natgillin/translations-raw huggingface dataset:
Difference: -0.29 [-0.65; 0.06] 
Razlika: -0,29 [-0,65; 0,06]
• Check the name and strength on the label of your pen to make sure that it contains Tresiba 100 units/mL. 
• Provjerite naziv i jačinu na naljepnici Vaše brizgalice kako biste bili sigurni da sadrži lijek Tresiba 100 jedinica/ml.
Tresiba 100 units/mL solution for injection in cartridge Before first use: 
Tresiba 100 jedinica/ml otopina za injekciju u ulošku Prije prve uporabe:
Pack sizes of 1 (with or without needles), 5 (without needles) and multipack containing 10 (2 packs of 5) (without needles) pre-filled pens. 
Veličine pakiranja: 1 (sa ili bez igala), 5 (bez igala) i višestruko pakiranje koje sadrži 10 (2 pakiranja po 5) (bez igala) napunjenih brizgalica.
Pack sizes of 1 (with or without needles), 2 (without needles), 3 (without needles), 5 (without needles) and multipack containing 6 (2 packs of 3) (without needles) pre-filled pens. 
Veličine pakiranja: 1 (sa ili bez igala), 2 (bez igala), 3 (bez igala), 5 (bez igala) i višestruko pakiranje koje sadrži 6 (2 pakiranja po 3) (bez igala) napunjenih brizgalica.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (100 units/mL cartridge (Penfill)) 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA (100 jedinica/ml uložak (Penfill))
• oral contraceptives (birth control pills) 
• oralne kontraceptive (tablete za sprječavanje začeća) • hormone štitnjače, za probleme sa štitnjačom
Tresiba 200 units/mL solution for injection in pre-filled pen 
Tresiba 200 jedinica/ml otopina za injekciju u napunjenoj brizgalici
Each pre-filled pen contains 300 units of insulin degludec in 3 mL solution. 
Jedna napunjena brizgalica sadrži 300 jedinica degludek inzulina u 3 ml otopine.
• your blood sugar got so low that you passed out 
• Vam se razina šećera u krvi toliko snizila da ste izgubili svijest • ste primijenili injekciju glukagona
If the insulin looks cloudy, do not use the pen. 
Ne koristite brizgalicu ako inzulin izgleda zamućeno.
Tresiba 100 units/mL solution for injection in cartridge Solution for injection (Penfill). 
Tresiba 100 jedinica/ml otopina za injekciju u ulošku Otopina za injekciju (Penfill).
Tresiba can be used in elderly. 
Stariji bolesnici (≥ 65 godina) Tresiba se može primjenjivati u starijih bolesnika.
Tresiba 200 units/mL solution for injection in pre-filled pen 3 mL solution in a cartridge (type 1 glass) with a plunger (halobutyl) and a laminate rubber sheet (halobutyl/polyisoprene) contained in a pre-filled multidose disposable pen made of polypropylene. 
Tresiba 200 jedinica/ml otopina za injekciju u napunjenoj brizgalici 3 ml otopine u ulošku (staklo tipa 1) s klipom (halobutil) i pokrovom od laminirane gume
Each cartridge contains 300 units of insulin degludec of insulin in 3 ml solution. 
Jedan uložak sadrži 300 jedinica degludek inzulina u 3 ml otopine.
Insulin glargine (100 units/mL)2 
Glargin inzulin (100 jedinica/ml)2
Hypersensitivity Urticaria 
Degludek inzulin
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PEN LABEL (200 units/mL pre-filled pen (FlexTouch)) 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BRIZGALICI (200 jedinica/ml napunjena brizgalica (FlexTouch))
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PEN LABEL (100 units/mL pre-filled pen (FlexTouch)) 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BRIZGALICI (100 jedinica/ml napunjena brizgalica (FlexTouch))
Keep the cartridge in the outer carton in order to protect it from light 
Uloške čuvati u vanjskoj kutiji radi zaštite od svjetlosti
Tresiba 200 units/mL solution for injection in pre-filled pen insulin degludec 
Tresiba 200 jedinica/ml otopina za injekciju u napunjenoj brizgalici degludek inzulin
Difference: -0.13 [-0.29; 0.03] 
Razlika: -0,13 [-0,29; 0,03]5
OTHER SPECIAL WARNINGS, IF NECESSARY Use only clear, colourless solution Single patient use only 
Upotrijebiti samo bistru, bezbojnu otopinu.
Insulin glargine (100 units/mL)1 
Glargin inzulin (100 jedinica/ml)1
Tresiba 100 units/mL solution for injection in cartridge After first opening or carried as a spare, the medicinal product may be stored for a maximum of 8 weeks. 
Nakon prvog otvaranja ili ako se nosi kao rezervni, lijek se može čuvati najviše 8 tjedana.
PHARMACEUTICAL FORM AND CONTENTS Solution for injection (Penfill) 5 x 3 mL 
Otopina za injekciju (Penfill)
4 Confirmed hypoglycaemia was defined as episodes confirmed by plasma glucose <3.1 mmol/L or by the patient needing third party assistance. 
4 Potvrđena hipoglikemija definirana je kao epizoda potvrđena razinom glukoze u plazmi < 3,1 mmol/l ili time što je bolesniku potrebna pomoć druge osobe.
PARTICULARS TO APPEAR ON THE INNER PACKAGING CARTON FOR MULTIPACK (100 units/mL pre-filled pen (FlexTouch)) 
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU KUTIJA ZA VIŠESTRUKO PAKIRANJE (100 jedinica/ml napunjena brizgalica (FlexTouch))
Keep the cap on the pen in order to protect from light. 
Zatvarač držati na brizgalici radi zaštite od svjetlosti.
STATEMENT OF ACTIVE SUBSTANCE One pre-filled pen contains 600 units of insulin degludec in 3 mL solution 1 mL solution contains 200 units of insulin degludec (equivalent to 7.32 mg) 
1 ml otopine sadrži 200 jedinica degludek inzulina (što odgovara 7,32 mg),
Insulin glargine (100 units/mL) 
glargin inzulin (100 jedinica/ml)
2 Confirmed hypoglycaemia was defined as episodes confirmed by plasma glucose <3.1 mmol/L or by the patient needing third party assistance. 
2 Potvrđena hipoglikemija definirana je kao epizoda potvrđena razinom glukoze u plazmi < 3,1 mmol/l ili time što je bolesniku potrebna pomoć druge osobe.
PARTICULARS TO APPEAR ON THE INNER PACKAGING CARTON FOR MULTIPACK (200 units/mL pre-filled pen (FlexTouch)) 
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU KUTIJA ZA VIŠESTRUKO PAKIRANJE (200 jedinica/ml napunjena brizgalica (FlexTouch))
6.1 List of excipients 
FARMACEUTSKI PODACI 6.1 Popis pomoćnih tvari Glicerol
PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK LABEL (200 units/mL pre-filled pen (FlexTouch)) 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU NALJEPNICA ZA VIŠESTRUKO PAKIRANJE (200 jedinica/ml napunjena brizgalica (FlexTouch))
Tresiba 100 units/mL solution for injection in pre-filled pen insulin degludec 
Tresiba 100 jedinica/ml otopina za injekciju u napunjenoj brizgalici degludek inzulin
PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK LABEL (100 units/mL pre-filled pen (FlexTouch)) 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU NALJEPNICA ZA VIŠESTRUKO PAKIRANJE (100 jedinica/ml napunjena brizgalica (FlexTouch))
Tresiba 100 units/mL solution for injection in pre-filled pen 3 mL solution in a cartridge (type 1 glass) with a plunger (halobutyl) and a laminate rubber sheet (halobutyl/polyisoprene) contained in a pre-filled multidose disposable pen made of polypropylene. 
Tresiba 100 jedinica/ml otopina za injekciju u napunjenoj brizgalici 3 ml otopine u ulošku (staklo tipa 1) s klipom (halobutil) i pokrovom od laminirane gume
Tresiba 100 units/mL solution for injection in cartridge insulin degludec 
Tresiba 100 jedinica/ml otopina za injekciju degludek inzulin
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (100 units/mL pre-filled pen (FlexTouch)) 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA (100 jedinica/ml napunjena brizgalica (FlexTouch))
Tresiba 100 units/mL and Tresiba 200 units/mL solution for injection in a pre-filled pen Tresiba is available in two strengths. 
Tresiba 100 jedinica/ml i Tresiba 200 jedinica/ml otopina za injekciju u napunjenoj brizgalici
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (200 units/mL pre-filled pen (FlexTouch)) 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA (200 jedinica/ml napunjena brizgalica (FlexTouch))
Elimination 
Lipodistrofija
NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Tresiba 200 units/mL solution for injection insulin degludec 
Uputa o lijeku: Informacije za bolesnika Tresiba 200 jedinica/ml otopina za injekciju u napunjenoj brizgalici degludek inzulin
STATEMENT OF ACTIVE SUBSTANCE One cartridge contains 300 units of insulin degludec in 3 mL solution 1 mL solution contains 100 units of insulin degludec (equivalent to 3.66 mg) 
1 ml otopine sadrži 100 jedinica degludek inzulina (što odgovara 3,66 mg),
NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Tresiba 100 units/mL solution for injection insulin degludec 
Uputa o lijeku: Informacije za bolesnika Tresiba 100 jedinica/ml otopina za injekciju u ulošku degludek inzulin
How to use Tresiba 
U korist lijeka Tresiba
MARKETING AUTHORISATION NUMBERS EU/1/12/807/007 5 cartridges of 3 mL EU/1/12/807/008 10 cartridges of 3 mL 
12. BROJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/12/807/007 5 uložaka od 3 ml
Discard the needle safely after each injection 
Nakon svakog injiciranja na siguran način iglu baciti u otpad.
In addition to standard of care for diabetes and cardiovascular disease Nocturnal severe hypoglycaemia was defined as episodes between midnight and 6 a.m. 
Teška noćna hipoglikemija definirana je kao epizode u razdoblju od ponoći do 6 sati ujutro
Tresiba Flex2 
Razlika je za Tresiba Flex - Tresiba
LIST OF EXCIPIENTS 
Naljepnica brizgalice
NAME OF THE MEDICINAL PRODUCT Tresiba 100 units/mL solution for injection in pre-filled pen insulin degludec 
Uputa o lijeku: Informacije za bolesnika Tresiba 100 jedinica/ml otopina za injekciju u napunjenoj brizgalici degludek inzulin
Your blood sugar level may either rise or fall. 
Može doći do porasta ili pada razine šećera u krvi.
(sinusitis), o inflamed nose or throat (nasopharyngitis) (signs of this may include a cold or a sore throat). 
NAVOĐENJE DJELATNE(IH) TVARI
Tell your doctor before you start taking Qtrilmet if you have any of these signs; 
Ako se bilo što od gore navedenoga odnosi na Vas (ili niste sigurni), obratite se svom liječniku prije nego uzmete Qtrilmet.
Each tablet is to be swallowed whole. 
Svaku tabletu treba progutati cijelu.
The increased/decreased risk was not statistically significant in any of the organ systems. 
Povećan/smanjen rizik nije bio statistički značajan ni u jednom organskom sustavu.
Consumption of alcohol and medicinal products containing alcohol should be avoided. 
Zbog toga se mora izbjegavati uzimanje alkohola i lijekova koji sadrže alkohol.
The safety and efficacy of this medicinal product in children and adolescents aged 0 to < 18 years have not yet been established. 
Sigurnost i djelotvornost ovog lijeka kod djece i adolescenata u dobi od 0 od < 18 godina još nisu ustanovljene.
Qtrilmet should not be used during pregnancy. 
Qtrilmet se ne smije koristiti tijekom trudnoće.
The recommended dose is two tablets once a day. 
Preporučena doza su dvije tablete jedanput na dan.
What to do if you forget to take Qtrilmet on time. 
Što trebate učiniti ako ste zaboravili uzeti Qtrilmet na vrijeme.
Take the tablets at around the same time each day. 
- Uzmite tablete svaki dan u približno isto vrijeme.
What Qtrilmet is and what it is used for 
Što je Qtrilmet i za što se koristi
Do not take a double dose of Qtrilmet to make up for a forgotten dose. 
- Nemojte uzeti dvostruku dozu lijeka Qtrilmet da biste nadoknadili zaboravljenu dozu.
Qtrilmet is not recommended during pregnancy and your doctor will ask you to stop taking this medicine if you become pregnant or plan to have a baby. 
Qtrilmet se ne preporučuje tijekom trudnoće, pa će Vaš liječnik zatražiti da ga prestanete uzimati ako zatrudnite ili planirate imati dijete.
Randomised and treated patients. 
Randomizirani i liječeni bolesnici.
Swallow the tablets whole with half a glass of water. 
Uzimanje lijeka - Tablete progutajte cijele, s pola čaše vode.
This leads to a high level of sugar (glucose) in your blood. 
To dovodi do visoke razine šećera (glukoze) u krvi.
Common A Uncommon B Rare Very rare Not known 
Često A Manje često B Rijetko Vrlo rijetko Nepoznato
Lactic acidosis is a medical emergency and must be treated in a hospital. 
Laktacidoza je hitno medicinsko stanje koje se mora liječiti u bolnici.
Following an oral dose, the apparent terminal elimination half-life is approximately 6.5 hours. 
Nakon peroralne doze prividni terminalni poluvijek eliminacije iznosi približno 6,5 sati.
Fournier's gangrene has to be treated immediately. 
Fournierova gangrena mora se odmah liječiti.
Your blood sugar may rise without this medicine. 
Razina šećera u krvi može porasti ako ne uzimate ovaj lijek.
UNIQUE IDENTIFIER 2D BARCODE 
17. JEDINSTVENI IDENTIFIKATOR 2D BARKOD
In both cases, treatment with Qtrilmet may be restarted once the patient's condition has stabilised. 
U oba se slučaja liječenje lijekom Qtrilmet može ponovno započeti nakon što se bolesnikovo stanje stabilizira.
This medicine is taken by mouth to treat diabetes and each of the active substances works in a different way to treat the condition. 
Ovaj se lijek uzima kroz usta za liječenje šećerne bolesti, a svaka od djelatnih tvari pritom djeluje na drugačiji način.
It is important to check your feet regularly - and follow the advice on foot care from your health care professional. 
Važno je da redovito provjeravate svoja stopala i da se pridržavate savjeta o njezi stopala koje Vam da Vaš zdravstveni radnik.
These pharmacokinetic effects are not clinically meaningful and do not require dose adjustment. 
Ti farmakokinetički učinci nisu klinički važni i ne zahtijevaju prilagodbu doze.
If you take more Qtrilmet tablets than you should, talk to a doctor or go to a hospital straight away. 
Ako uzmete više Qtrilmet tableta nego što ste trebali, odmah se obratite svom liječniku ili otiđite u bolnicu.
The requirements for submission of PSURs for this medicinal product are set out in the list of Union references dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal. 
Zahtjevi za podnošenje PSUR-eva za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
Qtrilmet is only given to adults aged 18 years and older. 
Qtrilmet se daje samo odraslim osobama u dobi od 18 ili više godina.
Do not take Qtrilmet if any of the above apply to you. 
Nemojte uzimati Qtrilmet ako se bilo što od prethodno navedenoga odnosi na Vas.
Each belongs to a group of medicines called “oral anti-diabetics”. 
Sve one pripadaju skupini lijekova koji se zovu ‘oralni antidijabetici'.
In particular, talk to your doctor before taking Qtrilmet if you are taking any of the following medicines: 
Osobito je važno da razgovarate sa svojim liječnikom prije nego što uzmete Qtrilmet ako uzimate bilo koji od sljedećih lijekova:
Your doctor may prescribe other medicines to lower the amount of sugar in your blood. 
Liječnik će Vam možda propisati i druge lijekove za snižavanje razine šećera u krvi.
If pregnancy is detected, treatment with this medicinal product should be discontinued. 
Ako se utvrdi trudnoća, liječenje ovim lijekom mora se prekinuti.
Generally, the most common adverse events reported in ≥ 65 years old were similar to < 65 years old. 
Općenito su najčešći štetni događaji prijavljeni kod ispitanika u dobi od ≥ 65 godina bili slični onima prijavljenima kod ispitanika u dobi od < 65 godina.
SGLT2 inhibitors should be used with caution in these patients. 
Inhibitore SGLT2 treba primjenjivati uz oprez kod tih bolesnika.
If you have type 2 diabetes, your pancreas does not make enough insulin or your body is not able to use the insulin it produces properly. 
Ako imate šećernu bolest tipa 2, gušterača Vam ne proizvodi dovoljno inzulina ili tijelo ne može pravilno iskoristiti inzulin koji proizvodi.
