FrancophonIA/ELRC3.0 huggingface dataset:
English: Adrenocortical suppression, cataract, infections, impact on the metabolic control of diabetes mellitus and increase of intra-ocular pressure can occur, especially after long term treatment.
Danish: Binyrebarksuppression, katarakt, infektioner, påvirkning af den metaboliske kontrol af diabetes mellitus og øget intraokulært tryk kan opstå, specielt efter langvarig behandling.
English: Studies of corticosteroids in animals have shown reproductive toxicity (cleft palate, skeletal malformations).
Danish: Kortikosteroidundersøgelser i dyr har vist reproduktionstoksicitet (ganespalte, skeletmisdannelser).
English: Swelling of the mouth/throat and trouble breathing may occur.
Danish: Hævelse af mund/hals og besvær med at trække vejret kan forekomme.
English: Use above the recommended dose may cause elevated serum calcium which should rapidly subside when treatment is discontinued.
Danish: Anvendelse af højere dosis end den anbefalede kan medføre forhøjet serum-calcium, som hurtigt falder efter seponering af behandlingen.
English: Adoption of the proposed text would give clinicians extra useful information regarding the specific actions of the corticosteroid component of Daivobet ointment.
Danish: Vedtagelsen af den foreslåede tekst ville give lægen yderligere nyttig information om de specifikke virkninger af kortikosteroid-komponenten i Daivobet salve.
English: The following adverse reactions are considered to be related to the pharmacological classes of calcipotriol and betamethasone, respectively:
Danish: Følgende bivirkninger skønnes relateret til de farmakologiske klasser for hhv. calcipotriol og betamethason:
English: Due to the thin stratum corneum of the face and genitals these areas are particularly susceptible to local and systemic adverse effects of corticosteroids.
Danish: Som følge af hudens tynde hornlag på ansigtet og genitalierne er disse områder særligt modtagelige for lokale og systemiske bivirkninger af kortikosteroider.
English: A dermal carcinogenicity study with calcipotriol in mice revealed no special hazard to humans.
Danish: Et dermalt karcinogenicitetsstudie med calcipotriol i mus viste ingen speciel risiko for mennesker.
English: The CHMP asked the MAH to clarify the adverse events of concern possibly related to long term corticoid use.
Danish: CHMP bad indehaveren af markedsføringstilladelsen om at specificere de mere alvorlige utilsigtede hændelser, der muligvis er forbundet med langtidsbrug af kortikoider.
English: 6.6 Special precautions for disposal and other handling No special requirements.
Danish: 6.6 Regler for destruktion og anden håndtering Specielle instruktioner er ikke påkrævet.
English: Other studies were submitted in support of the efficacy and safety of Daivobet ointment on the body (MCB 9802 INT and MCB 9904 INT), patients in these studies were allowed to use other topical medication on scalp psoriasis.
Danish: Der blev fremsendt andre undersøgelser til støtte for virkning og sikkerhed af Daivobet salve på kroppen (MCB 9802 INT og MCB 9904 INT), og patienterne i disse undersøgelser fik tilladelse til at bruge andre topiske lægemidler mod psoriasis i hovedbunden.
English: Penetration through the stratum corneum is enhanced under occlusion thus the addition of this information would make the clinician aware of this possibility.
Danish: Penetration gennem stratum corneum øges ved okklusion, og en tilføjelse af denne information ville således gøre lægen opmærksom på denne mulighed.
English: Regarding the contraindication for guttate psoriasis, this has been included in the SPC based on its exclusion from the clinical trial programme as well.
Danish: Hvad angår kontraindikationen for guttat psoriasis, var den ligeledes blevet medtaget i produktresuméet på baggrund af sygdommens udelukkelse fra det kliniske undersøgelsesprogram.
English: This medicine is authorised in the Member States of the EEA under the following names: [See Annex I - To be completed nationally]
Danish: Dette lægemiddel er godkendt i EEAs medlemslande under følgende navne: [Se bilag I - Udfyldes nationalt]
English: The following less serious side effects have been reported for Daivobet.
