FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients in the ATRA + chemotherapy treatment group received IV idarubicin at 12 mg/m2 on days 2, 4, 6, and 8 and oral ATRA at 45 mg/m2 daily until CR. During consolidation, patients received idarubicin at 5 mg/m2 on days 1 to 4 and ATRA at 45 mg/m2 daily for 15 days, then IV mitoxantrone at 10 mg/m2 on days 1
Danish: på dag 2, 4, 6 og 8 og ATRA 45 mg/m2 oralt dagligt indtil CR. Under konsolidering fik patienterne idarubicin 5 mg/m2 på dag 1 til 4 og ATRA 45 mg/m2 dagligt i 15 dage, og dernæst mitoxantron 10 mg/m2 i.v.
English: See section 2 “TRISENOX contains sodium”.
Danish: ”TRISENOX indeholder natrium”.
English: Cytotoxic: handle with caution
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Cytotoksisk: skal håndteres med forsigtighed
English: Conventional Cytogenetics [t(15;17)] Absent
Danish: Konventionel cytogenetik [t(15;17)] Fraværende Tilstede Kan ikke evalueres RT-PCR for PML/RAR
English: Teva Pharmaceuticals Europe B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands
Danish: Teva Pharmaceuticals Europe B.V., Swensweg 5, 2031 GA Haarlem, Holland
English: In one patient induction treatment was terminated because of severe prolongation of the QTc interval and electrolyte abnormalities on day 3.
Danish: Hos en patient blev induktionsbehandlingen seponeret på dag 3 på grund af en svær forlængelse af QTC-intervallet samt elektrolytanomalier.
English: Ketoacidosis
Danish: Ketoacidose
English: Renal impairment Plasma clearance of AsIII was not altered in patients with mild renal impairment (creatinine clearance of 50-80 ml/min) or moderate renal impairment (creatinine clearance of 30-49 ml/min).
Danish: (kreatininclearance 50-80 ml/min) eller moderat nedsat nyrefunktion (kreatininclearance 30-49 ml/min).
English: This medicine must not be used if you notice foreign particulate matter or if the solution is discoloured.
Danish: Brug ikke lægemidlet, hvis der er fremmede partikler i infusionsvæsken, eller hvis den er misfarvet.
English: Patients with significant arrhythmias, EKG abnormalities (congenital long QT syndrome, history or presence of significant ventricular or atrial tachyarrhythmia, clinically significant resting bradycardia (< 50 beats per minute), QTc > 450 msec on screening EKG, right bundle branch block plus left anterior hemiblock, bifascicular block) or neuropathy were excluded from the study.
Danish: Patienter med signifikant arytmi, ekg-anomali (medfødt langt QT-syndrom, tidligere eller aktuel signifikant ventrikulær eller atrial takyarytmi, klinisk signifikant bradykardi i hvile (< 50 slag/minut), QTc > 450 msek.
English: There did not appear to be a relationship between baseline white blood cell (WBC) counts and development of hyperleucocytosis nor did there appear to be a correlation between baseline WBC count and peak WBC counts.
Danish: Behandling med arsentrioxid er blevet sammenkædet med udvikling af hyperleukocytose (≥ 10 x 103/µl) hos nogle patienter med recidiverende/refraktær APL. Der syntes ikke at være nogen forbindelse mellem baseline-antallet af hvide blodlegemer (WBC) og udviklingen af hyperleukocytose, ligesom der ikke syntes at være en korrelation imellem baseline WBC-tal og topWBC-tal.
English: If you are able to become pregnant, you must use effective birth control during treatment with TRISENOX.
Danish: Hvis du er i den fødedygtige alder, skal du bruge sikker prævention under behandlingen med TRISENOX.
English: Excipients: sodium hydroxide, hydrochloric acid, water for injections
Danish: LISTE OVER HJÆLPESTOFFER Hjælpestoffer: natriumhydroxid, saltsyre, vand til injektionsvæsker
English: TRISENOX 1 mg/ml concentrate for solution for infusion Type I borosilicate glass ampoule containing 10 ml of concentrate.
