natgillin/translations-raw huggingface dataset:
The evaluation of advanced therapy products involves an assessment by the Committee for Advanced Therapies (CAT) before an opinion is adopted by the Committee for Medicinal Products for Human Use (CHMP). 
Postopek ocenjevanja zdravil za napredno zdravljenje mora vključevati oceno Odbora za zdravila za napredno zdravljenje (CAT), preden lahko Odbor za zdravila za uporabo v humani medicini (CHMP) sprejme mnenje.
The company had not yet responded to the CAT's questions at the time of the withdrawal. 
Družba v času umika še ni odgovorila na zastavljena vprašanja.
Further data on its benefits and safety were being awaited from the company. 
Odbor je čakal, da družba predloži dodatne podatke o koristih in varnosti zdravila.
The main data submitted by the company came from two published studies involving 126 patients with femoral cartilage defects, which compared Hyalograft C autograft with a surgical technique known as microfracture repair. 
Glavni podatki, ki jih je predložila družba, so izvirali iz dveh objavljenih študij, ki sta vključevali 126 bolnikov z okvarami hrustanca femoralnega kondila, v katerih so avtologni presadek Hyalograft C primerjali s kirurško tehniko, imenovano postopek mikrofrakture.
At the time of the withdrawal, the CAT had not issued its final recommendation but had some concerns about the data submitted in the application. 
Odbor CAT v času umika še ni izdal končnega priporočila, vendar pa je izrazil določene pomisleke glede podatkov, predloženih v podporo vlogi.
The cells are then planted on the square inserts, which are used by a surgeon to fill in the spaces on the bone where cartilage has been damaged. 
Celice se nato nasadi na kvadratne vsadke, s katerimi kirurg zapolni prazne prostore na kosti, kjer je bil hrustanec poškodovan.
The company informed the EMA that there were no ongoing clinical trials or compassionate use programmes with Hyalograft C autograft at the time of the withdrawal. 
Družba je Evropsko agencijo za zdravila (EMA) obvestila, da v času umika niso potekala nobena klinična preskušanja ali programi sočutne uporabe avtolognega presadka Hyalograft C.
Hyalograft C autograft is a type of advanced therapy product called a ‘tissue engineered product'. 
Avtologni presadek Hyalograft C je vrsta zdravila za napredno zdravljenje, ki ga imenujemo „izdelek tkivnega inženiringa“.
officially notified the European Medicines Agency that it wishes to withdraw its application for a marketing authorisation for Hyalograft C autograft, for repairing defects in the cartilage of the femoral condyles and trochlea (the end of the thigh bone that forms part of the knee) caused by sudden or repetitive trauma. 
je dne 14. januarja 2013 uradno obvestila Evropsko agencijo za zdravila, da želi umakniti vlogo za pridobitev dovoljenja za promet z avtolognim presadkom Hyalograft C, namenjenim zdravljenju okvar hrustanca femoralnih kondilov in trohlee (končnega dela stegnenice, ki je del kolena), ki jih povzročijo nenadne ali ponavljajoče se poškodbe.
regulation on advanced therapies in 2009.1 Under the regulation, advanced therapies already available in the EU are to undergo an evaluation by the EMA in order to obtain an EU wide marketing authorisation. 
1, V skladu z uredbo mora zdravila za napredno zdravljenje, ki so na voljo v EU, oceniti Evropska agencija za zdravila, preden se lahko zanje odobri dovoljenje za promet, veljavno po vsej EU.
Hyalograft C autograft is an implant consisting of cartilage cells derived from the patient and planted on 2x2 cm square inserts. 
Avtologni presadek Hyalograft C je vsadek, sestavljen iz hrustančnih celic, ki so bile odvzete bolniku in nasajene na kvadratne vsadke velikosti 2 x 2 cm.
Hyalograft C autograft is made from chondrocytes (cartilage cells) taken from the patient and grown outside the body. 
Avtologni presadek Hyalograft C sestoji iz hondrocitov (hrustančnih celic), ki se jih odvzame bolniku in vzgoji zunaj telesa.
