FrancophonIA/ELRC3.0 huggingface dataset:
English: Itraconazole (a potent CYP3A4 inhibitor) at 200 mg/day given orally for four days had no significant effect on the pharmacokinetics of intravenous fentanyl.
Danish: Peroral administration af itraconazol, som er en stærkt virkende CYP3A4-hæmmer, i døgndoser på 200 mg i fire dage havde ingen signifikant virkning på fentanyls farmakokinetik efter intravenøs brug.
English: - If you have any further questions, ask your doctor or pharmacist.
Danish: Er De i tvivl så spørg lægen eller apoteket.
English: Other symptoms may be hypothermia, decreased muscle tonus, bradycardia, hypotension.
Danish: Øvrige symptomer omfatter hypotermi, nedsat muskeltonus, bradykardi, hypotoni.
English: Regarding the therapeutic indication, the MAH has provided a scientific statement, which summarises the publications related to the treatment of chronic non cancer pain with strong opioids and particularly transdermal fentanyl.
Danish: Vedrørende den terapeutiske indikation har indehaveren af markedsføringstilladelsen forelagt en videnskabelig gennemgang af publikationerne om anvendelse af stærke opioder, navnlig transdermalt fentanyl, til behandling af andre kroniske smerter end cancersmerter.
English: The skin area to which the patch is applied should be free of microlesions (e.g. due to irradiation or shaving) and skin irritation.
Danish: Hudområdet, hvor plasteret anbringes, skal være uden småsår (fx på grund af strålebehandling eller barbering) og hudirritation.
English: As a general rule, the discontinuation of opioid analgesia should be gradual, in order to prevent withdrawal symptoms (nausea, vomiting, diarrhoea, anxiety and muscular tremor).
Danish: Opioidanalgetika bør generelt seponeres gradvist for at forebygge abstinenssymptomer (kvalme, opkastning, diaré, angst og muskeltremor).
English: Equianalgesic doses (mg)
Danish: Ækvianalgetiske doser (mg)
English: Directly after removal from the pack and the release liner, the patch is applied to a non-hairy area of skin on the upper body (chest, back, upper arm).
Danish: Umiddelbart efter det er taget ud af pakningen og beskyttelsesfolien er fjernet, anbringes depotplasteret på et hårløst område af huden på overkroppen (bryst, ryg eller overarm).
English: Fentanyl is metabolized primarily in the liver via CYP3A4.
Danish: Biotransformation Fentanyl metaboliseres hovedsageligt i leveren via CYP3A4.
English: By combining several transdermal patches, a fentanyl release rate of over 100 micrograms/h can be achieved.
Danish: Ved at kombinere flere depotplastre kan der opnås en frigivelseshastighed for fentanyl på over 100 mikrogram i timen.
English: - In children, the upper back is the preferred location to apply the patch, to minimize the potential of the child removing the patch.
Danish: - Hos børn anbringes plasteret fortrinsvis øverst på ryggen, så det bliver sværest muligt for barnet at fjerne plasteret.
English: The symptoms of fentanyl overdose are an extension of its pharmacological actions, e.g. lethargy, coma, respiratory depression with Cheyne-Stokes respiration and/or cyanosis.
Danish: Symptomerne på overdosering af fentanyl er forstærkede farmakologiske virkninger som fx apati, koma, respirationsdepression med Cheyne-Stokes respiration og/eller cyanose.
English: Pack containing 3, 5, 10 or 20 transdermal patches
Danish: Pakninger à 3, 5, 10 eller 20 depotplastre.
English: When changing over from oral or parenteral opioids to fentanyl treatment, the initial dosage should be calculated as follows:
Danish: Den initiale dosis ved overgang fra perorale eller parenterale opioider til behandling med fentanyl beregnes som følger:
English: The transdermal patch is then applied using slight pressure with the palm of the hand for approximately 30 seconds.
Danish: Dernæst anbringes depotplasteret, som trykkes fast med et let tryk med håndfladen i ca.30 sekunder.
English: It is not recommended to use those together with Fentanyl-ratiopharm.
Danish: De bør ikke anvende disse midler sammen med Fentanyl-ratiopharm.
