FrancophonIA/ELRC3.0 huggingface dataset:
English: Close the other nostril with a finger from your other hand (Figure 5).
Croatian: Drugu nosnicu zatvorite prstom druge ruke (slika 5).
English: Before you use a new bottle of PecFent you need to prepare it for use.
Croatian: Prije nego što počnete upotrebljavati novu bočicu lijeka PecFent, morate je pripremiti za upotrebu.
English: • painful, sore or inflamed throat or nose
Croatian: • bolno ili upaljeno grlo ili nos
English: Method of titration
Croatian: Postupak titracije
English: Make sure that you use the strength that your doctor has prescribed for you.
Croatian: Pazite da primijenite onu jačinu lijeka koju Vam je propisao liječnik.
English: • loss of taste, loss or change in sense of smell
Croatian: • gubitak okusa, gubitak ili promjena osjeta mirisa
English: PecFent should be discontinued immediately if the patient no longer experiences breakthrough pain episodes.
Croatian: PecFent se mora odmah ukinuti ako bolesnik više nema epizode probijajuće boli.
English: The efficacy of a given dose should be assessed over the ensuing 30 minute period.
Croatian: Djelotvornost primijenjene doze mora se procijeniti tijekom perioda od 30 minuta nakon doze.
English: • Tell your doctor about your pain and how PecFent is working.
Croatian: • Kažite liječniku o bolovima koje imate i kako PecFent djeluje.
English: PecFent should not be used during pregnancy unless clearly necessary.
Croatian: PecFent se ne smije primjenjivati u trudnoći, osim ako je to neophodno.
English: • you feel that PecFent is becoming less effective in treating your episodes of breakthrough pain
Croatian: • ako osjećate da PecFent postaje manje učinkovit u liječenju Vaših epizoda probijajuće boli
English: These effects could either be indirect effects due to altered maternal care and/or decreased lactation rate or a direct effect of fentanyl on the pups.
Croatian: Ti učinci bi mogli biti ili neizravni učinci zbog promjena u majčinskoj skrbi i/ili smanjene stope dojenja ili izravni učinak fentanila na mladunčad.
English: Due to physico-chemical properties of excipients included in the formulation, intravenous or intra-arterial injection must be avoided in particular.
Croatian: Zbog fizikalno-kemijskih svojstava pomoćnih tvari uključenih u pripravak, osobito se mora izbjegavati intravensko ili intraarterijsko injiciranje.
English: • you have ever developed adrenal insufficiency or lack of sex hormones (androgen deficiency) with opioid use
Croatian: • ako ste uz primjenu opioida ikada razvili adrenalnu insuficijenciju ili manjak spolnih hormona (nedostatak androgena).
English: • The starting dose is 100 micrograms.
Croatian: • Početna je doza 100 mikrograma.
English: Partially used PecFent bottles may contain enough medicine to be harmful or life-threatening to a child.
Croatian: Djelomično upotrijebljene bočice lijeka PecFent mogu sadržavati dovoljno lijeka da naštete ili ugroze život djeteta.
English: If serotonin syndrome is suspected, treatment with PecFent should be discontinued.
Croatian: Ako se posumnja na pojavu serotoninskog sindroma treba prekinuti liječenje PecFentom.
English: This is because the medicine can get into your breast milk and may cause side effects in the breast-fed child.
Croatian: To je zato što lijek može dospjeti u Vaše mlijeko i prouzročiti popratne učinke u dojenčeta.
English: Patients should be advised not to drive or operate machinery if they experience somnolence, dizziness, or visual disturbance or other adverse reactions which can impair their ability to drive or operate machinery.
Croatian: Bolesnicima se mora savjetovati da ne upravljaju vozilima ili ne rukuju strojevima ako osjete somnolenciju, omaglicu ili smetnje vida ili druge nuspojave koje mogu narušiti njihovu sposobnost vožnje ili rukovanja strojevima.
