natgillin/translations-raw huggingface dataset:
Hvis den eksisterende beskrivelse ikke anses for fyldestgørende, skal der forelægges en revideret tekst.
If the existing advice is not considered sufficient a proposal for revised text should be submitted.
I: Association of Exotic Mammal Veterinarians (AEMV) Sessions, Preceedings, 2006
In: Association of Exotic Mammal Veterinarians (AEMV) Sessions, Preceedings, 2006
Forebyggelse og behandling af luftvejssygdom
Prevention and treatment of respiratory disease
Betingelsen for markedsføringstilladelserne fremgår af bilag IV.
The condition of the Marketing Authorisations is described in Annex IV.
Medlemssta t EU/EØS
Member State EU/EEA
A-4600 Wels ØSTRIG
A-4600 Wels AUSTRIA
Tilberedningen og pelleteringen blev beskrevet.
The conditioning and pelleting were described.
Under den foregående henvisningsprocedure i henhold til artikel 34 i direktiv 2001/82/EF (EMEA/V/A/037)
During the previous referral procedure under Article 34 of Directive 2001/82/EC (EMEA/V/A/037)
Resultaterne af undersøgelserne forelægges for de relevante myndigheder senest 12 måneder efter Kommissionens afgørelse vedrørende denne henvisningsprocedure.
The results of those studies should be provided to the relevant authorities for assessment not later than 12 months after the Commission Decision on this referral procedure.
Data til støtte for den anbefalede dosis
Supporting data for the recommended dose
20041 Agrate Brianza (MB) ITALIEN
20041 Agrate Brianza (MB) ITALY
De nationale kompetente myndigheder sikrer, med referencemedlemsstaten som koordinerende instans, hvor dette er relevant, at indehaverne af markedsføringstilladelserne opfylder følgende betingelser:
National Competent Authorities, coordinated by the Reference Member State as applicable, should ensure that following conditions are fulfilled by the marketing authorisation holders:
Disse højere værdier kræver nærmere gennemgang, da de medfører højere dosis end den tilsigtede.
These higher values require further consideration as they would lead to higher than target dose.
Indehaveren af markedsføringstilladelsen blev anmodet om at indsende følgende:
The marketing authorisation holders were requested to provide the following:
Stabilitetsundersøgelserne viste, at der efter 3 måneder ikke var væsentlige ændringer i udseende eller tørringstab.
According to stability results, after 3 months no significant change was observed for appearance and loss on drying.
Det skal godtgøres, at dette krav opfyldes af alle pakningsstørrelser for alle styrker.
Confirmation should be provided that this requirement will be fulfilled by all of the pack sizes for all the different strengths.
En kanin på 1,5 kg kan således gennemsnitligt indtage 180 g foder dagligt.
Thus, one rabbit of 1.5 kg can consume in average 180 g of feed per day.
Liste over veterinærlægemidlernes navne, lægemiddelformer, aktive indholdsstof, styrker, måldyrearter og indehavere af markedsføringstilladelse i medlemsstaterne
List of the names, pharmaceutical forms, active substance, strengths of the veterinary medicinal products, animal species, marketing authorisation holders in the Member States
For at opnå korrekt dosering skal koncentrationen af tilmicosin justeres i henhold dertil.
In order to obtain a correct dosage the concentration of tilmicosin has to be adjusted accordingly.
De farmakokinetiske parametre bekræfter den effektive dosis af tilmicosin.
The pharmacokinetic parameters confirm the effective dose of tilmicosin.
Syge dyr indtager mindre, 100 g dagligt er acceptabelt.
Sick animals hereby consume less, being acceptable at 100 g per day.
Der blev påvist homogenitet, idet variationskoefficienten var under 5 % i alle
Homogeneity was demonstrated as the coefficient of variation was less than 5 % in all the cases tested.
Tyskland Lilly Deutschland GmbHAbt.
Germany Lilly Deutschland GmbHAbt.
Spanien ELANCO VALQUÍMICA, S.A. Avda.
ELANCO VALQUÍMICA, S.A. Avda.
Betingelser for markedsføringstilladelserne
Conditions of the marketing authorisation
Den indtagne mængde medicineret foder afhænger af dyrets kliniske tilstand.
The uptake of medicated feed depends on the clinical condition of the animals.
Der er ifølge det oplyste ikke tilsat overskud i formuleringen, og ingen begrundelse er fundet for disse resultater, som falder uden for det iagttagne normalområde i andre undersøgelser af foderet.
Even though it was confirmed that no overage was used in the formulation, no justification was found for those results and it was considered that the results do not fall into the normal range observed in other feed studies.
Indehaverne af markedsføringstilladelserne oplyste, at der anvendes fuldfoder til fødevareproducerende kaniner.
The marketing authorisation holders reported that the administration of feed to the food producing rabbits is via complete feedingstuff.
3991 RA Houten NEDERLANDENE
3991 RA Houten
Diskussionen skal underbygges med passende data, der viser, at betingelserne under pelletering er hensigtsmæssige og ikke forringer den godkendte opbevaringstid af det medicinerede foder (1 måned).
This discussion should be supported with the appropriate data, i.e. data confirming the pelleting conditions suitability and demonstrating that these conditions do not affect the shelf-life granted for the medicated feedingstuff (1 month).
Frankrig SOGEVAL 200 Route de Mayenne Zi des Touches 53000 Laval
200 Route de Mayenne Zi des Touches 53000 Laval FRANCE
Som anført i CVMP's vejledning (EMEA/CVMP/080/95) skal der gives en beskrivelse af, hvordan premixen skal tilsættes foderet.
As outlined in the CVMP's Note for guidance (EMEA/CVMP/080/95) a description should be provided of how the pre-mix is to be incorporated into the feedingstuff.
Dette støttedes af yderligere forelagte data, som ikke viste tilsvarende problemer for batcher i pilotskala.
This was further supported considering further data provided in which no such problems were presented thus far with pilot scale batches.
D-61352 Bad Homburg TYSKLAND
D-61352 Bad Homburg GERMANY
Det blev anset for velbegrundet kun at teste én styrke, da koncentrationen af tilmicosin i det endelige medicinerede foder i alle tilfælde ville være 200 ppm, eftersom homogeniteten af de andre medicinerede premixer var tilfredsstillende godtgjort.
The testing of only one strength was considered valid because the concentration of tilmicosin in the final medicated feeding stuffs would be 200 ppm in all cases, as the homogenicity of the other medicated premixes was sufficiently justified.
kg premix/ton foder = Dosis (mg/kg kropsvægt) x kropsvægt (kg) Dagligt indtag af foder (kg) x styrke af premix (g/kg)
kg pre-mix/ton feed = Dose rate (mg/kg bodyweight) x bodyweight (kg) Daily feed intake (kg) x pre-mix strength (g/kg)
Dette anses for acceptabelt, da der opnås homogenitet af medicineret foder med lave koncentrationer af medicineret premix.
This was considered acceptable, as homogeneity of medicated feedingstuffs is reached with low concentrations of medicated pre-mixes.
CVMP's udtalelse efter en artikel 34-indbringelse vedrørende Pulmotil 40 VET Premix, Pulmotil 100 VET Premix, Pulmotil 200 VET Premix og relaterede navne (2009)http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/Pulmotil_Premix_34/WC500036654 .pdf
CVMP opinion following an Article 34 referral on Pulmotil 40 VET Premix, Pulmotil 100 VET Premix, Pulmotil 200 VET Premix and associated names (2009)http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/Pulmotil_Premix_34/WC500036654 .pdf
Danmark Elanco Animal Health Eli Lilly Danmark A/S Nybrovej 110
Denmark Elanco Animal Health Eli Lilly Danmark A/S Nybrovej 110
Denne beskrivelse, der gives i produktinformationen, skal være ledsaget af en diskussion af, om dette er i overensstemmelse med CVMP's vejledning (EMEA/CVMP/080/95).
The relevant advice given in the product literature should be provided along with a discussion of whether this is in line with CVMP's Note for guidance (EMEA/CVMP/080/95).
Opbevaringstid efter iblanding i foder eller pelleteret foder: 3 måneder
Shelf life after incorporation into meal or pelleted feed: 3 months
Der blev ikke forelagt data om tilsætning for tilmicosin 40 g premix.
