FrancophonIA/ELRC3.0 huggingface dataset:
English: If severe or persistent hypotension occurs, hypovolemia should be considered, and the condition should be managed with appropriate parenteral fluid therapy.
Slovenian: Če se pojavi huda ali trdovratna hipotenzija, je treba upoštevati možnost hipovolemije in stanje obvladati z ustreznim parenteralnim dovajanjem tekočin.
English: You might need a different patch strength when you restart
Slovenian: Morda boste pri ponovni uporabi potrebovali drugačno jakost.
English: • Put it back in its original sachet and dispose of the sachet as instructed by your pharmacist
Slovenian: • Uporabljene obliže dajte nazaj v originalno blazinico in jo odstranite tako, kot vam je naročil farmacevt.
English: 4.1 Therapeutic indications
Slovenian: 4.1 Terapevtske indikacije Odrasli
English: You may notice rashes, redness or slight itching of the skin at the site of the patch.
Slovenian: Morda boste opazili izpuščaje, rdečico ali rahlo srbenje kože na mestu, kjer je nameščen obliž.
English: • Stopping breathing from time to time (apnoea)
Slovenian: • občasna zaustavitev dihanja (apneja)
English: In a rat study fentanyl did not influence male fertility.
Slovenian: V študiji na podganah fentanil ni vplival na plodnost samcev.
English: • Apply the patch on a flat part of your upper body or arm (not over a joint).
Slovenian: • Obliž nalepite na ravno površino zgornjega dela telesa ali rame (ne preko sklepa).
English: DUROGESIC may impair mental and/or physical ability required for the performance of potentially hazardous tasks such as driving or operating machinery.
Slovenian: 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.
English: Dose adjustments should be done in 12 mcg/h steps.
Slovenian: Odmerek je treba prilagajati v korakih po 12 mikrogramov/h.
English: Fentanyl is excreted into human milk and may cause sedation/respiratory depression in a breastfed infant.
Slovenian: Fentanil se izloča v materino mleko in lahko povzroči sedacijo/depresijo dihanja pri dojenčku.
English: • Skin that is very hairy.
Slovenian: • zelo poraščeno kožo.
English: Using and changing the patches
Slovenian: Uporaba in zamenjava obližev
English: Repeated use of the patches may make the medicine become less effective (you become ‘tolerant' to it) or become dependent on it.
Slovenian: Pri dolgotrajni uporabi lahko postane to zdravilo manj učinkovito (postanete lahko ‘tolerantni' na obliž)
English: 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%.
Slovenian: 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 %.
English: • If increasing the strength of the patch does not help, your doctor may decide to stop the use of the patches
Slovenian: • Če povečevanje jakosti obliža ne pomaga, se bo zdravnik morda odločil, da prenehate z uporabo obližev.
English: Mutagenicity testing in bacteria and in rodents yielded negative results.
Slovenian: Rezultati testiranja mutagenosti na bakterijah in glodalcih so bili negativni.
English: • Always remove the old patch before applying a new one.
Slovenian: • Pred namestitvijo novega obliža vedno odstranite starega.
English: Respiratory depression following an overdose may outlast the duration of action of the opioid antagonist.
Slovenian: Depresija dihanja po prevelikem odmerjanju lahko traja dalj časa kot delovanje opioidnega antagonista.
English: 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.
Slovenian: 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.
English: Oral 24-hour morphine (mg/day)
Slovenian: Peroralni 24-urni odmerek morfina (mg/dan)
English: 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
Slovenian: 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).
English: • Feeling extremely happy (euphoria)
Slovenian: • občutek pretirane sreče (evforija)
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Fentanyl concentrations may increase if the skin temperature increases (see section 5.2).
Slovenian: Koncentracija fentanila se lahko poveča, če se zviša temperatura kože (glejte poglavje 5.2).
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 (see also Section 4.4).
Slovenian: 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).
English: Patients reach and maintain a steady-state serum concentration that is determined by individual variation in skin permeability and body clearance of fentanyl.
Slovenian: Bolniki dosežeejo in obdržijo serumske koncentracije v dinamičnem ravnovesju, ki so določene z individualno variabilnostjo v prepustnosti kože in telesnim očistkom fentanila.
English: Fever/external heat application
Slovenian: Zvišana telesna temperatura/zunanja toplota
English: If analgesia is insufficient during the first application only, the DUROGESIC patch may be replaced after 48 hours with a patch of the same dose, or the dose may be increased after 72 hours.
