FrancophonIA/ELRC3.0 huggingface dataset:
English: The full EPAR for Effentora can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Effentora findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Doses of Effentora above 800 micrograms have not been tested.
Danish: Doser af Effentora over 800 mikrogram er ikke blevet afprøvet.
English: After 30 minutes, any pieces of tablet remaining can be swallowed with a glass of water.
Danish: Efter 30 minutter kan eventuelle resterende dele af tabletten synkes med et glas vand.
English: Effentora was more effective than placebo in reducing pain in both studies.
Danish: Effentora var mere effektivt end placebo til at nedsætte smerterne i begge undersøgelser.
English: Patients should not eat or drink anything while the tablet is in the mouth.
Danish: Patienterne bør ikke spise eller drikke noget som helst, mens tabletten er i munden.
English: This is a summary of the European public assessment report (EPAR) for Effentora.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Effentora.
English: The patient should be monitored carefully while the dose is increased.
Danish: Patienten overvåges omhyggeligt, mens dosis øges.
English: Because fentanyl has been in use for many years, the company presented data from the scientific literature, as well as from studies that it had carried out.
Danish: Da fentanyl har været anvendt i mange år, fremlagde virksomheden data fra faglitteraturen og fra de undersøgelser, virksomheden har gennemført.
English: A risk management plan has been developed to ensure that Effentora is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Effentora anvendes så sikkert som muligt.
English: The tablets usually dissolve in 14 to 25 minutes, releasing the active substance, which is absorbed directly into the bloodstream.
Danish: Tabletten opløses typisk i løbet af 14-25 minutter og frigiver det aktive stof, der absorberes direkte ind i blodbanen.
English: The tablets should not be broken or crushed, and they should not be sucked, chewed or swallowed whole.
Danish: Tabletten må ikke knækkes eller knuses, og den må ikke suttes, tygges eller synkes hel.
English: It is available as ‘buccal tablets' (tablets that dissolve in the mouth).
Danish: Det fås som bukkaltabletter (tabletter, der opløses i munden).
English: Once the appropriate dose for the patient has been found, the patient should take this dose as a single tablet.
Danish: Når der er fastlagt en egnet dosis for patienten, bør patienten tage denne dosis som en enkelt tablet.
English: It must not be used to treat short-term pain other than breakthrough pain.
Danish: Det må ikke anvendes til behandling af anden kortvarig smerte end gennembrudssmerte.
English: The main measure of effectiveness was the change in pain intensity over the first 30 or 60 minutes after taking the tablet.
Danish: Virkningen blev hovedsagelig målt på ændringen i smerteintensitet i de første 30 eller 60 minutter efter indtagelse af tabletten.
English: The tablets should be removed from the packaging immediately before being placed between the gum and the cheek.
Danish: Tabletten bør først fjernes fra pakningen, lige før den placeres mellem gummen og kinden.
English: For more information about treatment with Effentora, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Effentora, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The active substance in Effentora, fentanyl, is an opioid.
Danish: Det aktive stof i Effentora, fentanyl, er et opioid.
English: Effentora can also cause the side effects typically seen with other opioids, but these tend to decrease or stop with continued use.
Danish: Effentora kan også medføre de bivirkninger, der typisk ses ved andre opioider, men bivirkningerne har tendens til at aftage eller helt forsvinde ved fortsat brug.
English: Other information about Effentora
Danish: Andre oplysninger om Effentora
English: What measures are being taken to ensure the safe and effective use of Effentora?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Effentora?
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Effentora.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Effentora skal anvendes.
English: Breakthrough pain is when a patient experiences additional, sudden pain in spite of ongoing treatment with painkillers.
Danish: Gennembrudssmerte er, når en patient oplever yderligere, pludselig smerte på trods af igangværende behandling med smertestillende midler.
English: They should only have the necessary strengths of Effentora tablets available at any one time, to prevent confusion and possible overdose.
Danish: De bør kun have adgang til Effentora-tabletter i de nødvendige styrker for at undgå forvekslinger og eventuel overdosering.
English: The company that makes Effentora will also provide educational materials in each European Union (EU) Member State to make sure that patients and doctors are aware of how the medicine should be used safely, the risks of accidental exposure to fentanyl and how to dispose of Effentora.
Danish: Virksomheden, der fremstiller Effentora, vil desuden udarbejde undervisningsmateriale i hver enkelt EU-medlemsstat for at sikre, at patienter og læger er klar over, hvordan lægemidlet anvendes sikkert, hvilke risici der er forbundet med utilsigtet eksponering for fentanyl, og hvordan Effentora skal bortskaffes.
English: Effentora is a medicine that contains the active substance fentanyl.
Danish: Effentora er et lægemiddel, der indeholder det aktive stof fentanyl.
English: The most common side effects with Effentora (that may affect more than 1 patient in 10) are dizziness, headache, nausea (feeling sick), vomiting, and reactions at the site of application including bleeding, pain, ulcers, irritation, unusual sensations, numbness, redness, swelling and spots.
Danish: De hyppigste bivirkninger ved Effentora (som optræder hos flere end 1 ud af 10 patienter) er svimmelhed, hovedpine, kvalme, opkastning og reaktioner på applikationsstedet, herunder blødning, smerte, sår, irritation, unormal fornemmelse, følelsesløshed, rødmen, hævelse og pletter.
English: This means that because the medicine can be misused or cause addiction, it is used under stricter conditions than normal.
Danish: Dette betyder, at lægemidlet anvendes under strengere betingelser end normalt, fordi det kan misbruges eller medføre afhængighed.
English: The most serious of these are respiratory depression (inhibition of breathing), circulatory depression (slow heartbeat), hypotension (low blood pressure) and shock (a steep fall in blood pressure).
Danish: De mest alvorlige bivirkninger blandt disse er respirationsdepression (hæmmet vejrtrækning), kredsløbsdepression (langsom hjerterytme), hypotension (lavt blodtryk) og chok (kraftigt blodtryksfald).
English: Effentora must not be used in patients who are not already taking opioids to maintain pain control, who have severe respiratory depression, or who have severe obstructive lung conditions (diseases that severely impede breathing).
Danish: Effentora må ikke anvendes hos patienter, som ikke allerede tager opioider for at holde smerterne under kontrol, som har svær respirationsdepression, eller som har svære obstruktive lungesygdomme (sygdomme, der giver alvorlige vejrtrækningsproblemer).
English: Patients should not possess or use any other medicines containing fentanyl for the treatment of breakthrough cancer pain at the same time as using Effentora.
Danish: Patienterne må ikke besidde eller anvende andre lægemidler indeholdende fentanyl til behandling af gennembrudssmerte ved kræft samtidig med, at de tager Effentora.
English: In both studies, each patient was treated during 10 separate episodes of breakthrough pain: in seven of these episodes, each patient received Effentora, and in the other three episodes, each patient received placebo (a dummy tablet).
Danish: I begge undersøgelser blev alle patienter behandlet under 10 separate episoder med gennembrudssmerte: I syv af episoderne blev alle patienterne behandlet med Effentora, og i de tre andre med placebo (uvirksom tablet).
English: Treatment with Effentora should be started by and remain under the guidance of a doctor who has experience in the management of opioid treatment in cancer patients.
Danish: Behandling med Effentora bør indledes og gennemføres under vejledning af en læge, der har erfaring med opioidbehandling af kræftpatienter.
English: In the second study, pain intensity had fallen by 9.7 points at 60 minutes after Effentora and by 4.9 points after placebo.
Danish: I den anden undersøgelse faldt smerteintensiteten med 9,7 point 60 minutter efter indtagelse af Effentora og med 4,9 point efter indtagelse af placebo.
English: The CHMP decided that Effentora's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Effentora opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Effentora.
English: If this dose stops controlling the pain well enough, the doctor will need to work out a new individual dose.
Danish: Hvis smerten ikke længere kan kontrolleres tilstrækkeligt med denne dosis, skal lægen fastlægge en ny individuel dosis.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Effentora, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Effentora, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: The ability of Effentora to treat breakthrough pain was tested in two main studies involving a total of 150 adults with cancer who were being treated with opioids.
Danish: Virkningen af Effentora ved behandling af gennembrudssmerte er blevet undersøgt i to hovedundersøgelser, hvori der deltog i alt 150 voksne kræftpatienter, der blev behandlet med opioider.
English: Effentora is used to treat ‘breakthrough' pain in adults with cancer who are already using opioids (a group of painkillers that includes morphine and fentanyl) to control long-term cancer pain.
