FrancophonIA/ELRC3.0 huggingface dataset:
English: However, the incidence of other equally common drug-related adverse events such as pruritus, oedema, exfoliative dermatitis and dry skin did not appear to increase as a function of the frequency of application.
Danish: Incidensen af andre lige så almindelige lægemiddelrelaterede, uønskede hændelser så som pruritus, ødem, exfoliativ dermatitis, og tør hud syntes dog ikke at stige som et resultat af applikationsfrekvensen.
English: In lesions that have responded to treatment during this time, application may be continued provided that the response improves or is maintained and the product continues to be tolerated.
Danish: Ved læsioner, som har responderet på behandling i denne tid, kan applikation fortsættes, forudsat at respons bedres eller opretholdes, og at produktet fortsat tåles.
English: However, because of the potential for undesirable effects from Panretin gel in infants being breast-fed, mothers must discontinue breast-feeding prior to using the medicinal product and not initiate breast-feeding while using the medicinal product.
Danish: På grund af potentialet for uønskede virkninger af Panretin gel hos børn, der ammes, skal mødre dog ophøre med at amme før anvendelse af lægemidlet og ikke påbegynde amning under brugen af lægemidlet.
English: At Least One At Least Four
Danish: Mindst fire
English: Panretin is used in patients with AIDS-related Kaposi's sarcoma (KS) and is for the treatment of the KS lesions: - that are on the skin only - which have not responded to your HIV treatment - where the skin or lesion is not broken - where the surrounding skin is not swollen - if your doctor thinks that other treatments are not suitable for you.
Danish: Panretin anvendes hos patienter med AIDS-relateret Kaposis sarkom (KS) og er til behandling af de KS-læsioner: - der kun er på huden - som ikke har reageret på Deres HIV-behandling, - hvor der ikke er hul på huden eller læsionen - hvor den omgivende hud ikke er hævet - hvis Deres læge mener, at andre behandlingsformer ikke er egnede til Dem.
English: Table 1 Grading of local dermal irritation GRADE
Danish: Tabel 1 Graduering af lokal hudirritation GRAD
English: Do not breast-feed your baby while you are using Panretin.
Danish: Am ikke Deres barn, mens De anvender Panretin.
English: The results suggest that alitretinoin absorbs light in the UV range and is subject to photodegradation to other isomers (predominantly all-trans-retinoic acid).
Danish: Resultaterne tyder på, at alitretinoin absorberer lys i UV-området og er genstand for fotonedbrydning til andre isomerer (fortrinsvis all-trans-retinsyre).
English: Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Danish: Fortæl altid lægen eller apotekspersonalet, hvis De tager anden medicin eller har gjort det for nylig, også hvis der er tale om ikke-receptpligtige lægemidler.
English: - Avoid showering, bathing, or swimming for at least three hours after any application.
Danish: - Undgå brusebadning, karbadning eller svømning i mindst 3 timer efter enhver påsmøring.
English: On a theoretical basis, no dose adjustment is necessary in patients with renal insufficiency or liver disease, but these patients should be closely monitored and treatment frequency reduced, or withdrawn, if they experience adverse effects.
Danish: Teoretisk er dosisjustering ikke nødvendig hos patienter med nyreinsufficiens eller leversygdom, men disse patienter skal kontrolleres tæt og behandlingshyppigheden reduceres, eller behandlingen seponeres, hvis de får uønskede virkninger.
English: Orally administered retinoids have been associated with congenital abnormalities.
Danish: Oralt administrerede retinoider har været forbundet med kongenitale anormaliteter.
English: - Allow the gel to dry for three to five minutes before covering a treated area with loose clothing.
Danish: - Lad gelen tørre i 3-5 minutter, før behandlede områder dækkes med løstsiddende tøj.
English: - Do not apply the gel on or near sensitive parts of your body such as eyes, nostrils, mouth,
Danish: - Påsmør ikke gelen på eller nær følsomme dele af kroppen så som øjne, næsebor, mund,
English: Always use the cap to close the tube tightly after each use.
