FrancophonIA/ELRC3.0 huggingface dataset:
English: Both studies showed a significant reduction in the incidence of flares (p<0.001) in favour of <Invented Name> treatment; <Invented Name> treatment showed better efficacy in all secondary assessments (Eczema Area Severity Index, Investigators Global Assessment, subject assessment); pruritus was controlled within a week with <Invented Name>.
Danish: Behandling med {(Sær)navn} viste bedre effekt i alle sekundære målinger (EASI, IGA, patientens egen vurdering); pruritus blev afhjulpet inden for 1 uges behandling med {(Sær)navn}.
English: p-value <Invente d Name>
Danish: p-værdi {(Sær)navn} (N=123)
English: However, a link to the treatment with Elidel Cream has not been confirmed or refuted on the available evidence so far.
Danish: Det kan dog hverken bekræftes eller afvises, at der er en forbindelse til behandlingen med {(Sær)navn}, ud fra det materiale, der til dato er tilgængeligt.
English: NAME OF THE MEDICINAL PRODUCT <<Invented Name>>
Danish: LÆGEMIDLETS NAVN {(Sær)navn}
English: Interactions with other medicines that you take are unlikely to occur.
Danish: Det er ikke sandsynligt, at {(Sær)navn} vil påvirke anden medicin, som De bruger.
English: Medium chain triglycerides Oleyl alcohol
Danish: Triglycerider, middelkædelængde Oleylalkohol
English: Elidel cream 1% 1% Cream 30 g
Danish: Elidel cream 1% 1% Creme 30 g
English: <Invented Name> should only be applied to areas affected with atopic dermatitis.
Danish: {(Sær)navn} bør kun påsmøres områder der er angrebet af atopisk dermatitis.
English: 1% Cream 15 g
Danish: 1% Creme 15 g
English: Elidel cream 1% 1% Cream 15 g
Danish: Elidel cream 1% 1% Creme 15 g
English: <Invented Name> is not approved for children younger than 2 years of age.
Danish: Vær særlig forsigtig med at anvende {(Sær)navn} {(Sær)navn} creme er ikke godkendt til behandling af børn yngre end 2 år.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Topical administration.
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Kutan anvendelse.
English: 1% Cream 60 g
Danish: 1% Creme 60 g
English: GENERAL CLASSIFICATION FOR SUPPLY <[To be completed nationally]> <Medicinal product subject to medical prescription.> <Medicinal product not subject to medical prescription.>
Danish: GENEREL KLASSIFIKATION FOR UDLEVERING Receptpligtigt lægemiddel.
English: Skin infections such as impetigo (a bacterial skin infection), herpes simplex (cold sores), herpes zoster (shingles), herpes simplex dermatitis (eczema herpeticum), molluscum contagiosum (a viral skin infection), warts and furuncles (boils).
Danish: Ikke almindelige bivirkninger, forekommer hos mellem 1 og 10 ud af 1.000 patienter: Hudinfektioner, som f.eks. impetigo (en bakteriel infektion), herpes simplex (forkølelsessår), herpes zoster (helvedesild), herpes simplex dermatitis (udbrud af herpes simplex i et tidligere eller aktivt atopisk eksem), molluscum contagiosum (en virusinfektion), vorter og bylder.
English: Long term treatment should be intermittent and not continuous.
Danish: Langtidsbehandling bør være med cremefri perioder og ikke en uafbrudt behandling.
English: Endpoint Criteria
Danish: Endpoint
English: Read all of this leaflet carefully before you start using <Invented Name> cream - Keep this leaflet.
Danish: Læs hele denne indlægsseddel omhyggeligt, inden De begynder at anvende {(Sær)navn}.
English: Rarely, cases of malignancy, including lymphomas and skin cancers, have been reported in patients using Elidel .
Danish: Kun sjældent har der været indrapporteret tilfælde af ondartede sygdomme, herunder lymfeknudekræft og hudkræft, hos patienter der bruger {(Sær)navn}.
English: PHARMACEUTICAL FORM AND CONTENTS 1% Cream
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) Creme
English: Post marketing: Cases of malignancy, including cutaneous and other types of lymphoma, and skin cancers, have been reported in patients using pimecrolimus cream (See Section 4.4) .
Danish: Efter markedsføring: Der er rapporteret tilfælde af malignitet, inklusiv kutane og andre typer af lymfomer og hudcancere hos patienter, som har været behandlet med pimecrolimus creme (se pkt.
English: Based on the minimal extent of pimecrolimus absorption after topical application of <Invented Name> (see Section 5.2 “Pharmacokinetic properties”), the potential risk for humans is considered limited.
