FrancophonIA/ELRC3.0 huggingface dataset:
English: For all three aetiologies efficacy was maintained throughout the 12-week study period.
Danish: For alle 3 ætiologier blev effekten fastholdt gennem den 12 uger lange forsøgsperiode.
English: Qutenza acts locally on your skin and is not expected to influence other medicines.
Danish: Qutenza virker lokalt på huden og forventes ikke at have nogen indvirkning på andre lægemidler.
English: Adverse reactions were transient, self limiting and usually mild to moderate in intensity.
Danish: Bivirkningerne var forbigående, selvbegrænsende og sædvanligvis lette til moderate i intensitet.
English: The painful area should be determined by the physician and marked on the skin.
Danish: Det smertefulde område skal bestemmes af lægen og markeres på huden.
English: However, caution should be exercised when prescribing to pregnant women.
Danish: Der bør dog alligevel udvises forsigtighed ved ordination til gravide.
English: The cutaneous patch should be applied to the most painful skin areas (using up to a maximum of 4 patches).
Danish: Kutanplastret skal appliceres på de mest smertefulde hudområder (med anvendelse af op til 4 plastre).
English: No formal interaction studies with other medicinal products have been performed as only transient low levels of systemic absorption have been shown to occur with Qutenza.
Danish: Der er ikke udført formelle interaktionsundersøgelser med andre lægemidler, eftersom der kun er observeret forbigående lave niveauer af systemisk absorption med Qutenza.
English: The patch should be held in place.
Danish: Plastret skal holdes på plads.
English: TUBE OF CLEANSING GEL - LABEL
Danish: RENSEGEL-TUBE - ETIKET
English: In clinical trials, patients were pre-treated with topical lidocaine (4%), lidocaine (2.5%)/prilocaine (2.5%) or with 50 mg of tramadol.
Danish: I kliniske forsøg blev patienter forbehandlet med topikalt lidocain (4 %), lidocain (2,5 %)/prilocain (2,5 %) eller med 50 mg tramadol.
English: • to provide supportive treatment if patients experience increased pain during Qutenza administration
Danish: • at give støttebehandling, hvis patienterne oplever en smerteforøgelse under administrationen af Qutenza
English: Because of the pain, your blood pressure may go up and therefore, your doctor will measure your blood pressure several times during your treatment.
Danish: Dit blodtryk kan stige på grund af smerten, og derfor vil lægen måle dit blodtryk flere gange under behandlingen.
English: For painful diabetic peripheral neuropathy consistent and reproducible efficacy has been demonstrated with repeated treatments during a 52-week period.
Danish: For smertefuld diabetisk perifer neuropati blev der påvist konsistent og reproducerbar effekt ved gentagne behandlinger gennem en 52-ugers periode.
English: Disposal of used and unused Qutenza patches.
Danish: Bortskaffelse af brugte og ubrugte Qutenza-plastre.
English: Do not use Qutenza on any part of your head or face.
Danish: Brug ikke Qutenza på noget som helst sted på dit hoved eller i ansigtet.
English: These precautions should be taken to avoid unintentional contact with the patches or other materials that have come in contact with the treated areas.
Danish: Disse forsigtighedsregler skal iagttages for at undgå utilsigtet kontakt med plastrene eller andre materialer, der har været i kontakt med de behandlede områder.
English: Treatment-related discomfort
Danish: Behandlingsrelateret ubehag
English: • because of the risk of accidental exposure, the use of nitrile gloves, a mask and protective glasses are recommended
Danish: • som følge af risikoen for utilsigtet eksponering anbefales anvendelse af nitrilhandsker, maske og beskyttelsesbriller.
English: Do not touch your eyes, mouth or other sensitive areas as it may cause irritation and pain.
Danish: Rør ikke dine øjne, mund eller andre følsomme steder da det kan medføre irritation og smerte.
English: Blood pressure should be monitored during the treatment procedure.
