FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients assessed pain intensity on a 11-point scale.
Slovenian: Intenzivnost bolečine pri bolnikih so ocenjevali na 11-točkovni lestvici.
English: Therefore it is not possible to definitively separate the effects of Effentora alone.
Slovenian: Zato ni možno natančno opredeliti samo učinkov zdravila Effentora.
English: • You have a history of alcoholism or any drug abuse or dependence.
Slovenian: • Če imate anamnezo alkoholizma ali kakršne koli druge zasvojenosti ali odvisnosti od zdravil.
English: • Do not use this medicine after the expiry/use before date which is stated on the blister package label and the carton.
Slovenian: • Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na oznaki pretisnega omota in na škatli.
English: Do not drive or operate machinery if you: are feeling sleepy or dizzy; have blurred or double vision; or have difficulty in concentrating.
Slovenian: Ne vozite in ne upravljajte strojev, če ste zaspani ali omotični, imate zamegljen ali dvojni vid ali imate težave s koncentracijo.
English: Approximately 50% of the total dose administered is rapidly absorbed transmucosally and becomes systemically available.
Slovenian: Približno 50 % celotnega apliciranega odmerka se hitro absorbira transmukozno in postane sistemsko razpoložljivo.
English: The treatment for the persistent background pain should be kept as prescribed.
Slovenian: Zdravljenje trajne bolečine v ozadju naj se nadaljuje kot je predpisano.
English: Opioids may obscure the clinical course of a patient with a head injury and should be used only if clinically warranted.
Slovenian: Opioidi lahko zakrijejo klinični potek bolnika s poškodbo glave, zato naj se uporabljajo samo, če je to klinično potrebno.
English: Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.
Slovenian: Bolniki, ki prejemajo vzdrževalno opioidno terapijo so tisti, ki prejemajo vsaj 60 mg morfija peroralno dnevno, vsaj 25 mikrogramov transdermalnega fentanila na uro, vsaj 30 mg oksikodona dnevno, vsaj 8 mg peroralnega hidromorfona dnevno ali ekvivalenten analgetični odmerek drugega opioida en teden ali dlje.
English: • Open the blister only when you are ready to use the tablet.
Slovenian: • Odprite pretisni omot, ko ste pripravljeni vzeti tableto.
English: In the second pivotal study (study 2), the primary endpoint was SPID30, which was also statistically significant compared to placebo (p<0.0001).
Slovenian: V drugi osrednji študiji (študija 2) je bila primarna končna točka SPID30, kar je bilo prav tako statistično značilno v primerjavi s placebom (p < 0,0001).
English: Because of these risks, concomitant prescribing of opioids and benzodiazepines or related drugs should be made only in patients for whom alternative treatment options are inadequate.
Slovenian: Zaradi teh tveganj se lahko opioidi in benzodiazepini ali povezana zdravila sočasno predpisujejo le pri bolnikih, za katere alternativne možnosti zdravljenja niso primerne.
English: If you become very sleepy or have slow and/or shallow breathing, you or your carer should contact your doctor immediately and call for emergency help.
Slovenian: Če postanete zelo zaspani ali opazite počasno in/ali plitko dihanje, morate o tem sami ali prek negovalca nemudoma obvestiti zdravnika in poklicati urgentno pomoč.
English: Further findings at maternally toxic doses in F1 pups were delayed physical development, sensory functions, reflexes and behaviour.
Slovenian: Nadaljnji izsledki pri odmerkih, toksičnih za mater pri mladičih F1 so bili zapoznel fizični razvoj, senzorične funkcije, refleksi in vedenje.
English: • Safe use, storage and disposal of EFFENTORA.
Slovenian: • Varna uporaba, shranjevanje in odstranjevanje zdravila EFFENTORA.
English: Cmax and AUC0-8 were 1% and 25% higher in patients with mucositis compared to those without mucositis, respectively.
Slovenian: Cmax je bil za 1 % in AUC0-8 za 25 % višji pri bolnikih z mukozitisom v primerjavi z bolniki brez mukozitisa.
