FrancophonIA/ELRC3.0 huggingface dataset:
English: For practical information about using Entyvio, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Entyvio, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: In ulcerative colitis, the Committee considered that the benefit of Entyvio has been clearly demonstrated, which is relevant for patients who do not respond to TNF-alfa therapy.
Danish: Udvalget fandt, at fordelen af Entyvio ved ulcerøs colitis var klart bevist, og at den var relevant for patienter, hos hvem TNF-alfa-behandling ikke virker.
English: What benefits of Entyvio have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Entyvio?
English: Vedolizumab is used to treat moderate to severe active disease when conventional therapy or medicines called TNF-alfa antagonists are ineffective, no longer effective, or cannot be tolerated by the patient.
Danish: Vedolizumab anvendes til behandling af moderat til svær aktiv sygdom, når sædvanlig behandling eller lægemidler af type TNF-antagonister enten ikke virker, er holdt op med at virke eller ikke tåles af patienten.
English: It is used to treat adult patients with ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut) or Crohn's disease (a disease causing inflammation of the digestive tract).
Danish: Det anvendes til behandling af voksne med en form for tyktarmsbetændelse, der medfører inflammation og sår i tarmslimhinden (ulcerøs kolitis), og en særlig form for tarmbetændelse (Crohns sygdom).
English: In ulcerative colitis, Entyvio has been investigated in a main study in patients with moderate to severe active disease in whom conventional therapy or TNF-alfa antagonists were ineffective or could not be tolerated.
Danish: Ved ulcerøs kolitis er Entyvio undersøgt i én hovedundersøgelse hos patienter med moderat til svær aktiv sygdom, hos hvem sædvanlig behandling eller TNF-alfa-hæmmere ikke virkede eller ikke tåltes.
English: How does Entyvio work?
Danish: Hvordan virker Entyvio?
English: The company will also provide educational material to all healthcare professionals expected to prescribe Entyvio to remind them of the need to monitor patients for signs of neurological disease or PML, in particular those treated with certain biological medicines which may potentially cause PML.
Danish: Heri vil de blive gjort opmærksom på, at patienterne skal overvåges for tegn på hjertesygdom og PML, navnlig hvis de får visse biologiske lægemidler, der kan være årsag til PML.
English: Entyvio is available as a powder to be made up into a solution for infusion (drip) into a vein.
Danish: Entyvio leveres som et pulver, der anvendes til at fremstille en injektionsvæske, som gives ved infusion (med drop i en vene).
English: Patients received either Entyvio or placebo (a dummy treatment) and the main measure of effectiveness was the proportion of patients whose symptoms improved after 6 weeks of treatment.
Danish: Patienterne fik enten Entyvio eller placebo (virkningsløs behandling).
English: In one main study in adult patients with moderate to severe active Crohn's disease in whom conventional therapy or TNF-alfa antagonists were ineffective or could not be tolerated, 15% (32 out of 220) of patients receiving Entyvio showed improved symptoms after 6 weeks of treatment, compared with 7% (10 out of 148) of patients on placebo.
Danish: Efter seks ugers behandling var der bedring i symptomerne hos 15 %, (32 ud af 220) af dem, der fik Entyvio, sammenholdt med 7 % (10 ud af 148) af dem, der fik placebo.
English: Immediate Packaging Pack size
Danish: Paknings størrelse
English: The use in children was further clarified.
Danish: Der blev skabt yderligere klarhed om anvendelsen hos børn.
English: The European Commission issued a decision on 2 September 2011.
Danish: Europa-Kommissionen traf en afgørelse den 2. september 2011.
English: What is Diflucan?
Danish: Hvad er Diflucan?
English: Diflucan is authorised in the EU via national procedures.
Danish: Diflucan er godkendt i EU efter nationale procedurer.
English: It contains the active substance fluconazole.
Danish: Det indeholder det aktive stof fluconazol.
English: Why was Diflucan reviewed?
Danish: Hvorfor blev Diflucan vurderet igen?
English: Terfenadine must also not be used in patients receiving Diflucan at multiple doses of 400 mg per day or higher.
Danish: Terfenadin må heller ikke anvendes til patienter, der får Diflucan i flere doser af 400 mg pr. dag eller derover.
English: Without ergosterol, the fungus dies or is prevented from spreading.
Danish: Uden ergosterol dør svampen, eller den forhindres i at sprede sig.
English: On 18 February 2010, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Diflucan in the EU.
Danish: Den 18. februar 2010 henviste Europa-Kommissionen sagen til CHMP med henblik på harmonisering af markedsføringstilladelserne for Diflucan i EU.
English: The CHMP harmonised the dosing recommendations for the various indications to be in line with international guidelines.
Danish: CHMP harmoniserede doseringsanbefalingerne for de forskellige indikationer, så de er på linje med de internationale retningslinjer.
English: The European Medicines Agency has completed a review of Diflucan.
Danish: Det Europæiske Lægemiddelagentur (EMA) har foretaget en revurdering af Diflucan.
English: The Committee harmonised the wording on the use of the medicine for these conditions, specifying when it is to be used for treatment and prophylaxis (prevention) and introducing restrictions for certain indications.
Danish: CHMP harmoniserede ordlyden om anvendelse af lægemidlet til disse lidelser og angav, hvornår det skal anvendes til behandling og profylakse (forebyggelse), og indførte begrænsninger for visse indikationer.
English: Medicines known to prolong the QT interval and which are metabolised via the cytochrome P450 (CYP) 3A4 such as cisapride, astemizole, pimozide, quinidine and erythromycin should also not be given to patients receiving Diflucan.
Danish: Lægemidler, som man ved forlænger QT-intervallet, og som metaboliserer via cytochrom P450 (CYP) 3A4, såsom cisaprid, astemizol, pimozid, quinidin og erytromycin, bør heller ikke gives til patienter, som får Diflucan.
English: Other sections harmonised by the CHMP include sections on special warnings, side effects, interactions, pharmacological properties and quality.
Danish: De øvrige afsnit, som CHMP har harmoniseret, omfatter afsnittene om særlige advarsler, bivirkninger, interaktioner og lægemidlets farmakologiske egenskaber og kvalitet.
English: Diflucan works by preventing the formation of ergosterol, which is an important part of fungal cell walls.
Danish: Diflucan fungerer ved at forhindre dannelsen af ergosterol, som er en vigtig del af svampecellevæggen.
English: The CHMP agreed that Diflucan should not be used in patients who are hypersensitive (allergic) to the active substance, to related azole substances, or to any of other ingredient of the medicine.
Danish: CHMP fastslog, at Diflucan ikke må anvendes hos patienter, der er overfølsomme (allergiske) over for det aktive stof, relaterede azolstoffer eller et eller flere af lægemidlets øvrige indholdsstoffer.
English: Diflucan is also available in the EU under other trade names: Fluconazole, Fungustatin, Fungata, Triflucan.
Danish: Diflucan markedsføres ligeledes i EU under andre særnavne: Fluconazol, Fungustatin, Fungata og Triflucan.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Diflucan in the European Union (EU).
Danish: EMA's Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at der er behov for at harmonisere ordinationsoplysningerne for Diflucan i Den Europæiske Union (EU).
English: Diflucan is an antifungal medicine that belongs to the triazoles group.
Danish: Diflucan er et lægemiddel mod svampeinfektioner, der tilhører gruppen triazoler.
English: The CHMP agreed that Diflucan can be used for the following conditions: mucosal and invasive candidiasis, genital candidiasis (trush), crypotococcal meningitis, dermatomycosis, coccidiodomycosis and onychomycosis.
Danish: CHMP vedtog, at Diflucan kan anvendes til følgende lidelser: mucosal candidainfektion og invasiv candidiasis, genital candidiasis (trøske), kryptokokmeningitis, dermatomykose, coccidioidomykose og onychomykose.
English: Diflucan is used to treat various fungal infections, including candidiasis (thrush) and fungus in the nails.
Danish: Diflucan anvendes til behandling af forskellige svampeinfektioner, herunder candidiasis (trøske) og neglesvamp.
English: Diflucan was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Danish: Det blev bestemt af den humanmedicinske koordineringsgruppe for gensidig anerkendelse og decentraliserede procedurer (CMD(h)), at Diflucan skulle harmoniseres.
English: As a result of the following weaknesses identified with this study the results could not be accepted:
Danish: På grund af følgende svagheder, som blev klarlagt under denne undersøgelse, kunne resultaterne ikke accepteres:
English: • The possibility of release into the environment has not been investigated.
Danish: • Sandsynligheden for frigivelse til miljøet er ikke blevet undersøgt.
English: The guidance document also allows for the use of alternative values if appropriately justified.
Danish: Det vejledende dokument tillader også brugen af alternative værdier, hvis det er tilstrækkeligt begrundet.
English: In the first phase the DT50 was calculated to be 4 hours, while it was 12 hours in the second phase.
Danish: I den første fase blev DT50 beregnet til fire timer, mens den var 12 timer i den anden fase.
English: The CVMP therefore recommends that the two sentences of the therapeutic indication should be combined as follows:
Danish: CVMP anbefaler derfor, at de to sætninger om den terapeutiske indikation kombineres på følgende måde:
English: The CVMP therefore considers that the objections raised by Germany and The Netherlands should not prevent the granting of a Marketing Authorisation.
Danish: CVMP vurderer derfor, at de indsigelser, som Tyskland og Nederlandene rejste, ikke bør forhindre udstedelsen af en markedsføringstilladelse.
English: Member State Applicant/Marketing Authorisation Holder
Danish: Ansøger/indehaver af markedsføringstilladelsen
English: However at the end of the study (27 days), 64% of the dose formed non-extractable residues.
Danish: Ved undersøgelsens afslutning (27 dage) bestod 64 % af dosis dog af ikkeekstraherbare restkoncentrationer.
English: It is assumed that veterinary medicinal products with limited use and limited environmental exposure will have a limited impact on the environment.
Danish: Det antages, at veterinærlægemidler med begrænset anvendelse og begrænset påvirkning af miljøet har en begrænset indvirkning på miljøet.
English: Therefore it was concluded that all extractable degradation products would represent less than 5% of the dose by day 27.
Danish: Det blev derfor konkluderet, at alle ekstraherbare nedbrydningsprodukter ville udgøre under 5 % af dosis på dag 27.
English: When such specific information is not available the default values given in the guideline are applied.
Danish: Hvis sådanne specifikke oplysninger ikke er tilgængelige, anvendes standardværdierne i retningslinjen.
English: The incidence takes into account the number of ill animals at the start of the study and all additional animals becoming ill during the observation period.
Danish: Ved forekomsten tages der hensyn til antallet af syge dyr ved undersøgelsens påbegyndelse samt alle de øvrige dyr, der bliver syge i løbet af observationsperioden.
English: Invented name Pharmaceutical form
Danish: Særnavn Lægemiddelform Styrke
English: The environmental risk assessment is carried out as a two Phase process.
Danish: Miljørisikovurderingen udføres i to faser.
English: The DT50 was further recalculated in accordance with a biphasic model.
Danish: DT50 blev derefter genberegnet i overensstemmelse med en tofaset model.
English: In Phase I the calculation of the initial PEC in soil is performed when more than a “small number of animals” are treated.
Danish: I fase I udføres beregningen af den indledende PEC i jord, hvis mere end et mindre antal dyr behandles.
English: 2.2 PECsoil CALCULATION
Danish: 2.2 BEREGNING AF PECsoil
English: Phase I identifies veterinary medicinal products that require a more extensive environmental risk assessment.
Danish: I fase I identificeres de veterinærlægemidler, der kræver en mere omfattende miljørisikovurdering.
English: The valid Summary of Product Characteristics, Labelling and Package Leaflet are the final versions achieved during the Coordination Group procedure with the following amendment:
Danish: De gældende tekster til produktresumé, etikettering og indlægsseddel er de endelige versioner, der er fastlagt ved behandlingen i koordinationsgruppen med følgende ændring:
English: All other potential degradation products of florfenicol were below the LOD by day 2.
Danish: Alle andre potentielle nedbrydningsprodukter af florfenicol lå under detektionsgrænsen på dag to.
English: • The nature of the binding is not known,
Danish: • Bindingens art kendes ikke.
English: • The nature and the biological activity of bound residues is not known,
Danish: • De bundne restkoncentrationers art og biologiske aktivitet kendes ikke.
English: LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER/APPLICANT IN THE MEMBER STATES
Danish: FORTEGNELSE OVER VETERINÆRLÆGEMIDLETS NAVNE, LÆGEMIDDELFORM, STYRKE, DYREARTER, INDGIVELSESVEJ, ANSØGER/INDEHAVER AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATERNE
English: = Nitrogen produced in one year per place [kg.N.
Danish: = Kvælstof produceret på et år per sted [kg.N.
English: From the above data it can be concluded that incidence of BRD within herds in the EU is generally below 50%.
Danish: Ud fra de ovenstående data kan det konkluderes, at forekomsten af bovin luftvejssygdom i besætninger i EU generelt ligger under 50 %.
English: = Depth of penetration into soil [m]
Danish: = Penetrationsdybde i jorden [m]
English: 2.3 Degradation of residues in manure
Danish: 2.3 Nedbrydning af restkoncentrationer i gødning
English: In relation to the proportion of a herd to be treated, it was noted that disease incidence and subsequent therapy are difficult to dissociate.
Danish: I forbindelse med andelen af en besætning, der skal behandles, blev det bemærket, at forekomsten af sygdommen og den deraf følgende behandling kan være svære at adskille.
English: If appropriate, the assessment proceeds to the second phase where the fate and effects of the product are determined and a risk assessment for the relevant environmental compartment is carried out.
Danish: Om nødvendigt fortsætter vurderingen til anden fase, hvor produktets videre skæbne og virkninger fastlægges, og en risikovurdering for det relevante delmiljø udføres.
English: The CVMP considers that the therapeutic indication as currently authorised in the Reference Member State does not make the limitations of the approved use clear as the existing wording could be interpreted as allowing use of the product for preventative and therapeutic treatment of all diseases caused by florfenicol susceptible bacteria.
Danish: CVMP vurderer, at den terapeutiske indikation, som på nuværende tidspunkt er godkendt i referencemedlemsstaten, ikke opstiller tydelige begrænsninger for den godkendte anvendelse, da den nuværende formulering kunne tolkes, som om produktet er godkendt til forebyggende og terapeutisk behandling af alle sygdomme forårsaget af bakterier, der er følsomme over for florfenicol.
English: The proportion of animals in the herd which are treated may be available from information in the dossier such as field trial data or from the scientific literature.
Danish: Andelen af dyr i besætningen, der behandles, kan være tilgængelig blandt oplysningerne i dokumentationen, såsom data fra feltundersøgelser, eller fra faglitteraturen.
English: Considering the totality of the data the CVMP considered that this figure represents a conservative estimate of the overall BRD incidence rate within herds in the EU.
Danish: På baggrund af de samlede data mente CVMP, at dette tal udgør et konservativt overslag over den samlede forekomst af bovin luftvejssygdom inden for besætningerne i EU.
English: PECsoil initial = Predicted Environmental Concentration in soil [μg.kg-1] D
Danish: PECsoil initial = Predicted Environmental Concentration i jord [μg.kg-1] D
English: The incidence rate observed by Martin et al, 2007 was refined to include the animals presenting clinical signs of BRD before the study, with the result that the incidence was increased to 37.7%.
Danish: Den angivelse af hyppighed, som blev observeret af Martin et al, 2007, blev gjort mere detaljeret ved at medtage dyr, der viste kliniske tegn på bovin luftvejssygdom inden undersøgelsen, hvilket resulterede i, at forekomsten blev øget til 37,7 %.
English: The CVMP reviewed bibliographical information on the incidence of BRD in several EU countries and on the percentage of animals that have been treated therapeutically and preventatively.
Danish: CVMP har vurderet bibliografiske oplysninger om forekomsten af bovin luftvejssygdom i flere EUlande samt om den procentuelle andel af dyr, der er blevet behandlet terapeutisk og forebyggende.
English: Fenflor contains florfenicol, which is a broad-spectrum primarily bacteriostatic antibiotic with a range of activity, including many Gram-negative and Gram-positive organisms.
Danish: Fenflor indeholder florfenicol, som er et bredspektret primært bakteriostatisk antibiotikum med en række virkeområder, herunder mange gramnegative og grampositive organismer.
English: In the first phase the extent of environmental exposure is determined based on the intended use of the veterinary medicinal product.
Danish: I den første fase afgøres omfanget af eksponeringen af påvirkningen af den tilsigtede anvendelse af veterinærlægemidlet.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET
Danish: BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉET OG INDLÆGSSEDLEN
English: During the mutual recognition procedure concerns were raised that Fenflor 300 mg/ml solution for injection for cattle may present a potential serious risk to the environment.
Danish: Under den gensidige anerkendelsesprocedure blev der ytret betænkeligheder med hensyn til, om Fenflor 300 mg/ml injektionsvæske, opløsning, til kvæg kan udgøre en potentielt alvorlig miljørisiko.
English: To support the argument that the environmental risk assessment could be completed at Phase I, the Marketing Authorisation Holder also provided a manure degradation study, which was performed in accordance with the criteria laid out in the above mentioned CVMP guideline.
Danish: Med henblik på at understøtte argumentet om, at miljørisikovurderingen kunne fuldføres i fase I, har indehaveren af markedsføringstilladelsen også fremlagt en undersøgelse af nedbrydning i gødning, som er udført i overensstemmelse med de kriterier, der er fastsat i den ovennævnte CVMPretningslinje.
English: The data available on BRD incidence within herds in the EU can be summarized as follows:
Danish: De tilgængelige oplysninger om tilfælde af bovin luftvejssygdom i besætningerne i EU kan sammenfattes således:
English: place-1.y-1] (see Table 3 of the guideline)
Danish: place-1.y-1] (se tabel 3 i retningslinjerne)
English: 2.1 Incidence of BRD (Bovine Respiratory Disease)
Danish: 2.1 Forekomsten af bovin luftvejssygdom
English: Florfenicol concentrations were below the limit of quantification (LOQ) (0.4 mg/kg) by day 2 and below the limit of detection (LOD) (0.1 mg/kg) by day 27.
Danish: Florfenicolkoncentrationerne var under kvantificeringsgrænsen (0,4 mg/kg) på dag to, og under detektionsgrænsen (0,1 mg/kg) på dag 27.
English: All PECsoil values calculated are below the Phase II trigger value of 100 μg/kg, with the highest PECsoil (88.6 μg/kg) calculated for cattle of over 2 years of age.
Danish: Alle PECsoil-værdier beregnet ovenfor ligger under fase II-udløsningsværdien på 100 μg/kg, hvor den højeste PECsoil (88,6 μg/kg) er beregnet for kvæg over to år.
English: The Marketing Authorisation Holder provided a study to demonstrate that florfenicol degrades rapidly, with a DT50 of 14 hours (calculated using the Arrhenius equation to extrapolate from a DT50 of 5 hours measured at 20°C rather than at 10°C, as recommended in the CVMP guideline).
Danish: Indehaveren af markedsføringstilladelsen fremlagde en undersøgelse for at vise, at florfenicol nedbrydes hurtigt med en DT50 på 14 timer (beregnet ved at anvende Arrhenius' ligning til at ekstrapolere fra en DT50 på fem timer målt ved 20°C frem for ved 10°C, som det anbefales i CVMP's retningslinje).
English: The value of the resulting PECsoil determines whether or not a Phase II environmental risk assessment is required.
Danish: Værdien af den beregnede PECsoil afgør, hvorvidt en fase II-miljørisikovurdering er påkrævet.
English: As this is below the Phase II trigger value of 100 µg/kg no Phase II environmental risk assessment is required.
Danish: Da dette ligger under fase II-udløsningsværdien på 100 µg/kg, er en fase II-miljørisikovurdering ikke påkrævet.
English: However, given that the CVMP considers that no Phase II environmental risk assessment is required for this application (because the calculated PECsoil values are below the trigger value), the manure degradation study is not pivotal to the environmental risk assessment.
Danish: Eftersom CVMP vurderer, at en fase II-miljørisikovurdering ikke er påkrævet i forbindelse med denne ansøgning (fordi de beregnede PECsoil-værdier ligger under udløsningsværdien), er undersøgelsen af nedbrydning i gødning ikke afgørende for miljørisikovurderingen.
English: Using the value of 38% for the proportion of treated animals in a herd, a maximum PECsoil value of 88.6 μg/kg was calculated.
Danish: Med denne værdi på 38 % for andelen af behandlede dyr i en besætning blev der beregnet en maksimal PECsoil-værdi på 88,6 μg/kg.
English: Because Fenflor 300 mg/ml solution for injection for cattle is indicated for treatment only (i.e. it is indicated only for use in clinically ill animals not for preventative use) it was considered that, in this case, it was appropriate to use the disease incidence within the herd as the proportion of animals treated.
Danish: Da Fenflor 300 mg/ml injektionsvæske, opløsning, til kvæg kun er indiceret til behandling (dvs., at det kun er indiceret til klinisk syge dyr og ikke til forebyggende brug), blev det vurderet, at det i dette tilfælde var passende at anvende sygdomsforekomsten i en besætning som andelen af behandlede dyr.
English: = Daily dose of the active ingredient [mg.kgbw
Danish: = Daglig dosis af det aktive stof [mg.kglv
English: The dossier as submitted in the referral procedure is considered to fulfil the necessary requirements with regards to the environmental risk assessment (as established in Article 12(3)(j) of Directive 2001/82/EC, as amended by Directive 2004/28/EC) provided that the product is used only for therapeutic treatment of respiratory tract infections in cattle due to Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.
Danish: Det dossier, som blev indsendt under indbringelsesproceduren, anses for at opfylde de nødvendige krav med hensyn til miljørisikovurderingen (som fastsat i artikel 12, stk. 3, litra j, i direktiv 2001/82/EF, som ændret ved direktiv 2004/28/EF), forudsat at produktet kun bruges til terapeutisk behandling af luftvejsinfektioner hos kvæg forårsaget af Mannheimia haemolytica, Pasteurella multocida og Histophilus somni.
English: Section 4.2 of the SPC and Section 4 of the Package Leaflet:
Danish: Produktresuméets punkt 4.2 og indlægssedlens punkt 4: