FrancophonIA/ELRC3.0 huggingface dataset:
English: The influence of hepatic and renal impairment on the pharmacokinetics of the medicinal product has not been evaluated, however, when administered intravenously the clearance of fentanyl has been shown to be altered in hepatic and renal impairment due to alterations in metabolic clearance and plasma proteins.
Slovenian: Vpliv okvarjenega delovanja jeter ali ledvic na farmakokinetiko zdravila ni bil ocenjen, vendar pa se je pri intravenski aplikaciji pokazalo, da je očistek fentanila drugačen pri okvari jeter in ledvic zaradi spremenjenega presnovnega očistka in plazemskih beljakovin.
English: • The most common side effects are feeling sleepy, sick or dizzy.
Slovenian: • Najbolj običajni neželeni učinki so občutek zaspanosti, slabost ali vrtoglavica.
English: Tel: +371 67 323 666
Slovenian: Tel: Tel: +371 67 323 666
English: Agents that affect CYP3A4 activity
Slovenian: Zdravila, ki vplivajo na dejavnost CYP3A4
English: • In case of irritation, you may change the placement of the tablet on the gum.
Slovenian: • V primeru draženja lahko spremenite mesto, kamor tableto vstavite.
English: Fentanyl is metabolised mainly via the human cytochrome P450 3A4 isoenzyme system (CYP3A4), therefore potential interactions may occur when Effentora is given concurrently with agents that affect CYP3A4 activity.
Slovenian: Glavna presnovna pot fentanila je preko izoencimskega sistema (CYP3A4) človeškega citokroma P450 3A4, zato se lahko pojavijo interakcije, če se daje zdravilo Effentora hkrati z zdravili, ki vplivajo na dejavnost CYP3A4.
English: After administration of Effentora, impaired hepatic and renal function may both increase the bioavailability of swallowed fentanyl and decrease its systemic clearance, which could lead to increased and prolonged opioid effects.
Slovenian: Po apliciranju zdravila Effentora se lahko pri bolnikih z okvarjenim delovanjem jeter in ledvic poviša biološka razpoložljivost zaužitega fentanila in zmanjša njegov sistemski očistek, kar lahko povzroči zvečane in podaljšane opioidne učinke.
English: Each blister contains 4 buccal tablets, supplied in cartons of 4 or 28 buccal tablets.
Slovenian: En pretisni omot vsebuje 4 bukalne tablete, pakirane v škatle po 4 ali 28 bukalnih tablet.
English: • lack of testosterone, abnormal sensation in eye, observing flashes of light, brittle nails
Slovenian: • pomanjkanje testosterona, nenormalen občutek v ušesih, pojav svetlobnih bliskov, krhki nohti
English: The blister unit should then be flexed along the line printed on the backing foil where indicated.
Slovenian: Enote pretisnega omota nato prepognite po črtkani liniji na hrbtni strani folije, kjer je označeno.
English: Fentanyl can get into breast milk and may cause side effects in the breast-fed infant.
Slovenian: Fentanil lahko preide v materino mleko in povzroči neželene učinke pri dojenih otrocih.
English: Effentora should be administered with caution to patients with moderate or severe hepatic or renal impairment (see section 4.4).
Slovenian: Zdravilo Effentora je treba previdno aplicirati pri bolnikih z zmerno do resno jetrno ali ledvično okvaro (glejte poglavje 4.4).
English: After buccal administration of Effentora, fentanyl undergoes initial rapid distribution that represents an equilibration of fentanyl between plasma and the highly perfused tissues (brain, heart and lungs).
Slovenian: Po bukalni aplikaciji zdravila Effentora se fentanil najprej hitro porazdeli, kar predstavlja ekvilibracijo fentanila med plazmo in izjemno prekrvavljenim tkivom (možgani, srce in pljuča).
English: TEVA B.V. Swensweg 5 2031 GA Haarlem Netherlands
Slovenian: Swensweg 5 2031 GA Haarlem Nizozemska
English: Effentora must not be prescribed in pain other than breakthrough cancer pain 2.
Slovenian: Zdravila Effentora ni dovoljeno predpisati za drugo bolečino, kot za prebijajočo bolečino zaradi raka 2.
