FrancophonIA/ELRC3.0 huggingface dataset:
English: If the patient experiences recurrent episodes of epistaxis or nasal discomfort while taking PecFent, an alternative method of administration for treatment of breakthrough pain should be considered.
Croatian: Ako bolesnik tijekom primjene PecFenta ima ponavljane epizode epistakse ili osjeća nelagodu u nosu, mora se razmotriti zamjenski način primjene lijeka za liječenje probijajuće boli.
English: • Only use PecFent nasal spray if you are using other opioid pain medicine on a daily basis
Croatian: PecFent sprej za nos upotrijebite samo ako svakodnevno uzimate druge opioidne lijekove protiv bolova.
English: 2 spray bottle:
Croatian: Bočica sa 2 potiska:
English: • nose bleed, discomfort in the nose, runny nose
Croatian: • krvarenje iz nosa, nelagoda u nosu, curenje nosa
English: • The pharmacist must make use of the checklist for pharmacist
Croatian: o Ljekarnik se mora koristiti podsjetnikom za provjeru za ljekarnike.
English: • When you see a red 8 in the counting window, the bottle is finished and you will no longer be able to get a full spray from it.
Croatian: • Kada u prozorčiću brojača ugledate crveni broj 8, bočica je iskorištena i iz nje više nećete moći istisnuti punu dozu raspršenog lijeka.
English: • you suffer from short-term pain other than breakthrough pain.
Croatian: • ako patite od kratkotrajnih bolova koji nisu probijajuća bol
English: o After the 8 therapeutic sprays have been emitted, the patient will not hear a click and the counter will not advance beyond “8”; further sprays emitted will not be full sprays and should not be used therapeutically.
Croatian: o Nakon što je istisnuto 8 terapijskih doza spreja, bolesnik više neće čuti klik, a brojač se neće pomaknuti s broja "8"; potisci koji će se dalje raspršivati nisu potpune doze i ne smiju se terapijski koristiti.
English: o After the 2 therapeutic sprays have been emitted, the patient will not hear a click and the counter will not advance beyond “2”; further sprays emitted will not be full sprays and should not be used therapeutically.
Croatian: Nakon što su istisnute 2 terapijske doze spreja, bolesnik više neće čuti klik, a brojač se neće pomaknuti s broja "2"; potisci koji će se dalje raspršivati nisu potpune doze i ne smiju se terapijski koristiti.
English: • If you have any further questions, ask your doctoror pharmacist.
Croatian: • Ako imate dodatnih pitanja, obratite se liječniku ili ljekarniku.
English: • nasal sprays to treat a stuffy nose (containing a decongestant such as oxymetazoline)
Croatian: • sprejeve za nos protiv začepljenosti nosa (koji sadrže tvar protiv oticanja sluznice nosa pod nazivom oksimetazolin)
English: Figure 1: Mean (± SE) Pain Intensity Scores at Each Time Point (mITT Population)
Croatian: Slika 1: Srednja vrijednost (± SE) rezultata za intenzitet bola u svakoj vremenskoj točki mjerenja
English: Pharmacokinetic parameters (mean (%CV))
Croatian: Farmakokinetički parametri u odraslih osoba koje uzimaju PecFent i OTFC Farmakokinetički parametri (srednja vrijednost (%CV))
English: PecFent is only to be used by adults who are already taking other opioid medicines daily for their constant cancer pain.
Croatian: PecFent smiju upotrebljavati samo odrasli bolesnici koji već uzimaju druge opioidne lijekove protiv stalnih bolova povezanih s rakom.
English: A double-blind, randomised, placebo-controlled crossover study has been conducted in which 114 patients who experienced on average 1 to 4 episodes of break through pain (BTP) per day while taking maintenance opioid therapy were entered into an initial open-label titration phase in order to identify an effective dose of PecFent (Study CP043).
Croatian: 114 bolesnika koji su imali prosječno 1 do 4 epizode probijajuće boli na dan uz opioidnu terapiju održavanja, bilo uključeno u početnu otvorenu fazu titracije kako bi se ustanovila djelotvorna doza
English: PecFent could be life-threatening if taken by a child by accident.
Croatian: PecFent može ugroziti život djeteta ako ga ono nehotice primijeni.
