FrancophonIA/ELRC3.0 huggingface dataset:
English: Other factors to be considered are the current general condition and medical status of the patient, including body size, age, and extent of debilitation as well as degree of opioid tolerance.
Croatian: Drugi faktori koje treba uzeti u obzir su trenutačno opće stanje i medicinski status bolesnika, što uključuje veličinu tijela, dob i razinu onesposobljenosti kao i stupanj tolerancije na opioide.
English: Depending on the additional analgesic needs and the pain status of the child, it may be decided to increase the dose.
Croatian: Ovisno o potrebama za dodatnom analgezijom te statusu boli kod djeteta, može se donijeti odluka o povećanju doze.
English: UNIQUE IDENTIFIER - 2D BARCODE <Not applicable>
Croatian: JEDINSTVENI IDENTIFIKATOR - 2D BARKOD <Nije primjenjivo.>
English: Alternative routes of administration (oral, parenteral) should be considered.
Croatian: Treba razmotriti druge moguće putove primjene (peroralnu, parenteralnu).
English: Operations
Croatian: Operacije
English: It may take 20 hours or more for the fentanyl serum concentrations to decrease 50%.
Croatian: Može biti potrebno 20 sati ili dulje da se serumska koncentracija fentanila smanji za 50%.
English: The patches help relieve pain that is very bad and long-lasting:
Croatian: Flasteri pomažu ublažiti vrlo jaku i dugotrajnu bol:
English: High inter-subject variability in plasma concentrations has been observed.
Croatian: Primijećena je visoka interindividualna varijabilnost plazmatskih koncentracija.
English: The safety profile in children and adolescents treated with DUROGESIC was similar to that observed in adults.
Croatian: Profil sigurnosti kod djece i adolescenata liječenih lijekom DUROGESIC bio je sličan onom primijećenom kod odraslih.
English: Opioids may cause hypotension, especially in patients with acute hypovolaemia.
Croatian: Opioidi mogu uzrokovati hipotenziju, osobito kod bolesnika s akutnom hipovolemijom.
English: • If you stop using the patches, don't start again without asking your doctor first.
Croatian: • Ako prestanete primjenjivati flastere, nemojte ih početi ponovno primjenjivati, a da se najprije ne posavjetujete sa svojim liječnikom.
English: • You have ever had persistent headaches or a head injury
Croatian: • ako ste ikada imali dugotrajne glavobolje ili ozljedu glave
English: • Blue colour to the skin caused by low oxygen in the blood (cyanosis)
Croatian: • plavičasta boja kože zbog niske razine kisika u krvi (cijanoza)
English: Fentanyl is rapidly distributed to various tissues and organs, as indicated by the large volume of distribution (3 to 10 L/kg after intravenous dosing in patients).
Croatian: Fentanil se brzo raspodjeljuje u različita tkiva i organe, na što ukazuje velik volumen distribucije (od 3 do 10 l/kg nakon intravenske primjene bolesnicima).
English: • If you forget, change your patch as soon as you remember and make note of the day and time.
Croatian: • Ako zaboravite, promijenite flaster čim se sjetite i zabilježite dan i sat.
English: How long will you use the patches for?
Croatian: Koliko dugo ćete primjenjivati flastere?
English: • If you are very late changing your patch, you should talk to your doctor because you might need some extra painkillers, but do not apply an extra patch.
Croatian: • Ako jako kasnite s promjenom flastera, trebali biste razgovarati sa svojim liječnikom jer će Vam možda biti potrebni dodatni lijekovi protiv boli, ali nemojte primijeniti dodatni flaster.
English: • You can shower or bathe while wearing a patch, but do not scrub the patch itself
Croatian: • Možete se tuširati ili kupati dok nosite flaster, ali nemojte izravno trljati flaster
English: • After this, the patch should help to relieve pain continuously so that you can stop taking other painkillers.
Croatian: • Nakon toga, flaster bi trebao kontinuirano ublažavati bol, tako da možete prestati uzimati druge lijekove protiv boli.
English: In the next 12 hours, these analgesics should be provided based on clinical need.
