natgillin/translations-raw huggingface dataset:
Behandling af hud- og sårinfektioner forårsaget af enrofloxacin-følsomme stammer af Staphylococcus aureus.
Treatment of skin and wound infections caused by enrofloxacin susceptible strains of: Staphylococcus aureus.
Kvæg, svin, geder, får, hunde
Cattle, pigs, goats, sheep, dogs
Behandling af urinvejsinfektioner forårsaget af enrofloxacinfølsomme stammer af Escherichia coli.
Treatment of infections of the urinary tract caused by enrofloxacin susceptible strains of Escherichia coli.
1 ml/5 kg kropsvægt en gang dagligt ved subkutan injektion i op til 5 dage.
5 mg of enrofloxacin/kg body weight (bw), corresponding to 1 ml/5 kg bw, once daily by subcutaneous injection for up to 5 days.
Smågrise (styrken 25 mg/ml)
Piglets (25 mg/ml strength)
Svin, kvæg, hunde, katte
Pigs, cattle, dogs, cats
Katte, kvæg, hunde, svin
Cats, cattle, dogs, Pigs
- Dosering: 5 mg/kg kropsvægt intramuskulært én gang dagligt i 3 dage.
- Dosage: 5 mg/kg bw, once daily for 3 days by intramuscular injection.
- Dosering til gnavere: 10 mg/kg kropsvægt subkutant én gang dagligt i 5-10 på hinanden følgende dage.
- Dosage for rodents: 10 mg/kg bw, once daily by subcutaneous injection for 5-10 consecutive days
0,4 ml/kg kropsvægt en gang dagligt ved subkutan injektion 510 dage i træk.
10 mg/kg bw, corresponding to 0.4 ml/kg bw, once daily by subcutaneous injection for 5 to 10 consecutive days.
Kvæg, hunde, svin
Cattle, dogs, pigs
Kalve, svin, fjerkræ, hunde, katte
Calves, pigs, poultry dogs, cats
Slagtning: 6 døgn
Meat and offal: 6 days.
Behandling af septikæmi forårsaget af enrofloxacin-følsomme stammer af E.coli.
Treatment of septicaemia caused by enrofloxacin susceptible strains of E. coli.
- Dosering: 5 mg/kg kropsvægt subkutant én gang dagligt i 3 dage.
- Dosage: 5 mg/kg bw, once daily for 3 days by subcutaneous administration.
Behandling af infektioner i fordøjelseskanal, luft- og urinveje (inklusiv prostatitis, støttende antibiotikabehandling ved pyometra), hud- og sårinfektioner, otitis (externa/media) forårsaget af enrofloxacinfølsomme stammer af Staphylococcus spp., Escherichia coli, Pasteurella spp., Klebsiella spp., Bordetella spp., Pseudomonas spp.
Treatment of infections of the alimentary, respiratory and urogenital tracts (including prostatitis, adjunctive antibiotic therapy for pyometra), skin and wound infections, otitis (externa/media) caused by enrofloxacin susceptible strains of Staphylococcus spp., Escherichia coli, Pasteurella spp., Klebsiella spp., Bordetella spp., Pseudomonas spp.
Kvæg, svin, hunde, får, geder
Cattle, pigs, dogs, sheep, goats
Kvæg, får, svin, hunde
Cattle, sheep, pigs, dogs
9 CVMP guideline on safety and residue data requirements for veterinary medicinal products intended for minor uses or minor species (EMEA/CVMP/SWP/66781/2005)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004581.pdf
9 CVMP guideline on safety and residue data requirements for veterinary medicinal products intended for minor uses or minor species (EMEA/CVMP/SWP/66781/2005)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004581.pdf span of 20% to compensate for deficiencies in the study results in a withdrawal period of 6 days recommended for rabbit meat and offal for animals treated at the recommended dose of 10 mg/kg bw with the 25 mg/ml strength by subcutaneous injection.
Bulgarien Bayer Animal Health GmbH Kaiser-Wilhelm-Allee 50
Sweden Bayer Animal Health GmbH Kaiser-Wilhelm-Allee 50
Kvæg, svin, får, geder
Cattle, pigs, sheep, goats
Kvæg, får, geder, svin, hunde
Cattle, sheep, goats, pigs, dogs
- Dosering: 5 mg/kg kropsvægt én gang dagligt i 5 dage.
