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.
Danish: Effentora bør kun administreres med yderste forsigtighed til patienter, der kan være specielt følsomme over for de intrakranielle virkninger af CO2-retention, såsom patienter med tegn på forhøjet intrakranielt tryk eller svækket bevidsthed.
English: The active substance of Effentora is fentanyl citrate.
Danish: Det aktive stof i Effentora er fentanylcitrat.
English: For treatment of overdose in opioid-maintained patients, intravenous access should be obtained.
Danish: Overdosering hos patienter i opioid-vedligeholdelsesbehandling Til behandling af overdosering hos patienter i opioid-vedligeholdelsesbehandling bør der sørges for intravenøs adgang.
English: • drug abuse
Danish: • stofmisbrug
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.
Danish: Ved langvarig anvendelse af fentanyl under graviditeten, er der en risiko for neonatalt opioidt abstinenssyndrom, som kan være livstruende hvis det ikke opdages og behandles.Det kræver behandling i henhold til instruktioner udarbejdet af eksperter i neonatalogi.
English: Blister packs are supplied in cartons of 4 or 28 tablets.
Danish: Blisterpakninger leveres i æsker af 4 eller 28 tabletter.
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).
Danish: Hvis anvendelse af opioider er nødvendigt i lange perioder til en gravid kvinde, skal patienten informeres om risikoen for neonatalt opioidt abstinenssyndrom, og det skal sikres, at passende behandling er tilgængelig (se pkt.
English: • Do not bite, suck, chew, or swallow the tablet, as this will result in less pain relief than when taken as directed.
Danish: • De må ikke bide i, suge/sutte på, tygge eller synke tabletten, da dette vil resultere i mindre smertelindring, end hvis tabletten tages som anvist.
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.
Danish: “Dwell time” (defineret som den tid, det tager, til tabletten er fuldstændigt opløst, efter at den er lagt op under kinden), har ikke indflydelse på, hvor tidligt den systemiske eksponering for fentanyl indtræder.
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.
Danish: Effentora er indiceret til behandling af gennembrudssmerter hos voksne med cancer, der i forvejen modtager opioid-vedligeholdelsesbehandling for kroniske cancersmerter.
English: • You experience symptoms such as difficulty in breathing or dizziness, swelling of the tongue, lip or throat while using Effentora.
Danish: • De får symptomer, såsom åndedrætsbesvær eller svimmelhed, hævelse af tungen, læberne eller halsen, mens De bruger Effentora.
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).
Danish: • Tag tabletten ud af blisteren, og placer omgående hele tabletten nær en kindtand mellem gummen og kinden (som vist på billedet).
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)
Danish: • De vigtigste forsigtighedsregler for brug: Hvordan forebygges de største risici (tag medicinen som anvist; forbliv i opioidbehandling, opbevar EFFENTORA utilgængeligt for børn; forebyg tyveri og misbrug)
English: The free fraction of fentanyl increases with acidosis.
Danish: Den frie fraktion af fentanyl øges ved acidose.
English: • decrease in white cells in the blood, decrease in red blood cells, decreased or raised blood pressure, unusually fast heart rate
Danish: • nedsat antal hvide og røde blodlegemer, nedsat eller forhøjet blodtryk, usædvanlig hurtig hjerterytme (puls)
English: Dose readjustment of the background opioid therapy may be required if patients consistently present with more than four BTP episodes per 24 hours.
Danish: Det kan være nødvendigt at justere baggrundsbehandlingen med opioider, hvis patienten konsekvent har flere end fire anfald af gennembrudssmerter i løbet af 24 timer.
English: • If you are allergic to fentanyl or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis De er allergisk over for fentanyl eller et af de øvrige indholdsstoffer i Effentora (angivet i punkt 6).
English: Tell your doctor or pharmacist before starting Effentora if you are taking or have recently taken or might take any of the following medicines:
Danish: Fortæl det altid til lægen eller apotekspersonalet, inden De begynder at tage Effentora, hvis De tager et eller flere af følgende lægemidler eller har gjort det for nylig:
English: • Certain type of strong pain killers, calledpartial agonist/antagonists e.g. buprenorphine, nalbuphine and pentazocine (medicines for treatment of pain).
