FrancophonIA/ELRC3.0 huggingface dataset:
English: Inform your doctor if you develop a fever during the treatment, as the increased body temperature may cause too much medicine to pass through the skin.
Danish: De bør fortælle det til Deres læge, hvis De får feber under behandlingen, da forhøjet kropstemperatur kan bevirke, at for meget medicin passerer gennem huden.
English: Prolonged use of Fentanyl-ratiopharm can cause physical dependence.
Danish: Langvarig brug af Fentanyl-ratiopharm kan give fysisk afhængighed.
English: If you wish to interrupt or stop the treatment, you should always talk to your doctor about the reasons for discontinuation and your continued treatment.
Danish: Hvis De ønsker at afbryde eller stoppe behandlingen, skal De først tale med Deres læge om, hvorfor De vil holde op, og hvordan De kan blive behandlet fremover.
English: Ask your doctor or pharmacist for advice before taking any medicine.
Danish: Spørg Deres læge eller apotek til råds, før De bruger nogen form for medicin.
English: If intravenous administration is impossible, naloxone hydrochloride can also be given intramuscularly or subcutaneously.
Danish: Hvis intravenøs administration ikke er muligt, kan naloxonhydrochlorid også gives intramuskulært eller subkutant.
English: The initial evaluation of the maximum analgesic effect of Fentanyl-ratiopharm should not be made before the patch has been worn for 24 hours.
Danish: Den indledende evaluering af den maksimale analgetiske virkning af Fentanyl-ratiopharm må ikke finde sted, før plasteret har været i brug i 24 timer.
English: While waiting for the doctor, keep the person awake by talking to or shaking her/him now and then.
Danish: Mens De venter på lægen, skal De holde personen vågen ved at tale til vedkommende og af og til ruske i ham eller hende.
English: If needed, a similar dose can be given every 2 or 3 minutes, or be administered as continued infusion as 2 mg in 500 ml sodium chloride 9 mg/ml (0.9 %) solution for injection or glucose 50 mg/ml (5 %) solution.
Danish: Efter behov kan der gives en tilsvarende dosis hvert 2.-3. minut, eller der kan gives en kontinuerlig infusion af 2 mg i 500 ml isotonisk natriumchlorid injektionsvæske 9 mg/ml (0,9 %) eller isotonisk glucose 5 mg/ml (5 %).
English: • the degree of severity of the disorder.
Danish: • sygdommens sværhedsgrad.
English: Finally, regarding the demonstration of bioequivalence, the discussions pertained to the deviations to the guideline “Note for guidance on modified release oral and trans-dermal dosage forms: section II: pharmacokinetic and clinical evaluation- (CPMP/EWP/280/96)”.
Danish: Hvad endelig angår påvisning af bioækvivalens vedrørte drøftelserne afvigelserne fra guidelinen "Note for guidance on modified release oral and trans-dermal dosage forms: section II: pharmacokinetic and clinical evaluation (CPMP/EWP/280/96)".
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity.
Danish: De prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle undersøgelser af sikkerhedsfarmakologi, toksicitet efter gentagne doser og genotoksicitet.
English: Pay special attention to see that the patch sticks properly at the edges.
Danish: Vær særlig opmærksom på, om plasteret klæber ordentligt fast ved kanterne.
English: For management of respiratory depression immediate countermeasures should be started, including removing the patch and physically or verbally stimulating the patient.
Danish: Til behandling af respirationsdepression skal der omgående træffes forholdsregler, der omfatter fjernelse af plasteret og fysisk eller verbal stimulering af patienten.
English: On the outer package you can write the date and time you applied the patch.
Danish: På den ydre emballage kan De skrive dato og tidspunkt for, hvornår De tog plasteret på.
English: Patients with fever/external heat
Danish: Feber/ekstern varmepåvirkning
English: If this should occur - remove the patches and contact a doctor immediately.
Danish: Hvis dette forekommer, skal De fjerne plastrene og omgående tilkalde lægen.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM, STYRKER, INDGIVELSESVEJ, ANSØGERE OG INDEHAVERE AF MARKEDSFØRINGSTILLADELSER I MEDLEMSSTATERNE
English: Using Fentanyl-ratiopharm with food and drink
Danish: Brug af Fentanyl-ratiopharm sammen med mad og drikke
English: Caution should be exercised when treating patients with myasthenia gravis.
Danish: Forsigtighed er påkrævet ved behandling af patienter med myasthenia gravis.
English: Long-term treatment during pregnancy may cause withdrawal symptoms in the infant.
Danish: Langtidsbehandling under graviditet kan medføre abstinenssymptomer hos spædbarnet.
English: If you take concomitantly medicines that affect brain function it is more likely that you'll have side effects especially difficulty in breathing.
Danish: Hvis De samtidig tager medicin, der påvirker hjernens funktion, har De en større sandsynlighed for at få bivirkninger, især åndedrætsbesvær.
English: The infusion rate should be adjusted according to previous bolus injections and the individual response of the patient.
Danish: Infusionshastigheden justeres i forhold til tidligere bolusinjektioner og den enkelte patients respons.
English: Fentanyl-ratiopharm should not be administered to children under 12 years of age because there is limited experience of use in children.
Danish: Fentanyl-ratiopharm bør ikke anvendes til børn under 12 år, da der kun er begrænset erfaring med behandling af børn.
English: amblyopia.
Danish: Amblyopi.
English: The need to perform a bioequivalence study with the highest strength and a valid study with replicate design was discussed.
Danish: Nødvendigheden af at udføre en bioækvivalensundersøgelse for den højeste styrke og en valid undersøgelse med gentagelser blev drøftet.
English: The dose should be titrated individually until analgesic efficacy is attained.
Danish: Dosis bør titreres individuelt, indtil der opnås analgetisk effekt.
English: 10 (rectal)
Danish: 10 (rektalt)
English: Do not use Fentanyl-ratiopharm after the expiry date which is stated on the package.
Danish: Brug ikke Fentanyl-ratiopharm efter den udløbsdato, der står på pakningen.
English: Pharmacotherapeutic group: opioids; Phenylpiperidine derivatives, ATC code: N02AB03
Danish: Farmakoterapeutisk klassifikation: opioider; phenylpiperidin-derivater. ATC-kode: N02AB03
English: These medicines may increase the effects and side effects of Fentanyl-ratiopharm.
Danish: Disse midler kan øge virkninger og bivirkninger af Fentanyl-ratiopharm.
English: Its principal therapeutic effects are analgesia and sedation.
Danish: Fentanyls primære terapeutiske virkning er analgesi og sedation.
English: Both the lowest effective fentanyl concentration and the concentration causing adverse reactions will increase with the development of increasing tolerance.
Danish: Såvel den laveste virksomme fentanylkoncentration som koncentrationen, ved hvilken der opstår bivirkninger, øges i takt med stigende udvikling af tolerance.
English: Respiratory depression due to overdose can persist longer than the effect of the opioid antagonist.
Danish: Respirationsdepression, der skyldes en overdosis, kan vare længere end virkningen af opioidantagonisten.
English: A new skin area must be selected for each application.
Danish: Til hver applikation vælges et nyt hudområde.
English: If traces of the transdermal patch remain on the skin after its removal, these can be cleaned off using copious amounts of soap and water.
Danish: Hvis der er spor af plasteret på huden, efter at det er taget af, kan de fjernes med rigeligt vand og sæbe.
English: The CHMP considered also that bioequivalence between test and reference medicinal product has been sufficiently characterised in 2 studies (single and multiple dose) performed with a reduced patch size (7.5 cm²).
Danish: CHMP fandt også bioækvivalensen mellem testproduktet og referenceproduktet tilstrækkelig velkarakteriseret i de to undersøgelser (med enkeltdosering og gentagen dosering), hvor der blev anvendt en reduceret plasterstørrelse (7,5 cm²).
English: Tables 2 and 3 should not be used to switch from transdermal fentanyl to a morphine treatment.
Danish: Tabel 2 og 3 må ikke anvendes ved skift fra fentanyl depotplastre til morphinbehandling.
English: As the risk of withdrawal symptoms is greater when the treatment is stopped suddenly, you should never stop treatment with Fentanyl-ratiopharm independently but always consult your doctor first.
Danish: Da risikoen for abstinenssymptomer er større, når behandlingen stoppes brat, må De aldrig selv stoppe behandlingen med Fentanyl-ratiopharm, men altid først konsultere lægen.
English: If discontinuation of the patch is necessary, any replacement with other opioids should be gradual, starting at a low dose and increasing slowly.
Danish: Hvis det er nødvendigt at seponere plasteret, bør det gradvist erstattes af andre opioider, idet der indledes med en lav dosis, som langsomt øges.
English: Therefore, fentanyl should not be used within 14 days after discontinuation of treatment with MAO-inhibitors.
Danish: Fentanyl må derfor ikke anvendes inden for 14 dage efter seponering af behandling med MAO-hæmmere.
English: The demonstration of bioequivalence with the lowest strength was questioned, as in the results, a higher initial input is suggested for the reference reservoir patch (comparatively to the test patch) and a lower final input (at the end of the patch application) is evidenced.
Danish: Påvisningen af bioækvivalens for den laveste styrke blev draget i tvivl, da resultaterne peger på større initial afgivelse fra referencedepotplasteret (end fra det afprøvede plaster), og da der ses lavere slutafgivelse (ved slutningen af plasterets applikationsperiode).
English: The patch should be changed after 72 hours.
Danish: Plasteret bør skiftes efter 72 timer.
English: - The patch application site should not be exposed to heat from external heat sources (see “Take special care with Fentanyl-ratiopharm”).
Danish: - Stedet, hvor plasteret anbringes, må ikke udsættes for varme fra ydre varmekilder (se "Vær særlig forsigtig med at anvende Fentanyl-ratiopharm").
English: As with all potent opioids some patients may experience respiratory depression with Fentanylratiopharm, and patients must be observed for this effect.
Danish: Som med alle potente opioider kan nogle patienter få respirationsdepression af Fentanyl-ratiopharm, og patienterne skal være under observation for denne virkning.
English: Please tell your doctor if you are taking MAO inhibitors (e.g. moclobemide against depression or selegiline against Parkinson's disease) or have taken them within the last 14 days.
Danish: Fortæl det til lægen, hvis De får MAO-hæmmere (gruppe af midler mod depression, f.eks. moclobemid mod depression eller selegilin mod Parkinsons sygdom) eller har fået sådanne midler inden for de seneste 14 dage.
English: For the same reason you should avoid exposing the patch on the skin to direct heat such as electric blankets, hot-water bottles, sauna, solarium or hot baths.
Danish: Af samme grund skal De passe på, at plasteret på huden ikke udsættes for direkte varme fra elektriske tæpper, varmedunke, sauna, solarium eller varme bade.
English: The following frequencies are used for the description of the occurrence of adverse reactions: Very common (≥1/10), Common (≥1/100, <1/10), Uncommon (≥1/1000, <1/100), Rare (≥1/10,000, <1/1000), Very rare (<1/10,000)
Danish: Meget almindelige (>1/10), almindelige (≥1/100 til <1/10), ikke almindelige (≥1/1.000 til <1/100), sjældne (≥1/10.000 til <1/1.000) og meget sjældne (<1/10.000).
English: This means that it is possible to give the product to nursing mothers, but breast-feeding has to be discontinued during the use of fentanyl patches and 72 hours thereafter.
Danish: Produktet kan altså anvendes af ammende mødre, men amning bør ophøre under brug af plasteret og 72 timer efter.
English: Following administration of Fentanyl-ratiopharm, fentanyl is continuously absorbed through the skin over a period of 72 hours.
Danish: Efter administration af Fentanyl-ratiopharm absorberes fentanyl kontinuerligt gennem huden over 72 timer.
English: Corrective treatment may often be required (see section 4.8).
Danish: Ofte vil der være behov for afhjælpende behandling (se pkt.
English: Due to the polymer matrix and the diffusion of fentanyl through the skin layers, the release rate remains relatively constant.
Danish: På grund af polymermatrixen og stoffets diffusion gennem hudlagene frigives fentanyl med relativt konstant hastighed.
English: The quantity of analgesics required over the last 24 hours should be determined.
Danish: Mængden af analgetikaforbrug i de forudgående 24 timer bestemmes.
English: About 9 % of the dose is recovered in the faeces, primarily as metabolites.
Danish: Omkring 9 % af dosis genfindes i fæces hovedsageligt som metabolitter.
English: Around 75 % of fentanyl is excreted into the urine, mostly as metabolites, with less than 10 % as unchanged active substance.
Danish: Omkring 75 % af fentanyl udskilles i urinen hovedsageligt som metabolitter, mens under 10 % udskilles som uomdannet aktivt stof.
English: Fentanyl is one of a group of strong painkillers called opioids.
Danish: Fentanyl hører til en gruppe af stærke smertestillende midler, der hedder opioider.
English: sedation, nervousness, loss of appetite.
Danish: Sedation, nervøsitet, manglende appetit.
English: xerostomia, dyspepsia.
Danish: Xerostomi, dyspepsi.
English: The most serious undesirable effect of fentanyl is respiratory depression.
Danish: Den alvorligste bivirkning ved fentanyl er respirationsdepression.
English: Prior to application, the skin should be carefully washed with clean water (no cleaning agents) and thoroughly dried.
Danish: Før plasteret anbringes, vaskes huden omhyggeligt med rent vand (uden rensemiddel) og tørres godt.
English: Any breast milk produced during treatment or within 72 hours after the removal of the last patch should be discarded.
Danish: Modermælk bør kasseres, hvis den er produceret under behandlingen eller inden for 72 timer efter fjernelse af det sidste plaster.
English: This is due to the gradual increase in serum fentanyl concentrations during the first 24 hours after application of the patch.
Danish: Det skyldes den gradvise stigning i fentanyls serumkoncentration i løbet af de første 24 timer efter applikation af plasteret.
English: Safe use during pregnancy has not been established.
Danish: Sikker brug hos gravide kvinder er ikke fastlagt.
English: Fentanyl is metabolised to inactive metabolites in the liver, so patients with hepatic disease might have a delayed elimination.
Danish: Fentanyl metaboliseres til inaktive metabolitter i leveren, og patienter med leversygdom kan derfor have forsinket elimination.
English: The effect is reached within 24 hours after the first patch has been applied and its effects fall gradually after the patch is removed.
Danish: Virkningen indtræffer i løbet af et døgn efter, at det første plaster sættes på, og plasterets virkning aftager gradvist, efter at det er fjernet.
English: If an earlier change becomes necessary in individual cases, no change should be made before 48 hours have elapsed, otherwise a rise in mean fentanyl concentrations may occur.
Danish: Hvis der i enkelte tilfælde er behov for at skifte det tidligere, bør det ikke gøres, før der er gået mindst 48 timer, da den gennemsnitlige koncentration af fentanyl ellers kan stige.
English: At least 7 days should elapse before the same part is used again.
Danish: Der bør gå mindst 7 dage, før samme område af huden anvendes igen.
English: Fentanyl-ratiopharm is a medicinal product that could be life-threatening to children.
Danish: Fentanyl-ratiopharm er et lægemiddel, der kan være livsfarligt for børn.
English: Less than 10 % of fentanyl is excreted unchanged by the kidneys, and unlike morphine, there are no known active metabolites eliminated by the kidneys.
Danish: Under 10 % af fentanyl udskilles uomdannet via nyrerne, og til forskel fra morphin udskilles ingen kendte aktive metabolitter via nyrerne.
English: Fentanyl-ratiopharm is used for treatment of severe and long-lasting pain that can only adequately be managed with strong pain relievers.
Danish: Fentanyl-ratiopharm anvendes til behandling af svære og langvarige smerter, der kun kan lindres tilstrækkeligt med stærke smertestillende midler.
English: Physical dependence may develop as well and you might experience withdrawal symptoms, if you do suddenly stop using the patches.
Danish: Der kan også opstå fysisk afhængighed, og De kan få abstinenssymptomer, hvis De pludselig holder op med at anvende depotplastrene.
English: Furthermore, a study at the highest dose (100 µg/h) would be possible only in intensive care units and under concomitant treatment with opioid antagonists (naltrexone) in order to avoid life threatening side effects.
Danish: En undersøgelse, hvor der anvendes den højeste dosis (100 µg i timen), vil desuden kun kunne gennemføres på intensivafdelinger og vil kræve sideløbende behandling med opioidantagonister (naltrexon) for at undgå livstruende bivirkninger.
English: The major metabolite, norfentanyl, is inactive.
Danish: Hovedmetabolitten norfentanyl er inaktiv.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Transdermal use
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Transdermal anvendelse
English: Additional dose adjustment should normally be performed in 25 micrograms/hour increments, although the supplementary analgesic requirements and pain status of the patient should be taken into account.
Danish: Yderligere dosisjustering bør normalt foretages med dosisintervaller på 25 mikrogram i timen, idet der dog bør tages højde for patientens behov for yderligere analgesi og smertestatus.
English: All of these effects can be expected and should, therefore, be anticipated in order to optimise treatment, especially constipation.
Danish: Alle disse bivirkninger må forventes, og der bør derfor tages højde for dem, specielt obstipation, ved at optimere behandlingen.
English: Common less than 1 in 10, but more than 1 in 100 patients Uncommon less than 1 in 100, but more than 1 in 1000 patients Rare less than 1 in 1000, but more than 1 in 10,000 patients Very rare less than 1 in 10,000 patients, including isolated reports
Danish: Bivirkningerne opdeles efter hyppighed: Meget almindelige hos flere end 1 ud af 10 patienter Almindelige hos færre end 1 ud af 10, men flere end 1 ud af 100 patienter Ikke almindelige hos færre end 1 ud af 100, men flere end 1 ud af 1000 patienter Sjældne hos færre end 1 ud af 1000, men flere end 1 ud af 10.000 patienter
English: If you are an elderly patient or if you are in a very bad physical condition (cachectic) your doctor will monitor you more carefully, because it may be necessary to prescribe a lower dose.
Danish: Hvis De er oppe i årene eller i meget dårlig fysisk form (kakektisk), vil lægen følge Dem nøje, da det kan være nødvendigt at give Dem en lavere dosis.
English: Avenida de Burgos 16D, 5º Planta, 28036 Madrid, Spain
Danish: Avenida de Burgos 16D, 5º Planta, 28036 Madrid, Spanien
English: This may increase or prolong both the therapeutic effects and the adverse reactions, which may cause severe respiratory depression.
Danish: Derved øges eller forlænges såvel den terapeutiske virkning som bivirkningerne, hvilket kan medføre svær respirationsdepression.
English: The small differences observed are not deemed to be of clinical importance and suggests that Fentanyl ratiopharm has a somewhat more pronounced prolonged release profile, which is as expected for a matrix patch in comparison with a reservoir patch.
Danish: De iagttagne små forskelle anses ikke for at have klinisk betydning og tyder på, at Fentanyl "ratiopharm" har en noget mere udtalt depotvirkning, hvilket da også er forventeligt for et matrixplaster i forhold til et reservoirplaster.
English: Fentanyl-ratiopharm should not be used in this population.
Danish: Fentanyl-ratiopharm depotplaster må ikke anvendes til denne population.
English: respiratory depression, apnoea.
Danish: Respirationsdepression, apnø.
English: When treatment with Fentanyl-ratiopharm is withdrawn, serum fentanyl concentrations decline gradually, falling approximately 50 % in 13-22 hours in adults or 22-25 hours in children, respectively.
Danish: Efter afbrydelse af behandlingen med fentanyl depotplastre aftager serumkoncentrationen af fentanyl gradvist med ca. 50 % i løbet af henholdsvis 13-22 timer hos voksne og 22-25 timer hos børn.
English: In patients with existing respiratory depression, fentanyl should only be used with caution and at a lower dose.
Danish: Hos patienter med eksisterende respirationsdepression bør fentanyl kun anvendes med forsigtighed og i en lavere dosis.
English: Uncommon: hypertension, hypotension.
Danish: Hypertension, hypotension.
English: The CHMP considers that the criteria of the guideline on transdermal dosage formsCPMP/EWP/280/96- (i.e. exact proportionality of the formulation and acceptable in vitro release test) were met with the fentanyl ratiopharm transdermal patch as well as with the reference medicinal product.
Danish: CHMP finder, at kriterierne i guidelinen for transdermale doseringsformer − CPMP/EWP/280/96(dvs. eksakt proportionalitet af formuleringen og acceptabel in vitro-udløsningsprøve) opfyldes både af Fentanyl "ratiopharm" og af referenceproduktet.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY(IES) OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
Danish: BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSE FOR ÆNDRING AF PRODUKTRESUMÉET (-RESUMÉERNE), ETIKETTERINGEN OG INDLÆGSSEDLEN FREMLAGT AF EMEA
English: Studies have shown that almost all patients, despite treatment with a fentanyl patch, require supplemental treatment with potent rapid-release medicinal products to arrest breakthrough pain.
Danish: I undersøgelser har det vist sig, at næsten alle patienter til trods for behandling med et fentanylplaster fik behov for supplerende behandling med stærkt virkende lægemidler med konventionel udløsning til at standse gennembrudssmerter.
English: Uncommon: tachycardia, bradycardia.
Danish: Takykardi, bradykardi.
English: The analgesic effect may persist for some time after removal of the transdermal patch.
Danish: Den analgetiske virkning holder sig i nogen tid, efter at depotplasteret fjernes.
English: - if you suffer from pain which lasts only for a short period, e. g. after a surgical procedure.
Danish: - hvis De har smerter, som kun varer ved i kort tid, f.eks. efter en operation.
English: However, from the clinical point of view, this aspect represents only a minor risk for patients receiving transdermal fentanyl pain therapy in average doses.
Danish: Fra et klinisk synspunkt repræsenterer dette dog kun en mindre risiko for patienter i transdermal smertebehandling med fentanyl i sædvanlig dosis.
English: If you are very late changing your patch then you should contact your doctor because you might need some extra painkillers.
Danish: Hvis De er meget længe om at skifte plasteret, bør De konsultere lægen, da De muligvis vil få behov for ekstra smertelindring.
English: Elderly and debilitated patients may have reduced clearance of fentanyl leading to prolonged terminal half life.
Danish: Ældre og svækkede patienter kan have nedsat clearance af fentanyl, hvilket forlænger den terminale halveringstid.
English: Like all medicines, Fentanyl-ratiopharm can cause side effects, although not everybody gets them.
Danish: BIVIRKNINGER Fentanyl-ratiopharm kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: However sometimes you may still need extra painkillers.
Danish: Det er dog muligt, at De af og til får behov for ekstra smertemedicin.