English: Breakthrough pain episodes may vary in intensity and the required Effentora dose might increase over time due to progression of the underlying cancer disease.
Slovenian: Intenzivnost epizod prebijajoče bolečine se lahko razlikuje, zato bo morda treba odmerek zdravila Effentora sčasoma povečati zaradi napredovanja osnovnega rakavega obolenja.
English: Wait at least 4 hours before treating another episode of breakthrough pain with Effentora.
Slovenian: Počakajte vsaj 4 ure, preden zdravite naslednjo epizodo prebijajoče bolečine z zdravilom Effentora.
English: Loss of consciousness and respiratory arrest have been observed in the context of overdose (see section 4.9).
Slovenian: V kontekstu prevelikega odmerjanja so opazili izgubo zavesti in respiratorni arest (glejte poglavje 4.9).
English: Effentora is indicated for the treatment of breakthrough pain (BTP) in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain.
Slovenian: Zdravilo Effentora je indicirano za zdravljenje prebijajoče bolečine (PBB) pri odraslih s karcinomom, ki že prejemajo vzdrževalno opioidno terapijo za kronično bolečino pri karcinomu.
English: Effentora 400 micrograms
Slovenian: Effentora 400 mikrogramov
English: Tachycardia Bradycardia
Slovenian: Srčne bolezni tahikardija bradikardija
English: The correct method of releasing the tablet from the blister is: One of the blister units should be separated from the blister card by tearing it apart at the perforations.
Slovenian: Pravilen način odstranitve tablete iz pretisnega omota je: Eno od enot pretisnega omota strgajte po perforaciji in jo ločite od preostanka pretisnega omota.
English: The following adverse reactions have been reported with Effentora and/or other fentanyl-containing compounds during clinical studies and post marketing experience.
Slovenian: Z uporabo zdravila Effentora in/ali drugih zdravil, ki vsebujejo fentanil, so poročali o naslednjih neželenih učinkih iz kliničnih študij in obdobja po začetku trženja.
English: In clinical studies, the effective dose of Effentora for BTP was not predictable from the daily maintenance dose of opioid.
Slovenian: V kliničnih študijah ni bilo možno predvideti učinkovitega odmerka zdravila Effentora za PBB na podlagi dnevnega vzdrževalnega odmerka opioida.
English: Effentora should be discontinued immediately if the patient no longer experiences breakthrough pain episodes.
Slovenian: Zdravljenje z zdravilom Effentora je treba prekiniti takoj, ko bolnik nima več epizod prebijajoče bolečine.
English: Effentora is a pain-relieving medicine known as an opioid, which is used to treat breakthrough pain in adult patients with cancer who are already taking other opioid pain medicines for their persistent (around-the-clock) cancer pain.
Slovenian: Effentora je zdravilo za lajšanje bolečine, znano kot opioid, ki se uporablja za zdravljenje prebijajoče bolečine pri odraslih bolnikih s karcinomom, ki že jemljejo druga opioidna zdravila za lajšanje stalne (24-urne) bolečine zaradi karcinoma.
English: If this dose is considered to be the effective dose, treatment of successive episodes of BTP may be continued with a single 400 micrograms tablet of Effentora.
Slovenian: Če se oceni, da ta odmerek učinkuje, se lahko zdravljenje naslednjih epizod PBB nadaljuje z eno 400-mikrogramsko tableto zdravila Effentora.
English: Bend 3.
Slovenian: Prepognite 3.
English: Although muscle rigidity interfering with respiration has not been seen following the use of Effentora, this is possible with fentanyl and other opioids.
Slovenian: Čeprav po uporabi zdravila Effentora niso opazili togosti mišic, ki bi ovirala respiracijo, je to pri fentanilu in drugih opioidih možno.
English: • If you suffer from severe breathing problems or severe obstructive lung conditions.
Slovenian: • če imate resne težave z dihanjem ali resno obstruktivno bolezen pljuč.
English: Patients should be advised not to drive or operate machinery if they experience somnolence, dizziness, or visual disturbance while taking Effentora and not to drive or operate machinery until they know how they react.
Slovenian: Bolnikom je treba svetovati, naj ne vozijo in ne upravljajo strojev, če čutijo zaspanost, omotičnost ali opazijo motnje vida pri jemanju zdravila
English: Fentanyl is highly lipophilic and can be absorbed very rapidly through the oral mucosa and more slowly by the conventional gastrointestinal route.
Slovenian: Fentanil je zelo lipofilen in se izjemno hitro absorbira skozi oralno sluznico, nekoliko počasneje pa po običajni prebavni poti.
English: Following oromucosal administration of Effentora, fentanyl is readily absorbed with an absolute bioavailability of 65%.
Slovenian: Absorpcija: Po aplikaciji zdravila Effentora prek ustne sluznice se fentanil absorbira z absolutno biološko razpoložljivostjo 65 %.
English: The maintenance dose of Effentora should be increased when a patient requires more than one tablet per BTP episode for several consecutive BTP episodes.
Slovenian: Vzdrževalni odmerek zdravila Effentora je treba dvigovati pri bolnikih, kjer je za več zaporednih epizod PBB potrebna več kot ena tableta na epizodo PBB.
English: Using benzodiazepines can increase the chances of getting serious side effects including death
Slovenian: Uporaba benzodiazepinov lahko poveča možnost za resne neželene učinke, vključno s smrtjo.
English: • Severe respiratory depression or severe obstructive lung conditions.
Slovenian: • Resna respiratorna depresija ali huda obstruktivna bolezen pljuč.
English: Improper patient selection (e.g., use in patients without maintenance opioid therapy) and/or improper dosing have resulted in fatal outcome with Effentora as well as with other fentanyl products.
Slovenian: Neustrezen izbor bolnikov (na primer uporaba pri bolnikih brez vzdrževalne terapije z opioidi) in/ali neprimerno odmerjanje lahko z zdravilom Effentora in drugimi zdravili, ki vsebujejo fentanil povzroči smrten izid.
English: Patients should be instructed not to use two different formulations of fentanyl concurrently for the treatment of breakthrough pain, and to dispose of any fentanyl product prescribed for BTP when switching to Effentora.
Slovenian: Bolnikom je treba dati navodilo, naj ne uporabljajo dveh različnih formulacij fentanila hkrati za zdravljenje prebijajoče bolečine in da zdravila s fentanilom, predpisana za zdravljenje PBB, ob prehodu na zdravilo Effentora zavržejo.
English: Once an effective dose has been established during titration, patients should continue to take this dose as a single tablet of that given strength.
Slovenian: Bolniki, pri katerih je bil med titriranjem ugotovljen učinkovit odmerek, naj nadaljujejo z jemanjem tega odmerka v obliki ene tablete te jakosti.
English: Together these symptoms may be a sign of a potentially life-threatening condition called adrenal insufficiency, a condition in which the adrenal glands do not produce enough hormones.
Slovenian: Kombinacija vseh teh simptomov je lahko znak bolezni, ki je lahko smrtno nevarna, in se imenuje oslabljeno delovanje nadledvične žleze; pri tej bolezni nadledvični žlezi ne izdelujeta dovolj hormonov.
English: If Effentora is used for a long time during pregnancy, there is also a risk of the new-born child having withdrawal symptoms which might be life-threatening if not recognized and treated by a doctor.
Slovenian: Če zdravilo Effentora med nosečnostjo uporabljate dlje časa, obstaja tveganje za odtegnitvene sindrome pri novorojencu, ki so lahko življenjsko nevarni, če jih zdravnik ne prepozna in zdravi.
English: Not applicable.
Slovenian: ne priporočajo.
English: Discontinuation of therapy
Slovenian: Prekinitev terapije
English: For treatment of overdose in opioid-maintained patients, intravenous access should be obtained.
Slovenian: Preveliko odmerjanje pri bolnikih z vzdrževalnim opioidnim zdravljenjem Za zdravljenje prevelikega odmerka pri bolnikih z vzdrževalnim opioidnim zdravljenjem je treba ustvariti intravenski dostop.
English: If treatment of a BTP episode requires more than one tablet, an increase in dose to the next higher available strength should be considered to treat the next BTP episode.
Slovenian: Če je treba za zdravljenje epizode PBB uporabiti več kot eno tableto, je treba za zdravljenje naslednje epizode PBB razmisliti o uporabi naslednje višje jakosti zdravila.