English: How much to use
Croatian: Koliko lijeka upotrijebiti
English: The use of concomitant central nervous system depressants may increase the risk of respiratory depression (see section 4.5).
Croatian: Istodobna primjena depresora središnjeg živčanog sustava može povećati rizik od respiratorne depresije (vidjeti dio 4.5).
English: If you are not sure about the right dose or how much PecFent to use, ask your doctor.
Croatian: Ako niste sigurni je li Vaša doza najpovoljnija ili koliko PecFenta morate primijeniti, pitajte liječnika.
English: • you think you are becoming dependent on PecFent
Croatian: • ako mislite da postajete ovisni o lijeku PecFent
English: The duration of respiratory depression following overdose may be longer than the effects of the opioid antagonist's action (e.g. the half life of naloxone ranges from 30 to 81 minutes) and repeated administration may be necessary.
Croatian: Trajanje respiratorne depresije nakon predoziranja može biti dulje od učinaka opioidnih antagonista (npr. poluvijek naloksona ima raspon od 30 do 81 minute) pa može biti potrebna ponovljena primjena.
English: • The pharmacist must be familiar with the educational material of PecFent nasal spray before using it in his/her organization
Croatian: o Ljekarnik mora biti upoznat s edukacijskim materijalom za PecFent sprej za nos prije nego što ga počne upotrebljavati u svojoj organizaciji.
English: Check that there is a green bar or a number showing in the counting window (Figure 4): this confirms that the PecFent bottle has been primed (see ‘Preparing the PecFent bottle for use' above).
Croatian: Provjerite vidite li zelenu crtu ili broj u prozorčiću s brojačem (slika 4); to potvrđuje da je bočica lijeka PecFent aktivirana (pogledajte poglavlje iznad 'Priprema bočice lijeka PecFent za upotrebu').
English: Opioid analgesics may impair the mental and/or physical ability required for driving or operating machinery.
Croatian: Opioidni analgetici mogu smanjiti mentalne i/ili tjelesne sposobnosti potrebne za upravljanje vozilima ili rukovanje strojevima.
English: • After the first spray, number 1 will appear in the counting window.
Croatian: • Poslije raspršivanja prve doze, u prozorčiću s brojačem pojavit će se broj 1.
English: If you stop using PecFent
Croatian: Ako prestanete primjenjivati PecFent
English: If discontinuation of all opioid therapy is required, the patient must be closely followed by the doctor as gradual downward opioid titration therapy is necessary in order to avoid the possibility of abrupt withdrawal effects.
Croatian: Ako je potrebno prekinuti svu opioidnu terapiju, liječnik mora bolesnika pomno pratiti jer je postupno snižavanje opioidne terapije titracijom neophodno kako bi se izbjegla mogućnost pojave naglih učinaka ustezanja lijeka.
English: The following adverse reactions have been reported with PecFent and/or other fentanyl-containing compounds during clinical studies and post marketing experience (frequencies defined as very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to
Croatian: Tablični prikaz nuspojava Sljedeće su nuspojave prijavljene s PecFentom i/ili drugim tvarima koje sadrže fentanil tijekom kliničkih ispitivanja te nakon stavljanja lijeka u promet (učestalost je definirana kao vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000);
English: Treatment of acute pain other than breakthrough pain.
Croatian: Liječenje akutne boli osim probijajuće boli.
English: • you are allergic to fentanyl or any of the other ingredients of this medicine (listed in Section 6).
Croatian: • ako ste alergični na fentanil ili neki drugi sastojak ovog lijeka (naveden u dijelu 6)
English: Prior to launch in each member State the MAH shall agree the final educational material with the National Competent Authority.
Croatian: Prije puštanja lijeka u promet u svakoj zemlji članici, nositelj odobrenja će s nadležnim nacionalnim tijelom usuglasiti konačni edukacijski materijal.
English: The free fraction of fentanyl increases with acidosis.
Croatian: Slobodna frakcija fentanila povećava se s acidozom.
English: This medicine should only be used by patients taking other opioids.
