' referenza jinstab ukoll fis-sit elettroniku tal-Aġenzija.
English: The company also carried out a study that showed that it is ‘bioequivalent' to the reference medicine.
Maltese: Il-kumpanija wettqet ukoll studju li wera li huwa "bijoekwivalenti" għall-mediċina ta' referenza.
English: The Committee recommended that Ucedane be approved for use in the EU.
Maltese: Il-Kumitat irrakkomanda li Ucedane jkun approvat għall-użu fl-UE.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Ucedane has been shown to have comparable quality and to be bioequivalent to Carbaglu.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, Ucedane wera li għandu kwalità komparabbli u huwa bijoekwivalenti għal Carbaglu.
English: How has Ucedane been studied?
Maltese: Kif ġie studjat Ucedane?
English: Therefore, the CHMP's view was that, as for Carbaglu, the benefit outweighs the identified risk.
Maltese: Għaldaqstant, il-fehma tas-CHMP kienet li, bħal fil-każ ta' Carbaglu, il-benefiċċju huwa akbar mir-riskju identifikat.
English: How does Ucedane work?
Maltese: Kif jintuża Ucedane?
English: Ucedane is available as dispersible tablets (200 mg) that are to be dispersed (mixed) in a small amount of water.
Maltese: Ucedane jiġi bħala pilloli li jinħallu fil-ħalq (200 mg) li għandhom jinħallu (jitħalltu) f'ammont żgħir ta' ilma.
English: The medicine can only be obtained with a prescription and treatment should be started by a doctor who has experience in treating patients with metabolic diseases such as NAGS deficiency.
Maltese: Il-mediċina tista' tinkiseb biss b'riċetta ta' tabib u l-kura għandha tinbeda minn tabib li jkun esperjenzat fil-kura ta' pazjenti b'mard metaboliku bħal nuqqas ta' NAGS.
English: Probable DKA
Maltese: DKA probabbli
English: Date of first authorisation: 09 November 2015
Maltese: Data tal-ewwel awtorizzazzjoni: 9 ta' Novembru 2015
English: UNIQUE IDENTIFIER 2D BARCODE
Maltese: IDENTIFIKATUR UNIKU BARCODE 2D
English: SE-151 85 Södertälje Sweden
Maltese: SE-151 85 Södertälje L-Isvezja
English: p < 0.0001 versus placebo
Maltese: p < 0.0001 kontra plaċebo
English: > 1.5-3.0 mmol/L Moderate
Maltese: > 1.5-3.0 mmol/L Moderat
English: Ketonaemia 0.6-1.5 mmol/L
Maltese: Ketonemija 0.6-1.5 mmol/L
English: Study MB102229
Maltese: Studju MB102229
English: Do not take Edistride:
Maltese: Tiħux Edistride:
English: Study MB102230
Maltese: Studju MB102230
English: C]-dapagliflozin dose, 96% was recovered, 75% in urine and 21% in faeces.
Maltese: C]-dapagliflozin, 96% kien rekuperat, 75% fl-awrina u 21% fl-ippurgar.
English: DPP-4 Inhibitor (sitagliptin 2) ± Metformin
Maltese: Inibitur DPP-4 (sitagliptin ± Metformin
English: Blood Ketone (betahydroxybutyrate)
Maltese: Ketone fid-Demm (betahydroxybutyrate)
English: Placebo + Insulin
Maltese: Plaċebo + Insulina
English: Mean HbA1c was 8.3% and mean BMI was 32.1 kg/m
Maltese: L-HbA1c medju kien 8.3% u lBMI medju kien 32.1 kg/m
English: 2D barcode carrying the unique identifier included.
Maltese: barcode 2D li jkollu l-identifikatur inkluż.
English: Clinical stage
Maltese: KLINIKU
English: • Signs/symptoms of DKA.
Maltese: Sinjali/sintomi ta' DKA.
