FrancophonIA/ELRC3.0 huggingface dataset:
English: Increased intracranial pressure, impaired consciousness Effentora should only be administered with extreme caution in patients who may be particularly susceptible to the intracranial effects of CO2 retention, such as those with evidence of increased intracranial pressure or impaired consciousness.
Croatian: Effentoru treba primjenjivati s krajnjim oprezom u bolesnika koji mogu biti posebno osjetljivi na intrakranijalne učinke retencije CO2 poput onih s potvrđenim porastom intrakranijalnog tlaka ili poremećajem svijesti.
English: If switching from another oral fentanyl citrate product, independent dose titration with Effentora is required as bioavailability between products differs significantly.
Croatian: Kod prebacivanja s drugog peroralnog lijeka koji sadrži fentanilcitrat, potrebna je neovisna titracija doze s Effentorom jer se bioraspoloživost između lijekova značajno razlikuje.
English: Once the right dose has been determined with your doctor, use 1 tablet for an episode of breakthrough pain as a general rule.
Croatian: Kada Vam liječnik odredi pravilnu dozu, uzimajte u pravilu 1 tabletu za epizodu probijajuće boli.
English: Effentora should be administered with caution to patients with moderate or severe hepatic or renal impairment (see section 4.4).
Croatian: Effentoru treba primijeniti s oprezom bolesnicima s umjerenim ili teškim oštećenjem funkcije jetre ili bubrega (vidjeti dio 4.4).
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.
Croatian: Effentora je indicirana za liječenje probijajuće boli u odraslih bolesnika s rakom koji već primaju opioidnu terapiju održavanja za kroničnu malignu bol.
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.
Croatian: Effentora je lijek za olakšavanje boli poznat i kao opioid, a koristi se za liječenje probijajuće boli u odraslih bolesnika s rakom koji već uzimaju druge opioidne lijekove protiv trajne (neprekidne) boli kod raka.
English: The tablet should not be stored once removed from the blister package as the tablet integrity cannot be guaranteed and a risk of accidental exposure to a tablet can occur.
Croatian: Tableta izvađena iz blistera više se ne smije spremati jer se ne može jamčiti integritet tablete te može doći do slučajnog izlaganja tableti.
English: • decrease in white cells in the blood, decrease in red blood cells, decreased or raised blood pressure, unusually fast heart rate
Croatian: • pad broja leukocita, pad broja eritrocita, pad ili porast krvnog tlaka, neuobičajeno brzi otkucaji srca
English: The symptoms of fentanyl overdose are expected to be similar in nature to those of intravenous fentanyl and other opioids, and are an extension of its pharmacological actions, with the most serious significant effects being altered mental status, loss of consciousness, hypotension, respiratory depression, respiratory distress, and respiratory failure, which have resulted in death.
Croatian: Očekuje se da će simptomi predoziranja fentanilom biti slični onima koji se javljaju uz intravensku primjenu fentanila i drugih opioida te su nastavak njegovog farmakološkog djelovanja s najozbiljnijim značajnim učincima poput promjene mentalnog statusa, gubitka svijesti, hipotenzije, respiratorne depresije, respiratornog distresa i respiratornog zatajenja koje rezultira smrću.
English: • Any medicines that might have an effect on the way in which your body breaks down Effentora, such as ritonavir, nelfinavir, amprenavir, and fosamprenavir (medicines that help control HIV infection) or other so-called CYP3A4 inhibitors such as ketoconazole, itraconazole, or fluconazole (used for treatment of fungal infections), troleandomycine, clarithromycine, or erythromycine (medicines for treatment of bacterial infections), aprepitant (used for severe nausea) and diltiazem and verapamil (medicines for treatment of high blood pressure or heart diseases).
Croatian: • Bilo koji lijek koji bi mogao utjecati na način na koji Vaše tijelo razgrađuje Effentoru, poput ritonavira, nelfinavira, amprenavira i fosamprenavira (lijekova koji pomažu držati pod kontrolom HIV infekciju) ili drugih takozvanih inhibitora CYP3A4 poput ketokonazola, itrakonazola ili flukonazola (koji se koriste za liječenje gljivičnih infekcija), troleandomicina, klaritromicina ili eritromicina (lijekovi za liječenje bakterijskih infekcija), aprepitant (za liječenje jake mučnine) i diltiazem te verapamil (lijekovi za liječenje visokog krvnog tlaka ili bolesti srca).
English: The length of time that the tablet takes to fully disintegrate following oromucosal administration does not appear to affect early systemic exposure to fentanyl.
Croatian: Vrijeme potrebno za potpuni raspad tablete nakon primjene na sluznicu usne šupljine čini se da ne utječe na rano sistemsko izlaganje fentanilu.
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.
Croatian: Međutim, najozbiljnije su nuspojave respiratorna depresija (koja može uzrokovati apneju ili respiratorni arest), depresija krvotoka, hipotenzija i šok te je stoga nužno pomno nadzirati sve bolesnike na znakove spomenutih poremećaja.
English: Following oromucosal administration of Effentora, fentanyl is readily absorbed with an absolute bioavailability of 65%.
Croatian: Apsorpcija Nakon primjene Effentore kroz usnu sluznicu, fentanil se odmah apsorbira apsolutnom bioraspoloživošću od 65%.
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.
Croatian: Bolesnike treba savjetovati da ne voze ili upravljaju strojevima ako osjete pospanost, omaglicu ili smetnje vida za vrijeme liječenja
English: If you still have some of these fentanyl treatments at home, contact your pharmacist to check how to dispose of them.
Croatian: Ako još uvijek imate neke lijekove s fentanilom kod kuće, obratite se ljekarniku za savjet o njihovu pravilnom zbrinjavanju.
English: You could experience symptoms of withdrawal syndrom (nausea, vomiting, diarrhoea, anxiety, chills, tremor, and sweating) while using these medicines.
Croatian: Možete dobiti simptome sindroma ustezanja (mučninu, povraćanje, tjeskobu, zimice, nevoljno drhtanje i znojenje) dok uzimate te lijekove.
English: Approximately 50% of the total dose administered is rapidly absorbed transmucosally and becomes systemically available.
Croatian: Približno 50% ukupne primijenjene doze brzo se apsorbira kroz sluznicu i postaje sistemski dostupno.
English: Effentora employs a delivery technology which utilises an effervescent reaction which enhances the rate and extent of fentanyl absorbed through the buccal mucosa.
Croatian: Effentora se temelji na tehnologiji oslobađanja koja koristi reakciju efervescencije koja povećava brzinu i stupanj apsorpcije fentanila kroz bukalnu sluznicu.
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”.
Croatian: Ako je netko slučajno uzeo Effentoru može imati iste nuspojave kao i one opisane u dijelu 3.
English: Anaphylaxis and hypersensitivity
Croatian: Anafilaksija i preosjetljivost
English: Fentanyl is highly lipophilic and is well distributed beyond the vascular system, with a large apparent volume of distribution.
Croatian: Fentanil je visoko lipofilan lijek te se dobro raspodjeljuje izvan krvožilnog sustava s velikim prividnim volumenom raspodjele.
English: Titration in patients not switching from other fentanyl containing products The initial dose of Effentora should be 100 micrograms, titrating upwards as necessary through the range of available tablets strengths (100, 200, 400, 600, 800 micrograms).
Croatian: Početna doza Effentore treba biti 100 mikrograma s titracijom na veću dozu po potrebi, kroz raspon dostupnih jačina tableta (100, 200, 400, 600 i 800 mikrograma).
English: Opioid withdrawal symptoms such as nausea, vomiting, diarrhoea, anxiety, chills, tremor and sweating have been observed with transmucosal fentanyl.
Croatian: Simptomi ustezanja od opioida poput mučnine, povraćanja, proljeva, anksioznosti, zimica, tremora i znojenja primijećeni su kod transmukozne primjene fentanila.
English: The buccal tablets are flat-faced, round bevelled-edge tablet, embossed one side with a “C” and on the other side with “1” for Effentora 100 micrograms, with “2” for Effentora 200 micrograms, with “4” for Effentora 400 micrograms, with “6” for Effentora 600 micrograms, with “8” for Effentora 800 micrograms.
Croatian: Bukalne tablete su plosnate, okrugle ukošenih rubova, s oznakom „C“ s jedne strane, a s druge strane s oznakom „1“ za Effentoru 100 mg, „2“ za Effentoru 200 mikrograma, „4“ za Effentoru 400 mikrograma, „6“ za Effentoru 600 mikrograma i „8“ za Effentoru 800 mikrograma.
