FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: 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.
English: No effects were seen at 5 mg/kg/day (at exposures similar to clinical exposure).
Slovenian: Ob odmerku 5 mg/kg/dan (izpostavljenosti, podobne kliničnim izpostavljenostim) niso opazili učinkov.
English: 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.
Slovenian: 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).
English: ITTa (N)
Slovenian: ZNZa (N)
English: DO NOT shake the pen to avoid foaming, which may affect your dose.
Slovenian: NE STRESAJTE peresnika, da se ne pojavi pena, ki lahko neugodno vpliva na vaš odmerek .
English: If you have questions or do not understand how to use your pen, talk to your doctor, nurse or pharmacist.
Slovenian: Če imate vprašanja, ali če ne razumete, kako uporabiti peresnik, se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom.
English: • DO NOT reuse needles, recap needles, or remove used needles from the pen.
Slovenian: • Igel peresnika NE UPORABITE ZNOVA, ne nameščajte nanje snetega pokrovčka ter uporabljenih igel ne odstranjujte s peresnika.
English: Albiglutide showed no impact on the safety of simvastatin in clinical studies.
Slovenian: Albiglutid v kliničnih študijah ni vplival na varnost simvastatina.
English: If you do not push the needle on completely, the pen may jam or leak.
Slovenian: Če igle ne potisnete do konca na peresnik, se peresnik lahko zatakne ali pušča.
English: Set a timer for 15 minutes.
Slovenian: Nastavite štoparico na 15 minut.
English: Get medical help immediately if you get these symptoms.
Slovenian: Če dobite te simptome, nemudoma poiščite zdravniško pomoč.
English: Table 8.
Slovenian: IN 8.
English: Eperzan is indicated for the treatment of type 2 diabetes mellitus in adults to improve glycaemic control as: Monotherapy
Slovenian: Zdravilo Eperzan je indicirano za zdravljenje sladkorne bolezni tipa 2 pri odraslih za izboljšanje urejenosti glikemije kot:
English: Reductions in oestrous cycles were observed at 50 mg/kg/day, a dose associated with maternal toxicity (body weight loss and reduced food consumption).
Slovenian: 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).
English: 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%).
Slovenian: 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.
English: After I give my medicine, there is some liquid still seen in the clear cartridge.
Slovenian: Potem ko si injiciram zdravilo, v prozornem vložku še vedno ostane nekaj tekočine.
English: There is no experience in patients with NYHA class III-IV cardiac failure.
Slovenian: Izkušenj pri bolnikih s srčnim popuščanjem v razredih III in IV po NYHA ni.
English: Change at Week 52b
Slovenian: Sprememba po 52 tednihb
English: 9b Immediately put the pen (with needle attached) in a container for pen disposal.
Slovenian: 9b Peresnik (z nameščeno iglo) takoj dajte v vsebnik za odlaganje peresnika.
English: Populations not studied
Slovenian: Neraziskane populacije
English: ITT a (N)
Slovenian: ZNZ a (N)
English: After you have used the pen, do not remove the needle.
Slovenian: Po uporabi peresnika ne odstranite igle.
English: 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.
Slovenian: 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)
English: Acarbose is contraindicated in patients with intestinal obstruction.
Slovenian: Akarboza je kontraindicirana pri bolnikih z zaporo črevesa.
English: The change from baseline in weight for Eperzan did not differ significantly from placebo but was significantly less compared to pioglitazone (see Table 5).
Slovenian: 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).
English: 4a Again, slowly and gently rock the pen side-to-side side 5 times (like a windscreen wiper) (Figure J).
Slovenian: 4a Znova počasi in rahlo 5-krat zanihajte peresnik z ene strani na drugo (premikanje, podobno avtomobilskemu brisalcu) (Slika J).
English: Hold Upright & Twist to 2
Slovenian: Držite pokonci in zasučite do 2
English: (See ‘Very common side effects' in section 4 for signs of low blood sugar).
