FrancophonIA/ELRC3.0 huggingface dataset:
English: The primary endpoint was the comparison between the summed pain intensity difference at 30 minutes after dosing (SPID30), which was 6.57 in the PecFent-treated episodes compared to 4.45 for placebo (p<0.0001 ).
Croatian: Primarni ishod bila je usporedba između razlike u intenzitetu ukupne boli 30 minuta nakon doze (summed pain intensity difference, SPID30), koja je iznosila 6,57 za epizode liječene PecFentom u usporedbi s 4,45 za placebo (p<0,0001).
English: May cause allergic reactions (possibly delayed), and exceptionally, bronchospasm (if you do not use the nasal spray correctly).
Croatian: Može uzrokovati alergijske reakcije (moguće i odgođene) i, iznimno bronhospazam (ako sprej za nos ne upotrebljavate pravilno).
English: • Talk to your doctor about whether it will be safe for you to drive or use tools or machines after using PecFent.
Croatian: • Upitajte liječnika je li za Vas sigurno da vozite ili rukujete alatima ili strojevima nakon što ste primijenili PecFent.
English: Other side effects (frequency not known (frequency cannot be estimated from the available data))
Croatian: Druge nuspojave (učestalost nije poznata (ne može se procijeniti iz dostupnih podataka))
English: In these patients, opioids may decrease respiratory drive and increase airway resistance.
Croatian: U tih bolesnika opioidi mogu smanjiti poticaj na disanje i povećati otpor dišnih putova.
English: If the PecFent nasal spray is blocked or does not spray properly
Croatian: Ako je sprej lijeka PecFent zakočen ili ne raspršuje pravilno
English: Prolonged treatment with fentanyl during pregnancy may cause withdrawal symptoms in the newborn which can be life-threatening (see section 2).
Croatian: Produljeno liječenje fentanilom u trudnoći može u novorođenčadi prouzročiti simptome ustezanja koji mogu biti opasni za život (pogledajte dio 2).
English: The MAH shall ensure that, at launch, all physicians, pharmacists and patients expected to prescribe/use PecFent are provided with educational material informing about the correct and safe use of the product.
Croatian: Nositelj odobrenja će osigurati da prilikom puštanja lijeka na tržište svi liječnici za koje se očekuje da će propisivati PecFent, ljekarnici i bolesnici za koje se očekuje da će ga primjenjivati, dobiju edukacijski materijal s uputama o pravilnoj i sigurnoj upotrebi lijeka.
English: Figure 3: Mean plasma fentanyl concentrations following single doses of PecFent and OTFC in healthy subjects
Croatian: Slika 3: Prosječne koncentracije fentanila u plazmi nakon jednokratnih doza PecFenta i OTFC-a u zdravih ispitanika
English: • muscle convulsions or trembling
Croatian: • grčevi (konvulzije) mišića ili drhtanje
English: As soon as PecFent is no longer needed, patients and members of their household must be advised to systematically dispose of any bottles remaining from a prescription as soon as possible by returning them to their child-resistant container and discarding them, according to local requirements or by returning them to the pharmacy.
Croatian: Čim PecFent više nije potreban, bolesnike i članove kućanstva se mora upozoriti da što prije sustavno zbrinu sve bočice koje su preostale od propisane količine lijeka i to tako da ih vrate u njihove spremnike sigurne za djecu i bace u skladu s lokalnim propisima ili da ih vrate u ljekarnu.
English: Immediate management of opioid overdose includes ensuring a patent airway, physical and verbal stimulation of the patient, assessment of the level of consciousness, ventilatory and circulatory status, and assisted ventilation (ventilatory support) if necessary.
Croatian: Trenutno zbrinjavanje predoziranja opioidima uključuje osiguravanje otvorenih dišnih putova, tjelesnu i verbalnu stimulaciju bolesnika, procjenu razine svijesti, ventilacijski i cirkulacijski status te po potrebi potpomognutu ventilaciju (podršku disanju).
English: It is subject to first pass hepatic and intestinal metabolism and the metabolites do not contribute to fentanyl's therapeutic effects.
