FrancophonIA/ELRC3.0 huggingface dataset:
English: Less than 7 % of an administered dose of fentanyl is excreted unchanged in the urine and only about 1 % is excreted unchanged in the faeces.
Slovenian: Manj kot 7 % danega odmerka fentanila se izloči nespremenjenega v urinu in samo okrog 1 % se ga izloči nespremenjenega v blatu.
English: • Breakthrough pain comes on suddenly.
Slovenian: • Prebijajoča bolečina se pojavi nenadoma.
English: • seeing or hearing things that are not really there (hallucinations/delirium), feeling confused
Slovenian: • vidite ali slišite stvari, ki jih v resnici ni (halucinacije/delirij), zmedenost,
English: If your doctor has prescribed a second spray, repeat steps 5 to 9, using the other nostril.
Slovenian: Če vam je zdravnik predpisal še drugi vpih, ponovite korake 5 do 9 in uporabite drugo nosnico.
English: Of the 355 patients treated in the open-label treatment phase, 90 % required no increase in dose.
Slovenian: Od 335 bolnikov, zdravljenih v odprti fazi zdravljenja, jih 90 % ni potrebovalo zvečanja odmerka.
English: This leaflet was last revised Other sources of information
Slovenian: Navodilo je bilo nazadnje revidirano dne Drugi viri informacij
English: Once you have found the right dose
Slovenian: Ko najdete pravi odmerek
English: The risk of side effects increases if you are taking medicines such as certain antidepressants or antipsychotics.
Slovenian: Tveganje neželenih učinkov se poveča, če jemljete zdravila, kot so nekateri antidepresivi ali antipsihotiki.
English: Other side effects (frequency not known (frequency cannot be estimated from the available data))
Slovenian: Drugi neželeni učinki (neznana pogostnost; ni mogoče oceniti iz razpoložljivih podatkov):
English: Blow your nose if you feel you need to.
Slovenian: Useknite se, če se vam zdi, da je treba.
English: • Do not drive or use tools or machines until you know how this medicine makes you feel.
Slovenian: • Ne vozite in ne uporabljajte orodij ali strojev, dokler ne veste, kako to zdravilo vpliva na vaše počutje.
English: If this occurs, patients should be advised to discontinue their decongestant.
Slovenian: Če se to zgodi, bolnikom svetujemo, naj ukinejo dekongestiv.
English: Make sure that you use the strength that your doctor has prescribed for you.
Slovenian: Prepričajte se, da uporabljate jakost, ki vam jo je predpisal zdravnik.
English: Your doctor may need to check the dose.
Slovenian: Vaš zdravnik bo moral mogoče preveriti odmerek.
English: PecFent is not approved for use in children under 18 years of age.
Slovenian: Zdravilo PecFent ni odobreno za uporabo pri otrocih, mlajših od 18 let.
English: This may occur within the recommended dose (see section 4.5).
Slovenian: Pojavi se lahko znotraj priporočenega odmerka (glejte poglavje 4.5).
English: micrograms micrograms micrograms micrograms micrograms
Slovenian: mikrogramov mikrogramov mikrogramov mikrogramov mikrogramov
English: PecFent with food, drink and alcohol
Slovenian: Zdravilo PecFent skupaj s hrano, pijačo in alkoholom
English: This medicine should only be used by patients taking other opioids.
Slovenian: To zdravilo smejo uporabljati samo bolniki, ki jemljejo druge opioide.
English: The safety and efficacy of PecFent in children and adolescents aged below 18 years have not yet been established.
Slovenian: Varnost in učinkovitost zdravila PecFent pri otrocih in mladostnikih, starih do 18 let, še nista bili dokazani.
English: This is because it may cause breathing problems in your baby.
Slovenian: Lahko namreč povzroči težave z dihanjem pri vašem otroku.
English: If you have not been using these medicines you must not use PecFent, because it may increase the risk that breathing could become dangerously slow and/or shallow, or even stop.
Slovenian: Če niste uporabljali teh zdravil, ne smete uporabljati zdravila PecFent, saj lahko poviša tveganje, da postane dihanje nevarno počasno in/ali plitko ali se celo ustavi;
English: • After the first spray, number 1 will appear in the counting window.
Slovenian: • Po prvem vpihu se bo v okencu števca pokazalo število 1.
English: Dose increase should be undertaken with caution.
Slovenian: Zvečanja odmerka se moramo lotiti previdno.
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.
Slovenian: Opozorilo: Mogoče sploh ne boste imeli občutka, da se je v nosu kaj zgodilo - ne mislite, da to pomeni, da pršilo ni delovalo - verjemite kliku in števcu.
English: • The counter will stay on the number “8”.
Slovenian: • Števec bo ostal na številu “8”.
English: Of the patients entering the titration phase, only 7 (6.1 %) were unable to be titrated to an effective dose due to lack of efficacy and 6 (5.3 %) withdrew due to adverse events.
Slovenian: Od bolnikov, ki so se vključili v fazo titracije, jih samo 7 (6,1 %) ni bilo mogoče titrirati do učinkovitega odmerka zaradi neučinkovitosti, 6 (5,3 %) pa jih je izstopilo iz študije zaradi neželenih učinkov.
English: Therefore it is not possible to definitively separate the effects of PecFent alone.
Slovenian: Zato ni mogoče dokončno ločiti učinkov zdravila PecFent samega.
English: Kyowa Kirin Holdings B.V. Bloemlaan 2,
Slovenian: Kyowa Kirin Holdings B.V.
English: Dose required (micrograms)
Slovenian: Potrebni odmerek (mikrogrami)
English: The efficacy of a given dose should be assessed over the ensuing 30 minute period.
Slovenian: Učinkovitost danega odmerka moramo ocenjevati v obdobju 30 minut po odmerku.
English: Your doctor will evaluate if you need medicine to reduce or eliminate the withdrawal symptoms.
Slovenian: Zdravnik bo ocenil, ali potrebujete zdravilo, ki bo ublažilo ali odpravilo odtegnitvene simptome.
English: After first use: 60 days
Slovenian: Po prvi uporabi: 60 dni.
English: • Do not use PecFent if you are pregnant or might get pregnant, unless your doctor has told you to.
Slovenian: • Ne uporabljajte zdravila PecFent, če ste noseči ali bi lahko zanosili, razen če vam je to naročil zdravnik.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a signficant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Slovenian: • ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
English: Call an ambulance or ask someone else to call one straight away if you:
Slovenian: Takoj pokličite rešilca ali prosite nekoga, naj ga takoj pokliče:
English: • PecFent that has passed the expiry date or is no longer required may still contain enough medicine to be harmful to other people, especially children.
Slovenian: • Zdravilo PecFent, ki mu je potekel rok uporabnosti ali ga ne potrebujete več, lahko še vedno vsebuje dovolj zdravila, da je lahko škodljivo za druge ljudi, predvsem otroke.
English: • you have not been taking the same dose of your daily opioid medicine for your constant pain for some time
Slovenian: • že nekaj časa ne jemljete enakega odmerka svojega vsakodnevnega opioidnega zdravila za svojo stalno bolečino;
English: General introduction
Slovenian: Splošen uvod
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
Slovenian: • imate bolečino ali zvečano občutljivost za bolečino (hiperalgezijo), ki se ne odziva na večje odmerke zdravila, ki vam jih predpiše zdravnik;
English: Before you use a new bottle of PecFent you need to prepare it for use.
Slovenian: Preden začnete uporabljati novo steklenico zdravila PecFent, jo morate pripraviti za uporabo.
English: Dry mouth
Slovenian: suha usta,
English: • The counter will stay on the number “2”.
Slovenian: • Števec bo ostal na številu “2”.
English: • It is more than 5 days since you primed your bottle for the first time.
Slovenian: • je od prve aktivacije steklenice preteklo več kot 5 dni.
English: • You will feel some increased resistance when you press down and the finger grips will only move a small amount.
Slovenian: • Pri pritiskanju boste začutili nekoliko večji upor, sprožilec pa se bo le malo premaknil.
English: Point it inwards towards the wall of your nose.
Slovenian: Usmerite jo navznoter proti nosni steni.
English: Coadministration with medicinal products that induce 3A4 activity may reduce the efficacy of PecFent.
Slovenian: Sočasna uporaba z zdravili, ki inducirajo aktivnost 3A4, lahko zmanjša učinkovitost zdravila PecFent.
English: Opioid analgesics may impair the mental and/or physical ability required for driving or operating machinery.
Slovenian: Opioidni analgetiki lahko zmanjšajo duševne in/ali telesne sposobnosti, potrebne za upravljanje vozil ali strojev.
English: • Talk to your doctor about whether it will be safe for you to drive or use tools or machines after using PecFent.
Slovenian: • Pogovorite se z zdravnikom o tem, ali bo za vas po uporabi zdravila PecFent varno voziti ali uporabljati orodja ali stroje.
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.
Slovenian: Če boste zelo omotični, zelo zaspani ali boste počasi ali plitvo dihali, takoj pokličite reševalni avto ali prosite nekoga, naj ga takoj pokliče.
English: The number counter will move forward after each use and show how many sprays have been used.
Slovenian: Števec se bo ob vsaki uporabi pršila pomaknil naprej in pokazal, koliko vpihov ste porabili.
English: • you think you are becoming dependent on PecFent
Slovenian: • mislite, da postajate odvisni od zdravila PecFent;
English: • If your nasal spray is still not working properly, dispose of the faulty bottle and start a new one.
Slovenian: • Če vaše pršilo za nos še vedno ne deluje pravilno, zavrzite pokvarjeno steklenico in načnite novo.
English: This is because it may then give you the wrong dose.
Slovenian: Če bi to storili, bi namreč lahko prejeli napačen odmerek.
English: Increased intracranial pressure
Slovenian: Zvišan intrakranialni tlak
English: • you have low blood pressure or a low amount of fluid in your circulation
Slovenian: • imate nizek krvni tlak ali zmanjšano količino tekočine v krvnem obtoku;
English: L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A Strada Statale 67 Tosco Romagnola, Fraz.
Slovenian: L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.AStrada Statale 67 Tosco Romagnola, Fraz.
English: Some changes that can be seen include an increase in serum prolactin, and decreases in plasma cortisol and testosterone.
Slovenian: Med nekaterimi spremembami, ki jih lahko opazimo, so zvišanje serumskega prolaktina in znižanje plazemskega kortizola in testosterona.
English: PecFent should not be used during pregnancy unless clearly necessary.
Slovenian: Zdravilo PecFent naj se med nosečnostjo ne uporablja, če to ni nujno potrebno.
English: For details about such use the Summary of Product Characteristics of the individual opioid antagonist should be consulted.
Slovenian: Za podrobnosti glede take uporabe je treba gledati Povzetek glavnih značilnosti zdravila posameznih opioidnih antagonistov.
English: Close the other nostril with a finger from your other hand (Figure 5).
Slovenian: Zamašite drugo nosnico s prstom druge roke (slika 5).
English: Breathe in gently through your nose and out through your mouth.
Slovenian: Plitvo vdihavajte skozi nos in izdihavajte skozi usta.
English: Patients receiving PecFent concomitantly with moderate or strong CYP3A4 inhibitors should be carefully monitored for an extended period of time.
Slovenian: Bolnike, ki prejemajo zdravilo PecFent sočasno z zmernimi ali močnimi inhibitorji CYP3A4, je treba daljše časovno obdobje skrbno spremljati.
English: • changes in blood cells (detected by laboratory tests)
Slovenian: • spremembe krvničk (odkrijemo jih z laboratorijskimi preiskavami).
English: Patients without maintenance opioid therapy as there is an increased risk of respiratory depression.
Slovenian: Bolniki brez vzdrževalne opioidne terapije, saj obstaja povišano tveganje depresije dihanja.
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.
Slovenian: Če je potrebna ukinitev vse opioidne terapije, mora zdravnik bolnika skrbno spremljati, ker je treba opioidno terapijo postopoma titrirati navzdol, da se izognemo možnosti nenadnih odtegnitvenih učinkov.
English: Partially used PecFent bottles may contain enough medicine to be harmful or life-threatening to a child.
Slovenian: Delno porabljene steklenice zdravila PecFent lahko vsebujejo dovolj zdravila, da bi lahko škodovale otroku ali celo ogrozile njegovo življenje.
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.
Slovenian: Bolnikom morate svetovati, naj ne vozijo ali upravljajo s stroji, če opazijo zaspanost, omotico, motnje vida ali druge neželene učinke, ki lahko zmanjšajo njihovo sposobnost vožnje ali upravljanja s stroji.
English: Hyperalgesia
Slovenian: Hiperalgezija
English: There was no indication that older patients tended to titrate to lower doses or experience more adverse reactions.
Slovenian: Nič ni kazalo na to, da bi se starejši bolniki titrirali na manjše odmerke ali imeli več neželenih učinkov.
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.
Slovenian: Ko med titracijo ugotovimo učinkoviti odmerek, naj bolniki jemljejo ta odmerek do največ štirikrat na dan.