Croatian: Ovaj lijek smiju primjenjivati samo bolesnici koji uzimaju druge opioide.
English: • Do not use PecFent during child birth.
Croatian: • Ne primjenjujte PecFent tijekom porođaja.
English: If adverse reactions are intolerable or persistent, the dose should be reduced or treatment with PecFent replaced by another analgesic.
Croatian: Ako su nuspojave nepodnošljive ili ustrajne, dozu se mora smanjiti ili liječenje PecFentom zamijeniti nekim drugim analgetikom.
English: There is a risk of clinically significant respiratory depression associated with the use of fentanyl.
Croatian: Postoji rizik od klinički značajne respiratorne depresije povezane s primjenom fentanila.
English: Pharmacotherapeutic group: Analgesics; opioids; phenylpiperidine derivatives; ATC code: N02AB03.
Croatian: Farmakoterapijska skupina: analgetici; opioidi, derivati fenilpiperidina; ATK oznaka: N02AB03.
English: Do not change the dose of PecFent or your other pain medicines yourself.
Croatian: Ne mijenjajte sami dozu PecFenta ili drugih lijekova protiv bolova.
English: • Speak to your local pharmacy about disposal of empty bottles (see ‘How to store PecFent')
Croatian: • Upitajte svog ljekarnika kako baciti prazne bočice (pogledajte 'Kako čuvati PecFent').
English: The total plasma clearance of fentanyl following intravenous administration is approximately 42 L/h.
Croatian: Ukupni plazmatski klirens fentanila nakon intravenske primjene iznosi približno 42 l/h.
English: • Fentanyl is absorbed quickly through the lining of your nose and into the blood stream.
Croatian: • Fentanil se brzo apsorbira kroz unutrašnju sluznicu nosa i zatim u optok krvi.
English: Clinical signs and symptoms may be manifest from these hormonal changes.
Croatian: Ove hormonske promjene mogu se očitovati kliničkim znakovima i simptomima.
English: Your doctor will tell you whether PecFent is suitable for you.
Croatian: Vaš liječnik će Vam reći je li PecFent odgovarajući lijek za Vas.
English: This will go up each time the spray is used.
Croatian: Broj će se povećati svaki put kad upotrijebite sprej.
English: Patients with pain who receive chronic opioid therapy develop tolerance to respiratory depression and hence the risk of respiratory depression in these patients is reduced.
Croatian: Bolesnici s bolovima koji primaju kroničnu terapiju opioidima razviju toleranciju prema respiratornoj depresiji pa je time rizik od respiratorne depresije u tih bolesnika smanjen.
English: There was no indication that older patients tended to titrate to lower doses or experience more adverse reactions.
Croatian: Ništa nije ukazivalo na to da u starijih bolesnika postoji tendencija prema titraciji na niže doze ili da imaju više nuspojava.
English: Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.
Croatian: Bolesnici koji primaju opioidnu terapiju održavanja su oni koji uzimaju najmanje 60 mg peroralnog morfina na dan, najmanje 25 mikrograma transdermalnog fentanila na sat, najmanje 30 mg oksikodona na dan, najmanje 8 mg peroralnog hidromorfona na dan ili ekvianalgetsku dozu nekog drugog opioida tjedan dana ili dulje.
English: Frequently, these will cease or decrease in intensity with continued use of the medicinal product, as the patient is titrated to the most appropriate dose.
Croatian: Te će nuspojave često prestati ili će se njihov intenzitet smanjiti uz kontinuiranu primjenu lijeka, jer će bolesnik biti titriran na najprikladniju dozu.
English: Your doctor may change the medicine for your constant pain.
Croatian: Liječnik će Vam možda promijeniti lijek protiv stalnih bolova.
English: If you or your carer notice any of the side effects above, call an ambulance straight away.
Croatian: Ako Vi ili osoba koja skrbi o Vama opazite bilo koju od gore navedenih nuspojava, odmah pozovite hitnu pomoć.
English: • It comes on even though you have taken your usual opioid pain killer (such as morphine,
Croatian: • Bol se pojavi iako ste uzeli svoj uobičajeni opioidni analgetik (kao što su morfij, fentanil,
English: However, the most serious adverse reactions are respiratory depression (potentially leading to apnoea or respiratory arrest), circulatory depression, hypotension and shock and all patients should be monitored for these.
Croatian: Međutim, najozbiljnije su nuspojave respiratorna depresija (potencijalno dovodi do apneje ili respiratornog aresta), cirkulatorna depresija, hipotenzija i šok, i sve se bolesnike mora nadzirati zbog takvih nuspojava.
English: • You may feel sleepy, dizzy or have problems with your eyesight after using PecFent.
Croatian: • Možete osjećati pospanost, omaglicu ili imati tegobe s vidom nakon primjene PecFenta.
English: Once an effective dose has been established during titration, patients should continue to take this dose up to a maximum of 4 doses per day.
Croatian: Kad se titracijom odredi djelotvorna doza bolesnici moraju nastaviti uzimati tu dozu do najviše 4 doze na dan.
English: If it occurs, it should be managed by the use of assisted ventilation, by an opioid antagonist, and as a final alternative, by a neuromuscular blocking agent.
Croatian: Ako se to dogodi, mora se zbrinuti potpomognutim disanjem, nekim opioidnim antagonistom, a kao zadnju mogućnost nekim neuromuskularnim blokirajućim lijekom.
English: In studies on pre and postnatal development in rats the survival rate of offspring was significantly reduced at doses causing severe maternal toxicity.
Croatian: U ispitivanjima prenatalnog i postnatalnog razvoja u štakora, stopa preživljenja potomstva bila je značajno snižena pri dozama koje su uzrokovale tešku toksičnost za majke.
English: If you feel very dizzy, very sleepy or have slow or shallow breathing, call an ambulance or ask someone else to call one straight away.
Croatian: Ako osjećate jaku omaglicu, veliku pospanost i disanje Vam je sporo ili plitko, odmah pozovite hitnu pomoć ili zamolite nekog drugog da to učini.
English: In order to minimise the risks of opioid-related adverse reactions and to identify the effective dose, it is imperative that patients be monitored closely by health professionals during the titration process.
Croatian: Kako bi se rizici od nuspojava povezanih s primjenom opioida sveli na najmanju moguću mjeru te da se odredi učinkovita doza, nužno je da zdravstveni radnici pomno nadziru bolesnike za vrijeme postupka titracije.
English: • If your nasal spray is still not working properly, dispose of the faulty bottle and start a new one.
Croatian: • Ako Vam sprej za nos i dalje ne raspršuje kako treba, zbrinite neispravnu bočicu i uzmite novu.
English: After first use: 60 days
Croatian: 3 godine Nakon prve primjene: 60 dana
English: However, you should keep taking your other opioid medicine to treat your constant pain.
Croatian: Ipak, morate nastaviti uzimati druge opioidne lijekove protiv svojih stalnih bolova.
English: The superior efficacy of PecFent over placebo was supported by data from secondary endpoints including the number of BTP episodes with clinically meaningful pain relief, defined as a reduction in pain intensity score of at least 2 (Figure 2).
Croatian: Veću djelotvornost PecFenta u odnosu na placebo poduprli su podaci sekundarnih ishoda uključujući broj epizoda probijajuće boli s klinički značajnim ublažavanjem boli, što je bilo definirano kao smanjenje rezultata za intenzitet boli od najmanje 2 točke (slika 2).
English: • This means the medicine gets into your system quickly to relieve your breakthrough pain.
Croatian: • To znači da lijek brzo ulazi u tijelo kako bi ublažio probijajuću bol.
English: It is important that the long acting opioid treatment used to treat the patient's persistent pain has been stabilised before PecFent therapy begins.
Croatian: Važno je da liječenje bolesnika dugodjelujućim opioidima za liječenje uporne boli bude stabilizirano prije nego što započne terapija PecFentom.