Danish: Følgende mindre alvorlige bivirkninger er blevet indberettet for Daivobet.
English: The statement “After this period repeated treatment with Daivobet ointment can be initiated under medical supervision” was considered unclear by the CHMP as Daivobet treatment is presumably initiated by a doctor and treatment is presumably monitored.
Danish: CHMP anså sætningen “Efter denne periode kan gentagen behandling med Daivobet salve indledes under lægeligt opsyn” for at være uklar, eftersom behandling med Daivobet formodentlig indledes af en læge, og eftersom behandlingen formodentlig monitoreres.
English: One SPC did not include: “Based on data from clinical trials and post market use the common undesirable effects are pruritus, rash and burning sensation of skin.
Danish: Et af produktresuméerne medtog ikke følgende: “På baggrund af data fra kliniske undersøgelser og brug efter markedsføringen er almindelige bivirkninger kløe, hududslæt og brændende fornemmelse i huden.
English: This leaflet was last approved in {MM/YYYY}.
Danish: Denne indlægsseddel blev senest godkendt { MM/ÅÅÅÅ }
English: One SPC did not include information about the possibility of increased absorption of topical steroids under occlusive dressings.
Danish: I et af produktresuméerne var der ikke medtaget information om muligheden for øget absorption af topiske steroider under okklusionsbandage.
English: Betamethasone is metabolised especially in the liver, but also in the kidneys to glucuronide and sulphate esters.
Danish: Betamethason metaboliseres fortrinsvist i leveren, men også i nyrerne som glukuronid og sulfatestere.
English: INFORMATION IN BRAILLE [To be completed nationally] Carton text: Daivobet gel.
Danish: [Udfyldes nationalt] Tekst på karton: Daivobet gel.
English: After first opening: 1 year.
Danish: Efter anbrud: 1 år.
English: With regard to the contraindication in patients with severe renal and severe hepatic disorder, the MAH clarified that the contraindication has been included in the SPC based on its exclusion from the clinical trial programme, being not an absolute contraindication the information was removed from section 4.3 and the following was added in section 4.2: “The safety and efficacy of Daivobet ointment in patients with severe renal insufficiency or severe hepatic disorders have not been evaluated”.
Danish: Hvad angår kontraindikationen hos patienter med svære nyre- og leversygdomme, oplyste indehaveren af markedsføringstilladelsen, at kontraindikationen var blevet medtaget i produktresuméet på baggrund af disse sygdommes udelukkelse fra det kliniske undersøgelsesprogram, men eftersom det ikke var en absolut kontraindikation, blev informationen flyttet fra punkt 4.3, og følgende blev tilføjet i punkt 4.2: “Sikkerhed og virkning af Daivobet salve hos patienter med svær nyreinsufficiens eller svær leversygdom er ikke blevet undersøgt”.
English: When lesions become secondarily infected, they should be treated with antimicrobiological therapy.
Danish: Hvis læsioner inficeres sekundært, skal de behandles med antimikrobielle midler.
English: Exacerbation of psoriasis Burning sensation of skin Skin pain or irritation Folliculitis
Danish: Eksacerbation af psoriasis Brændende fornemmelse i huden Smerte på huden eller irritation Folliculitis
English: “Penetration through the stratum corneum is enhanced under occlusion” was also added in order to make clinician aware of this possibility.
Danish: Odlyden “Penetration gennem stratum corneum øges ved okklusion” blev ligeledes tilføjet for at gøre lægen opmærksom på denne mulighed.
English: Therefore it was proposed to add the wording “the maximum daily dose should not exceed 15 g, and the maximum weekly dose should not exceed 100 g” and “the body surface area treated with calcipotriol containing products should not exceed 30%”.
Danish: Derfor blev det foreslået at tilføje ordlyden “den maksimale daglige dosis bør ikke overstige 15 g, og den maksimale ugentlige dosis bør ikke overstige 100 g” og “der bør ikke behandles mere end højst 30 % af kroppens overfladeareal med lægemidler, som indeholder calcipotriol”.
English: In two MS's the text “When lesions become secondarily infected, they should be treated with antimicrobiological therapy.
Danish: I to medlemsstater var teksten “Hvis læsioner sekundært inficeres, bør de behandles med antimikrobielle midler.
English: What Daivobet contains
Danish: Daivobet indeholder
English: However, if infection worsens, treatment with corticosteroids should be stopped” was not included in the SPC.
Danish: Hvis infektionen forværres, bør behandlingen med kortikosteroider dog stoppes” ikke medtaget i produktresuméet.
English: Serious side effects known to be caused by calcipotriol - Allergic reactions with deep swelling of the face or other parts of the body such as the hands or feet.
Danish: Alvorlige bivirkninger, der kendes for calcipotriol - Allergiske reaktioner med hævelse af ansigt eller andre dele af kroppen, fx hænder og fødder.
English: Rebound effect - included in section 4.4
Danish: Rebound effekt - inkluderet i pkt.
English: Approximately 1 in 12 people may experience side effects, but most of these are reactions at the site where the gel has been applied.
Danish: Ca. 1 ud af 12 personer kan forvente at få bivirkninger, men de fleste reaktioner forekommer der, hvor gelen er påsmurt.
English: There was no evidence of change of calcium metabolism observed in these patients.
Danish: Der var ingen evidens for en ændring i calciummetabolismen hos disse patienter.
English: When the ointment and body were assessed, other treatments were allowed for face and scalp.
Danish: Når salven og kroppen blev vurderet, var det tilladt at anvende andre behandlinger i ansigtet og i hovedbunden.
English: Signs of increased calcium in blood is bone pain, constipation, poor appetite, nausea and vomiting.
Danish: Tegn på øget kalcium i blodet er smerter i knoglerne, forstoppelse, appetitløshed, kvalme og opkastning.
English: The CHMP endorsed the harmonised text under this section.
Danish: CHMP godkendte den harmoniserede tekst under dette punkt.
English: Exacerbation of psoriasis Skin pain or irritation Dermatitis
Danish: Eksacerbation af psoriasis Smerte på huden eller irritation Dermatitis
English: A borderline decrease in cortisol response at 30 minutes post ACTH challenge was seen in 5 of 32 patients (15.6 %) after 4 weeks of treatment and in 2 of 11 patients (18.2 %) who continued treatment until 8 weeks.
Danish: Der blev set et marginalt nedsat cortisolrespons 30 minutter efter eksponering for ACTH hos 5 ud af 32 patienter (15,6 %) efter 4 ugers behandling og hos 2 ud af 11 patienter (18,2 %), som fortsatte behandlingen til i alt 8 uger.
English: The CHMP agreed to the MAH proposal regarding the addition of Rebound effect as stated in section 4.4. and endorsed following: “Rebound effect after end of treatment has been reported but the frequency of this is not known”.
Danish: CHMP var enig i indehaveren af markedsføringstilladelsens forslag om at tilføje “rebound-effekt” som nævnt i punkt 4.4, og CHMP godkendte følgende ordlyd: “Rebound-effekt efter endt behandling er rapporteret, men hyppigheden er ikke kendt”.
English: You should tell your doctor as soon as possible if any of the serious side effects occur: - Your adrenal glands may stop working properly.
Danish: Du skal kontakte din læge så hurtigt som muligt, hvis du får nogen af følgende alvorlige bivirkninger: - Dine binyrer kan holde op med at fungere normalt.
English: In two MSs the SPC did not include the information on the spontaneous report of overdose of Daivobet ointment.
Danish: I to medlemsstater omfattede produktresuméet ikke information om den spontane indberetning af en overdosis af Daivobet salve.
English: Let Daivobet remain on the scalp during the night or during the day.
Danish: Lad Daivobet sidde i hårbunden natten over eller hele dagen.
English: Daivobet gel in bottles of 15 g, 30 g and 60 g
Danish: Daivobet gel i flasker a 15 g, 30 g og 60 g
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)” was not included in the SPC.
Danish: Topisk calcipotriol bør udelukkende bruges sammen med UV-stråling, hvis lægen og patienten er af den opfattelse, at de potentielle fordele opvejer de potentielle risici (se punkt 5.3)” ikke medtaget i produktresuméet.
English: Therefore, during pregnancy, Daivobet ointment should only be used when the potential benefit justifies the potential risk.
Danish: Derfor bør Daivobet salve kun anvendes under graviditet, når den potentielle fordel retfærdiggør den potentielle risiko.
English: Your doctor may need to carry out blood tests to check that using too much ointment has not caused a problem with calcium in your blood.
Danish: Din læge kan være nødt til at tage nogle blodprøver for at sikre sig, at den overdrevne brug af salven ikke har medført problemer med kalciumindholdet i dit blod.
English: In reproduction toxicity studies with long-term oral administration of corticosteroids to rats, prolonged gestation and prolonged and difficult labour were detected.
Danish: I undersøgelser af reproduktionstoksicitet efter lang tids oral administration af kortikosteroider til rotter er forlænget svangerskab og langvarige og besværlige fødsler set.
English: In some MSs betamethasone dipropionate was described as a “glucocorticoid showing the general characteristics of the corticosteroids”.
Danish: I nogle medlemsstater blev betamethasondipropionat beskrevet som et “glukokortikoid med kortikosteroiders generelle karakteristika”.
English: Like other topical corticosteroids, betamethasone dipropionate has anti-inflammatory, antipruritic, vasoconstrictive and immunosuppresive properties, however, without curing the underlying condition.
Danish: I lighed med andre topikale kortikosteroider har betamethasondipropionat anti-inflammatoriske, kløestillende, vasokonstriktive og immunsupprimerende egenskaber, men kurerer dog ikke den tilgrundliggende tilstand.
English: If you have used more Daivobet than you should Contact your doctor if you have used more than 15 grams in one day.
Danish: Kontakt din læge, hvis du har anvendt mere end 15 g på en dag.
English: SPECIAL STORAGE CONDITIONS Do not store above 25 °C
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares ved temperatur over 25 °C
English: In local tolerability studies in rabbits, Daivobet gel caused mild to moderate skin irritation and a slight transient irritation of the eye.
Danish: Undersøgelser af lokal tolerance i kaniner har vist, at Daivobet gel forårsager mild til moderat hudirritation og en let, forbigående irritation i øjnene.
English: As outlined in section 4.4, information about results from a clinical study, MBL 0404 FR, where adrenal response to adrenocorticotropic hormone (ACTH) was determined, has been included.
Danish: Som nævnt i punkt 4.4 blev der medtaget information om resultaterne af en klinisk undersøgelse, MBL 0404 FR, hvor binyreresponsen på adrenokortikotropisk hormon (ACTH) blev bestemt.
English: Following systemic exposure, both active ingredients - calcipotriol and betamethasone dipropionateare rapidly and extensively metabolised.
Danish: Efter systemisk absorption bliver begge de aktive substanser - calcipotriol og betamethasondipropionat - hurtigt og ekstensivt metaboliseret.
English: Therefore the MAH proposed a text more specific regarding the known cutaneous effects of betamethasone dipropionate.
Danish: Derfor foreslog indehaveren af markedsføringstilladelsen en mere specifik tekst om de kendte kutane virkninger af betamethasondipropionat.
English: Daivobet ointment in tubes of 3 g
Danish: Daivobet salve i tuber a 3 g
English: Daivobet gel has no influence on the ability to drive and use machines.
Danish: Daivobet gel har ingen indflydelse på evnen til at føre motorkøretøj eller betjene maskiner.
English: Rare (affects less than 1 in 1,000 people) - Pustular psoriasis may occur (a red area with yellowish pustules usually on the hands or feet).
