natgillin/translations-raw huggingface dataset:
If the dose selector stops before your needed dose lines up with the pointer, there is not enough liraglutide left for a full dose.
Če se izbirnik odmerka ustavi, preden se želeni odmerek poravna s kazalnikom, to pomeni, da ni več dovolj liraglutida za celotni odmerek.
The CHMP recommends that the terms of the marketing authorisation should be varied.
Odbor CHMP zato priporoča spremembo pogojev dovoljenja (dovoljenj) za promet z zdravilom.
The HR for liraglutide vs placebo was 0.78 [0.67, 0.92] for time to first nephropathy event and 1.15 [0.87, 1.52] for time to first retinopathy event.
Razmerje ogroženosti za liraglutid v primerjavi s placebom je bilo 0,78 [0,67, 0,92] pri času do prvega dogodka nefropatije in 1,15 [0,87, 1,52] pri času do prvega dogodka retinopatije.
In rats, a no observed adverse effect level (NOAEL) was not observed.
(NOAEL - No Observed Adverse Effect Level).
Some patients are expected to benefit from an increase in dose from 1.2 mg to 1.8 mg and based on clinical response, after at least one week, the dose can be increased to 1.8 mg to further improve glycaemic control.
Po vsaj enem tednu je treba odmerek povečati na 1,2 mg. Nekaterim bolnikom lahko koristi povečanje odmerka z 1,2 mg na 1,8 mg; glede na klinični odziv je mogoče odmerek po vsaj enem tednu zdravljenja povečati na 1,8 mg za dodatno izboljšanje urejenosti glikemije.
No data are available for children below 10 years of age (see sections 5.1 and 5.2).
let, podatki niso na voljo (glejte poglavji 5.1 in 5.2).
Cartridge (type 1 glass) with a plunger (bromobutyl) and a laminate rubber sheet (bromobutyl/polyisoprene) contained in a pre-filled multidose disposable pen made of polyolefin and polyacetal.
Vložek (steklo tipa I) z batom (brombutil) in laminatno gumijasto prevleko (brombutil/poliizopren) v večodmernem napolnjenem injekcijskem peresniku za enkratno uporabo iz poliolefina in poliacetala.
The small delay of gastric emptying with liraglutide may influence absorption of concomitantly administered oral medicinal products.
Rahla upočasnitev pri praznjenju želodca pri zdravljenju z liraglutidom lahko vpliva na absorpcijo sočasno uporabljenih peroralnih zdravil.
Titration of the insulin glargine dose was managed by the patient after instruction by the investigator:
Odmerek insulina glargin je prilagajal bolnik po navodilih raziskovalca.
Patients receiving liraglutide in combination with a sulfonylurea or insulin may have an increased risk of hypoglycaemia (see section 4.8).
Bolniki, ki dobivajo liraglutid skupaj s sulfonilsečnino ali insulinom, imajo lahko večje tveganje za hipoglikemijo (glejte poglavje 4.8).
If you forget to use Victoza
Če ste pozabili uporabiti zdravilo Victoza
Be careful not to touch the display with your other fingers or press the dose selector sideways when you inject.
Pazite, da se med injiciranjem z drugimi prsti ne boste dotaknili zaslona ali izbirnika odmerka potisnili vstran.
In both groups a decrease in body weight was seen: -2.4 kg with liraglutide vs -1.09 kg with placebo.
V obeh skupinah so ugotovili zmanjšanje telesne mase; -2,4 kg z liraglutidom in -1,09 kg s placebom.
After first use: Store below 30°C or store in a refrigerator (2°C-8°C).
Po prvi uporabi: Shranjujte pri temperaturi do 30 °C ali shranjujte v hladilniku (2 °C - 8 °C).
Generally, the patients reported severe nausea, vomiting and diarrhoea.
Večinoma so bolniki poročali o hudi navzeji, bruhanju in driski.
Your doctor may reduce your dose of these medicines before you start using Victoza.
Zdravnik lahko pred uvedbo zdravljenja z zdravilom Victoza odmerek teh zdravil zmanjša.
Following a [3H]-liraglutide dose, intact liraglutide was not detected in urine or faeces.
Po odmerku [3H]-liraglutida v urinu ali blatu ni bilo nespremenjenega liraglutida.
In a 104-week clinical trial, 57% of patients with type 2 diabetes treated with insulin degludec in combination with metformin achieved a target HbA1c <7% and the remaining patients continued in a
V 104-tedenskem kliničnem preskušanju je 57 % bolnikov s sladkorno boleznijo tipa 2 pri zdravljenju z insulinom degludek v kombinaciji z metforminom doseglo ciljno vrednost HbA1c < 7 %.
Additional trials were conducted with liraglutide that included 1,901 patients in four unblinded, randomised, controlled clinical trials (including 464, 658, 323 and 177 patients per trial) and one double-blind, randomised, controlled clinical trial in patients with type 2 diabetes mellitus and moderate renal impairment (279 patients).
Z liraglutidom so opravili dodatna štiri slepa, randomizirana, kontrolirana klinična preskušanja s skupno 1.901 bolnikom (v posameznih preskušanjih je bilo vključenih 464, 658, 323 oz. 177 bolnikov) in eno dvojno slepo, randomizirano, kontrolirano klinično preskušanje pri bolnikih s sladkorno boleznijo tipa 2 in zmerno okvaro ledvic (vključenih 279 bolnikov).
Pack sizes of 1, 2, 3, 5 or 10 pre-filled pens.
V pakiranju je 1, 2, 3, 5 ali 10 napolnjenih injekcijskih peresnikov.
Pull off the inner needle cap and dispose of it.
Snemite notranji pokrovček igle in ga zavrzite.
As there is sufficient evidence to conclude on a causal relationship between delayed gastric emptying and liraglutide, delayed gastric emptying should be included as an ADR in section 4.8 of the SmPC with a frequency allocation of ‘uncommon' and in section 4 of the Package Leaflet.
Ker je na voljo dovolj dokazov, ki kažejo na vzročno povezanost med zakasnelim praznjenjem želodca in liraglutidom, je treba zakasnelo praznjenje želodca vključiti kot neželeni učinek zdravila v poglavje 4.8 Povzetka glavnih značilnosti zdravila s pogostnostjo ‘občasni', in v poglavje 4
There is limited experience in patients with inflammatory bowel disease and diabetic gastroparesis.
Izkušenj pri zdravljenju bolnikov s kronično vnetno črevesno boleznijo in diabetično gastroparezo je malo.
Diabetic ketoacidosis has been reported in insulin-dependent patients after rapid discontinuation or dose reduction of insulin (see section 4.2).
Pri bolnikih, odvisnih od insulina, so po hitri ukinitvi ali zmanjšanju odmerka insulina poročali o diabetični ketoacidozi (glejte poglavje 4.2).
• Cardiovascular evaluation
• Vrednotenje srčno-žilnega sistema
The safety profile of liraglutide in combination with premix insulin was overall comparable to that observed for placebo in combination with premix insulin (see section 4.8).
Varnostni profil kombinacije liraglutida in pripravljene mešanice insulina je bil v celoti primerljiv z varnostnim profilom kombinacije placeba in pripravljene mešanice insulina (glejte poglavje 4.8).
Be careful not to press the dose button when turning the dose selector backwards, as liraglutide may come out.
Pazite, da ne boste med vrtenjem izbirnika odmerka pritisnili na potisni gumb, ker bi s tem lahko iztisnili liraglutid.
Additional components in expanded MACE: Unstable angina pectoris (hospitalisation) Coronary revascularisation Heart failure (hospitalisation) Other secondary endpoints:
Dodatne komponente razširjenih MACE: Nestabilna angina pektoris (hospitalizacija)
Name and address of the manufacturer responsible for batch release
Ime in naslov proizvajalca, odgovornega za sproščanje serij
- The other ingredients are disodium phosphate dihydrate, propylene glycol, phenol and water for injections.
- Druge sestavine zdravila so natrijev hidrogenfosfat dihidrat, propilenglikol, fenol in voda za injekcije.
Simultaneously, liraglutide lowers inappropriately high glucagon secretion, also in a glucose-dependent manner.
Hkrati liraglutid zmanjšuje neprimerno veliko izločanje glukagona, prav tako odvisno od koncentracije glukoze.
When initiating treatment with Victoza, you may in some cases experience loss of fluids/dehydration, e.g. in case of vomiting, nausea and diarrhoea.
Po uvedbi zdravljenja z zdravilom Victoza se lahko v nekaterih primerih pojavi izguba tekočine (dehidracija), npr. v primeru bruhanja, siljenja na bruhanje in driske.
The rate of hypoglycaemic episodes (per patient year of exposure) was statistically significantly lower when adding liraglutide compared to adding a single dose of insulin aspart (1.0 vs 8.15; ratio: 0.13; 95% CI: 0.08 to 0.21).
Pri dodatku liraglutida je bil delež hipoglikemičnih epizod (na bolnik-let izpostavljenosti) statistično pomembno manjši kot pri dodatku enega odmerka insulina aspart (1,0 v primerjavi z 8,15; razmerje: 0,13; 95 % IZ: 0,08 do 0,21).
Liraglutide exposure was decreased by 13-23% in patients with mild to moderate hepatic impairment compared to healthy subjects.
Izpostavljenost liraglutidu je bila pri bolnikih z blago do zmerno okvaro jeter za 13-23 % manjša kot pri zdravih osebah.
Insert the needle into your skin using the injection technique shown by your doctor or nurse.
Iglo zabodite v kožo tako, kot sta vam pokazala zdravnik ali medicinska sestra.
A single dose administration of digoxin 1 mg with liraglutide resulted in a reduction of digoxin AUC by 16%; Cmax decreased by 31%.
Enkratni odmerek 1 mg digoksina skupaj z liraglutidom je zmanjšal AUC digoksina za 16 % ter Cmax za 31 %.
What Victoza looks like and contents of the pack
Izgled zdravila Victoza in vsebina pakiranja
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
se zdravila ne sme mešati z drugimi zdravili.
Very few episodes (0.001 events/patient year) were observed with administration of liraglutide in combination with oral antidiabetics other than sulfonylureas.
Zelo malo takšnih primerov (0,001 primerov/bolnik-let) je bilo zabeleženih med uporabo liraglutida skupaj z nesulfonilsečninskimi peroralnimi antidiabetiki.
If you stop using Victoza
Če ste prenehali uporabljati zdravilo Victoza
The most frequently reported adverse reactions were gastrointestinal disorders, infections and infestations.
Najpogosteje opisani neželeni učinki so bile bolezni prebavil, infekcijske in parazitske bolezni.
The best places to give yourself the injection are the front of your thighs, the front of your waist (abdomen), or your upper arm.
Najprimernejša mesta za injiciranje so sprednji del stegna, sprednji del trebuha ali nadlaket.
Upon initiation of liraglutide treatment in patients on warfarin or other coumarin derivatives, more frequent monitoring of INR (International Normalised Ratio) is recommended.
Pri bolnikih, ki jemljejo varfarin ali druge kumarinske derivate, na začetku zdravljenja z liraglutidom priporočamo pogostejši nadzor mednarodnega normaliziranega razmerja
MedDRA system organ classes
MedDRA organski sistem
• Gastro-oesophageal reflux disease (GORD).
• gastroezofagealna refluksna bolezen (GERB); med znaki je zgaga
Therefore, no dose adjustment of atorvastatin is required when given with liraglutide.
Zato prilagoditev odmerka atorvastatina pri hkratni uporabi liraglutida ni potrebna.
Treatment with liraglutide produced clinically and statistically significant improvements in glycosylated haemoglobin A1c (HbA1c), fasting plasma glucose and postprandial glucose compared with placebo.
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.
Increased lipase*
povečana koncentracija amilaze*
To improve gastro-intestinal tolerability, the starting dose is 0.6 mg liraglutide daily.
Da bi izboljšali prenašanje v prebavilih, je začetni odmerek 0,6 mg liraglutida na dan.
After first use of the pen, store below 30°C or in a refrigerator.
Po prvi uporabi shranjujte injekcijski peresnik pri temperaturi do 30 °C ali v hladilniku.
Victoza contains less than 1 mmol sodium (23 mg) per dose, therefore the medicinal product is essentially ‘sodium-free'.
Zdravilo Victoza vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni "brez natrija".
Please dispose of the pen and needle in accordance with local requirements.
Injekcijski peresnik in iglo zavrzite v skladu z lokalnimi predpisi.
Inject the full dose with a new pen:
Celotni odmerek injicirate z novim injekcijskim peresnikom:
With continued therapy, the frequency and severity decreased in most patients who initially experienced nausea.
Med nadaljnjim zdravljenjem se je pri večini bolnikov, pri katerih se je na začetku pojavila navzea, pogostnost in izrazitost teh težav zmanjšala.
Patients >70 years may experience more gastrointestinal effects when treated with liraglutide.
Bolniki, starejši od 70 let, imajo lahko med zdravljenjem z liraglutidom več neželenih učinkov na prebavilih.
Neonatal growth was reduced in rats while exposed to Victoza, and persisted in the post-weaning period in the high dose group.
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.
Taking into account the PRAC Assessment Report on the PSUR for liraglutide, the scientific conclusions of CHMP are as follows:
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:
A drop of liraglutide should appear at the needle tip.
Na konici igle se mora pojaviti kapljica liraglutida.
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).
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).
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.
Ko ugotovite, kdaj je za vas najprimernejši čas, priporočamo, da si zdravilo Victoza vsak dan injicirate približno ob istem času.
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.
Pri uporabi liraglutida skupaj z metforminom se je pri 20,7 % bolnikov vsaj enkrat pojavila navzea in pri 12,6 % bolnikov vsaj enkrat driska.
Most episodes were mild to moderate and occurred in a dose-dependent fashion.
V večini primerov so bili ti neželeni učinki blagi do zmerni, pojavili pa so se odvisno od odmerka.
Hazard Ratio (95% CI)
(95 % IZ)
Liraglutide exposure was reduced in patients with renal impairment compared to individuals with normal renal function.
Izpostavljenost liraglutidu je bila pri bolnikih z okvaro ledvic manjša kot pri osebah z normalnim delovanjem ledvic.
NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION
IME ZDRAVILA IN POT UPORABE
A single dose administration of lisinopril 20 mg with liraglutide resulted in a reduction of lisinopril AUC by 15%; Cmax decreased by 27%.
Enkratni odmerek 20 mg lizinoprila skupaj z liraglutidom je zmanjšal AUC lizinoprila za 15 % ter Cmax za 27 %.
Guide the needle tip into the outer needle cap without touching the needle or the outer needle cap.
Konico igle vstavite v zunanji pokrovček igle, ne da bi se dotaknili igle ali zunanjega pokrovčka igle.
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.
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.
Pancreatitis was also reported from marketed use.
O primerih pankreatitisa so poročali tudi po prihodu zdravila na trg.
Table 1 Adverse reactions from long-term controlled phase 3a trials, the long-term cardiovascular outcome trial (LEADER) and spontaneous (post-marketing) reports
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
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).
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).
Victoza can be used in adolescents and children aged 10 years and above.
Otroci in mladostniki Zdravilo Victoza se lahko uporablja pri mladostnikih in otrocih, starih 10 let ali več.
Only a minor part of the administered radioactivity was excreted as liraglutide-related metabolites in urine or faeces (6% and 5%, respectively).
Samo manjši del aplicirane radioaktivnosti se je v urinu (6 %) ali blatu (5 %) izločil v obliki liraglutidu sorodnih presnovkov.
There was no consistent pattern with respect to system organ class of events.
Konsistentnega vzorca pojavljanja neželenih učinkov glede na organski sistem ni bilo.
Talk to your doctor, pharmacist or nurse:
Z zdravnikom, farmacevtom ali medicinsko sestro se posvetujte:
Screw the needle straight and tightly onto your pen.
Iglo naravnost in trdno privijte na injekcijski peresnik.
Victoza is not recommended for use in patients with severe hepatic impairment (see section 5.2).
Zdravljenje z zdravilom Victoza ni priporočljivo pri bolnikih s hudo okvaro jeter (glejte poglavje 5.2).
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).
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).
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).
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)
The intra-subject coefficient of variation for liraglutide AUC was 11% following single dose administration.
Intraindividualni koeficient variacije AUC liraglutida je bil po enkratnem odmerku 11 %.
Elderly patients
Posebne skupine bolnikov Starejši bolniki
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.
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..
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.
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).
The pharmacokinetics of liraglutide was evaluated in patients with varying degree of hepatic impairment in a single-dose trial.
Farmakokinetiko liraglutida pri bolnikih z različno stopnjo okvare jeter so ocenili v preskušanju z enkratnim odmerkom.
Diarrhoea may affect the absorption of concomitant oral medicinal products.
Driska lahko prav tako vpliva na absorpcijo peroralnih zdravil, ki jih bolnik jemlje sočasno.
The use of Victoza is not recommended if you have severe liver disease.
Uporaba zdravila Victoza ni priporočljiva, če imate hudo bolezen jeter.
Contents of the pack and other information
Shranjevanje zdravila Victoza Vsebina pakiranja in dodatne informacije
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.
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.
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.
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.
The risk of hypoglycaemia is low with combined use of basal insulin and liraglutide (1.0 events per patient year, see section 5.1).
Pri uporabi bazalnega insulina v kombinaciji z liraglutidom je tveganje za hipoglikemijo majhno (1,0 dogodka na bolnik let, glejte poglavje 5.1).
INSTRUCTIONS FOR USING THE VICTOZA PEN Please read these instructions carefully before using your pen.
NAVODILA ZA UPORABO INJEKCIJSKEGA PERESNIKA VICTOZA Pred uporabo injekcijskega peresnika natančno preberite ta navodila.
When you are not using the pen, keep the pen cap on in order to protect from light.
Kadar injekcijskega peresnika ne uporabljate, naj bo pokrit s pokrovčkom, za zagotovitev zaščite pred svetlobo.
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.
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.
Turn the dose selector until your needed dose lines up with the pointer (0.6 mg, 1.2 mg or 1.8 mg).
Izbirnik odmerka zavrtite, dokler potrebni odmerek ni poravnan s kazalnikom (0,6 mg, 1,2 mg ali 1,8 mg).
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]).
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]).
In the LEADER trial, microvascular events comprised nephropathy and retinopathy outcomes.
• Vrednotenje mikrovaskularnih dogodkov V preskušanju LEADER so mikrovaskularni dogodki obsegali nefropatijo in retinopatijo.
- The active substance is liraglutide.
- Učinkovina je liraglutid.
>5.5 and <6.7 mmol/l (>100 and <120 mg/dl) 0-2 IUa ≥6.7 mmol/l (≥120 mg/dl)
> 5,5 in < 6,7 mmol/l (> 100 in < 120 mg/dl)
Non-fatal myocardial infarction Expanded MACE
Miokardni infarkt brez smrtnega izida Razširjeni MACE
Clear and colourless or almost colourless, isotonic solution; pH=8.15.
raztopina za injiciranje Bistra in brezbarvna ali skoraj brezbarvna, izotonična raztopina s pH 8,15.
• Sulfonylurea (such as glimepiride or glibenclamide) or insulin.
• sulfonilsečnino (na primer glimepirid ali glibenklamid) ali insulin; med uporabo zdravila
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.
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.