FrancophonIA/ELRC3.0 huggingface dataset:
English: Adverse reactions are listed below as MedDRA preferred term by system organ class and frequency (frequencies are defined as: very common ≥1/10, common ≥1/100 to <1/10, uncommon ≥ 1/1,000 to <1/100, rare (≥1/10,000 to
Croatian: Nuspojave su navedene u nastavku u skladu s preporučenom terminologijom MedDRA prema klasifikaciji organskih sustava i učestalosti (učestalosti se definiraju kao: vrlo često ≥1/10, često ≥1/100 i <1/10, manje često ≥1/1000 i <1/100,
English: If a second tablet of Effentora was required for several consecutive times, the usual maintenance dose is to be readjusted (see below).
Croatian: Ako je potrebna druga tableta Effentore za nekoliko uzastopnih primjena, potrebno je ponovno prilagoditi uobičajenu dozu održavanja (vidjeti u nastavku).
English: The metabolites are mainly excreted in the urine, while faecal excretion is less important.
Croatian: Metaboliti se uglavnom izlučuju u mokraći, dok je izlučivanje fecesom manje važno.
English: In the further course of treatment your requirement for analgesic therapy may change.
Croatian: Vaše se potrebe za analgetskom terapijom mogu promijeniti.
English: If discontinuation of all opioid therapy is required, the patient must be closely followed by the doctor in order to manage the risk of abrupt withdrawal effects.
Croatian: Ako je potrebno prekinuti svu opioidnu terapiju, liječnik mora pažljivo pratiti bolesnika kako bi zbrinuo rizik od naglog izbijanja učinaka ustezanja.
English: If the breakthrough pain is still ongoing, you may take Effentora as prescribed by your physician.
Croatian: Ako probijajuća bol još uvijek traje, možete uzeti Effentoru kako Vam je to propisao liječnik.
English: A Daily Pain Journal to record daily pain levels, providing patients and physicians with a follow-up tool for daily symptoms and treatment efficacy.
Croatian: Dnevnik bola za svakodnevno bilježenje razine bola, koji bolesnicima i liječnicima služi kao sredstvo praćenja svakodnevnih simptoma i učinkovitosti liječenja.
English: Opioids may influence the hypothalamic-pituitary-adrenal or -gonadal axes.
Croatian: Opioidi mogu utjecati na hipotalamo-hipofizno-adrenalnu ili -gonadalnu os.
English: Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.
Croatian: Terapiju održavanja opioidima primaju bolesnici koji uzimaju najmanje 60 mg morfija peroralno na dan, najmanje 25 mikrograma fentanila transdermalno po satu, najmanje 30 mg oksikodona na dan i najmanje 8 mg hidromorfona peroralno na dan ili analgetski jednaku dozu drugog opioida tjedan dana ili dulje.
English: Do not drive or operate machinery if you: are feeling sleepy or dizzy; have blurred or double vision; or have difficulty in concentrating.
Croatian: Nemojte voziti ni upravljati strojevima ako se osjećate pospano ili imate vrtoglavicu, ako imate zamagljen vid ili dvostruku sliku, ako imate teškoća s koncentracijom.
English: It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above.
Croatian: Bilo bi korisno opisati gore navedene znakove i simptome prijateljima i rodbini kako bi ih mogli prepoznati.
English: Frequently, these will cease or decrease in intensity with continued use of the medicinal product, as the patient is titrated to the most appropriate dose.
Croatian: Često se te nuspojave povlače ili im se intenzitet smanji s kontinuiranom uporabom lijeka jer se bolesnik titrira na najprikladniju dozu.
English: • Your other opioid pain medicine taken for your persistent (around-the-clock) cancer pain is not stabilised yet.
Croatian: • ako Vaš drugi opioidni lijek koji uzimate protiv trajnih (cjelodnevnih) bolova zbog karcinoma još nije stabiliziran.
English: If this recommendation does not result in an appropriate effervescence, then a switch of therapy may be advised.
Croatian: Ako se uz ovu preporuku ne postigne odgovarajuća efervescencija može se savjetovati zamjena terapije.
English: Contact your doctor if your right dose of Effentora does not relieve your breakthrough pain.
Croatian: Obratite se svom liječniku ako Vaša pravilna doza Effentore ne ublaži probijajuću bol.
English: Carcinogenicity studies (26-week dermal alternative bioassay in Tg.AC transgenic mice; two-year subcutaneous carcinogenicity study in rats) with fentanyl did not reveal any findings indicative of oncogenic potential.
Croatian: Ispitivanja kancerogenosti fentanila (26-tjedni dermalni alternativni biotest u Tg.AC transgeničnih miševa; dvogodišnje supkutano ispitivanje kancerogenosti u štakora) nisu otkrila nalaze koji bi ukazivali na onkogeni potencijal.
English: Consult the Summary of Product Characteristics of the individual opioid antagonist for details about such use.
Croatian: Pogledajte sažetak opisa svojstava lijeka pojedinog antagonista opioida za pojedinosti o takvoj primjeni.
English: Once an effective dose has been established during titration, patients should continue to take this dose as a single tablet of that given strength.
Croatian: Nakon utvrđivanja djelotvorne doze tijekom titracije, bolesnici trebaju nastaviti uzimati ovu dozu kao jednu tabletu te određene jačine.
English: • Main precautions for use: How to prevent main risks (take the drug as prescribed; remain on maintenance opioid therapy; keep EFFENTORA out of the reach and the sight of children; prevent theft and misuse)
Croatian: • Glavne mjere opreza pri uporabi: Kako spriječiti glavne rizike (uzimati lijek kako je propisano; ostati na terapiji održavanja opioidima; čuvati EFFENTORU izvan dohvata i pogleda djece; spriječiti krađu i zloporabu)
English: Effentora should be individually titrated to an “effective” dose that provides adequate analgesia and minimises adverse reactions.
Croatian: Effentoru treba individualno titrirati na „učinkovitu“ dozu koja osigurava odgovarajuću analgeziju i minimizira nuspojave.
English: • You should not drink grapefruit juice while using Effentora because it may affect the way your body breaks down Effentora.
Croatian: • Ne biste smjeli piti sok od grejpfruta dok uzimate Effentoru jer može utjecati na način na koji Vaše tijelo razgrađuje ovaj lijek.
English: The dose and duration of concomitant use should be limited (see section 4.4).
Croatian: Doza i trajanje istodobne primjene moraju biti ograničeni (vidjeti dio 4.4).
English: Following the intravenous administration of fentanyl, less than 7% of the administered dose is excreted unchanged in the urine, and only about 1% is excreted unchanged in the faeces.
Croatian: Nakon intravenske primjene fentanila, manje od 7% primijenjene doze izlučuje se nepromijenjeno mokraćom te samo oko 1% izlučuje se nepromijenjeno fecesom.
English: • The tablet should be left between the cheek and gum until dissolved, which usually takes approximately 14 to 25 minutes.
Croatian: • Tabletu ostavite između obraza i desni sve dok se ne otopi što obično traje od 14 do 25 minuta.
English: The risk of respiratory depression is less in patients receiving chronic opioid therapy as these patients will develop tolerance to respiratory depressant effects.
Croatian: Rizik od respiratorne depresije manji je u bolesnika koji primaju kroničnu opioidnu terapiju jer će oni razviti toleranciju na učinke respiratornih depresora.
English: • A serious side effect of Effentora is slow and/or shallow breathing.
Croatian: • Ozbiljna nuspojava Effentore je sporo i/ili plitko disanje.
English: During determination of your right dose, your doctor may instruct you to take more than one tablet per episode.
Croatian: Tijekom određivanja Vaše pravilne doze liječnik Vam može savjetovati da uzimate više od jedne tablete po epizodi.
English: If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available (see section 4.8).
Croatian: Ako je potrebna dugotrajna primjena opioida u trudnice, obavijestite bolesnicu o riziku od sindroma ustezanja od opioida u novorođenčeta i osigurajte dostupnost odgovarajućeg liječenja (vidjeti dio 4.8).