English: Careful consideration should be given to patients with hypovolaemia and hypotension.
Croatian: Nužna je pažljiva procjena bolesnika s hipovolemijom i hipotenzijom.
English: Embryo-foetal developmental toxicity studies conducted in rats and rabbits revealed no compoundinduced malformations or developmental variations when administered during the period of organogenesis.
Croatian: Ispitivanja toksičnosti za embriofetalni razvoj provedena u štakora i kunića nisu pokazala malformacije ili razvojne varijacije inducirane lijekom kada je primjenjivan tijekom perioda organogeneze.
English: Concomitant use of PecFent and other medicinal products (other than oxymetazoline) administered via the nose has not been evaluated in the clinical trials.
Croatian: Istodobna primjena PecFenta i drugih lijekova (osim oksimetazolina) koji se primjenjuju u nos nije ispitivana u kliničkim ispitivanjima.
English: Opioids may influence the hypothalamic-pituitary-adrenal or -gonadal axes.
Croatian: Opioidi mogu utjecati na hipotalamo-hipofizno-adrenalnu ili -gonadnu os.
English: • Your doctor will then help you find the right dose to relieve your breakthrough pain.
Croatian: • Liječnik će Vam pomoći odrediti pravu dozu koja će Vam ublažiti probijajuću bol.
English: Increased intracranial pressure
Croatian: Povišen intrakranijalni tlak
English: Don't use any other kind of nasal spray for at least 15 minutes after using PecFent.
Croatian: Nemojte primijeniti nijednu drugu vrstu spreja za nos barem 15 minuta nakon primjene PecFenta.
English: • Put the protective cap back on the spray bottle.
Croatian: • Vratite zaštitnu kapicu na bočicu spreja.
English: • you have not been taking the same dose of your daily opioid medicine for your constant pain for some time
Croatian: • ako neko vrijeme niste uzimali istu dozu dnevnog opioidnog lijeka protiv svojih stalnih bolova
English: Firmly press down on the finger grips until a ‘click' is heard and then let go of the grips (Figure 2).
Croatian: Čvrsto pritisnite prstima prema dolje dok ne čujete ‘klik' a zatim otpustite pritisak (slika 2).
English: Patients without maintenance opioid therapy as there is an increased risk of respiratory depression.
Croatian: Bolesnici koji se ne nalaze na terapiji održavanja opioidima jer postoji povećan rizik od respiratorne depresije.
English: The treatment for persistent backgound pain should be kept as prescribed.
Croatian: Liječenje uporne osnovne boli mora se nastaviti kako je propisano.
English: The patient should be advised to write the date of first use in the space provided on the label of the child resistant container.
Croatian: Bolesniku treba savjetovati da upiše datum prve primjene u za to predviđen prostor na naljepnici spremnika sigurnog za djecu.
English: Opioids may obscure the clinical course of patients with a head injury and should be used only if clinically warranted.
Croatian: Opioidi mogu prikriti klinički tijek u bolesnika s ozljedom glave i smiju se primjenjivati samo ako je to klinički opravdano.
English: If you use more PecFent than you should
Croatian: Ako primijenite više lijeka PecFent nego što ste trebali
English: Norfentanyl is not pharmacologically active in animal studies.
Croatian: U ispitivanjima na životinjama norfentanil nije farmakološki aktivan.
English: Figure 2: Clinically Meaningful Pain Relief - PecFent vs placebo: % Patients' Episodes With ≥2 Point Reduction in Pain Intensity
Croatian: Slika 2: Klinički značajno ublažavanje bola - PecFent naspram placeba: % epizoda u bolesnika sa smanjenim intenzitetom bola za ≥2 točke
English: After priming, use within 5 days.
Croatian: Nakon aktivacije, primijeniti unutar 5 dana.
English: Secondary pharmacological effects are respiratory depression, bradycardia, hypothermia, constipation, miosis, physical dependence and euphoria.
