natgillin/translations-raw huggingface dataset:
The patches help relieve pain that is very bad and long-lasting:
Obliži pomagajo lajšati hude in dolgotrajne bolečine:
• Watch your child very closely for 48 hours after: - The first patch has been put on - A higher dose patch has been put on
• Otroke je treba zelo pozorno spremljati 48 ur po: - prvi namestitvi obliža
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.
Če ste noseči ali dojite, menite da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
In a study on pre- and postnatal development the survival rate of offspring was significantly reduced at doses which slightly reduced maternal weight.
V študiji pre- in postnatalnega razvoja je bila stopnja preživetja mladičev pomembno zmanjšana pri odmerkih, ki so nekoliko zmanjšali telesno maso samice.
Soaps, oils, lotions, or any other agent that might irritate the skin or alter its characteristics should not be used.
Mila, olj, losjonov ali drugih sredstev, ki bi lahko razdražila kožo in spremenila njene lastnosti, se ne sme uporabiti.
The average bioavailability of fentanyl after application of the transdermal patch is 92%.
Povprečna biološka uporabnost fentanila po aplikaciji transdermalnega obliža je 92%.
It should be noted that this conversion schedule for children only applies to the switch from oral morphine (or its equivalent) to DUROGESIC patches.
Upoštevati je treba, da ta shema preračunavanja za otroke velja le v primeru prehoda s peroralnega morfina (ali njegovega ekvivalenta) na transdermalne obliže DUROGESIC.
In a study in cancer patients treated with transdermal fentanyl, plasma protein binding was on average 95% (range 77-100%).
V študiji pri bolnikih z rakom, ki so prejemali fentanil transdermalno, je bila povprečna vezava na plazemske beljakovine 95 % (od 77 do 100 %).
• Always change your patch at the same time of day every 3 Days (72 hours).
• Obliž vedno zamenjajte ob istem času vsake 3 dni (72 ur).
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.
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.
• Swollen hands, ankles or feet (peripheral oedema)
• otečene dlani, gležnji ali stopala (periferni edem)
6.6 Special precautions for disposal and other handling Instructions for disposal:
6.6 Posebni varnostni ukrepi za odstranjevanje Navodila za odstranjevanje:
If there is hair, do not shave it (shaving irritates the skin).
Če so na koži dlake, jih ne brijte (britje draži kožo).
• Make a note of the day, date and time you apply a patch, to remind you when you need to change your patch.
• Zapišite si dan, datum in čas, ko ste si obliž namestili, da boste vedeli, kdaj morate obliž zamenjati.
• Slow heart beat (bradycardia) or low blood pressure
• počasnejše bitje srca (bradikardija) ali nizek krvni tlak
• You have a condition called ‘myasthenia gravis' in which muscles become weak and tire easily.
• če imate bolezen, imenovano miastenija gravis, pri kateri mišice postanejo šibke in se hitro utrudijo
Following a 72-hour patch application, the mean fentanyl half-life ranges from 20 to 27 hours.
Po 72 urni aplikaciji je povprečni razpolovni čas 20-27 ur.
However, your doctor may still prescribe extra painkillers from time to time
Kljub temu vam bo zdravnik morda od časa do časa predpisal dodatna protibolečinska zdravila.
• You have ever had a brain tumour
• če ste kadar koli imeli možganski tumor
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.
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.
• Blue colour to the skin caused by low oxygen in the blood (cyanosis)
• modro obarvanje kože zaradi pomanjkanja kisika v krvi (cianoza)
• You have ever had problems with your heart, liver, kidneys, or low blood pressure
• če ste kadar koli imeli težave s srcem, jetri, ledvicami ali nizek krvni tlak
DUROGESIC should not be used in children aged less than 2 years because the safety and efficacy have not been established.
Zdravilo DUROGESIC se ne sme uporabljati pri otrocih, mlajših od 2 let, ker varnost in učinkovitost še nista bili dokazani.
The pharmacokinetics of transdermal fentanyl do not change with repeated application.
Farmakokinetika transdermalnega fentanila se s ponavljajočimi aplikacijami ne spremeni.