Danish: Blodtrykket skal monitoreres under behandlingsproceduren.
English: CARTON OF 1 OR 2 PATCHES
Danish: ÆSKE MED 1 ELLER 2 PLASTRE
English: The active substance is capsaicin.
Danish: Aktivt stof: capsaicin.
English: If you experience very severe pain, ask your doctor to remove the patch.
Danish: Hvis du oplever voldsomme smerter, skal du bede lægen om at fjerne plastret.
English: • administration of capsaicin should only be done under medical supervision
Danish: • applikation af capsaicin bør kun ske under supervision af en læge
English: As a result of treatment-related increases in pain, transient increases in blood pressure (on average < 8.0 mm Hg) may occur during and shortly after the Qutenza treatment.
Danish: Som følge af behandlingsrelaterede stigninger i smerter kan der optræde forbigående stigninger i blodtrykket (i gennemsnit < 8,0 mmHg) under og kort efter Qutenza-behandlingen.
English: There is no data in humans available on fertility.
Danish: Der findes ingen tilgængelige data om virkning på fertilitet hos mennesker.
English: When using Qutenza, only very small amounts of the active substance may be present in the blood stream for a very short time.
Danish: Ved behandling med Qutenza vil kun meget små mængder af det aktive stof være til stede i blodbanen og kun i meget kort tid.
English: If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby ask your doctor for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du bruger dette lægemiddel.
English: Your doctor or nurse will remove the patches after 30 minutes if you're being treated for nerve pain on your feet or 60 minutes if you're being treated for nerve pain on other parts of your body.
Danish: Lægen eller sygeplejersken fjerner plastrene efter 30 minutter, hvis du behandles for nervesmerter i fødderne, eller 60 minutter, hvis du behandles for nervesmerter i andre dele af kroppen.
English: Capsaicin, or 6-nonenamide, N-[(4-hydroxy-3-methoxyphenyl) methyl]-8-methyl, (6E), is a highly selective agonist for the transient receptor potential vanilloid 1 receptor (TRPV1).
Danish: Capsaicin, eller 6-nonenamid, N-[(4-hydroxy-3-methoxyphenyl) methyl]-8-methyl, (6E), er en stærk selektiv agonist for TRPV1-receptoren (transient receptor potential vanilloid 1).
English: Following capsaicin exposure, cutaneous nociceptors become less sensitive to a variety of stimuli.
Danish: Efter eksponering for capsaicin bliver kutane nociceptorer mindre følsomme over for en række stimuli.
English: These later-stage effects of capsaicin are frequently referred to as “desensitization” and are thought to underlie the pain relief.
Danish: Disse virkninger af capsaicin, der optræder på et senere stadie, omtales ofte som 'desensibilisering' og menes at være grunden til smertelindringen.
English: Do not use Qutenza on broken skin or open wounds.
Danish: Brug ikke Qutenza på beskadiget hud eller åbne sår.
English: The safety profile of Qutenza in diabetic patients was consistent with that seen in the non-diabetic population.
Danish: Qutenzas sikkerhedsprofil hos patienter med diabetes var i overensstemmelse med observationerne hos en non-diabetisk population.
English: A teratology study conducted in rabbits did not show any potential for embryofetal toxicity.
Danish: Et teratogenicitetsstudie hos kaniner viste ikke potentiale for embryoføtal toksicitet.
English: A carcinogenicity study performed in mice indicates that capsaicin is not carcinogenic.
Danish: Data fra et karcinogenicitetsforsøg hos mus peger på, at capsaicin ikke er karcinogent.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single-dose toxicity, and repeated-dose toxicity.
Danish: Prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle undersøgelser af sikkerhedsfarmakologi, toksicitet efter enkeltdoser og efter gentagne doser.