- Dosage: 5 mg/kg bw, once daily for 5 days
2 ml/5 kg kropsvægt en gang dagligt ved subkutan injektion 510 dage i træk.
10 mg/kg bw, corresponding to 2 ml/5 kg bw, once daily by subcutaneous injection for 5 to 10 consecutive days.
Hunde, katte burfugle, krybdyr
Dogs, cats, cage birds, reptiles
0,5 ml/20 kg kropsvægt en gang dagligt ved intramuskulær injektion i 3 dage.
2.5 mg of enrofloxacin/kg bw, corresponding to 0.5 ml/20 kg bw, once daily by intramuscular injection for 3 days.
For E. coli blev der udført en PK/PD-undersøgelse ved den ansøgte dosis.
- Dosage: 5 mg/kg bw, once daily for two consecutive days Regarding E. coli, a PK/PD study was conducted at the proposed dose.
0,2-0,4 ml/kg kropsvægt en gang dagligt ved intramuskulær injektion 5 dage i træk.
5-10 mg/kg bw, corresponding to 0.2-0.4 ml/kg bw, once daily by intramuscular injection for 5 consecutive days.
Behandling af infektioner i fordøjelseskanal, luft- og urinveje (støttende antibiotikabehandling ved pyometra), hud- og sårinfektioner forårsaget af enrofloxacinfølsomme stammer af eksempelvis: Staphylococcus spp., Escherichia coli, Pasteurella spp., Klebsiella spp., Bordetella spp., Pseudomonas spp.
Treatment of infections of the alimentary, respiratory and urogenital tracts (as adjunctive antibiotic therapy for pyometra), skin and wound infections, caused by enrofloxacin susceptible strains of, e.g.: Staphylococcus spp., Escherichia coli, Pasteurella spp., Klebsiella spp., Bordetella spp., Pseudomonas spp.
1 ml/20 kg kropsvægt en gang dagligt ved subkutan injektion i 3 dage.
5 mg of enrofloxacin/kg bw, corresponding to 1 ml/20 kg bw, once daily by subcutaneous injection for 3 days.
Hunde, kvæg, svin
Dogs, cattle and pigs
Slagtning: 6 døgn Mælk: 4 døgn
Meat and offal: 4 days.
Virkningsmåde
Mode of action
Gnavere, krybdyr og prydfugle
Rodents, reptiles and ornamental birds
Infektioner i fordøjelseskanalen eller septikæmi forårsaget af Escherichia coli: 5 mg enrofloxacin/kg kropsvægt, svt.
Alimentary tract infection or septicaemia caused by Escherichia coli: 5 mg of enrofloxacin/kg of bw, corresponding to 2 ml/10 kg bw, once daily by intramuscular injection for 3 days.
Katte: Behandling af infektioner i mave-tarm-kanal, luftveje og urogenitalsystem (som supplerende antibiotikabehandling af pyometra) samt hud- og sårinfektioner, forårsaget af følsomme stammer af: Staphylococcus spp., Escherichia coli, Pasteurella spp., Klebsiella spp., Bordetella spp., Pseudomonas spp.
Treatment of infections of the alimentary, respiratory and urogenital tracts (as adjunctive antibiotic therapy for pyometra), skin and wound infections, caused by enrofloxacin susceptible strains of: Staphylococcus spp., Escherichia coli, Pasteurella spp., Klebsiella spp., Bordetella spp., Pseudomonas spp.
Akut mastitis forårsaget af Escherichia coli: 5 mg enrofloxacin/kg kropsvægt, svt.
Acute mastitis caused by Escherichia coli: 5 mg enrofloxacin/kg bw, corresponding to 1 ml/20 kg bw, by slow intravenous injection once daily for two consecutive days.
Akut yverbetændelse forårsaget af Escherichia coli: 5 mg enrofloxacin/kg kropsvægt, svt.
Alimentary tract infection or septicaemia caused by Escherichia coli: 5 mg of enrofloxacin/kg bw, corresponding to 2 ml/10 kg bw, once daily by intramuscular injection for 3 days.
1 ml/20 kg kropsvægt en gang dagligt 5 dage.
5 mg of enrofloxacin/kg body weight (bw), corresponding to 1 ml/20 kg bw, once daily for 3-5 days.