English: The main binding protein is alpha-1-acid glycoprotein, but both albumin and lipoproteins contribute to some extent.
Slovenian: Glavna vezavna beljakovina je alfa-1-kisli glikoprotein, nekaj pa prispevajo tako albumini kot lipoproteini.
English: Figure 1: Mean (± SE) Pain Intensity Scores at Each Time Point (mITT Population)
Slovenian: Slika 1: Povprečni (± SE) rezultati intenzivnosti bolečine v vseh časovnih točkah (populacija mITT)
English: • Drug dependence (addiction)
Slovenian: • odvisnost od zdravil (zasvojenost),
English: Norfentanyl is not pharmacologically active in animal studies.
Slovenian: Norfentanil v študijah na živalih ni farmakološko aktiven.
English: • It comes on even though you have taken your usual opioid pain killer (such as morphine,
Slovenian: • Pojavi se, čeprav ste vzeli svoj običajni opioidni analgetik (na primer morfin, fentanil,
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.
Slovenian: Ti učinki bi lahko bili bodisi posredni učinki zaradi spremenjene materine nege in/ali zmanjšane pogostnosti dojenja ali neposreden učinek fentanila na mladiče.
English: If the PecFent nasal spray is blocked or does not spray properly
Slovenian: Če je pršilo za nos PecFent blokirano ali ne prši pravilno
English: PecFent should be discontinued immediately if the patient no longer experiences breakthrough pain episodes.
Slovenian: Zdravilo PecFent je treba nemudoma ukiniti, če bolnik nima več epizod prebijajoče bolečine.
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.
Slovenian: Depresija dihanja po prevelikem odmerku lahko traja dlje kot učinki opioidnega antagonista (npr. razpolovni čas naloksona je 30 do 81 minut) in je zato lahko potrebna ponavljajoča se uporaba.
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.
Slovenian: Da se tveganja neželenih učinkov, povezanih z opioidi, kar najbolj zmanjšajo in da se ugotovi učinkoviti odmerek, je nujno potrebno, da bolnike med postopkom titracije skrbno nadzirajo zdravstveni delavci.
English: Patients and their carers must be instructed that PecFent contains an active substance in an amount that can be fatal to a child.
Slovenian: Bolnike in njihove negovalce morate opozoriti, da vsebuje zdravilo PecFent zdravilno učinkovino v količini, ki je lahko za otroka smrtna.
English: It can increase the risk of getting serious side effects.
Slovenian: Alkohol lahko zveča tveganje nastanka resnih neželenih učinkov.
English: • Your doctor will then help you find the right dose to relieve your breakthrough pain.
Slovenian: • Zdravnik vam bo nato pomagal najti pravi odmerek za lajšanje vaše prebijajoče bolečine.
English: After priming, use within 5 days.
Slovenian: Po aktivaciji porabite v 5 dneh.
English: Once your constant pain is controlled, your doctor may then change your dose of PecFent.
Slovenian: Ko bo vaša stalna bolečina obvladana, vam bo mogoče zdravnik spremenil odmerek zdravila.
English: There are no adequate data from the use of fentanyl in pregnant women.
Slovenian: Ni zadostnih podatkov o uporabi fentanila pri nosečnicah.
English: In absence of adequate pain control, the possibility of hyperalgesia, tolerance and progression of underlying disease should be considered (see section 4.4).
Slovenian: V odsotnosti zadostnega obvladovanja bolečine, je potrebno upoštevati, da lahko pride dohiperalgezije, tolerance in napredovanja osnovne bolezni (glejte poglavje 4.4).
English: Severe respiratory depression or severe obstructive lung conditions.
Slovenian: Težka depresija dihanja ali težke obstruktivne pljučne bolezni.
English: The total plasma clearance of fentanyl following intravenous administration is approximately 42 L/h.
Slovenian: Celotni plazemski očistek fentanila po intravenskem dajanju je približno 42 l/h.
English: • Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP.
Slovenian: • Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in steklenici poleg oznake Uporabno do/EXP.
English: Do not change the dose of PecFent or your other pain medicines yourself.
Slovenian: Odmerka zdravila PecFent ali drugih zdravil proti bolečinam ne spreminjajte sami.
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.
Slovenian: V nekaterih primerih je lahko upravičena razumna uporaba naloksona ali kakega drugega opioidnega antagonista, vendar je povezana s tveganjem sprožitve akutnega odtegnitvenega sindroma.
