FrancophonIA/ELRC3.0 huggingface dataset:
English: Medicinal products containing bufexamac are authorised in twelve EU Member States presented as ointment, cream, and/or suppository formulations (see Annex I for the list of bufexamac containing medicinal products authorised in the EU).
Danish: Lægemidler indeholdende bufexamac er tilladt i 12 EU-medlemsstater, hvor det fås som salve, creme og/eller i stikpilleform (se bilag I for listen over lægemidler indeholdende bufexamac, der er tilladt i EU).
English: The CHMP considered the matter in accordance with Article 107(2) of Directive 2001/83/EC, as amended during the April 2010 CHMP plenary meeting.
Danish: CHMP behandlede spørgsmålet i henhold til artikel 107, stk. 2, i direktiv 2001/83/EF, med senere ændringer, på CHMP's plenarmøde i april 2010.
English: Additional data on the incidence of contact allergies to bufexamac showed that in a sample of ca. 40.000 patch-tested patients, 1.4% exhibited sensitisation to bufexamac.
Danish: Yderligere data om forekomsten af kontaktallergier over for bufexamac viste, at i en prøvetagning blandt ca. 40.000 patienter, der havde fået foretaget lappeprøve, udviste 1,4 % sensibilisering over for bufexamac.
English: However, the CHMP maintains the opinion that the proposed risk minimisation measures are not sufficient to substantially reduce or avoid the risk of contact allergy in patient populations treated with bufexamac containing medicinal products.
Danish: CHMP fastholder imidlertid den opfattelse, at de foreslåede foranstaltninger til risikominimering ikke er tilstrækkelige til væsentligt at reducere eller undgå risikoen for kontaktallergi hos patientpopulationer, der behandles med lægemidler indeholdende bufexamac.
English: Risk minimisation measures such as changes to the Product Information (contraindications and strengthened warnings) and/or restriction of availability were proposed by the MAHs in their response document to the List of Questions adopted by the Committee.
Danish: Indehaverne af markedsføringstilladelse foreslog foranstaltninger til risikominimering, såsom ændringer i produktinformationen (kontraindikationer og skærpede advarsler) og/eller begrænsning med hensyn til adgangen, i svardokumentet til den liste med spørgsmål, som udvalget havde vedtaget.
English: Therefore, the CHMP considers that the exposure to bufexamac increases the risk for the occurrence of contact allergic reactions and even prolong in some cases the duration of the disease.
Danish: CHMP mener derfor, at eksponering for bufexamac øger risikoen for forekomst af kontaktallergiske reaktioner og endda i visse tilfælde forlænger sygdomsforløbet.
English: The CHMP, reviewing evidence from these controlled studies, is of the opinion that, there is only very limited evidence of efficacy for bufexamac in the above mentioned indications.
Danish: CHMP er på baggrund af sin gennemgang af evidensen fra disse kontrollerede undersøgelser af den opfattelse, at der kun foreligger en meget begrænset evidens for effektiviteten af bufexamac i ovennævnte indikationer.
English: The following factors were associated with a significantly increased risk for bufexamac sensitisation: anogenital localisation of eczema, other sensitisations, atopic dermatitis, eczema of the legs, female gender, and geographic factors.
Danish: Følgende faktorer blev forbundet med en signifikant øget risiko for sensibilisering over for bufexamac: anogenital forekomst af eksem, anden sensibilisering, atopisk dermatitis, eksem på benene, det kvindelige køn og geografiske faktorer.
English: Since the granting of the marketing authorisations, several reviews on these medicinal products have been performed at national levels leading to changes of the Summary of product characteristics (SPC), labelling, package leaflet, or change to the legal status from non-prescription to prescription only medicine.
Danish: Siden udstedelsen af markedsføringstilladelsen er der blevet foretaget adskillige gennemgange af disse lægemidler på nationalt niveau, hvilket har medført ændringer i produktresuméet, etiketteringen og indlægssedlen eller ændring af den retlige status fra ikkereceptpligtigt til receptpligtigt lægemiddel.
English: Rectal use and Cutaneous use
Danish: Rektal anvendelse and Kutan anvendelse
English: • The Committee considered the benefit-risk ratio of bufexamac under the normal conditions of use and considered that the aforementioned evidenced risk of contact allergic reactions is not acceptable, taking into account that the efficacy of bufexamac is limited in the treatment of dermatological and proctological diseases.
Danish: • Udvalget tog benefit/risk-forholdet for bufexamac under normale anvendelsesbetingelser i betragtning og var af den opfattelse, at ovennævnte påviste risiko for kontaktallergiske reaktioner ikke er acceptabel, eftersom effektiviteten ved bufexamac er begrænset ved behandling af dermatologiske og proktologiske sygdomme.
