FrancophonIA/ELRC3.0 huggingface dataset:
English: If there is a delay in the administration of ataluren of less than 3 hours after the morning or midday doses or less than 6 hours after the evening dose, the dose should be taken with no changes to the subsequent dose schedules.
Croatian: Ako je došlo do odgode u primjeni atalurena kraće od 3 sata nakon jutarnje ili podnevne doze ili kraće od 6 sati nakon večernje doze, doza se mora uzeti bez promjena u rasporedu naredne doze.
English: In these patients, the mean change in timed function tests from baseline to Week 48 was better in the ataluren 40 mg/kg/day arm than placebo in time to run/walk 10 meters (better by 3.5 seconds), time to climb 4 stairs (better by 6.4 seconds), and time to descend 4 stairs (better by 5.0 seconds).
Croatian: U ovih bolesnika, srednja promjena u vremenski mjerenim testovima funkcije od početne vrijednosti do 48. tjedna bila je bolja u skupini koja je primala ataluren 40 mg/kg/dan nego u skupini koja je primala placebo u vremenu trčanja/hodanja na 10 metara (bolje za 3,5 sekundi), vremenu uspinjanja uz 4 stepenice (bolje za 6,4 sekunde) i vremenu silaska niz 4 stepenice (bolje za 5,0 sekundi).
English: The full contents of each sachet should be mixed with at least 30 ml of liquid (water, milk, fruit juice) or 3 tablespoons of semi-solid food (yoghurt or apple sauce).
Croatian: Cjelokupan sadržaj svake vrećice treba pomiješati s najmanje 30 ml tekućine (vode, mlijeka, voćnoga soka) ili 3 jušne žlice polukrute hrane (jogurta ili gustog soka od jabuke).
English: Hepatic impairment
Croatian: - nevoljno mokrenje
English: Aminoglycosides have been shown to reduce the readthrough activity of ataluren in vitro.
Croatian: Dokazano je da aminoglikozidi in vitro smanjuju aktivnost atalurena za transkripciju gena preko terminacijskog kodona.
English: Thus, the mean change in observed 6MWD from baseline to Week 48 was 31.3 meters better in the ataluren 40 mg/kg/day arm than in the placebo arm (p=0.056).
Croatian: Stoga, srednja promjena u uočenoj udaljenosti prijeđenoj tijekom 6-minutnog testa hoda od početne vrijednosti do 48. tjedna bila je 31,3 metra u korist skupine koja je primala ataluren od 40 mg/kg/dan u odnosu na skupinu koja je primala placebo (p=0,056).
English: Renal function monitoring
Croatian: Praćenje funkcije bubrega
English: In patients with a baseline 6MWD <350 meters, the mean change in observed 6MWD from baseline to Week 48 was 68 meters better in the ataluren 40 mg/kg/day arm than in the placebo arm (p=0.0053).
Croatian: U bolesnika s početnom vrijednosti udaljenosti prijeđene u 6 minuta < 350 metara, srednja promjena zabilježene udaljenosti prijeđene u 6 minuta od početne vrijednosti do 48. tjedna bila je 68 metara bolja u skupini koja je primala ataluren 40 mg/kg/dan nego u skupini koja je primala placebo (p=0,0053).
English: In Study 1, a post hoc analysis of the primary endpoint showed that from baseline to Week 48, patients receiving ataluren 40 mg/kg/day had a 12.9 meters mean decline in 6MWD, and patients receiving placebo had a 44.1-meter mean decline in 6MWD (Figure 1).
Croatian: U Ispitivanju 1, post hoc analiza mjere primarnog ishoda je pokazala da su bolesnici koji su primali ataluren u dozi od 40 mg/kg/dan imali srednje smanjenje od 12,9 m u udaljenosti prijeđenoj tijekom 6
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Croatian: Time se omogućuje kontinuirano praćenje omjera koristi i rizika lijeka.Od zdravstvenih radnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava: navedenog u Dodatku V.
