FrancophonIA/ELRC3.0 huggingface dataset:
English: The influence of renal impairment on the pharmacokinetics of fentanyl is expected to be limited because urinary excretion of unchanged fentanyl is less than 10% and there are no known active metabolites eliminated by the kidney.
Croatian: Očekuje se da će utjecaj oštećenja bubrežne funkcije na farmakokinetiku fentanila biti ograničen jer je izlučivanje nepromijenjenog fentanila putem mokraće manje od 10% i nema poznatih aktivnih metabolita koji se izlučuju putem bubrega.
English: DUROGESIC has not been studied in children under 2 years of age.
Croatian: DUROGESIC se nije ispitivao kod djece mlađe od 2 godine.
English: It should be noted that this conversion schedule for children only applies to the switch from oral morphine (or its equivalent) to DUROGESIC patches.
Croatian: Treba imati na umu da se ovakav način preračunavanja doze za djecu odnosi samo na prelazak s oralnog morfina (ili njegova ekvivalenta) na DUROGESIC
English: • Keep the empty sachet to dispose of the used patch later
Croatian: • Čuvajte praznu vrećicu do odlaganja iskorištenog flastera
English: In such patients, opioids may decrease respiratory drive and increase airway resistance.
Croatian: Kod takvih bolesnika opioidi mogu smanjiti respiracijski poticaj i povećati otpor dišnih putova.
English: Mutagenicity testing in bacteria and in rodents yielded negative results.
Croatian: 12 Ispitivanje mutagenosti na bakterijama i glodavcima dalo je negativne rezultate.
English: If a patch falls off
Croatian: Ako se flaster odlijepi
English: Standard reproductive and developmental toxicity studies have been carried out using parenteral administration of fentanyl.
Croatian: 8 Provedena su standardna ispitivanja reproduktivne i razvojne toksičnosti uz parenteralnu primjenu fentanila.
English: The adverse reactions are presented by System Organ Class and in order of decreasing seriousness within each frequency category.
Croatian: Nuspojave su prikazane prema organskim sustavima i u padajućem nizu prema ozbiljnosti unutar svake kategorije učestalosti.
English: • Do not use soap or any other cleansers, creams, moisturisers, oils or talc before applying the patch
Croatian: • Ne koristite sapun ili drugo sredstvo za čišćenje, kreme, ovlaživače, ulja ili puder prije primjene flastera
English: • Watch your child very closely for 48 hours after: - The first patch has been put on - A higher dose patch has been put on
Croatian: • pomno nadzirite svoje dijete tijekom 48 sati: - nakon što se primijeni prvi flaster
English: The patches are designed to deliver approximately 12, 25, 50, 75, and 100 mcg/h fentanyl to the systemic circulation, which represent about 0.3, 0.6, 1.2, 1.8, and 2.4 mg per day respectively.
Croatian: Flasteri su oblikovani tako da u sistemsku cirkulaciju otpuštaju približno 12, 25, 50, 75 i 100 µg fentanila na sat, što odgovara približno 0,3; 0,6; 1,2; 1,8 odnosno 2,4 mg na dan.
English: In a study on pre- and postnatal development the survival rate of offspring was significantly reduced at doses which slightly reduced maternal weight.
Croatian: U ispitivanju prenatalnog i postnatalnog razvoja, stopa preživljenja mladunčadi bila je značajno smanjena pri dozama koje su blago smanjile tjelesnu težinu majke.
English: The analgesic effect of the first dose of DUROGESIC patches will not be optimal within the first 24 hours.
Croatian: Analgetski učinak prve doze DUROGESIC flastera neće biti optimalan unutar prva 24 sata.
English: Severe and unpredictable interactions with MAOIs, involving the potentiation of opiate effects or the potentiation of serotoninergic effects, have been reported.
Croatian: Prijavljene su teške i nepredvidljive interakcije s MAO inhibitorima, koje su uključivale potenciranje opijatnih učinaka ili potenciranje serotoninergičkih učinaka.
English: An optimal therapeutic concentration range of fentanyl can therefore not be established.
Croatian: Stoga se ne može odrediti optimalan raspon terapijskih koncentracija za fentanil.