English: Dysgeusia, hypoaesthesia
Danish: Dysgeusi, hypæstesi
English: • administration of Qutenza in a well ventilated area to reduce the risk of occupational exposure - instructions regarding the administration of Qutenza - warnings and precautions, including the need:
Danish: • applikation af Qutenza bør foretages i et godt ventileret arbejdsområde for at reducere risikoen for eksponering på arbejdspladsen - instrukser vedrørende administration af Qutenza - advarsler og forholdsregler, herunder nødvendigheden af:
English: 52078 Aachen Germany
Danish: 52078 Aachen Tyskland
English: Delays in skeletal ossification (reductions in ossified metatarsals) were observed in a rat teratology study at dose levels higher than human therapeutic levels; the significance of this finding for humans is unknown.
Danish: Forsinkelse i knogledannelsen (reduktion i forbenede mellemfodsknogler) observeredes i et teratogenicitetsstudie hos rotter ved doser, der var højere end humanterapeutiske niveauer; betydningen af dette fund for mennesker er ikke kendt.
English: The outer surface of the backing layer is imprinted with ‘capsaicin 8%'.
Danish: Den ydre overflade af bagsidelaget har påtrykt 'capsaicin 8%'.
English: If you experience a lot of pain, your doctor will apply local cooling or give you medicine for pain.
Danish: Hvis du oplever mange smerter, vil lægen behandle dig med lokal kulde eller give dig et smertestillende lægemiddel.
English: No detectable levels of metabolites were observed in any subject.
Danish: Der blev ikke konstateret påviselige niveauer af metabolitter hos nogen forsøgsperson.
English: Lactating rats exposed to Qutenza daily for 3 hours showed measurable levels of capsaicin in the mothers' milk.
Danish: Studier hos ammende rotter, der blev eksponeret for Qutenza hver dag i tre timer, viste målbare niveauer af capsaicin i mælken.
English: The Qutenza patches should be removed gently and slowly by rolling them inward to minimize the risk of aerosolisation of capsaicin.
Danish: Qutenza-plastrene skal fjernes forsigtigt og langsomt ved at rulle dem sammen indad, således at risikoen for aerosolisering af capsaicin mindskes.
English: Based on in vitro studies, approximately 1% of capsaicin is estimated to be absorbed into the epidermal and dermal layers of skin during one-hour applications.
Danish: På grundlag af in vitro-forsøg skønnes det, at cirka 1 % capsaicin absorberes i de epidermale og dermale hudlag ved applikation i én time.
English: Hair in treatment areas will be clipped.
Danish: Behåring i behandlingsområdet vil blive klippet.
English: Although neither statistically significant nor dose dependent, the Fertility Index and the number of pregnancies per number of rats in cohabitation were reduced in all capsaicin-treated groups.
Danish: Selvom det hverken var statistisk signifikant eller dosisafhængigt, faldt fertilitetsindekset og antallet af drægtige samlevende rotter i alle capsaicin-behandlede grupper.
English: Pharmacotherapeutic group: Anaesthetics, other local anaesthetics, ATC code: N01BX04
Danish: Farmakoterapeutisk klassifikation: Anæstetika, andre lokale anæstetika, ATC-kode: N01BX04
English: Precautions to be taken before handling or administering the medicinal product It is advisable to administer Qutenza in a well ventilated treatment area.
Danish: Sikkerhedsforanstaltninger, der skal tages før håndtering og administration af lægemidlet Det tilrådes at administrere Qutenza i et godt ventileret arbejdsområde.
English: If topical anaesthetic is used prior to patch application proceed with 3, otherwise move to 5.
Danish: Hvis der anvendes et topikalt anæstetikum inden applikation af plastret, fortsættes med 3; ellers gå videre til 5.
English: Qutenza therapy may be repeated at 90-day intervals, if necessary.
Danish: Qutenza-behandlingen kan om nødvendigt gentages med intervaller på 90 dage.
English: Eye irritation
Danish: Irritation af øjnene
English: Based on human pharmacokinetics, which show transient, low systemic exposure to capsaicin, the likelihood that Qutenza increases the risk of developmental abnormalities when given to pregnant women is very low.
