FrancophonIA/ELRC3.0 huggingface dataset:
English: In order to minimise the risks of opioid-related undesirable effects and to identify the effective dose, it is imperative that patients be monitored closely by health professionals during the titration process.
Danish: For at mindske risikoen for opioidrelaterede bivirkninger og fastlægge den "effektive" dosis er det af største vigtighed, at patienten nøje overvåges af uddannet sundhedspersonale under titreringsprocessen.
English: Tear 2.
Danish: Riv af 2.
English: • Open the blister only when you are ready to use the tablet.
Danish: • Åbn først blister-enheden, når De er klar til at tage tabletten.
English: Your doctor may change the treatment for your persistent pain; when your persistent pain is controlled, your doctor may need to change the dose of Effentora.
Danish: Lægen kan ændre behandlingen for Deres vedvarende smerte, når Deres vedvarende smerte er under kontrol, kan det være nødvendigt for lægen at foretage ændring i doseringen af Effentora.
English: In clinical studies, the effective dose of Effentora for BTP was not predictable from the daily maintenance dose of opioid.
Danish: I kliniske studier kunne den effektive Effentora-dosis for gennembrudssmerter ikke forudsiges ud fra den daglige vedligeholdelsesdosis af opioider.
English: Fentanyl should be used with caution in patients with previous or pre-existing bradyarrythmias.
Danish: Fentanyl bør anvendes med forsigtighed til patienter med tidligere eller allerede eksisterende bradyarytmier.
English: • Information on the titration process as indicated in the labelling - Instructions on the safe use (to avoid the risk of overdosing), on storage (to avoid the risk of accidental exposure), and disposal of fentanyl buccal tablet - Boxed statements as follows:
Danish: • Information om titreringsprocessen som anvist i etiketteringen - Vejledning i sikker brug (for at undgå risikoen for overdosering) og opbevaring (for at undgå utilsigtet eksponering) samt i bortskaffelse af fentanylbukkaltabletten - Mærkning som følger:
English: The analgesic effects of fentanyl are related to its plasma level.
Danish: Den analgetiske virkning af fentanyl er relateret til plasmakoncentrationen.
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.
Danish: Intensiteten af anfaldene af gennembrudssmerter kan variere, og den nødvendige Effentora-dosis kan stige med tiden på grund af progression af den tilgrundliggende cancersygdom.
English: Fentanyl is highly lipophilic and can be absorbed very rapidly through the oral mucosa and more slowly by the conventional gastrointestinal route.
Danish: Fentanyl er meget lipofilt og absorberes meget hurtigt fra mundslimhinden og langsommere via den konventionelle gastrointestinale vej.
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.
Danish: Hvis behandling af et anfald af gennembrudssmerter kræver mere end én tablet, bør man overveje en dosisforhøjelse til næste tilgængelige højere styrke til behandling af det næste anfald af gennembrudssmerter.
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.
Danish: I farmakokinetiske studier, der sammenlignede Effentoras absolutte og relative biotilgængelighed med oral transmukosal fentanylcitrat (OTFC), resulterede hastigheden og omfanget af fentanyl-absorption i Effentora i en eksponering, der var mellem 30 % og 50 % større end eksponeringen efter dosering med oral transmukosal fentanylcitrat.
English: Subsequently, fentanyl is redistributed between the deep tissue compartment (muscle and fat) and the plasma.
Danish: Efterfølgende redistribueres fentanyl mellem de dybe væv (muskel og fedt) og plasma.
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.
Danish: Sammen kan disse symptomer være tegn på en potentielt livstruende tilstand, der kaldes binyreinsufficiens, en tilstand, hvor binyrerne ikke danner nok hormoner.
English: Breakthrough pain is additional, sudden pain that occurs in spite of you having taken your usual opioid pain-relieving medicines.
Danish: Gennembrudssmerte er en yderligere pludselig smerte, der optræder på trods af, at De tager Deres normale smertestillende medicin.
English: • You should not drink grapefruit juice while using Effentora because it may affect the way your body breaks down Effentora.
Danish: • De må ikke drikke grapefrugtjuice, mens De tager Effentora, da det kan påvirke den måde, hvorpå Effentora bliver nedbrudt i kroppen.
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.
Danish: Patienterne bør rådes til ikke at køre bil eller betjene maskiner, hvis de oplever søvnighed, svimmelhed eller synsforstyrrelser, mens de tager Effentora, og til først at køre bil eller betjene maskiner når de ved, hvordan de reagerer på medicinen.
English: During determination of your right dose, your doctor may instruct you to take more than one tablet per episode.
Danish: Under fastsættelsen af den dosis, der er bedst egnet til Dem, vil Deres læge muligvis bede Dem om at tage mere end én tablet pr. episode.
English: • Some muscle relaxants - such as baclofen, diazepam (see also section “Warnings and precautions”.
Danish: • Nogle muskelafslappende midler - såsom baclofen, diazepam (se også pkt.
English: Patients should be instructed not to attempt to crush or split the tablet.
Danish: Patienterne bør informeres om, at de ikke må forsøge at knuse eller dele tabletten.
English: Tolerance and physical and/or psychological dependence may develop upon repeated administration of opioids such as fentanyl.
Danish: Der kan udvikles tolerance og fysisk og/eller psykisk afhængighed efter gentagen administration af opioider såsom fentanyl.
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.
Danish: De mest alvorlige bivirkninger er dog respirationsdepression (der kan føre til apnø eller respirationsophør), kredsløbsdepression, hypotension og shock, og alle patienter bør overvåges nøje for disse bivirkninger.
English: Bend 3.
Danish: Bøj 3.
English: You should not start breast-feeding until at least 5 days after the last dose of Effentora.
Danish: De må først begynde at amme mindst 5 dage efter den sidste dosis Effentora.
English: They have high affinity to opioid receptors with relatively low intrinsic activity and therefore partially antagonise the analgesic effect of fentanyl and may induce withdrawal symptoms in opioid dependant patients.
Danish: De har høj affinitet til opioide receptorer med relativt lav egenvirkning og modvirker derfor delvist fentanyls analgetiske virkning og kan forårsage abstinenssymptomer hos opioidafhængige patienter.
English: If a second tablet of Effentora was required for several consecutive times, the usual maintenance dose is to be readjusted (see below).
Danish: Hvis tillæg af én Effentora-tablet har været påkrævet flere gange i træk, skal den sædvanlige vedligeholdelsesdosis justeres (se nedenstående).
English: No more than two tablets should be used to treat any individual BTP episode, except when titrating using up to four tablets as described above.
Danish: Der bør ikke anvendes mere end to tabletter til at behandle et enkelt anfald af gennembrudssmerter bortset fra under titrering med op til fire tabletter, som beskrevet ovenfor.
English: The treatment for the persistent background pain should be kept as prescribed.
Danish: Behandlingen for vedvarende baggrundssmerter skal opretholdes i henhold til ordinationen.
English: If discontinuation of all opioid therapy is required, the patient must be closely followed by the doctor in order to manage the risk of abrupt withdrawal effects.
Danish: Hvis det er påkrævet at seponere al opioidbehandling, skal lægen følge patienten nøje, for at håndtere risikoen for abstinensymptomer fra pludeligt ophør.
English: Following the administration of Effentora, the terminal elimination phase of fentanyl is the result of the redistribution between plasma and a deep tissue compartment.
Danish: Efter administration af Effentora er fentanyls terminale eliminationsfase resultatet af redistribution mellem plasma og dybt væv.
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.
Danish: Hvor længe det tager tabletten at blive fuldstændig opløst efter oromukosal administration synes ikke at have indflydelse på, hvor tidligt den systemiske eksponering for fentanyl indtræder.
English: Mechanism of action and pharmacodynamic effects Fentanyl is an opioid analgesic, interacting predominantly with the opioid µ-receptor.
Danish: Virkningsmekanisme og farmakodynamiske virkninger Fentanyl er et opioidanalgetikum, der overvejende interagerer med opioid-µ-receptoren.
