FrancophonIA/ELRC3.0 huggingface dataset:
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Slovenian: se zdravila ne sme mešati z drugimi zdravili.
English: Very few episodes (0.001 events/patient year) were observed with administration of liraglutide in combination with oral antidiabetics other than sulfonylureas.
Slovenian: Zelo malo takšnih primerov (0,001 primerov/bolnik-let) je bilo zabeleženih med uporabo liraglutida skupaj z nesulfonilsečninskimi peroralnimi antidiabetiki.
English: If you stop using Victoza
Slovenian: Če ste prenehali uporabljati zdravilo Victoza
English: The most frequently reported adverse reactions were gastrointestinal disorders, infections and infestations.
Slovenian: Najpogosteje opisani neželeni učinki so bile bolezni prebavil, infekcijske in parazitske bolezni.
English: The best places to give yourself the injection are the front of your thighs, the front of your waist (abdomen), or your upper arm.
Slovenian: Najprimernejša mesta za injiciranje so sprednji del stegna, sprednji del trebuha ali nadlaket.
English: Upon initiation of liraglutide treatment in patients on warfarin or other coumarin derivatives, more frequent monitoring of INR (International Normalised Ratio) is recommended.
Slovenian: Pri bolnikih, ki jemljejo varfarin ali druge kumarinske derivate, na začetku zdravljenja z liraglutidom priporočamo pogostejši nadzor mednarodnega normaliziranega razmerja
English: MedDRA system organ classes
Slovenian: MedDRA organski sistem
English: • Gastro-oesophageal reflux disease (GORD).
Slovenian: • gastroezofagealna refluksna bolezen (GERB); med znaki je zgaga
English: Therefore, no dose adjustment of atorvastatin is required when given with liraglutide.
Slovenian: Zato prilagoditev odmerka atorvastatina pri hkratni uporabi liraglutida ni potrebna.
English: Treatment with liraglutide produced clinically and statistically significant improvements in glycosylated haemoglobin A1c (HbA1c), fasting plasma glucose and postprandial glucose compared with placebo.
Slovenian: Pri zdravljenju z liraglutidom so v primerjavi s placebom ugotovili klinično pomembno in statistično značilno izboljšanje vrednosti glikiranega hemoglobina A1c (HbA1c) ter koncentracije glukoze v plazmi na tešče in postprandialno.
English: Increased lipase*
Slovenian: povečana koncentracija amilaze*
English: To improve gastro-intestinal tolerability, the starting dose is 0.6 mg liraglutide daily.
Slovenian: Da bi izboljšali prenašanje v prebavilih, je začetni odmerek 0,6 mg liraglutida na dan.
English: After first use of the pen, store below 30°C or in a refrigerator.
Slovenian: Po prvi uporabi shranjujte injekcijski peresnik pri temperaturi do 30 °C ali v hladilniku.
English: Victoza contains less than 1 mmol sodium (23 mg) per dose, therefore the medicinal product is essentially ‘sodium-free'.
Slovenian: Zdravilo Victoza vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni "brez natrija".
English: Please dispose of the pen and needle in accordance with local requirements.
Slovenian: Injekcijski peresnik in iglo zavrzite v skladu z lokalnimi predpisi.
English: Inject the full dose with a new pen:
Slovenian: Celotni odmerek injicirate z novim injekcijskim peresnikom:
English: With continued therapy, the frequency and severity decreased in most patients who initially experienced nausea.
Slovenian: Med nadaljnjim zdravljenjem se je pri večini bolnikov, pri katerih se je na začetku pojavila navzea, pogostnost in izrazitost teh težav zmanjšala.
English: Patients >70 years may experience more gastrointestinal effects when treated with liraglutide.
Slovenian: Bolniki, starejši od 70 let, imajo lahko med zdravljenjem z liraglutidom več neželenih učinkov na prebavilih.
English: Neonatal growth was reduced in rats while exposed to Victoza, and persisted in the post-weaning period in the high dose group.
Slovenian: Pri podganah se je med izpostavljenostjo zdravilu Victoza upočasnila neonatalna rast, to pa se je v skupini, ki je prejemala velik odmerek, nadaljevalo tudi v obdobju po prenehanju sesanja.
English: Taking into account the PRAC Assessment Report on the PSUR for liraglutide, the scientific conclusions of CHMP are as follows:
Slovenian: Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za liraglutid je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
English: A drop of liraglutide should appear at the needle tip.
Slovenian: Na konici igle se mora pojaviti kapljica liraglutida.
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).
Slovenian: V preskušanju LEADER je bila pogostnost holelitiaze in holecistitisa 1,5 % oziroma 1,1 % pri liraglutidu in 1,1 % oziroma 0,7 % pri placebu (glejte poglavje 5.1).
English: When you have found the most convenient time of the day it is preferred that you inject Victoza around the same time of the day.
Slovenian: Ko ugotovite, kdaj je za vas najprimernejši čas, priporočamo, da si zdravilo Victoza vsak dan injicirate približno ob istem času.
English: When combining liraglutide with metformin, 20.7% of patients reported at least one episode of nausea, and 12.6% of patients reported at least one episode of diarrhoea.
Slovenian: Pri uporabi liraglutida skupaj z metforminom se je pri 20,7 % bolnikov vsaj enkrat pojavila navzea in pri 12,6 % bolnikov vsaj enkrat driska.
English: Dehydration
Slovenian: Dehidracija
English: Most episodes were mild to moderate and occurred in a dose-dependent fashion.
Slovenian: V večini primerov so bili ti neželeni učinki blagi do zmerni, pojavili pa so se odvisno od odmerka.
English: Hazard Ratio (95% CI)
Slovenian: (95 % IZ)
English: Liraglutide exposure was reduced in patients with renal impairment compared to individuals with normal renal function.
Slovenian: Izpostavljenost liraglutidu je bila pri bolnikih z okvaro ledvic manjša kot pri osebah z normalnim delovanjem ledvic.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION
Slovenian: IME ZDRAVILA IN POT UPORABE
English: A single dose administration of lisinopril 20 mg with liraglutide resulted in a reduction of lisinopril AUC by 15%; Cmax decreased by 27%.
Slovenian: Enkratni odmerek 20 mg lizinoprila skupaj z liraglutidom je zmanjšal AUC lizinoprila za 15 % ter Cmax za 27 %.
English: Guide the needle tip into the outer needle cap without touching the needle or the outer needle cap.
Slovenian: Konico igle vstavite v zunanji pokrovček igle, ne da bi se dotaknili igle ali zunanjega pokrovčka igle.
English: Based on adequate glycaemic control or tolerability, 30% of trial subjects remained on a dose of 0.6 mg, 17% escalated to a dose of 1.2 mg and 53% escalated to a dose of 1.8 mg.
Slovenian: Na podlagi ustrezne glikemične urejenosti oziroma prenašanja je 30 % preiskovancev v preskušanju ostalo na odmerku 0,6 mg, 17 % so odmerek povečali na 1,2 mg in 53 % na 1,8 mg.
English: Pancreatitis was also reported from marketed use.
Slovenian: O primerih pankreatitisa so poročali tudi po prihodu zdravila na trg.
English: Table 1 Adverse reactions from long-term controlled phase 3a trials, the long-term cardiovascular outcome trial (LEADER) and spontaneous (post-marketing) reports
Slovenian: Preglednica 1 Neželeni učinki iz dolgotrajnih kontroliranih preskušanj faze 3a, dolgotrajnega preskušanja o srčno-žilnih izidih (LEADER) in neželeni učinki, spontano poročani po začetku trženja
English: In the LEADER trial, severe hypoglycaemic episodes were reported at a lower rate with liraglutide vs placebo (1.0 vs 1.5 events per 100 patient years; estimated rate ratio 0.69 [0.51 to 0.93]) (see section 5.1).
Slovenian: V preskušanju LEADER so o primerih hude hipoglikemije po uporabi liraglutida poročali pri manjšem deležu bolnikov kot pri placebu (1,0 napram 1,5 primera na 100 bolnik-let; ocenjeno razmerje pojavnosti 0,69 [0,51 do 0,93]) (glejte poglavje 5.1).
