FrancophonIA/ELRC3.0 huggingface dataset:
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amended SPC, Labelling and Package Leaflet in Annex III.
Danish: Listen over de pågældende produktnavne fremgår af bilag I. De faglige konklusioner findes i bilag II og det ændrede produktresumé og den ændrede etikettering og indlægsseddel i bilag III.
English: Singulair and associated names, 4mg, chewable tablets and oral granules, is a leukotriene-1 receptor antagonist used for the add-on treatment (concomitantly with inhaled steroids), as alternative monotherapy to low-dose inhaled corticosteroids, and to prevent exercise-induced bronchoconstriction.
Danish: Singulair og tilknyttede navne, 4 mg, tyggetabletter og oralt granulat, er en leukotrien-1-receptorantagonist, der anvendes som tillægsbehandling (samtidig med inhalationssteroider), som alternativ monoterapi til inhalationskortikosteroider i lav dosis og som forebyggelse af anstrengelsesudløst bronkokonstriktion.
English: During its 21 - 24 April 2008 meeting, the CHMP, in the light of the overall submitted data and the scientific discussion within the Committee, was of the opinion that the proposal for the harmonisation of the SPC, Labelling and Package leaflet including the quality aspects was acceptable and that they should be amended.
Danish: På mødet den 21.- 24. april 2008 var CHMP på baggrund af de samlede fremlagte oplysninger og den faglige drøftelse i udvalget af den opfattelse, at forslaget om harmonisering af produktresuméet, etiketteringen og indlægssedlen, herunder de kvalitetsmæssige aspekter, var acceptabelt, og at disse følgelig skulle ændres.
English: The CHMP gave a positive opinion on 24 April 2008 recommending the harmonisation of the SPC, Labelling and Package Leaflet including quality aspects for Singulair and associated names.
Danish: CHMP afgav den 24. april 2008 en positiv udtalelse, hvori udvalget anbefalede harmonisering af produktresumé, etikettering og indlægsseddel, inklusive kvalitetsmæssige aspekter af Singulair og tilknyttede navne.
English: On 13 September 2007, Merck Sharp & Dohme presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, as amended, in order to harmonise the nationally authorised Summaries of Product Characteristics (SPC), Labelling and Package Leaflet including quality aspects of the medicinal product Singulair and associated names.
Danish: Den 13. september 2007 indbragte Merck Sharp & Dohme en sag for EMEA i henhold til artikel 30 i direktiv 2001/83/EF, med ændringer, med henblik på en harmonisering af de nationale produktresuméer, indlægssedler og etiketteringer for lægemidlet Singulair og tilknyttede navne.
English: Member State EU/EEA
Danish: Medlemsstat EU/EØS
English: Therefore, this scenario was not considered for sheep.
Danish: Dette scenarie blev derfor ikke taget i betragtning for får.
English: 2909 LD Capelle a/d IJssel THE NETHERLANDS
Danish: 2909 LD Capelle a/d IJssel NEDERLANDENE
English: Postępu 17 B 02-676 Warszawa POLAND
Danish: Postępu 17 B 02-676 Warszawa POLEN
English: 1123 Budapest HUNGARY
Danish: 1123 Budapest UNGARN
English: This is a likely source of the variation in the observed residue levels.
Danish: Dette er en sandsynlig årsag til variationen i de iagttagne restkoncentrationer.
English: The marketing authorisation holders provided a Phase II environmental risk assessment.
Danish: Indehaverne af markedsføringstilladelse forelagde en fase II-miljørisikovurdering.
English: According to the VICH Guideline 38 Phase II, a Tier B assessment is required.
Danish: I henhold til VICH Guideline 38, fase II, kræves der en niveau B-vurdering.
English: Doramectin is an antiparasitic agent.
Danish: Doramectin er et antiparasitikum.
English: It is a macrocyclic lactone closely related to ivermectin.
Danish: Det er en makrocyklisk lacton, der er nært beslægtet med ivermectin.
English: The figure of 66 days was rounded up to 70 days, to bring it into line with the figure recommended for cattle.
Danish: Antallet 66 dage blev rundet op til 70 dage for at bringe det på linje med det, der anbefales for kvæg.
English: Kennedy L-1855 Luxembourg LUXEMBOURG
Danish: Kennedy L-1855 Luxembourg
English: Via Isonzo, 71 04100 Latina ITALY
Danish: Via Isonzo, 71 04100 Latina ITALIEN
English: The information in some of these products is considered insufficient to mitigate the risk to the environment.
Danish: For visse af disse produkter anses oplysningerne for utilstrækkelige til at afhjælpe miljørisikoen.
English: 811 09 Bratislava SLOVAK REPUBLIC
Danish: 811 09 Bratislava SLOVAKIET
English: Therefore, risk mitigation measures are considered necessary to be included in the product information as specified above.
Danish: Det anses derfor nødvendigt med risikoafhjælpende foranstaltninger, der indsættes i produktinformationen som angivet ovenfor.
English: Amend where applicable:
Danish: Ændres hvor det er relevant:
English: Applicant/marketing authorisation holder
Danish: Ansøger / indehavere avmarkedføringstilladelsen
English: This period was also considered sufficiently conservative for use in reindeer.
Danish: Denne periode blev også anset for tilstrækkeligt restriktiv ved anvendelse hos rensdyr.
English: Several studies in cattle were provided.
Danish: Der blev forelagt flere undersøgelser hos kvæg.
English: Lilly Deutschland GmbH Teichweg 3
Danish: Tyskland Lilly Deutschland GmbH Teichweg 3
English: This conclusion applies to both the pour-on and to the injectable products.
Danish: Denne konklusion gælder både for pour-on- og injektionspræparater.
English: Consumer safety
Danish: Sikkerheden for forbrugerne
English: 13 Rue Pages 92158 Suresnes Cedex FRANCE
Danish: 13 Rue Pages 92158 Suresnes Cedex FRANKRIG
English: Both compounds share a wide spectrum of antiparasitic activity and produce a similar paralysis in nematodes and parasitic arthropods.
Danish: Begge stoffer har et bredt antiparasitært spektrum og frembringer samme form for paralyse hos nematoder og parasitære arthropoder.
English: With regard to pour-on products the information received from Member States indicates that the withdrawal period for cattle meat and offal is 35 days in all Member States (EU/EEA), where the products are authorised or pending authorisations.
Danish: For pour-on-produkter viser oplysningerne fra medlemsstaterne, at tilbageholdelsestiden for kød og indmad fra kvæg er 35 dage i alle de medlemsstater (af EU/EØS), hvor produkterne er godkendt eller ansøgninger om godkendelse er under behandling.
English: As some data in reindeer were available it was considered appropriate to refine this estimate.
Danish: Da der forelå nogle data hos rensdyr, blev det anset for hensigtsmæssigt at forbedre dette skøn.
English: For cattle it was considered that the standard 2 month period between treatment and calving could be accepted.
Danish: For kvæg godkendtes den sædvanlige 2 måneders periode mellem behandling og kælvning.
English: Environmental safety
Danish: Miljøsikkerhed
English: Residue data
Danish: Restkoncentrationsdata
English: Following treatment, excretion of potentially toxic levels of doramectin may take place over a period of several weeks.
Danish: Efter behandling kan udskillelse af potentielt toksiske koncentrationer af doramectin finde sted i en periode på flere uger.
English: However, as reindeer is considered to be a minor species (with cattle being the corresponding major species) the possibility of extrapolating a withdrawal period from cattle was considered appropriate.
Danish: Da rensdyr anses for at være en mindre betydningsfuld dyreart (hvor kvæg er den tilsvarende mere betydningsfulde dyreart), blev det dog anset for hensigtsmæssigt at ekstrapolere en tilbageholdelsestid fra kvæg.
English: The value of 3.44 µg/l was rounded down to 3 µg/l, which was considered to represent a safe doramectin level in milk.
Danish: Værdien 3,44 µg/l blev rundet ned til 3 µg/l, som blev anset for at repræsentere et sikkert indhold af doramectin i mælk.
English: Czech republic Pfizer Limited Veterinary Medical Research & Development
Danish: Rumænien Pfizer Limited Veterinary Medical Research & Development
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, routes of administration, applicants/marketing authorisation holders in the Member States
Danish: Liste over det veterinærlægemidlets navn, lægemiddelform, styrke, dyrearter, indgivelsesveje, tilbageholdelsestider, ansøgere / indehavere avmarkedføringstilladelsen i medlemsstaterne
English: Environmental risk assessment
Danish: Miljørisikovurdering
English: The MRLs currently established for doramectin in tissues use 90% (60 μg/person per day) of the ADI, leaving 10% (6 μg) available to cover exposure to residues resulting from other sources, such as via milk.
Danish: De nuværende maksimalgrænseværdier for restkoncentrationer af doramectin i væv udnytter 90 % (60 μg/person pr. dag) af ADI-værdien, således at der resterer 10 % (6 µg) til at dække eksponering for restkoncentrationer fra andre kilder, såsom gennem mælk.
English: As part of the CVMP evaluation the Committee considered whether further recommendations are necessary in order to ensure that use during the non-lactating period would not lead to residues in milk that, combined with residues from other foodstuffs, would result in consumer exposure exceeding the acceptable daily intake (ADI) (60 μg/person per day).
Danish: Som led i CVMP's vurdering tog udvalget stilling til, om der er behov for yderligere anbefalinger for at sikre, at anvendelse i den ikke-lakterende periode ikke medfører restkoncentrationer i mælk, som sammen med restkoncentrationer fra andre fødevarer medfører, at eksponeringen af forbrugeren overstiger den acceptable daglige indtagelse (ADI) (60 μg/person pr. dag).
English: In terms of bioaccumulation the log Pow value is not considered to be robust given the method employed (shake flask), but nevertheless indicates doramectin being potentially bioaccumulative.
Danish: Log Pow-værdien anses ikke for robust vedrørende bioakkumulering på grund af den anvendte metode (shake flask) men viser, at doramectin er potentielt bioakkumulerende.
English: Add, to all products:
Danish: Tilføj for alle produkter
English: Two studies in sheep were provided.
Danish: Der blev forelagt to undersøgelser hos får.
English: Therefore an evaluation of the withdrawal periods in meat and offal for pour-on products was not necessary.
Danish: Det var derfor ikke nødvendigt at vurdere tilbageholdelsestiderne for kød og indmad for pour-on-produkter.
English: By applying this ratio to milk and using 6 µg as the total amount of doramectin residues that can be considered safe in 1.5 litres of milk (i.e. the amount of milk considered to be consumed on a daily basis), one can calculate the concentration of doramectin in milk that can be considered safe to be 3.44 µg/l (6 µg x 0.86/1.5 l).
Danish: Når dette forhold anvendes på mælk og det forudsættes, at den samlede mængde doramectin-rester på 6 µg, der kan anses for sikker, er indeholdt i et anslået dagligt mælkeforbrug på 1,5 l, kan den koncentration af doramectin i mælk, der anses for sikker, beregnes til 3,44 µg/l (6 µg x 0,86/1,5 l).
English: However, in view of the fact that the study was not performed in line with standards in place today, it was considered that the withdrawal period of 70 days recommended in the 2005 referral procedure under Article 34 of Directive 2001/82/EC for Dectomax 1% injectable solution for cattle and sheep (EMEA/V/A/009) should be maintained.
Danish: Da undersøgelsen ikke var udført efter de nugældende normer, blev det imidlertid vedtaget at opretholde den tilbageholdelsestid på 70 dage, der anbefaledes i 2005-indbringelsesproceduren i medfør af artikel 34 i direktiv 2001/82/EF for Dectomax, injektionsvæske, 1 %, til kvæg og får (EMEA/V/A/009).
English: No studies in lactating or non-lactating doe were provided.
Danish: Der blev ikke forelagt undersøgelser hos lakterende eller ikke-lakterende dyr.
English: Like other macrocyclic lactones, doramectin has the potential to adversely affect non-target organisms.
Danish: Som andre makrocykliske lactoner, har doramectin potentiale til at skade organismer uden for målgruppen.
English: Amend where applicable: WITHDRAWAL PERIOD
Danish: Ændres hvor det er relevant: Tilbageholdelsestid
English: 35396 Gießen GERMANY
Danish: 35396 Gießen
English: Overall summary of the scientific evaluation of all injectable and pour-on veterinary medicinal products containing doramectin that are intended for use in mammalian food producing species (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af alle doramectinholdige veterinære injektionspræparater og pouron-præparater, der er bestemt til anvendelse hos fødevareproducerende pattedyrarter (se bilag I)
English: As indicated above 3 µg/l is considered to represent a safe level of doramectin in milk.
Danish: Som nævnt anses 3 µg/l for at repræsentere et sikkert niveau af doramectin i mælk.
English: This withdrawal period (70 days) is recommended for both doses in sheep (i.e. 200 µg/kg bw and 300 µg/kg bw) approved for intramuscular administration.
Danish: Denne tilbageholdelsestid (70 dage) anbefales for begge af de godkendte doseringer til får (dvs. 200 µg/kg kropsvægt og 300 µg/kg kropsvægt intramuskulært).
English: However, these products have been used during the dry period with different precautionary measures in place to limit residues in milk, in particular instructions are given on the time that must be allowed to elapse between treatment and calving or lambing.
Danish: Disse produkter er imidlertid blevet anvendt i goldperioden med forskellige forsigtighedsforanstaltninger til begrænsning af restkoncentrationerne i mælk, herunder anvisninger for det tidsrum, der skal gå fra behandlingen indtil kælvning eller læmning.
English: For the dung fauna, the results of the Tier A assessment showed a very high RQ indicating an unacceptable acute risk.
Danish: For organismer i gødning viste niveau A-vurderingen et meget højt risikoforhold som tegn på en uacceptabel akut risiko.
English: As no harmonised guidance on how to conduct Tier B assessment studies for dung insects is currently available, risk mitigation measures to reduce exposure are considered to overcome the identified risk.
Danish: Da der ikke findes en harmoniseret vejledning for niveau B-vurdering for insekter i gødning, anses denne risiko for at kunne afhjælpes ved foranstaltninger til mindskelse af eksponeringen.
English: However, the existing warning sentence in the product information (Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving) is considered to be conservative.
Danish: Den eksisterende advarsel i produktinformationen (må ikke anvendes hos mælkeproducerende køer, herunder drægtige kvier, mindre end 60 dage før kælvning) anses imidlertid for at være restriktiv.
English: As a result these studies did not include quality control measures and the accuracy of the injection site sampling is therefore questionable.
Danish: I disse undersøgelser blev der ikke anvendt kvalitetskontrolforanstaltninger, hvilket rejser tvivl om nøjagtigheden af prøvetagningen fra injektionsstedet.
English: In respect to the environmental impact for the use of the solution for injection in sheep the CVMP considered that according to the CVMP guidance, only cattle are concerned with the scenario “direct excretion into surface water”.
Danish: Vedrørende miljøpåvirkningen ved anvendelse af injektionsvæsken til får tog CVMP i betragtning, at scenariet “direkte udskillelse i overfladevand” kun omfatter kvæg i henhold til CVMP's vejledning.
English: In the first case, the risk to aquatic invertebrates could not be ruled out by performing several PEC refinements for the direct excretion scenario.
Danish: I det første tilfælde kunne risiko over for akvatiske hvirvelløse dyr ikke udelukkes gennem udførelse af flere forbedrede PEC-bestemmelser for scenariet med direkte udskillelse.
English: This would yield a withdrawal period of 105 days for reindeer.
Danish: Derved fås en tilbageholdelsestid på 105 dage fra rensdyr.
English: Three residue depletion studies were evaluated by the CVMP.
Danish: CVMP vurderede tre restkoncentrationsundersøgelser.
English: The supplementary data provided did not allow ruling out a medium to long-term risk to dung insects.
Danish: forelagte supplerende data kunne det ikke udelukkes, at der er mellemlangsigtet til langsigtet risiko forinsekter i gødning.
English: However, in view of the fact that sampling of the injection site was not in line with standards in place today and in view of the relatively large extrapolation from the last time point of slaughter (35 days) to the calculated withdrawal period, it was considered appropriate to apply a 30% safety span to the calculated withdrawal period of 60 days.
Danish: På baggrund af, at prøvetagningen fra injektionsstedet ikke fulgte de nugældende normer, og at der var tale om en relativt stor ekstrapolation fra sidste slagtetidspunkt (35 dage) til den beregnede tilbageholdelsestid, blev det imidlertid anset for nødvendigt at tillægge en 30 procents sikkerhedsmargin til den beregnede tilbageholdelsestid på 60 dage.
English: One GLP residue study (1998) in reindeer was available for evaluation by the CVMP but could not be used to determine the withdrawal period as there were only two slaughter time points, the number of animals/group was relatively small and at the last time point one of the injection site samples contained residues above the MRL for muscle (40 μg/kg).
Danish: Der forelå én GLP-restkoncentrationsundersøgelse fra 1998 hos rensdyr, men CVMP kunne ikke anvende den til at fastsætte tilbageholdelsestiden, da der kun var to slagtetidspunkter, antallet af dyr pr. gruppe var relativt lille, og restkoncentrationerne var over maksimalgrænseværdien for muskel (40 µg/kg) i den ene prøve fra injektionsstedet ved sidste prøvetagningstidspunkt.
English: Add, to all products: 4.5 Special precaution for use
Danish: Tilføj for alle produkter 4.5 Særlige forsigtighedsregler vedrørende brugen
English: While no data were available that would allow the establishment of the ratio of marker to total residues for milk, it was considered that the ratio established by CVMP for fat (0.86) could be applied to milk.
Danish: Der forelå ingen data til fastlæggelse af forholdet mellem markører og totale restkoncentrationer for mælk, men det af CVMP beregnede forhold for fedt (0,86) fandtes at kunne anvendes på mælk.
English: Conclusion on the benefit-risk balance
Danish: Konklusion om benefit/risk-forholdet
English: PFIZER HELLAS AE 243 Av Mesogeion 15451, Athens GREECE
Danish: PFIZER HELLAS AE 243 Av Mesogeion 15451, Athens GRÆKENLAND
English: Using the data from a pivotal study with Dectomax Incjectable a withdrawal period of 65 days could be derived.
Danish: På grundlag af én hovedundersøgelse med Dectomax Incjectable kunne der beregnes en tilbageholdelsestid på 65 dage.
English: For the run-off scenario, as the highest PECcattle (0.84 µg/kg) is higher than the highest PECsheep (0.48 µg/kg), the conclusion from the cattle can be extrapolated to sheep.
Danish: For spildscenariet gælder, at den højeste PECværdi for kvæg (0,84 µg/kg) er højere end den højeste PEC-værdi for får (0,48 µg/kg).
English: the CVMP has recommended variations of the marketing authorisations for all injectable and pour-on veterinary medicinal products containing doramectin that are intended for use in mammalian food producing species (see annex I) in order to amend the summaries of product characteristics, labelling and package leaflets in line with recommended changes in the product information as set out in annex III.
Danish: anbefalede CVMP ændring af markedsføringstilladelserne for alle doramectinholdige injektionspræparater og pour-on-præparater, der er bestemt til anvendelse hos fødevareproducerende pattedyr (se bilag I), idet produktresuméerne, etiketteringen og indlægssedlerne ændres i henhold til de anbefalinger, der fremgår af bilag III.
English: Aquatic organisms were considered not at risk from doramectin entering surface water bodies via run-off from use in sheep.
Danish: Der blev ikke fundet risiko for akvatiske organismer ved tilførsel af doramectin til overfladevand gennem spild under anvendelse hos får.
English: The CVMP guideline on safety and residue data requirements for veterinary medicinal products intended for minor uses or minor species (EMEA/CVMP/SWP/66781/2005)3 suggests that, in the absence of any data in the minor species a withdrawal period of 1.5 times that approved for the major species can be considered.
Danish: CVMP's retningslinjer om krav til sikkerhedskrav og restkoncentrationsdata for veterinærlægemidler bestemt til mindre betydningsfuld anvendelse eller mindre betydningsfulde arter (EMEA/CVMP/SWP/66781/2005)3 foreslår, at det i mangel af data for en mindre betydningsfuld art overvejes at godkende en tilbageholdelsestid på 1,5 gange den, der er godkendt for den mere betydningsfulde art.
English: Pfizer Luxembourg SARL 51, Avenue J.F.
Danish: Slovenien Pfizer Luxembourg SARL 51, Avenue J.F.
English: Using the data from the most appropriate study a calculated withdrawal period of 54 days could be derived.
Danish: På grundlag af den bedst egnede undersøgelse kunne der beregnes en tilbageholdelsestid på 54 dage.
English: 4.5 Special precaution for use
Danish: 4.5 Særlige forsigtighedsregler vedrørende brugen Andre forsigtighedsregler
English: From the pivotal study representative of the worst case a withdrawal period of 60 days could be calculated.
Danish: På grundlag af hovedundersøgelsen, der repræsenterer værste tilfælde, kunne der beregnes en tilbageholdelsestid på 60 dage.
English: The Committee therefore calculated a minimum time spans of 2 months for cattle and reindeer and 70 days for sheep that should elapse between administration of these doramectin containing products and calving or lambing.
Danish: Udvalget beregnede derfor, at der skal gå et tidsrum på 2 måneder for kvæg og rensdyr og 70 dage for får mellem administration af disse doramectinholdige produkter og kælvning eller læmning.
English: The available study in reindeer provided residue data at the injection site at 10 days after product administration.
Danish: Den foreliggende undersøgelse hos rensdyr indeholdt restkoncentrationsdata for injektionsstedet 10 dage efter administration af produktet.
English: Meat and offal:
Danish: Kød og indmad:
English: Based on the data available it was considered that the existing warning sentence in the product information (Do not use in dry dairy ewes including pregnant dairy ewes within 70 days prior to lambing) is conservative and gives sufficient assurance in terms of consumer safety following administration at the highest recommended dose of 300 μg/kg bw.
Danish: På grundlag af de foreliggende data fandtes den eksisterende advarselssætning i produktinformationen (må ikke anvendes hos malkefår, herunder drægtige malkefår, inden for 70 dage før læmning) at være restriktiv og at give tilstrækkelig sikkerhed for forbrugerne efter administration af den højeste anbefalede dosis på 300 µg/kg kropsvægt.
English: Based on these data it was considered that a time span of 2 months between treatment and calving in non-lactating cattle would ensure safe residue levels in milk following administration of injectable products containing doramectin at the recommended dose.
Danish: På grundlag heraf fandtes det, at et tidsrum på 2 måneder mellem behandling og kælvning hos ikke-lakterende kvæg ville indebære et sikkert niveau af restkoncentrationer i mælk efter administration af injektionspræparater indeholdende doramectin i den anbefalede dosis.
English: Special warnings
Danish: SÆRLIGE ADVARSLER
English: Benefit-Risk Assessment
Danish: Benefit/risk-vurdering