English: Agents that affect CYP3A4 activity
Danish: Stoffer, der påvirker CYP3A4-aktivitet
English: • decrease in cells that help the blood to clot,
Danish: • fald i antallet af celler, der hjælper med til at få blodet til at størkne (blodplader)
English: Because of these risks, concomitant prescribing of opioids and benzodiazepines or related drugs should be made only in patients for whom alternative treatment options are inadequate.
Danish: På grund af disse risici må opioider og benzodiazepiner eller relaterede lægemidler kun ordineres sammen med Effentora hos patienter, hvor alternative behandlingsmuligheder er utilstrækkelige.
English: Dysgeusia Somnolence Lethargy Tremor Sedation Hypoaesthesia Migraine
Danish: Dysgeusi Døsighed Letargi Tremor Sedation Hypæstesi Migræne
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”.
Danish: Hvis en anden person utilsigtet tager Effentora, kan de opleve de samme bivirkninger, som de bivirkninger, der er beskrevet i afsnit 3 “Hvis De har taget for meget Effentora”.
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.
Danish: Der skal derfor udvises særlig forsigtighed i forbindelse med titrering af Effentora hos patienter med ikke alvorlig kronisk obstruktiv lungesygdom eller andre medicinske tilstande, der gør dem disponerede for respirationsdepression, da selv normale terapeutiske doser af Effentora yderligere kan nedsætte respirationsrefleksen indtil respirationssvigt.
English: Hypogonadism Adrenal insufficiency, androgen deficiency
Danish: Hypogonadisme Adrenal insufficiens
English: If Effentora is administered, an antidote for the child should be readily available.
Danish: Hvis der administreres Effentora, skal der være en antidot parat til barnet.
English: Patients should remove the tablet from the blister unit and immediately place the entire Effentora tablet in the buccal cavity (near a molar between the cheek and gum).
Danish: Patienterne skal tage tabletten ud af blisterpakningen og straks placere hele Effentora-tabletten i mundhulen (nær en kindtand mellem gummen og kinden).
English: Contains sodium
Danish: Indeholder natrium
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.
Danish: Effentora bør ikke anvendes til patienter, som er blevet behandlet med MAO-hæmmere inden for de seneste 14 dage, da der er rapporteret alvorlig og uforudsigelig øget virkning af MAO-hæmmere i forbindelse med opioide analgetika.
English: • You have a head injury.
Danish: • De har en hovedlæsion.
English: When you first start using Effentora, your doctor will work with you to find the dose that will relieve your breakthrough pain.
Danish: Når De starter med at tage Effentora, vil Deres læge hjælpe Dem med at finde lige netop den dosis, der kan lindre Deres gennembrudssmerter.
English: • Titration guide tool Key elements to be included in the educational material for healthcare professionals: - Prescription of EFFENTORA only by physicians experienced in the management of opioid therapy in cancer patients - Prescription of EFFENTORA only to critically selected patients with close following on
Danish: • Vejledning i titrering Hovedelementer, der skal inkluderes i undervisningsmaterialet til læger: - Ordination af EFFENTORA kun af læger med erfaring i behandling med opioider til cancerpatienter - Ordination af EFFENTORA kun til nøje udvalgte patienter med omhyggelig monitorering af
English: If this recommendation does not result in an appropriate effervescence, then a switch of therapy may be advised.
Danish: Hvis dette ikke giver tilstrækkelig brusende virkning, kan det være tilrådeligt af skifte til en anden behandlingsform.
English: It is important that the maintenance opioid treatment used to treat the patient's persistent pain has been stabilised before Effentora therapy begins and that the patient continues to be treated with the maintenance opioid treatment whilst taking Effentora.
Danish: Det er vigtigt, at opioid-vedligeholdelsesbehandlingen mod vedvarende smerter er stabiliseret, inden behandlingen med Effentora indledes, og at patienten fortsat får opioid-vedligeholdelsesbehandling under behandlingen med Effentora.
English: The Effentora tablet should not be sucked, chewed or swallowed, as this will result in lower plasma concentrations than when taken as directed.
Danish: Effentora-tabletten må ikke suges/suttes på, tygges eller synkes, da dette vil resultere i lavere plasmakoncentrationer, end når tabletten tages som anvist.
English: resulting in a median terminal elimination half-life t1/2 of approximately 22 hours following buccal administration of the effervescent formulation and approximately 18 hours following intravenous administration.
Danish: Denne eliminationsfase er langsom, hvilket resulterer i en middel terminal eliminationshalveringstid t1/2 på cirka 22 timer efter bukkal administration af det brusende præparat og cirka 18 timer efter intravenøs administration.
English: Transient pH changes accompanying the effervescent reaction may optimise dissolution (at a lower pH) and membrane permeation (at a higher pH).
Danish: Forbigående pH-ændringer i forbindelse med den brusende reaktion kan optimere opløsningen af tabletten (ved en lavere pH-værdi) samt gennemtrængningen af membranen (ved en højere pH-værdi).
English: • Do not use this medicine after the expiry/use before date which is stated on the blister package label and the carton.
Danish: • Brug ikke lægemidlet efter den udløbsdato, der står på blisterkortet og på æsken efter EXP.
English: Iatrogenic addiction following therapeutic use of opioids is known to occur.
Danish: Der er kendt forekomst af iatrogen afhængighed efter terapeutisk anvendelse af opioider.
English: • For titration to 600 micrograms and 800 micrograms, tablets of 200 micrograms should be used.
Danish: • Til titrering til 600 mikrogram og 800 mikrogram bør der anvendes tabletter af 200 mikrogram.
English: Nervousness Hallucination Visual hallucination Mental status changes Disorientation
Danish: Euforisk stemning Nervøsitet Hallucination Synshallucination Ændring af mental tilstand Desorientering
English: Immediate management of opioid overdose includes removal of the Effentora buccal tablet, if still in the mouth, ensuring a patent airway, physical and verbal stimulation of the patient, assessment of the level of consciousness, ventilatory and circulatory status, and assisted ventilation (ventilatory support) if necessary.
Danish: Umiddelbar behandling af opioidoverdosering omfatter fjernelse af Effentora-bukkaltabletten, hvis den stadig er i munden, at sikre frie luftveje, fysisk og verbal stimulering af patienten, vurdering af bevidsthedsniveau, åndedræts- og kredsløbsstatus samt om nødvendigt assisteret ventilation (åndedrætshjælp).
English: Effentora like other fentanyl products can cause very severe breathing problems which can lead to death.
Danish: Effentora kan i lighed med anden medicin indeholdende fentanyl forårsage meget alvorlige vejrtrækningsproblemer, som kan medføre død.
English: • If you suffer from severe breathing problems or severe obstructive lung conditions.
Danish: • hvis De lider af alvorlige åndedrætsproblemer eller alvorlig obstruktiv lungesygdom.
English: Opening the blister package
Danish: Åbning af blisterpakningen
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OF 4 TABLETS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER MED 4 TABLETTER
English: Biliary dilatation
Danish: Biliær dilatation
English: • What is Breakthrough pain?
Danish: • Hvad er gennembrudssmerter?
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.
Danish: Bukkaltabletterne er flade, runde tabletter med skrå kanter, præget på den ene side med et “C” og på den anden side med “1” for Effentora 100 mikrogram, med “2” for Effentora 200 mikrogram, med “4” for Effentora 400 mikrogram, med “6” for Effentora 600 mikrogram og med “8” for Effentora 800 mikrogram.
English: Contact your doctor if your right dose of Effentora does not relieve your breakthrough pain.
Danish: Kontakt Deres læge, hvis Deres fastsatte Effentora-dosis ikke lindrer Deres gennembrudssmerter.
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.
Danish: Hvis Effentora anvendes i lang tid under graviditeten, er der også en risiko for, at det nyfødte barn får abstinenssymptomer, som kan være livstruende, hvis de ikke opdages og behandles af lægen.