Danish: Sjældne (ses hos mindre end 1 ud af 1.000 personer) - Pustuløs psoriasis kan forekomme (et rødt område med gullige, pusholdige blærer, som sædvanligvis optræder på hænder og fødder).
English: Medical supervision should therefore continue in the post-treatment period.
Danish: Lægen bør derfor følge patienten i en periode efter behandlingsophør.
English: Excessive prolonged use can also cause your adrenal glands to stop working properly (the adrenal glands are found near the kidneys and produce hormones).
Danish: Overdreven lang tids brug kan også medføre, at dine binyrer holder op med at fungere normalt (binyrerne sidder i nærheden af dine nyrer og producerer hormoner).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS, TUBE
Danish: MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER, TUBER
English: If you use other calcipotriol containing medicines, the total amount of calcipotriol medicines must not exceed 15 grams per day and the area treated should not exceed 30 % of the total body surface.
Danish: Hvis du bruger anden medicin, der indeholder calcipotriol, må den totale mængde af præparaterne, der indeholder calcipotriol, ikke overstige 15 g om dagen, og hele det behandlede område må ikke overstige 30 % af kroppens samlede overflade.
English: In one MSs SPC there were no recommendations regarding the maximum daily dose (15g) or the percentage of the body surface area to be treated (30%).
Danish: I en af medlemsstaternes produktresumé var der ikke nogen anbefalinger med hensyn til den maksimale daglige dosis (15 g) eller den procentdel af kroppens overfladeareal, der må behandles (30 %).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Daivobet ointment in tubes of 3 g
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Daivobet salve i tuber a 3 g
English: There are no adequate data from the use of Daivobet gel in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af Daivobet gel til gravide kvinder.
English: The clinical trial programme for Daivobet gel has so far included more than 4,700 patients of whom more than 2,100 were treated with Daivobet gel.
Danish: Mere end 4.700 patienter har været inkluderet i kliniske afprøvninger med Daivobet gel, hvoraf mere end 2.100 er blevet behandlet med Daivobet gel.
English: In one MSs SPC was not included the information that after a period of 4 weeks repeated treatment with Daivobet ointment can be initiated under medical supervision.
Danish: I en af medlemsstaternes produktresumé var der ikke medtaget information om, at det efter en periode på 4 uger er muligt at indlede gentagen behandling med Daivobet salve under lægeligt opsyn.
English: INFORMATION IN BRAILLE Carton for 3 g pack size: [To be completed nationally] Daivobet ointment
Danish: INFORMATION I BRAILLE-SKRIFT Karton til 3 g pakning: [Udfyldes nationalt]
English: Application site pigmentation changes
Danish: Ændringer i hudens pigmentering på applikationsstedet
English: The study MBL 0404 FR investigated also the systemic effects of the combined use of Daivobet gel (used on the scalp) and Daivobet ointment (used on the body) in patients with psoriasis vulgaris on these areas.
Danish: I undersøgelsen MBL 0404 FR undersøgte man også de systemiske virkninger af den kombinerede brug af Daivobet gel (brugt på hovedbunden) og Daivobet salve (brugt på kroppen) hos patienter med psoriasis vulgaris på disse områder.
English: When treating psoriasis there may be a risk of generalised pustular psoriasis.
Danish: Ved behandling af psoriasis kan der være en risiko for generaliseret pustuløs psoriasis.
English: Betamethasone (as dipropionate)
Danish: Betamethason (som dipropionat)
English: - Apply Daivobet to the affected area with your fingertips, and rub it in gently until the area affected by psoriasis is covered by a thin layer of gel.
Danish: - Påfør Daivobet på det angrebne sted med fingerspidserne og gnid den forsigtigt ind, indtil området med psoriasis er dækket af et tyndt lag gel.
English: Your doctor may need to carry out blood tests to check that using too much gel has not caused a problem with calcium in your blood.
Danish: Din læge kan være nødt til at tage nogle blodprøver for at sikre sig, at den overdrevne brug af gelen ikke har medført problemer med kalciumindholdet i dit blod.
English: The systemic exposure to calcipotriol and betamethasone dipropionate from topically applied Daivobet gel is comparable to Daivobet ointment in rats and minipigs.
Danish: Den systemiske eksponering for calcipotriol og betamethasondipropionat fra topikalt anvendt Daivobet gel er sammenlignelig med Daivobet salve hos rotter og minigrise.
English: The CHMP did not consider necessary to provide the detail of the photocarcinogenicity study and endorsed the following: "Photo(co)carcinogenicity studies in mice suggest that calcipotriol may enhance the effect of UVR to induce skin tumours".
Danish: CHMP mente ikke, at det var nødvendigt at give en detaljeret beskrivelse af fotocarcinogenicitetsundersøgelsen, og CHMP godkendte følgende: "Foto(co)carcinogenicitetsundersøgelser hos mus tyder på, at calcipotriol kan øge UV-strålings hudkræftfremkaldende virkning".
English: Calcipotriol and betamethasone.
Danish: Calcipotriol og betamethason.
English: The CHMP proposed that the MAH either omits a weekly dose and endorsed the following: “When using calcipotriol containing medicinal products, the maximum daily dose should not exceed 15 g.”
Danish: CHMP foreslog, at indehaveren af markedsføringstilladelsen i så fald udelader den ugentlige dosis, og CHMP godkendte følgende ordlyd: “Ved anvendelse af lægemidler, der indeholder calcipotriol, må den maksimale daglige dosis ikke overstige 15 g.”
English: Comparators were betamethasone dipropionate in the gel vehicle, calcipotriol in the gel vehicle and (in one of the studies) the gel vehicle alone, all used once daily.
Danish: Sammenligningspræparaterne var betamethasondipropionat i gel-vehiklet, calcipotriol i gel-vehiklet og (i en af undersøgelserne) gel-vehiklet alene, alle anvendt én gang dagligt.
English: In case of chronic toxicity, the corticosteroid treatment must be discontinued gradually.
Danish: I tilfælde af kronisk toksicitet skal kortikosteroidbehandlingen seponeres gradvist.
English: Bottle text: 15 g
Danish: Tekst på flasken: 15 g
English: If you notice the above or any other changes in your health while taking this medicine, tell your doctor.
Danish: Tal med din læge, hvis du bemærker nogle af de ovenfor nævnte bivirkninger eller andre ændringer i dit helbred, mens du bruger denne medicin.
English: Three MSs SPC stated: “there is experience with repeated courses of Daivobet up to 52 weeks” which was supported by study MCB 0102 INT.
Danish: I tre medlemsstaters produktresumé stod der, at “der er erfaringer med gentagne behandlingsforløb med Daivobet i op til 52 uger”, hvilket blev underbygget af undersøgelsen MCB 0102 INT.
English: Children Daivobet is not recommended for the use in children below the age of 18 years.
Danish: Børn Daivobet anbefales ikke til børn under 18 år.
English: Duration of treatment - Use the gel once a day.
Danish: Behandlingsvarighed - Brug salven én gang daglig.
English: The MAH proposed to add some detailed information from these mentioned studies in the harmonized SPC.
Danish: Indehaveren af markedsføringstilladelsen foreslog, at der blev tilføjet nogle detaljerede informationer fra de nævnte undersøgelser i det harmoniserede produktresumé.
English: Psoriasis is caused by your skin cells being produced too quickly.
Danish: Når du har psoriasis, sker celledelingen i din hud for hurtigt.
English: Furthermore, since Daivobet gel is an extension to Daivobet ointment and there were some differences in the SPCs.
Danish: Desuden er Daivobet gel et supplement til Daivobet salve, og der var nogle forskelle i produktresuméerne.
English: Tell your doctor/nurse immediately or as soon as possible if any of the following happens.
Danish: Kontakt din læge øjeblikkeligt eller så hurtigt som muligt, hvis du får nogen af følgende bivirkninger.