Danish: TRISENOX 1 mg/ml koncentrat til infusionsvæske, opløsning Glasampul (type I borsilicat) indeholdende 10 ml koncentrat.
English: Each carton contains 10 single-use glass ampoules.
Danish: Hver æske indeholder 10 glasampuller til engangsbrug.
English: In newly diagnosed patients with low to intermediate risk APL 63.2 % developed grade 3 or 4 hepatic toxic effects during induction or consolidation treatment with arsenic trioxide in combination with ATRA (see section 4.8).
Danish: Hos nydiagnosticerede patienter med lav til intermediær risiko APL udviklede 63,2 % grad 3 eller 4 levertoksiske virkninger i løbet af induktions- eller konsolideringsbehandlingen med arsentrioxid i kombination med ATRA (se pkt.
English: Each ampoule of 10 ml contains 10 mg of arsenic trioxide.
Danish: Hver ampul med 10 ml indeholder 10 mg arsentrioxid.
English: Hydrochloric acid (for pH adjustment) Water for injections
Danish: Saltsyre (til pH-justering)
English: Manufacturer Teva Pharmaceuticals Europe B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands
Danish: Fremstiller Teva Pharmaceuticals Europe B.V., Swensweg 5, 2031 GA Haarlem, Holland
English: Electrocardiogram QT prolonged
Danish: QT-forlængelse i elektrokardiogram
English: TRISENOX 2 mg/ml concentrate for solution for infusion Each ml of concentrate contains 2 mg of arsenic trioxide.
Danish: TRISENOX 2 mg/ml koncentrat til infusionsvæske, opløsning Hver ml koncentrat indeholder 2 mg arsentrioxid.
English: - nausea, vomiting, diarrhoea - dizziness, muscle pain, numbness or tingling - rash or itching, increased blood sugar, oedema (swelling due to excess fluid) - shortness of breath, fast heart beat, abnormal ECG heart tracing - reduced potassium or magnesium in the blood, liver function tests abnormal including presence of excess bilirubin or gamma-glutamyltransferase in the blood
Danish: - træthed (mathed), smerter, feber, hovedpine - kvalme, opkastning, diarré, - svimmelhed, muskelsmerter, følelsesløshed eller snurrende fornemmelser i huden, - udslæt eller kløe, - øget blodsukker, ødemer (hævelse som følge af væskeophobning), - kortåndethed, hurtig hjerterytme (puls), unormalt hjertediagram (ekg), - nedsat indhold af kalium eller magnesium i blodet, unormale prøver for leverfunktion inklusive forhøjet indhold af bilirubin eller gammaglutamyltransferase i blodet.
English: to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8 °C, unless dilution has taken place in controlled and validated aseptic conditions.
Danish: Hvis det ikke anvendes umiddelbart, vil anvendelsesholdbarheden og -forholdene være at betragte som brugerens ansvar og vil normalt ikke være længere end 24 timer ved 2-8 C, medmindre fortynding har fundet sted under kontrollerede og aseptiske forhold.
English: Each ml of concentrate contains 1 mg of arsenic trioxide.
Danish: Hver ml koncentrat indeholder 1 mg arsentrioxid.
English: Single centre trial N=12
Danish: Enkeltcenterstudie N=12 Multicenterstudie N=40
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION TRISENOX 1 mg/ml sterile concentrate arsenic trioxide
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) TRISENOX 1 mg/ml, sterilt koncentrat arsentrioxid i.v.
English: Systemic exposure to MMAV and DMAV tended to be larger in patients with renal impairment; the clinical consequence of this is unknown but no increased toxicity was noted.
Danish: Systemisk eksponering for MMAV og DMAV syntes at være større hos patienter med nedsat nyrefunktion.
English: Treatment with TRISENOX must be discontinued before the scheduled end of therapy at any time that a hepatotoxicity grade 3 or greater on the National Cancer Institute Common Toxicity Criteria is observed.
Danish: Behandlingen med TRISENOX skal afbrydes midlertidigt før behandlingens planlagte afslutning, hvis der observeres en toksicitetsgrad på 3 eller derover iht.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION TRISENOX 2 mg/ml sterile concentrate arsenic trioxide
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) TRISENOX 2 mg/ml, sterilt koncentrat arsentrioxid i.v.
English: Do not use the preparation if foreign particulate matter is present.
Danish: Infusionsvæsken må ikke anvendes, hvis den indeholder fremmede partikler.
English: TRISENOX 1 mg/ml concentrate for solution for infusion TRISENOX 2 mg/ml concentrate for solution for infusion
Danish: TRISENOX 1 mg/ml koncentrat til infusionsvæske, opløsning TRISENOX 2 mg/ml koncentrat til infusionsvæske, opløsning
English: In a phase 3, multicentre, non-inferiority trial comparing all-trans-retinoic acid (ATRA) plus chemotherapy with ATRA plus arsenic trioxide in newly diagnosed low-to-intermediate risk APL patients (Study APL0406; see also section 5.1), serious adverse reactions including hepatic toxicity, thrombocytopenia, neutropenia and QTc prolongation were observed in patients treated with arsenic trioxide.
Danish: I et non-inferioritets fase 3-multicenterstudie, der sammenlignede all-trans-retinoinsyre (ATRA) plus kemoterapi med ATRA plus arsentrioxid hos nydiagnosticerede patienter med lav til intermediær risiko APL (studie APL0406; se også pkt.
English: TRISENOX 1 mg/ml concentrate for solution for infusion 4 years.
Danish: TRISENOX 1 mg/ml koncentrat til infusionsvæske, opløsning 4 år.
English: D.
Danish: Anv.
English: Each ml of concentrate contains 2 mg of arsenic trioxide.
Danish: Hver ml koncentrat indeholder 2 mg arsentrioxid.
English: Intravenous use after dilution Single use only
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Intravenøs anvendelse efter fortynding Kun til engangsbrug
English: In clinical trials, in the relapsed/refractory setting, 40 % of patients treated with TRISENOX experienced at least one QT corrected (QTc) interval prolongation greater than 500 msec. Prolongation of the QTc was observed between 1 and 5 weeks after TRISENOX infusion, and then returned to baseline by the end of 8 weeks after TRISENOX infusion.
Danish: QTc-forlængelse blev observeret mellem 1 og 5 uger efter TRISENOXinfusionen og vendte derefter tilbage til baseline efter 8 uger efter TRISENOX-infusionen.
English: Dilution of TRISENOX
Danish: Fortynding af TRISENOX
English: How TRISENOX is given
Danish: Sådan gives TRISENOX
English: Pulmonary alveolar haemorrhage
Danish: Blødning fra lungealveole
English: In the total single dose range of 7 to 32 mg (administered as 0.15 mg/kg), systemic exposure (AUC) appears to be linear.
Danish: Den systemiske eksponering (AUC) synes at være lineær i hele dosisintervallet efter enkeltdosis fra 7 til 32 mg (indgivet som 0,15 mg/kg).
English: In one newly diagnosed patient induction treatment was terminated because of severe prolongation of the QTc interval and electrolyte abnormalities on day 3 of induction treatment.
Danish: Induktionsbehandlingen blev seponeret på dag 3 hos en nydiagnosticeret patient på grund af alvorlig forlængelse af QTc-intervallet samt elektrolytanomalier.
English: TRISENOX 2 mg/ml concentrate for solution for infusion 3 years.
Danish: TRISENOX 2 mg/ml koncentrat til infusionsvæske, opløsning 3 år.
English: Vascular disorders Vasculitis
Danish: Vaskulære sygdomme Vaskulitis
English: - lung infection, infection in the blood - inflammation of the lungs which causes chest pain and breathlessness, cardiac failure - dehydration, confusion - Cerebral disease (Encephalopathy, Wernicke encephalopathy) with various manifestations including difficulties to use arms and legs, speech disorders and confusion
Danish: hjertesvigt - væskemangel (dehydrering), forvirring - cerebral sygdom (encefalopati, Wernickes encefalopati) med forskellige manifestationer,
English: Thereafter, in the absence of worsening of the previous toxicity, TRISENOX might be resumed at full dosage.
Danish: Derefter kan TRISENOX genoptages ved den fulde dosering, hvis den tidligere toksicitet ikke forværres.
English: Each vial of 6 ml contains 12 mg of arsenic trioxide.
Danish: Hvert hætteglas med 6 ml indeholder 12 mg arsentrioxid.
English: What TRISENOX is and what it is used for What you need to know before you are given TRISENOX How TRISENOX is given
Danish: Det skal du vide, før du begynder at få TRISENOX Sådan gives TRISENOX
English: Single use only
Danish: ADMINISTRATIONSMETODE Kun til engangsbrug
English: (see section 4.2)
Danish: Se punkt 2
English: IV use after dilution
Danish: anvendelse efter fortynding
English: 6.6 Special precautions for disposal and other handling
Danish: 6.6 Regler for bortskaffelse og anden håndtering Klargøring af TRISENOX
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Danish: - Kontakt lægen, apotekspersonalet eller sundhedspersonalet, hvis du får bivirkninger, herunder bivirkninger, som ikke er nævnt her.
English: The plasma clearance of AsIII in patients with severe renal impairment (creatinine clearance less than 30 ml/min)
Danish: Plasmaclearance for AsIII hos patienter med alvorligt nedsat nyrefunktion
English: TRISENOX may cause harm to the foetus when used by pregnant women.
Danish: Du må ikke få TRISENOX, hvis du er gravid, da det kan skade fosteret.
English: was 40 % lower when compared with patients with normal renal function (see section 4.4).
Danish: (kreatininclearance mindre end 30 ml/min) var 40 % lavere sammenlignet med patienter med normal nyrefunktion (se pkt.
English: Eye disorders Vision blurred
Danish: Øjne Sløret syn
English: Each pack contains 10 vials.
Danish: Hver pakning indeholder 10 hætteglas.
English: TRISENOX must then be diluted immediately with 100 to 250 ml of glucose 50 mg/ml (5 %) solution for injection or sodium chloride 9 mg/ml (0.9 %) solution for injection.
Danish: Fortynding: Før forsigtigt kanylen på en injektionssprøjte ind i ampullen og træk alt indholdet op. TRISENOX skal derefter straks fortyndes med 100 til 250 ml 50 mg/ml (5 %) glucose injektionsvæske, opløsning, eller 9 mg/ml (0,9 %) natriumchlorid injektionsvæske, opløsning.
English: Concentrate for solution for infusion 10 ampoules
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Koncentrat til infusionsvæske, opløsning 10 ampuller
English: Medicinal products known to cause hepatotoxic effects Hepatotoxic effects may occur during the treatment with arsenic trioxide, caution is advised when TRISENOX is co-administered with other medicinal products known to cause hepatotoxic effects (see section 4.4 and 4.8).
Danish: Der tilrådes forsigtighed, når TRISENOX administreres sammen med andre lægemidler, der vides at forårsage hepatotoksiske virkninger (se pkt.
English: Nervous system disorders Paraesthesia
Danish: Nervesystemet Paræstesi
English: Arsenic trioxide can cause QT interval prolongation (see section 4.4).
Danish: Arsentrioxid kan forårsage QT-intervalforlængelse.
English: Pericardial effusion
Danish: Perikardieeffusion
English: Lymphopenia
Danish: Pleuraeffusion
English: TRISENOX 2 mg/ml concentrate for solution for infusion arsenic trioxide
Danish: TRISENOX 2 mg/ml koncentrat til infusionsvæske, opløsning arsentrioxid
English: 18-Month
Danish: 18-mdr.
English: TRISENOX 1 mg/ml concentrate for solution for infusion arsenic trioxide
Danish: TRISENOX 1 mg/ml koncentrat til infusionsvæske, opløsning arsentrioxid
English: If your disease responds to TRISENOX, you will be given a second treatment cycle of 25 doses given 5 days per week (followed by 2 days interruption) for 5 weeks.
Danish: Du vil få en dosis 5 dage om ugen (efterfulgt af en pause på 2 dage) i 5 uger.
English: In newly diagnosed patients with low to intermediate risk APL, gastrointestinal toxicity, grade 3-4 neutropenia and grade 3 or 4 thrombocytopenia occurred, however these were 2.2 times less frequent in patients treated with TRISENOX in combination with ATRA compared to patients treated with ATRA + chemotherapy.
Danish: Disse hændelser var imidlertid 2,2 gange mindre hyppige hos patienter, der fik TRISENOX i kombination med ATRA, sammenlignet med patienter, der fik ATRA + kemoterapi.
English: Pleural effusion
Danish: Pleuritissmerter
English: Hypomagnesaemia
Danish: Hypermagnesiæmi
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each ml of concentrate contains 2 mg of arsenic trioxide.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver ml koncentrat indeholder 2 mg arsentrioxid Hvert hætteglas med 6 ml indeholder 12 mg arsentrioxid.
English: - fatigue (weariness), pain, fever, headache
Danish: Knogler, led, muskler og bindevæv Myalgi
English: PHARMACEUTICAL FORM AND CONTENTS
Danish: LÆGEMIDDELFORM
English: Weight increased
Danish: Nedsat leverfunktion
English: Hypernatraemia
Danish: Hypernatriæmi
English: Table 3 Endpoint
Danish: Tabel 3
English: The treatment may be repeated every three months depending on the patient's symptoms.
Danish: Behandlingen kan gentages hver tredje måned afhængigt af patientens symptomer.
English: It is applied to the most painful areas of the skin.
Danish: Det påføres de mest smertefulde områder af huden.
English: It can be used alone or together with other medicines for pain.
Danish: Det kan anvendes alene eller sammen med andre smertestillende lægemidler.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Qutenza on 15 May 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Qutenza den 15. maj 2009.
English: The full EPAR for Qutenza can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Qutenza findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Qutenza.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Qutenza.
English: Because of this, healthcare professionals should wear nitrile gloves while applying and removing the patch.
Danish: Derfor skal de sundhedsuddannede personer bære nitrilhandsker, når de påfører og fjerner plasteret.
English: It may take up to three weeks for Qutenza to have an effect.
Danish: Det kan tage op til tre uger, før Qutenza virker.
English: Alternatively, medicines for pain may be taken.
Danish: Alternativt kan smertestillende lægemidler anvendes.
English: Qutenza can cause a burning sensation on the skin.
Danish: Qutenza kan give en brændende fornemmelse på huden.
English: A risk management plan has been developed to ensure that Qutenza is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Qutenza anvendes så sikkert som muligt.
English: Qutenza should remain in place for 30 minutes for the feet and 60 minutes for other parts of the body.
Danish: Qutenza skal sidde på i 30 minutter, hvis det er på fødderne, og i 60 minutter, hvis det er på andre dele af kroppen.
English: Qutenza should be applied by a doctor or by a healthcare professional under the supervision of a doctor.
Danish: Qutenza bør påføres af en læge eller af andet sundhedspersonale under overvågning af en læge.
English: The active substance in Qutenza, capsaicin, is a substance normally found in chilli peppers.
Danish: Det aktive stof i Qutenza, capsaicin, er et stof, der normalt findes i chillipeber.