Ingen kendte.
None known
Medlemsstat /EEA
Member State/EEA
antibakterica til systemisk brug
antibacterial for systemic use
Forebyggelsesstrategien bør omfatte bestræbelser for at eliminere infektionen fra forældregenerationen.
The prevention strategy should include efforts to eliminate the infection from the parent generation.
ATCvet-kode:
ATCvet code:
Hvis dette ikke er muligt, bør behandlingen være baseret på lokal (regional, bedriftsniveau) epidemiologisk information om følsomheden hos målbakterier.
If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of target bacteria.
SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF TIAMUTIN PREMIX OG TILKNYTTEDE NAVNE (se bilag I)
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF TIAMUTIN PREMIX AND ASSOCIATED NAMES (see Annex I)
Grækenland Premier Shukuroglou Hellas S.A
Premier Shukuroglou Hellas S.A
Indehaverne af markedsføringstilladelserne blev anmodet om:
The Marketing Authorisation Holders were requested:
På grund af de forskellige nationale beslutninger i medlemsstaterne vedrørende godkendelse af disse midler blev sagen indbragt for CVMP i henhold til artikel 34, stk. 1, i direktiv 2001/82/EF for at løse divergenser mellem de nationalt godkendte produktresuméer i EU.
Due to the divergent national decisions taken by Member States concerning the authorisation of these products, the issue was referred to CVMP under Article 34(1) of Directive 2001/82/EC, in order to resolve divergences amongst the nationally authorised Summary of Product Characteristics (SPC) across the European Union.
TEKSTEN "KUN TIL DYR" SAMT BETINGELSER ELLER BEGRÆNSNINGER FOR
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
Indtaget af foderlægemiddel afhænger af dyrenes kliniske tilstand.
The intake of medicated feed depends on the clinical condition of the animals.
En mindste dødelig dosis er ikke fastsat hos grise.
A minimum lethal dose has not been established in pigs.
Det skal især nævnes, at der, til trods for at fremkomsten af antimikrobiel resistens mod M. hyopneumoniae ikke synes at være en umiddelbar bekymring, er behov for også at overveje resistens i forhold til andre mikrober, som er til stede i svinebesætninger, f.eks. B. hyodysenteriae.
Notably although emergence of antimicrobial resistance against M. hyopneumoniae does not seem to be of immediate concern there is a need to consider resistance also against other microbes present in swine herds such as B. hyodysenteriae.
Forebyggende medicin med tiamulin bør gives i 2-4 uger.
Preventive medication with tiamulin should be given for 2-4 weeks.
Tiamulin, som ikke er absorberet eller omsat, passerer ned gennem tarmene til tyktarmen og koncentreres der.
Tiamulin, which has not been absorbed or metabolised, passes down the intestines to the colon and concentrates there.
ANGIVELSE AF AKTIVE STOFFER OG ANDRE STOFFER Udfyldes nationalt
STATEMENT OF ACTIVE AND OTHER SUBSTANCES To be completed nationally
Hvis der forekommer tegn på en interaktion, bør indgiften af det kontaminerede foder straks standses.
If signs of an interaction do occur, administration of contaminated feed should be stopped immediately.
Premix med tiamulin markedsføres i 20 EU-medlemsstater under en række forskellige handelsnavne (se bilag I).
Premixes with tiamulin are marketed in 20 European Member States under a variety of invented names (see Annex I).
I tilfælde af nedsat foderindtag kan det være nødvendigt at øge inklusionsniveauerne i foderet for at opnå måldosis.
In case of reduced feed intake, the inclusion levels in feed may need to be increased to achieve target dosage.
Dette kan medføre svær væksthæmning eller dødsfald.
Severe growth depression or death may result.
1. en udtømmende liste over forskellene mellem produktresuméerne for det lægemiddel, der er godkendt i medlemsstaterne 2. at gennemgå alle afsnit i produktresuméerne og foreslå passende ændringer i teksten, hvor der er forskelle, og foreslå harmoniseret produktinformation (produktresumé og etikettering), idet der tages højde for de seneste retningslinjer 3. tilgængelige relevante data, især data, som underbygger den foreslåede harmoniserede produktinformation i forhold til de ovenfor identificerede forskelle.
1. to provide an exhaustive list of differences between the SPCs of the product authorised in the Member States; 2. to review all sections of the SPCs and to suggest appropriate changes in the text where divergences exist and to propose a harmonised Product Information (SPC and labelling), taking into account the latest guidance; 3. to provide available relevant data, in particular substantiating such proposed harmonised Product Information in relation to the discrepancies identified above.
Tiamulin absorberes godt hos kyllinger (70-95 %) efter oral indgift.
Tiamulin is well absorbed in chickens (70-95%) after oral administration.
De godkendte premixformuleringer er baseret på tiamulinhydrogenfumarat i en koncentration på:
The authorised premix-formulations are based on tiamulin hydrogen fumarate in a concentration of:
For at sikre den korrekte dosis skal legemsvægten bestemmes så nøjagtigt som muligt med henblik på at undgå underdosering.
To ensure a correct dosage body weight should be determined as accurately as possible to avoid underdosing.
Udskillelsen sker hovedsaglig via galden (55-65 %) og nyren (15-30 %) som primært mikrobiologisk inaktive metabolitter, og er ganske hurtig, 99 % af dosis inden for 48 timer.
Excretion is mainly via the bile (55-65%) and kidney (15-30%) as mainly microbiologically inactive metabolites and is quite rapid, 99% of the dose within 48 hours.
Inklusionsniveauer i det højere område vil i de fleste tilfælde være nødvendige for at undgå underdosering.
Inclusion levels in the higher range will in most cases be needed to avoid underdosing.
Affaldsmateriale skal destrueres i overensstemmelse med de lokale krav.
Dispose of waste material in accordance with local requirements
- CVMP vurderede, at tilbageholdelsestiderne bør harmoniseres for hver art, som følger: Svin
- the CVMP considered that the withdrawal periods should be harmonised for each species as follows: Pigs
CVMP har anbefalet ændringen af markedsføringstilladelserne, for hvilke produktresuméet og etiketteringen fremgår af bilag III for Tiamutin Premix og tilknyttede navne (se bilag I).
the CVMP has recommended the amendment of the Marketing Authorisations for which the Summary of Product Characteristics and labelling are set out in Annex III for Tiamutin premix and associated names (see Annex I).
Det er god klinisk praksis at basere behandlingen på følsomhedsbestemmelse af bakterier isoleret fra dyret.
It is sound clinical practice to base treatment on susceptibility testing of the bacteria isolated from the animal.
Ved 55 mg/kg givet i 14 dage forekom der forbigående spytsekretion og let gastrisk irritation.
At 55 mg/kg given for 14 days a transient salivation and slight gastric irritation occurred.
FREMSTILLERENS BATCHNUMMER {Implementeres nationalt}
MANUFACTURER'S BATCH NUMBER {For national implementation}
Forebyggelse skal administreres i 3-4 uger fra den første uge efter fravænning.
Prevention should be administered during 3 - 4 weeks from the first week after weaning.
Resistens over for tiamulin kan være forbundet med nedsat følsomhed over for andre pleuromutiliner.
Resistance to tiamulin may be associated with decreased susceptibility to other pleuromutilins.
Med hensyn til harmonisering af indikationer og på grundlag af de indsendte effektdata vedtages det at harmonisere indikationerne, som følger:
As regards harmonisation of indications and based on the efficacy data provided it is agreed to harmonise the indications as follows:
Kaniner Der forefindes ingen tilgængelige data for kaniner.
Rabbits There are no pharmacokinetic data available for rabbits.
Tiamulin-niveauerne i serum hos kalkuner svarer til niveauerne hos kyllinger.
In turkeys serum levels of tiamulin are similar to chickens.
FARMAKOLOGISKE EGENSKABER Farmakoterapeutisk gruppe:
PHARMACOLOGICAL PROPERTIES Pharmacotherapeutic group:
Klinisk relevant resistens over for tiamulin kræver kombinationer af mutationer omkring bindingsstedet for tiamulin.
Clinically relevant resistance to tiamulin requires combinations of mutations around the tiamulin binding site.
Behandlingen bør indgives indtil 2-3 dage efter, at de kliniske tegn er ophørt.
Treatment should be administered until 2 - 3 days after clinical signs has resolved.