English: Co-administration of fentanyl with other central nervous system depressants, including other opioids, sedatives or hypnotics, (including benzodiazepines), general anaesthetics, phenothiazines, tranquillisers, skeletal muscle relaxants, sedating antihistamines and alcohol can produce additive depressant effects which may result in a fatal outcome (see section 4.4).
Slovenian: Hkratno dajanje fentanila z drugimi zaviralci osrednjega živčnega sistema, vključno z drugimi opioidi, sedativi ali hipnotiki (vključno z benzodiazepini), splošnimi anestetiki, fenotiazini, pomirjevali, relaksanti skeletnih mišic, sedativnimi antihistaminiki in alkoholom, lahko poveča pomirjevalne učinke, kar lahko povzroči smrt (glejte poglavje4.4).
English: • If a single 200 micrograms tablet of Effentora (or two 100 micrograms tablets) is not considered to be efficacious the patient can be instructed to use two 200 micrograms tablets (or four 100 micrograms tablets) to treat the next episode of BTP.
Slovenian: • Če se oceni, da ena 200-mikrogramska tableta zdravila Effentora (ali dve 100-mikrogramski tableti) ni dovolj učinkovita, dajte bolniku navodila, da za zdravljenje naslednje epizode PBB uporabi dve 200-mikrogramski tableti (ali štiri 100-mikrogramske tablete).
English: You should not start breast-feeding until at least 5 days after the last dose of Effentora.
Slovenian: Preden začnete dojiti, morate počakati vsaj 5 dni od zadnjega odmerka zdravila Effentora.
English: • cold sweat, swollen face, generalised itching, hair loss, muscle twitching, muscular weakness,
Slovenian: • hladen znoj, otekel obraz, generalizirana srbečica, izguba las, trzanje mišic, mišična oslabelost,
English: Particular caution should be used when titrating Effentora in patients with non-severe chronic obstructive pulmonary disease or other medical conditions predisposing them to respiratory depression, as even normally therapeutic doses of Effentora may further decrease respiratory drive to the point of respiratory failure.
Slovenian: Kronična obstruktivna pljučna bolezen Pri titriranju zdravila Effentora pri bolnikih z manj hudo obstruktivno pljučno boleznijo ali drugimi zdravstvenimi tegobami, zaradi katerih so nagnjenih k respiratorni depresiji, je potrebna posebna previdnost, saj lahko celo običajni terapevtski odmerki zdravila Effentora dodatno znižajo dihalno kapaciteto do take mere, da pride do dihalne odpovedi.
English: You should discuss with your doctor whether it is safe for you to drive, or operate machinery after taking Effentora.
Slovenian: Pogovorite se z zdravnikom, ali lahko po uporabi zdravila Effentora varno vozite ali upravljate stroje.
English: • You are suffering from any condition that has an effect on your breathing (such as asthma,
Slovenian: • Imate bolezen, ki vpliva na vaše dihanje (kot na primer astma, zasoplost ali kratka sapa).
English: 4 buccal tablets 28 buccal tablets
Slovenian: 4 bukalne tablete 28 bukalnih tablet
English: Talk to your doctor or pharmacist BEFORE using Effentora if:
Slovenian: Zdravniku ali farmacevtu povejte PRED začetkom uporabe zdravila Effentora, če:
English: It is advised not to use fentanyl during labour and delivery (including caesarean section) because fentanyl passes through the placenta and may cause respiratory depression in the foetus.
Slovenian: Svetujemo, da fentanila ne uporabljate med popadki in porodom (vključno s carskim rezom), saj prehaja skozi placento in lahko pri plodu povzroči respiratorno depresijo.
English: • You experience a combination of the following symptoms: nausea, vomiting, anorexia, fatigue, weakness, dizziness and low blood pressure.
Slovenian: • Imate kombinacijo naslednjih simptomov: navzea (občutek siljenja na bruhanje), bruhanje, anoreksija (izguba teka), utrujenost, šibkost, omotica in znižan krvni tlak.
English: Fentanyl is metabolised in the liver and in the intestinal mucosa to norfentanyl by CYP3A4 isoform.
Slovenian: Fentanil se presnavlja v jetrih in v črevesni sluznici v norfentanil s pomočjo izoforme CYP3A4.