Croatian: Podložan je jetrenom i crijevnom metabolizmu prvog prolaza i metaboliti ne pridonose terapijskim učincima fentanila.
English: This is called ‘priming'.
Croatian: To se naziva 'aktivacija' bočice.
English: The metabolites are mainly excreted in the urine, while faecal excretion is less important.
Croatian: Metaboliti se većinom izlučuju mokraćom, dok je izlučivanje stolicom manje značajno.
English: In a pharmacokinetic study comparing PecFent (100, 200, 400 and 800 micrograms) with oral transmucosal fentanyl citrate (OTFC, 200 micrograms), fentanyl was shown to be rapidly absorbed following single dose intranasal administration of PecFent, with median Tmax ranging from 15 to 21 minutes (Tmax for OTFC was approximately 90 minutes).
Croatian: U farmakokinetičkom ispitivanju u kojemu se PecFent (100, 200, 400 i 800 mikrograma) usporedio s oralnim transmukoznim fentanilcitratom (OTFC, 200 mikrograma), pokazalo se da se fentanil brzo apsorbira nakon jedne doze intranazalno primijenjenog PecFenta, s medijanom Tmax u rasponu od 15 minuta do 21 minute (Tmax za OTFC bio je otprilike 90 minuta).
English: Firmly press down on the finger grips so that PecFent sprays into your nostril.
Croatian: Čvrsto pritisnite mjesta za prste ispod mlaznice tako da se PecFent rasprši u nosnicu.
English: Physicians should keep in mind the potential for abuse of fentanyl.
Croatian: Liječnici moraju voditi računa o mogućnosti zlouporabe fentanila.
English: The variability of the pharmacokinetics of fentanyl was considerable following treatment with both PecFent and OTFC.
Croatian: Varijabilnost farmakokinetike fentanila bila je znatna nakon liječenja i PecFentom i OTFC-om.
English: If the spray has not been used within 5 days after priming, the bottle should be discarded.)
Croatian: Ako sprej nije upotrebljavan u roku od 5 dana od aktiviranja, bočicu treba baciti.)
English: o If there are any unwanted therapeutic sprays remaining in the bottle, the patient should be instructed to expel these as follows:
Croatian: o Ako je u bočici ostalo nepotrebnih terapijskih doza lijeka, bolesnika treba uputiti da ih isprazni iz bočice na sljedeći način:
English: It is contained in a clear glass bottle, fitted with a metering pump and a protective cap.
Croatian: Nalazi se u bočici od prozirnog stakla s pričvršćenom odmjernom pumpicom i zaštitnom kapicom.
English: Propylparahydroxybenzoate may cause allergic reactions (possibly delayed) and, exceptionally, bronchospasm (if the medicinal product is not correctly administered).
Croatian: Propilparahidroksibenzoat može uzrokovati alergijske reakcije (moguće i odgođene), i, iznimno, bronhospazam (ako se lijek ne primjenjuje pravilno).
English: • you experience pain or increased sensitivity to pain (hyperalgesia) which does not respond to a higher dosage of your medicine as prescribed by your doctor
Croatian: • ako osjećate bol ili povećanu osjetljivost na bol (hiperalgezija) koja se ne smanjuje uz višu dozu lijeka koju Vam je propisao liječnik
English: Fentanyl is highly lipophilic and can be absorbed very rapidly through the nasal mucosa and more slowly by the gastrointestinal route.
Croatian: Fentanil je visoko lipofilan i može se apsorbirati vrlo brzo preko nosne sluznice, a sporije gastrointestinalnim putem.
English: The concomitant use of nasally administered vasoconstrictive decongestants during titration is, therefore, not recommended as this may lead to patients titrating to a dose that is higher than required.
Croatian: Stoga se ne preporučuje istodobna primjena nazalnih vazokonstriktivnih dekongestiva tijekom titracije jer to može dovesti do titracije bolesnika na dozu višu od potrebne.
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 raspodjeljuje izvan krvožilnog sustava, uz veliki prividni volumen distribucije.
English: Consult your doctor while using PecFent if:
Croatian: Pitajte svog liječnika za savjet dok primjenjujete PecFent:
English: Fentanyl is an opioid analgesic, interacting predominantly with the opioid µ-receptor.