Croatian: Tijekom narednih 12 sati te analgetike treba davati sukladno kliničkoj potrebi.
English: This leaflet was last revised in <{MM/YYYY}> <{month YYYY}>.
Croatian: Ova uputa je zadnji puta revidirana u <{MM/GGGG}> <{mjesec/GGGG}.
English: You should also tell your pharmacist that you are using DUROGESIC if you buy any medicines from your pharmacy.
Croatian: Također biste trebali obavijestiti svog ljekarnika da koristite lijek DUROGESIC ako kupujete bilo koje lijekove u ljekarni.
English: • Do not use the patch if it has been divided, cut or looks damaged
Croatian: • Nemojte koristiti flaster ako je raspolovljen, zarezan ili se čini da je oštećen
English: Multiplication Factor morphine oral
Croatian: Multiplikacijski faktor morfin peroralni
English: • Take the patch out and use straight away
Croatian: • Izvadite flaster i odmah ga primijenite
English: Therefore, the use of any of these medicinal products concomitantly with DUROGESIC requires special patient care and observation.
Croatian: Zbog toga primjena bilo kojeg od tih lijekova istodobno s lijekom DUROGESIC zahtijeva posebnu skrb i nadzor bolesnika.
English: • You have ever had a brain tumour
Croatian: • ako ste ikada imali moždani tumor
English: • It is important that your child does not remove the patch and put it in their mouth as this could be life threatening or even fatal.
Croatian: • važno je da dijete ne ukloni flaster i da ga ne stavi u usta jer to može biti opasno po život ili čak smrtonosno
English: • Do not stick a patch on straight after a hot bath or shower
Croatian: • Nemojte stavljati flaster odmah nakon vruće kupke ili tuširanja
English: Careful monitoring should be continued until stable drug effects are achieved.
Croatian: Bolesnika treba pažljivo nadzirati sve dok se ne postignu stabilni učinci lijeka.
English: • Do not take the patch out of its sachet until you are ready to use it
Croatian: • Nemojte vaditi flaster iz vrećice sve dok niste spremni za njegovu primjenu
English: If you want to stop using the patches
Croatian: Ako želite prestati primjenjivati flastere
English: DUROGESIC should not be used in children aged less than 2 years because the safety and efficacy have not been established.
Croatian: DUROGESIC se ne smije primjenjivati u djece dobi ispod 2 godine zbog toga što sigurnost i djelotvornost nisu još ustanovljene.
English: A mutagenic risk for the use of therapeutic doses seems unlikely since effects appeared only at high concentrations.
Croatian: Rizik od mutagenih učinaka kod primjene terapijskih doza čini se malo vjerojatnim jer izgleda da ti učinci nastupaju samo pri visokim koncentracijama.
English: Then they should be safely discarded by putting them back into the original sachet and stored out of sight and reach of other people, especially children, until safely disposed.
Croatian: Zatim ih treba odložiti na siguran način, tako da ih vratite u originalnu vrećicu i čuvate izvan pogleda i dohvata drugih ljudi, osobito djece, do trajnog sigurnog zbrinjavanja.
English: Linearity/non-Linearity
Croatian: Linearnost/nelinearnost
English: • Make sure that the patch will be covered by loose clothing and not stuck under a tight or elasticated band
Croatian: • Pobrinite se da flaster bude pokriven širokom odjećom i nemojte ga pokrivati tijesnim ili elastičnim trakama
English: Effects on the embryo were due to maternal toxicity and not to direct effects of the substance on the developing embryo.
Croatian: 10 Učinci na embrij bili su posljedica toksičnih učinaka za majku, a ne izravni učinci tvari na embrij u razvoju.
English: • in children above 2 years of age who are already using opioid medication and who need continuous pain treatment.
Croatian: • kod djece starije od 2 godine koja već koriste opioidne lijekove i kojoj je potrebno neprekidno liječenje boli
English: Patients and their carers must be instructed that DUROGESIC contains an active substance in an amount that can be fatal, especially to a child.
Croatian: Bolesnicima i njihovim njegovateljima mora se dati informacija o tome da DUROGESIC sadrži djelatnu tvar u količini koja može biti smrtonosna, naročito za dijete.
