natgillin/translations-raw huggingface dataset:
Invented name Strength 
Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina velikost pakiranja
Package size 
280 tablet (skupno pakiranje)
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. 
Začetni dnevni odmerek zdravila Ucedane naj bo 100 mg na kilogram telesne mase, če pa je treba, se lahko daje do 250 mg/kg.
What measures are being taken to ensure the safe and effective use of Ucedane? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ucedane?
It is not intended to provide practical advice on how to use Ucedane. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Ucedane carglumic acid 
Ucedane kargluminska kislina
The full EPAR for Ucedane can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Ucedane je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What is Ucedane and what is it used for? 
Kaj je zdravilo Ucedane in za kaj se uporablja?
Ucedane is available as dispersible tablets (200 mg) that are to be dispersed (mixed) in a small amount of water. 
Zdravilo Ucedane je na voljo v obliki disperzibilnih tablet (200 mg), ki jih je treba dispergirati (zmešati) v majhni količini vode.
Treatment may be started as early as the first day of life and the medicine is used for the patient's whole life. 
Zdravljenje se lahko začne že prvi dan po rojstvu, zdravilo pa bolnik jemlje vse življenje.
When ammonia builds up in the blood, it is toxic to the body, especially the brain. 
Če se amoniak kopiči v krvi, je toksičen za telo, zlasti za možgane.
What are the benefits and risks of Ucedane? 
Kakšne so koristi in tveganja, povezani z zdravilom Ucedane?
As for every medicine, the company provided studies on the quality of Ucedane. 
Kot to velja za vsako zdravilo, je družba zagotovila študije o kakovosti zdravila Ucedane.
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. 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Ucedane primerljivo raven kakovosti kot zdravilo Carbaglu ter da mu je biološko enakovredno.
The dose should then be adjusted to maintain normal blood ammonia levels. 
Odmerek je nato treba prilagajati za vzdrževanje normalne ravni amoniaka v krvi.
This is a summary of the European public assessment report (EPAR) for Ucedane. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Ucedane.
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. 
Predpisovanje in izdaja zdravila Ucedane je le na recept, zdravljenje z njim pa mora uvesti zdravnik, ki ima izkušnje z zdravljenjem bolnikov s presnovnimi boleznimi, kot je pomanjkanje NAGS.
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. 
Ker je zdravilo Ucedane generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
The Committee recommended that Ucedane be approved for use in the EU. 
Priporočil je, da se zdravilo Ucedane odobri za uporabo v EU.
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. 
Študije o koristih in tveganjih zdravilne učinkovine pri dovoljenih uporabah so že bile izvedene z referenčnim zdravilom Carbaglu, zato jih ni treba ponoviti za zdravilo Ucedane.
Why is Ucedane approved? 
Zakaj je bilo zdravilo Ucedane odobreno?
For more information about treatment with Ucedane, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Ucedane preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
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. 
To pomeni, da vsebuje enako zdravilno učinkovino in ima enak način delovanja kot referenčno zdravilo Carbaglu, ki je že odobreno v Evropski uniji (EU).
If the enzyme is not present, ammonia cannot be broken down and it builds up in the blood. 
Če encima ni, se amoniak ne more razgraditi in se začne kopičiti v krvi.
Patients with this lifelong disease lack a liver enzyme called NAGS, which normally helps to break down ammonia. 
Bolnikom s to doživljenjsko boleznijo primanjkuje jetrnega encima NAGS, ki običajno pripomore k razgradnji amoniaka.
Ucedane therefore helps break down ammonia, reducing ammonia blood levels and its toxic effects. 
Zdravilo Ucedane torej pripomore k razgradnji amoniaka in tako zmanjšuje raven amoniaka v krvi ter njegove toksične učinke.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ucedane have been included in the summary of product characteristics and the package leaflet. 
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Ucedane upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
For practical information about using Ucedane, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Ucedane naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Ucedane contains the active substance carglumic acid and is a ‘generic medicine'. 
Zdravilo Ucedane vsebuje zdravilno učinkovino kargluminsko kislino in je „generično zdravilo“.
Ucedane is a medicine used for the treatment of hyperammonaemia (high blood levels of ammonia) in patients with N-acetylglutamate synthase (NAGS) deficiency. 
Ucedane je zdravilo, ki se uporablja za zdravljenje hiperamoniemije (visokih ravni amoniaka v krvi) pri bolnikih s pomanjkanjem N-acetilglutamat-sintaze.
The active substance in Ucedane, carglumic acid, is very similar in structure to N-acetylglutamate, which activates an enzyme that breaks down ammonia. 