English: Translarna 125 mg granules for oral suspension ataluren
Croatian: Translarna 125 mg granule za oralnu suspenziju ataluren
English: There were no apparent differences in either steady-state relative bioavailability or apparent clearance due to loss of ambulation.
Croatian: Nema očitih razlika u relativnoj bioraspoloživosti u stanju dinamičke ravnoteže ili prividnom klirensu u bolesnika koji postanu nepokretni.
English: The full contents of each sachet should be mixed with at least 30 ml of liquid (water, milk, fruit juice), or 3 tablespoons of semi-solid food (yoghurt or apple sauce).
Croatian: Puni sadržaj jedne vrećice treba pomiješati s najmanje 30 ml tekućine (vode, mlijeka, voćnoga soka), ili 3 jušne žlice polukrute hrane (jogurta ili gustog soka od jabuke).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 1000 mg
English: Translarna 250 mg granules for oral suspension ataluren
Croatian: Translarna 250 mg granule za oralnu suspenziju ataluren
English: Each sachet contains 1000 mg of ataluren
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Svaka vrećica sadrži 1000 mg atalurena POPIS POMOĆNIH TVARI
English: During the randomised, placebo-controlled studies, small increases in mean serum creatinine, BUN, and cystatin C were observed.
Croatian: Tijekom randomiziranih placebom kontroliranih ispitivanja Duchenneove mišićne distrofije (DMD) s besmislenom mutacijom, uočena su manja povećanja u srednjim vrijednostima kreatinina u serumu, ureje u krvi i cistatina C.
English: 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).
Croatian: Preporučena doza iznosi 10 mg/kg tjelesne težine ujutro, 10 mg/kg tjelesne težine u podne i 20 mg/kg tjelesne težine navečer (što zajedno čini ukupnu dnevnu dozu od 40 mg/kg tjelesne težine).
English: The recommended dose is the same for all age ranges, i.e. 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).
Croatian: Preporučena doza je ista za sve dobne raspone tj. 10 mg/kg tjelesne težine ujutro, 10 mg/kg tjelesne težine u podne i 20 mg/kg tjelesne težine uvečer (kako bi ukupna dnevna doza bila 40 mg/kg tjelesne težine).
English: Translarna 125 mg granules for oral suspension Each sachet contains 125 mg ataluren.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Translarna 125 mg granule za oralnu suspenziju Jedna vrećica sadrži 125 mg atalurena.
English: The mean change in timed function tests from baseline to Week 48 was better in the ataluren 40 mg/kg/day arm than placebo in time to run/walk 10 meters (better by 1.5 seconds), time to climb 4 stairs (better by 2.4 seconds), and time to descend 4 stairs (better by 1.6 seconds), Figure 3.
Croatian: Srednja promjena u vremenski mjerenim testovima funkcije od početne vrijednosti do 48. tjedna bila je bolja u skupini koja je primala ataluren 40 mg/kg/dan nego u skupini koja je primila placebo u vremenu za trčanje/hodanje na 10 metara (bolje za 1,5 sekunde), za uspinjanje uz 4 stube (bolje za 2,4 sekunde) i silazak niz 4 stube (bolje za 1,6 sekunde), Slika 3.
English: Change in lipid profile (increased triglycerides and cholesterol)
Croatian: Poremećaji metabolizma i prehrane smanjeni apetit hipertrigliceridemija promjena u lipidogramu (povišeni trigliceridi i kolesterol)
English: 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).
Croatian: Preporučena je doza od 10 mg/kg tjelesne težine ujutro, 10 mg/kg tjelesne težine u podne, i 20 mg/kg tjelesne težine navečer (kako bi se dobila ukupna dnevna doza od 40 mg/kg tjelesne težine).
English: Each sachet contains 125 mg of ataluren
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Svaka vrećica sadrži 125 mg atalurena POPIS POMOĆNIH TVARI
English: Each sachet contains 250 mg of ataluren
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Svaka vrećica sadrži 250 mg atalurena POPIS POMOĆNIH TVARI
English: Midday
Croatian: Podne
English: Final study report to be submitted Due date:
Croatian: Ažurirani RMP treba dostaviti:
English: An open-label study was performed including patients aged 2-5 years (n=14) to evaluate the PK and safety of ataluren.
