FrancophonIA/ELRC3.0 huggingface dataset:
English: caution is recommended in these patients (see section 4.4).
Croatian: Međutim, preporučuje se oprez u navedenih bolesnika (vidjeti dio 4.4).
English: The digital display will show the number of doses that have been
Croatian: Digitalni zaslon prikazat će broj isporučenih doza.
English: When the system is applied on the lower inner arm, the amount of fentanyl absorbed is approximately 20% lower than at the upper outer arm or chest.
Croatian: Kada se sustav primijeni na unutarnji dio podlaktice, količina apsorbiranog fentanila približno je 20% niža nego kada se primijeni na vanjski dio nadlaktice ili na prsište.
English: 2 years Use immediately after opening.
Croatian: Primijeniti odmah nakon otvaranja.
English: Itraconazole, a potent CYP3A4 inhibitor, at 200 mg/day orally for 4 days had no significant effect on the pharmacokinetics of intravenous fentanyl.
Croatian: Itrakonazol, snažni inhibitor CYP3A4, pri dozi od 200 mg/dan peroralno tijekom 4 dana nije imao značajan učinak na farmakokinetiku intravenskog fentanila.
English: • Information highlighting that IONSYS is a patient-controlled device to be used in a hospital setting only and that standard practices for monitoring patients using such devices should be followed by healthcare professionals.
Croatian: • Informacije koje ističu da je IONSYS uređaj koji kontrolira bolesnik, koji se koristi samo u bolničkom okruženju, te da se zdravstveni radnici trebaju pridržavati standardnih praksi za nadzor bolesnika koji koriste takve uređaje.
English: If using tape, apply it along the edges of IONSYS system, do not cover the dosing button or display.
Croatian: Ako koristite traku, primijenite je uzduž rubova sustava IONSYS, nemojte prekrivati dugme za doziranje ili zaslon.
English: In summary, the limited size of the overall paediatric exposure is insufficient to guide safe and effective dosing of IONSYS in patients younger than 18 years of age.
Croatian: Ukratko, ograničen opseg cjelokupne pedijatrijske izloženosti nedovoljan je da bi se mogao koristiti kao vodič za sigurno i učinkovito doziranje sustava IONSYS u bolesnika mlađih od
English: When IONSYS is applied without activating the electrical current, the average absorption rate of fentanyl over 24 hours was 2.3 micrograms fentanyl/hour, indicating minimal passive delivery.
Croatian: Kada se IONSYS primijenio bez aktiviranja električne struje, prosječna stopa apsorpcije fentanila tijekom 24 sata bila je 2,3 mikrograma fentanila/sat, što ukazuje na minimalnu pasivnu isporuku.
English: • The importance of reading the “IONSYS Instructions for Use and Disposal” including the troubleshooting guide and ensuring that the patient understands what to do in the event
Croatian: • Važnost čitanja „Uputa za primjenu i zbrinjavanje lijeka IONSYS“, uključujući vodič za rješavanje problema, i osiguravanja da bolesnik razumije što treba raditi u slučaju kvara/neispravnosti uređaja.
English: The used IONSYS system contains a dangerous amount of fentanyl within the red hydrogel housing.
Croatian: Iskorišten sustav IONSYS sadrži opasnu količinu fentanila u crvenom kućištu hidrogela.
English: If it beeps at any other time, or more than once, tell your doctor or nurse immediately.
Croatian: Ako se oglasi u bilo kojem drugom trenutku, ili više od jedanput, obavijestite odmah liječnika ili medicinsku sestru.
English: The concomitant use of partial opioid agonists/antagonists (e.g. buprenorphine, nalbuphine, pentazocine) is not recommended.
Croatian: Istodobna primjena djelomičnih agonista/antagonista opioida (npr. buprenorfina, nalbufina, pentazocina) se ne preporučuje.
English: • Checklist for monitoring inadequate product disposal to ensure healthcare professionals understand the dangers of inappropriate handling and accidental exposure to the IONSYS
Croatian: • Kontrolni popis za nadzor neogovarajućeg zbrinjavanja lijeka, kako bi se osiguralo da zdravstveni radnici razumiju opasnosti neodgovarajućeg rukovanja i slučajnog izlaganja
English: In general, the maximum serum fentanyl concentration occurs approximately 15 minutes after the initiation of a dose.
Croatian: Općenito gledano, najviša koncentracija fentanila u serumu postiže se približno 15 minuta nakon početka doze.
English: To avoid oral ingestion of the fentanylcontaining hydrogel, which may cause life-threatening hypoventilation or death, the hydrogel must not touch the mouth or other mucosal areas.
Croatian: Kako bi se izbjeglo gutanje hidrogela koji sadrži fentanil, što može prouzročiti hipoventilaciju opasnu po život ili smrt, hidrogel ne smije dodirivati usta ili druga područja prekrivena sluznicom.
English: For management of respiratory depression, immediate countermeasures include removing the IONSYS system and physically or verbally stimulating the patient.
Croatian: Za liječenje bolesnika u kojima se razvije respiratorna depresija, hitne protumjere uključuju uklanjanje sustava IONSYS i fizička ili verbalna stimulacija bolesnika.
English: • Patients should not wear more than one IONSYS at the same time.
Croatian: • Bolesnici ne smiju koristiti više od jednog sustava IONSYS istovremeno.
English: • you are taking medicines that might make you sleepy such as sleeping tablets, tranquilisers, medicines for anxiety or medicines for allergies (anti-histamines);
Croatian: • uzimate lijekove koji vas mogu učiniti pospanima poput tableta za spavanje, sedativa (sredstva za smirenje), lijekova za tjeskobu ili lijekova za alergije (antihistaminika);
English: Patients with genetic polymorphisms affecting CYP3A4 and CYP3A5
Croatian: Bolesnici s genetskim polimorfizmima koji se odnose na CYP3A4 i CYP3A5
English: A potentially dangerous amount of fentanyl remains in the IONSYS system after use.
Croatian: Potencijalno opasna količina fentanila ostane u sustavu IONSYS nakon uporabe.
English: If system beeps again, then remove and dispose of system, and place a new system on a different skin site.
Croatian: Ako se sustav ponovno oglasi, uklonite i zbrinite sustav, a zatim postavite novi sustav na drugo mjesto na koži.
English: The dosing button must not be pressed.
Croatian: Ne smije se pritisnuti dugme za doziranje.
English: The manifestations of fentanyl overdose are an extension of its pharmacologic actions, the most serious effect being respiratory depression (see section 5.2).
Croatian: Manifestacije predoziranja fentanilom su produljenje njegovog farmakološkog djelovanja, od kojih je najozbiljnija respiratorna depresija (vidjeti dio 5.2).
English: Literature has shown that the genetic polymorphisms only account for a small amount of variability in concentrations of fentanyl with transdermal administration.
Croatian: Literatura je pokazala da se genetskim polimorfizmima može pripisati samo mala količina varijabilnosti u koncentracijama fentanila pri transdermalnoj primjeni.
English: • you are severely obese or have a condition called sleep apnoea that causes interrupted breathing during sleep and which can occur in severely obese individuals.
Croatian: • ako ste jako pretili ili imate zdravstveno stanje koje se zove apneja u snu koja uzrokuje isprekidano disanje tijekom sna i koja se može pojaviti u jako pretilih osoba.
English: Upon system removal after the last dose, the decline in serum fentanyl concentration is similar to that of intravenous fentanyl.
Croatian: Pri uklanjanju sustava nakon zadnje doze, pad koncentracije fentanila u serumu sličan je onom intravenskog fentanila.
English: Patients who completed 24 hours of IONSYS treatment in the seven controlled studies used a wide range of the available 80 doses, with a mean of 29.0 doses/patient (range of 0-93 doses) with the majority of patients (56.5%) using between 11 to 50 doses.
Croatian: Bolesnici koji su dovršili liječenje sustavom IONSYS u trajanju od 24 sata u sedam kontroliranih ispitivanja primijenili su širok raspon dostupnih 80 doza, sa srednjom vrijednosti od 29,0 doza/bolesnik (raspon 0-93 doza), a većina bolesnika (56,5%) primijenila je između 11 i 50 doza.
English: • you have a severe or persistent lung disease, or any breathing problems
Croatian: • ako imate tešku ili ustrajnu bolest pluća, ili bilo kakve probleme s disanjem
English: • Risk Management Plan (RMP)
Croatian: LIJEKA • Plan upravljanja rizikom (PUR)
English: The primary endpoint in each placebo-controlled study was the proportion of withdrawals due to inadequate analgesia during the period from 3 to 24-hours after IONSYS application.
Croatian: Primarni ishod u svakom placebom kontroliranom ispitivanju bio je udio prekida liječenja zbog neadekvatne analgezije u razdoblju od 3 do 24 sata nakon primjene sustava IONSYS.
English: Depression Thinking abnormal thoughts
Croatian: • depresija, neuobičajene misli
English: • you are taking medicines used to help treat nausea and vomiting (such as aprepitant); • you are taking medicines used for high blood pressure or heart problems (such as diltiazem
Croatian: • uzimate lijekove koji se koriste kao pomoć u liječenju mučnine i povraćanja (kao što je aprepitant); • uzimate lijekove za visok krvni tlak ili probleme sa srcem (kao što su diltiazem i verapamil);
English: Upon successful dose initiation, IONSYS will emit a beep indicating the start of delivery.
Croatian: Kada je uspješno započeto doziranje, IONSYS ispušta zvučni signal koji označava početak isporuke.
English: The green light will change from a slow flash rate to a rapid flash rate and the digital display will alternate between a rotating circle and the number of completed doses during the entire 10-minute dose delivery period.
Croatian: Zeleno svjetlo će se promijeniti od sporog treperenja do brzog treperenja, a na digitalnom zaslonu će se izmjenjivati rotirajući krug i broj dovršenih doza tijekom cijelog 10-minutnog razdoblja isporuke doze.
English: IONSYS is removed from the patient by lifting the system at the red tab and peeling it away from the skin site.
Croatian: IONSYS se uklanja s bolesnika tako što se sustav podigne za crveni jezičak i odlijepi s mjesta na koži.
English: IONSYS is a small device applied to the skin of your upper arm or chest.
Croatian: IONSYS je mali uređaj koji se primjenjuje na kožu nadlaktice ili prsišta.
English: Consequently, the patient may activate IONSYS more frequently to maintain fentanyl blood levels.
Croatian: Zbog toga bolesnik će možda aktivirati sustav IONSYS češće kako bi održao razine fentanila u krvi.
English: IONSYS should be used with caution in patients with hearing impairment who might not be able to hear the audible signals from the system.
Croatian: Oštećenje sluha IONSYS je potrebno koristiti uz oprez u bolesnika s oštećenjem sluha koji možda ne čuju zvučne signale sustava.
English: IONSYS should only be activated by the patient, to avoid potential overdosing.
Croatian: IONSYS smije aktivirati samo bolesnik kako bi se spriječila mogućnost predoziranja.
English: IONSYS is used to treat short-term moderate to severe pain in adults after an operation.
Croatian: IONSYS se primjenjuje za liječenje kratkotrajne umjerene do teške boli u odraslih nakon operacije.
English: • IONSYS may be removed at any time.
Croatian: • IONSYS se smije ukloniti u bilo kojem trenutku.
English: This effect could either be due to altered maternal care or a direct effect of fentanyl on the pups.
Croatian: Taj učinak može biti posljedica promijenjene majčine skrbi ili izravnog učinka fentanila na mladunčad.
English: The main binding protein is alpha-1-acid glycoprotein, but both albumin and lipoproteins contribute to some extent.
Croatian: Glavna bjelančevina na koju se veže je alfa-1-kiseli glikoprotein, ali i albumin i lipoproteini doprinose u određenom opsegu.
English: • Excessive hair at the application site should be clipped (not shaved as this can irritate the skin) before application.
Croatian: • Suvišak dlaka na mjestu primjene treba podrezati (ne brijati jer bi to moglo nadražiti kožu) prije primjene.
English: The flashing digital display may be turned off by pressing the dose button for six seconds.
Croatian: Trepereći digitalni prikaz može se isključiti pritiskom na dugme za doziranje u trajanju od šest sekundi.
English: You will hear one single beep upon successful dose initiation.
Croatian: Čut ćete jedan zvučni signal nakon uspješnog početka primjene doze.
English: 3.7%)a, b
Croatian: (-9,7 %; 3,7 %)a,
English: • Information to aid healthcare professionals in selecting patients appropriate for treatment with IONSYS.
Croatian: • Informacije koje pomažu zdravstvenim radnicima u odabiru bolesnika podobnih za liječenje lijekom IONSYS.
English: The MAH shall ensure that, following discussions and agreement with the National Competent Authorities in each Member State where IONSYS is launched all healthcare professionals who are expected to prescribe, dispense or administer IONSYS are informed through an information letter on having access to / are provided with the following items:
Croatian: Nositelj odobrenja za stavljanje lijeka u promet će osigurati da, nakon rasprave i dogovora s nadležnim nacionalnim tijelima u svakoj državi članici u kojoj se IONSYS stavlja u promet, svi zdravstveni radnici za koje se očekuje da propisuju, izdaju ili primjenjuju IONSYS budu putem informativnog pisma obaviješteni o svom pristupu sljedećim dokumentima, odnosno da im budu osigurani sljedeći dokumenti:
English: Fentanyl is an opioid analgesic, interacting predominantly with the opioid μ-receptor.
Croatian: Fentanil je opioidni analgetik, koji pretežno međudjeluje s μ-opioidnim receptorom.
English: • Dispose of remainder of the system, containing electronics, according to hospital procedures for battery waste.
Croatian: • Zbrinite preostali dio sustava, koji sadrži elektroniku, u skladu s postupcima bolnice vezanim za iskorištene baterije.
English: • itching skin
Croatian: • svrbež kože
English: IONSYS is restricted to hospital use only.
Croatian: IONSYS je ograničen samo na bolničku uporabu.
English: If you are given IONSYS during childbirth your baby may need to be given an antidote when it is born.
Croatian: Ako dobijete IONSYS tijekom poroda Vaše dijete će možda morati primiti protulijek nakon rođenja.
English: Instructing the patient how to use IONSYS
Croatian: Upute bolesniku kako koristiti IONSYS
English: Steady state absorption of the nominal 40 microgram dose is achieved about 12 hours after application, indicating that the skin becomes more permeable to fentanyl during the first 12 hours.
Croatian: Apsorpcija u stanju dinamičke ravnoteže nominalne doze od 40 mikrograma postiže se približno 12 sati nakon primjene, što ukazuje da koža postaje propusnija za fentanil tijekom prvih 12 sati.
English: However, caution is advised when prescribing IONSYS in morbidly obese patients because they may be at increased risk of other comorbid respiratory conditions (i.e., sleep apnoea) potentially pre-disposing them to hypoventilation or more severe adverse reactions (see section 4.8).
Croatian: Međutim, savjetuje se oprez prilikom propisivanja sustava IONSYS u morbidno pretilih bolesnika jer mogu imati povećan rizik od drugih komorbidnih respiratornih stanja (npr. apneja u snu) koja ih mogu predisponirati na hipoventilaciju ili teže nuspojave (vidjeti dio 4.8).
English: There are 6 systems per carton.
Croatian: U svakoj kutiji nalazi se 6 sustava.
English: Similar to the placebo-controlled studies, in the immediate postoperative period, patients were titrated to comfort with intravenous fentanyl or morphine per hospital protocol.
Croatian: Slično kao i u ispitivanjima kontroliranima placebom, u neposrednom postoperativnom razdoblju bolesnici su titrirani kako bi se prilagodili intravenskoj primjeni fentanila ili morfina u skladu s bolničkim protokolom.
English: Fentanyl pharmacokinetics are similar with both single and multiple 24 hour applications.
Croatian: Farmakokinetika fentanila je slična kod jednostruke i višestruke 24-satne primjene.
English: Study C-2000-007 evaluated patients after undergoing abdominal, thoracic, or orthopedic surgeries; Study CAPSS-319 evaluated patients after undergoing total hip replacement; Study CAPSS-320 assessed IONSYS in patients following abdominal and pelvic surgeries; and Study FEN-PPA-401 assessed patients following major abdominal or orthopedic surgery.