Danish: • Visse former for kraftige smertelindrende lægemidler, delvise agonister/antagonister, f.eks. buprenorfin, nalbufin og pentazocin (lægemidler til behandling af smerte).
English: • You experience a combination of the following symptoms: nausea, vomiting, anorexia, fatigue, weakness, dizziness and low blood pressure.
Danish: • De oplever en kombination af følgende symptomer: kvalme, opkastning, anoreksi, træthed, svaghed, svimmelhed og lavt blodtryk.
English: Feeling cold Feeling hot
Danish: Frysende fornemmelse Varmefølelse
English: Tolerance, physical and/or psychological dependence may develop upon repeated administration of opioids such as fentanyl (see section 4.4).
Danish: Tolerance, fysisk og/eller psykisk afhængighed kan udvikles ved gentagen administration af opioider såsom fentanyl (se pkt.
English: Contents of the pack and other information What Effentora contains
Danish: Pakningsstørrelser og yderligere oplysninger Effentora indeholder:
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.
Danish: Vedligeholdelsesdosen af Effentora bør øges, hvis en patient har behov for mere end én tablet pr. anfald af gennembrudssmerter ved flere på hinanden følgende anfald.
English: • Severe respiratory depression or severe obstructive lung conditions.
Danish: • Svær respirationsdepression eller svære obstruktive lungesygdomme.
English: The concomitant use of partial opioid agonists/antagonists (e.g. buprenorphine, nalbuphine, pentazocine) is not recommended.
Danish: Samtidig brug af partielle opioide agonister/antagonister (f.eks. buprenorfin, nalbufin, pentazocin) frarådes.
English: • Educational material for the healthcare professionals
Danish: • Undervisningsmateriale til læger
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”).
Danish: Hvis lægen mistænker en Effentora-relateret øget følsomhed over for smerter (hyperalgesi), kan det overvejes at nedsætte Deres dosis af Effentora (se pkt.
English: The safety and efficacy of Effentora have been evaluated in patients taking the drug at the onset of the breakthrough pain episode.
Danish: Sikkerheden og effekten af Effentora er blevet evalueret hos patienter, der tager lægemidlet, når anfaldet af gennembrudssmerte starter.
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.
Danish: Den korrekte måde at tage en tablet ud af blisterpakningen er: Riv én af blister-enhederne af blisterkortet ved perforeringerne.
English: You may experience withdrawal symptoms similar to the possible side effects of Effentora when discontinuing Effentora.
Danish: De kan opleve abstinenssymptomer, der ligner de mulige bivirkninger ved Effentora, når De afbryder Effentora.
English: Therefore patients should be instructed not to open the blister until ready to place the tablet in the buccal cavity.
Danish: Patienterne bør derfor instrueres i ikke at tage tabletten ud af blisterpakningen, før de er klar til at placere tabletten i mundhulen.
English: You must however continue to take your usual opioid pain relieving medicine to treat your persistent cancer pain as advised by your doctor.
Danish: De skal imidlertid fortsætte med at tage Deres normale smertelindrende lægemidler med opioider til at behandle Deres vedvarende kræftsmerter efter lægens anvisning.
English: Fentanyl can get into breast milk and may cause side effects in the breast-fed infant.
Danish: Fentanyl kan passere over i modermælken og kan forårsage bivirkninger hos det diende barn.
English: The effect of renal or hepatic impairment on the pharmacokinetics of Effentora has not been studied.
Danish: Indflydelsen af nedsat nyre- eller leverfunktion på Effentoras farmakokinetik er ikke blevet undersøgt.
English: Consult your doctor WHILE using Effentora if:
Danish: Kontakt lægen, MENS De bruger Effentora, hvis:
English: There are no human data on fertility available.
Danish: Der foreligger ingen humane data vedrørende virkningen af fentanyl på fertilitet.
English: In animal studies, male fertility was impaired (See Section 5.3).
Danish: I dyreforsøg var fertiliteten hos hanner nedsat (se pkt 5.3).
English: 2031 GA Haarlem Netherlands
Danish: 2031 GA HAARLEM Holland
English: 2031 GA HAARLEM Netherlands
Danish: 2031 GA Haarlem Holland
English: Patients should be instructed NOT to attempt to push the tablet through the blister because this could damage the buccal tablet.
Danish: Patienterne bør informeres om, at de IKKE må forsøge at presse tabletten ud gennem blistret, da dette kan beskadige tabletten.
English: Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis De tager anden medicin eller har gjort det for nylig.
English: Effentora should be discontinued immediately if the patient no longer experiences breakthrough pain episodes.
Danish: Effentora skal straks seponeres, når patienten ikke længere har episoder med gennembrudssmerter.
English: The rate of development of tolerance varies widely among individuals.
Danish: Hvor hurtigt patienterne udvikler tolerance varierer meget fra patient til patient.
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:
Danish: Når der er opnået enighed mellem Sundhedsstyrelsen og markedsføringsindehaveren skal denne sikre, at alle læger i hver enkel medlemsstat, som kan forventes at ordinere EFFENTORA, får udleveret en informationspakke med følgende indhold:
English: Opioid withdrawal symptoms such as nausea, vomiting, diarrhoea, anxiety, chills, tremor and sweating have been observed with transmucosal fentanyl.
Danish: Opioidabstinenssymptomer såsom kvalme, opkastning, diaré, angst, kulderystelser, tremor og svedtendens er observeret med transmukusalt fentanyl.
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.
Danish: • Hvis den første 100 mikrogram tablet ikke har nogen virkning, instrueres patienten i at behandle det næste anfald af gennembrudssmerter med to 100 mikrogram tabletter.
English: Fentanyl is metabolised in the liver and in the intestinal mucosa to norfentanyl by CYP3A4 isoform.
Danish: Fentanyl metaboliseres i leveren og i tarmenes slimhinder til norfentanyl af CYP3A4isoformen.
English: Absolute bioavailability Fraction absorbed transmucosally Tmax (minute) ** Cmax (ng/ml)
Danish: Absolut biotilgængelighed Andel der absorberes transmukosalt Tmax (minut) ** Cmax (ng/ml) AUC0-tmax (ng.t/ml) AUC0-inf (ng.t/ml)
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).
Danish: Efter bukkal administration af Effentora fordeles fentanyl hurtigt, hvilket resulterer i, at fentanyl fordeles ligeligt mellem plasma og de højt perfunderede væv (hjerne, hjerte og lunger).
English: Its primary therapeutic actions are analgesia and sedation.
Danish: Dets primære terapeutiske virkninger er smertestillende og beroligende.
English: BTP is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain.
Danish: Gennembrudssmerter er en forbigående forværring af smerte, der fremkommer hos patienter, som ellers har en kontrolleret vedvarende smerte.
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.
Danish: Effentora er et smertestillende lægemiddel, også kaldet et opioid, som anvendes til behandling af gennembrudssmerter hos voksne kræftpatienter, der allerede tager andre opioide lægemidler for deres vedvarende kræftsmerter (smerter, der er der hele døgnet).
English: Therefore it is not possible to definitively separate the effects of Effentora alone.
Danish: Det er derfor ikke muligt definitivt at skelne virkningerne fra Effentora fra virkningerne fra anden smertestillende medicin.
English: You should discontinue Effentora when you no longer have any breakthrough pain.
Danish: De bør ophøre med at tage Effentora, når De ikke længere har gennembrudssmerter.
English: The remaining half of the total dose is swallowed and slowly absorbed from the gastrointestinal tract.
Danish: Den resterende halvdel af den totale dosis sluges og bliver langsomt absorberet fra mave-tarm-kanalen.
