FrancophonIA/ELRC3.0 huggingface dataset:
English: Depending on the additional analgesic needs and the pain status of the child, it may be decided to increase the dose.
Slovenian: Odvisno od dodatnih potreb po analgeziji in izraženosti bolečine pri otroku se je mogoče odločiti za povečanje odmerka.
English: • If you stop using the patches, don't start again without asking your doctor first.
Slovenian: • Če obliže prenehate uporabljati, jih ne začnite ponovno uporabljati ne da bi se pred tem najprej posvetovali z vašim zdravnikom.
English: • Do not take the patch out of its sachet until you are ready to use it
Slovenian: • Obliža ne vzemite iz vrečice, dokler niste pripravljeni, da ga boste uporabili.
English: Everyday activities while using the patches
Slovenian: Vsakodnevne aktivnosti med uporabo obliža
English: • There is enough medicine in each patch to last 3 days (72 hours).
Slovenian: • V vsakem obližu je dovolj zdravila, da zadostuje za 3 dni (72 ur).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION <Date of first authorisation: {DD month YYYY}> <Date of latest renewal: {DD month YYYY}>
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: {DD. mesec LLLL} Datum zadnjega podaljšanja: {DD. mesec LLLL}
English: Eighty of the children were aged 2 to 6 years, inclusive.
Slovenian: Osemdeset otrok je bilo starih 2 do 6 let.
English: Step 1: Preparing the skin
Slovenian: 1. korak: Priprava kože
English: A mutagenic risk for the use of therapeutic doses seems unlikely since effects appeared only at high concentrations.
Slovenian: Tveganje mutagenih učinkov se zdi pri uporabi terapevtskih odmerkov malo verjetno, saj so se učinki pojavili samo pri velikih koncentracijah.
English: Fentanyl can be abused in a manner similar to other opioid agonists.
Slovenian: Fentanil je možno zlorabiti na podoben način kot ostale opioidne agoniste.
English: • Your doctor may give you other painkillers as well for the first day or so
Slovenian: • Vaš zdravnik vam utegne dati še dodatna protibolečinska zdravila za prvi dan ali dva.
English: Standard reproductive and developmental toxicity studies have been carried out using parenteral administration of fentanyl.
Slovenian: Standardne študije reproduktivne in razvojne toksičnosti so opravili s parenteralnim dajanjem fentanila.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Interakcije, povezane s farmakodinamiko
English: The adverse reactions are presented by System Organ Class and in order of decreasing seriousness within each frequency category.
Slovenian: Neželeni učinki so navedeni po organskih sistemih in padajoči resnosti znotraj vsake kategorije pogostnosti.
English: Change the patch again after 3 days (72 hours) as usual.
Slovenian: Obliž ponovno zamenjajte po 3 dneh (72 urah) kot običajno.
English: • You have pain which lasts only for a short period, such as sudden pain or pain after having an operation
Slovenian: • če imate bolečine, ki trajajo le krajše obdobje, npr. nenadna bolečina ali bolečina po kirurškem posegu,
English: • You have ever had persistent headaches or a head injury
Slovenian: • če ste kadar koli imeli vztrajne glavobole ali poškodbo glave
English: Abuse or intentional misuse of DUROGESIC may result in overdose and/or death.
Slovenian: Zloraba ali namerna napačna uporaba zdravila DUROGESIC lahko vodi v prekomerno odmerjanje in/ali smrt.
English: Opioids may cause hypotension, especially in patients with acute hypovolaemia.
Slovenian: Opioidi lahko povzročijo hipotenzijo, še posebno pri bolnikih z akutno hipovolemijo.
English: This may result in increased serum concentrations (see section 5.2) and the patient should be monitored closely.
Slovenian: To lahko privede do zvečanja serumskih koncentracij (glejte poglavje 5.2), zato je treba bolnika skrbno spremljati.
English: • Make sure that the patch will be covered by loose clothing and not stuck under a tight or elasticated band
Slovenian: • Poskrbite, da bo obliž nameščen pod ohlapnimi oblačili in ne pod tesnim ali elastičnim trakom.
English: Alternative routes of administration (oral, parenteral) should be considered.
Slovenian: Razmisliti je treba o drugih načinih uporabe (peroralna, parenteralna).
English: Studies in animals have shown some reproductive toxicity (see section 5.3).
Slovenian: Študije na živalih so pokazale nekaj reprodukcijske toksičnosti (glejte poglavje 5.3).
English: The patches help relieve pain that is very bad and long-lasting:
Slovenian: Obliži pomagajo lajšati hude in dolgotrajne bolečine:
English: • Watch your child very closely for 48 hours after: - The first patch has been put on - A higher dose patch has been put on
Slovenian: • Otroke je treba zelo pozorno spremljati 48 ur po: - prvi namestitvi obliža
English: If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Slovenian: Če ste noseči ali dojite, menite da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
English: In a study on pre- and postnatal development the survival rate of offspring was significantly reduced at doses which slightly reduced maternal weight.
Slovenian: V študiji pre- in postnatalnega razvoja je bila stopnja preživetja mladičev pomembno zmanjšana pri odmerkih, ki so nekoliko zmanjšali telesno maso samice.
English: Soaps, oils, lotions, or any other agent that might irritate the skin or alter its characteristics should not be used.
Slovenian: Mila, olj, losjonov ali drugih sredstev, ki bi lahko razdražila kožo in spremenila njene lastnosti, se ne sme uporabiti.
English: The average bioavailability of fentanyl after application of the transdermal patch is 92%.
Slovenian: Povprečna biološka uporabnost fentanila po aplikaciji transdermalnega obliža je 92%.
English: It should be noted that this conversion schedule for children only applies to the switch from oral morphine (or its equivalent) to DUROGESIC patches.
Slovenian: Upoštevati je treba, da ta shema preračunavanja za otroke velja le v primeru prehoda s peroralnega morfina (ali njegovega ekvivalenta) na transdermalne obliže DUROGESIC.
English: In a study in cancer patients treated with transdermal fentanyl, plasma protein binding was on average 95% (range 77-100%).
Slovenian: V študiji pri bolnikih z rakom, ki so prejemali fentanil transdermalno, je bila povprečna vezava na plazemske beljakovine 95 % (od 77 do 100 %).
English: • Always change your patch at the same time of day every 3 Days (72 hours).
Slovenian: • Obliž vedno zamenjajte ob istem času vsake 3 dni (72 ur).
English: Adjusting for body weight, clearance (L/h/kg) appears to be approximately 80% higher in children 2 to 5 years old and 25% higher in children 6 to 10 years old when compared to children 11 to 16 years old, who are expected to have a similar clearance as adults.
Slovenian: Očistek (l/h/kg), ob upoštevanju telesne mase, je približno 80% večji pri otrocih, starih 2 do 5 let, in za 25% večji pri otrocih, starih 6 do 10 let, kot pri otrocih, starih 11 do 16 let, pri katerih se pričakuje podoben očistek kot pri odraslih.
English: • Swollen hands, ankles or feet (peripheral oedema)
Slovenian: • otečene dlani, gležnji ali stopala (periferni edem)
English: 6.6 Special precautions for disposal and other handling Instructions for disposal:
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje Navodila za odstranjevanje:
English: If there is hair, do not shave it (shaving irritates the skin).
Slovenian: Če so na koži dlake, jih ne brijte (britje draži kožo).
English: • Make a note of the day, date and time you apply a patch, to remind you when you need to change your patch.
Slovenian: • Zapišite si dan, datum in čas, ko ste si obliž namestili, da boste vedeli, kdaj morate obliž zamenjati.
English: • Slow heart beat (bradycardia) or low blood pressure
Slovenian: • počasnejše bitje srca (bradikardija) ali nizek krvni tlak
English: • You have a condition called ‘myasthenia gravis' in which muscles become weak and tire easily.
Slovenian: • če imate bolezen, imenovano miastenija gravis, pri kateri mišice postanejo šibke in se hitro utrudijo
English: Following a 72-hour patch application, the mean fentanyl half-life ranges from 20 to 27 hours.
Slovenian: Po 72 urni aplikaciji je povprečni razpolovni čas 20-27 ur.
English: However, your doctor may still prescribe extra painkillers from time to time
Slovenian: Kljub temu vam bo zdravnik morda od časa do časa predpisal dodatna protibolečinska zdravila.
English: • You have ever had a brain tumour
Slovenian: • če ste kadar koli imeli možganski tumor
English: A carcinogenicity study (daily subcutaneous injections of fentanyl hydrochloride for two years in Sprague Dawley rats) did not induce any findings indicative of oncogenic potential.
Slovenian: V študiji kancerogenosti (dnevne podkožne injekcije fentanilijevega klorida v obdobju dveh let pri podganah Sprague Dawley) ni bilo ugotovitev, ki bi kazale na onkogeni potencial.
English: • Blue colour to the skin caused by low oxygen in the blood (cyanosis)
Slovenian: • modro obarvanje kože zaradi pomanjkanja kisika v krvi (cianoza)
English: • You have ever had problems with your heart, liver, kidneys, or low blood pressure
Slovenian: • če ste kadar koli imeli težave s srcem, jetri, ledvicami ali nizek krvni tlak
English: DUROGESIC should not be used in children aged less than 2 years because the safety and efficacy have not been established.
Slovenian: Zdravilo DUROGESIC se ne sme uporabljati pri otrocih, mlajših od 2 let, ker varnost in učinkovitost še nista bili dokazani.
English: The pharmacokinetics of transdermal fentanyl do not change with repeated application.
Slovenian: Farmakokinetika transdermalnega fentanila se s ponavljajočimi aplikacijami ne spremeni.
English: Other factors to be considered are the current general condition and medical status of the patient, including body size, age, and extent of debilitation as well as degree of opioid tolerance.
Slovenian: Upoštevati je treba tudi trenutno splošno in zdravstveno stanje bolnika, vključno z velikostjo, starostjo, obsegom prizadetosti in stopnjo tolerance na opioide.
English: * the assigned frequency (uncommon) is based on analyses of incidence including only adult and paediatric clinical study subjects with non-cancer pain.
Slovenian: *dodeljena pogostnost (občasni) temelji na analizi pogostnosti, v katero so vključili samo odrasle in pediatrične preiskovance z bolečinami, ki niso bile povezane z rakavimi obolenji.
English: • You can shower or bathe while wearing a patch, but do not scrub the patch itself
Slovenian: • Med uporabo obliža se lahko tuširate ali kopate, vendar samega obliža ne drgnite.
English: <[To be completed nationally]> <Other sources of information> <Detailed information on this medicine is available on the website of {name of MS Agency (link)}>
Slovenian: Drugi viri informacij <Podrobne informacije o zdravilu so objavljene na spletni strani {ime agencije v državi članici (povezava)}
English: Fentanyl accumulates in skeletal muscle and fat and is released slowly into blood.
Slovenian: Fentanil se akumulira v skeletnih mišicah in maščobi ter se počasi sprošča v kri.
English: • If you are very late changing your patch, you should talk to your doctor because you might need some extra painkillers, but do not apply an extra patch.
Slovenian: • Če ste pri zamenjavi obliža zelo pozni, obvestite zdravnika, ker boste morda potrebovali dodatna protibolečinska zdravila, vendar si dodatnega obliža ne namestite.
English: Pharmacotherapeutic group: Analgesics, Opioids, phenylpiperidine derivatives, ATC code: N02AB03
Slovenian: Farmakoterapevtska skupina: opioidi; derivati fenilpiperidina Oznaka ATC: N02AB03
English: You should also tell your pharmacist that you are using DUROGESIC if you buy any medicines from your pharmacy.
Slovenian: Tudi farmacevtu morate povedati, da uporabljate zdravilo DUROGESIC, če boste v lekarni kupili katero koli zdravilo.
English: Opioid withdrawal symptoms are possible in some patients after conversion or dose adjustment.
Slovenian: Opioidni odtegnitveni simptomi so pri nekaterih bolnikih možni po zamenjavi zdravila ali prilagoditvi odmerka.
