FrancophonIA/ELRC3.0 huggingface dataset:
English: No clinically relevant effects on the pharmacokinetics of R-and S- enantiomers of warfarin were observed when a single dose of racemic warfarin (25 mg) was administered with steady-state albiglutide (50 mg weekly).
Croatian: Nisu primijećeni klinički relevantni učinci na farmakokinetiku R- i S-enantiomera varfarina kada je jedna doza racemičnog varfarina (25 mg) primijenjena uz albiglutid u stanju dinamičke ravnoteže
English: As albiglutide is an albumin fusion molecule, plasma protein binding has not been assessed.
Croatian: Budući da je albiglutid molekula spojena s albuminom (fuzijska molekula), nije ispitivano njegovo vezanje za proteine u plazmi.
English: How to take Eperzan
Croatian: Kako primjenjivati Eperzan
English: The model-adjusted mean decrease in HbA1c from baseline with Eperzan was -0.80 (n = 125), -0.83 (n = 98), and -1.08 (n = 19) in patients with mild (eGFR 60 to 89 ml/min/1.73m2), moderate (eGFR 30 to 59 ml/min/1.73m2), and severe (eGFR <30 ml/min/1.73m2) renal impairment, respectively (see Table 9).
Croatian: Za model prilagođeno srednje smanjenje vrijednosti HbA1c od početne vrijednosti kod primjene lijeka Eperzan iznosilo je -0,80 (n = 125) u bolesnika s blagim oštećenjem (eGFR 60-89 ml/min/1,73 m2), -0,83 (n = 98) u bolesnika s umjerenim oštećenjem (eGFR 30-59 ml/min/1,73 m2), odnosno -1,08 (n = 19) u bolesnika s teškim oštećenjem bubrežne funkcije (eGFR <30 ml/min/1,73 m2) (vidjeti Tablicu 9).
English: You should not take acarbose if you suffer from bowel obstruction.
Croatian: Ne smijete uzimati akarbozu ako imate blokadu crijeva.
English: 6.6 Special precautions for disposal and other handling
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Zbrinjavanje
English: The adjusted mean change in body weight from baseline at 104 weeks was -2.6 kg for Eperzan (N = 184) and +1.4 kg for insulin glargine (N = 104).
Croatian: Prilagođena srednja promjena tjelesne težine nakon 104 tjedna u odnosu na početnu vrijednost iznosila je -2,6 kg za Eperzan (N = 184) i +1,4 kg za inzulin glargin (N = 104).
English: Pens are supplied in packs of 4 pens and 4 needles and multipacks comprising 3 packs, each containing 4 pens and 4 needles.
Croatian: Brizgalice dolaze u pakiranjima s 4 brizgalice i 4 igle te u višestrukom pakiranju koji se sastoji od 3 pakiranja, od kojih svaki sadrži 4 brizgalice i 4 igle.
English: The white injection button will also pop out from the bottom of the pen.
Croatian: Iz donjega dijela brizgalice tada će iskočiti bijelo dugme za injiciranje.
English: However, if you take Eperzan with sulphonylurea or insulin, you may get low blood sugar (hypoglycaemia).
Croatian: Međutim, ako Eperzan primjenjujete sa sulfonilurejom ili inzulinom, može Vam pasti razina šećera u krvi (hipoglikemija).
English: No effects were seen at 5 mg/kg/day (at exposures similar to clinical exposure).
Croatian: Pri dozi od 5 mg/kg na dan (izloženost slična kliničkoj izloženosti) nisu primijećeni nikakvi učinci.
English: A decision should be made whether to discontinue breast-feeding or to discontinue therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the mother.
Croatian: Uzimajući u obzir korist dojenja za dijete i dobrobit liječenja za majku, mora se donijeti odluka hoće li se prekinuti dojenje ili obustaviti liječenje.
English: Add-on to metformin
Croatian: Dodatak metforminu
English: Following SC administration of a single 30 mg dose to subjects with type 2 diabetes, maximum concentrations were reached 3 to 5 days post dose with mean peak albiglutide concentration (Cmax) of 1.74 mcg/ml and mean area under the time-concentration curve (AUC) of 465 mcg.h/ml.
Croatian: Apsorpcija Nakon supkutane primjene jedne doze od 30 mg u ispitanika sa šećernom bolešću tipa 2, maksimalne koncentracije postignute su 3 do 5 dana nakon primjene doze, pri čemu je srednja vršna koncentracija albiglutida (Cmax) iznosila 1,74 µg/ml, a srednja vrijednost površine ispod krivulje koncentracija vrijeme (AUC) 465 µg.h/ml.
English: • low blood sugar (hypoglycaemia) when you use Eperzan in combination with insulin or sulphonylurea.
Croatian: • niska razina šećera u krvi (hipoglikemija) kada primjenjujete Eperzan u kombinaciji s inzulinom ili sulfonilurejom.
English: Albiglutide is an agonist of the GLP-1 receptor and augments glucose-dependent insulin secretion.
Croatian: Mehanizam djelovanja Albiglutid je agonist GLP-1 receptora koji pojačava izlučivanje inzulina ovisno o glukozi.
English: In patients who completed the study (52 weeks), the adjusted mean change in baseline in HbA1c was -1.0% for Eperzan (N = 121) and -0.9% for insulin lispro (N = 141).
Croatian: U bolesnika koji su dovršili ispitivanje (52 tjedna), prilagođena srednja promjena HbA1c od početne vrijednosti iznosila je -1,0% za Eperzan (N = 121) i -0,9% za inzulin lispro (N = 141).
English: This medicinal product contains less than 1 mmol sodium (23 mg) per 0.5 ml dose, i.e. essentially “sodiumfree”.
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po dozi od 0,5 ml, tj. zanemarive količine natrija.
English: In pre- and postnatal development studies in mice administered albiglutide during pregnancy or while nursing, reduced pre-weaning body weight of F1 offspring was observed at 1 mg/kg/day (at exposures below clinical exposure).
Croatian: U ispitivanjima prenatalnog i postnatalnog razvoja u kojima su ženke miševa primale albiglutid tijekom skotnosti ili laktacije, primijećena je smanjena tjelesna težina mladunčadi prve filijalne generacije (F1) prije početka sisanja kod primjene doza od ≥1 mg/kg na dan (izloženost manja od kliničke izloženosti).
English: 3 Place pen into cup with clear cartridge pointing up (Figure I).
Croatian: 3 Stavite brizgalicu u čašu tako da prozirni uložak bude usmjeren prema gore (slika I).
English: Adverse reactions reported from a pooled analysis of seven placebo- and active-controlled phase III studies over the entire treatment period are presented in Table 1.
Croatian: U Tablici 1 navode se nuspojave iz objedinjene analize sedam ispitivanja faze III kontroliranih placebom i aktivnim lijekom koje su prijavljivane tijekom čitavog razdoblja liječenja.
English: Caution should be exercised in patients with a history of pancreatitis.
Croatian: Potreban je oprez u bolesnika koji imaju pankreatitis u anamnezi.
English: At 26 weeks, the between-treatment difference in HbA1c of 0.2% for Eperzan and insulin lispro met the pre-specified noninferiority margin (0.4%).
Croatian: Nakon 26 tjedana, razlika u vrijednosti HbA1c između liječenja lijekom Eperzan i liječenja inzulinom lispro od 0,2% postigla je unaprijed određenu graničnu vrijednost neinferiornosti (0,4%).
English: Also contains: Sodium dihydrogen phosphate monohydrate, disodium phosphate, anhydrous, trehalose dihydrate, mannitol (E421), polysorbate 80, water for injections
Croatian: Također sadrži: natrijev dihidrogenfosfat hidrat, natrijev hidrogenfosfat bezvodni, trehalozu dihidrat, manitol (E421), polisorbat 80, vodu za injekcije
English: Offspring of mice dosed with 50 mg/kg/day during organogenesis had reduced weight during the pre-weaning period (which recovered after weaning), dehydration and coldness, and a delay in balanopreputial separation.
Croatian: U mladunčadi ženki miševa koje su primale doze od 50 mg/kg na dan tijekom organogeneze primijećeni su smanjena tjelesna težina prije prekida sisanja (tjelesna težina vratila se u normalu nakon prekida sisanja), dehidracija i hladnoća te zakašnjelo odvajanje glansa i prepucija.
English: What if I leave my pen for more than 15 minutes after turning the pen to the Number 2 (Step
Croatian: Što ako ostavim brizgalicu dulje od 15 minuta nakon što je okrenem na broj 2 (2. korak)?
English: Your doctor may need to change your dose of these other medicines to reduce this risk.
Croatian: Liječnik će možda morati promijeniti dozu tih drugih lijekova kako bi smanjio ovaj rizik. (Pogledajte 'Vrlo česte nuspojave' u dijelu 4. za znakove niske razine šećera u krvi).
English: Follow instructions to twist the cartridge until ‘2' appears in the number window and a “click” is heard.
Croatian: Slijedite upute kako biste zavrnuli uložak sve dok se u prozorčiću za prikaz brojeva ne prikaže broj ‘2' i dok ne čujete
English: Other blood glucose lowering drugs excl. insulins.
Croatian: Ostali lijekovi za sniženje glukoze u krvi izuzev inzulina.
English: 5b Push needle straight down onto the clear cartridge until you hear a “click” and feel the needle “snap” into place.
Croatian: 5b Iglu čvrsto nataknite ravno na prozirni uložak sve dok ne čujete ‘klik' i osjetite da je igla ‘sjela' na svoje mjesto.
English: This can result in particles floating in the clear cartridge, not getting your full dose, or a blocked needle.
Croatian: To može dovesti do pojave čestica u prozirnom ulošku, isporuke samo dijela doze ili začepljenja igle.
English: The median daily dose of insulin glargine used prior to hyperglycaemic rescue was 10 units (range 2 to 40 units) at study start and 30 units (range 3 to 230 units) at Week 52.
Croatian: Medijan dnevne doze inzulina glargina primijenjenog prije uporabe lijekova za hitno ublažavanje hiperglikemije iznosio je 10 jedinica (raspon: 2 do 40 jedinica) na početku ispitivanja te 30 jedinica (raspon 3 do 230 jedinica)
English: For shelf life of the reconstituted product, see section 6.3.
Croatian: Za rok valjanosti rekonstituiranog lijeka vidjeti dio 6.3.
English: Water for injections
Croatian: Otapalo: voda za injekcije
English: There are no adequate data to support the use of Eperzan during breast-feeding in humans.
Croatian: Dojenje Nema odgovarajućih podataka koji bi podupirali primjenu lijeka Eperzan tijekom dojenja u ljudi.
English: Read all of this leaflet carefully before you start taking this medicine, as well as all the instructions including the Pen Storage and Important Warnings.
Croatian: Pažljivo pročitajte sve upute prije primjene ovog lijeka, uključujući odlomke ‘Čuvanje brizgalice' i
English: If it is more than 3 days since you missed your dose, wait until your usually scheduled day for your next injection.
Croatian: Ako je od propuštene doze prošlo više od 3 dana, pričekajte i primijenite sljedeću dozu prema uobičajenom rasporedu.
English: A single dose of simvastatin (80 mg) was administered with steady-state albiglutide (50 mg weekly).
Croatian: Jedna doza simvastatina (80 mg) primijenjena je uz albiglutid u stanju dinamičke ravnoteže (50 mg tjedno).
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection 4 pens
Croatian: OBLIK I SADRŽAJ Prašak i otapalo za otopinu za injekciju 4 brizgalice
English: In addition, albiglutide did not significantly alter the pharmacodynamic effects of warfarin as measured by the international normalized ratio.
Croatian: Osim toga, albiglutid nije značajno izmijenio farmakokinetičke učinke varfarina,
English: Rock Pen Again
Croatian: Ponovno njišite brizgalicu
English: 2a Hold pen body with clear cartridge pointing up so that you can see the [1] in the window.
Croatian: Korak 2 Pomiješajte lijek 2a Držite tijelo brizgalice s prozirnim uloškom usmjerenim prema gore tako da možete vidjeti broj [1] u prozorčiću.
English: DO NOT attach by screwing the needle on
Croatian: NEMOJTE pričvrstiti iglu navijanjem na brizgalicu
English: 6a With needle pointing up, gently tap the clear cartridge 2-3 times to bring large air bubbles to the top (Figure N).
Croatian: 6a S iglom usmjerenom prema gore, prstima 2 - 3 puta nježno lupnite po prozirnom ulošku kako biste velike mjehuriće zraka potjerali na vrh (slika N).
English: Steady-state exposures are achieved following 3-5 weeks of once-weekly administration.
Croatian: Stanje dinamičke ravnoteže izloženosti postiže se nakon 3-5 tjedana liječenja uz primjenu lijeka jedanput tjedno.
English: In patients who were treated for at least 104 weeks, the adjusted mean change in baseline in HbA1c was -0.97% for Eperzan (N = 182) and -1.04% for insulin glargine (N = 102).
Croatian: U bolesnika koji su liječeni najmanje 104 tjedna, prilagođena srednja promjena HbA1c u odnosu na početnu vrijednost iznosila je -0,97% za Eperzan (N = 182) i -1,04% za inzulin glargin (N = 102).
English: What if I leave my pen for more than 30 minutes after turning the pen to the Number 2 (Step
Croatian: Što ako ostavim brizgalicu dulje od 30 minuta nakon što je okrenem na broj 2 (2. korak)?
English: At Week 26, the mean daily dose of insulin glargine was 53 IU for Eperzan and 51 IU for lispro.
Croatian: Nakon 26 tjedana, srednja dnevna doza inzulina glargina iznosila je 53 IU kod primjene lijeka Eperzan te 51 IU kod primjene inzulina lispro.
English: The pen injector contains powder and water which you need to mix before you can use it. After section 6 of this leaflet there are Instructions For Use giving you step-by-step instructions on how to mix your medicine and how to inject it.
Croatian: Nakon dijela 6. ove Upute navode se Upute za uporabu, u kojima se korak po korak objašnjava kako pomiješati lijek i kako ga injicirati.
English: The Instructions for Use included in the Package Leaflet provide directions for the patient to wait 15 minutes for the 30 mg pen and 30 minutes for the 50 mg pen after the lyophilised powder and diluent are mixed to ensure reconstitution.
Croatian: Uputama za uporabu, koje se nalaze u Uputi o lijeku, navodi se da bolesnik nakon miješanja liofiliziranog praška i otapala mora pričekati 15 minuta ako koristi brizgalicu od 30 mg, odnosno 30 minuta ako koristi brizgalicu od 50 mg, kako bi se osigurala rekonstitucija.
English: At Week 156, 77% of patients treated with Eperzan were uptitrated to 50 mg SC weekly.
Croatian: U 156. tjednu, u 77% bolesnika liječenih lijekom Eperzan doza je bila povećana na
English: Inspect the pen to ensure that the number ‘1' is visible in the number window.
Croatian: Pregledajte brizgalicu kako biste provjerili prikazuje li se broj ‘1' u prozorčiću za prikaz brojeva.
English: Use immediately after needle is attached.
Croatian: Primijeniti odmah nakon što se pričvrsti igla.
English: REMOVING BOTH NEEDLE CAPS AND INJECTING YOUR MEDICINE (STEPS 7-8) After I turn the pen to Number 3 (Step 6), there are still some small air bubbles remaining.
Croatian: Nakon što okrenem brizgalicu na broj 3 (6. korak), u ulošku još uvijek ima malih mjehurića zraka.
English: A small increase in islet cell number was also observed.
Croatian: Primijećeno je i blago povećanje broja stanica Langerhansovih otočića.
English: Step 2
Croatian: KORAK)
English: Dispose of the pen as instructed by your doctor, pharmacist or nurse.
Croatian: Zbrinite brizgalicu u skladu s uputama koje ste dobili od liječnika, ljekarnika ili medicinske sestre.
English: Eperzan 30 mg/50 mg Weekly
Croatian: Eperzan 30 mg/50 mg tjedno
English: At the end of this period the pen should be used or discarded.
Croatian: Nakon isteka toga razdoblja brizgalicu treba upotrijebiti ili baciti.
English: Infections and infestations
Croatian: Infekcije i infestacije upala pluća
English: Treatment with Eperzan resulted in a mean weight loss for Eperzan (-0.7 kg) compared to a mean weight gain for insulin lispro (+0.8 kg) and the difference between treatment groups was statistically significant (see Table 6).
Croatian: Liječenje lijekom Eperzan dovelo je do srednjeg smanjenja tjelesne težine (-0,7 kg), dok je kod primjene inzulina lispro zabilježeno srednje povećanje tjelesne težine (+0,8 kg), a razlika između ispitivanih skupina bila je statistički značajna
English: Age had no clinically relevant effect on the pharmacokinetics of albiglutide based on a population pharmacokinetic analysis of subjects aged 24-83 years (see section 4.2).
Croatian: 83 godine, dob nije imala klinički značajnog učinka na farmakokinetiku albiglutida (vidjeti dio 4.2).
English: Patients with hepatic insufficiency
Croatian: Bolesnici s insuficijencijom jetre
English: lv-epasts@gsk.com customercontactuk@gsk.com
Croatian: gskcyprus@gsk.com
English: Eperzan 30 mg SC weekly (with uptitration to 50 mg weekly if needed) was compared to sitagliptin.
Croatian: Eperzan u supkutanoj dozi od 30 mg tjedno (uz povećanje doze na 50 mg tjedno po potrebi) uspoređivao se sa sitagliptinom.
English: The durability of glycaemic control for Eperzan over time relative to other classes of type 2 antidiabetic agents and placebo is shown in Figure 1 as add-on to metformin.
Croatian: Postojanost glikemijske kontrole tijekom vremena kod primjene lijeka Eperzan kao dodatka liječenju metforminom u odnosu na druge skupine lijekova za liječenje šećerne bolesti tipa 2 i placebo prikazana je na Slici 1.
English: Difference from insulin glargineb (95% CI) P value (noninferiority) Proportion Achieving HbA1c <7% Body Weight (kg)
Croatian: Promjena nakon 52 tjednab Razlika u odnosu na inzulin glarginb (95% CI) P-vrijednost (neinferiornost) Udio bolesnika koji su postigli HbA1c < 7% Tjelesna težina (kg)
English: The average weekly steady state concentrations following SC administration of 30 mg or 50 mg albiglutide estimated in the population PK analyses from phase III patient studies were approximately 2.6 mcg/ml and 4.4 mcg/ml, respectively.
Croatian: primjene doze od 30 mg odnosno 50 mg albiglutida, procijenjene u populacijskim farmakokinetičkim analizama u ispitivanjima faze III s bolesnicima, iznosile su približno 2,6 µg/ml odnosno 4,4 µg/ml.
English: For liquids, gastric emptying t1/2 increased from 0.28 h to 0.69 h (p=0.0018).
Croatian: Za tekućine se t1/2 pražnjenja želuca povećao s 0,28 h na 0,69 h
English: No overall differences in glycaemic effectiveness or body weight were observed across demographic subgroups (age, gender, race/ethnicity, duration of diabetes).
Croatian: Među demografskim podskupinama (dob, spol, rasa/etničko podrijetlo, trajanje šećerne bolesti) sveukupno nisu primijećene razlike u glikemijskoj učinkovitosti niti tjelesnoj težini.
English: Each pen delivers a single 30 mg or 50 mg dose of Eperzan in a volume of 0.5 ml.
Croatian: Jedna brizgalica osigurava primjenu jednokratne doze od 30 mg ili 50 mg lijeka Eperzan u volumenu od 0,5 ml.
English: • if you are taking a sulphonylurea or insulin for your diabetes, as low blood sugar (hypoglycaemia) can occur.
Croatian: • ako za liječenje šećerne bolesti primjenjujete sulfonilureju ili inzulin, jer može doći do pada razine šećera u krvi (hipoglikemije).
English: Powder: lyophilised white to yellow powder.
Croatian: OBLIK Prašak i otapalo za otopinu za injekciju Prašak: liofilizirani prašak bijele do žute boje.
English: Follow the steps below in the exact order they are presented.
Croatian: Slijedite korake u nastavku točnim redoslijedom kojim su navedeni.
English: Step 1 Check pen
Croatian: Korak 1 Pregledajte brizgalicu
English: Albiglutide slowed gastric emptying compared with placebo for both solids and liquids when 100 mg was administered as a single dose in healthy subjects.
Croatian: Albiglutid je usporio pražnjenje želuca u usporedbi s placebom i kod krute hrane i kod tekućina kod zdravih ispitanika koji su primili jednu dozu od 100 mg.
English: Sodium content This medicine contains less than 1 mmol sodium (23 mg) per 0.5 ml dose, so is essentially ‘sodium free'.
Croatian: Sadržaj natrija Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po dozi od 0,5 ml, tj. zanemarive količine natrija.
English: Placebo Metformin 1,500 mg daily
Croatian: Placebo metformin ≥1500 mg na dan
English: A single carton of 4 pens and 4 needles may be stored at room temperature, not exceeding 30C, for no more than a total of 4 weeks prior to use.
Croatian: Jedna kutija od 4 brizgalice i 4 igle se prije uporabe može čuvati na sobnoj temperaturi, ne višoj od 30°C, tijekom najviše 4 tjedna.
English: Name and address of the manufacturer responsible for batch release:
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet:
English: Compared to placebo, treatment with Eperzan 30 mg and 50 mg SC weekly resulted in statistically significant reductions in HbA1c from baseline at Week 52.
Croatian: Eperzan u supkutanoj dozi od 30 mg i 50 mg tjedno dovelo je do statistički značajnog smanjenja vrijednosti HbA1c nakon 52 tjedna.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 30 mg
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA
English: Use of GLP-1 receptor agonists may be associated with gastrointestinal adverse reactions.
Croatian: Primjena agonista GLP-1 receptora može biti povezana s nuspojavama u probavnom sustavu.
English: In a 52-week monkey study, there was a small increase in pancreas tissue weight at 50 mg/kg/week (75 times clinical exposure based on AUC) associated with acinar cell hypertrophy.
Croatian: U 52-tjednom ispitivanju na majmunima je kod primjene doze od 50 mg/kg tjedno (izloženost 75 puta veća od kliničke, na temelju AUC-a) primijećeno blago povećanje težine tkiva gušterače povezano s hipertrofijom acinarnih stanica.
English: Sitagliptin was dosed according to creatinine clearance estimated by Cockcroft-Gault formula (100 mg daily in mild, 50 mg daily in moderate, and 25 mg daily in severe renal impairment) The primary endpoint was change in HbA1c from baseline at 26 weeks.
Croatian: Sitagliptin je doziran u skladu s klirensom kreatinina procijenjenim Cockcroft-Gaultovom formulom (100 mg na dan kod blagog, 50 mg na dan kod umjerenog i 25 mg na dan kod teškog oštećenja bubrežne funkcije).
English: Twist the clear cartridge slightly in the direction of the arrows (clockwise) to complete the “click” and center the number in the window.
Croatian: Blago zakrenite prozirni uložak u smjeru strelice (u smjeru kazaljke na satu) kako biste čuli ‘klik' i centrirali broj u prozorčiću.
English: Figure 1: Kaplan-Meier curve showing durability of glycaemic control (measured by time to rescue) for Eperzan, relative to two active controls (sitagliptin and glimepiride) and placebo
Croatian: Slika 1: Kaplan-Meierova krivulja koja pokazuje postojanost glikemijske kontrole (mjereno vremenom do primjene lijekova za hitno ublažavanje simptoma) kod primjene lijeka Eperzan u odnosu na dva aktivna kontrolna lijeka (sitagliptin i glimepirid) i placebo os x; Tjedni (bez primjene lijekova za hitno ublažavanje simptoma); os y; Vjerojatnost događaja
English: Decreased body weight in offspring was observed in mice treated with albiglutide during gestation and lactation (see section 5.3).
Croatian: Kod ženki miševa koje su primale albiglutid tijekom gestacije i laktacije primijećena je smanjena tjelesna težina mladunčadi (vidjeti dio 5.3).
English: The incidence rates observed for first MACE+ were 1.2 and 1.1 events per 100 person-years for Eperzan versus all comparators, respectively.
Croatian: 100 bolesnik-godina za Eperzan odnosno 1,1 događaj na 100 bolesnik-godina za sve usporedne lijekove.
English: Eperzan 30 mg SC weekly was compared to placebo in patients inadequately controlled on pioglitazone 30 mg daily (with or without metformin 1,500 mg daily).
Croatian: Eperzan u supkutanoj dozi od 30 mg tjedno uspoređivao se s placebom u bolesnika u kojih glikemija nije bila dovoljno dobro regulirana pioglitazonom u dozi od ≥30 mg na dan (s metforminom u dozi od ≥1500 mg na dan ili bez njega).
English: If you do not push the needle on completely, the pen may jam or leak.
Croatian: Ako iglu ne pričvrstite do kraja, brizgalica se može zaglaviti ili iz nje može istjecati lijek.
English: • Throw away the pen if leaking or jammed.
Croatian: • Bacite brizgalicu ako iz nje istječe lijek ili ako se zaglavila.
English: Results of an active-controlled trial of Eperzan 30 mg SC weekly (with uptitration to 50 mg weekly) versus liraglutide 1.8 mg daily at 32 weeksa
Croatian: Rezultati aktivnim lijekom kontroliranog ispitivanja lijeka Eperzan u s.c. dozi od 30 mg tjedno (uz povećanje doze na 50 mg tjedno) naspram 1,8 mg liraglutida na dan nakon 32 tjednaa
English: Eperzan 30 mg powder and solvent for solution for injection Eperzan 50 mg powder and solvent for solution for injection
Croatian: Eperzan 30 mg prašak i otapalo za otopinu za injekciju Eperzan 50 mg prašak i otapalo za otopinu za injekciju
English: The percentage of patients who developed antibodies to albiglutide on treatment was 4% (137/3,267).
Croatian: Postotak bolesnika u kojih su se tijekom liječenja razvila protutijela na albiglutid iznosio je 4%