FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: The most common sign of overdose is reduced ability to breathe.
Danish: Det mest almindelige tegn på en overdosis er besvær med at trække vejret.
English: Withdrawal symptoms have been reported when changing from long-term treatment with morphine to transdermal fentanyl despite adequate analgesic efficacy.
Danish: Der foreligger rapporter om abstinenssymptomer ved skift fra langtidsbehandling med morphin til transdermalt fentanyl til trods for tilstrækkelig analgetisk effekt.
English: The patch should be replaced every 72 hours.
Danish: Plasteret bør skiftes hver 72. time.
English: The peak-to-trough fluctuations of plasma concentrations are higher with the reference product and are not of a high magnitude.
Danish: Svingningerne i plasmakoncentrationerne mellem spidsværdi og minimumværdi er størst for referenceproduktet, men er ikke store.
English: A starting dose of 0.4-2 mg naloxone hydrochloride i.v.
Danish: Til voksne anbefales en startdosis på 0,4-2 mg naloxonhydrochlorid i.v.
English: According to your reaction the strength of the patch or the number of patches may need to be adjusted.
Danish: Det kan være nødvendigt at tilpasse plasterets styrke eller antallet af plastre til Deres reaktion.
English: The patch application site should not be exposed to heat from external heat sources, e.g. sauna.
Danish: Plasterets applikationssted må ikke udsættes for varme fra eksterne varmekilder, fx sauna.
English: 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.
Danish: 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.
English: Fentanyl-ratiopharm is available in packs of 3, 5, 10 or 20 transdermal patches.
Danish: Fentanyl-ratiopharm fås i pakninger à 3, 5, 10 eller 20 depotplastre.
English: 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.
Danish: Behandling med Fentanyl-ratiopharm må kun indledes af en erfaren læge, der har kendskab til farmakokinetikken bag fentanyl depotplastre og risikoen for svær hypoventilation.
English: 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).
Danish: 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)).
English: 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.
Danish: 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.
English: - 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,
Danish: - mulige sundhedsmæssige betænkeligheder i forbindelse med udvidelsen af den kliniske indikation - påvisning af bioækvivalens med referenceproduktet og - harmonisering af produktresuméet, etiketteringen og indlægssedlen,
English: Reversing the narcotic effect can give rise to acute pain and release of catecholamines.
Danish: Reversering af fentanyls virkning kan medføre akutte smerter og frigivelse af katekolaminer.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON BOX
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE
English: 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).
Danish: Kompositfolien indeholder følgende lag udefra og ind: overtrukket Kraft-papir, lavdensitets polyethylenfilm, aluminiumsfolie, Surlyn (termoplastisk ethylenmetha-acrylsyre copolymer).
English: Do not under any circumstances use a double dose.
Danish: De må under ingen omstændigheder bruge en dobbeltdosis som erstatning for det glemte plaster.
English: The concomitant use of barbituric acid derivatives should be avoided, since the respiratory depressing effect of fentanyl may be increased.
Danish: Samtidig brug af barbitursyrederivater bør undgås, da fentanyls respirationsundertrykkende virkning derved kan øges.
English: Immune system disorders Very rare:
Danish: Immunsystemet Meget sjældne:
English: 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 %.
Danish: Dette er nødvendigt, fordi fentanylniveauet aftager gradvist, når plasteret fjernes, og det tager mindst 17 timer at få halveret fentanyls serumkoncentration.
English: No alcohol or other solvents must be used for cleaning, as these may penetrate the skin due to the effect of the patch.
Danish: Huden må ikke renses med alkohol eller andre opløsningsmidler, da de kan trænge ind i huden på grund af plasterets virkning.
English: Tolerance, physical or psychological dependence may develop if you use Fentanyl-ratiopharm for a longer period.
Danish: Der kan opstå tilvænding og fysisk eller psykologisk afhængighed, hvis De bruger Fentanylratiopharm i længere tid.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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
Danish: 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
English: 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)
Danish: 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)
English: The incidence of respiratory depression increases as the fentanyl dose is increased.
Danish: Incidensen af respirationsdepression stiger med stigende doser fentanyl.
English: Occasionally, additional adhesion of the patch may be required.
Danish: Lejlighedsvist kan der være behov for yderligere fastklæbning af plasteret.
English: Patches with a release rate of 12.5 micrograms/hour are available and are appropriate for dose titration in the lower dosage area.
Danish: Der foreligger plastre med en frigivelseshastighed på 12,5 mikrogram i timen, som er egnet til dosistitrering i det lave dosisområde.
English: 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.
Danish: 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.
English: Signs of toxicity are deep sedation, ataxia, miosis, convulsions and respiratory depression, which is the main symptom.
Danish: Symptomerne på toksicitet er dyb sedation, ataksi, miosis, kramper samt respirationsdepression, som er det væsentligste symptom.
English: 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).
Danish: 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.
English: 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.
Danish: De må ikke tage de nedenfor nævnte lægemidler samtidig med, at De får Fentanyl-ratiopharm, med mindre De er under nøje lægetilsyn.
English: Duration of administration
Danish: Behandlingens varighed
English: Rash, erythema and pruritus will usually disappear within one day after the patch has been removed.
Danish: Udslæt, erytem og pruritus går sædvanligvis væk i løbet af et døgns tid efter, at plasteret fjernes.
English: Patients may require periodic supplemental doses of a short-acting analgesic for breakthrough pain.
Danish: Lejlighedsvis kan patienten få behov for supplerende doser af et kortvirkende analgetikum mod gennembrudssmerter.
English: Simultaneous use of Fentanyl-ratiopharm and alcoholic beverages increases the risk of severe adverse reactions, and may cause breathing difficulties, a fall of blood pressure, profound sedation and coma.
Danish: Samtidig brug af Fentanyl-ratiopharm og alkoholiske drikke øger risikoen for svære bivirkninger og kan give åndedrætsbesvær, blodtryksfald, kraftig bedøvelse og koma.
English: Please tell your doctor if you use barbiturates (used for treating sleep disorders), buprenorphine, nalbuphine or pentazocine (other strong painkillers).
Danish: Fortæl det til lægen, hvis De får barbiturater (medicin mod søvnforstyrrelser), buprenorphin, nalbuphin eller pentazocin (andre stærke smertestillende midler).
English: The patches should not be cut into smaller parts, because the quality, efficacy and safety of such divided patches have not been demonstrated.
Danish: Plastrene må ikke klippes over, da kvalitet, virkning og sikkerhed af mindre stykker ikke kendes.
English: The safety of fentanyl in pregnancy has not been established.
Danish: Fentanyls sikkerhed under graviditet er ikke fastlagt.
English: General disorders and administration site conditions Rare:
Danish: Almene symptomer og reaktioner på administrationsstedet Sjældne:
English: The transdermal patch should not be cut, since no information is available on the quality, efficacy and safety of such divided patches.
Danish: Depotplastret må ikke klippes over, da der ikke er kendskab til kvalitet, virkning og sikkerhed af plastre, der deles i flere stykker.
English: Polyethylene terephthalate foil (siliconised)
Danish: Polyethylenterephthalatfolie (silikonebehandlet)
English: Fentanyl, a high clearance active substance, is rapidly and extensively metabolised mainly by CYP3A4.
Danish: Fentanyl er et aktivt stof med høj clearance, som metaboliseres hurtigt og i omfattende grad, hovedsageligt via CYP3A4.
English: Uncommon: euphoria, amnesia, insomnia, hallucinations, agitation.
Danish: Eufori, amnesi, insomni, hallucinationer, agitation.
English: Fentanyl-ratiopharm should not be used during pregnancy and breast-feeding unless clearly necessary.
Danish: Fentanyl ratiopharm depotplaster må ikke anvendes under graviditet og amning, med mindre det er klart nødvendigt.
English: They have high affinity to opioid receptors with relatively low intrinsic activity and therefore partially antagonise the analgesic effect of fentanyl and may induce withdrawal symptoms in opioid dependant patients (see also section 4.4).
Danish: Disse lægemidler har høj affinitet til opioidreceptorer med relativt lav naturlig aktivitet, hvorfor de delvist modvirker fentanyls analgetiske virkning og kan udløse abstinenssymptomer hos opioidafhængige patienter (se også pkt.
English: Animal studies have shown reduced fertility and increased mortality in rat foetuses.
Danish: Nedsat fertilitet og øget mortalitet hos rottefostre er forekommet i dyreforsøg.
English: What Fentanyl-ratiopharm is and what it is used for Before you use Fentanyl-ratiopharm How to use Fentanyl-ratiopharm Possible side effects
Danish: Fentanyl-ratiopharms virkning og hvad De skal bruge det til Det skal De vide, før De begynder at bruge Fentanyl-ratiopharm Sådan skal De bruge Fentanyl-ratiopharm Bivirkninger
English: Fentanyl should only be used during pregnancy when clearly necessary.
Danish: Fentanyl bør kun anvendes på tvingende indikation under graviditet.
English: After this, the Fentanyl-ratiopharm should help to relieve pain continuously and you should be able to stop taking these extra painkillers.
Danish: Derefter skulle Fentanyl-ratiopharm give løbende smertelindring, og De skulle kunne holde op med at tage ekstra smertemedicin.
English: Fentanyl is an opioid analgesic which interacts predominantly with the µ-receptor.
Danish: Fentanyl er et opioidanalgetikum, der overvejende påvirker µ-receptoren.
English: In patients who experience a marked decrease in the period 48-72 hours after application, replacement of fentanyl after 48 hours may be necessary.
Danish: Det kan være nødvendigt at skifte depotplasteret efter 48 timer hos patienter, som oplever et markant fald 48-72 timer efter applikation.
English: However, studies of fentanyl transdermal patch in elderly patients demonstrated fentanyl pharmacokinetics which did not differ significantly from young patients although serum concentrations tended to be higher.
Danish: Ifølge undersøgelser af depotplastre med fentanyl hos ældre er fentanyls farmakokinetik dog ikke signifikant anderledes hos denne patientgruppe end hos yngre patienter, om end der er en tendens til højere serumkoncentrationer.
English: A period of 7 days should be allowed to elapse before applying a new patch to the same area of skin.
Danish: Der bør gå 7 dage, før et nyt plaster anbringes på det samme hudområde.
English: Cardiac disease
Danish: Kardielle lidelser
English: ataxia, seizures (including clonic and grand mal seizures).
Danish: Ataksi, epileptiske anfald (inklusive kloniske og tonisk-kloniske krampeanfald).
English: For all practical purposes by the second 72-hour application, a steady state serum concentration is reached and is maintained during subsequent applications of a patch of the same size.
Danish: I praksis nås steady-state serumkoncentration ved den anden applikation af et 72-timers plaster og opretholdes under de efterfølgende applikationer af plastre med samme størrelse.
English: The dosing is individual and based on the patient's opioid history and takes into account:
Danish: Doseringen individualiseres ud fra den enkelte patients tidligere opioidbehandling under hensyntagen til
English: Other side effects
Danish: Andre bivirkninger:
English: In this context, the CHMP accepted the indication “Severe chronic pain which can be adequately managed only with opioid analgesics”.
Danish: I denne forbindelse godtog CHMP indikationen "Svære kroniske smerter, hvor kun opioidanalgetika har tilfredsstillende virkning".
English: If the skin needs washing, wash with water.
Danish: Huden kan evt. vaskes med vand.
English: In addition, the CHMP recommends including the following information in section 4.4 of the SPC:
Danish: Desuden anbefaler CHMP følgende oplysninger medtaget i pkt.
English: Increased plasma concentrations were, however, observed in individual subjects.
Danish: Hos enkelte forsøgspersoner sås dog forhøjet plasmakoncentration.
English: After exhibiting a serious adverse reaction a patient should be monitored for 24 hours following removal of a transdermal patch due to the half life of fentanyl (see section 5.2).
Danish: I tilfælde af alvorlige bivirkninger skal patienten monitoreres i 24 timer efter fjernelse af depotplasteret på grund af fentanyls halveringstid (se pkt.
English: The obtained sum should be converted to correspond the oral morphine dosage using Table 1.
Danish: Denne sum konverteres til den tilsvarende perorale morphindosis ifølge tabel 1.
English: headache, visual disturbances), changes in your state of consciousness or loss of consciousness or coma - slow irregular heartbeat (bradyarrhythmias) - myasthenia gravis (a disease causing tiredness and weakness of the muscles)
Danish: hovedpine, synsforstyrrelser), forandringer i bevidsthedsniveau (hvor vågen man er),bevidstløshed eller koma - langsom uregelmæssig hjertebanken (bradyarytmi) - myasthenia gravis (en sygdom, der medfører muskeltræthed og -svækkelse)
English: The painkiller, fentanyl, slowly passes from the patch, through the skin and into the body.
Danish: Det smertestillende middel fentanyl overføres langsomt fra plasteret gennem huden til kroppen.
English: - low blood pressure - impaired liver function - impaired kidney function - if you have had a head injury, a brain tumour, signs of increased intracranial pressure (e.g.
Danish: - nedsat leverfunktion - nedsat nyrefunktion - hvis De har haft hovedet beskadiget, hjernesvulst, symptomer på øget tryk i kraniet (f.eks.
English: What Fentanyl-ratiopharm contains - The active substance is fentanyl.
Danish: Fentanyl-ratiopharm indeholder: - Aktivt stof: fentanyl.
English: Due to limited experience in children under 12 years of age, Fentanyl-ratiopharm should be used in this age group only after careful consideration has been given to the benefit versus risk ratio.
Danish: Erfaring med behandling af børn under 12 år er begrænset, og Fentanyl-ratiopharm bør kun anvendes til denne patientgruppe efter en nøje afvejning af fordele og risici.
English: Concomitant use of potent CYP3A4-inhibitors (e.g. ritonavir) with transdermally administered fentanyl may result in increased plasma concentrations of fentanyl.
Danish: Samtidig brug af stærkt virkende CYP3A4-hæmmere (fx ritonavir) og transdermalt administreret fentanyl kan give øget plasmakoncentration af fentanyl.
English: In very elderly or weak patients, it is not recommended to initiate an opioid treatment with Fentanylratiopharm, due to their known susceptibility to opioid treatments.
Danish: Hos gamle eller svagelige bør opioidbehandling ikke indledes med Fentanylratiopharm, da denne patientgruppe er kendt for at være meget modtagelig over for opioider.
English: If you have been using Fentanyl-ratiopharm for some time, it might happen that Fentanyl-ratiopharm will become less effective for you so that a dose adjustment will be necessary (tolerance may develop).
Danish: Hvis De har brugt Fentanyl-ratiopharm i nogen tid, kan De opleve, at virkningen af depotplastrene aftager, og De får behov for dosistilpasning (der kan opstå tolerance).
English: Always use Fentanyl-ratiopharm exactly as your doctor has told you.
Danish: Tag altid Fentanyl-ratiopharm nøjagtigt efter lægens anvisning.
English: Oral administration of ritonavir (one of the most potent CYP3A4 inhibitors) reduced the clearance of intravenous fentanyl by two thirds and doubled the halflife.
Danish: Efter peroral administration af ritonavir, som er en af de stærkest virkende CYP3A4-hæmmere, nedsattes clearance af intravenøst fentanyl med to tredjedele, og halveringstiden fordobledes.
English: For environmental and safety reasons, used as well as unused and out of date patches must be discarded or returned to the pharmacy for disposal.
Danish: Af sikkerheds- og miljøhensyn skal brugte depotplastre og depotplastre, der har overskredet udløbsdatoen, kasseres eller indleveres på apoteket til bortskaffelse.
English: The transdermal patches are equipped with a blue imprint with the strength.
Danish: Depotplastrene er forsynet med blåt tryk til angivelse af styrken.
English: - A fentanyl transdermal patch is usually used for 72 hours (3 days).
Danish: - Normalt skal et fentanyl depotplaster sidde på i 72 timer (3 døgn).
English: If you use more Fentanyl-ratiopharm than you should If you have stuck on more patches than prescribed, remove the patches and contact your doctor or hospital on their opinion of the risk.
Danish: Hvis De har sat flere plastre på, end lægen har foreskrevet, skal De fjerne plastrene og kontakte lægen eller hospitalet, så de kan bedømme risikoen.
English: Fentanyl-ratiopharm has major influence on the ability to drive and use machines.
Danish: Fentanyl-ratiopharm påvirker i væsentlig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: Teratogenic effects have, however, not been demonstrated.
Danish: Medfødte misdannelser er imidlertid ikke påvist.