English: • What is EFFENTORA for?
Croatian: • Za što se koristi EFFENTORA?
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
Croatian: • jedan ili više od sljedećih teškoća u ustima: ranice, gubitak osjeta, nelagoda, neuobičajena boja, poremećaji mekog tkiva, poremećaji jezika, bolan jezik ili mjehurići ili ranice na jeziku, bol u desnima, ispucale usne, poremećaji zuba
English: /AG Tel/Tél: +32 3 820 73 73
Croatian: Tél/Tel: +32 3 820 73 73
English: TEVA B.V. Swensweg 5 2031 GA Haarlem Netherlands
Croatian: Swensweg 5 2031 GA Haarlem, Nizozemska
English: BTP is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain.
Croatian: Probijajuća bol je prolazna egzacerbacija boli koja se javlja uz trajnu bol koja je inače pod kontrolom.
English: The metabolic pathways following buccal administration of Effentora have not been characterised in clinical studies.
Croatian: Metabolički putevi nakon bukalne primjene Effentore nisu utvrđeni u kliničkim ispitivanjima.
English: Feeling cold Feeling hot
Croatian: • crvenilo uz osjećaj vrućine
English: If you stop using Effentora
Croatian: Ako prestanete uzimati Effentoru
English: There are no human data on fertility available.
Croatian: Nema podataka o utjecaju na plodnost u ljudi.
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.
Croatian: • Ako početna tableta od 100 mikrograma nije djelotvorna, bolesniku se može savjetovati da za sljedeću epizodu probijajuće boli uzme dvije tablete od 100 mikrograma.
English: 4 buccal tablets 28 buccal tablets
Croatian: 4 bukalne tablete 28 bukalnih tableta
English: Effentora 400 micrograms
Croatian: Effentora 400 mikrograma
English: The development of a potentially life-threatening serotonin syndrome may occur with the concomitant use of serotonergic drugs such as Selective Serotonin Re-uptake Inhibitors (SSRIs) and Serotonin Norepinephrine Re-uptake Inhibitors (SNRIs), and with drugs which impair metabolism of serotonin (including Monoamine Oxidase Inhibitors [MAOIs]).
Croatian: Do razvoja serotoninskog sindroma potencijalno opasnog po život može doći pri istodobnoj primjeni serotoninergičkih lijekova kao što su selektivni inhibitori ponovne pohrane serotonina (SSRI) ili selektivni inhibitori ponovne pohrane serotonina i noradrenalina (SNRI) te lijekova koji narušavaju metabolizam serotonina (uključujući inhibitore monoaminooksidaze [MAOI]).
English: If you forget to use Effentora
Croatian: Ako ste zaboravili uzeti Effentoru
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.
Croatian: Ako se smatra da je ta doza učinkovita doza, liječenje sukcesivnih epizoda probijajuće boli može se nastaviti s jednom tabletom Effentore od 400 mikrograma.
English: Fentanyl is highly lipophilic and can be absorbed very rapidly through the oral mucosa and more slowly by the conventional gastrointestinal route.
Croatian: Fentanil je visoko lipofilan lijek koji se može apsorbirati vrlo brzo kroz oralnu sluznicu, a sporije standardnim načinom kroz probavni sustav.
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).
Croatian: Može doći do interakcije Effentore s tim lijekovima i mogli biste doživjeti promjene mentalnog statusa (npr. nemir, halucinacije, komu) i druge posljedice kao što su povišenje tjelesne temperature iznad 38°C, ubrzani otkucaji srca, nestabilan krvni tlak, prenaglašeni refleksi, mišićna ukočenost, nekoordiniranost i/ili probavni simptomi (npr. mučnina, povraćanje, proljev).
English: • In case of irritation, you may change the placement of the tablet on the gum.
Croatian: • U slučaju nadraženosti možete promijeniti mjesto na desnima na koje stavljate tabletu.
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.
Croatian: Dozu održavanja Effentore treba povećati kada je za nekoliko uzastopnih epizoda probijajuće boli bolesniku potrebno više od jedne tablete po epizodi.
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.
Croatian: Epizode probijajuće boli mogu varirati u intenzitetu te se s vremenom, zbog napredovanja osnovnog malignog oboljenja, potrebna doza Effentore može povećati.
English: Typical opioid adverse reactions are to be expected with Effentora.
Croatian: Kod Effentore treba očekivati tipične nuspojave opioida.
