FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients treated with insulin prior to a confirmed hypoglycaemic episode the rate was higher with liraglutide (1.82 events/patient year) compared to placebo (0.91 events/patient years).
Croatian: U bolesnika liječenih inzulinom prije potvrđene epizode hipoglikemije, stopa je bila viša uz liraglutid (1,82 događaja/bolesnik godina) u usporedbi s placebom (0,91 događaja/bolesnik godina).
English: No dose adjustment is recommended for patients with mild or moderate hepatic impairment.
Croatian: Ne preporučuje se prilagođavati dozu u bolesnika s blagim ili umjerenim oštećenjem jetre.
English: You may get hypoglycaemia (low blood sugar) when using Victoza together with a sulfonylurea or insulin, as sulfonylureas and insulin increase the risk of hypoglycaemia.
Croatian: (niska razina šećera u krvi) kad lijek Victoza primjenjujete zajedno sa sulfonilurejom ili inzulinom, jer sulfonilureja i inzulin povećavaju rizik od hipoglikemije.
English: Significantly more patients achieved HbA1c below 7% with liraglutide compared with exenatide (54.2% vs 43.4%, p=0.0015).
Croatian: Značajno veći broj bolesnika postigao je HbA1c ispod 7% s liraglutidom u usporedbi s eksenatidom (54,2% naspram 43,4%, p=0,0015).
English: Severe hypoglycaemia may occur uncommonly and has primarily been observed when liraglutide is combined with a sulfonylurea (0.02 events/patient year).
Croatian: Teška hipoglikemija može se pojaviti manje često i to je prije svega zabilježeno kad se liraglutid kombinirao sa sulfonilurejom (0,02 događaja/bolesnik-godina).
English: Select your dose Always check that the pointer lines up with 0 mg.
Croatian: Uvijek provjerite je li pokazivač poravnan sa 0 mg.
English: There was a small increase in the rate of minor hypoglycaemic episodes (0.23 versus 0.03 events per patient years).
Croatian: Došlo je do malog porasta stope epizoda lakših hipoglikemija (0,23 naspram 0,03 događaja po bolesnik-godini).
English: Common • Vomiting.
Croatian: Često • Povraćanje.
English: When combining liraglutide with a sulfonylurea, 9.1% of patients reported at least one episode of nausea and 7.9% of patients reported at least one episode of diarrhoea.
Croatian: Kad se liraglutid kombinirao sa sulfonilurejom, 9,1% bolesnika prijavilo je barem jednu epizodu mučnine, dok je 7,9%
English: Severe hypoglycaemia has primarily been observed when combined with a sulfonylurea.
Croatian: Teška hipoglikemija je prvenstveno zabilježena u kombinaciji sa sulfonilurejom.
English: Additional components in expanded MACE: Unstable angina pectoris (hospitalisation) Coronary revascularisation Heart failure (hospitalisation) Other secondary endpoints:
Croatian: Dodatne sastavnice proširenih MACE događaja: Nestabilna angina pektoris (hospitalizacija)
English: The most frequently reported adverse reactions were gastrointestinal disorders, infections and infestations.
Croatian: Od nuspojava najčešće su prijavljivani gastrointestinalni poremećaji te infekcije i infestacije.
English: • Cases of inflammation of the pancreas (pancreatitis).
Croatian: • Slučajevi upale gušterače (pankreatitis).
English: Disodium phosphate dihydrate Propylene glycol Phenol
Croatian: Natrijev hidrogenfosfat dihidrat Propilenglikol
English: Each pen contains 3 ml solution, delivering 30 doses of 0.6 mg, 15 doses of 1.2 mg or 10 doses of 1.8 mg.
Croatian: Jedna brizgalica sadrži 3 ml otopine za davanje 30 doza od 0,6 mg, 15 doza od 1,2 mg ili 10 doza od 1,8 mg.
English: The use of Victoza is not recommended if you have severe heart failure.