Danish: Brug altid hætten for at lukke tuben tæt efter brug.
English: Progressive Disease %
Danish: Progredierende sygdom %
English: It is recommended that Panretin gel should be applied for an initial treatment period of up to 12 weeks.
Danish: Det anbefales, at Panretin gel appliceres i en initial behandlingsperiode på op til 12 uger.
English: Very red, with oedema, with or without vesiculation
Danish: Meget rødt, med ødem, med eller uden vesikeldannelse
English: Based on the plasma concentrations observed in patients, milk concentrations of 9-cis-retinoic acid probably pose a low risk for the infant.
Danish: På basis af de observerede plasmakoncentrationer hos patienter udgør mælkekoncentrationer af 9-cis-retinsyre sandsynligvis en lav risiko for barnet.
English: The regulation of gene expression by alitretinoin controls the process of cellular differentiation and proliferation in both normal and neoplastic cells.
Danish: Alitretinoins regulering af genekspression styrer den cellulære differentieringsproces og proliferation i både normale og neoplastiske celler.
English: Patients should initially apply Panretin twice a day to cutaneous KS lesions.
Danish: Patienterne skal indledningsvis påsmøre Panretin 2 gange dagligt på kutane KS-læsioner.
English: Panretin gel can be expected to have local therapeutic effects only and it has no role in the prevention or treatment of visceral KS.
Danish: Det kan forventes, at Panretin gel kun har lokalterapeutisk effekt, og det har ingen rolle i forebyggelsen eller behandlingen af visceralt KS.
English: Systemic toxicity following acute overdose with topical application of Panretin gel is unlikely.
Danish: Systemisk toksicitet efter akut overdosering med lokal applikation af Panretin gel er usandsynligt.
English: Panretin is not approved for use in children and adolescents under 18 years of age.
Danish: Panretin er ikke godkendt til brug til børn og unge under 18 år.
English: - lesions are not ulcerated or lymphoedematous - treatment of visceral KS is not required - lesions are not responding to systemic antiretroviral therapy - radiotherapy or chemotherapy are not appropriate
Danish: - læsionerne ikke er ulcererede eller lymfødematøse - behandling af visceralt KS ikke er påkrævet - læsionerne ikke responderer på systemisk, antiretroviral behandling - røntgenterapi eller kemoterapi ikke er hensigtsmæssig
English: Observed effects at the application site included erythema, epidermal thickening, scaling and loosening of the stratum corneum.
Danish: Virkninger observeret på applikationsstedet omfattede erytem, epidermisfortykkelse, afskalning og løsning af stratum corneum.
English: The frequency of application should be adjusted for each lesion independently.
Danish: Applikationshyppigheden skal tilpasses til hver enkelt læsion for sig.
English: If you use more Panretin than you should There has been no experience with overdose of Panretin.
Danish: Hvis De har brugt for meget Panretin Der er ingen erfaringer med overdosering af Panretin.
English: Three doses of alitretinoin (0.01%, 0.05%, or 0.5%) in a topical gel formulation were given to rats in a 28-day dermal toxicology study.
Danish: 3 doser af alitretinoin (0,01%, 0,05%, eller 0,5%) i en lokal gelformulering blev givet til rotter i en 28 dages undersøgelse af hudtoksikologi.
English: Panretin gel should not be used concurrently with products containing DEET.
Danish: Panretin gel må ikke anvendes samtidig med produkter, der indeholder DEET.
English: - Do not use insect repellents containing DEET (N,N-diethyl-m-toluamide) or other products containing DEET while using Panretin.
Danish: - Brug ikke insektafvisende midler, der indeholder DEET (N,N-diethyl-m-toluamid) eller andre produkter, der indeholder DEET, mens De anvender Panretin.
English: There were no reports of photosensitivity associated with the use of Panretin gel in the clinical studies.
Danish: Der var ingen rapporter om fotosensibilitet i forbindelse med anvendelsen af Panretin gel i de kliniske undersøgelser.
