natgillin/translations-raw huggingface dataset:
PACKAGE SIZE 1 dose 
Shema 1
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Per dose of 1 ml: 
V odmerku po 1 ml:
PARTICULARS TO APPEAR ON THE OUTER PACKAGE 
PODATKI NA ZUNANJI OVOJNINI
It must also not be used together with certain medicines such as: 
Ne sme se jemati tudi sočasno z določenimi zdravili, kot so:
This overview was last updated in 03-2019. 
Pregled je bil nazadnje posodobljen 03-2019.
Further information on Maviret can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Maviret. 
Nadaljnje informacije o zdravilu Maviret so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/Maviret.
The recommended dose is three tablets once a day, with food, for 8, 12 or 16 weeks. 
Priporočeni odmerek so tri tablete, ki se jemljejo enkrat na dan skupaj s hrano 8, 12 ali 16 tednov.
Maviret received a marketing authorisation valid throughout the EU on 26 July 2017. 
Za zdravilo Maviret je bilo 26. julija 2017 izdano dovoljenje za promet, veljavno po vsej Evropski uniji.
A negative test result means that the virus was not found. 
Negativni rezultat testa pomeni, da virus ni bil odkrit.
What measures are being taken to ensure the safe and effective use of Maviret? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Maviret?
The European Medicines Agency therefore decided that Maviret's benefits are greater than its risks and it can be authorised for use in the EU. 
Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Maviret večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
In addition, results showed that the way the medicine was absorbed, modified and removed from the body was similar to that in adults. 
Poleg tega so rezultati pokazali, da je bil način absorpcije, modifikacije in odstranjevanja zdravila iz telesa podoben kot pri odraslih.
The medicine's effectiveness in clearing genotype 3 was slightly lower than for other genotypes (95%). 
Učinkovitost zdravila pri odstranjevanju genotipa 3 je bila nekoliko nižja od učinkovitosti pri drugih genotipih (95 %).
Maviret (glecaprevir / pibrentasvir) 
Maviret (glekaprevir/pibrentasvir)
Other information about Maviret 
Druge informacije o zdravilu Maviret
Based on data available in adults, it is expected that Maviret is also effective in children with genotypes 5 and 6. 
Na podlagi razpoložljivih podatkov pri odraslih se pričakuje, da bo zdravilo Maviret učinkovito tudi pri otrocih z genotipoma 5 in 6.
As for all medicines, data on the use of Maviret are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Maviret stalno spremljajo.
What is Maviret and what is it used for? 
Kaj je zdravilo Maviret in za kaj se uporablja?
Why is Maviret authorised in the EU? 
Zakaj je zdravilo Maviret odobreno v EU?
What benefits of Maviret have been shown in studies? 
Kakšne koristi je zdravilo Maviret izkazalo v študijah?
The duration of treatment depends on whether patients have liver cirrhosis (scarring of the liver) or whether they have received previous treatments with pegylated interferon and ribavirin, with or without sofosbuvir, or sofosbuvir and ribavirin. 
Trajanje zdravljenja je odvisno od tega, ali je pri bolnikih prisotna ciroza jeter (brazgotinjenje jeter) oziroma ali so bili predhodno zdravljeni s pegiliranim interferonom in ribavirinom, skupaj s sofosbuvirjem ali brez njega, ali s sofosbuvirjem in ribavirinom.
What are the risks associated with Maviret? 
Kakšna tveganja so povezana z zdravilom Maviret?
Results were similar for genotypes 2 and 4-6. 
Za genotip 2 in genotipe od 4 do 6 so bili rezultati podobni.
Glecaprevir blocks the action of a protein called NS3/4A protease, while pibrentasvir blocks a protein called NS5A. 
Glekaprevir zavira delovanje beljakovine, imenovane proteaza NS3/4A, medtem ko pibrentasvir zavira delovanje beljakovine, imenovane NS5A.
An overview of Maviret and why it is authorised in the EU 
Pregled zdravila Maviret in zakaj je odobreno v EU
Side effects reported with Maviret are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Maviret, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
The most common side effects with Maviret (which may affect more than 1 in 10 people) are headache and tiredness. 