English: If a second tablet of Effentora was required for several consecutive times, the usual maintenance dose is to be readjusted (see below).
Slovenian: Če je večkrat zaporedoma potrebna še druga tableta zdravila Effentora, je treba običajni vzdrževalni odmerek prilagoditi (glejte spodaj).
English: No studies of the effects on the ability to drive and use machines have been performed.
Slovenian: Študij vpliva na sposobnost vožnje in upravljanja strojev niso izvajali.
English: * See section Description of selected adverse reactions
Slovenian: * Glejte poglavje Opis izbranih neželenih učinkov
English: If you think someone has accidentally taken Effentora please seek immediate medical assistance.
Slovenian: Če menite, da je nekdo pomotoma uporabil zdravilo Effentora, nemudoma poiščite zdravniško pomoč.
English: Alternatively, the tablet could be placed sublingually (see section 5.2).
Slovenian: Druga možnost je, da se tableta vstavi pod jezik (glejte poglavje 5.2).
English: If you are not sure about the right dose, or if you have questions about taking this medicine, you should contact your doctor.
Slovenian: Če niste prepričani o pravem odmerku ali če imate vprašanja v zvezi z jemanjem tega zdravila, se posvetujte z zdravnikom.
English: Pharmacokinetic Parameters* in Adult Subjects Receiving Effentora
Slovenian: Farmakokinetični parametri* pri odraslih, ki so dobivali zdravilo Effentora
English: However, in these patients, a starting dose higher than 100 micrograms may be considered.
Slovenian: Vendar pa je lahko pri teh bolnikih začetni odmerek višji od 100 mikrogramov.
English: • If 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: The duration of respiratory depression following overdose may be longer than the effects of the opioid antagonist's action (e.g., the half-life of naloxone ranges from 30 to 81 minutes) and repeated administration may be necessary.
Slovenian: Trajanje respiratorne depresije po prevelikem odmerku je lahko daljše kot učinek delovanja opioidnega antagonista (npr. razpolovna doba naloksona niha med 30 in 81 minutami), zato ga bo morda treba ponovno aplicirati.
English: • Your other opioid pain medicine taken for your persistent (around-the-clock) cancer pain is not stabilised yet.
Slovenian: • Vaše drugo opioidno zdravilo, ki ga jemljete za lajšanje stalne (24-urne) bolečine zaradi karcinoma, še ni stabilizirano.
English: Fentanyl concentrations obtained in serum were higher than in plasma: Serum AUC and Cmax were approximately 20% and 30% higher than plasma AUC and Cmax, respectively.
Slovenian: Koncentracije fentanila v serumu so bile višje kot v plazmi: AUC v serumu je bil približno 20 % višji in Cmax v serumu približno 30 % višji, kot sta AUC in Cmax v plazmi.
English: Time after Dose Administration (hours)
Slovenian: Čas po apliciranju odmerka (ure)
English: The judicious use of naloxone or another opioid antagonist may be warranted in some instances, but it is associated with the risk of precipitating an acute withdrawal syndrome.
Slovenian: V nekaterih primerih je morda potrebna razsodna uporaba naloksona ali drugih opioidnih antagonistov, vendar je povezana s tveganjem, da povzroči akutni odtegnitveni sindrom.
English: The risk of respiratory depression is less in patients receiving chronic opioid therapy as these patients will develop tolerance to respiratory depressant effects.
Slovenian: Tveganje respiratorne depresije je manjše pri bolnikih, ki prejemajo kronično opioidno terapijo, saj se pri teh bolnikih razvije toleranca na učinke respiratorne depresije.
English: Effentora should be individually titrated to an “effective” dose that provides adequate analgesia and minimises adverse reactions.
Slovenian: Zdravilo Effentora je treba titrirati individualno do ‘učinkovitega' odmerka, ki daje ustrezne analgetične rezultate in zmanjšuje neželene reakcije na najmanjšo možno mero.
English: A Daily Pain Journal to record daily pain levels, providing patients and physicians with a follow-up tool for daily symptoms and treatment efficacy.