English: Pale skin
Danish: Bleg hud
English: Gel should not be applied on or near eyes or mucosal surfaces of the body.
Danish: Gelen må ikke påsmøres på eller nær ved øjne eller på kroppens mukøse overflader.
English: Table 4 Best response according to ACTG criteria for vehicle controlled phase Study 1 (TID, QID)
Danish: Tabel 4 Bedste respons ifølge ACTG-kriterier for vehikel-kontrolleret fase Undersøgelse 1 (3xdgl., 4xdgl.)
English: Guidelines for treatment adjustments necessitated by local dermal treatment-related toxicity are specified in Table 2.
Danish: Retningslinier for behandlingsjusteringer nødvendiggjort af lokal, behandlingsrelateret hudtoksicitet er specificeret i Tabel 2.
English: Take special care with Panretin - Panretin is not approved for use in children and adolescents under 18 years of age.
Danish: Vær ekstra forsigtig med at bruge Panretin - Panretin er ikke godkendt til brug til børn eller unge under 18 år.
English: Table 5 provides the individual lesion response rates for patients being treated with Panretin gel in the Phase III studies.
Danish: Tabel 5 viser responsraterne for de enkelte læsioner for patienter, der er i behandling med Panretin gel i Fase III-undersøgelserne.
English: - This medicine has been prescribed for you.
Danish: - Lægen har ordineret dette lægemiddel til Dem personligt.
English: If a complete response of a lesion occurs, no further application of Panretin gel should be made to the responding lesion.
Danish: Hvis der forekommer et komplet læsionsrespons, bør der ikke påsmøres yderligere Panretin til den responderende læsion.
English: For cutaneous use.
Danish: Til kutan anvendelse.
English: Clinical chemistry evaluations revealed biologically relevant significant increases in the mean BUN and alkaline phosphatase values in females after the 28-day treatment.
Danish: Klinisk kemiske vurderinger afslørede biologisk relevante, signifikante stigninger i middel-BUN og alkaliske fosfataseværdier hos kvinder efter behandlingen på 28 dage.
English: Table 3 Adverse reactions reported in patients in clinical trials
Danish: Tabel 3 Bivirkninger rapporteret hos patienter i kliniske forsøg
English: Response rates were analysed both by the patient as the unit of analysis and by the lesion.
Danish: Responsraterne blev både analyseret med patienten og med læsionen som analyseenhed.
English: Clinical pathology evaluations revealed significant increases in absolute polymorphonuclear leukocyte counts, monocyte counts, percentage of monocytes and decreases in percentage of lymphocyte differential white blood cell counts on day 29 of rats treated with alitretinoin 0.5% gel.
Danish: Klinisk patologiske vurderinger afslørede signifikante stigninger i absolutte polymorfkernede leukocyttal, monocyttal, procentvist antal monocytter og nedgang i det procentvise antal lymfocytter ved differentialtælling af hvide blodlegemer på dag 29 hos rotter behandlet med alitretinoin 0,5% gel.
English: Panretin gel is indicated for the topical treatment of cutaneous lesions in patients with AIDSrelated Kaposi's sarcoma (KS) when:
Danish: Panretin gel er indiceret til lokal behandling af kutane læsioner hos patienter med AIDS-relateret Kaposis sarkom (KS), når:
English: The opening of the Panretin tube is covered by a metal safety seal.
Danish: Panretin gel-tubens åbning er dækket af en sikkerhedsforsegling af metal.
English: There was no clinical evidence in the vehicle-controlled studies of interactions with systemic antiretroviral agents, including protease inhibitors; macrolide antibiotics and azole antifungals.
Danish: Der var i de vehikelkontrollerede undersøgelser ingen kliniske holdepunkter for lægemiddelinteraktioner med systemiske antiretrovirale midler, inklusive protease-hæmmere; makrolidantibiotika og azol-svampemidler.
English: - Women of child-bearing age must use an effective method of birth control while using Panretin, and for one month after finishing treatment.
Danish: - Kvinder i den fødedygtige alder skal anvende en effektiv metode til fødselskontrol, mens de anvender Panretin og i 1 måned efter afslutningen af behandlingen.
English: (Graded per Table 1)
Danish: Tabel 1)
English: However, patients must be cautioned to minimise exposure of treated areas to sunlight or other ultraviolet (UV) light.
Danish: Patienterne skal dog tilrådes at udsætte behandlede områder mindst muligt for sollys eller andet ultraviolet (UV) lys (se pkt.
English: For those lesions that have shown a decrease in height and/or area by week 12, applications may be continued providing that there is continued improvement or at least maintenance of the response and that the product continues to be tolerated.
Danish: For de læsioner, som har vist tilbagegang i højde og/eller størrelse senest uge 12, kan applikationerne fortsættes forudsat at der stadig sker forbedring eller i det mindste vedligeholdelse af reaktionen, og at produktet fortsat tåles.
English: The adverse events seen with Panretin gel are similar to those seen with other topical retinoids.
Danish: De uønskede hændelser, der er set med Panretin gel, er lig dem, der ses med andre topiske retinoider.
English: When dermal irritation improves to Grade 0 or 1, treatment may be restarted at twice daily, increasing every two weeks as tolerated.
Danish: Når hudirritationen forbedres til Grad 0 eller 1, må behandlingen genoptages med 2 gange dagligt stigende hver anden uge afhængig af, hvordan den tåles.
English: Patients should apply Panretin to cutaneous KS lesions using sufficient gel so as to cover each lesion with a generous coating.
Danish: Patienterne skal påsmøre Panretin på kutane KS-læsioner ved brug af tilstrækkeligt gel til at dække hver enkelt læsion med et rigeligt lag.
English: The side effects are most likely to appear at the site where Panretin was applied and typically begins as redness.
Danish: Bivirkningerne fremkommer mest sandsynligt på det sted, hvor Panretin er blevet påsmurt, og begynder typisk som rødme.
English: AIDSrelated Kaposi's sarcoma is infrequent in this population.
Danish: AIDS-relateret Kaposis sarkom er sjælden I denne population.
English: While no data are available, it is possible that co-administration of medicinal products which induce CYP isozymes may reduce circulating levels of alitretinoin, with a possible negative effect on the efficacy of Panretin gel.
Danish: Selv om der ikke er tilgængelige data, er det muligt, at samtidig indgivelse af lægemidler, som inducerer CYP-isozymer, kan reducere koncentrationerne af alitretinoin i blodbanen med en mulig negativ virkning på effekten af Panretin gel.
English: Alitretinoin was shown to have a weak potential to be a photo-irritant based on histidine and photoprotein binding.
Danish: Det blev påvist, at alitretinoin har et svagt potentiale for at være en fotoirritans på basis af histidin- og fotoproteinbinding.
English: The phototoxicity potential of alitretinoin was assessed based on its chemical properties and data from a battery of in vitro tests.
Danish: Det fototoksiske potential hos alitretinoin blev vurderet på basis af dets kemiske egenskaber og data fra en gruppe in vitro-test.
English: Clear yellow gel.
Danish: Gel Klar, gul gel
English: The dermal toxicity typically begins as erythema; with continued application of Panretin gel erythema may increase and oedema may develop.
Danish: Hudtoksicitet begynder typisk som erytem; ved fortsat applikation af Panretin gel kan erytemet forøges, og der kan udvikles ødem.
English: Care should be taken not to bring your baby into contact with areas of your skin treated recently with Panretin.
Danish: De skal passe på ikke at bringe Deres barn i kontakt med områder af Deres hud, som for nylig er behandlet med Panretin.
English: After opening the tube for application, the tube cap must be replaced and closed tightly to provide an airtight seal.
Danish: Efter åbning af tuben i forbindelse med applikation skal tubens hætte sættes på igen og lukkes tæt til for at være lufttæt.
English: Table 5 Index/indicator lesion 1 responses within patients during the first 12 weeks on study in initial blinded phase Patients with given number of index/indicator lesion responses (CCR or PR) Study 1
Danish: 1-respons hos patienter i de første 12 uger i undersøgelsen i den initiale, blindede fase Patienter med angivet antal indeks-/indikator-læsionsrespons (CCR eller PR) Undersøgelse 1
English: The efficacy of Panretin gel in treating KS lesions may be related to the demonstrated ability of alitretinoin to inhibit the in vitro growth of KS cells.
Danish: Effekten af Panretin gel ved behandling af KS-læsioner kan være relateret til den påviste evne hos alitretinoin til at hæmme in vitro-væksten af KS-celler.
English: DEFINING CLINICAL SIGNS
Danish: DEFINITION AF KLINISKE SYMPTOMER
English: It is not recommended for patients to apply Panretin gel concurrently with products that contain N,N-diethyl-m-toluamide (DEET ), a common component of insect repellent products.
Danish: Det kan ikke anbefales patienter at påsmøre Panretin gel samtidig med produkter, som indeholder N,N-diethyl-m-toluamid (DEET), en almindelig bestanddel i insektsafvisende produkter.
English: There are no data regarding the use of Panretin gel in patients with renal insufficiency or liver disease.
Danish: Der findes ingen data angående anvendelse af Panretin gel hos patienter med nyreinsufficiens eller leversygdom.
English: The application frequency can be increased stepwise to three or four times a day according to individual lesion tolerance, allowing no less than two weeks between dose increases.
Danish: Applikationshyppigheden kan øges trinvist til 3 eller 4 gange dagligt i overensstemmelse med individuel læsionstolerance, idet der skal gå mindst 2 uger mellem dosisforhøjelser.
English: 1 g of gel contains 1 mg of alitretinoin.
Danish: 1 g gel indeholder 1 mg alitretinoin.
English: However, mineral oil must not be applied for at least two hours before or after the application of Panretin.
Danish: Dog må mineralsk olie ikke påsmøres mindre end 2 timer før eller efter applikation af Panretin.
English: What Panretin looks like and contents of the pack Panretin is a clear yellow gel.
Danish: Udseende og pakningstørrelser Panretin er en klar, gul gel.
English: The incidence of drug-related skin disorder, skin ulcer, pain and rash appeared to be greater in patients applying Panretin gel four times daily than in those applying it less frequently.
Danish: Incidensen af lægemiddelrelateret hudlidelse, hudsår, smerter, og udslæt viste sig at være højere hos patienter, der påsmurte Panretin gel 4 gange dagligt end hos dem, der påsmurte det mindre hyppigt.
English: It is recommended that Panretin should be applied to lesions for an initial period of up to 12 weeks.
Danish: Det anbefales, at påsmøre Panretin på læsionerne i en initial periode på op til 12 uger.
English: 1 g of gel contains 1 mg alitretinoin (0.1%).
Danish: 1 g gel indeholder 1 mg alitretinoin (0,1%).
English: What you need to know before you use Panretin
Danish: Det skal De vide, før De begynder at bruge Panretin
English: Alitretinoin may cause harm to the foetus.
Danish: Alitretinoin kan forårsage fosterskade.
English: Apply Panretin to your KS lesions using a clean finger.
Danish: Påsmør Panretin på KS-læsionerne ved brug af en ren finger.
English: Pain (burning, pain, soreness)
Danish: Smerter (brænden, smerter, ømhed)
English: - Avoid prolonged exposure of the treated area to sunlight or other ultraviolet (UV) light (such as tanning lamps).
Danish: - Undgå at udsætte det behandlede område for sollys eller andet ultraviolet (UV) lys (så som solarielamper) i længere tid.
English: The safety and efficacy of Panretin gel in children under 18 years has not been established.
Danish: Panretin gels sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
English: Keep away from naked flame.
Danish: Holdes væk fra åben ild.