Danish: Baseret på humane farmakokinetiske data, der viser forbigående, lav systemisk eksponering for capsaicin, er sandsynligheden for, at Qutenza øger risikoen for udvikling af abnormiteter ved behandling af gravide, meget lille.
English: The MAH shall agree the details of an educational programme for health care practitioners with the National Competent Authorities and implement such programme nationally before launch.
Danish: Yderligere risikominimeringsforanstaltninger Indehaveren af markedsføringstilladelsen skal aftale et undervisningsprogram for sundhedspersonale med de relevante nationale myndigheder og implementere dette program nationalt inden markedsføringen.
English: The safety and efficacy of Qutenza in children from birth to 18 years has not been established.
Danish: Qutenzas sikkerhed og virkning hos børn i alderen 0 til 18 år er ikke klarlagt.
English: Most quantifiable levels were observed at the time of Qutenza removal, with a clear trend towards disappearance by 3 to 6 hours after Qutenza removal.
Danish: De mest kvantificerbare niveauer sås på det tidspunkt, Qutenza blev fjernet, og havde en klar tendens til at forsvinde 3-6 timer efter fjernelse af Qutenza.
English: In patients reporting severe pain, the patch should be removed and the skin examined for chemical burn.
Danish: Hos patienter, der rapporterer om svære smerter, skal plastret fjernes og huden undersøges for forbrænding.
English: To ensure Qutenza maintains contact to the treatment area, stretchable socks or rolled gauze may be used.
Danish: For at sikre at Qutenza-plastret fastholder kontakten med behandlingsområdet, kan strækbare sokker eller gazebind anvendes.
English: The initial effect of capsaicin is the activation of TRPV1-expressing cutaneous nociceptors, which results in pungency and erythema due to the release of vasoactive neuropeptides.
Danish: Capsaicins initiale virkning er at aktivere de TRPV1-udtrykkende kutane nociceptorer, der medfører en stikkende fornemmelse og erytem på grund af frigivelsen af vasoaktive neuropeptider.
English: EXP Use the patch within 2 hours of opening the sachet.
Danish: EXP Brug plastret inden for 2 timer efter åbning af brevet.
English: The highest concentration of capsaicin detected in patients treated for 60 minutes was 4.6 ng/mL, which occurred immediately after Qutenza removal.
Danish: Den højeste koncentration af capsaicin, der blev opdaget hos patienter behandlet i 60 minutter, var 4,6 ng/ml målt lige efter fjernelse af Qutenza.
English: Pain reduction was observed at week 1 in PHN, week 2 in HIV-AN and week 3 in painful diabetic peripheral neuropathy.
Danish: Smertereduktion blev set i uge 1 ved PHN, i uge 2 ved HIV-AN og i uge 3 ved smertefuld diabetisk perifer neuropati.
English: Do not remove release liner from the patch until ready for application.
Danish: Fjern ikke beskyttelsesfilmen fra plastret, før der er gjort klar til applicering.
English: The Qutenza patch is supplied with a tube of cleansing gel, which contains no active substance.
Danish: Qutenza-plastret leveres med en tube rensegel, der ikke indeholder aktivt stof.
English: A population pharmacokinetic analysis of patients treated for 60 and 90 minutes indicated that capsaicin levels in plasma peaked around 20 minutes after Qutenza removal and declined very rapidly, with a mean elimination half-life of about 130 minutes.
Danish: En farmakokinetisk populationsanalyse af patienter behandlet i 60 og 90 minutter tydede på, at capsaicin-niveauerne i plasma toppede omkring 20 minutter efter fjernelse af Qutenza og faldt meget hurtigt med en gennemsnitlig halveringstid på ca. 130 minutter.
English: Each patch is 14 cm x 20 cm (280 cm2) and consists of an adhesive side containing the active substance and an outer surface backing layer.