Zdravilna učinkovina v zdravilu Ucedane, kargluminska kislina, je po strukturi zelo podobna N--acetilglutamatu, ki aktivira encim za razgradnjo amoniaka.
Therefore, the CHMP's view was that, as for Carbaglu, the benefit outweighs the identified risk. 
Zato je menil, da njegove koristi enako kot pri zdravilu Carbaglu odtehtajo znana tveganja.
How is Ucedane used? 
Kako se zdravilo Ucedane uporablja?
Other information about Ucedane 
Druge informacije o zdravilu Ucedane
How has Ucedane been studied? 
Kako je bilo zdravilo Ucedane raziskano?
How does Ucedane work? 
Kako zdravilo Ucedane deluje?
Bottle (HDPE) 
Steklenička (HDPE)
Oral use 
Peroralno dajanje
Invented name Strength Pharmaceutical form Route of administration Packaging 
Farmacevtska oblika Način uporabe zdravila Ovojnina
EU number 
Številka EU Izmišljeno ime Jakost
l t o r 
o ā t
Strength Pharmaceutical Form 
Številka EU Zaščiteno ime jakost farmacevtska oblika pot uporabe ovojnina velikost pakiranja
Date of first authorisation: 09 November 2015 
Datum prve odobritve: 09. november 2015
An updated RMP should be submitted: • At the request of the European Medicines Agency; 
Posodobljen RMP je treba predložiti: • na zahtevo Evropske agencije za zdravila
These effects were sustained in longer-term studies. 
Ti učinki so se ohranili v dolgoročnih študijah.
It can also help prevent heart disease. 
Lahko pomaga tudi preprečiti srčno bolezen.
• Signs/symptoms of DKA. 
• Znake/simptome DKA.
• if you have a liver problem. 
• če imate težave z jetri.
The patient may need to take extra insulin and drink water. 
Bolnik bo morda potreboval dodaten insulin in pitje vode.
This finding was consistent across subgroups. 
Ta izsledek se je skladal po vseh podskupinah.
Large to very large 
Veliko do zelo veliko
Subjects with mean daily insulin dose reduction of at least 10% (%) 
Osebe z zmanjšanjem povprečnega dnevnega odmerka insulina za vsaj 10 % (%)
Trace or Small 
Sled ali malo
Probable DKA 
Verjetna DKA
Diet and exercise can help your body use its blood sugar better. 
Dieta in telesna dejavnost lahko telesu pomagata, da bolje porablja krvni sladkor.
Ketone monitoring during treatment: 
Spremljanje ketonov med zdravljenjem:
Frequency is based on annual rate. 
Pogostnost na podlagi letnega deleža.
• Signs/symptoms of DKA - if not adequately managed DKA can be severe and fatal. 
• Znaki/simptomi DKA - če DKA ni ustrezno obravnavana, je lahko huda in smrtna.
Throughout the study, insulin dose was adjusted as deemed appropriate. 
Med celotno študijo so odmerek insulina prilagajali, kot se je zdelo primerno.
• Patients with excessive alcohol consumption or who use illicit drugs. 
• Bolniki, ki prekomerno uživajo alkohol ali uporabljajo prepovedane droge.
See “Description of selected adverse reactions” and section 4.4. 
Glejte "Opis izbranih neželenih učinkov" in poglavje 4.4.
More information is given below under ‘Other medicines and Edistride'. 
Več informacij je na voljo v nadaljevanju v poglavju "Druga zdravila in zdravilo Edistride".
Not evaluated for statistical significance as a result of the sequential testing procedure for secondary end points 
Ni ocenjeno za statistično značilnost zaradi postopka zaporednega preskušanja za sekundarne opazovane dogodke
• Patients unable or unwilling to monitor ketones. 
• Bolniki, ki niso zmožni ali niso voljni kontrolirati ketonov.
• Insulin therapy should be continuously optimised. 
• Je treba zdravljenje z insulinom stalno optimizirati.
• Prior to initiation of concomitant medicinal products that may reduce renal function and periodically thereafter. 
• Pred začetkom sočasnega zdravljenja z zdravili, ki lahko zmanjšajo delovanje ledvic in periodično potem.
Edistride is not recommended for children and adolescents under 18 years of age, because it has not been studied in these patients. 
Uporaba zdravila Edistride ni priporočljiva pri otrocih in mladostnikih, starih manj kot 18 let, ker pri teh bolnikih zdravilo ni bilo raziskano.
Dapagliflozin is approximately 91% protein bound. 
