FrancophonIA/ELRC3.0 huggingface dataset:
English: Further information on the HMPC assessment of matricaria oil medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Danish: Yderligere oplysninger om HMPC's vurdering af lægemidler, der indeholder kamilleolie, herunder detaljerede oplysninger om udvalgets konklusioner, findes under "All documents" på Det Europæiske Lægemiddelagenturs websted: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Further information on the risks associated with matricaria oil medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Danish: Yderligere oplysninger om risici forbundet med lægemidler, der indeholder kamilleolie, herunder passende forholdsregler, som skal følges med henblik på sikker anvendelse, findes i monografien under fanebladet "All documents" på Det Europæiske Lægemiddelagenturs websted: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Matricaria oil can also be found in combination with other herbal substances in some herbal medicines.
Danish: Kamilleolie findes desuden kombineret med andre droger i visse plantelægemidler.
English: The HMPC conclusions on the use of matricaria oil medicines for irritation of the skin and areas around anus and genitals are based on their ‘traditional use' in this condition.
Danish: HMPC's konklusioner vedrørende brugen af lægemidler med kamilleolie mod irritation af huden og området omkring anus og kønsdele, er baseret på den "traditionelle anvendelse".
English: Matricaria oil
Danish: Kamilleolie
English: Herbal medicines containing matricaria oil are usually available in liquid forms to be used as bath additives.
Danish: Plantelægemidler med kamilleolie fås normalt i flydende form til anvendelse som badeadditiv.
English: How are matricaria oil medicines approved in the EU?
Danish: Hvordan godkendes lægemidler, der indeholder kamilleolie, i EU?
English: The HMPC concluded that, on the basis of its long-standing use, matricaria oil medicines can be used as add-on treatment of irritation of the skin and areas around the anus and genitals, once serious conditions have been excluded by a medical doctor.
Danish: På baggrund af den mangeårige anvendelse har HMPC konkluderet, at kamilleolie kan bruges til supplerende behandling af irritation af huden og området omkring anus og kønsdele, når læge har udelukket alvorlige sygdomme.
English: Therefore, the HMPC conclusions on the use of matricaria oil medicines are based on their long-standing use.
Danish: HMPC's konklusioner om anvendelsen af lægemidler indeholdende kamilleolie er derfor baseret på den mangeårige anvendelse til disse formål.
English: This summary is not intended to provide practical advice on how to use medicines containing matricaria oil.
Danish: Dette sammendrag er ikke en praktisk vejledning i, hvordan plantelægemidler, der indeholder kamilleolie, anvendes.
English: What evidence supports the use of matricaria oil medicines?
Danish: Hvilken dokumentation underbygger den medicinske anvendelse af kamilleolie?
English: What are the risks associated with matricaria oil medicines?
Danish: Hvilke risici er der forbundet med lægemidler, der indeholder kamilleolie?
English: For more information about treatment with matricaria oil medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med lægemidler, der indeholder kamilleolie, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: For practical information about using matricaria oil medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktiske oplysninger om anvendelsen af lægemidler med kamilleolie, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: Patients with severe heart and circulation problems should not have full baths with matricaria oil.
Danish: Patienter med svære hjerte-karsygdomme bør ikke anvende karbade (til hele kroppen) med kamilleolie.
English: Matricaria oil medicines must not be used in patients who are allergic to matricaria oil or other plants of the same family (Asteraceae (Compositae)).
Danish: Lægemidler med kamilleolie må ikke anvendes hos patienter, der er allergiske over for kamilleolie eller andre planter i kurvblomstfamilien.
English: Allergic reactions, sometimes severe, have been reported following contact of liquid chamomile preparations with internal moist surfaces such as the lining of the mouth.
Danish: Ved kontakt af flydende kamillepræparater med slimhinder er beskrevet allergiske reaktioner, undertiden alvorlige.
English: A doctor or a qualified healthcare practitioner should be consulted if symptoms persist for more than one
Danish: Hvis symptomerne varer længere end en uge under behandlingen, bør der søges råd hos en læge eller en anden kvalificeret sundhedsmedarbejder.
English: Use in the elderly (older than 65 years)
Danish: Brugen hos ældre (over 65 år)
English: These differences continued to be significant at each subsequent time point in each individual study.
Danish: Disse forskelle fortsatte med at være signifikante ved hvert efterfølgende tidspunkt i hvert enkelt studie.
English: Each tablet contains either:
Danish: Hver tablet indeholder enten:
English: Date of first authorisation: 04 April 2008 Date of latest renewal: 20 February 2013
Danish: Dato for første markedsføringstilladelse: 4. april 2008 Dato for seneste fornyelse: 20. februar 2013
English: The reason of this difference is unknown.
Danish: Grunden til denne forskel er ukendt.
English: • Information on the correct indication and the risk for abuse
Danish: • Information om korrekt indikation og risikoen for misbrug
English: Time after Dose Administration (hours)
Danish: Tid efter administration af dosis (timer)
English: Try to keep the person awake until emergency help arrives.
Danish: Forsøg at holde personen vågen, indtil ambulancen kommer.
English: The differences observed were not clinically significant.
Danish: De observerede forskelle var ikke klinisk signifikante.
English: Higher doses may be necessary.
Danish: Det kan være nødvendigt med højere doser.
English: Tolerance, dependence
Danish: Tolerance, afhængighed
English: Dosage increase should be done with caution.
Danish: Dosisstigning bør foretages med forsigtighed.
English: Patients should be carefully monitored until an effective dose is reached.
Danish: Patienterne bør monitoreres omhyggeligt, indtil den effektive dosis nås.
English: This may occur within the recommended dose.
Danish: Dette kan forekomme med den anbefalede dosis.
English: • Safe use, storage and disposal of EFFENTORA.
Danish: • Sikker brug, opbevaring og bortskaffelse af EFFENTORA.
English: Accidental use in children
Danish: Utilsigtet brug hos børn
English: It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above.
Danish: Det kan være en hjælp af informere venner eller slægtninge, så de er opmærksomme på de tegn og symptomer, der angives ovenfor.
English: This product should only be used by patients already taking other opioids.
Danish: Dette produkt bør kun anvendes af patienter, der allerede tager andre opioider.
English: • Effentora may be used before or after, but not during, meals.
Danish: • Effentora kan anvendes før eller efter, men ikke under måltider.
English: • You are over 65 years old - you may need a lower dose and any dose increase will be reviewed very carefully by your doctor.
Danish: • De er over 65 år - De kan have behov for en lavere dosis, og alle dosisforhøjelser vil blive meget grundigt gennemgået af Deres læge.
English: The educational material for patients shall consist of the following three items:
Danish: Undervisningsmaterialet til patienter skal bestå af følgende tre dele:
English: Seek URGENT medical advice if:
Danish: Søg AKUT lægehjælp, hvis:
English: • Contact your doctor immediately if you experience a combination of the following symptoms
Danish: • Kontakt straks lægen, hvis De oplever en kombination af følgende symptomer
English: Because of this, concomitant use should only be considered when other treatment options are not possible.
Danish: På grund af dette må en samtidig anvendelse kun overvejes, når andre behandlingsmuligheder ikke er mulige.
English: Patients with xerostomia
Danish: Patienter med xerostomi
English: Contact your doctor when experiencing such symptoms.
Danish: Kontakt lægen, når De oplever sådanne symptomer.
English: If this occurs, please seek immediate medical assistance.
Danish: Hvis dette sker, skal De omgående søge lægehjælp.
English: • Risk of interactions with other medications
Danish: • Risiko for interaktioner med andre lægemidler
English: Do not give this medicine to children and adolescents below18 years of age.
Danish: Giv ikke denne medicin til børn og unge under 18 år.
English: Any change in dosage must be prescribed and monitored by your doctor.
Danish: En ændring i doseringen skal ordineres og overvåges af Deres læge.
English: The primary efficacy variable was the patient's assessment of pain intensity.
Danish: Den primære effektvariabel var patientens vurdering af smerteintensitet.
English: * Based on venous blood samples (plasma).
Danish: * Baseret på venøse blodprøver (plasma).
English: The plasma protein binding of fentanyl is 80% to 85%.
Danish: Fentanyls plasmaproteinbinding er 80 % til 85 %.
English: Patients assessed pain intensity on a 11-point scale.
Danish: Patienterne vurderede smerteintensiteten på en 11 punkts-skala.
English: In clinical studies patients older than 65 years tended to titrate to a lower effective dose than younger patients.
Danish: I kliniske studier blev patienter over 65 år generelt titreret til en lavere effektiv dosis end yngre patienter.
English: There are no adequate data from the use of fentanyl in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af fentanyl til gravide kvinder.
English: A Q&A document, providing answers to potential questions on the following topics:
Danish: En vejledende brochure, der giver svar på eventuelle spørgsmål om følgende emner:
English: • In case of irritation, you may change the placement of the tablet on the gum.
Danish: • I tilfælde af irritation kan De ændre placeringen af tabletten på gummen.
English: The number of tablet strengths available to the patients at any time should be minimised to prevent confusion and potential overdose.
Danish: Antallet af tabletstyrker, som til enhver tid er tilgængelige for patienten, bør minimeres for at forhindre forvirring og mulig overdosering.
English: Sometimes, your doctor may tell you to place the tablet under your tongue instead.
Danish: I nogle tilfælde kan lægen give Dem besked om, at De skal placere tabletten under tungen i stedet.
English: Doses above 800 micrograms were not evaluated in clinical studies.
Danish: Der blev ikke evalueret doser over 800 mikrogram i kliniske studier.
English: A Daily Pain Journal to record daily pain levels, providing patients and physicians with a follow-up tool for daily symptoms and treatment efficacy.
Danish: En daglig smertedagbog til notering af daglige smerteniveauer, som giver patienter og læger et redskab til opfølgning af daglige symptomer og behandlingseffektivitet.
English: The safety and efficacy of Effentora in children aged 0 to 18 years have not been established.
Danish: Effentoras sikkerhed og virkning hos børn i alderen 0 til 18 år er ikke klarlagt.
English: Oral candidiasis Pharyngitis
Danish: Oral candidiasis Faryngitis
English: Linearity/non-linearity Dose proportionality from 100 micrograms to 1000 micrograms has been demonstrated.
Danish: Linearitet/non-linearitet Der er påvist dosisproportionalitet fra 100 mikrogram til 1.000 mikrogram.
English: Patients who identified an effective dose entered the double-blind phase of the study.
Danish: Patienter, som identificerede en effektiv dosis, gik videre i studiets dobbeltblinde fase.
English: • Possible side effects (the most likely ones, how to recognise them and when to alert physicians)
Danish: • Bivirkninger (de mest sandsynlige bivirkninger, hvordan disse konstateres, og hvornår lægen skal underrettes)
English: confusion, fear, seeing or hearing things that are not really there, sleep disturbance, nightmares)
Danish: forvirring, angst, se eller høre ting, der faktisk slet ikke er der, søvnforstyrrelser, mareridt)
English: • You have a history of alcoholism or any drug abuse or dependence.
Danish: • De har en sygehistorie med alkoholisme eller andet stofmisbrug eller afhængighed.
English: Your doctor will tell you whether Effentora is suitable for you.
Danish: Deres læge vil fortælle Dem, om Effentora er egnet til Dem.
English: Patients and their carers must be instructed that Effentora contains an active substance in an amount that can be fatal, especially to a child.
Danish: Patienter og deres plejere/hjælpere skal informeres om, at Effentora indeholder et aktivt stof i en mængde, der kan være dødelig især for børn.
English: This can occur if your dose of Effentora is too high or if you take too much Effentora.
Danish: Dette kan forekomme, hvis Deres Effentora-dosis er for stor, eller hvis De tager for meget Effentora.
English: A document explaining the titration process and the dosing recommendations after treatment initiation
Danish: Et dokument, der forklarer titreringsprocessen og doseringsanbefalingerne efter behandlingsinitiering
English: • Do not attempt to crush or split the tablet.
Danish: • Forsøg ikke at knuse eller dele tabletten.
English: However, opioid analgesics impair the mental and/or physical ability required for the performance of potentially dangerous tasks (e.g., driving a car or operating machinery).
Danish: Imidlertid nedsætter opioide analgetika den mentale og/eller fysiske evne, der kræves til at udføre farlige opgaver (f.eks. at køre bil eller betjene maskiner).
English: The main binding protein is alpha-1-acid glycoprotein, but both albumin and lipoproteins contribute to some extent.
Danish: Det vigtigste bindingsprotein er alfa-1-syreglykoprotein, men både albumin og lipoproteiner medvirker i nogen grad.
English: In general, the effective concentration and the concentration at which toxicity occurs increase with increasing tolerance to opioids.
Danish: Generelt stiger den effektive koncentration og den koncentration, der fremkalder toksicitet, i takt med øget tolerance over for opioider.
English: Adverse reactions are listed below as MedDRA preferred term by system organ class and frequency (frequencies are defined as: very common ≥1/10, common ≥1/100 to <1/10, uncommon ≥ 1/1,000 to <1/100, rare (≥1/10,000 to
Danish: Bivirkningerne er anført herunder i henhold til foretrukken MedDRA-terminologi efter systemorganklasser og hyppighed (hyppigheder defineres som: meget almindelig ≥1/10, almindelig ≥1/100 til <1/10, ikke almindelig ≥ 1/1.000 til < 1/100, sjælden (≥
English: It is recommended that two tablets should be placed in each side of the mouth.
Danish: Det anbefales, at to tabletter placeres i hver side af munden.
English: Dosage and frequency
Danish: Dosering og hyppighed
English: Cmax and AUC0-8 were 1% and 25% higher in patients with mucositis compared to those without mucositis, respectively.
Danish: Cmax og AUC0-8 var henholdsvis 1 % og 25 % højere hos patienter med mucositis end hos patienter uden mucositis.
English: ** Data for Tmax presented as median (range).
Danish: ** Data for Tmax vist som middel (område).
English: Partial opioid agonists/antagonists
Danish: Partielle opioide agonister/antagonister
English: Abnormal sensation in eye
Danish: Unormal fornemmelse i øjet
English: • lack of sex hormones (androgen deficiency)
Danish: • mangel på kønshormoner (androgenmangel)
English: No studies of the effects on the ability to drive and use machines have been performed.
Danish: Der er ikke foretaget studier af virkningen på evnen til at føre motorkøretøj og betjene maskiner.
English: Effentora should not be used during pregnancy unless you have discussed this with your doctor.
Danish: Effentora bør ikke anvendes under graviditet, medmindre De har drøftet det med Deres læge.
English: Effentora should not be used in pregnancy unless clearly necessary.
Danish: Effentora bør ikke anvendes under graviditeten, medmindre det er klart nødvendigt.
English: • You experience pain or increased sensitivity to pain (hyperalgesia) which does not respond to a higher dosage of your medicine as prescribed by your doctor.
Danish: • De oplever smerter eller øget følsomhed for smerte (hyperalgesi), der ikke reagerer på en højere dosis af Deres medicin, som lægen har ordineret.
English: These effects could either be indirect effects due to altered maternal care and/or decreased lactation rate or a direct effect of fentanyl on the pups.
Danish: Disse virkninger kunne enten være indirekte effekter grundet ændret maternel omsorg og/eller nedsat ammefrekvens eller en direkte virkning af fentanyl på ungerne.
English: Titration in patients switching from other fentanyl containing products Due to different absorption profiles, switching must not be done at a 1:1 ratio.
Danish: Titrering hos patienter, der skifter fra andre produkter, der indeholder fentanyl På grund af forskellige absorptionsprofiler må der ikke skiftes i forholdet 1:1.
English: Your doctor will evaluate if you need medicine to reduce or eliminate the withdrawal symptoms.
Danish: Deres læge vil evaluere, om De behøver medicin til at reducere eller eliminere abstinenssymptomer.
English: Physicians should keep in mind the potential of abuse of fentanyl.
Danish: Lægen bør være opmærksom på risikoen for misbrug af fentanyl.
English: You should discuss with your doctor whether it is safe for you to drive, or operate machinery after taking Effentora.
Danish: De bør drøfte med Deres læge, hvorvidt det er sikkert for Dem at køre bil eller betjene maskiner, efter at De har taget Effentora.
English: Following the intravenous administration of fentanyl, less than 7% of the administered dose is excreted unchanged in the urine, and only about 1% is excreted unchanged in the faeces.
Danish: Efter intravenøs administration af fentanyl udskilles mindre end 7 % af den administrerede dosis uændret i urinen, og kun cirka 1 % udskilles uændret i fæces.
English: Any used or unused but no longer required medicinal product or waste material should be disposed of in accordance with local requirements.
Danish: Anvendt og ikke anvendt lægemiddel, som ikke længere behøves, samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: Pharmacotherapeutic group: analgesics; opioids; ATC code N02AB03.
Danish: Farmakoterapeutisk klassifikation: analgetika; opioider; ATC-kode: N02AB03.
English: • The tablet should be left between the cheek and gum until dissolved, which usually takes approximately 14 to 25 minutes.
Danish: • Tabletten bør blive liggende mellem gummen og kinden, indtil den er opløst, hvilket normalt tager cirka 14 til 25 minutter.
English: Not to be sucked, chewed or swallowed whole.
Danish: Må ikke suges/suttes på, tygges eller synkes hel.
English: • How to use EFFENTORA (how to take it, how to reach the effective dose during the titration process)?
Danish: • Sådan skal EFFENTORA bruges (hvordan tages præparatet, og hvordan nås den effektive dosis under titreringsprocessen)?
English: Your doctor will decide if your dose needs to be changed.
Danish: Deres læge vil tage stilling til, hvorvidt det er nødvendigt at ændre Deres dosis.
English: Effentora with food, drink and alcohol
Danish: Brug af Effentora sammen med mad, drikke og alkohol
English: • The risk of side effects increases if you are taking medicines such as certain antidepressants or antipsychotics.
Danish: • Risikoen for bivirkninger øges, hvis De tager medicin såsom visse former for medicin mod depression eller antipsykotiske midler.
English: Frequently, these will cease or decrease in intensity with continued use of the medicinal product, as the patient is titrated to the most appropriate dose.
Danish: Ofte ophører disse eller aftager i intensitet ved fortsat brug af lægemidlet, når medicinen er titreret til den rette dosis til patienten.
English: • Educational material for the patients
Danish: • Undervisningsmateriale til patienter
English: Aluminium laminated blister of PVC/Al foil/Polyamide/PVC with paper/polyester lidding.
Danish: Aluminiumlamineret blisterkort af PVC/aluminiumfolie/polyamid/PVC med papir/polyester lågmateriale.
English: Consult the Summary of Product Characteristics of the individual opioid antagonist for details about such use.
Danish: Der henvises til produktresumeet for den enkelte opioid-antagonist for nærmere oplysninger om sådan anvendelse.
English: Fentanyl concentrations obtained in serum were higher than in plasma: Serum AUC and Cmax were approximately 20% and 30% higher than plasma AUC and Cmax, respectively.
Danish: De koncentrationer af fentanyl, der blev opnået i serum var højere end koncentrationerne i plasma: Serum AUC og Cmax var henholdsvis cirka 20 % og 30 % højere end plasma AUC og Cmax.
English: • A serious side effect of Effentora is slow and/or shallow breathing.
Danish: • En alvorlig bivirkning fra Effentora er langsomt og/eller overfladisk åndedræt.
English: The duration of respiratory depression following overdose may be longer than the effects of the opioid antagonist's action (e.g., the half-life of naloxone ranges from 30 to 81 minutes) and repeated administration may be necessary.
Danish: Respirationsdepression efter overdosering kan vare længere end effekten af opioid-antagonisten (f.eks. er halveringstiden af naloxon mellem 30 og 81 minutter), og gentagen indgivelse kan være nødvendig.
English: Patients should be closely monitored for signs and symptoms of respiratory depression and sedation (see section 4.5).
Danish: Patienterne skal overvåges nøje for tegn og symptomer på respirationsdepression og sedation (se pkt.
English: Taking the medicine
Danish: Hvordan De tager medicinen
English: If it occurs, it should be managed by the use of assisted ventilation, by an opioid antagonist, and as a final alternative, by a neuromuscular blocking agent.
Danish: Skulle dette forekomme, bør det behandles ved brug af assisteret ventilation, med en opioid-antagonist og som det sidste alternativ med et neuromuskulært blokerende middel.
English: • disturbed or blurred vision, red eye
Danish: • forstyrret eller sløret syn, røde øjne
English: The metabolites are mainly excreted in the urine, while faecal excretion is less important.
Danish: Metabolitterne udskilles hovedsageligt i urinen, mens fækal udskillelse er mindre væsentlig.
English: • What is EFFENTORA for?
Danish: • Hvad er EFFENTORA beregnet til?
English: • Patients without maintenance opioid therapy as there is an increased risk of respiratory depression.
Danish: • Patienter der ikke modtager opioid-vedligeholdelsesbehandling, da der er øget risiko for respirationsdepression.
English: • delirium (symptoms may include a combination of agitation, restlessness, disorientation,
Danish: • delirium (symptomer kan omfatte en kombination af ophidselse, rastløshed, desorientering,
English: Opioids may obscure the clinical course of a patient with a head injury and should be used only if clinically warranted.
Danish: Opioider kan maskere det kliniske forløb hos en patient med en hovedlæsion og bør kun anvendes, hvis det er klinisk forsvarligt.
English: If you think someone has accidentally taken Effentora please seek immediate medical assistance.
Danish: Hvis De mener, at en anden person utilsigtet har taget Effentora, skal De omgående søge lægehjælp.
English: It is important you know how you react to Effentora before driving or operating machinery.
Danish: Det er vigtigt, at De ved, hvordan De reagerer på Effentora, inden De kører bil eller arbejder med maskiner.