No data on incorporation were provided for Tilmicosin 40 g pre-mix.
1, at den daglige dosis af den medicinerede premix skal være fordelt i mindst halvdelen af det behandlede dyrs daglige foderration.
states that the daily dose of the medicated pre-mix must be contained in at least half the daily ration of the animals under treatment.
Om måldyreartens ædeadfærd vides, at kaniner æder hyppigt (2-8 g foder i løbet af 4-6 minutter op til 30 gange dagligt)
Regarding the target species feeding behaviour, it is known that rabbits feed frequently (up to 30 times per day of 2-8 g of feed over 4-6 minute periods
Bemærkning: I nedenstående gælder tekst med grå skygge ikke for MICLOZAN 200 premix (se bilag I til udtalelsen)
Note: The text in grey shading below is not applicable for MICLOZAN 200 premix (see Annex I of the opinion)
Denne dosis bør opretholdes ved korrekt iblanding af medicineret premix med forskellig koncentration i foderet.
This dose should be maintained by a proper mixing of medicated pre-mixes of different concentrations into feedingstuffs.
Tyskland Lilly Deutschland GmbH Abt. Elanco Animal Health Werner-Reimers-Str. 2-4
Germany Lilly Deutschland GmbH Abt. Elanco Animal Health Werner-Reimers-Str. 2-4
Der blev kun anvendt medicineret kaninfoder tilberedt med tilmicosin 100 g premix.
Only medicated rabbit feed prepared with tilmicosin 100 g pre-mix was used.
For at sikre grundig opblanding af produktet skal dette først opblandes i en passende mængde foder (20-50 kg), før det iblandes i det færdige foder.
“To ensure through dispersion of the product, it should first be mixed with a suitable quantity of feed ingredients (20 - 50 kg) before incorporation into the finished feed.
4.9 Dosering og indgivelsesvej:
4.9 Amounts to be administered and administration route:
Holdbarheden af pellets blev vurderet ved undersøgelse af ændringen i koncentrationen af tilmicosin gennem 12 uger ved 25 °C og 60 % relativ fugtighed (RH) samt ved 40 °C og 70 % RH.
Pellet storage stability was evaluated by examining the difference in the level of tilmicosin assay over a 12 week period at 25 °C/60% relative humidity (RH) and 40 °C/70% RH.
Bemærkning: I nedenstående gælder tekst med grå skygge ikke for MICLOZAN 200 premix (se bilag I):
Note: The text in grey shading below is not applicable for MICLOZAN 200 pre-mix (see Annex I):
De høje koncentrationer af tilmicosin i det medicinerede foder inden pelletering kræver nærmere afklaring.
The high values of tilmicosin in the medicated feed prior to the pelleting process need further explanation.
Videnskabelige konklusioner og begrundelse for ændringen af produktresuméet og etiketteringen
Scientific conclusions and grounds for amendment of the Summary of Product Characteristics and labelling
Det fremgår af CVMP's “Note for guidance on additional quality requirements for products intended for incorporation into animal feedingstuffs (medicated pre-mixes) (EMEA/CVMP/080/95)”
The CVMP's Note for guidance on additional quality requirements for products intended for incorporation into animal feedingstuffs (medicated pre-mixes) (EMEA/CVMP/080/95)
Opbevaringstid efter iblanding i pelleteret foder indeholdende mere end 30 % hvede: 1 måned
Shelf life after incorporation into pelleted feed containing more than 30% wheat: 1 month
CVMP anmoder derfor om, at der udføres stabilitetsundersøgelser vedrørende forbehandling og pelletering på 3 batcher medicineret kaninfoder for at fastslå, om de høje koncentrationer af tilmicosin er typiske (se bilag IV).
The CVMP therefore requests that conditioning/pelleting stability studies with three batches of medicated rabbit feeds are carried out in order to confirm whether or not the high tilmiscosin valuies are typical results (see Annex IV).