Danish: Hvert plaster er 14 cm x 20 cm (280 cm2) og består af et klæbende lag med det aktive stof og et ydre bagsidelag.
English: Following hair removal and washing, the skin should be thoroughly dried.
Danish: Efter hårfjerning og vask skal huden tørres grundigt.
English: Do not touch Qutenza or other materials that have come in contact with the treated areas as it may cause burning and stinging.
Danish: Rør ikke Qutenza eller andre materialer, der har været i kontakt med de behandlede områder, da dette kan medføre en brændende og stikkende fornemmelse.
English: Reductions in sensory function have been reported following administration of Qutenza.
Danish: Der er rapporteret om nedsat sensorisk funktion efter administration af Qutenza.
English: Caution should be exercised in patients with reduced sensation in the feet and in those at increased risk for such changes in sensory function.
Danish: Der skal udvises forsigtighed hos patienter med nedsat følesans i fødderne og hos patienter med øget risiko for sådanne ændringer i den sensoriske funktion.
English: Decreases in sensory functions are generally minor and temporary (including to thermal and sharp stimuli), however, a single case of persistent hypoesthesia has been reported in clinical studies in painful diabetic neuropathy.
Danish: Reduktionen i sensorisk funktion er sædvanligvis lille og forbigående (inklusive overfor varme og skarpe stimuli), dog er der rapporteret et enkelt tilfælde af vedvarende hypæstesi i kliniske studier med patienter med smertefuld diabetisk neuropati.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of capsaicin/metabolites in milk (for details see 5.3).
Danish: Tilgængelige farmakodynamiske/toksikologiske data fra dyr har vist, at capsaicin/metabolitter udskilles i mælk (se pkt.
English: Your doctor or nurse may wear gloves, and sometimes a mask and protective glasses, while handling the Qutenza patches.
Danish: Lægen eller sygeplejersken vil bære handsker og sommetider maske og beskyttelsesbriller under håndteringen af Qutenza-plastrene.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: In addition, there have been reported cases of burns, including second degree burns, in patients treated with capsaicin patches (see section 4.8).
Danish: Der er desuden rapporteret om forbrændinger, herunder andengradsforbrændinger, hos patienter behandlet med capsaicin-plastre (se pkt.
English: 640 micrograms of capsaicin per cm 2 of patch (8% w/w).
Danish: 640 mikrogram capsaicin pr. cm 2 plaster (8 % w/w).
English: In vitro data (active substance dissolution and skin permeation assays) demonstrate that the rate of release of capsaicin from Qutenza is linear during the application time.
Danish: Det fremgår af data fra in vitroforsøg (opløsning af det aktive stof og test af hudgennemtrængning), at hastigheden af capsaicinfrigivelse fra Qutenza er lineær i løbet af applikationstiden.
English: A reproductive toxicology study conducted in rats showed a statistically significant reduction in the number and percent of motile sperms in rats treated 3 hours/day beginning 28 days before cohabitation, through cohabitation and continuing through the day before sacrifice.
Danish: En undersøgelse af reproduktiv toksicitet hos rotter viste en statistisk signifikant reduktion i antallet og procentdelen af motile sædceller hos rotter behandlet i 3 timer pr. dag fra 28 dage, før de blev sat sammen, gennem deres tid sammen og indtil og med dagen før aflivning.
English: The topical anaesthetic should be applied to cover the entire Qutenza treatment area and surrounding 1 to 2 cm.
Danish: Det topikale anæstetikum bør appliceres, så det dækker hele det område, der skal behandles med Qutenza, og 1-2 cm omkring dette område.
English: Apply topical anaesthetic to treatment area.
Danish: Applicér et topikalt anæstetikum på behandlingsområdet.
English: • if you are allergic to capsaicin, chilli peppers or any other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for capsaicin, chilipeber eller andre indholdsstoffer i denne medicin
English: Remove anaesthetic.
Danish: Fjern anæstetikummet.
