natgillin/translations-raw huggingface dataset:
Patients were randomised (1:1:1) to Eperzan 30 mg once weekly, Eperzan 30 mg once weekly uptitrated to 50 mg once weekly at week 12, or placebo.
Bolniki so bili randomizirani (1:1:1) na zdravilo Eperzan 30 mg enkrat na teden, zdravilo Eperzan 30 mg enkrat na teden z zviševanjem na 50 mg enkrat na teden 12. teden ali na placebo.
It is not known if Eperzan passes into your breast milk.
Eperzan prehaja v materino mleko.
• chest infection (pneumonia)
• okužba v prsnem košu (pljučnica),
6b Hold pen upright, slowly twist the clear cartridge several times in the direction of the arrow until you feel/hear the pen “click” and you see the [3] in the number window (Figure O).
6b Peresnik držite pokonci in prozorni vložek počasi večkrat zasučite v smeri puščice, dokler ne začutite ali zaslišite, da peresnik "klikne" in v številčnem okencu vidite [3] (Slika O).
Eperzan demonstrated glycaemic lowering and was statistically superior in reduction in HbA1c from baseline compared to placebo, sitagliptin, or glimepiride (see Table 3).
Zdravilo Eperzan je znižalo glikemijo in je bilo statistično značilno superiorno pri znižanju HbA1c od izhodišča v primerjavi s placebom, sitagliptinom ali glimepiridom (glejte preglednico 3).
An endpoint called MACE+ (major adverse cardiac events plus) included hospitalisation for unstable angina in addition to the MACE endpoints (acute myocardial infarction, stroke, and CV death).
Opazovani dogodek, imenovan MACE+ (major adverse cardiac events plus - hujši srčni neželeni učinki plus), je poleg opazovanih dogodkov MACE (akutni miokardni infarkt, možganska kap in kardiovaskularna smrt) obsegal še hospitalizacijo zaradi nestabilne angine pektoris.
2a Hold pen body with clear cartridge pointing up so that you can see the [1] in the window.
2a Držite telo peresnika tako, da je prozorni vložek obrnjen navzgor in lahko v okencu vidite [1].
In a 52-week monkey study, there was a small increase in pancreas tissue weight at 50 mg/kg/week (75 times clinical exposure based on AUC) associated with acinar cell hypertrophy.
V 52-tedenski študiji na opicah so ugotovili majhno povečanje mase pankreatičnega tkiva z odmerkom 50 mg/kg/teden (75-kratnik klinične izpostavljenosti na podlagi AUC), povezano s hipertrofijo acinarnih celic.
• allergic reaction (hypersensitivity) ; this includes symptoms such as local or widespread rash, redness or itching of the skin and difficulty breathing (also see ‘Conditions you need to look out for' at the
• alergijska reakcija (preobčutljivost); to lahko vključuje simptome, kot so lokalni ali razpršen izpuščaj, pordela ali srbeča koža in oteženo dihanje (glejte tudi "Stanja na katera morate biti pozorni"
Albiglutide is an agonist of the GLP-1 receptor and augments glucose-dependent insulin secretion.
Albiglutid je agonist receptorjev GLP-1 in poveča od glukoze odvisno izločanje insulina.
The hazard ratio for Eperzan versus comparators for MACE+ was 1.0 (95% CI 0.68, 1.49).
Razmerje ogroženosti za MACE+ je bilo z zdravilom Eperzan v primerjavi s primerjalnimi zdravili 1,0 (95 % IZ: 0,68, 1,49).
A total of 2,365 patients with type 2 diabetes were treated with Eperzan and 2,530 received other study medications in 8 active and placebo-controlled phase III clinical trials.
Eperzan dobivalo skupaj 2.365 bolnikov s sladkorno boleznijo tipa 2, 2.530 pa jih je dobivalo druga raziskovana zdravila.
If a dose is missed, it should be administered as soon as possible within 3 days after the missed dose.
