FrancophonIA/ELRC3.0 huggingface dataset:
English: A new IONSYS system was applied every 24 hours to different skin sites, or earlier if all doses were used.
Croatian: Nov sustav IONSYS primjenjivan je svakih 24 sata na različita mjesta na koži, ili ranije ako su iskorištene sve doze.
English: Effects on somatic development and behaviour of the offspring were not observed.
Croatian: Nisu opaženi učinci na tjelesni razvoj i ponašanje mladunčadi.
English: Respiratory depression following an overdose may outlast the duration of action of the opioid antagonist.
Croatian: Respiratorna depresija nakon predoziranja može trajati duže nego djelovanje antagonista opioida.
English: Patients should not wear more than one system at a time.
Croatian: Bolesnici ne smiju koristiti više od jednog sustava istovremeno.
English: IONSYS should not be used in pregnancy unless clearly necessary.
Croatian: IONSYS se ne smije primjenjivati u trudnica, osim ako za time ne postoji jasna potreba.
English: Norfentanyl is not pharmacologically active in animal studies.
Croatian: Norfentanil nije bio farmakološki aktivan u ispitivanjima na životinjama.
English: IONSYS (fentanyl) n=1271
Croatian: IONSYS (fentanil) n = 1271
English: • Call your doctor or nurse if you hear additional beeps.
Croatian: • Nazovite svog liječnika ili medicinsku sestru ako čujete dodatne zvučne signale.
English: • Information on the adequate use of the product with regards to medication errors (including accidental exposure), Device malfunction/failure, Product Disposal and Misuse/abuse/diversion/addiction and dependence.
Croatian: • Informacije o odgovarajućoj uporabi lijeka u pogledu medikacijskih pogrešaka (uključujući slučajno izlaganje), neispravnosti/kvara uređaja, zbrinjavanja lijeka i pogrešne primjene/zlouporabe/primjene u nedopuštene svrhe/ovisnosti.
English: • Choose healthy, unbroken skin (non-irritated and nonirradiated skin) site on the chest or upper outer arm ONLY.
Croatian: • Odaberite zdravo, neoštećeno mjesto na koži (nenadražena i neozračena koža) SAMO na prsištu ili vanjskom dijelu nadlaktice.
English: After this point 727 patients remained in the studies using only the IONSYS or control system, and were evaluated for efficacy.
Croatian: Nakon toga, 727 bolesnika ostalo je u ispitivanjima uz primjenu samo sustava IONSYS ili kontrolnog sustava te je procijenjena djelotvornost.
English: The plasma protein binding of fentanyl is 80% to 85%.
Croatian: Vezanje fentanila na bjelančevine plazme je 80 do 85%.
English: No specific dose adjustment is required in elderly patients.
Croatian: U starijih bolesnika nije potrebna posebna prilagodba doze.
English: Fentanyl is metabolised into inactive metabolites in the liver.
Croatian: Fentanil se metabolizira u neaktivne metabolite u jetri.
English: However, once it has been removed, the same IONSYS should not be reapplied.
Croatian: No kad se jednom ukloni, taj isti IONSYS ne smije se ponovno primijeniti.
English: Severe respiratory depression or cystic fibrosis.
Croatian: Teška respiratorna depresija ili cistična fibroza.
English: • The doctor or nurse will put IONSYS on your skin, and take it off or replace it when needed.
Croatian: • Liječnik ili medicinska sestra stavit će IONSYS na Vašu kožu i skinuti ga ili zamijeniti kad je to potrebno.
English: Abuse or intentional misuse of IONSYS may result in overdose and/or death.
Croatian: Zlouporaba ili namjerno pogrešna primjena sustava IONSYS može rezultirati predoziranjem i/ili smrću.
English: • Do not let your family or friends start IONSYS for you.
Croatian: • Nemojte dopustiti da Vaša obitelj ili prijatelji započnu primjenu sustava IONSYS
English: Supplemental intravenous opioid medication (fentanyl or morphine) was only allowed during the first 3 hours of IONSYS or PCA morphine treatment.
Croatian: Dodatno intravensko opioidno liječenje (fentanil ili morfin) bilo je dopušteno samo tijekom prva 3 sata liječenja sustavom IONSYS ili PCA morfinom.
English: As illustrated in Table 1 below, IONSYS (fentanyl hydrochloride) was superior to placebo in all studies.
Croatian: Kao što je prikazano u Tablici 1 u nastavku, IONSYS (fentanilklorid) bio je superioran u odnosu na placebo u svim ispitivanjima.
English: Remove the sachet and the controller.
Croatian: Izvadite vrećicu i kontroler.
English: Error message/feedback
Croatian: Poruka o pogrešci/povratna informacija
English: • The importance of the healthcare professional ensuring that the patient understands how to operate the IONSYS system and that only he/she can press the dosing button during use.
Croatian: • Važnost osiguravanja, od strane zdravstvenih radnika, da bolesnik razumije način rukovanja IONSYS sustavom i da samo on/ona može pritisnuti gumb za doziranje tijekom primjene.
English: Patients were enrolled shortly after major surgery if they were not opioid tolerant, were expected to have an uncomplicated recovery, and required at least 24 hours of parenteral opioid treatment.
Croatian: Bolesnici su bili uključeni brzo nakon velikog operativnog zahvata ako nisu imali toleranciju na opioide, ako se očekivalo se da će se njihovo stanje poboljšati bez komplikacija i ako je bilo potrebno najmanje 24 sata parenteralnog liječenja opioidima.
English: years.
Croatian: 2 godine
English: Reversal of the narcotic effect may also result in acute onset of pain and release of catecholamines.
Croatian: Revrzija učinka narkotika može rezultirati također akutnom pojavom boli i otpuštanjem kateholamina.
English: Patients should be advised not to drive or operate machinery if they experience somnolence, dizziness, or visual disturbance.
Croatian: Bolesnike treba upozoriti da ne voze ili upravljaju sa strojevima ako se u njih pojave somnolencija, omaglica ili poremećaj vida.
English: • low calcium/glucose/potassium in blood serum
Croatian: • nizak kalcij/glukoza/kalij u krvnom serumu
English: Among these patients, the incidence of nausea was similar to adult patients; however, vomiting (32.1%) and fever (60.7%) were each reported at a higher incidence in paediatric patients relative to adults.
Croatian: U tih je bolesnika incidencija mučnine bila slična onoj u odraslih bolesnika; međutim povraćanje (32,1%) i vrućica (60,7%) prijavljene su sa višom incidencijom u pedijatrijskih bolesnika u odnosu na odrasle.
English: Transdermal system
Croatian: Transdermalni sustav
English: A single IONSYS system provided a sufficient number of doses for 99% of the studied patients over 24 hours.
Croatian: Jedan sustav IONSYS omogućio je dovoljan broj doza u 99% ispitanih bolesnika tijekom 24 sata.
English: Do not press the dosing button.
Croatian: Nemojte pritiskati dugme za doziranje.
English: If you have a genetic condition (polymorphism) which affects certain enzymes in your body (CYP3A4 and CYP3A5), inform your doctor.
Croatian: Ako imate genetsko stanje (polimorfizam) koje utječe na određene enzime u Vašem tijelu (CYP3A4 i CYP3A5), obavijestite svog liječnika.
English: The assembled IONSYS product measures 47 mm x 75 mm.
Croatian: Dimenzije sastavljenog sustava IONSYS iznose 47 mm x 75 mm.
English: Used systems should not be reapplied to a patient.
Croatian: Iskorišteni sustavi ne smiju se ponovno primijeniti na bolesnika.
English: • severe headache (migraine)
Croatian: • jaka glavobolja (migrena)
English: Paralytic ileus
Croatian: Paralitički ileus
English: What you need to know before you use IONSYS
Croatian: Što morate znati prije nego počnete primjenjivati IONSYS
English: • Remove and discard the clear plastic liner covering the adhesive.
Croatian: • Uklonite i zbrinite prozirni plastični pokrov koji prekriva ljepilo.
English: Fentanyl can be abused in a manner similar to other opioid agonists.
Croatian: Fentanil se zlouporabljuje na sličan način kao i drugi agonisti opioida.