Dapagliflozin je približno v 91 % vezan na beljakovine.
Edistride is used in adult patients (aged 18 years and older). 
Zdravilo Edistride se uporablja pri odraslih bolnikih (starih 18 let ali več).
If you have type 2 diabetes, it can also help prevent heart disease. 
Če imate sladkorno bolezen tipa 2, lahko pomaga tudi preprečiti srčno bolezen.
• It should be ensured that ketone levels are normal. 
• Zagotoviti je treba, da je koncentracija ketonov normalna.
This may occur regardless of blood sugar level. 
To se lahko pojavi ne glede na količino sladkorja v krvi.
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). 
Kategorije pogostosti so opredeljene po naslednjem dogovoru: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
HR=Hazard ratio CI=Confidence interval. 
HR = razmerje ogroženosti (Hazard ratio) IZ = interval zaupanja.
This increase was not accompanied by any increase in the percentage of 24-hour glucose readings < 70 mg/dL. 
Tega povečanja ni spremljalo povečanje odstotka 24-urnih odčitkov glukoze < 70 mg/dl.
• For renal function with GFR < 60 mL/min, at least 2 to 4 times per year. 
• V primeru delovanja ledvic z GFR < 60 ml/min vsaj 2 do 4-krat na leto.
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. 
Enainpetdeset odstotkov (51 %) preiskovancev je bilo moških, 84 % belcev, 8 % Azijcev, 4 % črncev in 4 % drugih rasnih skupin.
It may be more pronounced in patients with very high blood glucose concentrations. 
To je lahko bolj izraženo pri bolnikih z zelo velikimi koncentracijami glukoze v krvi.
• If it is 12 hours or more until your next dose, take a dose of Edistride as soon as you remember. 
• Če je do naslednjega odmerka 12 ur ali več, vzemite odmerek zdravila Edistride takoj, ko se spomnite.
Therefore, glucose monitoring must be supplemented by ketone monitoring. 
Zato je treba spremljanje glukoze dopolniti s spremljanjem ketonov.
Measure your ketone levels again in 2 hours. 
Koncentracijo ketonov ponovno izmerite čez 2 uri.
Clinical stage 
Klinični stadij
The recommended actions are listed in Table 1 (see section 4.2). 
Priporočeno ukrepanje je navedeno v preglednici 1 (glejte poglavje 4.2).
Do not use this medicine after the expiry date, which is stated on the blister or carton after ‘EXP'. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu ali škatli poleg oznake "EXP".
The patient alert card should contain the following key elements: 
Opozorilna kartica za bolnika mora obsegati naslednje ključne elemente:
Edistride can be taken orally once daily at any time of day with or without food. 
Zdravilo Edistride se jemlje peroralno, enkrat na dan, kadar koli tekom dneva, s hrano ali brez nje.
The recommended actions are listed in Table 1. 
Priporočeno ukrepanje je navedeno v preglednici 1.
Other medicines and Edistride Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. 
Druga zdravila in zdravilo Edistride Obvestite zdravnika, farmacevta ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
DKA events occurred evenly distributed over the clinical study period. 
Primeri DKA so bili enakomerno porazdeljeni skozi obdobje klinične študije.
Study MB102229 
Študija MB102229
• Dapagliflozin is not a substitute for insulin (and does not alter insulin-sensitivity). 
• Dapagliflozin ni nadomestilo za insulin (in ne spremeni občutljivosti za insulin).
• Summary of the recommendations for patients, particularly regarding blood ketone measurement and managing sick days. 
• Povzetek priporočil za bolnike, zlasti za merjenje ketonov v krvi in vodenje bolniških odsotnosti.
C]-dapagliflozin dose, 96% was recovered, 75% in urine and 21% in faeces. 
C]-dapagliflozina se ga je 96 % izločilo, in sicer 75 % v urinu in 21 % v blatu.
Ketone levels should be measured again after two hours. 
Koncentracijo ketonov mora ponovno izmeriti po dveh urah.
Study MB102230 
Študija MB102230
• Patients with low insulin needs. 
• Bolniki z majhno potrebo po insulinu.
If you suspect you have diabetic ketoacidosis, contact a doctor or the nearest hospital straight away and do not take this medicine. 
Če sumite, da imate diabetično ketoacidozo, se takoj posvetujte z zdravnikom ali pojdite v najbližjo bolnišnico ter ne vzemite tega zdravila.
Patients should consider monitoring ketones levels three to four hours after changing pump materials. 