English: • Do not stick a patch on straight after a hot bath or shower
Slovenian: • Obliža si ne namestite takoj po vroči kopeli ali tušu.
English: Reversal of the narcotic effect may result in acute onset of pain and release of catecholamines.
Slovenian: Odprava narkotičnega učinka lahko povzroči akuten pojav bolečin in sproščanje kateholaminov.
English: Avoid touching the adhesive side of the patch.
Slovenian: Izogibajte se dotikanju lepljive strani obliža.
English: Fentanyl crosses the blood-brain barrier easily.
Slovenian: Fentanil zlahka prehaja skozi krvno-možgansko bariero.
English: Bear in mind that a sticky patch (unused or used) could be tempting to a child and if it sticks to a child's skin or they put it in their mouth, the result may be fatal.
Slovenian: Ne pozabite, da je lepljiv obliž (neuporabljen ali uporabljen) lahko privlačen za otroka in, če se prilepi na otrokovo kožo ali ga otrok da v usta, lahko povzroči smrt.
English: • After this, the patch should help to relieve pain continuously so that you can stop taking other painkillers.
Slovenian: • Potem bi obliž moral odpravljati bolečino nepretrgano in boste lahko prenehali jemati druga protibolečinska zdravila.
English: The expiry date refers to the last date of that month.
Slovenian: Datum uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: After intravenous administration, fentanyl mean total clearance values across studies range in general between 34 and 66 L/h.
Slovenian: Po intravenskem injiciranju so bile skupne povprečne vrednosti očistka fentanila med študijami v splošnem med 34 in 66 l/h.
English: • Decreased feeling or sensitivity, especially in the skin (hypoaesthesia)
Slovenian: • zmanjšana občutljivost na dražljaje, zlasti v koži (hipestezija)
English: This leaflet was last revised in <{MM/YYYY}> <{month YYYY}>.
Slovenian: Navodilo je bilo nazadnje revidirano dne <{MM/LLLL}> <{mesec LLLL}>
English: Initial dosage selection
Slovenian: Izbira začetnega odmerka
English: This is usually mild and disappears after you have removed the patch.
Slovenian: To je običajno blago in izzveni, ko odstranite obliž.
English: • Areas that you move a lot (joints), skin that is irritated or with cuts.
Slovenian: • območja, ki jih zelo veliko premikate (sklepi), razdraženo kožo ali kožo z vrezninami.
English: • Every so often check that the patch remains stuck to the skin.
Slovenian: • Vsake toliko časa preverite, da obliž ostane dobro prilepljen na kožo.
English: • You are allergic to fentanyl or any of the other ingredients of this medicine (listed in section 6)
Slovenian: • če ste alergični na fentanil ali katero koli sestavino tega zdravila (navedeno v poglavju 6),
English: Therefore, your child might need to use other painkillers as well until the patches become effective.
Slovenian: Zato bo vaš otrok morda potreboval dodatna protibolečinska zdravila, dokler obliž ne začne delovati v celoti.
English: Children aged 16 years and above Follow adult dosage.
Slovenian: Otroci, stari 16 let in starejši Upoštevajte odmerjanje za odrasle.
English: • If a patch falls off before it needs changing, stick a new one on straight away and make note of the day and time.
Slovenian: • Če se vam obliž odlepi, preden je čas za zamenjavo, si takoj namestite novega in zabeležite dan in čas.
English: Due to accumulation, the AUC and Cmax values over a dosing interval at steady state are approximately 40% higher than after a single application.
Slovenian: Zaradi akumulacije sta vrednosti AUC in Cmax med celotnim intervalom odmerjanja v dinamičnem ravnovesju približno za 40% večji kot po enkratni aplikaciji.
English: DUROGESIC has not been studied in children under 2 years of age.
Slovenian: Zdravila DUROGESIC niso preučevali pri otrocih, mlajših od 2 let.
English: Apply the patch to the skin by applying light pressure with the palm of the hand for about 30 seconds.
Slovenian: Obliž prilepimo na kožo tako, da ga z dlanjo pritiskamo na kožo približno 30 sekund.
English: In such patients, opioids may decrease respiratory drive and increase airway resistance.
Slovenian: Pri teh bolnikih lahko opioidi zmanjšajo dražljaj za dihanje in povečajo upor v dihalnih poteh.
English: Tables 1, 2, and 3 should only be used to convert from other opioids to DUROGESIC and not from DUROGESIC to other therapies to avoid overestimating the new analgesic dose and potentially causing overdose.
Slovenian: Preglednice 1, 2 in 3 se sme uporabljati le za prehod z drugih opioidov na zdravilo DUROGESIC, ne pa z zdravila DUROGESIC na druga zdravila, da ne bi precenili odmerka novega analgetika in tako povzročili prevelikega odmerjanja.
English: • DUROGESIC can have life-threatening side effects in people who are not already regulary using prescribed opioid medicines.
Slovenian: • Zdravilo DUROGESIC ima lahko smrtno nevarne neželene učinke pri osebah, ki še ne uporabljajo redno predpisanih opioidnih zdravil.
English: If the patches are out of date, take them to your pharmacy.
Slovenian: Če je rok uporabnosti obližev pretečen, jih odnesite v lekarno.
English: If you think that you are going to receive anaesthesia tell your doctor or dentist that you are using DUROGESIC.
Slovenian: Če menite, da boste prejeli anestetik, povejte svojemu zdravniku ali zobozdravniku, da uporabljate zdravilo DUROGESIC.
English: Patients and their carers must be instructed that DUROGESIC contains an active substance in an amount that can be fatal, especially to a child.
Slovenian: Bolniki in njihove skrbnike je treba opozoriti, da zdravilo DUROGESIC vsebuje zdravilno učinkovino v količini, ki je lahko smrtna, predvsem to velja za otroke.
English: A pharmacokinetic model has suggested that serum fentanyl concentrations may increase by 14% (range 0-26%) if a new patch is applied after 24 hours rather than the recommended 72-hour application.
Slovenian: Farmakokinetični model je pokazal, da se serumske koncentracije fentanila lahko zvečajo za 14 % (v razponu 0-26 %), če se nov obliž namesti po 24 urah in ne po 72 urah, kot je priporočljivo.
English: • Some antihistamines, especially ones that make you sleepy (such as chlorpheniramine, clemastine,
Slovenian: • Nekatere antihistaminike, še posebej tiste, ki vas uspavajo (kot so klorfeniramin, klemastin,
English: These findings have been taken into consideration in determining the dosing recommendations for paediatric patients (see sections 4.2 and 4.4).
Slovenian: Ta ugotovitev je bila upoštevana pri določanju priporočil za odmerjanje pri pediatričnih bolnikih (glejte poglavji 4.2 in 4.4).
English: Patches that are cut, divided, or damaged in any way should not be used.
Slovenian: Razdeljenega, prerezanega ali kakorkoli poškodovanega obliža ne smemo uporabiti.
English: Step 2: Open the sachet
Slovenian: 2. korak: Odprite blazinico
English: Some studies with female rats revealed reduced fertility and enhanced embryo mortality.
Slovenian: Nekatere študije na podganjih samicah so pokazale zmanjšano plodnost in povečano umrljivost zarodkov.
English: This is because the medicine may pass into breast milk.
Slovenian: Majhne količine mleka lahko namreč prehajajo v materino mleko.
English: For management of respiratory depression, immediate countermeasures include removing the DUROGESIC patch and physically or verbally stimulating the patient.
Slovenian: Za obvladovanje depresije dihanja je potrebno takojšnje ukrepanje, kar vključuje odstranitev zdravila DUROGESIC in telesno ali besedno stimulacijo bolnika.
English: These subjects received at least one dose of DUROGESIC and provided safety data.
Slovenian: Preiskovanci so prejeli najmanj en odmerek zdravila DUROGESIC in posredovali podatke o varnosti.
English: These subjects received at least one dose of DUROGESIC and provided safety data (see section 5.1).
Slovenian: Ti preiskovanci so prejeli najmanj en odmerek zdravila DUROGESIC in posredovali podatke o varnosti (glejte poglavje 5.1).