English: Oral doses are those recommended when changing from a parenteral to an oral route.
Croatian: Peroralne doze su one koje se preporučuju pri prelasku s parenteralnog na peroralni put primjene.
English: • Each patch is sealed in its own sachet
Croatian: • Svaki flaster zatvoren je u posebnoj vrećici
English: Eighty of the children were aged 2 to 6 years, inclusive.
Croatian: Osamdesetero djece bilo je u dobi između (i uključujući) 2 i 6 godina.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION <Date of first authorisation: {DD month YYYY}> <Date of latest renewal: {DD month YYYY}>
Croatian: <Datum prvog odobrenja: {DD mjesec GGGG}> <Datum posljednje obnove odobrenja: {DD mjesec GGGG}>
English: There are no clinical data on the effects of fentanyl on fertility.
Croatian: Nema kliničkih podataka o učincima fentanila na plodnost.
English: Fentanyl crosses the blood-brain barrier easily.
Croatian: Fentanil lako prolazi kroz krvno-moždanu barijeru.
English: 6.6 Special precautions for disposal and other handling Instructions for disposal:
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Upute za zbrinjavanje:
English: You may need to be closely monitored if you are taking some of the types of medicines listed below or if you stop taking some of the types of medicines listed below, as this may affect the strength of DUROGESIC you need.
Croatian: Možda će Vas biti potrebno pažljivo nadzirati ako uzimate neke vrste lijekova navedenih u nastavku ili ako prestanete uzimati neke vrste lijekova navedene u nastavku, jer mogu utjecati na jačinu lijeka DUROGESIC koja
English: Abuse or intentional misuse of DUROGESIC may result in overdose and/or death.
Croatian: Zlouporaba ili namjerna pogrešna primjena lijeka DUROGESIC mogu dovesti do predoziranja i/ili smrti.
English: Adjusting for body weight, clearance (L/h/kg) appears to be approximately 80% higher in children 2 to 5 years old and 25% higher in children 6 to 10 years old when compared to children 11 to 16 years old, who are expected to have a similar clearance as adults.
Croatian: Nakon prilagodbe za tjelesnu težinu, čini se da je klirens (l/h/kg) približno 80% veći kod djece u dobi od 2 do 5 godina te 25% veći kod djece u dobi od 6 do 10 godina nego kod djece u dobi od 11 do 16 godina, kod koje se očekuje sličan klirens kao i kod odraslih.
English: The skin should be completely dry before the patch is applied.
Croatian: Koža mora biti potpuno suha prije stavljanja flastera.
English: If you are not sure, talk to your doctor or pharmacist before using DUROGESIC.
Croatian: Ako niste sigurni, obratite se svom liječniku ili ljekarniku prije nego primijenite DUROGESIC.
English: • Feeling unusually drowsy, breathing that is more slow or shallow than expected.
Croatian: • neuobičajenu omamljenost, sporije ili pliće disanje nego što se očekuje.
English: • If a patch falls off before it needs changing, stick a new one on straight away and make note of the day and time.
Croatian: • Ako se flaster odlijepi prije nego što ga treba promijeniti, stavite odmah novi i zabilježite dan i sat.
English: Pharmacotherapeutic group: Analgesics, Opioids, phenylpiperidine derivatives, ATC code: N02AB03
Croatian: Farmakoterapijska skupina: analgetici, opioidi, derivati fenilpiperidina, ATK oznaka: N02AB03
English: DUROGESIC contains a medicine called fentanyl.
Croatian: DUROGESIC sadrži lijek koji se zove fentanil.
English: Bear in mind that a sticky patch (unused or used) could be tempting to a child and if it sticks to a child's skin or they put it in their mouth, the result may be fatal.
Croatian: Imajte na umu da ljepljiv flaster (upotrijebljen ili neupotrijebljen) može biti primamljiv za djecu, a ako se zalijepi za djetetovu kožu ili ga dijete stavi u usta, posljedice mogu biti smrtonosne.
English: DUROGESIC may impair mental and/or physical ability required for the performance of potentially hazardous tasks such as driving or operating machinery.