Bolniki naj bi tri do štiri ure po menjavi materialov črpalke kontrolirali koncentracijo ketonov.
• if you have very high levels of sugar in your blood which may make you dehydrated (lose too much body fluid). 
• če imate zelo veliko koncentracijo sladkorja v krvi zaradi česar ste dehidrirani (čezmerno izgubljate telesne tekočine).
• DKA should be treated as per standard of care. 
• DKA je treba zdraviti v skladu z običajnim zdravljenjem.
Do not stop taking Edistride without talking to your doctor first. 
Ne prenehajte z jemanjem zdravila Edistride, ne da bi se prej posvetovali z zdravnikom.
• if you have type 2 diabetes and are taking other medicines that lower the amount of sugar in your blood such as insulin or a “sulphonylurea” medicine. 
• če imate sladkorno bolezen tipa 2 in jemljete druga zdravila, ki zmanjšujejo količino sladkorja v vaši krvi, npr. insulin ali kakšno ''sulfonilsečninsko'' zdravilo.
Insulin injections should be given within 2 hours of an unexplained high blood glucose/ketone value and dapagliflozin treatment should be interrupted. 
Injekcije insulina je treba dati v obdobju 2 ur po nepojasnjeni visoki vrednosti glukoze/ketonov v krvi, zdravljenje z dapagliflozinom pa je treba prekiniti.
The recommended dose is 5 mg once daily. 
Priporočeni odmerek je 5 mg enkrat na dan.
Mechanism of action Dapagliflozin is a highly potent (Ki: 0.55 nM), selective and reversible inhibitor of SGLT2. 
Mehanizem delovanja Dapagliflozin je zelo močan (Ki: 0,55 nM), selektivni in reverzibilni zaviralec SGLT2.
Eighty-one percent (81%) of the subjects had a body mass index (BMI)  27. 
Enainosemdeset odstotkov (81 %) preiskovancev je imelo indeks telesne mase (ITM)  27.
The MAH shall ensure that in each Member State where dapagliflozin is marketed for type 1 diabetes, all healthcare professionals and patients/carers who are expected to prescribe, dispense or use the product have access to: 
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo v vseh državah članicah, kjer je dapagliflozin na trgu za zdravljenje sladkorne bolezni tipa 1, imeli vsi zdravstveni delavci in bolniki/skrbniki, za katere se pričakuje da bodo predpisovali, izdajali ali uporabljali to zdravilo, dostop do:
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP. 
Imetnik dovoljenja za promet z zdravilom bo izvedel farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem v RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
• Guidance to the physician for assessing whether the patient is prepared and engaged to perform self-ketone testing before and during therapy. 
• Navodila zdravniku za oceno, ali je bolnik pripravljen in zavzet za izvajanje samotestiranja ketonov pred zdravljenjem in med njim.
If you are taking Edistride for type 1 diabetes, it is important that you keep using insulin. 
Če zdravilo Edistride jemljete za zdravljenje sladkorne bolezni tipa 1, je pomembno, da še naprej uporabljate insulin.
• if you are on medicines to lower your blood pressure (anti-hypertensives) and have a history of low blood pressure (hypotension). 
• če uporabljate zdravila za znižanje krvnega tlaka (antihipertenzive) in imate ali ste kdaj imeli nizek krvni tlak (hipotenzijo).
Twelve studies had a treatment period of 24 weeks duration, 8 with long-term extensions ranging from 24 to 80 weeks (up to a total study duration of 104 weeks), one study had a 28-week treatment period, and one study was 52 weeks in duration with long-term extensions of 52 and 104 weeks (total study duration of 208 weeks). 
V dvanajstih študijah je zdravljenje trajalo 24 tednov in 8 od teh študij je imelo dolgoročna podaljšanja, ki so trajala od 24 do 80 tednov (do celotnega trajanja študije 104 tedne); v eni študiji je zdravljenje trajalo 28 tednov in ena študija je trajala 52 tednov z dolgoročnima podaljšanjema 52 tednov in 104 tedne (celotno trajanje študije 208 tednov).
• Risk factors for diabetic ketoacidosis (DKA) should be assessed (see section 4.4). 
• Oceniti je treba dejavnike tveganja za diabetično ketoacidozo (DKA) (glejte poglavje 4.4).
Dapagliflozin should not be initiated when patients are at a higher risk of DKA, such as: 
Dapagliflozina se ne sme uvesti, če imajo bolniki večje tveganje za DKA, na primer:
If you are taking Edistride for type 1 diabetes: • The recommended dose is one 5 mg tablet each day. 
