FrancophonIA/ELRC3.0 huggingface dataset:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each syringe contains 7.32 g of paste and delivers: Firocoxib 8.2 mg/g
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING 1 sprøjte à 7,32 g pasta indeholder:
English: NAME OF THE VETERINARY MEDICINAL PRODUCT EQUIOXX 20 mg/ml solution for injection for horses
Danish: VETERINÆRLÆGEMIDLETS NAVN EQUIOXX 20 mg/ml injektionsvæske, opløsning, til hest.
English: PACKAGE LEAFLET EQUIOXX 57 mg chewable tablets for horses
Danish: EQUIOXX 57 mg tyggetabletter til hest
English: MARKETING AUTHORISATION NUMBER(S) EU/2/08/083/002
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/08/083/002
English: Liver Kidney
Danish: Tyggetabletter
English: 0.12 μM, whereas the IC50 for COX-1 is 20.14 to 33.1 μM.
Danish: Den koncentration af firocoxib, der kræves for at hæmme 50% af COX-2 enzymet (i.e. IC50) er 0,0369 til 0,12 μM, hvorimod IC50 for COX-1 er 20,14 - 33,1 μM.
English: Firocoxib 20 mg
Danish: Firocoxib 8,2 mg/g
English: MARKETING AUTHORISATION NUMBER(S) EU/2/08/083/001
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/08/083/001
English: 6.5 Nature and composition of immediate packaging The chewable tablets are available in the following pack sizes:
Danish: Tyggetabletterne findes i følgende pakningsstørrelser:
English: IV
Danish: B.
English: Concurrent administration of potentially nephrotoxic drugs should be avoided, as there might be an increased risk of renal toxicity.
Danish: Undgå samtidig anvendelse af potentielt nyretoksiske præparater, da der kan være forøget risiko for nyretoksicitet.
English: The safety of the product for use in breeding, pregnant or lactating horses has not been evaluated.
Danish: Da sikkerheden ved produktets anvendelse i avlsdyr, drægtige eller lakterende dyr ikke er undersøgt, skal præparatet ikke anvendes til avlsdyr, drægtige og lakterende dyr.
English: Evaluation of the environmental risk assessment
Danish: Evaluering af miljørisikovurderingen
English: The VICH GL 6 states that:
Danish: I VICH GL 6 bestemmes følgende:
English: The Phase II evaluation performed by the Applicant was based on:
Danish: Den fase II-evaluering, som ansøgeren havde foretaget, var baseret på:
English: Therefore, in principle, a Phase II could exceptionally be requested.
Danish: Derfor kan der i princippet rent undtagelsesvis anmodes om en fase II.
English: In view of the disagreement the issue was referred to CVMP.
Danish: På grund af disse uoverensstemmelser blev spørgsmålet indbragt for CVMP.
English: These situations are expected to be the exception rather than the rule and some evidence in support of the concern should be available.”
Danish: Disse situationer forventes at være undtagelsen frem for reglen, og der bør foreligge dokumentation, som understøtter betænkelighederne.«
English: The product is a generic of Baycox 5% oral solution.
Danish: Produktet er en generisk form af Baycox 5 % oral opløsning.
English: Furthermore, the scenarios for pig and poultry manure are not necessary comparable as breeding conditions, application and agricultural practises for handling of manure are often very different.
Danish: Desuden er scenarierne for grise- og fjerkrægødning ikke nødvendigvis sammenlignelige, da opdrætsbetingelser, anvendelse og landbrugspraksis med hensyn til håndtering af gødning ofte er meget forskellige.
English: Potential variation in metabolism is therefore of little practical importance in the Phase I calculation of the PEC value.