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.
Upoštevati je treba tudi trenutno splošno in zdravstveno stanje bolnika, vključno z velikostjo, starostjo, obsegom prizadetosti in stopnjo tolerance na opioide.
* the assigned frequency (uncommon) is based on analyses of incidence including only adult and paediatric clinical study subjects with non-cancer pain.
*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.
• You can shower or bathe while wearing a patch, but do not scrub the patch itself
• Med uporabo obliža se lahko tuširate ali kopate, vendar samega obliža ne drgnite.
<[To be completed nationally]> <Other sources of information> <Detailed information on this medicine is available on the website of {name of MS Agency (link)}>
Drugi viri informacij <Podrobne informacije o zdravilu so objavljene na spletni strani {ime agencije v državi članici (povezava)}
Fentanyl accumulates in skeletal muscle and fat and is released slowly into blood.
Fentanil se akumulira v skeletnih mišicah in maščobi ter se počasi sprošča v kri.
• 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.
• Če ste pri zamenjavi obliža zelo pozni, obvestite zdravnika, ker boste morda potrebovali dodatna protibolečinska zdravila, vendar si dodatnega obliža ne namestite.
Pharmacotherapeutic group: Analgesics, Opioids, phenylpiperidine derivatives, ATC code: N02AB03
Farmakoterapevtska skupina: opioidi; derivati fenilpiperidina Oznaka ATC: N02AB03
You should also tell your pharmacist that you are using DUROGESIC if you buy any medicines from your pharmacy.
Tudi farmacevtu morate povedati, da uporabljate zdravilo DUROGESIC, če boste v lekarni kupili katero koli zdravilo.
Opioid withdrawal symptoms are possible in some patients after conversion or dose adjustment.
Opioidni odtegnitveni simptomi so pri nekaterih bolnikih možni po zamenjavi zdravila ali prilagoditvi odmerka.
• Do not stick a patch on straight after a hot bath or shower
• Obliža si ne namestite takoj po vroči kopeli ali tušu.
Reversal of the narcotic effect may result in acute onset of pain and release of catecholamines.
Odprava narkotičnega učinka lahko povzroči akuten pojav bolečin in sproščanje kateholaminov.
Avoid touching the adhesive side of the patch.
Izogibajte se dotikanju lepljive strani obliža.
Fentanyl crosses the blood-brain barrier easily.
Fentanil zlahka prehaja skozi krvno-možgansko bariero.
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.
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.
• After this, the patch should help to relieve pain continuously so that you can stop taking other painkillers.
• Potem bi obliž moral odpravljati bolečino nepretrgano in boste lahko prenehali jemati druga protibolečinska zdravila.
The expiry date refers to the last date of that month.
Datum uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
After intravenous administration, fentanyl mean total clearance values across studies range in general between 34 and 66 L/h.
Po intravenskem injiciranju so bile skupne povprečne vrednosti očistka fentanila med študijami v splošnem med 34 in 66 l/h.
• Decreased feeling or sensitivity, especially in the skin (hypoaesthesia)
• zmanjšana občutljivost na dražljaje, zlasti v koži (hipestezija)
This leaflet was last revised in <{MM/YYYY}> <{month YYYY}>.
Navodilo je bilo nazadnje revidirano dne <{MM/LLLL}> <{mesec LLLL}>
Initial dosage selection
Izbira začetnega odmerka
This is usually mild and disappears after you have removed the patch.
To je običajno blago in izzveni, ko odstranite obliž.
• Areas that you move a lot (joints), skin that is irritated or with cuts.
• območja, ki jih zelo veliko premikate (sklepi), razdraženo kožo ali kožo z vrezninami.
• Every so often check that the patch remains stuck to the skin.
• Vsake toliko časa preverite, da obliž ostane dobro prilepljen na kožo.
• You are allergic to fentanyl or any of the other ingredients of this medicine (listed in section 6)
• če ste alergični na fentanil ali katero koli sestavino tega zdravila (navedeno v poglavju 6),
Therefore, your child might need to use other painkillers as well until the patches become effective.
