FrancophonIA/ELRC3.0 huggingface dataset:
English: Once the right dose has been determined with your doctor, use 1 tablet for an episode of breakthrough pain as a general rule.
Danish: Så snart den rigtige dosis er blevet fastsat af Dem og Deres læge, skal De generelt tage 1 tablet mod en episode af gennembrudssmerter.
English: Effentora employs a delivery technology which utilises an effervescent reaction which enhances the rate and extent of fentanyl absorbed through the buccal mucosa.
Danish: Effentora overføres ved en brusende reaktion, som øger hastigheden og mængden af det fentanyl, der bliver absorberet gennem slimhinden i mundhulen.
English: Depressed level of consciousness Disturbance in attention Balance disorder Dysarthria
Danish: Nedsat bevidsthedsniveau Opmærksomheds forstyrrelse Balanceforstyrrelse
English: In addition, Effentora should be administered with caution to patients with hepatic or renal impairment.
Danish: Effentora bør desuden administreres med forsigtighed til patienter med nedsat lever- eller nyrefunktion.
English: OTFC data was dose adjusted (800 mcg to 400 mcg)
Danish: OTFC data normaliseret (800 mikrogram til 400 mikrogram)
English: Anaphylaxis and hypersensitivity
Danish: Anafylaksi og overfølsomhed
English: Effentora 200, 400, 600 and 800 micrograms buccal tablets contain 20 mg sodium per tablet.
Danish: Effentora 200, 400, 600 og 800 mikrogram bukkaltabletter indeholder 20 mg natrium pr. tablet.
English: Sodium starch glycolate type A Sodium hydrogen carbonate Sodium carbonate anhydrous Citric acid anhydrous Magnesium stearate
Danish: Natriumstivelsesglycolat type A Natriumhydrogencarbonat Natriumcarbonat, vandfri Citronsyre, vandfri Magnesiumstearat
English: The concomitant use of alcohol with fentanyl can produce increased depressant effects which may result in a fatal outcome (see section 4.5).
Danish: Samtidig brug af alkohol og fentanyl kan potensere de suppressive virkninger, hvilket kan resultere i død (se pkt.
English: • loss of consciousness, stop in breathing, convulsion (fits)
Danish: • bevidsthedstab, vejrtrækningsstop, krampeanfald (kramper)
English: B. CONDITIONS OR RESTRICTION(S) REGARDING SUPPLY AND USE
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE
English: If your breakthrough pain is not relieved after 30 minutes, use only 1 more tablet of Effentora during the titration period.
Danish: Hvis Deres gennembrudssmerter ikke er lindret efter 30 minutter, må De kun tage 1 ekstra Effentora-tablet i titreringsperioden.
English: Respiratory depression Sleep apnoea syndrome
Danish: Respirationsdepression Søvnapnøsyndrom
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.
Danish: Indehaveren af markedsføringstilladelsen skal blive enig med Sundhedsstyrelsen om et opdateret undervisningsprogram i hver enkel medlemsstat, hvor EFFENTORA markedsføres.
English: • Bend the blister unit along the line where indicated.
Danish: • Bøj blister-enheden langs stregen, som vist.
English: Therefore they must keep all tablets out of the sight and reach of children.
Danish: Derfor skal alle tabletter opbevares utilgængeligt for børn.
English: Effentora 400 micrograms
Danish: Effentora 400 mikrogram
English: Wait at least 4 hours before treating another episode of breakthrough pain with Effentora.
Danish: Vent mindst fire timer, inden De behandler et nyt anfald af gennembrudssmerter med Effentora.
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).
Danish: Effentora kan påvirke disse lægemidler, og De kan opleve ændringer af Deres mentale status (f.eks. ophidselse, hallucinationer, koma) og andre virkninger som en kropstemperatur over 38 °C, øget hjertefrekvens, ustabilt blodtryk og overdrevne reflekser, muskelstivhed, manglende koordination og/eller mave-tarm-symptomer (f.eks. kvalme, opkastning, diarré).
English: Other medicines and Effentora
Danish: Brug af anden medicin sammen med Effentora
English: Do not use Effentora if you are breast-feeding.
Danish: De må ikke anvende Effentora, hvis De ammer.
English: Co-administration of fentanyl with a serotoninergic agent, such as a Selective Serotonin Re-uptake Inhibitor (SSRI) or a Serotonin Norepinephrine Re-uptake Inhibitor (SNRI) or a Monoamine Oxidase Inhibitor (MAOI), may increase the risk of serotonin syndrome, a potentially life-threatening condition.
