natgillin/translations-raw huggingface dataset:
Given that albiglutide is an albumin-based protein therapeutic agent, it is likely to be present in human milk.
Glede na to, da je albiglutid beljakovinsko zdravilo na podlagi albumina, je verjetno prisoten v materinem mleku pri človeku.
7c Place both needle caps into a container for pen disposal.
7c Oba pokrovčka igle zavrzite v vsebnik za odlaganje peresnika.
1b Check dosage and expiration date on pen (Figure E).
1b Na peresniku preverite odmerek in datum izteka roka uporabnosti peresnika (Slika E).
However, in healthy volunteers following 50 mg the steady state concentration was 7.39 µg/ml at day 36, thus higher than population PK analyses from phase III patient studies predicted.
Toda pri zdravih prostovoljcih je bila koncentracija v stanju dinamičnega ravnovesja po odmerku 50 mg 36. dan 7,39 µg/ml in torej višja kot napovedana v populacijskih farmakokinetičnih analizah v študijah III. faze pri bolnikih.
Frequency categories below reflect combined data for the 2 doses of Eperzan, 30 mg or 50 mg weekly subcutaneously.
Spodaj navedene kategorije pogostnosti odražajo združene podatke za 2 odmerka zdravila Eperzan, 30 mg ali 50 mg na teden subkutano.
Figure 1: Kaplan-Meier curve showing durability of glycaemic control (measured by time to rescue) for Eperzan, relative to two active controls (sitagliptin and glimepiride) and placebo
Slika 1: Kaplan-Meierjeva krivulja, ki prikazuje trajnost urejenosti glikemije (merjeno s časom do rešilnega ukrepanja) za zdravilo Eperzan glede na dve aktivni primerjalni učinkovini (sitagliptin in glimepirid) in placebo
The majority of the observed reduction in fasting plasma glucose occurs after a single dose, consistent with the pharmacokinetic profile of albiglutide.
Večina opaženega znižanja glukoze v plazmi na tešče se pojavi po posameznem odmerku; to se sklada s farmakokinetičnimi značilnostmi albiglutida.
Clean Empty Cup Clock/Timer
Prazna, čista posodica Ura/štoparica
Eperzan must not be injected into a vein (intravenously) or into a muscle (intramuscularly).
Zdravila Eperzan ne smete injicirati v veno (intravensko) ali v mišico (intramuskularno).
Eperzan has no or negligible influence on your ability to drive or use machines.
Zdravilo Eperzan nima ali ima zanemarljiv vpliv na vašo sposobnost vožnje in upravljanja s stroji.
In a population pharmacokinetic analysis including a phase III trial in patients with mild, moderate and severe renal impairment, exposures were increased by approximately 30 to 40% in severe renal impairment compared to those observed in type 2 diabetic patients with normal renal function.
V populacijski farmakokinetični analizi vključno s preskušanjem III. faze pri bolnikih z blago, zmerno ali hudo okvaro ledvic se je izpostavljenost pri hudi okvari ledvic povečala za približno 30 do 40 % v primerjavi z izpostavljenostjo, ugotovljeno pri sladkornih bolnikih tipa 2 z normalnim delovanjem ledvic.
In combination with other glucose-lowering medicinal products including basal insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see section 4.4 and 5.1 for available data on different combinations).
V kombinaciji z drugimi zdravili za zniževanje glukoze, vključno z bazalnim insulinom, če ta zdravila skupaj z dieto in telesno dejavnostjo ne dosežejo ustrezne urejenosti glikemije (glejte poglavji 4.4 in 5.1 za podatke o različnih kombinacijah).
Talk to your doctor, nurse or pharmacist about how to inject Eperzan the right way.
Posvetujte se z zdravnikom, medicinsko sestro ali farmacevtom o tem, kako pravilno injicirati zdravilo Eperzan.
Do not inject a double dose to make up for a forgotten dose.
Ne injicirajte si dvojnega odmerka, če ste pozabili uporabiti prejšnji odmerek.
Remaining cartons must be stored at 2C to 8C until required.
Preostale škatle je treba shranjevati pri temperaturi 2 °C do 8 °C do uporabe.
This can result in particles floating in the clear cartridge, not getting your full dose, or a blocked needle.
To lahko povzroči, da v prozornem vložku plavajo delci, da ne dobite celotnega odmerka, ali da se igla zamaši.
There is no specific antidote for overdose with Eperzan.
Specifičnega antidota za preveliko odmerjanje zdravila Eperzan ni.
Step 7 Prepare for injection
7. korak Priprava za injiciranje
Background therapies in these studies included diet and exercise, metformin, sulphonylurea, thiazolidinedione, insulin glargine, or a combination of antidiabetic medicinal products.
Osnovna zdravljenja v teh študijah so vključevala dieto in telesno dejavnost, metformin, sulfonilsečnino, tiazolidindion, insulin glargin ali kombinacijo antidiabetičnih zdravil.
Paediatric population: No pharmacokinetic data are available in paediatric patients.
Farmakokinetičnih podatkov za pediatrične bolnike ni.
It is not known if albiglutide is excreted in human milk.
Ni znano, ali se albiglutid izloča v materino mleko.
Viewing Window Number Window
Opazovalno okence Številčno okence
The mean estimate of apparent volume of distribution of albiglutide following SC administration is 11 litres.
Povprečni ocenjeni navidezni volumen porazdelitve albiglutida po subkutani uporabi je 11 litrov.
Otherwise, the pattern of adverse events was generally similar for antibody positive and negative patients.
Sicer pa je bil vzorec neželenih učinkov na splošno podoben pri bolnikih s pozitivnim in negativnim izvidom protiteles.
Choose Injection Site
Izberite mesto za injiciranje
Water for injections
Vehikel: voda za injekcije
Step 1.
1. korakom.
Once weekly.
Enkrat na teden.
Experience in patients with severe renal impairment (<30 ml/min/1.73m2) or on dialysis is very limited and therefore Eperzan is not recommended in this population (see sections 4.4, 4.8, 5.1, 5.2).
Izkušenj pri bolnikih s hudo okvaro ledvic (< 30 ml/min/1,73m2) in pri bolnikih na dializi je zelo malo, zato zdravilo Eperzan v tej populaciji ni priporočljivo (glejte poglavja 4.4, 4.8, 5.1 in 5.2).
During clinical studies of patients with type 2 diabetes, the highest dose of Eperzan administered was 100 mg subcutaneously every four weeks for 12 weeks.
V kliničnih študijah pri bolnikih s sladkorno boleznijo tipa 2 je bil najvišji uporabljeni odmerek zdravila Eperzan 100 mg subkutano na štiri tedne 12 tednov.
6.6 Special precautions for disposal and other handling
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Odlaganje
The clinical relevance of the observed thyroid C-cell tumours in rodents is unknown.
Klinični pomen pri glodalcih opaženih tumorjev ščitničnih celic C ni znan.
9a Pull the needle out of your skin (Figure U).
9a Potegnite iglo iz kože (Slika U).
Atrial fibrillation/flutter
Atrijska fibrilacija/undulacija
The mean daily dose of insulin lispro at Week 26 was 31 IU, and at Week 52, 69% of patients treated with Eperzan were on 50 mg weekly.
Povprečni dnevni odmerek insulina lispro 26. teden je bil 31 i.e. in 52. teden je 69 % bolnikov, zdravljenih z zdravilom Eperzan, prejemalo 50 mg na teden.
These types of gastrointestinal events may lead to dehydration, and worsen renal function.
Ti učinki na prebavilih lahko povzročijo dehidracijo in poslabšajo delovanje ledvic.
Exposures at the 30 mg and 50 mg dose levels were consistent with a dose-proportional increase.
Izpostavljenost pri odmerku 30 mg in 50 mg se je skladala z zvišanjem, sorazmernim odmerku.
Eperzan comes in a pen injector that you can inject yourself.
Zdravilo Eperzan je na voljo v injekcijskem peresniku, ki si ga lahko injicirate sami.
Most patients with severe hypoglycaemic events in clinical studies were receiving concurrent sulphonylurea or insulin and none required hospitalisation or led to withdrawal of treatment.
Večina bolnikov, ki so imeli v kliničnih študijah hude hipoglikemije, je sočasno prejemala sulfonilsečnino ali insulin; v nobenem od teh primerov ni bil potreben sprejem v bolnišnico in ni bilo treba opustiti zdravila.
Store in a refrigerator (between 2C and 8C).
Shranjujte v hladilniku (med 2 °C in 8 °C).
Although most patients with injection site reactions were antibody negative (~85%), injection site reactions were reported more frequently for antibody positive (41%, N = 116) than antibody negative patients (14%, N = 1,927).
Večina bolnikov, ki so imeli reakcije na mestu injiciranja, je sicer imela negativen izvid protiteles (~85 %), toda reakcije na mestu injiciranja so bile pri bolnikih s pozitivnim izvidom protiteles pogostejše (41 %, N = 116) kot pri tistih z negativnim izvidom (14 %, N = 1.927).
With the clear cartridge pointing up, gently swirl the pen for one minute.
S prozornim vložkom obrnjenim navzgor previdno vrtite peresnik eno minuto.
Offspring of mice dosed with 50 mg/kg/day during organogenesis had reduced weight during the pre-weaning period (which recovered after weaning), dehydration and coldness, and a delay in balanopreputial separation.
Mladiči miši, ki so prejemale 50 mg/kg/dan med obdobjem organogeneze, so imeli manjšo telesno maso pred odstavitvijo (ki se je popravila po odstavitvi), dehidriranost in hladnost ter zapoznelo balanoprepucijsko ločevanje.
Stop taking Eperzan and talk to your doctor straight away
Nehajte uporabljati zdravilo Eperzan in se nemudoma posvetujte z zdravnikom.
When Eperzan is used in combination with insulin secretagogues (such as sulphonylureas) or insulin, patients should be advised to take precautions to avoid hypoglycaemia while driving and using machines (see section 4.4).
Če je zdravilo Eperzan uporabljeno v kombinaciji z insulinskimi sekretagogi (kot so sulfonilsečnine) ali insulinom, je treba bolnikom naročiti, naj uporabijo previdnostne ukrepe, da se izognejo hipoglikemijam med vožnjo in upravljanjem s stroji (glejte poglavje 4.4).
A single dose of albiglutide 50 mg did not impair the glucagon, epinephrine, norepinephrine, cortisol or growth hormone counter-regulatory hormone response to hypoglycaemia.
Posamezen odmerek 50 mg albiglutida ni okrnil protiregulacijskega hormonskega odziva glukagona, adrenalina, noradrenalina, kortizola ali rastnega hormona na hipoglikemijo.
If you think this applies to you, don't use Eperzan until you have checked with your doctor, nurse or pharmacist.
Če menite, da to velja za vas, ne uporabite zdravila Eperzan, dokler se ne posvetujete z zdravnikom, medicinsko sestro ali farmacevtom.
Fertility For both men and women, it is not known if Eperzan could affect your fertility.
Ne za moške ne za ženske ni znano, ali zdravilo Eperzan lahko vpliva na plodnost.
• heartburn (gastro-oesophageal reflux)
• zgaga (gastroezofagealni refluks).
After reconstitution, continue to follow the steps in the instructions for use to attach the needle, prime the pen injector and administer the injection.
Po pripravi nadaljujte s koraki v navodilih za uporabo, da boste namestili iglo, pripravili peresnik in injicirali zdravilo.
Albiglutide also produced dose-dependent increases in serum calcitonin levels in a 21-day study in mice, suggesting that thyroid tumours in rodents are a theoretical possibility for albiglutide as well.
Tudi albiglutid je v 21-dnevni študiji pri miših povzročil od odmerka odvisno zvišanje koncentracije kalcitonina v serumu; to kaže, da so ščitnični tumorji pri glodalcih teoretična možnost tudi z albiglutidom.
Treatment with Eperzan alone or in combination with one or two oral antidiabetic medicinal products resulted in a reduction in fasting plasma glucose from baseline as compared to placebo of 1.3 to 2.4 mmol/l.
Zdravljenje z zdravilom Eperzan samim ali v kombinaciji z enim ali dvema peroralnima antidiabetičnima zdraviloma je znižalo glukozo v plazmi na tešče od izhodišča za 1,3 do 2,4 mmol/l v primerjavi s placebom.
Store pens and needles in the original carton until use.
Peresnike in igle do uporabe shranjujte v originalni ovojnini.
Anticipated symptoms of an overdose may be severe nausea, vomiting or headache.
Pričakovani simptomi prevelikega odmerjanja so huda navzea, bruhanje in glavobol.
Allergic reactions
Alergijska reakcija
Albiglutide is a protein for which the expected metabolic pathway is degradation to small peptides and individual amino acids by ubiquitous proteolytic enzymes.
Albiglutid je beljakovina in pričakovana pot njegove presnove je razgradnja v majhne peptide in posamezne aminokisline s široko razprostranjenimi proteolitičnimi encimi.
• When initiating treatment with albiglutide, you may experience fluid loss from vomiting, nausea, diarrhoea or dehydration.
• ob začetku zdravljenja z albiglutidom lahko pride do izgube tekočine zaradi bruhanja, slabosti, driske ali dehidracije.
Change at Week 104 b
Sprememba po 104 tednihb
The risk of hypoglycaemia is increased when Eperzan is used in combination with insulin secretagogues (such as sulphonylurea) or with insulin.
Tveganje za hipoglikemijo se poveča, če se zdravilo Eperzan uporabi v kombinaciji z insulinskimi sekretagogi (kot so sulfonilsečnine) ali z insulinom.
Eperzan has not been studied in combination with prandial insulin, dipeptidyl peptidase-4 (DPP-4) inhibitors, or sodium/glucose cotransporter 2 (SGLT2) inhibitors.
Zdravilo Eperzan ni raziskano v kombinaciji s prandialnim insulinom, zaviralci dipeptidilpeptidaze-4 (DPP-4) ali zaviralci soprenašalca natrija/glukoze 2 (SGLT2).
What Eperzan looks like and contents of the pack
Izgled zdravila Eperzan in vsebina pakiranja
IMPORTANT: Make sure you do not twist the pen to [3] until you have attached the needle in step 5.
POMEMBNO: Poskrbite, da ne boste zasukali peresnika na [3], dokler v 5. koraku ne namestite igle.
None of these antibodies were shown to neutralise the activity of albiglutide in an in vitro assay and antibody formation was generally transient and was not associated with reduced efficacy (HbA1c and FPG).
Nobeno od protiteles ni nevtraliziralo delovanja albiglutida v preizkusu in vitro; nastajanje protiteles je bilo na splošno prehodno in ga ni spremljala manjša učinkovitost (HbA1c in glukoza v plazmi na tešče).
Albiglutide delays gastric emptying, and has the potential to impact the absorption of concomitantly administered oral medicinal products.
Albiglutid upočasni praznjenje želodca in tako lahko vpliva na absorpcijo sočasno peroralno uporabljenih zdravil.
After discontinuation, the effect of Eperzan may continue as plasma levels of albiglutide decline slowly over about 3 to 4 weeks.
Prenehanje zdravljenja Po prenehanju uporabe lahko učinek zdravila Eperzan traja še približno 3 do 4 tedne, ker se koncentracija albiglutida v plazmi znižuje počasi.
The durability of glycaemic control for Eperzan over time relative to other classes of type 2 antidiabetic agents and placebo is shown in Figure 1 as add-on to metformin.
Trajnost urejenosti glikemije z zdravilom Eperzan po času glede na druge skupine antidiabetičnih zdravil za tip 2 in glede na placebo prikazuje slika 1 kot dodatek metforminu.
Pancreatitis, intestinal obstruction
pankreatitis, obstrukcija prebavil
However, when used in combination with a sulphonylurea or a basal insulin, blood glucose self-monitoring may become necessary to adjust the dose of the sulphonylurea or the basal insulin.
Če pa se to zdravilo uporablja v kombinaciji s sulfonilsečnino ali bazalnim insulinom, lahko postane samomerjenje glukoze v krvi potrebno za prilagoditev odmerka sulfonilsečnine ali bazalnega insulina.
The mean apparent clearance of albiglutide is 67 ml/h with an elimination half-life of approximately 5 days based on estimations from the population PK analyses from phase III patient studies and measured values.
Povprečni navidezni očistek albiglutida je 67 ml/uro in eliminacijski razpolovni čas je približno 5 dni; vrednosti temeljita na ocenah populacijskih farmakokinetičnih analiz iz študij III. faze pri bolnikih in na izmerjenih vrednostih.
Caution is advised if used concomitantly with albiglutide (see section 4.8).
V primeru sočasne uporabe z albiglutidom je potrebna previdnost (glejte poglavje 4.8).
If you forget to use Eperzan
Če ste pozabili uporabiti zdravilo Eperzan
• low blood sugar (hypoglycaemia) if you use Eperzan on its own or in combination with metformin or pioglitazone
• nizek krvni sladkor (hipoglikemija), če zdravilo Eperzan uporabljate v kombinaciji z metforminom ali pioglitazonom,
• Use the pen immediately after you have attached and primed the needle otherwise the solution can dry up inside the needle and block it.
• Peresnik uporabite takoj zatem, ko ste nanj namestili iglo in jo pripravili za uporabo, sicer se lahko raztopina v igli posuši in zamaši iglo.
INFORMATION IN BRAILLE eperzan 30
PODATKI V BRAILLOVI PISAVI eperzan 30
There is limited experience of albiglutide when combined with thiazolidinediones alone, sulphonylureas + thiazolidinediones, and metformin + sulphonylureas + thiazolidinediones.
Malo je izkušenj z albiglutidom v kombinaciji s samimi tiazolidindioni, sulfonilsečninami + tiazolidindioni in metforminom + sulfonilsečninami + tiazolidindioni.
Severe hypoglycaemia requiring the assistance of another person for treatment occurred uncommonly: 0.3% among patients receiving Eperzan and 0.4% among patients receiving a comparator.
Hude hipoglikemije, ki so za zdravljenje zahtevale posredovanje druge osebe, so bile občasne: 0,3 % med prejemniki zdravila Eperzan in 0,4 % med prejemniki primerjalnih zdravil.
After reconstitution, the pen should be used within 8 hours.
Po pripravi je treba peresnik uporabiti v 8 urah.
Do not dispose of the used pen in the household waste.
Porabljenega peresnika ne odvrzite med gospodinjske odpadke.
Studies in mice showed reduced oestrous cycling at maternally toxic doses, but did not indicate harmful effects with respect to fertility (see section 5.3).
Študije na miših so v odmerkih, toksičnih za samice-matere, pokazale zmanjšanje estrusnih ciklusov, niso pa pokazale škodljivih učinkov na plodnost (glejte poglavje 5.3).
Use of GLP-1 receptor agonists has been associated with a risk of developing acute pancreatitis.
Akutni pankreatitis Uporaba agonistov receptorjev GLP-1 je bila povezana s tveganjem za pojav akutnega pankreatitisa.
Steady-state exposures are achieved following 3-5 weeks of once-weekly administration.
Izpostavljenost v stanju dinamičnega ravnovesja je dosežena po 3 do 5 tednih uporabe enkrat na teden.
A needle is provided with each pen.
Vsakemu peresniku je priložena igla.
DO NOT use if the pen is expired or shows the incorrect dose.
NE UPORABITE peresnika, če se je rok uporabnosti že iztekel, ali če kaže nepravilen odmerek.
DO NOT attach the needle before Step 5.
NE NAMESTITE igle pred 5. korakom.
When using Eperzan with insulin, each medicinal product must be administered as a separate injection.
Če bolnik zdravilo Eperzan uporablja z insulinom, je treba zdravili injicirati ločeno.
If it is more than 3 days after the missed dose, patients should wait and administer their next regularly scheduled weekly dose.
Če so od izpuščenega odmerka pretekli že več kot 3 dnevi, mora bolnik počakati in uporabiti naslednji odmerek ob rednem času zanj.
• because your body does not make enough insulin to control the level of sugar in your blood or
• ker vam v telesu ne nastaja dovolj insulina, da bi uravnal koncentracijo krvnega sladkorja
There is no information about the safety of Eperzan in pregnant women.
O varnosti zdravila Eperzan pri nosečnicah ni podatkov.
Hold the pen upright before attaching the needle.
Držite peresnik pokonci, preden namestite iglo.
What you need to know before you use Eperzan
Kaj morate vedeti, preden boste uporabili zdravilo Eperzan
Step 3 Wait 30 minutes
3. korak Počakajte 30 minut
Follow instructions to twist the cartridge until ‘2' appears in the number window and a “click” is heard.
Sledite navodilom in zasučite vložek, dokler se v številskem okencu ne pojavi "2" in zaslišite klik.
There are no data on the effects of Eperzan on human fertility.
Podatkov o vplivu zdravila Eperzan na plodnost pri človeku ni.
Step 3 Wait 15 minutes
3. korak Počakajte 15 minut
DO NOT use the pen if the injection button does not pop out.
NE UPORABITE peresnika, dokler gumb za injiciranje ne pogleda ven.
If you do not hear a “click” when the [2] or when the [3] is moved into the number window, you may not have the number fully centered in the window.
Če ne zaslišite "klik", ko se v številčno okence pomakneta [2] ali [3], številki morda nista povsem v sredini okenca.
The rate of symptomatic hypoglycaemia was higher for Eperzan when used in combination with a sulphonylurea (15% to 22%) or with insulin (18%) compared to combinations not including a sulphonylurea or insulin (1% to 4%).
Delež simptomatskih hipoglikemij je bil večji, če se je zdravilo Eperzan uporabilo v kombinaciji s sulfonilsečnino (od 15 do 22 %) ali insulinom (18 %), kot če se je uporabljalo v kombinacijah, ki niso vključevale sulfonilsečnine ali insulina (od 1 do 4 %).
As albiglutide is an albumin fusion molecule, plasma protein binding has not been assessed.
Ker je albiglutid albuminska fuzijska molekula, vezave na beljakovine v plazmi niso ocenili.
After this time, pens should be used or thrown away.
Po tem času morate peresnike uporabiti ali zavreči.
There are no adequate data to support the use of Eperzan during breast-feeding in humans.
Ni ustreznih podatkov, ki bi podpirali uporabo zdravila Eperzan med obdobjem dojenja pri človeku.
Injection site reactions (typically including rash, erythema, or itching at the injection site) occurred in 15% of patients treated with Eperzan compared to 7% with all comparators and led to discontinuation in 2% of all patients treated with Eperzan.
Reakcije na mestu injiciranja (po navadi z izpuščajem, rdečino ali srbenjem na mestu injiciranja) so se pojavile pri 15 % bolnikov, zdravljenih z zdravilom Eperzan, in pri 7 % bolnikov, zdravljenih z vsemi primerjalnimi zdravili; te reakcije so povzročile prekinitev zdravljenja pri 2 % vseh bolnikov, zdravljenih z zdravilom Eperzan.
Durability of glycaemic control
Trajnost urejenosti glikemije
Inspect the pen to ensure that the number ‘1' is visible in the number window.
Preglejte peresnik in se prepričajte, da je v številčnem okencu vidna številka "1".
Adverse reactions reported from a pooled analysis of seven placebo- and active-controlled phase III studies over the entire treatment period are presented in Table 1.
Neželeni učinki, zabeleženi v kumulativni analizi sedmih študij III. faze, kontroliranih s placebom ali zdravilno učinkovino med celotnim obdobjem zdravljenja, so prikazani v preglednici 1.
INFORMATION IN BRAILLE eperzan 50
PODATKI V BRAILLOVI PISAVI eperzan 50
Avoid shaking as this can result in foaming.
Ne stresajte, ker to lahko povzroči penjenje.
You can use your abdomen, thigh, or upper arm.
Lahko uporabite trebuh, stegno ali nadlaket.
Use of GLP-1 receptor agonists may be associated with gastrointestinal adverse reactions.
Uporaba agonistov receptorjev GLP-1 je lahko povezana z neželenimi učinki na prebavilih.
If you have attached the needle, EPERZAN should be used right away.
Če ste že namestili iglo, morate zdravilo EPERZAN uporabiti takoj.
• rash, redness or itching of the skin where you have injected Eperzan
• izpuščaj, rdečina ali srbenje kože na mestu, kjer ste injicirali zdravilo Eperzan.
Eperzan may be administered at any time of day without regard to meals.
Zdravilo Eperzan se lahko uporabi kadar koli tekom dneva in ne glede na obroke.
Throw away the pen if frozen.
Če peresnik zmrzne, ga zavrzite.
The warning signs of low blood sugar may include cold sweat, cool pale skin, headache, feeling drowsy, weakness, dizziness, feeling confused or irritable, feeling hungry, fast heart beat and feeling jittery.
• nizek krvni sladkor (hipoglikemija), če zdravilo Eperzan uporabljate v kombinaciji z insulinom ali sulfonilsečnino; med opozorilnimi znaki nizkega krvnega sladkorja so lahko mrzel pot, hladna bleda koža, glavobol, zaspanost, šibkost, omotičnost, zmedenost ali razdražljivost, občutek lakote, hitro bitje srca in občutek tresenja.
The incidence rates observed for first MACE+ were 1.2 and 1.1 events per 100 person-years for Eperzan versus all comparators, respectively.
Stopnja incidence za prvi MACE+ je bila pri zdravilu Eperzan 1,2 in pri vseh primerjalnih zdravilih 1,1 dogodka na 100 bolnik-let.