English: B. CONDITIONS OR RESTRICTION(S) REGARDING SUPPLY AND USE
Croatian: UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I
English: The other ingredients are mannitol, sodium starch glycolate type A, sodium hydrogen carbonate, sodium carbonate anhydrous, citric acid anhydrous, magnesium stearate.
Croatian: Drugi sastojci su manitol; natrijev škroboglikolat, vrsta A; natrijev hidrogenkarbonat; natrijev karbonat, bezvodni; citratna kiselina, bezvodna; magnezijev stearat.
English: Mean Plasma Concentration Versus Time Profiles Following Singles Doses of EFFENTORA and OTFC in Healthy Subjects
Croatian: Profili nakon pojedinačnih doza EFFENTORE i OTFC u zdravih ispitanika
English: • If you suffer from severe breathing problems or severe obstructive lung conditions.
Croatian: • ako patite od teških problema s disanjem ili stanja teške opstrukcije pluća.
English: Keep using the opioid pain medicine you take for your persistent (around-the-clock) cancer pain during your Effentora treatment.
Croatian: Nastavite uzimati opioidni lijek protiv trajnih (neprekidnih) bolova tijekom liječenja Effentorom.
English: Effentora 200, 400, 600 and 800 micrograms buccal tablets contain 20 mg sodium per tablet.
Croatian: Effentora 200, 400, 600 i 800 mikrograma bukalne tablete sadrže 20 mg natrija po tableti.
English: Consult your doctor WHILE using Effentora if:
Croatian: Potražite savjet liječnika DOK uzimate Effentoru:
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
Croatian: • osjećaj ushićenosti, nervoze, neuobičajen osjećaj, osjećaj treme ili usporenosti; vidite ili čujete nešto što zapravo ne postoji (halucinacije), smanjena razina svijesti, promjene u mentalnom statusu, naviknutost (oslanjanje na lijekove, ovisnost), dezorijentacija, gubitak koncentracije,
English: Fentanyl is metabolised in the liver and in the intestinal mucosa to norfentanyl by CYP3A4 isoform.
Croatian: Fentanil se metabolizira u jetri te sluznici crijeva na norfentanil putem izooblika enzima CYP3A4.
English: • You experience a combination of the following symptoms: nausea, vomiting, anorexia, fatigue, weakness, dizziness and low blood pressure.
Croatian: • Odmah se obratite liječniku ako osjetite kombinaciju sljedećih simptoma Mučnina, povraćanje, anoreksija, umor, slabost, omaglica i nizak krvni tlak
English: • Separate one of the blister units from the blister card by tearing apart at the perforations.
Croatian: • Jednu jedinicu blistera treba odvojiti od kartice blistera tako da se otkine po perforaciji.
English: For treatment of overdose in opioid-maintained patients, intravenous access should be obtained.
Croatian: Za liječenje predoziranja u bolesnika koji su na terapiji održavanja opioidima, treba osigurati venski put.
English: Do not use Effentora if you are breast-feeding.
Croatian: Nemojte uzimati Effentoru ako dojite.
English: If your breakthrough pain is not relieved after 30 minutes, use only 1 more tablet of Effentora during the titration period.
Croatian: Ako se probijajuća bol ne ublaži nakon pola sata, možete uzeti samo još 1 tabletu Effentore tijekom razdoblja titracije.
English: Tear 2.
Croatian: PRILOG II.
English: Effentora 100 micrograms buccal tablets Effentora 200 micrograms buccal tablets Effentora 400 micrograms buccal tablets Effentora 600 micrograms buccal tablets Effentora 800 micrograms buccal tablets
Croatian: Effentora 100 mikrograma bukalne tablete Effentora 200 mikrograma bukalne tablete Effentora 400 mikrograma bukalne tablete Effentora 600 mikrograma bukalne tablete Effentora 800 mikrograma bukalne tablete
English: This medicine must be kept out of the sight and reach of children.
Croatian: Ovaj lijek čuvajte izvan pogleda i dohvata djece.
English: Bradyarrhythmias
Croatian: Bradiaritmije
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.
Croatian: unutar 14 dana jer je prijavljeno teško i nepredvidljivo potenciranje MAOI s opioidnim analgeticima.
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).