English: Take off the white plastic protective cap from the nozzle (Figure 1).
Croatian: Skinite s mlaznice bijeli plastični zaštitni zatvarač (slika 1).
English: PecFent is not recommended for use in patients who have received monoamine oxidase (MAO) inhibitors within the previous 14 days because severe and unpredictable potentiation by MAO inhibitors has been reported with opioid analgesics.
Croatian: (MAO) unutar proteklih 14 dana, jer je prijavljeno teško i nepredvidljivo potenciranje MAO inhibitora s opioidnim analgeticima.
English: • PecFent nasal spray should not be used to treat any other short-term pain or pain status.
Croatian: o PecFent sprej za nos ne smije se koristiti za liječenje nekih drugih kratkotrajnih bolova ili bolnih stanja.
English: How to store PecFent
Croatian: Kako primjenjivati PecFent
English: 1.55 ml - 8 sprays
Croatian: 1,55 ml - 8 potisaka
English: • loss of or increase in appetite, weight increase
Croatian: • gubitak ili pojačani apetit, povećanje težine • dehidracija, osjećaj žeđi
English: Hold the PecFent nasal spray upright with your thumb on the bottom of the bottle, and your first and middle fingers on the finger grips each side of the nozzle (Figure 2).
Croatian: Primite PecFent sprej za nos tako da uspravnu bočicu uhvatite palcem s donje strane, a kažiprst i srednji prst stavite na mjesta za prste sa svake strane mlaznice (slika 2).
English: PecFent should, therefore, be used with caution in patients with previous or pre-existing bradyarrhythmias.
Croatian: Stoga u bolesnika s prijašnjim ili postojećim bradiaritmijama
English: Patients must be advised that they may not feel the spray being administered, and that they should, therefore, rely on the audible click and the number on the counter advancing to confirm that a spray has been delivered.
Croatian: Bolesnicima se mora napomenuti da možda neće osjetiti raspršivanje lijeka u nosnicama pa se za potvrdu primjene potiska moraju osloniti na čujni klik i povećani broj na brojaču.
English: PecFent is indicated for the management of breakthrough pain (BTP) in adults who are already receiving maintenance opioid therapy for chronic cancer pain.
Croatian: PecFent je indiciran za zbrinjavanje probijajuće boli u odraslih koji već primaju opioidnu terapiju održavanja protiv kronične boli uzrokovane rakom.
English: • increased blood sugar
Croatian: • povišena razina šećera u krvi • proteini u mokraći
English: • misusing the medicine
Croatian: • kriva upotreba lijeka
English: • Put the bottle back in the child resistant container.
Croatian: • Vratite bočicu u spremnik siguran za djecu.
English: vomiting, diarrhoea, anxiety, chills, tremor, and sweating)
Croatian: proljev, tjeskoba, zimica, nevoljno drhtanje i znojenje)
English: For treatment of overdose (accidental ingestion) in the opioid-naïve person, intravenous access should be obtained and naloxone or other opioid antagonists should be employed as clinically indicated.
Croatian: Za liječenje predoziranja (nehotična ingestija) u osobe koja prije nije uzimala opioide, nužno je pripremiti intravenski pristup te s obzirom na kliničku indikaciju moraju se primijeniti nalokson ili drugi opioidni antagonisti.
English: The bottle should be removed from the child resistant container immediately prior to use and the protective cap removed.
Croatian: Neposredno prije primjene bočicu se mora izvaditi iz spremnika sigurnog za djecu i ukloniti zaštitni zatvarač.
English: Tell your doctor or pharmacist if you have taken an MAOI medicine in the past 2 weeks before using PecFent.
Croatian: PecFent kažite liječniku ili ljekarniku ako ste u protekla 2 tjedna uzimali neki takav lijek.
English: In a double-blind, randomized comparator-controlled study (Study 044) of similar design to Study 043 conducted in opioid-tolerant patients with breakthrough cancer pain on stable doses of regularly scheduled opioids, PecFent was shown to be superior to immediate-release morphine sulfate (IRMS).
Croatian: 044) osmišljenom slično ispitivanju 043 koje je provedeno u bolesnika s podnošljivošću na opioide s probijajućom boli uzrokovanom rakom, na postojanim dozama redovito uzimanih opioida, PecFent se pokazao superiornim u odnosu na morfin sulfat s trenutačnim otpuštanjem.
