FrancophonIA/ELRC3.0 huggingface dataset:
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, route of administration, applicant in the Member States
Danish: Liste med navne, lægemiddelformer, veterinærlægemidlerts styrker, dyrearter, som lægemidler er beregnet til, indgivelsesmåde, ansøger i medlemslandene
English: Quality, target animal safety, user safety and residues were not assessed in this referral procedure, as no concern was notified by the reference Member State.
Danish: Kvalitet, sikkerhed for måldyrearten, brugersikkerhed og restkoncentrationer blev ikke vurderet i denne indbringelsesprocedure, da referencemedlemsstaten ikke havde nogen betænkeligheder.
English: Data from an acceptable study gave a bioconcentration factor of 510 l/kg which is below the value of 2000 l/kg which would indicate a potential to bioaccumulate.
Danish: Data fra en acceptabel undersøgelse viste en biokoncentrationsfaktor på 510 l/kg, som ligger under værdien på 2000 l/kg, hvilket tyder på et potentiale for bioakkumulering.
English: Overall deltamethrin was not considered to be a PBT compound.
Danish: Samlet set kunne deltamethrin ikke anses for at være en PBT-forbindelse.
English: For the spot-on product Belgium, France, Germany and the Netherlands are involved as CMS.
Danish: For spot-on-produktet er Belgien, Frankrig, Tyskland og Nederlandene berørte medlemsstater.
English: New acute OECD studies were carried out on aquatic organisms followed by an OECD chronic study with daphnia.
Danish: Nye akutte OECD-undersøgelser var udført på vandlevende organismer efterfulgt af en kronisk OECD-undersøgelse med dafnier.
English: Add, where applicable, “Deltamethrin is toxic to aquatic organisms and honey bees and may accumulate in sediment.”
Danish: Tilføj hvor det er relevant, ”Deltamethrin er giftigt for vandorganismer og honningbier og kan akkumuleres i sedimenter”
English: No additional studies were carried out in order to further refine the risk as guidance in this area is not currently available.
Danish: Der var ikke gennemført nogen supplerende undersøgelser for yderligere at forbedre risikovurderingen, eftersom der i øjeblikket ikke findes
English: Efficacy was not assessed in this referral procedure.
Danish: Virkningen blev ikke vurderet i denne procedure for indbringelse af sager.
English: The reference member state (RMS) is the United Kingdom for both products.
Danish: Det Forenede Kongerige er referencemedlemsstat for begge produkter.
English: These PNECs were compared with the PEC values (calculated using agreed methods) for surface water exposed via drainage through soil, via direct excretion by cattle and via loss from the fleece of sheep.
Danish: Disse PNEC'er blev sammenlignet med PEC-værdier (beregnet ved hjælp af vedtagne metoder) for overfladevand udsat via afvanding gennem jord, via direkte ekskretion fra kvæg og via tab af fleece fra får.
English: The RQ values for surface water were <1 for all target animal types.
Danish: RQ-værdier for overfladevand var <1 for alle dyrearter.
English: The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination Group procedure with the following amendments:
Danish: Det gældende Produktresumé, etikettering og indlægsseddel er de endelige udgaver jf. den koordinerede procedure med følgende ændringer:
English: The adsorption/desorption of deltamethrin was determined by the HPLC method which showed that deltamethrin was expected to be non-mobile in soil.
Danish: Adsorption/desorption af deltamethrin blev bestemt ved hjælp af HPLC-metoden, der viste, at deltamethrin ikke kunne forventes at være mobil i jord.
English: As the active substance is an ectoparasiticide a Phase II ERA was presented.
Danish: Eftersom det aktive stof er et ektoparasitdræbende middel, var der fremlagt en fase III-miljørisikovurdering.
English: Consequently in order to mitigate the risk for dung insects RMMs were included in the SPC in sections 4.5.iii and 5 (Environmental properties).
Danish: For at begrænse risikoen for gødningsinsekter blev risikobegrænsningsforanstaltninger derfor inkluderet i produktresuméet i afsnit 4.5.iii og 5 (miljømæssige egenskaber).
English: The applications in question, submitted via the decentralised procedure, are generic applications according to Art. 13(3) of Directive 2001/82/EC, as amended, referring to the reference products Pfizer Pour On Insecticide 1% w/v Cutaneous Solution and Pfizer Spot On Insecticide 1% w/v Cutaneous Solution multidose authorised in the United Kingdom.
