FrancophonIA/ELRC3.0 huggingface dataset:
English: The proportion of patients achieving HbA1c < 7% was 47.9% with immediate-release exenatide and 42.8% with insulin lispro.
Croatian: Postotak bolesnika koji su ostvarili HbA1c < 7% bio je 47,9% sa eksenatidom s trenutnim oslobađanjem te 42,8% sa inzulinom lispro.
English: When immediate-release exenatide is added to sulphonylurea therapy, a reduction in the dose of sulphonylurea should be considered to reduce the risk of hypoglycaemia (see section 4.4.).
Croatian: Kada se eksenatid s trenutnim oslobađanjem dodaje terapiji sulfonilurejom, treba razmotriti smanjenje doze sulfonilureje kako bi se smanjio rizik od hipoglikemije (vidjeti dio 4.4).
English: In female rats given exenatide for 2 years, an increased incidence of benign thyroid C-cell adenomas was observed at the highest dose, 250 mcg/kg/day, a dose that produced an exenatide plasma exposure 130-fold the human clinical exposure.
Croatian: U ženki štakora koje su primale eksenatid tijekom 2 godine opažena je povećana incidencija benignih adenoma C-stanica štitnjače pri najvećoj dozi od 250 µg/kg na dan, koja je proizvela izloženost eksenatidu u plazmi 130 puta veću od kliničke izloženosti u ljudi.
English: Since immediate-release exenatide has been marketed, acute pancreatitis has been reported with a frequency not known and acute renal failure has been reported uncommonly (see section 4.4).
Croatian: Nakon stavljanja eksenatida s trenutnim oslobađanjem u promet, prijavljen je akutni pankreatitis uz nepoznatu učestalost i akutno zatajenje bubrega prijavljeno je manje često (vidjeti dio 4.4).
English: Administration of a combination oral contraceptive (30 mcg ethinyl estradiol plus 150 mcg levonorgestrel) one hour before immediate-release exenatide (10 mcg BID) did not alter the AUC, Cmax or Cmin of either ethinyl estradiol or levonorgestrel.
Croatian: Primjena kombiniranog oralnog kontraceptiva (30 µg etinilestradiola i 150 µg levenorgestrela) sat vremena prije eksenatida s trenutnim oslobađanjem (10 µg dvaput na dan) nije promijenila AUC, Cmax i Cmin ni etinilestradiola ni levonorgestrela.
English: The incidence and type of other adverse events observed were similar to those seen in the 30-week controlled clinical trials with a sulphonylurea, metformin or both.
Croatian: Incidencija i vrsta drugih opaženih štetnih događaja bile su slične onima u 30-tjednim kontroliranim kliničkim ispitivanjima sa sulfonilurejom, metforminom odnosno kombinacijom tih dvaju lijekova.
English: • To prevent this, for your next dose, firmly push and hold the injection button in and slowly count to 5 (see Section 3, Step 4: Inject the Dose).
Croatian: • Da biste to spriječili, kod primjene sljedeće doze čvrsto pritisnite i držite gumb za injiciranje te polako brojite do 5 (pogledajte Dio 3., Korak 4.: Injicirajte dozu).
English: INR should be closely monitored during initiation and dose increase of immediate-release exenatide therapy in patients on warfarin and/or cumarol derivatives (see section 4.8).
Croatian: Treba pomno kontrolirati vrijednosti INR-a tijekom započinjanja terapije kao i pri povećanju eksenatida s trenutnim oslobađanjem u bolesnika koji se liječe varfarinom i/ili derivatima kumarola (vidjeti dio 4.8).
English: • Grip pen firmly.
Croatian: • Čvrsto uhvatite brizgalicu.
English: Set up your new pen just before you use it for the first time.
Croatian: Podesite novu brizgalicu neposredno prije prve uporabe.
English: Weight loss of 2.3 kg (2.6%) was achieved with immediate-release exenatide in the 26-week study and a loss of 2.5 kg (2.7%) in a 52-week study whereas treatment with insulin was associated with weight gain.
Croatian: Eksenatidom s trenutnim oslobađanjem postignut je gubitak tjelesne težine od 2,3 kg (2,6%) u 26-tjednom ispitivanju odnosno 2,5 kg (2,7%) u 52-tjednom ispitivanju, dok je liječenje inzulinom bilo udruženo s povećanjem težine.
