FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Zato sočasna uporaba nazalnih vazokonstriktivnih dekongestivov med titracijo ni priporočljiva, ker bi se zaradi tega lahko bolniki titrirali na večji odmerek, kot je potreben.
English: Pharmacotherapeutic group: Analgesics; opioids; phenylpiperidine derivatives; ATC code: N02AB03.
Slovenian: Farmakoterapevtska skupina: Analgetiki; opioidi; derivati fenilpiperidina; oznaka ATC: N02AB03.
English: Prolonged treatment with fentanyl during pregnancy may cause withdrawal symptoms in the newborn which can be life-threatening (see section 2).
Slovenian: Dolgotrajno zdravljenje s fentanilom v nosečnosti lahko pri novorojenčku povzroči odtegnitvene simptome, ki so lahko smrtno nevarni (glejte poglavje 2).
English: • Fentanyl is absorbed quickly through the lining of your nose and into the blood stream.
Slovenian: • Fentanil se hitro absorbira skozi vašo nosno sluznico v krvni obtok.
English: Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
English: • If you are an athlete, using PecFent may result in positive doping-tests.
Slovenian: • Če ste športnik, lahko uporaba zdravila PecFent povzroči pozitivne teste na nedovoljena poživila (doping).
English: PecFent should not be disposed of via wastewater or household waste.
Slovenian: Zdravila PecFent ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
English: If you are not sure about the right dose or how much PecFent to use, ask your doctor.
Slovenian: Če ste negotovi glede pravilnega odmerka ali glede tega, koliko zdravila PecFent naj uporabite, se posvetujte z zdravnikom.
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.
Slovenian: Pomembno je, da stabiliziramo dolgotrajno delujoče opioidno zdravljenje, ki se uporablja za zdravljenje bolnikove dolgotrajne bolečine, preden se začne zdravljenje z zdravilom PecFent.
English: Figure 2: Clinically Meaningful Pain Relief - PecFent vs placebo: % Patients' Episodes With ≥2 Point Reduction in Pain Intensity
Slovenian: Slika 2: Klinično pomembno olajšanje bolečine - zdravilo PecFent proti placebu: % epizod pri bolnikih z zmanjšanjem intenzivnosti bolečine za ≥2 točki
English: PecFent should be titrated to an “effective” dose that provides adequate analgesia and minimises adverse reactions without causing undue (or intolerable) adverse reactions, for two consecutively treated episodes of BTP.
Slovenian: Zdravilo PecFent je treba titrirati do "učinkovitega" odmerka, ki nudi zadostno analgezijo in kar najbolj zmanjša neželene učinke, ne da bi povzročil pretirane (ali neprenosljive) neželene učinke, pri dveh zaporedno zdravljenih epizodah BTP.
English: Opioids may obscure the clinical course of patients with a head injury and should be used only if clinically warranted.
Slovenian: Opioidi lahko pri bolnikih s poškodbo glave zabrišejo klinični potek, zato se smejo uporabiti le, če je to klinično upravičeno.
English: [8 spray bottle:]
Slovenian: [Steklenica z 8 vpihi:]
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
Slovenian: Z uporabo zdravila PecFent in/ali drugih zdravil, ki vsebujejo fentanil, so poročali o naslednjih neželenih učinkih iz kliničnih študij in obdobja po začetku trženja (pogostnost je opredeljena kotzelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (<1/10.000); neznana (ni mogoče oceniti iz razpoložljivih podatkov):
English: Prior to launch in each member State the MAH shall agree the final educational material with the National Competent Authority.
Slovenian: Pred prihodom zdravila na trg v vsaki državi članici se mora imetnik dovoljenja za promet z zdravilom s pristojnim nacionalnim organom dogovoriti glede končne oblike izobraževalnega gradiva.
English: • being less aware or responsive, losing consciousness
Slovenian: • zmanjšano zavedanje ali zmanjšana odzivnost, izguba zavesti,
English: • This means the medicine gets into your system quickly to relieve your breakthrough pain.
Slovenian: • To pomeni, da zdravilo hitro pride v vaše telo in ublaži prebijajočo bolečino.
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.
Slovenian: Fentanil se presnavlja pretežno preko izoencimskega sistema človeškega citokroma P450 3A4 (CYP3A4), zato lahko nastopijo možne interakcije, če damo zdravilo PecFent sočasno z zdravili, ki vplivajo na aktivnost CYP3A4.
English: • you suffer from recurrent nose bleeding - he may advise an alternative treatment
Slovenian: • imate ponavljajoče se krvavitve iz nosu-mogoče vam bo svetoval drugo zdravilo;
English: Granatieri - 50018 Scandicci (FI) Italy
Slovenian: Granatieri - 50018 Scandicci (FI)
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).
Slovenian: Večjo učinkovitost zdravila PecFent kot placeba so podprli podatki glede sekundarnih končnih opazovanih dogodkov, vključno s številom epizod BTP s klinično pomembnim olajšanjem bolečine, ki je bilo definirano kot zmanjšanje rezultata intenzivnosti bolečine vsaj za 2 točki (slika 2).
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.
Slovenian: Pri bolnikih z bolečino, ki prejemajo kronično opioidno zdravljenje, se razvije toleranca na depresijo dihanja, zato je tveganje depresije dihanja pri teh bolnikih zmanjšano.
English: Warnings and precautions Keeping PecFent safe from children
Slovenian: Opozorila in previdnostni ukrepi Shranjevanje zdravila PecFent na varnem pred otroki
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.
Slovenian: Študije kancerogenega potenciala (26-tedenski dermalni alternativni biotest pri transgenih miših Tg.AC; dveletna subkutana študija kancerogenega potenciala pri podganah) s fentanilom niso pokazale ugotovitev, ki bi kazale na onkogeni potencial.
English: Your doctor will tell you whether PecFent is suitable for you.
Slovenian: Vaš zdravnik vam bo povedal, ali je zdravilo PecFent za vas primerno;
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.
Slovenian: Bolniki, ki so se vključili v dvojno slepo fazo, so si zdravili po največ 10 epizod BTP bodisi z zdravilom PecFent (7 epizod) bodisi s placebom (3 epizode) v randomiziranem zaporedju.
English: The curves for each dose level are similar in shape with increasing dose levels producing increasing plasma fentanyl levels.
Slovenian: Krivulje za vsako raven odmerkov so podobne po obliki, pri čemer naraščajoče ravni odmerkov povzročajo naraščajoče koncentracije fentanila v plazmi.
English: Dispose of the PecFent bottle and start a new one if:
Slovenian: Zavrzite steklenico zdravila PecFent in uporabite novo, če:
English: Your doctor will decide if your dose needs to be changed.
Slovenian: Zdravnik bo odločil, ali bo treba spremeniti vaš odmerek.
English: • Speak to your local pharmacy about disposal of empty bottles (see ‘How to store PecFent')
Slovenian: • Posvetujte se s farmacevtom o odstranjevanju praznih steklenic (glejte 'Shranjevanje zdravila
English: Evaluation of brain slides from the carciogenicity study in rats revealed brain lesions in animals administered high doses of fentanyl citrate.
Slovenian: Ocena posnetkov možganov iz študije karcinogenosti pri podganah je pokazala možganske lezije pri živalih, ki so jim dajali visoke odmerke fentanil citrata.
English: • Do not use PecFent more than 4 times daily • Wait at least 4 hours to take the next dose of PecFent.
Slovenian: • Ne uporabljajte zdravila PecFent pogosteje kot štirikrat na dan. • Počakajte vsaj 4 ure, preden uporabite naslednji odmerek zdravila PecFent.
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.
Slovenian: Imajo veliko afiniteto za opioidne receptorje z razmeroma majhno intrinzično aktivnostjo, zato delno antagonizirajo analgetični učinek fentanila in lahko inducirajo odtegnitvene simptome pri bolnikih, odvisnih od opioidov.
English: The green bar means the PecFent nasal spray is ready to use.
Slovenian: Zeleni stolpec pomeni, da je zdaj pršilo za nos PecFent pripravljeno za uporabo.
English: • Tell your doctor if your dose of PecFent does not relieve your breakthrough pain.
Slovenian: • Povejte zdravniku, če vaš odmerek zdravila PecFent ne olajša vaše prebijajoče bolečine.
English: The clinical studies of PecFent were designed to evaluate safety and efficacy in treating BTP and all patients were also on background opioid therapies, such as sustained-release morphine or transdermal fentanyl, for their persistent pain.
Slovenian: Klinične študije zdravila PecFent so bile zasnovane za ocenjevanje varnosti in učinkovitosti zdravljenja BTP in vsi bolniki so bili zaradi dolgotrajne bolečine tudi na osnovnih opioidnih terapijah, na primer na morfinu s stalnim sproščanjem ali transdermalnem fentanilu.
English: • medicines that might have an effect on the way your body breaks down PecFent.
Slovenian: • zdravila, ki bi lahko vplivala na to, kako vaše telo razgrajuje zdravilo PecFent.
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.
Slovenian: Takojšnje zdravljenje prevelikega opioidnega odmerka vključuje zagotavljanje odprtih dihalnih poti, telesno in besedno spodbujanje bolnika, oceno ravni zavesti in stanja dihal in krvnih obtočil ter po potrebi asistirano ventilacijo (podporo dihanja).
English: If adverse reactions are intolerable or persistent, the dose should be reduced or treatment with PecFent replaced by another analgesic.
Slovenian: Če neželenih učinkov ni mogoče prenašati ali so dolgotrajni, je treba odmerek zmanjšati ali pa zdravljenje z zdravilom PecFent zamenjati z drugim analgetikom.
English: In a fertility and early embryonic development study in rats, a male-mediated effect was observed at high doses (300 mcg/kg/day, s.c.) and is consistent with the sedative effects of fentanyl in animal studies.
Slovenian: V študiji plodnosti in zgodnjega embrionalnega razvoja pri podganah so opazili učinek, prenesen preko samcev, pri velikih odmerkih (300 mikrogramov/kg/dan, s.c.), ki je skladen s sedativnimi učinki fentanila v študijah na živalih.
English: In studies on pre and postnatal development in rats the survival rate of offspring was significantly reduced at doses causing severe maternal toxicity.
Slovenian: V študijah prenatalnega in postnatalnega razvoja pri podganah se je preživetje potomstva pri odmerkih, ki so povzročali težko toksičnost za mater, značilno zmanjšalo.
English: • The PecFent nasal spray dose strengths can not be compared with other PecFent products
Slovenian: • jakosti odmerkov pršila za nos PecFent niso primerljive z drugimi izdelki PecFent;
English: Firmly press down on the finger grips until a ‘click' is heard and then let go of the grips (Figure 2).
Slovenian: Čvrsto pritisnite na sprožilec, dokler ne slišite ‘klik', nato ju spustite (slika 2).
English: It should be noted that although statistically significant increases in Cmax levels were seen following a second dose of PecFent given either one or two hours after the initial dose, this increase is not considered to be large enough to suggest that clinically concerning accumulation or over-exposure would occur, providing a wide safety margin for the recommended dose interval of four hours.
Slovenian: Čeprav so po drugem odmerku zdravila PecFent, danega bodisi eno ali dve uri po začetnem odmerku, ugotovili statistično značilno zvečanje Cmax, menimo, da to zvečanje ni dovolj veliko, da bi kazalo na to, da pride do klinično zaskrbljujočega kopičenja ali prevelike izpostavljenosti, če poskrbimo za širok varnostni razpon za priporočeni interval štirih ur med odmerki.
English: If you or your carer notice any of the side effects above, call an ambulance straight away.
Slovenian: Če opazite ali če vaš negovalec opazi katerega od navedenih neželenih učinkov, nemudoma pokličite rešilca.
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.
Slovenian: Zdravilo PecFent se ne priporoča pri bolnikih, ki so v zadnjih 14 dneh dobili zaviralce monoaminoksidaze (MAO), saj poročajo o resnih in nepredvidljivih povečanjih učinkov zaviralcev MAO z opioidnimi analgetiki.
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.
Slovenian: Takoj ko zdravila PecFent ne potrebujejo več, naj bolniki in člani njihovih gospodinjstev čim prej dosledno zavržejo vse steklenice, ki so jim še ostale, tako da jih shranijo nazaj v vsebnike z zaporko, varno za otroke, in jih odvržejo v skladu z lokalnimi predpisi ali jih vrnejo v lekarno.
English: Don't use any other kind of nasal spray for at least 15 minutes after using PecFent.
Slovenian: Ne uporabljajte nobenih drugih pršil za nos vsaj 15 minut po tistem, ko uporabite zdravilo PecFent.
English: Even if there is little or no medicine left in the bottle, PecFent must be disposed of properly, according to the following steps: o Patients and caregivers must be instructed to properly dispose of all unused, partially used and used PecFent bottles.
Slovenian: Tudi če je v steklenici ostalo malo ali nič zdravila, moramo zdravilo PecFent pravilno odvreči v skladu z naslednjimi koraki: o Bolniki in negovalci morajo biti poučeni o tem, kako se pravilno odvržejo vse neporabljene,
English: PecFent is used in adults with cancer for a type of pain called ‘breakthrough' pain.
Slovenian: Zdravilo PecFent se uporablja pri odraslih z rakom za vrsto bolečine, ki se imenuje ‘prebijajoča' bolečina.
English: Treatment of acute pain other than breakthrough pain.
Slovenian: Zdravljenje druge akutne bolečine kot prebijajoče.
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.
Slovenian: Ti neželeni učinki bodo izginili ali se bo njihova intenzivnost zmanjšala pri stalni uporabi zdravila, ko bo bolnik stitriran na najprimernejši odmerek.
English: Secondary pharmacological effects are respiratory depression, bradycardia, hypothermia, constipation, miosis, physical dependence and euphoria.
Slovenian: Sekundarni farmakološki učinki so depresija dihanja, bradikardija, hipotermija, zaprtost, mioza, telesna odvisnost in evforija.
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).
Slovenian: V farmakokinetični študiji, v kateri so primerjali zdravilo PecFent (100, 200, 400 in 800 mikrogramov) s peroralnim transmukoznim fentanilcitratom (oral transmucosal fentanyl citrateOTFC, 200 mikrogramov), so pokazali, da se fentanil po enkratni intranazalni aplikaciji zdravila PecFent hitro absorbira, mediani Tmax je med 15 in 21 minutami (Tmax za OTFC je bil približno 90 minut).
English: • All unused devices or empty containers should be returned systematically according to the local regulation.
Slovenian: • Vse neuporabljene pripomočke ali prazne vsebnike je treba sistematično vrniti v skladu z lokalnimi predpisi.
English: As with other opioids, in case of insufficient pain control in response to an increased dose of fentanyl, the possibility of opioid-induced hyperalgesia should be considered.
Slovenian: Tako kot pri drugih opioidih, je treba v primeru nezadostnega obvladovanja bolečine v odziv na zvečan odmerek fentanila, upoštevati, da lahko pride do z opioidi sprožene hiperalgezije.
English: As you repeat step 5, the red bar will become smaller and smaller until you see a green bar in the counting window (Figure 3b-e).
Slovenian: Pri ponavljanju koraka 5 bo rdeči stolpec postajal čedalje manjši, dokler se ne bo v okencu števca pojavil zelen stolpec (slika 3b-e).
English: Contents of the pack and other information What PecFent contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo PecFent
English: • When you spray PecFent into your nose the very small spray droplets form a thin gel.
Slovenian: • Ko si razpršite zdravilo PecFent v nos, oblikujejo zelo majhne kapljice pršila redek gel.
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.
Slovenian: Študije toksičnosti za embriofetalni razvoj, opravljene pri podganah in kuncih, niso pokazale malformacij ali razvojnih variacij, povzročenih z zdravilom, ki so ga dajali med organogenezo.
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.
Slovenian: Bolnikom morate povedati, da mogoče ne bodo čutili pršenja, zato morajo verjeti slišnemu kliku in zvečanju števila na števcu, ki potrjujeta, da je bil vpih apliciran.
English: Athletes should be informed that treatment with fentanyl could lead to positive doping tests.
Slovenian: Športnikom morate povedati, da lahko zdravljenje s fentanilom povzroči pozitivne teste na nedovoljena poživila (doping).
English: After the PecFent bottle has been primed (prepared for use) it delivers 2 full sprays.
Slovenian: Potem ko je bila steklenica z zdravilom PecFent ‘aktivirana' (pripravljena za uporabo), odda 2 polnih vpihov.