English: It may take between 1 to 3 weeks before you experience pain relief with Qutenza.
Danish: Der kan gå mellem 1 og 3 uger, før du oplever smertelindring med Qutenza.
English: Temporary, minor changes in heat detection (1°C to 2°C) and sharp sensations were detected at the Qutenza application site in clinical trials with healthy volunteers.
Danish: Midlertidige, mindre ændringer af følsomhed for varmesensibilisering (1°C til 2°C) og fornemmelse af skarpe genstande blev observeret på applikationsstedet for Qutenza i kliniske forsøg med raske frivillige forsøgspersoner.
English: Disposable socks may be worn on top of the Qutenza patches if your feet are being treated.
Danish: Du kan anvende engangssokker oven på Qutenza-plastrene, hvis dine fødder behandles.
English: Therefore, overdosing is unlikely to occur.
Danish: Overdosering er derfor usandsynlig.
English: Patients experiencing pain during and after patch application should be provided with supportive treatment such as local cooling (such as a cool compress) or oral analgesics (i.e. short acting opioids).
Danish: Patienter, som oplever smerte under og efter påsætning af plaster, bør gives understøttende behandling såsom lokal afkøling (såsom et kuldekompres) eller orale analgetika (f.eks. korttidsvirkende opioider).
English: It is common for the skin to sting or become red and burn during Qutenza treatment.
Danish: Det er normalt, at huden svier eller bliver rød og brænder efter behandling med Qutenza.
English: The release liner should slowly and carefully be peeled from underneath with one hand while the patch should simultaneously be smoothed onto the skin with the other to ensure that there is complete contact between the patch and the skin, with no air bubbles and no moisture.
Danish: Beskyttelsesfilmen rives langsomt og forsigtigt af med den ene hånd, mens den anden hånd samtidigt glatter plastret ud på huden for at sikre, at der er fuld kontakt mellem plastret og huden, samt at der ikke er luftbobler eller fugt.
English: If necessary, hairs in the affected area should be clipped to promote patch adherence (do not shave).
Danish: Om nødvendigt klippes behåringen i det berørte område for at gøre det lettere at få plastret til at klæbe (undgå barbering af området).
English: Cleansing gel will be left on your skin for one minute and then wiped off to remove any remaining medicine that may be left on your skin after treatment.
Danish: Rensegelen vil blive påført din hud i ét minut og derefter tørret bort for at fjerne eventuelle medicinrester, der er tilbage på huden efter behandlingen.
English: Assuming 1000 cm2 of patch area delivers approximately 1% of capsaicin from the patch to a 60 kg person, the maximum potential exposure to capsaicin is approximately 0.12 mg/kg, once every 3 months.
Danish: Hvis man antager, at der fra et plasterområde på 1.000 cm applikationsområde på 1.000 cm2 frigives cirka 1 % capsaicin fra plastret til en person, der vejer 60 kg, udgør den maksimale potentielle eksponering for capsaicin cirka 0,12 mg/kg én gang hver 3 måned.
English: Generally small, short-term changes in the ability to feel when something is hot or sharp have been seen after use of capsaicin.
Danish: Der er set ændringer i evnen til at føle varme eller skarpe genstande efter brugen af capsaicin.
English: EU/1/09/524/001 1 patch EU/1/09/524/002 2 patches
Danish: EU/1/09/524/001 1 plaster EU/1/09/524/002 2 plastre
English: In case of suspected overdose, the patches should be removed gently, cleansing gel should be applied for one minute and then wiped off with dry gauze and the area should be gently washed with soap and water.
Danish: I tilfælde af formodet overdosering skal plastrene fjernes forsigtigt, rensegel skal appliceres i ét minut og derefter tørres af med tørt gazebind; området skal vaskes forsigtigt med vand og sæbe.
English: Gauze wraps or socks may be used to promote contact between patch and skin.
Danish: Gazebind eller sokker kan anvendes for at sikre god kontakt mellem plastret og huden.