natgillin/translations-raw huggingface dataset:
Patienter bør derfor spørge deres læge, om de må køre eller betjene maskiner. 
Therefore, patients should consult their physician as to whether driving or use of machines is permitted.
Fordeling Bindingen til plasmaproteiner er 84 %. 
Distribution The plasma protein binding for fentanyl is 84 %.
Dette gælder især i begyndelsen af behandlingen, ved hver dosisændring samt i forbindelse med alkohol eller sedativa. 
This has to be expected especially at the beginning of treatment, at any change of dosage as well as in connection with alcohol or tranquilizers.
Hvis der er behov for højere doser end 500 mg morphinækvivalent, anbefales det at revurdere opioidbehandlingen. 
If higher dosages than 500 mg morphine-equivalent are needed, a reassessment of opioid-therapy is recommended.
Patienter med myasthenia gravis 
Patients with myasthenia gravis
Albert-SchweitzerGasse 3, 1140 WIEN, Østrig 
Albert-SchweitzerGasse 3, 1140 WIEN, Austria
Hvis en sådan undersøgelse skulle udføres i EU, ville styrken 50 µg/time sædvanligvis blive anbefalet. 
As a general rule in EU, if such a study would have to be conducted, the 50 µg/h strength would be recommended.
- Plasteret skal sættes på umiddelbart efter, at pakningen åbnes. 
- The patch must be stuck on immediately after opening the package.
Huden skal være helt tør, før plasteret anbringes. 
The skin must be completely dry before applying the patch.
Hudreaktioner ved applikationsstedet. 
skin reactions on the application site.
Plasteret skal skiftes på samme tid af dagen hver tredje dag (efter 72 timer), med mindre lægen har givet andre anvisninger. 
You should change your patch at the same time of day every three days (every 72 hours), unless directed otherwise by your doctor.
Læs denne indlægsseddel grundigt, inden De begynder at bruge medicinen. 
Read all of this leaflet carefully before you start using this medicine.
Udendørs ophold i solen er tilladt, men Deres påklædning skal holde plasteret tildækket på varme sommerdage. 
It is allowed to stay outside in the sun, but you must protect the patch with some piece of clothing during hot summer days.
Intramuskulær administration giver en længere virkning end intravenøs administration. 
Intramuscular administration will give a more prolonged effect than intravenous administration.
Doseringen af fentanyl tilpasses individuelt og bør vurderes løbende efter hver administration. 
The required fentanyl dosage is adjusted individually and should be assessed regularly after each administration.
Patienter, der er stabiliseret med en specifik dosering, vil ikke nødvendigvis opleve sådanne begrænsninger. 
Patients stabilized on a specific dosage will not necessarily be restricted.
Præparatet bør udelukkende anvendes som led i en integreret smertebehandling i tilfælde, hvor der foreligger en fuldstændig vurdering af patienten såvel medicinsk som socialt og psykologisk. 
The product should be used only as part of an integrated treatment of pain in cases where the patient is adequately assessed medically, socially and psychologically.
I så fald anbefales ekstra pleje og observation af patienten. 
In such cases increased care and observation of the patient should be undertaken.
Undersøgelser med den højeste styrke vil derfor etisk og sikkerhedsmæssigt være problematiske, når al nødvendig information kan fås ved undersøgelser med depotplastre af lavere styrke. 
Therefore, due to ethical and safety reasons, it would be questionable to conduct studies with the highest strength when all necessary information could be derived from studies with lower patch strengths.
- Akutte eller postoperative smerter, da dosistitrering ikke kan udføres under kortvarig brug. 
- Acute or postoperative pain, since dosage titration is not possible during short-term use.
Området må ikke være bestrålet i forbindelse med strålebehandling. 
The body part must not have been irradiated in connection with radiation therapy.
Øget intrakranielt tryk 
Increased intracranial pressure
- hvis Deres centralnervesystem er alvorligt svækket, for eksempel på grund af en hjerneskade. 
- if your central nervous system is severely impaired, for instance by brain injury.
- Alvorlig svækkelse af centralnervesystemet. 
- Severe impairment of the central nervous system.
Yderligere eller alternative metoder til analgesi eller alternativ administration af opioider bør overvejes, når doseringen af Fentanyl-ratiopharm overstiger 300 mikrogram/time. 
Additional or alternative methods of analgesia or alternative administration of opioids should be considered when the Fentanyl-ratiopharm dose exceeds 300 micrograms/hour.
Tolerance og fysisk og psykologisk afhængighed kan opstå efter gentagen administration af opioider, men forekommer sjældent under behandling af cancersmerter. 
Tolerance and physical and psychological dependence may develop upon repeated administration of opioids, but is rare in treatment of cancer related pain.
Der kan dog gøres en undtagelse, hvis lægen udtrykkeligt har ordineret Fentanylratiopharm. 
An exception can be made if the doctor has expressly prescribed Fentanyl-ratiopharm.
Derimod holder obstipation ikke op, hvis behandlingen fortsættes. 
Constipation, on the other hand, does not stop if treatment continues.
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. 
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.
Langvarig brug af Fentanyl-ratiopharm kan give fysisk afhængighed. 
Prolonged use of Fentanyl-ratiopharm can cause physical dependence.
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. 
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.
Spørg Deres læge eller apotek til råds, før De bruger nogen form for medicin. 
Ask your doctor or pharmacist for advice before taking any medicine.
Hvis intravenøs administration ikke er muligt, kan naloxonhydrochlorid også gives intramuskulært eller subkutant. 
If intravenous administration is impossible, naloxone hydrochloride can also be given intramuscularly or subcutaneously.
Den indledende evaluering af den maksimale analgetiske virkning af Fentanyl-ratiopharm må ikke finde sted, før plasteret har været i brug i 24 timer. 
The initial evaluation of the maximum analgesic effect of Fentanyl-ratiopharm should not be made before the patch has been worn for 24 hours.
Mens De venter på lægen, skal De holde personen vågen ved at tale til vedkommende og af og til ruske i ham eller hende. 
While waiting for the doctor, keep the person awake by talking to or shaking her/him now and then.
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 %). 
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.
• sygdommens sværhedsgrad. 
• the degree of severity of the disorder.
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)". 
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)”.
De prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle undersøgelser af sikkerhedsfarmakologi, toksicitet efter gentagne doser og genotoksicitet. 
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity.
Vær særlig opmærksom på, om plasteret klæber ordentligt fast ved kanterne. 
Pay special attention to see that the patch sticks properly at the edges.
Til behandling af respirationsdepression skal der omgående træffes forholdsregler, der omfatter fjernelse af plasteret og fysisk eller verbal stimulering af patienten. 
For management of respiratory depression immediate countermeasures should be started, including removing the patch and physically or verbally stimulating the patient.
På den ydre emballage kan De skrive dato og tidspunkt for, hvornår De tog plasteret på. 
On the outer package you can write the date and time you applied the patch.
Feber/ekstern varmepåvirkning 
Patients with fever/external heat
Hvis dette forekommer, skal De fjerne plastrene og omgående tilkalde lægen. 
If this should occur - remove the patches and contact a doctor immediately.
BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM, STYRKER, INDGIVELSESVEJ, ANSØGERE OG INDEHAVERE AF MARKEDSFØRINGSTILLADELSER I MEDLEMSSTATERNE 
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
Brug af Fentanyl-ratiopharm sammen med mad og drikke 
Using Fentanyl-ratiopharm with food and drink
Forsigtighed er påkrævet ved behandling af patienter med myasthenia gravis. 
Caution should be exercised when treating patients with myasthenia gravis.
Langtidsbehandling under graviditet kan medføre abstinenssymptomer hos spædbarnet. 
Long-term treatment during pregnancy may cause withdrawal symptoms in the infant.
Hvis De samtidig tager medicin, der påvirker hjernens funktion, har De en større sandsynlighed for at få bivirkninger, især åndedrætsbesvær. 
If you take concomitantly medicines that affect brain function it is more likely that you'll have side effects especially difficulty in breathing.
Infusionshastigheden justeres i forhold til tidligere bolusinjektioner og den enkelte patients respons. 
The infusion rate should be adjusted according to previous bolus injections and the individual response of the patient.
Fentanyl-ratiopharm bør ikke anvendes til børn under 12 år, da der kun er begrænset erfaring med behandling af børn. 
Fentanyl-ratiopharm should not be administered to children under 12 years of age because there is limited experience of use in children.
Amblyopi. 
amblyopia.
Nødvendigheden af at udføre en bioækvivalensundersøgelse for den højeste styrke og en valid undersøgelse med gentagelser blev drøftet. 
The need to perform a bioequivalence study with the highest strength and a valid study with replicate design was discussed.
Dosis bør titreres individuelt, indtil der opnås analgetisk effekt. 
The dose should be titrated individually until analgesic efficacy is attained.
10 (rektalt) 
10 (rectal)
Brug ikke Fentanyl-ratiopharm efter den udløbsdato, der står på pakningen. 
Do not use Fentanyl-ratiopharm after the expiry date which is stated on the package.
Farmakoterapeutisk klassifikation: opioider; phenylpiperidin-derivater. ATC-kode: N02AB03 
Pharmacotherapeutic group: opioids; Phenylpiperidine derivatives, ATC code: N02AB03
Disse midler kan øge virkninger og bivirkninger af Fentanyl-ratiopharm. 
These medicines may increase the effects and side effects of Fentanyl-ratiopharm.
Fentanyls primære terapeutiske virkning er analgesi og sedation. 
Its principal therapeutic effects are analgesia and sedation.
Såvel den laveste virksomme fentanylkoncentration som koncentrationen, ved hvilken der opstår bivirkninger, øges i takt med stigende udvikling af tolerance. 
Both the lowest effective fentanyl concentration and the concentration causing adverse reactions will increase with the development of increasing tolerance.
Respirationsdepression, der skyldes en overdosis, kan vare længere end virkningen af opioidantagonisten. 
Respiratory depression due to overdose can persist longer than the effect of the opioid antagonist.
Til hver applikation vælges et nyt hudområde. 
A new skin area must be selected for each application.
Hvis der er spor af plasteret på huden, efter at det er taget af, kan de fjernes med rigeligt vand og sæbe. 
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.
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). 
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).
Tabel 2 og 3 må ikke anvendes ved skift fra fentanyl depotplastre til morphinbehandling. 
Tables 2 and 3 should not be used to switch from transdermal fentanyl to a morphine treatment.
Da risikoen for abstinenssymptomer er større, når behandlingen stoppes brat, må De aldrig selv stoppe behandlingen med Fentanyl-ratiopharm, men altid først konsultere lægen. 
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.
Hvis det er nødvendigt at seponere plasteret, bør det gradvist erstattes af andre opioider, idet der indledes med en lav dosis, som langsomt øges. 
If discontinuation of the patch is necessary, any replacement with other opioids should be gradual, starting at a low dose and increasing slowly.
Fentanyl må derfor ikke anvendes inden for 14 dage efter seponering af behandling med MAO-hæmmere. 
Therefore, fentanyl should not be used within 14 days after discontinuation of treatment with MAO-inhibitors.
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). 
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.
Plasteret bør skiftes efter 72 timer. 
The patch should be changed after 72 hours.
- Stedet, hvor plasteret anbringes, må ikke udsættes for varme fra ydre varmekilder (se "Vær særlig forsigtig med at anvende Fentanyl-ratiopharm"). 
- The patch application site should not be exposed to heat from external heat sources (see “Take special care with Fentanyl-ratiopharm”).
Som med alle potente opioider kan nogle patienter få respirationsdepression af Fentanyl-ratiopharm, og patienterne skal være under observation for denne virkning. 
As with all potent opioids some patients may experience respiratory depression with Fentanylratiopharm, and patients must be observed for this effect.
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. 
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.
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. 
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.
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). 
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)
Produktet kan altså anvendes af ammende mødre, men amning bør ophøre under brug af plasteret og 72 timer efter. 
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.
Efter administration af Fentanyl-ratiopharm absorberes fentanyl kontinuerligt gennem huden over 72 timer. 
Following administration of Fentanyl-ratiopharm, fentanyl is continuously absorbed through the skin over a period of 72 hours.
Ofte vil der være behov for afhjælpende behandling (se pkt. 
Corrective treatment may often be required (see section 4.8).
På grund af polymermatrixen og stoffets diffusion gennem hudlagene frigives fentanyl med relativt konstant hastighed. 
Due to the polymer matrix and the diffusion of fentanyl through the skin layers, the release rate remains relatively constant.
Mængden af analgetikaforbrug i de forudgående 24 timer bestemmes. 
The quantity of analgesics required over the last 24 hours should be determined.
Omkring 9 % af dosis genfindes i fæces hovedsageligt som metabolitter. 
About 9 % of the dose is recovered in the faeces, primarily as metabolites.
Omkring 75 % af fentanyl udskilles i urinen hovedsageligt som metabolitter, mens under 10 % udskilles som uomdannet aktivt stof. 
Around 75 % of fentanyl is excreted into the urine, mostly as metabolites, with less than 10 % as unchanged active substance.
Fentanyl hører til en gruppe af stærke smertestillende midler, der hedder opioider. 
Fentanyl is one of a group of strong painkillers called opioids.
Sedation, nervøsitet, manglende appetit. 
sedation, nervousness, loss of appetite.
Xerostomi, dyspepsi. 
xerostomia, dyspepsia.
Den alvorligste bivirkning ved fentanyl er respirationsdepression. 
The most serious undesirable effect of fentanyl is respiratory depression.
Før plasteret anbringes, vaskes huden omhyggeligt med rent vand (uden rensemiddel) og tørres godt. 
Prior to application, the skin should be carefully washed with clean water (no cleaning agents) and thoroughly dried.
Modermælk bør kasseres, hvis den er produceret under behandlingen eller inden for 72 timer efter fjernelse af det sidste plaster. 
Any breast milk produced during treatment or within 72 hours after the removal of the last patch should be discarded.
Det skyldes den gradvise stigning i fentanyls serumkoncentration i løbet af de første 24 timer efter applikation af plasteret. 
This is due to the gradual increase in serum fentanyl concentrations during the first 24 hours after application of the patch.
Sikker brug hos gravide kvinder er ikke fastlagt. 
Safe use during pregnancy has not been established.
Fentanyl metaboliseres til inaktive metabolitter i leveren, og patienter med leversygdom kan derfor have forsinket elimination. 
Fentanyl is metabolised to inactive metabolites in the liver, so patients with hepatic disease might have a delayed elimination.
Virkningen indtræffer i løbet af et døgn efter, at det første plaster sættes på, og plasterets virkning aftager gradvist, efter at det er fjernet. 
The effect is reached within 24 hours after the first patch has been applied and its effects fall gradually after the patch is removed.
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. 
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.
Der bør gå mindst 7 dage, før samme område af huden anvendes igen. 
At least 7 days should elapse before the same part is used again.
Fentanyl-ratiopharm er et lægemiddel, der kan være livsfarligt for børn. 
Fentanyl-ratiopharm is a medicinal product that could be life-threatening to children.
Under 10 % af fentanyl udskilles uomdannet via nyrerne, og til forskel fra morphin udskilles ingen kendte aktive metabolitter via nyrerne. 
Less than 10 % of fentanyl is excreted unchanged by the kidneys, and unlike morphine, there are no known active metabolites eliminated by the kidneys.
Fentanyl-ratiopharm anvendes til behandling af svære og langvarige smerter, der kun kan lindres tilstrækkeligt med stærke smertestillende midler. 
Fentanyl-ratiopharm is used for treatment of severe and long-lasting pain that can only adequately be managed with strong pain relievers.
Der kan også opstå fysisk afhængighed, og De kan få abstinenssymptomer, hvis De pludselig holder op med at anvende depotplastrene. 
Physical dependence may develop as well and you might experience withdrawal symptoms, if you do suddenly stop using the patches.
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. 
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.
Hovedmetabolitten norfentanyl er inaktiv. 
The major metabolite, norfentanyl, is inactive.
ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Transdermal anvendelse 
METHOD AND ROUTE(S) OF ADMINISTRATION Transdermal use
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. 
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.
Alle disse bivirkninger må forventes, og der bør derfor tages højde for dem, specielt obstipation, ved at optimere behandlingen. 
All of these effects can be expected and should, therefore, be anticipated in order to optimise treatment, especially constipation.
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 
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
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. 
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.
Avenida de Burgos 16D, 5º Planta, 28036 Madrid, Spanien 
Avenida de Burgos 16D, 5º Planta, 28036 Madrid, Spain
Derved øges eller forlænges såvel den terapeutiske virkning som bivirkningerne, hvilket kan medføre svær respirationsdepression. 
This may increase or prolong both the therapeutic effects and the adverse reactions, which may cause severe respiratory depression.
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. 
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.
Fentanyl-ratiopharm depotplaster må ikke anvendes til denne population. 
Fentanyl-ratiopharm should not be used in this population.
Respirationsdepression, apnø. 
respiratory depression, apnoea.