English: Pneumonia Nasopharyngitis Pharyngitis Rhinitis
Croatian: Infekcije i infestacije pneumonija nazofaringitis faringitis rinitis
English: • All unused devices or empty containers should be returned systematically according to the local regulation.
Croatian: Sve neupotrijebljene dijelove dobivene uz lijek ili prazne spremnike treba redovito vraćati prema lokalnim propisima.
English: • If you can see a number, other than 2 in the counting window, you have NOT used all 2 sprays in the bottle.
Croatian: • Ako u prozorčiću brojača vidite neki drugi broj a ne broj 2, to znači da NISTE primijenili oba dva potiska iz bočice.
English: Take off the clear plastic protective cap from the nozzle (Figure 1).
Croatian: Skinite s mlaznice prozirni plastični zaštitni zatvarač (slika 1).
English: Fentanyl passes into breast milk and may cause sedation and respiratory depression in the breast-fed child. Fentanyl should not be used by breastfeeding women and breast-feeding should not be restarted until at least 5 days after the last administration of fentanyl.
Croatian: Žene koje doje ne smiju primjenjivati fentanil, a dojenje se ne smije ponovno započeti još najmanje 5 dana nakon zadnje primjene fentanila.
English: 1.55 ml (1,550 micrograms fentanyl) - 8 spray bottle
Croatian: 1,55 ml (1550 mikrograma fentanila) - bočica sa 8 potisaka
English: What PecFent is used for
Croatian: Što je PecFent i za što se koristi
English: Package leaflet: Information for the user PecFent 100 micrograms/spray nasal spray, solution - two-spray bottle
Croatian: Uputa o lijeku: Informacije za korisnika PecFent 100 mikrograma/potisak sprej za nos, otopina - bočica sa 2 potiska fentanil
English: The protective cap should be replaced after each use and the bottle returned to the child resistant container for safe storage.
Croatian: Poslije svake upotrebe na bočicu se mora vratiti zaštitni zatvarač, a bočicu staviti natrag u spremnik siguran za djecu kako bi bila sigurno pohranjena.
English: • sore or painful joints
Croatian: • osjetljivi ili bolni zglobovi
English: • You must keep PecFent in the child resistant storage container when you are not using it, even if you have used all 8 sprays.
Croatian: • Kada PecFent ne upotrebljavate morate ga držati u spremniku sigurnom za djecu kojega ne mogu otvoriti, čak i ako ste potrošili svih 8 doza za raspršivanje.
English: • feeling tired or weak, problems moving
Croatian: • osjećaj umora ili slabosti, teškoće s gibanjem
English: In each case the product is packed in a clam-shell-like child resistant container.
Croatian: U svakom slučaju, lijek je pakiran u spremniku u obliku školjke sigurnom za djecu.
English: Also contains: pectin (E440), mannitol (E421), phenylethyl alcohol, propylparahydroxybenzoate (E216), sucrose, purified water and hydrochloric acid (0.36%) or sodium hydroxide for pH adjustment.
Croatian: Sadrži također: pektin (E440), manitol (E421), feniletilni alkohol, propilparahidroksibenzoat (E216), saharozu, pročišćenu vodu i kloridnu kiselinu (0,36%) ili natrijev hidroksid za podešavanje pH.
English: The PecSys system allows the product to be sprayed into the front area of the nasal cavity as a fine mist of droplets, which gel on contact with the calcium ions present in the nasal mucosa.
Croatian: Taj sustav omogućava raspršivanje lijeka u prednji dio nosne šupljine kao finu maglicu kapljica koje se u dodiru s kalcijevim ionima prisutnim u nosnoj sluznici pretvaraju u gel.
English: If you are not going to use your medicine straight away, put the protective cap back on. Then put the PecFent bottle in the child-resistant storage container.
Croatian: Ako ne mislite odmah primijeniti lijek, vratite natrag zaštitni zatvarač.
English: • Patients must wait at least 4 hours before treating another episode of BTP with PecFent.
Croatian: • Bolesnici moraju pričekati barem 4 sata prije nego što za drugu epizodu probijajuće boli primijene PecFent.