Najpogostejša neželena učinka zdravila Maviret (ki lahko pojavita pri več kot 1 bolniku od 10) sta glavobol in utrujenost.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Maviret have also been included in the summary of product characteristics and the package leaflet. 
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Maviret upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Maviret has been shown to be highly effective in clearing the hepatitis C virus from the blood, particularly in patients who have not been treated previously or who do not have cirrhosis. 
Zdravilo Maviret se je izkazalo za zelo učinkovito pri odstranjevanju virusa hepatitisa C iz krvi, še posebno pri bolnikih, ki predhodno še niso bili zdravljeni ali nimajo ciroze.
Maviret is available as tablets that contain 100 mg glecaprevir and 40 mg pibrentasvir. 
Zdravilo Maviret je na voljo v obliki tablet, ki vsebujejo 100 mg glekaprevirja in 40 mg pibrentasvirja.
• rifampicin (antibiotic usually used to treat tuberculosis); 
• rifampicin (antibiotik, ki se običajno uporablja za zdravljenje tuberkuloze);
For more information about using Maviret, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Maviret glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
In a study in 47 children aged between 12 and 18 years with genotypes 1 to 4 and without cirrhosis, all patients tested negative for the virus after 12 weeks of treatment. 
V študiji pri 47 otrocih, starih od 12 do 18 let, z genotipi od 1 do 4 in brez ciroze, je bil test za prisotnost virusa pri vseh bolnikih, ki so bili testirani po 12 tednih zdravljenja, negativen.
• atorvastatin, simvastatin (medicines for lowering cholesterol levels in the blood); 
• atorvastatin, simvastatin (zdravili za zniževanje ravni holesterola v krvi);
• carbamazepine, phenobarbital, phenytoin, primidone (medicines for epilepsy); 
• karbamazepin, fenobarbital, fenitoin, primidon (zdravila za zdravljenje epileptičnih napadov);
Maviret is an antiviral medicine used to treat adults and adolescents aged 12 years and older with chronic (long-term) hepatitis C, an infectious disease that affects the liver, which is caused by the hepatitis C virus. 
Maviret je protivirusno zdravilo, ki se uporablja za zdravljenje odraslih in mladostnikov, starejših od 12 let, s kroničnim (dolgotrajnim) hepatitisom C, tj. nalezljivo boleznijo, ki prizadene jetra in jo povzroča virus hepatitisa C.
Maviret must not be used in patients with severely reduced liver function. 
Zdravila Maviret ne smejo uporabljati bolniki s hudo okvaro jeter.
By blocking these proteins, Maviret stops the hepatitis C virus from multiplying and infecting new cells. 
Zdravilo Maviret z zaviranjem teh beljakovin prepreči virusu hepatitisa C, da bi se razmnoževal in okužil nove celice.
In 8 main studies involving over 2,300 adults with hepatitis C, 99% of non-cirrhotic patients with genotype 1, the most common genotype, tested negative for the virus after 8 weeks of Maviret treatment and 97% cirrhotic patients were negative after 12 weeks. 
V osmih glavnih študijah, ki so vključevale več kot 2 300 odraslih bolnikov s hepatitisom C, je bil test za prisotnost virusa po osmih tednih zdravljenja z zdravilom Maviret negativen pri 99 % bolnikov brez ciroze in z genotipom 1, ki je najpogostejši genotip virusa hepatitisa C, in pri 97 % bolnikov s cirozo po 12 tednih zdravljenja.
This study is being carried out in light of data suggesting that patients treated with medicines belonging to the same class as Maviret and who have had liver cancer could be at risk of their cancer returning early. 
Ta študija se izvaja na podlagi podatkov, ki kažejo, da pri bolnikih, zdravljenih z zdravili istega razreda, kot je zdravilo Maviret, in predhodno obolelih za rakom jeter, obstaja tveganje zgodnje ponovitve raka.
Maviret can only be obtained with a prescription, and treatment should be started and monitored by a doctor experienced in the management of patients with hepatitis C virus infection. 
Predpisovanje in izdaja zdravila Maviret je le na recept, zdravljenje pa mora uvesti in spremljati zdravnik, ki ima izkušnje z zdravljenjem bolnikov, okuženih z virusom hepatitisa C.
With regard to its safety, Maviret's pattern of side effects raises no particular concern. 
Vzorec neželenih učinkov zdravila Maviret ne vzbuja posebnih pomislekov glede varnosti.
There are 6 varieties (genotypes) of the hepatitis C virus and Maviret has been shown to be effective at clearing all genotypes from the blood. 
Obstaja šest različic (genotipov) virusa hepatitisa C, zdravilo Maviret pa iz krvi dokazano učinkovito odstranjuje vse genotipe.
• ethinyl estradiol-containing products (such as contraceptive medicines); 
• zdravila, ki vsebujejo etinilestradiol (kot so kontraceptivi);
The active substances in Maviret, glecaprevir and pibrentasvir, block two proteins essential for the hepatitis C virus to multiply. 
Učinkovini v zdravilu Maviret, glekaprevir in pibrentasvir, zavirata dve beljakovini, ki ju virus hepatitisa C potrebuje za razmnoževanje.
For the full list of restrictions and side effects with Maviret, see the package leaflet. 
Za celoten seznam omejitev in neželenih učinkov pri uporabi zdravila Maviret glejte navodilo za uporabo.
How does Maviret work? 
Kako zdravilo Maviret deluje?
How is Maviret used? 
Kako se zdravilo Maviret uporablja?
The company that markets Maviret will carry out a study in patients who previously have had liver cancer to evaluate the risk of liver cancer returning after treatment with direct-acting antivirals such as Maviret. 
Družba, ki trži zdravilo Maviret, bo za oceno tveganja ponovitve raka jeter po zdravljenju z neposredno delujočimi protivirusnimi zdravili, kot je Maviret, izvedla študijo pri bolnikih, ki so preboleli raka jeter.
Maviret contains the active substances glecaprevir and pibrentasvir. 
Zdravilo Maviret vsebuje učinkovini glekaprevir in pibrentasvir.
The fact that Maviret can be given without ribavirin and without dose adjustments in patients with severe kidney problems is a further advantage in comparison with similar medicines. 
V primerjavi s podobnimi zdravili je njegova dodatna prednost za bolnike s hudo okvaro ledvic ta, da ga je mogoče dajati brez ribavirina in da odmerkov ni treba prilagajati.
A/Michigan/45/2015 (H1N1)pdm09 - like strain (A/Michigan/45/2015, NYMC X-275)………………………………...15 micrograms HA** A/Hong Kong/4801/2014 (H3N2) - like strain (A/Hong Kong/4801/2014, NYMC X-263B)........................15 micrograms HA** B/Brisbane/60/2008 - like strain (B/Brisbane/60/2008, wild type)…………………………………………………………….….15 micrograms HA** 
A/Michigan/45/2015, NYMC X-275, ki je podoben sevu A/Michigan/45/2015 (H1N1)pdm09) ...................... 15 mikrogramov HA** A/Hong Kong/4801/2014, NYMC X-263B, ki je podoben sevu A/Hong Kong/4801/2014 (H3N2) .................. 15 mikrogramov HA** B/Brisbane/60/2008, divji tip, ki je podoben sevu B/Brisbane/60/2008 ................................................... 15 mikrogramov HA**
Influenza virus (inactivated, split) of the following strains*: 
--1 Virusi influence (inaktivirani, razcepljeni) naslednjih sevov*:
Per 0.1 ml dose * propagated in fertilised hens' eggs from healthy chicken flocks ** haemagglutinin 
na 0,1 ml odmerka razmnožen v oplojenih kokošjih jajcih zdravih piščančjih jat ** hemaglutinin
MA (EU) number (Invented) name Strength Pharmaceutical 
(Izmišljeno) ime Jakost Farmacevtska oblika Pot uporabe
Especially tell your doctor: 
Še zlasti obvestite svojega zdravnika:
- a change in your mood or feeling confused. 