Croatian: Fentanil je opioidni analgetik koji je uglavnom u interakciji s opioidnim µ-receptorom.
English: A new bottle of PecFent will show two red lines in the counting window in the white plastic top on the bottle (Figure 1 and Figure 3a).
Croatian: Nova bočica spreja PecFent imat će dvije crvene crte u prozorčiću brojača na bijelom plastičnom vrhu bočice (slika 1 i slika 3a).
English: The main binding protein is alpha-1-acid glycoprotein, but both albumin and lipoproteins contribute to some extent.
Croatian: Glavni vezni protein je alfa-1-kiseli glikoprotein, ali vezanju do neke mjere pridonose i albumin te lipoproteini.
English: Carcinogenicity studies (26-week dermal alternative bioassay in Tg.AC transgenic mice; two-year subcutaneous carcinogenicity study in rats) with fentanyl did not induce any findings indicative of oncogenic potential.
Croatian: Ispitivanja kancerogenosti s fentanilom (26-tjedni dermalni alternativni biotest u transgenih miševa Tg.AC; dvogodišnje ispitivanje supkutane kancerogenosti u štakora) nisu dala nalaze koji bi ukazivali na onkogeni potencijal.
English: This may occur within the recommended dose (see section 4.5).
Croatian: Do njegove pojave može doći pri primjeni preporučene doze (vidjeti dio 4.5).
English: Nevertheless, in view of the importance of renal and hepatic function in the metabolism and clearance of fentanyl, additional care should be exercised in the use of PecFent in the elderly.
Croatian: Ipak, s obzirom na važnost bubrežne i jetrene funkcije u metabolizmu i klirensu fentanila, nužna je dodatna pozornost kod primjene lijeka PecFent u starijih.
English: PecFent is used in adults with cancer for a type of pain called ‘breakthrough' pain.
Croatian: PecFent koriste odrasli bolesnici s rakom za vrstu boli koja se naziva 'probijajuća bol'.
English: The effect of renal or hepatic impairment on the pharmacokinetics of PecFent has not been studied.
Croatian: Učinak oštećenja funkcije bubrega ili jetre na farmakokinetiku lijeka PecFent nije ispitan.
English: PecFent is only intended for nasal use, and must not be administered by any other route.
Croatian: PecFent je namijenjen samo za primjenu za nos i ne smije se primijeniti ni na koji drugi način.
English: • A dose to treat a breakthrough pain episode might be either 1 spray or 2 sprays (one in each nostril).
Croatian: • Doza za liječenje epizode probijajuće boli može biti 1 potisak (raspršivanje) ili 2 potiska (po jedno raspršivanje u svaku nosnicu).
English: If PecFent is administered, an antidote for the child should be readily available.
Croatian: Ako se primijeni PecFent, za dijete mora biti spreman antidot.
English: Not all presentations or pack sizes may be marketed.
Croatian: Na tržištu se ne moraju nalaziti sve formulacije ili veličine pakiranja.
English: Athletes should be informed that treatment with fentanyl could lead to positive doping tests.
Croatian: Sportaše se mora upozoriti da liječenje fentanilom može rezultirati pozitivnim nalazima testova na nedozvoljene tvari (doping testovi).
English: If you are not sure, talk to your doctor or pharmacist before using PecFent.
Croatian: Ako niste sigurni, obratite se liječniku ili ljekarniku prije nego što uzmete PecFent.
English: Caution is advised when PecFent is coadministered with medicinal products that affect the serotoninergic neurotransmitter systems.
Croatian: Preporučuje se oprez kod istodobne primjene PecFenta i lijekova koji utječu na serotoninergički neurotransmitorski sustav.
English: The SPID for PecFent-treated episodes was also significantly different to placebo at 10 15, 45 and 60 minutes after administration.
Croatian: Vrijednost SPID za epizode liječene PecFentom bila je također značajno različita u odnosu na placebo 10, 15, 45 i 60 minuta nakon primjene.
English: It is advised not to use fentanyl during labour and delivery (including caesarean section) because fentanyl passes through the placenta and may cause respiratory depression in the foetus.