English: Victoza can be used in adolescents and children aged 10 years and above.
Slovenian: Otroci in mladostniki Zdravilo Victoza se lahko uporablja pri mladostnikih in otrocih, starih 10 let ali več.
English: Only a minor part of the administered radioactivity was excreted as liraglutide-related metabolites in urine or faeces (6% and 5%, respectively).
Slovenian: Samo manjši del aplicirane radioaktivnosti se je v urinu (6 %) ali blatu (5 %) izločil v obliki liraglutidu sorodnih presnovkov.
English: There was no consistent pattern with respect to system organ class of events.
Slovenian: Konsistentnega vzorca pojavljanja neželenih učinkov glede na organski sistem ni bilo.
English: Talk to your doctor, pharmacist or nurse:
Slovenian: Z zdravnikom, farmacevtom ali medicinsko sestro se posvetujte:
English: Screw the needle straight and tightly onto your pen.
Slovenian: Iglo naravnost in trdno privijte na injekcijski peresnik.
English: Gender
Slovenian: Spol
English: Victoza is not recommended for use in patients with severe hepatic impairment (see section 5.2).
Slovenian: Zdravljenje z zdravilom Victoza ni priporočljivo pri bolnikih s hudo okvaro jeter (glejte poglavje 5.2).
English: Pancreatitis
Slovenian: Pankreatitis
English: When Victoza is added to a sulfonylurea or insulin, a reduction in the dose of sulfonylurea or insulin should be considered to reduce the risk of hypoglycaemia (see section 4.4).
Slovenian: Če se zdravilo Victoza uporablja kot dodatek k sulfonilsečnini ali insulinu, pride v poštev zmanjšanje odmerka sulfonilsečnine ali insulina, da bi zmanjšali tveganje za hipoglikemijo (glejte poglavje 4.4).
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).
Slovenian: V preskušanju LEADER je bila pogostnost s presojo potrjenega akutnega pankreatitisa 0,4 % pri liraglutidu in 0,5 % pri placebu (glejte poglavji 4.4 in 5.1)
English: The intra-subject coefficient of variation for liraglutide AUC was 11% following single dose administration.
Slovenian: Intraindividualni koeficient variacije AUC liraglutida je bil po enkratnem odmerku 11 %.
English: Elderly patients
Slovenian: Posebne skupine bolnikov Starejši bolniki
English: Post-hoc analysis of serious major adverse cardiovascular events (cardiovascular death, myocardial infarction, stroke) from all intermediate and long-term phase 2 and 3 trials (ranging from 26 and up to 100 weeks duration) including 5,607 patients (3,651 exposed to liraglutide), showed no increase in cardiovascular risk (incidence ratio of 0.75 (95% CI 0.35; 1.63)) for liraglutide versus all comparators.
Slovenian: Post hoc analiza pomembnih srčno-žilnih resnih neželenih dogodkov (smrt zaradi srčno-žilnih zapletov, miokardni infarkt, možganska kap) iz vseh srednje- in dolgoročnih preskušanj faze 2 in 3, ki so trajala od 26 do 100 tednov in so zajemala skupno 5.607 bolnikov (3.651 izpostavljenih liraglutidu) pri liraglutidu ni pokazala povečanega tveganja za srčno-žilne dogodke (incidenčni delež 0,75 (95 % IZ: 0,35 do 1,63)) v primerjavi z vsemi primerjalnimi učinkovinami..
English: In the LEADER trial, (see subsection Cardiovascular evaluation), 873 patients were on premix insulin (with or without OAD(s)) at baseline and at least for the following 26 weeks.
Slovenian: V preskušanju LEADER (glejte podpoglavje Vrednotenje srčno-žilnega sistema) je 873 bolnikov od začetka in še najmanj naslednjih 26 tednov prejemalo pripravljeno mešanico insulina (s peroralnim/i antidiabetikom/i ali brez).
English: The pharmacokinetics of liraglutide was evaluated in patients with varying degree of hepatic impairment in a single-dose trial.
Slovenian: Farmakokinetiko liraglutida pri bolnikih z različno stopnjo okvare jeter so ocenili v preskušanju z enkratnim odmerkom.
English: Diarrhoea may affect the absorption of concomitant oral medicinal products.
Slovenian: Driska lahko prav tako vpliva na absorpcijo peroralnih zdravil, ki jih bolnik jemlje sočasno.
English: The use of Victoza is not recommended if you have severe liver disease.
Slovenian: Uporaba zdravila Victoza ni priporočljiva, če imate hudo bolezen jeter.
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Victoza Vsebina pakiranja in dodatne informacije
English: Liraglutide has 24-hour duration of action and improves glycaemic control by lowering fasting and postprandial blood glucose in patients with type 2 diabetes mellitus.
Slovenian: Liraglutid deluje 24 ur in pri bolnikih s sladkorno boleznijo tipa 2 izboljša uravnavanje glikemije z znižanjem koncentracije glukoze v krvi na tešče in postprandialno.
English: Treatment with liraglutide in combination with metformin, metformin and glimepiride, metformin and rosiglitazone or SGLT2i with or without metformin was associated with a sustained weight reduction in the range from 0.86 kg to 2.62 kg compared with placebo.
Slovenian: Zdravljenje z liraglutidom skupaj z metforminom, metforminom in glimepiridom, metforminom in rosiglitazonom ali zaviralcem SGLT2 ± metformin je bilo povezano s stalnim zmanjševanjem telesne mase od 0,86 do 2,62 kg v primerjavi s placebom.
English: The risk of hypoglycaemia is low with combined use of basal insulin and liraglutide (1.0 events per patient year, see section 5.1).
Slovenian: Pri uporabi bazalnega insulina v kombinaciji z liraglutidom je tveganje za hipoglikemijo majhno (1,0 dogodka na bolnik let, glejte poglavje 5.1).
English: INSTRUCTIONS FOR USING THE VICTOZA PEN Please read these instructions carefully before using your pen.
Slovenian: NAVODILA ZA UPORABO INJEKCIJSKEGA PERESNIKA VICTOZA Pred uporabo injekcijskega peresnika natančno preberite ta navodila.
English: When you are not using the pen, keep the pen cap on in order to protect from light.
Slovenian: Kadar injekcijskega peresnika ne uporabljate, naj bo pokrit s pokrovčkom, za zagotovitev zaščite pred svetlobo.
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.
Slovenian: V preglednici 1 je prikazan seznam neželenih učinkov, ki so bili ugotovljeni v dolgotrajnih kontroliranih preskušanjih faze 3a, preskušanju LEADER (dolgotrajno preskušanje o srčno-žilnih izidih) in tistih, ki so bili spontano poročani po začetku trženja.
English: Turn the dose selector until your needed dose lines up with the pointer (0.6 mg, 1.2 mg or 1.8 mg).
Slovenian: Izbirnik odmerka zavrtite, dokler potrebni odmerek ni poravnan s kazalnikom (0,6 mg, 1,2 mg ali 1,8 mg).
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]).
Slovenian: Pri liraglutidu je bilo opaženo pomembno in konstantno znižanje HbA1c od izhodišča do 36. meseca v primerjavi s placebom, poleg standardne oskrbe (1,16 % napram -0,77 %; ocenjena razlika med zdravljenji -0,40 % [-0,45; -0,34]).
English: Do not freeze.
Slovenian: Ne zamrzujte.
English: In the LEADER trial, microvascular events comprised nephropathy and retinopathy outcomes.
Slovenian: • Vrednotenje mikrovaskularnih dogodkov V preskušanju LEADER so mikrovaskularni dogodki obsegali nefropatijo in retinopatijo.
English: - The active substance is liraglutide.
Slovenian: - Učinkovina je liraglutid.
English: >5.5 and <6.7 mmol/l (>100 and <120 mg/dl) 0-2 IUa ≥6.7 mmol/l (≥120 mg/dl)
Slovenian: > 5,5 in < 6,7 mmol/l (> 100 in < 120 mg/dl)
English: Non-fatal myocardial infarction Expanded MACE
Slovenian: Miokardni infarkt brez smrtnega izida Razširjeni MACE
English: Clear and colourless or almost colourless, isotonic solution; pH=8.15.
Slovenian: raztopina za injiciranje Bistra in brezbarvna ali skoraj brezbarvna, izotonična raztopina s pH 8,15.
English: • Sulfonylurea (such as glimepiride or glibenclamide) or insulin.
Slovenian: • sulfonilsečnino (na primer glimepirid ali glibenklamid) ali insulin; med uporabo zdravila
English: During the 26 weeks, there were 12 serious events in 235 patients (5.1%) using liraglutide, whereas there were 6 serious adverse events in 232 patients (2.6%) using exenatide.
Slovenian: resnih neželenih učinkov pri 235 bolnikih (5,1 %), ki so prejemali liraglutid, in 6 resnih neželenih učinkov pri 232 bolnikih (2,6 %), ki so prejemali eksenatid.
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).
Slovenian: Pri bolnikih, ki so bili pred potrjeno hipoglikemijo zdravljeni z insulinom, je bil delež z liraglutidom večji (1,82 dogodka/bolnik leto) kot s placebom (0,91 dogodka/bolnik-leto).
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.
Slovenian: 9.340 bolnikov je bilo naključno razporejenih v skupino z liraglutidom (4.668) ali placebom (4.672),
English: Subcutaneous use
Slovenian: za subkutano uporabo
English: If you use more Victoza than you should, talk to your doctor straight away.
Slovenian: Če ste uporabili večji odmerek zdravila Victoza, kot bi smeli Če ste uporabili večji odmerek zdravila Victoza, kot bi smeli, se nemudoma posvetujte z zdravnikom.
English: None of the patients reported severe hypoglycaemia.
Slovenian: Pri nobenem bolniku pa se ni pojavila huda hipoglikemija.
English: Non-clinical studies have shown a treatment-related reduction of neonatal growth in suckling rat pups (see section 5.3).
Slovenian: Neklinične študije na dojenih podganjih mladičih so pokazale z zdravljenjem povezano zmanjšanje neonatalne rasti (glejte poglavje
English: Marketing Authorisation Holder and Manufacturer
Slovenian: Imetnik dovoljenja za promet z zdravilom in proizvajalec
English: However, it is preferable that Victoza is injected around the same time of the day, when the most convenient time of the day has been chosen.
Slovenian: Vendar je priporočljivo zdravilo Victoza injicirati vsak dan ob istem času,
English: Following subcutaneous administration, the protracted action profile is based on three mechanisms: self-association, which results in slow absorption; binding to albumin; and higher enzymatic stability towards the dipeptidyl peptidase -4 (DPP-4) and neutral endopeptidase (NEP) enzymes, resulting in a long plasma half-life.
Slovenian: ki upočasni absorpcijo, vezavi na albumin ter večji stabilnosti proti delovanju dipeptidil peptidaze 4 (DPP-4) in nevtralne endopeptidaze, kar povzroči dolg razpolovni čas v plazmi.
English: MARKETING AUTHORISATION NUMBERS
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET
English: Body weight loss was observed in both treatment arms (-4.3 kg with liraglutide and -3.7 kg with lixisenatide).
Slovenian: V obeh skupinah zdravljenja so opazili zmanjšanje telesne mase (-4,3 kg pri liraglutidu in -3,7 kg pri liksisenatidu).
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.
Slovenian: Victoza skupaj s sulfonilsečnino ali insulinom lahko pride do hipoglikemije (nizkega krvnega sladkorja), ker sulfonilsečnine ali insulin povečujejo tveganje za nastanek hipoglikemije.
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).
Slovenian: 26-tedensko kombinirano zdravljenje z liraglutidom in metforminom, glimepiridom ali metforminom in rosiglitazonom ali zaviralcem SGLT2 ± metformin je povzročilo statistično značilno in trajno zmanjšanje vrednosti HbA1c v primerjavi z bolniki, ki so prejemali placebo (preglednica 2).