Croatian: procjenjivalo je bolesnike nakon što su podvrgnuti abdominalnom, torakalnom ili ortopedskom kirurškom zahvatu; ispitivanje CAPSS-319 procjenjivalo je bolesnike nakon što su podvrgnuti potpunoj zamjeni kuka; ispitivanje CAPSS-320 procjenjivalo je sustav IONSYS u bolesnika nakon kirurškog zahvata abdomena i zdjelice; a ispitivanje FEN-PPA-401 procjenjivalo je bolesnike nakon velikog abdominalnog ili ortopedskog kirurškog zahvata.
English: Only you know how much pain you are having, and only you should operate IONSYS to start a dose of medicine.
Croatian: Samo Vi znate kolika je Vaša bol i samo Vi smijete rukovati sustavom IONSYS
English: The mean amount of supplemental opioid used during this time was also similar among patients treated with IONSYS or PCA morphine i.e. a range across the 4 studies of a mean dose of 5.0 - 7.5 mg morphine in patients treated with IONSYS compared to a mean dose of 5.4 - 7.7mg morphine in patients receiving PCA morphine.
Croatian: Srednja vrijednost količine dodatnih opioida koji su primijenjeni tijekom tog razdoblja bila je također slična među bolesnicima liječenim sustavom IONSYS ili PCA morfinom, tj. raspon u 4 ispitivanja srednje vrijednosti doze 5,0 - 7,5 mg morfina u bolesnika liječenih sustavom IONSYS u usporedbi sa srednjom vrijednosti doze 5,4 - 7,7 mg morfina u bolesnika koji su primali PCA morfin.
English: Significant respiratory depression may occur with IONSYS; patients must be observed for these effects (see section 4.9).
Croatian: Sa sustavom IONSYS može se pojaviti značajna respiratorna depresija; bolesnike treba promatrati zbog pojave takvih štetnih učinaka (vidjeti dio 4.9).
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Croatian: PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET B. UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU
English: The concomitant use of other central nervous system depressants including other opioids, sedatives or hypnotics, general anaesthetics, phenothiazines, tranquilizers, skeletal muscle relaxants, sedating antihistamines, and alcoholic beverages, may produce additive depressant effects.
Croatian: Istodobna primjena drugih depresora središnjeg živčanog sustava, uključujući druge opioide, sedative ili hipnotike, opće anestetike, fenotiazine, sedative, relaksanse skeletnih mišića, sedativne antihistaminike i alkoholna pića može izazvati aditivni depresivni učinak.
English: IONSYS should, therefore, be used with caution in these patients.
Croatian: Stoga IONSYS treba primjenjivati uz oprez u tih bolesnika.
English: At the initiation of each dose, an electrical current moves a pre-determined amount of fentanyl from the active substance-containing reservoir through the skin and into systemic circulation.
Croatian: Na početku svake doze, električna struja pokreće unaprijed određenu količinu fentanila iz spremnika koji sadrži djelatnu tvar kroz kožu u sistemsku cirkulaciju.
English: In these studies, 1313 patients undergoing major surgery were randomized to PCA with intravenous morphine (1 mg morphine bolus, 5 minute lock-out, total of 10 mg/h) delivered by a pump, and 1288 patients were randomized to IONSYS.
Croatian: U tim ispitivanjima je 1313 bolesnika podvrgnutih velikom kirurškom zahvatu randomizirano u skupinu koja je primala PCA intravenskim morfinom (bolus morfina od 1 mg, 5 minuta pauze, ukupno 10 mg/h) isporučenog pumpom te 1288 bolesnika randomizirano je u skupinu kojoj je primijenjen sustav IONSYS.
English: If the clinical situation warrants, a patent airway should be established and maintained, possibly with an oropharyngeal airway or endotracheal tube.
Croatian: Ako klinička situacija to zahtijeva, potrebno je uspostaviti i održavati prohodni dišni put, po mogućnosti orofaringalnim ili endotrahealnim tubusom.
English: The pharmacokinetic absorption profile will repeat with each application to a new skin site, therefore with each new application,
Croatian: Farmakokinetički profil apsorpcije ponovit će se sa svakom primjenom na drugo mjesto na koži, stoga pri svakoj novoj primjeni apsorpcija će na početku biti niža.