Croatian: Primjena lijeka Victoza se ne preporučuje ako imate teško zatajenje srca.
English: No dose adjustment is required for patients with mild, moderate or severe renal impairment.
Croatian: Nije potrebno prilagođavanje doze u bolesnika s blagim, umjerenim ili teškim oštećenjem bubrega.
English: The mean HbA1c at baseline was 8.7% for liraglutide and placebo.
Croatian: Srednja vrijednost HbA1c na početku ispitivanja iznosila je 8,7% i uz liraglutid i uz placebo.
English: Liraglutide exposure was decreased by 13-23% in patients with mild to moderate hepatic impairment compared to healthy subjects.
Croatian: U usporedbi sa zdravim bolesnicima, izloženost liraglutidu bila je smanjena za 13-23% u bolesnika s blažim do umjerenim oštećenjem jetre.
English: Tmax was delayed by 1.5 h with liraglutide for both compounds.
Croatian: Uz liraglutid je tmax bio odgođen za 1,5 h za oba spoja.
English: Immune system disorders
Croatian: Poremećaji imunološkog sustava
English: Pancreatitis
Croatian: Pankreatitis
English: Anaphylactic reactions
Croatian: Anafilaktičke reakcije
English: When the needle is covered, carefully push the outer needle cap completely on. Then unscrew the needle.
Croatian: Kad je igla pokrivena, pažljivo gurnite vanjski zatvarač igle do kraja.
English: MARKETING AUTHORISATION NUMBERS
Croatian: 12. BROJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: There is no therapeutic experience in patients with congestive heart failure New York Heart Association (NYHA) class IV, and liraglutide is therefore not recommended for use in these patients.
Croatian: New York Heart Association) klasifikaciji pa se stoga primjena liraglutida ne preporučuje u ovih bolesnika.
English: Lisinopril median tmax was delayed from 6 h to 8 h with liraglutide.
Croatian: Uz liraglutid je medijan tmax lizinoprila bio odgođen sa 6 h na 8 h.
English: Grounds for the variation to the terms of the marketing authorisation
Croatian: Razlozi za izmjenu uvjeta odobrenja za stavljanje lijeka u promet
English: Few cases (0.05%) of angioedema have been reported during all long-term clinical trials with Victoza.
Croatian: Tijekom svih dugotrajnih kliničkih ispitivanja lijeka Victoza prijavljeno je nekoliko (0,05%) slučajeva angioedema.
English: • A delay in the emptying of the stomach.
Croatian: • Odgođeno pražnjenje želuca.
English: Add-on to glimepiride (4 mg/day)
Croatian: Dodatak glimepiridu (4 mg/dan)
English: Victoza 6 mg/ml injection Liraglutide
Croatian: Victoza 6 mg/ml injekcija liraglutid
English: Never try to put the inner needle cap back on the needle.
Croatian: Kad jednom skinete unutarnji zatvarač igle, nikad ga ne pokušavajte vratiti na iglu.
English: Keep the needle pointing up and press the dose button until 0 mg lines up with the pointer.
Croatian: Držeći iglu prema gore pritisnite gumb za doziranje sve dok se 0 mg ne poravna s pokazivačem.
English: Switching patients from exenatide to liraglutide after 26 weeks of treatment resulted in an additional and statistically significant reduction in HbA1c (-0.32%, 95% CI: -0.41 to -0.24) at week 40, but a formal control group was not available.
Croatian: Prelazak bolesnika s eksenatida na liječenje liraglutidom nakon 26 tjedana liječenja rezultiralo je dodatnim i statistički značajnim smanjenjem HbA1c (-0,32%, 95% CI: -0,41 do -0,24) u 40. tjednu, ali nije bila dostupna zvanična kontrolna skupina.
English: The treatment difference in HbA1c was 1.3% after additional 26 weeks of open label extension, confirming the sustained glycaemic control with Victoza.
Croatian: Nakon dodatnih 26 tjedana otvorene produžne faze razlika u liječenju u HbA1c bila je 1,3%, te je potvrđena kontinuirana kontrola glikemije s lijekom
English: No pharmacokinetic or pharmacodynamic interactions were observed between liraglutide and insulin detemir when administering a single dose of insulin detemir 0.5 U/kg with liraglutide 1.8 mg at steady state in patients with type 2 diabetes.
Croatian: Nisu uočene farmakokinetičke ili farmakodinamičke interakcije između liraglutida i detemir inzulina za pojedinačne doze detemir inzulina od 0,5 U/kg i 1,8 mg liraglutida u stanju dinamičke ravnoteže, u bolesnika sa šećernom bolešću tipa 2.
English: Mean baseline weight (kg)
Croatian: Srednja početna vrijednost tjelesne težine (kg)
English: Significantly more patients achieved HbA1c below 7% with liraglutide compared with placebo (52.8% vs 19.5%).
Croatian: U usporedbi s placebom, značajno više bolesnika je postiglo HbA1c ispod 7% s liraglutidom (52,8% naspram 19,5%).
English: If you have thyroid disease including thyroid nodules and enlargement of the thyroid gland, consult your doctor.
Croatian: Ako imate bolest štitnjače uključujući čvoriće u štitnjači i povećanu štitnu žlijezdu, posavjetujte se sa svojim liječnikom.
English: For patients treated with premix insulin at baseline and at least for the following 26 weeks, the rate of severe hypoglycaemia for both liraglutide and placebo was 2.2 events per 100 patient years.
Croatian: U bolesnika koji su na početku ispitivanja i tijekom barem sljedećih 26 tjedana bili liječeni predmiješanim inzulinom, stopa teške hipoglikemije iznosila je 2,2 događaja na 100 bolesnik-godina i uz liraglitud i uz placebo.
English: • Proportion of patients achieving reductions in HbA1c Liraglutide alone resulted in a statistically significant greater proportion of patients achieving HbA1c ≤6.5% at 52 weeks compared with patients receiving glimepiride (37.6% for 1.8 mg and 28.0% for 1.2 mg vs 16.2% for comparator).
Croatian: • Udio bolesnika koji su postigli smanjenje HbA1c Liraglutid primijenjen samostalno doveo je do statistički značajno većeg udjela bolesnika koji su postigli HbA1c ≤6,5% nakon 52 tjedna u usporedbi s bolesnicima koji su primali glimepirid (37,6% uz dozu od 1,8 mg te 28,0% uz dozu od 1,2 mg naspram 16,2% uz usporedni lijek).
English: Liraglutide in combination therapy, for 26 weeks, with metformin, glimepiride or metformin and rosiglitazone or SGLT2i ± metformin resulted in statistically significant and sustained reductions in HbA1c compared with patients receiving placebo (Table 2).
Croatian: Liraglutid je tijekom 26-tjednog kombiniranog liječenja s metforminom, glimepiridom ili metforminom i roziglitazonom ili inhibitorom SGLT2 ± metforminom doveo do statistički značajnog i održanog smanjenja HbA1c u usporedbi s bolesnicima koji su primali placebo (Tablica 2).
English: OTHER
Croatian: a
English: Guide the needle tip into the outer needle cap without touching the needle or the outer needle cap.
Croatian: Gurnite vrh igle u vanjski zatvarač igle ne dotičući iglu ili vanjski zatvarač igle.
English: In vitro, liraglutide has shown very low potential to be involved in pharmacokinetic interactions with other active substances related to cytochrome P450 and plasma protein binding.
Croatian: 4.5 Interakcije s drugim lijekovima i drugi oblici interakcija In vitro je liraglutid pokazao vrlo nizak potencijal za farmakokinetičke interakcije s drugim djelatnim tvarima koje se vežu na citokrom P450 i na proteine plazme.
English: Griseofulvin
Croatian: Grizeofulvin
English: 1 ml solution for injection contains 6 mg liraglutide.
Croatian: Jedan ml otopine za injekciju sadrži 6 mg liraglutida.
English: In the LEADER trial, the frequency of acute pancreatitis confirmed by adjudication was 0.4% for liraglutide and 0.5% for placebo, respectively (see sections 4.4 and 5.1).
Croatian: Učestalost neovisno potvrđenih slučajeva akutnog pankreatitisa u ispitivanju LEADER iznosila je 0,4% uz liraglutid te 0,5% uz placebo (vidjeti dijelove 4.4 i 5.1).
English: Use in patients with renal impairment
Croatian: Primjena u bolesnika s oštećenjem bubrega
English: • Warfarin or other oral anti-coagulation medicines.
Croatian: • Varfarin ili druge lijekove protiv zgrušavanja krvi koji se uzimaju kroz usta.
English: In the LEADER trial, the frequency of cholelithiasis and cholecystitis was 1.5% and 1.1% for liraglutide and 1.1% and 0.7% for placebo, respectively (see section 5.1).
Croatian: U ispitivanju LEADER učestalost kolelitijaze i kolecistitisa iznosila je 1,5% odnosno 1,1% uz liraglutid te 1,1% odnosno 0,7% uz placebo (vidjeti dio 5.1).
English: Table 1 Adverse reactions from long-term controlled phase 3a trials, the long-term cardiovascular outcome trial (LEADER) and spontaneous (post-marketing) reports
Croatian: Tablica 1 Nuspojave zabilježene u dugotrajnim kontroliranim ispitivanjima faze 3a i u dugotrajnom ispitivanju kardiovaskularnih ishoda (LEADER) te spontano prijavljene nuspojave (nakon stavljanja lijeka na tržište)
English: The apparent volume of distribution after subcutaneous administration is 11-17 l. The mean volume of distribution after intravenous administration of liraglutide is 0.07 l/kg.
Croatian: Srednja vrijednost volumena distribucije nakon intravenske primjene liraglutida je 0,07 l/kg.
English: In a 52-week clinical trial, the addition of insulin detemir to liraglutide 1.8 mg and metformin in patients not achieving glycaemic targets on liraglutide and metformin alone resulted in a HbA1c decrease from baseline of 0.54%, compared to 0.20% in the liraglutide 1.8 mg and metformin control group.
Croatian: U kliničkom ispitivanju koje je trajalo 52 tjedna dodatak detemir inzulina liraglutidu od 1,8 mg i metforminu, u bolesnika koji nisu postigli ciljnu glikemiju samo na liraglutidu i metforminu, rezultirao je smanjenjem HbA1c za 0,54% od početne vrijednosti u odnosu na 0,20% u kontrolnoj skupini liječenoj liraglutidom od 1,8 mg i metforminom.
English: Victoza pen is designed to be used with NovoFine or NovoTwist disposable needles.
Croatian: Brizgalica Victoza namijenjena je primjeni s jednokratnim iglama NovoFine ili NovoTwist.
English: This prevents contamination, infection and leakage.
Croatian: Tako se sprječava onečišćenje, infekcija i istjecanje lijeka.
English: Table 1 lists adverse reactions reported in long-term phase 3a controlled trials, the LEADER trial (a long-term cardiovascular outcome trial) and spontaneous (post-marketing) reports.
Croatian: U tablici 1 navode se nuspojave prijavljene u dugotrajnim, kontroliranim ispitivanjima faze 3a i ispitivanju LEADER (dugotrajnom ispitivanju kardiovaskularnih ishoda) te spontano prijavljene nuspojave (nakon stavljanja lijeka na tržište).
English: The need for treatment intensification with insulin was reduced by 48% with liraglutide vs placebo in insulin-naive patients at baseline (HR 0.52 [0.48;
Croatian: Potreba za intenziviranjem liječenja inzulinom smanjila se za 48% uz liraglutid u odnosu na placebo među bolesnicima koji prije početka ispitivanja nisu bili liječeni inzulinom (HR 0,52 [0,48; 0,57]).
English: Titration of the insulin glargine dose was managed by the patient after instruction by the investigator:
Croatian: Titriranje doze glargin inzulina regulirao je bolesnik prema uputama dobivenima od ispitivača: Smjernice za titriranje glargin inzulina
English: Pull off the inner needle cap and dispose of it.
Croatian: Skinite unutarnji zatvarač igle i bacite ga u otpad.
English: Press the dose button to inject until 0 mg lines up with the pointer.
Croatian: Injicirajte tako da pritisnete gumb za doziranje sve dok se 0 mg ne poravna s pokazivačem.
English: Glimepiride 8 mg/day 248 8.23
Croatian: Glimepirid 8 mg/dan 248 8,23
English: Liraglutide stimulates insulin secretion in a glucosedependent manner.
Croatian: Liraglutid potiče lučenje inzulina u ovisnosti od glukoze.
English: Liraglutide monotherapy for 52 weeks resulted in statistically significant and sustained reductions in HbA1c compared with glimepiride 8 mg (-0.84% for 1.2 mg, -1.14% for 1.8 mg vs -0.51% for comparator) in patients previously treated with either diet and exercise or OAD monotherapy at no more than half-maximal dose (Table 2).
Croatian: Monoterapija liraglutidom tijekom 52 tjedna dovela je do statistički značajnog i održanog smanjenja HbA1c u usporedbi s glimepiridom u dozi od 8 mg (-0,84% uz dozu od 1,2 mg, -1,14% uz dozu od 1,8 mg naspram -0,51% uz usporedni lijek) u bolesnika prethodno liječenih dijetom i tjelovježbom ili monoterapijom nekim oralnim antidijabetikom u dozi od najviše pola maksimalne doze (Tablica 2).
English: In both groups a decrease in body weight was seen: -2.4 kg with liraglutide vs -1.09 kg with placebo.
Croatian: Gubitak tjelesne težine zabilježen je u obje skupine: -2,4 kg s liraglutidom naspram -1,09 kg s placebom.
English: Very common: may affect more than 1 in 10 people
Croatian: Vrlo često: mogu se javiti u više od 1 na 10 osoba
English: Lisinopril
Croatian: Lizinopril
English: Body weight loss was observed in both treatment arms (-4.3 kg with liraglutide and -3.7 kg with lixisenatide).
Croatian: U obje je liječene skupine primijećen gubitak tjelesne težine (-4,3 kg uz liraglutid te -3,7 kg uz liksisenatid).
English: Non-fatal stroke
Croatian: Moždani udar bez smrtnog ishoda
English: Disodium phosphate dihydrate, propylene glycol, phenol, water for injections
Croatian: POPIS POMOĆNIH TVARI Natrijev hidrogenfosfat dihidrat, propilenglikol, fenol, voda za injekcije
English: The pen is designed to be used with NovoFine or NovoTwist disposable needles.
Croatian: Brizgalica je namijenjena primjeni s jednokratnim iglama NovoFine ili NovoTwist.
English: Glimepiride 4 mg/day 242 8.4
Croatian: Glimepirid 4 mg/dan 242 8,4
English: Table 2 Liraglutide clinical phase 3 trials in monotherapy (52 weeks) and in combination with oral antidiabetics (26 weeks)
Croatian: (52 tjedna) i u kombinaciji s oralnim antidijabeticima (26 tjedana)
English: How to store Victoza
Croatian: Kako čuvati lijek Victoza
English: Thus, when blood glucose is high, insulin secretion is stimulated and glucagon secretion is inhibited.
Croatian: Tako, kad je glukoza u krvi visoka, potiče se lučenje inzulina i inhibira lučenje glukagona.
English: Combination with oral antidiabetics
Croatian: Kombinacija s oralnim antidijabeticima (OAD)
English: PHARMACEUTICAL FORM
Croatian: FARMAKOLOŠKA SVOJSTVA
English: Improved first and second phase insulin secretion after 52 weeks treatment with liraglutide was demonstrated in a subset of patients with type 2 diabetes (n=29).
Croatian: U podskupini bolesnika sa šećernom bolešću tipa 2 (n=29) dokazana je poboljšana prva i druga faza lučenja inzulina nakon 52 tjedna liječenja liraglutidom.
English: Very rare: may affect up to 1 in 10,000 people
Croatian: Vrlo rijetko: mogu se javiti u do 1 na 10 000 osoba
English: (74.2% vs 45.5%, p<0.0001), as well as the HbA1c target below or equal 6.5% (54.6% vs 26.2%, p<0.0001).
Croatian: Značajno veći broj bolesnika postigao je HbA1c ispod 7% uz liraglutid u usporedbi s liksisenatidom (74,2% naspram 45,5%, p<0,0001), jednako kao i ciljni HbA1c od 6,5% ili manje (54,6% naspram 26,2%, p<0,0001).
English: Add-on to metformin (2,000 mg/day)
Croatian: Dodatak metforminu (2000 mg/dan)
English: Insulin
Croatian: Inzulin
English: Rare: may affect up to 1 in 1,000 people
Croatian: Rijetko: mogu se javiti u do 1 na 1000 osoba
English: Hold the pen with the needle pointing up.
Croatian: Držite brizgalicu s iglom okrenutom prema gore.
English: With each new pen, check the flow Check the flow before your first injection with each new pen.
Croatian: Provjerite protok prije prvog injiciranja svaki puta kad uzmete novu brizgalicu.
English: Package leaflet: Information for the user Victoza 6 mg/ml solution for injection in pre-filled pen
Croatian: Uputa o lijeku: Informacije za korisnika Victoza 6 mg/ml otopina za injekciju u napunjenoj brizgalici liraglutid
English: One pre-filled pen contains 18 mg liraglutide in 3 ml.
Croatian: Jedna napunjena brizgalica sadrži 18 mg liraglutida u 3 ml.
English: Victoza contains less than 1 mmol sodium (23 mg) per dose, therefore the medicinal product is essentially ‘sodium-free'.
Croatian: Victoza sadrži manje od 1 mmol (23 mg) natrija po dozi, tj. zanemarive količine natrija.
English: Flatulence Abdominal distension Gastroesophageal reflux disease Abdominal discomfort Toothache
Croatian: Gastroezofagealna refluksna bolest Nelagoda u abdomenu Zubobolja
English: 9,340 patients were randomly allocated to either liraglutide (4,668) or placebo (4,672), both in addition to standards of care for HbA1c and cardiovascular (CV) risk factors.
Croatian: Outcome Results) bilo je multicentrično, placebom kontrolirano, dvostruko slijepo kliničko ispitivanje, u kojem je 9340 bolesnika bilo randomizirano za primanje liraglutida (4668) ili placeba (4672), oba kao dodatak standardnim terapijama za HbA1c i faktore kardiovaskularnog (KV) rizika.
English: Pull off the pen cap.
Croatian: Skinite zatvarač brizgalice.
English: Age had no clinically relevant effect on the pharmacokinetics of liraglutide based on the results from a pharmacokinetic study in healthy subjects and population pharmacokinetic data analysis of patients (18 to 80 years).
Croatian: Prema rezultatima farmakokinetičkog ispitivanja u zdravih ispitanika i analize populacijskih farmakokinetičkih podataka bolesnika (18 do 80 godina), dob nije imala klinički značajnog učinka na farmakokinetiku liraglutida.
English: Switching patients from sitagliptin to liraglutide after 52 weeks of treatment resulted in additional and statistically significant reduction in HbA1c (-0.24% and -0.45%, 95% CI: -0.41 to -0.07 and -0.67 to -0.23) at week 78, but a formal control group was not available.
Croatian: Prebacivanje bolesnika sa sitagliptina na liraglutid nakon 52 tjedna liječenja rezultiralo je dodatnim i statistički značajnim smanjenjem HbA1c (-0,24% i -0,45%, 95% CI: -0,41 do -0,07 i -0,67 do -0,23) u 78. tjednu,
English: This medicine contains less than 1 mmol sodium (23 mg) per dose.
Croatian: Važne informacije o nekim sastojcima lijeka Victoza Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po dozi, tj. zanemarive količine natrija.
English: Conversely, during hypoglycaemia liraglutide diminishes insulin secretion and does not impair glucagon secretion.
Croatian: Suprotno tome, za vrijeme hipoglikemije liraglutid smanjuje lučenje inzulina, ali ne remeti lučenje glukagona.
English: Elderly patients (>65 years old) No dose adjustment is required based on age (see section 5.2).
Croatian: Nije potrebno prilagođavanje doze prema dobi (vidjeti dio 5.2).
English: 1 ml contains 6 mg of liraglutide.
Croatian: Jedan ml sadrži 6 mg liraglutida.
English: In a double-blind study comparing the efficacy and safety of Victoza 1.8 mg versus placebo as add-on to metformin ± insulin in adolescents and children aged 10 years and above with type 2 diabetes, Victoza was superior to placebo treatment in reducing HbA1c after 26 weeks (-1.06, [-1.65, 0.46]).
Croatian: U dvostruko slijepom ispitivanju koje je usporedilo djelotvornost i sigurnost lijeka Victoza 1,8 mg naspram placeba kao dodatka metforminu ± inzulinu u adolescenata i djece u dobi od 10 ili više godina sa šećernom bolešću tipa 2, Victoza je bila superiorna u smanjenju HbA1c nakon 26 tjedana (-1,06, [-1,65; 0,46]) u odnosu na liječenje placebom.
English: Injection site reactions have been reported in approximately 2% of patients receiving Victoza in longterm (26 weeks or longer) controlled trials.
Croatian: U dugotrajnim (26 tjedana ili duže) kontroliranim ispitivanjima reakcije na mjestu injiciranja prijavljene su u otprilike 2% bolesnika koji su primali lijek Victoza.
English: Victoza contains the active substance liraglutide.
Croatian: Victoza sadrži djelatnu tvar liraglutid.
English: Injection site reactions
Croatian: Reakcije na mjestu injiciranja
English: • Diarrhoea.
Croatian: • Mučnina.
English: Few cases of cholelithiasis (0.4%) and cholecystitis (0.1%) have been reported during long-term, controlled phase 3a clinical trials with liraglutide.
Croatian: Kolelitijaza i kolecistitis Tijekom dugotrajnih kontroliranih kliničkih ispitivanja liraglutida faze 3a prijavljeno je nekoliko slučajeva kolelitijaze (0,4%) i kolecistitisa (0,1%).
English: Estimated maximum liraglutide concentration was 9.4 nmol/l (mean body weight approximately 73 kg) for a subcutaneous single dose of liraglutide 0.6 mg. At 1.8 mg liraglutide, the average steady state concentration of liraglutide (AUCτ/24) reached approximately 34 nmol/l (mean body weight approximately 76 kg).
Croatian: Za jednu supkutanu dozu liraglutida od 0,6 mg procijenjena maksimalna koncentracija liraglutida bila je 9,4 nmol/l (srednja vrijednost tjelesne težine približno 73 kg).
English: A significant and sustained reduction in HbA1c from baseline to month 36 was observed with liraglutide vs placebo, in addition to standard of care (-1.16% vs -0.77%; estimated treatment difference [ETD] -0.40% [-0.45; -0.34]).
Croatian: Kod primjene liraglutida kao dodatka standardnom liječenju primijećeno je značajno i održano sniženje HbA1c od početka ispitivanja do 36. mjeseca u odnosu na placebo (-1,16% naspram -0,77%; procijenjena razlika između liječenja: -0,40% [-0,45; -0,34]).