FrancophonIA/ELRC3.0 huggingface dataset:
English: The potential risk for humans is unknown, although fentanyl as an IV anaesthetic has been found to cross the placenta in human pregnancies.
Croatian: Mogući rizik za ljude nije poznat, iako je utvrđeno da fentanil kao intravenski anestetik prolazi kroz posteljicu tijekom trudnoće kod ljudi.
English: There is a potential for temperature-dependent increases in fentanyl released from the system resulting in possible overdose and death.
Croatian: Može doći do temperaturno uvjetovanog porasta količine fentanila koji se otpušta iz sustava, što može dovesti do predoziranja i smrti.
English: In young children, the upper back is the preferred location to minimize the potential of the child removing the patch.
Croatian: Kod male djece poželjno je flaster staviti na gornji dio leđa kako bi se minimizirala vjerojatnost da će ga dijete skinuti.
English: Fentanyl is an opioid analgesic, interacting predominantly with the µ opioid receptor.
Croatian: Fentanil je opioidni analgetik koji ulazi u interakcije uglavnom s µ-opioidnim receptorom.
English: • Some medicines used to treat cancer of the blood (such as idelalisib).
Croatian: • neke lijekove koji se koriste za liječenje raka krvi (npr. idelalisib).
English: Pharmacokinetic/Pharmacodynamic Relationships
Croatian: Farmakokinetički/farmakodinamički odnos
English: DUROGESIC with antidepressants
Croatian: DUROGESIC i antidepresivi
English: DUROGESIC should be applied immediately upon removal from the sealed package.
Croatian: DUROGESIC treba primijeniti odmah nakon vađenja iz zatvorene vrećice.
English: As a result of continued absorption of fentanyl from the skin depot after removal of the patch, the half-life of fentanyl after transdermal administration is about 2- to 3-fold longer than intravenous administration.
Croatian: Zbog kontinuirane apsorpcije fentanila iz kožnog depoa nakon uklanjanja flastera, poluvijek fentanila nakon transdermalne primjene približno je 2 do 3 puta dulji nego nakon intravenske primjene.
English: In a study conducted with DUROGESIC, healthy elderly subjects had fentanyl pharmacokinetics which did not differ significantly from healthy young subjects although peak serum concentrations tended to be lower and mean half-life values were prolonged to approximately 34 hours.
Croatian: DUROGESIC, farmakokinetika fentanila kod zdravih starijih ispitanika nije se značajno razlikovala od one kod zdravih mlađih ispitanika, iako su vršne koncentracije u serumu bile manje, dok je srednja vrijednost poluvijeka bila produljena na približno 34 sata.
English: Convert this amount to the equianalgesic 24-hour oral morphine dose using the multiplication factors in Table 1 for the appropriate route of administration.
Croatian: Preračunajte tu dozu u ekvianalgetsku 24-satnu dozu oralnog morfina koristeći multiplikacijske faktore u Tablici 1 za odgovarajući put primjene.
English: A patient who is treated with DUROGESIC should wait at least 1 week after removal of the last patch before initiating treatment with a CYP3A4 inhibitor.
Croatian: Bolesnik koji se liječi lijekom DUROGESIC treba pričekati najmanje tjedan dana nakon uklanjanja posljednjeg flastera prije nego što započne liječenje inhibitorom CYP3A4.
English: Even though impairment of renal function is not expected to affect fentanyl elimination to a clinically relevant extent, caution is advised because fentanyl pharmacokinetics has not been evaluated in this patient population (see section 5.2).
Croatian: Iako se ne očekuje da će oštećenje bubrežne funkcije utjecati na eliminaciju fentanila u klinički značajnoj mjeri, preporučuje se oprez jer se farmakokinetika fentanila nije ocjenjivala u toj populaciji bolesnika (vidjeti dio 5.2).
English: Step 1: Preparing the skin
Croatian: Kako staviti flaster 1. korak: Priprema kože
English: A patch accidently sticking to another person (particularly a child) can cause the medicine in the patch to go through the skin of the other person and cause serious side effects such as breathing difficulties, with slow or shallow breathing which may be fatal.