Danish: Den potentielle variation i metabolismen er derfor af ringe praktisk betydning i fase I-beregningen af PEC-værdien.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, APPLICANT/ MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
Danish: BILAG I LISTE OVER LÆGEMIDLETS NAVNE, LÆGEMIDDELFORM, STYRKER , DYREARTER, INDGIVELSESVEJ, ANSØGER/INDEHAVER AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATERNE
English: 2.1 Evaluation of Phase I and considerations on the need for a Phase II assessment
Danish: 2.2 Evaluering af fase I og betragtninger omkring behovet for en fase II-vurdering
English: La Ballastière 33500 Libourne FRANCE Bristol
Danish: La Ballastière 33500 Libourne FRANCE Bristol UK
English: It is indicated for the prevention of clinical signs of coccidiosis in neonatal piglets on farms with a confirmed history of coccidiosis caused by Isospora sui.
Danish: Det er indiceret til forebyggelse af kliniske symptomer på coccidiose hos neonatale smågrise på landbrug med tidligere bekræftede tilfælde af coccidiose forårsaget af Isospora sui.
English: • The rearing and production methods are similar in poultry and pigs,
Danish: • Opdræts- og produktionsmetoder er ens for fjerkræ og grise
English: 2.1 Assessment of Phase II data provided
Danish: 2.1 Vurdering af de fremsendte fase II-data
English: It is acknowledged that the main metabolite is probably the same for pigs and poultry for this compound and that the calculations in Phase I of the ERA take 100% of the dose into account (total residue approach) when environmental exposure is calculated.
Danish: Det anerkendes, at den vigtigste metabolit sandsynligvis er den samme for grise og fjerkræ for dette stof, og at beregningerne i fase I af miljørisikovurderingen tager 100 % af dosis i betragtning (metoden med samlet restkoncentration), når miljøeksponeringen beregnes.
English: This response was accepted by the reference Member State but rejected by some Concerned Member States on the basis that the reference to end point values from published summary of an assessment was not sufficient to substitute environmental risk assessment data.
Danish: Referencemedlemsstaten godtog dette svar, mens nogle af de berørte medlemsstater kunne ikke godtage det med den begrundelse, at henvisningen til slutpunktværdier fra det offentliggjorte resumé af en vurdering ikke var tilstrækkelig til at erstatte data fra en miljørisikovurdering.
English: “Some VMPs that might otherwise stop in Phase I may require additional environmental information to address particular concerns associated with their activity and use.
Danish: »Nogle veterinærlægemidler, der ellers kunne stoppe ved fase I, kan kræve yderligere miljøinformation for at behandle særlige betænkeligheder med hensyn til deres virkning og anvendelse.
English: Having considered the overall data submitted in writing and in the oral explanation the CVMP concluded after consulting with its Environmental Risk Assessment Working Party that the objections raised during the decentralised procedure should not prevent the granting of a Marketing Authorisation.
Danish: Efter at have vurderet de samlede oplysninger, som var indsendt skriftligt og afgivet ved den mundtlige forklaring, konkluderede CVMP efter at have hørt sin arbejdsgruppe om miljørisikovurdering, at de indsigelser, der blev rejst under den decentrale procedure, ikke burde forhindre udstedelse af en markedsføringstilladelse.
English: • The metabolism of toltrazuril was considered as qualitatively similar in poultry and in pigs Therefore the Applicant considered that the conclusions from the CVMP referral for poultry could be extrapolated to piglets.
Danish: • Metaboliseringen af toltrazuril blev anset for at være kvalitativt ens hos fjerkræ og grise Ansøgeren mente derfor, at konklusionerne af indbringelsen for CVMP for fjerkræ kunne ekstrapoleres til smågrise.
English: In addition to the question whether the provided data was sufficient for a Phase II assessment (see above) the Committee revisited the Phase I submitted with the application in order to reach an opinion on whether the marketing authorisation for the product could be granted or should be refused in accordance with Article 36 of Directive 2001/82/EC.
Danish: Ud over spørgsmålet om, hvorvidt der var fremlagt tilstrækkelige data til en fase II-vurdering (se ovenfor) behandlede udvalget igen fase I, som var indsendt sammen med ansøgningen, for at nå frem til en udtalelse om, hvorvidt der kunne udstedes en markedsføringstilladelse for produktet, eller om der skulle gives afslag herpå i henhold til artikel 36 i direktiv 2001/82/EF.