English: The biostatistical evaluation of the existing single dose study with replicate design (but showing nonbioequivalence) could be considered suitable to evaluate intra-individual variability and to determine the influence of the biopharmaceutical performance, in relation to the different release mechanisms (reservoir versus matrix).
Danish: Biostatistisk analyse af denne undersøgelse kan muligvis være velegnet til at vurdere den intra-individuelle variation og betydningen af de forskellige udløsningssystemers biofarmaceutiske funktion (reservoir kontra matrix).
English: Keep out of the reach and sight of children, even after use.
Danish: Opbevares utilgængeligt for børn - også efter brug.
English: Chronic pulmonary disease
Danish: Kronisk lungesygdom
English: oedema, cold feeling.
Danish: Ødemer, kuldefornemmelse.
English: Do not shave, as shaving irritates the skin.
Danish: Hårene må ikke barberes af, da det irriterer huden.
English: The most common adverse reactions following administration at usual doses are drowsiness, confusion, nausea, vomiting and constipation.
Danish: De mest almindelige bivirkninger efter administration af normale doser er sløvhed, konfusion, kvalme, opkastning og obstipation.
English: In these cases, it would be preferable to initiate a treatment with low doses of immediate release morphine and to prescribe Fentanyl-ratiopharm after determination of the optimal dosage.
Danish: I så fald skal behandlingen fortrinsvis indledes med lave doser af et morphinpræparat med konventionel udløsning, og Fentanyl-ratiopharm gives først, når den optimale dosering er fastlagt.
English: In the first 12 hours after changing to Fentanyl-ratiopharm the patient continues to receive the previous analgesic at the previous dose; over the next 12 hours this analgesic is administered according to need.
Danish: I de første 12 timer efter skift til Fentanyl-ratiopharm vil patienten fortsat få det hidtil anvendte analgetikum i den hidtidige dosis.
English: Lactation should therefore be discontinued for at least 72 hours after the removal of fentanyl transdermal patch”
Danish: Amning bør der derfor tidligst finde sted 72 timer efter aftagning af fentanyl depotplasteret"
English: In case of withdrawal symptoms it is recommended to treat those with short-acting morphine in low doses.
Danish: Til behandling af abstinenssymptomer anbefales kortvirkende morphin i lave doser.
English: There is also no clinical data available which demonstrates withdrawal symptoms in patients treated with transdermal fentanyl after injection of buprenorphine.
Danish: I den foreliggende kliniske dokumentation forekommer der da heller ikke abstinenssymptomer ved behandling med transdermalt fentanyl efter injektion af buprenorphin.
English: Do not drive or operate dangerous machines while using Fentanyl-ratiopharm, unless your doctor has told you that such is permitted.
Danish: Undgå bilkørsel eller maskinbetjening, mens De tager Fentanyl-ratiopharm, indtil lægen har udtalt, at det er i orden.
English: The serum fentanyl concentrations attained are dependant on the fentanyl transdermal patch size.
Danish: De opnåede serumkoncentrationer af fentanyl afhænger af fentanyl depotplasterets størrelse.
English: The corresponding fentanyl dosage should be determined as follows: a) using Table 2 for patients who have a need for opioid rotation (conversion ratio of oral morphine to transdermal fentanyl equal to150:1) b) using Table 3 for patients on stable and well tolerated opioid therapy (conversion ratio of oral morphine to transdermal fentanyl equal to 100:1)
Danish: Den tilsvarende fentanyldosis fastsættes som følger: a) Ved hjælp af tabel 2 for patienter, som har behov for opioidrotation (med konvertering fra peroralt morphin til transdermalt fentanyl i forholdet 150:1) b) Ved hjælp af tabel 3 for patienter på stabil og veltolereret opioidterapi (med konvertering fra peroralt morphin til transdermalt fentanyl i forholdet 100:1)
English: All dosages given in the table are equivalent in analgesic effect to 10 mg parenteral morphine.
Danish: Tabel 1: Ækvianalgetiske doser ved konvertering Alle de i tabellen opgivne doseringer har en analgetisk virkning svarende til 10 mg parenteralt morphin.