Slovenian: Dnevnik bolečine v katero bolnik beleži raven dnevne bolečine, ki bolniku in zdravniku omogoča spremljanje dnevnih simptomov in učinkovitosti zdravljenja.
English: • Educational material for the healthcare professionals
Slovenian: • Izobraževalno gradivo za zdravstvene delavce.
English: Patients should be closely monitored for signs and symptoms of respiratory depression and sedation (see section 4.5).
Slovenian: Bolnike je treba natančno spremljati zaradi znakov in simptomov respiratorne depresije in sedacije (glejte poglavje 4.5).
English: Norfentanyl is not pharmacologically active in animal studies.
Slovenian: V študijah na živalih norfentanil ni farmakološko aktiven.
English: The safety and efficacy of Effentora in children aged 0 to 18 years have not been established.
Slovenian: Pediatrična populacija Varnost in učinkovitost zdravila Effentora pri otrocih, starih 0 do 18 let, nista bili dokazani.
English: It is recommended that two tablets should be placed in each side of the mouth.
Slovenian: Priporoča se, da bolnik vstavi ti dve tableti na vsako stran ust.
English: • You have low amount of fluid in the circulation or low blood pressure.
Slovenian: • Imate malo tekočine v obtoku ali nizek krvni tlak.
English: Patients and carers must be advised to dispose of any unopened tablets remaining from a prescription as soon as they are no longer needed.
Slovenian: Bolnike in negovalce je treba poučiti, da vse zaprte tablete, ki jih niso porabili, odstranijo takoj, ko jih več ne potrebujejo.
English: Dosage and frequency
Slovenian: Odmerjanje in pogostost
English: OTFC data was dose adjusted (800 mcg to 400 mcg)
Slovenian: OTFC podatki so bili prilagojeni (800 mcg do 400 mcg)
English: • A serious side effect of Effentora is slow and/or shallow breathing.
Slovenian: • Resen neželeni učinek zdravila Effentora je počasno in/ali plitko dihanje.
English: During determination of your right dose, your doctor may instruct you to take more than one tablet per episode.
Slovenian: Med določanjem pravilnega odmerka vam lahko zdravnik naroči, da vzamete več kot eno tableto na epizodo.
English: Effentora should not be used during pregnancy unless you have discussed this with your doctor.
Slovenian: Nosečnost Zdravila Effentora ne smete uporabljati med nosečnostjo, razen če ste se tako dogovorili s svojim zdravnikom.
English: • The most serious side effects are shallow breathing, low blood pressure and shock.
Slovenian: • Najresnejši neželeni učinki so plitko dihanje, nizek krvni tlak in šok.
English: B. CONDITIONS OR RESTRICTION(S) REGARDING SUPPLY AND USE
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
English: The analgesic effects of fentanyl are related to its plasma level.
Slovenian: Analgetični učinki fentanila so povezani s plazemsko ravnjo.
English: The total plasma clearance of fentanyl following intravenous administration is approximately 42 L/h.
Slovenian: Skupni plazemski očistek fentanila po intravenski aplikaciji je približno 42 L/h.
English: Breakthrough pain is additional, sudden pain that occurs in spite of you having taken your usual opioid pain-relieving medicines.
Slovenian: Prebijajoča bolečina je dodatna, nenadna bolečina, ki se pojavi kljub temu, da jemljete običajno opioidno zdravilo za lajšanje bolečine.
English: The remaining half of the total dose is swallowed and slowly absorbed from the gastrointestinal tract.
Slovenian: Preostala polovica skupnega odmerka se pogoltne in počasi absorbira iz prebavnega trakta.
English: If you experience withdrawal symptoms or if you are concerned about your pain relief, you should contact your doctor.
Slovenian: Če se pojavijo odtegnitveni simptomi ali če ste zaskrbljeni glede lajšanja bolečin, se posvetujte z zdravnikom.