Danish: Samtidig administration af fentanyl og et serotonergt stof, såsom en selektiv serotoningenoptagelseshæmmer (SSRI) eller en serotonin-noradrenalingenoptagelseshæmmer (SNRI) eller en monoamineoxidasehæmmer (MAO-hæmmer), kan øge risikoen for serotonergt syndrom, en muligt livstruende sygdom.
English: • You are suffering from any condition that has an effect on your breathing (such as asthma,
Danish: • De har en lidelse, der påvirker Deres åndedræt (som for eksempel astma, hiven efter vejret eller kortåndethed).
English: • sleepiness, sedation, excessive tiredness, weakness, migraine, numbness, swelling of arms or legs,
Danish: • søvnighed, sedation, voldsom træthed, svaghed, migræne, følelsesløshed, hævede arme eller ben,
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
Danish: Effentora 100 mikrogram bukkaltabletter Effentora 200 mikrogram bukkaltabletter Effentora 400 mikrogram bukkaltabletter Effentora 600 mikrogram bukkaltabletter Effentora 800 mikrogram bukkaltabletter
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.
Danish: Risici ved administration sammen med benzodiazepiner eller relaterede lægemidler Brug af opioider, herunder Effentora, sammen med benzodiazepiner eller relaterede lægemidler kan føre til dyb sedation, respirationsdepression, koma og død.
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”).
Danish: Brugen af disse lægemidler sammen med Effentora kan føre til et serotoninsyndrom, en mulig livstruende tilstand (se pkt.
English: If you stop using Effentora
Danish: Hvis De holder op med at tage Effentora
English: The pain-relieving medicine in Effentora is very strong and could be life-threatening if taken accidentally by a child.
Danish: Det smertelindrende stof i Effentora er meget stærkt, og det kan være livstruende, hvis et barn utilsigtet kommer til at tage det. Opbevar dette lægemiddel utilgængeligt for børn.
English: • shortness of breath, painful throat
Danish: • åndenød, smertende svælg
English: During titration, if adequate analgesia is not obtained within 30 minutes after the start of administration of a single tablet, a second Effentora tablet of the same strength may be used.
Danish: Hvis der under titreringen ikke opnås tilstrækkelig analgesi inden for 30 minutter efter, at patienten har taget en enkelt tablet, kan patienten tage endnu en Effentora-tablet af samme styrke.
English: If you forget to use Effentora
Danish: Hvis De har glemt at tage Effentora
English: If this dose is considered to be the effective dose, treatment of successive episodes of BTP may be continued with a single 200 micrograms tablet of Effentora.
Danish: Hvis denne dosis synes at være effektiv, kan efterfølgende anfald af gennembrudssmerter behandles med en enkelt 200 mikrogram Effentora-tablet.
English: Very common: may affect more than 1 in 10 people
Danish: Meget almindelige: kan påvirke flere end 1 ud af 10 personer
English: drug withdrawal syndrome (may manifest by the occurrence of the following side effects nausea,
Danish: abstinenser (kan manifestere sig ved, at der opstår de følgende bivirkninger kvalme, opkastning,
English: CYP3A4 inhibitors
Danish: CYP3A4-induktorer
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.
Danish: • Brug af Effentora sammen med sløvende lægemidler, såsom benzodiazepiner eller relaterede lægemidler, øger risikoen for døsighed, åndedrætsbesvær (respirationsdepression), koma og kan være livstruende.
English: These might be early symptoms of a serious allergic reaction (anaphylaxis, hypersensitivity; see section 4 under “Serious side effects”)
Danish: Det kan være tidlige symptomer på en alvorlig allergisk reaktion (anafylaksi, overfølsomhed, se pkt.
English: • Brochure on breakthrough pain
Danish: • Brochure om gennembrudssmerter
English: Effentora buccal tablets are for oromucosal use.
Danish: Effentora-bukkaltabletter er til anvendelse i mundhulen.
English: Effentora should be administered with caution to patients with moderate or severe hepatic or renal impairment (see section 4.4).
Danish: Effentora bør administreres med forsigtighed til patienter med moderat eller svært nedsat lever- eller nyrefunktion (se pkt.