English: o If there are any unwanted therapeutic sprays remaining in the bottle, the patient should be instructed to expel these as follows:
Slovenian: o Če v steklenici ostane kaj neželenih terapevtskih vpihov, je treba bolnika podučiti, naj steklenico izpraznipo naslednjih navodilih:
English: The plasma protein binding of fentanyl is 80 - 85 %.
Slovenian: 80-85 % fentanila se veže na plazemske beljakovine.
English: • feel very sleepy
Slovenian: • če ste zelo zaspani,
English: • medicines that might make you sleepy such as sleeping tablets, tranquilisers, muscle relaxants, medicines for anxiety or medicines for allergies (anti-histamines)
Slovenian: • zdravila, zaradi katerih bi lahko bili zaspani, na primer uspavala, pomirjevala, mišične relaksante, zdravila za anksioznost ali zdravila za alergije (antihistaminike);
English: PecFent can deliver 100, 200, 400 and 800 microgram doses as follows:
Slovenian: Zdravilo PecFent omogoča dajanje odmerkov po 100, 200, 400 in 800 mikrogramov, in sicer:
English: It is subject to first pass hepatic and intestinal metabolism and the metabolites do not contribute to fentanyl's therapeutic effects.
Slovenian: Izpostavljen je metabolizmu prvega prehoda skozi jetra in črevo, presnovki pa ne prispevajo k terapevtskim učinkom fentanila.
English: This is because the medicine can get into your breast milk and may cause side effects in the breast-fed child.
Slovenian: Zdravilo namreč lahko pride v vaše mleko in povzroči neželene učinke pri dojenem otroku.
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.
Slovenian: Pričakujemo, da bodo simptomi prevelikega odmerka fentanila po nazalni poti po naravi podobni simptomom prevelikega odmerka intravenskega fentanila in drugih opioidov in da bodo razširitev njegovih farmakoloških učinkov, tako da bo najresnejši pomembni učinek depresija dihanja.
English: The metabolites are mainly excreted in the urine, while faecal excretion is less important.
Slovenian: Presnovki se v glavnem izločijo z urinom, izločanje z blatom pa je manj pomembno.
English: If you experience withdrawal symptoms, you should contact your doctor.
Slovenian: Če opazite odtegnitvene simptome, se posvetujte z zdravnikom.
English: • you have breathing problems such as asthma, wheezing or shortness of breath
Slovenian: • imate težave z dihanjem, na primer astmo, sopenje ali kratko sapo;
English: • loss of taste, loss or change in sense of smell
Slovenian: • izguba čuta za okus, izguba ali sprememba voha,
English: May cause allergic reactions (possibly delayed), and exceptionally, bronchospasm (if you do not use the nasal spray correctly).
Slovenian: Lahko povzroča alergijske reakcije (lahko odložene) in izjemoma bronhospazem (če nepravilno uporabljate pršilo za nos).
English: To prime the bottle, please follow the instructions below:
Slovenian: Steklenico aktivirate tako, da se ravnate po navodilih v nadaljevanju:
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.
Slovenian: Kljub temu je glede na pomembnost delovanja ledvic in jeter v presnovi in očistku fentanila pri uporabi zdravila PecFent pri starejših bolnikih potrebna še dodatna skrbnost.
English: Following long-term treatment, fentanyl may cause withdrawal in the new-born infant.
Slovenian: Po dolgoročnem zdravljenju lahko fentanil pri novorojenčku povzroči odtegnitvene simptome.
English: [8 spray bottle:] After first-use, use within 60 days
Slovenian: [Steklenica z 8 vpihi:] Porabite v 60 dneh po prvi uporabi.
English: If this dose is not successful, the patient may be prescribed a bottle of PecFent 400 micrograms/spray and instructed to change to one 400 microgram spray for their next episode of pain.
Slovenian: Če ta odmerek ne zadošča, lahko bolniku predpišemo steklenico zdravila PecFent 400 mikrogramov/vpih in mu naročimo, naj za naslednjo epizodo bolečine uporabi en 400-mikrogramski vpih.
English: Coma is also known to occur.
Slovenian: da lahko nastopi tudi koma.