English: • blisters in the mouth, dry lips, collection of pus under the skin in the mouth
Slovenian: • mehurčki v ustih, suhe ustnice, nabiranje gnoja pod kožo v ustih
English: In each Member State where EFFENTORA is marketed the Marketing Authorisation Holder (MAH) shall agree an updated educational programme with the National Competent Authority.
Slovenian: V vseh državah članicah, kjer je zdravilo EFFENTORA v prometu, se bo imetnik dovoljenja za promet z zdravilom s pristojnim nacionalnim organom dogovoril za posodobljen izobraževalni program.
English: Effentora is not recommended for use in patients who have received MAOIs within 14 days because severe and unpredictable potentiation by MAOIs has been reported with opioid analgesics.
Slovenian: Uporabe zdravila Effentora se ne priporoča pri bolnikih, ki so v zadnjih 14 dneh dobili MAOI, saj poročajo o resnih in nepredvidljivih povečanjih učinkov MAOI z opioidnimi analgetiki.
English: Carcinogenicity studies (26-week dermal alternative bioassay in Tg.AC transgenic mice; two-year subcutaneous carcinogenicity study in rats) with fentanyl did not reveal any findings indicative of oncogenic potential.
Slovenian: Študije kancerogenosti (26-tedenska vsebnost v kožnem nadomestku na Tg.AC transgenih miših; dvoletna študija subkutane kancerogenosti na podganah) s fentanilom niso razkrile izsledkov, ki bi kazali na onkogeni potencial.
English: Plasma Fentanyl Concentration (ng/mL)
Slovenian: Plazemska koncentracija fentanila (ng/ml)
English: • prolonged treatment with fentanyl during pregnancy may cause withdrawal symptoms in the newborn which can be life-threatening (see section 2)
Slovenian: • dolgotrajno zdravljenje s fentanilom v nosečnosti lahko pri novorojenčku povzroči odtegnitvene simptome, ki so lahko smrtno nevarni (glejte poglavje 2)
English: Pharmacokinetic parameter (mean)
Slovenian: Farmakokinetični parametri (srednji)
English: About 30% of the amount swallowed (50% of the total dose) escapes hepatic and intestinal first-pass elimination and becomes systemically available.
Slovenian: Približno 30 % zaužite količine (50 % skupnega odmerka) se izogne učinku prvega prehoda skozi jetra in črevesje in postane sistemsko razpoložljivo.
English: • You use benzodiazepines (see section 2 under “Other medicines and Effentora”).
Slovenian: • Če uporabljate benzodiazepine (glejte poglavje 2 pod »Druga zdravila in zdravilo Effentora«).
English: If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available (see section 4.8).
Slovenian: Če mora nosečnica dlje časa uporabljati opioide, je treba bolnici svetovati o tveganju opioidnega odtegnitvenega sindroma pri novorojencih in zagotoviti, da je na voljo ustrezno zdravljenje (glejte poglavje 4.8).
English: During an initial open-label phase, patients were titrated to an effective dose of Effentora.
Slovenian: V začetni odprti fazi so bili bolniki titrirani na učinkovit odmerek zdravila Effentora.
English: In clinical studies patients older than 65 years tended to titrate to a lower effective dose than younger patients.
Slovenian: Uporaba pri starejših (starih več kot 65 let) V kliničnih študijah je bil učinkovit odmerek pri bolnikih, starih več kot 65 let, običajno nižji kot pri mlajših bolnikih.
English: Mean Plasma Concentration Versus Time Profiles Following Singles Doses of EFFENTORA and OTFC in Healthy Subjects
Slovenian: Srednja koncentracija v plazmi v primerjavi s časovnimi profili po enojnem odmerku zdravila EFFENTORA in OTFC pri zdravih osebkih
English: These effects could either be indirect effects due to altered maternal care and/or decreased lactation rate or a direct effect of fentanyl on the pups.
Slovenian: Ti učinki so lahko bodisi posredni zaradi spremenjene materine nege in/ali manjše stopnje laktacije, bodisi neposredni učinek fentanila na mladiče.
English: It is recommended that one tablet should be placed in each side of the mouth.