English: • Hypersensitivity to retinoids in general, to the active substance alitretinoin or to any of the excipients listed in section 6.1.
Danish: • Overfølsomhed over for retinoider i almindelighed, over for det aktive stof alitretinoin eller over for et eller flere af hjælpestofferne anført i pkt.
English: Clinical Complete Response (CCR) %
Danish: Klinisk komplet respons (CCR) % 0,7 Partielt respons (PR) %
English: Dermal toxicity may become treatment-limiting, with intense erythema, oedema, and vesiculation.
Danish: Hudtoksicitet kan blive behandlingsbegrænsende med intenst erytem, ødem og vesikeldannelse.
English: Showering, bathing, or swimming for at least three hours after any application should be avoided.
Danish: Brusebadning, karbadning eller svømning skal undgås i mindst 3 timer efter enhver påsmøring.
English: In contrast to these findings in rats, plasma concentrations of 9-cis-retinoic acid in patients with KS applying Panretin gel never exceeded 0.638 ng/ml (2.13 nMol).
Danish: I modsætning til disse fund hos rotter oversteg plasmakoncentrationerne af 9-cis-retinsyre hos patienter med KS, der påsmurte Panretin gel, aldrig 0,638 ng/ml (2,13 nmol).
English: Also contains ethanol, macrogol 400, hydroxypropylcellulose, butylhydroxytoluene.
Danish: Indeholder desuden ethanol, macrogol 400, hydroxypropylcellulose, butylhydroxytoluen.
English: With continued application of Panretin redness and irritation may increase and swelling at the site of the application may develop.
Danish: Ved fortsat påsmøring af Panretin kan rødme og irritation øges, og der kan udvikle sig hævelse på påsmøringsstedet.
English: In cell-based in vitro assays, alitretinoin showed weak phototoxic potential.
Danish: Ved celle-baserede in vitro-analyser viste alitretinoin et svagt fototoksisk potentiale.
English: There are no data regarding the efficacy of Panretin gel when applied to complicated lesions (e.g., when lymphoedema is present).
Danish: Der findes ingen data angående effekten af Panretin gel, når det påsmøres på komplicerede læsioner (f.eks. ved tilstedeværelse af lymfødem).
English: Hydroxypropylcellulose Butylhydroxytoluene
Danish: Hydroxypropylcellulose Butylhydroxytoluen 6.2 Uforligeligheder
English: To open for the first time, use the pointed portion of the cap to puncture the metal safety seal.
Danish: Når tuben skal åbnes første gang, anvendes den spidse del af hætten til at punktere sikkerhedsforseglingen af metal.
English: Table 3 shows the following application-site drug-related adverse reactions were reported during clinical studies in patients with KS.
Danish: Tabel 3 viser de følgende, uønskede, lægemiddelrelaterede bivirkninger på applikationsstedet blev rapporteret under kliniske undersøgelser hos patienter med KS.
English: In an oral dose-ranging study in rabbits, alitretinoin induced gross malformations at a dose 35 times the topical human dose.
Danish: I en oral, dosisbestemmende undersøgelse hos kaniner fremkaldte alitretinoin umiddelbart synlige misdannelser på en dosis 35 gange den lokale, humane dosis.
English: Number of Responding
Danish: Antal respon-derende
English: - The other ingredients are ethanol, macrogol 400, hydroxypropylcellulose, and butylhydroxytoluene.
Danish: - Øvrige indholdsstoffer: ethanol, macrogol 400, hydroxypropylcellulose og butylhydroxytoluen.
English: Adverse events associated with the use of Panretin gel in AIDS-related KS occurred almost exclusively at the site of application.
Danish: Bivirkninger i forbindelse med anvendelse af Panretin gel ved AIDS-relateret KS forekom næsten udelukkende på applikationsstedet.
English: Study 2 (BD)
Danish: Undersøgelse 2 (2xdgl.)
English: AIDS-related Kaposi's sarcoma is infrequent in women.
Danish: AIDS-relateret Kaposis sarkom er sjælden hos kvinder.