Slovenian: (Za znake nizkega krvnega sladkorja glejte "Zelo pogosti
English: - in combination with other diabetes medicines that are taken by mouth (such as metformin, or medicines known as sulphonylureas or thiazolidinediones), or with insulin.
Slovenian: - v kombinaciji z drugimi zdravili za sladkorno bolezen, ki jih zaužijete (kot so metformin ali zdravila, imenovana sulfonilsečnine ali tiazolidindioni), ali z insulinom.
English: 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.
Slovenian: Celotna navodila za pripravo in dajanje, ki jih mora uporabiti bolnik, so navedena v poglavju Navodila za uporabo v navodilih za uporabo tega zdravila.
English: Pen storage
Slovenian: Shranjevanje peresnika
English: 5b Push needle straight down onto the clear cartridge until you hear a “click” and feel the needle “snap” into place.
Slovenian: 5b Potisnite iglo naravnost navzdol na prozorni vložek, dokler ne zaslišite "klik" in začutite, da je igla "sedla" na mesto.
English: Twist the clear cartridge slightly in the direction of the arrows (clockwise) to complete the “click” and center the number in the window.
Slovenian: Prozorni vložek rahlo zasukajte v smeri puščic (v smeri urnega kazalca), da boste dosegli "klik" in bo številka na sredi okenca.
English: Gastrointestinal events occurred with a higher frequency for Eperzan compared to all comparators (38% versus 32%).
Slovenian: Učinki na prebavilih so bili med uporabo zdravila Eperzan pogostejši kot med uporabo vseh primerjalnih zdravil (38 % v primerjavi z 32 %).
English: Dispose of it as your doctor or pharmacist has instructed.
Slovenian: Zavrzite ga, kot vam je naročil zdravnik ali farmacevt.
English: • DO NOT attach needle until instructed in Step 5.
Slovenian: • NE NAMESTITE igle, dokler v 5. koraku ne dobite navodila za to.
English: Very common: may affect more than 1 in 10 people:
Slovenian: Zelo pogosti: pojavijo se lahko pri več kot 1 od 10 bolnikov:
English: Intent to Treat Population (N)
Slovenian: Populacija z-namenom-zdravljenja (n)
English: It is very important that you continue to follow any diet and lifestyle advice from your doctor while taking Eperzan.
Slovenian: Zelo pomembno je, da med jemanjem zdravila Eperzan upoštevate vsa zdravnikova navodila glede diete in načina življenja.
English: • A clock or timer (Figure C).
Slovenian: • Uro ali štoparico (Slika C) • Vsebnik za odlaganje peresnika
English: Therefore, patients may require a lower dose of sulphonylurea or insulin to reduce the risk of hypoglycaemia (see sections 4.2, 4.8).
Slovenian: Da bi zmanjšali tveganje za hipoglikemijo, lahko bolniki potrebujejo nižji odmerek sulfonilsečnine ali insulina (glejte poglavji 4.2 in 4.8).
English: Eperzan lowers fasting glucose and reduces postprandial glucose excursions.
Slovenian: Zdravilo Eperzan zniža glukozo na tešče in zmanjša postprandialne poraste glukoze.
English: Intent to Treat Population (N) HbA1c (%)
Slovenian: Populacija z-namenom-zdravljenja (n) HbA1c (%)
English: Trace levels of albiglutide were detected in plasma of offspring.
Slovenian: V plazmi mladičev so odkrili albiglutid v sledovih.
English: No dose adjustment is recommended for patients with hepatic impairment.
Slovenian: Za bolnike z okvaro jeter ni priporočena prilagoditev odmerka.
English: Rare: may affect up to 1 in 1000 people:
Slovenian: Redki: pojavijo se lahko pri do 1 od 1.000 bolnikov:
English: Insulin glargine  Metformin (with or without sulphonylurea)
Slovenian: Insulin glargin ± metformin (s sulfonilsečnino ali brez nje)
English: DO NOT recap the needle or take the needle off the pen.