Danish: Effentora anvendes til behandling af "gennembrudssmerter" hos voksne kræftpatienter, der allerede får opioider (en gruppe smertestillende midler såsom morfin og fentanyl) for at kontrollere langvarig kræftsmerte.
English: Effentora is taken at the start of a breakthrough pain episode.
Danish: Effentora tages, når en episode med gennembrudssmerte starter.
English: In Effentora, it is given as a buccal tablet, so that the fentanyl is absorbed through the lining of the mouth.
Danish: Med Effentora gives fentanyl som en bukkaltablet, således at fentanyl absorberes gennem mundslimhinden.
English: When a patient starts to take Effentora, the doctor will need to work out the appropriate individual dose that will provide adequate pain relief for the patient with few side effects.
Danish: Når en patient starter med at tage Effentora, er lægen nødt til at beregne, hvilken dosis der lindrer patientens smerter tilstrækkeligt med så få bivirkninger som muligt.
English: Once in the bloodstream, fentanyl acts on receptors in the brain and spinal cord to prevent pain
Danish: Når først fentanyl er i blodbanen, påvirker det receptorer i hjernen og rygmarven og har derigennem en smerteforebyggende virkning.
English: In the first study, pain intensity had fallen by an average of 3.2 points at 30 minutes after the patients took Effentora and by 2.0 points after they took placebo.
Danish: I den første undersøgelse faldt smerteintensiteten gennemsnitligt med 3,2 point 30 minutter efter indtagelsen af Effentora og med 2,0 point, efter at patienterne havde taget placebo.
English: What is the risk associated with Effentora?
Danish: Hvilken risiko er der forbundet med Effentora?
English: Why has Effentora been approved?
Danish: Hvorfor blev Effentora godkendt?
English: For the full list of all side effects reported with Effentora, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Effentora fremgår af indlægssedlen.
English: What is Effentora?
Danish: Hvad er Effentora?
English: See the package leaflet for further information.
Danish: Yderligere oplysninger fremgår af indlægssedlen.
English: How has Effentora been studied?
Danish: Hvordan blev Effentora undersøgt?
English: What is Effentora used for?
Danish: Hvad anvendes Effentora til?
English: What benefit has Effentora shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Effentora?
English: How is Effentora used?
Danish: Hvordan anvendes Effentora?
English: How does Effentora work?
Danish: Hvordan virker Effentora?
English: EU/1/15/995/001 DUTREBIS 150 mg / 300 mg Film-coated tablet
Danish: EU/1/15/995/001 DUTREBIS 150 mg / 300 mg Filmovertrukken tablet
English: MA (EU) Number (Invented) name
Danish: MF (EU)-nummer (Særnavn) navn
English: Oral use bottle (HDPE)
Danish: Flaske (HDPE)
English: Pharmaceutical form Route of administration Immediate Packaging
Danish: Lægemiddelform Administration
English: Protein binding is 85-90%.
Danish: Proteinbindingsgraden er 85-90%.
English: They should be treated additionally if needed.
Danish: De bør behandles yderligere efter behov.
English: You can either use this medicine:
Danish: Du kan enten anvende dette lægemiddel:
English: ATC Code: R01AD05
Danish: ATC-kode: R01AD05
English: The desired clinical effect appears within about 1-2 weeks.
Danish: Den ønskede kliniske effekt indtræffer inden for 1-2 uger.
English: Note, it is not necessary to breathe in at the same time as you spray.
Danish: Bemærk, at det ikke er nødvendigt at trække vejret indad, samtidig med at du sprayer.
English: GROUNDS FOR POSITIVE OPINION
Danish: BEGRUNDELSE FOR EN POSITIV UDTALELSE
English: Adults, adolescents and children from 6 years of age:
Danish: Voksne, unge og børn fra 6 år:
English: The patient should be informed that the full effect is not achieved until after a few days of treatment.
Danish: Patienten skal gøres opmærksom på, at den fulde virkning først indtræffer efter nogle dages behandling.
English: A reduction of the dose may also be considered.
Danish: Dosisreduktion kan også overvejes.
English: Maintenance dose It takes 7 to 14 days for this medicine to work.
Danish: Vedligeholdelsesdosis: Det tager 7 til 14 dage, inden lægemidlet virker.