Croatian: Ne preporučuje se upotreba fentanila tijekom trudova i porođaja (uključujući carski rez) jer fentanil prolazi kroz posteljicu i može prouzročiti respiratornu depresiju fetusa.
English: • a lack of concentration or increased activity
Croatian: • nedostatak koncentracije ili povećana aktivnost • gubitak pamćenja
English: Dose-proportionality was demonstrated for Cmax and AUC in the dose range 100 micrograms to 800 micrograms.
Croatian: Proporcionalnost doze dokazana je za Cmax i AUC u rasponu doza od 100 mikrograma do 800 mikrograma.
English: • This is a single spray into one nostril from the 100 microgram per spray bottle.
Croatian: • To je jedno raspršivanje u jednu nosnicu iz bočice spreja od 100 mikrograma po potisku.
English: If you experience withdrawal symptoms, you should contact your doctor.
Croatian: Ako osjetite simptome ustezanja, obratite se svom liječniku.
English: Fertility There are no clinical data on the effects of fentanyl on fertility.
Croatian: Nema kliničkih podataka o učincima fentanila na plodnost.
English: In patients with chronic obstructive pulmonary diseases, fentanyl may cause more serious adverse reactions.
Croatian: U bolesnika s kroničnim opstruktivnim bolestima pluća fentanil može prouzročiti ozbiljnije nuspojave.
English: Patients should be advised not to blow their nose immediately after PecFent administration.
Croatian: Bolesnicima se mora reći da ne ispuhuju nos neposredno nakon primjene PecFenta.
English: Preparing the PecFent bottle for use
Croatian: Priprema bočice lijeka PecFent za upotrebu
English: If your doctor has prescribed a second spray, repeat steps 5 to 9, using the other nostril.
Croatian: 11. Ako Vam je liječnik propisao dvije doze tj. dva raspršivanja u nos, ponovite korake od 5 do 9
English: • medicines that might have an effect on the way your body breaks down PecFent.
Croatian: • lijekove koji bi mogli imati učinak na to kako će Vaše tijelo razgraditi PecFent, a oni uključuju:
English: • Patients whose initial dose is 100 micrograms and who need to titrate to a higher dose due to a lack of effect can be instructed to use two 100 microgram sprays (one in each nostril) for their next BTP episode.
Croatian: • Bolesnicima kojima je početna doza 100 mikrograma, a potrebna im je titracija na višu dozu zbog nedovoljnog učinka, može se savjetovati da za sljedeću epizodu probijajuće boli primijene dva potiska od 100 mikrograma (po jedan u svaku nosnicu).
English: Fentanyl diffuses from the gel and is absorbed through the nasal mucosa; this gel-modulated absorption of fentanyl restrains the peak in plasma concentration (Cmax) whilst allowing the attainment of an early time to that peak (Tmax).
Croatian: Fentanil difundira iz gela i apsorbira se kroz nosnu sluznicu; ta gelom modulirana apsorpcija fentanila snižava vršnu koncentraciju u plazmi (Cmax) dok istodobno omogućava dosezanje te vršne vrijednosti u kratkom vremenu (Tmax).
English: The curves for each dose level are similar in shape with increasing dose levels producing increasing plasma fentanyl levels.
Croatian: Krivulje za svaku razinu doze sličnog su oblika s tim da veće razine doza stvaraju veće razine fentanila u plazmi.
English: Common side effects (may affect up to 1 in 10 people):
Croatian: Česte nuspojave (mogu se javiti u do 1 na svakih 10 osoba):
English: The influence of hepatic and renal impairment on the pharmacokinetics of the medicinal product has not been evaluated; however, when administered intravenously the clearance of fentanyl has been shown to be altered in hepatic and renal impairment due to alterations in metabolic clearance and plasma proteins.
Croatian: Utjecaj oštećenja funkcije jetre i bubrega na farmakokinetiku lijeka nije bio procjenjivan; međutim, pokazalo se da se pri intravenskoj primjeni klirens fentanila promijenio u slučajevima oštećenja jetre i bubrega zbog promjena u metaboličkom klirensu i proteinima plazme.