English: The skin should be completely dry before the patch is applied.
Slovenian: Pred uporabo obliža mora biti koža popolnoma suha.
English: However, the duration of inhibition varies and for some CYP3A4 inhibitors with a long elimination half-life, such as amiodarone, or for time-dependent inhibitors such as erythromycin, idelalisib, nicardipine and ritonavir, this period may need to be longer.
Slovenian: Vendar pa zaviranje traja različno dolgo in je pri nekaterih zaviralcih CYP3A4 z dolgim razpolovnim časom izločanja, kot je amiodaron, ali od časa odvisnih zaviralcih, kot so eritromicin, idelalizib, nikardipin in ritonavir, lahko to obdobje daljše.
English: Patients with a prior history of drug dependence/alcohol abuse are more at risk to develop dependence and abuse in opioid treatment.
Slovenian: Pri bolnikih z anamnezo odvisnosti od prepovedanih drog/alkohola je tveganje za razvoj odvisnosti in zlorabe pri zdravljenju z opioidi večje.
English: Patients who have experienced serious adverse events should be monitored for at least 24 hours after removal of DUROGESIC, or more, as clinical symptoms dictate, because serum fentanyl concentrations decline gradually and are reduced by about 50% 20 to 27 hours later.
Slovenian: Bolnike, pri katerih so se pojavili resni neželeni učinki, moramo opazovati najmanj 24 ur po odstranitvi zdravila DUROGESIC ali več, odvisno od kliničnih simptomov, ker serumske koncentracije fentanila upadajo postopoma in se v 20 do 27 urah zmanjšajo za približno 50%.
English: • If you get a fever while using DUROGESIC, tell your doctor - this may increase the amount of medicine that passes through your skin
Slovenian: • Če se vam med uporabo zdravila DUROGESIC poviša telesna temperatura, to povejte svojemu zdravniku, saj se lahko poveča količino zdravila, ki prehaja skozi vašo kožo.
English: • Carefully peel one half of the shiny plastic backing away from the centre of the patch.
Slovenian: • Previdno odlepite polovico plastične zaščitne plasti v smeri od središča obliža.
English: • If your doctor agrees, you can exercise or play sport while wearing the patch
Slovenian: • Če želite in če se vaš zdravnik strinja, lahko med uporabo obliža tudi telovadite ali se ukvarjate s športnimi dejavnostmi.
English: • Being unable to pass urine or empty bladder completely
Slovenian: • nezmožnost uriniranja ali popolnega izpraznenja sečnega mehurja
English: • Grasp both sides of the opened sachet and pull apart
Slovenian: • Primite obe strani odprte vrečice in potegnite narazen.
English: These actions can be followed by administration of a specific opioid antagonist such as naloxone.
Slovenian: Tem ukrepom lahko sledi uporaba specifičnega opioidnega antagonista, kot je nalokson.
English: Effects on the embryo were due to maternal toxicity and not to direct effects of the substance on the developing embryo.
Slovenian: Učinki na zarodek so nastopili zaradi toksičnosti za mater, torej ni šlo za neposredne učinke na razvijajoči se zarodek.
English: • Feeling very tired, weak or generally unwell
Slovenian: • občutek hude utrujenosti, šibkost ali splošno slabo počutje
English: 0.4b tapentadol oral parenteral tramadol oral parenteral a The oral/IM potency for morphine is based on clinical experience in patients with chronic pain.
Slovenian: 0,4b tapentadol peroralna parenteralna tramadol peroralna parenteralna a Učinkovitost peroralnega/i.m.morfina temelji na osnovi kliničnih izkušenj pri bolnikih s kronično bolečino.
English: • If your pain gets worse while you are using these patches, your doctor may try a higher strength patch, or give you additional painkillers (or both)
Slovenian: • Če se med uporabo obliža bolečina poslabša, zdravnik lahko poskusi z večjo jakostjo obliža ali pa vam predpiše dodatna protibolečinska zdravila (ali oboje).
English: The following side effects have also been reported
Slovenian: Poročali so tudi o naslednjih neželenih učinkih: