FrancophonIA/ELRC3.0 huggingface dataset:
English: In all studies the effectiveness of Veraflox was compared to antibiotics which are commonly used for the treatment of the infection studied.
Danish: I alle undersøgelserne blev effekten af Veraflox sammenlignet med effekten af antibiotika, der sædvanligvis anvendes til behandling af den undersøgte infektion.
English: Pradofloxacin is an antibiotic.
Danish: Pradofloxacin er et antibiotikum.
English: Veraflox Tablets contain 15 mg, 60 mg & 120 mg of the active substance, pradofloxacin.
Danish: Veraflox tabletter indeholder 15 mg, 60 mg & 120 mg af det aktive stof, pradofloxacin.
English: Which were the major concerns that lead the CVMP to recommend the refusal of a marketing authorisation?
Danish: Hvori bestod de vigtigste betænkeligheder, som førte til, at CVMP anbefalede at give afslag på ansøgningen om markedsføringstilladelse?
English: What is Veraflox?
Danish: Hvad er Veraflox?
English: No adverse consequences for animals have been identified by the CVMP, as other medicines exist for all the infections in cats and dogs which Veraflox was intended to treat.
Danish: CVMP finder ikke, at afslaget får negative konsekvenser for dyr, da der findes andre lægemidler til alle de infektioner hos katte og hunde, som Veraflox var beregnet til at behandle.
English: What was Veraflox to be used for?
Danish: Hvad forventedes Veraflox anvendt til?
English: The company presented the results of studies examining the effectiveness of Veraflox against a range of conditions involving bacterial infections in cats and dogs.
Danish: Firmaet fremlagde resultater fra undersøgelser, der så på effekten af Veraflox til behandling af en række tilstande, der involverede bakterieinfektioner hos katte og hunde.
English: What are the consequences for animals of the refusal for Veraflox?
Danish: Hvilke konsekvenser har det for dyr, at der gives afslag på ansøgningen om markedsføringstilladelse for Veraflox?
English: Hence, the CVMP recommended that Veraflox be refused a marketing authorisation.
Danish: CVMP anbefalede derfor at give afslag på ansøgningen om markedsføringstilladelse for Veraflox.
English: Veraflox Oral Suspension was to be used for the treatment of cats with acute infections of the upper respiratory tract and also some skin conditions caused by certain specific bacteria.
Danish: Veraflox oral suspension var beregnet til at blive anvendt til behandling af katte med akutte infektioner i de øvre luftveje samt til visse hudlidelser, forårsaget af visse specifikke bakterier.
English: In cats, the medicine was studied in acute infections of the upper respiratory tract and also some skin conditions caused by certain specific bacteria.
Danish: Hos katte blev lægemidlet afprøvet til akutte infektioner i de øvre luftveje samt til nogle hudlidelser, der var forårsaget af visse specifikke bakterier.
English: In dogs, Veraflox Tablets were to be used for the treatment of skin, urinary tract and gum infections caused by certain specific bacteria.
Danish: Hos hunde var Veraflox tabletter beregnet til at blive anvendt til behandling af infektioner i hud, urinveje og tandkød, hvor infektionerne var forårsaget af visse specifikke bakterier.
English: In dogs, the medicine was studied in some skin, urinary tract and gum infections caused by certain specific bacteria.
Danish: Hos hunde blev lægemidlet afprøvet til nogle hud-, urinvejs- og tandkødsinfektioner, som var forårsaget af visse specifikke bakterier.
English: In cats, Veraflox Tablets were to be used for the treatment of acute infections of the upper respiratory tract caused by certain specific bacteria.
Danish: Hos katte var Veraflox tabletter beregnet til at blive anvendt til behandling af akutte infektioner i de øvre luftveje, hvor infektionerne var forårsaget af visse specifikke bakterier.
English: A European Commission issued a decision on 27 July 2010.
Danish: Europa-Kommissionen traf en afgørelse den 27. juli 2010.
English: Andrea Laslop (Austria)
Danish: Andrea Laslop (Østrig)
English: Alternative anti-inflammatory treatments are widely available.
Danish: Alternative antiinflammatoriske behandlinger er bredt tilgængelige.
English: Medicines containing bufexamac have been authorised in Austria, Bulgaria, the Czech Republic, France, Hungary, Italy, Latvia, Lithuania, Luxembourg, Portugal, Romania and Slovakia.
Danish: Lægemidler indeholdende bufexamac er godkendt i Østrig, Bulgarien, Den Tjekkiske Republik, Frankrig, Ungarn, Italien, Letland, Litauen, Luxembourg, Portugal, Rumænien og Slovakiet.
English: What is bufexamac?
Danish: Hvad er bufexamac?
English: The allergic reactions can be serious enough to require hospitalisation.
Danish: De allergiske reaktioner kan være så alvorlige, at de kræver hospitalsindlæggelse.
English: Most of the studies dated from the original development of bufexamac in the 1970s and 1980s, and were of a lower standard than that expected today.
Danish: De fleste af undersøgelserne stammede fra den oprindelige udvikling af bufexamac i 1970'erne og 1980'erne, og deres standard var ringere end den, der forventes i dag.
English: Bufexamac is a non-steroidal anti-inflammatory drug (NSAID).
Danish: Bufexamac er et non-steroidt, antiinflammatorisk lægemiddel (NSAID).
English: Furthermore, because these reactions are very similar to the disease being treated, it can lead to delays in the diagnosis or treatment of the patient's condition.
Danish: Eftersom disse reaktioner er meget lig den sygdom, der behandles, kan det desuden føre til forsinkelser i diagnosen eller behandlingen af patientens tilstand.
English: • Patients currently using bufexamac-containing medicines should speak to their doctor so they can switch to an appropriate alternative treatment.
Danish: • Patienter, som i øjeblikket bruger lægemidler indeholdende bufexamac bør tale med deres læge, så de kan skifte til en passende alternativ behandling.
English: Prostaglandins are messengers in the development of inflammation.
Danish: Prostaglandiner er signalstoffer ved udvikling af betændelse.
English: They may be available as creams, rectal ointments and suppositories, and under the following invented names: Parfenac, Bufal, Calmaderm, Fansamac, Mastu S, Parfenoide, Proctosan, and other trade names.
Danish: Lægemidlerne kan fås som cremer, rektalsalve og suppositorier og markedsføres under følgende særnavne: Parfenac, Bufal, Calmaderm, Fansamac, Mastu S, Parfenoide, Proctosan og andre handelsnavne.
English: It is also likely that the difficulty to differentiate between a treatment failure and an allergic reaction has led to the cases of contact allergic reaction being underreported.
Danish: Det er ligeledes sandsynligt, at vanskeligheden ved at skelne mellem en mislykket behandling og en allergisk reaktion har ført til for få indberettede tilfælde af kontaktallergiske reaktioner.
English: Why was bufexamac reviewed?
Danish: Hvorfor blev bufexamac vurderet igen?
English: The CHMP noted that bufexamac-containing medicines have been available since the 1970s, and that contact allergic reactions have been reported over the years, leading to restrictions on the use of the medicines in a number of countries.
Danish: CHMP bemærkede, at lægemidler indeholdende bufexamac har været tilgængelige siden 1970'erne, og at der i årenes løb er indberettet kontaktallergiske reaktioner, som har ført til begrænsninger i lægemidlernes anvendelse i en række lande.
English: The risk of developing a contact allergic reaction to bufexamac is high, and the risk is even higher in patients with pre-disposing conditions, such as certain forms of eczema, for which bufexamac is frequently prescribed.
Danish: Risikoen for at udvikle en kontaktallergisk reaktion på bufexamac er høj, og den er endnu højere hos patienter med prædisponerende tilstande såsom visse former for eksem, som bufexamac ofte ordineres mod.
English: The Committee noted that the data presented to support the effectiveness of bufexamac were very limited.
Danish: Udvalget bemærkede, at dataene til støtte for bufexamacs virkning var meget begrænsede.
English: • Doctors should stop prescribing medicines containing bufexamac.
Danish: • Læger bør ikke længere ordinere lægemidler indeholder bufexamac.
English: In particular, the Committee considered the responses given by the companies to a list of questions on allergic reactions reported following contact with bufexamac.
Danish: Udvalget så navnlig på de svar, som virksomhederne havde givet på en række spørgsmål om indberettede allergiske reaktioner efter kontakt med bufexamac.
English: Bufexamac is used to control the symptoms of inflammation of the skin (such as redness and itching) in diseases such as eczema and dermatitis.
Danish: Bufexamac anvendes til at dæmpe symptomerne på betændelse i huden (såsom rødme og kløe) ved sygdomme som f.eks. eksem og dermatitis.
English: It can also be used, in combination with other substances, to control the symptoms of inflammation that can occur around the anus in patients with haemorrhoids (piles) or an anal fissure (a tear in the lining of the anal canal).
Danish: Det kan ligeledes anvendes i kombination med andre stoffer for at dæmpe de betændelsessymptomer, der kan opstå rundt om anus hos patienter med hæmorider eller analfissur (en revne i endetarmskanalens slimhinde).
English: As required by Article 107, the agency informed the CHMP of its action so that the Committee could prepare an opinion on whether the marketing authorisations for products containing bufexamac should be maintained, changed, suspended or revoked across the EU.
Danish: Sådan som artikel 107 foreskriver, informerede den tyske lægemiddelkontrolmyndighed CHMP om de foranstaltninger, den havde truffet, så udvalget kunne udarbejde en udtalelse om, hvorvidt markedsføringstilladelserne for lægemidler indeholdende bufexamac burde opretholdes, ændres, suspenderes eller tilbagekaldes i hele EU.
English: The European Medicines Agency has completed a review of the safety and effectiveness of bufexamac.
Danish: Det Europæiske Lægemiddelagentur (EMA) har foretaget en revurdering af bufexamacs sikkerhed og virkning.
English: In December 2009, the German medicines regulatory agency completed a review of the benefits and risks of bufexamac-containing medicines.
Danish: I december 2009 foretog den tyske lægemiddelkontrolmyndighed en revurdering af fordele og risici ved lægemidler indeholdende bufexamac.
English: The CHMP also noted that bufexamac is a ‘sensitizer' causing reactions to get worse with repeated exposure.
Danish: CHMP bemærkede ligeledes, at bufexamac er et allergen, hvor reaktionerne bliver værre med en gentagen eksponering.
English: In addition, when looking at the few more recent, controlled studies, the CHMP noted that the effectiveness of bufexamac had not been shown.
Danish: Desuden bemærkede CHMP, at når man kiggede på de få nyere og kontrollerede undersøgelser, var bufexamacs virkning ikke blevet påvist.
English: During this review, the agency obtained information from the companies marketing bufexamac in Germany, and looked at published studies on the effectiveness of bufexamac.
Danish: Under denne revurdering indhentede lægemiddelkontrolmyndigheden oplysninger fra de virksomheder, der markedsfører bufexamac i Tyskland, og tog offentliggjorte undersøgelser af bufexamacs virkning i betragtning.
English: The CHMP looked at the data used by the German agency in its review, and the information provided by the companies marketing bufexamac in other EU countries.
Danish: I sin revurdering tog CHMP de data i betragtning, som den tyske lægemiddelkontrolmyndighed havde undersøgt, og de oplysninger, som var blevet fremsendt af de virksomheder, der markedsfører bufexamac i andre EU-lande.
English: The German agency concluded that the benefits of bufexamac-containing medicines do not outweigh their risks, and recommended that the marketing authorisations be withdrawn in Germany.
Danish: Den tyske lægemiddelkontrolmyndighed konkluderede, at fordelene ved lægemidler indeholdende bufexamac ikke opvejer risiciene, og anbefalede tilbagetrækning af markedsføringstilladelserne i Tyskland.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of bufexamac do not outweigh its risks, and recommended that the marketing authorisations for medicines containing bufexamac be revoked (withdrawn) throughout the European Union (EU).
Danish: EMA's Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved bufexamac ikke opvejer risiciene, anbefalede tilbagekaldelse (tilbagetrækning) af markedsføringstilladelserne for lægemidler indeholdende bufexamac i hele EU.
English: Because of this, no evidence of the effectiveness of bufexamac could be derived from them.
Danish: Derfor gav de ikke nogen evidens for bufexamacs virkning.
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of bufexamac-containing medicines do not outweigh their risks, and therefore recommended that all marketing authorisations be revoked in the EU.
Danish: På baggrund af en vurdering af de aktuelt tilgængelige data og de videnskabelige drøftelser i udvalget konkluderede CHMP, at fordelene ved lægemidler indeholdende bufexamac ikke opvejer risiciene.
English: Company responses provided on: 19 February 2010 Opinion date:
Danish: Dato for virksomhedens svar:
English: 26 rue de la Chapelle 68330 Huningue France
Danish: 26 rue de la Chapelle 68330 Huningue Frankrig
English: It is important to follow the above recommendations to achieve the optimal treatment effect.
Danish: Det er vigtigt at følge ovenstående anbefalinger for at opnå den optimale behandlingseffekt.
English: Date of first authorisation: 27 July 2000 Date of latest renewal: 05 May 2010
Danish: Dato for første markedsføringstilladelse: 27. juli 2000 Dato for seneste fornyelse: 05. maj 2010
English: Half-life, however, was significantly increased by approximately 20%.
Danish: Halveringstiden var dog øget med omkring 20%.
English: Patients should be re-evaluated every 3 months.
Danish: Patienterne bør vurderes hver 3. måned.
English: No additional safety concern was identified.
Danish: Ingen yderligere sikkerhedsproblemer blev konstateret.
English: Elderly (65 years of age or above)
Danish: Ældre (i alderen 65 år eller derover)
English: Ethnic groups/races
Danish: Etniske grupper/racer
English: Your doctor will advise you.
Danish: Din læge vil give dig besked.
English: This indicates that clinical benefit may diminish over time.
Danish: Dette antyder, at den kliniske fordel måske mindskes med tiden.
English: Use of rubber gloves and eye protection is recommended.
Danish: Brug af gummihandsker og øjenbeskyttelse anbefales.
English: Eye and skin contact should be avoided.
Danish: Øjen- og hudkontakt bør undgås.
English: No death was considered to be related to treatment.
Danish: Ingen dødsfald blev anset for at være relateret til behandlingen.
English: Some side effects could be serious:
Danish: Nogle bivirkninger kan være alvorlige:
English: Not known (frequency cannot be estimated from the available data)
Danish: Hyppighed ikke kendt (hyppighed kan ikke anslås ud fra tilgængelige data)
English: During this time, you will have to follow your doctor's instructions and keep your eyes still.
Danish: Du skal i denne periode følge lægens instruktioner og holde øjet i ro.
English: - if you have any severe liver problems.
Danish: - hvis du har en hvilken som helst alvorlig leversygdom.
English: In relation to VIP-PM extension:
Danish: Angående VIP-PM ekstensionsforsøget:
English: Normal indoor lighting is safe.
Danish: Normal indendørsbelysning er sikker.
English: Your doctor will put a special contact lens onto your eye and treat your eye using a special laser.
Danish: Din læge vil sætte en speciel kontaktlinse på dit øje og foretage behandlingen med en speciel laser.
English: Chemical and physical in-use stability has been demonstrated for 4 hours at 25°C.
Danish: Kemiske og fysiske in-use stabilitetstest er blevet påvist for 4 timer ved 25C.
English: This medicinal product is intended for intravenous infusion only.
Danish: Dette lægemiddel er udelukkende beregnet til intravenøs infusion.
English: Visudyne should not be used during pregnancy unless clearly necessary (only if the benefit justifies the potential risk to the foetus).
Danish: Visudyne bør ikke anvendes under graviditet, medmindre det er klart nødvendigt (kun hvis fordelen opvejer de potentielle risici for fostret).
English: Dark green to black powder.
Danish: Mørkegrønt til sort pulver.
English: It is not known how the potential for DNA damage with PDT agents translates into human risk.
Danish: Det er uvist, hvorvidt potentialet for DNA-skade med PDT-midler kan overføres til human risiko.
English: UNIQUE IDENTIFIER - 2D BARCODE
Danish: ENTYDIG IDENTIFIKATOR - 2D -STREGKODE
English: There are two types of choroidal neovascularisation: classic and occult.
Danish: Der findes to former for choroidal neovaskularisering: Klassisk og okkult.
English: No experience is available in these patients.
Danish: Der er ingen tilgængelig erfaring med denne patientgruppe.
English: In vitro studies did not show any significant involvement of oxidative metabolism by cytochrome P450 enzymes.
Danish: In vitro forsøg viste ingen signifikant involvering af oxidativ metabolisering med cytochrom P450 enzymer.
English: Sunscreens offer no protection.
Danish: Solcremer yder ingen beskyttelse.
English: These diseases lead to vision loss.
Danish: Disse sygdomme fører til synstab.
English: Pre-dosing with diphenhydramine diminished these effects, suggesting that histamine may play a role in this process.
Danish: Præmedicinering med diphenhydramin mindsker disse virkninger, hvilket indicerer at histamin kan spille en rolle i denne process.
English: Infusion-related problems may also include sudden loss of consciousness.
Danish: Infusions-relaterede problemer kan også omfatte pludselig bevidstløshed.
English: UV sunscreens are not effective in protecting against photosensitivity reactions.
Danish: UV solskærme er ikke effektive som beskyttelse mod lysfølsomhedsreaktioner.
English: It takes 83 seconds to deliver the laser dose required to activate Visudyne.
Danish: Det tager 83 sekunder at give den laserdosis, som kræves for at aktivere Visudyne.
English: In the event of recurrent CNV leakage, Visudyne therapy may be given up to 4 times per year.
Danish: I tilfælde af gendannet CNV lækage, kan Visudynebehandlingen gives op til 4 gange om året.
English: The adverse reactions are listed by system organ class and frequency using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: Bivirkningerne er anført efter organklasse og hyppighed ved hjælp af følgende konvention: Meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: If this happens to you, do not drive or use any tools or machines until your vision improves.
Danish: Forekommer dette, må du ikke køre bil, arbejde med værktøj eller maskiner, før dit syn er blevet bedre.
English: Photosensitivity and exposure to light
Danish: Fotosensitivitet og udsættelse for lys
English: For storage conditions, please see section 5 of this leaflet.
Danish: Opbevaringsbetingelser, se punkt 5 i denne indlægsseddel.
English: The extent and severity of these effects were consistent among all studies and were dependent on drug dose and dosing duration.
Danish: Omfanget og sværhedsgraden af disse påvirkninger var konsistente i alle studier og afhang af lægemiddeldosis og doseringsvarighed.
English: Pregnancy and breast-feeding - There is very little experience of using Visudyne in pregnant women.
Danish: Graviditet og amning - Der er meget lidt erfaring med Visudyne-behandling til gravide kvinder.
English: BPD-DA is also a photosensitiser but its systemic exposure is low (5-10% of the verteporfin exposure, suggesting that most of the active substance is eliminated unchanged).
Danish: BPD-DA er også et fotosensibiliserende stof men den systemiske eksponering er lav (5-10% of verteporfineksponeringen indikerende at det meste af den aktive substans udskilles uændret).
English: The nasal edge of the treatment spot must be at least 200 m from the temporal edge of the optic disc.
Danish: Den nasale rand af pletten skal være mindst 200 m fra den temporale kant af den optiske disk.
English: - You will be sensitive to bright light for 48 hours after the infusion.
Danish: - Du vil være følsom overfor skarpt lys i 48 timer efter infusionen.
English: Patients of reproductive age should be made aware of the lack of fertility data, and Visudyne should only be given after consideration of individual risks and benefits.
Danish: Patienter i den fødedygtige alder bør gøres opmærksom på de manglende fertilitetsdata, og Visudyne bør kun gives efter overvejelse af individuelle risici og fordele.
English: If extravasation occurs, infusion should be stopped immediately.
Danish: Hvis der sker ekstravasation bør infusionen straks standses.
English: You should only be given Visudyne if your doctor considers it absolutely essential.
Danish: Visudyne bør kun anvendes, såfremt lægen vurderer, at det er absolut nødvendigt.
English: To ensure treatment of poorly demarcated lesion borders, an additional margin of 500 µm should be added around the visible lesion.
Danish: For at sikre behandling af en dårligt markeret læsionsrand, bør der tillægges en yderligere margin på 500 m rundt om den synlige læsion.
English: Verteporfin, also referred to as benzoporphyrin derivative monoacids (BPD-MA) consists of a 1:1 mixture of the equally active regioisomers BPD-MAC and BPD-MAD.
Danish: Verteporfin, som også betegnes benzoporphyrin monosyrederivat (BPD-MA), består af en 1:1 blanding af de lige aktive regioisomerer BPD-MAC og BPD-MAD.
English: When energy absorbed by the porphyrin is transferred to oxygen, highly reactive short-lived singlet oxygen is generated.
Danish: Når energi, absorberet af porphyrin, overføres til oxygen, dannes højaktivt kortlivet singlet oxygen.
English: However, if treatment of the second eye is deemed necessary, light should be applied to the second eye immediately after light application in the first eye but no later than 20 minutes from the start of the infusion.
Danish: Hvis samtidig behandling af begge øjne skønnes nødvendigt, bør lysbehandlingen af det andet øje ske umiddelbart efter belysningen af det første øje og ikke mere end 20 minutter efter start af infusionen.
English: In the event of suspected heart attack, seek medical attention immediately.
Danish: Hvis du har mistanke om et hjertetilfælde, skal du omgående søge lægehjælp.
English: • Localised death of skin tissue (necrosis).
Danish: • Lokaliseret dødt hudvæv (nekrose)
English: The maximum spot size used for the first treatment in the clinical studies was 6,400 m.
Danish: Det største behandlingsområde, anvendt under de kliniske forsøg var 6.400 m.
English: Effects of gender At the intended dose, pharmacokinetic parameters are not significantly affected by gender.
Danish: Kønsforskelle Ved den anbefalede dosis påvirkes de farmakokinetiske parametre ikke signifikant af kønnet.
English: It is used as a light-activated medicinal product (photosensitiser).
Danish: Det bruges som et lysaktiveret lægemiddel (fotosensibiliserende stof).
English: From a microbiological point of view, the medicinal product should be used immediately.
Danish: Set fra en mikrobiologisk synsvinkel bør lægemidlet anvendes straks.
English: Localised (skin) necrosis at the injection site following extravasation has also been reported.
Danish: Yderligere er lokal (hud) nekrose på injektionsstedet efter extravasation blevet rapporteret.
English: - if you have porphyria (a rare condition that may increase sensitivity to light).
Danish: - hvis du lider af porfyri (en sjælden stofskiftelidelse, som kan øge følsomheden over for lys).
English: Most adverse reactions were mild to moderate and transient in nature.
Danish: De fleste bivirkninger var milde til moderate og forbigående.