English: In active- and placebo-controlled clinical studies (dapagliflozin, N=5936, All control, N=3403), the frequency of rash was similar for dapagliflozin (1.4%) and all control (1.4%), respectively.
Maltese: Fi studji kliniċi attivi u kkontrollati bi plaċebo (dapagliflozin, N=5936, Kull kontroll, N=3403), il-frekwenza tar-raxx kienet simili għal dapagliflozin (1.4%) u kull kontroll (1.4%), rispettivament.
English: The recommended actions are listed in Table 1 (see section 4.2).
Maltese: L-azzjonijiet rakkomandati huma elenkati fit-Tabella 1 (ara sezzjoni 4.2).
English: Glycaemic control in patients with moderate renal impairment CKD 3A (eGFR ≥ 45 to < 60 mL/min/1.73 m
Maltese: Kontroll gliċemiku f'pazjenti b'indeboliment renali moderat CKD 3A (eGFR ≥ 45 sa < 60 mL/min/1.73 m
English: Metformin ≥ 1500 mg/day; sitagliptin 100 mg/day
Maltese: Metformin ≥ 1500 mg/jum;
English: • Insulin therapy should be continuously optimised.
Maltese: It-terapija bl-insulina għandha tiġi ottimizzata kontinwament.
English: Pharmacotherapeutic group: Drugs used in diabetes, Sodium-glucose co-transporter 2 (SGLT2) inhibitors, ATC code: A10BK01
Maltese: Mediċini li jintużaw fid-dijabete, inibituri ta' ko-trasportatur 2 ta' sodium-glucose (SGLT2, sodium-glucose co-transporter 2) inhibitors, Kodiċi ATC:
English: Dapagliflozin 5 mg + Insulin
Maltese: Dapagliflozin 5 mg + Insulina
English: Mean eGFR was 85.2 mL/min/1.73 m 7.4% of patients had eGFR < 60 mL/min/1.73 m2, and 30.3% of patients had micro- or macroalbuminuria (urine albumin to creatinine ratio [UACR] ≥ 30 to ≤ 300 mg/g or > 300 mg/g, respectively).
Maltese: L-eGFR medja kienet 85.2 mL/min/1.73 m 2, 7.4% tal-pazjenti kellhom eGFR < 60 mL/min/1.73 m 2, u 30.3% tal-pazjenti kellhom mikro- jew makroalbuminurja (proporzjon ta' albumina għal kreatinina fl-awrina [UACR] ≥ 30 sa ≤ 300 mg/g jew > 300 mg/g, rispettivament).
English: Edistride has not been studied in severe renal impairment (GFR < 30 mL/min) or end-stage renal disease (ESRD).
Maltese: Edistride ma ġiex studjat f'każijiet ta' indeboliment renali sever (GFR < 30 mL/min) jew mard renali fl-aħħar-stadju (ESRD).
English: Edistride 5 mg Tablets
Maltese: Edistride 5 mg Pilloli
English: Fifty-one percent (51%) of the subjects were men, 84% were White, 8% were Asian, 4% were Black and 4% were of other racial groups.
Maltese: Wieħed u ħamsin fil-mija (51%) tal-individwi kienu rġiel, 84% kienu Bojod, 8% kienu Ażjatiċi, 4% kienu Suwed u 4% kienu minn gruppi ta' razzez oħra.
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 (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), and not known (cannot be estimated from the available data).
Maltese: Il-kategoriji tal-frekwenza huma skont il-konvenzjoni li ġejja: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa' < 1/10), mhux komuni (≥ 1/1000 sa' < 1/100), rari (≥ 1/10,000 sa < 1/1000), rari ħafna (< 1/10,000), u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
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 ta' glukows mill-filtrat tal-glomeruli lura fiċ-ċirkolazzjoni.
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: Il-bidla medja perċentwali mil-linja bażi għal 10 mg dapagliflozin meta mqabbla ma' plaċebo, rispettivament, kienet: kolesterol totali 2.5% kontra 0.0%; kolesterol HDL 6.0% kontra 2.7%; kolesterol LDL 2.9% kontra1.0%; trigliċeridi -2.7% kontra -0.7%.