English: Other information about Qutenza
Danish: Andre oplysninger om Qutenza
English: The rapid release of high doses of capsaicin from Qutenza overstimulates the TRPV1 receptors so they become less sensitive to the stimuli that normally cause neuropathic pain.
Danish: Den hurtige frigivelse af høje doser af capsaicin fra Qutenza overstimulerer TRPV1receptorerne, så de bliver mindre følsomme over for de stimuli, som normalt forårsager neuropatiske smerter.
English: For more information about treatment with Qutenza, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Qutenza, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: It stimulates the ‘transient receptor potential vanilloid 1' (TRPV1) receptor which is found in the nerves in the skin that detect pain.
Danish: Det stimulerer receptoren for TRPV1 ("transient receptor potential vanilloid 1") i de nerver i huden, der detekterer smerte.
English: What measures are being taken to ensure the safe and effective use of Qutenza?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Qutenza?
English: The painful area should be determined by a doctor and marked on the skin.
Danish: Lægen skal afgøre, hvor det smertefulde sted er, og markere det på huden.
English: Once the patch is removed, the area is cleaned using the cleansing gel provided.
Danish: Når plastret er fjernet, skal området renses ved hjælp af den medfølgende rensegel.
English: Supportive data showed benefit when Qutenza was repeated over a 1-year period in combination with other treatments.
Danish: Underbyggende data viste en fordel, når behandlingen med Qutenza blev gentaget over en etårig periode i kombination med andre behandlinger.
English: The programme will include information on how to administer, handle and dispose of Qutenza and on warnings and precautions that should be considered during treatment.
Danish: Programmet skal indeholde oplysninger om, hvordan Qutenza administreres, håndteres og bortskaffes, og om, hvilke advarsler og forholdsregler der skal træffes under behandlingen.
English: Qutenza has been compared with control patches containing lower amounts of capsaicin (0.04%) in four main studies involving a total of 1,619 adults with moderate to severe neuropathic pain.
Danish: Qutenza blev sammenlignet med kontrolplastre, der indeholdt lavere mængder af capsaicin (0,04 %), i fire hovedundersøgelser, som omfattede 1 619 voksne med moderate til svære neuropatiske smerter.
English: In addition, the company that makes Qutenza will make sure that an educational programme is available for healthcare professionals who will prescribe Qutenza.
Danish: Virksomheden, som fremstiller Qutenza, skal desuden sikre sig, at der stilles et oplysningsprogram til rådighed for det sundhedsuddannede personale, der skal ordinere Qutenza.
English: The main measure of effectiveness in all main studies was the reduction in the 24-hour pain score during an eight- or 12-week period after application of the patch.
Danish: Det primære effektmål i alle hovedundersøgelserne var et fald i 24-timers smertescoren i løbet af en periode på otte eller 12 uger efter påføringen af plasteret.
English: Qutenza is a cutaneous patch (a patch that delivers a medicine into the skin).
Danish: Qutenza er et kutanplaster (et plaster, som afgiver et lægemiddel gennem huden).
English: Patches can be cut to match the area to cover.
Danish: Plastrene kan tilskæres, så de passer til det område, de skal dække.
English: No more than four patches should be used on the patient at the same time.
Danish: Patienten må højst påføres fire plastre ad gangen.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Qutenza.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Qutenza skal anvendes.
English: All of the patients had neuropathic pain due to either post-herpetic neuralgia (pain that occurs in people who have had shingles, an infection caused by the varicella zoster virus) or HIV-associated neuropathy (damage to the nerves caused by HIV infection).
Danish: Alle patienterne havde neuropatiske smerter enten som følge af postherpetisk neuralgi (smerter, som forekommer hos personer, der har haft helvedesild, en infektion forårsaget af varicella zoster-virus) eller som følge af HIV-associeret neuropati (beskadigelse af nerver forårsaget af HIV-infektion).
English: Qutenza can only be applied to unbroken, non-irritated, dry skin.
Danish: Qutenza må kun påføres hud, som er hel og tør og ikke er irriteret.