Hyalograft C autograft is a ‘combined advanced therapy product' as it incorporates a medical device (the scaffold). 
Avtologni presadek Hyalograft C je „kombinirano zdravilo za napredno zdravljenje‟, saj vključuje tudi medicinski pripomoček (nosilec).
What is Hyalograft C autograft? 
Kaj je avtologni presadek Hyalograft C?
How does Hyalograft C autograft work? 
Kako avtologni presadek Hyalograft C deluje?
Hyalograft C autograft was being evaluated for use in repairing cartilage defects at the end of the femur (the thigh bone), where the bone forms part of the knee joint. 
Avtologni presadek Hyalograft C je bil ovrednoten glede uporabe pri zdravljenju okvar hrustanca na končnem delu femorja (stegnenice), tj. delu, ki sestavlja kolenski sklep.
What was Hyalograft C autograft being evaluated for? 
Zakaj je bil avtologni presadek Hyalograft C ovrednoten?
B.V. can be started between a few days and 35 days after the attack; 
lahko začnejo jemati od nekaj dni po napadu do 35 dni po njem;
It is available as pink, capsule-shaped tablets (75 mg). 
Na voljo je v obliki 75-miligramskih rožnatih tablet, ki so podobne kapsulam.
This means that Clopidogrel Teva Pharma B.V. is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix. 
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Plavix.
The standard dose of Clopidogrel Teva Pharma B.V. is one 75-mg tablet once a day, taken with or without food. 
je ena 75-miligramska tableta enkrat na dan, ki se vzame s hrano ali brez nje.
For genetic reasons, some patients may not be able to convert Clopidogrel Teva Pharma B.V. as effectively as others, which could reduce their response to the medicine. 
morda nekateri bolniki zaradi genetskih vzrokov pretvarjajo manj učinkovito kot drugi, zaradi česar je njihov odziv na zdravilo manjši.
This document is a summary of the European public assessment report (EPAR) for Clopidogrel Teva Pharma B.V. 
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Clopidogrel Teva Pharma B.V.
The full EPAR for Clopidogrel Teva Pharma B.V. can be found on the Agency's website under EMA website/Find medicine/Human medicines/European Public Assessment Reports. 
je na voljo na spletni strani agencije EMA website/Find medicine/Human medicines/European Public Assessment Reports.
Because Clopidogrel Teva Pharma B.V. is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine. 
generično zdravilo in je biološko enakovredno referenčnemu zdravilu, velja, da so njegove koristi in tveganja enake kot pri referenčnem zdravilu.
Clopidogrel Teva Pharma B.V. can be used in patients who are having a heart attack with ‘ST segment elevation' (an abnormal reading on the ECG or electrocardiogram) when the doctor thinks that they would benefit from the treatment. 
se lahko uporablja pri bolnikih, ki so imeli srčni napad z „dvigom spojnice ST“ (nenormalni zapis na elektrokardiogramu ali EKG-ju), če zdravnik meni, da jim zdravilo lahko pomaga.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Clopidogrel Teva Pharma B.V. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Clopidogrel Teva Pharma B.V., na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z zdravilom in priporočila glede pogojev njegove uporabe.
In acute coronary syndrome, Clopidogrel Teva Pharma B.V. is used together with aspirin and treatment generally starts with a loading dose of four tablets. 
uporablja skupaj z aspirinom, zdravljenje pa se na splošno začne z udarnim odmerkom štirih tablet.
For more information about treatment with Clopidogrel Teva Pharma B.V., read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
Because Clopidogrel Teva Pharma B.V. is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix. 
generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Plavix.
The active substance in Clopidogrel Teva Pharma B.V., clopidogrel, is an inhibitor of platelet aggregation. 
Zdravilna učinkovina v zdravilu Clopidogrel Teva Pharma B.V., klopidogrel, je zaviralec agregacije trombocitov.
• patients who have had a recent ischaemic stroke (stroke caused by failure of the blood supply to part of the brain). 
• bolnikom, ki so nedavno utrpeli ishemično kap (kap, ki jo povzroči pomanjkljiva oskrba določenega dela možganov s krvjo); Zdravilo Clopidogrel Teva Pharma B.V.
What are the benefit and risk of Clopidogrel Teva Pharma B.V.? 
Kakšne so koristi in tveganja, povezani z zdravilom Clopidogrel Teva Pharma B.V.
Clopidogrel Teva Pharma B.V. is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries). 
se uporablja za preprečevanje aterotrombotičnih dogodkov pri odraslih (težav, ki jih povzročajo krvni strdki v arterijah).
Clopidogrel Teva Pharma 
Zdravilo Clopidogrel Teva Pharma
The European Commission granted a marketing authorisation valid throughout the European Union for Clopidogrel Teva Pharma B.V. to Teva Pharma B.V. on 16 June 2011. 
Evropska komisija je dovoljenje za promet z zdravilom Clopidogrel Teva Pharma B.V., veljavno po vsej Evropski uniji, odobrila družbi Teva Pharma B.V.
The CHMP concluded that, in accordance with EU requirements, Clopidogrel Teva Pharma B.V. has been shown to have comparable quality and to be bioequivalent to Plavix. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Clopidogrel Teva Pharma B.V.
The Committee recommended that Clopidogrel Teva Pharma B.V. be given marketing authorisation. 
Odbor je priporočil, da se za zdravilo Clopidogrel Teva Pharma B.V.
Clopidogrel Teva Pharma B.V. can be given to the following groups of patients: 
se lahko daje naslednjim skupinam bolnikov:
Clopidogrel Teva Pharma B.V. can be started between seven days and six months after the stroke; 
lahko začnejo jemati od sedem dni po kapi do šest mesecev po njej;
Other information about Clopidogrel Teva Pharma B.V.: 
Druge informacije o zdravilu Clopidogrel Teva Pharma B.V.
• 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). 
• bolnikom z akutnim koronarnim sindromom, pri katerih se mora zdravilo dajati skupaj z aspirinom
What is Clopidogrel Teva Pharma B.V.? 
Kaj je zdravilo Clopidogrel Teva Pharma B.V.
What is Clopidogrel Teva Pharma B.V. used for? 
Za kaj se zdravilo Clopidogrel Teva Pharma B.V.
How has Clopidogrel Teva Pharma B.V. been studied? 
Kako se zdravilo Clopidogrel Teva Pharma B.V.
How is Clopidogrel Teva Pharma B.V. used? 
Kako je bilo zdravilo Clopidogrel Teva Pharma B.V.
Why has Clopidogrel Teva Pharma B.V. been approved? 
Zakaj je bilo zdravilo Clopidogrel Teva Pharma B.V.
Invented name Strength Pharmaceutical form 
Farmacevtska oblika
Packaging size 
Velikost pakiranja
Strength Pharmaceutical Form Route of administration 
Številka EU Izmišljeno ime Jakost Farmacevtska oblika
Especially tell your doctor: 
Še zlasti morate zdravniku povedati:
Make sure to ask your doctor for advice regarding when you can start your treatment again. 
Ne pozabite vprašati vašega zdravnika za nasvet, kdaj lahko ponovno začnete z vašim zdravljenjem.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 16 January, 2014 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM 16. januar 2014
Do not take this medicine if any of the above apply to you. 
Ne jemljite tega zdravila, če karkoli od navedenega velja za vas.
These conditions can cause dehydration. 
Vse to lahko povzroči dehidracijo.
• For renal function approaching moderate renal impairment, at least 2 to 4 times per year. 
• V primeru delovanja ledvic, ki se bliža zmerni okvari ledvic, vsaj 2- do 4-krat na leto.
• Prior to initiation of concomitant medicinal products that may reduce renal function and periodically thereafter 
• Pred uvedbo sočasnih zdravil, ki lahko zmanjšajo delovanje ledvic, in redno pozneje.
It particularly effects patients whose kidneys are not working properly. 
Pojavi se zlasti pri bolnikih, ki jim ledvice ne delujejo pravilno.
This is a build up of lactic acid in the blood that can cause death. 
Gre za kopičenje mlečne kisline v krvi, ki lahko povzroči smrt.
Monitoring of renal function is recommended as follows: 
Delovanje ledvic je priporočljivo kontrolirati takole:
Diagnosis 
Diagnoza
You will need to tell your doctor and stop taking this medicine for a certain period of time and for 2 or more days after depending on how your kidneys are working. 
To boste morali povedati zdravniku in nehati jemati to zdravilo za določeno obdobje v času rentgenske preiskave ter 2 ali več dni po njej, odvisno od delovanja vaših ledvic.
Lactic acidosis is a medical emergency and must be treated in hospital. 
Laktacidoza je nujno stanje, ki ga je treba zdraviti v bolnišnici.
• if you are going to have an operation under anaesthesia. 
• če imate predvideno operacijo v anesteziji.
More information is given below in ‘Other medicines and Xigduo'. 
Več informacij najdete v poglavju "Druga zdravila in zdravilo Xigduo",
15% of the dose was excreted as parent drug. 
V blatu se je približno 15 % odmerka izločilo kot matično zdravilo.
Gastrointestinal symptomsi,§ 
Bolezni prebavil gastrointestinalni simptomii,§
As this medicinal product contains metformin, the treatment must be discontinued 48 hours before elective surgery with general, spinal or epidural anaesthesia. 
To zdravilo vsebuje metformin, zato je zdravljenje treba prekiniti 48 ur pred elektivno operacijo, ki bo opravljena v splošni, spinalni ali epiduralni anesteziji.
Your kidneys should be checked before you start taking this medicine and at least once every year whilst you are taking it. 
Delovanje ledvic je treba preveriti pred začetkom jemanja tega zdravila in vsaj enkrat vsako leto med zdravljenjem.
• Prior to initiation of treatment and at least yearly thereafter (see sections 4.2, 4.8, 5.1 and 5.2) 
• Pred uvedbo zdravljenja in nato vsaj enkrat na leto (glejte poglavja 4.2, 4.8, 5.1 in 5.2).
• if you have a condition called ‘diabetic ketoacidosis', a problem you can get with diabetes. 
• če imate motnjo, ki jo imenujemo "diabetična ketoacidoza"; to je težava, ki se lahko pojavi pri sladkorni bolezni.
If metabolic acidosis is suspected, treatment with the medicinal product should be discontinued and the patient hospitalised immediately (see section 4.9). 
Če obstaja sum na metabolično acidozo, je treba zdravljenje s tem zdravilom prekiniti in bolnika takoj hospitalizirati (glejte poglavje 4.9).
Stop taking this medicine immediately and contact a doctor or the nearest hospital straight away. 
Takoj nehajte jemati to zdravilo in nemudoma obvestite zdravnika ali najbližjo bolnišnico.
(≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data). 
občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), ni znano (ni mogoče oceniti iz razpoložljivih podatkov).
• if you are taking a medicine used to remove water from the body (diuretic). 
• če jemljete kakšno zdravilo za odvajanje vode iz telesa (diuretik).
Stop taking this medicine immediately and contact a doctor or the nearest hospital straight away (see section 4). 
Takoj nehajte jemati to zdravilo in nemudoma obvestite zdravnika ali najbližjo bolnišnico (glejte poglavje 4).
Avoid alcohol, including medicines containing alcohol, while taking this medicine since alcohol may increase the risk of lactic acidosis (see section 4 ‘Possible side effects'). 
Med jemanjem tega zdravila se izogibajte alkoholu - tudi zdravilom, ki vsebujejo alkohol, kajti alkohol lahko poveča tveganje za laktacidozo (glejte poglavje 4 "Možni neželeni učinki").
Metformin The prospective randomised (UKPDS) study has established the long-term benefit of intensive blood glucose control in type 2 diabetes. 
Prospektivna randomizirana študija (UKPDS) je ugotovila dolgoročne koristi intenzivnega obvladovanja glukoze v krvi pri sladkorni bolezni tipa 2.