English: • The Committee considered the procedure under Article 107 of Directive 2001/83/EC, as amended, for medicinal products containing bufexamac.
Danish: • Udvalget fulgte proceduren i artikel 107 i direktiv 2001/83/EF, med senere ændringer, for lægemidler indeholdende bufexamac.
English: Taking all these elements into account, the CHMP concluded that the medicinal products containing bufexamac for topical use are harmful under the normal conditions of use, and that the benefit/risk balance for bufexamac is not considered favourable.
Danish: På baggrund af alle disse oplysninger konkluderede CHMP, at lægemidler indeholdende bufexamac til topisk brug er skadelige under normale anvendelsesbetingelser, og at benefit/risk-forholdet for bufexamac ikke anses for at være positivt.
English: 61118 Bad Vilbel Germany
Danish: 61118 Bad Vilbel
English: The decision of the German Competent Authority was based on numerous publications and spontaneous reports on contact-allergic reactions following the administration of medicinal products containing bufexamac and recent publications of data on the incidence of and the risk factors for contact sensitisation to bufexamac.
Danish: Den tyske kompetente myndigheds beslutning var baseret på en række publikationer og spontane indberetninger om kontaktallergiske reaktioner efter administration af lægemidler indeholdende bufexamac samt nylige publikationer af data om forekomsten af og risikofaktorerne for kontaktsensibilisering over for bufexamac.
English: • inflammatory conditions of anus and rectum,
Danish: • inflammatoriske tilstande i anus og rectum
English: Following the provisions under Article 107(2) of Directive 2001/83/EC, as amended, the Agency's Committee for Medicinal Products for Human Use (CHMP) recommends the revocation of the Marketing Authorisations for all bufexamac containing medicinal products listed in Annex I.
Danish: I henhold til bestemmelserne i artikel 107, stk. 2, i direktiv 2001/83/EF, med senere ændringer, anbefaler EMA's Udvalg for Humanmedicinske Lægemidler (CHMP) en tilbagekaldelse af markedsføringstilladelserne for alle lægemidler indeholdende bufexamac, som er opført i bilag I.
English: Updated results of the postmarketing experience regarding the serious allergic contact dermatitis with bufexamac and data from a recent publication on this subject (e.g. Schnuch A et al.: A common and insidious side-effect: Allergic contact dermatitis caused by bufexamac used in the treatment of dermatitis.
Danish: De ajourførte resultater af erfaringerne efter markedsføringen vedrørende alvorlig allergisk kontaktdermatitis med bufexamac og data fra en nylig publikation om dette emne (f.eks. Schnuch A et al.: A common and insidious side-effect: Allergic contact dermatitis caused by bufexamac used in the treatment of dermatitis.
English: ANNEX I LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES (EEA)
Danish: BILAG I LISTE OVER LÆGEMIDLETS NAVNE, LÆGEMIDDELFORMER, STYRKER, INDGIVELSESVEJE OG INDEHAVERE AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATERNE (EØS)
English: • to reduce inflammatory symptoms of skin in neurodermatitis and chronic eczema,
Danish: • til at reducere inflammatoriske hudsymptomer ved neurodermatitis og kronisk eksem
English: On 12 January 2010, the Federal Institute for Drugs and Medical Devices (BfArM) issued a Rapid Alert informing the Members States, the European Medicines Agency and the European Commission in accordance with Article 107 of Directive 2001/83/EC, as amended, of its intention to revoke the marketing authorisations of all bufexamac containing medicinal products for topical use in Germany due to an increased risk of serious allergic contact dermatitis and risk factors for contact sensitisation to bufexamac.
Danish: Den 12. januar 2010 udsendte den kompetente tyske myndighed (Bundesinstitut für Arzneimittel und Medizinprodukte - BfArM) en hurtig varslingsmeddelelse, som i henhold til artikel 107 i direktiv 2001/83/EF, med senere ændringer, informerede medlemsstaterne, Det Europæiske Lægemiddelagentur og Europa-Kommissionen om myndighedens hensigt om at trække markedsføringstilladelserne tilbage for alle lægemidler indeholdende bufexamac til topisk brug i Tyskland på grund af en øget risiko for alvorlig allergisk kontaktdermatitis og risikofaktorer for kontaktsensibilisering over for bufexamac.
English: • The Committee concluded, after having reviewed the available data, that bufexamac for topical use is harmful under normal conditions of use due to cutaneous effects and particularly to contact allergic reactions, some of which are serious, generalised or requiring hospitalisation.