Your doctor may ask you to stop taking Qtrilmet. 
Liječnik će možda zatražiti da prestanete uzimati Qtrilmet.
Frequency categories were defined according to 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 ( 1/100,000 to < 1/10,000) and not known (cannot be estimated from the available data). 
Kategorije učestalosti definirane su kao: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko ( 1/10 000 i < 1/1000), vrlo rijetko ( 1/100 000 i < 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
If you take more Qtrilmet than you should 
Ako uzmete više lijeka Qtrilmet nego što ste trebali
A GFR should be assessed before initiation of treatment with metformin containing medicinal products and at least annually thereafter. 
Potrebno je ocijeniti GFR prije uvođenja lijekova koji sadrže metformin i najmanje jednom godišnje nakon toga.
Take your tablets with food. 
- Uzmite tablete s hranom.
Concomitant use not recommended 
Istodobna primjena se ne preporučuje
The efficacy and safety profiles of Qtrilmet in these patients have not been established. 
Nije utvrđen profil djelotvornosti i sigurnosti lijeka Qtrilmet kod tih bolesnika.
UNIQUE IDENTIFIER HUMAN READABLE DATA 
JEDINSTVENI IDENTIFIKATOR PODACI ČITLJIVI LJUDSKIM OKOM
It is unknown whether this constitutes a class effect. 
Nije poznato radi li se o učinku razreda lijekova.
Your doctor may decide to temporarily or permanently stop your treatment with Qtrilmet. 
Liječnik će možda odlučiti privremeno ili trajno prekinuti liječenje lijekom Qtrilmet.
Occasionally, the inactive ingredients of this medicine will be eliminated in the faeces as a soft, hydrated mass that may resemble the original tablet. 
Ponekad se neaktivni sastojci ovog lijeka eliminiraju kroz feces u obliku mekane, hidrirane mase koja može nalikovati izvornoj tableti.
This is normal and what is left of the tablet after all the medicine has been released. 
To je normalna pojava, a radi se o dijelovima tablete koji preostanu nakon što se iz nje otpusti sav lijek.
Your kidney function will be checked at least once every year or more frequently if you are elderly or if you have worsening kidney function. 
Liječnik će Vam kontrolirati rad bubrega najmanje jednom godišnje, a možda i češće ako ste starija osoba ili ako Vam se pogoršava bubrežna funkcija.
What you need to know before you take Qtrilmet 
Što morate znati prije nego počnete uzimati Qtrilmet
Therapeutic experience in patients 65 years and older is limited, and very limited in patients 75 years and older. 
Iskustvo s liječenjem bolesnika u dobi od 65 i više godina je ograničeno, dok je kod bolesnika u dobi od 75 i više godina vrlo ograničeno.
Surgery and operations 
Kirurški zahvati i operacije
Qtrilmet is not recommended for children and adolescents under 18 years of age because it has not been studied in these patients. 
Primjena lijeka Qtrilmet ne preporučuje se kod djece i adolescenata mlađih od 18 godina jer se lijek nije ispitivao kod tih bolesnika.
The clinical relevance of the skin lesions is not known, and skin lesions have not been observed in humans. 
Klinički značaj kožnih lezija nije poznat i one nisu primijećene kod ljudi.
The treatment groups were proportionally well balanced with regard to demographics, subject characteristics, disease characteristics, and medical history. 
Liječene skupine bile su proporcionalno dobro ujednačene s obzirom na demografske podatke, značajke bolesnika, značajke bolesti i anamnezu.
The dose should be taken as two tablets orally, once daily at the same time of the day, with food. 
Dozu treba uzimati peroralno, kao dvije tablete jedanput na dan, svaki dan u isto vrijeme, uz hranu.
If pancreatitis is suspected, this medicinal product should be discontinued; if acute pancreatitis is confirmed, it should not be restarted. 
Posumnja li se na pankreatitis, treba prekinuti primjenu ovog lijeka; ako se akutni pankreatitis potvrdi, liječenje ovim lijekom ne smije se ponovno započinjati.
What Qtrilmet is and what it is used for What you need to know before you take Qtrilmet How to take Qtrilmet 
Što je Qtrilmet i za što se koristi Što morate znati prije nego počnete uzimati Qtrilmet
If you need major surgery, you must stop taking Qtrilmet during and for some time after the operation. 
Ako se trebate podvrgnuti velikom kirurškom zahvatu, morate prestati uzimati Qtrilmet tijekom i još neko vrijeme nakon operacije.
In case of suspected symptoms, the patient should stop taking Qtrilmet and seek immediate medical attention. 
U slučaju sumnje na simptome, bolesnik treba prestati uzimati Qtrilmet i odmah potražiti liječničku pomoć.
Consideration of such etiology is recommended if a patient presents with megaloblastic anaemia. 
Preporučuje se razmotriti tu etiologiju ako bolesnik pokazuje znakove megaloblastične anemije.
Like for all diabetic patients it is important to counsel patients on routine preventative foot care. 
Kao i kod svih drugih bolesnika sa šećernom bolešću, važno je savjetovati bolesnike o rutinskoj, preventivnoj njezi stopala.
To control your diabetes, you need to follow your doctor's advice on diet and exercise, even when you are taking this medicine. 
Da biste šećernu bolest držali pod kontrolom, morate se pridržavati liječnikovih savjeta o prehrani (dijeti) i tjelovježbi, čak i dok uzimate ovaj lijek.
Combinations requiring precautions for use 
Kombinacije kod kojih je potreban oprez
The majority of patients in this study had a baseline HbA1c of > 8% (see Table 4). 
Većina bolesnika u tom ispitivanju imala je početnu vrijednost HbA1c > 8% (vidjeti Tablicu 4).
A limited amount of data from the use of metformin in pregnant women does not indicate an increased risk of congenital malformations. 
Ograničena količina podataka o primjeni metformina kod trudnica ne ukazuje na povećan rizik od prirođenih malformacija.
Treatment should be interrupted in patients who are hospitalised for major surgical procedures or acute serious medical illnesses. 
Liječenje treba privremeno prekinuti kod bolesnika koji su hospitalizirani zbog velikih kirurških zahvata ili ozbiljne akutne bolesti.
The most effective method to remove lactate and metformin is haemodialysis. 
Najučinkovitija metoda uklanjanja laktata i metformina je hemodijaliza.
Modified-release tablet (tablet). 
Tableta s prilagođenim oslobađanjem (tableta).
Laboratory findings 
Laboratorijski nalazi
The mean Vd ranged between 63-276 L. 
Srednji volumen distribucije (Vd) kretao se između 63 l i 276 l.
In patients at increased risk of further progression of renal impairment and in the elderly, renal function should be assessed more frequently, e.g. every 3-6 months. 
Kod bolesnika s povećanim rizikom od daljnje progresije oštećenja bubrežne funkcije i kod starijih osoba funkciju bubrega treba ocjenjivati i češće, npr. svakih 3 - 6 mjeseci.
Saxagliptin: Elderly patients (65-80 years) had about 60% higher saxagliptin AUC than young patients (18-40 years). 
Saksagliptin: Kod starijih je bolesnika (65 - 80 godina) AUC saksagliptina bio približno 60% veći nego kod mlađih bolesnika (18 - 40 godina).
The volume of distribution of saxagliptin was 205 L. 
Volumen distribucije saksagliptina iznosio je 205 l.
Proportion of patients achieving HbA1c < 7% 
Udio bolesnika koji su postigli HbA1c < 7%
Due to the limited therapeutic experience with this medicinal product in patients 75 years and older, initiation of therapy is not recommended in this population. 
Zbog ograničenog terapijskog iskustva s primjenom ovog lijeka kod bolesnika u dobi od 75 i više godina, ne preporučuje se uvoditi ga u liječenje u toj populaciji.
Dapagliflozin: There were no clinically relevant differences in systemic exposures between White, Black or Asian races. 
Dapagliflozin: Nije bilo klinički značajnih razlika u sistemskoj izloženosti između bijelaca, crnaca i Azijaca.
Risk of volume depletion with this medicinal product should also be taken into account (see sections 4.4 and 5.2). 
Treba uzeti u obzir i rizik od deplecije volumena kod primjene ovog lijeka (vidjeti dijelove 4.4 i 5.2).
Patients should be advised of the characteristic symptoms of heart failure, and to immediately report such symptoms. 
Bolesnike treba upozoriti na karakteristične simptome zatajenja srca i napomenuti da takve simptome moraju odmah prijaviti.