FrancophonIA/ELRC3.0 huggingface dataset:
English: No more than two tablets should be used to treat any individual BTP episode, except when titrating using up to four tablets as described above.
Slovenian: Za zdravljenje posamičnih epizod PBB ne uporabite več kot dve tableti, razen v zgoraj opisanih primerih titriranja z do štirimi tabletami.
English: If the breakthrough pain has stopped, do not take Effentora until the next breakthrough pain episode.
Slovenian: Če je prebijajoča bolečina prenehala, ne uporabite zdravila Effentora, dokler se ne pojavi naslednja epizoda prebijajoče bolečine.
English: Evaluation of brain slides from the carcinogenicity 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: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določenev seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7)
English: What Effentora is and what it is used for
Slovenian: Kaj je zdravilo Effentora in za kaj ga uporabljamo
English: Patients should be instructed NOT to attempt to push the tablet through the blister because this could damage the buccal tablet.
Slovenian: Bolnike je treba opozoriti, da naj NE poskusijo potisniti tablete skozi pretisni omot, saj bi s tem lahko poškodovali bukalno tableto.
English: Fentanyl may produce bradycardia.
Slovenian: Fentanil lahko povzroči bradikardijo.
English: Subsequently, fentanyl is redistributed between the deep tissue compartment (muscle and fat) and the plasma.
Slovenian: Posledično se fentanil ponovno porazdeli med ložami globokega tkiva (mišice in maščoba) in plazmo.
English: • You have problems with your heart especially slow heart rate.
Slovenian: • Če imate težave s srcem, zlasti počasni srčni utrip.
English: Iatrogenic addiction following therapeutic use of opioids is known to occur.
Slovenian: Vendar pa je znano, da se pojavlja iatrogena zasvojenost po terapevtski uporabi opioidov.
English: Do not change doses of Effentora or your other pain medicines on your own.
Slovenian: Odmerkov zdravila Effentora ali drugih zdravil proti bolečini ne spreminjajte sami.
English: Dwell time (defined as the length of time that the tablet takes to fully disintegrate following buccal administration), does not affect early systemic exposure to fentanyl.
Slovenian: Čas zadrževanja (opredeljen kot dolžina časa, ki jo tableta potrebuje za popolni razkroj po bukalni aplikaciji) ne vpliva na zgodnjo sistemsko izpostavljenost fentanilu.
English: Clinical signs and symptoms may be manifest from these hormonal changes (see also section 4.8).
Slovenian: Te hormonske spremembe se lahko kažejo kot linični znaki in simptomi (glejte tudi poglavje 4.8).
English: Differences in exposure with Effentora were observed in a clinical study with patients with grade 1 mucositis.
Slovenian: Razlike v izpostavljenosti pri zdravilu Effentora so opazili v kliničnih študijah pri bolnikih z mukozitisom stopnje 1.
English: When you first start using Effentora, your doctor will work with you to find the dose that will relieve your breakthrough pain.
Slovenian: Ko začnete uporabljati zdravilo Effentora, vam bo zdravnik pomagal najti odmerek, ki olajša vašo prebijajočo bolečino.
English: During titration, multiple tablets may be used: up to four 100 micrograms or up to four 200 micrograms tablets may be used to treat a single episode of BTP during dose titration according to the following schedule:
Slovenian: Med titriranjem je možno uporabiti več tablet: do štiri 100-mikrogramske ali do štiri 200mikrogramske tablete se lahko uporabijo za zdravljenje ene epizode PBB med titriranjem odmerka po naslednjem režimu:
English: • Effentora may be used before or after, but not during, meals.
Slovenian: • Zdravilo Effentora lahko uporabite pred obroki ali po njih, vendar ne med njimi.
English: If it occurs, it should be managed by the use of assisted ventilation, by an opioid antagonist, and as a final alternative, by a neuromuscular blocking agent.
Slovenian: V takem primeru je treba uvesti podporno ventilacijo, opioidni antagonist in kot zadnjo možnost zdravilo za živčno-mišično blokado.
English: • Brochure on breakthrough pain
Slovenian: • Brošuro o prebijajoči bolečini
English: Secondary pharmacological effects are respiratory depression, bradycardia, hypothermia, constipation, miosis, physical dependence and euphoria.
Slovenian: Sekundarni farmakološki učinki so respiratorna depresija, bradikardija, hipotermija, zaprtost, mioza, fizična odvisnost in evforija.