English: Severe respiratory depression or severe obstructive lung conditions.
Croatian: Teška respiratorna depresija ili teške opstruktivne bolesti pluća.
English: Any unwanted PecFent should be disposed of as soon as possible following the instructions under Disposal of unused PecFent.
Croatian: Sav PecFent koji više nije potreban mora se ukloniti što je prije moguće prema uputama navedenim u odjeljku Zbrinjavanje neupotrijebljenog lijeka PecFent.
English: The medicine is a clear to almost clear, colourless nasal spray, solution.
Croatian: Ovaj lijek je bistra do gotovo bistra, bezbojna otopina spreja za nos.
English: Check with your doctor or pharmacist before using PecFent if:
Croatian: Provjerite s liječnikom ili ljekarnikom prije nego što primijenite PecFent:
English: When you hear a click let go of the grips.
Croatian: Kada čujete 'klik' otpustite pritisak.
English: • 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: • Do not store PecFent above 25°C.
Croatian: • PenFent ne čuvajte na temperaturi iznad 25°C.
English: 1.55 ml ensuring delivery of 8 full sprays.
Croatian: 1,55 ml što osigurava 8 potpunih potisaka.
English: Note: You may not feel anything happen in your nose at all - do not trust this to mean the spray did not operate - rely on the click and number counter.
Croatian: Napomena: Moguće je da niste osjetili kako se sprej raspršio u nosnicu - ali nemojte misliti da to znači da je sprej zatajio - oslanjajte se na 'klik' koji ste čuli i na ono što pokazuje prozorčić s brojačem.
English: To administer PecFent the nozzle is placed a short distance (about 1 cm) into the nostril and pointed slightly towards the bridge of the nose.
Croatian: Za primjenu PecFenta, mlaznicu treba gurnuti malo u nosnicu (otprilike 1 cm) i neznatno usmjeriti prema hrptu nosa.
English: PecFent contains fentanyl, which is a strong pain-relieving medicine known as an opioid pain killer.
Croatian: PecFent sadrži fentanil, koji je snažan lijek za ublažavanje bolova poznat kao opioidni analgetik.
English: • If the spray is blocked, aim the spray away from you (and any other people) and push firmly down on the pump.
Croatian: • Ako je sprej zakočen, usmjerite ga na stranu suprotnu od sebe (i drugih osoba) i pumpicu čvrsto stisnite prema dolje.
English: • Do not use PecFent nasal spray for treatment of more than four breakthrough cancer pain episodes a day
Croatian: Ne upotrebljavajte PecFent sprej za nos za liječenje više od četiri epizode probijajuće boli zbog raka na dan.
English: • The pharmacist must inform the patients that in order to prevent theft and misuse of PecFent nasal spray they have to keep it in a safe place to avoid misuse and diversion
Croatian: o Ljekarnik mora upozoriti bolesnike da PecFent sprej za nos moraju držati na sigurnom mjestu kako bi izbjegli nepravilnu upotrebu i krađu.
English: Your doctor will evaluate if you need medicine to reduce or eliminate the withdrawal symptoms.
Croatian: Vam potreban lijek koji bi smanjio ili uklonio simptome ustezanja.
English: The symptoms of fentanyl overdose via the nasal route are expected to be similar in nature to those of intravenous fentanyl and other opioids, and are an extension of its pharmacological actions, with the most serious significant effect being respiratory depression.
Croatian: Očekuje se da su simptomi predoziranja fentanilom putem nosa slične naravi kao i simptomi predoziranja intravenskim fentanilom i drugim opioidima te da su produžetak njegovih farmakoloških učinaka, s respiratornom depresijom kao najozbiljnijim značajnim učinkom.
English: • You will NOT hear a click when you press down .
Croatian: • Kad pritisnete, NEĆETE čuti klik.
English: • From treatment initiation, patients should be closely followed and the dose titrated until an effective dose is reached and confirmed for two consecutively treated episodes of BTP.
Croatian: • Od početka liječenja bolesnike se mora pomno pratiti te titrirati dozu dok se ne dosegne djelotvorna doza i ona potvrdi tijekom liječenja u dvije uzastopne epizode probijajuće boli.
English: Bottle (clear Type I glass) with an attached metering pump incorporating an audible dose counter and a protective cap (solid white cap for the 2 spray and translucent cap for the 8 spray).
Croatian: Bočica (prozirno staklo tipa I) s pričvršćenom odmjernom pumpicom koja uključuje čujni brojač doza i zaštitni zatvarač (neprozirni bijeli zatvarač za 2 potiska i prozirni zatvarač za 8 potisaka).
English: Your doctor will decide if your dose needs to be changed.
Croatian: Liječnik će odlučiti treba li promijeniti dozu.
English: • medicines for depression called ‘monoamine-oxidase inhibitors' (MAOI).
Croatian: • lijekove protiv depresije koji se nazivaju ‘inhibitori monoaminooksidaze'; prije upotrebe lijeka
English: The judicious use of naloxone or another opioid antagonist may be warranted in some instances, but it is associated with the risk of precipitating an acute withdrawal syndrome.
Croatian: U nekim je slučajevima potrebna razumna upotreba naloksona ili drugog opioidnog antagonista, ali to je povezano s rizikom od poticanja akutnog sindroma ustezanja.
English: Evaluation of brain slides from the carciogenicity study in rats revealed brain lesions in animals administered high doses of fentanyl citrate.
Croatian: Pregled rezova mozgova štakora na kojima je ispitivana kancerogenost pokazao je lezije mozga u životinja kojima su davane visoke doze fentanilcitrata.
English: In the randomised, placebo-controlled study (CP043) 9.4% of 459 PecFent-treated BTP episodes in 73 patients required use of any further (rescue) medicinal products within 60 minutes of dosing.
Croatian: U randomiziranom, placebom kontroliranom ispitivanju (CP043) 9,4% od 459 epizoda probijajuće boli liječenih PecFentom u 73 bolesnika zahtijevalo je upotrebu nekih dodatnih (simptomatskih) lijekova unutar 60 minuta nakon doze.
English: 0.95 ml ensuring delivery of 2 full sprays or
Croatian: 0,95 ml što osigurava 2 potpuna potiska ili
English: An audible click will be heard and the number displayed on the counter will advance by one.
Croatian: Začut će se 'klik' a broj prikazan u prozorčiću brojača povisit će se za jedan.
English: • When you spray PecFent into your nose the very small spray droplets form a thin gel.
Croatian: • Kada raspršite PecFent u nos vrlo male kapljice spreja oblikuju tanki gel.
English: For details about such use the Summary of Product Characteristics of the individual opioid antagonist should be consulted.
Croatian: Za detalje o takvoj primjeni potrebno je pogledati Sažetak opisa svojstava lijeka za pojedini opioidni antagonist.
English: In particular tell your doctor or pharmacist before using PecFent if you are taking or have recently taken any of the following medicines:
Croatian: Osobito je važno da prije nego što upotrijebite PecFent, liječniku ili ljekarniku kažete uzimate li ili ste nedavno uzimali neki od ovih lijekova:
English: Platelet count decreased Weight increased
Croatian: Pretrage sniženi broj trombocita povećanje težine
English: Therefore, special care should be taken during the titration process in patients with moderate or severe hepatic or renal impairment.
Croatian: Stoga je nužan poseban oprez za vrijeme postupka titracije u bolesnika s umjerenim ili teškim oštećenjem jetre ili bubrega.
English: PecFent maintenance treatment may also be less effective in patients with rhinitis when administered concomitantly with a nasal vasoconstrictive decongestant.
Croatian: Liječenje održavanjem lijekom PecFent također može biti manje djelotvorno u bolesnika s rinitisom kada se primjenjuje istodobno s nazalnim vazokonstriktivnim dekongestivom.
English: During the longer-term, open-label study (CP045) this was 6.0 % of 42,227 episodes in 355 patients treated with PecFent during up to 159 days of treatment.
Croatian: Za vrijeme dugotrajnog, otvorenog ispitivanja (CP045) to je iznosilo 6,0% od 42 227 epizoda u 355 bolesnika liječenih PecFentom tijekom najviše 159 dana liječenja.