FrancophonIA/ELRC3.0 huggingface dataset:
English: These restrictions were introduced to avoid excessive exposure to calcipotriol and the possibility of vitamin D related adverse events (e.g. hypercalcaemia).
Danish: Disse begrænsninger blev medtaget for at undgå overdreven eksponering for calcipotriol og muligheden for vitamin D-relaterede utilsigtede hændelser (f.eks. hypercalcæmi).
English: Tilt your head to make sure Daivobet does not run onto your face.
Danish: Bøj hovedet forover, så Daivobet ikke løber ned i ansigtet.
English: If your psoriasis gets worse, tell your doctor as soon as possible.
Danish: Hvis din psoriasis bliver værre, skal du kontakte din læge så hurtigt som muligt.
English: The CHMP found the changes proposed appropriate and acceptable.
Danish: CHMP anså de foreslåede ændringer for at være hensigtsmæssige og acceptable.
English: This will avoid accidentally spreading the gel to other parts of your body (especially the face, mouth and eyes)
Danish: Det vil forhindre uhensigtsmæssig overførsel af gelen til andre dele af din krop (specielt ansigt, mund og øjne).
English: This will avoid accidentally spreading the ointment to other parts of your body
Danish: Det vil forhindre uhensigtsmæssig overførsel af salven til andre dele af din krop
English: The reference to patients with severe renal insufficiency or severe hepatic disorders was removed from this section and included under section 4.2
Danish: Henvisningen til patienter med svær nyreinsufficiens eller svær leversygdom blev fjernet fra dette punkt og medtaget under punkt 4.2.
English: White soft paraffin
Danish: Hvid blød paraffin
English: Due to the content of calcipotriol, hypercalcaemia may occur if the maximum daily dose (15 g) is exceeded.
Danish: På grund af calcipotriolindholdet kan der forekomme hyperkalcæmi, hvis den maksimale daglige dosis (15 g) overskrides.
English: week 2 week 8
Danish: uge 2 uge 8
English: Do not apply directly to the face or eyes.
Danish: Smør ikke direkte på ansigt eller øjne.
English: This can be serious, and you should contact your doctor immediately.
Danish: Dette kan være alvorligt, og du skal derfor straks kontakte din læge.
English: In one SPC the undesirable effects were not tabulated by MedDRA SOC (System Organ Class) as recommended in the EU SPC guideline.
Danish: I et af produktresuméerne var bivirkningerne ikke opstillet i henhold til MedDRA-systemorganklasse (SOC), sådan som det anbefales i EU's retningslinjer for produktresuméer.
English: Daivobet gel is a different formulation which contains the same active substances in the same concentrations as in Daivobet ointment.
Danish: Daivobet gel er en anden formulering, der indeholder det samme aktive stof i de samme koncentrationer som i Daivobet salve.
English: In such cases, symptomatic treatment is indicated.
Danish: I sådanne tilfælde behandles symptomerne.
English: Treatment of more than 30 % of the body surface should be avoided (see section 4.2).
Danish: Behandling af mere end 30 % af kroppens overflade bør undgås (se pkt.
English: Signs are tiredness, depression and anxiety.
Danish: Tegn herpå er træthed, depression og angst.
English: The CHMP endorsed the mention of such warnings.
Danish: CHMP godkendte medtagelsen af sådanne advarsler.
English: Other ingredients:
Danish: Øvrige indholdsstoffer:
English: The CHMP considered the addition of the information on misuse of Daivobet helpful and appropriate and other changes were considered acceptable.
Danish: CHMP mente, at tilføjelsen af informationen om forkert brug af Daivobet var nyttig og hensigtsmæssig, og andre ændringer blev ligeledes anset for acceptable.
English: Concurrent treatment and UV exposure
Danish: Samtidig behandling og UV-eksponering
English: Less serious side effects
Danish: Mindre alvorlige bivirkninger
English: The quality module for Daivobet ointment has also been assessed and its harmonisation has been agreed by the CHMP.
Danish: Kvalitetsafsnittet for Daivobet salve blev ligeledes vurderet, og CHMP vedtog dets harmonisering.
English: With regard to the risk of rebound effects mentioned in section 4.4, the CHMP questioned if there was any evidence that tapering the dose will reduce the chance of this happening.
Danish: Hvad angår den risiko for rebound-effekt, der er nævnt i punkt 4.4, stillede CHMP spørgsmål ved, om der var nogen evidens for, at en gradvist aftagende dosis vil reducere sandsynligheden for dette.
English: Usually an amount between 1 g and 4 g per day is sufficient for treatment of the scalp (4 g corresponds to one teaspoon).
Danish: Normalt er 1-4 g dagligt tilstrækkeligt til behandling af hårbunden (4 g svarer til en teskefuld).
English: The pharmaco-therapeutic group “Like other topical corticosteroids” has also been added.
Danish: Den farmakoterapeutiske klassifikation “I lighed med andre topiske kortikosteroider” blev ligeledes tilføjet.
English: However, to comply with the latest version of the guidance on the SPC, the indication was amended to include adults as the intended to treat population.
Danish: For at skabe overensstemmelse med den seneste udgave af retningslinjerne for produktresuméer blev indikationen dog ændret, så voksne blev medtaget som "Intent to Treat"-population.
English: week 4 week 8
Danish: uge 4 uge 8
English: The harmonisation of the quality module was requested by the MAH at the beginning of this Referral procedure.
Danish: Indehaveren af markedsføringstilladelsen bad om en harmonisering af kvalitetsmodulet ved begyndelsen af denne indbringelsesprocedure.
English: Daivobet gel should not be applied directly to the face or eyes.
Danish: Daivobet gel må ikke påsmøres direkte i ansigtet eller øjnene.
English: The active substances are :
Danish: Aktive stoffer:
English: The CHMP noted that the contraindications in erythrodermic, exfoliative and pustular psoriasis are based on medical risk of use in these conditions and are therefore considered to be absolute contraindications.
Danish: CHMP bemærkede, at kontraindikationerne for erytrodermisk, eksfoliativ og pustuløs psoriasis er baseret på den medicinske risiko i forbindelse med brugen ved disse tilstande, og at de derfor må anses for at være absolutte kontraindikationer.
English: Wash hands after use.
Danish: Vask hænderne efter brug.
English: Unevaluated uses
Danish: Ikke-undersøgt brug
English: The mechanism of the antiinflammatory activity of the topical steroids, in general, is unclear.
Danish: Virkningsmekanismen for den anti-inflammatoriske aktivitet af topikale steroider er generelt uklar.
English: Vitamin D related adverse events resulting from extensive exposure to calcipotriol have been reported in a few cases in the literature.
Danish: Vitamin D-relaterede utilsigtede hændelser, der skyldes overdreven eksponering for calcipotriol, er blevet beskrevet i nogle få tilfælde i litteraturen.
English: Many patients who respond well to Daivobet ointment over the recommended 4 week treatment period still require repeated treatment for long term control of their psoriasis.
Danish: Mange patienter, der responderer godt på Daivobet salve i løbet af den 4 uger lange behandlingsperiode, kræver stadig gentagen behandling med henblik på langtidskontrol af deres psoriasis.
English: Controlled disease was defined as ‘clear' or ‘minimal disease' for patients with moderate disease at baseline or ‘clear' for patients with mild disease at baseline.
Danish: Kontrolleret sygdomsgrad var defineret som "clear" eller "minimal sygdomsgrad" for patienter med moderat sygdomsgrad ved udgangspunktet og "clear" for patienter med mild sygdomsgrad ved udgangspunktet.
English: This can be serious and you should contact your doctor as soon as possible.
Danish: Dette kan være alvorligt, og du skal kontakte din læge så hurtigt som muligt.
English: Patients with psoriasis vulgaris often have lesions on the scalp as well as the body.
Danish: Patienter med psoriasis vulgaris har ofte læsioner både i hovedbunden og på kroppen.
English: Do not refrigerate.
Danish: - Må ikke opbevares koldt.
English: The CHMP agreed to this proposal.
Danish: CHMP godkendte dette forslag.
English: The risk of rebound is well documented and the EU guidelines on the investigation of products for use in psoriasis recommend the investigation of rebound.
Danish: Risikoen for rebound-effekt er veldokumenteret, og i EU's retningslinjer for undersøgelse af lægemidler til behandling af psoriasis anbefales det, at rebound-effekten undersøges.
English: Not known frequency - Rebound effect: A worsening of symptoms/psoriasis after ended treatment.
Danish: Ukendt hyppighed - Forværring af symptomerne/psoriasis efter afsluttet behandling.
English: Systemic reactions due to topical use of corticosteroids are rare in adults, however they can be severe.
Danish: Systemiske bivirkninger på grund af brug af topikale kortikosteroider er meget sjældne hos voksne, men de kan være alvorlige.
English: Adverse events possibly related to long-term use of corticosteroids on the scalp, were identified by an independent, blinded panel of dermatologists.
Danish: Bivirkninger, som kunne være opstået på grund af langvarig brug af kortikosteroider i hårbunden, blev identificeret af et uafhængigt, blindet panel af dermatologer.
English: Approximately 8 % of patients treated with Daivobet gel experienced a non-serious adverse reaction.
Danish: Ca. 8 % af patienterne behandlet med Daivobet gel fik en ikke alvorlig bivirkning.
English: The CHMP noted that, according to the Guideline on Summary of Product Characteristics, the findings of the non-clinical testing, the carcinogenicity study and the photo(co)carcinogenicity study, should be described in brief and qualitative statements.
Danish: CHMP bemærkede, at i henhold til retningslinjerne for produktresuméer bør resultaterne af de ikkekliniske undersøgelser, carcinogenicitetsundersøgelsen og foto(co)carcinogenicitetsundersøgelsen beskrives på en kort og kvalitativ måde.
English: This text was originally proposed by the MAH as part of a type II variation to update the SPC following the results of two non-clinical studies, a carcinogenicity study and a photo(co)carcinogenicity study.
Danish: Denne tekst blev oprindeligt foreslået af indehaveren af markedsføringstilladelsen som en del af en type II-ændring med henblik på at opdatere produktresuméet efter resultaterne af to ikke-kliniske undersøgelser, en carcinogenicitetsundersøgelse og en foto(co)carcinogenicitetsundersøgelse.
English: The following serious effects have been reported for Daivobet:
Danish: Følgende alvorlige bivirkninger er blevet indberettet for Daivobet:
English: The text for the outer packaging (carton) and immediate packaging (bottle) is the same, except where it is indicated to apply for carton or bottle, respectively.
Danish: Teksten er den samme på den ydre emballage (karton) og indre emballage (flaske), bortset fra hvor det er anført at gælde for henholdsvis karton eller flaske.
English: Serum calcium is, however, quickly normalised when treatment is discontinued.
Danish: Serum-calcium normaliseres dog hurtigt, når behandlingen seponeres.
English: It did appear that there was no experience of combination use of Daivobet and other topical treatments at the same site therefore the CHMP endorsed the following sentence:” There is no experience for the use of this medicinal product on the scalp.
Danish: Det viste sig, at der ikke var nogen erfaring med kombineret brug af Daivobet og andre topiske behandlinger samme sted, og derfor godkendte CHMP følgende sætning: ”Der er ingen erfaring med brugen af dette lægemiddel i hovedbunden.
English: There is experience with repeated courses of Daivobet up to 52 weeks.
Danish: Der er erfaring med gentagne behandlinger med Daivobet i op til 52 uger.
English: The CHMP noted that the changes proposed by the MAH reflect the current safety experience.
Danish: CHMP bemærkede, at de ændringer, som indehaveren af markedsføringstilladelsen havde foreslået, afspejler de aktuelle sikkerhedserfaringer.
English: The CHMP accepted the inclusion of the above in the harmonised text.
Danish: CHMP godkendte medtagelsen af ovenstående i den harmoniserede tekst.
English: Calcipotriol is a vitamin D analogue.
Danish: Calcipotriol er en D-vitamin-analog.
English: The efficacy and safety of Daivobet ointment has been investigated for periods longer than 4 weeks in study MCB 0102 INT.
Danish: Virkningen og sikkerheden af Daivobet salve blev undersøgt i perioder, der var længere end 4 uger, i undersøgelsen MCB 0102 INT.
English: Secondary infection is a documented local adverse effect of treatment with topical corticosteroids.
Danish: Sekundær infektion er en dokumenteret lokal bivirkning af behandlingen med topiske kortikosteroider.
English: Pustular psoriasis is a rare undesirable effect”.
Danish: Pustuløs psoriasis er en sjælden bivirkning”.
English: In the same MS SPC there was also no mention of the increased risk of local and systemic corticosteroid undesirable effects in long term use which could lead to systemic adverse events that are as well known and documented.
Danish: I samme medlemsstats produktresumé var der heller ikke nogen henvisning til den øgede risiko for lokale og systemiske kortikosteroidbivirkninger ved langtidsbrug, der kunne føre til systemiske utilsigtede hændelser, som er velkendte og dokumenterede.
English: In all cases, the serum cortisol levels were normal at 60 minutes post ACTH challenge.
Danish: I alle tilfælde var serum-cortisolniveauerne normale 60 minutter efter eksponering for ACTH.
English: Hypersensitivity to the active substances or to any of the excipients.
Danish: Overfølsomhed over for de aktive stoffer eller over for et eller flere af hjælpestofferne.
English: Pustular psoriasis
Danish: Pustuløs psoriasis
English: Considering that hypercalcaemia, resulting from extensive exposure to calcipotriol, has been reported in a few cases in the literature, the CHMP endorsed the MAH proposal and added a cross reference to section 4.2.
Danish: I betragtning af at hypercalcæmi som følge af en omfattende eksponering for calcipotriol er beskrevet i nogle få tilfælde i litteraturen, godkendte CHMP indehaveren af markedsføringstilladelsens forslag og tilføjede en krydshenvisning til punkt 4.2.
English: Effects on calcium metabolism
Danish: Virkninger på calciummetabolismen
English: These areas should only be treated with weaker corticosteroids” was either partly or not included in the SPC.
Danish: Disse områder bør kun behandles med svagere kortikosteroider” delvist i fire medlemsstaters produktresuméer, eller også var den slet ikke medtaget.
English: In study MCB 0102 INT there was a trend towards greater efficacy and a lower incidence of adverse events reported in patients who remained on Daivobet ointment applied as required compared with patients who switched to other treatments.
Danish: I undersøgelsen MCB 0102 INT var der en tendens til større virkning og en lavere incidens af indberettede utilsigtede hændelser hos patienter, som forblev i behandling med Daivobet salve, der blev anvendt som foreskrevet, sammenlignet med patienter, der skiftede over til andre behandlinger.
English: The purpose of this Art 30 referral is to harmonise the SPC across EU member states for Daivobet ointment authorised via the Mutual Regognition Procedure (MRP) and the national authorisation.
Danish: Formålet med denne indbringelsesprocedure i henhold til artikel 30 er at harmonisere produktresuméet i EU's medlemsstater for Daivobet salve, der er godkendt via den gensidige anerkendelsesprocedure og national godkendelse.
English: The most current indication in the Member States (MSs) was “treatment of psoriasis vulgaris” and in other two MSs the indication was “combined treatment of psoriasis”.
Danish: Den mest almindelige indikation i medlemsstaterne var “behandling af psoriasis vulgaris”, og i to medlemsstater var indikationen “kombinationsbehandling af psoriasis”.
English: Through occlusion the effect can be enhanced due to increased penetration of the stratum corneum.
Danish: Virkningen forstærkes ved okklusion på grund af øget penetration af stratum corneum.
English: Like all medicines, Daivobet can cause side effects, although not everybody gets them.
Danish: Daivobet kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: If you stop using Daivobet
Danish: Hvis du holder op med at bruge Daivobet
English: The information was therefore considered of relevance to the prescriber in recognising the safety profile of Daivobet ointment and in supporting precautionary measures that are included in other relevant sections of the SPC as Section 4.4.
Danish: Derfor blev informationen anset for at være relevant for den ordinerende læge, når det gælder om at forstå Daivobet salves sikkerhedsprofil, og når det gælder om at underbygge de forsigtighedsregler, der er medtaget i andre relevante punkter i produktresuméet såsom punkt 4.4.
English: There was no difference in the percentages of patients experiencing such adverse events between the treatment groups (2.6 % in the Daivobet gel group and 3.0 % in the calcipotriol group; P=0.73).
Danish: Der var ingen forskel i procentdelen af patienter med sådanne bivirkninger imellem behandlingsgrupperne (2,6 % i Daivobet gel og 3,0 % i calcipotriolgruppen; p = 0,73).
English: Other antipsoriatics for topical use, Calcipotriol, combinations.
Danish: Andre midler mod psoriasis til topikalt brug, calcipotriol, kombinationer.
English: These data do not contain any evidence that tapering the dose of Daivobet ointment will reduce the risk of rebound effects.
Danish: Disse data indeholder ikke nogen evidens for, at en gradvist aftagende dosis Daivobet salve vil mindske risikoen for rebound-effekt.
English: In three MSs there was a warning “due to lack of experience it is necessary to be more careful with serious liver or kidney diseases”.
Danish: Tre medlemsstaters produktresuméer indeholdt advarslen “På grund af manglende erfaring er det nødvendigt at være mere forsigtig med svære lever- eller nyresygdomme”.
English: There are no data on the excretion of calcipotriol in breast milk.
Danish: Der er ingen data for udskillelse af calcipotriol i modermælk.
English: This is in accordance with the DCP approved Daivobet gel SPC.
Danish: Dette er i overensstemmelse med det DCP-godkendte produktresumé for Daivobet gel.
English: The risk of rebound effect has been included in the SPC based on data from post marketing use.
Danish: Risikoen for rebound-effekt er blevet medtaget i produktresuméet på baggrund af data fra brugen efter markedsføringen.
English: Duration of treatment - Use the ointment once a day.
Danish: Behandlingsvarighed - Brug gelen én gang dagligt.
English: Daivobet gel should remain on the skin during the night or during the day.
Danish: Daivobet gel skal blive på huden natten over eller hele dagen.
English: The adverse reactions are listed by MedDRA System Organ Class, and the individual adverse reactions are listed starting with the most frequently reported.
Danish: Bivirkningerne er listet i systemorganklasser efter MedDRA, og de enkelte bivirkninger er listet efter hyppighed med den hyppigst rapporterede bivirkning først.
English: The MAH proposed to delete this sentence but the CHMP considered useful to include the information in the harmonised SPC.
Danish: Indehaveren af markedsføringstilladelsen foreslog at slette denne sætning, men CHMP mente, at det ville være nyttigt at medtage denne information i det harmoniserede produktresumé.
English: This describes accurately the subjects included in the clinical studies submitted in support of the efficacy and safety of Daivobet ointment.
Danish: Dette giver en præcis beskrivelse af de personer, der deltog i de kliniske undersøgelser, hvis resultater blev fremsendt til støtte for Daivobet salves virkning og sikkerhed.
English: All the affected scalp areas may be treated with Daivobet gel.
Danish: Alle de angrebne områder i hårbunden kan behandles med Daivobet gel.
English: The MAH accepted the recommendation for rewording section 4.2 and the CHMP endorsed the proposed wording: “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: Indehaveren af markedsføringstilladelsen godkendte anbefalingen om at omformulere punkt 4.2, og CHMP godkendte følgende ordlyd: “Hvis det er nødvendigt at fortsætte eller genoptage behandlingen efter denne periode, bør behandlingen fortsættes efter lægens vurdering og under jævnligt lægeligt opsyn”.
English: The text proposed by the MAH gave the clinician more specific information on the available pharmacokinetic data.
Danish: Den tekst, som indehaveren af markedsføringstilladelsen foreslog, gav lægen mere specifik information om de tilgængelige farmakokinetiske data.
English: Since there is no documented information on safety and efficacy for Daivobet ointment about guttate, erythrodermic, exfoliative and pustular psoriasis as none about patients with severe renal insufficiency or severe hepatic disorders, the MAH proposed to contraindicate Daivobet in these cases based on their exclusion from the clinical trial programme.
Danish: Eftersom der ikke er nogen dokumenteret information om sikkerhed og virkning af Daivobet salve ved guttat, erytrodermisk, eksfoliativ og pustuløs psoriasis, og heller ikke hos patienter med svær nyreinsufficiens eller svær leversygdom, foreslog indehaveren af markedsføringstilladelsen, at Daivobet kontraindiceres i sådanne tilfælde på baggrund af deres udelukkelse fra det kliniske undersøgelsesprogram.
English: In several MS's the statement “treatment of more than 30% of the body surface should be avoided” was not included in the SPC and the MAH proposed to include this wording under section 4.4.
Danish: I flere medlemsstater var ordlyden “behandling af mere end 30 % af kroppens overfladeareal bør undgås” ikke medtaget i produktresuméet, og indehaveren af markedsføringstilladelsen foreslog, at denne ordlyd blev medtaget under punkt 4.4.
English: Due to the formation of a depot in the skin elimination after dermal application is in order of days.
Danish: På grund af depotdannelse i huden er udskillelsen efter dermal applikation i størrelsesordenen dage.
English: The side effects include the following: - Your adrenal glands may stop working properly.
Danish: Følgende bivirkninger kan forekomme: - Dine binyrer kan holde op med at fungere normalt.
English: No carcinogenicity or photocarcinogenicity studies have been performed with betamethasone dipropionate.
Danish: Der er ikke udført karcinogenicitets- eller fotokarcinogenicitetsundersøgelser med betamethason diproprionat.
English: Betamethasone passes into breast milk, but risk of an adverse effect on the infant seems unlikely with therapeutic doses.
Danish: Betamethason udskilles i modermælk, men risiko for bivirkninger hos barnet synes usandsynlig ved terapeutiske doser.
English: Therefore, during pregnancy, Daivobet gel should only be used when the potential benefit justifies the potential risk.
Danish: Derfor bør Daivobet gel kun anvendes under graviditet, når den potentielle fordel retfærdiggør den potentielle risiko.
English: The CHMP commented that, as suggested from the MAH's wording, a patient using the maximum daily dose of 15 g will exceed the maximum weekly dose of 100 g, reaching 105 g. The MAH answered to this comment that some patients may need a daily dose of 15 g during the first few days of treatment, but since efficacy during the first week of treatment is high it would be reasonable to expect that patients would apply less treatment by the end of the week as the psoriasis lesions decrease in size and severity.
Danish: CHMP bemærkede, at den ordlyd, som indehaveren af markedsføringstilladelsen har anvendt, tyder på, at en patient, der bruger den maksimale daglige dosis på 15 g, vil overskride den maksimale ugentlige dosis på 100 g og nå op på 105 g. Indehaveren af markedsføringstilladelsens svar på denne bemærkning var, at nogle patienter kan have brug for en daglig dosis på 15 g i de første par dage af behandlingsforløbet, men eftersom virkningen er stor i den første behandlingsuge, kan det med rimelighed forventes, at patienterne vil bruge mindre Daivobet ved ugens slutning, efterhånden som psoriasislæsionerne bliver mindre i omfang og sværhedsgrad.