Danish: 5.2 ”Farmakokinetiske egenskaber”), betragtes den potentielle risiko for mennesker som værende begrænset.
English: B-1800 Vilvoorde Belgium
Danish: Novartis Pharma N.V.Medialaan 40 B-1800 Vilvoorde Belgien
English: 1% Cream 30 g
Danish: 1% Creme 30 g
English: <Invented Name> cream is available in tubes of 15 g, 30 g, 60 g and 100 g. The cream is used to treat signs and symptoms of mild or moderate eczema (e.g. redness and itch) in children (aged 2 years and above), teenagers and adults When used to treat early signs and symptoms it can prevent progression to severe flare-ups.
Danish: Cremen bruges til at behandle tegn og symptomer på mild til moderat eksem (f.eks. rødmen og kløe) hos børn (2 år og derover), teenagers og voksne.
English: However, based on the minimal extent of pimecrolimus absorption after topical application of <Invented Name>, (see Section 5.2 “Pharmacokinetic properties”), the potential risk for humans is considered limited.
Danish: 5.2 ”Farmakokinetiske egenskaber”), vurderes den potentielle risiko for mennesker dog som værende begrænset.
English: <Invented Name> may be associated with an increased risk of a severe herpes simplex skin infection (eczema herpeticum).
Danish: {(Sær)navn} kan være forbundet med en øget risiko for udbrud af en alvorlig herpes simplex infektion (eczema herpeticum: udbrud af herpes simplex i et tidligere eller aktivt atopisk eksem).
English: Apply a thin layer of <Invented Name> to the affected skin twice daily and rub in gently and completely.
Danish: Smør 2 gange daglig et tyndt lag {(Sær)navn} creme på den afficerede hud, og gnid forsigtigt cremen fuldstændig ind. Alle påvirkede områder af huden bør behandles med {(Sær)navn}, indtil symptomerne er svundne.
English: 1% Cream 100 g
Danish: 1% Creme 100 g
English: DATE OF REVISION OF THE TEXT <<Date of revision>>
Danish: DATO FOR ÆNDRING AF TEKSTEN [Udfyldes nationalt]
English: • Apply only on areas affected with eczema
Danish: • Anvend kun cremen på hud, der er angrebet af eksem
English: STORING <INVENTED NAME> CREAM
Danish: Dato for sidste revision: {(Sær)navn} creme
English: Elidel 1 % cream 1 % Cream
Danish: Elidel 1 % cream 1 % Creme
English: Elidel 1% Krém 1% Cream
Danish: Elidel 1% Krém 1% Creme
English: Lactation
Danish: Dyredata
English: Elidel cream 1% 1% Cream
Danish: Elidel cream 1% 1% Creme
English: However, patients with atopic dermatitis treated with <Invented Name> have not been found to have significant systemic pimecrolimus levels.
Danish: Der er dog ikke fundet signifikante systemiske koncentrationer af pimecrolimus hos atopisk dermatitis patienter, som er behandlet med {(Sær)navn}.
English: 1% Cream
Danish: 1% Creme
English: Therefore if you develop painful sores anywhere on your body, tell your doctor immediately.
Danish: Kontakt straks lægen, hvis De udvikler smertefulde sår/betændelse et hvilket som helst sted på kroppen.
English: 1% cream Cream
Danish: 1% creme Creme
English: No incidents of accidental ingestion have been reported.
Danish: Der er ikke indberettet tilfælde af overdosering.
English: • Rub in gently and fully.
Danish: • Gnid forsigtigt cremen helt ind
English: You can use moisturisers (emollients) with <Invented Name> .
Danish: De kan godt anvende fugtighedscreme sammen med {(Sær)navn}.
English: Mono-and di-glycerides Sodium cetostearyl sulphate Benzyl alcohol Citric acid anhydrous Sodium hydroxide Purified water
Danish: Mono- og diglycerider Natriumcetostearylsulfat
English: Emollients can be applied together with <Invented Name> (see Section 4.2 “Posology and method of administration”).
Danish: 4.2 ”Dosering og indgivelsesmåde”).
English: <Detailed information on this medicine is available on the web site of {MA/Agency}>
Danish: Denne indlægsseddel blev senest godkendt den { MM/ÅÅÅÅ }
English: PSURs
Danish: Pimecrolimus
English: - The Committee considered that pimecrolimus cream is effective in the treatment of mild or moderate atopic dermatitis; however the CHMP considered that the therapeutic indications should be restricted for patients where treatment with topical corticosteroids is either inadvisable or not possible.
Danish: - Komitéen vurderede, at pimecrolimus creme er effektiv i behandlingen af mild eller moderat atopisk dermatitis.
English: Pruritus: Absent or mild EASI°:
Danish: Ingen eller mild
English: Skin infections (e.g. folliculitis).
Danish: Hudinfektioner (f.eks. betændelse i hårsække).
English: MARKETING AUTHORISATION HOLDER [To be completed nationally]
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN {Udfyldes nationalt}
English: PACKAGE LEAFLET
Danish: Propylenglycol
English: Before commencing treatment with <Invented Name>, clinical infections at treatment sites should be cleared.
Danish: Kliniske infektioner ved behandlingsstedet bør være færdigbehandlede, inden behandlingen med {(Sær)navn} påbegyndes.
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER INDGIVELSESVEJ(E)
English: 2100 U
Danish: 2100 E
English: Powder: 2100 U Solvent: 20 ml
Danish: Pulver: 2100 E Solvens: 20 ml
English: 1 vial + 1 vial + 2 vial adapters + 1 syringe + 1 infusion set + 2 alcohol swabs +1 sterile swab + 1 plaster
Danish: hætteglasadapt ere + 1 kanyle infusionssæt med kanyle + 2 alkoholswabs + 1 steril ikkevævet tampon selvklæbende plaster
English: 2100 U Powder and solvent for solution for injection
Danish: 2100 E Pulver og solvens til injektionsvæske, opløsning
English: 2100 U Powder for solution for injection
Danish: 2100 E Pulver til injektionsvæske, opløsning
English: Intravenous use Powder: vial (glass)
Danish: Pulver: hætteglas (glas) Solvens: hætteglas (glas)
English: Solvent: vial (glass)
Danish: Hætteglas (glas)
English: The full EPAR for Intanza can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Intanza findes på agenturets websted under ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Influenza vaccine (split virion, inactivated)
Danish: Influenzavaccine (split virion, inaktiveret)
English: Intanza is a vaccine.
Danish: Intanza er en vaccine.
English: This is a summary of the European public assessment report (EPAR) for Intanza.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Intanza.
English: Intanza contains 15 micrograms of each of three different strains (varieties) of influenza virus (an H1N1 subtype, A/California/7/2009, NYMC X-179A; an H3N2 subtype, A/Hong Kong/4801/2014, NYMC X-263B; and a type B, B/Brisbane/60/2008, wild type).
Danish: Intanza indeholder 15 mikrogram af hver af tre forskellige stammer (varianter) af influenzavirus (en H1N1-undertype, A/California/7/2009, NYMC X-179A; en H3N2-undertype, A/Hong Kong/4801/2014, NYMC X-263B; og en type B, B/Brisbane/60/2008, vildtype).
English: What measures are being taken to ensure the safe and effective use of Intanza?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Intanza?
English: The CHMP decided that Intanza's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Intanza opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: Why has Intanza been approved?
Danish: Hvorfor blev Intanza godkendt?
English: Intanza must not be used in people who are hypersensitive (allergic) to the active substances, to any of the other ingredients, or to any component that may be present in very small amounts such as egg (ovalbumin, chicken proteins), neomycin, formaldehyde or octoxinol 9.
Danish: Intanza må ikke anvendes hos patienter, der er overfølsomme (allergiske) over for de aktive stoffer, over for nogen af indholdsstofferne eller over for nogen af komponenterne, som kan forekomme i meget små mængder, såsom æg (ovalbumin, kyllingeproteiner), neomycin, formaldehyd eller octoxinol 9.
English: Intanza is used to vaccinate adults aged 60 years and over against flu, especially those who are at an increased risk of developing complications from the disease.
Danish: Intanza anvendes til at vaccinere personer i alderen 60 år og derover mod influenza, navnlig de, der har øget risiko for at udvikle komplikationer af sygdommen.
English: The most common side effects with Intanza (seen in more than 1 patient in 10) are headache, muscle pain and local reactions at the site of the vaccination (redness, swelling, hardening of the skin, pain and itching).
Danish: De hyppigste bivirkninger ved Intanza (som optræder hos mere end 1 ud af 10 patienter) er hovedpine, muskelsmerter og lokale reaktioner på vaccinationsstedet (rødme, hævelse, dannelse af hård hud, smerte og kløe).
English: The ability of Intanza to trigger the production of antibodies (immunogenicity) was first assessed in five main studies involving almost 9,000 people.
Danish: Intanzas evne til at udløse dannelsen af antistoffer (immunogenicitet) blev først vurderet i fem hovedundersøgelser, som omfattede knap 9 000 personer.
English: Fragments of the virus strains that are expected to cause flu in the upcoming season, according to the recommendations from the WHO for the northern hemisphere and from the European Union (EU), need to be included in Intanza before the
Danish: Fragmenter af de virusstammer, der ifølge anbefalingerne fra WHO for den nordlige halvkugle og fra Den Europæiske Union (EU) forventes at forårsage influenza i den kommende sæson, skal være indeholdt i Intanza, inden vaccinen
English: The studies compared the ability of the vaccines to trigger the production of antibodies (immunogenicity) by comparing antibody levels before injection and three weeks afterwards.
Danish: I undersøgelserne sammenlignedes vaccinernes evne til at fremkalde antistofdannelse (immunogenicitet) ved at sammenholde antistofindholdet før injektionen og tre uger efter.
English: Intanza contains fragments from three different strains of flu virus.
Danish: Intanza indeholder brudstykker fra tre forskellige influenzavirusstammer.
English: The European Commission granted a marketing authorisation valid throughout the EU for Intanza on
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Intanza den 24. februar 2009.
English: What is the risk associated with Intanza?
Danish: Hvilken risiko er der forbundet med Intanza?
English: Intanza is given as one ‘intradermal' injection into the upper layer of the skin, using a special micro-injection system.
Danish: Intanza gives som én "intradermal" indsprøjtning i det øverste hudlag ved hjælp af et særligt mikroinjektionssystem.
English: How does Intanza work?
Danish: Hvordan fungerer Intanza?
English: People who have a fever or an acute (short-lived) infection should not receive the vaccine until they have recovered.
Danish: Personer med feber eller akutte (kortvarige) infektioner bør ikke vaccineres, før de er raske.
English: In one study in people aged 60 years and over, Intanza was compared with a flu vaccine containing an adjuvant (a compound added to enhance the immune response).
Danish: I en undersøgelse af personer i alderen 60 år og derover blev Intanza sammenlignet med en vaccine indeholdende en adjuvans (en forbindelse, som tilføjes for at give en bedre immunrespons).
English: For more information about treatment with Intanza, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Intanza, kan du læse indlægssedlen (også en del af denne EPAR) eller
English: In the five original studies, both Intanza and the comparator vaccine brought about adequate levels of antibodies for protection against all three flu strains.
Danish: I de fem oprindelige undersøgelser bevirkede både Intanza og sammenligningsvaccinen dannelse af tilstrækkelige mængder beskyttende antistoffer mod alle tre influenzastammer.
English: Later seasonal formulations of Intanza have been shown to bring about similar antibody responses against the three flu strains included in the vaccine to those seen in the main studies.
Danish: Senere sæsoners formuleringer af Intanza har vist sig at fremkalde lignende antistofreaktioner mod de tre influenzastammer, som er indeholdt i vaccinen, svarende til reaktionerne i hovedundersøgelsen.
English: In all studies, Intanza was compared with another flu vaccine given by injection into a muscle.
Danish: I alle undersøgelserne blev Intanza sammenlignet med en anden influenzavaccine indgivet ved injektion i en muskel.
English: Two other studies looked at use of a lower strength in people under the age of 60.
Danish: To andre undersøgelser omfattede personer under 60 år, der var blevet vaccineret med en lavere styrke.
English: In people aged 60 years and over, the 15-microgram strength provided as good a level of protection as the comparator vaccines.
Danish: Hos personer i alderen 60 år og derover gav styrken på 15 mikrogram en ligeså god beskyttelse som
English: Intanza is a vaccine, which is available as a suspension for injection in a pre-filled syringe.
Danish: Intanza er en vaccine, der leveres som injektionsvæske (suspension) i en fyldt sprøjte.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Intanza have been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Intanza.
English: For the full list of all side effects reported with Intanza, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Intanza fremgår af
English: What benefit has Intanza shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Intanza?
English: 15 g l t o r
Danish: 15 g r l
English: Invented name Strength Pharmaceutical Form Route of Administration Packaging
Danish: Særnavn Styrke Lægemiddelform Indgivelsesvej
English: Tube (polythylene)
Danish: Kutan Αnvendelse Tube (polyethylen)
English: Package size
Danish: Emballage Indhold Pakningsstørrelse
English: Ameluz received a marketing authorisation valid throughout the EU on 14 December 2011.
Danish: Ameluz fik en markedsføringstilladelse med gyldighed i hele EU den 14. december 2011.
