FrancophonIA/ELRC3.0 huggingface dataset:
English: This is of particular importance because Coxiella burnetii can lead to a disease in humans called Qfever and decreasing the disease in animals will decrease the likelihood of transmitting the disease to humans.
Croatian: Ovo je od posebne važnosti budući da bakterija Coxiella burnetii može rezultirati bolešću u ljudi naziva Q-groznica, te smanjivanjem bolesti u životinja smanjuju se izgledi za prijenos ove bolesti na ljude.
English: When Coxevac is given to cattle and goats, their immune system recognises the bacteria contained in the vaccine as ‘foreign' and makes antibodies to defend against them.
Croatian: Ako se Coxevac primjenjuje u goveda i koza, njihov imunosni sustav prepoznaje bakterije sadržane u cjepivu kao „strane“ te proizvodi protutijela protiv njih.
English: What is Coxevac?
Croatian: Što je Coxevac?
English: Why has Coxevac been approved?
Croatian: Zašto je Coxevac odobren?
English: The vaccine is given as two injections under the skin, three weeks apart.
Croatian: Cjepivo se primjenjuje kao dvije supkutane injekcije u razmaku od tri tjedna.
English: What is the risk associated with Coxevac?
Croatian: Koji su rizici povezani s VMP-om Coxevac?
English: The effectiveness of the vaccine in goats has been determined in two field studies with pregnant goats exposed to Coxiella burnettii.
Croatian: Djelotvornost cjepiva u koza utvrđena je u dva terenska ispitivanja provedena u gravidnih koza izloženih bakteriji Coxiella burnettii.
English: The withdrawal period is the time allowed after administration of the medicine before the animal can be slaughtered and the meat or the milk used for human consumption.
Croatian: Karencije je razdoblje koje treba proći od primjene VMP-a do klanja životinja i konzumacije mesa u ljudskoj prehrani ili mlijeka u ljudskoj prehrani.
English: A field study determined the effectiveness of the vaccine in cattle that came from farms where Coxiella burnetii was present.
Croatian: Terenskim ispitivanjem utvrđena je djelotvornost cjepiva u goveda koja potječu s farmi, na kojima je zabilježena bakterija Coxiella burnetii.
English: In the future, if the animals are exposed to Coxiella burnetii bacteria, the immune system will be able to respond more quickly.
Croatian: U buduće, imunosni će sustav moći brže reagirati ako je životinja izložena bakteriji Coxiella burnetii.
English: The studies in goats also showed a lower proportion of abortions in the goats that were vaccinated compared with unvaccinated goats.
Croatian: Ispitivanjima provedenima u koza utvrđen je mali udio pobačaja u koza koje su cijepljene u usporedbi s onima koje nisu cijepljene.
English: What benefit has Coxevac shown during the studies?
Croatian: Koje su koristi VMP-a Coxevac utvrđene u ispitivanjima?
English: How does Coxevac work?
Croatian: Kako djeluje Coxevac?
English: How has Coxevac been studied?
Croatian: Kako je Coxevac ispitivan?
English: What is Coxevac used for?
Croatian: Zašto se Coxevac koristi?
English: 448 (4 x 112) capsules
Croatian: 448 (4 x 112) kapsula
English: Capsule, hard bottle (HDPE)
Croatian: Boca (HDPE)
English: Especially tell your doctor:
Croatian: Posebno je važno obavijestiti svog liječnika:
English: Elderly patients (≥ 65 years)
Croatian: Starije osobe(≥ 65 godina)
English: Make sure to ask your doctor for advice regarding when you can start your treatment again.
Croatian: Pobrinite se da pitate svog liječnika za savjet kada možete ponovno započeti svoju terapiju.
English: • if you are going to have an operation under anaesthesia.
Croatian: • ako idete na operaciju pod anestezijom.
English: It particularly effects patients whose kidneys are not working properly.
Croatian: Osobito pogađa bolesnike čiji bubrezi ne rade pravilno.
English: The safety and efficacy of Xigduo in children and adolescents aged 0 to < 18 years have not yet been established.
Croatian: Sigurnost i djelotvornost lijeka Xigduo u djece i adolescenata od rođenja do < 18 godina još nisu ustanovljene.
English: If you forget to take Xigduo Do not take a double dose of this medicine to make up for a forgotten dose.
Croatian: Ako ste zaboravili uzeti Xigduo Nemojte uzeti dvostruku dozu ovog lijeka da biste nadoknadili zaboravljenu dozu.
English: Your doctor may ask you to stop taking this medicine until you recover in order to prevent dehydration.
Croatian: Vaš liječnik može zatražiti da prestanete uzimati ovaj lijek dok se ne oporavite kako biste spriječili dehidraciju.
English: As this medicinal product contains metformin, the treatment must be discontinued 48 hours before elective surgery with general, spinal or epidural anaesthesia.
Croatian: Budući da ovaj lijek sadrži metformin, liječenje se mora prekinuti 48 sati prije elektivnog kirurškog zahvata pod općom, spinalnom ili epiduralnom anestezijom.
English: This is a build up of lactic acid in the blood that can cause death.
Croatian: Radi se o nakupljanju mliječne kiseline u krvi, koje može izazvati smrt.
English: See section 4.4
Croatian: k Vidjeti dio 4.4
English: Your kidneys should be checked before you start taking this medicine and at least once every year whilst you are taking it.
Croatian: Bubrege treba provjeriti prije početka uzimanja ovog lijeka i najmanje jednom svake godine tijekom liječenja ovim lijekom.
English: • if you have or develop nausea (feeling sick), vomiting or fever or if you are not able to eat or drink.
Croatian: • ako osjećate ili se pojavi mučnina, povraćanje ili imate vrućicu ili ako ne možete jesti ni piti.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 16 January, 2014
Croatian: DATUM PRVOG ODOBRENJA/DATUM OBNOVE ODOBRENJA
English: 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.
Croatian: Trebat ćete o tome obavijestiti svog liječnika te prestati uzimati ovaj lijek na određeno vrijeme te još dva ili više dana nakon snimanja, ovisno o tome kako
English: 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.
Croatian: Morate prestati uzimati Xigduo barem 48 sati prije planirane operacije pod općom anestezijom i ne smijete ga ponovno početi uzimati najmanje 48 sati nakon operacije; slijedite upute svog liječnika prije prestanka uzimanja lijeka i njegove ponovne primjene.
English: (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Croatian: < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Long-term treatment with metformin has been associated with a decrease in vitamin B12 absorption which may very rarely result in clinically significant vitamin B12 deficiency (e.g. megaloblastic anaemia).
Croatian: hDugoročno liječenje metforminom povezano je sa smanjenjem apsorpcije vitamina B12, što vrlo rijetko može dovesti do klinički značajnog nedostatka vitamina B12 (npr. megaloblastične anemije).
English: • 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.
Croatian: • ako trebate dobiti injekciju lijeka koji se zove kontrastno sredstvo koje sadrži jod, na primjer prije rentgenskog snimanja.
English: Difference from placebod
Croatian: Razlika u odnosu na placebod
English: Stop taking this medicine immediately and contact a doctor or the nearest hospital straight away (see section 4).
Croatian: Odmah prestanite uzimati ovaj lijek i smjesta se javite liječniku ili u najbližu bolnicu (pogledajte dio 4.).
English: Pruritus genital**
Croatian: genitalni pruritus**
English: Constipation** Dry mouth**
Croatian: konstipacija** suha usta**
English: • Prior to initiation of treatment and at least yearly thereafter (see sections 4.2, 4.8, 5.1 and 5.2)
Croatian: • prije početka liječenja i barem jednom godišnje nakon toga (vidjeti dijelove 4.2, 4.8, 5.1 i 5.2)
English: 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').
Croatian: Izbjegavajte alkohol, uključujući lijekove koji sadrže alkohol, dok uzimate ovaj lijek jer alkohol može povećati rizik od laktacidoze (pogledajte dio 4 ‘Moguće nuspojave').
English: • 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.
Croatian: • ako doživite "laktacidozu": metformin, jedna od djelatnih tvari ovog lijeka, može prouzrokovati rijetku ali ozbiljnu nuspojavu koja se zove laktacidoza (nakupljanje mliječne kiseline u krvi) i koja može dovesti do smrti.
English: PHARMACEUTICAL FORM AND CONTENTS 98 film-coated tablets.
Croatian: OBLIK I SADRŽAJ 98 filmom obloženih tableta.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Xigduo in all subsets of the paediatric population in the treatment of type 2 diabetes (see section 4.2 for information on paediatric use).
Croatian: Pedijatrijska populacija Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja lijeka Xigduo u svim podskupinama pedijatrijske populacije u liječenju šećerne bolesti tipa 2 (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: If metabolic acidosis is suspected, treatment with the medicinal product should be discontinued and the patient hospitalised immediately (see section 4.9).
Croatian: Posumnja li se na metaboličku acidozu, treba odmah obustaviti primjenu lijeka i hospitalizirati bolesnika (vidjeti dio 4.9).
English: Metformin increases the transport capacity of specific types of membrane glucose transporters (GLUT-1 and GLUT-4).
Croatian: Metformin povećava transportni kapacitet specifičnih tipova membranskih prijenosnika glukoze (GLUT-1 i
English: Renal clearance of metformin is > 400 ml/min, indicating that metformin is eliminated by glomerular filtration and tubular secretion.
Croatian: Bubrežni klirens metformina iznosi > 400 ml/min, što ukazuje na to da se metformin eliminira glomerularnom filtracijom i tubularnom sekrecijom.
English: In the clinical program, 34.4% of subjects had a history of cardiovascular disease (excluding hypertension) at baseline and 67.9% had hypertension.
Croatian: U kliničkom je programu na početku liječenja 34,4% ispitanika imalo neku kardiovaskularnu bolest (osim hipertenzije) u anamnezi, a njih 67,9% imalo je hipertenziju.
English: Lactic acidosis is a very rare, but serious (high mortality in the absence of prompt treatment), metabolic complication that can occur due to accumulation of metformin, a component of this medicinal product.
Croatian: Laktacidoza je vrlo rijetka, ali ozbiljna (s visokom smrtnošću ako se pravodobno ne liječi) metabolička komplikacija koja može nastupiti uslijed nakupljanja metformina, sastavnice ovog lijeka.
English: The effects of smoking, diet, herbal products and alcohol use on the pharmacokinetics of dapagliflozin have not been studied.
Croatian: Nisu ispitani učinci pušenja, prehrane, biljnih preparata i alkohola na farmakokinetiku dapagliflozina.
English: Volume depletion includes, e.g. the predefined preferred terms: dehydration, hypovolaemia, hypotension.
Croatian: eDeplecija volumena uključuje, primjerice, unaprijed određene preferirane pojmove: dehidracija, hipovolemija, hipotenzija.
English: Frequency categories are defined according to the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare
Croatian: Učestalost pojavljivanja definirana je kao: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i
English: Gastrointestinal symptomsi,§
Croatian: Poremećaji probavnog sustava gastrointestinalni simptomii,§
English: Stop taking this medicine immediately and contact a doctor or the nearest hospital straight away.
Croatian: Odmah prestanite uzimati ovaj lijek i javite se svom liječniku ili u najbližu bolnicu.
English: This may induce metformin accumulation which may increase the risk for lactic acidosis.
Croatian: Ovo može prouzrokovati nakupljanje metformina koje može povećati rizik za laktacidozu.
English: 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.
Croatian: Pri uobičajenim dozama i režimima primjene metformina koncentracije u stanju dinamičke ravnoteže u plazmi postižu se unutar 24-48 sati i obično su niže od 1 µg/ml.
English: • if you have a condition called ‘diabetic ketoacidosis', a problem you can get with diabetes.
Croatian: • ako imate ‘dijabetičku ketoacidozu', stanje koje se može javiti kod šećerne bolesti.
English: Polyuria includes the preferred terms: pollakiuria, polyuria, urine output increased.
Croatian: fPoliurija uključuje preferirane pojmove: polakizurija, poliurija, pojačano mokrenje.
English: Gastrointestinal symptoms such as nausea, vomiting, diarrhoea, abdominal pain and loss of appetite occur most frequently during initiation of therapy and resolve spontaneously in most cases.
Croatian: iGastrointestinalni simptomi poput mučnine, povraćanja, proljeva, boli u abdomenu i gubitka teka, najčešće se javljaju na početku liječenja, a u većini se slučajeva spontano povlače.
English: Xigduo should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Croatian: Općenito Xigduo se ne smije primjenjivati u bolesnika sa šećernom bolešću tipa 1 niti za liječenje dijabetičke ketoacidoze.
English: In controlled clinical trials, maximum metformin plasma levels (Cmax) did not exceed 5 μg/ml, even at maximum doses.
Croatian: U kontroliranim kliničkim ispitivanjima vršne vrijednosti metformina u plazmi (Cmax) nisu čak ni pri najvišim dozama prelazile vrijednost od 4 µg/ml.
English: Diagnosis
Croatian: Dijagnoza
English: Diabetic ketoacidosisk Lactic acidosis Vitamin B12 deficiencyh,
Croatian: dijabetička ketoacidozak laktacidoza nedostatak vitamina B12h,§
English: AstraZeneca GmbH Tinsdaler Weg 183 22880 Wedel Germany
Croatian: AstraZeneca GmbH Tinsdaler Weg 183 22880 Wedel
English: If this happens to you, you may need immediate hospital treatment, as lactic acidosis may lead to coma.
Croatian: Ako se ovo dogodi Vama, možda ćete odmah trebati bolničko liječenje budući da laktacidoza može dovesti do kome.
English: 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).
Croatian: Tijekom kliničkih ispitivanja ukupan udio ispitanika sa zloćudnim ili nespecificiranim tumorima bio je podjednak među bolesnicima liječenima dapagliflozinom (1,50%) i onima koji su primali placebo/usporedni lijek (1,50%), a u podacima iz istraživanja na životinjama nije bilo signala za kancerogenost niti mutagenost (vidjeti dio 5.3).
English: They have “5/850” on one side and “1067” on the other side.
Croatian: “5/850” na jednoj i “1067” na drugoj strani.
English: Other medicines and Xigduo Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika, ljekarnika ili medicinsku sestru ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: Urinary tract infections were more frequently reported for dapagliflozin compared with placebo (4.7% versus 3.5%, respectively; see section 4.4).
Croatian: Infekcije mokraćnih putova češće su prijavljene kod primjene dapagliflozina u usporedbi s placebom (4,7% naspram 3,5%; vidjeti dio 4.4).
English: Stop taking Xigduo and contact a doctor straight away if you notice any of the following serious or potentially serious side effects:
Croatian: Prestanite uzimati Xigduo i odmah se javite liječniku ako se pojavi bilo koja od navedenih ozbiljnih ili potencijalno ozbiljnih nuspojava:
English: PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING INNER CARTON - PART OF MULTIPACK - WITHOUT BLUE BOX
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU UNUTARNJA KUTIJA - DIO VIŠESTRUKOG PAKIRANJA - BEZ PLAVOG OKVIRA
English: 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.
Croatian: Incidencija laktacidoze može se i mora smanjiti procjenom ostalih čimbenika rizika poput loše regulirane šećerne bolesti, ketoze, dugotrajnog gladovanja, prekomjerne konzumacije alkohola, insuficijencije jetre i bilo kojeg stanja povezanog s hipoksijom.
English: Xigduo is contraindicated in patients with:
Croatian: 4.3 Kontraindikacije Xigduo je kontraindiciran u bolesnika:
English: Liver function disorders§ Hepatitis§
Croatian: Poremećaji jetre i žuči poremećaji jetrene funkcije hepatitis§
English: Lactic acidosis is characterised by acidotic dyspnoea, abdominal pain and hypothermia followed by coma.
Croatian: Značajke laktacidoze su acidozna dispneja, bol u abdomenu i hipotermija nakon koje slijedi koma.
English: Diagnostic laboratory findings are decreased blood pH, plasma lactate levels above 5 mmol/l, and an increased anion gap and lactate/pyruvate ratio.
Croatian: Dijagnostički laboratorijski nalazi su sniženi pH krvi, razina laktata u plazmi iznad 5 mmol/l te povišen anionski procijep i omjer laktata/piruvata.
English: 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 enrollment.
Croatian: Metformin (oblici sa trenutnim ili produljenim oslobađanjem) ≥1500 mg/dan plus maksimalna podnošljiva doza sulfonilureje, koja mora biti najmanje pola maksimalne doze, tijekom najmanje 8 tjedana prije uključivanja u ispitivanje.
English: Weight decreased**
Croatian: smanjenje tjelesne težine**
English: (95% CI) Subjects (%) achieving: HbA1c < 7% Adjusted for baseline
Croatian: (95% CI) Ispitanici (%) koji su postigli: HbA1c < 7%
English: 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).
Croatian: Poseban oprez potreban je u okolnostima kada može doći do oštećenja bubrežne funkcije, primjerice kada se uvodi liječenje antihipertenzivima ili diureticima, odnosno započinje s primjenom nesteroidnih protuupalnih lijekova
English: PHARMACEUTICAL FORM AND CONTENTS Multipack: 196 (2 packs of 98) film-coated tablets
Croatian: OBLIK I SADRŽAJ Višestruko pakiranje: 196 (2 kutije s 98) filmom obloženih tableta
English: − tablet core: hydroxypropyl cellulose (E463), microcrystalline cellulose (E460(i)), magnesium stearate (E470b), sodium starch glycolate.
Croatian: − jezgra tablete: hidroksipropilceluloza (E463), mikrokristalična celuloza (E460(i)), magnezijev stearat (E470b), natrijev škroboglikolat.
English: Temporary interruption of treatment with this medicinal product is recommended for patients who develop volume depletion until the depletion is corrected (see section 4.8).
Croatian: bolesnika s deplecijom volumena preporučuje se privremeni prekid liječenja ovim lijekom dok se deplecija ne korigira (vidjeti dio 4.8).
English: After administration of a 50 mg [14C]-dapagliflozin dose, 96% was recovered, 75% in urine and 21% in feces.
Croatian: Nakon primjene [14C] dapagliflozina u dozi od 50 mg pronađeno je 96% lijeka, od čega 75% u mokraći i 21%
English: Elderly patients are more likely to have impaired renal function, and/or to be treated with anti-hypertensive medicinal products that may cause changes in renal function such as angiotensin-converting enzyme inhibitors (ACE-I) and angiotensin II type 1 receptor blockers (ARB).
Croatian: Starije osobe (≥ 65 godina) U starijih je bolesnika veća vjerojatnost postojanja oštećenja bubrežne funkcije i/ili liječenja antihipertenzivima koji mogu izmijeniti bubrežnu funkciju, poput inhibitora angiotenzin konvertirajućeg enzima (ACE) te blokatora receptora angiotenzina II tipa 1 (ARB).
English: This glucose excretion (glucuretic effect) is observed after the first dose, is continuous over the 24-hour dosing interval and is sustained for the duration of treatment.
Croatian: (glikozurija) vidljivo nakon prve doze, kontinuirano traje tijekom 24-satnog doznog intervala i održava se za cijelog trajanja liječenja.
English: The efficacy of dapagliflozin, a component of this medicinal product, is dependent on renal function, and efficacy is reduced in patients who have moderate renal impairment and likely absent in patients with severe renal impairment (see section 4.2).
Croatian: Djelotvornost dapagliflozina, sastavnice ovog lijeka, ovisi o bubrežnoj funkciji, pa je tako njegova djelotvornost smanjena u bolesnika s umjerenim oštećenjem bubrežne funkcije, dok će u bolesnika s teškim oštećenjem bubrežne funkcije vjerojatno u potpunosti izostati (vidjeti dio 4.2).
English: Primary episodes occurred at a rate of 1.62% per patient-year in subjects treated with dapagliflozin and 2.06% in comparator-treatment subjects, per patient-year.
Croatian: Stopa primarnih epizoda iznosila je 1,62% na bolesnik-godinu u ispitanika liječenih dapagliflozinom i 2,06% na bolesnik-godinu u ispitanika liječenih usporednim lijekom.
English: Glucocorticoids (given by systemic and local routes), beta-2 agonists, and diuretics have intrinsic hyperglycaemic activity.
Croatian: Kombinacije kod kojih je potreban oprez Glukokortikoidi (primijenjeni sustavno i lokalno), beta-2 agonisti i diuretici sami po sebi djeluju hiperglikemijski.
English: Geometric mean steady-state dapagliflozin Cmax and AUCτ values following once daily 10 mg doses of dapagliflozin were 158 ng/ml and 628 ng h/ml, respectively.
Croatian: Geometrijske srednje vrijednosti Cmax i AUCτ dapagliflozina u stanju dinamičke ravnoteže nakon primjene doza dapagliflozina od 10 mg jedanput na dan iznosile su 158 ng/ml, odnosno 628 ng h/ml.
English: Hepatic impairment This medicinal product must not be used in patients with hepatic impairment (see sections 4.3, 4.4 and
Croatian: Oštećenje jetrene funkcije Ovaj lijek se ne smije primjenjivati u bolesnika s oštećenjem jetrene funkcije (vidjeti dijelove 4.3, 4.4
English: At 24 weeks, reductions in serum uric acid concentrations ranged from -48.3 to -18.3 micromoles/l (-0.87 to -0.33 mg/dl).
Croatian: U 24. tjednu se smanjenje koncentracije mokraćne kiseline u serumu kretalo između -48,3 i -18,3 mikromola/l
English: The signs include rapid weight loss, feeling sick or being sick, stomach pain, fast and deep breathing, sleepiness, a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat.
Croatian: Znakovi uključuju nagli gubitak tjelesne težine, mučninu ili povraćanje bol u želucu, brzo i duboko disanje, pospanost, sladak miris Vašeg daha, sladak ili metalan okus u Vašim ustima ili drugačiji miris Vašeg urina ili znoja.
English: 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.
Croatian: 48 sati nakon kirurškog zahvata ili ponovnog postizanja hranjenja na usta, i to samo onda ako je uspostavljena normalna funkcija bubrega.
English: When Xigduo is used in combination with insulin or an insulin secretagogue such as sulphonylurea, a lower dose of insulin or sulphonylurea may be considered to reduce the risk of hypoglycaemia (see sections 4.5 and 4.8).
Croatian: Xigduo primjenjuje u kombinaciji s inzulinom ili sa inzulinskim sekretagogom poput sulfonilureje, može se razmotriti smanjenje doze inzulina ili sulfonilureje kako bi se smanjio rizik od hipoglikemije (vidjeti dijelove 4.5 i 4.8).