English: 3 CVMP/VICH GL6: Environmental impact assessment (EIAS) for veterinary medicinal products - Phase I (CVMP/VICH/592/98-FINAL), CVMP/VICH GL38: Environmental impact assessments for veterinary medicinal products (VMPs) - Phase II (CVMP/VICH/790/03-FINAL) and Environmental Impact Assessment for Veterinary Medicinal Products in support of the VICH guidelines GL6 and GL38 (EMEA/CVMP/ERA/418282/2005- Rev.1)
Danish: 3 CVMP/VICH GL6: Miljøkonsekvensvurdering (VVM) for veterinærlægemidler - Fase I (CVMP/VICH/592/98-FINAL), CVMP/VICH GL38: miljøkonsekvensvurderinger for veterinærlægemidler - fase II (CVMP/VICH/790/03-FINAL) og miljøkonsekvensvurderinger for veterinærlægemidler til støtte for VICH-retningslinje GL6 og GL38 (EMEA/CVMP/ERA/418282/2005- Rev.1).
English: The information provided does not contain details on the design, conduct, analysis and results of the study allowing a full and independent assessment therefore does not allow for a Phase II evaluation according to the legal requirements and relevant guidelines3 in force.
Danish: Den fremsendte information indeholder ikke nogen nærmere oplysninger om udformning, gennemførelse, analyse og resultater af undersøgelsen, der muliggør en fuldstændig og uafhængig vurdering, og der kan derfor ikke gennemføres en fase II-evaluering i henhold til de gældende lovkrav og relevante retningslinjer3.
English: Some evidence from the public domain indicates that the main metabolite and degradation product in soil of toltrazuril - toltrazuril sulphone - is persistent, phytotoxic and mobile with the potential to leach to groundwater.
Danish: Dokumentation fra det offentlige område tyder på, at den vigtigste metabolit og nedbrydningsproduktet i jord for toltrazuril - toltrazurilsulfon - er persistent, fytotoksisk og mobil og kan udsive til grundvandet.
English: During the decentralised procedure the disagreement between the Member States was on the adequacy of the data provided for the Phase II Environmental Risk Assessment.
Danish: Under den decentrale procedure angik uenigheden blandt medlemsstaterne, hvorvidt der var fremlagt tilstrækkelige data i forbindelse med fase II-miljørisikovurderingen.
English: Some concerned Member States raised potential concerns with the persistence of the main metabolite of toltrazuril, toltrazuril sulphone, and therefore the applicant was required to submit a Phase II.
Danish: Nogle af de berørte medlemsstater rejste mulige betænkeligheder vedrørende persistensen af den vigtigste metabolit i toltrazuril, toltrazurilsulfon, og ansøgeren skulle derfor fremsende en fase II-evaluering.
English: The CVMP has, however, previously concluded that toltrazuril and toltrazuril sulphone do not pose an unacceptable risk at environmental concentrations exceeding the concentrations predicted as a result of normal use of Cevazuril 50mg/ml oral suspension for piglets.
Danish: CVMP har dog tidligere konkluderet, at toltrazuril og toltrazurilsulfon ikke udgør en uacceptabel risiko ved miljøkoncentrationer, der overstiger de koncentrationer, som forventes som følge af normal anvendelse af Cevazuril 50 mg/ml oral suspension til smågrise.
English: Therefore the environmental risk assessment could stop at Phase I, unless there were particular concerns justifying a request for a Phase II evaluation as foreseen in the VICH GL 6.
Danish: Miljørisikovurderingen kunne derfor stoppe ved fase I, medmindre der var særlige hensyn, som berettigede en anmodning om en fase II-evaluering som fastsat i VICH GL 6.
English: The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Danish: Det nuværende produktresumé, etikettering og indlægsseddel er de endelige udgaver, der blev fastlagt under behandlingen i koordinationsgruppen.
English: The CVMP therefore concluded that the environmental risk assessment of the product can stop at Phase I.
Danish: CVMP konkluderede derfor, at miljørisikovurderingen af produktet kan stoppe ved fase I.
English: • argumentation for that the predicted environmental concentration (PEC) resulting from the use of the product in pigs is inferior to that, which arises from its use in poultry.
Danish: • argumentationen for, at den forventede miljøkoncentration (PEC) efter brug af produktet hos grise er lavere end efter brug hos fjerkræ.
English: The Applicant initially provided a Phase I evaluation only for the environmental risk assessment of the product concluding that the PECsoil was largely below 100 μg/kg.
Danish: Ansøgeren fremlagde indledningsvis en fase I-evaluering udelukkende med henblik på miljørisikovurderingen af produktet, hvori det konkluderedes, at PECjord lå langt under 100 μg/kg.
English: • The PECsoil was clearly inferior in pigs compared to poultry,
Danish: • PECjord var tydeligvis lavere hos grise end hos fjerkræ
English: • the conclusions from the referral procedure under Article 35 of Directive 2001/82/EC regarding veterinary medicinal products containing toltrazuril intended for use in poultry species in relation to environmental risk assessment and;
Danish: • Konklusionerne fra indbringelsesproceduren i henhold til artikel 35 i direktiv 2001/82/EF vedrørende veterinærlægemidler indeholdende toltrazuril beregnet til brug hos fjerkræ i forbindelse med miljørisikovurdering, og
English: In summary the CVMP concludes that the information submitted by the Applicant with regard to the Phase II evaluation is insufficient and therefore should a Phase II assessment be required for the evaluation of the product, a marketing authorisation should not be granted.
Danish: Sammenfattende konkluderer CVMP, at den information, som ansøgeren har fremsendt i forbindelse med fase II-evalueringen, er utilstrækkelig, og hvis der derfor er behov for en fase II-vurdering for, at produktet kan evalueres, bør der ikke udstedes en markedsføringstilladelse.
English: The Committee considered the Phase I evaluation of the environmental risk assessment from the Applicant for Cevazuril 50 mg/kg for oral use in piglets in order to establish whether the environmental risk assessment of the product could stop at Phase I or whether a Phase II evaluation would be required.
Danish: Udvalget tog fase I-evalueringen af miljørisikovurderingen fra ansøgeren for Cevazuril 50 mg/kg til oral indgift hos smågrise i betragtning for at fastslå, om miljørisikovurderingen for produktet kunne stoppe ved fase I, eller om en fase II-evaluering ville være nødvendig.
English: The CVMP considers that on the basis of the current information there is no scientific justification to request a Phase II evaluation and therefore the environmental risk assessment of the product can stop at Phase I.
Danish: CVMP mener ikke, at der på grundlag af de nuværende oplysninger foreligger en videnskabelig begrundelse for at anmode om en fase II-evaluering, og miljørisikovurderingen af produktet kan derfor stoppe ved fase I.
English: The environmental risk assessment of the product in accordance to the VICH GL 6 (Environmental Impact Assessment for veterinary medicinal products- Phase I, CVMP/VICH/592/98-Final) concluded that the PECsoil for piglets was 12 µg/kg, which is well below the trigger value for a Phase II assessment of 100 µg/kg.
Danish: Konklusionen på miljørisikovurderingen for produktet i henhold til VICH GL 6 (Environmental Impact Assessment for veterinary medicinal products - Phase I, CVMP/VICH/592/98-Final) var, at PECjord for smågrise var 12 µg/kg, hvilket er langt under udløsningsværdien for en fase II-vurdering på 100 µg/kg.
English: The CVMP concludes that the information provided by the Applicant does not allow for a Phase II evaluation according to the legal requirements and guidelines in force.
Danish: CVMP konkluderer, at den information, som ansøgeren har fremsendt, ikke åbner mulighed for en fase IIevaluering i henhold til de gældende lovkrav og gældende retningslinjer.