English: Contact with the hydrogel should be avoided.
Croatian: Potrebno je izbjegavati dodir s hidrogelom.
English: 5.6%)a, b 7.4%)a, b 4.0%)a, b a 95% Confidence Interval for difference in proportions The pre-specified equivalence boundary was ± 10%
Croatian: (-6,2%; 4,0%)a, b a 95%-tni interval pouzdanosti za razliku u udjelima b Unaprijed određena granica ekvivalencije bila je ±10%
English: Mutagenicity testing in bacteria and in rodents yielded negative results.
Croatian: Ispitivanje mutagenosti u bakterija i glodavaca dalo je negativne rezultate.
English: • you have a very slow heart rate, low blood pressure, or other serious heart problem
Croatian: • ako imate vrlo spor puls, nizak krvni tlak ili druge ozbiljne poteškoće sa srcem
English: What IONSYS looks like and contents of the pack IONSYS is a transdermal system and is made up of an electronic controller (the top housing) and a drug unit (the red bottom housing).
Croatian: Kako IONSYS izgleda i sadržaj pakiranja IONSYS je transdermalni sustav i sastoji se od elektroničkog kontrolera (gornje kućište) i odjeljka s lijekom (crveno donje kućište).
English: Data on IONSYS in paediatrics is limited to information from a single clinical trial.
Croatian: Podaci o sustavu IONSYS u pedijatriji ograničeni su na informacije iz samo jednog kliničkog ispitivanja.
English: If you feel faint or if you have difficulty in breathing while being treated with IONSYS, tell a doctor or nurse immediately.
Croatian: Ako osjetite da ćete pasti u nesvijesti ili imate poteškoća s disanjem dok se liječite sustavom IONSYS, odmah obavijestite liječnika ili medicinsku sestru.
English: If you do use more IONSYS than you should then you may experience shortness of breath, difficulty breathing, rapid and shallow breathing, or feeling faint.
Croatian: Ako primijenite više lijeka IONSYS nego štoiste trebali, možete osjetiti nedostatak zraka, poteškoće s disanjem, ubrzano i plitko disanje, ili osjećaj padanja u nesvijest.
English: Only let the doctor or nurse place or remove IONSYS.
Croatian: Samo liječnik ili medicinska sestra smije postavljati ili uklanjati IONSYS.
English: The used system should be handled carefully by the sides and top.
Croatian: Potrebno je oprezno rukovati iskorištenim sustavom držeći ga sa strane i za vrh.
English: In such patients, opioids may decrease respiratory drive and increase airway resistance.
Croatian: U takvih bolesnika opioidi mogu smanjiti nagon za disanjem i povećati otpor u dišnim putevima.
English: Long-lasting or any non-opioid analgesics were not permitted.
Croatian: Dugodjelujući ili bilo kakvi neopioidni analgetici nisu bili dozvoljeni.
English: Standard reproductive and developmental toxicity studies have been carried out using parenteral administration of fentanyl.
Croatian: Provedena su standardna ispitivanja reproduktivne i razvojne toksičnosti kod parenteralne primjene fentanila.
English: As shown below, the primary endpoint, proportion of patients reporting “Good or Excellent” ratings for the two methods of pain relief in all four studies demonstrated equivalence, with each 95% confidence interval contained within the prespecified ± 10% equivalence boundaries.
Croatian: Kao što je prikazano u nastavku, primarna mjera ishoda, udio bolesnika koji je dao „dobru ili odličnu“ ocjenu dvjema metodama ublažavanja boli u svih četiri ispitivanja pokazao je ekvivalenciju, sa svakim 95%-tnim intervalom pouzdanosti sadržanim unutar unaprijed određenih ±10%-tnih granica ekvivalencije.
English: IONSYS is composed of an electronic controller and a drug unit with two hydrogels.
Croatian: IONSYS se sastoji od elektroničkog kontrolera i odjeljka s lijekom s dva hidrogela.
English: If severe or persistent hypotension occurs, hypovolaemia should be considered and the condition should be managed with appropriate parenteral fluid therapy or other interventions as needed, based upon the clinical judgment of the treating health care professional.
Croatian: Ako se pojavi teška ili perzistirajuća hipotenzija, potrebno je uzeti u obzir hipovolemiju i stanje treba kontrolirati prikladnom parenteralnom primjenom tekućine ili drugim zahvatima po potrebi, na temelju kliničke procjene odgovornog zdravstvenog radnika.
English: Studies with female rats revealed reduced fertility and enhanced embryo mortality.
Croatian: Ispitivanja na ženkama štakora pokazala su smanjenu plodnost i povećani mortalitet embrija.
English: Administration during childbirth is not recommended because fentanyl crosses the placenta and the fetal respiratory centre is sensitive to opiates.
Croatian: Primjena tijekom porođaja se ne preporučuje jer fentanil prolazi kroz posteljicu, a centar disanja fetusa je osjetljiv na opijate.
English: Each time you are given a new IONSYS you may find you initially need to have more doses to relieve your pain than later on during treatment.
Croatian: Svaki put kada dobijete novi sustav IONSYS, možda ćete na početku trebati primiti više doza nego kasnije tijekom liječenja kako biste ublažili bol.
English: Some medicines can affect the way IONSYS works, or make it more likely that you will have side effects.
Croatian: Određeni lijekovi mogu utjecati na način na koji IONSYS djeluje, ili povećati vjerojatnost da imate nuspojave.
English: • No light
Croatian: • Nema svjetla
English: Fentanyl should not be used 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: Fentanil se ne smije koristiti u bolesnika kod kojih postoji mogućnost da su posebno osjetljivi na intrakranijalne učinke retencije CO2, kao što su bolesnici kod kojih je dokazan povišen intrakranijalni tlak, narušena svijest ili koma.
English: • tightness/tension in muscles, muscle pain
Croatian: • stezanje/napetost u mišićima, bol u mišićima
English: Special precautions for disposal should be followed (see section 6.6).
Croatian: Potrebne su posebne mjere opreza prilikom zbrinjavanja (vidjeti dio 6.6).
English: Very common (may affect more than 1 in 10 people) • feeling sick (nausea) or being sick (vomiting)
Croatian: Vrlo često (mogu se javiti u više od 1 na 10 osoba) • mučnina ili povraćanje
English: IONSYS should be removed prior to certain procedures such as cardioversion (electrical current used to restore normal heart rhythm), defibrillation (electric shock given to the heart) or diathermy (electrical current used in physical therapy or surgery).
Croatian: IONSYS se mora ukloniti prije određenih postupaka kao što su kardioverzija (električna struja koja se koristi za ponovno uspostavljanje normalnog srčanog ritma), defibrilacija (električni šok koji se primijenjuje na srcu) ili dijatermija (električna struja koja se koristi u fizikalnoj terapiji ili kirurškim zahvatima).
English: Unlike morphine, no active fentanyl metabolites are eliminated by the kidney.
Croatian: Za razliku od morfina, nema aktivnih metabolita fentanila koji se eliminiraju putem bubrega.
English: Each IONSYS carton contains 6 systems.
Croatian: Jedna kutija lijeka IONSYS sadrži 6 sustava.
English: If you have a history of drug abuse, inform your doctor.
Croatian: Ako u povijesti bolesti imate zlouporabu droga/lijekova, obavijestite svog liječnika.
English: IONSYS is a transdermal system (to be applied on intact skin) that contains a strong analgesic (pain reliever) medicine called fentanyl.
Croatian: IONSYS je transdermalni sustav (koji treba nanijeti na neoštećenu kožu) koji sadrži jak analgetski (za ublažavanje boli) lijek koji se zove fentanil.
English: In Study CAPSS-319, half the patients in each group received rofecoxib perioperatively and in Study FEN-PPA-401 patients were allowed non-opioid analgesics throughout the study period.
Croatian: U ispitivanju CAPSS-319, polovica bolesnika u svakoj skupini primalo je rofekoksib perioperativno, a u ispitivanju FEN-PPA-401 bolesnicima su dopušteni neopioidni analgetici tijekom cijelog razdoblja ispitivanja.