Croatian: Za procjenu farmakokinetike i sigurnosti atalurena provedeno je otvoreno ispitivanje koje je uključivalo bolesnike u dobi 2-5 godina (n=14).
English: Translarna 1000 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Translarna 1000 mg
English: Meters (±SE)
Croatian: Metri (±standardna pogreška)
English: Similarly, ataluren is not expected in vivo to be an inducer of cytochrome P450 isoenzymes.
Croatian: Slično tome, očekuje se da ataluren neće biti aktivator izoenzima citokroma
English: Translarna 250 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Translarna 250 mg
English: Pyrexia, weight decreased
Croatian: Opći poremećaji i reakcije na mjestu primjene pireksija, smanjenje tjelesne težine
English: Respiratory, thoracic, and mediastinal disorders
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja kašalj, epistaksa
English: Effect of other medicinal products on ataluren pharmacokinetics Based on in vitro studies, ataluren is a substrate of UGT1A9.
Croatian: Na temelju in vitro ispitivanja, ataluren je supstrat UGT1A9.
English: Read the package leaflet before use Oral use
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitajte uputu o lijeku Primjena kroz usta
English: 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.
Croatian: Translarna 125 mg granule za oralnu suspenziju Translarna 250 mg granule za oralnu suspenziju Translarna 1000 mg granule za oralnu suspenziju ataluren
English: Musculoskeletal and connective tissue disorders
Croatian: Krvožilni poremećaji hipertenzija
English: Translarna 125 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Translarna 125 mg
English: Serum lipids
Croatian: Lipidi u serumu
English: Renal function tests
Croatian: Testiranje bubrežne funkcije
English: You should not do both.
Croatian: Ne biste smjeli činiti oboje.
English: The slower you press, the easier the injection will feel.
Croatian: Što polaganije pritisnete, to će injekcija biti ugodnija.
English: Figure T -------WAIT!
Croatian: Slika T ---PRIČEKAJTE!
English: The potential risk for humans is unknown.
Croatian: Nije poznat mogući rizik za ljude.
English: Can I still use the pen?
Croatian: Mogu li ipak upotrijebiti brizgalicu?
English: The two medicinal products should never be mixed.
Croatian: Ta se dva lijeka nikada ne smiju miješati.
English: Most of this reduction was observed within the first two weeks of treatment.
Croatian: Glavnina toga smanjenja primijećena je unutar prva dva tjedna liječenja.
English: QUESTIONS AND ANSWERS
Croatian: PITANJA I ODGOVORI
English: Step 7 Prepare for injection
Croatian: Korak 7 Pripremite se za injekciju
English: Do not sell separately.
Croatian: Ne prodavati odvojeno.
English: If this happens, don't drive or use machines.
Croatian: Ako se to dogodi, nemojte upravljati vozilima niti raditi sa strojevima.
English: Always store in the box.
Croatian: Brizgalice uvijek čuvajte u kutiji.
English: P value (noninferiority)
Croatian: P-vrijednost (neinferiornost)
English: This leaflet was last revised in <{MM/YYYY}>
Croatian: Ova uputa je zadnji puta revidirana u <{MM/YYYY}>
English: Get medical help immediately if you get these symptoms.
Croatian: Odmah potražite liječničku pomoć ako primijetite ove simptome.
English: Conditions you need to look out for:
Croatian: Stanja na koja trebate obratiti pažnju:
English: Elderly patients (>65 years)
Croatian: Stariji bolesnici (≥ 65 godina)
English: This effect was not considered clinically relevant.
Croatian: Taj se učinak nije smatrao klinički značajnim.
English: 893 River Road Conshohocken, PA 19428 USA
Croatian: 893 River Road Conshohocken, PA 19428 SAD
English: Read both sides of this leaflet
Croatian: Pročitajte ovu uputu s obje strane
English: Alternate method of reconstitution (healthcare professional use only):
Croatian: Alternativna metoda rekonstitucije (samo za zdravstvene radnike):
English: This medicine is injected once a week.
