FrancophonIA/ELRC3.0 huggingface dataset:
English: Apply pressure with the fingers around the outer edges to ensure adhesion to the skin site.
Croatian: Primijenite pritisak prstima oko vanjskih rubova kako bi se osiguralo prianjanje na mjestu na koži.
English: Following an on-demand dose of fentanyl by IONSYS, fentanyl has an absorption half-life of approximately 15 minutes.
Croatian: Nakon doze fentanila isporučene na zahtjev sustavom IONSYS, fentanil ima poluvijek apsorpcije od približno 15 minuta.
English: • No display
Croatian: • Nema prikaza
English: IONSYS will ignore additional button presses during this 10-minute dosing period.
Croatian: IONSYS će zanemariti dodatne pritiske na dugme tijekom 10-minutnog razdoblja doziranja.
English: Talk to your doctor or nurse before using IONSYS if:
Croatian: Obratite se svom liječniku ili medicinskoj sestri prije nego primijenite IONSYS:
English: Less than 10% of administered fentanyl is excreted unchanged by the kidney.
Croatian: Manje od 10% primijenjenog fentanila izlučuje se nepromijenjeno putem bubrega.
English: After IONSYS has been removed, it may leave small reddish marks at the skin site.
Croatian: Nakon uklanjanja sustava IONSYS, mogu ostati mali crvenkasti tragovi na mjestu primjene na koži.
English: • When replacing an IONSYS system, the new system must be applied to a different site on the chest or upper outer arm.
Croatian: • Prilikom zamjene sustava IONSYS, nov sustav mora se primijeniti na drugo mjesto na prsištu ili vanjskom dijelu nadlaktice.
English: Co-administration of fentanyl with a serotoninergic agent, such as a Selective Serotonin Re-uptake Inhibitor (SSRI) or a Serotonin Norepinephrine Re-uptake Inhibitor (SNRI) or a Monoamine Oxidase Inhibitor (MAOI), may increase the risk of serotonin syndrome, a potentially life-threatening condition.
Croatian: Serotonergički lijekovi Istodobna primjena fentanila i serotonergičkih lijekova, kao što su selektivni inhibitor ponovne pohrane serotonina (SSRI), ili inhibitor ponovne pohrane serotonina i noradrenalina (SNRI), ili inhibitor monoamino oksidaze (MAOI), može povećati rizik od serotoninskog sindroma, stanje koje može biti po život opasno.
English: Fentanyl is metabolised primarily in the liver to norfentanyl by CYP3A4 isoform.
Croatian: Fentanil se metabolizira primarno u jetri u norfentanil izoformom CYP3A4.
English: Oral ritonavir, one of the most potent CYP3A4 inhibitors, reduced the clearance of intravenous fentanyl by two thirds.
Croatian: Oralni ritonavir, jedan od najsnažnijih inhibitora CYP3A4, smanjio je klirens intravenskog fentanila za dvije trećine.
English: Elderly patients should be observed carefully for adverse effects of fentanyl during IONSYS administration (see sections 4.2 and 4.8).
Croatian: Starije bolesnike treba pozorno nadzirati kako bi se uočili eventualni štetni učinci fentanila tijekom primjene lijeka IONSYS (vidjeti dijelove 4.2 i 4.8).
English: In a rat study fentanyl did not influence male fertility.
Croatian: U ispitivanju na štakorima, fentanil nije utjecao na plodnost u mužjaka.
English: • you have severe headaches, have had a significant head injury, or have a brain tumour
Croatian: • ako imate problema s jetrom ili bubrezima • ako imate jake glavobolje, imali ste značajnu ozljedu glave, ili imate tumor na mozgu
English: The placebo-controlled trials included 791 patients that were predominantly female (72%), Caucasian (82%), with a mean age of 45-54 years (range, 18-90 years), and primarily comprised of surgeries including lower abdominal (including pelvic) and orthopedic bone procedures.
Croatian: Placebom kontrolirana ispitivanja uključivala su 791 bolesnika koji su bili pretežno ženskog spola (72%), bijelci (82%), srednje vrijednosti dobi 45-54 godina (raspon 18-90 godina), i primarno su se sastojala od kirurških zahvata koji su uključivali postupke na donjim abdominalnim (uključujući zdjelične) kostima i ortopedske postupke na kostima.
English: Application of the IONSYS system on skin on which any topical medicine has been applied should be avoided.
Croatian: Potrebno je izbjegavati primjenu sustava IONSYS na kožu na kojoj je nanesen bilo koji topikalni lijek.
English: Pressure should be applied with the fingers around the outer edges to ensure adhesion to the skin site.
Croatian: Potrebno je primijeniti pritisak prstima oko vanjskih rubova kako bi se osiguralo prianjanje na mjestu na koži.
English: • Dispose of the folded hydrogel housing in accordance with local requirements for opioid medicinal products
Croatian: • Zbrinite savijeno kućište hidrogela u skladu s lokalnim propisima za opioidne lijekove.
English: Published literature indicates potential for increased fentanyl exposure in patients with genetic polymorphisms affecting CYP3A4 and CYP3A5, with a small variability in concentrations with transdermal administration; therefore, IONSYS should be used with caution in these patients (see section 5.2)
Croatian: Objavljena literatura ukazuje na potencijal za povećanu izloženost fentanilu u bolesnika s genetskim polimorfizmima koji se odnose na CYP3A4 i CYP3A5, uz malu varijabilnost u koncentracijama pri transdermalnoj primjeni; stoga, IONSYS treba oprezno koristiti u tih bolesnika (pogledajte dio 5.2).
English: When applying tape, care should be taken not to tape over the light window, the digital display, or the dosing button.
Croatian: Prilikom primjene trake, potreban je oprez kako se ne bi prekrio svjetlosni indikator, digitalni zaslon ili dugme za doziranje.
English: Clinical relevance is unknown from these published articles; however, caution should be used if administering IONSYS in patients with genetic polymorphisms of CYP3A4 and CYP3A5 (see section 4.4).
Croatian: Iz ovih objavljenih članaka proizlazi da je klinička relevantnost nepoznata; međutim, treba biti na oprezu ako se IONSYS primjenjuje u bolesnika s genetskim polimorfizmima CYP3A4 i CYP3A5 (vidjeti dio 4.4).
English: If device failure or malfunction is suspected by a healthcare professional, IONSYS should be immediately removed from the patient and The Medicines Company contacted straightaway.
Croatian: Ako zdravstveni radnik posumnja da postoji kvar ili neispravnost na uređaju, IONSYS je potrebno odmah ukloniti s bolesnika i kontaktirati tvrtku The Medicines Company.
English: Do not use this medicine after the expiry date which is stated on the carton, or tray or sachet label, after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji, naljepnici na podlošku ili vrećici iza oznake Rok valjanosti i EXP.
English: You will know you have started a dose when you hear a beep.
Croatian: Znat ćete da ste započeli primjenu doze kada čujete zvučni signal.
English: Gloves must be worn when removing IONSYS from the patient's skin and during disposal.
Croatian: Potrebno je nositi rukavice kada se IONSYS uklanja s kože bolesnika i tijekom zbrinjavanja.
English: Fentanyl exhibits three compartment distribution pharmacokinetics.
Croatian: Fentanil pokazuje farmakokinetiku distribucije u tri odjeljka.
English: In this study 28 paediatric patients, 6 to 16 years old, were treated with IONSYS fentanyl 40 micrograms after experiencing inadequate analgesia with IONSYS fentanyl 25 micrograms.
Croatian: U tom ispitivanju 28 pedijatrijskih bolesnika u dobi od 6 do 16 godina liječeno je sustavom IONSYS fentanil 40 mikrograma nakon neadekvatne analgezije sustavom IONSYS fentanil
English: If IONSYS is administered to the mother during this time, an antidote for the child should be readily available.
Croatian: Ako se IONSYS primjenjuje u majke tijekom porođaja, mora odmah biti dostupan protulijek za dijete.
English: The controller is made of white plastic with the identifier “IONSYS” and has a digital display, a light window, and a dosing button.
Croatian: Kontroler je izrađen od bijele plastike s oznakom „IONSYS“ i ima digitalni zaslon, svjetlosni indikator i dugme za doziranje.
English: IONSYS should be used with caution in patients with paralytic ileus.
