FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAH believed that the addition of this information would give the clinician a useful short summary of the derivation of the data in this section and the more uncommon undesirable effects of Daivobet ointment.
Danish: Indehaveren af markedsføringstilladelsen var af den opfattelse, at tilføjelsen af denne information ville give lægen en nyttig kort oversigt over dataenes oprindelse i dette punkt og de mere sjældne bivirkninger ved Daivobet salve.
English: Calcipotriol helps to bring the rate of skin cell growth back to normal and betamethasone acts to reduce inflammation.
Danish: Calcipotriol hjælper til at normalisere hudcellernes vækst, og betamethason mindsker vævsirritation (inflammation).
English: Uncommon (affects less than 1 in 100 people) - Worsening of your psoriasis.
Danish: Ikke almindelige (ses hos mindre end 1 ud af 100 personer) - Forværring af psoriasis.
English: The CHMP concluded that the MAH has justified not adding specific wording on rebound or on atrophy and has provided all requested information.
Danish: CHMP konkluderede, at indehaveren af markedsføringstilladelsen havde givet en begrundelse for, at der ikke blev tilføjet en særlig bemærkning om rebound-effekt eller atrofi, og at indehaveren af markedsføringstilladelsen havde givet alle de informationer, der var blevet anmodet om.
English: The CHMP considered acceptable that in the studies performed to support the gel and ointment formulations, concomitant medication to treat psoriasis of the body and scalp respectively was permitted.
Danish: CHMP anså det for acceptabelt, at det i de undersøgelser, der blev foretaget til støtte for gel- og salveformuleringerne, var tilladt samtidig at bruge andre lægemidler til behandling af psoriasis henholdsvis i hovedbunden og på kroppen.
English: The following serious side effects have been reported for Daivobet Uncommon (affect less than 1 in 100 people) - Worsening of your psoriasis.
Danish: Følgende alvorlige bivirkninger er blevet indberettet for Daivobet Ikke almindelige bivirkninger (ses hos mindre end 1 ud af 100 personer) - Forværring af din psoriasis.
English: This description is more general than in the MRP SPC: “Like other topical corticosteroids, betamethasone dipropionate has anti-inflammatory, antipruritic, vasoconstrictive and immunosuppressive properties, however, without curing the underlying condition”.
Danish: Denne beskrivelse er mere generel end i det gensidigt anerkendte produktresumé: “I lighed med andre topiske kortikosteroider har betamethasondipropionat anti-inflammatoriske, kløestillende, vasokonstriktive og immunsuppresive egenskaber, men kurerer ikke den underliggende tilstand”.
English: Approximately 1 in 10 people may experience side effects but most of these are reactions at the site where the ointment has been applied and are usually mild and temporary.
Danish: Ca. 1 ud af 10 personer kan forvente at få bivirkninger, men de fleste er sædvanligvis milde og forbigående reaktioner på det sted, hvor salven er påsmurt.
English: These reactions are usually mild and cover mainly various skin reactions like rash, pruritus and burning sensation.
Danish: Disse bivirkninger er sædvanligvis milde og omfatter hovedsageligt forskellige hudreaktioner som udslæt, kløe og en brændende fornemmelse i huden.
English: Photo(co)carcinogenicity studies in mice suggest that calcipotriol may enhance the effect of UVR to induce skin tumours.
Danish: Et foto(co)karcinogenicitetsstudie i mus indikerer, at calcipotriol kan fremme UV-strålers induktion af hudtumorer.
English: Carton text: Lot/EXP - see the bottom of the carton.
Danish: Tekst på karton: Lot/EXP - se bunden af kartonen.
English: If it is necessary to continue or restart treatment after this period, treatment should be continued after medical review and under regular medical supervision.
Danish: Hvis det skønnes nødvendigt at fortsætte eller genstarte behandlingen efter denne periode, bør det ske under lægeligt tilsyn.
English: In three MSs the wording regarding contraindications of corticosteroids was more general than in the MRP SPC.
Danish: I tre medlemsstater var teksten om kortikosteroiders kontraindikationer mere generel end i det gensidigt anerkendte produktresumé.
English: The adverse drug reactions that were reported by more than 2 % of the patients in the Daivobet ointment group were pruritus (5.8 %) and psoriasis (5.3 %).
Danish: Bivirkningerne, som blev rapporterede af mere end 2% af patienterne i Daivobet salve gruppen, var kløe (5,8 %) og psoriasis (5,3 %).
English: If you notice this, stop taking Daivobet and tell your doctor as soon as possible.
Danish: Hvis du opdager sådanne reaktioner, skal du holde op med at bruge Daivobet og kontakte din læge så hurtigt som muligt.
English: No cases of skin atrophy were reported.
Danish: Ingen tilfælde af hudatrofi blev rapporteret.
English: However, if infection worsens, treatment with corticosteroids should be stopped.
Danish: Hvis infektionen forværres, skal behandling med kortikosteroider stoppes.
English: Concomitant skin infections
Danish: Samtidige hudinfektioner
English: If it is necessary to continue or restart treatment after 4 weeks, treatment should be continued after medical review and under regular medical supervision.
Danish: Hvis det skønnes nødvendigt at fortsætte eller genstarte behandlingen efter 4 uger, bør det ske under lægeligt tilsyn.
English: The text “impact on the metabolic control of diabetes mellitus” has been added to the undesirable effects of betamethasone dipropionate as already stated in section 4.4 of the DCP SPC.
Danish: Teksten “indvirkning på stofskiftekontrollen af diabetes mellitus” blev tilføjet til betamethasondipropionats bivirkninger som allerede nævnt i punkt 4.4 i DCP-produktresuméet.
English: Subjects with unstable psoriasis (erythrodermic, exfoliative or pustular psoriasis) were excluded.
Danish: Personer med ustabil psoriasis (erytrodermisk, exfoliativ og pustuløs psoriasis) blev udelukket.
English: The hands should be washed after use.
Danish: Hænderne skal vaskes efter påsmøring.
English: The study MBL 0404 FR, conducted for the development of Daivobet gel, investigated the adrenal response to adrenocorticotropic hormone (ACTH) and its results were included in the approved Daivobet gel SPC.
Danish: I undersøgelsen MBL 0404 FR, der blev foretaget med henblik på udviklingen af Daivobet gel, undersøgte man binyreresponsen på adrenokortikotropisk hormon (ACTH), og resultaterne blev medtaget i det godkendte produktresumé for Daivobet gel.
English: 4.6 Fertility, pregnancy and lactation
Danish: 4.6 Fertilitit, graviditet og amning
English: Daivobet gel contains butylated hydroxytoluene (E321), which may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.
Danish: Daivobet gel indeholder butylhydroxytoluen (E321), som kan forårsage lokale hudreaktioner (fx kontaktdermatitis) eller irritation i øjne og slimhinder.
English: The text “impact on the metabolic control of diabetes mellitus” has also been agreed by the CHMP as undesirable effects of betamethasone dipropionate accordingly to the cross reference from section 4.4.
Danish: Teksten “indvirkning på stofskiftekontrollen af diabetes mellitus” blev også godkendt af CHMP som en af betamethasondipropionats bivirkninger i henhold til krydshenvisningen fra punkt 4.4.
English: Daivobet has no or negligible influence on the ability to drive and to use machines.
Danish: Daivobet påvirker ikke eller ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: Quality Module
Danish: Kvalitetsafsnit
English: Daivobet ointment is a combination product which contains the vitamin D analogue, calcipotriol monohydrate and betamethasone dipropionate.
Danish: Daivobet salve er et kombinationslægemiddel, der indeholder D-vitamin-analogen calcipotriolmonohydrat og betamethasondipropionat.
English: These side effects are more likely to happen after long-term use, use in skin folds (e.g. groin, armpits or under breasts), use under bandages or dressings or use on large areas of skin.