Danish: • Efter at have gennemgået de tilgængelige data konkluderede udvalget, at bufexamac til topisk brug er skadelig under normale anvendelsesbetingelser på grund af kutane virkninger, særlig kontaktallergiske reaktioner, hvoraf nogle er alvorlige, nogle er generaliserede, og nogle kræver indlæggelse.
English: • The Committee, in light of the above findings, concluded that the benefit/risk balance of bufexamac containing medicinal products for topical use is not favourable under the normal conditions of use.
Danish: • I lyset af ovenstående betragtninger konkluderede udvalget, at benefit/risk-forholdet ved lægemidler indeholdende bufexamac til topisk brug ikke er positivt under normale anvendelsesbetingelser.
English: Therefore, the CHMP is of the opinion that Bufexamac is a potent sensitizer in a high proportion of patients exposed even after short-term use leading to adverse reactions (contact allergies, severe or generalised in some cases) that can not be distinguished clinically from the diseases to be treated leading to misdiagnosis or late correct diagnostic of the allergy and consequently worsening the disease to be treated.
Danish: CHMP mener derfor, at bufexamac hos en stor andel af de eksponerede patienter, selv efter kortvarig brug, er et potent allergen, der kan medføre bivirkninger (kontaktallergier, alvorlig eller generaliseret i nogle tilfælde), og som ikke kan skelnes klinisk fra de sygdomme, der skal behandles, hvilket kan medføre fejldiagnose eller forsinket korrekt diagnose af allergien og som følge heraf forværre den sygdom, der skal behandles.
English: Suppositories
Danish: Suppositorie
English: The updated results of the postmarketing experience regarding the serious allergic contact dermatitis with bufexamac and data from recent publications on this subject show that bufexamac exhibits questionable efficacy in association with high allergenic potential.
Danish: De ajourførte resultater af erfaringerne efter markedsføringen vedrørende alvorlig allergisk kontaktdermatitis med bufexamac og data fra nylige publikationer om dette emne viser, at bufexamac har en tvivlsom effekt i forbindelse med højt allergifremkaldende potentiale.
English: Despite measures being taken at national level in various Member States, the cutaneous effects and particularly the contact allergic reactions, some of which serious, generalised or requiring hospitalisation caused by bufexamac containing medicinal products for topical use have continued to occur.
Danish: På trods af at der træffes nationale foranstaltninger i de forskellige medlemsstater, forekommer der fortsat kutane virkninger, særlig kontaktallergiske reaktioner, hvoraf nogle er alvorlige, nogle er generaliserede, og nogle kræver indlæggelse, forårsaget af lægemidler indeholdende bufexamac til topisk brug.
English: Based on the aforementioned data, especially with regard to the clinical manifestation of these ADRs compared with the symptoms to be treated, the CHMP concludes that the clinical picture of the undesirable effects (contact allergic eczema) is identical or very similar to the symptomatology of the disease to be treated (contributing to misdiagnosis, a delay in correct diagnosis and prolongation of the disease).
Danish: På baggrund af ovennævnte data, særlig hvad angår den kliniske manifestation af disse bivirkninger sammenlignet med de symptomer, som skal behandles, konkluderer CHMP, at det kliniske billede af bivirkningerne (kontaktallergisk eksem) er identisk eller har stor lighed med symptomatologien for den sygdom, der skal behandles (hvilket kan medføre fejldiagnose, forsinkelse i korrekt diagnose og forlænget sygdomsforløb).
English: • acute und chronic anal inflammatory symptoms of skin,
Danish: • akutte og kroniske anale inflammatoriske hudsymptomer
English: It should also be noted that significant differences between epidemiological data and the number of spontaneous reports on contact dermatitis in the various pharmacovigilance databases clearly suggest significant underreporting and probably underestimation of the frequency of contact-allergic reactions.
Danish: Det skal endvidere bemærkes, at signifikante forskelle mellem epidemiologiske data og antallet af spontane indberetninger om kontaktdermatitis i de forskellige lægemiddelovervågningsdatabaser tydeligt antyder, at der sker en væsentlig underindberetning og sandsynligvis en undervurdering af forekomsten af kontaktallergiske reaktioner.
English: • The Committee noted that the pre-existence of some of the indicated diseases to be treated with bufexamac may constitute risk factors for bufexamac sensitisation and serious hypersensitivity reactions.
Danish: • Udvalget bemærkede, at forudgående tilstedeværelse af nogle af de anførte sygdomme, der skal behandles med bufexamac, kan udgøre risikofaktorer for sensibilisering over for bufexamac og alvorlige overfølsomhedsreaktioner.