English: Children should be treated under guidance of an adult.
Danish: Børn skal behandles under vejledning af en voksen.
English: • increased pressure in the eyes
Danish: • Øget tryk i øjet.
English: Be sure to tell your doctor immediately if you are pregnant, think you may be pregnant, or if you are planning to become pregnant.
Danish: Fortæl det straks til lægen, hvis du er gravid, tror du er gravid eller planlægger at blive gravid.
English: Special care is needed in patients with tuberculosis.
Danish: Der skal udvises særlig forsigtighed hos patienter med tuberkulose.
English: After first opening: 3 months
Danish: 2 år Efter åbning: 3 måneder
English: Undesirable effects frequencies were defined as follows:
Danish: Bivirkningsfrekvenserne er defineret som følger:
English: The CHMP agrees with the responses.
Danish: CHMP er enig i ansøgerens svar.
English: It should be sprayed into your nostrils as described below.
Danish: Det skal sprayes ind i næseborene, som beskrevet nedenfor.
English: Shake the bottle (figure 1).
Danish: Ryst flasken (tegning 1).
English: Veluwezoom 22 1327 AH Almere Netherlands
Danish: Veluwezoom 22 1327 AH Almere Holland
English: Hold the bottle as shown in figure 2.
Danish: Hold flasken som vist på tegning 2.
English: However, disagreement between the member states involved in the procedure regarding the inclusion of children and adolescents remained, and the procedure was referred to the CHMP.
Danish: Der var dog fortsat uenighed blandt de medlemsstater, der er involveret i proceduren, med hensyn til om børn og unge skal medtages i indikationen, og proceduren blev henvist til CHMP.
English: • if you are a child and are taking high doses of this medicine for a long time, your doctor will check your height regularly
Danish: • Hvis du er et barn og bruge høje doser af dette lægemiddel over en lang periode, vil din læge regelmæssigt tjekke din højde.
English: • slowing of the growth rate in children and adolescents, particularly after taking high doses for a long time
Danish: • Nedsat vækst hos børn og unge, særligt efter lang tids brug af høje doser.
English: Clinically, the most important outcome measure of human growth is the final height in relation to the expected final height.
Danish: Klinisk set er det vigtigste resultatmål for human vækst sluthøjden i forhold til den forventede sluthøjde.
English: If you notice these symptoms you should contact your doctor immediately.
Danish: Hvis du får sådanne symptomer, skal du straks kontakte lægen.
English: There is no information about this interaction following nasal administration of budesonide, but increased plasma concentrations are expected.
Danish: Der foreligger ingen information om denne interaktion efter nasal administration af budesonid, men der forventes øgede plasmakoncentrationer.
English: The dosage should be determined individually.
Danish: Dosis bør tilpasses individuelt.
English: The impact of the differences of the two preparations is unknown.
Danish: Det vides ikke, hvilken betydning forskellene mellem de to formuleringer har.
English: The Applicant therefore concludes that there is no justification for additional clinical data in the paediatric population.
Danish: Ansøgeren konkluderede derfor, at der ikke er belæg for nødvendigheden af yderligere kliniske data i den pædiatriske population.
English: The Applicant stated that growth is divided into 3 distinct age-related phases and that conclusions from studies in one age group cannot be generalised to other age groups.
Danish: Ansøgeren fremførte, at væksten inddeles i tre særskilte aldersrelaterede faser, og at konklusionerne fra undersøgelserne i én aldersgruppe ikke uden videre kan overføres til andre aldersgrupper.
English: Budesonide is eliminated through metabolism, mainly by the enzyme CYP3A4.
Danish: Budesonid udskilles via metabolisering, hovedsageligt via enzymet CYP3A4.
English: You should also tell your doctor if you are takng any other medicines such as:
Danish: Du skal også fortælle det til lægen, hvis du tager andre lægemidler, såsom:
English: 6.5 Nature and contents of container Not all pack sizes may be marketed.
Danish: 6.5 Emballagetype og pakningsstørrelser Ikke alle pakningsstørrelser er nødvendigvis markedsført.
English: 6.6 Special precautions for disposal <and other handling> No special requirements
Danish: 6.6 Regler for destruktion <og anden håndtering> Ingen særlige forholdsregler.
English: Allergic rhinitis
Danish: Allergisk rhinitis
English: The metabolites are eliminated in the urine in unchanged or conjugated form.
Danish: Metabolitter udskilles i urinen enten uændret eller konjungeret.
English: • if you have been taking this medicine continuously for a long time, your doctor will want to examine the inside of your nose at least every six months
Danish: • Hvis du har brugt dette lægemiddel i længere tid, vil din læge undersøge din næse indvendigt mindst hver 6. måned.
English: The volume of distribution of budesonide is approximately 3 L/kg.
Danish: Budesonids distributionsvolumen er ca. 3 l/kg.
English: This is an infection that can affect your lungs.
Danish: Det er en infektion, der kan påvirke lungefunktionen.
English: Czech Republic
Danish: Tjekkiske republik
English: c.) No paediatric data has been presented so far in this application.
Danish: c.) Der er indtil videre ikke fremlagt pædiatriske data i forbindelse med denne ansøgning.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, APPLICANT(S) IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), INDGIVELSESVEJ(E), ANSØGER(E), INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE(R) I MEDLEMSSTATERNE
English: Similar effects are considered unlikely to occur in humans at therapeutic doses.
Danish: Lignende bivirkninger er usandsynlige hos mennesker ved terapeutiske doser.
English: If you were previously treated with steroid tablets or injections but your doctor has now prescribed this medicine instead, you might experience a worsening of some of your other symptoms (eg red and itchy eyes).
Danish: Hvis du hidtil har været behandlet med steroidtabletter eller steroidinjektioner, og din læge nu har ordineret dette lægemiddel i stedet, kan du opleve, at nogle af dine andre symptomer vil forværres (f.eks. røde og kløende øjne).
English: - the ascorbic acid contained in the product is not expected to impact the systemic exposure of budesonide,
Danish: - den ascorbinsyre, der er indeholdt i produktet, forventes ikke at have indflydelse på den systemiske eksponering for budesonid,
English: Insert the tip of the nozzle into your nostril as shown in figure 3 and spray once (or more if your doctor has told you to).
Danish: Indfør pumpens spids i næseboret som vist på tegning 3 og spray en gang (eller mere, hvis din læge har anvist det).
English: Ideally, you should start to use this medicine up to 14 days before you expect your symptoms to start.
Danish: Du skal helst starte med at bruge dette lægemiddel 14 dage før, du forventer at få dine første symptomer.
English: No paediatric data has been presented so far.
Danish: Der er indtil videre ikke fremlagt pædiatriske data.
English: Make sure you tell your doctor if you are taking ketoconasole tablets, a medicine used to treat fungal infections, such as thrush.
Danish: Vær særligt opmærksom på at fortælle det til lægen, hvis du tager ketoconazol-tabletter, der anvendes til behandling mod svampeinfektioner, såsom trøske.
English: Ascorbic acid E 300
Danish: Ascorbinsyre (E 300)
English: • if you have had an operation on your nose or any other injury to your nose that has not yet fully recovered
Danish: • Hvis du har fået en næseoperation eller har anden skade på næsen, der endnu ikke er helet.
English: Animal studies have shown reproductive toxicity (see section 5.3).
Danish: Dyreforsøg har påvist reproduktionstoksicitet (se pkt.
English: The main metabolites 6-beta-hydroxybudesonide and 16-alpha-hydroxyprednisolon are almost ineffective.
Danish: Hovedmetabolitterne 6-beta-hydroxybudesonid og 16-alfa-hydroxyprednisolon er stort set uden klinisk effekt.
English: Comparable systemic exposure of the test and reference product has not unequivocally been shown in the adult population.
Danish: Tilsvarende systemisk eksponering for test- og referenceproduktet er ikke blevet entydigt påvist i den voksne population.
English: In addition, consideration should be given to referring the patient to the paediatric specialist.
Danish: Herudover bør det overvejes at henvise patienten til en børnelæge.
English: BATCH NUMBER
Danish: BATCHNUMMER Batchnummer:
English: Discard the opened bottle with any remaining solution after 3 months.
Danish: Kasser den åbnede flaske og al overskydende opløsning efter 3 måneder.
English: No better efficacy is to be expected with a dose greater than 256 micrograms.
Danish: Der kan ikke forventes yderligere effekt ved doser over 256 mikrogram.