Slovenian: NE NAMEŠČAJTE pokrovčka nazaj na iglo in ne odstranjujte igle s peresnika.
English: 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).
Slovenian: 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.
English: Set a timer for 30 minutes.
Slovenian: Nastavite štoparico na 30 minut.
English: Mortalities have not been observed in previous toxicology studies in nonlactating or non-pregnant mice, nor in pregnant mice.
Slovenian: V predhodnih toksikoloških študijah miši, ki niso dojile ali niso bile breje, in pri brejih miših niso opažali umrljivosti.
English: 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.
Slovenian: 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.
English: At Week 26, the mean daily dose of insulin glargine was 53 IU for Eperzan and 51 IU for lispro.
Slovenian: Šestindvajseti teden je bil povprečni dnevni odmerek insulina glargina 53 i.e. z zdravilom Eperzan in 51 i.e. z insulinom lispro.
English: Store refrigerated at 2C to 8C.
Slovenian: Shranjujte v hladilniku pri temperaturi od 2 °C do 8 °C.
English: 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.
Slovenian: 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.
English: If you do not wait the full 30 minutes the medicine may not be mixed with the water the right way.
Slovenian: Če ne počakate polnih 30 minut, zdravilo še ne bo pravilno zmešano z vodo.
English: Eperzan 30 mg SC weekly (with uptitration to 50 mg weekly if needed) was compared to sitagliptin.
Slovenian: Zdravilo Eperzan 30 mg subkutano na teden (z zvišanjem na 50 mg na teden, če je bilo potrebno) so primerjali s sitagliptinom.
English: No clinical studies were conducted to examine the effects of hepatic impairment on the pharmacokinetics of Eperzan.
Slovenian: Kliničnih študij za ugotavljanje vplivov okvare jeter na farmakokinetiko zdravila Eperzan niso izvedli.
English: Atrial fibrillation/flutter occurred in 1% of patients receiving Eperzan and 0.5% of patients in the all comparators group.
Slovenian: 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.
English: The change from baseline in weight did not differ significantly between treatment groups (see Table 4).
Slovenian: Sprememba telesne mase od izhodišča se med terapevtskima skupinama ni značilno razlikovala (glejte preglednico 4).
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection 4 pens
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Prašek in vehikel za raztopino za injiciranje 4 peresniki
English: If you do not wait the full 15 minutes the medicine may not be mixed with the water the right way.
Slovenian: Če ne počakate polnih 15 minut, zdravilo še ne bo pravilno zmešano z vodo.
English: • A new needle (Figure B).
Slovenian: • Novo iglo (Slika B)
English: The recommended dose of Eperzan is 30 mg once weekly, administered subcutaneously.
Slovenian: Priporočeni odmerek zdravila Eperzan je 30 mg enkrat na teden subkutano.
English: Pneumonia occurred in 2% of patients receiving Eperzan compared to 0.8% of patients in the all comparators group.
Slovenian: 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.
English: The lyophilised powder contained within the pen must be reconstituted prior to administration.
Slovenian: Liofilizirani prašek v peresniku je treba pred uporabo pripraviti.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per 0.5 ml dose, i.e. essentially “sodiumfree”.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 0,5-ml odmerek; to pomeni, da je praktično "brez natrija".
English: 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.
Slovenian: 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).
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Azijce in bolnike hispanskega/nehispanskega porekla, rasa in etnična pripadnost nista klinično pomembno vplivali na farmakokinetiko zdravila Eperzan.
English: Also contains: Sodium dihydrogen phosphate monohydrate, disodium phosphate, anhydrous, trehalose dihydrate, mannitol (E421), polysorbate 80, water for injections
Slovenian: Vsebuje tudi: natrijev dihidrogenfosfat monohidrat, brezvodni natrijev hidrogenfosfat, trehaloza dihidrat, manitol (E421), polisorbat 80, voda za injekcije
English: Conditions you need to look out for: Risk of acute pancreatitis (an inflamed pancreas) Pancreatitis has been reported as an uncommon side effect.
Slovenian: Stanja na katera morate biti pozorni: Tveganje za akutni pankreatitis (vnetje trebušne slinavke).
English: Active-controlled study versus liraglutide in combination with metformin, thiazolidinedione, or sulphonylurea (as monotherapy or dual therapy)
Slovenian: Z aktivno učinkovino kontrolirana študija v primerjavi z liraglutidom v kombinaciji z metforminom, tiazolidindionom ali sulfonilsečnino (kot monoterapija ali dvotirno zdravljenje)
English: Use immediately after needle is attached.
Slovenian: Uporabite takoj po namestitvi igle.
English: If you are unable to turn to position [3], throw it away and use another pen.
Slovenian: Če peresnika ne morete obrniti do položaja [3], ga zavrzite in uporabite drugega.
English: 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.
Slovenian: Pred začetkom jemanja zdravila natančno preberite to navodilo in tudi vsa navodila, vključno s poglavjema
English: 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.
Slovenian: 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.
English: You may feel the pain going from your front (abdomen) through to your back.
Slovenian: Bolečine lahko spremlja bruhanje ali pa tudi ne. Občutite lahko širjenje bolečin iz sprednjega dela (trebuha) v hrbet.
English: Name and address of the manufacturer responsible for batch release:
Slovenian: Ime in naslov izdelovalca, odgovornega za sproščanje serij:
English: 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.
Slovenian: Če ste slišali in čutili, da je gumb za injiciranje "kliknil" in ste počasi prešteli do 5,
English: At Week 156, 77% of patients treated with Eperzan were uptitrated to 50 mg SC weekly.
Slovenian: Pri 77 % bolnikov, ki so prejemali zdravilo Eperzan, je bil 156. teden odmerek zvišan na 50 mg subkutano na teden.
English: Treatment with Eperzan did not meet the pre-specified noninferiority margin (0.3%) against liraglutide for HbA1c (see Table 8).
Slovenian: Zdravljenje z zdravilom Eperzan v primerjavi z liraglutidom ni doseglo vnaprej opredeljene meje neinferiornosti (0,3 %) za HbA1c (glejte preglednico 8).
English: 2b Slowly and gently rock the pen side-to-side 5 times (like a windscreen wiper) (Figure H).
Slovenian: 2b Počasi in rahlo 5-krat zanihajte peresnik z ene strani na drugo (premikanje, podobno avtomobilskemu brisalcu) (Slika H).
English: 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.
Slovenian: imenovano agonisti receptorjev GLP-1, ki se uporabljajo za znižanje krvnega sladkorja (glukoze) pri odraslih s sladkorno boleznijo tipa 2.
English: Step 2 Mix Medicine
Slovenian: 2. korak Premešajte zdravilo
English: 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.
Slovenian: 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.
English: • if you are taking a sulphonylurea or insulin for your diabetes, as low blood sugar (hypoglycaemia) can occur.
Slovenian: • če za sladkorno bolezen jemljete kakšno sulfonilsečnino ali uporabljate insulin, ker se lahko pojavi nizek krvni sladkor (hipoglikemija).
English: Difference from insulin glargineb (95% CI) P value (noninferiority) Proportion Achieving HbA1c <7% Body Weight (kg)
Slovenian: Sprememba po 52 tednihb Razlika od insulina glarginab (95 % IZ) Vrednost p (neinferiornost) Delež bolnikov, ki so dosegli HbA1c < 7 % Telesna masa (kg)
English: • Store your pens at room temperature, not to exceed 30°C, for up to 4 weeks.
Slovenian: • Peresnike shranjujte pri sobni temperaturi do 30 °C in ne več kot 4 tedne.
English: Patients with hepatic insufficiency
Slovenian: Bolniki z insuficienco jeter
English: This can cause your needle to block, you should continue from Step 5 to Step 6 right away.
Slovenian: Po 5. koraku morate nemudoma nadaljevati s 6. korakom.
English: For liquids, gastric emptying t1/2 increased from 0.28 h to 0.69 h (p=0.0018).