Croatian: IONSYS je potrebno primjenjivati uz oprez u bolesnika s paralitičkim ileusom.
English: Only limited data are available in patients with thoracic/chest and upper abdominal surgeries.
Croatian: Dostupni su samo ograničeni podaci u bolesnika s kirurškim zahvatima na prsištu i gornjem dijelu abdomena.
English: Other medicines and IONSYS Tell your doctor or nurse if you are using, have recently used or might use any other medicines.
Croatian: Obavijestite svog liječnika ili medicinsku sestru ako primjenjujete, nedavno ste primijenili ili biste mogli primijeniti bilo koje druge lijekove.
English: Systemic absorption of fentanyl increases as a function of time independent of the frequency of dosing, with the initial dose being approximately 16 micrograms.
Croatian: Sistemska apsorpcija fentanila povećava se u ovisnosti o vremenu bez obzira na učestalost doziranja, s početnom dozom od približno 16 mikrograma.
English: Fentanyl may produce bradycardia or hypotension and should, therefore, be administered with caution to patients with bradyarrhythmias or any significant cardiovascular disease.
Croatian: Bolest srca Fentanil može izazvati bradikardiju ili hipotenziju, zbog čega je potreban oprez u bolesnika s bradiaritmijama ili bilo kojom značajnom kardiovaskularnom bolešću.
English: The tray contains one Controller and one sachet containing a Drug Unit.
Croatian: Podložak sadrži jedan kontroler i jednu vrećicu koja sadrži odjeljak s lijekom.
English: • Continuous blinking red light
Croatian: • Stalno trepereće crveno svjetlo
English: If the fentanyl hydrogel contacts the skin during application or removal, the area should be washed with copious amounts of water.
Croatian: Ako hidrogel fentanila dođe u dodir s kožom tijekom primjene ili uklanjanja, to područje kože treba oprati obilnim količinama vode.
English: 95% CIa, b Patient Global Assessment of Method of Pain Control -1st 24 hour (% of patients rating good or excellent) C-2000-007
Croatian: 95%-tni CIa, b Globalna procjena bolesnika metode kontrole boli - prvih 24 sata
English: Fentanyl is excreted into human milk.
Croatian: Fentanil se izlučuje u majčino mlijeko.
English: Dose delivery
Croatian: Isporuka doze
English: During the first 3 hours post-enrollment, patients could supplement with bolus intravenous fentanyl given, as needed, to achieve comfort.
Croatian: Tijekom prvih 3 sata nakon uključivanja, bolesnici su mogli uzimati dodatnu količinu fentanila primijenjenog intravenski u obliku bolusa, po potrebi, kako bi postigli adekvatnu analgeziju.
English: Patients were initially titrated to comfort with intravenous fentanyl or morphine, at which point they were randomized to IONSYS or a matching placebo system.
Croatian: Bolesnici su na početku titrirani do stanja adekvatne analgezije intravenski primjenim fentanilom ili morfinom, te su u tom trenutku randomizirani u skupinu kojoj je primijenjen sustav IONSYS ili odgovarajući sustav placeba.
English: • Hold the controller in one hand and pull the red tab with the other hand to separate the hydrogel housing from the system.
Croatian: Držite kontroler u jednoj ruci i povucite crveni jezičak drugom rukom za odvajanje kućišta hidrogela od sustava.
English: - You will know the dose is being delivered when the green light blinks faster.
Croatian: Znat ćete da je doza isporučena kada zeleno svjetlo treperi brže.
English: Fentanyl, a high clearance active substance, is rapidly and extensively metabolised mainly by CYP3A4.
Croatian: Fentanil, djelatna tvar s visokim klirensom, brzo se i opsežno metabolizira prvenstveno putem CYP3A4.
English: • The doctor or nurse will get IONSYS ready to use and attach it to your upper outer arm or chest.
Croatian: • Liječnik ili medicinska sestra pripremit će IONSYS za primjenu i pričvrstiti ga na vanjski dio nadlaktice ili na prsište.
English: • if you suffer from severe breathing problems or cystic fibrosis.
Croatian: • ako imate teške probleme s disanjem ili cističnu fibrozu.
English: IONSYS should be removed before a magnetic resonance imaging (MRI) procedure, cardioversion, defibrillation, X-ray, CT scan or diathermy is undertaken.
Croatian: IONSYS je potrebno ukloniti prije postupka snimanja magnetskom rezonancijom (MR), kardioverzije, defibrilacije, RTG-a, CT-a ili dijatermije.
English: The Drug Unit should be removed from the sachet and the Controller should be snapped on by aligning the shape and firmly pressing the two parts together.
Croatian: Odjeljak s lijekom treba izvaditi iz vrećice, a kontroler pričvrstiti tako da se rubovi poravnaju i dva dijela čvrsto pritisnu jedan o drugi.
English: Fentanyl induced mutagenic effects in mammalian cells in vitro, comparable to other opioid analgesics.
Croatian: Fentanil je izazvao mutagene učinke u stanica sisavaca in vitro, što je usporedivo s drugim opioidnim analgeticima.
English: SPECIAL STORAGE CONDITIONS Do not store above 25°C.
Croatian: 6.4 Posebne mjere pri čuvanju lijeka Ne čuvati na temperaturi iznad 25°C.
English: As with all fentanyl products, the clearance of fentanyl may be reduced in elderly patients, with a consequent increase in half life.
Croatian: Kao i kod svih lijekova koji sadrže fentanil, klirens fentanila može biti smanjen u starijih bolesnika, s rezultirajućim produljenjem poluvijeka.
English: Prolonged treatment with fentanyl, the active substance in IONSYS, may cause withdrawal symptoms in the newborn baby.
Croatian: Produženo liječenje fentanilom, djelatnom tvari u sustavu IONSYS, može prouzročiti simptome ustezanja u novorođenčeta.
English: IONSYS is used in hospital only.
Croatian: IONSYS se primjenjuje samo u bolnicama.
English: Fentanyl should be used with caution in patients with brain tumours or other significant space occupying lesions of the brain.
Croatian: Fentanil je potrebno koristiti uz oprez u bolesnika s tumorima mozga ili drugim značajnim lezijama u mozgu.
English: IONSYS should not be administered during childbirth.
Croatian: IONSYS se ne smije primjenjivati tijekom poroda.
English: Breast-feeding is not recommended for 24 hours following removal of IONSYS.
Croatian: Dojenje se ne preporučuje do 24 sata nakon uklanjanja sustava
English: The sachet foil is comprised of a lamination of nylon, aluminium foil and a heat seal layer of a copolymer of polyethylene and polymethacrylic acid.
Croatian: Višeslojna folija vrećice izrađena je od najlona, aluminijske folije i toplinsko lijepljenog sloja kopolimera polietilena i polimetakrilne kiseline.
English: In patients with chronic obstructive pulmonary disease or patients with conditions pre-disposing them to hypoventilation, more severe adverse reactions may be experienced.
Croatian: U bolesnika s kroničnom opstruktivnom bolesti pluća ili u bolesnika s predisponirajućim stanjima za hipoventilaciju, mogu se pojaviti teže nuspojave.
English: Absorption of fentanyl from IONSYS is similar whether applied to the upper outer arm or chest.
Croatian: Apsorpcija fentanila iz sustava IONSYS je slična bilo da se primijeni na vanjski dio nadlaktice ili na prsište.
English: The following adverse reactions have been reported with IONSYS during clinical studies and post marketing experience.
Croatian: Tablični popis nuspojava Sljedeće nuspojave zabilježene su sa sustavom IONSYS tijekom kliničkih ispitivanja i nakon stavljanja lijeka u promet.
English: With each new IONSYS application the patient may use IONSYS more frequently than during the remainder of the 24 hour dosing period, due to a lower absorption of fentanyl from the system for the first few hours (see section 5.2).
Croatian: IONSYS češće nego tijekom preostalog razdoblja doziranja od 24 sata, zbog slabije apsorpcije fentanila iz sustava tijekom prvih nekoliko sati (vidjeti dio 5.2).
English: IONSYS is designed so that you can't use too much, provided that only you operate it, and that only you use it when you need pain relief.
Croatian: Ako primijenite više lijeka IONSYS nego što ste trebali IONSYS je izrađen tako da ga ne možete primijeniti previše, uz uvjet da ga samo Vi koristite i to samo kada trebate ublažiti bol.
English: The following side effects may occur whilst using IONSYS:
Croatian: Sljedeće nuspojave mogu se pojaviti tijekom primjene sustava IONSYS:
English: The average volume of distribution for fentanyl at steady state is 6 L/kg, the average clearance is 53 L/h.
Croatian: Prosječni volumen distribucije fentanila u stanju dinamičke ravnoteže je 6 l/kg, prosječni klirens je
English: About 9% of the dose is recovered in the faeces, primarily as metabolites.
Croatian: Oko 9% doze izlučuje se stolicom uglavnom u obliku metabolita.
English: • The slow blinking green light means IONSYS is ready to dose.
Croatian: • Sporo trepereće zeleno svjetlo znači da je IONSYS spreman za isporuku doze.
English: to <1/1,000).
Croatian: (≥1/10 000 i <1/1000).
English: IONSYS should not be placed on abnormal skin sites, such as scars, burns, and tattoos, or on skin on which topical medicines have been applied.
Croatian: IONSYS se ne smije stavljati na promijenjena mjesta na koži kao što su ožiljci, opekotine i tetovaže, niti na kožu na kojoj su primijenjeni topikalni lijekovi.
English: IONSYS is for transdermal use only.
Croatian: IONSYS je namijenjen samo za transdermalnu primjenu.
English: • you are taking medicines for bacterial infections (such as troleandomycin, clarithromycin or
Croatian: • uzimate lijekove za bakterijske infekcije (kao što su troleandomicin, klaritromicin ili eritromicin);
English: Physicians should evaluate patients for a history of drug abuse and follow such patients closely.
Croatian: Liječnici trebaju provjeriti imaju li bolesnici zlouporabu droga/lijekova u anamnezi i pomno pratiti takve bolesnike.
English: • Once assembled, the digital display of the controller will complete a short self-test during which there will an audible beep, the red light will flash once, and the digital display will flash the number “88”.
Croatian: • Nakon sastavljanja, digitalni zaslon kontrolera provest će kratko samotestiranje, tijekom kojeg će se oglasiti zvučni signal, crveno svjetlo zatreperit će jedanput, a na digitalnom zaslonu treperit će broj „88“.
English: The hospital staff will store IONSYS.
Croatian: Bolničko osoblje čuva sustav IONSYS.
English: If at any point during use the system loosens from the skin, a non-allergenic tape may be used to secure the edges to ensure complete contact with the skin.
Croatian: Ako se u bilo kojem trenutku tijekom primjene sustav olabavi od kože, može se koristiti traka za pričvršćivanje rubova koja nije alergena kako bi se osiguralo potpuno prianjanje uz kožu.
English: The controller is white with the identifier ‘IONSYS®' and has a digital display, a light window, and a recessed dose activation button.
Croatian: Kontroler je bijele boje s oznakom „IONSYS®“ i ima digitalni zaslon, svjetlosni indikator i udubljeno dugme za aktivaciju doze.
English: The use of concomitant CNS-active medicinal products may increase the risk of respiratory depression (see section 4.5).
Croatian: Istodobna primjena lijekova koji djeluju na središnji živčani sustav može povećati rizik od respiratorne depresije (vidjeti dio 4.5).
English: • IONSYS will ignore any button presses during the 10-minute dosing period.
Croatian: • IONSYS će zanemariti bilo koji pritisak na dugme tijekom
English: Name and address of the manufacturer responsible for batch release Penn Pharmaceutical Services Ltd 23-24 Tafarnaubach Industrial Estate Tredegar
Croatian: Penn Pharmaceutical Services Ltd 23-24 Tafarnaubach Industrial Estate Tredegar
English: For further details, see section 6.6.
Croatian: Za dodatne informacije, vidjeti dio 6.6.
English: If the patient requires additional treatment for pain, a new system may be applied to a new skin site on the upper outer arm or chest.
Croatian: Ako bolesnik zahtijeva dodatnu liječenje protiv boli, smije se primijeniti novi sustav na drugo mjesto na koži na vanjskom dijelu nadlaktice ili na prsištu.
English: Secure system to patient's skin by pressing the edges firmly or by applying non-allergenic tape 2.
Croatian: Pričvrstite sustav za kožu bolesnika pritišćući rubove ili primjenom trake koja nije alergena
English: • if you are allergic (hypersensitive) to fentanyl, or any of the other ingredients of IONSYS (listed in section 6).
Croatian: Nemojte primjenjivati IONSYS: • ako ste alergični (preosjetljivi) na fentanil ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Following long-term treatment fentanyl may cause withdrawal symptoms in the newborn.
Croatian: Nakon dugotrajnog liječenja, fentanil može izazvati simptome ustezanja u novorođenčeta.
English: Minimum effective analgesic serum concentrations of fentanyl in opioid-naïve patients treated for acute post-operative pain range from 0.2 to 1.2 ng/ml; undesirable effects increase in frequency at serum levels above 2 ng/ml.
Croatian: Farmakokinetički/farmakokinetički odnos Najmanje učinkovite analgetske koncentracije fentanila u serumu u bolesnika koji prije nisu primali opioide, za liječenje akutne postoperativne boli, bile su u rasponu od 0,2 do 1,2 ng/ml; povećala se učestalost nuspojava na serumskim razinama iznad 2 ng/ml.
English: Each new system should be placed on a new skin site.
Croatian: Svaki novi sustav mora se postaviti na drugo mjesto na koži.
English: The application site should be wiped with a standard alcohol swab and the skin should be allowed to dry completely before IONSYS is applied.
Croatian: Mjesto primjene mora se obrisati standardnim tupferom natopljenim alkoholom, a koža se mora potpuno osušiti prije primjene sustava IONSYS.
English: • The application site should be wiped with a standard alcohol swab and the skin should be allowed to dry completely before IONSYS is applied.
Croatian: • Mjesto primjene mora se obrisati standardnim tupferom natopljenim alkoholom, a koža se mora potpuno osušiti prije primjene sustava IONSYS.
English: The drug unit is blue on the side that connects to the controller and has a red bottom housing containing the hydrogels, one of which contains the fentanyl hydrochloride.
Croatian: Odjeljak s lijekom je plave boje sa strane koja se spaja na kontroler i ima crveno donje kućište koje sadrži hidrogelove, od kojih jedan sadrži fentanilklorid.
English: The drug unit is blue on the side that connects to the controller and has a red bottom housing containing the hydrogels, one of which contains the fentanyl.
Croatian: Odjeljak s lijekom je plave boje sa strane koja se spaja na kontroler i ima crveno donje kućište koje sadrži hidrogelove, od kojih jedan sadrži fentanil.
English: • You will know the dose is being delivered when you see the fast blinking green light.
Croatian: • Znat ćete da se doza isporučuje kada vidite zeleno svjetlo koje brzo treperi.
English: A used IONSYS should not be reapplied to patients.
Croatian: Iskorišteni sustav IONSYS ne smije se ponovno primijeniti na bolesnika.
English: • Gloves should be worn during the assembly/handling of IONSYS.
Croatian: • Potrebno je nositi rukavice tijekom sastavljanja/rukovanja sustavom IONSYS.
English: • You will know the 10-minute dosing period is complete when the fast blinking green light becomes slow again.
Croatian: • Znat ćete da je 10-minutno razdoblje doziranja dovršeno kada zeleno svjetlo koje brzo treperi počne ponovno sporo treperiti.
English: If you experience any of these symptoms then tell your doctor or nurse immediately.
Croatian: Ako imate bilo koji od navedenih simptoma, odmah obavijestite svog liječnika ili medicinsku sestru.
English: • Align the matching shapes of the controller and the drug unit and firmly press the two parts together at both ends.
Croatian: • Poravnajte odgovarajuće rubove kontrolera i odjeljka s lijekom te čvrsto pritisnite dva dijela jedan o drugi na oba kraja.
English: When assembled, the digital display of the Controller will complete a short self-test during which there will be an audible beep, the red light will flash once, and the digital display will flash the number 88.
Croatian: Nakon sastavljanja, digitalni zaslon kontrolera dovršit će kratko samotestiranje tijekom kojeg će se oglasiti zvučni signal, crveno svjetlo zatreperit će jedanput, a na digitalnom zaslonu treperit će broj 88.
English: • Blinking display number
Croatian: • Trepereće prikazan broj