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: Njihova intenzivnost pogosto narašča in pada s trajanjem jemanja zdravila, saj se odmerek prilagodi na najbolj ustreznega za bolnika.
English: • loss of consciousness, stop in breathing, convulsion (fits)
Slovenian: • izguba zavesti, prenehanje dihanja, konvulzije (epileptični napadi)
English: Immediate management of opioid overdose includes removal of the Effentora buccal tablet, if still in the mouth, 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: Takojšnji ukrepi v zvezi s prevelikim odmerkom opioida vključujejo odstranitev bukalne tablete zdravila Effentora, če je še vedno v ustih, stimulacijo bolnikovih dihalnih poti, njegovo fizično in verbalno spodbujanje, ocenitev stopnje zavestnosti, status predihanosti in obtočil ter po potrebi uvedbo pomoči pri dihanju (ventilacijska podpora).
English: During titration, if adequate analgesia is not obtained within 30 minutes after the start of administration of a single tablet, a second Effentora tablet of the same strength may be used.
Slovenian: Način titriranja Če se med titriranjem ustrezen analgetični učinek ne doseže v 30 minutah po začetku apliciranja ene tablete, se lahko uporabi druga tableta zdravila Effentora enake jakosti.
English: • If you are not regularly using a prescribed opioid medicine (e.g codeine, fentanyl, hydromorphone, morphine, oxycodone, pethidine), every day on a regular schedule, for at least a week, to control your persistent pain.
Slovenian: • če za nadzor svoje stalne bolečine ne uporabljate redno predpisanega opioidnega zdravila že vsaj en teden (npr. kodeina, fentanila, hidromorfona, morfina, oksikodona, petidina), vsak dan in po rednem režimu.
English: • Do not bite, suck, chew, or swallow the tablet, as this will result in less pain relief than when taken as directed.
Slovenian: • Tablete ne grizite, sesajte, žvečite in ne pogoltnite, saj je s tem učinek lajšanja bolečine slabši kot pri uporabi po navodilih.
English: In the pivotal clinical study (study 1), the primary endpoint was the average sum of differences in pain intensity scores from dosing to 60 minutes, inclusive (SPID60), which was statistically significant compared to placebo (p<0.0001).
Slovenian: V osrednji klinični študiji (študija 1) je bila primarna končna točka povprečni seštevek razlik v skupnem številu intenzivnosti bolečin od apliciranja do vključno 60 minut (SPID60), kar je bilo statistično značilno v primerjavi s placebom (p < 0,0001).
English: For the most effective relief, let your doctor know about your pain and how Effentora is working for you, so that the dose can be changed if needed.
Slovenian: Za bolj učinkovito lajšanje bolečine zdravnika o njej obveščajte in mu povejte, kako zdravilo Effentora učinkuje na vas, zato da lahko odmerek po potrebi prilagodi.
English: The tablet must be used immediately once removed from the blister.
Slovenian: Tableto morate uporabiti takoj, ko odstranite pretisni omot.
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 razvojne toksičnosti za embrio in zarodek pri podganah in kuncih niso pokazale malformacij ali razvojnih odstopanj, ki bi jih povzročile sestavine, pri dajanju v obdobju organogeneze.
English: However, opioid analgesics impair the mental and/or physical ability required for the performance of potentially dangerous tasks (e.g., driving a car or operating machinery).
Slovenian: Vendar pa opioidni analgetiki vplivajo na mentalno in/ali fizično sposobnost, potrebno za opravljanje potencialno nevarnih nalog
English: • You drink alcohol; please refer to section Effentora with food, drink and alcohol.
Slovenian: • Če pijete alkohol, glejte poglavje Zdravilo Effentora skupaj s hrano, pijačo in alkoholom.
English: Taking the medicine in this way allows it to be absorbed quickly to relieve your breakthrough pain.
Slovenian: Tak način jemanja omogoča hitro absorpcijo zdravila in olajšanje prebijajoče bolečine.
English: Nausea, vomiting, anorexia, fatigue, weakness, dizziness and low blood pressure Together these symptoms may be a sign of a potentially life-threatening condition called adrenal insufficiency.
Slovenian: Siljenje na bruhanje, bruhanje, anoreksija, utrujenost, šibkost, omotica in nizek krvni tlak Skupaj so lahko ti simptomi znak potencialno življenjsko nevarnega stanja, ki se imenuje oslabljeno delovanje nadledvične žleze.