English: Overdose (accidental ingestion) in the opioid-naive person For treatment of overdose (accidental ingestion) in the opioid-naive person, intravenous access should be obtained and naloxone or other opioid antagonists should be employed as clinically indicated.
Slovenian: Preveliko odmerjanje (nezgodno zaužitje) pri osebi brez predhodnega jemanja opioidov Za zdravljenje prevelikega odmerka (nezgodnega zaužitja) pri osebi brez predhodnega jemanja opioidov, je treba ustvariti intravenski dostop in dovajati nalokson ali druge opioidne antagoniste, kot je klinično indicirano.
English: /AG Tel/Tél: +32 3 820 73 73
Slovenian: Tél/Tel: +32 3 820 73 73
English: The other ingredients are mannitol, sodium starch glycolate type A, sodium hydrogen carbonate, sodium carbonate anhydrous, citric acid anhydrous, magnesium stearate.
Slovenian: Druge sestavine zdravila so manitol, natrijev karboksimetilškrob (vrsta A), natrijev hidrogenkarbonat, brezvodni natrijev karbonat, brezvodna citronska kislina, magnezijev stearat.
English: feeling unwell, chest discomfort, thirst, feeling cold, feeling hot, difficulty passing urine
Slovenian: slabo počutje, nelagodje v prsih, žeja, občutek mrazu, občutek vročine, težave pri odvajanju urina
English: Caution is advised when Effentora is co-administered with drugs that affect the serotoninergic neurotransmitter systems.
Slovenian: Pri sočasni uporabi zdravila Effentora z zdravili, ki vplivajo na sistem serotoninergičnih nevrotransmiterjev, je potrebna previdnost.
English: • one or more of the following problems in the mouth: ulcer, loss of sensation, discomfort, unusual colour, soft tissue disorder, tongue disorder, painful or blistered or ulcerated tongue, gum pain, chapped lips, tooth disorder
Slovenian: • ena ali več od naslednjih težav v ustih: razjede, izguba občutka, nelagodje, neobičajna barva, bolezni mehkega tkiva, bolezni jezika, boleč jezik, mehurčki ali razjede na jeziku, bolečina dlesni,
English: What Effentora looks like and contents of the pack
Slovenian: Izgled zdravila Effentora in vsebina pakiranja
English: redness, swelling or spots
Slovenian: pordelost, znojenje ali lise
English: Effentora may interact with these medicines and you may experience mental status changes (e.g. agitation, hallucinations, coma), and other effects such as body temperature above 38°C, increase in heart rate, unstable blood pressure, and exaggeration of reflexes, muscular rigidity, lack of coordination and/or gastrointestinal symptoms (e.g nausea, vomiting, diarrhoea).
Slovenian: Zdravilo Effentora lahko medsebojno učinkuje s temi zdravili in pojavi se lahko sprememba mentalnega stanja (npr. agitacija, halucinacije, koma) in drugi učinki, kot so telesna temperatura, višja kot 38 °C, hitrejši srčni utrip, nestabilen krvni tlak in pretirano izraženi refleksi, mišična okorelost, pomanjkanje koordinacije in/ali gastrointestinalni simptomi (npr. navzea, bruhanje, driska).
English: Bradyarrhythmias
Slovenian: Bradiaritimije
English: Careful consideration should be given to patients with hypovolaemia and hypotension.
Slovenian: Pri bolnikih s hipovolemijo in hipotenzijo je potreben skrben preudarek.
English: If you forget to use Effentora
Slovenian: Če ste pozabili uporabiti zdravilo Effentora
English: Patients should be instructed not to attempt to crush or split the tablet.
Slovenian: Bolnikom je treba naročiti, naj tablete ne drobijo in ne lomijo.
English: Effentora contains sodium
Slovenian: Zdravilo Effentora vsebuje natrij
English: In addition, Effentora should be administered with caution to patients with hepatic or renal impairment.
Slovenian: Poleg tega je treba zdravilo Effentora dajati previdno bolnikom z okvarjenim delovanjem jeter ali ledvic.
English: Keep using the opioid pain medicine you take for your persistent (around-the-clock) cancer pain during your Effentora treatment.