English: Your doctor will decide if your PecFent dose needs to be changed.
Croatian: Liječnik će odlučiti treba li promijeniti dozu lijeka PecFent.
English: However, iatrogenic addiction following therapeutic use of opioids is known to occur.
Croatian: Međutim, poznato je da se nakon terapijske upotrebe opioida zna pojaviti jatrogena ovisnost.
English: You may experience withdrawal symptoms similar to the possible side effects of PecFent when discontinuing PecFent.
Croatian: Kad prestanete primjenjivati PecFent, možete dobiti simptome ustezanja slične mogućim nuspojavama PecFenta.
English: • Instructions for opening and closing of the child-resistant box
Croatian: o Upute za otvaranje i zatvaranje kutije sigurne za djecu.
English: o After the counter has advanced to “2”, the patient should continue to push down on the finger grips (there will be some increased resistance) a total of four times in order to expel any residual medicine from the bottle.
Croatian: Kada se u brojaču pojavio broj "2", bolesnik treba nastaviti pritiskati još četiri puta na mjesta za prste ispod mlaznice (osjetit će nešto veći otpor) kako bi se ispraznio preostali lijek iz bočice.
English: Do not store above 25 °C.
Croatian: POSEBNE MJERE ČUVANJA Ne čuvati na temperaturi iznad 25°C.
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati PecFent Ovaj lijek čuvajte izvan pogleda i dohvata djece.
English: Hydrochloric acid (0.36%) or sodium hydroxide (for pH adjustment) Purified water
Croatian: saharozu, pročišćenu vodu i kloridnu kiselinu (0,36%) ili natrijev hidroksid za podešavanje pH.
English: • Only use PecFent nasal spray if you have been experiencing breakthrough cancer pain episodes
Croatian: PecFent sprej za nos upotrijebite samo ako imate epizode probijajuće karcinomske boli.
English: This should clear any blockage.
Croatian: To bi trebalo ukloniti zakočenost spreja.
English: • Do not use PecFent nasal spray to treat any other short-term pain or pain status
Croatian: 6. Ne upotrebljavajte PecFent sprej za nos za liječenje nekih drugih kratkotrajnih bolova ili bolnih stanja.
English: Take off the protective cap from the nozzle.
Croatian: Skinite zaštitni zatvarač s mlaznice.
English: Number of sprays in this PecFent bottle
Croatian: Broj raspršivanja (potisaka) u ovoj bočici lijeka PecFent
English: PecFent is a nasal spray, solution
Croatian: PecFent je sprej za nos, otopina.
English: Using the PecFent bottle
Croatian: Upotreba bočice lijeka PecFent
English: Fentanyl is metabolised mainly via the human cytochrome P450 3A4 isoenzyme system (CYP3A4), therefore potential interactions may occur when PecFent is given concurrently with medicinal products that affect CYP3A4 activity.
Croatian: (CYP3A4), stoga do potencijalnih interakcija može doći kada se PecFent daje istodobno s lijekovima koji utječu na aktivnost CYP3A4.
English: o After the counter has advanced to “8”, the patient should continue to push down on the finger grips (there will be some increased resistance) a total of four times in order to expel any residual medicine from the bottle.
Croatian: Kada se u brojaču pojavio broj "8", bolesnik treba nastaviti pritiskati još četiri puta na mjesta za prste ispod mlaznice (osjetit će nešto veći otpor) kako bi se ispraznio preostali lijek iz bočice.
English: • you have a serious breathing or lung problem.
Croatian: • ako imate ozbiljne teškoće s disanjem ili plućima.
English: Each PecFent bottle is supplied in a child resistant container.
Croatian: Svaka bočica lijeka PecFent nalazi se u spremniku sigurnom za djecu.
English: No data on the pharmacokinetics of PecFent in elderly patients are available.
Croatian: PecFenta u starijih bolesnika nisu dostupni.
English: Disposal of unused PecFent
Croatian: Zbrinjavanje neupotrijebljenog lijeka PecFent
English: • blue skin colour
Croatian: • svrbež kože
English: • Patients should be prescribed an initial titration supply of one bottle (2 sprays or 8 sprays) of PecFent 100 micrograms/spray.