Croatian: Lijekovi koji mogu pojačati učinak depresora na SŽS Istodobna primjena fentanila s drugim depresorima središnjeg živčanog sustava uključujući druge opioide, sedative ili hipnotike, (uključujući benzodiazepine), opće anestetike, fenotiazine, trankvilizatore, mišićne relaksanse, sedativne antihistaminike i alkohol može uzrokovati dodatni učinak depresora, koji može dovesti do smrtnog ishoda (vidjeti dio 4.4).
English: In animal studies, male fertility was impaired (See Section 5.3).
Croatian: U ispitivanjima na životinjama, plodnost je bila narušena u mužjaka (vidjeti dio 5.3).
English: • Severe respiratory depression or severe obstructive lung conditions.
Croatian: • Teška respiratorna depresija ili stanja teške opstrukcije pluća.
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.
Croatian: • Istodobna primjena Effentore i sedativa poput benzodiazepina ili sličnih lijekova povećava rizik od omamljenosti, teškoća s disanjem (respiratorna depresija), kome i može biti životno opasna.
English: It can increase the risk of experiencing serious side effects including death.
Croatian: To može povećati rizik od ozbiljnih nuspojava,
English: Overdose in opioid-maintained patients
Croatian: Predoziranje u bolesnika koji su na terapiji održavanja opioidima
English: • Information on the correct indication and the risk for abuse
Croatian: • Uputa kako otvoriti sigurnosne blistere za djecu • Informacija o ispravnim indikacijama i riziku od zloporabe
English: Effentora like other fentanyl products can cause very severe breathing problems which can lead to death.
Croatian: Effentora poput drugih lijekova koji sadrže fentanil može uzrokovati vrlo ozbiljne probleme s disanjem koji uzrokuju smrt.
English: Risks of concomitant administration with benzodiazepines or related drugs Concomitant use of opioids, including Effentora, with benzodiazepines or related drugs may result in profound sedation, respiratory depression, coma, and death.
Croatian: Rizici istodobne primjene s benzodiazepinima ili sličnim lijekovima Istodobna primjena opioida, uključujući Effentoru, s benzodiazepinima ili sličnim lijekovima može dovesti do duboke sedacije, respiratorne depresije, kome i smrti.
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.
Croatian: Effentore i oralnog fentanilcitrata za primjenu kroz sluznicu usta (OTFC), brzina i stupanj apsorpcije fentanila kod Effentore pokazali su izloženost između 30 i 50% veću od one kod fentanilcitrata za primjenu kroz sluznicu usta.
English: Contains sodium
Croatian: Sadrži natrij
English: • The most common side effects are feeling sleepy, sick or dizzy.
Croatian: • Najčešće nuspojave su pospanost, osjećaj slabosti ili omaglica.
English: Each tablet of Effentora 100 micrograms contains 10 mg of sodium.
Croatian: Jedna tableta Effentore 100 mikrograma sadrži 10 g natrija.
English: • EFFENTORA prescribing guide
Croatian: • Upute za propisivanje EFFENTORE
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.
Croatian: Bolesnicima treba savjetovati da istodobno ne koriste dvije različite formulacije fentanila za liječenje probijajuće boli te da prilikom prelaska na liječenje lijekom Effentora prestanu koristiti bilo koji drugi lijek s fentanilom propisan za liječenje probijajuće boli.
English: • blisters in the mouth, dry lips, collection of pus under the skin in the mouth
Croatian: • poteškoće u razmišljanju, poteškoće u pokretima • mjehurići u ustima, suha usta, nakupljanje gnoja ispod kože u ustima
English: Effentora 100 micrograms buccal tablets contain 10 mg sodium per tablet.
Croatian: Effentora 100 mikrograma bukalne tablete sadrže 10 mg natrija po tableti.
English: If you notice any of these, contact your doctor.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika.
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.
Croatian: Zajedno, ovi simptomi mogu biti znak insuficijencije nadbubrežnih žlijezda, što je stanje koje može biti opasno po život.
English: What you need to know before you use Effentora Do NOT use Effentora:
Croatian: Što morate znati prije nego počnete uzimati Effentoru
English: If your breakthrough pain is not relieved after 30 minutes, use only 1 more tablet of Effentora during this dose-readjustment period.
Croatian: Ako se probijajuća bol ne ublaži nakon pola sata, možete uzeti samo još 1 dodatnu tabletu Effentore u razdoblju ponovne prilagodbe doze.