English: It is especially of concern that the clinical picture of the undesirable effect (contact allergic eczema) is identical or very similar to the disease to be treated, leading to misdiagnosis, a delay in diagnosis and prolongation of the disease.
Danish: Særlig giver det anledning til betænkelighed, at det kliniske billede af bivirkningerne (kontaktallergisk eksem) er identisk eller har stor lighed med den sygdom, der skal behandles, hvilket kan medføre fejldiagnose, forsinkelse i korrekt diagnose og forlænget sygdomsforløb.
English: Bufexamac is a non-steroidal anti-inflammatory drug (NSAID) authorised for topical treatment of dermatological and proctological diseases, as follows: - Dermatological
Danish: Bufexamac er et ikkesteroidt antiinflamatorisk lægemiddel (NSAID), som er godkendt til topisk behandling af følgende dermatologiske og proktologiske sygdomme: - Dermatologiske:
English: 50mg Bufexamac (+5mg Lidocaine)/ 1g ointment
Danish: 50mg Bufexamac (+5mg Lidocaine)/ 1g
English: Moreover, the pre-existence of some of the indicated diseases to be treated may constitute risk factors for bufexamac sensitisation.
Danish: Forudgående tilstedeværelse af nogle af de anførte sygdomme, der skal behandles, kan endvidere udgøre risikofaktorer for sensibilisering over for bufexamac.
English: Furthermore, significant differences between epidemiological data and the number of spontaneous reports on contact dermatitis in the various pharmacovigilance databases clearly suggest significant underreporting and probably underestimation of the frequency of contact-allergic reactions.
Danish: Endvidere antyder signifikante forskelle mellem epidemiologiske data og antallet af spontane indberetninger om kontaktdermatitis i de forskellige lægemiddelovervågningsdatabaser tydeligt, at der sker en væsentlig underindberetning og sandsynligvis en undervurdering af forekomsten af kontaktallergiske reaktioner.
English: Numerous case reports of allergic contact-dermatitis after application of bufexamac, partly serious and generalised or requiring hospitalisation, have been collected in ADR databases.
Danish: Der er blevet indsamlet en lang række kasuistikker om allergisk kontaktdermatitis efter anvendelse af bufexamac - som var enten alvorlig, generaliseret, eller som krævede indlæggelse - i bivirkningsdatabaser.
English: In addition the CHMP notes that the pre-existence of some of the indicated diseases to be treated with bufexamac constitute risk factors for bufexamac sensitisation.
Danish: CHMP bemærker endvidere, at forudgående tilstedeværelse af nogle af de anførte sygdomme, der skal behandles med bufexamac, udgør risikofaktorer for sensibilisering over for bufexamac.
English: Bufexamac is used as a non-steroidal antiphlogistic substance for topical treatment of several dermatological and proctological diseases.
Danish: Bufexamac anvendes som et ikkesteroidt antiphlogistisk stof til topisk behandling af en række dermatologiske og proktologiske sygdomme.
English: • chronic dermatoses,
Danish: • kronisk dermatose
English: Bufexamac is used as a non-steroidal antiphlogistic substance for topical treatment of dermatological and proctological diseases.
Danish: Bufexamac anvendes som et ikkesteroidt antiphlogistisk stof til topisk behandling af dermatologiske og proktologiske sygdomme.
English: 250mg Bufexamac, +10mg Lidocaine suppository
Danish: 250mg Bufexamac, +10mg Lidocaine
English: • hyperkeratotic conditions, chronic und subacute, - Proctological
Danish: • hyperkeratotiske tilstande, kroniske og subakutte.
English: • dermatitis, chronic and subacute,
Danish: • dermatitis, kronisk og subakut
English: Rectal ointment
Danish: Rektal salve
English: Cutaneous emulsion
Danish: Kutan emulsion Kutan anvendelse
English: Bulgaria Stada Arzneimittel AG Stadastrasse 2-1
Danish: Bulgarien Stada Arzneimittel AG Stadastrasse 2-1
English: 250 mg suppository
Danish: 250 mg
English: Bulgaria Stada Arzneimittel AG, Stadastrasse 2-18
Danish: Bulgarien Stada Arzneimittel AG, Stadastrasse 2-18
English: MASTU S FORTE Bufexamac 250 mg, Bismuth subgallate 100 mg, Titanium dioxide 100 mg, Lidocaine hydrochloride 10 mg suppository
Danish: MASTU S FORTE Bufexamac 250 mg, Bismuth subgallate 100 mg, Titanium dioxide 100 mg, Lidocaine hydrochloride 10 mg
English: • eczema,
Danish: • eksem
English: Slovakia STADA Arzneimittel AG Stadastrasse 2 - 18
Danish: STADA Arzneimittel AG Stadastrasse 2 - 18
English: Romania STADA ARZNEIMITTEL AG Stadastrasse 2-18
Danish: Rumænien STADA ARZNEIMITTEL AG Stadastrasse 2-18
English: Bufexamac 50 mg/g, Bismuth subgallate 50 mg/g, Titanium dioxide 50 mg/g, Lidocaine hydrochloride 5 mg/g rectal ointment
Danish: Bufexamac 50 mg/g, Bismuth subgallate 50 mg/g, Titanium dioxide 50 mg/g, Lidocaine hydrochloride 5 mg/g
English: The patient usually receives 3 infusions within one week.