Den 8. april 2011 indledte Europa-Kommissionen en indbringelse i henhold til artikel 35 i direktiv 2001/82/EF, som ændret, for alle premixer, der anvendes til fremstilling af medicineret foder til kaniner og indeholder 40, 100 eller 200 g tilmicosin pr. kg premix.
On 8 April 2011, the European Commission initiated a referral under Article 35 of Directive 2001/82/EC, as amended, for all pre-mixes for medicated feedingstuff containing 40, 100 or 200 g tilmicosin per kg pre-mix and administered to rabbits.
For tilmicosin 40 g premix ville iblandingsforholdet for foderet være 5 kg pr. ton (jf. kravet i Ph.Eur.monografien om premix til medicineret foder til veterinær anvendelse).
The incorporation rate of Tilmicosin 40 g pre-mix in the feed would be 5 kg per ton (the requirement of the European Pharmacopoeia monograph on pre-mixes for medicated feedingstuffs for veterinary use).
I en undersøgelse af homogeniteten af en 200 g premix blev der anvendt to forskellige batcher af 200 g premix til fremstilling af fire prøvebatcher medicineret foder (2 batcher fodergranulat og 2 batcher pelleteret foder).
In a study provided on the homogeneity of a 200 g pre-mix two different batches of 200 g premix were used to prepare 4 pilot batches of medicated feedingstuff (2 batches of crumble feed and 2 batches of pelleted feed).
Da produktinformationen er fælles for svin og kaniner, ansås det for acceptabelt med en opbevaringstid på en måned efter iblanding i pelleteret foder indeholdende mere end 30 % hvede.
As the product information is common for pigs and rabbits, the one month shelf life after incorporation into pelleted feed containing more than 30% wheat was considered acceptable.
Ved sammenligning af indholdet af tilmicosin i foderet fra undersøgelsen af blandingshomogenitet (dvs. før pelletering) med indholdet af tilmicosin i det pelleterede foder sås et betydeligt fald i indholdet af tilmicosin, der dog var inden for det fastsatte acceptområde på ± 15 %.
When comparing tilmicosin content in the meal feeds during the mixing uniformity test (i.e. prior to pelleting) versus tilmicosin content of the pelleted feeds, a significant decrease in tilmicosin content was observed, although that decrease was within the ± 15% preset acceptance range.
Ved iblanding i foderet er koncentrationerne 10-13 % højere end den forventede nominelle koncentration på 200 mg/kg.
Regarding meal feeds, concentrations are 10 - 13% higher than the expected nominal concentration of 200 mg/kg.
På baggrund af beskaffenheden af det kaninfoder, der anvendes til fremstilling af pelleteret medicineret foder, konkluderedes det, at indholdet af korn i kommercielt foder til opfedning af kaniner maksimalt må være 30 % (tilsætning af 30 % hvedemel er ikke hensigtsmæssig på grund af risiko for svære tarmproblemer).
Taking into account the characteristics of a rabbit feed used to prepare pelleted medicated feedingstuffs, it was concluded that the maximum limit of cereal meals that can be used in commercial feedingstuffs for fattening rabbits should be less than 30% (the inclusion of 30% of wheat meal is not appropriate due to the risk of triggering severe enteric problems).
Dosis af tilmicosin Behandlingsvarighed Mængde, der skal tilsættes foderet
Dose of tilmicosin Duration of treatment Inclusion rate in feed
Ændringer i de relevante afsnit af etiketteringen
Amendments in the relevant sections of the labelling
Det bemærkedes, at der var et fald i indholdet af tilmicosin for medicineret pelleteret svinefoder med et indhold af hvede på over 30 %.
Decrease on tilmicosin content for swine medicated pelleted feeds containing more than 30% wheat was noted.
Koncentrationerne er således 10-13 % over den nominelle koncentration på 200 mg/kg.
Concentrations are 10 - 13% higher than the expected nominal concentration of 200 mg/kg.
Uanset den uforklarede høje koncentration i foderet fandt udvalget, at hvis kaninfoder formuleres korrekt med en koncentration på 200 ppm (i stedet for de beskrevne høje værdier), må indholdet af tilmicosin i det pelleteret foder forventes at være inden for det specificerede område på ±15 % af den nominelle værdi.
Regardless of the unexplained high meal assay results, it has been considered that if rabbit feed meal was correctly formulated with a concentration of 200 ppm (instead of the high values reported) it would be expected that the tilmicosin content in the pelleted feed would still be within the specification range of ±15 % of nominal value.
Oral anvendelse af tilmicosin hos kaniner i en dosering på 12,5 mg/kg legemsvægt/dag i 7 dage viste, at koncentrationen i lungevævet og i makrofagerne i lungealveolerne fra den anden behandlingsdag var henholdsvis 7 og 400 gange højere end i plasma, og at der vedvarende var høje koncentrationer i hele behandlingsperioden.
The use of tilmicosin in rabbits orally at 12.5 mg/kg bw/day for 7 days showed that from the second day of treatment, tilmicosin concentrations attained in lung tissue and pulmonary alveolar macrophages exceeded those in plasma by 7 and 400 fold, respectively, and high levels were maintained in lung tissues during the entire treatment duration.
Mens homogeniteten fandtes tilfredsstillende godtgjort, kræves der en forklaring på disse resultater, da koncentrationen i det foder, der gives til dyrene, vil være over målværdien på 200 ppm.
Whilst the demonstration of homogeneity was considered acceptable, the higher than expected values need explanation, taking into account that if those meal feeds were administered to animals, the concentration in those feeds would be higher than the target dose of 200 ppm.
Da det er uhensigtsmæssigt at tilsætte 30 % hvedemel til medicinerede pelleteret kaninfoder, fandtes iblanding i foderet ved en arbejdsdelingsprocedure ikke ville medføre problemer i form af begrænset opbevaringstid, da dette tilfælde ikke forventes at opstå for kaniner.
Consequently, since the inclusion of 30% of wheat meal in medicated pelleted feed in rabbits would not be appropriate, it was considered that there would be no problem with the restriction on the shelf life after incorporation into meal adopted through a worksharing procedure because that case was not expected to be presented in rabbit.
Ved vurderingen er der fundet en risiko i form af højt indhold af tilmicosin i foderet før tilberedning/pelletering, uden at der er givet en forklaring på dette forhold.
A risk has been identified on the assessment due to the high values of tilmicosin content in the meal feed prior to the conditioning/pelleting process and no explanation has been provided
Den godkendte dosering er 12,5 mg/kg kropsvægt/dag i 7 dage, hvilket opnås ved tilsætning af tilmicosin i et forhold på 200 g pr. ton færdigt foder (svarende til 200 ppm).
The approved dose is 12.5 mg/kg bw/day for 7 days, which is achieved by incorporating tilmicosin at a rate of 200 g per ton of finished feed (equivalent to 200 ppm).
Da resultaterne af stabilitetsundersøgelsen af medicineret pelleteret kaninfoder var de samme som for medicineret pelleteret svinefoder, kunne udvalget godkende en opbevaringstid på tre måneder efter tilsætning til foderet.
Taking into account that stability results on medicated pelleted rabbit feeds were similar to those obtained for medicated pelleted pig feeds, a shelf life period of 3 months after incorporation into feeding stuffs was considered acceptable.
12,5 mg/kg kropsvægt/dag
12.5 mg/kg bodyweight/day
anbefalede CVMP ændring af markedsføringstilladelserne for alle premixer, der er bestemt til medicineret foder til kaniner og indeholder 40, 100 eller 200 g tilmicosin pr. kg premix (se bilag I), idet produktresuméet og etiketteringen ændres i overensstemmelse med de anbefalede ændringer, som fremgår af bilag III.
The CVMP has recommended variations of the Marketing Authorisation for all the pre-mixes for medicated feedingstuff containing 40, 100 or 200 g tilmicosin per kg pre-mix and administered to rabbits (see Annex I) in order to amend the Summary of Product Characteristics and labelling in line with recommended changes in the product information as set out in Annex III.
De anvendte foderblandere har en gennemsnitskapacitet på 3-5 tons, en størrelse, der også anvendes til produktion af det medicinerede fuldfoder til kaniner.
The average size of a feed mixer can vary from 3 to 5 tons and complete medicated rabbit feedingstuff is produced in the same size mixers.