English: A pharmacodynamic study demonstrated in patients with type 2 diabetes (n=13) a restoration of first phase insulin secretion and improved second phase insulin secretion in response to an intravenous bolus of glucose.
Croatian: Farmakodinamičko ispitivanje pokazalo je da se u bolesnika sa šećernom bolešću tipa 2 (n=13) kao odgovor na intravenski bolus glukoze ponovno uspostavlja prva faza lučenja inzulina te poboljšava druga faza lučenja inzulina.
English: Byetta is also indicated as adjunctive therapy to basal insulin with or without metformin and/or pioglitazone in adults who have not achieved adequate glycaemic control with these medicinal products.
Croatian: Byetta je indicirana i kao dopuna terapiji bazalnim inzulinom sa ili bez metformina i/ili pioglitazona u odraslih bolesnika u kojih glikemija nije dovoljno dobro regulirana navedenim lijekovima.
English: In patients at increased risk of hypoglycaemia reducing the dose of basal insulin should be considered (see section 4.8).
Croatian: U bolesnika s povećanim rizikom od hipoglikemije potrebno je razmotriti smanjenje doze bazalnog inzulina (vidjeti dio 4.8).
English: Your Byetta pen is suitable for use with Becton, Dickinson and Company pen injection needles.
Croatian: Vaša Byetta brizgalica prikladna je za uporabu s iglama za brizgalicu proizvođača Becton, Dickinson and Company.
English: NN:
Croatian: Napomena:
English: Follow the New Pen Setup only once.
Croatian: Slijedite upute u dijelu Podešavanje nove brizgalice samo jedanput.
English: Immediate-release exenatide is not expected to have any clinically relevant effects on the pharmacokinetics of metformin or sulphonylureas.
Croatian: Ne očekuju se klinički značajni učinci eksenatida s trenutnim oslobađanjem na farmakokinetiku metformina ni sulfeonilureje.
English: Byetta contains the active substance exenatide.
Croatian: Byetta sadrži djelatnu tvar eksenatid.
English: • Mark the date when you first used your pen and the date 30 days later in the spaces below:
Croatian: • U dolje navedena polja upišite datum prve uporabe brizgalice te datum 30 dana nakon toga:
English: Immediate-release exenatide reduced HbA1c and body weight in patients treated for 30 weeks in three placebo-controlled studies, whether the immediate-release exenatide was added to metformin, a sulphonylurea or a combination of both.
Croatian: Eksenatid s trenutnim oslobađanjem je snizio vrijednosti HbA1c i tjelesnu težinu u bolesnika liječenih tijekom 30 tjedana u tri placebom kontrolirana ispitivanja, neovisno o tome je li eksenatid s trenutnim oslobađanjem bio dodan metforminu, sulfonilureji ili kombinaciji tih dvaju lijekova.
English: Hypoglycaemia was reported in 11% and 7% of patients treated with exenatide and placebo respectively.
Croatian: Hipoglikemija je prijavljena u 11% bolesnika liječenih eksenatidom te 7% onih koji su primali placebo.
English: - If you have severe kidney disease or you are on dialysis, as the use of this medicine is not recommended.
Croatian: - Ako imate tešku bolest bubrega ili se liječite dijalizom, primjena ovog lijeka se ne preporučuje.
English: The effect of immediate-release exenatide to slow gastric emptying may reduce the extent and rate of absorption of orally administered medicinal products.
Croatian: Učinak eksenatida s trenutnim oslobađanjem na usporavanje pražnjenja želuca može smanjiti opseg i brzinu apsorpcije peroralno primijenjenih lijekova.
English: 6.6 Special precautions for disposal and other handling.
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom
English: No pharmacokinetic study has been performed in patients with hepatic insufficiency.
Croatian: Nisu provedena farmakokinetička ispitivanja u bolesnika s oštećenjem jetre.
English: Use this medicine at any time within the 60 minutes (1 hour) before your meal.
Croatian: Primijenite ovaj lijek bilo kada unutar 60 minuta (1 sat) prije obroka. (Vidjeti dio 3 „Kako primjenjivati lijek Byetta“).
English: 5 mcg: Each pre-filled pen contains 60 doses (approximately 1.2 ml of solution).
Croatian: 5 µg: Jedna napunjena brizgalica sadrži 60 doza (približno 1,2 ml otopine).
English: Anaphylactic reaction Metabolism and nutrition disorders Hypoglycaemia (with metformin and a sulphonylurea) Hypoglycaemia (with a sulphonylurea) Decreased appetite Dehydration, generally associated with nausea, vomiting and/or diarrhoea.
Croatian: Poremećaji imunološkog sustava anafilaktička reakcija Poremećaji metabolizma i prehrane hipoglikemija (s metforminom i sulfonilurejom) hipoglikemija (sa sulfonilurejom) smanjen tek dehidracija, u pravilu povezana s mučninom, povraćanjem i/ili proljevom
English: A trend for a decrease in triglycerides has been observed with weight loss.
Croatian: Uz gubitak tjelesne težine primijećen je trend opadanja vrijednosti triglicerida.
English: Immediate-release exenatide use can be continued when a basal insulin is added to existing therapy.
Croatian: S primjenom eksenatida s trenutnim oslobađanjem može se nastaviti i nakon što se postojećoj terapiji pridoda bazalni inzulin.
English: No adjustment to paracetamol dosing is required based on these study results.
Croatian: Na temelju rezultata ovog ispitivanja nije potrebno prilagođavati doziranje paracetamola.
English: • flatulence (passing gas)
Croatian: • plinovi (vjetrovi)
English: Premeal blood glucose concentrations were generally lower in patients taking insulin compared to immediate-release exenatide.
Croatian: Koncentracije glukoze u krvi prije obroka bile su općenito niže u bolesnika koji su primali inzulin u odnosu na one koji su primali eksenatid s trenutnim oslobađanjem.
English: Note: If you cannot turn the dose knob, or if your pen leaks, your full dose has not been delivered.
Croatian: Napomena: Ako ne možete okrenuti gumb za doziranje, ili lijek istječe iz brizgalice, to znači da niste primijenili čitavu dozu.
English: WHAT YOU NEED TO KNOW ABOUT YOUR BYETTA PEN
Croatian: - Što trebate znati o svojoj Byetta brizgalici.
English: Of the immediate-release exenatide patients, 12% were treated with a thiazolidinedione and immediate-release exenatide and 82% were treated with a thiazolidinedione, metformin and immediate-release exenatide.
Croatian: Među bolesnicima koji su primali eksenatid s trenutnim oslobađanjem, 12% ih je bilo liječeno tiazolidindionom i eksenatidom s trenutnim oslobađanjem, a njih 82% tiazolidindionom, metforminom i eksenatidom s trenutnim oslobađanjem.
English: Injection Button
Croatian: Gumb za injiciranje
English: For oral medicinal products that are particularly dependent on threshold concentrations for efficacy, such as antibiotics, patients should be advised to take those medicinal products at least 1 hour before immediate-release exenatide injection.
Croatian: Bolesnike treba upozoriti da peroralne lijekove čija djelotvornost jako ovisi o graničnim koncentracijama, poput antibiotika, uzimaju najmanje 1 sat prije injekcije eksenatida s trenutnim oslobađanjem
English: In clinical trials, background therapies included metformin, a sulphonylurea, a thiazolidinedione, or a combination of oral glucose-lowering medicinal products.
Croatian: U kliničkim ispitivanjima, osnovna terapija uključivala je metformin, sulfonilureju, tiazolidindion ili kombinaciju oralnih lijekova za snižavanje glukoze u krvi.
English: The instructions for using the pen, included with the leaflet, must be followed carefully.
Croatian: Moraju se pažljivo slijediti upute za uporabu brizgalice, koje su priložene uz Uputu o lijeku.
English: Do not use this medicine if you notice particles in the solution, or if it is cloudy or coloured.
Croatian: Ovaj lijek se ne smije upotrijebiti ako su u otopini vidljive čestice ili je otopina zamućena ili obojena.
English: In patients where existing therapy also included a sulphonylurea the incidence of patients with at least one minor hypoglycaemic episode was 48% and 54% respectively and one patient reported major hypoglycaemia.
Croatian: U bolesnika čija je postojeća terapija obuhvaćala i sulfonilureju incidencija bolesnika u kojih se javila barem jedna epizoda blage hipoglikemije bila je 48% odnosno 54%, a jedan je bolesnik prijavio izrazitu hipoglikemiju.
English: Exenatide slows gastric emptying thereby reducing the rate at which meal-derived glucose appears in the circulation.
Croatian: Eksenatid usporava pražnjenje želuca te na taj način smanjuje brzinu kojom se glukoza iz hrane pojavljuje u krvotoku.