Slovenian: Priporoča se, da bolnik vstavi po eno tableto na vsako stran ust.
English: All opioid µ-receptor agonists, including fentanyl, produce dose dependent respiratory depression.
Slovenian: Vsi antagonisti µ-opioidnih receptorjev, vključno s fentanilom, povzročajo od odmerka odvisno respiratorno depresijo.
English: If the breakthrough pain is still ongoing, you may take Effentora as prescribed by your physician.
Slovenian: Če je prebijajoča bolečina še vedno prisotna, lahko uporabite zdravilo Effentora, kot vam je predpisal zdravnik.
English: Effentora should only be used for conditions specified in section 4.1.
Slovenian: Zdravilo Effentora naj se uporablja samo za stanja, podana v poglavju 4.1.
English: The metabolites are mainly excreted in the urine, while faecal excretion is less important.
Slovenian: Presnovki se po večini izločajo v urinu, medtem ko je izločanje prek blata manj pomembno.
English: In absence of adequate pain control, the possibility of hyperalgesia, tolerance and progression of underlying disease should be considered (see section 4.4).
Slovenian: V odsotnosti zadostnega obvladovanja bolečine je treba upoštevati, da lahko pride do hiperalgezije, tolerance in napredovanja osnovne bolezni (glejte poglavje 4.4).
English: If someone has accidentally taken Effentora, they may have the same side effects as described in the section 3 “If you use more Effentora than you should”.
Slovenian: Če je nekdo po nezgodi uporabil zdravilo Effentora, lahko izkusi enake neželene učinke, kot so opisani v poglavju 3 "Če ste uporabili večji odmerek zdravila Effentora, kot bi smeli".
English: • Information on the titration process as indicated in the labelling - Instructions on the safe use (to avoid the risk of overdosing), on storage (to avoid the risk of accidental exposure), and disposal of fentanyl buccal tablet - Boxed statements as follows:
Slovenian: • Informacijah o postopku titriranja kot so navedene na oznaki - Navodil o varni uporabi (v izogib tveganju prevelikega odmerjanja), shranjevanju (v izogib tveganju nezgodne izpostavitve) in odstranjevanja bukalnih tablet s fentanilom
English: The clinical studies of Effentora were designed to evaluate safety and efficacy in treating BTP and all patients were also taking concomitant opioids, such as sustained-release morphine or transdermal fentanyl, for their persistent pain.
Slovenian: Klinične študije zdravila Effentora so bile zasnovane za ocenitev varnosti in učinkovitosti zdravljenja PBB in vsi bolniki so hkrati jemali opioide, kot so morfij z zadržanim sproščanjem ali transdermalni fentanil za stalno bolečino.
English: However, the most serious adverse reactions are respiratory depression (potentially leading to apnoea or respiratory arrest), circulatory depression, hypotension and shock and all patients should be closely monitored for these.
Slovenian: Vendar pa so najbolj resni neželeni učinki respiratorna depresija (ki potencialno vodi v apnejo ali respiratorni arest), depresija obtočil, hipotenzija in šok, zato je treba vse bolnike skrbno nadzirati v zvezi s temi pojavi.
English: In pharmacokinetic studies that compared the absolute and relative bioavailability of Effentora and oral transmucosal fentanyl citrate (OTFC), the rate and extent of fentanyl absorption in Effentora demonstrated exposure that was between 30% to 50% greater than that for oral transmucosal fentanyl citrate.
Slovenian: V farmakokinetičnih študijah, v katerih so primerjali absolutno in relativno biološko razpoložljivost zdravila Effentora in peroralnega transmukoznega fentanil citrata (OTFC), je bila prikazana stopnja in količina absorpcije fentanila pri zdravilu Effentora med 30 % in 50 % višja kot pri peroralnem transmukoznem fentanil citratu.
English: • Instructions for use of fentanyl buccal tablet and how to place the tablet
Slovenian: • Navodilih za uporabo bukalnih tablet s fentanilom in namestitev tablet
English: The use of these medicines with Effentora can lead to a serotonin syndrome a potentially life-threatening condition (see section 2 under “Other medicines and Effentora”).
Slovenian: Uporaba teh zdravil z zdravilom Effentora lahko povzroči serotoninski sindromi, ki je potencialno življenjsko nevarno stanje (glejte poglavje 2 »Druga zdravila in zdravilo Effentora«).
English: • shortness of breath, painful throat
Slovenian: • kratka sapa, boleče grlo
English: Tear 2.
Slovenian: Odtrgajte 2.
English: • severe breathing problems, trouble breathing during sleep,
Slovenian: • težave z dihanjem, težave z dihanjem v spanju
English: For dose-readjustment the same principles apply as outlined for dose titration (see above).
Slovenian: Za ponovno prilagoditev odmerka velja enako načelo kot za titriranje odmerka (glejte zgoraj).
English: Maintenance opioid treatment
Slovenian: Vzdrževalno opioidno zdravljenje
English: The number of tablet strengths available to the patients at any time should be minimised to prevent confusion and potential overdose.
Slovenian: Število jakosti tablet, ki so bolniku vedno na voljo, mora biti čim manjše, da jih bolnik ne zameša in da s tem preprečite morebitno preveliko odmerjanje.
English: Statistically significant improvement in pain intensity difference was seen with Effentora versus placebo as early as 10 minutes in Study 1 and as early as 15 minutes (earliest time point measured) in Study 2.
Slovenian: Statistično pomembno izboljšanje razlike v intenzivnosti bolečine so opazili pri zdravilu Effentora v primerjavi s placebom po 10 minutah v študiji 1 in po 15 minutah (najzgodnejše merjenje) v študiji 2.
English: Once the right dose has been determined with your doctor, use 1 tablet for an episode of breakthrough pain as a general rule.
Slovenian: Ko zdravnik ugotovi pravilni odmerek, uporabite kot splošno pravilo 1 tableto na epizodo prebijajoče bolečine.
English: For each BTP episode, pain intensity was assessed prior to and at several time points after treatment.
Slovenian: Intenzivnost bolečine so za vsako epizodo PBB ocenili pred številnimi časovnimi točkami po zdravljenju in ob njih.
English: The Effentora tablet should not be sucked, chewed or swallowed, as this will result in lower plasma concentrations than when taken as directed.
Slovenian: Tablet zdravila Effentora se ne sme sesati, žvečiti ali pogoltniti, saj to povzroči nižje koncentracije v plazmi, kot so po navodilu.
English: Therefore patients should be instructed not to open the blister until ready to place the tablet in the buccal cavity.
Slovenian: Zato je treba bolnikom naročiti, da pretisnega omota ne odpirajo, dokler niso pripravljeni za vstavitev tablete v ustno votlino.
English: Titration in patients switching from other fentanyl containing products Due to different absorption profiles, switching must not be done at a 1:1 ratio.
Slovenian: Titriranje pri bolnikih, ki so jemali drugo zdravilo s fentanilom Zaradi različnih absorpcijskih profilov zdravila ni dovoljeno menjati v razmerju 1:1.
English: However if your doctor does prescribe Effentora together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor.
Slovenian: Če pa vam zdravnik vseeno predpiše zdravilo Effentora skupaj s sedativnimi zdravili, mora zdravnik omejiti odmerek in trajanje sočasnega zdravljenja.
English: More than 90% of the administered dose of fentanyl is eliminated by biotransformation to N-dealkylated and hydroxylated inactive metabolites.
Slovenian: Več kot 90 % apliciranega odmerka fentanila se izloči z biološko transformacijo v N-dealkilirane in hidroksilirane neaktivne presnovke.
English: If discontinuation of all opioid therapy is required, the patient must be closely followed by the doctor in order to manage the risk of abrupt withdrawal effects.
Slovenian: Če je treba vsakršno opioidno zdravljenje prekiniti, je treba bolnika skrbno spremljati zaradi obvladovanja tveganja odtegnitvenih učinkov zaradi nenadne prekinitve.