natgillin/translations-raw huggingface dataset:
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).
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).
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.
9.340 bolnikov je bilo naključno razporejenih v skupino z liraglutidom (4.668) ali placebom (4.672),
Subcutaneous use
za subkutano uporabo
If you use more Victoza than you should, talk to your doctor straight away.
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.
None of the patients reported severe hypoglycaemia.
Pri nobenem bolniku pa se ni pojavila huda hipoglikemija.
Non-clinical studies have shown a treatment-related reduction of neonatal growth in suckling rat pups (see section 5.3).
Neklinične študije na dojenih podganjih mladičih so pokazale z zdravljenjem povezano zmanjšanje neonatalne rasti (glejte poglavje
Marketing Authorisation Holder and Manufacturer
Imetnik dovoljenja za promet z zdravilom in proizvajalec
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.
Vendar je priporočljivo zdravilo Victoza injicirati vsak dan ob istem času,
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.
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.
MARKETING AUTHORISATION NUMBERS
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET
Body weight loss was observed in both treatment arms (-4.3 kg with liraglutide and -3.7 kg with lixisenatide).
V obeh skupinah zdravljenja so opazili zmanjšanje telesne mase (-4,3 kg pri liraglutidu in -3,7 kg pri liksisenatidu).
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.
Victoza skupaj s sulfonilsečnino ali insulinom lahko pride do hipoglikemije (nizkega krvnega sladkorja), ker sulfonilsečnine ali insulin povečujejo tveganje za nastanek hipoglikemije.
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).
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).
Self-monitoring of blood glucose is not needed in order to adjust the dose of Victoza.
Za prilagoditev odmerka zdravila Victoza ni potrebna samokontrola glukoze v krvi.
Substances added to Victoza may cause degradation of liraglutide.
6.2 Inkompatibilnosti Snovi, dodane zdravilu Victoza, lahko povzročijo razgradnjo liraglutida.
• if you have or have had a disease of the pancreas.
• pred začetkom uporabe zdravila Victoza, • če imate ali ste kdaj imeli bolezen trebušne slinavke.
even if their signs of illness are the same as yours.
Njim bi lahko celo škodovalo, čeprav imajo znake bolezni, podobne vašim.
Dispose of it carefully and put the pen cap back on.
Pazljivo jo zavrzite in na injekcijski peresnik znova namestite njegov pokrovček.
Cholelithiasis and cholecystitis
Holelitiaza in holecistitis
The dose selector clicks when you turn it. Do not use these clicks to select your dose.
Ne uporabljajte teh klikov za izbiro odmerka.
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.
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.
Elderly patients (>65 years old) No dose adjustment is required based on age (see section 5.2).
Prilagoditev odmerka glede na starost ni potrebna (glejte poglavje 5.2).
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.
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.
Victoza pen is designed to be used with NovoFine or NovoTwist disposable needles.
Injekcijski peresnik Victoza je namenjen za uporabo z iglami NovoFine ali NovoTwist za enkratno uporabo.
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.
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.
Furthermore, hypoglycaemia was common, and very common when liraglutide is used in combination with a sulfonylurea.
Pogosta je bila tudi hipoglikemija, pri bolnikih, ki so prejemali liraglutid skupaj s sulfonilsečnino, pa je bila zelo pogosta.
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.
To je bilo ugotovljeno na podlagi meril, kakršni sta na primer ocena delovanja celic beta s homeostatskim modelom (HOMA-B)
Liraglutide was superior in preventing MACE vs placebo (Figure 1).
Liraglutid je bil superioren pri preprečevanju pomembnih srčno-žilnih neželenih dogodkov v primerjavi s placebom (slika 1).
Studies in animals have shown reproductive toxicity (see section 5.3).
Študije na živalih so pokazale toksične učinke na sposobnost razmnoževanja (glejte poglavje 5.3) Možno tveganje za ljudi ni znano.
Keep the needle pointing up and press the dose button until 0 mg lines up with the pointer.
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.
In a clinical trial with liraglutide as monotherapy, rates of hypoglycaemia reported with liraglutide were lower than rates reported for patients treated with active comparator (glimepiride).
V kliničnem preskušanju monoterapije z liraglutidom je bil delež hipoglikemij manjši med bolniki, ki so dobivali liraglutid, kot med bolniki, ki so dobivali primerjalno zdravilo (glimepirid).