- sprememba razpoloženja ali občutek zmedenosti.
These are the signs of low blood sugar: 
Znaki nizkega krvnega sladkorja so:
Talk to your doctor about the best way to control your blood sugar while you are pregnant. 
Posvetujte se s svojim zdravnikom o tem, kako najbolje obvladati krvni sladkor med nosečnostjo.
Contact your doctor as soon as possible if you have any of the following side effects: Very common (may affect more than 1 in 10 people) 
Čim prej se posvetujte s svojim zdravnikom, če imate katerega od naslednjih neželenih učinkov: Zelo pogosti (lahko se pojavijo pri več kot 1 od 10 bolnikov):
Fifty-one percent (51 %) of the subjects were men, 84 % were White, 9 % were Asian, 3 % were Black and 4 % were of other racial groups. 
Enainpetdeset odstotkov (51 %) preiskovancev je bilo moških, 84 % belcev, 9 % Azijcev, 3 % črncev in 4 % drugih rasnih skupin.
Dapagliflozin is approximately 91 % protein bound. 
Dapagliflozin je približno v 91 % vezan na beljakovine.
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. 
Obvestite svojega zdravnika, farmacevta ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
Eighty percent (80 %) of the subjects had a body mass index (BMI)  27. 
Osemdeset odstotkov (80 %) preiskovancev je imelo indeks telesne mase (ITM)  27.
Although uncommon, if you see blood in your urine, tell your doctor immediately. 
Običajno se kri v urinu ne pojavi, a če jo opazite, takoj obvestite svojega zdravnika.
Film-coated tablet (tablet). 
filmsko obložena tableta (tableta).
- shaking, sweating, feeling very anxious, fast heart beat 
- tresenje, znojenje, občutek hude tesnobe, hitro utripanje srca
- feeling hungry, headache, change in vision 
- lakota, glavobol, spremembe vida
• if you are 75 years old or older, you should not start taking Edistride. 
• če ste stari 75 let ali več, ne smete začeti z jemanjem zdravila Edistride.
Do not stop taking Edistride without talking to your doctor first. 
Ne prenehajte z jemanjem zdravila Edistride, ne da bi se prej posvetovali s svojim zdravnikom.
Results of 24-week (LOCF 
Rezultati 24-tedenskih (LOCF
• 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".
After administration of a 50 mg [ 
Po dajanju 50-mg odmerka [
• if you are taking another medicine for diabetes that contains “pioglitazone”, you should not start taking Edistride. 
• če jemljete drugo zdravilo za zdravljenje sladkorne bolezni, ki vsebuje "pioglitazon", ne smete začeti z jemanjem zdravila Edistride.
C]-dapagliflozin dose, 96 % was recovered, 75 % in urine and 21 % in feces. 
C]-dapagliflozina se ga je 96 % izločilo, in sicer 75 % v urinu in 21 % v blatu.
Edistride has no or negligible influence on the ability to drive and use machines. 
Zdravilo Edistride nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
Patients with baseline HbA1c ≥ 9 % 
Bolniki z izhodiščno vrednostjo HbA1c ≥ 9 %
Fifty-two percent (52 %) had mild renal impairment and 11 % had moderate renal impairment. 
Dvainpetdeset odstotkov (52 %) preiskovancev je imelo blago, 11 % pa zmerno okvaro ledvic.
Edistride should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. 
Zdravila Edistride se ne sme uporabljati pri bolnikih s sladkorno boleznijo tipa 1 ali za zdravljenje diabetične ketoacidoze.
• Edistride is used if your diabetes cannot be controlled with other medicines for diabetes, diet and exercise. 
• Zdravilo Edistride se uporablja, če vaše sladkorne bolezni ni mogoče urediti z drugimi zdravili proti sladkorni bolezni, z dieto in s telesno dejavnostjo.
Final analysis of these studies, after unblinding, will provide further information on the benefit/risk of SGLT2 inhibitors particularly of the risk of lower limb amputations. 
