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 over navne, farmaceutiske former, veterinærlægemidlernes styrker, dyrearter, Indgivelsesvej, ansøger i medlemsstaterne
English: Therefore, a referral to CVMP under Article 33(4) of Directive 2001/82/EC was made.
Danish: Der blev derfor foretaget en indbringelse for CVMP i medfør af artikel 33, stk. 4, i direktiv 2001/82/EF
English: 5.3 Environmental properties
Danish: 5.3 Miljømæssige forhold
English: The benefit-risk for the product can be considered to be positive.
Danish: Benefit/riskforholdet for produktet vurderes at være positivt.
English: Because eprinomectin is a parasiticide a Phase II assessment according to VICH GL38 was presented
Danish: Da eprinomectin er et parasiticid, blev der forelagt en fase II-vurdering i henhold til VICH GL38 for det
English: Based on available data, the P and T criteria are met and so the remaining B component should be fully assessed.
Danish: På grundlag af de foreliggende data er P- og T-kriterierne opfyldt, og den tilbageværende B-komponent bør vurderes fuldstændigt.
English: In conclusion eprinomectin was not considered to be a PBT compound.
Danish: Som konklusion kunne eprinomectin ikke anses for at være en PBT-forbindelse.
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: Gældende produktresumé, mærkning og indlægsseddel er de endelige versioner, der er fundet frem til under Koordinationsgruppeindsats med følgende ændringer:
English: Eprinomectin fulfils the 'P' criterion as a conclusion from the PBT assessment and has a high adsorption coefficient (KOC).
Danish: Eprinomectin opfylder “P”-kriteriet som konklusion af PBT-vurderingen og har en høj adsorptionskoefficient (KOC).
English: However, Germany considered no acceptable data in the environmental risk assessment has been provided on bioaccumulation in order to assess the B criterion.
Danish: Tyskland fandt imidlertid, at miljørisikovurderingen ikke indeholder acceptable oplysninger om bioakkumulering til vurdering af B-kriteriet.
English: Following treatment, excretion of potentially toxic levels of eprinomectin may take place over a period of several weeks.
Danish: Efter behandling kan der udskilles toksiske niveauer af eprinomectin i en periode af flere uger.
English: Other precautions
Danish: Andre forsigtighedsregler
English: Like other macrocyclic lactones, eprinomectin has the potential to adversely affect non-target organisms.
Danish: Som andre makrocykliske laktoner har eprinomectin potentiale til at påvirke ikke-målarter negativt.
English: The use of the product poses a risk for aquatic organisms in groundwater and surface water as well as for dung fauna.
Danish: Produktets anvendelse udgør en risiko for akvatiske organismer i grundvand og overfladevand samt for gødningsfaunaen.
English: Potential serious risks were identified during the decentralised procedure by Germany who considered that eprinomectin might potentially be a PBT (persistent, bioaccumulative and toxic) substance.
Danish: Under den decentrale procedure konstateredes der potentielle alvorlige risici af Tyskland, som fandt, at eprinomectin kunne være et potentielt PBT-stof (persistent, bioakkumulerende og toksisk).
English: The risk to aquatic ecosystems will be further reduced by keeping treated cattle away from water bodies for two to five weeks after treatment.
Danish: Risikoen for vandholdige økosystemer kan yderligere reduceres ved at holde behandlet kvæg væk fra vandområder 2-5 uger efter behandling.
English: Results from a bioaccumulation study according to OECD guideline 3055 demonstrate that eprinomectin is not likely to concentrate to levels that would pose a risk to aquatic organisms.
Danish: Resultater af en bioakkumuleringsundersøgelse i henhold til OECD's retningslinje 3055 viser, at eprinomectin ikke forventes at blive koncentreret i et omfang, der udgør en risiko for akvatiske organismer.
English: Risk management or mitigation measures
Danish: Foranstaltninger til risikohåndtering eller risikobegrænsning
English: Evaluation of secondary poisoning showed the risk quotient values for terrestrial and aquatic predators were <1 and further assessment was not required.
Danish: Vurderingen af sekundær forgiftning viste, at risikoforholdet for terrestriske og akvatiske rovdyr var <1, og der ikke var behov for yderligere vurdering.
English: Risk assessment
Danish: Risikovurdering
English: The risk to aquatic ecosystems and dung fauna can be reduced by avoiding too frequent and repeated use of eprinomectin (and products of the same anthelmintic class) in cattle.
Danish: Risikoen for vandholdige økosystemer og gødningsfauna kan reduceres ved at undgå hyppig og gentagen brug af eprinomectin (og produkter fra samme anthelmintikaklasse) til kvæg.
English: A screening for PBT properties as required by the CVMP guidelines indicated that eprinomectin fulfils the criteria for 'P' and 'T' but it was considered not to be 'B'.
Danish: En screening for PBT-egenskaber i henhold til CVMP-retningslinjerne viste, at eprinomectin opfylder kriteriet for “P” og “T”, men ikke blev anset for at være “B”.
English: The amended summary of product characteristics and package leaflet of the reference Member State are set out in Annex III.
Danish: Referencemedlemsstatens ændrede produktresumé og indlægsseddel er anført i bilag III.
English: Quality, target animal safety, user safety, residues and resistance were not assessed in this referral procedure, but all risks were addressed during the decentralised procedure.
Danish: Denne henvisningsprocedure omfatter ikke kvalitet, sikkerhed for måldyrearten, brugersikkerhed, restkoncentrationer eller resistens, men alle risici er behandlet ved den decentrale procedure.
English: Eprinomectin has a n-octanol/water partition coefficient (KOW, expressed as log KOW) of 6.5 which was tested in a valid KOW study according to guideline 117 of the Organisation for Economic Co-operation and Development (OECD)4.
Danish: Eprinomectins fordelingskoefficient n-oktanol/vand (KOW, angivet som log KOW) blev bestemt til 6,5 ved en valid KOW-undersøgelse i overensstemmelse med vejledning 117 fra Organisationen for Økonomisk Samarbejde og Udvikling (OECD)4.
English: These characteristics are also addressed in the SPC and the package leaflet with the information "... is persistent in soils and may accumulate in sediments ".
Danish: Disse karakteristika er også taget i betragtning i produktresuméet og indlægssedlen med oplysningen “... er persistent i jord og kan akkumuleres i sedimenter”.
English: Eprinomectin is very toxic to aquatic organisms, is persistent in soils and may accumulate in sediments.
Danish: Eprinomectin er meget giftigt for vandlevende organismer, vedvarende i jord og kan akkumuleres i sedimenter.
English: The benefit of the products is treatment and control of infections from gastrointestinal roundworms (adults and fourth stage larvae), lungworms (adults and fourth stage larvae), warbles (parasitic stages, mange mites, lice and horn flies by using this product.
Danish: Produktets fordele er dets anvendelse til behandling og kontrol af angreb af gastrointestinale rundorm (voksne og larver i fjerde stadium), lungeorm (voksne og larver i fjerde stadium), bremselarver (parasitære stadier), skabmider, lus og stikfluer.
English: Amendments in the relevant sections of the Summary of product characteristics and package leaflet
Danish: Ændringer i de relevante dele af produktresuméet og indlægssedlen
English: The application in question, submitted via the decentralised procedure, is a ‘hybrid' application according to Art. 13(3) of Directive 2001/82/EC, as amended, referring to the reference product Eprinex Pour-On Solution for Beef and Dairy Cattle authorised in the United Kingdom.
Danish: Den omhandlede ansøgning, der er indsendt via den decentrale procedure, er en “hybrid” ansøgning i overensstemmelse med artikel 13, stk. 3, i direktiv 2001/82/EF, som ændret, idet den henviser til et referenceprodukt, Eprinex, pour-on, opløsning, til kødkvæg og malkekvæg, der er godkendt i Det Forenede Kongerige.
English: Pour-on solution Cattle Topical use
Danish: Pour-on opløsning Kvæg Lokal anvendelse
English: Annex III
Danish: Bilag III
English: Based on the fate data of eprinomectin and the outcome of the PBT assessment it was additionally considered to address the persistency in soil.
Danish: På grundlag af eprinomectins skæbne og resultatet af PBT-vurderingen blev det yderligere overvejet at tage stilling til persistens i jord.
English: The deriving bioaccumulation potential and the potential for being considered a PBT compound and secondary poisoning were addressed as required by VICH and CVMP guidelines.
Danish: Det beregnede potentiale for bioakkumulering og potentialet for at blive anset for et PBT-stof og sekundær forgiftning blev behandlet i overensstemmelse med VICH- og CVMP-og retningslinjerne.
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 er rejst i indbringelsesproceduren, har ansøgeren foretaget en miljørisikovurdering i overensstemmelse med VICH-retningslinjerne GL61 og GL382 og i overensstemmelse med Udvalget for Veterinærlægemidlers (CVMP) retningslinjer til støtte for VICHretningslinjerne GL6 og GL38 (EMEA/CVMP/ERA/418282/2005)3.
English: Germany Norbrook Laboratories Limited
Danish: Tyskland Norbrook Laboratories Limited
English: Eprinomectin residues will be introduced into the environment following direct excretion onto pasture.
Danish: Miljøet udsættes for restkoncentrationer af eprinomectin efter direkte ekskretion på græsarealer.
English: SPECIAL WARNINGS
Danish: SÆRLIGE ADVARSLER
English: Valid data on the acute and developmental toxicity of eprinomectin to dung beetle larvae were provided which indicated that risk quotient values for dung insects were >1.
Danish: Der blev forelagt valide data om akut toksicitet og udviklingstoksicitet af eprinomectin over for larver af gødningsbillen, som viste, at risikoforholdet for gødningsinsekter var >1.
English: Having considered all the overall submitted data in writing the CVMP concluded that the ERA for Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle shows that the product is not expected to pose a risk for the environment when used as recommended in the SPC which includes following the recommended RMM.
Danish: Efter at have gennemgået samtlige skriftligt fremlagte data konkluderede CVMP, at miljørisikovurderingen for Norbonex, pour-on, opløsning, 5 mg/ml, til kødkvæg og malkekvæg viser, at produktet ikke forventes at udgøre en risiko for miljøet, når det anvendes som anbefalet i produktinformationen, der indeholder de anbefalede risikobegrænsende foranstaltninger.
English: 4 OECD guidelines for the testing of chemicals, Test No. 117: Partition Coefficient (n octanol/water), HPLC Method: http://www.oecd-ilibrary.org/environment/test-no-117partition-coefficient-n-octanol-water-hplc-method_9789264069824-en OECD guidelines for the testing of chemicals, Test No.305: Bioaccumulation in Fish: Aqueous and Dietary Exposure: http://www.oecdilibrary.org/content/book/9789264185296-en duration of eprinomectin excretion and the keep off from water bodies two to five weeks after treatment.
Danish: 4 OECD guidelines for the testing of chemicals, Test No. 117: Partition Coefficient (n octanol/water), HPLC Method: http://www.oecd-ilibrary.org/environment/test-no-117partition-coefficient-n-octanol-water-hplc-method_9789264069824-en OECD guidelines for the testing of chemicals, Test No.305: Bioaccumulation in Fish: Aqueous and Dietary Exposure: http://www.oecdilibrary.org/content/book/9789264185296-en
English: Consequently in order to mitigate the risk for dung insects RMM were included in the product information.
Danish: For at afbøde risikoen over for gødningsinsekter blev der derfor indsat risikobegrænsende foranstaltninger i produktoplysningerne.
English: Additionally, risk mitigation measures (RMM) have been considered and proposed for the risk identified for dung insects.
Danish: Der blev desuden overvejet og foreslået risikobegrænsende foranstaltninger vedrørende den konstaterede risiko over for gødningsinsekter.
English: Faeces containing eprinomectin excreted onto pasture by treated animals may reduce the abundance of dung feeding organisms which may impact on the dung degradation.
Danish: Fæces indeholdende epinomectin udskilt på marken af behandlede dyr, kan reducere mangfoldigheden af organismer, der lever af afføringen, hvilket kan påvirke nedbrydningen af afføringen.
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 både offentliggjorte og af ansøgeren bestilte undersøgelser og omfattede samtlige miljørisikoaspekter.
English: Strength Pharmaceutical form
Danish: Styrke LÆGEMIDDELFORM Dyrearter Indgivelsesvej
English: Package leaflet:
Danish: Indlægsseddel:
English: Evaluation of the benefit-risk balance
Danish: Vurdering af benefit/risk-forholdet
English: 3 CVMP Guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL38 (EMEA/CVMP/ERA/418282/2005)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC 500004386.pdf for the active ingredient in order to assess the fate of the substance and the effects on organisms that might occur in the environment by the use of the product.
Danish: 3 CVMP guideline on safety and residue data requirements for veterinary medicinal products intended for minor uses or minor species (EMEA/CVMP/SWP/418282/2005)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC 500004581.pdf aktive indholdsstof til vurdering af stoffets skæbne og eventuelle effekter på organismer i miljøet ved anvendelse af produktet.
English: Therefore, the CVMP recommended the granting of the marketing authorisation for Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle with amendment to the summary of product characteristics and package leaflet of the reference Member State.
Danish: CVMP anbefalede derfor udstedelse af markedsføringstilladelse for Norbonex, pour-on, opløsning, 5 mg/ml, til kødkvæg og malkekvæg med ændring af referencemedlemsstatens produktresumé og indlægsseddel.
English: Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle contains eprinomectin, a synthetic avermectin.
Danish: Norbonex, pour-on, opløsning, 5 mg/ml, til kødkvæg og malkekvæg indeholder eprinomectin, der er et syntetisk avermectin.
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/WC 500004393.pdf
Danish: VICH GL48: Guideline on environmental impact assessment (EIAs) for veterinary medicinal products - Phase I http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC 500004394.pdf
English: The ERA was full and complete in terms of data requirements.
Danish: Miljørisikovurderingen overholdt fuldt ud datakravene.
English: An ERA was provided for Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle which was in accordance with VICH and CVMP guidelines.
Danish: Der var forelagt en miljørisikovurdering for Norbonex, pour-on, opløsning, 5 mg/ml, til kødkvæg og malkekvæg, som var i overensstemmelse med VICH- og CVMP-retningslinjerne.
English: Annex I
Danish: Bilag 1
English: Based on the identified risks in the ERA RMM were proposed to address the risk.
Danish: På grundlag af de konstaterede risici i miljørisikovurderingen blev der foreslået risikobegrænsende foranstaltninger.
English: Scientific conclusions and grounds for the granting of the marketing authorisation for Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle
Danish: Videnskabelige konklusioner og begrundelse for udstedelsen af markedsføringstilladelse for Norbonex, pour-on, opløsning, 5 mg/ml, til kødkvæg og malkekvæg
English: The benefit-risk balance is considered positive for Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle.
Danish: Benefit/risk-forholdet anses for at være positivt for Norbonex, pour-on, opløsning, 5 mg/ml, til kødkvæg og malkekvæg.
English: Overall summary of the scientific evaluation of Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle
Danish: Samlet resumé af den videnskabelige vurdering af Norbonex, pour-on, opløsning, 5 mg/ml, til kødkvæg og malkekvæg
English: The RMM and warnings in the summary of product characteristics (SPC) and package leaflet address the risk to dung fauna and aquatic organisms by advising on the frequency of re-treatments, the
Danish: De risikobegrænsende foranstaltninger og advarslerne i produktresuméet og indlægssedlen varetager risikoen for gødningsfaunaen og akvatiske organismer gennem anvisninger om hyppigheden af genbehandling og om udskillelsesvarigheden for eprinomectin og om, at dyrene ikke må have adgang til vandområder i 2-5 uger efter behandlingen.
English: Grounds for the granting of the marketing authorisation for Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle
Danish: Begrundelse for udstedelsen af markedsføringstilladelsen for Norbonex, pour-on, opløsning, 5 mg/ml, til kødkvæg og malkekvæg
English: On the basis of the ERA no other RMMs were proposed by the applicant.
Danish: Ansøgeren har ikke foreslået andre risikobegrænsende foranstaltninger på baggrund af miljørisikovurderingen.
English: MA (EU) Number
Danish: MF (EU)-nummer
English: Strength Pharmaceutical form
Danish: Særnavn Styrke Lægemiddelform Administration Emballage
English: Pack size
Danish: Pakningsstørrelse
English: Contact our press officer Monika Benstetter
Danish: Kontakt vores pressemedarbejder Monika Benstetter
English: GFR should be assessed before initiation of treatment and at least annually thereafter.
Danish: GFR bør bestemmes før påbegyndelse af behandling og mindst én gang om året derefter.
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 12/12/2016.
Danish: CHMP's udtalelse blev fremsendt til Europa-Kommissionen, som traf en endelig juridisk bindende beslutning med gyldighed i alle EU-medlemsstater den 12. december 2016.
English: The review of metformin-containing medicines was initiated on 28 January 2016 at the request of the Netherlands, under Article 31 of Directive 2001/83/EC.
Danish: Gennemgangen af metforminholdige lægemidler blev iværksat den 28. januar 2016 på Nederlandenes foranledning, jf. artikel 31 i direktiv 2001/83/EF.
English: For further information about the centrally authorised medicines, see here.
Danish: Yderligere oplysninger om centralt godkendte lægemidler findes her.
English: The review was carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency's opinion.
Danish: Gennemgangen blev foretaget af Udvalget for Lægemidler til Mennesker (CHMP), som har ansvar for spørgsmål vedrørende lægemidler til mennesker, og som vedtog agenturets endelige udtalelse.
English: Tel. +44 (0)20 3660 8427 E-mail: press@ema.europa.eu
Danish: Tlf. +44 (0) 20 3660 8427 E-mail: press@ema.europa.eu
English: In addition, the combination glibenclamide/metformin (Glucovance) has been nationally authorised.
Danish: Desuden er kombinationen glibenclamid/metformin (Glucovance) godkendt nationalt.
English: • If you have any question or concern about your diabetes treatment or your kidney function level, speak with your doctor, nurse or pharmacist.
Danish: • Hvis du har nogen spørgsmål eller bekymringer om din diabetesbehandling eller din nyrefunktion, skal du kontakte din læge, sygeplejerske eller apotekspersonalet.
English: If you experience severe vomiting, diarrhoea or fever, are exposed to heat, or drink less fluid than normal, you could become dehydrated.
Danish: Hvis du oplever kraftig opkastning, diarré eller feber, er udsat for varme eller drikker mindre væske end normalt, kan du blive dehydreret.
English: • Several fixed-dose combination products containing metformin are available in Europe (see below).
Danish: • Adskillige fastdosis-kombinationsprodukter, der indeholder metformin, kan fås i Europa (se nedenfor).
English: • Dehydration (significant loss of body fluids) increases the risk of developing lactic acidosis.
Danish: • Dehydrering (betydeligt tab af kropsvæsker) øger risikoen for at udvikle laktatacidose.
English: The current product information also varies between countries and products in the EU and is no longer consistent with clinical guidelines.
Danish: Den aktuelle produktinformation er også forskellig fra land til land og fra lægemiddel til lægemiddel i EU og er ikke længere i overensstemmelse med kliniske retningslinjer.
English: Information for patients
Danish: Information til patienter
English: The product information also details risk factors for lactic acidosis which should be reviewed prior to and during treatment.
Danish: Produktinformationen indeholder også oplysninger om risikofaktorer for laktatacidose, der bør gennemgås før og under behandlingen.
English: In these cases, stop taking metformin for a short time and speak with your doctor for further instruction.
Danish: Hvis det sker, skal du kortvarigt holde op med at tage metformin og kontakte din læge med henblik på yderligere vejledning.
English: Medicines containing metformin alone have been authorised nationally in the EU since the 1960s, marketed as Glucophage and other tradenames.
Danish: Lægemidler, der kun indeholder metformin, er blevet godkendt nationalt i EU siden 1960'erne under handelsnavnet Glucophage eller lignende.
English: Recommendations for patients with kidney impairment updated in product information
Danish: Anbefalinger for patienter med nedsat nyrefunktion opdateret i produktinformationen
English: Clear dosing recommendations and monitoring before and during treatment aim to minimise any possible increased risk in these patients.
Danish: Klare doseringsanbefalinger og overvågning før og under behandling skal sikre, at en eventuel øget risiko hos disse patienter minimeres.
English: However, after considering the scientific literature, clinical data, epidemiological studies and clinical guidelines from medical bodies, EMA concluded that the large patient population with moderately reduced kidney function can benefit from use of metformin.
Danish: Efter at have gennemgået den videnskabelige litteratur, kliniske data, epidemiologiske undersøgelser og kliniske retningslinjer fra lægelige instanser er EMA imidlertid nået frem til, at den store patientpopulation med moderat nedsat nyrefunktion kan have gavn af metformin.
English: Companies marketing metformin-containing medicines will be requested to closely monitor and analyse future lactic acidosis cases and report these during upcoming periodic safety reviews in order to follow up on any changes in the frequency of this side effect.
Danish: Virksomheder, der markedsfører metforminholdige lægemidler, vil blive bedt om nøje at overvåge og analysere fremtidige tilfælde af laktatacidose og indberette disse ved kommende periodiske sikkerhedsindberetninger med henblik på at følge op på eventuelle ændringer i hyppigheden af denne bivirkning.
English: The product information for metformincontaining medicines will be updated to reflect the new recommendations and to ensure that the same advice is given to all patients in the EU.
Danish: Produktinformationen for metforminholdige lægemidler vil blive opdateret, så den afspejler de nye anbefalinger, og så det sikres, at alle patienter i EU får den samme vejledning.