English: Self-monitoring of blood glucose is not needed in order to adjust the dose of Victoza.
Slovenian: Za prilagoditev odmerka zdravila Victoza ni potrebna samokontrola glukoze v krvi.
English: Substances added to Victoza may cause degradation of liraglutide.
Slovenian: 6.2 Inkompatibilnosti Snovi, dodane zdravilu Victoza, lahko povzročijo razgradnjo liraglutida.
English: • if you have or have had a disease of the pancreas.
Slovenian: • pred začetkom uporabe zdravila Victoza, • če imate ali ste kdaj imeli bolezen trebušne slinavke.
English: even if their signs of illness are the same as yours.
Slovenian: Njim bi lahko celo škodovalo, čeprav imajo znake bolezni, podobne vašim.
English: Dispose of it carefully and put the pen cap back on.
Slovenian: Pazljivo jo zavrzite in na injekcijski peresnik znova namestite njegov pokrovček.
English: Cholelithiasis and cholecystitis
Slovenian: Holelitiaza in holecistitis
English: The dose selector clicks when you turn it. Do not use these clicks to select your dose.
Slovenian: Ne uporabljajte teh klikov za izbiro odmerka.
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.
Slovenian: Med liraglutidom in insulinom detemir niso opazili medsebojnih farmakokinetičnih ali farmakodinamskih interakcij, če je bil insulin detemir pri osebah s sladkorno boleznijo tipa 2 uporabljen v enkratnem odmerku 0,5 e./kg skupaj z 1,8 mg liraglutida v stanju dinamičnega ravnovesja.
English: Lisinopril
Slovenian: Lizinopril
English: Elderly patients (>65 years old) No dose adjustment is required based on age (see section 5.2).
Slovenian: Prilagoditev odmerka glede na starost ni potrebna (glejte poglavje 5.2).
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.
Slovenian: Pri bolnikih, ki so bili na začetku in še najmanj 26 tednov zdravljeni s pripravljeno mešanico insulina, je bil delež hude hipoglikemije pri tistih, ki so prejemali liraglutid, kot tudi tistih, ki so prejemali placebo, 2,2 primera na 100 bolnik-let.
English: Victoza pen is designed to be used with NovoFine or NovoTwist disposable needles.
Slovenian: Injekcijski peresnik Victoza je namenjen za uporabo z iglami NovoFine ali NovoTwist za enkratno uporabo.
English: Each pen contains 3 ml of solution, delivering 30 doses of 0.6 mg, 15 doses of 1.2 mg or 10 doses of 1.8 mg.
Slovenian: En injekcijski peresnik vsebuje 3 ml raztopine, ki zadostuje za 30 odmerkov po 0,6 mg, 15 odmerkov po 1,2 mg ali 10 odmerkov po 1,8 mg.
English: Furthermore, hypoglycaemia was common, and very common when liraglutide is used in combination with a sulfonylurea.
Slovenian: Pogosta je bila tudi hipoglikemija, pri bolnikih, ki so prejemali liraglutid skupaj s sulfonilsečnino, pa je bila zelo pogosta.
English: Clinical trials with liraglutide indicate improved beta-cell function based on measures such as the homeostasis model assessment for beta-cell function (HOMA-B) and the proinsulin to insulin ratio.
Slovenian: To je bilo ugotovljeno na podlagi meril, kakršni sta na primer ocena delovanja celic beta s homeostatskim modelom (HOMA-B)
English: Liraglutide was superior in preventing MACE vs placebo (Figure 1).
Slovenian: Liraglutid je bil superioren pri preprečevanju pomembnih srčno-žilnih neželenih dogodkov v primerjavi s placebom (slika 1).
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Slovenian: Študije na živalih so pokazale toksične učinke na sposobnost razmnoževanja (glejte poglavje 5.3) Možno tveganje za ljudi ni znano.
English: Keep the needle pointing up and press the dose button until 0 mg lines up with the pointer.
Slovenian: Še naprej držite injekcijski peresnik tako, da bo igla obrnjena navzgor, in pritisnite potisni gumb, dokler oznaka za 0 mg ne bo poravnana s kazalnikom.