English: If a decision is made to prescribe Effentora concomitantly with benzodiazepines or related drugs, the lowest effective dosages and minimum durations of concomitant use should be chosen.
Slovenian: Pri odločitvi za predpisovanje zdravila Effentora sočasno z benzodiazepini ali povezanimi zdravili je treba izbrati najmanjši učinkoviti odmerek in najkrajše trajanje hkratnega dajanja.
English: Pre-emptive use of Effentora for predictable pain episodes was not investigated in the clinical trials.
Slovenian: Profilaktične uporabe zdravila Effentora za predvidljive epizode bolečin v kliničnih preskušanjih niso raziskali.
English: What to do if someone accidentally takes Effentora
Slovenian: Kaj storiti, če kdo pomotoma uporabi zdravilo Effentora
English: With long-term use of fentanyl during pregnancy, there is a risk of neonatal opioid withdrawal syndrome which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts.
Slovenian: Po dolgotrajni uporabi fentanila med nosečnostjo obstaja tveganje opioidnega odtegnitvenega sindroma pri novorojencih, ki je lahko življenjsko nevaren, če ni prepoznan in zdravljen, in ga je treba ustrezno zdraviti v skladu s protokolom, ki so ga razvili strokovnjaki za neonatalogijo.
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: If this recommendation does not result in an appropriate effervescence, then a switch of therapy may be advised.
Slovenian: Če se tableta s tem ne raztopi dovolj, je morda priporočljivo menjati terapijo.
English: Patients experiencing xerostomia are advised to drink water to moisten the buccal cavity prior to administration of Effentora.
Slovenian: Priporoča se, da bolniki s kserostomijo pijejo vodo, da navlažijo ustno votlino pred aplikacijo zdravila Effentora.
English: • For titration to 600 micrograms and 800 micrograms, tablets of 200 micrograms should be used.
Slovenian: • Za titriranje do 600 mikrogramov in 800 mikrogramov se uporabljajo 200-mikrogramske tablete.
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 dependant patients.
Slovenian: Slednji imajo veliko afiniteto za vezavo na opioidne receptorje z relativno nizko intrinzično dejavnostjo, zato delno zavrejo analgetični učinek fentanila in lahko inducirajo odtegnitveni simptome pri bolnikih, ki so odvisni od opioidov.
English: The safety and efficacy of Effentora have been evaluated in patients taking the drug at the onset of the breakthrough pain episode.
Slovenian: Varnost in učinkovitost zdravila Effentora je bila ocenjena pri bolnikih, ki zdravilo jemljejo ob pojavu epizode prebijajoče bolečine.
English: The MAH shall ensure that, following discussions and agreement with the National Competent Authorities in each Member State where EFFENTORA is marketed all healthcare professionals who are expected to prescribe EFFENTORA are provided with an information pack containing the following items:
Slovenian: Imetnik dovoljenja za promet z zdravilom bo po razgovoru in v soglasju s pristojnim nacionalnim organom v vseh državah članicah, kjer je zdravilo EFFENTORA v prometu, zagotovil, da bodo vsi zdravstveni delavci, za katere se pričakuje, da bodo zdravilo EFFENTORA predpisovali,
English: If your doctor suspects Effentora-related increased sensitivity to pain (hyperalgesia), a reduction of your Effentora dose may be considered (see section 2 under “Warnings and precautions”).
Slovenian: Če zdravnik sumi na povečano občutljivost na bolečino (hiperalgezijo), povezano z zdravilom Effentora, je treba razmisliti o zmanjšanju odmerka zdravila Effentora (glejte poglavje 2 »Opozorila in previdnostni ukrepi«).
English: • Instructions on how to open the child-resistant blister
Slovenian: • Navodilih o odpiranju za otroke varnega pretisnega omota
English: Fentanyl is highly lipophilic and is well distributed beyond the vascular system, with a large apparent volume of distribution.
Slovenian: Fentanil je izjemno lipofilen in se dobro porazdeli prek vaskularnega sistema z velikim navideznim volumnom porazdelitve.
English: • You have an exceptionally slow heart rate or other heart problems.
Slovenian: • Vaš srčni utrip je izjemno počasen ali imate druge težave s srcem.
English: • Separate one of the blister units from the blister card by tearing apart at the perforations.
Slovenian: • Eno enoto pretisnega omota ločite od kartice s pretisnimi omoti tako, da jo odtrgate po perforaciji.
English: • Treatment of acute pain other than breakthrough pain
Slovenian: • Zdravljenje druge akutne bolečine kot prebijajoče.
English: Following the administration of Effentora, the terminal elimination phase of fentanyl is the result of the redistribution between plasma and a deep tissue compartment.
Slovenian: Po apliciranju zdravila Effentora je končna faza izločanja fentanila rezultat ponovne distribucije med plazmo in ložami globokega tkiva.
English: Consult your doctor WHILE using Effentora if:
Slovenian: Posvetujte se z zdravnikom, MEDTEM KO uporabljate zdravilo Effentora, če:
English: • drug abuse
Slovenian: • zloraba zdravil
English: It is important that the maintenance opioid treatment used to treat the patient's persistent pain has been stabilised before Effentora therapy begins and that the patient continues to be treated with the maintenance opioid treatment whilst taking Effentora.
Slovenian: Pomembno je, da se vzdrževalno opioidno zdravljenje, s katerim se bolnika zdravi zaradi stalne bolečine, stabilizira pred začetkom zdravljenja z zdravilom Effentora in bolnik nadaljuje z vzdrževalnim opioidnim zdravljenjem med jemanjem zdravila Effentora.
English: Linearity/non-linearity Dose proportionality from 100 micrograms to 1000 micrograms has been demonstrated.
Slovenian: Dokazana je bila sorazmernost odmerka od 100 mikrogramov do 1000 mikrogramov.
English: • Do not drink alcohol while using Effentora.
Slovenian: • Med uporabo zdravila Effentora ne pijte alkohola.
English: Other medicines and Effentora
Slovenian: Druga zdravila in zdravilo Effentora
English: BTP is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain.
Slovenian: PBB je prehodno poslabšanje bolečine, ki se pojavi ob prisotnosti stalne bolečine, ki je sicer pod nadzorom.
English: The effect of renal or hepatic impairment on the pharmacokinetics of Effentora has not been studied.
Slovenian: Učinkov ledvične ali jetrne okvare na farmakokinetiko zdravila Effentora nisi preučili.
English: Buccal tablet.
Slovenian: bukalna tableta
English: Contents of the pack and other information What Effentora contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Effentora
English: If serotonin syndrome is suspected, treatment with Effentora should be discontinued.
Slovenian: Pri sumu na serotoninski sindrom je treba zdravljenje z zdravilom Effentora prekiniti.
English: What Effentora is and what it is used for What you need to knowbefore you use Effentora How to use Effentora
Slovenian: Kaj je zdravilo Effentora in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Effentora Kako uporabljati zdravilo Effentora
English: The free fraction of fentanyl increases with acidosis.
Slovenian: Prosta frakcija fentanila narašča z acidozo.
English: Effentora buccal tablets are for oromucosal use.
Slovenian: Zdravilo Effentora bukalne tablete so samo za oralno uporabo.
English: You should not use Effentora during childbirth because fentanyl may cause respiratory depression in the new-born child.
Slovenian: Med porodom ne uporabljajte zdravila Effentora, saj lahko fentanil povzroči respiratorno depresijo pri novorojencu.
English: • You should not drink grapefruit juice while using Effentora because it may affect the way your body breaks down Effentora.
Slovenian: • Ko uporabljate zdravilo Effentora, ne pijte soka grenivke, saj lahko vpliva na način, kako vaš organizem razgrajuje zdravilo Effentora.
English: Dose readjustment of the background opioid therapy may be required if patients consistently present with more than four BTP episodes per 24 hours.
Slovenian: Ponovna prilagoditev osnovne opioidne terapije je morda potrebna pri bolnikih, ki doživijo več kot štiri epizode PBB v 24 urah.
English: If you use more Effentora than you should
Slovenian: Če ste uporabili večji odmerek zdravila Effentora, kot bi smeli
English: Contact your doctor if your right dose of Effentora does not relieve your breakthrough pain.
Slovenian: Posvetujte se z zdravnikom, če menite, da vaš pravilni odmerek zdravila Effentora ne zadošča za olajšanje vaše prebijajoče bolečine.
English: The absorption profile of Effentora is largely the result of an initial rapid absorption from the buccal mucosa, with peak plasma concentrations following venous sampling generally attained within an hour after oromucosal administration.
Slovenian: Absorpcijski profil zdravila Effentora je v veliki meri rezultat začetne hitre absorpcije skozi lično sluznico z najvišjimi koncentracijami v plazmi po venskemu vzorčenju v približno eni uri po oralni aplikaciji.