V primeru izpuščenega odmerka je treba odmerek uporabiti čim prej v 3 dneh po izpuščenem odmerku.
The Instructions for Use included in the Package Leaflet provide directions for the patient to wait 15 minutes for the 30 mg pen and 30 minutes for the 50 mg pen after the lyophilised powder and diluent are mixed to ensure reconstitution.
Navodila za uporabo v navodilu za uporabo tega zdravila navajajo, da mora bolnik po premešanju liofiliziranega praška in vehikla počakati 15 minut za 30-mg peresnik in 30 minut za 50-mg peresnik, da je rekonstitucija zagotovljena.
The table presents the adverse reactions that occurred more frequently among patients treated with Eperzan than patients treated with all comparators.
Preglednica prikazuje neželene učinke, ki so se med prejemniki zdravila Eperzan pojavili pogosteje kot med prejemniki vseh primerjalnih zdravil.
For solids, gastric emptying t1/2 increased from 1.14 h to 2.23 h (p=0.0112).
Za trdne snovi se je t1/2 praznjenja želodca podaljšal z 1,14 ure na 2,23 ure (p = 0,0112).
This mixes the diluent in the rear chamber of the cartridge with the lyophilised powder in the front chamber.
To premeša vehikel v zadnjem razdelku vložka z liofiliziranim praškom v sprednjem razdelku.
As albiglutide is a recombinant protein, no genotoxicity studies have been conducted.
Albiglutid je rekombinantna beljakovina, zato študij genotoksičnosti niso izvedli.
In the Phase III studies in type 2 diabetes patients, small increases in heart rate (1 to 2 bpm) were observed with albiglutide.
V študijah III. faze pri bolnikih s sladkorno boleznijo tipa 2 so med uporabo albiglutida opažali majhen porast srčne frekvence (1 do 2 utripa na minuto).
The most frequent adverse reactions during clinical trials which occurred in 5% of patients receiving Eperzan were diarrhoea, nausea, and injection site reactions including rash, erythema, or itching at the injection site.
Najpogostejši neželeni učinki v kliničnih preskušanjih, zabeleženi pri ≥ 5 % bolnikov, ki so prejemali zdravilo Eperzan, so bili driska, naveza in reakcije na mestu injiciranja, vključno z izpuščajem, rdečino ali srbenjem na mestu injiciranja.
No effects were seen at 5 mg/kg/day (at exposures similar to clinical exposure).
Ob odmerku 5 mg/kg/dan (izpostavljenosti, podobne kliničnim izpostavljenostim) niso opazili učinkov.
The starting total daily dose of insulin glargine ranged between 2 and 40 units (median daily dose of 10 units) and ranged between 3 and 230 units (median daily dose of 30 units) at Week 52.
Začetni celotni dnevni odmerek insulina glargina je segal od 2 do 40 enot (mediani dnevni odmerek 10 enot), 52. teden pa od 3 do 230 enot (mediani dnevni odmerek 30 enot).
ITTa (N)
ZNZa (N)
DO NOT shake the pen to avoid foaming, which may affect your dose.
NE STRESAJTE peresnika, da se ne pojavi pena, ki lahko neugodno vpliva na vaš odmerek .
If you have questions or do not understand how to use your pen, talk to your doctor, nurse or pharmacist.
Če imate vprašanja, ali če ne razumete, kako uporabiti peresnik, se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom.
• DO NOT reuse needles, recap needles, or remove used needles from the pen.
• Igel peresnika NE UPORABITE ZNOVA, ne nameščajte nanje snetega pokrovčka ter uporabljenih igel ne odstranjujte s peresnika.
Albiglutide showed no impact on the safety of simvastatin in clinical studies.
Albiglutid v kliničnih študijah ni vplival na varnost simvastatina.
If you do not push the needle on completely, the pen may jam or leak.