English: One to deliver doses of 5micrograms and one 10micrograms.
Croatian: Jednom se primjenjuju doze od 5 mikrograma, a drugom doze od 10 mikrograma.
English: • Pull the dose knob out until appears.
Croatian: • Izvlačite gumb za doziranje dok se ne pojavi
English: This treatment effect was comparable to that of insulin glargine in a 26-week study (mean insulin dose 24.9 IU/day, range 4-95 IU/day, at the end of study) and biphasic insulin aspart in a 52-week study (mean insulin dose 24.4
Croatian: Ovaj učinak liječenja usporediv je s onim inzulina glargina u 26-tjednom ispitivanju (prosječna doza inzulina 24,9 IU/dan, raspon 4-95 IU/dan, na kraju ispitivanja) odnosno s učinkom aspart inzulina u 52-tjednom ispitivanju (prosječna doza inzulina 24,4 IU/dan, raspon 3-78 IU/dan, na kraju ispitivanja).
English: • For your next dose, be sure to firmly push and hold the injection button in and slowly count to 5 before removing needle from skin.
Croatian: • Kod sljedeće doze, pazite da čvrsto pritisnete i držite pritisnutim gumb za injiciranje te polako izbrojite do 5 prije nego što iglu izvadite iz kože.
English: - Firmly push the injection button in all the way until it stops.
Croatian: Čvrsto pritisnite gumb za injiciranje do kraja, dok se ne zaustavi.
English: In a single-dose pharmacokinetic study in 13 patients with type 2 diabetes and between the ages of 12 and 16 years, administration of exenatide (5 mcg) resulted in slightly lower mean AUC (16% lower) and Cmax (25% lower) compared to those observed in adults.
Croatian: U farmakokinetičkom ispitivanju s primjenom jedne doze eksenatida dvaput na dan u 13 bolesnika sa šećernom bolešću tipa 2 u dobi između 12 i 16 godina, primjena eksenatida (5 µg) rezultirala je nešto nižim prosječnim vrijednostima AUC-a (16% niže) i Cmax (25% niže) u odnosu na vrijednosti zabilježene u odraslih.
English: Its use is commonly associated with gastrointestinal adverse reactions, including nausea, vomiting, and diarrhoea.
Croatian: Primjena ovog lijeka često je povezana s gastrointestinalnim nuspojavama, uključujući mučninu, povraćanje i proljev.
English: In the clinical studies patients on a sulphonylurea combination, with mild renal impairment had an increased incidence of hypoglycaemia compared to patients with normal renal function.
Croatian: U kliničkim ispitivanjima su ispitanici s blagim oštećenjem bubrega koji su primali kombinaciju sa sulfonilurejom imali povećanu incidenciju hipoglikemije u usporedbi s bolesnicima s normalnom bubrežnom funkcijom.
English: • Use a Byettapen for only 30 days after setting up a new pen for first use.
Croatian: • Koristite Byetta brizgalicu samo 30 dana nakon što ste novu brizgalicu podesili za prvo korištenje.
English: Immediate-release exenatide lowered HbA1c from 8.21 (n=228) and 8.6% (n=222) by 1.13 and 1.01% while insulin glargine lowered from 8.24 (n=227) by 1.10% and biphasic insulin aspart from 8.67 (n=224) by 0.86%.
Croatian: Eksenatid s trenutnim oslobađanjem je snizio vrijednosti HbA1c s 8,21% (n=228) odnosno 8,6% (n=222) za 1,13% odnosno 1,01%, inzulin glargin ga je snizio s 8,24% (n=227) za 1,10%, a bifazični aspart inzulin s 8,67% (n=224) za 0,86%.
English: If you use this medicine in combination with a sulphonylurea or insulin, low blood sugar (hypoglycaemia) can occur.
Croatian: Ako primjenjujete ovaj lijek u kombinaciji sa sulfonilurejom ili inzulinom, može doći do sniženja razine šećera u krvi (hipoglikemije).
English: - Each millilitre (ml) of the solution for injection contains 0.25 milligrams (mg) of exenatide.
Croatian: - Jedan mililitar (ml) otopine za injekciju sadrži 0,25 miligrama (mg) eksenatida.
English: See Commonly Asked Questions, numbers 5 and 9, in Section 4 of this user manual.
Croatian: Pogledajte dio Česta pitanja, pitanja broj 5. i 9., u Dijelu 4. ovih Uputa za uporabu.