English: A carcinogenicity study (daily subcutaneous injections of fentanyl hydrochloride for two years in Sprague Dawley rats) did not induce any findings indicative of oncogenic potential.
Croatian: Ispitivanje kancerogenosti (dnevne potkožne injekcije fentanilklorida tijekom dvije godine u SpragueDawley štakora) nije dalo rezultate koji bi ukazivali na onkogeni potencijal.
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 u anamnezi imaju ovisnost o lijekovima ili drogama/zlouporabu alkohola izloženi su većem riziku od razvoja ovisnosti i zlouporabe tijekom liječenja opioidima.
English: Do not drive, operate machines or power tools when you leave hospital if you experience any of these side effects.
Croatian: Nemojte upravljati vozilima, rukovati strojevima niti električnim alatima kad izađete iz bolnice ako imate bilo koju od navedenih nuspojava.
English: The efficacy and safety of IONSYS for treatment of acute, moderate to severe postoperative pain was evaluated in seven controlled studies in 1763 IONSYS patients: three placebo-controlled studies and four active-controlled studies.
Croatian: Klinička djelotvornost i sigurnost Djelotvornost i sigurnost sustava IONSYS u liječenju akutne, umjerene do teške postoperativne boli procijenjena je u sedam kontroliranih ispitivanja u 1763 bolesnika sa sustavom IONSYS: tri placebom kontrolirana ispitivanja i četiri ispitivanja kontrolirana aktivnim lijekom.
English: Therefore, the use of any of these medicinal products concomitantly with IONSYS requires special patient care and observation.
Croatian: Zbog toga, kod istodobne primjene bilo kojeg od navedenih lijekova sa sustavom IONSYS potrebna je posebna skrb i nadzor bolesnika.
English: Dose proportionality has been demonstrated from 25 to 60 micrograms per dose.
Croatian: Linearnost/nelinearnost Dokazana je proporcionalnost doze od 25 do 60 mikrograma po dozi.
English: The concomitant use of ritonavir or other potent or moderate CYP3A4 inhibitors and IONSYS is not recommended unless the patient is closely monitored.
Croatian: Istodobna primjena ritonavira ili drugih snažnih ili umjerenih inhibitora CYP3A4 uz IONSYS se ne preporučuje osim kada je bolesnik pažljivo nadziran.
English: • you are taking muscle relaxants (prescribed for back pain), or if you are undergoing general
Croatian: • uzimate lijekove za opuštanje mišića (propisane za bol u leđima), ili ako se podvrgavate općoj anesteziji;
English: Fentanyl is highly lipophilic and is well distributed beyond the vascular system, with a large apparent volume of distribution.
Croatian: Fentanil je visoko lipofilan i dobro se distribuira izvan krvožilnog sustava, s velikim prividnim volumenom distribucije.
English: An alternative application site should be chosen.
Croatian: Potrebno je odabrati drugo mjesto primjene.
English: You will hear IONSYS beep once each time you start a dose.
Croatian: Čut ćete zvučni signal sustava IONSYS jedanput svaki put kad započnete dozu.
English: Oxygen should be administered and respiration assisted or controlled, as appropriate.
Croatian: Potrebno je primijeniti kisik i potpomognutu ili kontroliranu ventilaciju, prema potrebi.
English: • you have any difficulty hearing as you will need to be able to hear the device's ‘beep(s)' to know if it is working properly or if there is a problem
Croatian: • ako imate bilo kakve poteškoće sa sluhom jer biste trebali moći čuti zvučne signale uređaja kako bio znali radi li ispravno ili postoji li problem
English: IONSYS should not be applied to a previously used skin site.
Croatian: IONSYS se ne smije primijeniti na prethodno korišteno mjesto na koži.
English: Hypoventilation, hypotension, and profound sedation or coma may occur.
Croatian: Mogu se pojaviti hipoventilacija, hipotenzija i duboka sedacija ili koma.
English: IONSYS is not recommended for use in patients who have received monoamine oxidase (MAO) inhibitors within 14 days because severe and unpredictable potentiation by MAO inhibitors has been reported with opioid analgesics
Croatian: Primjena sustava IONSYS se ne preporučuje u bolesnika koji su primili inhibitore monoamino oksidaze (MAO) unutar 14 dana jer je prijavljeno teško i nepredvidljivo potenciranje MAO inhibitorima kada su korišteni opioidni analgetici.
English: • At the end of 24 hours of use, or after 80 doses have been delivered, remove IONSYS by gently lifting the red tab and loosening it from the skin application site.
Croatian: • Na kraju 24 sata primjene, ili nakon što je isporučeno 80 doza, uklonite IONSYS tako da nježno podignete crveni jezičak i olabavite ga s mjesta primjene na koži.
English: IONSYS may be removed at any time.
Croatian: IONSYS se smije ukloniti u bilo kojem trenutku.
English: Do not drink alcohol or grapefruit juice whilst you are wearing IONSYS because it can increase the risk of experiencing dangerous side effects.
Croatian: Nemojte piti alkoholna pića niti sok od grejpa dok nosite sustav IONSYS jer to može povećati rizik od dobivanja opasnih nuspojava.
English: Pressing the button during delivery of a dose will not result in additional fentanyl being administered.
Croatian: Pritisak na dugme tijekom isporuke doze neće rezultirati primjenom dodatne količine fentanila.
English: If additional opioid analgesia is required, a new IONSYS should be applied to a different skin site, after removal and disposal of the previous IONSYS.
Croatian: Ako je potrebna dodatna opioidna analgezija, potrebno je primijeniti novi IONSYS na drugo mjesto na koži, nakon uklanjanja i zbrinjavanja prethodnog sustava IONSYS.
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu/.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu/.
English: Hepatic disease may delay elimination.
Croatian: Bolest jetre može odgoditi njegovu eliminaciju.
English: More than 90% of the administered dose of fentanyl is eliminated by biotransformation to N-dealkylated and hydroxylated inactive metabolites.
Croatian: Više od 90% primijenjene doze fentanila eliminira se biotransformacijom u neaktivne N-dealkilirane i hidroksilirane metabolite.
English: IONSYS should be applied to intact, non-irritated and non-irradiated skin.
Croatian: IONSYS je potrebno primijeniti na neoštećenu, nenadraženu i neozračenu kožu.
English: Table 2 Active Comparator Trials (n=2569) Evaluable Patients
Croatian: Tablica 2 Ispitivanja kontrolirana aktivnim lijekom (n= 2569) Bolesnici koji se mogu procijeniti
English: Additional analyses suggest that the surgical procedure type did not influence the trends in efficacy endpoints and the efficacy of IONSYS was similar across the range of body mass indices studied (< 25 to > 40 kg/m2
Croatian: Dodatne analize upućuju na to da vrsta kirurškog zahvata nije utjecala na trendove u mjerama ishoda djelotvornosti, a djelotvornost sustava IONSYS bila je slična u ispitanom rasponu indeksa tjelesne mase (indeks tjelesne mase od <25 do ≥40 kg/m2).
English: To dispose of a used IONSYS system:
Croatian: Za zbrinjavanje iskorištenog sustava IONSYS:
English: These actions can be followed by administration of a specific opioid antagonist such as naloxone, based on the clinical judgment of the treating health care professional.
Croatian: Nakon tih postupaka mogu se primijeniti specifični antagonist opioida kao što je nalokson, na temelju kliničke procjene zdravstvenog radnika koji liječi bolesnika.
English: The most commonly reported adverse reactions were nausea, vomiting, and application site reactions such as erythema and pruritus.
Croatian: Najčešće zabilježene nuspojave bile su mučnina, povraćanje i reakcije na mjestu primjene kao što su eritem i svrbež.
English: Treatment should be initiated by and remain under the guidance of a physician experienced in the management of opioid therapy.
Croatian: Liječenje treba započeti i voditi liječnik koji ima iskustva u liječenju opioidnom terapijom.
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: Oni imaju visok afinitet prema opioidnim receptorima s relativno niskom intrinzičnom aktivnošću te zbog toga djelomično antagoniziraju analgetski učinak fentanila i mogu izazvati simptome ustezanja kod bolesnika koji su ovisni o opioidima.