Če igle ne potisnete do konca na peresnik, se peresnik lahko zatakne ali pušča.
Set a timer for 15 minutes.
Nastavite štoparico na 15 minut.
Get medical help immediately if you get these symptoms.
Če dobite te simptome, nemudoma poiščite zdravniško pomoč.
Table 8.
IN 8.
Eperzan is indicated for the treatment of type 2 diabetes mellitus in adults to improve glycaemic control as: Monotherapy
Zdravilo Eperzan je indicirano za zdravljenje sladkorne bolezni tipa 2 pri odraslih za izboljšanje urejenosti glikemije kot:
Reductions in oestrous cycles were observed at 50 mg/kg/day, a dose associated with maternal toxicity (body weight loss and reduced food consumption).
Pri 50 mg/kg/dan so opazili zmanjšanje estrusnih ciklusov; ta odmerek je bil povezan s toksičnostjo za samice-matere (izguba telesne mase in manjše uživanje hrane).
When Eperzan was used as monotherapy, the incidence of symptomatic hypoglycaemia (<3.9 mmol/l) was similar for Eperzan 30 mg (2%), Eperzan 50 mg (1%) and placebo (3%).
Med monoterapijo z zdravilom Eperzan je bila incidenca simptomatskih hipoglikemij (< 3,9 mmol/l) z zdravilom Eperzan 30 mg (2 %), Eperzan 50 mg (1 %) in placebom (3 %) podobna.
After I give my medicine, there is some liquid still seen in the clear cartridge.
Potem ko si injiciram zdravilo, v prozornem vložku še vedno ostane nekaj tekočine.
There is no experience in patients with NYHA class III-IV cardiac failure.
Izkušenj pri bolnikih s srčnim popuščanjem v razredih III in IV po NYHA ni.
Change at Week 52b
Sprememba po 52 tednihb
9b Immediately put the pen (with needle attached) in a container for pen disposal.
9b Peresnik (z nameščeno iglo) takoj dajte v vsebnik za odlaganje peresnika.
Populations not studied
Neraziskane populacije
ITT a (N)
ZNZ a (N)
After you have used the pen, do not remove the needle.
Po uporabi peresnika ne odstranite igle.
In patients with type 2 diabetes who received 2 doses of albiglutide 32 mg (Day 1 and 8), a statistically significant reduction (24%) in postprandial glucose AUC(0.5-4.5 h) was observed compared to placebo following a standardised breakfast meal on Day 9.
Pri bolnikih s sladkorno boleznijo tipa 2, ki so prejeli 2 odmerka 32 mg albiglutida (1. in 8. dan), so po standardiziranem zajtrku 9. dan opažali statistično značilno znižanje (24 %) postprandialne AUC(0,5-4,5 ure)
Acarbose is contraindicated in patients with intestinal obstruction.
Akarboza je kontraindicirana pri bolnikih z zaporo črevesa.
The change from baseline in weight for Eperzan did not differ significantly from placebo but was significantly less compared to pioglitazone (see Table 5).
Sprememba telesne mase v primerjavi z izhodiščem se z zdravilom Eperzan ni značilno razlikovala od placeba, bila pa je značilno manjša kot s pioglitazonom (glejte preglednico 5).
4a Again, slowly and gently rock the pen side-to-side side 5 times (like a windscreen wiper) (Figure J).
4a Znova počasi in rahlo 5-krat zanihajte peresnik z ene strani na drugo (premikanje, podobno avtomobilskemu brisalcu) (Slika J).
Hold Upright & Twist to 2
Držite pokonci in zasučite do 2
(See ‘Very common side effects' in section 4 for signs of low blood sugar).
(Za znake nizkega krvnega sladkorja glejte "Zelo pogosti
- in combination with other diabetes medicines that are taken by mouth (such as metformin, or medicines known as sulphonylureas or thiazolidinediones), or with insulin.
- v kombinaciji z drugimi zdravili za sladkorno bolezen, ki jih zaužijete (kot so metformin ali zdravila, imenovana sulfonilsečnine ali tiazolidindioni), ali z insulinom.
Reconstitution and administration by the patient Full instructions for reconstitution and administration to be used by the patient are provided in the Instructions for Use section of the Package Leaflet.
Celotna navodila za pripravo in dajanje, ki jih mora uporabiti bolnik, so navedena v poglavju Navodila za uporabo v navodilih za uporabo tega zdravila.
Pen storage
Shranjevanje peresnika
5b Push needle straight down onto the clear cartridge until you hear a “click” and feel the needle “snap” into place.
5b Potisnite iglo naravnost navzdol na prozorni vložek, dokler ne zaslišite "klik" in začutite, da je igla "sedla" na mesto.
Twist the clear cartridge slightly in the direction of the arrows (clockwise) to complete the “click” and center the number in the window.
Prozorni vložek rahlo zasukajte v smeri puščic (v smeri urnega kazalca), da boste dosegli "klik" in bo številka na sredi okenca.
Gastrointestinal events occurred with a higher frequency for Eperzan compared to all comparators (38% versus 32%).
Učinki na prebavilih so bili med uporabo zdravila Eperzan pogostejši kot med uporabo vseh primerjalnih zdravil (38 % v primerjavi z 32 %).
Dispose of it as your doctor or pharmacist has instructed.
Zavrzite ga, kot vam je naročil zdravnik ali farmacevt.
• DO NOT attach needle until instructed in Step 5.
• NE NAMESTITE igle, dokler v 5. koraku ne dobite navodila za to.
Very common: may affect more than 1 in 10 people:
Zelo pogosti: pojavijo se lahko pri več kot 1 od 10 bolnikov:
Intent to Treat Population (N)
Populacija z-namenom-zdravljenja (n)
It is very important that you continue to follow any diet and lifestyle advice from your doctor while taking Eperzan.
Zelo pomembno je, da med jemanjem zdravila Eperzan upoštevate vsa zdravnikova navodila glede diete in načina življenja.
• A clock or timer (Figure C).
• Uro ali štoparico (Slika C) • Vsebnik za odlaganje peresnika
Therefore, patients may require a lower dose of sulphonylurea or insulin to reduce the risk of hypoglycaemia (see sections 4.2, 4.8).
Da bi zmanjšali tveganje za hipoglikemijo, lahko bolniki potrebujejo nižji odmerek sulfonilsečnine ali insulina (glejte poglavji 4.2 in 4.8).
Eperzan lowers fasting glucose and reduces postprandial glucose excursions.
Zdravilo Eperzan zniža glukozo na tešče in zmanjša postprandialne poraste glukoze.
Intent to Treat Population (N) HbA1c (%)
Populacija z-namenom-zdravljenja (n) HbA1c (%)
Trace levels of albiglutide were detected in plasma of offspring.
V plazmi mladičev so odkrili albiglutid v sledovih.
No dose adjustment is recommended for patients with hepatic impairment.
Za bolnike z okvaro jeter ni priporočena prilagoditev odmerka.
Rare: may affect up to 1 in 1000 people:
Redki: pojavijo se lahko pri do 1 od 1.000 bolnikov:
Insulin glargine  Metformin (with or without sulphonylurea)
Insulin glargin ± metformin (s sulfonilsečnino ali brez nje)
DO NOT recap the needle or take the needle off the pen.
NE NAMEŠČAJTE pokrovčka nazaj na iglo in ne odstranjujte igle s peresnika.
Dual Chamber Cartridge (DCC) composed of a Type 1 glass barrel sealed with bromobutyl rubber stoppers and a bromobutyl rubber closure disc encased in a polypropylene snap on cap. Each cartridge is assembled into a disposable single use plastic pen injector (pen).