English: • disturbance in thinking, movements disturbance
Danish: • tankeforstyrrelse, bevægelsesforstyrrelse
English: Patients should not consume any food and drink when a tablet is in the buccal cavity.
Danish: Patienterne må ikke indtage mad eller drikke, mens de har en tablet i munden.
English: • Treatment of acute pain other than breakthrough pain
Danish: • Behandling af andre akutte smerter end gennembrudssmerter.
English: If a decision is made to prescribe Effentora concomitantly with benzodiazepines or related drugs, the lowest effective dosages and minimum durations of concomitant use should be chosen.
Danish: Hvis det besluttes at ordinere Effentora sammen med benzodiazepiner eller relaterede lægemidler, skal der vælges den lavest effektive dosering og den samtidige anvendelse skal være af minimal varighed.
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.
Danish: • Hvis en enkelt 200 mikrogram Effentora-tablet (eller to 100 mikrogram tabletter) ikke synes at være effektiv, instrueres patienten i at anvende to 200 mikrogram tabletter (eller fire 100 mikrogram tabletter) til at behandle det næste anfald af gennembrudssmerter.
English: Embryo-foetal developmental toxicity studies conducted in rats and rabbits revealed no compoundinduced malformations or developmental variations when administered during the period of organogenesis.
Danish: Studier af embryo/føtal udviklingstoksicitet hos rotter og kaniner viste ingen stoffremkaldte misdannelser eller udviklingsafvigelser ved indgift i organogeneseperioden.
English: • severe breathing problems, trouble breathing during sleep,
Danish: • svære vejrtrækningsproblemer, vejrtrækningbesvær under søvn
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.
Danish: Det frarådes at bruge fentanyl under veer og fødsel (herunder kejsersnit), da fentanyl passerer placentaen og kan forårsage respirationsdepression hos fostret.
English: • Separate one of the blister units from the blister card by tearing apart at the perforations.
Danish: • Fjern én blister-enhed fra blisterkortet ved at rive den af langs perforeringerne.
English: In the pivotal clinical study (study 1), the primary endpoint was the average sum of differences in pain intensity scores from dosing to 60 minutes, inclusive (SPID60), which was statistically significant compared to placebo (p<0.0001).
Danish: I det pivotale, kliniske studie (studie 1) var det primære endepunkt den gennemsnitlige sum af forskellene i smerteintensitet fra doseringen til 60 minutter efter, inklusive (SPID60), som var statistisk signifikant sammenlignet med placebo (p<0,0001).
English: If you experience withdrawal symptoms or if you are concerned about your pain relief, you should contact your doctor.
Danish: Hvis De oplever abstinenssymptomer, eller Deres smertelindring bekymrer Dem, bør De kontakte lægen.
English: The dose and duration of concomitant use should be limited (see section 4.4).
Danish: Dosis og varigheden af samtidig anvendelse skal begrænses (se pkt.
English: • You drink alcohol; please refer to section Effentora with food, drink and alcohol.
Danish: • De drikker alkohol, se punktet om brug af Effentora sammen med mad, drikke og alkohol.
English: Vertigo Tinnitus Ear discomfort
Danish: Vertigo Tinnitus Øreproblemer
English: Each blister contains 4 buccal tablets, supplied in cartons of 4 or 28 buccal tablets.
Danish: Hvert blisterkort indeholder 4 bukkaltabletter og leveres i æsker af 4 eller 28 bukkaltabletter.
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.
Danish: Dårlig patientudvælgelse (f.eks. brug hos patienter, der ikke er i opioidvedligeholdelsesbehandling) og/eller fejldosering har medført død med Effentora og med andre fentanylpræparater.
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.
Danish: Patienten bør instrueres om ikke sideløbende at bruge to forskellige fentanylformuleringer til behandling af gennembrudssmerter samt at kassere ethvert fentanylprodukt, der er ordineret til behandling af gennembrudssmerter, når der skiftes til Effentora.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder or call the following number:
Danish: Hvis De ønsker yderligere oplysninger om dette lægemiddel, skal De henvende Dem til den lokale repræsentant for indehaveren af markedsføringstilladelsen: