FrancophonIA/ELRC3.0 huggingface dataset:
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Rinvoq have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Rinvoq.
English: Rinvoq was effective at controlling moderate to severe rheumatoid arthritis in patients whose disease had not improved enough with other disease-modifying anti-rheumatic medicines.
Danish: Rinvoq er effektivt til at behandle moderat til svær leddegigt hos patienter, hvis sygdom ikke er tilstrækkeligt bedret efter behandling med andre sygdomsmodificerende gigtlægemidler.
English: The fourth study was also in patients whose disease was not controlled well enough with methotrexate.
Danish: Også i det fjerde studie undersøgte man patienter, hvis sygdom ikke var tilstrækkeligt kontrolleret med methotrexat.
English: It found that 45% of the patients treated with Rinvoq on its own had low disease activity after 14 weeks compared with 19% of patients continuing their methotrexate treatment.
Danish: Det blev i studiet påvist, at 45 % af de patienter, der fik Rinvoq som enkeltstofbehandling, havde lav sygdomsaktivitet efter 14 uger, sammenholdt med 19 % af de patienter, der fortsatte methotrexat-behandlingen.
English: It found that after 24 weeks, 48% of patients were in remission (clear of symptoms) after treatment with Rinvoq compared with 19% of patients receiving methotrexate.
Danish: Efter 24 uger sås en bedring (symptomfrihed) hos 48 % af de patienter, der fik Rinvoq, sammenholdt med 19 % af de patienter, der fik methotrexat.
English: What benefits of Rinvoq have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Rinvoq?
English: The second study was in patients whose disease was not well controlled with disease-modifying antirheumatic medicines.
Danish: I det andet studie undersøgte man patienter, hvis sygdom ikke var godt kontrolleret med sygdomsmodificerende gigtlægemidler.
English: It found that of patients treated with Rinvoq, 48% had low disease activity after 12 weeks compared with 17% of patients receiving placebo (a dummy treatment).
Danish: Det blev i dette studie påvist, at 48 % af de patienter, der fik Rinvoq, havde lav sygdomsaktivitet efter 12 uger sammenholdt med 17 % af de patienter, der fik placebo (en uvirksom behandling).
English: The third study was in patients whose disease was not controlled well with methotrexate.
Danish: I det tredje studie undersøgte man patienter, hvis sygdom ikke var godt kontrolleret med methotrexat.
English: How does Rinvoq work?
Danish: Hvordan virker Rinvoq?
English: Unopened: 3 years.
Danish: Uåbnet: 3 år.
English: No action required except continued monitoring.
Danish: Ingen handling påkrævet, bortset fra fortsat kontrol.
English: 0 = No reaction
Danish: 0 = Ingen reaktion
English: As for Grade 3 irritation.
Danish: Som for Grad 3-irritation.
English: Date of first authorization: 11 October 2000 Date of latest renewal: 27 September 2010
Danish: Dato for første markedsføringstilladelse: 11. oktober 2000 Dato for seneste fornyelse: 27. September 2010
English: There are no specific recommendations for use in elderly men (above 65 years of age).
Danish: Der er ingen specifikke anbefalinger for anvendelse hos ældre mænd (over 65 år).
English: Your doctor can give you more information.
Danish: Deres læge kan give Dem flere oplysninger.
English: • Women planning a pregnancy.
Danish: • Kvinder, som planlægger en graviditet.
English: It is important that you consult your doctor, who will tell you what to do.
Danish: Det er vigtigt, at De konsulterer Deres læge, som vil fortælle Dem, hvad De skal gøre.
English: System Organ Class (MedDRA terminology)
Danish: Systemorganklasse (MedDRA-terminologi)
English: Grade 0, 1 or 2
Danish: Grad 0, 1 eller 2
English: - Panretin contains alcohol.
Danish: - Panretin indeholder alkohol.
English: • Do not stop treatment at the first sign of improvement.
Danish: • Stands ikke behandlingen ved det første tegn på bedring.
English: • It may take up to 12 weeks for any improvement to show.
Danish: • Det kan tage op til 12 uger, før en bedring viser sig.
English: The medicinal product was not genotoxic.
Danish: Lægemidlet var ikke genotoksisk.
English: • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: • BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: Infection, including bacterial infection
Danish: Infektion, inklusive bakteriel infektion
English: Therefore, there is a low potential for interactions with systemic medicinal products.
Danish: Der er derfor et lavt potentiale for lægemiddelinteraktioner med systemiske midler.
English: It is not known whether this medicinal product is excreted in human milk.
Danish: Det er ukendt, om dette lægemiddel udskilles i human mælk.
English: Apply the next dose at the usual time.
Danish: Påsmør den næste dosis til sædvanlig tid.
English: • Do not be discouraged if you do not see immediate improvement.
Danish: • Tab ikke modet, hvis De ikke ser bedring omgående.
English: Your doctor will tell you how long your treatment will last.
Danish: Deres læge vil fortælle Dem, hvor længe Deres behandling vil vare.
English: Only two serious adverse reactions were reported (sepsis and cellulitis in the same patient).
Danish: Der blev kun rapporteret 2 alvorlige, uønskede reaktioner (sepsis og cellulitis hos den samme patient).
English: However there could be individual factors (e.g. damaged skin barrier, excessive use) that contribute to an increased systemic exposure.
Danish: Der kan dog være individuelle faktorer (f.eks skadet hudbarriere og overdreven brug), som bidrager til en øget systemisk eksponering.
English: - Avoid scratching the treated areas.
Danish: - Undgå at kradse i de behandlede områder.
English: Do not use a double dose to make up for forgotten individual doses.
Danish: De må ikke anvende en dobbeltdosis som erstatning for glemte enkeltdoser.
English: The frequency of adverse events are classified as very common (≥1/10), common (≥1/100 to <1/10), and uncommon (≥1/1,000 to <1/100).
Danish: Hyppigheden af uønskede hændelser er klassificeret som meget almindelig (≥1/10), almindelig (≥1/100 til <1/10) og ikke almindelig (≥1/1.000 til <1/100) .
English: Serum LDL was increased in both male and female groups at Day 29.
Danish: Serum-LDL var forøget hos både mands- og kvindegrupper på Dag 29.
English: The incidence of severe skin rash was independent of the duration of treatment (10% in both cases).
Danish: Incidensen af svært hududslæt var uafhængig af behandlingsvarigheden (10% i begge tilfælde).
English: No specific studies on fertility have been conducted in men or women.
Danish: Der er ikke udført specifikke undersøgelser af fertilitet hos mænd eller kvinder.
English: Study 2 was followed by an open label study (Study 2a), which included only patients electing to continue from Study 2.
Danish: Undersøgelse 2 blev fulgt af en åben undersøgelse (Undersøgelse 2a), som kun inkluderede patienter, der valgte at fortsætte fra Undersøgelse 2.
English: - A mild soap is recommended when bathing or showering.
Danish: - Der anbefales en mild sæbe ved kar- eller brusebadning.
English: Precautions to be taken before handling or administering the medicinal product Patients should wash their hands before and after applications; it is not necessary to wear gloves.
Danish: Sikkerhedsforanstaltninger, der skal tages før håndtering og administration af lægemidlet Patienterne skal vaske hænder før og efter påsmøringer; det er ikke nødvendigt at bruge handsker.
English: 2 = Moderate
Danish: 2 = Moderat
English: Do not cover the treated lesions with any bandage or other material.
Danish: Dæk ikke de behandlede læsioner med nogen form for bandage eller andet materiale.
English: In Study 2a (N = 99), the overall response rate increased to 56.1%.
Danish: I Undersøgelse 2a (N = 99) steg den samlede responsrate til 56,1%.
English: • Treatment of KS lesions in close proximity to other skin disorders.
Danish: • Behandling af KS-læsioner i umiddelbar nærhed af andre hudsygdomme.
English: DO NOT use Panretin if you are pregnant or thinking of becoming pregnant.
Danish: BRUG IKKE Panretin, hvis De er gravid eller planlægger at blive gravid.
English: Proper application will leave some gel visible on the surface of the lesion when you are finished.
Danish: Korrekt påsmøring vil efterlade noget gel synligt på overfladen af læsionen, når De er færdig.
English: Package leaflet: Iinformation for the user
Danish: Indlægsseddel: Information til brugeren
English: Adverse events include verbatim terms in parentheses.
Danish: Uønskede hændelser omfatter ordrette udtryk i parenteser.
English: Animal toxicology studies showed increased DEET toxicity when DEET was included as part of the formulation.
Danish: Dyretoksikologiske undersøgelser viste øget DEET-toksicitet, når DEET var inkluderet som en del af formuleringen.
English: How to apply Panretin: For cutaneous use (on the skin) only Apply Panretin twice a day to start with, once in the morning and once in the evening.
Danish: Hvordan De skal påsmøre Panretin: Kun til anvendelse på huden (kutan anvendelse) Påsmør Panretin 2 gange dagligt til at begynde med: En gang om morgenen og en gang om aftenen.
English: Definite pink to red coloration
Danish: Tydelig lyserød til rød farvetegning
English: There are no data on the efficacy of Panretin applied less frequently than twice daily.
Danish: Der findes ikke data for effekten af Panretin påført mindre hyppigt end 2 gange dagligt.
English: If you forget to take Panretin
Danish: Hvis De har glemt at tage Panretin
English: Like all medicines, Panretin can have side effects, although not everybody gets them.
Danish: Panretin kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: There were no biologically relevant haematology differences or serum chemistry differences after the 14-day period.
Danish: Der var ingen biologisk relevante hæmatologiforskelle eller serum-kemiforskelle efter den 14 dages periode.
English: If the product is used during pregnancy, or if the patient becomes pregnant while taking this drug, treatment should be discontinued.
Danish: Hvis lægemidlet anvendes under graviditet, eller hvis patienten bliver gravid under anvendelsen af dette lægemiddel, bør behandlingen seponeres.
English: Panretin belongs to a group of medicines that are related to vitamin A and known as retinoids.
Danish: Panretin tihører en gruppe lægemidler, der er beslægtet med vitamin A og kendt som retinoider.
English: The incidence of mild/moderate rash (all events regardless of causality) was less in patients treated for less than 16 weeks than in those treated for 16 weeks or more (mild, 33% v 63%; moderate, 29% v 43%).
Danish: Incidensen af mildt/moderat udslæt (alle hændelser uanset kausalitet) var lavere hos patienter behandlet i mindre end 16 uger end hos dem, der blev behandlet i 16 uger eller mere (mildt: 33% mod 63%; moderat: 29% mod 43%).
English: The projected time for lesions that were in partial response (PR) to later attain clinical complete response (CCR) was 168 days.
Danish: Den projekterede tid for læsioner, som havde partielt respons (PR), til senere at opnå klinisk komplet respons (CCR) var 168 dage.
English: A subset of these patients were followed during treatment of up to 64 lesions (range 4-64, median 11.5 lesions) for up to 44 weeks (range 2-44, median 15 weeks).
Danish: En undergruppe af disse patienter blev fulgt under behandling af op til 64 læsioner (fra 4 til 64, median 11,5 læsioner) i op til 44 uger (fra 2 til 44, median 15 uger).
English: After that, your doctor will decide how often you should apply the gel depending on the response of your KS and any side effects.
Danish: Derefter vil Deres læge beslutte, hvor ofte De skal påsmøre gelen afhængig af, hvordan Deres KS reagerer, samt af en hvilken som helst bivirkning.
English: If your side effects become too uncomfortable, with intense redness and irritation, rash, swelling, or pain, you should ask your doctor for advice on adjusting the dosage of your treatment.
Danish: Hvis Deres bivirkninger bliver for generende med kraftig rødme og irritation, udslæt, hævelse eller smerte, bør De bede Deres læge om vejledning i at justere doseringen af Deres behandling.
English: Stable Disease %
Danish: Stabil sygdom %
English: However, alitretinoin is teratogenic so both men and women should take adequate precautions to avoid female partners becoming pregnant.
Danish: Alitretinoin er dog teratogent, så både mænd og kvinder bør tage tilstrækkelige forholdsregler for at undgå, at kvindelige partnere bliver gravide.
English: Panretin may cause unwanted irritation or redness on healthy skin.
Danish: Panretin kan forårsage uønsket irritation eller rødme på sund hud.
English: Safety and effectiveness in women have not been established because of the paucity of clinical data.
Danish: Sikkerhed og effekt hos kvinder er ikke fastslået, da mængden af kliniske data er utilstrækkelig.
English: Each carton contains one tube of gel.
Danish: Hver enkelt karton indeholder én tube gel.
English: Opened tubes of Panretin gel must not be stored above 25C, and should be protected from exposure to strong light and heat (e.g., direct sunlight).
Danish: Åbnede tuber med Panretin gel må ikke opbevares ved temperaturer over 25 °C og skal beskyttes mod udsættelse for kraftigt lys og varme (f.eks. direkte sollys).
English: Treatment of lesions that have not shown a decrease in area and/or height by week 12 should be discontinued.
Danish: Behandling af læsioner, som ikke har vist tilbagegang i størrelse og/eller højde senest uge 12, skal seponeres.
English: The following side effects have been noted on the skin where Panretin has been applied:
Danish: Følgende bivirkninger er blevet bemærket på huden, hvor Panretin er blevet påsmurt:
English: Local dermal irritation may be graded according to the five-point scale shown in Table 1.
Danish: Lokal hudirritation kan gradueres ifølge fempunktsskalaen vist i Tabel 1.
English: Treatment frequency for that lesion should be reduced or suspended.
Danish: Behandlingshyppigheden for den pågældende læsion skal reduceres eller indstilles.
English: • You may need to reduce the number of daily applications, or stop using Panretin for a short while, if you develop unwanted skin effects.
Danish: • De kan få behov for at nedsætte antallet af påsmøringer pr. dag eller at standse anvendelsen af Panretin i en kort tid, hvis De udvikler uønskede virkninger på huden.
English: Pharmacotherapeutic group: other antineoplastic agents, ATC code: LO1XX22
Danish: Farmakoterapeutisk klassifikation: andre antineoplastiske midler, ATC-kode: LO1XX22
English: Once activated, these receptors function as ligand dependent transcription factors that regulate the expression of specific genes.
Danish: Når disse receptorer først er aktiverede, virker de som ligandafhængige transkriptionsfaktorer, som regulerer ekspressionen af specifikke gener.
English: However, an increased rate of fused sternebrae was observed.
Danish: Dog sås en øget hyppighed af sammenvokset sternebrae.
English: Most patients can continue to use Panretin by altering the number of times a day it is applied.
Danish: De fleste patienter kan fortsætte med at anvende Panretin ved at ændre antallet af gange pr. dag, gelen påsmøres.
English: TREATMENT ADJUSTMENTS
Danish: BEHANDLINGSJUSTERINGER
English: If application site toxicity occurs, the application frequency can be reduced as described below.
Danish: Hvis der forekommer toksicitet på applikationsstedet, kan applikationshyppigheden reduceres som beskrevet nedenfor.
English: However, treatment should not be restarted if Grade 4 toxicity occurred at an application frequency of less than twice a day.
Danish: Behandlingen må dog ikke genoptages, hvis Grad 4-toksicitet er fremkommet ved en applikationshyppighed på mindre end 2 gange dagligt.
English: When applying Panretin gel, 69.1% of patients experienced adverse drug reactions at the application site.
Danish: Ved applikation af Panretin gel oplevede 69,1% af patienterne uønskede lægemiddelreaktioner på applikationsstedet.
English: In the open label phase of Study 1 (N = 184), the overall response rate increased to 66.7%.
Danish: I den åbne fase af Undersøgelse 1 (N = 184) steg den samlede responsrate til 66,7%.
English: The gel must be allowed to dry for three to five minutes before covering with clothing.
Danish: Gelen skal have lov til at tørre i 3-5 minutter før tildækning med tøj.
English: 4 = Very severe
Danish: 4 = Meget svær
English: Men using Panretin should take precautions to ensure that their female partners do not become pregnant.
Danish: Mænd, der bruger Panretin skal tage forholdsregler for at sikre, at deres kvindelige partnere ikke bliver gravide.
English: Place a generous coating of gel over the whole surface of each lesion that you want to treat.
Danish: Anbring et rigeligt lag gel over hele overfladen af hver enkelt læsion, som De ønsker at behandle.
English: Panretin does not treat KS that is inside the body.
Danish: Panretin behandler ikke KS, som findes inden i kroppen.
English: If this seal has been punctured or is not visible when you first open the package, DO NOT USE and return the product to your pharmacy.
Danish: Hvis denne forsegling er punkteret eller ikke er synlig, når De første gang åbner pakningen, MÅ DEN IKKE ANVENDES, og produktet skal returneres til apoteket.
English: Studies have not been performed to determine the carcinogenic potential of alitretinoin.
Danish: Der er ikke udført undersøgelser til bestemmelse af det carcinogene potentiale hos alitretinoin.
English: Do not use Panretin: - if you are allergic to alitretinoin or to similar medicines containing retinoids - if you are allergic to any of the other ingredients of this medicine (listed in section 6) - if you are pregnant - if you are planning a pregnancy - if you are breast-feeding - on KS lesions close to any other skin complaint
Danish: Brug ikke Panretin: - hvis De er allergisk over for alitretinoin eller lignende lægemidler indeholdende retinoider - hvis De er allergisk over for et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6) - hvis De er gravid - hvis De planlægger graviditet - hvis De ammer - på KS-læsioner tæt ved en hvilken som helst anden hudsygdom
English: When used in accordance with the prescribing information topically administered retinoids are generally assumed to result in low systemic exposure due to minimal dermal absorption.
Danish: Når de anvendes i henhold til ordinationsvejledningen, antages topikalt administrerede retinoider generelt at resultere i lav systemisk eksponering som følge af minimal dermal absorption.
English: Retinoids as a class have been associated with photosensitivity.
Danish: Retinoider er som gruppe blevet forbundet med fotosensibilitet.
English: In study 1, of 110 responding patients, 36 (33%) relapsed, while all but four still being on active treatment.
Danish: I Undersøgelse 1 fik 36 (33%) ud af 110 responderende patienter relaps, hvoraf alle pånær fire stadig fik aktiv behandling.
English: Occlusive dressings should be avoided.
Danish: Okklusive bandager skal undgås.
English: It is recommended that daily dietary intake of vitamin A should not exceed the Recommended Dietary Intake value.
Danish: Det anbefales, at den daglige indtagelse af vitamin A i kosten ikke overstiger værdien for Anbefalet Daglig Dosis.
English: - If you think that the effect of Panretin is too strong or too weak, talk to your doctor or pharmacist.
Danish: - Hvis De mener, at virkningen af Panretin er for kraftig eller for svag, bør De tale med deres læge eller apotek herom.
English: Study 1, 6 index lesions; Study 2, up to 8 index lesions Each index lesion assessed individually for response.
Danish: Undersøgelse 1: 6 indekslæsioner; Undersøgelse 2: op til 8 indekslæsioner Hver indekslæsion vurderet særskilt for respons.
English: In one trial, 29% of the lesions that had reached a partial response (PR) but had not attained clinical complete response (CCR) within the first 12 weeks of treatment developed a CCR during continuing treatment beyond 12 weeks.
Danish: I én undersøgelse udviklede 29% af læsionerne, som havde nået et partielt respons (PR), men ikke opnået klinisk komplet respons (CCR) inden for de første 12 uger af behandlingen, et CCR ved fortsat behandling ud over de 12 uger.
English: Carefully applying the gel only to the area of the KS lesion will help to lessen any irritation or redness that may occur.
Danish: Ved at påføre gelen omhyggeligt udelukkende i området med KS-læsionen vil det medvirke til at mindske enhver irritation eller rødme, som kan forekomme.
English: Carcinogenesis, mutagenesis, impairment of fertility
Danish: Carcinogenese, mutagenese, svækkelse af fertilitet
English: In-use: Any remaining tube should be discarded 90 days after first opening.
Danish: Efter anbrud: Al tiloversbleven medicin i tuben skal bortskaffes 90 dage efter første anbrud.
English: The safety of Panretin gel has been assessed in clinical studies of more than 469 patients with AIDS-related KS, 439 of whom were treated with an alitretinoin concentration of 0.1%.
Danish: Sikkerheden af Panretin gel er blevet vurderet i kliniske undersøgelser af mere end 469 patienter med AIDS-relateret KS, hvoraf 439 blev behandlet med en alitretinoin-koncentration på 0,1%.
English: OUTER CARTON TEXT AND TUBE LABEL TEXT
Danish: TEKST PÅ YDRE KARTON OG TEKST PÅ TUBETIKET
English: Do not use after the expiry date which is stated on the end of the tube.
Danish: Brug ikke lægemidlet efter den udløbsdato (Exp), som er angivet på tuben.
English: Overall Response %
Danish: Samlet respons %
English: Treatment of any lesion that has fully resolved on clinical assessment should be discontinued.
Danish: Behandling af en hvilken som helst læsion, der er svundet helt ved klinisk vurdering, skal seponeres.
English: Lesions responding during the first 12 weeks on study, initial blinded phase, confirmed over at least four study weeks (confirmation of response may have occurred after 12 weeks for some lesions in Study 1).
Danish: Læsionsresponderende i de første 12 uger i undersøgelsen, initial, blindet fase, bekræftet over mindst 4 undersøgelsesuger (bekræftelse af respons kan være sket efter 12 uger for nogle læsioner i Undersøgelse 1).
English: Observed increases in mean heart-to-final body weight differences were attributed principally to the difference in the terminal body weights.
Danish: Observerede forøgelser af gennemsnitlige forskelle i forholdet mellem hjertets vægt og sidste legemsvægt blev hovedsageligt tilskrevet forskelle i slutlegemsvægten.
English: Wash your hands using soap and water and wipe the healthy skin touched by the gel.
Danish: Vask hænderne ved brug af vand og sæbe og aftør den sunde hud, der har været i berøring med gelen.
English: Deep red, swelling and oedema with or without signs of bullae formation and necrosis
Danish: Dybt rødt, hævelse og ødem med eller uden tegn til dannelse af bullae og nekrose
English: Panretin therapy should only be initiated and maintained by specialist physicians experienced in the treatment of patients with KS.
Danish: Panretin-behandling må kun påbegyndes og vedligeholdes af speciallæger, der har erfaring med behandlingen af patienter med KS.
English: Increased redness, possible oedema
Danish: Øget rødme, muligt ødem
English: After opening, use within 90 days.
Danish: Bruges inden for 90 dage efter anbrud.
English: Percentages calculated as number of patients with responding lesions divided by total number of patients in the initial blinded phase.
Danish: Procentdel beregnet som antal patienter med responderende læsioner divideret med totalt antal patienter i den initiale, blindede fase.