Danish: Patienten får sædvanligvis 3 infusioner i løbet af en uge.
English: These side effects can be serious in more than 1 in 10 people.
Danish: Disse bivirkninger kan være alvorlige hos mere end 1 ud af hver 10 personer.
English: As for all medicines, data on the use of Mylotarg are continuously monitored.
Danish: Som for alle lægemidler, er data vedrørende brug af Mylotarg løbende overvåget.
English: The calicheamicin then breaks up the cells' DNA, eventually killing the cells.
Danish: Calicheamicinet bryder derefter cellernes DNA, så cellerne til sidst dræbes.
English: If the cancer responds to initial treatment, the patient may receive further ‘consolidation' treatment to keep the cancer from coming back.
Danish: Hvis kræften reagerer på den indledende behandling, kan patienten få supplerende "konsoliderende" behandling til at forebygge, at kræften vender tilbage.
English: Other information about Mylotarg
Danish: Andre oplysninger om Mylotarg
English: For more information about using Mylotarg, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Mylotarg, se indlægssedlen, eller kontakt lægen eller apotekspersonalet.
English: The European Medicines Agency decided that Mylotarg's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Mylotarg opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: The patient is also given medicines to help prevent reactions such as reddening of the skin, chills and fever.
Danish: Patienten får desuden lægemidler til forebyggelse af reaktioner som rødme af huden, kulderystelser og feber.
English: Mylotarg infusions must be given in a place (such as a hospital) where the patient can be resuscitated if there are severe reactions.
Danish: Infusioner af Mylotarg skal gives et sted (såsom på et hospital), hvor der er mulighed for at genoplive patienten i tilfælde af svære reaktioner.
English: Further information on Mylotarg can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Mylotarg findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It is not used for a type of AML called acute promyelocytic leukaemia (APL).
Danish: Det anvendes ikke til den type AML, der hedder akut promyelocytisk leukæmi (APL).
English: Further information on the orphan designation can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Yderligere information om lægemiddel til sjældne sygdomme kan findes her: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Side effects reported with Mylotarg are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Mylotarg vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
English: What measures are being taken to ensure the safe and effective use of Mylotarg?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Mylotarg?
English: AML is rare, and Mylotarg was designated an ‘orphan medicine' (a medicine used in rare diseases) on 18 October 2000.
Danish: AML er sjælden, og Mylotarg blev udpeget som "lægemiddel til sjældne sygdomme" den 18. oktober 2000.
English: Although some side effects with Mylotarg can be serious, they were considered acceptable in light of the severity of the patients' condition.
Danish: Selvom visse bivirkninger med Mylotarg kan være alvorlige, blev de anset for acceptable på baggrund af sværhedsgraden afpatienternes sygdom.
English: An overview of Mylotarg and why it is authorised in the EU
Danish: En oversigt over Mylotarg og hvorfor det er godkendt i EU
English: What is Mylotarg and what is it used for?
Danish: Hvad er Mylotarg, og hvad anvendes det til?
English: It is used in combination with daunorubicin and cytarabine (other cancer medicines).
Danish: Det anvendes i kombination med daunorubicin og cytarabin (andre kræftlægemidler).
English: Mylotarg can only be obtained with a prescription.
Danish: Mylotarg udleveres kun efter recept.
English: Mylotarg is used in patients with a protein called CD33 on their cancer cells (which is the case in most patients with AML).
Danish: Mylotarg anvendes til patienter, der har proteinet CD33 på deres kræftceller (dette gælder de fleste patienter med AML).
English: Why is Mylotarg authorised in the EU?
Danish: Hvorfor blev Mylotarg godkendt i EU?
English: The most common side effects with Mylotarg when given in combination with daunorubicin and cytarabine (which may affect more than 3 in 10 people) are bleeding and severe infections.
Danish: De hyppigste bivirkninger ved Mylotarg givet i kombination med daunorubicin og cytarabin (som kan forekomme hos mere end 3 ud af 10 personer) er blødning og svære infektioner.