På grundlag af det oplyste anses det for muligt at opnå målværdien på 200 g tilmicosin pr. ton pelleteret kaninfoder (200 ppm) ved at anvende det korrekte iblandingsforhold for tilmicosin 40 g premix, tilmicosin 100 g premix og tilmicosin 200 g premix og med alle de nævnte pakningsstørrelser.
Taking into account the information provided, it is considered that the target of 200 g of tilmicosin per ton of rabbit pelleted feed (200 ppm) could be achieved with the appropriate inclusion rate of the tilmicosin 40 g pre-mix, tilmicosin 100 g pre-mix and tilmicosin 200 g pre-mix, and with all of the pack sizes mentioned.
For foderet var gennemsnitsindholdet ikke inden for området 90-110 % af det nominelle indhold (180220 ppm).
Regarding meal feeds, mean content was not in the range of 90-110% of the nominal content (180220 ppm), since concentration values were higher than the expected nominal concentration of 200 ppm ± 10% (values rate between 198.1 - 243.6 ppm).
Gives i foderet i en mængde af tilmicosin 12,5 mg/kg kropsvægt/dag (svarende til 200 ppm i foderet) i 7 dage.
Administer in the feed at 12.5 mg/kg bodyweight/day of tilmicosin (equivalent to 200 ppm in the feed) for 7 days.
Frankrig QALIAN 34 Rue Jean Monnet Zi D'Etriche
34 Rue Jean Monnet Zi D'Etriche 49500 Serge FRANCE
Samlet resumé af den videnskabelige vurdering af alle premixer, der er bestemt til medicineret foder til kaniner og indeholder 40, 100 eller 200 g tilmicosin pr. kg premix (se bilag I)
Overall summary of the scientific evaluation of all pre-mixes for medicated feedingstuff containing 40, 100 or 200 g tilmicosin per kg pre-mix and administered to rabbits (see Annex I)
Desuden tog udvalget hensyn til produkternes tidligere anvendelse og de forskellige foranstaltninger vedrørende anvendelsen, der nu beskrives i det harmoniserede produktresumé (bakteriologiske prøver og følsomhedsbestemmelse anbefales).
The CVMP also considered that rabbits are minor species, with specific problems concerning availability of authorised veterinary products for this species and considered the history of use and the various management steps now set out in the harmonised SPC (bacteriological sampling and susceptibility testing are recommended).
Desuden er de indiceret til forebyggelse og behandling af luftvejssygdom hos kaniner forårsaget af tilmicosin-følsomme stammer af Pasteurella multocida og Bordetella bronchiseptica.
Additionally, these veterinary medicinal products are indicated in rabbits for the prevention and treatment of respiratory disease caused by Pasteurella multocida and Bordetella bronchiseptica, susceptible to tilmicosin.
• CVMP tog i betragtning, at der er målt høje koncentrationer af tilmicosin i kaninfoderet inden forbehandling og pelletering,
• the CVMP considered that high values of tilmicosin content in the meal rabbit feed have been observed prior to the conditioning/pelleting process.
Konklusioner om benefit/risk-forholdet
Conclusion on the benefit-risk balance
Rumænien Eli Lilly Regional Operations GmbH
Romania Eli Lilly Regional Operations GmbH
Nederlande ne
THE NETHERLANDS
Vurdering af fordele
Benefit Assessment
I besvarelsen af CVMP's spørgsmål henvistes til den farmakokinetiske/farmakodynamiske undersøgelse og MIC-værdierne som støtte for anvendelsen ved luftvejssygdom hos kaniner i en dosis på 12.5 mg/kg kropsvægt/dag i 7 dage (tidligere forelagt).
The pharmakokinetic/pharmacodynamic study and MIC data to support use in respiratory disease in rabbits at dose of 12.5 mg/kg bw/day for 7 days (submitted previously) were referenced in the answers to the CVMP list of questions and were found to be acceptable.
Ændringer i de relevante afsnit af produktresuméet og etiketteringen
Amendments in the relevant sections of the Summary of Product Characteristics and labelling
Ændringer i de relevante afsnit af produktresuméet
Amendments in the relevant sections of the Summary of Product Characteristics