Croatian: DUROGESIC može narušiti mentalnu i/ili fizičku sposobnost koja je potrebna za izvođenje potencijalno opasnih zadataka kao što su upravljanje vozilima ili rad sa strojevima.
English: * the assigned frequency (uncommon) is based on analyses of incidence including only adult and paediatric clinical study subjects with non-cancer pain.
Croatian: *Dodijeljena učestalost (manje često) temelji se na analizama incidencije koje su uključivale samo odrasle i pedijatrijske ispitanike s nekarcinomskom boli iz kliničkih ispitivanja.
English: Oral 24-hour morphine (mg/day)
Croatian: 24-satna doza oralnog morfina (mg/dan)
English: It belongs to a group of strong painkillers called opioids.
Croatian: On pripada skupini jakih analgetika koji se zovu opioidi.
English: The pharmacokinetics of transdermal fentanyl do not change with repeated application.
Croatian: Farmakokinetika transdermalnog fentanila ne mijenja se pri ponovljenoj primjeni.
English: • Decreased feeling or sensitivity, especially in the skin (hypoaesthesia)
Croatian: • smanjeni osjeti, pogotovo na koži (hipoestezija)
English: DUROGESIC and associated names (see Annex I) 12 micrograms/hour transdermal patch DUROGESIC and associated names (see Annex I) 25 micrograms/hour transdermal patch DUROGESIC and associated names (see Annex I) 50 micrograms/hour transdermal patch DUROGESIC and associated names (see Annex I) 75 micrograms/hour transdermal patch DUROGESIC and associated names (see Annex I) 100 micrograms/hour transdermal patch
Croatian: DUROGESIC i pridružena imena (vidjeti Prilog I.) 12 mikrograma/sat transdermalni flaster DUROGESIC i pridružena imena (vidjeti Prilog I.) 25 mikrograma/sat transdermalni flaster DUROGESIC i pridružena imena (vidjeti Prilog I.) 50 mikrograma/sat transdermalni flaster DUROGESIC i pridružena imena (vidjeti Prilog I.) 75 mikrograma/sat transdermalni flaster DUROGESIC i pridružena imena (vidjeti Prilog I.) 100 mikrograma/sat transdermalni flaster
English: • You have ever had problems with your heart, liver, kidneys, or low blood pressure
Croatian: • ako ste ikada imali tegoba sa srcem, jetrom, bubrezima ili niskim krvnim tlakom
English: • Seeing, feeling, hearing, or smelling things that are not there (hallucinations)
Croatian: • halucinacije (kada vidite, osjećate, čujete ili možete namirisati stvari kojih nema)
English: A pharmacokinetic model has suggested that serum fentanyl concentrations may increase by 14% (range 0-26%) if a new patch is applied after 24 hours rather than the recommended 72-hour application.
Croatian: Farmakokinetički model pokazao je da koncentracije fentanila u serumu mogu porasti za 14% (raspon: 0 - 26%), ako se novi flaster primjeni nakon 24 sata, a ne nakon preporučene 72-satne primjene.
English: • Grasp both sides of the opened sachet and pull apart
Croatian: • Uhvatite obje strane otvorene vrećice i razdvojite ih
English: • If your pain gets worse while you are using these patches, your doctor may try a higher strength patch, or give you additional painkillers (or both)
Croatian: • Ako se bol pogorša tijekom primjene ovih flastera, Vaš liječnik može pokušati s primjenom veće jačine flastera ili Vam dati dodatne lijekove protiv boli (ili oboje).
English: Try not to touch the sticky side of the patch
Croatian: Pokušajte ne dodirnuti ljepljivu stranu flastera
English: If analgesia is insufficient during the first application only, the DUROGESIC patch may be replaced after 48 hours with a patch of the same dose, or the dose may be increased after 72 hours.
Croatian: Ako je analgezija nedostatna samo tijekom prve primjene, DUROGESIC flaster može se nakon 48 sati zamijeniti flasterom iste doze ili se doza može povećati nakon 72 sata.
English: Some studies with female rats revealed reduced fertility and enhanced embryo mortality.
Croatian: Neka ispitivanja provedena na ženkama štakora pokazala su smanjenu plodnost i povećanu smrtnost embrija.
English: Long term management of severe chronic pain in children from 2 years of age who are receiving opioid therapy.
Croatian: Dugotrajno liječenje teške kronične boli kod djece od navršene 2 godine koja primaju terapiju opioidima.
English: 4.1 Therapeutic indications
Croatian: 4.1 Terapijske indikacije Odrasli
English: There have been reports of patches accidentally sticking to a family member while in close physical contact or sharing the same bed as the person wearing the patch.
Croatian: Prijavljeni su slučajevi slučajnog prijenosa flastera na člana obitelji tijekom bliskog fizičkog kontakta ili spavanja u istom krevetu s osobom koja nosi flaster.
English: • Slow heart beat (bradycardia) or low blood pressure
Croatian: • zamagljen vid • usporeni otkucaji srca (bradikardija) ili nizak krvni tlak
English: Therefore, your child might need to use other painkillers as well until the patches become effective.
Croatian: Stoga će Vaše dijete možda trebati uzimati dodatne lijekove protiv boli dok flasteri ne počnu djelovati.
English: Patch sticking to another person
Croatian: Prijenos flastera na drugu osobu
English: • DUROGESIC is a medicine that could be life-threatening to children, even if the patches have been used.
Croatian: • DUROGESIC je lijek koji može biti po život opasan za djecu, čak i ako su se flasteri već koristili.
English: Patients with myasthenia gravis
Croatian: Bolesnici s miastenijom gravis
English: • Put it back in its original sachet and dispose of the sachet as instructed by your pharmacist
Croatian: • Vratite ga u pripadajuću originalnu vrećicu i odložite sukladno uputama koje ste dobili od ljekarnika
English: In case the patch sticks to the skin of another person, take the patch off right away and get medical attention.
Croatian: Ako se flaster zalijepi za kožu druge osobe, odmah ga skinite i potražite liječničku pomoć.
English: Patients may require periodic supplemental doses of a short acting analgesic for “breakthrough” pain.
Croatian: Bolesnicima mogu povremeno biti potrebne dodatne doze kratkodjelujućih analgetika za „probojnu“ bol.
English: Paediatric population Interaction studies have only been performed in adults.
Croatian: • Pedijatrijska populacija • Ispitivanja interakcija provedena su samo u odraslih.
English: Step 2: Open the sachet
Croatian: 2. korak: Otvorite vrećicu
English: This was determined in a human keratinocyte cell assay and in clinical studies in which 92% of the dose delivered from the system was accounted for as unchanged fentanyl that appeared in the systemic circulation.
Croatian: To je utvrđeno u testu na stanicama ljudskih keratinocita i kliničkim ispitivanjima u kojima je 92% doze isporučene iz sustava činio nepromijenjeni fentanil koji se nalazio u sistemskoj cirkulaciji.
English: Table 5: Adverse reactions in adult and paediatric patients System/organ class
Croatian: Tablica 5: Nuspojave kod odraslih i pedijatrijskih bolesnika Organski sustav
English: Step 4: Disposing of the patch
Croatian: 4. korak: Odlaganje flastera
English: Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity.
Croatian: 5.3 Neklinički podaci o sigurnosti primjene 6 Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja toksičnosti ponovljenih doza.
English: Of the 289 subjects enrolled in these 3 studies, 110 initiated DUROGESIC treatment with a dosage of 12 mcg/h.
Croatian: Od 289 ispitanika uključenih u ta 3 ispitivanja, njih 110 započelo je liječenje lijekom DUROGESIC u dozi od 12 µg/h.
English: If it does not, or if the patch irritates your skin badly, tell your doctor.
Croatian: Ako se to ne dogodi, ili ako flaster jako nadražuje kožu, obavijestite svog liječnika.
English: • Keep used patches out of sight and reach of children - even used patches contain some medicine which may harm children and may even be fatal
Croatian: • Čuvajte upotrijebljene flastere izvan pogleda i dohvata djece - čak i upotrijebljeni flasteri sadrže izvjesnu količinu lijeka koji bi mogao naštetiti djeci, pa čak uzrokovati smrt
English: The average bioavailability of fentanyl after application of the transdermal patch is 92%.
Croatian: Prosječna bioraspoloživost fentanila nakon nanošenja transdermalnog flastera iznosi 92%.
English: Adjustment of the individual fentanyl dose must be based on the patient's response and level of tolerance.
Croatian: Prilagodba individualne doze fentanila mora se temeljiti na bolesnikovu odgovoru i razini tolerancije.
English: Studies in animals have shown some reproductive toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su određen stupanj reproduktivne toksičnosti (vidjeti dio 5.3).
English: Reversal of the narcotic effect may result in acute onset of pain and release of catecholamines.
Croatian: Reverzija narkotičkog učinka može dovesti do naglog nastupa boli i otpuštanja katekolamina.
English: • You have breathing difficulties, with slow or shallow breathing Do not use this medicine if any of the above apply to you or your child.
Croatian: • ako teško dišete, uz spore ili plitke udisaje i izdisaje Nemojte primijeniti ovaj lijek ako se bilo što od navedenoga odnosi na Vas ili Vaše dijete.
English: A carcinogenicity study (daily subcutaneous injections of fentanyl hydrochloride for two years in Sprague Dawley rats) did not induce any findings indicative of oncogenic potential.
Croatian: 14 Ispitivanje kancerogenosti (dvogodišnja svakodnevna primjena supkutanih injekcija fentanilklorida Sprague Dawley štakorima) nije dalo nalaze koji bi ukazivali na onkogeni potencijal.
English: b Based on single-dose studies in which an IM dose of each active substance listed was compared with morphine to establish the relative potency.
Croatian: b Temelji se na ispitivanjima provedenima s jednokratnom dozom, u kojima se intramuskularna doza svake od navedenih djelatnih tvari uspoređivala s morfinom radi određivanja relativne jačine.
English: Due to accumulation, the AUC and Cmax values over a dosing interval at steady state are approximately 40% higher than after a single application.
Croatian: Zbog kumulacije, vrijednosti AUC i Cmax tijekom intervala doziranja u stanju dinamičke ravnoteže približno su 40% više nego nakon jednokratne primjene.
English: If discontinuation of DUROGESIC is necessary, replacement with other opioids should be gradual, starting at a low dose and increasing slowly.
Croatian: Ako je potrebno prekinuti primjenu lijeka DUROGESIC, zamjena drugim opioidima mora biti postupna i započeti niskom dozom koja se zatim polako povećava.
English: Patients at increased risk of opioid abuse may still be appropriately treated with modified-release opioid formulations; however, these patients will require monitoring for signs of misuse, abuse, or addiction.
Croatian: Bolesnike s povećanim rizikom od zlouporabe opioida i dalje se može na odgovarajući način liječiti opioidima u formulacijama s prilagođenim oslobađanjem; međutim, te bolesnike treba nadzirati kako bi se uočili mogući znakovi pogrešne primjene, zlouporabe ili ovisnosti.
English: Because fentanyl is metabolised to inactive metabolites in the liver, hepatic impairment might delay its elimination.
Croatian: Budući da se fentanil metabolizira u neaktivne metabolite u jetri, oštećenje jetrene funkcije može produljiti njegovu eliminaciju.
English: • It may take some time for the patch to have its maximum effect.
Croatian: • možda će biti potrebno neko vrijeme da flasteri postignu puni učinak.
English: • Gently tear or cut off the edge of the sachet completely (if you use scissors, cut close to the sealed edge of the sachet to avoid damaging the patch)
Croatian: • Nježno otrgnite ili odrežite rub vrećice do kraja (ako koristite škare, odrežite blizu zapečaćenog ruba vrećice da ne oštetite flaster)
English: <[To be completed nationally]> <Other sources of information> <Detailed information on this medicine is available on the website of {name of MS Agency (link)}>
Croatian: Ostali izvori informacija Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici {naziv nadležnog tijela države članice (poveznica)}
English: 4.5 Interaction with other medicinal products and other forms of interaction
Croatian: 4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Interakcije povezane s farmakodinamikom