Danish: Risikoen for, at disse bivirkninger forekommer, er større ved lang tids brug, ved brug i hudfolder (fx lysken, armhuler eller under brysterne), ved brug under bandager eller ved behandling af store hudområder.
English: Long-term use
Danish: Langtidsbehandling
English: In rats, tissue distribution studies with radiolabelled calcipotriol and betamethasone dipropionate, respectively, showed that the kidney and liver had the highest level of radioactivity.
Danish: Hos rotter viste vævsfordelingsundersøgelser med henholdsvis radioaktivt mærket calcipotriol og betamethasondipropionat, at nyrer og lever havde det højeste radioaktivitetsniveau.
English: Daivobet 50 mikrogramov/500 mikrogramov v 1g mazilo
Danish: 50 mikrogramov/ 500 mikrogramov v 1g mazilo
English: Systemic reactions occur more frequently when applied under occlusion (plastic, skin folds), when applied on large areas and during long term treatment (see section 4.4).
Danish: Systemiske bivirkninger er hyppigere ved okklusion (plastik, hudfolder), ved anvendelse på store hudområder og ved langvarig behandling (se pkt.
English: Topical calcipotriol should be used with UVR only if the physician and patient consider that the potential benefits outweigh the potential risks (see section 5.3).
Danish: Topikal calcipotriol må kun bruges med UV-bestråling, hvis lægen og patienten vurderer, at de potentielle fordele opvejer de potentielle risici (se pkt.
English: • the scope of the referral was the harmonisation of the summary of products characteristics, labelling and package leaflet
Danish: • formålet med indbringelsen af sagen var at harmonisere produktresuméet, etiketteringen og indlægssedlen,
English: Betamethasone dipropionate (n=1,118)
Danish: Betamethasondipropionat (n=1.118)
English: These reactions are usually mild and cover mainly various skin reactions with pruritus being the most common.
Danish: Disse bivirkninger er sædvanligvis milde og omfatter hovedsageligt forskellige hudreaktioner, hvoraf kløe er den almindeligste.
English: Betamethasone dipropionate (n=68)
Danish: Betamethasondipropionat (n=68)
English: Daivobet gel should be applied to affected areas once daily.
Danish: Daivobet gel påsmøres de angrebne områder én gang daglig.
English: The CHMP found the MAH's proposal appropriate and acceptable and endorsed the harmonised wording under this section.
Danish: CHMP var af den opfattelse, at indehaveren af markedsføringstilladelsens forslag er hensigtsmæssigt og acceptabelt, og CHMP godkendte den harmoniserede ordlyd under dette punkt.
English: In order to achieve optimal effect, it is not recommended to take a shower or bath immediately after application of Daivobet ointment.
Danish: For at opnå optimal effekt anbefales det ikke at tage brusebad eller karbad lige efter påsmøring af Daivobet salve.
English: Pack sizes: 15 g
Danish: Pakningsstørrelser: 15 g
English: With regards to HPA suppression, therefore, this study shows some evidence that very high doses of Daivobet gel and ointment may have a weak effect on the HPA axis.”
Danish: Hvad angår HPA-suppression, viser denne undersøgelse en vis evidens for, at meget høje doser af Daivobet gel og salve kan have en svag effekt på HPA-aksen.”
English: Comparators were betamethasone dipropionate in the gel vehicle, calcipotriol in the gel vehicle and the gel vehicle alone, all used once daily.
Danish: Sammenligningsprodukter var betamethasondipropionat i gel-vehiklet, calcipotriol i gel-vehiklet og gel-vehiklet alene, alle anvendt én gang dagligt.
English: There are no adequate data from the use of Daivobet ointment in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af Daivobet salve til gravide kvinder.
English: With long-term use there is an increased risk of local and systemic corticosteroid adverse reactions.
Danish: Ved langtidsbehandling er der en øget risiko for lokale og systemiske kortikosteroidbivirkninger.
English: When the gel and scalp psoriasis were assessed, other treatments were permitted for body psoriasis.
Danish: Når gelen og psoriasis i hovedbunden blev vurderet, var det tilladt at anvende andre behandlinger af psoriasis på kroppen.
English: The MAH replied that they would prefer to keep the detailed description of the tests because their result indicates a reduction in the time required for UVR to induce the formation of skin tumours in male mice.
Danish: Indehaveren af markedsføringstilladelsen svarede, at de ville foretrække at beholde den detaljerede beskrivelse af undersøgelserne, eftersom deres resultater viser en reduktion af den tid, der går, før UVstråling fremkalder hudkræft hos hanmus.
English: The safety and efficacy of Daivobet gel in patients with severe renal insufficiency or severe hepatic disorders have not been evaluated.
Danish: Sikkerhed og virkning af Daivobet gel hos patienter med alvorlig nyreinsufficiens eller alvorlige leversygdomme er ikke blevet undersøgt.
English: Skin of the face and genitals are very sensitive to corticosteroids.
Danish: Ansigts- og genitalhud er meget følsom over for kortikosteroider.
English: The MAH proposed a harmonised text drafted accordingly to the one used in the MRP procedure with some amendments.
Danish: Indehaveren af markedsføringstilladelsen foreslog en harmoniseret tekst, som udarbejdes i overensstemmelse med den tekst, der anvendes i den gensidige anerkendelsesprocedure, med nogle få ændringer.
English: Do not store above 25 °C.
Danish: - Må ikke opbevares ved temperaturer over 25 °C.
English: Adverse reactions found in connection with systemic corticosteroid treatment, such as adrenocortical suppression or impact on the metabolic control of diabetes mellitus, may occur also during topical corticosteroid treatment due to systemic absorption.
Danish: Bivirkninger, der ses i forbindelse med systemisk kortikosteroidbehandling, fx adrenokortikal suppression og påvirkning af den metaboliske kontrol af diabetes mellitus, kan også opstå ved topikal kortikosteroidbehandling på grund af systemisk absorption.
English: Results for speed of onset based on similar data at week 2 also showed Daivobet gel to be statistically significantly more effective than the comparators.
Danish: Resultaterne for, hvor hurtigt virkningen indtraf, baseret på lignende data i uge 2, viste også, at Daivobet gel var mere effektivt end sammenligningspræparaterne (statistisk signifikant).
English: Daivonex Scalp solution (n=105)
Danish: Daivonex kutanopløsning til hårbunden (n=105)
English: Uncommon undesirable effects are skin pain or irritation, dermatitis, erythema, exacerbation of psoriasis, folliculitis and application site pigmentation changes.
Danish: Ikke almindelige bivirkninger er hudsmerter eller hudirritation, dermatitis, erytem, forværring af psoriasis, folliculitis og pigmentforandringer på anvendelsesstedet.
English: Important information about some of the ingredients of Daivobet Daivobet contains butylated hydroxytoluene (E321), which may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Daivobet Daivobet indeholder butylhydroxytoluen (E321), der kan give lokalt hududslæt (fx kontakteksem) eller irritation af øjne og slimhinder.
English: In vitro data suggest that calcipotriol induces differentiation and suppresses proliferation of keratinocytes.
Danish: In vitro data tyder på, at calcipotriol stimulerer differentieringen og hæmmer proliferationen af keratinocytter.
English: Application under occlusive dressings should be avoided since it increases the systemic absorption of corticosteroids.
Danish: Anvendelse under okklusionsbandager bør undgås, da det forøger den systemiske absorption af kortikosteroider.
English: The efficacy of once daily use of Daivobet gel was investigated in two randomised, double-blind, 8week clinical studies including a total of more than 2,900 patients with scalp psoriasis of at least mild severity according to the Investigator's Global Assessment of disease severity (IGA).
Danish: Virkningen af Daivobet gel én gang dagligt blev undersøgt i 2 randomiserede, dobbeltblindede, 8ugers kliniske undersøgelser, der inkluderede mere end 2.900 patienter med psoriasis i hårbunden af mindst lettere sværhedsgrad ifølge Investigator's Global Assessment of disease severity (IGA).
English: Gel vehicle (n=136)
Danish: Gel-vehikel (n=136)
English: The recommended treatment period is 4 weeks for scalp areas and 8 weeks for “non-scalp” areas.
Danish: Den anbefalede behandlingstid er 4 uger ved behandling af hårbunden og 8 uger ved behandling af resten af kroppen.
English: This causes redness, scaling and thickness of your skin.
Danish: Dette viser sig ved rødme, skæl og fortykkelse af huden.
English: The treatment should be discontinued in case of adverse reactions related to long-term use of corticosteroid (see section 4.8).
Danish: Behandlingen bør seponeres, hvis der opstår bivirkninger i forbindelse med langtidsbehandling med kortikosteroider (se pkt.
English: Daivobet gel contains a potent group III steroid and concurrent treatment with other steroids must be avoided.
Danish: Daivobet gel indeholder et stærkt virkende gruppe III-steroid, og samtidig behandling med andre steroider skal undgås.
English: The following less serious side effects have been reported for Daivobet Common side effects (affect less than 1 in 10 people) - Itching.
Danish: Følgende mindre alvorlige bivirkninger er blevet indberettet for Daivobet: Almindelige bivirkninger (ses hos mindre end 1 ud af 10 personer)
English: The contraindication in patients with known disorder of calcium metabolism seemed appropriate by the CHMP that endorsed the following: “Due to the content of calcipotriol Daivobet ointment is contraindicated in patients with known disorders of calcium metabolism”.
Danish: CHMP var af den opfattelse, at kontraindikationen for patienter med kendte calciummetabolismesygdomme var hensigtsmæssig, og CHMP godkendte følgende: “På grund af indholdet af calcipotriol er Daivobet salve kontraindiceret til patienter med kendte calciummetabolismesygdomme”.
English: Caution should be exercised when prescribing Daivobet ointment to women who breast feed.
Danish: Forsigtighed bør udvises ved behandling af kvinder, som ammer.
English: One metabolite of calcipotriol and one metabolite of betamethasone dipropionate were quantifiable in some of the patients.”
Danish: En metabolit af calcipotriol og en metabolit af betamethasondipropionat var kvantificerbar hos nogle af patienterne.”
English: Based on data from clinical trials and postmarket use the following adverse reactions are listed for Daivobet gel.
Danish: Baseret på data fra kliniske afprøvninger og anvendelse efter markedsføring er nedenstående bivirkninger blevet rapporteret for Daivobet gel.
English: Before you use Daivobet How to use Daivobet Possible side effects
Danish: Det skal du vide, før du begynder at bruge Daivobet Sådan skal du bruge Daivobet Bivirkninger
English: Bottle text: Lot/EXP - see the bottom of the bottle.
Danish: Tekst på flaske: Lot/EXP - se bunden af flasken.
English: There is no experience for the use of this medicinal product on the scalp.
Danish: Der er ingen erfaring med brug af dette præparat i hårbunden.
English: Based on data from clinical trials and postmarket use the following adverse reactions are listed for Daivobet ointment.
Danish: Baseret på data fra kliniske afprøvninger og anvendelse efter markedsføring er nedenstående bivirkninger blevet rapportert for Daivobet salve.
English: The safety and efficacy of Daivobet ointment in patients with severe renal insufficiency or severe hepatic disorders have not been evaluated.
Danish: Sikkerhed og virkning af Daivobet salve hos patienter med alvorlig nyreinsufficiens eller alvorlige leversygdomme er ikke blevet undersøgt.
English: The patient should be instructed not to use Daivobet on the breast when breast-feeding.
Danish: Patienten bør informeres om ikke at bruge Daivobet salve på brystet ved amning.
English: Studies in animals with glucocorticoids have shown reproductive toxicity (see section 5.3), but a number of epidemiological studies have not revealed congenital anomalies among infants born to women treated with corticosteroids during pregnancy.
Danish: 5.3), men en række epidemiologiske undersøgelser har ikke vist medfødte anormaliteter hos børn født af kvinder behandlet med kortikosteroider under graviditeten.
English: Excessive prolonged use of topical corticosteroids may suppress the pituitary-adrenal functions, resulting in secondary adrenal insufficiency which is usually reversible.
Danish: Overdreven langvarig brug af topikale kortikosteroider kan supprimere hypofyse-binyrefunktionerne og give sekundær binyrebarkinsufficiens, som normalt er reversibel.
English: The MAH proposed the following amendment in section 5.1: “A safety study in 634 psoriasis patients has investigated repeated courses of Daivobet ointment used once daily as required, either alone or alternating with Daivonex for up to 52 weeks, compared with Daivonex used alone for 48 weeks after an initial course of Daivobet ointment.
Danish: Indehaveren af markedsføringstilladelsen foreslog følgende ændring af punkt 5.1: “I en sikkerhedsundersøgelse, der omfattede 634 psoriasispatienter, undersøgte man gentagne behandlingsforløb med Daivobet salve anvendt én gang om dagen som foreskrevet, enten alene eller skiftende med Daivonex i op til 52 uger, sammenlignet med Daivonex anvendt alene i 48 uger efter et indledende behandlingsforløb med Daivobet salve.
English: Unevaluated uses There is no experience for the use of Daivobet ointment in guttate psoriasis.
Danish: Ikke-evalueret brug Der er ingen erfaring med brug af Daivobet salve ved guttat psoriasis.
English: Calcipotriol and betamethasone dipropionate were below the lower limit of quantification in all blood samples of 34 patients treated for 4 or 8 weeks with both Daivobet gel and Daivobet ointment for extensive psoriasis involving the body and scalp.
Danish: Calcipotriol og betamethasondipropionat var under den lave grænse for kvantificering i alle blodprøver fra 34 patienter behandlet i 4 eller 8 uger med både Daivobet gel og Daivobet salve for udbredt psoriasis på kroppen og i hårbunden.
English: You should tell your doctor as soon as possible if any of the serious side effects occur.
Danish: Du skal kontakte din læge så hurtigt som muligt, hvis du får alvorlige bivirkninger.
English: Excessive prolonged use of Daivobet may cause a problem with calcium in your blood, which usually normalises when discontinuing treatment.
Danish: Overdreven for lang tids brug af Daivobet kan give problemer med kalciumkoncentrationen i dit blod, men den vil sædvanligvis blive normal igen, når du stopper behandlingen.
English: Gel vehicle (n=35)
Danish: Gel vehikel (n=35)
English: When treating psoriasis with topical corticosteroids there may be a risk of generalised pustular psoriasis or of rebound effects when discontinuing treatment.
Danish: Ved behandling af psoriasis med topikale kortikosteroider kan der være risiko for generaliseret pustuløs psoriasis eller rebound effekt ved behandlingsophør.
English: Daivobet ointment contains a potent group III steroid and concurrent treatment with other steroids must be avoided.
Danish: Daivobet salve indeholder et stærktvirkende gruppe III-steroid, og samtidig behandling med andre steroider skal undgås.
English: Aluminium/epoxyphenol tubes with polyethylene screw cap.
Danish: Aluminium/epoxyphenoltuber med polyethylenskruelåg.
English: It has been reported that due to misuse one patient with extensive erythrodermic psoriasis treated with 240 g of Daivobet ointment weekly (corresponding to a daily dose of approximately 34 g) for 5 months (maximum recommended dose 15 g daily) developed Cushing's syndrome and pustular psoriasis after abruptly stopping treatment.
Danish: Det er rapporteret, at på grund af misbrug har en patient med ekstensiv erytrodermisk psoriasis, som blev behandlet med 240 g Daivobet salve om ugen (svarende til en daglig dosis på ca. 34 g) i 5 måneder (anbefalet maksimal dosis er 15 g om dagen), udviklet Cushing's syndrom og pustuløs psoriasis efter abrupt seponering af behandlingen.