Press the dose button to inject until 0 mg lines up with the pointer.
Pritisnite potisni gumb in injicirajte zdravilo, dokler se vrednost 0 mg ne poravna s kazalnikom.
Significantly more patients achieved HbA1c below 7% with liraglutide compared with placebo (52.8% vs 19.5%).
Z liraglutidom je v primerjavi s placebom značilno več bolnikov doseglo znižanje HbA1c pod 7 % (52,8 % v primerjavi z 19,5 %).
Animal studies have shown that the transfer of liraglutide and metabolites of close structural relationship into milk is low.
Študije na živalih so pokazale majhno prehajanje liraglutida in njegovih presnovkov s podobno zgradbo v mleko.
• Increased pulse
• zvišan srčni utrip
Disodium phosphate dihydrate, propylene glycol, phenol, water for injections
natrijev hidrogenfosfat dihidrat, propilenglikol, fenol in vodo za injekcije.
p<0.001 for non-inferiority p=0.005 for superiority
95 % IZ [0,78; 0,97] p<0,001 za neinferiornost p=0,005 za superiornost
Few patients treated with liraglutide reported at least one episode of severe diarrhoea.
Pri nekaterih bolnikih, ki so se zdravili z liraglutidom, se je vsaj enkrat pojavila huda driska.
The pen is designed to be used with NovoFine or NovoTwist disposable needles.
Injekcijski peresnik je namenjen za uporabo z iglami NovoFine ali NovoTwist za enkratno uporabo.
After that, you may see a drop liraglutide at the needle tip.
Na konici igle boste morda videli kapljico liraglutida.
When the needle is covered, carefully push the outer needle cap completely on. Then unscrew the needle.
Ko je igla pokrita, zunanji pokrovček previdno do konca potisnite nanjo.
No severe hypoglycaemic episodes occurred in the liraglutide treatment group.
V terapevtski skupini z liraglutidom ni prišlo do pojava hudih hipoglikemij.
Renal impairment Renal failure acute
Bolezni sečil okvara ledvic, akutna odpoved ledvic
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.
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij V poskusih in vitro je bila ugotovljena zelo majhna možnost medsebojnega farmakokinetičnega delovanja liraglutida in drugih učinkovin, ki bi bilo povezano s citokromom P450 ali vezavo na beljakovine v plazmi.
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).
Monoterapija 52-tedensko zdravljenje z liraglutidom v monoterapiji je povzročilo statistično pomembno in trajno zmanjšanje vrednosti HbA1c v primerjavi z glimepiridom v odmerku 8 mg (-0,84 % pri odmerku 1,2 mg in -1,14 % pri odmerku 1,8 mg v primerjavi z -0,51 % pri primerjalnem zdravilu) pri bolnikih, ki so se predhodno zdravili z dieto in telesno vadbo ali s peroralnim antidiabetikom v monoterapiji z ne več kot polovico največjega odmerka (preglednica 2).
• A delay in the emptying of the stomach.
• zakasnelo praznjenje želodca
Injection site reactions have been reported in approximately 2% of patients receiving Victoza in longterm (26 weeks or longer) controlled trials.
Victoza v dolgotrajnih kontroliranih preskušanjih (26 tednov ali dlje).
This usually goes away over time.
• driska; ponavadi sčasoma izgine
Always remove the needle after each injection, and store your pen without a needle attached.
Po vsakem injiciranju odstranite iglo in injekcijski peresnik shranite brez nameščene igle.
Solution for injection.
raztopina za injiciranje
Figure 1: Kaplan Meier plot of time to first MACE - FAS population
Slika 1: Kaplan Meier-jeva krivulja časa do prvega pojava pomembnih srčno-žilnih neželenih dogodkov - analiza podatkov celotne populacije (FAS (Full Analysis Set) Population)
Liraglutide reduces body weight and body fat mass through mechanisms involving reduced hunger and lowered energy intake, GLP-1 is a physiological regulator of appetite and food intake, but the exact mechanism of action is not entirely clear.
GLP-1 je fiziološki regulator apetita in vnosa hrane, vendar pa natančen mehanizem delovanja ni v celoti znan.
Very common: may affect more than 1 in 10 people
Zelo pogosti: pojavijo se lahko pri več kot 1 od 10 bolnikov
Few cases of cholelithiasis (0.4%) and cholecystitis (0.1%) have been reported during long-term, controlled phase 3a clinical trials with liraglutide.
Med dolgotrajnimi, kontroliranimi kliničnimi preskušanji z liraglutidom faze 3a so poročali o nekaj primerih holelitiaze (0,4 %) in holecistitisa (0,1 %).
These trials included 3,978 exposed patients with type 2 diabetes mellitus (2,501 patients treated with liraglutide), 53.7% men and 46.3% women, 797 patients (508 treated with liraglutide) were ≥65 years of age and 113 patients (66 treated with liraglutide) were ≥75 years of age.
V teh preskušanjih je bilo zdravljenju izpostavljenih 3.978 bolnikov s sladkorno boleznijo tipa 2 (2.501 se jih je zdravilo z liraglutidom), od tega 53,7 % moških in 46,3 % žensk.
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;
Potreba po stopnjevanju zdravljenja z insulinom pri bolnikih, ki v izhodišču še niso bili zdravljeni z insulinom, je bila pri liraglutidu zmanjšana do 48 % v primerjavi s placebom (razmerje ogroženosti 0,52 [0,48; 0,57]).
A mean increase in heart rate from baseline of 2 to 3 beats per minute has been observed with liraglutide in long-term clinical trials including LEADER.
V dolgotrajnih kliničnih preskušanjih, vključno s preskušanjem LEADER, je bilo opaženo povprečno povečanje srčnega utripa za 2 do 3 utripe na minuto v primerjavi z izhodiščem.
Thyroid adverse events, such as goitre, have been reported in clinical trials and in particular in patients with pre-existing thyroid disease.
Bolezen ščitnice V kliničnih preskušanjih so bili opisani ščitnični neželeni učinki, kot je golša, in to zlasti pri bolnikih z obstoječo boleznijo ščitnice.
Cardiovascular death
Smrt zaradi srčno-žilnih zapletov
In the insulin degludec + liraglutide arm, the insulin dose was reduced by 20% in order to minimize the risk of hypoglycaemia.
Da bi zmanjšali tveganje za hipoglikemijo, so v skupini z insulinom degludek + liraglutidom odmerek insulina zmanjšali za 20 %.
The reductions in HbA1c and superiority vs sitagliptin observed after 26 weeks of liraglutide treatment (1.2 mg and 1.8 mg) were sustained after 52 weeks of treatment (-1.29% and -1.51% vs -0.88%, p<0.0001).
Znižanje HbA1c in superiornost v primerjavi s sitagliptinom, opažena po 26 tednih zdravljenja z liraglutidom (1,2 mg in 1,8 mg), sta se ohranila tudi po 52 tednih zdravljenja (-1,29 % in -1,51 % v prim.
Liraglutide stimulates insulin secretion in a glucosedependent manner.
Liraglutid spodbudi izločanje insulina odvisno od koncentracije glukoze.
Keep the pen cap on in order to protect from light.
Injekcijski peresnik naj bo pokrit s pokrovčkom za zagotovitev zaščite pred svetlobo.
For use by one person only
Izključno za uporabo pri enem samem bolniku.
The analysis of time to first microvascular event for liraglutide vs placebo had a HR of 0.84 [0.73, 0.97].
Pri analizi časa do prvega mikrovaskularnega dogodka je bilo razmerje ogroženosti 0,84 [0,73, 0,97] za liraglutid v primerjavi s placebom.
The use of Victoza is not recommended if you are on dialysis.
Uporaba zdravila Victoza ni priporočljiva, če se zdravite z dializo.
This is more likely to happen if you also take a sulfonylurea or insulin.
Pojav teh opozorilnih znakov je bolj verjeten, če uporabljate tudi sulfonilsečnino ali insulin.
1 pen 2 pens 3 pens 5 pens 10 pens
1 injekcijski peresnik 2 injekcijska peresnika 3 injekcijski peresniki 5 injekcijskih peresnikov 10 injekcijskih peresnikov
Turn the dose selector in either direction until 0.6 mg or 1.2 mg lines up with the pointer.
Izbirnik odmerka vrtite v ustrezno smer, dokler se s kazalnikom ne poravna vrednost 0,6 mg ali 1,2 mg. Injicirajte odmerek.
Conversely, during hypoglycaemia liraglutide diminishes insulin secretion and does not impair glucagon secretion.
Nasprotno med hipoglikemijo liraglutid zmanjša izločanje insulina, ne zmanjša pa izločanja glukagona.
Greater proportions of patients treated with liraglutide experienced transient nausea vs patients treated with sitagliptin (20.8% and 27.1% for liraglutide vs 4.6% for sitagliptin).
zdravljenimi s sitagliptinom (20,8 % in 27,1 % pri liraglutidu v prim.
This is to make sure that you get your full dose.
Tako zagotovite injiciranje celotnega odmerka.
1 ml contains 6 mg of liraglutide.
1 ml vsebuje 6 mg liraglutida.
Other side effects
Drugi neželeni učinki
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).
Ocenjena največja koncentracija liraglutida pri enkratnem subkutanem 0,6-miligramskem odmerku liraglutida je bila 9,4 nmol/l (pri povprečni telesni masi približno 73 kg).
You may experience nausea, vomiting or diarrhoea.
Pojavi se lahko siljenje na bruhanje, bruhanje ali driska.
Increased amylase* * From controlled phase 3b and 4 clinical trials only where they were measured.
* Podatki iz tistih kliničnih preskušanj faze 3b in 4, kjer so spremljali koncentracijo encimov.
(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).
Pri uporabi liraglutida je statistično značilno več bolnikov doseglo vrednost HbA1c, manjšo od 7 %, kot pri uporabi liksisenatida (74,2 % v primerjavi s 45,5 %, p<0,0001), prav tako pa tudi ciljno vrednost HbA1c, manjšo ali enako 6,5 % (54,6 % v primerjavi s 26,2 %, p<0,0001).
Select your dose Always check that the pointer lines up with 0 mg.
Vedno se prepričajte, da je kazalnik poravnan z vrednostjo 0 mg.
Victoza is used with other medicines for diabetes when they are not enough to control your blood sugar levels.
Zdravilo Victoza se uporablja skupaj z drugimi zdravili za zdravljenje sladkorne bolezni (če ta zdravila ne zadostujejo za ureditev koncentracije krvnega sladkorja), in sicer s:
Non-lethal thyroid C-cell tumours were seen in 2-year carcinogenicity studies in rats and mice.
V dveletni študiji kancerogenosti so pri podganah in miših opazili tumorje parafolikularnih celic ščitnice, ki niso bili smrtni.
Patients treated with liraglutide had a significant decrease in body weight compared to that of patients treated with sitagliptin (-2.9 kg and -3.4 kg vs -1.0 kg, p<0.0001).
Bolnikom, ki so prejemali liraglutid, se je telesna masa značilno bolj znižala kot bolnikom, ki so prejemali sitagliptin (-2,9 kg in -3,4 kg v prim.
Do not use the pen if a drop of liraglutide still does not appear.
Če se kapljica liraglutida še vedno ne pojavi, ne uporabite injekcijskega peresnika.
Serious side effects
Resni neželeni učinki
Rare: may affect up to 1 in 1,000 people
Redki: pojavijo se lahko pri največ 1 od 1.000 bolnikov
• oral antidiabetics (such as metformin, pioglitazone, sulfonylurea, sodium-glucose cotransporter
• peroralnimi antidiabetiki (kot so metformin, pioglitazon, sulfonilsečnine, zaviralci natrijevih glukoznih koprenašalcev 2 (zaviralci SGLT2)) in/ali insulinom.
No dose adjustment is required for adolescents and children aged 10 years and above.
Pediatrična populacija Mladostnikom in otrokom, starim 10 let ali več, odmerka ni treba prilagoditi.
• Keep your pen away from dust, dirt and all kinds of liquids.
• Hranite ga na čistem mestu, kjer ni prahu, umazanije ali tekočin.
Gender had no clinically meaningful effect on the pharmacokinetics of liraglutide based on the results of population pharmacokinetic data analysis of male and female patients and a pharmacokinetic study in healthy subjects.