English: 4 buccal tablets 28 buccal tablets
Danish: 4 bukkaltabletter 28 bukkaltabletter
English: Sedative medicines such as benzodiazepines or related drugs The concomitant use of opioids with sedative medicines such as benzodiazepines or related drugs increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect.
Danish: Sederende lægemidler, såsom benzodiazepiner eller relaterede lægemidler Hvis opioider bruges sammen med sederende lægemidler, såsom benzodiazepiner eller relaterede lægemidler, øger det risikoen for sedation, respirationsdepression, koma og død på grund af den additive CNS-undertrykkende virkning.
English: Each tablet of Effentora 100 micrograms contains 10 mg of sodium.
Danish: Hver Effentora-tablet af 100 mikrogram indeholder 10 mg natrium.
English: Differences in exposure with Effentora were observed in a clinical study with patients with grade 1 mucositis.
Danish: I et klinisk studie med patienter med grad 1-mucositis blev der observeret forskelle i eksponeringen med Effentora.
English: Rare: may affect up to 1 in 1,000 people
Danish: Sjældne: kan påvirke op til 1 ud af 1.000 personer
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.
Danish: Hvis denne dosis synes at være effektiv, kan efterfølgende anfald af gennembrudssmerter behandles med en enkelt 400 mikrogram Effentoratablet.
English: OTFC (normalized to 400 mcg)
Danish: 400 mikrogram EFFENTORA OTFC (normaliseret til 400 mcg)
English: Keep using the opioid pain medicine you take for your persistent (around-the-clock) cancer pain during your Effentora treatment.
Danish: Fortsæt med at tage Deres smertestillende medicin (opioider) for Deres vedvarende kræftsmerter (smerter, der er der hele døgnet), mens De bliver behandlet med Effentora.
English: The blister unit should then be flexed along the line printed on the backing foil where indicated.
Danish: Bøj derefter blister-enheden langs stregen på folien på bagsiden af blistret.
English: Effentora 100 micrograms buccal tablets contain 10 mg sodium per tablet.
Danish: Effentora 100 mikrogram bukkaltabletter indeholder 10 mg natrium pr. tablet.
English: Effentora tablet once exposed to moisture utilises an effervescent reaction to deliver the active substance.
Danish: Så snart en Effentora-tablet kommer i kontakt med fugt, reagerer den ved at bruse op, hvorved det aktive stof afgives.
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.
Danish: Efter administration af Effentora kan nedsat lever- og nyrefunktion både øge biotilgængeligheden og nedsætte den systemiske clearance af slugt fentanyl.
English: • constipation, inflammation of the mouth, dry mouth, diarrhoea, heartburn, loss of appetite,
Danish: • forstoppelse, betændelse i munden, tør mund, diare, halsbrand, appetitmangel, mavesmerter,
English: Careful consideration should be given to patients with hypovolaemia and hypotension.
Danish: Behandling af hypovolæmiske patienter og patienter med hypotension bør kun ske efter nøje overvejelse.
English: You should take this into consideration if you are on a controlled sodium diet and seek advice from your doctor.
Danish: Hvis De er på natrium- eller saltfattig diæt, skal De tage hensyn hertil og spørge Deres læge til råds.
English: vomiting, diarrhoea, anxiety, chills, tremor, and sweating), shaking, falls, chills
Danish: diarré, angst, kulderystelser, tremor og svedtendens), rystelser, faldtendens, kulderystelser
English: If you notice any of these, contact your doctor.
Danish: Hvis De oplever en eller flere af disse bivirkninger, bør De kontakte Deres læge.
English: Constipation Stomatitis Dry mouth Diarrhoea Abdominal pain Gastrooesophageal reflux disease Stomach discomfort Dyspepsia Toothache
Danish: Mavesmerter Gastroøsofageal reflukssygdom Maveubehag Dyspepsi Tandpine
English: <1/1,000), not known (cannot be estimated from the available data); within each frequency group, undesirable effects are presented in order of decreasing seriousness:
Danish: 1/10.000 til < 1/1.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: • EFFENTORA prescribing guide
Danish: • Vejledning i ordination af EFFENTORA
English: Controlled sodium diet
Danish: Natrium- eller saltfattig diæt
English: • Peel the blister backing to expose the tablet.
Danish: • Træk blister-enhedens bagside af for at blotlægge tabletten.