Croatian: Ako se flaster slučajno zalijepi na kožu druge osobe (osobito djeteta), može se dogoditi da lijek u flasteru prođe kroz kožu te druge osobe i uzrokuje ozbiljne nuspojave, kao što je otežano disanje uz spore ili plitke udisaje i izdisaje, koje može biti smrtonosno.
English: Hypoaesthesia, Convulsion (including clonic convulsions and grand mal convulsion), Amnesia, Depressed level of consciousness, Loss of consciousness
Croatian: (uključujući kloničke i grand mal konvulzije), amnezija, smanjena razina svijesti, gubitak svijesti
English: If the clinical situation warrants, a patent airway should be established and maintained, possibly with an oropharyngeal airway or endotracheal tube, and oxygen should be administered and respiration assisted or controlled, as appropriate.
Croatian: Ako to zahtijeva klinička situacija, treba uspostaviti i održavati prohodnost dišnih putova, po mogućnosti uz pomoć orofaringealnog ili endotrahealnog tubusa, te po potrebi davati kisik i provoditi asistiranu ili kontroliranu ventilaciju.
English: Fentanyl
Croatian: fentanil
English: DUROGESIC should be administered to only those opioid-tolerant paediatric patients (ages 2 to 16 years) who are already receiving at least 30 mg oral morphine equivalents per day.
Croatian: DUROGESIC se smije primijeniti isključivo kod pedijatrijskih bolesnika s tolerancijom na opioide (u dobi od 2 do 16 godina) koji već primaju dozu opioida ekvivalentnu najmanje 30 mg oralnog morfina na dan.
English: If the patches are out of date, take them to your pharmacy.
Croatian: Ako je rok valjanosti flastera istekao, vratite ih u ljekarnu.
English: 0.23b diamorphine oral parenteral
Croatian: 0,23b diamorfin peroralni parenteralni
English: Fentanyl is excreted into human milk and may cause sedation/respiratory depression in a breastfed infant.
Croatian: Fentanil se izlučuje u majčino mlijeko te može izazvati sedaciju/depresiju disanja kod dojenčeta.
English: For management of respiratory depression, immediate countermeasures include removing the DUROGESIC patch and physically or verbally stimulating the patient.
Croatian: Protumjere koje se moraju odmah poduzeti za liječenje depresije disanja uključuju uklanjanje DUROGESIC flastera te fizičku ili verbalnu stimulaciju bolesnika.
English: Fentanyl concentrations were measured in more than 250 children aged 2 to 17 years who were applied fentanyl patches in the dose range of 12.5 to 300 mcg/h.
Croatian: Koncentracije fentanila određivale su se kod više od 250 djece u dobi od 2 do 17 godina kojima su primijenjeni flasteri s fentanilom u dozi od 12,5 do 300 µg/h.
English: • Tear or cut open the sachet at the notch, shown by the arrow
Croatian: • Otrgnite ili odrežite vrećicu na mjestu zareza duž ruba, na koji pokazuje strelica
English: There have been reports also of newborn infants experiencing withdrawal effects after their mothers have used DUROGESIC for a long time during pregnancy.
Croatian: Prijavljeni su slučajevi pojave simptoma ustezanja i kod novorođenčadi, nakon što su njihove majke koristile DUROGESIC dulje vrijeme tijekom trudnoće.
English: If you do, you may increase the amount of medicine you get from the patch.
Croatian: U protivnom možete povećati količinu lijeka koja se otpušta iz flastera.
English: Therefore, during the first 12 hours after switching to DUROGESIC, the patient should be given the previous regular dose of analgesics.
Croatian: Stoga tijekom prvih 12 sati nakon prelaska na DUROGESIC bolesniku treba nastaviti davati i dotadašnju uobičajenu dozu analgetika.
English: Dosage titration should normally be performed in 12 mcg/h or 25 mcg/h increments, although the supplementary analgesic requirements (oral morphine 45/90 mg/day ≈ DUROGESIC 12/25 mcg/h) and pain status of the patient should be taken into account.
Croatian: Doza se uobičajeno treba povećavati u koracima od 12 ili 25 µg/h, ali treba uzeti u obzir i dodatne potrebe za analgezijom (oralni morfin 45/90 mg/dan ≈ DUROGESIC 12/25 µg/h) te status boli kod bolesnika.
English: There are no adequate data from the use of DUROGESIC in pregnant women.