Glede na rezultate populacijske farmakokinetične analize podatkov bolnikov in bolnic ter rezultate farmakokinetične študije zdravih oseb spol ne vpliva klinično pomembno na farmakokinetiko liraglutida.
• Headache
• glavobol
Very rare: may affect up to 1 in 10,000 people
Zelo redki: pojavijo se lahko pri največ 1 od 10.000 bolnikov
The study population included patients ≥65 years (n=4,329) and ≥75 years (n=836) and patients with mild (n=3,907), moderate (n=1,934) or severe (n=224) renal impairment.
Populacija v študiji je vključevala bolnike ≥ 65 let (n = 4.329) in ≥ 75 let
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).
Po 52 tednih zdravljenja z liraglutidom so pri skupini bolnikov s sladkorno boleznijo tipa 2 (n = 29) ugotovili izboljšano prvo in drugo stopnjo izločanja insulina.
Headache and nasopharyngitis were also common.
Pogosta sta bila tudi glavobol in nazofaringitis.
• Fasting plasma glucose
• Koncentracija glukoze v plazmi na tešče
Non-cardiovascular death
Smrt, ki ni posledica srčno-žilnega zapleta
The pen is designed to be used with NovoFine or NovoTwist disposable injection needles up to a length of 8 mm and as thin as 32G (0.25/0.23 mm).
8 mm in ne tanjšimi kot 32G (0,25/0,23 mm).
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED PEN LABEL
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Contact your doctor if you have any questions or concerns.
Če imate kakšna vprašanja ali vas kaj skrbi, se posvetujte z zdravnikom.
Lisinopril median tmax was delayed from 6 h to 8 h with liraglutide.
Mediani čas do največje koncentracije lizinoprila (tmax) se je pri hkratnem zdravljenju z liraglutidom podaljšal s 6 na 8 ur.
Thus, when blood glucose is high, insulin secretion is stimulated and glucagon secretion is inhibited.
Ko je torej koncentracija glukoze v krvi velika, se izločanje insulina poveča, izločanje glukagona pa zmanjša.
One pre-filled pen contains 18 mg liraglutide in 3 ml.
En napolnjen injekcijski peresnik vsebuje 18 mg liraglutida v 3 ml.
1 ml solution for injection contains 6 mg liraglutide.
1 mililiter raztopine za injiciranje vsebuje 6 mg liraglutida.
No dose adjustment is required for patients with mild, moderate or severe renal impairment.
Okvara ledvic Pri zdravljenju bolnikov z blago, zmerno ali hudo okvaro ledvic prilagoditev odmerka ni potrebna.
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.
Prehod bolnikov s sitagliptina na liraglutid po 52 tednih zdravljenja je povzročil dodatno in statistično značilno znižanje HbA1c (-0,24 % in -0,45 %, 95 % IZ: -0,41 do -0,07
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).
Glede na rezultate farmakokinetične študije zdravih oseb in populacijske farmakokinetične analize podatkov bolnikov (starih od 18 do 80 let) starost ne vpliva klinično pomembno na farmakokinetiko liraglutida.
• 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).
• Delež bolnikov, pri katerih se je vrednost HbA1c zmanjšala Pri uporabi liraglutida samega je bil delež bolnikov, ki so po 52 tednih dosegli vrednost HbA1c ≤ 6,5 %, statistično značilno večji, kot pri bolnikih, ki so prejemali glimepirid (37,6 % pri odmerku
- if you are allergic to liraglutide or any of the other ingredients of this medicine (listed in section
Kaj morate vedeti, preden boste uporabili zdravilo Victoza Ne uporabljajte zdravila Victoza, - če ste alergični na liraglutid ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Severe hypoglycaemia has primarily been observed when combined with a sulfonylurea.
Huda hipoglikemija je bila opisana predvsem pri bolnikih, ki so hkrati prejemali sulfonilsečnino.
You can select doses of 0.6 mg, 1.2 mg and 1.8 mg.
Izberete lahko odmerke 0,6 mg, 1,2 mg in 1,8 mg. Injekcijski peresnik je namenjen za uporabo z iglami
Liraglutide is extensively bound to plasma proteins (>98%).
Liraglutid je v veliki meri vezan na beljakovine v plazmi
Name and address of the manufacturer of the biological active substance
Ime in naslov proizvajalca biološke učinkovine Novo Nordisk A/S