English: In these studies the incidence of hypoglycaemia was similar for immediate-release exenatide and insulin treatment.
Croatian: U ovim je ispitivanjima incidencija hipoglikemije bila podjednaka kod liječenja eksenatidom s trenutnim oslobađanjem i inzulinom.
English: Similar exposure is achieved with subcutaneous administration of exenatide in the abdomen, thigh, or arm.
Croatian: Podjednaka se izloženost postiže primjenom eksenatida u abdomen, bedro ili ruku.
English: Clinical studies with immediate-release exenatide have indicated improved beta-cell function, using measures such as the homeostasis model assessment for beta-cell function (HOMA-B) and the proinsulin to insulin ratio.
Croatian: Klinička ispitivanja eksenatida s trenutnim oslobađanjem ukazala su na poboljšanje funkcije beta stanica, koristeći mjere kao što je procjena modela homeostaze (engl.
English: How do I clean my Byetta pen?
Croatian: Kako trebam čistiti Byetta brizgalicu?
English: Once in use: Store below 25 ºC for 30 days.
Croatian: Nakon prve uporabe: Čuvati na temperaturi ispod 25 ºC najdulje 30 dana.
English: Mean daily blood glucose values were similar between immediate-release exenatide and insulin.
Croatian: Prosječne dnevne vrijednosti glukoze u krvi bile su slične kod primjene eksenatida s trenutnim oslobađanjem i inzulina.
English: When this medicine is used with a medicine that contains a sulphonylurea or an insulin, episodes of low blood sugar (hypoglycaemia, generally mild to moderate) can occur very commonly.
Croatian: Kada se ovaj lijek primjenjuje s lijekovima koji sadrže sulfonilureju ili inzulin, vrlo često može doći do pojave niske razine šećera u krvi (hipoglikemija, uglavnom blaga do umjerena).
English: Note: If you do not see liquid after 4 times, see Commonly Asked Questions, number 3, in Section 4 of this user manual.
Croatian: Napomena: Ako ne vidite tekućinu nakon 4 pokušaja, pogledajte dio Česta pitanja, pitanje broj 3., u Dijelu 4. ovih Uputa za uporabu.
English: The immediate-release exenatide arm compared to placebo had significantly lowered postprandial blood glucose excursions at the morning meal (- 2.0 versus0.2 mmol/l) and evening meal (- 1.6 versus + 0.1 mmol/l), there was no difference between treatments at midday.
Croatian: U skupini liječenoj eksenatidom s trenutnim oslobađanjem , u usporedbi sa skupinom koja je primala placebo, ispitanici su imali značajno manje postprandijalne skokove glukoze u krvi nakon jutarnjeg (-2,0 naspram -0,2 mmol/l) i večernjeg obroka (-1,6 naspram +0,1 mmol/l), dok nije bilo razlika između terapija u podnevnom obroku.
English: Warnings and precautions Talk to your doctor, pharmacist, or diabetes nurse before using Byetta about the following: - Using this medicinein combination with a sulphonylurea, as low blood sugar (hypoglycaemia) can occur.
Croatian: Prije primjene lijeka Byetta, obratite se svom liječniku, ljekarniku ili medicinskoj sestri u dijabetološkoj ambulanti u vezi sljedećeg: - Primjena ovog lijeka u kombinaciji sa sulfonilurejom jer može doći do sniženja razine šećera u krvi (hipoglikemije).
English: Byetta 10 mcg: Each dose contains 88 mcg metacresol.
Croatian: Byetta 10 µg: Jedna doza sadrži 88 µg metakrezola.
English: This medicine should not be used if breast-feeding.
Croatian: Ovaj lijek se ne smije koristiti ako dojite.
English: Once in use, keep your pen below 25 ºC for 30 days.
Croatian: Nakon prve uporabe, čuvajte brizgalicu na temperaturi ispod 25°C najdulje 30 dana.
English: Byetta 5 mcg: Each dose contains 44 mcg metacresol.
Croatian: Byetta 5 µg: Jedna doza sadrži 44 µg metakrezola.
English: When immediate-release exenatide was used in combination with basal insulin therapy the incidence and types of other adverse events observed were similar to those seen in the controlled clinical trials with exenatide as monotherapy, with metformin and/or sulphonylurea or a thiazolidinedione, with or without metformin.
