natgillin/translations-raw huggingface dataset:
An increase in ataluren exposure and in ataluren metabolite has been reported in patients with severe renal impairment (eGFR <30 ml/min). 
Pri bolnikih s hudo okvaro ledvic (eGFR < 30 ml/min) so poročali o povečanju izpostavljenosti atalurenu in njegovem presnovku.
Musculoskeletal and connective tissue disorders 
Bolezni mišično-skeletnega sistema in vezivnega tkiva bolečine v udih,
In vivo, the only metabolite detected in plasma after oral administration of radio-labelled ataluren was the ataluren-O-1β-acyl glucuronide; exposure to this metabolite in humans was approximately 8% of the plasma AUC of ataluren. 
In vivo je bil edini presnovek, opažen v plazmi po peroralnem dajanju radioaktivno označenega atalurena, ataluren-O-1β-acil glukuronid.
How to store Translarna 
Shranjevanje zdravila Translarna
Translarna 125 mg granules for oral suspension Each sachet contains 125 mg ataluren. 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Translarna 125 mg zrnca za peroralno suspenzijo Ena vrečica vsebuje 125 mg atalurena.
Translarna 250 mg granules for oral suspension ataluren 
Translarna 250 mg zrnca za peroralno suspenzijo ataluren
The amount of the liquid or semi-solid food can be increased based on patient preference. 
Če bolnik želi, lahko količino tekočine ali redke hrane poveča.
The recommended dose is 10 mg/kg body weight in the morning, 10 mg/kg body weight at midday, and 20 mg/kg body weight in the evening (for a total daily dose of 40 mg/kg body weight). 
Priporočeni odmerek je 10 mg/kg telesne mase zjutraj, 10 mg/kg telesne mase popoldne in 20 mg/kg telesne mase zvečer (skupni dnevni odmerek je torej 40 mg/kg telesne mase).
The recommended dose is 10 mg/kg body weight in the morning, 10 mg/kg body weight at midday, and 20 mg/kg body weight in the evening (adding up to a total daily dose of 40 mg/kg body weight). 
Priporočeni odmerek je 10 mg/kg telesne mase zjutraj, 10 mg/kg telesne mase zgodaj popoldne in 20 mg/kg telesne mase zvečer (to pomeni, da je skupni dnevni odmerek 40 mg/kg telesne mase).
Each sachet contains 1000 mg of ataluren 
NAVEDBA ENE ALI VEČ UČINKOVIN Ena vrečica vsebuje 1000 mg atalurena
The pharmacokinetics of ataluren are unlikely to be affected by medicinal products that inhibit the p-glycoprotein transporter. 
Verjetnost, da bi zdravila, ki zavirajo prenašalec p-glikoprotein, vplivala na farmakokinetiko atalurena, je majhna.
Placental transfer was shown of radiolabelled ataluren in rats. 
Pri podganah so opazili, da je radioaktivno označen ataluren prehajal skozi placento.
≥75 meters without the need for assistive devices during a screening 6-Minute Walk Test (6MWT). 
Vsi bolniki so morali biti v presejalnem 6-minutnem testu hoje sposobni prehoditi ≥ 75 metrov, ne da bi potrebovali medicinsko tehnične pripomočke.
Effect of other medicinal products on ataluren pharmacokinetics Based on in vitro studies, ataluren is a substrate of UGT1A9. 
Študije in vitro so pokazale, da je ataluren substrat UGT1A9.
125 mg sachets 
125-mg vrečice
Metabolism and nutrition disorders 
Žilne bolezni hipertenzija
Change in renal function tests (increased creatinine, blood urea nitrogen, cystatin C) 
sečninskega dušika v krvi in cistatina C)
Each sachet contains 250 mg of ataluren 
NAVEDBA ENE ALI VEČ UČINKOVIN Ena vrečica vsebuje 250 mg atalurena SEZNAM POMOŽNIH SNOVI
During the randomised, placebo-controlled studies, small increases in mean serum creatinine, BUN, and cystatin C were observed. 
Med randomiziranima, s placebom kontroliranima študijama pri bolnikih z nmDMD so opazili rahlo zvišanje povprečnih koncentracij kreatinina v serumu, sečninskega dušika v krvi in cistatina C. Vrednosti so se stabilizirale v zgodnjem obdobju študije in se med nadaljevanjem zdravljenja niso dodatno zvišale.