English: • For renal function with GFR < 60 mL/min, at least 2 to 4 times per year.
Maltese: • Għall-funzjoni renali b'GFR < 60 mL/min, mill-anqas darbtejn sa' 4 darbiet fis-sena.
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% and 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: Urine Ketone
Maltese: Ketone fl-Awrina Azzjonijiet
English: Edistride is used in adult patients (aged 18 years and older).
Maltese: Edistride jintuża f'pazjenti adulti (li għandhom 18-il sena u aktar).
English: Dapagliflozin 10 mg + insulin ± oral glucose-lowering medicinal products
Maltese: Dapagliflozin 10 mg + insulina ± prodotti mediċinali orali li jbaxxu l-glukows
English: At 24 weeks, reductions in serum uric acid concentrations ranged from -48.3 to -18.3 micromoles/L (-0.87 to -0.33 mg/dL).
Maltese: Mal-24 ġimgħa, tnaqqis talkonċentrazzjonijiet ta' uric acid fis-serum kellhom medda ta' -48.3 sa' -18.3 micromoles/L (-0.87 sa' -0.33mg/dL).
English: Edistride should not be initiated in patients with a glomerular filtration rate [GFR] < 60 mL/min and should be discontinued at GFR persistently below 45 mL/min (see sections 4.4, 4.8, 5.1 and 5.2).
Maltese: [GFR] < 60 ml/min u għandu jitwaqqaf f'GFR li b'mod persistenti tkun taħt 35 mL/min (ara sezzjonijiet 4.4, 4.8, 5.1 u 5.2).
English: Change from baseline Difference from glipizide + metformin c
Maltese: Differenza minn glipizide + metformin c
English: • Patients with elevated ketones levels (BHB reading is greater than 0.6 mmol/L or urine ketones one plus (+)).
Maltese: • Pazjenti b'livelli tal-“ketones” għoljin (qari tal-BHB akbar minn 0.6 mmol/L jew “ketones” fl awrina wieħed plus (+)).
English: Placebo + insulin ± oral glucose-lowering medicinal products
Maltese: Plaċebo + insulina ± prodotti mediċinali orali li jbaxxu l-glukows
English: Edistride contains lactose
Maltese: Edistride fih lactose
English: Supplemental carbohydrate may be required in addition to hydration and additional rapid insulin (see Table 1 in section 4.2).
Maltese: Jista' jkun meħtieġ kaboidrat supplimentali minbarra l-idratazzjoni u insulina rapida addizzjonali (ara Tabella 1 f'sezzjoni 4.2).
English: Mean duration of diabetes ranged from 1.4 to 16.9 years.
Maltese: Il-medja tat-tul taddijabete kienet bejn 1.4 sa' 16.9 snin.
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 flimkien mal-insulina.
English: For study results with respect to combination of therapies, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.
Maltese: Għal riżultati tal-istudju fir-rigward tal-kombinazzjoni ta' terapiji, effetti fuq il-kontroll gliċemiku u avvenimenti kardjovaskulari, u l-popolazzjonijiet li ġew studjati, ara sezzjonijiet 4.4, 4.5 u 5
English: See “Description of selected adverse reactions” and section 4.4.
Maltese: Ara “Deskrizzjoni tar-reazzjonijiet avversi magħżulin” u sezzjoni 4.4.
English: Impending DKA
Maltese: DKA imminenti
English: Vulvovaginitis, balanitis and related genital infections In the 13-study safety pool, 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: Vulvovaġinite, balanite u infezzjonijiet ġenitali relatati Fil-ġabra ta' 13-il studju ta' sigurtà, vulvovaġinite, balanite u infezzjonijiet ġenitali relatati kienu rrappurtati f'5.5% u 0.6% tal-individwi li rċievew dapagliflozin 10 mg u plaċebo, rispettivament.