Končna analiza teh študij bo po razkritju zagotovila več informacij o razmerju med tveganji in koristmi zaviralcev SGLT2, zlasti o tveganju za amputacije spodnjih okončin.
Edistride is used for a type of diabetes called “type 2 diabetes mellitus” in adult patients (aged 18 years and older). 
Zdravilo Edistride se uporablja za zdravljenje sladkorne bolezni, ki jo imenujemo "sladkorna bolezen tipa 2" pri odraslih bolnikih (starih 18 let in več).
Possible signs of losing too much fluid from your body are listed at the top of section 4 ‘Possible side effects'. 
Možni znaki čezmernega izgubljanja tekočine iz telesa so našteti na začetku poglavja 4, 'Možni neželeni učinki'.
Cardiovascular death, MI and stroke were observed with a hazard ratio of 0.77 (95 % CI: 0.54, 1.10). 
Kardiovaskularna smrt, MI in možganska kap so bile opažene z vrednostjo razmerja ogroženosti 0,77 (95 % IZ: 0,54, 1,10).
Gender The mean dapagliflozin AUCss in females was estimated to be about 22 % higher than in males. 
Spol Ocenjeno je, da je povprečna AUCss dapagliflozina pri ženskah približno 22 % večja kot pri moških.
In rats, dapagliflozin was neither embryolethal nor teratogenic at exposures up to 1,441 times the maximum recommended human dose. 
Pri podganah ni bil dapagliflozin ne embrioletalen ne teratogen pri izpostavljenostih, ki so bile do 1441-krat tolikšne kot pri največjemu priporočenemu odmerku za človeka.
The absolute oral bioavailability of dapagliflozin following the administration of a 10 mg dose is 78 %. 
Absolutna peroralna biološka uporabnost dapagliflozina po dajanju odmerka 10 mg je 78 %.
Edistride is indicated in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control as: 
Zdravilo Edistride je indicirano pri odraslih, starih 18 let in več, s sladkorno boleznijo tipa 2 za izboljšanje urejenosti glikemije kot:
Other medicines and Edistride 
Druga zdravila in zdravilo Edistride
More information is given below in Other medicines and Edistride. 
Več informacij je na voljo v nadaljevanju v "Druga zdravila in zdravilo Edistride".
In the clinical program, 34.4 % of subjects had a history of cardiovascular disease (excluding hypertension) at baseline and 67.9 % had hypertension. 
V kliničnem programu je imelo izhodiščno anamnezo kardiovaskularne bolezni (izključujoč hipertenzijo) 34,4 % preiskovancev in 67,9 % jih je imelo hipertenzijo.
Dapagliflozin does not inhibit other glucose transporters important for glucose transport into peripheral tissues and is > 1,400 times more selective for SGLT2 versus SGLT1, the major transporter in the gut responsible for glucose absorption. 
Dapagliflozin ne zavira drugih prenašalcev glukoze, pomembnih za prenos glukoze v periferna tkiva, in je > 1400-krat bolj selektiven za SGLT2 kot za SGLT1, tj. glavnega prenašalca, odgovornega za absorpcijo glukoze v črevesu.
Administration with a high-fat meal decreased dapagliflozin Cmax by up to 50 % and prolonged Tmax by approximately 1 hour, but did not alter AUC as compared with the fasted state. 
Dajanje zelo mastnega obroka je zmanjšala Cmax dapagliflozina za do 50 % in podaljšala tmax za približno 1 uro, ni pa spremenila AUC v primerjavi s stanjem na tešče.
Your doctor may want to lower the dose of these other medicines, to prevent you from getting low blood sugar levels (hypo-glycaemia). 
Zdravnik vam bo morda zmanjšal odmerek teh drugih zdravil, da bi preprečil prekomerno zmanjšanje količine sladkorja v vaši krvi (hipoglikemijo).
Diabetic Ketoacidosis 
Diabetična ketoacidoza
The hazard ratio comparing dapagliflozin to comparator was 0.79 (95 % Confidence interval [CI]: 0.58, 1.07), indicating that in this analysis Edistride is not associated with an increase in cardiovascular risk in patients with type 2 diabetes mellitus. 
Razmerje ogroženosti z dapagliflozinom v primerjavi s primerjalnim zdravilom je bilo 0,79 (95 % interval zaupanja [IZ]: 0,58; 1,07), kar nakazuje, da v tej analizi zdravilo Edistride ni bilo povezano s povečanjem kardiovaskularnega tveganja pri bolnikih s sladkorno boleznijo tipa 2.
glimepiride 4 mg/day; 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.
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. 
O teh okužbah so pogosteje poročali pri ženskah (8,4 % za dapagliflozin in 1,2 % za placebo) ter pri preiskovancih s predhodno anamnezo in torej večjo verjetnostjo za pojav ponovne okužbe.
What Edistride looks like and contents of the pack 
Izgled zdravila Edistride in vsebina pakiranja
Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Edistride, and during treatment: 
Opozorila in previdnostni ukrepi Posvetujte s svojim zdravnikom, s farmacevtom ali z medicinsko sestro pred jemanjem zdravila Edistride:
For patients receiving dapagliflozin, in case of intercurrent conditions that may lead to volume depletion, careful monitoring of volume status (e.g. physical examination, blood pressure measurements, laboratory tests including haematocrit) and electrolytes is recommended. 
Pri bolnikih, ki prejemajo dapagliflozin, v primeru sočasno prisotnih stanj, ki lahko povzročijo pomanjkanje volumna, je priporočljivo skrbno spremljanje statusa volumna (npr. fizični pregled, meritve srčnega tlaka, laboratorijske preiskave, vključno s hematokritom) in elektrolitov.
• if you are taking other medicines that lower the amount of sugar in your blood such as insulin or a “sulphonylurea” medicine. 
• če jemljete druga zdravila, ki zmanjšujejo količino sladkorja v vaši krvi, npr. insulin ali kakšno
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). 
Po 24 tednih je zmanjšanje koncentracije sečne kisline v serumu segalo od -48,3 do -18,3 do mikromolov/l (-0,87 do -0,33 mg/dl).
Further evaluation of patients who had renal-related adverse events showed that most had serum creatinine changes of ≤ 0.5 mg/dl from baseline. 
Dodatne ocene bolnikov, ki so imeli z ledvicami povezane neželene učinke, so pokazale, da se je večini kreatinin v serumu spremenil za ≤ 0,5 mg/dl v primerjavi z izhodiščem.
During clinical trials, the overall proportion of subjects with malignant or unspecified tumours was similar between those treated with dapagliflozin (1.50 %) and placebo/comparator (1.50 %), and there was no carcinogenicity or mutagenicity signal in animal data (see section 5.3). 
Med kliničnimi preskušanji je bil celotni delež oseb z malignimi ali nespecificiranimi tumorji med tistimi, ki so prejemali dapagliflozin (1,50 %) in tistimi, ki so prejemali placebo/primerjalno zdravilo (1,50 %) podoben in podatki na živalih niso pokazali signalov kancerogenosti ali mutagenosti (glejte poglavje 5.3).
In particular, if you are following a diabetic weight control diet, continue to follow it while you are taking Edistride. 
Še zlasti, če se držite diabetične diete za obvladovanje telesne mase, nadaljujte z dieto tudi med jemanjem zdravila Edistride.
• low blood sugar levels (hypo-glycaemia) - when taking this medicine with a sulphonylurea or insulin 
• nizek krvni sladkor (hipoglikemija) - če jemljete to zdravilo skupaj s kakšnim sulfonilsečninskim zdravilom ali insulinom.
In a pre-specified pooled analysis of 13 placebo-controlled studies, 2,360 subjects were treated with dapagliflozin 10 mg and 2,295 were treated with placebo. 
V vnaprej specificirani kumulativni analizi 13, s placebom kontroliranih študij, je 2360 preiskovancev bilo zdravljenih z 10 mg dapagliflozina in 2295 je prejemalo placebo.