Artificial vanilla flavour: maltodextrin, artificial flavours and propylene glycol. 
krospovidon hidroksietilceluloza umetna vanilijeva aroma: maltodekstrin, umetne arome in propilenglikol silicijev dioksid, koloidni brezvodni (E551)
Each sachet contains 125 mg of ataluren 
NAVEDBA ENE ALI VEČ UČINKOVIN Ena vrečica vsebuje 125 mg atalurena.
Read the package leaflet before use Oral use 
POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo!
B a s e lin e 
PRILOGA I
Vascular disorders 
Razpredelnica za odmerjanje
TRANSLARNA 10 mg/kg/ 10 mg/kg, 20 mg/kg (N=114) 
Translarna 10, 10 in 20 mg/kg ali večje.
Posology 
Izhodišče
Package leaflet: Information for the patient Translarna 125 mg granules for oral suspension Translarna 250 mg granules for oral suspension Translarna 1000 mg granules for oral suspension ataluren This medicine is subject to additional monitoring. 
IME ZDRAVILA IN POT(I) UPORABE Translarna 125 mg zrnca za peroralno suspenzijo ataluren peroralna uporaba POSTOPEK UPORABE Pred uporabo preberite priloženo navodilo!
Check with them if you are not sure. 
Posvetujte se tudi, če opazite neželene učinke, ki niso navedeni v tem navodilu.
Elderly patients (>65 years) 
Starejši bolniki (> 65 let)
Most of this reduction was observed within the first two weeks of treatment. 
Večino tega znižanja so zabeležili v prvih dveh tednih zdravljenja.
The slower you press, the easier the injection will feel. 
Počasneje ko boste pritiskali, lažji bo občutek pri
QUESTIONS AND ANSWERS 
VPRAŠANJA IN ODGOVORI
Count to 5------ 
Preštejte do 5------
The two medicinal products should never be mixed. 
Teh dveh zdravil se nikdar ne sme mešati.
Your doctor will tell you what to do if you get low blood sugar. 
Zdravnik vam bo povedal, kaj morate narediti, če imate nizek krvni sladkor.
Always store in the box. 
Peresnike vedno shranjujte v škatli.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 March 2014 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 21. marec 2014
Your doctor may need to change your dose of these other medicines to reduce this risk. 
Zdravnik vam bo za zmanjšanje tega tveganja morda moral spremeniti odmerek teh drugih zdravil.
This removes the large air bubbles. 
To odstrani velike zračne mehurčke.
Small air bubbles are okay and do not need to rise to the top. 
Majhni zračni mehurčki so v redu in ni treba, da pridejo na vrh.
Can I still use the pen? 
Lahko peresnik kljub temu uporabim?
If you need to give yourself both at the same time, use two separate injections. 
Če si morate oba dati hkrati, ju morate dati v dveh ločenih injekcijah.
Read both sides of this leaflet 
Preberite obe strani tega navodila!
Results at 104 weeks are presented in Table 3. 
Rezultati po 104 tednih so prikazani v preglednici 3.
Cardiovascular Evaluation: 
Kardiovaskularno ocenjevanje:
• because your body is not able to use the insulin properly. 
• ker telo ne more pravilno uporabljati insulina.
Do not sell separately. 
Ni za ločeno prodajo.
P value (noninferiority) 
Vrednost p (neinferiornost)
It is important to avoid dehydration by drinking plenty of fluids. 
Pomembno je, da se izognete dehidraciji s pitjem velike količine tekočine.
If this happens, don't drive or use machines. 
Če se vam to zgodi, ne upravljajte vozil in strojev.
A small increase in islet cell number was also observed. 
Ugotovili so tudi majhno povečanje števila celic otočkov.
Don't stop unless your doctor advises you to. 
Ne prenehajte ga jemati, razen če vam to svetuje zdravnik.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. 
Ker študij kompatibilnosti ni, se tega zdravila ne sme mešati z drugimi zdravili.
The duration of studies ranged from 32 weeks to up to 3 years. 
Študije so trajale od 32 tednov do 3 let.
1a Wash your hands (Figure D). 
1a Umijte si roke (Slika D).
This effect was not considered clinically relevant. 
Tega učinka niso ocenili kot klinično pomembnega.
Figure T -------WAIT! 
-------POČAKAJTE!
Use each pen only once. 
Vsak peresnik uporabite le enkrat.
5 Times 
5-krat
This medicine is injected once a week. 
To zdravilo se injicira enkrat na teden.
Push Straight Down 
Potisnite naravnost navzdol
• swelling, sometimes of the face, mouth or throat, causing difficulty in breathing. 
• otekanje, včasih obraza, ust ali grla, povzroča težave z dihanjem.
These events were predominately mild and did not lead to discontinuation. 
Ti dogodki so bili pretežno blagi in niso povzročili prenehanja uporabe.
You should not do both. 
Enega in drugega ne smete hkrati.
It is not known if Eperzan is safe and effective in people under 18 years of age. 
Ni znano, ali je zdravilo Eperzan varno in učinkovito pri osebah, mlajših od 18 let.
• reduced appetite 
• zmanjšan apetit.
Use within 8 hours of reconstitution. 
Uporabite v 8 urah po pripravi.
Important warnings 
Pomembna opozorila
IMPORTANT: After the needle has been securely attached, make sure to complete the remaining steps of the injection procedure right away. 
POMEMBNO: Ko je igla varno nameščena, poskrbite, da boste preostale korake injiciranja opravili takoj.
A small amount of foam on top of the solution at the end of the reconstitution is normal. 
Malo pene na vrhu raztopine ob koncu priprave je normalno.
Healthcare professionals may utilise the following alternate method of reconstitution that allows for more rapid dissolution. 
Zdravstveno osebje lahko za pripravo uporabi naslednji alternativni način, ki omogoči hitrejše raztapljanje.
ATC code: A10BJ04 
Oznaka ATC: A10BJ04
• if you are allergic to albiglutide or any of the other ingredients of this medicine (listed in section 6). 
• če ste alergični na albiglutid ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, (see also earlier in section 2 ‘Warnings and precautions'). 
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo (glejte tudi zgoraj, v 2. poglavju, "Opozorila in previdnostni ukrepi").
• If stored in the refrigerator, allow the pen to sit at room temperature for 15 minutes before starting 
• Če je peresnik shranjen v hladilniku, ga pustite pri sobni temperaturi 15 minut, preden začnete s
• DO NOT allow the pen to freeze. 
• NE PUSTITE, da bi peresnik zamrznil.
Pancreatitis can be severe and life-threatening. 
Pankreatitis je lahko hud in smrtno nevaren.
• severe stomach (abdominal) pain that does not go away, this can be a symptom of pancreatitis. 
• hude bolečine v trebuhu, ki ne minejo, je to lahko simptom pankreatitisa.
• if you have ever had pancreatitis (inflammation of the pancreas). 
• če ste kdaj imeli pankreatitis (vnetje trebušne slinavke).
Because this method relies on appropriate swirling and visual inspection of the solution, it is intended only for healthcare professionals. 
Ker ta način temelji na ustreznem vrtenju in pregledovanju raztopine, je namenjen le za zdravstveno osebje.
Alternate method of reconstitution (healthcare professional use only): 
Alternativni način priprave (samo za uporabo s strani zdravstvenega osebja):
Eperzan is not recommended for children and adolescents. 
Zdravilo Eperzan ni priporočljivo za otroke in mladostnike.
5 Times min. sec. 
5-krat min. sek.
It should be yellow and see-through, without any particles (Figure K). 
Biti mora rumeno in prozorno, brez delcev (Slika K).
Insert, Push Button, & Wait 
Zabodite, pritisnite gumb in počakajte
Hold Upright and Twist to 3 
Držite pokonci in zasučite do 3
Count to 5 
Preštejte do 5
Wash Hands and Check Pen 
Umijte si roke in preverite peresnik
This is because it takes time for Eperzan to clear from your body. 
To je potrebno, ker je potreben čas, da se zdravilo Eperzan očisti iz telesa.
The safety and efficacy of Eperzan in children and adolescents under 18 years have not been established (see section 5.2). 
Varnost in učinkovitost zdravila Eperzan pri otrocih in mladostnikih, mlajših od 18 let, nista ugotovljeni (glejte poglavje 5.2).
You have Type 2 diabetes either: 
Sladkorno bolezen tipa 2 imate:
If there is a possibility that you could become pregnant, you must use effective contraception while using this medicine. 
Če obstaja možnost, da bi lahko zanosili, morate med uporabo tega zdravila uporabljati učinkovito kontracepcijsko zaščito.
4b Check medicine through the viewing window. 
4b Preverite zdravilo skozi opazovalno okence.
In addition some other side effects have been reported (frequency not known, cannot be estimated from the available data): 
Dodatno so poročali o drugih neželenih učinkih (pogostnost ni znana, pogostnosti iz razpoložljivih podatkov ni mogoče oceniti):
Glucagon-like peptide-1 (GLP-1) analogues. 
Analogi glukagonu podobnega peptida-1 (GLP-1).
Description of selected adverse reactions: 
Opis izbranih neželenih učinkov:
These differences were not considered clinically relevant (see section 4.2). 
Teh razlik niso ocenili za klinično pomembne (glejte poglavje 4.2).
In the event of a suspected overdose, the appropriate supportive clinical care should be instituted, as dictated by the subject's clinical status. 
V primeru domnevnega prevelikega odmerjanja je treba uvesti ustrezno podporno klinično oskrbo, kot jo narekuje bolnikovo klinično stanje.
Eperzan should not be used for treatment of diabetic ketoacidosis. 
Zdravila Eperzan se ne sme uporabljati za zdravljenje diabetične ketoacidoze.
If you are planning to have a baby, your doctor may decide to stop your treatment with Eperzan at least one month before you try to get pregnant. 
Če nameravate zanositi, se bo zdravnik morda odločil, da vaše zdravljenje z zdravilom Eperzan konča vsaj en mesec prej, preden poskusite zanositi.
• If a box of pens will be stored for more than 4 weeks, keep them refrigerated (2°C to 8°C). 
• Če bo škatla s peresniki shranjena več kot 4 tedne, jo shranite v hladilniku (od 2 °C do 8 °C).
Sixty seven percent of patients were Caucasian, 15% African American/African heritage and 11% Asian; 26% of patients were Hispanic/Latino. 
67 % bolnikov je bilo belcev, 15 % Afroameričanov ali afriškega porekla in 11 % Azijcev; 26 % bolnikov je bilo hispanskega/latino porekla.
It is okay to have large air bubbles on top of the liquid. 
V redu je, če so na vrhu tekočine veliki zračni mehurčki.
These are removed in step 6. 
Te boste odstranili v 6. koraku.
Patient frequencies are defined as: very common ≥1/10; common ≥1/100 to <1/10; uncommon ≥1/1,000 to <1/100; rare: ≥1/10,000 to <1/1,000; very rare: <1/10,000 and not known (cannot be estimated from the available data). 
Pogostnosti pri bolnikih so opredeljene takole: zelo pogosti ≥ 1/10, pogosti ≥ 1/100 do < 1/10, občasni ≥ 1/1.000 do < 1/100, redki: ≥ 1/10.000 do < 1/1.000, zelo redki: < 1/10.000 in neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti).
You may give both injections in the same body area (for example, your stomach area), but you should not give the injections very close together. 
Obe injekciji lahko daste v isti predel telesa (npr. v predel trebuha), vendar pa ju ne smete dati zelo blizu skupaj.
Use Eperzan only if it is a clear yellow solution and contains no particles. 
Zdravilo Eperzan uporabite le, če je bistra, rumena raztopina, ki ne vsebuje delcev.
Eperzan that has been frozen must not be used. 
Zdravila Eperzan, ki je zamrznilo, ne smete uporabiti.
Patients should be informed of the characteristic symptom of acute pancreatitis. 
Bolnike je treba seznaniti z značilnim simptomom akutnega pankreatitisa.
What if I do not attach the needle as instructed? 
Kaj, če igle ne namestim po navodilih?
• if you have a serious problem with emptying your stomach (gastroparesis) or if you have severe bowel disease (severe gastrointestinal disease). 
• če imate resne težave s praznjenjem želodca (gastroparezo) ali imate hudo bolezen prebavil (hudo gastrointestinalno bolezen).
If possible show them the pack, or this leaflet. 
Če je mogoče, jim pokažite pakiranje zdravila ali to navodilo.
What Eperzan is and what it is used for 2. 
Kaj je zdravilo Eperzan in za kaj ga uporabljamo 2.
Since the relative stress of lactation energy demands is much lower in humans than mice and humans have large energy reserves, the mortalities observed in lactating mice are considered not relevant to humans. 
Ker je relativni stres energijskih potreb med obdobjem dojenja pri človeku veliko manjši kot pri miših in ker so energijske rezerve pri človeku velike, je umrljivost, opažena pri doječih miših, ocenjena kot nepomembna za človeka.
A decision should be made whether to discontinue breast-feeding or to discontinue therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the mother. 
Odločiti se je treba za prenehanje dojenja ali za prenehanje zdravljenja, upoštevaje koristi dojenja za otroka in koristi zdravljenja za žensko.
Keep twisting until you see [3] in the window. 
Nadaljujte s sukanjem, dokler v okencu ne vidite [3].
This can make it difficult to concentrate and make you dizzy or sleepy. 
Zaradi tega se lahko težko zberete, ste omotični ali zaspani.
Complete dissolution for the 50 mg pen usually occurs within 7 minutes but may take up to 10 minutes. 
Popolna raztopitev je s 50-mg peresnikom po navadi dosežena v 7 minutah, a lahko traja do 10 minut.
Do not use the pen if the number ‘1' is not showing. 
Ne uporabite peresnika, če ni prikazana številka "1".
Each pen injector should be used by one person only and is for single use. 
Vsak injekcijski peresnik sme uporabiti le ena oseba in je namenjen za enkratno uporabo.
† The numbers on the clear cartridge represent stages of preparation for your medicine. 
† Številke na prozornem vložku pomenijo stopnje priprave vašega zdravila.
The cup, timer and container are not provided in the pack. 
Posodica, štoparica in vsebnik niso priloženi v pakiranju.
It must not be administered intravenously or intramuscularly. 
Ne sme se ga uporabljati intravensko ali intramuskularno.
The pancreas changes were not associated with histomorphologic abnormalities or evidence of increased proliferation. 
Pankreatičnih sprememb niso spremljale histomorfološke nepravilnosti ali znaki povečane proliferacije.
Seeing small air bubbles remaining is normal and you can still use the pen. 
Nekaj preostalih majhnih zračnih mehurčkov je normalno in peresnik lahko kljub temu uporabite.
Do not use this medicine after the expiry date which is stated on the pen and the carton after ‘EXP'. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na peresniku in škatli poleg oznake "EXP".
Glaxo Operations UK Limited (Trading as Glaxo Wellcome Operations) Harmire Road 
Glaxo Operations UK Limited (posluje kot Glaxo Wellcome Operations) Harmire Road
A pen cannot be re-used. 
Peresnika ni mogoče ponovno uporabiti.
Simvastatin AUC was decreased by 40% and simvastatin Cmax was increased by 18%. 
AUC simvastatina se je zmanjšala za 40 %, Cmax simvastatina pa se je povečala za 18 %.
Inspect, and continue to swirl the pen until all the powder is dissolved. 
Raztopino preglejte in nadaljujte z vrtenjem peresnika, dokler se ves prašek ne raztopi.
This will help mix the medicine. 
To bo pomagalo premešati zdravilo.
Each pen is used to deliver one dose. 
Vsak peresnik je namenjen za dajanje enega odmerka.
What you need to know before you take Eperzan 3. 
Kaj morate vedeti, preden boste vzeli zdravilo Eperzan 3.
7a Choose your injection site (Figure P). 
7a Izberite mesto za injiciranje (Slika P).
What if I leave my pen with the needle attached (Step 5), and then come back to finish the next step much later? 
Kaj, če pustim peresnik z nameščeno iglo (5. korak) in naslednji korak dokončam šele veliko pozneje?
These are rare in people taking Eperzan (may affect up to 1 in 1000 people). 
Te so redke pri ljudeh, ki prejemajo zdravilo Eperzan (pojavijo se lahko pri do 1 od 1.000 bolnikov).
Figure A * Injection Button is inside the pen until the pen is ready for injection. 
Slika A * Gumb za injiciranje je znotraj peresnika, dokler peresnik ni pripravljen za injiciranje.
Eperzan should not be used during pregnancy, and is not recommended in women of childbearing potential not using effective contraception. 
Zdravila Eperzan se ne sme uporabljati med nosečnostjo ter ni priporočljivo za ženske v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.
The recommended dose is 30 mg once a week, injected on the same day each week. 
Priporočeni odmerek je 30 mg enkrat na teden, injiciran vsak teden na isti dan.
Your doctor will decide if you can use Eperzan, and will explain the symptoms of pancreatitis (see ‘Conditions you need to look out for' 
Zdravnik bo presodil, ali lahko uporabljate zdravilo Eperzan, in vas bo seznanil s simptomi pankreatitisa (glejte "Stanja na katera morate biti
You can use Eperzan at any time of day, with or without meals. 
Zdravilo Eperzan lahko uporabite kadar koli tekom dneva, s hrano ali brez nje.
After that, you can go back to having your injection on the usual day. 
Potem se lahko vrnete k injiciranju zdravila na vaš običajni dan.
The AUC of simvastatin acid was increased by 36% and Cmax was increased by approximately 100%. 
simvastatinske kisline se je povečala za 36 %, Cmax pa se je povečala za približno 100 %.
If necessary you can change the day of the week on which you use Eperzan, as long as it is at least 4 days since your last dose. 
lahko spremenite dan v tednu, na katerega uporabljate zdravilo Eperzan; pogoj je, da so minili vsaj 4 dnevi od vašega zadnjega odmerka.
Lift Pen from Skin 
Dvignite peresnik s kože
(122 mild, 99 moderate, 15 severe)a 
(122 blaga, 99 zmerna, 15 huda)a
The day of weekly administration can be changed if necessary as long as the last dose was administered 4 or more days previously. 
Če je treba, se lahko dan tedenske uporabe spremeni; pogoj za to je, da je bil zadnji odmerek uporabljen 4 ali več dni pred tem.
• if you have Type 1 (insulin-dependent) diabetes or ketoacidosis (a very serious complication of diabetes which happens when your body is not able to break down glucose because there is not enough insulin), this medicine will not be right for you. 
• če imate sladkorno bolezen tipa 1 (od insulina odvisno sladkorno bolezen) ali ketoacidozo (to je zelo resen zaplet sladkorne bolezni, ki se pojavi, kadar telo ne more uporabljati glukoze, ker ni dovolj insulina), to zdravilo ni pravo za vas.
Instruct the patient to read the full Instructions for Use (IFU) including the Questions and Answers before starting the therapy and refer back to the IFU each time before injecting the dose. 
Bolnika poučite, naj prebere celotna Navodila za uporabo, vključno z Vprašanji in odgovori, pred začetkom zdravljenja ter se obrne na Navodila za uporabo vsakič pred injiciranjem odmerka.
This will mix the medicine powder and liquid. 
To bo zmešalo prašek z zdravilom in tekočino.
For Eperzan, these were single episodes of pneumonia in patients participating in studies with 32 weeks up to 3 years of observation. 
Z zdravilom Eperzan so bili to enkratni pojavi pljučnice pri bolnikih v študijah, ki so obsegale od 32 tednov do 3 let opazovanja.
The European Medicines Agency has deferred the obligation to submit the results of studies with Eperzan in one or more subsets of the paediatric population in the treatment of type 2 diabetes mellitus (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Eperzan za eno ali več podskupin pediatrične populacije za zdravljenje sladkorne bolezni tipa 2 (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
As long as the needle has not been attached, the pen can be used for up to 8 hours from the time Step 2 was started. 
Če še niste namestili igle, lahko peresnik uporabite v času do 8 ur po začetku 2. koraka.
Clean Empty Cup Clock/Timer min. sec. 
Prazna, čista posodica Ura/štoparica min. sek.
Each pen contains a white to yellow powder and a colourless solvent in separate compartments. 
Vsak peresnik vsebuje bel do rumen prašek in brezbarvno topilo (vehikel) v ločenih razdelkih.
Wait 15 Minutes 
Počakajte 15 minut
It is acceptable to inject Eperzan and insulin in the same body region but the injections should not be adjacent to each other. 
Sprejemljivo je injiciranje zdravila Eperzan in insulina v isti predel telesa, vendar mesti injiciranja ne smeta biti eno zraven drugega.