Slovenian: Še naprej uporabljajte opioidno zdravilo proti bolečinam, ki ga uporabljate za stalno (24-urno) bolečino zaradi karcinoma v času zdravljenja z zdravilom Effentora.
English: Cold sweat Facial swelling Generalised pruritus Alopecia
Slovenian: izpuščaj hladen znoj, obrazno znojenje, generalizirani pruritus, alopecija onihoreksa
English: If switching from another oral fentanyl citrate product, independent dose titration with Effentora is required as bioavailability between products differs significantly.
Slovenian: Ob menjavi dosedanjega peroralnega zdravila s fentanilijevim citratom z zdravilom Effentora je potrebno neodvisno titriranje odmerka z zdravilom Effentora, saj se biološka razpoložljivost med zdravili znatno razlikuje.
English: Excipient with known effect: Each tablet contains 20 mg of sodium.
Slovenian: Pomožna snov z znanim učinkom: Ena tableta vsebuje 20 mg natrija.
English: Two double-blind, randomized, placebo-controlled crossover studies have been conducted involving a total of 248 patients with BTP and cancer who experienced on average 1 to 4 episodes of BTP per day while taking maintenance opioid therapy.
Slovenian: Na skupno 248 bolnikih s PBB in karcinomom, ki so povprečno imeli 1 do 4 epizode PBB dnevno med jemanjem opioidne terapije, so izvedli dve dvojno slepi, randomizirani, s placebom kontrolirani križni študiji.
English: Contains sodium
Slovenian: Vsebuje natrij.
English: • decrease in cells that help the blood to clot,
Slovenian: • vneto grlo • zmanjšano število celic, ki sodelujejo pri strjevanju krvi
English: • Main precautions for use: How to prevent main risks (take the drug as prescribed; remain on maintenance opioid therapy; keep EFFENTORA out of the reach and the sight of children; prevent theft and misuse)
Slovenian: • Glavni previdnostni ukrepi: Kako preprečiti glavna tveganja (jemanje zdravila kot je predpisano; ohranjanje vzdrževalnega opioidnega zdravljenja; shranjevanje zdravila
English: Therefore, special care should be taken during the titration process in patients with moderate or severe hepatic or renal impairment.
Slovenian: Zato bodite pri postopku titriranja posebno previdni pri bolnikih z zmerno do resno okvaro delovanja jeter ali ledvic.
English: • decrease in white cells in the blood, decrease in red blood cells, decreased or raised blood pressure, unusually fast heart rate
Slovenian: • zmanjšano število levkocitov v krvi, zmanjšano število eritrocitov v krvi, znižan ali zvišan krvni tlak, neobičajno hiter srčni utrip • bolečina v mišicah, bolečina v hrbtu
English: • If the initial 100 micrograms tablet is not efficacious, the patient can be instructed to treat the next episode of BTP with two 100 micrograms tablets.
Slovenian: • Če začetna 100-mikrogramska tableta ne učinkuje, dajte bolniku navodila, da za naslednjo epizodo PBB uporabi dve 100-mikrogramski tableti.
English: • itching, excessive sweating, rash
Slovenian: • srbenje, prekomerno znojenje, izpuščaj
English: If you stop using Effentora
Slovenian: Če ste prenehali uporabljati zdravilo Effentora
English: Hypogonadism Adrenal insufficiency, androgen deficiency
Slovenian: Bolezni endokrinega sistema hipogonadizem oslabljeno delovanje nadledvične žleze, pomanjkanje androgena
English: • Concomitant use of Effentora and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening.
Slovenian: • Sočasna uporaba zdravila Effentora in sedativnih zdravil, kot so benzodiazepini ali povezana zdravila, povečajo tveganje za zaspanost, težave z dihanjem (respiratorna depresija), komo in so lahko življenjsko nevarni.
English: How to use Effentora
Slovenian: Kako uporabljati zdravilo Effentora
English: If your breakthrough pain is not relieved after 30 minutes, use only 1 more tablet of Effentora during this dose-readjustment period.
Slovenian: Če prebijajoča bolečina ne preneha čez 30 minut, tokrat uporabite samo 1 dodatno tableto zdravila Effentora v obdobju ponovne prilagoditve odmerka.