Croatian: Nema odgovarajućih podataka o primjeni lijeka DUROGESIC kod trudnica.
English: However, as the influence of renal impairment on the pharmacokinetics of fentanyl has not been evaluated, caution is advised (see sections 4.2 and 4.4).
Croatian: Međutim, kako se utjecaj oštećenja bubrežne funkcije na farmakokinetiku fentanila nije ocjenjivao, preporučuje se oprez (vidjeti dijelove 4.2 i 4.4)
English: DATE OF REVISION OF THE TEXT <{DD month YYYY}> [To be completed nationally]
Croatian: DATUM REVIZIJE TEKSTA <{DD mjesec GGGG}>
English: Patients with a prior history of drug dependence/alcohol abuse are more at risk to develop dependence and abuse in opioid treatment.
Croatian: Bolesnici koji su prethodno bili ovisni o lijekovima ili su prekomjerno uživali alkohol izloženi su većem riziku razvoja ovisnosti i zlouporabe tijekom liječenja opioidima.
English: Caution should be exercised when treating patients with myasthenia gravis.
Croatian: Potreban je oprez kada se liječe bolesnici s miastenijom gravis.
English: • DUROGESIC patches are for long-term pain.
Croatian: • DUROGESIC flasteri namijenjeni su za liječenje dugotrajne boli.
English: • Press this sticky part of the patch onto the skin
Croatian: • Pritisnite ljepljivi dio flastera na kožu
English: DUROGESIC may have more severe adverse effects in patients with chronic obstructive or other pulmonary disease.
Croatian: DUROGESIC može imati teže nuspojave kod bolesnika s kroničnom opstruktivnom ili drugom plućnom bolešću.
English: A lag time of 12 to 24 hours after application of the first patch and after a dose increase must be taken into account.
Croatian: Mora se uzeti u obzir vrijeme do nastupa punog učinka od 12 do 24 sata nakon prve primjene flastera i povećanja doze.
English: • Remove the other part of the backing and press the whole patch onto the skin with the palm of your hand
Croatian: • Uklonite drugu polovicu zaštitne folije i dlanom pritisnite cijeli flaster na kožu
English: • Medicines for helping you sleep (such as temazepam, zaleplon, or zolpidem).
Croatian: • lijekove koji Vam pomažu zaspati (npr. temazepam, zaleplon ili zolpidem)
English: To prevent overdose it is recommended that opioid-naïve patients receive low doses of immediate-release opioids (eg, morphine, hydromorphone, oxycodone, tramadol, and codeine) that are to be titrated until an analgesic dosage equivalent to DUROGESIC with a release rate of 12 mcg/h or 25 mcg/h is attained.
Croatian: Kako bi se spriječilo predoziranje, preporučuje se da bolesnici koji prethodno nisu primali opioide primaju male doze opioida s trenutnim oslobađanjem (npr. morfina, hidromorfona, oksikodona, tramadola i kodeina), koje treba titrirati dok se ne dosegne analgetska doza koja odgovara lijeku DUROGESIC s brzinom oslobađanja od 12 µg/h ili 25 µg/h.
English: The dose should be titrated individually on the basis of average daily use of supplemental analgesics, until a balance between analgesic efficacy and tolerability is attained.
Croatian: Dozu treba titrirati kod svakog bolesnika pojedinačno na temelju prosječne dnevne doze dodatnih analgetika dok se ne postigne ravnoteža između analgetske djelotvornosti i podnošljivosti.
English: Respiratory depression may persist beyond the removal of the DUROGESIC patch.
Croatian: Depresija disanja može potrajati i nakon uklanjanja DUROGESIC
English: Underlying, symptomatic hypotension and/or hypovolaemia should be corrected before treatment with fentanyl transdermal patches is initiated.
Croatian: Podležeću simptomatsku hipotenziju i/ili hipovolemiju treba korigirati prije početka liječenja transdermalnim flasterima s fentanilom.
English: • Constricted pupils (miosis)
Croatian: • sužene zjenice (mioza)
English: Extra caution should be used in patients with chronic constipation.
Croatian: Potreban je dodatan oprez kod bolesnika s kroničnom konstipacijom.
English: Caution is advised upon concomitant use of CYP3A4 inducers and DUROGESIC.
Croatian: Preporučuje se oprez pri istodobnoj primjeni induktora CYP3A4 i lijeka DUROGESIC.
English: The dose should be titrated individually until a balance between analgesic efficacy and tolerability is attained.
Croatian: Dozu treba titrirati kod svakog bolesnika pojedinačno dok se ne postigne ravnoteža između analgetske djelotvornosti i podnošljivosti.
English: • Heart beat feels fast or uneven (palpitations, tachycardia)
Croatian: • ubrzani ili neravnomjerni otkucaji srca (palpitacije, tahikardija)
English: The dose of DUROGESIC may need to be increased or a switch to another analgesic active substance may be needed.
Croatian: Možda će biti potrebno povećati dozu lijeka DUROGESIC ili prebaciti bolesnika na drugu analgetsku djelatnu tvar.
English: DUROGESIC may interact with these medicines and you may experience changes to mental status such as feeling agitated, seeing, feeling, hearing, or smelling things that are not there (hallucinations) and other effects such as changing blood pressure, fast heart beat, high body temperature, overactive reflexes, lack of coordination, muscle stiffness, nausea, vomitting and diarrhoea.
Croatian: DUROGESIC može imati djelovati na te lijekove i može doći do promjena psihičkog stanja kao što su uznemirenost, halucinacije (kada vidite, osjećate, čujete ili možete namirisati stvari koje nisu prisutne) i drugih učinaka poput promjena krvnog tlaka, ubrzanog rada srca, povišene tjelesne temperature, pojačanih refleksa, nedostatka koordinacije, ukočenosti mišića, mučnine, povraćanja i proljeva.
English: Examples of active substance that may decrease fentanyl plasma concentrations include: carbamazepine, phenobarbital, phenytoin and rifampicin (this list is not exhaustive).
Croatian: Primjeri djelatnih tvari koje mogu smanjiti koncentracije fentanila u plazmi uključuju: karbamazepin, fenobarbital, fenitoin i rifampicin (ovaj popis nije konačan).
English: Therefore, they must keep all patches out of the sight and reach of children, both before and after use.
Croatian: Stoga, sve flastere i prije i poslije primjene moraju čuvati izvan pogleda i dohvata djece.
English: It is recommended that DUROGESIC be used in patients who have demonstrated opioid tolerance.
Croatian: Preporučuje se koristiti DUROGESIC kod bolesnika koji su pokazali toleranciju na opioide.
English: DUROGESIC doses should be individualised based upon the status of the patient and should be assessed at regular intervals after application.
Croatian: Doze lijeka DUROGESIC treba odrediti za svakog bolesnika pojedinačno na temelju njegova statusa te ih nakon početka primjene treba redovito procjenjivati.
English: Of these 110 subjects, 23 (20.9%) had previously been receiving <30 mg of oral morphine equivalents per day, 66 (60.0%) had been receiving 30 to 44 mg of oral morphine equivalents per day, and 12 (10.9%) had been receiving at least 45 mg of oral morphine equivalents per day (data not available for 9 [8.2%] subjects).
Croatian: 110 ispitanika, njih 23 (20,9%) prethodno je primalo dozu opioida ekvivalentnu < 30 mg oralnog morfina na dan, 66 (60,0%) ih je primalo dozu opioida ekvivalentnu 30 do 44 mg oralnog morfina na dan, dok je 12 ispitanika primalo dozu opioida ekvivalentnu najmanje 45 mg oralnog morfina na dan (nisu bili dostupni podaci za 9 [8,2%] ispitanika).
English: If serotonin syndrome is suspected, treatment with DUROGESIC should be discontinued.
Croatian: U slučaju sumnje na serotoninski sindrom, liječenje lijekom DUROGESIC mora se prekinuti.
English: Initial evaluation of the maximum analgesic effect of DUROGESIC cannot be made before the patch is worn for 24 hours.
Croatian: Početnu ocjenu maksimalnog analgetskog učinka lijeka DUROGESIC nije moguće provesti prije nego što se flaster nosi 24 sata.
English: Therefore, DUROGESIC should not be used within 14 days after discontinuation of treatment with MAOIs.
Croatian: Stoga se DUROGESIC ne smije primjenjivati unutar 14 dana nakon završetka liječenja MAO inhibitorima.