English: • If you get a fever while using DUROGESIC, tell your doctor - this may increase the amount of medicine that passes through your skin
Croatian: • Ako tijekom primjene lijeka DUROGESIC dobijete vrućicu, obavijestite o tome svog liječnikato može povećati količinu lijeka koja prolazi kroz kožu
English: If you use too many patches or the wrong strength patch If you have stuck on too many patches or the wrong strength patch, take the patches off and contact a doctor straight away.
Croatian: Ako primijenite previše flastera ili pogrešnu jačinu flastera Ako ste zalijepili previše flastera ili pogrešnu jačinu flastera, skinite flastere i odmah se javite liječniku.
English: • Every so often check that the patch remains stuck to the skin.
Croatian: • provjeravajte češće je li flaster i dalje prilijepljen na kožu
English: Further open the sachet along both sides, folding the sachet open like a book.
Croatian: Vrećicu zatim treba rastvoriti s obje strane, tako da se otvori poput knjige.
English: Fentanyl accumulates in skeletal muscle and fat and is released slowly into blood.
Croatian: Fentanil se kumulira u skeletnim mišićima i masnom tkivu te se polako otpušta u krv.
English: Fold the patch in the middle and remove each half of the liner separately.
Croatian: Potrebno je presavinuti flaster u sredini i ukloniti svaku polovicu zaštitne folije zasebno.
English: You may notice rashes, redness or slight itching of the skin at the site of the patch.
Croatian: Možda ćete primijetiti osip, crvenilo ili blagi svrbež kože na mjestu primjene flastera.
English: An increase in skin temperature through the application of a heating pad on low setting over the DUROGESIC system during the first 10 hours of a single application increased the mean fentanyl AUC value by 2.2-fold and the mean concentration at the end of heat application by 61%.
Croatian: Povećanje temperature kože do kojega dolazi zbog stavljanja grijanog jastučića namještenog na nisku temperaturu preko DUROGESIC sustava tijekom prvih 10 sati nakon jednokratne primjene, povećao je srednju vrijednost AUC-a fentanila 2,2 puta, a srednju vrijednost koncentracije na kraju zagrijavanja za 61%.
English: • DUROGESIC may cause constipation, talk to your doctor or pharmacist for advice on how to prevent or relieve constipation.
Croatian: • DUROGESIC može izazvati zatvor, pa upitajte svog liječnika ili ljekarnika za savjet o tome kako spriječiti ili ublažiti zatvor.
English: If the patch needs to be replaced (eg, the patch falls off) before 72 hours, a patch of the same strength should be applied to a different skin site.
Croatian: Ako flaster treba zamijeniti (npr. ako otpadne) prije isteka 72 sata, može se primijeniti flaster iste jačine na neko drugo mjesto na koži.
English: Patches should be inspected prior to use.
Croatian: Flastere treba pregledati prije primjene.
English: However, the duration of inhibition varies and for some CYP3A4 inhibitors with a long elimination half-life, such as amiodarone, or for time-dependent inhibitors such as erythromycin, idelalisib, nicardipine and ritonavir, this period may need to be longer.
Croatian: Međutim, trajanje inhibicije varira, pa će kod nekih inhibitora CYP3A4 s dugim poluvijekom eliminacije, kao što je amiodaron ili za inhibitore ovisne o vremenu poput eritromicina, idelalisiba, nikardipina i ritonavira, to razdoblje možda morati biti i dulje.
English: The simulations suggest that the steady-state AUC of patients with Child-Pugh Grade B liver disease (Child-Pugh Score = 8) would be approximately 1.36 times larger compared with that of patients with normal liver function (Grade A; Child-Pugh Score = 5.5).
Croatian: Simulacije pokazuju da bi AUC u stanju dinamičke ravnoteže kod bolesnika s jetrenom bolešću Child-Pugh stadija B (Child-Pugh rezultat = 8) bio približno 1,36 puta veći nego kod bolesnika s normalnom jetrenom funkcijom (stadij A; Child-Pugh rezultat = 5,5).
English: Respiratory depression following an overdose may outlast the duration of action of the opioid antagonist.
Croatian: Depresija disanja nastala zbog predoziranja može trajati dulje od djelovanja opioidnog antagonista.
English: • Sudden swelling of the face or throat, severe irritation, reddening or blistering of your skin.
Croatian: • iznenadno oticanje lica ili grla, teška nadraženost, crvenilo ili pojava mjehurića na koži.
English: If you or your partner, or carer, notice any of the following about the person wearing the patch, take the patch off and call a doctor, or go to your nearest hospital, straight away.
Croatian: Ako Vi, Vaš partner ili njegovatelj primijetite kod osobe koja nosi flaster bilo što od sljedećeg, skinite flaster i odmah pozovite liječnika ili se uputite u najbližu bolnicu.
English: Patients can then switch to DUROGESIC.
Croatian: Bolesnici tada mogu prijeći na DUROGESIC.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući lijekove koje ste kupili bez recepta i biljne lijekove.
English: • If increasing the strength of the patch does not help, your doctor may decide to stop the use of the patches
Croatian: • Ako povećanje jačine flastera ne pomogne, liječnik može odlučiti da prestanete primjenjivati flastere
English: DUROGESIC should not be used during pregnancy unless clearly necessary.
Croatian: DUROGESIC se ne smije koristili u trudnoći, osim ako to nije posve neophodno.
English: Used patches should be folded so that the adhesive side of the patch adheres to itself and then they should be safely discarded.
Croatian: Upotrijebljene flastere treba presavinuti tako da ljepljiva strana naliježe sama na sebe, a zatim ih treba odložiti na siguran način.
English: • Areas that you move a lot (joints), skin that is irritated or with cuts.
Croatian: • na područja koja se često pokreću (zglobove), na kojima je koža nadražena ili ima posjekotina
English: Acute or postoperative pain because there is no opportunity for dose titration during short-term use and because serious or life-threatening hypoventilation could result.
Croatian: Akutna ili poslijeoperacijska bol jer nije moguće titrirati dozu tijekom kratkotrajne primjene i moglo bi doći do ozbiljne ili po život opasne hipoventilacije.
English: Within 72 hours of IV fentanyl administration, approximately 75% of the dose is excreted into the urine and approximately 9% of the dose into the faeces.
Croatian: Unutar 72 sata nakon intravenske primjene fentanila, približno 75% doze izluči se u mokraću, a približno 9% u feces.
English: Opioid-tolerant patients
Croatian: Bolesnici s tolerancijom na opioide
English: As for patients with Grade C liver disease (Child-Pugh Score = 12.5), the results indicate that fentanyl concentration accumulates with each administration, leading these patients to have an approximately 3.72 times larger AUC at steady state.
Croatian: Kada su u pitanju bolesnici s jetrenom bolešću Child-Pugh stadija C (Child-Pugh rezultat = 12,5), rezultati pokazuju da se koncentracije fentanila kumuliraju sa svakom primjenom, zbog čega je tim bolesnicima AUC u stanju dinamičke ravnoteže približno 3,72 puta veći.
English: They have high affinity to opioid receptors with relatively low intrinsic activity and therefore partially antagonise the analgesic effect of fentanyl and may induce withdrawal symptoms in opioid dependent patients (see also Section 4.4).
Croatian: Oni imaju visok afinitet prema opioidnim receptorima s relativno malom intrizičnom aktivnošću i stoga djelomično antagoniziraju analgetski učinak fentanila i mogu inducirati simptome ustezanja kod bolesnika koji su ovisni o opioidima (vidjeti i dio 4.4).
English: The minimum effective fentanyl concentration depends on the pain intensity and the previous use of opioid therapy.
Croatian: Minimalna učinkovita koncentracija fentanila ovisi o intenzitetu boli i prethodnoj primjeni opioidne terapije.
English: If the analgesic effect of DUROGESIC is insufficient, supplementary morphine or another short-duration opioid should be administered.
Croatian: Ako analgetski učinak lijeka DUROGESIC nije dostatan, treba primijeniti dodatne doze morfina ili nekog drugog kratkodjelujućeg opioida.
English: No risk was identified in the paediatric population beyond that expected with the use of opioids for the relief of pain associated with serious illness and there does not appear to be any paediatric-specific risk associated with DUROGESIC use in children as young as 2 years old when used as directed.
Croatian: U pedijatrijskoj populaciji nije zabilježen nikakav rizik koji bi odstupao od onoga koji se očekuje kod primjene opioida za ublažavanje boli povezane s ozbiljnim bolestima i čini se da ne postoji nikakav specifičan rizik za pedijatrijsku populaciju kada se DUROGESIC primjenjuje kod djece već od navršene 2 godine u skladu s uputama.
English: • Stopping breathing from time to time (apnoea)
Croatian: • povremen prestanak disanja (apneja)
English: Fentanyl concentrations may increase if the skin temperature increases (see section 5.2).
Croatian: Koncentracije fentanila mogu se povećati ako poraste temperatura kože (vidjeti dio 5.2).
English: These subjects received at least one dose of DUROGESIC and provided safety data (see section 5.1).
Croatian: Ti su ispitanici primili najmanje jednu dozu lijeka DUROGESIC i kod njih su se prikupljali podaci o sigurnosti (vidjeti dio 5.1).
English: These subjects received at least one dose of DUROGESIC and provided safety data.
Croatian: Ti su ispitanici primili najmanje jednu dozu lijeka DUROGESIC i kod njih su se prikupljali podaci o sigurnosti.
English: {Name and address} <{tel}> <{fax}> <{e-mail}> <This medicinal product is authorised in the Member States of the EEA under the following names:> <{Name of the Member State}> <{Name of the medicinal product}> <{Name of the Member State}> <{Name of the medicinal product}> [See Annex I - To be completed nationally]
Croatian: Ovaj lijek je odobren u državama članicama Europskog gospodarskog prostora (EGP) pod sljedećim nazivima:
English: In general, the discontinuation of opioid analgesia should be gradual in order to prevent withdrawal symptoms (see section 4.8).
Croatian: Općenito, prekid opioidne analgezije mora biti postupan kako bi se izbjegla pojava simptoma ustezanja (vidjeti dio 4.8).
English: Central nervous system depressants may increase the respiratory depression (see section 4.5).
Croatian: Lijekovi koji deprimiraju središnji živčani sustav mogu pojačati depresiju disanja (vidjeti dio 4.5).
English: Fentanyl may produce bradycardia and should therefore be administered with caution to patients with bradyarrhythmias.
Croatian: Fentanil može uzrokovati bradikardiju i stoga ga treba primjenjivati uz oprez kod bolesnika s bradiaritmijama.
English: DUROGESIC should be applied to non-irritated and non-irradiated skin on a flat surface of the torso or upper arms.
Croatian: DUROGESIC treba nanijeti na nenadraženu i neozračenu kožu, na ravnu površinu na trupu ili nadlakticama.
English: Monoamine Oxidase Inhibitors (MAOI)
Croatian: Inhibitori monoaminooksidaze (MAO inhibitori)
English: After the first DUROGESIC application, serum fentanyl concentrations increase gradually, generally leveling off between 12 and 24 hours and remaining relatively constant for the remainder of the 72-hour application period.
Croatian: Nakon prve primjene lijeka DUROGESIC, koncentracije fentanila u serumu postupno rastu i načelno se ustaljuju 12 do 24 sata nakon primjene te ostaju relativno konstantne tijekom ostatka 72-satnog razdoblja primjene.
English: DUROGESIC should not be used during childbirth as the medication can affect the breathing of the newborn child.
Croatian: DUROGESIC se ne smije primjenjivati tijekom poroda jer ovaj lijek može utjecati na disanje novorođenčeta.
English: Opioids increase the tone and decrease the propulsive contractions of the smooth muscle of the gastrointestinal tract.
Croatian: • Opioidi povećavaju tonus i smanjuju propulzivne kontrakcije glatkih mišića probavnog sustava.
English: What you need to know before you use DUROGESIC
Croatian: Što morate znati prije nego počnete primjenjivati DUROGESIC
English: Step 5: Wash • Always wash your hands after you have handled the patch using clean water only
Croatian: • Nakon rukovanja flasterima uvijek operite ruke samo čistom vodom
English: Therefore after a dose increase, patients should wear the higher dose patch through two 72-hour applications before any further increase in dose level is made.
Croatian: Stoga bi bolesnici nakon povećanja doze trebali nositi flaster s većom dozom dva puta po 72 sata prije nego što se doza dodatno povisi.
English: Skin does not appear to metabolise fentanyl delivered transdermally.
Croatian: Čini se da koža ne metabolizira transdermalno isporučen fentanil.
English: In a rat study fentanyl did not influence male fertility.
Croatian: U ispitivanju na štakorima, fentanil nije utjecao na plodnost mužjaka.
English: In a study in cancer patients treated with transdermal fentanyl, plasma protein binding was on average 95% (range 77-100%).
Croatian: vezanje fentanila za proteine u plazmi u prosjeku je iznosilo 95% (raspon: 77 - 100%).
English: DUROGESIC provides continuous systemic delivery of fentanyl during the 72-hour application period.
Croatian: DUROGESIC omogućuje kontinuiranu sistemsku isporuku fentanila tijekom 72-satnog razdoblja primjene.
English: Use in elderly patients
Croatian: Primjena kod starijih bolesnika
English: The incidence of respiratory depression increases as the DUROGESIC dose is increased (see section 4.9).
Croatian: Incidencija depresije disanja povećava se s povećanjem doze lijeka DUROGESIC (vidjeti dio 4.9).
English: Breastfeeding should therefore be discontinued during treatment with DUROGESIC and for at least 72 hours after removal of the patch.
Croatian: Dojenje stoga treba prekinuti tijekom liječenja lijekom DUROGESIC te još najmanje 72 sata nakon uklanjanja flastera.
English: The dosage may subsequently be titrated upwards or downwards, if required, in increments of either 12 or 25 mcg/h to achieve the lowest appropriate dosage of DUROGESIC depending on response and supplementary analgesic requirements.
Croatian: Ako je potrebno, doza se naknadno može povećavati ili smanjivati u koracima od 12 ili 25 µg/h kako bi se dosegla najmanja prikladna doza lijeka DUROGESIC u skladu s odgovorom i dodatnim potrebama za analgezijom.
English: DUROGESIC is indicated for management of severe chronic pain that requires continuous long term opioid administration.
Croatian: DUROGESIC je indiciran za liječenje teške kronične boli koja zahtijeva kontinuiranu dugotrajnu primjenu opioida.
English: Cases of serotonin syndrome have been reported when fentanyl was administered concomitantly with highly serotonergic drugs (see sections 4.4. and 4.5).
Croatian: Prijavljeni su slučajevi serotoninskog sindroma kada se fentanil primjenjivao istodobno s lijekovima s jakim serotoninergičkim učinkom (vidjeti dijelove 4.4 i 4.5).
English: After intravenous administration, fentanyl mean total clearance values across studies range in general between 34 and 66 L/h.
Croatian: Nakon intravenske primjene, srednja vrijednost ukupnog klirensa fentanila u svim ispitivanjima načelno se kretala u rasponu od 34 do 66 l/h.
English: The extent of interaction with strong CYP3A4 inhibitors is expected to be greater than with weak or moderate CYP3A4 inhibitors.
Croatian: Očekuje se da će opseg interakcije sa snažnim inhibitorima CYP3A4 biti veći nego kod primjene slabih ili umjerenih inhibitora CYP3A4.
English: • Carefully peel one half of the shiny plastic backing away from the centre of the patch.
Croatian: • Pažljivo odlijepite prvu polovicu sjajne plastične zaštitne folije sa sredine flastera.
English: Excretion occurs primarily, as metabolites, with less than 10% of the dose excreted as unchanged active substance.
Croatian: Lijek se prvenstveno izlučuje u obliku metabolita, a manje od 10% doze izlučuje se kao djelatna tvar u nepromijenjenom obliku.
English: Repeated use of the patches may make the medicine become less effective (you become ‘tolerant' to it) or become dependent on it.
Croatian: Opetovana primjena flastera može smanjiti učinkovitost lijeka (postajete „tolerantni“ na njega) ili uzrokovati ovisnost o lijeku.
English: Soaps, oils, lotions, or any other agent that might irritate the skin or alter its characteristics should not be used.
Croatian: Ne smiju se koristiti sapuni, ulja, losioni ili bilo koje druge tvari koje bi mogle nadražiti kožu ili promijeniti njezina svojstva.
English: Signs of overdose include trouble breathing or shallow breathing, tiredness, extreme sleepiness, being unable to think clearly, walk or talk normally and feeling faint, dizzy or confused.
Croatian: Znakovi predoziranja uključuju otežano ili plitko disanje, umor, iznimnu pospanost, nemogućnost jasnog mišljenja, hodanja ili normalnog govora te osjećaj nesvjestice, omaglice ili smetenosti.
English: This effect could either be due to altered maternal care or a direct effect of fentanyl on the pups.
Croatian: Taj bi učinak mogao biti posljedica promjena majčine skrbi za mladunčad ili izravnog djelovanja fentanila na mladunčad.
English: • Unusual feeling in the skin, such as tingling or crawling feelings (paraesthesia)
Croatian: • neuobičajeni osjeti po koži, kao što su trnci ili mravinjanje (parestezija)
English: • Apply the patch on a flat part of your upper body or arm (not over a joint).
Croatian: • stavite flaster na ravnu površinu na trupu ili nadlaktici (ne preko zgloba)
English: These findings have been taken into consideration in determining the dosing recommendations for paediatric patients (see sections 4.2 and 4.4).
Croatian: Ti su nalazi uzeti u obzir kada su se određivale preporuke za doziranje kod pedijatrijskih bolesnika (vidjeti dijelove 4.2 i 4.4).
English: If the site of DUROGESIC application requires cleansing prior to application of the patch, this should be done with clear water.
Croatian: Ako mjesto na koje se nanosi DUROGESIC treba prethodno očistiti, to treba učiniti čistom vodom.
English: • DUROGESIC can have life-threatening side effects in people who are not already regulary using prescribed opioid medicines.
Croatian: • DUROGESIC može izazvati po život opasne nuspojave kod osoba koje već redovito ne uzimaju propisane im opioidne lijekove.
English: Some studies in rats have revealed reduced fertility and enhanced embryo mortality at maternally toxic doses (see section 5.3).
Croatian: Neka ispitivanja na štakorima ukazala su na smanjenu plodnost i povećanu smrtnost embrija pri dozama koje su bile toksične za majku (vidjeti dio 5.3).
English: To remove the patch from the protective sachet, locate the pre-cut notch (indicated by an arrow on the patch label) along the edge of the seal.
Croatian: Da bi se flaster izvadio iz zaštitne vrećice, najprije treba pronaći zarez koji se nalazi uz rub zatvorene vrećice (označen strelicom na naljepnici vrećice).
English: • Some medicines used to treat angina (chest pain) or high blood pressure (such as nicardipine).
Croatian: • neke lijekove koji se koriste za liječenje angine (bol u prsnom košu) ili visokog krvnog tlaka (npr. nikardipin).
English: If severe or persistent hypotension occurs, hypovolemia should be considered, and the condition should be managed with appropriate parenteral fluid therapy.
Croatian: Ako nastupi teška ili perzistentna hipotenzija, treba razmotriti hipovolemiju i liječiti stanje odgovarajućim parenteralnim unosom tekućine.
English: Use of DUROGESIC during childbirth is not recommended because it should not be used in the management of acute or postoperative pain (see section 4.3).
Croatian: Ne preporučuje se primjena lijeka DUROGESIC tijekom poroda jer se on ne smije koristiti za liječenje akutne ili poslijeoperacijske boli (vidjeti dio 4.3).
English: The manifestations of fentanyl overdose are an extension of its pharmacologic actions, the most serious effect being respiratory depression.
Croatian: Predoziranje fentanilom manifestira se njegovim izraženijim farmakološkim učincima, od kojih je najozbiljniji depresija disanja.
English: Severe respiratory depression.
Croatian: Teška depresija disanja.