English: In response to the questions raised in the decentralised procedure the Applicant referred to the CVMP conclusions reached during the referral procedure under Article 35 of Directive 2001/82/EC regarding veterinary medicinal products containing toltrazuril intended for use in poultry species in relation to environmental risk assessment and argued that:
Danish: Som svar på de spørgsmål, der blev rejst under den decentrale procedure, henviste ansøgeren til de konklusioner, som CVMP nåede frem til under indbringelsesproceduren i henhold til artikel 35 i direktiv 2001/82/EF vedrørende veterinærlægemidler indeholdende toltrazuril beregnet til brug hos fjerkræ i forbindelse med miljørisikovurderingen, og fremførte følgende:
English: CEVAZURIL 50 mg/ml oral suspension for piglets is a suspension for oral administration, which contains 50 mg toltrazuril/ml as an active substance.
Danish: CEVAZURIL 50 mg/ml oral suspension til smågrise er en suspension til oral indgift, der indeholder 50 mg toltrazuril/ml som aktivt stof.
English: The current evidence is therefore not sufficient to justify a prevalence of particular concern and thereby to request a Phase II evaluation.
Danish: Den foreliggende dokumentation er derfor ikke tilstrækkelig til at retfærdiggøre betænkeligheder ved et bestemt spørgsmål og dermed til at anmode om en fase IIevaluering.
English: Marketing Authorisation granted
Danish: Markedsføringstilladelse udstedt.
English: The recommended dose is a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0.4 ml oral suspension per kg body weight, on day 3-5 of life.
Danish: Den anbefalede dosis er en enkelt oral dosis på 20 mg toltrazuril/kg legemsvægt, hvilket svarer til 0,4 ml oral suspension pr. kg legemsvægt, når grisene er 3-5 dage gamle.
English: 12 µg/kg, which is well below the trigger value for a Phase II assessment of 100 µg/kg.
Danish: Konklusionen på denne fase I var, at PECjord for smågrise var 12 µg/kg, hvilket er et godt stykke under udløsningsværdien for en fase II-vurdering på 100 µg/kg.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF CEVAZURIL 50mg/ml oral suspension for piglets
Danish: SAMLET RESUME AF DEN FAGLIGE VURDERING AF CEVAZURIL 50 MG/ML ORAL SUSPENSION TIL SMÅGRISE
English: Denmark Ceva Santé Animale Z.I.
Danish: Danmark Ceva Santé Animale Z.I.
English: Germany Ceva Santé Animale Z.I.
Danish: Tyskland Ceva Santé Animale Z.I.
English: Therefore, the CVMP recommends the granting of the marketing authorisation for CEVAZURIL 50 mg/ml oral suspension for piglets for which the Summary of Product Characteristics, labeling and package leaflet are set out in Annex III of the CVMP Opinion.
Danish: CVMP anbefaler således udstedelse af markedsføringstilladelse for CEVAZURIL 50 mg/ml oral suspension til smågrise.
English: Belgium Ceva Santé Animale Z.I.
Danish: Bulgarien Ceva Santé Animale Z.I.
English: Greece
Danish: Ungarn
English: Hungary Ceva Santé Animale Z.I.
Danish: Grækenland Ceva Santé Animale Z.I.
English: CEVAZURIL 50 mg/ml, Suspensija iekšķīgai
Danish: CEVAZURIL 50 mg/ml, Suspensija iekšķīgai lietošanai dēļ sivēni
English: • Tell your doctor immediately if you become pregnant.
Danish: • Fortæl det straks til lægen, hvis De bliver gravid.
English: The in vivo relevance of these interactions is not clear.
Danish: Relevansen in vivo af disse interaktioner er uklar.
English: • Do not give this medicine to children and adolescents under 18 years of age.
Danish: • Denne medicin må ikke gives til børn og unge under 18 år.
English: The absolute oral bioavailability has not been
Danish: Den absolutte orale biotilgængelighed er ikke fastlagt.
English: Your doctor will discuss the potential benefits and risks of taking Vitekta to you and your child.
Danish: Deres læge vil drøfte de potentielle fordele og risici ved at tage Vitekta for Dem og Deres barn.
English: This will improve your immune system and reduce the risk of developing illnesses linked to
Danish: Dette vil forbedre Deres immunsystem og nedsætte risikoen for at udvikle sygdomme forbundet med
English: Difference in percentages (95% CI)
Danish: Forskel i procent (95 % CI)
English: If you have hepatitis B infection, your doctor will carefully consider the best treatment for you.
Danish: Hvis De har en hepatitis B-infektion, vil Deres læge nøje overveje, hvilken behandling, der er den bedste for Dem.
English: a The difference in proportions and its 95% CIs between randomised treatment groups is based on normal approximation.
Danish: a Forskellen i andele og dets 95 % CI'er mellem randomiserede behandlingsgrupper er baseret på normal approksimation.
English: These symptoms may indicate that your body's improved immune system is fighting infection.
Danish: Disse symptomer kan indikere, at Deres krops forbedrede immunsystem bekæmper infektionen.
English: No data are available for children below 18 years of age.
Danish: Der foreligger ingen data for børn under 18 år.
English: The long-term effects of substantial increases in progesterone exposure are unknown.
Danish: De langvarige virkninger af betydeligt øget progesteroneksponering er ukendte.
English: • Women must not get pregnant while taking Vitekta.
Danish: • Kvinder må ikke blive gravide, mens de tager Vitekta.
English: Demographic characteristics Median age, years (min-max)
Danish: Demografiske karakteristika Medianalder, år (min.-maks.)
English: Table 2: Interactions between elvitegravir and other medicinal products
Danish: Tabel 2: Interaktioner mellem elvitegravir og andre lægemidler
English: Do not stop your treatment
Danish: Afbryd ikke behandlingen
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 13 November 2013
Danish: Dato for første markedsføringstilladelse: 13. november 2013
English: See section 3, How to take
Danish: Se punkt 3, Sådan skal
English: The film-coated tablet should
Danish: Den filmovertrukne tablet må
English: Elvitegravir has a relatively low genetic barrier to resistance.
Danish: Elvitegravir har en relativ lav genetisk barriere over for resistens.
English: The frequency of the following side effects is not known (frequency cannot be estimated from the
Danish: Hyppigheden af de følgende bivirkninger er ikke kendt (hyppigheden kan ikke estimeres ud fra forhåndenværende data):
English: (may affect up to 1 in every 100 patients treated)
Danish: (kan opstå hos op til 1 ud af 100 behandlede patienter)
English: The HIV virus produces an enzyme called HIV integrase.
Danish: Hiv-virus producerer et enzym kaldet hiv-integrase.
English: • Any signs of inflammation or infection.
Danish: • Ethvert tegn på betændelse eller infektion.
English: • didanosine (see also section 3 of this leaflet)  Tell your doctor if you are taking any of these HIV medicines.
Danish: • didanosin (se også punkt 3 i denne indlægsseddel)  Fortæl det altid til lægen, hvis De tager nogle af disse lægemidler mod hiv.
English: INR should continue to be monitored during the first weeks following cessation of treatment with Vitekta.
Danish: INR bør stadig overvåges i løbet af de første uger efter behandlingen med Vitekta stoppes.
English: Read all of this leaflet carefully before you start taking this medicine because it contains
Danish: Læs denne indlægsseddel grundigt, inden De begynder at tage dette lægemiddel, da den
English: Virologic response rate was evaluated in both treatment arms.
Danish: Virologisk responsrate blev evalueret i begge behandlingsarme.
English: If you are lactose-intolerant, or if you have been told that you have an intolerance to other sugars, talk to your doctor before taking this medicine.
Danish: Hvis De er lactoseintolerant, eller hvis De har fået at vide, at De er intolerant over for nogle andre sukkerformer, skal De tale med Deres læge, før De tager denne medicin.
English: Your treatment with Vitekta should only be started by a doctor who is experienced in treating
Danish: Deres behandling med Vitekta bør kun påbegyndes af en læge med erfaring i behandling af
English: (may affect 1 to 10 in every 100 patients treated)
Danish: (kan opstå hos mellem 1 og 10 ud af 100 behandlede patienter)
English: Look out for signs of inflammation or infection soon after you start taking Vitekta.
Danish: Vær opmærksom på tegn på betændelse eller infektion, snart efter De starter med at tage Vitekta.