English: Each tray is packaged in a folding cardboard carton.
Croatian: Jedan podložak pakiran je u sklopivoj kartonskoj kutiji.
English: After the 10-minute dose has been completely delivered, the green light will return to a slow flash rate, the digital display will show the number of doses that have been delivered, and IONSYS will be ready to be used again by the patient.
Croatian: Nakon što je 10-minutna doza u potpunosti isporučena, zeleno svjetlo će ponovno sporo treperiti, na digitalnom zaslonu bit će vidljiv broj isporučenih doza, a IONSYS će biti spreman za ponovnu primjenu od strane bolesnika.
English: Skin does not appear to metabolise fentanyl delivered transdermally.
Croatian: Čini se da koža ne metabolizira fentanil isporučen transdermalno.
English: IONSYS may make you feel sleepy, dizzy or cause blurred vision.
Croatian: IONSYS može prouzročiti pospanost, omaglicu ili zamagljen vid.
English: Around 75% of fentanyl is excreted into the urine, mostly as metabolites, with less than 10% as unchanged active substance.
Croatian: Oko 75% fentanila izlučuje se mokraćom uglavnom u obliku metabolita, a manje od 10% u nepromijenjenom obliku.
English: A recessed dosing button is located on the Controller of IONSYS.
Croatian: Udubljeno dugme nalazi se na kontroleru sustava IONSYS.
English: IONSYS should be removed before the patient is discharged.
Croatian: IONSYS se mora ukloniti prije otpuštanja bolesnika.
English: Studies in rats have revealed reduced fertility and enhanced embryo mortality (see section 5.3).
Croatian: Ispitivanja na štakorima pokazala su smanjenu plodnost i povećan mortalitet embrija (vidjeti dio 5.3).
English: The most serious adverse reactions reported were hypotension and apnoea and all patients should be closely monitored for these.
Croatian: Najozbiljnije nuspojave koje su prijavljene bile su hipotenzija i apneja te sve bolesnike treba pažljivo nadzirati zbog moguće pojave tih nuspojava.
English: Its secondary pharmacological effects are respiratory depression, bradycardia, hypothermia, constipation, miosis, physical dependence and euphoria (see section 5.2).
Croatian: Njegovi sekundarni farmakološki učinci su respiratorna depresija, bradikardija, hipotermija, zatvor, mioza, fizička ovisnost i euforija
English: In this situation, special patient care and observation are appropriate.
Croatian: U takvim je slučajevima potrebna posebna skrb i nadzor bolesnika.
English: The total plasma clearance of fentanyl following intravenous administration is approximately 42 L/h
Croatian: Ukupni klirens fentanila iz plazme nakon intravenske primjene približno je 42 l/h.
English: Data obtained with intravenous fentanyl in patients with renal failure suggest that the volume of distribution of fentanyl may be changed by dialysis.
Croatian: Podaci dobiveni korištenjem fentanila intravenozno u bolesnika sa zatajenjem bubrega upućuju na to da se volumen distribucije fentanila može promijeniti dijalizom.
English: At the end of 24 hours of use, or after 80 doses have been administered, the green light will switch off and the number of doses delivered will flash on and off.
Croatian: Na kraju 24-satne primjene, ili nakon što je primijenjeno 80 doza, zeleno svjetlo će se isključiti, a broj isporučenih doza će treperiti.
English: If IONSYS appears to be loose or lifting from the skin, secure it to patient's skin by pressing the edges firmly or by applying non-allergenic tape.
Croatian: Ako IONSYS izgleda olabavljeno ili se podiže s kože, pričvrstite ga za kožu bolesnika tako da čvrsto pritisnete rubove ili primijenite traku koja nije alergena.
English: The overall adverse reaction profile for morbidly obese patients (BMI > 40) does not suggest a meaningful difference in safety compared to patients with BMI ≤ 40.
Croatian: Ukupni profil nuspojava u morbidno pretilih bolesnika (indeks tjelesne mase, ITM >40) ne upućuje na značajnu razliku u sigurnosti u usporedbi s bolesnicima s ITM ≤40.