Če jemljete zdravilo Edistride za sladkorno bolezen tipa 1: Priporočeni odmerek je ena 5-mg tableta vsak dan.
Dapagliflozin 10 mg should not be used for treatment of patients with type 1 diabetes. 
Dapagliflozina se v odmerku 10 mg ne sme uporabljati za zdravljenje bolnikov s sladkorno boleznijo tipa 1.
• Do not take a double dose of Edistride to make up for a forgotten dose. 
• Ne vzemite dvojnega odmerka zdravila Edistride, če ste pozabili vzeti prejšnji odmerek.
Fifty percent (50%) had mild renal impairment and 11% had moderate renal impairment. 
Petdeset odstotkov (50 %) preiskovancev je imelo blago, 11 % pa zmerno okvaro ledvic.
The table shows up to 24-week (short-term) data regardless of glycaemic rescue. 
Preglednica prikazuje 24-tedenske (kratkoročne) podatke, ne glede na glikemično reševanje.
The patient should measure blood glucose and consider taking extra carbohydrates if the glucose levels are normal or low. 
Bolnik mora meriti glukozo v krvi in razmisliti o zaužitju dodatnih ogljikovih hidratov, če je koncentracija glukoze normalna ali nizka.
Efficacy Parameter 
Parameter učinkovitosti
Necrotising fasciitis of the perineum (Fournier's gangrene) 
Nekrotizirajoči fasciitis presredka (Fournierjeva gangrena)
Taking this medicine with other medicines called sulphonylureas or with insulin can cause too low blood sugar levels (hypoglycaemia), which may cause symptoms such as shaking, sweating and change in vision, and may affect your ability to drive and use machines. 
Jemanje tega zdravila z drugimi zdravili, imenovanimi sulfonilsečnine, ali z insulinom lahko povzročijo prekomerno zmanjšanje količine sladkorja v krvi (hipoglikemijo), kar lahko povzroči simptome kot so tresenje, znojenje in spremembe vida in lahko vpliva na vašo sposobnost za vožnjo in upravljanje strojev.
• When you are treated with Edistride, diabetic ketoacidosis can occur even if your blood sugar is normal. 
• če jemljete zdravilo Edistride, se lahko diabetična ketoacidoza pojavi, tudi če imate normalen krvni sladkor.
- together with other medicines to treat diabetes. 
- skupaj z drugimi zdravili za zdravljenje sladkorne bolezni.
Columns 1 and 2, HbA1c analysed using LOCF (see footnote d); Columns 3 and 4, HbA1c analysed using LRM (see footnote e) 
Stolpca 1 in 2, HbA1c analiziran po metodi LOCF (glejte opombo d), stolpca 3 in 4, HbA1c analiziran z metodo LRM (glejte opombo e)
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. 
Bolniki z redko dedno intoleranco za galaktozo, odsotnostjo encima laktaze ali malabsorbcijo glukoze/galaktoze ne smejo jemati tega zdravila.
Of 17,160 randomised patients, 6,974 (40.6%) had established cardiovascular disease and 10,186 (59.4%) did not have established cardiovascular disease. 
Od 17160 randomiziranih bolnikov jih je 6974 (40,6 %) imelo razvito srčno-žilno bolezen, 10186 (59,4 %) pa jih razvite srčno-žilne bolezni ni imelo.
The educational materials are aimed at providing guidance on how to manage risk of diabetic ketoacidosis (DKA) in patients with type 1 diabetes. 
Izobraževalna gradiva so namenjena zagotavljanju smernic za obvladovanje tveganja za diabetično ketoacidozo (DKA) pri bolnikih s sladkorno boleznijo tipa 1.
Metformin (immediate- or extended-release formulations) ≥1500 mg/day plus maximum tolerated dose, which must be at least half maximum dose, of a sulphonylurea for at least 8 weeks prior to enrolment. 
Metformin (oblike s takojšnjim ali podaljšanim sproščanjem) ≥ 1500 mg/dan ter največji tolerirani odmerek (ki mora biti vsaj polovičen maksimalni odmerek) sulfonilsečnine vsaj 8 tednov pred zajetjem v študijo.
Superiority of dapagliflozin over placebo was not demonstrated for MACE (p=0.172). 
Superiornost dapagliflozina v primerjavi s placebom za MACE ni bila dokazana (p = 0,172).
Ketone levels should be also checked in situations that may predispose to or increase risk of DKA. 
Koncentracijo ketonov je treba kontrolirati tudi v okoliščinah, ki lahko povečajo nagnjenost k DKA ali tveganje zanjo.