natgillin/translations-raw huggingface dataset:
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.
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.
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.
Hos patienter med eksisterende respirationsdepression bør fentanyl kun anvendes med forsigtighed og i en lavere dosis.
In patients with existing respiratory depression, fentanyl should only be used with caution and at a lower dose.
Hypertension, hypotension.
Uncommon: hypertension, hypotension.
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.
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.
BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSE FOR ÆNDRING AF PRODUKTRESUMÉET (-RESUMÉERNE), ETIKETTERINGEN OG INDLÆGSSEDLEN FREMLAGT AF EMEA
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY(IES) OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
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.
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.
Takykardi, bradykardi.
Uncommon: tachycardia, bradycardia.
Den analgetiske virkning holder sig i nogen tid, efter at depotplasteret fjernes.
The analgesic effect may persist for some time after removal of the transdermal patch.
- hvis De har smerter, som kun varer ved i kort tid, f.eks. efter en operation.
- if you suffer from pain which lasts only for a short period, e. g. after a surgical procedure.
Fra et klinisk synspunkt repræsenterer dette dog kun en mindre risiko for patienter i transdermal smertebehandling med fentanyl i sædvanlig dosis.
However, from the clinical point of view, this aspect represents only a minor risk for patients receiving transdermal fentanyl pain therapy in average doses.
Hvis De er meget længe om at skifte plasteret, bør De konsultere lægen, da De muligvis vil få behov for ekstra smertelindring.
If you are very late changing your patch then you should contact your doctor because you might need some extra painkillers.
Ældre og svækkede patienter kan have nedsat clearance af fentanyl, hvilket forlænger den terminale halveringstid.
Elderly and debilitated patients may have reduced clearance of fentanyl leading to prolonged terminal half life.
BIVIRKNINGER Fentanyl-ratiopharm kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
Like all medicines, Fentanyl-ratiopharm can cause side effects, although not everybody gets them.
Det er dog muligt, at De af og til får behov for ekstra smertemedicin.
However sometimes you may still need extra painkillers.
Når beskyttelseslaget er fjernet, anbringes plasteret ved at trykke det fast mod huden med håndfladen i ca. 30 sekunder for at sikre, at plasteret klæber godt fast til huden.
When the release liner has been removed, the patch is applied by pressing it firmly onto the skin with the palm of the hand for approximately 30 seconds to make sure that the patch sticks well to the skin.
Hos patienter med nedsat nyre- eller leverfunktion kan der ske forandringer i clearance af fentanyl på grund af ændringer i plasmaproteiner og metabolisk clearance, der fører til forhøjet serumkoncentration.
In patients with renal or hepatic impairment, clearance of fentanyl may be altered because of changes of plasma proteins and metabolic clearance resulting in increased serum concentrations.
Det mest almindelige tegn på en overdosis er besvær med at trække vejret.
The most common sign of overdose is reduced ability to breathe.
Der foreligger rapporter om abstinenssymptomer ved skift fra langtidsbehandling med morphin til transdermalt fentanyl til trods for tilstrækkelig analgetisk effekt.
Withdrawal symptoms have been reported when changing from long-term treatment with morphine to transdermal fentanyl despite adequate analgesic efficacy.
Plasteret bør skiftes hver 72. time.
The patch should be replaced every 72 hours.
Svingningerne i plasmakoncentrationerne mellem spidsværdi og minimumværdi er størst for referenceproduktet, men er ikke store.
The peak-to-trough fluctuations of plasma concentrations are higher with the reference product and are not of a high magnitude.
Til voksne anbefales en startdosis på 0,4-2 mg naloxonhydrochlorid i.v.
A starting dose of 0.4-2 mg naloxone hydrochloride i.v.
Det kan være nødvendigt at tilpasse plasterets styrke eller antallet af plastre til Deres reaktion.
According to your reaction the strength of the patch or the number of patches may need to be adjusted.
Plasterets applikationssted må ikke udsættes for varme fra eksterne varmekilder, fx sauna.
The patch application site should not be exposed to heat from external heat sources, e.g. sauna.
Efter første applikation af Fentanyl-ratiopharm øges serumkoncentrationen gradvist, idet den generelt udjævnes efter 12-24 timer, hvorefter den holder sig temmelig konstant i resten af den 72 timers applikationsperiode.
After the first application of Fentanyl-ratiopharm, serum fentanyl concentrations increase gradually, generally levelling off between 12 and 24 hours, and remaining relatively constant for the remainder of the 72-hour application period.
Fentanyl-ratiopharm fås i pakninger à 3, 5, 10 eller 20 depotplastre.
Fentanyl-ratiopharm is available in packs of 3, 5, 10 or 20 transdermal patches.
Behandling med Fentanyl-ratiopharm må kun indledes af en erfaren læge, der har kendskab til farmakokinetikken bag fentanyl depotplastre og risikoen for svær hypoventilation.
Treatment with Fentanyl-ratiopharm should only be initiated by an experienced physician familiar with the pharmacokinetics of fentanyl transdermal patches and the risk for severe hypoventilation.
Hvis De får en af de følgende alvorlige, meget sjældne bivirkninger, skal De afbryde behandlingen og omgående kontakte Deres læge eller tage på hospitalet: alvorlig respirationsdepression (svær åndenød, hvæsende åndedræt) eller fuldstændig blokering af fordøjelseskanalen (krampagtige smerter, opkastning, luft i maven (flatulens)).
If any of the following serious, very rare side effects occur your should discontinue treatment and immediately contact your doctor or visit a hospital: severe respiratory depression (severe breathlessness, rattling breath) or complete block of the digestion channel (convulsive pain, vomiting, flatulence).
Vedrørende anvendelse samtidig med andre opioider erkendes det, at der ved kombination af fentanyl med en partiel agonist/antagonist som buprenorphin, nalbuphin eller pentazocin for det første er risiko for nedsat analgetisk virkning på grund af kompetitive antagonistiske virkninger, for det andet for abstinenssyndrom, der ligeledes er en alvorlig tilstand.
Regarding the co-administration with other opioids, it is acknowledged that the risk of combining fentanyl with a mixed agonist/antagonist, like buprenorphine, nalbuphine and pentazocine, consists first in impaired analgesia, due to competitive antagonistic effects, and secondly in the onset of a withdrawal syndrome, which also represents a serious health concern.
- mulige sundhedsmæssige betænkeligheder i forbindelse med udvidelsen af den kliniske indikation - påvisning af bioækvivalens med referenceproduktet og - harmonisering af produktresuméet, etiketteringen og indlægssedlen,
- the scope of the referral was the potential public health concerns regarding the extension of the clinical indication - the demonstration of the bioequivalence with the reference product, - and the harmonisation of the Summary of Product Characteristics, labelling and package leaflet,
Reversering af fentanyls virkning kan medføre akutte smerter og frigivelse af katekolaminer.
Reversing the narcotic effect can give rise to acute pain and release of catecholamines.
OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON BOX
Kompositfolien indeholder følgende lag udefra og ind: overtrukket Kraft-papir, lavdensitets polyethylenfilm, aluminiumsfolie, Surlyn (termoplastisk ethylenmetha-acrylsyre copolymer).
The Composite foil containing the following layers from outside to inside: coated Kraft paper, low density polyethylene foil, aluminium foil, Surlyn (thermoplastic ethylene-methacrylic acid copolymer).
De må under ingen omstændigheder bruge en dobbeltdosis som erstatning for det glemte plaster.
Do not under any circumstances use a double dose.
Samtidig brug af barbitursyrederivater bør undgås, da fentanyls respirationsundertrykkende virkning derved kan øges.
The concomitant use of barbituric acid derivatives should be avoided, since the respiratory depressing effect of fentanyl may be increased.
Immunsystemet Meget sjældne:
Immune system disorders Very rare:
Dette er nødvendigt, fordi fentanylniveauet aftager gradvist, når plasteret fjernes, og det tager mindst 17 timer at få halveret fentanyls serumkoncentration.
This is because fentanyl levels fall gradually after the patch is removed; it takes at least 17 hours for the fentanyl serum concentration to decrease by 50 %.
Huden må ikke renses med alkohol eller andre opløsningsmidler, da de kan trænge ind i huden på grund af plasterets virkning.
No alcohol or other solvents must be used for cleaning, as these may penetrate the skin due to the effect of the patch.
Der kan opstå tilvænding og fysisk eller psykologisk afhængighed, hvis De bruger Fentanylratiopharm i længere tid.
Tolerance, physical or psychological dependence may develop if you use Fentanyl-ratiopharm for a longer period.
På grund af den betydning, som adækvat smertebehandling af moderen må tillægges, kan CHMP i overensstemmelse med "guideline on summary of product characteristics" tilslutte sig, at den forslåede tekst forbliver i pkt.
Because of the importance of an adequate pain management for the mother, the CHMP agrees, in accordance with the “guideline on summary of product characteristics”, that the proposed text stays in section 4.6 and should not be included as a contra-indication.
Hos patienter med kronisk obstruktiv lungesygdom eller andre sygdomme i lungerne kan fentanyl give mere alvorlige bivirkninger, og denne patientgruppen kan få nedsat respiratorisk drive og øget modstand i luftvejene.
In patients with chronic obstructive or other pulmonary diseases fentanyl may have more severe adverse reactions, in such patients opioids may decrease respiratory drive and increase airway resistance.
Fentanyl-ratiopharm bør anvendes med forsigtighed til patienter, som kan være særligt følsomme over for de intrakranielle virkninger af CO2-retention - fx patienter med dokumenteret øget intrakranielt tryk, nedsat bevidsthedsniveau eller koma.
Fentanyl-ratiopharm should be used with caution in patients who may be particularly susceptible to the intracranial effects of CO2 retention such as those with evidence of increased intracranial pressure, impaired consciousness or coma.
Indbringelsesproceduren i henhold til artikel 29, stk. 4, i direktiv 2001/83/EF vedrørte uenighed om følgende punkter: 1- Den påtænkte udvidelse af den terapeutiske indikation til andre svære kroniske smerter end cancersmerter 2- Hvilke(n) omregningstabel(ler), der skal indgå i produktresuméet 3- Hvorvidt amning og sideløbende brug af opioider af typen partielle agonister bør være kontraindiceret 4- Kravet om, at bioækvivalensundersøgelserne påviser ækvivalens med referenceproduktet
The points of disagreement leading to this referral procedure under Article 29(4) of Directive 2001/83/EC pertained to: 1- The therapeutic indication to be extended to non-cancer patients suffering of severe chronic pain 2- The choice of conversion tables(s) to be included in the SPC 3- Whether breast-feeding and co-administration with partial agonist opioids should be contraindicated 4- The bioequivalence studies needed to demonstrate the equivalence with the reference product
Det gælder for eksempel for: - ritonavir (til behandling af AIDS) - ketoconazol, itraconazol (til behandling af svamp) - diltiazem (til behandling af hjertesygdom) - cimetidin (til behandling af mave-tarmsygdom) - makrolidantibiotika (til behandling af infektioner)
This applies, for example, to: - ritonavir (used to treat AIDS) - ketoconazole, itraconazole (used to treat fungal diseases) - diltiazem (used to treat heart disease) - cimetidine (used to treat gastrointestinal diseases) - macrolide antibiotics (used to treat infections)
Incidensen af respirationsdepression stiger med stigende doser fentanyl.
The incidence of respiratory depression increases as the fentanyl dose is increased.
Lejlighedsvist kan der være behov for yderligere fastklæbning af plasteret.
Occasionally, additional adhesion of the patch may be required.
Der foreligger plastre med en frigivelseshastighed på 12,5 mikrogram i timen, som er egnet til dosistitrering i det lave dosisområde.
Patches with a release rate of 12.5 micrograms/hour are available and are appropriate for dose titration in the lower dosage area.
Hvis De har anvendt samme dosis Fentanyl-ratiopharm i længere tid, kan lægen give Dem grønt lys til at køre bil og betjene farlige maskiner.
If you have been using the same dose of Fentanyl-ratiopharm for a longer period of time, your doctor may decide that you are permitted to drive and use dangerous machines.
Symptomerne på toksicitet er dyb sedation, ataksi, miosis, kramper samt respirationsdepression, som er det væsentligste symptom.
Signs of toxicity are deep sedation, ataxia, miosis, convulsions and respiratory depression, which is the main symptom.
Vedrørende de i produktresuméet angivne tabeller til omregning af dosis fra oral morphin til fentanyl er det ud fra de foreliggende oplysninger CHMP's opfattelse, at begge tabeller bør være indeholdt i produktresuméet (pkt.
Regarding the dose conversion schemes provided in the SPC from oral morphine to transdermal fentanyl, the CHMP, based on the available data, is of the opinion that both tables should be mentioned in the SPC (section 4.2).
De må ikke tage de nedenfor nævnte lægemidler samtidig med, at De får Fentanyl-ratiopharm, med mindre De er under nøje lægetilsyn.
You should not take the medicines listed below at the same time as you are using Fentanylratiopharm, unless you are closely monitored by your doctor.
Behandlingens varighed
Duration of administration
Udslæt, erytem og pruritus går sædvanligvis væk i løbet af et døgns tid efter, at plasteret fjernes.
Rash, erythema and pruritus will usually disappear within one day after the patch has been removed.