Vložek z dvema razdelkoma (DCC - Dual Chamber Cartridge), ki ga sestavlja valj iz stekla tipa I, zaprt z zamaški iz brombutilne gume in zapornim diskom iz brombutilne gume, vloženim v polipropilensko zaskočno zaporko.
Set a timer for 30 minutes.
Nastavite štoparico na 30 minut.
Mortalities have not been observed in previous toxicology studies in nonlactating or non-pregnant mice, nor in pregnant mice.
V predhodnih toksikoloških študijah miši, ki niso dojile ali niso bile breje, in pri brejih miših niso opažali umrljivosti.
Albiglutide (50 mg weekly at steady-state) had no clinically relevant effects on the steady-state pharmacokinetics of a combination oral contraceptive containing norethindrone 0.5 mg and ethinyl estradiol 0.035 mg.
Albiglutid (50 mg na teden v stanju dinamičnega ravnovesja) ni klinično pomembno vplival na farmakokinetiko kombiniranih peroralnih kontraceptivov z 0,5 mg noretindrona in 0,035 mg etinilestradiola v stanju dinamičnega ravnovesja.
At Week 26, the mean daily dose of insulin glargine was 53 IU for Eperzan and 51 IU for lispro.
Šestindvajseti teden je bil povprečni dnevni odmerek insulina glargina 53 i.e. z zdravilom Eperzan in 51 i.e. z insulinom lispro.
Store refrigerated at 2C to 8C.
Shranjujte v hladilniku pri temperaturi od 2 °C do 8 °C.
Studies evaluated the use of Eperzan 30 mg and 50 mg once weekly, allowing for optional titration of Eperzan from 30 mg to 50 mg once weekly in 5 of the 8 studies.
Študije so ocenile uporabo 30 mg in 50 mg zdravila Eperzan enkrat na teden; v 5 od 8 študij je bilo dovoljeno fakultativno titriranje zdravila Eperzan s 30 mg na 50 mg enkrat na teden.
If you do not wait the full 30 minutes the medicine may not be mixed with the water the right way.
Če ne počakate polnih 30 minut, zdravilo še ne bo pravilno zmešano z vodo.
Eperzan 30 mg SC weekly (with uptitration to 50 mg weekly if needed) was compared to sitagliptin.
Zdravilo Eperzan 30 mg subkutano na teden (z zvišanjem na 50 mg na teden, če je bilo potrebno) so primerjali s sitagliptinom.
No clinical studies were conducted to examine the effects of hepatic impairment on the pharmacokinetics of Eperzan.
Kliničnih študij za ugotavljanje vplivov okvare jeter na farmakokinetiko zdravila Eperzan niso izvedli.
Atrial fibrillation/flutter occurred in 1% of patients receiving Eperzan and 0.5% of patients in the all comparators group.
Atrijska fibrilacija/undulacija se je pojavila pri 1 % bolnikov, ki so prejemali zdravilo Eperzan, in pri 0,5 % vseh bolnikov, ki so prejemali katero od primerjalnih zdravil.
The change from baseline in weight did not differ significantly between treatment groups (see Table 4).
Sprememba telesne mase od izhodišča se med terapevtskima skupinama ni značilno razlikovala (glejte preglednico 4).
PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection 4 pens
FARMACEVTSKA OBLIKA IN VSEBINA Prašek in vehikel za raztopino za injiciranje 4 peresniki
If you do not wait the full 15 minutes the medicine may not be mixed with the water the right way.
Če ne počakate polnih 15 minut, zdravilo še ne bo pravilno zmešano z vodo.
• A new needle (Figure B).
• Novo iglo (Slika B)
The recommended dose of Eperzan is 30 mg once weekly, administered subcutaneously.
Priporočeni odmerek zdravila Eperzan je 30 mg enkrat na teden subkutano.
Pneumonia occurred in 2% of patients receiving Eperzan compared to 0.8% of patients in the all comparators group.
Pljučnica Pljučnica se je pojavila pri 2 % bolnikov, ki so prejemali zdravilo Eperzan, in pri 0,8 % vseh bolnikov, ki so prejemali katero od primerjalnih zdravil.
The lyophilised powder contained within the pen must be reconstituted prior to administration.
Liofilizirani prašek v peresniku je treba pred uporabo pripraviti.
This medicinal product contains less than 1 mmol sodium (23 mg) per 0.5 ml dose, i.e. essentially “sodiumfree”.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 0,5-ml odmerek; to pomeni, da je praktično "brez natrija".
The average weekly steady state concentrations following SC administration of 30 mg or 50 mg albiglutide estimated in the population PK analyses from phase III patient studies were approximately 2.6 mcg/ml and 4.4 mcg/ml, respectively.
Povprečna tedenska koncentracija v stanju dinamičnega ravnovesja po subkutani uporabi 30 mg ali 50 mg albiglutida, ocenjena v populacijskih farmakokinetičnih analizah v študijah III. faze pri bolnikih, je bila približno 2,6 µg/ml (30 mg) in 4,4 µg/ml (50 mg).
The efficacy of Eperzan was evaluated in a randomised, double-blind, active-controlled 52-week study in 486 patients with mild, moderate, and severe renal impairment inadequately controlled on a current regimen of diet and exercise or other antidiabetic therapy.
52-tedenski študiji pri 486 bolnikih z blago, zmerno in hudo okvaro ledvic, neustrezno urejenih s trenutno shemo diete in telesne dejavnosti ali drugega antidiabetičnega zdravljenja.
Based on the results of population pharmacokinetic analyses that included Caucasian, African American/African, Asian and Hispanic/Non-Hispanic patients, race and ethnicity had no clinically meaningful effect on the pharmacokinetics of Eperzan clearance.
Azijce in bolnike hispanskega/nehispanskega porekla, rasa in etnična pripadnost nista klinično pomembno vplivali na farmakokinetiko zdravila Eperzan.
Also contains: Sodium dihydrogen phosphate monohydrate, disodium phosphate, anhydrous, trehalose dihydrate, mannitol (E421), polysorbate 80, water for injections
Vsebuje tudi: natrijev dihidrogenfosfat monohidrat, brezvodni natrijev hidrogenfosfat, trehaloza dihidrat, manitol (E421), polisorbat 80, voda za injekcije
Conditions you need to look out for: Risk of acute pancreatitis (an inflamed pancreas) Pancreatitis has been reported as an uncommon side effect.
Stanja na katera morate biti pozorni: Tveganje za akutni pankreatitis (vnetje trebušne slinavke).
Active-controlled study versus liraglutide in combination with metformin, thiazolidinedione, or sulphonylurea (as monotherapy or dual therapy)
Z aktivno učinkovino kontrolirana študija v primerjavi z liraglutidom v kombinaciji z metforminom, tiazolidindionom ali sulfonilsečnino (kot monoterapija ali dvotirno zdravljenje)
Use immediately after needle is attached.
Uporabite takoj po namestitvi igle.
If you are unable to turn to position [3], throw it away and use another pen.
Če peresnika ne morete obrniti do položaja [3], ga zavrzite in uporabite drugega.
Read all of this leaflet carefully before you start taking this medicine, as well as all the instructions including the Pen Storage and Important Warnings.
Pred začetkom jemanja zdravila natančno preberite to navodilo in tudi vsa navodila, vključno s poglavjema
A meta-analysis of 9 clinical studies (8 major effectiveness studies and 1 phase II dose finding study) of up to 3 years duration was conducted to assess the cardiovascular safety of Eperzan (N=2,524) compared to all comparators (N=2,583) within these trials.
faze za določitev odmerka), ki so trajale do 3 let, za oceno kardiovaskularne varnosti zdravila Eperzan (N = 2.524) v primerjavi z vsemi primerjalnimi zdravili (N = 2.583) v teh preskušanjih.
You may feel the pain going from your front (abdomen) through to your back.
Bolečine lahko spremlja bruhanje ali pa tudi ne. Občutite lahko širjenje bolečin iz sprednjega dela (trebuha) v hrbet.
Name and address of the manufacturer responsible for batch release:
Ime in naslov izdelovalca, odgovornega za sproščanje serij:
If you have heard and felt the injection button “click” and slowly counted to 5 before pulling the needle out of your skin, you should have received the full dose of your medicine.
Če ste slišali in čutili, da je gumb za injiciranje "kliknil" in ste počasi prešteli do 5,
At Week 156, 77% of patients treated with Eperzan were uptitrated to 50 mg SC weekly.
Pri 77 % bolnikov, ki so prejemali zdravilo Eperzan, je bil 156. teden odmerek zvišan na 50 mg subkutano na teden.
Treatment with Eperzan did not meet the pre-specified noninferiority margin (0.3%) against liraglutide for HbA1c (see Table 8).
Zdravljenje z zdravilom Eperzan v primerjavi z liraglutidom ni doseglo vnaprej opredeljene meje neinferiornosti (0,3 %) za HbA1c (glejte preglednico 8).
2b Slowly and gently rock the pen side-to-side 5 times (like a windscreen wiper) (Figure H).
2b Počasi in rahlo 5-krat zanihajte peresnik z ene strani na drugo (premikanje, podobno avtomobilskemu brisalcu) (Slika H).
Eperzan contains the active ingredient albiglutide which belongs to a group of medicines called GLP-1 receptor agonists that are used to lower blood sugar (glucose) in adults with Type 2 diabetes.
imenovano agonisti receptorjev GLP-1, ki se uporabljajo za znižanje krvnega sladkorja (glukoze) pri odraslih s sladkorno boleznijo tipa 2.
Step 2 Mix Medicine
2. korak Premešajte zdravilo
In a thorough QT study in healthy subjects, an increase in heart rate (6 to 8 bpm) was observed after repeat dosing with albiglutide 50 mg compared to baseline values.
V podrobni študiji intervala QT pri zdravih preiskovancih so po ponavljajočem se odmerjanju 50 mg albiglutida opažali porast srčne frekvence (od 6 do 8 utripov na minuto) v primerjavi z izhodiščnimi vrednostmi.
• if you are taking a sulphonylurea or insulin for your diabetes, as low blood sugar (hypoglycaemia) can occur.
• če za sladkorno bolezen jemljete kakšno sulfonilsečnino ali uporabljate insulin, ker se lahko pojavi nizek krvni sladkor (hipoglikemija).
Difference from insulin glargineb (95% CI) P value (noninferiority) Proportion Achieving HbA1c <7% Body Weight (kg)
Sprememba po 52 tednihb Razlika od insulina glarginab (95 % IZ) Vrednost p (neinferiornost) Delež bolnikov, ki so dosegli HbA1c < 7 % Telesna masa (kg)
• Store your pens at room temperature, not to exceed 30°C, for up to 4 weeks.
• Peresnike shranjujte pri sobni temperaturi do 30 °C in ne več kot 4 tedne.
Patients with hepatic insufficiency
Bolniki z insuficienco jeter
This can cause your needle to block, you should continue from Step 5 to Step 6 right away.
Po 5. koraku morate nemudoma nadaljevati s 6. korakom.
For liquids, gastric emptying t1/2 increased from 0.28 h to 0.69 h (p=0.0018).
Za tekočine se je t1/2 praznjenja želodca podaljšal z 0,28 ure na 0,69 ure (p =
The efficacy of Eperzan was evaluated in a 32-week, randomised, open-label, liraglutide-controlled noninferiority study (N = 805).
Učinkovitost zdravila Eperzan so ocenili v 32-tedenski randomizirani, odprti, z liraglutidom kontrolirani študiji neinferiornosti (n = 805).