Croatian: Kod primjene eksenatida s trenutnim oslobađanjem u kombinaciji s terapijom bazalnim inzulinom, incidencija i vrste drugih primijećenih nuspojava bile su slične onima opaženima tijekom kontroliranih ispitivanja eksenatida u monoterapiji, u kombinaciji s metforminom i/ili sulfonilurejom, odnosno tiazolidindionom s metforminom ili bez njega.
English: Doses higher than 10 mcg BID are not recommended.
Croatian: Ne preporučuju se doze veće od 10 µg dvaput na dan.
English: 10 mcg: Each pre-filled pen contains 60 doses (approximately 2.4 ml of solution).
Croatian: 10 µg: Jedna napunjena brizgalica sadrži 60 doza (približno 2,4 ml otopine).
English: What you need to know before you use Byetta
Croatian: Što morate znati prije nego počnete primjenjivati lijek Byetta:
English: See Commonly Asked Question 4.
Croatian: Pogledajte Česta pitanja u Dijelu 4.
English: • Remove the needle by carefully putting the outer needle shield back over the needle.
Croatian: • Skinite iglu tako da pažljivo vratite vanjski štitnik na iglu.
English: Exenatide suppresses glucagon secretion which is known to be inappropriately elevated in type 2 diabetes.
Croatian: Eksenatid potiskuje lučenje glukagona, koje je neprimjereno povećano u bolesnika sa šećernom bolešću tipa
English: • Do not use Byettaafter the expiry date, which is stated on the label and the carton after ‘EXP'.
Croatian: • Byetta se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i pakiranju iza oznake „EXP“.
English: A delay in tmax of about 2 h was observed when digoxin, lisinopril or warfarin was administered 30 min after exenatide.
Croatian: Kada su se digoksin, lizinopril ili varfarin davali 30 minuta nakon eksenatida, primijećena je odgoda tmax od približno 2 sata.
English: Weight loss of 2.6 kg from a baseline of 89.9 kg was observed with immediate-release exenatide whereas a weight gain of 1.9 kg from a baseline of 89.3 kg was observed with insulin lispro.
Croatian: Gubitak tjelesne težine od 2,6 kg od početne vrijedosti od 89,9 kg zapažen je sa eksenatidom s trenutnim oslobađanjem dok je dobivanje na tjelesnoj težini od 1,9 kg od početne vrijedosti od 89,3 kg zapaženo kod inzulina lispro.
English: • Use thumb to firmly push injection button in until it stops, then continue holding the injection button in while slowly counting to 5 in order to get a full dose.
Croatian: • Palcem čvrsto pritisnite gumb za injiciranje dok se ne zaustavi, a zatim nastavite držati gumb za injiciranje pritisnutim dok polako brojite do 5 kako biste primili cijelu dozu.
English: If the needle is left on, medicine may leak from the Byetta pen or air bubbles may form in the cartridge.
Croatian: Ako igla ostane na brizgalici, lijek može istjecati iz Byetta brizgalice ili se u ulošku mogu stvoriti mjehurići zraka.
English: In insulin-comparator studies immediate-release exenatide (5 mcg BID for 4 weeks, followed by 10 mcg BID) in combination with metformin and sulphonylurea significantly (statistically and clinically) improved glycaemic control, as measured by decrease in HbA1c.
Croatian: U ispitivanjima s inzulinom kao usporednim lijekom, eksenatid s trenutnim oslobađanjem (u dozi od 5 µg dvaput na dan tijekom 4 tjedna, a zatim 10 µg dvaput na dan) u kombinaciji s metforminom i sulfonilurejom značajno je (statistički i klinički) poboljšao kontrolu glikemije, mjereno sniženjem HbA1c.
English: Exenatide is not recommended for use in patients with end-stage renal disease or severe renal impairment (creatinine clearance < 30 ml/min) (see section 4.4).
Croatian: Ne preporučuje se primjena eksenatida u bolesnika u terminalnom stadiju bubrežne bolesti niti u bolesnika s teškim oštećenjem bubrežne funkcije (klirens kreatinina < 30 ml/min) (vidjeti dio 4.4).
English: - Each dose of Byetta 5 micrograms solution for injection (injection) contains 5 micrograms exenatide in 20 microlitre.
Croatian: - Jedna doza Byetta 5 mikrograma otopine za injekciju (injekcija) sadrži 5 mikrograma eksenatida u 20 mikrolitara.
English: Do not use Byetta:
Croatian: Nemojte primjenjivati lijek Byetta