English: • Bend the blister unit along the line where indicated.
Slovenian: • Enoto pretisnega omota prepognite vzdolž linije, kjer je označeno.
English: resulting in a median terminal elimination half-life t1/2 of approximately 22 hours following buccal administration of the effervescent formulation and approximately 18 hours following intravenous administration.
Slovenian: Ta faza izločanja je počasna, kar ima za posledico mediano končno razpolovno dobo izločanja t1/2 približno 22 ur po bukalni aplikaciji efervescentne formulacije in približno 18 ur po intravenski aplikaciji.
English: What you need to know before you use Effentora Do NOT use Effentora:
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Effentora NE uporabljajte zdravila Effentora:
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 razvojne toksičnosti za embrio in zarodek pri podganah je bila stopnja preživetja mladičev značilno manjša pri odmerkih, ki povzročajo hudo toksičnost matere.
English: • You have ever developed adrenal insufficiency or lack of sex hormones (androgen deficiency) with opioid use (see section 4 under “Serious side effects”).
Slovenian: • Če se je pri uporabi opioidov kdaj razvilo oslabljeno delovanje nadledvične žleze ali pomanjkanje spolnih hormonov (androgenov) (glejte poglavje 4 pod »Resni neželeni učinki«).
English: • After 30 minutes, if pieces of the tablet remain, they may be swallowed with a glass of water.
Slovenian: • Po 30 minutah lahko morebitne ostanke tablete pogoltnete s kozarcem vode.
English: There are no human data on fertility available.
Slovenian: Podatkov o vplivu na plodnost pri ljudeh ni.
English: • Remove the tablet from the blister unit and immediately place the entire tablet near a molar tooth between the gum and the cheek (as shown in the picture).
Slovenian: • Tableto vzemite iz enote pretisnega omota in jo takoj celo namestite poleg kočnika med dlesen in lice (kot kaže slika).
English: After 30 minutes, if remnants from the Effentora tablet remain, they may be swallowed with a glass of water.
Slovenian: Če so po 30 minutah v ustih še ostanki tablete zdravila Effentora, se jih lahko pogoltne s kozarcem vode.
English: Whilst you are being treated with Effentora, do not use other fentanyl treatments previously prescribed for your breakthrough pain.
Slovenian: Med zdravljenjem z zdravilom Effentora ne uporabljajte drugih zdravil s fentanilom, ki so vam jih pred tem predpisali za zdravljenje prebijajoče bolečine.
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 considered secondary to the sedative effects of fentanyl in animal studies.
Slovenian: V študiji plodnosti in zgodnjega razvoja zarodka pri podganah so pri visokih odmerkih (300 mikrogramov/kg/dan s.c.) opazili učinek pri samcih, ki so jih ocenili kot sekundarne sedativnim učinkom fentanila v študijah na živalih.
English: • feeling elated, nervous, abnormal, jittery or slow; seeing or hearing things that are not really there (hallucinations), reduced consciousness, change in mental state, dependence (reliance on the medicine, addiction), disorientation, lack of concentration, loss of balance, vertigo, problem with speaking, ringing in the ear, ear discomfort
Slovenian: • občutek vznesenosti, nervoze, abnormalnosti, živčnosti ali upočasnjenosti; videnje ali slišanje neobstoječih stvari (halucinacije), zmanjšanje zavesti, sprememba mentalnega stanja, odvisnost (odvisnost od zdravila, zasvojenost), dezorientacija, pomanjkanje koncentracije, izguba ravnotežja, vrtoglavica, težave z govorjenjem, zvonjenje v ušesih, nelagodje v ušesih
English: A comparison study between one 400 mcg Effentora tablet administered either buccally (i.e., between the cheek and the gum) or sublingually met the criteria of bioequivalence.
Slovenian: V primerjalni študiji med eno 400-mikrogramsko tableto zdravila Effentora, uporabljeno bodisi bukalno (tj. med lici in dlesnijo) ali pod jezikom so bili izpolnjeni kriteriji bioekvivalence.
English: Patients should remove the tablet from the blister unit and immediately place the entire Effentora tablet in the buccal cavity (near a molar between the cheek and gum).
Slovenian: Bolnik naj vzame tableto iz pretisnega omota in nemudoma celo tableto zdravila Effentora vstavi v ustno votlino (poleg molarja med lice in dlesen).