Croatian: Ovaj se lijek injicira jedanput tjedno.
English: If you are unable to turn to position [3], throw it away and use another pen.
Croatian: Ako ne možete zakrenuti uložak na broj [3], bacite brizgalicu i upotrijebite drugu.
English: 5 Times
Croatian: 5 puta
English: The duration of studies ranged from 32 weeks to up to 3 years.
Croatian: Ispitivanja su trajala od 32 tjedna do najviše 3 godine.
English: It is not known if Eperzan is safe and effective in people under 18 years of age.
Croatian: Nije poznato je li Eperzan siguran i djelotvoran u osoba mlađih od 18 godina.
English: In addition some other side effects have been reported (frequency not known, cannot be estimated from the available data):
Croatian: Dodatno su prijavljene neke druge nuspojave (učestalost nepoznata, ne može se procijeniti iz dostupnih podataka):
English: 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.
Croatian: Ako ne čujete ‘klik' kada se u prozorčiću za prikaz brojeva pojavi broj [2] ili broj [3], možda se broj ne nalazi u samom središtu prozorčića.
English: Count to 5
Croatian: Brojite do 5
English: Your doctor will tell you what to do if you get low blood sugar.
Croatian: Liječnik će Vam reći što trebate učiniti ako Vam padne razina šećera u krvi.
English: Healthcare professionals may utilise the following alternate method of reconstitution that allows for more rapid dissolution.
Croatian: Zdravstveni radnici mogu primijeniti sljedeću alternativnu metodu rekonstitucije, koja omogućuje brže otapanje.
English: This removes the large air bubbles.
Croatian: Time ćete ukloniti velike mjehuriće zraka.
English: You may feel the pain going from your front (abdomen) through to your back.
Croatian: Možda ćete osjetiti bol koja se širi s prednje strane (trbuha) prema leđima.
English: If there is a possibility that you could become pregnant, you must use effective contraception while using this medicine.
Croatian: Ako postoji mogućnost da zatrudnite, morate koristiti učinkovitu kontracepciju tijekom liječenja ovim lijekom.
English: 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').
Croatian: Obavijestite liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove (pogledajte i 'Upozorenja i mjere opreza' u dijelu 2.).
English: “Click”
Croatian: ‘Klik'
English: These are removed in step 6.
Croatian: Oni se uklanjaju u 6. koraku.
English: Pancreatitis can be severe and life-threatening.
Croatian: Pankreatitis može biti težak i opasan po život.
English: Wash Hands and Check Pen
Croatian: Operite ruke i pregledajte brizgalicu
English: Eperzan that has been frozen must not be used.
Croatian: Eperzan koji je bio zamrznut ne smije se primijeniti.
English: Throw away the pen if frozen.
Croatian: Bacite brizgalicu ako se smrzne.
English: Decreased appetite
Croatian: smanjeni apetit
English: Push Straight Down
Croatian: Pritisnite ravno prema dolje
English: • if you are allergic to albiglutide or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na albiglutid ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: Race and ethnicity
Croatian: Rasa i etničko podrijetlo
English: Other medicines and Eperzan
Croatian: Drugi lijekovi i Eperzan
English: If possible show them the pack, or this leaflet.
Croatian: Ako je moguće, pokažite im pakiranje lijeka ili ovu uputu.
English: Cardiovascular Evaluation:
Croatian: Kardiovaskularna procjena:
English: Count to 5------
Croatian: Brojite do 5--
English: Important warnings
Croatian: Važna upozorenja
English: ATC code: A10BJ04
Croatian: ATK oznaka: A10BJ04
English: 5 Times min. sec.
Croatian: 5 puta min. sek.
English: The pancreas changes were not associated with histomorphologic abnormalities or evidence of increased proliferation.
Croatian: Promjene na gušterači nisu bile povezane s histomorfološkim abnormalnostima niti dokazima pojačane proliferacije.
English: Don't stop unless your doctor advises you to.
Croatian: Nemojte prestati primjenjivati lijek, osim ako Vam to ne savjetuje liječnik.
English: A small amount of foam on top of the solution at the end of the reconstitution is normal.
Croatian: Mala količina pjene na površini otopine pri kraju rekonstitucije je normalna.
English: Insert, Push Button, & Wait
Croatian: Ubodite, pritisnite dugme i pričekajte
English: • severe stomach (abdominal) pain that does not go away, this can be a symptom of pancreatitis.
Croatian: • jaku bol u trbuhu (abdomenu) koja ne prolazi, to može biti simptom pankreatitisa.
English: IMPORTANT: After the needle has been securely attached, make sure to complete the remaining steps of the injection procedure right away.
Croatian: VAŽNO: Nakon što je igla sigurno pričvršćena, obavezno odmah dovršite preostale korake postupka injiciranja.
English: A few drops of liquid may come out of the needle.
Croatian: Iz igle može izaći nekoliko kapljica tekućine.
English: min. sec.
Croatian: min. sek.
English: What Eperzan looks like and contents of the pack
Croatian: Kako Eperzan izgleda i sadržaj pakiranja
English: Store pens and needles in the original carton until use.
Croatian: Brizgalice i igle čuvati u originalnom pakiranju do uporabe.
English: 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.
Croatian: Ako planirate imati dijete, liječnik će možda odlučiti prekinuti liječenje lijekom Eperzan najmanje mjesec dana prije nego što pokušate zatrudnjeti.
English: What if I do not attach the needle as instructed?
Croatian: Što ako ne pričvrstim iglu kako je navedeno u uputama?
English: Gastrointestinal events
Croatian: Gastrointestinalni događaji
English: • because your body is not able to use the insulin properly.
Croatian: • zbog toga što Vaše tijelo ne može pravilno iskoristiti inzulin.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 March 2014
Croatian: Datum prvog odobrenja: 21. ožujak 2014
English: Caution should be exercised in patients receiving medicinal products with a narrow therapeutic index or medicinal products that require careful clinical monitoring.
Croatian: Potreban je oprez u bolesnika koji primaju lijekove uskog terapijskog indeksa ili lijekove koji zahtijevaju pažljiv klinički nadzor.
English: • If a box of pens will be stored for more than 4 weeks, keep them refrigerated (2°C to 8°C).
Croatian: • Ako ćete kutiju brizgalica čuvati dulje od 4 tjedna, držite ih u hladnjaku (2°C - 8°C).
English: Speak to your doctor about how to recognise the symptoms of ketoacidosis and seek urgent medical treatment if they occur.
Croatian: Razgovarajte sa svojim liječnikom o tome kako prepoznati simptome ketoacidoze i odmah potražite liječničku pomoć ako se ti simptomi pojave.
English: Use Eperzan for as long as your doctor recommends.
Croatian: Primjenjujte Eperzan onoliko dugo koliko Vam liječnik preporuči.
English: (122 mild, 99 moderate, 15 severe)a
Croatian: (122 blago, 99 umjereno, 15 teško)a
English: Non-clinical data reveal no special hazards for humans based on studies of safety pharmacology or repeatdose toxicity.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju ispitivanja sigurnosne farmakologije i toksičnosti ponovljenih doza.
English: You can use Eperzan at any time of day, with or without meals.
Croatian: Eperzan možete primijeniti u bilo koje doba dana, s hranom ili bez nje.
English: • swelling, sometimes of the face, mouth or throat, causing difficulty in breathing.
Croatian: • oticanje, ponekad lica, usta ili grla, koje uzrokuje poteškoće u disanju.
English: This means the needle is attached (Figure M).
Croatian: To znači da je igla pričvršćena (slika M).
English: Glucagon-like peptide-1 (GLP-1) analogues.
Croatian: Analog glukagonu nalik peptid-1 (GLP-1).
English: These differences were not considered clinically relevant (see section 4.2).
Croatian: Te se razlike nisu smatrale klinički značajnima (vidjeti dio 4.2).
English: 1a Wash your hands (Figure D).
Croatian: 1a Operite ruke (slika D).
English: • After the powder and liquid are mixed within the pen, the pen should be used within 8 hours.
Croatian: • Nakon što se prašak i tekućina pomiješaju u brizgalici, ona se mora upotrijebiti unutar 8 sati.
English: It should be yellow and see-through, without any particles (Figure K).
Croatian: Mora biti žut i proziran te ne smije sadržavati nikakve čestice (slika K).
English: Throw out the pen in a container for pen disposal right away after injecting, as shown in Step 9.
Croatian: Bacite brizgalicu u spremnik za odlaganje brizgalica odmah nakon injiciranja, kako je prikazano u 9. koraku.
English: Generally, injection site reactions were mild in intensity and did not require treatment.
Croatian: Reakcije na mjestu injekcije obično su bile blagog intenziteta i nisu zahtijevale liječenje.
English: Glaxo Operations UK Limited (Trading as Glaxo Wellcome Operations) Harmire Road
Croatian: Glaxo Operations UK Limited (posluje kao Glaxo Wellcome Operations) Harmire Road
English: Do not use the pen if the number ‘1' is not showing.
Croatian: Nemojte upotrijebiti brizgalicu ako se ne prikazuje broj ‘1'.
English: † The numbers on the clear cartridge represent stages of preparation for your medicine.
Croatian: † Brojevi na prozirnom ulošku predstavljaju faze pripreme lijeka.
English: 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.
Croatian: Budući da je relativno opterećenje povezano s količinom energije potrebnom za laktaciju mnogo manje u ljudi nego u miševa i budući da ljudi imaju velike zalihe energije, smrtnost primijećena u ženki miševa u laktaciji ne smatra se relevantnom za ljude.
English: Stop taking Eperzan and talk to your doctor straight away
Croatian: Prestanite primjenjivati Eperzan i odmah se obratite svom liječniku.
English: Don't use Eperzan:
Croatian: Nemojte primijeniti Eperzan:
English: Other Supplies Needed
Croatian: Ostali pribor koji Vam je potreban
English: It is important to avoid dehydration by drinking plenty of fluids.
Croatian: Važno je spriječiti dehidraciju uzimanjem dovoljnih količina tekućine.
English: Because this method relies on appropriate swirling and visual inspection of the solution, it is intended only for healthcare professionals.
Croatian: Budući da se ta metoda oslanja na primjereno okretanje brizgalice i vizualni pregled otopine, namijenjena je samo zdravstvenim radnicima.
English: Eperzan is not recommended for children and adolescents.
Croatian: Primjena lijeka Eperzan ne preporučuje se u djece i adolescenata.
English: If you get:
Croatian: Ako primijetite:
English: Never mix insulin and Eperzan together.
Croatian: Nikada nemojte pomiješati inzulin i Eperzan.
English: 4b Check medicine through the viewing window.
Croatian: 4b Pregledajte lijek kroz prozorčić za provjeru lijeka.
English: • 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.
Croatian: • ako imate šećernu bolest tipa 1 (šećernu bolest ovisnu o inzulinu) ili ketoacidozu (vrlo ozbiljnu komplikaciju šećerne bolesti koja se javlja kada tijelo ne može razgraditi glukozu jer nema dovoljno inzulina), ovaj lijek nije prikladan za Vas.
English: If pancreatitis is suspected, Eperzan should be discontinued; if pancreatitis is confirmed, Eperzan should not be restarted.
Croatian: Ako se sumnja na pankreatitis, potrebno je prekinuti liječenje lijekom Eperzan; ako se pankreatitis potvrdi, liječenje lijekom Eperzan ne smije se ponovno započeti.
English: Eperzan should be administered once a week on the same day each week.
Croatian: Eperzan treba primjenjivati jedanput tjedno, svaki tjedan istoga dana.