Zato bo vaš otrok morda potreboval dodatna protibolečinska zdravila, dokler obliž ne začne delovati v celoti.
Children aged 16 years and above Follow adult dosage.
Otroci, stari 16 let in starejši Upoštevajte odmerjanje za odrasle.
• If a patch falls off before it needs changing, stick a new one on straight away and make note of the day and time.
• Če se vam obliž odlepi, preden je čas za zamenjavo, si takoj namestite novega in zabeležite dan in čas.
Due to accumulation, the AUC and Cmax values over a dosing interval at steady state are approximately 40% higher than after a single application.
Zaradi akumulacije sta vrednosti AUC in Cmax med celotnim intervalom odmerjanja v dinamičnem ravnovesju približno za 40% večji kot po enkratni aplikaciji.
DUROGESIC has not been studied in children under 2 years of age.
Zdravila DUROGESIC niso preučevali pri otrocih, mlajših od 2 let.
Apply the patch to the skin by applying light pressure with the palm of the hand for about 30 seconds.
Obliž prilepimo na kožo tako, da ga z dlanjo pritiskamo na kožo približno 30 sekund.
In such patients, opioids may decrease respiratory drive and increase airway resistance.
Pri teh bolnikih lahko opioidi zmanjšajo dražljaj za dihanje in povečajo upor v dihalnih poteh.
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.
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.
• DUROGESIC can have life-threatening side effects in people who are not already regulary using prescribed opioid medicines.
• Zdravilo DUROGESIC ima lahko smrtno nevarne neželene učinke pri osebah, ki še ne uporabljajo redno predpisanih opioidnih zdravil.
If the patches are out of date, take them to your pharmacy.
Če je rok uporabnosti obližev pretečen, jih odnesite v lekarno.
If you think that you are going to receive anaesthesia tell your doctor or dentist that you are using DUROGESIC.
Če menite, da boste prejeli anestetik, povejte svojemu zdravniku ali zobozdravniku, da uporabljate zdravilo DUROGESIC.
Patients and their carers must be instructed that DUROGESIC contains an active substance in an amount that can be fatal, especially to a child.
Bolniki in njihove skrbnike je treba opozoriti, da zdravilo DUROGESIC vsebuje zdravilno učinkovino v količini, ki je lahko smrtna, predvsem to velja za otroke.
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.
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.
• Some antihistamines, especially ones that make you sleepy (such as chlorpheniramine, clemastine,
• Nekatere antihistaminike, še posebej tiste, ki vas uspavajo (kot so klorfeniramin, klemastin,
These findings have been taken into consideration in determining the dosing recommendations for paediatric patients (see sections 4.2 and 4.4).
Ta ugotovitev je bila upoštevana pri določanju priporočil za odmerjanje pri pediatričnih bolnikih (glejte poglavji 4.2 in 4.4).
Patches that are cut, divided, or damaged in any way should not be used.
Razdeljenega, prerezanega ali kakorkoli poškodovanega obliža ne smemo uporabiti.
Step 2: Open the sachet
2. korak: Odprite blazinico
Some studies with female rats revealed reduced fertility and enhanced embryo mortality.
Nekatere študije na podganjih samicah so pokazale zmanjšano plodnost in povečano umrljivost zarodkov.
This is because the medicine may pass into breast milk.
Majhne količine mleka lahko namreč prehajajo v materino mleko.
For management of respiratory depression, immediate countermeasures include removing the DUROGESIC patch and physically or verbally stimulating the patient.
Za obvladovanje depresije dihanja je potrebno takojšnje ukrepanje, kar vključuje odstranitev zdravila DUROGESIC in telesno ali besedno stimulacijo bolnika.
These subjects received at least one dose of DUROGESIC and provided safety data.
Preiskovanci so prejeli najmanj en odmerek zdravila DUROGESIC in posredovali podatke o varnosti.
These subjects received at least one dose of DUROGESIC and provided safety data (see section 5.1).
Ti preiskovanci so prejeli najmanj en odmerek zdravila DUROGESIC in posredovali podatke o varnosti (glejte poglavje 5.1).