Slovenian: Če analgezija med prvo namestitvijo ni zadostna, lahko transdermalni obliž DUROGESIC zamenjate po 48 urah z obližem enake jakosti ali pa odmerek povečate po 72 urah.
English: As for patients with Grade C liver disease (Child-Pugh Score = 12.5), the results indicate that fentanyl concentration accumulates with each administration, leading these patients to have an approximately 3.72 times larger AUC at steady state.
Slovenian: Kot velja za bolnike z okvaro jeter razreda C (stopnja Child-Pugh = 12,5), rezultati kažejo, da se koncentracije fentanila akumulirajo z vsako aplikacijo, tako da imajo ti bolniki približno 3,72-krat večjo AUC v stanju dinamičnega ravnovesja.
English: (16.3%), constipation (13.5%), diarrhoea (12.8%), and pruritus (12.8%).
Slovenian: glavobol (16,3 %), zaprtje (13,5 %), driska (12,8 %) in srbenje (12,8 %).
English: The incidence of respiratory depression increases as the DUROGESIC dose is increased (see section 4.9).
Slovenian: Pojavnost depresije dihanja se povečuje s povečevanjem odmerka zdravila DUROGESIC (glejte poglavje 4.9).
English: Acute or postoperative pain because there is no opportunity for dose titration during short-term use and because serious or life-threatening hypoventilation could result.
Slovenian: Akutna ali pooperativna bolečina, ker med kratkotrajno uporabo prilagajanje odmerka ni mogoče, kar lahko vodi do resne ali življenjsko nevarne hipoventilacije.
English: The manifestations of fentanyl overdose are an extension of its pharmacologic actions, the most serious effect being respiratory depression.
Slovenian: Znaki prevelikega odmerjanja fentanila so posledica njegovih njegovih farmakoloških učinkov; najresnejši med njimi je depresija dihanja.
English: Do not apply the patch on
Slovenian: Obliža ne namestite na
English: • Do not use the patch if it has been divided, cut or looks damaged
Slovenian: • Obliža ne uporabite, če je razpolovljen, razrezan ali kakor koli drugače poškodovan.
English: Fentanyl then becomes available to the systemic circulation.
Slovenian: Takrat postane fentanil dostopen sistemskemu krvnemu obtoku.
English: It also crosses the placenta and is excreted in breast milk.
Slovenian: Prehaja tudi skozi placento in se izloča z materinim mlekom.
English: Of the 289 subjects enrolled in these 3 studies, 110 initiated DUROGESIC treatment with a dosage of 12 mcg/h.
Slovenian: vključenih preiskovancev, vključenih v te 3 študije, je 110 preiskovancev zdravljenje začelo z zdravilom DUROGESIC v odmerku 12 mikrogramov/h.
English: DUROGESIC is indicated for management of severe chronic pain that requires continuous long term opioid administration.
Slovenian: Zdravilo DUROGESIC je indicirano za obvladovanje hude kronične bolečine, ki zahteva kontinuirano dolgotrajno zdravljenje z opioidi.
English: The safety of DUROGESIC was evaluated in 1565 adult and 289 paediatric subjects who participated in 11 clinical studies (1 double-blind, placebo-controlled; 7 open-label, active-controlled; 3 open-label, uncontrolled) used for the management of chronic malignant or non-malignant pain.
Slovenian: Varnost zdravila DUROGESIC so ocenili pri 1.565 odraslih in 289 pediatričnih preiskovancih, ki so sodelovali v 11 kliničnih študijah (1 dvojno slepa, nadzorovana s placebom, 7 odprtih, nadzorovanih z učinkovino, 3 odprte, nenadzorovane) za zdravljenje kronične maligne ali nemaligne bolečine.
English: In these cases, only DUROGESIC 12 mcg/h dosage should be considered for initial treatment.
Slovenian: V takih primerih se za uvedbo zdravljenja uporablja le jakost zdravila DUROGESIC 12 mikrogramov/h.
English: Where to apply the patch
Slovenian: Kam namestiti obliž
English: • Keep the empty sachet to dispose of the used patch later
Slovenian: • Prazno vrečico shranite in jo uporabite kasneje, da zavržete uporabljen obliž.
English: Fentanyl induced mutagenic effects in mammalian cells in vitro, comparable to other opioid analgesics.
Slovenian: Fentanil je povzročil mutagene učinke na sesalskih celicah in vitro, podobno kot drugi opioidni analgetiki.
English: Therefore, DUROGESIC should not be used within 14 days after discontinuation of treatment with MAOIs.
Slovenian: Zato se zdravila DUROGESIC ne sme uporabljati še 14 dni po prenehanju zdravljenja z zaviralci MAO.
English: The extent of the interactions of CYP3A4 inhibitors with long-term transdermal fentanyl administration is not known, but may be greater than with short-term intravenous administration.
Slovenian: Obseg interakcij zaviralcev CYP3A4 z dolgotrajno transdermalno uporabo fentanila ni znan, je pa lahko večji kot pri kratkotrajni intravenski aplikaciji.
English: Patients at increased risk of opioid abuse may still be appropriately treated with modified-release opioid formulations; however, these patients will require monitoring for signs of misuse, abuse, or addiction.
Slovenian: Bolnike z večjim tveganjem za zlorabo opioidov se lahko še vedno ustrezno zdravi z oblikami opioidov s prirejenim sproščanjem, vendar je treba takšne bolnike skrbno spremljati glede znakov zlorabe, napačne uporabe ali odvisnosti.
English: • Medicines to treat tuberculosis (such as rifampicin).
Slovenian: • zdravila za zdravljenje tuberkuloze (kot je rifampicin).
English: • Always apply the patch to the upper back to make it difficult for your child to reach it or take it off.
Slovenian: • Otrokom obliž vedno nalepite na zgornji del hrbta tako, da ga ne more doseči ali odlepiti.
English: • Feeling anxious or confused
Slovenian: • občutek vznemirjenosti ali zmedenosti
English: DUROGESIC should not be used during pregnancy unless clearly necessary.
Slovenian: Zdravila DUROGESIC se ne sme uporabljati med nosečnostjo, če ni nujno potrebno.
English: Your doctor will know which medicines are safe to take with DUROGESIC.
Slovenian: Zdravnik ve, katera zdravila so varna za sočasno uporabo z zdravilom DUROGESIC.
English: • Remove the other part of the backing and press the whole patch onto the skin with the palm of your hand
Slovenian: • Odstranite drugi del zaščitne plasti obliža in celoten obliž z dlanjo pritisnite na kožo.
English: Skin temperature elevation may enhance the absorption of transdermally-applied fentanyl (see section 4.4).
Slovenian: Porast temperature v koži lahko zveča absorbcijo transdermalno uporabljenega fentanila (glejte poglavje 4.4).
English: • Tear or cut open the sachet at the notch, shown by the arrow
Slovenian: • Pretrgajte ali prerežite vrečico pri zarezi, kot kaže puščica.
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Slovenian: Če imate kakršna koli vprašanja o uporabi tega zdravila, se posvetujte z zdravnikom ali farmacevtom.
English: Used patches should be folded so that the adhesive side of the patch adheres to itself and then they should be safely discarded.
Slovenian: Uporabljene obliže je treba najprej prepogniti, tako da se lepilna plast zlepi, in šele nato varno zavreči.
English: Careful monitoring should be continued until stable drug effects are achieved.
Slovenian: Dokler ne dosežete stabilnega učinka zdravila, je potrebno nadaljnje skrbno spremljanje.
English: Signs of overdose include trouble breathing or shallow breathing, tiredness, extreme sleepiness, being unable to think clearly, walk or talk normally and feeling faint, dizzy or confused.
Slovenian: Znaki prevelikega odmerjanja so težko ali plitvo dihanje, utrujenost, huda zaspanost, nezmožnost jasnega razmišljanja, normalne hoje ali govora in občutek omedlevice, omotičnosti ali zmedenosti.
English: • It may take some time for the patch to have its maximum effect.
Slovenian: • Lahko traja nekaj časa, preden začne obliž v celoti delovati.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Transdermal Use
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA transdermalna uporaba
English: The minimum effective fentanyl concentration depends on the pain intensity and the previous use of opioid therapy.
Slovenian: Minimalne učinkovite koncentracije fentanila so odvisne od intenzitete bolečine in predhodne uporabe opioidov.
English: If you or your partner, or carer, notice any of the following about the person wearing the patch, take the patch off and call a doctor, or go to your nearest hospital, straight away.
Slovenian: Če vi ali vaš partner ali negovalec opazite karkoli od spodaj navedenega, obliž odstranite in nemudoma pokličite zdravnika ali pojdite v najbližjo bolnišnico.
English: • DUROGESIC patches are for long-term pain.
Slovenian: • Obliži zdravila DUROGESIC se uporabljajo za dolgotrajno bolečino.
English: • in children above 2 years of age who are already using opioid medication and who need continuous pain treatment.
Slovenian: •pri odraslih, ki potrebujejo neprekinjeno zdravljenje bolečine •pri otrocih, starih več kot 2 leti, ki že prejemajo opioidna zdravila in potrebujejo neprekinjeno zdravljenje bolečine
English: Based on pooled safety data from these 3 clinical studies in paediatric subjects, the most commonly reported (i.e. ≥10% incidence) adverse reactions were vomiting (33.9%), nausea (23.5%), headache
Slovenian: Na osnovi združenih podatkov o varnosti iz teh 3 kliničnih študij pri pediatričnih preiskovancih, so bili najpogosteje poročani neželeni učinki (pojavnost ≥ 10 %) bruhanje (33,9 %), navzea (23,5 %),
English: • Make sure your skin is completely dry, clean and cool before you put the patch on
Slovenian: • Poskrbite, da je pred namestitvijo obliža vaša koža popolnoma suha, čista in hladna.
English: If the clinical situation warrants, a patent airway should be established and maintained, possibly with an oropharyngeal airway or endotracheal tube, and oxygen should be administered and respiration assisted or controlled, as appropriate.
Slovenian: Če klinične okoliščine to zahtevajo, je treba zagotoviti in vzdrževati prehodnost dihalnih poti, lahko z orofaringealnim ali endotrahealnim tubusom; po potrebi dodajati kisik in zagotoviti asistirano ali kontrolirano ventilacijo.
English: The potential risk for humans is unknown, although fentanyl as an IV anaesthetic has been found to cross the placenta in human pregnancies.
Slovenian: Možno tveganje za ljudi ni znano, čeprav so ugotovili, da fentanil kot intravenski anestetik pri ljudeh med nosečnostjo prehaja skozi placento.
English: The conversion schedule should not be used to convert from DUROGESIC into other opioids, as overdosing could then occur.
Slovenian: Sheme za preračunavanje se ne sme uporabiti za prehod s transdermalnih obližev DUROGESIC na druge opioide, ker lahko pride do prevelikega odmerjanja.
English: If the analgesic effect of DUROGESIC is insufficient, supplementary morphine or another short-duration opioid should be administered.
Slovenian: Če analgetični učinek zdravila DUROGESIC ni zadosten, je treba bolniku dodatno dati morfin ali drug kratkodelujoči opioid.
English: • Itchy skin rash (eczema), allergic reaction or other skin disorders where the patch is placed
Slovenian: • zapora črevesja (ileus) • srbenje kože (ekcem), alergijske reakcije ali druge bolezni kože na mestu, kjer je nameščen obliž
English: Long term management of severe chronic pain in children from 2 years of age who are receiving opioid therapy.
Slovenian: Dolgoročno zdravljenje hude kronične bolečine pri otrocih, starih 2 leti ali več, ki že prejemajo zdravljenje z opioidi.
English: Fentanyl may produce bradycardia and should therefore be administered with caution to patients with bradyarrhythmias.
Slovenian: Srčne bolezni Fentanil lahko povzroči bradikardijo, zato ga je treba pri bolnikih z bradiaritmijami uporabljati previdno.
English: If you use too many patches or the wrong strength patch If you have stuck on too many patches or the wrong strength patch, take the patches off and contact a doctor straight away.
Slovenian: Če ste uporabili preveč obližev ali napačno jakost obliža Če ste prilepili prveč obližev ali ste uporabili napačno jakost obliža, jih odstranite in takoj obvestite zdravnika.
English: • Some medicines used to treat angina (chest pain) or high blood pressure (such as nicardipine).
Slovenian: • Nekatera zdravila za zdravljenje angine pektoris (bolečina v prsnem košu) ali visokega krvnega tlaka (kot je nikardipin).
English: Multiplication Factor morphine oral
Slovenian: Pot uporabe multiplikator morfin peroralna
English: There is a potential for temperature-dependent increases in fentanyl released from the system resulting in possible overdose and death.
Slovenian: Obstaja možnost povečanega sproščanja fentanila iz sistema zaradi zvišane temperature, kar lahko vodi v preveliko odmerjanje in smrt.
English: • Feeling unusually drowsy, breathing that is more slow or shallow than expected.
Slovenian: • Občutek neobičajne zaspanosti, počasnejše ali bolj plitvo dihanje od običajnega.
English: Monitoring of the patient for adverse events, which may include hypoventilation, is recommended for at least 48 hours after initiation of DUROGESIC therapy or up-titration of the dose (see section 4.4).
Slovenian: Spremljanje bolnikov glede neželenih učinkov, ki lahko vključujejo hipoventilacijo, je priporočljivo vsaj 48 ur po začetku zdravljenja z zdravilom DUROGESIC ali po zvečanju odmerka (glejte tudi poglavje 4.4).
English: Even though impairment of renal function is not expected to affect fentanyl elimination to a clinically relevant extent, caution is advised because fentanyl pharmacokinetics has not been evaluated in this patient population (see section 5.2).
Slovenian: Čeprav naj okvara ledvic ne bi vplivala na izločanje fentanila v klinično pomembnem obsegu, je priporočljiva previdnost, ker farmakokinetike fentanila v tej populaciji bolnikov niso ocenjevali (glejte poglavje 5.2).
English: The dose should be titrated individually until a balance between analgesic efficacy and tolerability is attained.
Slovenian: Odmerek je treba prilagajati individualno, dokler ne dosežemo ravnovesja med analgetično učinkovitostjo in prenašanjem zdravila.
English: Fentanyl concentrations were measured in more than 250 children aged 2 to 17 years who were applied fentanyl patches in the dose range of 12.5 to 300 mcg/h.
Slovenian: Koncentracije fentanila so merili pri več kot 250 otrocih, starih od 2 do 17 let, katerim so namestili obliže s fentanilom v jakostih od 12,5 do 300 mikrogramov/h.
English: This effect could either be due to altered maternal care or a direct effect of fentanyl on the pups.
Slovenian: Ta učinek bi lahko bil posledica spremenjene nege mladičev s strani samice ali neposrednega učinka fentanila na mladiče.
English: Fold the patch in the middle and remove each half of the liner separately.
Slovenian: Obliž po sredini upognemo in odstranimo vsako polovico zaščitne plasti posebej.
English: If it does not, or if the patch irritates your skin badly, tell your doctor.
Slovenian: Če ne izgine ali če obliž močno razdraži kožo, se posvetujte z zdravnikom.
English: • Take the patch out and use straight away
Slovenian: • Obliž vzemite iz vrečice in ga takoj uporabite.
English: The influence of renal impairment on the pharmacokinetics of fentanyl is expected to be limited because urinary excretion of unchanged fentanyl is less than 10% and there are no known active metabolites eliminated by the kidney.
Slovenian: Okvara ledvic Vpliv okvare ledvic na farmakokinetiko fentanila je majhen, ker se nespremenjen fentanil izloča z urinom v manj kot 10%, aktivni presnovki, ki bi se izločali preko ledvic, pa niso znani.
English: • Gently tear or cut off the edge of the sachet completely (if you use scissors, cut close to the sealed edge of the sachet to avoid damaging the patch)
Slovenian: • Previdno po celotni dolžini odtrgajte ali odrežite rob blazinice (blizu zavarjenega roba blazinice, da ne poškodujete obliža).
English: Application site hypersensitivity, Drug withdrawal syndrome, Pyrexia*
Slovenian: preobčutljivost na mestu namestitve, sindrom odtegnitve zdravila, pireksija*
English: Non-epileptic (myo)clonic reactions can occur.
Slovenian: Lahko se pojavijo (mio)klonične reakcije, ki niso posledica epilepsije.
English: The extent of interaction with strong CYP3A4 inhibitors is expected to be greater than with weak or moderate CYP3A4 inhibitors.
Slovenian: Pričakovati je večji obseg interakcij z močnimi zaviralci CYP3A4 kot s šibkimi ali zmernimi zaviralci CYP3A4.
English: By the end of the second 72-hour application, a steady-state serum concentration is reached and is maintained during subsequent applications of a patch of the same size.
Slovenian: Do konca druge 72 urne aplikacije je doseženo dinamično ravnovesje, ki se nato vzdržuje pri nadaljnih uporabah obližev enake velikosti.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity.
Slovenian: Neklinični podatki na osnovi običajnih študij toksičnosti pri ponavljajočih odmerkih ne kažejo posebnega tveganja za človeka.
English: After the first DUROGESIC application, serum fentanyl concentrations increase gradually, generally leveling off between 12 and 24 hours and remaining relatively constant for the remainder of the 72-hour application period.
Slovenian: Po začetni aplikaciji zdravila DUROGESIC serumske koncentracije fentanila postopno naraščajo, se po približno 12-24 urah ustalijo in nato ostanejo sorazmerno konstantne do 72 ur po aplikaciji.