English: Therefore, the use of any of the above mentioned concomitant medicinal products and active substances require observation of the patient.
Danish: Patienten skal derfor holdes under nøje observation, hvis et af de ovennævnte lægemidler og aktive stoffer anvendes samtidig med fentanyl.
English: The CNS depressants mentioned above include: - opioids - anxiolytics and tranquilizers - hypnotics - general anaesthetics - phenothiazines - skeletal muscle relaxants - sedating antihistamines - alcoholic beverages
Danish: Det drejer sig bl.a. om følgende CNS-deprimerende farmaka: - opioider - anxiolytika og sedativa - hypnotika - generelle anæstetika - phenothiaziner - muskelrelaksantia - sederende antihistaminer - alkoholiske drikke
English: What Fentanyl-ratiopharm looks like and contents of the pack Fentanyl-ratiopharm is a transparent, transdermal patch with a sticky back so that it can be stuck onto the skin.
Danish: Beskyttelseslag: Polyethylenterephthalatfolie (silikonebehandlet) Fentanyl-ratiopharms udseende og pakningstørrelse Fentanyl-ratiopharm er et gennemsigtigt depotplaster med et klæbemiddel på bagsiden, så det kan klæbes fast på huden.
English: WHAT Fentanyl-ratiopharm IS AND WHAT IT IS USED FOR
Danish: FENTANYL-RATIOPHARMS VIRKNING OG HVAD DE SKAL BRUGE DET TIL
English: As fentanyl is excreted into breast milk, lactation should be discontinued under the treatment with fentanyl (see also section 4.6)
Danish: Da fentanyl udskilles i modermælk, bør amningen ophøre under behandlingen med fentanyl (se også pkt.
English: Fentanyl-ratiopharm should be administered with caution to patients with bradyarrhythmias.
Danish: Fentanyl kan give bradykardi, og Fentanyl-ratiopharm bør administreres med forsigtighed til patienter med bradyarytmi.
English: Your doctor will base his judgement on: the severity of your pain, your general condition and the type of pain treatment that you have received so far.
Danish: Det er op til lægen at vælge den styrke Fentanyl-ratiopharm, der passer bedst til Dem, Lægen baserer sit skøn på styrken af Deres smerter, Deres almentilstand og den type smertebehandling, som De hidtil har fået.
English: High quantities of the active substance remain in the transdermal patches even after use.
Danish: Efter brug vil der stadig være store mængder af det aktive stof tilbage i plastrene.
English: Respiratory depression may persist beyond the removal of the patch.
Danish: Respirationsdepressionen kan vare ved efter fjernelse af plasteret.
English: Combined use of ritonavir or other potent CYP3A4-inhibitors with transdermal fentanyl is not recommended, unless the patient is carefully observed.
Danish: Kombinationsbehandling med ritonavir eller en anden stærkt virkende CYP3A4-hæmmer og transdermalt fentanyl frarådes, med mindre patienten observeres nøje.
English: The concomitant use of other CNS depressants may produce additive depressant effects and hypoventilation, hypotension as well as profound sedation or coma may occur.
Danish: Samtidig brug af andre CNS-deprimerende farmaka kan øge depressionen af centralnervesystemet og føre til hypoventilation, hypotoni samt kraftig sedation eller koma.
English: Generalised acute allergic reactions with a fall in the blood pressure and/or difficulty in breathing (anaphylactic reactions), delusional ideas, states of excitement, loss of physical strength, depression, anxiety, confusion, sexual dysfunction, withdrawal symptoms, coordination disturbances, seizures (including clonic and grand mal seizures), diminished visual acuity, impaired respiration (respiratory depression), respiratory arrest (apnoea), painful bloating, block of the digestion channel, urinary bladder pain, passing water less than normal (reduced urine excretion).