English: Anaphylaxis and hypersensitivity have been reported in association with the use of oral transmucosal fentanyl products (see Section 4.8).
Danish: Der er blevet rapporteret om anafylaksi og overfølsomhed i forbindelse med anvendelse af orale transmukøse fentanylpræparater (se pkt.
English: The other ingredients are mannitol, sodium starch glycolate type A, sodium hydrogen carbonate, sodium carbonate anhydrous, citric acid anhydrous, magnesium stearate.
Danish: Øvrige indholdsstoffer: mannitol, natriumstivelseglycolat type A, natriumhydrogencarbonat, vandfri natriumcarbonat, vandfri citronsyre, magnesiumstearat.
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.
Danish: Symptomerne på fentanyloverdosering forventes at svare til de symptomer, der forbindes med intravenøs fentanyl og andre opioider, og er i forlængelse af stoffets farmakologiske virkning, hvor de alvorligste signifikante bivirkninger er ændret mental tilstand, bevidsthedstab, hypotension, respirationsdepression, åndedrætsbesvær og respirationssvigt, som har resulteret i død.
English: Effentora should be placed and retained within the buccal cavity for a period sufficient to allow disintegration of the tablet which usually takes approximately 14-25 minutes.
Danish: Effentora-tabletten bør placeres og forblive inde i mundhulen indtil, den er helt opløst, hvilket normalt tager cirka 14-25 minutter.
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).
Danish: • Lægemidler, der kunne påvirke den måde, hvorpå Deres krop nedbryder Effentora, såsom ritonavir, nelfinavir, amprenavir og fosamprenavir (lægemidler, der hjælper med til at kontrollere HIV-infektion) eller andre såkaldte CYP3A4-hæmmere såsom ketoconazol, itraconazol eller fluconazol (anvendes til behandling af svampeinfektioner), troleandomycin, clarithromycin eller erythromycin (lægemidler til behandling af bakterieinfektioner), aprepitant (anvendes mod svær kvalme) og diltiazem og verapamil (lægemidler, der anvendes til behandling af højt blodtryk eller hjertesygdomme).
English: Effentora must not be prescribed in pain other than breakthrough cancer pain 2.
Danish: Effentora må ikke ordineres til andre smerter end cancergennembrudssmerter 2.
English: Pruritus Hyperhidrosis Rash
Danish: Pruritus Hyperhidrose Udslæt
English: • lack of testosterone, abnormal sensation in eye, observing flashes of light, brittle nails
Danish: • for lavt testosteron, unormal følelse i øjet, observation af lysglimt, skøre negle
English: Therefore, special care should be taken during the titration process in patients with moderate or severe hepatic or renal impairment.
Danish: Der bør derfor udvises særlig forsigtighed under titreringen hos patienter med moderat eller svær lever- eller nyresygdom.
English: Effentora must not be prescribed in patients with short term pain only 3.
Danish: Effentora må ikke ordineres til patienter, der kun har kortvarige smerter 3.
English: Loss of consciousness and respiratory arrest have been observed in the context of overdose (see section 4.9).
Danish: Bevidsthedstab og respirationsophør er observeret i forbindelse med overdosering (se pkt.
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.
Danish: Overdosering (utilsigtet indtagelse) hos en person, som ikke tidligere har fået opioider Ved behandling af overdosering (utilsigtet indtagelse) hos en person, som ikke tidligere har fået opioider, skal der sørges for intravenøs adgang, og naloxon eller en anden opioid-antagonist bør anvendes, alt efter hvad der er klinisk indiceret.
English: You could experience symptoms of withdrawal syndrom (nausea, vomiting, diarrhoea, anxiety, chills, tremor, and sweating) while using these medicines.
Danish: De kan opleve abstinenssymptomer (kvalme, opkastning, diarré, angst, kulderystelser, tremor og svedtendens), mens De anvender disse lægemidler.
English: TEVA B.V. Swensweg 5 2031 GA Haarlem Netherlands
Danish: Swensweg 5 2031 GA Haarlem Holland
English: Hypersensitivity reactions have been reported in post-marketing experience, including rash, erythema, lip and face swelling, and urticaria (see section 4.4).
Danish: Overfølsomhedsreaktioner er blevet rapporteret efter markedsføring, herunder udslæt, erytem, hævelse af læber og ansigt samt urticaria (se pkt.
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.
Danish: Så snart tabletten er taget ud af blistret, må den ikke gemmes, da tablettens beskaffenhed i så fald ikke kan garanteres, og fordi der kan ske utilsigtet eksponering over for tabletten.
English: Talk to your doctor or pharmacist BEFORE using Effentora if:
Danish: Kontakt lægen eller apotekspersonalet, FØR De bruger Effentora, hvis:
English: Dyspnoea Pharyngolaryngeal pain
Danish: Dyspnø Faryngolaryngealsmerte
English: If the breakthrough pain is still ongoing, you may take Effentora as prescribed by your physician.
Danish: Hvis De får et anfald af gennembrudssmerter, skal De tage Effentora som anvist af Deres læge.
English: • Allergic reactions such as rash, redness, swollen lip and face, hives
Danish: • allergiske reaktioner, såsom udslæt, rødme, hævelse af læber og ansigt, nældefeber
English: After 30 minutes, if remnants from the Effentora tablet remain, they may be swallowed with a glass of water.
Danish: Hvis der efter 30 minutter stadig er rester af Effentora-tabletten tilbage, kan de synkes sammen med et glas vand.
English: • After 30 minutes, if pieces of the tablet remain, they may be swallowed with a glass of water.
Danish: • Hvis der efter 30 minutter stadig er rester af Effentora-tabletten tilbage, kan de synkes sammen med et glas vand.
English: Effentora should only be used for conditions specified in section 4.1.
Danish: Effentora bør kun bruges ved tilstande som anført i pkt.
English: CYP3A4 inducers Co-administration with agents that induce 3A4 activity may reduce the efficacy of Effentora.
Danish: Samtidig administration med stoffer, der inducerer CYP3A4-aktivitet, kan reducere effekten af Effentora.
English: Typical opioid adverse reactions are to be expected with Effentora.
Danish: Der kan forventes typiske opioide bivirkninger fra Effentora-behandlingen.
English: • You have low amount of fluid in the circulation or low blood pressure.
Danish: • De har blodmangel eller lavt blodtryk.
English: What you need to know before you use Effentora Do NOT use Effentora:
Danish: Det skal De vide, før De begynder at tage effentora Tag IKKE Effentora:
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:
Danish: Der må anvendes op til fire 100 mikrogram eller op til fire 200 mikrogram tabletter til behandling af et enkelt anfald af gennembrudssmerter under dosistitreringen som angivet nedenfor:
English: • The most common side effects are feeling sleepy, sick or dizzy.
Danish: • De hyppigste bivirkninger er, at man bliver søvnig, føler at man skal kaste op eller bliver svimmel.
English: Malaise Sluggishness Chest discomfort Feeling abnormal Feeling jittery Thirst
Danish: Ubehag i brystet Unormal fornemmelse Anspændt følelse Tørst
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]).
Danish: Udviklingen af et muligt livstruende serotonergt syndrom kan forekomme ved samtidig brug af serotonerge lægemidler, såsom selektive serotoningenoptagelseshæmmere (selective serotonin reuptake inhibitors, SSRI'er) og serotonin-noradrenalingenoptagelseshæmmere (serotonin norepinephrine re-uptake inhibitors, SNRI'er), og sammen med lægemidler, der hæmmer serotoninmetabolismen (herunder monoaminoxidasehæmmere [monoamine oxidase inhibitors, MAOhæmmere]).
English: If your breakthrough pain is not relieved after 30 minutes, use only 1 more tablet of Effentora during this dose-readjustment period.
Danish: Hvis Deres gennembrudssmerter ikke er lindret efter 30 minutter, må De kun tage 1 ekstra Effentora-tablet i denne dosisjusteringsperiode.