English: Further information on Ameluz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Yderligere information om Ameluz findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Other information about Ameluz
Danish: Andre oplysninger om Ameluz
English: What measures are being taken to ensure the safe and effective use of Ameluz?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Ameluz?
English: For more information about using Ameluz, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Ameluz, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: As for all medicines, data on the use of Ameluz are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Ameluz løbende overvåget.
English: An overview of Ameluz and why it is authorised in the EU
Danish: En oversigt over Ameluz, og hvorfor det er godkendt i EU
English: Ameluz (5-aminolaevulinic acid)
Danish: Ameluz (5-aminolævulinsyre)
English: The Agency therefore concluded that the benefits of Ameluz are greater than its risks and it can be authorised.
Danish: Agenturet konkluderede derfor, at fordelene ved Ameluz opvejer risiciene, og at det kan godkendes til anvendelse.
English: It can only be obtained with a prescription and should only be given under the supervision of a healthcare professional experienced in using photodynamic therapy.
Danish: Det udleveres kun efter recept, og behandlingen bør kun udføres under opsyn af en sundhedsperson med erfaring i anvendelse af fotodynamisk terapi.
English: What is Ameluz and what is it used for?
Danish: Hvad er Ameluz, og hvad anvendes det til?
English: This method of treatment involves applying a source of light to activate the medicine.
Danish: Denne behandlingsmetode benytter en lyskilde til at aktivere lægemidlet.
English: Ameluz is available as a gel (78 mg/g) to be applied to the skin.
Danish: Ameluz fås som gel (78 mg/g), der smøres på huden.
English: The European Medicines Agency concluded that the benefits of treatment with Ameluz were greater than the few and mostly mild side effects, and that Ameluz was more effective and somewhat safer than the standard alternative.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved behandling med Ameluz opvejer de få og oftest milde bivirkninger, og at Ameluz er mere effektivt og i et vist omfang sikrere end det gængse alternativ.
English: Ameluz contains the active substance 5-aminolaevulinic acid.
Danish: Ameluz indeholder det aktive stof 5-aminolævulinsyre.
English: Side effects reported with Ameluz are carefully evaluated and any necessary action taken to protect patients.
Danish: Indberettede bivirkninger ved Ameluz vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: This kills the cells by reacting with and destroying their components, such as proteins and DNA.
Danish: Denne giftige ilt reagerer med og ødelægger cellernes bestanddele, f.eks. proteiner og DNA, hvorved cellerne dræbes.
English: The state of the growths or lesions should be monitored three months after treatment, and any remaining growths or lesions should be retreated.
Danish: Efter tre måneder bør væksterne eller forandringerne kontrolleres, og eventuelle tilbageværende vækster eller forandringer bør behandles igen.
English: Why is Ameluz authorised in the EU?
Danish: Hvorfor blev Ameluz godkendt i EU?
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom the photosensitising agent is activated and reacts with oxygen in the cells to create a highly reactive and toxic type of oxygen.
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom der dannes en meget reaktiv og giftig form for ilt.
English: What are the risks associated with Ameluz?
Danish: Hvilke risici er der forbundet med Ameluz?
English: Single or multiple actinic keratosis growths may be treated in one session, while basal cell carcinoma lesions will need two treatment sessions about one week apart.
Danish: Enkelte eller multiple aktiniske keratosevækster kan behandles i løbet af én konsultation, mens forandringer forårsaget af basalcellekarcinom kræver to behandlinger med ca. én uges mellemrum.
English: The most common side effects with Ameluz (seen in more than 1 patient in 10) are reactions at the site of application, including erythema (reddening of the skin), pain (including burning pain), irritation, itching, oedema (swelling), scab formation, exfoliation (skin peeling), hardening of the skin and paraesthesia (sensations like numbness, tingling, pins and needles).
Danish: De hyppigste bivirkninger ved Ameluz (som optræder hos mere end 1 ud af 10 patienter) er reaktioner på påføringsstedet, herunder erytem (rødme i huden), smerte (herunder svie), irritation, kløe, hævelser, skorpedannelse, afskalning af huden, hærdning af huden og paræstesi (følelsesløshed eller en prikkende/stikkende fornemmelse).
English: Ameluz was more effective than placebo (a dummy treatment) or a comparator medicine when used in photodynamic therapy to treat actinic keratosis or basal cell carcinoma.
Danish: Ameluz var mere effektivt end placebo (et uvirksomt stof) eller et sammenligningslægemiddel, når det blev anvendt i fotodynamisk terapi til behandling af aktinisk keratose eller basalcellekarcinom.