Danish: Omfattende og akutte allergiske reaktioner med blodtryksfald og/eller åndedrætsbesvær (anafylaktiske reaktioner), vrangforestillinger, ophidselse, nedsat fysisk styrke, depression, angst, konfusion, seksuelle forstyrrelser, abstinenssymptomer, koordinationsforstyrrelser, epileptiske anfald (inklusive kloniske og tonisk-kloniske krampeanfald), nedsat synsstyrke, svækket åndedræt (respirationsdepression), respirationsstop (apnø), smertefuld oppustethed, tarmforstoppelse, smerter i urinblæren, nedsat vandladning (nedsat urinudskillelse).
English: CNS active substances may worsen the respiratory depression (see section 4.5).
Danish: Stoffer, der påvirker centralnervesystemet, kan forværre respirationsdepression (se pkt.
English: The conservative conversion scheme (150:1) as specified in the present SPC of Fentanyl ratiopharm for patient who have a need for opioid rotation and the conversion scheme 100:1 (Donner's table) for patients under stable and well -tolerated opioid therapy.
Danish: I produktresuméet for Fentanyl "ratiopharm" angives det forsigtigt skønnede omregningsforhold (150:1) for patienter med behov for opioid-rotation og 100:1 (Donners tabel) for patienter i stabil, veltolereret opioidbehandling.
English: In chronic non-cancer pain, it might be preferable to initiate the treatment with immediate-release strong opoids (e.g. morphine) and to prescribe fentanyl transdermal patch after determination of the efficacy and the optimal dosage of the strong opioid.
Danish: Ved kroniske smerter, der ikke skyldes cancer, vil det muligvis være bedre at indlede behandlingen med stærke opioider med konventionel udløsning (fx morphin) og at ordinere fentanyl depotplaster efter bestemmelse af effekt og optimal dosering af det stærke opioid.
English: - Fold the used patch in half so that the sticky edges adhere to each other.
Danish: - Fold det brugte plaster sammen på midten, så kanterne med klæbemiddel klistrer sammen.
English: Patients receiving opioid treatment for the first time Patches with a release rate of 12.5 micrograms/hour are available and should be used for initial dosing.
Danish: Der foreligger plastre med en frigivelseshastighed på 12,5 mikrogram i timen, og de bør anvendes til indledning af behandlingen.
English: GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Danish: BEGRUNDELSE FOR ÆNDRINGEN AF PRODUKTRESUMÉET, ETIKETTERINGEN OG INDLÆGSSEDLEN
English: Feeling unusually drowsy or tired (depressant effect on brain function), nervousness, loss of appetite, dry mouth, stomach pain, skin reactions at the attachment site.
Danish: Usædvanlig sløvhed eller træthed (nedsættende virkning på hjernefunktionen), nervøsitet, manglende appetit, mundtørhed, mavesmerter, hudreaktioner ved applikationsstedet.
English: The product is indicated in severe chronic pain which can be adequately managed only with opioid analgesics.
Danish: Svære kroniske smerter, som kun kan lindres tilstrækkeligt med opioidanalgetika.
English: Regarding breast-feeding, section 4.6 of the proposed SPC reads: “Fentanyl is excreted into breast milk and may cause sedation and respiratory depression in the breastfed infant.
Danish: 4.6 i det foreslåede produktresumé: "Fentanyl udskilles med modermælk og kan medføre sedation og respirationsdepression hos det ammede barn.
English: DATE OF REVISION OF THE TEXT {MM/YYYY} [To be completed nationally]
Danish: DATO FOR ÆNDRING AF TEKSTEN MM/ÅR [Udfyldes nationalt]
English: The serum concentrations of fentanyl that cause a minimal analgesic effect in opioid-naive patients fluctuate between 0.3-1.5 ng/ml; an increased incidence of adverse reactions is observed if serum levels exceed 2 ng/ml.
Danish: Den serumkoncentration af fentanyl, der giver en minimal analgetisk virkning hos ikke-opioidbehandlede patienter, svinger mellem 0,3-1,5 ng/ml.
English: It is advised not to use fentanyl during labour and delivery (including caesarean section) since fentanyl passes the placenta and may cause respiratory depression in the new born infant.
Danish: Fentanyl bør ikke anvendes under veer og fødsel (inklusive kejsersnit), da stoffet passerer placenta og kan medføre respirationsdepression hos nyfødte.