Croatian: • Za početnu titraciju bolesnicima se mora propisati jednu bočicu (2 potiska ili 8 potisaka) lijeka
English: Together these symptoms may be a sign of a potentially life-threatening condition called adrenal insufficiency, a condition in which the adrenal glands do not produce enough hormones
Croatian: slabost, omaglica i nizak krvni tlak - ovi simptomi zajedno mogu biti znak stanja kod kojeg nadbubrežne žlijezde ne proizvode dovoljno hormona, a koje se zove adrenalna insuficijencija i može biti opasno za život
English: • Do not use PecFent if you are breast-feeding.
Croatian: • Ne primjenjujte PecFent ako dojite.
English: 8 spray bottle: o Aim the spray away from themselves (and any other people) and expel remaining spray until the red number “8” appears in the counting window and there are no more full therapeutic sprays obtainable from the bottle.
Croatian: Bočica sa 8 potisaka: o Sprej usmjerite u stranu suprotnu od sebe (i od drugih osoba) i raspršite preostali lijek sve dok se u prozorčiću brojača ne pojavi broj "8" crvene boje i dok više nije moguće iz bočice dobiti nijednu punu terapijsku dozu lijeka.
English: • See ‘Using the PecFent bottle' for instructions on how to use a dose.
Croatian: • Kako primijeniti dozu pogledajte pod naslovom 'Upotreba bočice lijeka PecFent'.
English: • You must keep PecFent in the child resistant storage container when you are not using it, even if you have used all 2 sprays.
Croatian: • Kada PecFent ne upotrebljavate morate ga držati u spremniku sigurnom za djecu kojega ne mogu otvoriti, čak i ako ste potrošili obje doze za raspršivanje.
English: If PecFent has not been used for 5 days, re-prime by spraying once.
Croatian: Ako PecFent nije upotrebljavan 5 dana, ponovno aktivirajte bočicu jednim raspršivanjem.
English: The other ingredients (excipients) are pectin (E440), mannitol (E421), phenylethyl alcohol, propylparahydroxybenzoate (E216), sucrose, purified water and hydrochloric acid or sodium hydroxide for pH adjustment.
Croatian: Drugi sastojci (pomoćne tvari) su: pektin (E440), manitol (E421), feniletilni alkohol, propilparahidroksibenzoat (E216), saharoza, pročišćena voda i kloridna kiselina ili natrijev hidroksid za podešavanje pH.
English: Excipients with known effect: Each spray contains 0.02 mg propylparahydroxybenzoate (E216).
Croatian: Jedan potisak sadrži 0,02 mg propilparahidroksibenzoata (E216).
English: • Keep the bottle in its child resistant container in order to protect from light.
Croatian: • Bočicu čuvati u spremniku sigurnom za djecu radi zaštite od svjetlosti.
English: In addition, PecFent should be administered with caution to patients with hepatic or renal impairment.
Croatian: Osim toga, PecFent se mora primjenjivati s oprezom u bolesnika s oštećenjem funkcije jetre ili bubrega.
English: Patients should wait at least 4 hours after a dose before treating another BTP episode with PecFent.
Croatian: Nakon doze bolesnici moraju pričekati barem 4 sata prije nego što ponovno primijene PecFent za drugu epizodu probijajuće boli.
English: [2 spray bottle:] 1 bottle - 0.95 ml (2 sprays) per bottle
Croatian: 1 bočica - 0,95 ml (2 potiska) po bočici
English: The green bar means the PecFent nasal spray is ready to use.
Croatian: PecFent sprej za nos spreman za upotrebu.
English: Number of sprays in a PecFent bottle
Croatian: Broj raspršivanja (potisaka) u bočici lijeka PecFent
English: The mean pain intensity scores (73 patients) for all PecFent-treated episodes (459 episodes) compared to those treated with placebo (200 episodes) were significantly lower at 5, 10, 15, 30, 45 and 60 minutes following administration (see Figure 1).
Croatian: epizoda) u usporedbi s onima liječenim placebom (200 epizoda) bila je značajno niža 5, 10, 15, 30, 45
English: • Tell your doctor if your dose of PecFent does not relieve your breakthrough pain.
Croatian: Kad ste odredili odgovarajuću dozu • Kažite liječniku ako Vam doza PecFenta ne ublažava probijajuću bol.
English: There was no clinically significant effect of acute rhinitis on Cmax, Tmax or overall exposure to fentanyl, comparing the unchallenged with the acutely challenged states.
Croatian: U usporedbi neprovociranog s akutno provociranim stanjem, nije bilo klinički značajnog učinka akutnog rinitisa na Cmax, Tmax ili ukupnu izloženost fentanilu.
English: Fentanyl is metabolised in the liver to norfentanyl by cytochrome CYP3A4 isoform.
Croatian: Izoforma citokroma CYP3A4 metabolizira fentanil u jetri u norfentanil.
English: The concomitant use of partial opioid agonists/antagonists (e.g. buprenorphine, nalbuphine, pentazocine) is not recommended.
Croatian: Ne preporučuje se istodobna primjena parcijalnih opioidnih agonista/antagonista (npr. buprenorfina,
English: • Only use PecFent nasal spray if you have received the proper information regarding the use of the device and the safety precautions from the prescriber and/or the pharmacist
Croatian: PecFent sprej za nos upotrijebite samo ako ste od liječnika koji Vam je propisao PecFent i/ili od ljekarnika dobili odgovarajuće upute kako upotrebljavati bočicu sa sprejom te saznali mjere opreza.
English: Product strength (micrograms)
Croatian: (mikrogrami)
English: muscular rigidity, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea).
Croatian: prenaglašeni refleksi, mišićna ukočenost, nekoordiniranost i/ili probavni simptomi (npr. mučnina, povraćanje, proljev).
English: It has been 60 days or more since you primed or used your bottle for the first time.
Croatian: Bacite bočicu lijeka PecFent i uzmite novu: • ako je prošlo 60 dana ili više otkako ste aktivirali ili upotrijebili tu bočicu prvi put.
English: • feel very sleepy
Croatian: • osjećate jaku pospanost
English: You could experience symptoms of withdrawal syndrome (nausea, vomiting, diarrhoea, anxiety, chills, tremor, and sweating) while using these medicines.
Croatian: Dok uzimate ove lijekove možete dobiti simptome sindroma ustezanja (mučninu, povraćanje, proljev, tjeskobu, zimicu, nevoljno drhtanje i znojenje).
English: PecFent 2 spray bottles in their child resistant containers are supplied in a carton containing 1 bottle.
Croatian: Bočica lijeka PecFent sa 2 potiska i njezin spremnik siguran za djecu dobiva se u kutiji koja sadržava
English: • Drug dependence (addiction)
Croatian: • ovisnost o lijeku
English: Tolerance and physical and/or psychological dependence may develop upon repeated administration of opioids such as fentanyl.
Croatian: Ponavljanom primjenom opioida poput fentanila, mogu se razviti tolerancija, tjelesna i/ili psihološka ovisnost.
English: Cardiovascular insufficiency Lymphoedema Hypotension Hot flush
Croatian: Krvožilni poremećaji kardiovaskularna insuficijencija limfedem hipotenzija navala vrućine crvenilo uz osjećaj vrućine
English: • You must empty this remaining dose of PecFent from the bottle by aiming the nasal spray away from you (and any other people) and pressing and releasing the grips until the red number “2” appears in the counting window.
Croatian: • Budući da iz bočice morate isprazniti preostale doze lijeka PecFent, usmjerite sprej za nos na stranu suprotnu od sebe (i svih drugih osoba) i naizmjence pritišćite i otpuštajte pritisak sve dok se u prozorčiću brojača ne pojavi broj “2“ crvene boje.
English: Keep the bottle in the child resistant container in order to protect from light.
Croatian: Bočicu čuvati u spremniku sigurnom za djecu radi zaštite od svjetlosti.
English: • Tell your doctor straight away if you have more than 4 episodes of breakthrough pain a day.
Croatian: • Ako imate više od 4 epizode probijajuće boli na dan, odmah obavijestite liječnika.
English: • The prescriber must make use of the checklist for prescribers
Croatian: o Propisivač se mora oslanjati na podsjetnik za propisivače.
English: • get slow or shallow breathing
Croatian: • osjećate jaku pospanost • počnete disati usporeno ili plitko
English: • retching, stomach pains, indigestion
Croatian: • dizanje želuca, bolovi u trbuhu, probavne smetnje