English: Concomitant use of PecFent and other medicinal products (other than oxymetazoline) administered via the nose has not been evaluated in the clinical trials.
Slovenian: Sočasne uporabe zdravila PecFent in drugih zdravil (razen oksimetazolina) skozi nos v kliničnih preskušanjih niso ovrednotili.
English: Physicians should keep in mind the potential for abuse of fentanyl.
Slovenian: Zdravniki ne smejo pozabiti na možnost zlorabe fentanila.
English: Serotonin Syndrome
Slovenian: Serotoninski sindrom
English: The use of concomitant central nervous system depressants may increase the risk of respiratory depression (see section 4.5).
Slovenian: Sočasna uporaba depresorjev centralnega živčevja lahko zveča tveganje depresije dihanja (glejte poglavje 4.5).
English: It is more than 90 % eliminated by biotransformation to N-dealkylated and hydroxylated inactive metabolites.
Slovenian: Več kot 90 % se ga odstrani iz telesa z biotransformacijo v N-dealkilirane in hidroksilirane neaktivne presnovke.
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.
Slovenian: Če pride do nje, jo je treba zdraviti z uporabo asistirane ventilacije, opioidnim antagonistom in, kot s končno alternativo, s sredstvom za nevromuskularno blokado.
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.
Slovenian: Bolniki, ki prejemajo vzdrževalno opioidno terapijo, so tisti, ki jemljejo najmanj 60 mg morfina peroralno na dan, najmanj 25 mikrogramov transdermalnega fentanila na uro, najmanj 30 mg oksikodona na dan, najmanj 8 mg peroralnega hidromorfona na dan ali ekvianalgetičen odmerek kakega drugega opioida najmanj en teden.
English: No data on the pharmacokinetics of PecFent in elderly patients are available.
Slovenian: Podatkov o farmakokinetiki zdravila PecFent pri starejših bolnikih ni na voljo.
English: • Tell your doctor about your pain and how PecFent is working.
Slovenian: • Povejte zdravniku o svoji bolečini in o tem, kako zdravilo PecFent deluje.
English: • medicines for depression called ‘monoamine-oxidase inhibitors' (MAOI).
Slovenian: • zdravila za depresijo, ki se imenujejo ‘zaviralci monoamin-oksidaze' (zaviralci MAO).
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Slovenian: Nosečnost, dojenje in plodnost Če ste noseči ali dojite, menite, da bi bili lahko noseči, ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
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.
Slovenian: Na splošno rečeno naj se vzdrževalni odmerek zdravila PecFent zveča šele takrat, ko trenutni odmerek ne zadošča za zadostno zdravljenje več zaporednih epizod BTP.
English: • The pharmacist must be familiar with the educational material of PecFent nasal spray before using it in his/her organization
Slovenian: • farmacevt mora biti seznanjen z izobraževalnim gradivom o pršilu za nos PecFent, preden ga začne uporabljati v svoji ustanovi;
English: However, iatrogenic addiction following therapeutic use of opioids is known to occur.
Slovenian: Vendar pa je znano, da se pojavlja iatrogena zasvojenost po terapevtski uporabi opioidov.
English: Due to physico-chemical properties of excipients included in the formulation, intravenous or intra-arterial injection must be avoided in particular.
Slovenian: Zaradi fizikalno-kemijskih lastnosti pomožnih snovi v tem zdravilu se morate še posebno izogibati intravenski ali intraarterijski injekciji.
English: The 2 spray bottle cannot be re-primed and once both doses are used, or if longer than 5 days since priming, the bottle and contents should be discarded as described in section 6.6.
Slovenian: Steklenice z 2 vpihoma ni mogoče reaktivirati in ko bolnik uporabi oba odmerka ali je od aktivacije preteklo več kot 5 dni, mora steklenico in vsebino zavreči po navodilih v poglavju 6.6.
English: In patients with chronic obstructive pulmonary diseases, fentanyl may cause more serious adverse reactions.
Slovenian: Pri bolnikih s kroničnimi obstruktivnimi pljučnimi boleznimi lahko fentanil povzroči resnejše neželene učinke.
English: Further findings at maternally toxic doses in F1 pups were delayed physical development, sensory functions, reflexes and behaviour.
Slovenian: Pri odmerkih, toksičnih za mater, so pri mladičih F1 ugotovili tudi zakasnitve telesnega razvoja, senzoričnih funkcij, refleksov in vedenja.