English: This is because fentanyl concentrations fall gradually after DUROGESIC is removed.
Croatian: To je potrebno zato što se koncentracije fentanila postupno smanjuju nakon odstranjenja lijeka DUROGESIC.
English: Skin temperature elevation may enhance the absorption of transdermally-applied fentanyl (see section 4.4).
Croatian: Porast temperature kože može pojačati apsorpciju transdermalno primijenjenog fentanila (vidjeti dio 4.4).
English: Pharmacokinetic-related interactions
Croatian: Interakcije povezane s farmakokinetikom
English: Data in subjects with cirrhosis and simulated data in subjects with different grades of impaired liver function treated with transdermal fentanyl suggest that fentanyl concentrations may be increased, and fentanyl clearance may be decreased compared to subjects with normal liver function.
Croatian: Podaci prikupljeni kod ispitanika s cirozom i simulirani podaci za ispitanike s različitim stupnjevima oštećenja jetrene funkcije liječene transdermalnim fentanilom ukazuju na to da koncentracije fentanila mogu biti povišene i da klirens fentanila može biti smanjen u usporedbi s ispitanicima s normalnom jetrenom funkcijom.
English: Other medicines and DUROGESIC
Croatian: Drugi lijekovi i DUROGESIC
English: Talk to your doctor or pharmacist before using this medicine if any of the following apply to youyour doctor may need to check you more closely if:
Croatian: Obratite se svom liječniku ili ljekarniku prije nego primijenite ovaj lijek ako se bilo što od navedenoga odnosi na Vas - liječnik će Vas možda morati pažljivije kontrolirati: • ako ste ikada imali tegobe s plućima ili disanjem
English: • As soon as you take a patch off, fold it firmly in half so that the sticky side sticks to itself
Croatian: • Odmah nakon što skinete flaster, presavinite ga čvrsto popola tako da ljepljive strane naliježu jedna na drugu
English: To guard against accidental ingestion by children, use caution when choosing the application site for DUROGESIC (see sections 4.2 and 6.6) and monitor adhesion of the patch closely.
Croatian: Kako bi se dijete zaštitilo od slučajnog gutanja flastera, potreban je oprez pri odabiru mjesta primjene lijeka DUROGESIC (vidjeti dijelove 4.2 i 6.6) i pažljivo praćenje prianjanja flastera.
English: DUROGESIC should not be used during pregnancy unless you have discussed this with your doctor.
Croatian: DUROGESIC se ne smije primjenjivati tijekom trudnoće ako o tome prethodno niste razgovarali sa svojim liječnikom.
English: In two paediatric studies, the required fentanyl transdermal patch dose was calculated conservatively: 30 mg to 44 mg oral morphine per day or its equivalent opioid dose was replaced by one DUROGESIC 12 mcg/h patch.
Croatian: U dva pedijatrijska ispitivanja, potrebna doza fentanila u transdermalnom flasteru preračunata je konzervativno: 30 mg do 44 mg oralnog morfina na dan ili ekvivalentna doza opioida zamijenjena je jednim DUROGESIC 12 µg/h flasterom.
English: There is a high inter-subject variability in fentanyl pharmacokinetics, in the relationships between fentanyl concentrations, therapeutic and adverse effects, and in opioid tolerance.
Croatian: Postoji velika interindividualna varijabilnost s obzirom na farmakokinetiku fentanila, odnose između koncentracija fentanila, terapijskih učinaka i nuspojava te toleranciju na opioide.
English: Patients who have experienced serious adverse events should be monitored for at least 24 hours after removal of DUROGESIC, or more, as clinical symptoms dictate, because serum fentanyl concentrations decline gradually and are reduced by about 50% 20 to 27 hours later.
Croatian: 4.4 Posebna upozorenja i mjere opreza pri uporabi Bolesnike kod kojih su se javile ozbiljne nuspojave treba nadzirati tijekom najmanje 24 sata ili dulje nakon uklanjanja lijeka DUROGESIC, sukladno kliničkim simptomima, jer serumske koncentracije fentanila opadaju postupno i smanjuju se za približno 50% nakon 20 do 27 sati.
English: DUROGESIC should be used with caution in patients with brain tumours.
Croatian: DUROGESIC treba primjenjivati uz oprez kod bolesnika s moždanim tumorima.
English: The safety of DUROGESIC was evaluated in 289 paediatric subjects (<18 years) who participated in 3 clinical studies for the management of chronic or continuous pain of malignant or non-malignant origin.
Croatian: Pedijatrijska populacija Sigurnost lijeka DUROGESIC ocjenjivala se kod 289 pedijatrijskih ispitanika (< 18 godina) koji su sudjelovali u 3 klinička ispitivanja primjene za liječenje kronične ili neprekidne boli malignog ili nemalignog podrijetla.
English: Caution is advised when DUROGESIC is co-administered with medicinal products that affect the serotonergic neurotransmitter systems.
Croatian: Preporučuje se oprez pri istodobnoj primjeni lijeka DUROGESIC i drugih lijekova koji utječu na sustave serotoninergičkih neuroprijenosnika.
English: 1 Conversion to DUROGESIC dosages greater than 25 mcg/h is the same for paediatric patients as it is for adult patients
Croatian: 1 Preračunavanje za doze lijeka DUROGESIC veće od 25 µg/h jednako je za pedijatrijske bolesnike i za odrasle bolesnike (vidjeti Tablicu 2).
English: Central Nervous System conditions including increased intracranial pressure DUROGESIC should be used with caution in patients who may be particularly susceptible to the intracranial effects of CO2 retention such as those with evidence of increased intracranial pressure, impaired consciousness, or coma.
Croatian: DUROGESIC treba primjenjivati uz oprez kod bolesnika koji bi mogli biti posebno osjetljivi na intrakranijalne učinke zadržavanja CO2, kao što su bolesnici s povišenim intrakranijalnim tlakom, poremećajima svijesti ili bolesnici u komi.
English: • Other medicines for pain, such as other opioid painkillers (such as buprenorphine, nalbuphine, or pentazocine).
Croatian: • druge lijekove za bol, kao što su drugi opioidni lijekovi protiv boli (npr. buprenorfin, nalbufin ili pentazocin)
English: Patients should be advised on measures to prevent constipation and prophylactic laxative use should be considered.
Croatian: Bolesnike treba upoznati s mjerama za sprječavanje konstipacije te treba razmotriti profilaktičku primjenu laksativa.
English: CYP3A4 Inhibitors
Croatian: Inhibitori CYP3A4
English: • Your upper body or arm
Croatian: • gornjem dijelu tijela ili nadlaktici
English: Cases of serious respiratory depression after coadministration of CYP3A4 inhibitors with transdermal fentanyl have been reported, including a fatal case after coadministration with a moderate CYP3A4 inhibitor.
Croatian: Prijavljeni su slučajevi ozbiljne depresije disanja nakon istodobne primjene inhibitora CYP3A4 i transdermalnog fentanila, uključujući smrtni slučaj nakon istodobne primjene s umjerenim inhibitorom CYP3A4.
English: DUROGESIC may be worn continuously for 72 hours.
Croatian: DUROGESIC se može nositi neprekidno tijekom 72 sata.
English: Following DUROGESIC application, the skin under the system absorbs fentanyl, and a depot of fentanyl concentrates in the upper skin layers.
Croatian: Nakon nanošenja lijeka DUROGESIC, koža ispod sustava apsorbira fentanil te se u gornjim slojevima kože stvara depo koncentrata fentanila.
English: The concomitant use of other central nervous system depressants, (including opioids, sedatives, hypnotics, general anaesthetics, phenothiazines, tranquilizers, sedating antihistamines, and alcoholic beverages) and skeletal muscle relaxants, may produce additive depressant effects; hypoventilation, hypotension, profound sedation, coma or death may occur.
Croatian: Lijekovi koji djeluju na središnji živčani sustav i alkohol Istodobna primjena drugih depresora središnjeg živčanog sustava (uključujući opioide, sedative, hipnotike, opće anestetike, fenotiazine, trankvilizatore, sedirajuće antihistaminike i alkoholna pića) i relaksansa skeletnih mišića može dovesti do aditivnih depresivnih učinaka; mogu nastupiti hipoventilacija, hipotenzija, duboka sedacija, koma ili smrt.
English: • Medicines to treat tuberculosis (such as rifampicin).
Croatian: • lijekove koji se koriste za liječenje tuberkuloze (npr. rifampicin)