English: • Some muscle relaxants - such as baclofen, diazepam (see also section “Warnings and precautions”.
Croatian: • Neki miorelaksansi (lijekovi za opuštanje mišića) poput baklofena, diazepama (pogledajte također dio „Upozorenja i mjere opreza“).
English: Cmax and AUC0-8 were 1% and 25% higher in patients with mucositis compared to those without mucositis, respectively.
Croatian: Vrijednost Cmax bila je 1% a AUC0-8 25% viša u bolesnika s mukozitisom u usporedbi s onima bez mukozitisa.
English: If the breakthrough pain has stopped, do not take Effentora until the next breakthrough pain episode.
Croatian: Ako je probijajuća bol prestala, nemojte uzimati Effentoru sve do sljedeće epizode probijajuće boli.
English: <1/1,000), not known (cannot be estimated from the available data); within each frequency group, undesirable effects are presented in order of decreasing seriousness:
Croatian: rijetko (≥1/10 000 i <1/1000), nepoznato (ne može se procijeniti iz dostupnih podataka); unutar svake grupe učestalosti, nuspojave su prikazane u padajućem nizu prema ozbiljnosti.
English: Pharmacokinetic parameter (mean)
Croatian: Farmakokinetički parametar (prosjek)
English: It is subject to first-pass hepatic and intestinal metabolism and the metabolites do not contribute to fentanyl's therapeutic effects.
Croatian: Podliježe metabolizmu prvog prolaska kroz jetru i crijeva, a metaboliti ne pridonose njegovu terapijskom učinku.
English: All opioid µ-receptor agonists, including fentanyl, produce dose dependent respiratory depression.
Croatian: Svi agonisti opioidnih µ-receptora, uključujući i fentanil, uzrokuju respiratornu depresiju ovisnu o dozi.
English: Any used or unused but no longer required medicinal product or waste material should be disposed of in accordance with local requirements.
Croatian: Korišteni lijek ili neiskorišteni lijek koji više nije potreban te otpadni materijal potrebno je zbrinuti sukladno nacionalnim propisima.
English: Clinical signs and symptoms may be manifest from these hormonal changes (see also section 4.8).
Croatian: Ove hormonske promjene mogu se očitovati kliničkim znakovima i simptomima (vidjeti također dio 4.8).
English: • decrease in cells that help the blood to clot,
Croatian: • pad broja stanica koje pomažu u zgrušavanju krvi
English: If serotonin syndrome is suspected, treatment with Effentora should be discontinued.
Croatian: Ako se posumnja na pojavu serotoninskog sindroma treba prekinuti liječenje Effentorom.
English: Effentora contains sodium
Croatian: Effentora sadrži natrij
English: A condition in which the adrenal glands do not produce enough hormones.
Croatian: U tom stanju, nadbubrežne žlijezde ne stvaraju dovoljno hormona.
English: The concomitant use of alcohol with fentanyl can produce increased depressant effects which may result in a fatal outcome (see section 4.5).
Croatian: Istodobna primjena alkohola s fentanilom može pojačati depresorne učinke koji mogu dovesti do smrtnog ishoda (vidjeti dio 4.5).
English: Therefore patients should be instructed not to open the blister until ready to place the tablet in the buccal cavity.
Croatian: Stoga bolesnike treba upozoriti da ne otvaraju blistere sve dok nisu spremni staviti tabletu u bukalnu šupljinu.
English: • Treatment of acute pain other than breakthrough pain
Croatian: • Liječenje akutne boli osim probijajuće boli.
English: If you use more Effentora than you should
Croatian: Ako uzmete više Effentore nego što ste trebali
English: If you experience withdrawal symptoms or if you are concerned about your pain relief, you should contact your doctor.
Croatian: Ako dobijete simptome ustezanja ili ste zabrinuti zbog ublažavanja bola, obratite se svom liječniku.
English: Method of titration
Croatian: Način titracije
English: Tell your doctor or pharmacist before starting Effentora if you are taking or have recently taken or might take any of the following medicines:
Croatian: Obavijestite svog liječnika ili ljekarnika prije nego počnete uzimati Effentoru ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koji od sljedećih lijekova:
English: As a result, the dose of Effentora should be individually titrated to achieve the desired effect (see section 4.2).
Croatian: Kao rezultat toga dozu Effentore treba individualno titrirati kako bi se postigao željeni učinak (vidjeti dio 4.2).
English: Two double-blind, randomized, placebo-controlled crossover studies have been conducted involving a total of 248 patients with BTP and cancer who experienced on average 1 to 4 episodes of BTP per day while taking maintenance opioid therapy.
Croatian: Provedena su dva dvostruko slijepa, randomizirana, placebom kontrolirana ispitivanja sa zamjenom terapija uključujući ukupno 248 bolesnika s probijajućom boli i karcinomom, koji su imali u prosjeku od 1 do 4 epizode probijajuće boli na dan dok su uzimali terapiju održavanja opioidima.
English: Using benzodiazepines can increase the chances of getting serious side effects including death
Croatian: Uzimanje benzodiazepina može povećati šanse za nastanak ozbiljnih nuspojava uključujući i smrt.
English: • Do not bite, suck, chew, or swallow the tablet, as this will result in less pain relief than when taken as directed.
Croatian: • Nemojte gristi, cuclati, žvakati ili progutati tabletu jer će time bol biti manje ublažena nego kad uzmete tabletu prema uputama.
English: In studies on pre and postnatal development in rats the survival rate of offspring was significantly reduced at doses causing severe maternal toxicity.
Croatian: U ispitivanjima prenatalnog i postnatalnog razvoja u štakora stupanj preživljenja podmlatka značajno je reduciran pri dozama koje uzrokuju ozbiljnu maternalnu toksičnost.
English: You should not start breast-feeding until at least 5 days after the last dose of Effentora.
Croatian: Ne smijete početi dojiti dok ne prođe najmanje 5 dana od uzimanja posljednje doze Effentore.
English: Subsequently, fentanyl is redistributed between the deep tissue compartment (muscle and fat) and the plasma.
Croatian: Fentanil se naknadno raspodjeljuje između dubokih odjeljaka tkiva (mišići i mast) i plazme.
English: • severe breathing problems, trouble breathing during sleep,
Croatian: • jake teškoće s disanjem, otežano disanje tijekom spavanja
English: • You have low amount of fluid in the circulation or low blood pressure.
Croatian: • ako imate manju količinu tekućine u krvotoku ili niski krvni tlak.
English: If it occurs, it should be managed by the use of assisted ventilation, by an opioid antagonist, and as a final alternative, by a neuromuscular blocking agent.
Croatian: Ako se to dogodi, treba primijeniti liječenje potpomognutom ventilacijom, antagonistom opioida te kao zadnja mogućnost lijekom za neuromuskularnu blokadu.
English: The blister unit should then be flexed along the line printed on the backing foil where indicated.
Croatian: Jedinicu blistera potom treba savinuti duž linije otisnute na poleđini folije tamo gdje je to naznačeno.
English: You should not use Effentora during childbirth because fentanyl may cause respiratory depression in the new-born child.
Croatian: Ne biste smjeli koristiti Effentoru tijekom porođaja jer fentanil može uzrokovati respiratornu depresiju u novorođenčeta.
English: Treatment should be initiated by and remain under the guidance of a physician experienced in the management of opioid therapy in cancer patients.
Croatian: Liječenje treba započeti i ostati pod vodstvom liječnika iskusnog u liječenju opioidnom terapijom bolesnika oboljelih od raka.
English: When you first start using Effentora, your doctor will work with you to find the dose that will relieve your breakthrough pain.
Croatian: Kad počnete uzimati Effentoru liječnik će u suradnji s Vama odrediti dozu koja će Vam ublažiti probijajuću bol.
English: The effect of renal or hepatic impairment on the pharmacokinetics of Effentora has not been studied.