English: Fentanyl passes into breast milk and may cause sedation and respiratory depression in the breast-fed child. Fentanyl should not be used by breastfeeding women and breastfeeding should not be restarted until at least 5 days after the last administration of fentanyl.
Danish: Fentanyl bør ikke anvendes af ammende kvinder, og amning bør ikke genoptages før mindst 5 dage efter den sidste dosis fentanyl.
English: Effentora must not be prescribed in patients without around-the-clock opioid pain medication
Danish: Effentora må ikke ordineres til patienter, der ikke er i behandling med opioider for smerter hele døgnet
English: The absorption profile of Effentora is largely the result of an initial rapid absorption from the buccal mucosa, with peak plasma concentrations following venous sampling generally attained within an hour after oromucosal administration.
Danish: Peak plasma-koncentrationer, målt med venøse blodprøver, opnås sædvanligvis inden for en time efter oromukosal administration.
English: Platelet count decreased Heart rate increased Haematocrit decreased Haemoglobin decreased
Danish: Nedsat blodpladetal Øget hjertefrekvens Nedsat hæmatokrit Nedsat hæmoglobin
English: Application site reactions including bleeding, pain, ulcer, irritation, paraesthesia, anaesthesia, erythema, oedema, swelling and vesicles
Danish: Reaktioner ved applikationsstedet herunder blødning, smerte, sår, irritation, paræstesi, anæstesi, erytem, ødem, hævelse og blærer
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
Danish: • følelse af at være opstemt, nervøs, unormal, anspændt eller langsom; se eller høre ting, der faktisk slet ikke er der (hallucinationer), nedsat bevidsthed, ændring i den mentale tilstand,
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).
Danish: Stoffer, der kan potensere de suppressive virkninger på CNS Samtidig administration af fentanyl og andre CNS-depressiva, herunder andre opioider, sedativa eller hypnotika (herunder benzodiazepiner), medikamenter til generel anæstesi, fenotiaziner, beroligende midler, skeletmuskel-relaxantia, sederende antihistaminer og alkohol kan potensere yderligere suppressive virkninger, hvilket kan resultere i død (se pkt.
English: Excipient with known effect: Each tablet contains 20 mg of sodium.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver tablet indeholder 20 mg natrium.
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.
Danish: Ved intravenøs administration er det dog påvist, at clearance af fentanyl ændres på grund af ændringer i den metaboliske clearance og i plasma proteiner hos patienter med nedsat levereller nyrefunktion.
English: In the further course of treatment your requirement for analgesic therapy may change.
Danish: Deres behov for smertestillende medicin kan ændre sig i løbet af behandlingen.
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.
Danish: Fentanyl metaboliseres hovedsagelig via det humane CYP3A4-isoenzymsystem (CYP3A4).
English: • You use antidepressants or antipsychotics (selective serotonin reuptake inhibitors [SSRIs],
Danish: • De bruger antidepressiv eller antipsykotisk medicin (selektive serotoningenoptagelseshæmmere [SSRI'er], serotonin-noradrenalingenoptagelseshæmmere [SNRI'er], monoaminoxidasehæmmere (MAO-hæmmere); se pkt.
English: Each tablet of Effentora 200 micrograms, Effentora 400 micrograms, Effentora 600 micrograms and Effentora 800 micrograms contains 20 mg of sodium.
Danish: Hver Effentora-tablet af 200 mikrogram, 400 mikrogram, 600 mikrogram og 800 mikrogram indeholder 20 mg natrium.
English: Tachycardia Bradycardia
Danish: Bradykardi
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.
Danish: Samtlige patienter tog endvidere opioider såsom morfin som depottabletter eller transdermal fentanyl for deres vedvarende smerte.
English: Some changes that can be seen include an increase in serum prolactin, and decreases in plasma cortisol and testosterone.
Danish: Nogle forandringer, der kan observeres, omfatter en stigning i serumprolactin og et fald plasmakortisol og plasmatestosteron.Kliniske tegn og symptomer kan være manifestationer fra disse hormonale forandringer (se også pkt.
English: • malaise
Danish: • træthed
English: Depression Anxiety Confusional state
Danish: Depression Angst Konfusion Søvnløshed
English: In case of buccal mucosa irritation, a change in tablet placement within the buccal cavity should be recommended.
Danish: Hvis der optræder irritation i gummen/kinden, anbefales det at finde en ny placering til tabletten.
English: The educational material for healthcare professionals shall consist of four items: • Opioid prescribing guide
Danish: Undervisningsmaterialet til læger skal bestå af fire dele:
English: Excipient with known effect: Each tablet contains 10 mg of sodium.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver tablet indeholder 10 mg natrium.
English: Patients should wait at least 4 hours before treating another BTP episode with Effentora during titration.
Danish: Under titreringen bør patienterne vente mindst fire timer, inden de behandler et nyt anfald af gennembrudssmerter med Effentora.
English: • You use benzodiazepines (see section 2 under “Other medicines and Effentora”).
Danish: 2 under ”Brug af anden medicin sammen med Effentora”).
English: Photopsia
Danish: Fotopsi
English: How to use Effentora
Danish: Sådan skal de tage Effentora
English: Hypersensitivit y*
Danish: Overfølsomhed*
English: • feeling nauseous, vomiting
Danish: • kvalme, opkastning
English: Bradyarrhythmias
Danish: Bradyarytmi
English: Visual disturbance Ocular hyperaemia Blurred vision Visual acuity reduced
Danish: Synsforstyrrelse Okular hyperæmi Sløret syn Nedsat syn
English: Patients should wait at least 4 hours before treating another BTP episode with Effentora during maintenance therapy.
Danish: Under vedligeholdelsesbehandlingen bør patienten vente mindst fire timer, inden et nyt anfald af gennembrudssmerter behandles med Effentora.
English: Mouth ulceration Oral hypoaesthesia Oral discomfort Oral mucosal discolouration Oral soft tissue disorder Glossodynia Tongue blistering Gingival pain Tongue ulceration Tongue disorder Oesophagitis Chapped lips Tooth disorder
Danish: Glossodyni Blister på tungen Smerte i gummen Sår på tungen Lidelse i tungen Øsofagitis Sprukne læber Tandlidelse
English: • If you suffer from short-term pain other than breakthrough pain
Danish: • hvis De lider af andre kortvarige smerter end gennembrudssmerter, såsom smerter fra skader eller efter en operation, hovedpine eller migræne.
English: amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, and verapamil) may result in increased fentanyl plasma concentrations, potentially causing serious adverse drug reactions including fatal respiratory depression.
Danish: Samtidig brug af Effentora og stærke CYP3A4-hæmmere (f.eks. ritonavir, ketoconazol, itraconazol, troleandomycin, clarithromycin og nelfinavir) eller moderate CYP3A4-hæmmere (f.eks. amprenavir, aprepitant, diltiazem, erythromycin, fluconazol, fosamprenavir, grapefrugtjuice og verapamil) kan resultere i forhøjede plasmakoncentrationer af fentanyl, hvilket potentielt kan forårsage alvorlige bivirkninger herunder dødelig respirationsdepression.
English: Whilst you are being treated with Effentora, do not use other fentanyl treatments previously prescribed for your breakthrough pain.
Danish: Brug ikke andre fentanylpræparater tidligere ordineret for Deres gennembrudssmerter, mens De bliver behandlet med Effentora.
English: Serotoninergic agents
Danish: Serotonerge stoffer:
English: Effentora 400 micrograms buccal tablets EU/1/08/441/005-006
Danish: Effentora 400 mikrogram bukkaltabletter EU/1/08/441/005-006
English: Drug dependence (addiction)*, Drug abuse, Delirium
Danish: Stofafhængighed Stofmisbrug Delirium
English: Oral pustule
Danish: Muskeltrækninger
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
Danish: • ét eller flere af følgende problemer i munden: sår, følelsesløshed, ubehag, unormal farve,
English: Effentora 200 micrograms buccal tablets EU/1/08/441/003-004
Danish: Effentora 200 mikrogram bukkaltabletter EU/1/08/441/003-004
English: Effentora 100 micrograms buccal tablets EU/1/08/441/001-002
Danish: Effentora 100 mikrogram bukkaltabletter EU/1/08/441/001-002
English: Effentora 800 micrograms buccal tablets EU/1/08/441/009-010
Danish: Effentora 800 mikrogram bukkaltabletter EU/1/08/441/009-010
English: Effentora 600 micrograms buccal tablets EU/1/08/441/007-008
Danish: Effentora 600 mikrogram bukkaltabletter EU/1/08/441/007-008
English: Effentora 800 micrograms buccal tablets Fentanyl
Danish: Effentora 800 mikrogram bukkaltabletter Fentanyl