The skin should be completely dry before the patch is applied.
Pred uporabo obliža mora biti koža popolnoma suha.
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.
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.
Patients with a prior history of drug dependence/alcohol abuse are more at risk to develop dependence and abuse in opioid treatment.
Pri bolnikih z anamnezo odvisnosti od prepovedanih drog/alkohola je tveganje za razvoj odvisnosti in zlorabe pri zdravljenju z opioidi večje.
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.
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%.
• If you get a fever while using DUROGESIC, tell your doctor - this may increase the amount of medicine that passes through your skin
• 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.
• Carefully peel one half of the shiny plastic backing away from the centre of the patch.
• Previdno odlepite polovico plastične zaščitne plasti v smeri od središča obliža.
• If your doctor agrees, you can exercise or play sport while wearing the patch
• Če želite in če se vaš zdravnik strinja, lahko med uporabo obliža tudi telovadite ali se ukvarjate s športnimi dejavnostmi.
• Being unable to pass urine or empty bladder completely
• nezmožnost uriniranja ali popolnega izpraznenja sečnega mehurja
• Grasp both sides of the opened sachet and pull apart
• Primite obe strani odprte vrečice in potegnite narazen.
These actions can be followed by administration of a specific opioid antagonist such as naloxone.
Tem ukrepom lahko sledi uporaba specifičnega opioidnega antagonista, kot je nalokson.
Effects on the embryo were due to maternal toxicity and not to direct effects of the substance on the developing embryo.
Učinki na zarodek so nastopili zaradi toksičnosti za mater, torej ni šlo za neposredne učinke na razvijajoči se zarodek.
• Feeling very tired, weak or generally unwell
• občutek hude utrujenosti, šibkost ali splošno slabo počutje
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.
0,4b tapentadol peroralna parenteralna tramadol peroralna parenteralna a Učinkovitost peroralnega/i.m.morfina temelji na osnovi kliničnih izkušenj pri bolnikih s kronično bolečino.
• 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)
• Če se med uporabo obliža bolečina poslabša, zdravnik lahko poskusi z večjo jakostjo obliža ali pa vam predpiše dodatna protibolečinska zdravila (ali oboje).
The following side effects have also been reported
Poročali so tudi o naslednjih neželenih učinkih:
If severe or persistent hypotension occurs, hypovolemia should be considered, and the condition should be managed with appropriate parenteral fluid therapy.
Če se pojavi huda ali trdovratna hipotenzija, je treba upoštevati možnost hipovolemije in stanje obvladati z ustreznim parenteralnim dovajanjem tekočin.
You might need a different patch strength when you restart
Morda boste pri ponovni uporabi potrebovali drugačno jakost.
• Put it back in its original sachet and dispose of the sachet as instructed by your pharmacist
• Uporabljene obliže dajte nazaj v originalno blazinico in jo odstranite tako, kot vam je naročil farmacevt.
4.1 Therapeutic indications
4.1 Terapevtske indikacije Odrasli
You may notice rashes, redness or slight itching of the skin at the site of the patch.
Morda boste opazili izpuščaje, rdečico ali rahlo srbenje kože na mestu, kjer je nameščen obliž.
• Stopping breathing from time to time (apnoea)
• občasna zaustavitev dihanja (apneja)
In a rat study fentanyl did not influence male fertility.
V študiji na podganah fentanil ni vplival na plodnost samcev.
• Apply the patch on a flat part of your upper body or arm (not over a joint).
• Obliž nalepite na ravno površino zgornjega dela telesa ali rame (ne preko sklepa).
DUROGESIC may impair mental and/or physical ability required for the performance of potentially hazardous tasks such as driving or operating machinery.
Zdravilo DUROGESIC lahko vpliva na mentalne in/ali psihofizične sposobnosti posameznika za opravljanje nalog, ki so lahko nevarne, kot sta vožnja in upravljanje s stroji.
Dose adjustments should be done in 12 mcg/h steps.
Odmerek je treba prilagajati v korakih po 12 mikrogramov/h.
Fentanyl is excreted into human milk and may cause sedation/respiratory depression in a breastfed infant.
Fentanil se izloča v materino mleko in lahko povzroči sedacijo/depresijo dihanja pri dojenčku.
• Skin that is very hairy.
• zelo poraščeno kožo.
Using and changing the patches
Uporaba in zamenjava obližev
Repeated use of the patches may make the medicine become less effective (you become ‘tolerant' to it) or become dependent on it.
Pri dolgotrajni uporabi lahko postane to zdravilo manj učinkovito (postanete lahko ‘tolerantni' na obliž)
An increase in skin temperature through the application of a heating pad on low setting over the DUROGESIC system during the first 10 hours of a single application increased the mean fentanyl AUC value by 2.2-fold and the mean concentration at the end of heat application by 61%.
Zvišanje temperature v koži zaradi ogrevalne blazine (na nizki jakosti) na mestu sistema zdravila DUROGESIC v prvih 10 urah v enkratni aplikaciji zveča povprečno AUC fentanila za 2,2krat, povprečne koncentracije ob koncu aplikacije toplote pa za 61 %.
• If increasing the strength of the patch does not help, your doctor may decide to stop the use of the patches
• Če povečevanje jakosti obliža ne pomaga, se bo zdravnik morda odločil, da prenehate z uporabo obližev.
Mutagenicity testing in bacteria and in rodents yielded negative results.
Rezultati testiranja mutagenosti na bakterijah in glodalcih so bili negativni.
• Always remove the old patch before applying a new one.
• Pred namestitvijo novega obliža vedno odstranite starega.
Respiratory depression following an overdose may outlast the duration of action of the opioid antagonist.
Depresija dihanja po prevelikem odmerjanju lahko traja dalj časa kot delovanje opioidnega antagonista.
If the patch needs to be replaced (eg, the patch falls off) before 72 hours, a patch of the same strength should be applied to a different skin site.
Če je treba obliž zamenjati (npr. če se odlepi) v manj kot 72 urah, je treba obliž enake jakosti namestiti na drugo mesto na koži.
Oral 24-hour morphine (mg/day)
Peroralni 24-urni odmerek morfina (mg/dan)
The displayed frequency categories use the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare
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 pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
• Feeling extremely happy (euphoria)
• občutek pretirane sreče (evforija)
The patches are designed to deliver approximately 12, 25, 50, 75, and 100 mcg/h fentanyl to the systemic circulation, which represent about 0.3, 0.6, 1.2, 1.8, and 2.4 mg per day respectively.
Obliži so zasnovani tako, da v sistemski krvni obtok sproščajo približno 12, 25, 50, 75 in100 mikrogramov fentanila/h, kar pomeni približno 0,3; 0,6; 1,2; 1,8 in 2,4 mg/dan.
This was determined in a human keratinocyte cell assay and in clinical studies in which 92% of the dose delivered from the system was accounted for as unchanged fentanyl that appeared in the systemic circulation.
To so ugotovili v testu na humanih keratinocitih in v kliničnih študijah, v katerih je 92% odmerka, sproščenega iz obliža v sistemski krvni obtok, predstavljal nespremenjeni fentanil.
Fentanyl concentrations may increase if the skin temperature increases (see section 5.2).
Koncentracija fentanila se lahko poveča, če se zviša temperatura kože (glejte poglavje 5.2).
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 (see also Section 4.4).
Ta zdravila imajo visoko afiniteto vezave na opioidne receptorje s sorazmerno nizko intrinzično aktivnostjo ter zato delno zmanjšajo analgetični učinek fentanila in lahko povzročijo nastanek odtegnitvenih simptomov pri odvisnikih od opioidov (glejte tudi poglavje 4.4).
Patients reach and maintain a steady-state serum concentration that is determined by individual variation in skin permeability and body clearance of fentanyl.
Bolniki dosežeejo in obdržijo serumske koncentracije v dinamičnem ravnovesju, ki so določene z individualno variabilnostjo v prepustnosti kože in telesnim očistkom fentanila.
Fever/external heat application
Zvišana telesna temperatura/zunanja toplota