English: - asthma, respiratory depression or any lung disease
Danish: - astma, åndedrætsbesvær eller anden lungesygdom - lavt blodtryk
English: Transdermal fentanyl release (micrograms/h)
Danish: Transdermal frigivelse af fentanyl (mikrogram/time)
English: If patients with renal impairment receive transdermal fentanyl they should be observed carefully for signs of fentanyl toxicity and the dose reduced if necessary.
Danish: Patienter med nedsat nyrefunktion, der får transdermalt fentanyl, skal observeres nøje for tegn på fentanyltoksicitet, og om nødvendigt reduceres dosis.
English: Blue printing ink
Danish: Blåt blæk
English: Fentanyl is excreted into breast milk and may cause sedation and respiratory depression in the breastfed infant.
Danish: Fentanyl udskilles i modermælk og kan medføre sedation og respirationsdepression hos brystbarnet.
English: Data obtained with intravenous fentanyl in patients with renal failure suggest that the volume of distribution of fentanyl may be changed by dialysis.
Danish: Data vedrørende intravenøst fentanyl hos patienter med nyresvigt tyder på, at fentanyls fordelingsvolumen ændres af dialyse, hvilket kan påvirke serumkoncentrationen.
English: delusional ideas, states of excitement, asthenia, depression, anxiety, confusion, sexual dysfunction, withdrawal symptoms.
Danish: Vrangforestillinger, ekscitation, asteni, depression, angst, konfusion, seksuel dysfunktion, abstinenssymptomer.
English: Used transdermal patches should be folded with the adhesive surfaces inwards and discarded or whenever possible returned to the pharmacy.
Danish: Derfor skal brugte depotplastre foldes med klæbesiden indad og destrueres eller eventuelt indleveres på apoteket.
English: It is advised not to use Fentanyl-ratiopharm during labour and delivery (including caesarean section) because fentanyl may cause breathing problems in the newborn child.
Danish: Brug af Fentanyl-ratiopharm under fødslen (inklusive kejsersnit) frarådes, da fentanyl passerer moderkagen og kan medføre åndedrætsbesvær hos det nyfødte barn.
English: Manufacturer Merckle GmbH Ludwig-Merckle-Str. 3 89143 Blaubeuren Germany
Danish: Ludwig-Merkle-Str. 3 D-89143 Blaubeuren Tyskland
English: Other signs and symptoms of overdose are drowsiness, low body temperature, slow heart rate, decreased muscle tone, deep sedation, loss of muscle co-ordination, constriction of the pupils and convulsions.
Danish: Andre symptomer på en overdosis er sløvhed, lav kropstemperatur, langsom hjerterytme, nedsat muskelspænding, dyb bedøvelse, tab af muskelkoordination (problemer med at kontrollere muskelbevægelser), sammentrækning af pupillerne og kramper.
English: MAO-inhibitors have been reported to increase the effect of narcotic analgesics, especially in patients with cardiac failure.
Danish: Det er rapporteret, at MAO-hæmmere kan øge virkningen af opioidanalgetika hos patienter med hjertesvigt.
English: Fentanyl passes into the breast-milk and may cause side effects in the breast-fed infant as sedation and respiratory depression.
Danish: Fentanyl bliver udskilt i modermælk og kan give bivirkninger hos brystbarnet såsom sedation og svækket åndedræt.
English: Caution should therefore be taken in treatment of patients with hypotension and/or patients with hypovolemia.
Danish: Opioider kan medføre hypotension, især hos patienter med hypovolæmi, og der bør udvises forsigtighed ved behandling af patienter med hypotension og/eller hypovolæmi.
English: Uncommon: exanthema, erythema.
Danish: Eksantem, erytem.
English: MARKETING AUTHORISATION NUMBERS [To be completed nationally]
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) [Udfyldes nationalt]
English: Polypropylene foil
Danish: Polypropylenfolie
English: Dose titration and maintenance therapy
Danish: Dosistitrering og vedligeholdelsesbehandling
English: Elderly or cachectic patients should be observed carefully and the dose reduced if necessary.
Danish: Ældre eller kakektiske patienter bør holdes under nøje observation, og om nødvendigt reduceres dosis.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally] {Name and Address}
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN [Se bilag I - Udfyldes nationalt] {Navn og adresse}
English: Table 3: Recommended initial dose of transdermal fentanyl based on daily oral morphine dose (for patients on stable and well tolerated opioid therapy)
Danish: Tabel 3: Anbefalet initial dosis af transdermalt fentanyl baseret på daglig peroral morphindosis (for patienter på stabil og veltolereret opioidterapi) Peroral morphindosis (mg/døgn)
English: Changing or ending therapy
Danish: Ændring eller afslutning af behandlingen
English: How to store Fentanyl-ratiopharm Further information
Danish: Sådan opbevarer De Fentanyl-ratiopharm Yderligere oplysninger
English: The CHMP recommended also adding the following statement in section 4.4 of the SPC: “In chronic non-cancer pain, it might be preferable to initiate the treatment with immediate-release strong opoids (e.g. morphine) and to prescribe fentanyl transdermal patch after determination of the efficacy and the optimal dosage of the strong opioid.”
Danish: 4.4 i produktresuméet: "Ved andre kroniske smerter end cancersmerter kan det være hensigtsmæssigt at indlede behandlingen med stærkt virkende opioider med umiddelbar frigivelse (f.eks. morphin) og først ordinere fentanyl depotplaster, efter at virkning og optimal dosering af stærkt virkende opioder er fastlagt."
English: Combination with barbituric acid derivatives, buprenorphine, nalbuphine and pentazocine should in general be avoided (see section 4.5).
Danish: Generelt bør det undgås at kombinere fentanyl med barbitursyrederivater, buprenorphin, nalbuphin og pentazocin (se pkt.
English: 3 transdermal patches 5 transdermal patches 10 transdermal patches 20 transdermal patches
Danish: 3 depotplastre 5 depotplastre 10 depotplastre 20 depotplastre
English: Continued absorption of fentanyl from the skin accounts for a slower reduction in serum concentration than is seen after an intravenous infusion.
Danish: Den langsomme reduktion i serumkoncentration i forhold til intravenøs infusion skyldes den fortsatte absorption af fentanyl fra huden.
English: If severe or persistent hypotension occurs, hypovolemia should be considered, and the condition should be managed with appropriate parenteral fluid therapy.
Danish: Det er vigtigt, at intensivafdelingsbehandlingen finder sted, hvis patientens kliniske tilstand kræver det. I tilfælde af alvorlig eller vedvarende hypotension kan der være tale om hypovolæmi, og tilstanden skal behandles med passende parenteral væsketerapi.
English: Uncommon: Unnatural feeling of happiness, memory loss, difficulties in sleeping, hallucinations, agitation, tremor, sensitivity disturbances, speech disorders, fall or rise in the blood pressure and heart rate, difficulties in breathing, diarrhoea, difficulty in passing urine, skin rash, skin reddening (erythema).
Danish: Usædvanlig opstemthed, hukommelsestab, søvnbesvær, hallucinationer, ophidselse, skælven, føleforstyrrelser, taleforstyrrelser, sænkning eller stigning i blodtryk og hjertefrekvens, åndenød, vandladningsbesvær, diaré, udslæt, rødmen (erytem).
English: How to change the transdermal patch - Remove the patch after the period your doctor has told you.
Danish: - Fjern plasteret, når der er gået den tid, lægen har angivet.
English: Table 2: Recommended initial dose of transdermal fentanyl based on daily oral morphine dose (for patients who have a need for opioid rotation)
Danish: Ketobemidon Tabel 2: Anbefalet initialdosis af transdermalt fentanyl ud fra daglig peroral morphindosis (for patienter med behov for opioidrotation) Peroral morphindosis (mg/døgn)
English: Bear in mind that the design of this medicinal product could be tempting to a child. Fentanyl-ratiopharm can have life-threatening side-effects in persons that are not using prescribed opioid medicines on a regular basis.
Danish: Fentanyl-ratiopharm kan have livstruende bivirkninger hos personer, der ikke regelmæssigt får opioider på recept.
English: cystalgia, oliguria.
Danish: Smerter i urinblæren, oliguri.