Danish: De pågældende ansøgninger, der er indgivet ved hjælp af den decentrale procedure, er generiske ansøgninger i henhold til art. 13, stk. 3, i direktiv 2001/82/EF, som ændret, der henviser til referenceprodukterne Pfizer Pour On Insecticide 1 % w/v Cutaneous Solution og Pfizer Spot On Insecticide 1% w/v Cutaneous Solution multidose, som er godkendt i Det Forenede Kongerige.
English: Published data from a field study using a pour-on deltamethrin product indicated that the effects of deltamethrin can persist for a number of weeks and have the potential to affect dung insect populations in some circumstances.
Danish: Publicerede data fra en feltundersøgelse med et deltamethrin-pour-on-produkt påviste, at deltamethrins virkninger kan vare i et vist antal uger og har under visse omstændigheder potentiale til at påvirke gødningsinsektpopulationer.
English: Acceptable data on the acute toxicity of deltamethrin to dung fly larvae and adult beetles were provided which indicated that RQ values for dung insects were in the order of 90 - 10 000.
Danish: Der blev forelagt acceptable data om deltamethrins akutte toksicitet for gødningsflyvelarver og voksne biller, som viste, at RQ-værdier for gødningsinsekter lå i størrelsesordenen 90-10 000.
English: The amended Summaries of Product Characteristics and package leaflets of the reference Member State are set out in Annex III.
Danish: Referencemedlemsstaternes ændrede produktresumér og indlægssedler er anført i bilag III.
English: Having considered all the overall submitted data in writing the CVMP concluded that the ERA for Deltanil Pour-On and Spot-on products shows that the products are not expected to pose a risk for the environment when used as recommended in the product information including the recommended RMMs.
Danish: Efter at have gennemgået samtlige skriftligt fremlagte data konkluderede CVMP, at miljørisikovurderingen for Deltanil Pour-On- og Spot-on-produkterne viser, at produkterne ikke forventes at udgøre en risiko for miljøet, når de anvendes som anbefalet i produktinformationen, herunder de anbefalede risikobegrænsningsforanstaltninger.
English: As deltamethrin has a n-octanol/water partition coefficient (KOW, expressed as logKOW) of >5.1, its bioaccumulation potential, potential for being considered a persistent, bioaccumulative and toxic (PBT) compound and secondary poisoning were addressed as required by the VICH and CVMP guidelines.
Danish: Da deltamethrin har en fordelingskoefficient for n-oktanol/vand (KOW, udtrykt som logKOW) på > 5,1, var dets potentiale for bioakkumulering, dets potentiale for at blive betragtet som en persistent, bioakkumulerende og toksisk forbindelse (PBT-forbindelse) og dets sekundære forgiftning blevet behandlet i overensstemmelse med kravene i VICH- og CVMP-retningslinjerne.
English: Amendments in the relevant sections of the Summaries of Product Characteristics and package leaflets
Danish: Ændringer i de relevante afsnit af Produktresumé og etikettering og indlægsseddel
English: No degradation rate for deltamethrin in sediment was required in order to complete the ERA, but some information in the published literature suggests that in some sediments degradation occurs with a half-life in soil of about 10 days (Åkerblom et al. 2008)4.
Danish: For at fuldføre miljørisikovurderingen krævedes der ingen nedbrydningsfrekvens for deltamethrin i sedimenter, men nogle af oplysningerne i den publicerede litteratur tyder dog på, at nedbrydningen i nogle sedimenter sker med en halveringstid i jord på omkring 10 dage (Åkerblom et al. 2008)4.
English: A new study was carried out on earthworms according to the recommended OECD guideline and a predicted no effect concentration (PNEC) was derived using the accepted assessment factor (10).
Danish: En ny undersøgelse blev i henhold til den anbefalede OECD-retningslinje udført på regnorme, og en beregnet nuleffektkoncentration (PNEC) blev udarbejdet ved hjælp af den accepterede vurderingsfaktor (10).
English: No further assessment of risks to surface water and sediment was necessary and no RMMs were needed.
Danish: Det var ikke nødvendigt at foretage yderligere vurdering af risikoen for overfladevand og sediment, og der var ikke behov for risikobegrænsningsforanstaltninger.
English: In order to address the concerns raised by the referral, the applicant provided an environmental risk assessment (ERA) in accordance with VICH guidelines GL61 and GL382 and in accordance with the CVMP guideline in support of VICH guidelines GL6 and GL38 (EMEA/CVMP/ERA/418282/2005)3.