In controlled clinical trials, maximum metformin plasma levels (Cmax) did not exceed 5 μg/ml, even at maximum doses. 
V kontroliranih kliničnih preskušanjih največja koncentracija metformina v plazmi (Cmax) tudi ob največjih odmerkih ni presegla 5 µg/ml.
Cardiovascular death, MI and stroke were observed with a hazard ratio of 0.77 (95% CI: 0.54, 1.10). 
Srčno-žilno smrt, MI in možgansko kap so zabeležili z razmerjem ogroženosti 0,77 (95 % IZ: 0,54, 1,10).
Renal clearance of metformin is > 400 ml/min, indicating that metformin is eliminated by glomerular filtration and tubular secretion. 
Ledvični očistek metformina je > 400 ml/min, kar kaže, da se zdravilo izloča z glomerularno filtracijo in tubularno sekrecijo.
Gender The mean dapagliflozin AUCss in females was estimated to be about 22% higher than in males. 
Ocenjena povprečna AUCss dapagliflozina pri ženskah je približno 22 % večja kot pri moških.
• if you experience “lactic acidosis”: metformin, one of the active substances in this medicine, can cause a rare but serious side effect called lactic acidosis (a build up of lactic acid in the blood) that can lead to death. 
• če se vam pojavi "laktacidoza": metformin, ena od zdravilnih učinkovin tega zdravila, lahko povzroči redek, toda resen neželen učinek, imenovan laktacidoza (kopičenje mlečne kisline v krvi), ki lahko vodi v smrt.
You should stop taking Xigduo at least 48 hours before planned surgery with general anaesthesia and should not start again until at least 48 hours afterwards; follow your doctor's instructions before stopping and re-starting your medicine. 
Zdravilo Xigduo morate nehati jemati vsaj 48 ur pred načrtovano operacijo v splošni anesteziji in ga ne smete znova začeti jemati vsaj še 48 ur po operaciji; preden nehate jemati zdravilo in preden ga znova začnete jemati, upoštevajte zdravnikova navodila.
Biotransformation Metformin is excreted unchanged in the urine. 
Metformin se nespremenjen izloči v urinu.
This may induce metformin accumulation which may increase the risk for lactic acidosis. 
Ta pa lahko povzroči kopičenje metformina, kar lahko poveča tveganje za laktacidozo.
After administration of a 50 mg [14C]-dapagliflozin dose, 96% was recovered, 75% in urine and 21% in feces. 
Po uporabi odmerka 50 mg [14C]-dapagliflozina se je izločenega pojavilo 96 %, in sicer 75 % v urinu in 21 % v blatu.
Constipation** Dry mouth** 
zaprtost** suha usta**
• if you need to have an injection of a medicine called a contrast agent that contains iodine, for example before an X-ray or scan. 
• če vam bodo injicirali zdravilo, imenovano kontrastno sredstvo, ki vsebuje jod, na primer pred rentgenskim slikanjem ali preiskavo.
Special caution should be exercised in situations where renal function may become impaired, for example when initiating anti-hypertensive or diuretic therapy or when starting treatment with a nonsteroidal anti-inflammatory drug (NSAID). 
Posebna previdnost je potrebna v okoliščinah, ko bi se lahko pojavila okvara delovanja ledvic, npr. na začetku zdravljenja z antihipertenzivi ali diuretiki ali ob uvedbi zdravljenja z nesteroidnimi protivnetnimi zdravili (NSAID).
• Swallow the tablet whole with half a glass of water. 
Jemanje tega zdravila • Tableto zaužijte celo s pol kozarca vode.
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 
Kategorije pogostnosti so opredeljene po naslednjem dogovoru: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10),
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. 
Razmerje ogroženosti z dapagliflozinom v primerjavi s primerjalnim zdravilom je bilo 0,79 (95 % interval zaupanja [IZ]: 0,58, 1,07); to kaže, da dapagliflozin v tej analizi ni bil povezan s povečanjem srčno-žilnega tveganja pri bolnikih s sladkorno boleznijo tipa 2.
If renal function falls below CrCl < 60 ml/min or eGFR < 60 ml/min/1.73 m2, treatment must be discontinued. 
Če delovanje ledvic upade na CrCl < 60 ml/min ali eGFR na < 60 ml/min/1,73 m2, je treba z zdravljenjem prekiniti.
PHARMACEUTICAL FORM AND CONTENTS Multipack: 196 (2 packs of 98) film-coated tablets 
FARMACEVTSKA OBLIKA IN VSEBINA Skupno pakiranje: 196 (2 pakiranji po 98) filmsko obloženih tablet
At the usual metformin doses and dosing schedules, steady-state plasma concentrations are reached within 24-48 hours and are generally less than 1 μg/ml. 
Ob običajnih odmerkih in odmernih shemah metformina je koncentracija v stanju dinamičnega ravnovesja v plazmi dosežena v 24 do 48 urah in je na splošno nižja od 1 µg/ml.
In addition, metformin is excreted by the kidney, and moderate to severe renal insufficiency increases the risk of lactic acidosis (see section 4.4). 
Poleg tega se metformin izloča skozi ledvice in zmerna do huda insuficienca ledvic poveča tveganje za laktacidozo (glejte poglavje 4.4).
• if you have or develop nausea (feeling sick), vomiting or fever or if you are not able to eat or drink. 
• če imate ali se vam pojavi občutek slabosti s siljenjem na bruhanje (navzea), bruhate, imate zvišano telesno temperaturo ali ne morete jesti ali piti.
Xigduo is contraindicated in patients with: 
4.3 Kontraindikacije Zdravilo Xigduo je kontraindicirano pri bolnikih s:
The treatment may be restarted no earlier than 48 hours following surgery or resumption of oral nutrition and only if normal renal function has been established. 
Zdravljenja se ne sme uvesti prej kot 48 ur po operaciji ali ponovni vzpostavitvi oralne prehrane in se ga lahko uvede samo, če je bilo vzpostavljeno normalno delovanje ledvic.
Diuretics, especially loop diuretics, may increase the risk of lactic acidosis due to their potential to decrease renal function. 
Diuretiki, zlasti diuretiki zanke, lahko povečajo tveganje za laktacidozo, ker lahko zmanjšajo delovanje ledvic.
The incidence of lactic acidosis can and should be reduced by also assessing other associated risk factors such as poorly controlled diabetes, ketosis, prolonged fasting, excessive alcohol intake, hepatic insufficiency and any conditions associated with hypoxia. 
Incidenco laktacidoze je mogoče in jo je treba zmanjšati tudi z ocenitvijo drugih spremljajočih dejavnikov tveganja, npr. slabe urejenosti sladkorne bolezni, ketoze, dolgotrajnega postenja, čezmernega uživanja alkohola, insuficience jeter in vseh motenj, povezanih s hipoksijo.
bSee corresponding subsection below for additional information. 
bZa dodatne informacije glejte ustrezno podpoglavje spodaj.
Difference from placebod 
Razlika v primerjavi s placebomc
(95% CI) Subjects (%) achieving: HbA1c < 7% Adjusted for baseline 
(95 % IZ) Preiskovanci (%), ki so dosegli: HbA1c < 7% Korigirano za izhodišče
The metabolism of dapagliflozin is primarily via glucuronide conjugation mediated by UDP-glucuronosyltransferase 1A9 (UGT1A9). 
Presnova dapagliflozina poteka predvsem z glukuronidno konjugacijo, ki poteka z UDP-glukuronoziltransferazo 1A9 (UGT1A9).
Nocturia** Renal impairment**,b 
*,f nikturija** okvara ledvic**,b
Diagnostic laboratory findings are decreased blood pH, plasma lactate levels above 5 mmol/l, and an increased anion gap and lactate/pyruvate ratio. 
Diagnostični laboratorijski izvidi so znižan pH krvi, koncentracija laktata v plazmi nad 5 mmol/l, povečana anionska vrzel in zvišano razmerje laktat/piruvat.