Croatian: Učinak oštećenja bubrega ili jetre na farmakokinetiku Effentore nije proučavan.
English: This may occur within the recommended dose.
Croatian: Do njegove pojave može doći pri primjeni preporučene doze.
English: Titration in patients switching from other fentanyl containing products Due to different absorption profiles, switching must not be done at a 1:1 ratio.
Croatian: Titracija u bolesnika koji su primali druge lijekove koji sadrže fentanil Zbog različitih profila apsorpcije, prebacivanje s drugih lijekova ne smije se provesti u omjeru 1:1.
English: For each BTP episode, pain intensity was assessed prior to and at several time points after treatment.
Croatian: Za svaku epizodu probijajuće boli procijenili su intenzitet boli prije i u nekoliko vremenskih točaka nakon liječenja.
English: You should take this into consideration if you are on a controlled sodium diet and seek advice from your doctor.
Croatian: O tome treba voditi računa ako ste na dijeti s ograničenim unosom natrija i posavjetujte se sa svojim liječnikom.
English: These might be early symptoms of a serious allergic reaction (anaphylaxis, hypersensitivity; see section 4 under “Serious side effects”)
Croatian: To mogu biti rani simptomi ozbiljne alergijske reakcije (anafilaksije, preosjetljivosti; pogledajte dio 4, pod „Ozbiljne nuspojave“).
English: The use of these medicines with Effentora can lead to a serotonin syndrome a potentially life-threatening condition (see section 2 under “Other medicines and Effentora”).
Croatian: Primjena ovih lijekova s Effentorom može dovesti do serotoninskog sindroma, što je potencijalno životno opasno stanje (pogledajte dio 2, pod „Drugi lijekovi i Effentora“).
English: The main binding protein is alpha-1-acid glycoprotein, but both albumin and lipoproteins contribute to some extent.
Croatian: Glavni protein koji veže fentanil je alfa-1kiseli glikoprotein ali i albumini i lipoproteini donekle sudjeluju u vezanju fentanila.
English: • You use benzodiazepines (see section 2 under “Other medicines and Effentora”).
Croatian: • ako uzimate benzodiazepine (pogledajte dio 2, pod „Drugi lijekovi i Effentora“).
English: In clinical studies, the effective dose of Effentora for BTP was not predictable from the daily maintenance dose of opioid.
Croatian: U kliničkim ispitivanjima, učinkovita doza Effentore za probijajuću bol nije bila predvidiva na temelju dnevne doze održavanja opioida.
English: Secondary pharmacological effects are respiratory depression, bradycardia, hypothermia, constipation, miosis, physical dependence and euphoria.
Croatian: Sekundarni farmakološki učinci su respiratorna depresija, bradikardija, hipotermija, konstipacija, mioza, fizička ovisnost i euforija.
English: Patients experiencing xerostomia are advised to drink water to moisten the buccal cavity prior to administration of Effentora.
Croatian: Bolesnicima koji imaju problema sa kserostomijom preporučuje se piti vodu kako bi ovlažili bukalnu šupljinu prije primjene Effentore.
English: Patients should be closely monitored for signs and symptoms of respiratory depression and sedation (see section 4.5).
Croatian: Bolesnike je potrebno pažljivo pratiti zbog mogućih znakova i simptoma respiratorne depresije i sedacije (vidjeti dio 4.5).
English: During titration, multiple tablets may be used: up to four 100 micrograms or up to four 200 micrograms tablets may be used to treat a single episode of BTP during dose titration according to the following schedule:
Croatian: Tijekom titracije može se primijeniti više tableta: do četiri tablete od 100 mikrograma ili do četiri tablete od 200 mikrograma mogu se primijeniti za liječenje pojedinačne epizode probijajuće boli tijekom titracije doze prema sljedećem rasporedu:
English: • Bend the blister unit along the line where indicated.
Croatian: • Presavijte blister duž naznačene linije.
English: If you are not sure about the right dose, or if you have questions about taking this medicine, you should contact your doctor.
Croatian: Ako niste sigurni koja je Vaša prava doza ili ako imate pitanja o ovom lijeku obratite se svom liječniku.
English: Differences in exposure with Effentora were observed in a clinical study with patients with grade 1 mucositis.
Croatian: Razlike u izloženosti Effentori primijećene su u kliničkom ispitivanju bolesnika s mukozitisom 1.
English: During an initial open-label phase, patients were titrated to an effective dose of Effentora.
Croatian: Tijekom početne otvorene faze bolesnici su titrirani na djelotvornu dozu Effentore.
English: • You have problems with your heart especially slow heart rate.
Croatian: • ako imate problema sa srcem, posebno sa sporim otkucajima srca.
English: A Q&A document, providing answers to potential questions on the following topics:
Croatian: Dokumenta s pitanjima i odgovorima u kojem se nude odgovori na moguća pitanja o sljedećim temama: • Što je probijajući bol?
English: About 30% of the amount swallowed (50% of the total dose) escapes hepatic and intestinal first-pass elimination and becomes systemically available.
Croatian: Približno 30% progutane doze (50% ukupne doze) zaobilazi jetreni i crijevni metabolizam prvog prolaska te postaje sistemski dostupno.
English: Embryo-foetal developmental toxicity studies conducted in rats and rabbits revealed no compoundinduced malformations or developmental variations when administered during the period of organogenesis.
Croatian: Ispitivanja razvojne toksičnosti za embrij i fetus provedene na štakorima i kunićima nisu otkrile malformacije uzrokovane lijekom ili varijacije u razvoju prilikom primjene lijeka u razdoblju organogeneze.
English: If Effentora is administered, an antidote for the child should be readily available.
Croatian: Ako se primjenjuje Effentora, potrebno je imati spreman antidot za dijete.
English: • unusually low heart rate, feeling very warm (hot flushes),
Croatian: • neuobičajeno spori otkucaji srca, osjećaj jake topline (navale vrućine)
English: In a fertility and early embryonic development study in rats, a male-mediated effect was observed at high doses (300 mcg/kg/day, s.c.) and is considered secondary to the sedative effects of fentanyl in animal studies.
Croatian: U ispitivanju plodnosti i ranog embrionalnog razvoja u štakora, učinak posredovan mužjakom primijećen je pri višim dozama (300 mikrograma/kg/dan, supkutano) i smatra se posljedicom sedativnog učinka fentanila u ispitivanjima na životinjama.
English: • If you are not regularly using a prescribed opioid medicine (e.g codeine, fentanyl, hydromorphone, morphine, oxycodone, pethidine), every day on a regular schedule, for at least a week, to control your persistent pain.
Croatian: • Ako za kontrolu stalne boli ne koristite propisani opioidni lijek (npr. kodein, fentanil, hidromorfon, morfin, oksikodon, petidin) redovito, svaki dan prema rasporedu, najmanje tjedan dana.
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 dependant patients.
Croatian: Imaju visoki afinitet vezivanja na opioidne receptore s relativno niskom intrinzičnom aktivnošću te tako parcijalno antagoniziraju analgetski učinak fentanila i mogu uzrokovati simptome ustezanja kod bolesnika ovisnih o opioidima.
English: If a decision is made to prescribe Effentora concomitantly with benzodiazepines or related drugs, the lowest effective dosages and minimum durations of concomitant use should be chosen.
Croatian: Ako je odlučeno da se Effentora primjenjuje istodobno s benzodiazepinima ili sličnim lijekovima, mora se odabrati najniža učinkovita doza i najkraće trajanje istodobne primjene.
English: Agents that affect CYP3A4 activity
Croatian: Lijekovi koji utječu na aktivnost CYP3A4
English: In the second pivotal study (study 2), the primary endpoint was SPID30, which was also statistically significant compared to placebo (p<0.0001).
Croatian: U drugom ključnom kliničkom ispitivanju (ispitivanje 2) primarni ishod bila je vrijednost SPID30 koja je također bila statistički značajna u usporedbi s placebom (p<0,0001).