Danish: For at imødekomme de betænkeligheder, som indbringelsesproceduren har medført, har ansøgeren foretaget en miljørisikovurdering i overensstemmelse med VICH-retningslinjerne GL61 og GL382 og i overensstemmelse med Udvalget for Veterinærlægemidlers (CVMP) retningslinje til støtte for VICH-retningslinjerne GL6 og GL38 (EMEA/CVMP/ERA/418282/2005)3.
English: Strength Pharmaceutical form
Danish: Styrke Lægemiddelform Dyrearter
English: Deltamethrin is used topically (dip, spray or pouron) for the control of ectoparasites in cattle and sheep.
Danish: Deltamethrin anvendes topikalt (dyp, spray eller pour-on) til kontrol af ektoparasitter hos kvæg og får.
English: Comparison of the predicted environmental concentration (PEC) value for soil with the PNEC showed that the RQ for the soil compartment was <1 and no further assessment was required.
Danish: Ved en sammenligning af værdien for den forventede miljøkoncentration (PEC-værdi) for jord med PNEC viste det sig, at RQ for jordmiljøet var <1, og at det ikke var nødvendigt med yderligere vurdering.
English: The RMMs and warnings in the Summary of Product Characteristics (SPC) and package leaflet address the risk to dung insects by advising on the frequency of re-treatments and the duration of deltamethrin excretion.
Danish: Risikobegrænsningsforanstaltningerne og advarslerne i produktresuméet og indlægssedlen vedrører risikoen for gødningsinsekter gennem rådgivning om hyppigheden af genbehandlinger og om varigheden af deltamin-ekskretionen.
English: The high soil adsorption coefficient (KOC, expressed as logKOC) of >4.2 suggests that any deltamethrin which enters the aquatic environment will move to the sediment.
Danish: Den høje jordadsorptionskoefficient (KOC, udtrykt som logKOC) på > 4,2 tyder på, at eventuel deltamethrin, som kommer i kontakt med vandmiljøet, videreføres til sedimentet.
English: The ERA was complete in terms of data requirements and quality of data.
Danish: Miljørisikovurderingen overholdt fuldt ud betingelserne for datakrav og -kvalitet.
English: This referral under Article 33(4) of Directive 2001/82/EC was made due to concerns that the applicant had not satisfactorily demonstrated the environmental safety of Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle due to lack of pivotal data without which it is not possible to conclude on the environmental safety of the products.
Danish: Denne indbringelsesprocedure i henhold til artikel 33, stk. 4, i direktiv 2001/82/EF blev iværksat som følge af betænkeligheder ved, at ansøgeren ikke i tilstrækkelig grad havde dokumenteret miljøsikkerheden for Deltanil, 10 mg/ml pour-on-opløsning, til kvæg og får samt for Deltanil, 100 mg spot-on-opløsning, til kvæg, idet der manglede afgørende data, uden hvilke det ikke er muligt at drage konklusioner om produkternes miljøsikkerhed.
English: As a result of this referral it was considered that due to the high adsorption coefficient (KOC) of deltamethrin the following environmental information should also be added to the previously agreed warning sentence in the SPC (section 5 Environmental Properties) and the package leaflet (section 15 Environmental Properties) "...and may accumulate in sediment".
Danish: Som et resultat af denne indbringelsesprocedure vurderedes det, at der på grund af deltamethrins høje adsorptionskoefficient (KOC) bør føjes følgende miljøoplysninger til den tidligere godkendte advarselssætning i produktresuméet (afsnit 5 vedrørende miljømæssige egenskaber) og indlægssedlen (afsnit 15 vedrørende miljømæssige egenskaber): "... og kan akkumuleres i sediment".
English: VICH GL38: Guideline on Environmental Impact Assessment for Veterinary Medicinal Products Phase II (CVMP/VICH/790/03)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004393.pdf 3 CVMP Guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines
Danish: VICH GL38: Guideline on Environmental Impact Assessment for Veterinary Medicinal Products Phase II (CVMP/VICH/790/03)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004393.pdf 3 CVMP Guideline on environmental impact assessment for veterinary medicinal products in support of the VICH
English: Potential serious risks were identified during the decentralised procedure by Germany and the Netherlands who considered no acceptable data in the environmental risk assessment has been provided on: n-octanol:water partition coefficient (KOW); soil adsorption coefficient (KOC); soil degradation; bioaccumulation (BCF); toxicity to dung insects, and therefore the environmental risk assessment cannot be finalised.
Danish: Potentielle alvorlige risici blev under den decentrale procedure identificeret af Tyskland og Nederlandene, som vurderede, at der ved miljørisikovurderingen ikke var blevet frembragt acceptable data vedrørende fordelingskoefficienten for n-oktanol/vand (KOW), jordadsorptionskoefficienten (KOC), jordforringelsen, bioakkumuleringen og toksiciteten for gødningsinsekter, hvorfor miljørisikovurderingen ikke kunne afsluttes.
English: Deltamethrin was shown to have a half-life in soil of 72 days based on acceptable published data.
Danish: Deltamethrin viste sig på grundlag af acceptable offentliggjorte data at have en halveringstid i jord på 72 dage.
English: Evaluation of secondary poisoning showed the risk quotient (RQ) values for terrestrial and aquatic predators were <1 and further assessment was not required.
Danish: En evaluering af sekundær forgiftning viste, at værdier for risikokvotient (RQ) for rovdyr på landjorden og i vandmiljøet var <1, og at yderligere vurdering ikke var nødvendig.
English: An ERA was provided for the Deltanil products, which was in accordance with VICH and CVMP guidelines.
Danish: Der var fremlagt en miljørisikovurdering for Deltanil-produkterne, som var i overensstemmelse med VICH- og CVMP-retningslinjerne.
English: Deltamethrin residues will be introduced into the environment following direct excretion onto pasture.
Danish: Miljøet udsættes for deltamethrin-restkoncentrationer som følge af direkte ekskretion på græsarealer.
English: An ERA in accordance with VICH and CVMP guidelines was provided which contained a mixture of published and bespoke studies from the applicant and addressed all aspects of environmental risk.
Danish: Denne indeholdt en blanding af offentliggjorte og af ansøgeren bestilte undersøgelser og omfattede samtlige miljørisikoaspekter.
English: GL6 and GL38 (EMEA/CVMP/ERA/418282/2005)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004386.pdf
Danish: guidelines GL6 and GL38 (EMEA/CVMP/ERA/418282/2005)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004386.pdf gødningsinsekter.
English: 5 Environmental properties
Danish: 5 Miljøoplysninger
English: The benefit of the products is that treatment and prevention of infestations by lice and flies on cattle; ticks, lice, keds and established blowfly strike on sheep and lice and ticks on lambs can be carried out using the products.
Danish: Fordelen ved produkterne er, at de kan anvendes til behandling og forebyggelse af luse- og flueangreb på kvæg, af flåter, lus, fårelus og etablerede spyflue-angreb på får samt af lus og tæger på lam. Deltanils virkning er blevet påvist i henhold til de nugældende regler under den decentrale procedure.
English: A screening for PBT properties as required by the CVMP guidelines indicated that deltamethrin did not fulfil the criteria for either 'P' or 'B' although it is considered to be 'T'.
Danish: En screening for PBT-egenskaber i henhold til CVMP-retningslinjerne påviste, at deltamethrin ikke levede op til kriterierne for hverken persistens eller bioakkumulering, selv om det anses for at være toksisk.
English: Additionally, RMMs have been considered and proposed for the risk identified for dung insects.
Danish: Risikobegrænsningsforanstaltninger blevet desuden taget i betragtning og foreslået for så vidt angår den risiko, der er identificeret for
English: A risk for dung insects was identified by the ERA and RMMs were proposed to address the risk.
Danish: Der blev i miljørisikovurderingen identificeret en risiko for gødningsinsekter, og der blev foreslået risikobegrænsningsforanstaltninger til håndtering af risikoen.
English: Furthermore, appropriate risk mitigation measures (RMMs) were considered missing in the product information as a consequence of the identified unacceptable risk to aquatic organisms.
Danish: Det blev desuden vurderet, at der som konsekvens af den identificerede uacceptable risiko for vandorganismer manglede passende risikobegrænsningsforanstaltninger i produktinformationen.
English: Spot-on solution Cattle
Danish: Spot-on opløsning Kvæg
English: On the basis of the ERA no other RMMs were proposed by the applicant.
Danish: Ansøgeren har på baggrund af miljørisikovurderingen ikke foreslået andre risikobegrænsningsforanstaltninger.
English: Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle contain deltamethrin, a synthetic pyrethroid.
Danish: Deltanil, 10 mg/ml pour-on-opløsning, til kvæg og får samt Deltanil, 100 mg spot-on-opløsning, til kvæg indeholder deltamethrin, et syntetisk pyrethroid.
English: Therefore, the CVMP recommended the granting of the marketing authorisations for Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle with amendment to the Summaries of Product Characteristics and package leaflets of the reference Member State.
Danish: Derfor anbefalede CVMP udstedelse af markedsføringstilladelser for Deltanil, 10 mg/ml pour-onopløsning, til kvæg og får samt Deltanil, 100 mg spot-on-opløsning, til kvæg med ændring af referencemedlemsstaternes produktresuméer og indlægssedler.
English: Based on acceptable published data for sediment species the RQ for sediment was <1.
Danish: RQ for sedimentet var <1 baseret på acceptable offentliggjorte data for sedimentarter.
English: ENVIRONMENTAL PROPERTIES
Danish: MILJØOPLYSNINGER
English: Scientific conclusions and grounds for the granting of the marketing authorisation for Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle
Danish: Videnskabelige konklusioner og begrundelser for udstedelse af markedsføringstilladelse for Deltanil, 10 mg/ml pour-onopløsning, til kvæg og får samt Deltanil, 100 mg spot-onopløsning, til kvæg
English: Overall summary of the scientific evaluation of Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle
Danish: Samlet resumé af den videnskabelige vurdering af Deltanil, 10 mg/ml pour-on-opløsning, til kvæg og får samt Deltanil, 100 mg spot-on-opløsning, til kvæg
English: The benefit-risk balance is considered positive for both Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle.
Danish: Benefit/risk-forholdet anses for at være positivt for både Deltanil, 10 mg/ml pour-on-opløsning, til kvæg og får og Deltanil, 100 mg spot-on-opløsning, til kvæg
English: Grounds for the granting of the marketing authorisations for Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle
Danish: Begrundelser for udstedelse af markedsføringstilladelser for Deltanil, 10 mg/ml pour-on-opløsning, til kvæg og får samt Deltanil, 100 mg spot-on-opløsning, til kvæg
English: Route of administration
Danish: Til udvortes brug
English: Czech Republic Virbac 1'ere Avenue, 2065m - LID 06516 Carros CEDEX FRANCE
Danish: Czech Republic Virbac 1'ere Avenue, 2065m - LID 06516 Carros CEDEX FRANKRIG
English: United Kingdom Virbac 1'ere Avenue, 2065m - LID 06516 Carros CEDEX FRANCE
Danish: United Kingdom Virbac 1'ere Avenue, 2065m - LID 06516 Carros CEDEX FRANKRIG
English: Belgium Virbac 1'ere Avenue, 2065m - LID 06516 Carros CEDEX FRANCE
Danish: Belgium Virbac 1'ere Avenue, 2065m - LID 06516 Carros CEDEX FRANKRIG
English: Luxembourg Virbac 1'ere Avenue, 2065m - LID 06516 Carros CEDEX FRANCE
Danish: Luxembourg Virbac 1'ere Avenue, 2065m - LID 06516 Carros CEDEX FRANKRIG
English: The European Commission granted a marketing authorisation valid throughout the European Union for Halaven on 17 March 2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Halaven den 17. marts 2011.
English: The full EPAR for Halaven can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Halaven findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: ‘Metastatic' means that the cancer has spread to other parts of the body.
Danish: "Metastatisk" betyder, at canceren har bredt sig til andre dele af kroppen.
English: A risk management plan has been developed to ensure that Halaven is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Halaven anvendes så sikkert som muligt.
English: This is a summary of the European public assessment report (EPAR) for Halaven.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Halaven.
English: Safety in this patient population was considered acceptable and similar to that in patients with breast cancer.
Danish: Sikkerheden for denne patientpopulation blev anset for acceptabel og sammenlignelig med situationen for patienter med brystkræft.
English: Other information about Halaven
Danish: Andre oplysninger om Halaven
English: What measures are being taken to ensure the safe and effective use of Halaven?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Halaven?
English: The calculated dose is given into a vein over two to five minutes on days 1 and 8 of each cycle.
Danish: Den beregnede dosis gives i en vene over 2-5 minutter på dag 1 og 8 i hver cyklus.
English: The dose to be given is calculated using the patient's height and weight.
Danish: Dosis afhænger af patientens højde og vægt.
English: What is the risk associated with Halaven?
Danish: Hvilken risiko er der forbundet med Halaven?
English: Why has Halaven been approved?
Danish: Hvorfor blev Halaven godkendt?
English: The CHMP decided that Halaven's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP konkluderede, at fordelene ved Halaven er større end risiciene, og anbefalede udstedelse af en markedsføringstilladelse.
English: Women in the Halaven group lived for an average of 13.1 months, compared with 10.6 months in the group that received other treatments.
Danish: Kvinderne i Halaven-gruppen overlevede i gennemsnit i 13,1 måneder sammenlignet med 10,6 måneder i den gruppe, der modtog andre behandlinger.