Croatian: Sekundarni su farmakološki učinci respiratorna depresija, bradikardija, hipotermija, konstipacija, mioza, tjelesna ovisnost i euforija.
English: Animal data have shown that, following absorption, fentanyl is rapidly distributed to the brain, heart, lungs, kidneys and spleen followed by a slower redistribution to muscles and fat.
Croatian: Podaci dobiveni na životinjama pokazali su da se fentanil nakon apsorpcije brzo raspodjeljuje u mozak, srce, pluća, bubrege i slezenu nakon čega slijedi sporija preraspodjela u mišiće i masno tkivo.
English: There are no adequate data from the use of fentanyl in pregnant women.
Croatian: Nema odgovarajućih podataka o primjeni fentanila u trudnica.
English: The patients entering the double-blind phase treated up to 10 episodes of BTP with either PecFent (7 episodes) or placebo (3 episodes) in a random order.
Croatian: Bolesnici koji su ušli u dvostruko slijepu fazu liječili su do 10 epizoda probijajuće boli PecFentom (7 epizoda) ili placebom (3 epizode) slučajnim redoslijedom.
English: • You will feel some increased resistance when you press down and the finger grips will only move a small amount.
Croatian: • Kada tako prišćete, osjetit ćete nešto veći otpor i moći ćete pritisnuti samo malo.
English: Patients and their carers must be instructed that PecFent contains an active substance in an amount that can be fatal to a child.
Croatian: Bolesnike i osobe koje za njih skrbe mora se upoznati s činjenicom da PecFent sadrži djelatnu tvar u količini koja može biti smrtonosna za dijete.
English: • You should not start breast-feeding within 5 days after the last dose of PecFent.
Croatian: • Ne smijete početi dojiti unutar 5 dana od primjene posljednje doze PecFenta.
English: PecFent should only be administered with extreme caution in patients who may be particularly susceptible to the intracranial effects of CO2 retention, such as those with evidence of increased intracranial pressure or impaired consciousness.
Croatian: PecFent se smije primijeniti samo uz krajnji oprez u bolesnika koji bi mogli biti posebno osjetljivi na intrakranijalne učinke retencije CO2, poput bolesnika sa znakovima povišenog intrakranijalnog tlaka ili s oštećenjem svijesti.
English: • Information on the correct indication
Croatian: Podaci o pravilnoj indikaciji.
English: • medicines that might make you sleepy such as sleeping tablets, tranquilisers, muscle relaxants, medicines for anxiety or medicines for allergies (anti-histamines)
Croatian: • lijekove od kojih biste mogli osjećati pospanost kao što su tablete za spavanje, lijekove za smirenje, za opuštanje mišića, lijekove protiv tjeskobe ili protiv alergija (antihistaminici)
English: Following treatment of the acute rhinitic state with oxymetazoline, there were reductions in Cmax and exposure, and increases in Tmax that were statistically, and possibly clinically, significant.
Croatian: Nakon liječenja stanja akutnog rinitisa oksimetazolinom, nastupila su smanjenja vrijednosti Cmax i izloženosti te povećanja vrijednosti Tmax koja su bila statistički i vjerojatno klinički značajna.
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 dependent patients.
Croatian: Oni imaju visoki afinitet za opioidne receptore s relativno malom intrinzičnom aktivnošću pa stoga djelomično antagoniziraju analgetski učinak fentanila i mogu izazvati simptome ustezanja u bolesnika ovisnih o opioidima.
English: PecFent utilises the PecSys nasal drug delivery system to modulate the delivery and absorption of fentanyl.
Croatian: PecFent se koristi PecSys sustavom nazalne isporuke lijeka za modulaciju isporuke i apsorpcije fentanila.
English: Generally, the maintenance dose of PecFent should be increased only where the current dose fails to adequately treat the BTP for several consecutive episodes.
Croatian: Najčešće, dozu održavanja lijeka PecFent mora se povećati samo onda kada se postojećom dozom ne uspije odgovarajuće liječiti probijajuću bol u nekoliko uzastopnih epizoda.