Slovenian: Za tekočine se je t1/2 praznjenja želodca podaljšal z 0,28 ure na 0,69 ure (p =
English: The efficacy of Eperzan was evaluated in a 32-week, randomised, open-label, liraglutide-controlled noninferiority study (N = 805).
Slovenian: Učinkovitost zdravila Eperzan so ocenili v 32-tedenski randomizirani, odprti, z liraglutidom kontrolirani študiji neinferiornosti (n = 805).
English: What if I leave my pen for more than 15 minutes after turning the pen to the Number 2 (Step
Slovenian: Kaj, če čakam več kot 15 minut po obratu peresnika na številko 2 (2. korak)?
English: Patients with severe renal impairment receiving Eperzan experienced a higher frequency of diarrhoea, nausea, and vomiting compared to patients with mild or moderate renal impairment.
Slovenian: Okvara ledvic Bolniki s hudo okvaro ledvic, ki so prejemali zdravilo Eperzan, so imeli drisko, navzeo in bruhanje pogosteje kot bolniki z blago ali zmerno okvaro ledvic.
English: Treatment with Eperzan resulted in a mean weight loss for Eperzan (-0.7 kg) compared to a mean weight gain for insulin lispro (+0.8 kg) and the difference between treatment groups was statistically significant (see Table 6).
Slovenian: Zdravljenje z zdravilom Eperzan je v povprečju povzročilo zmanjšanje telesne mase z zdravilom Eperzan (0,7 kg), medtem ko se je z insulinom lispro telesna masa v povprečju povečala (+0,8 kg); razlika med terapevtskima skupinama je bila statistično značilna (glejte preglednico 6).
English: The model-adjusted mean decrease in HbA1c from baseline with Eperzan was -0.80 (n = 125), -0.83 (n = 98), and -1.08 (n = 19) in patients with mild (eGFR 60 to 89 ml/min/1.73m2), moderate (eGFR 30 to 59 ml/min/1.73m2), and severe (eGFR <30 ml/min/1.73m2) renal impairment, respectively (see Table 9).
Slovenian: Za model korigirano povprečno znižanje HbA1c v primerjavi z izhodiščem je bilo za zdravilo Eperzan -0,80 (n = 125) pri bolnikih z blago okvaro ledvic (eGFR od 60 do 89 ml/min/1,73 m2), -0,83 (n = 98) pri bolnikih z zmerno okvaro ledvic (eGFR od 30 do 59 ml/min/1,73 m2) in -1,08 (n = 19) pri bolnikih s hudo okvaro ledvic (eGFR < 30 ml/min/1,73 m2) (glejte preglednico 9).
English: A single dose of simvastatin (80 mg) was administered with steady-state albiglutide (50 mg weekly).
Slovenian: Enkraten odmerek simvastatina (80 mg) so uporabili v stanju dinamičnega ravnovesja albiglutida (50 mg na teden).
English: Albiglutide did not meaningfully alter the pharmacokinetics of a single-dose of digoxin (0.5 mg) when coadministered with steady-state albiglutide (50 mg weekly).
Slovenian: Albiglutid ni pomembno spremenil farmakokinetike enkratnega odmerka digoksina (0,5 mg), če je bil ta uporabljen sočasno v stanju dinamičnega ravnovesja albiglutida (50 mg na teden).
English: A prolonged period of observation and treatment for these symptoms may be necessary, taking into account the half-life of albiglutide (5 days).
Slovenian: Zaradi razpolovnega časa albiglutida (5 dni) bi lahko bilo potrebno podaljšano opazovanje in zdravljenje teh simptomov.
English: There is no therapeutic experience with Eperzan in patients with type 1 diabetes mellitus and it should not be used in these patients.
Slovenian: 4.4 Posebna opozorila in previdnostni ukrepi Z zdravilom Eperzan ni terapevtskih izkušenj pri bolnikih s sladkorno boleznijo tipa 1; pri teh bolnikih se ga ne sme uporabljati.