Personligt beskyttelsesudstyr bør anvendes ved blanding af veterinærlægemidlet eller håndtering af det medicinerede foder: overalls, uigennemtrængelige handsker og enten engangsåndedrætsværn i form af en halvmaske, som er i overensstemmelse med den europæiske standard EN 149, eller et genbrugeligt åndedrætsværn, som er i overensstemmelse med den europæiske standard EN 140, med et filter, der er i overensstemmelse med den europæiske standard EN 143.
Personal protective equipment should be worn when mixing the veterinary medicinal product or handling the medicated feed: overalls, impervious gloves and either a disposable half-mask respirator conforming to European Standard EN 149 or a non-disposable respirator conforming to European Standard EN 140, with a filter to European Standard EN 143.
De store forskelle i de nuværende godkendte tilbageholdelsestider blev bemærket (f.eks. fra 1-20 dage hos svin, 3-8 dage hos høns og kalkuner, 0 dage hos kaniner).
Concerning withdrawal periods the very wide variation in currently approved withdrawal periods was noted (e.g. ranging from 1 day to 20 days in pigs, 3 to 8 days in chickens and turkeys, 0 days in rabbits).
Tiamulin absorberes godt hos grise (over 90 %) efter oral indgift og fordeles i hele kroppen.
Tiamulin is well absorbed in the pig (over 90%) following oral administration and widely distributed through the body.
Forskellene i dosering i de nationalt godkendte produktresuméer betød, at dette spørgsmål også skulle behandles i denne indbringelsesprocedure.
The variation in posology amongst the nationally authorised Summary of Product Characteristics (SPC) meant that this issue also needed to be addressed in this referral procedure.
Se afsnit 4.8 for oplysninger vedrørende interaktion mellem tiamulin og ionophor-præparater
Refer to section 4.8 for information regarding interaction between tiamulin and ionophores
For hver indikation og på grundlag af de indsendte data vedtages det at harmonisere den mængde, der skal administreres for hver indikation, som vist i nedenstående tabeller:
For each approved indication and based on the data provided it is agreed to harmonise the amount to be administered for each indication as shown in the tables below.
LISTE OVER VETERINÆRLÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM, STYRKER, DYREART, INDGIVELSESVEJ OG INDEHAVERE AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATEN
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
I sjældne tilfælde kan der forekomme erytemer eller milde ødemer på huden hos grise efter brug af tiamulin.
On rare occasions erythema or mild oedema of the skin may occur in pigs following the use of tiamulin.
Officiel vejledning vedrørende iblanding af medicineret premix i det færdige foder bør tages i betragtning.
Consideration should be given to official guidance on the incorporation of medicated premixes in final feeds.
THF-mængde (mg/g) pr. premixformulering
Amount of THF (mg/g) per premix formulation
Akutte tilfælde og alvorligt syge dyr med nedsat foderindtag bør behandles med et præparat med en egnet formulering, f.eks. en injektionsopløsning eller en vandopløsning.
Acute cases and severely diseased animals with reduced feed intake should be treated with a product of suitable formulation such as an injectable or water solution.
Tiamulin er bakteriostatisk ved terapeutiske koncentrationer, og det er blevet påvist, at det fungerer på 70S-ribosomniveau, og det primære bindingssted er på 50S-subunit og muligvis et andet sted, hvor 50S- og 30S-subunits er forbundet.
Tiamulin is bacteriostatic at therapeutic concentrations and has been shown to act at the 70S ribosome level and the primary binding site is on the 50S subunit and possibly a secondary site where the 50S and 30S subunits join.
Foderet bør fjernes og erstattes med frisk foder, der ikke indeholder midlerne mod coccidiose: monensin, salinomycin eller narasin.
The feed should be removed and replaced with fresh feed not containing the anticoccidials monensin, salinomycin or narasin.
Dette kan medføre svær væksthæmning, ataksi, lammelse eller dødsfald.
Severe growth depression, ataxia, paralysis or death may result.
Hvis tegnene på forgiftning forekommer hurtigt, skal det medicinerede foder fjernes og erstattes af frisk foder uden medicin, og der skal anvendes understøttende, symptomatisk terapi.
If signs of intoxication do occur promptly remove the medicated feed, replace with fresh unmedicated feed and apply supportive, symptomatic therapy.
Mekanismerne, der er ansvarlige for udviklingen af resistens i Brachyspira spp over for pleuromutilin-klassen af antibiotika, anses for at være baseret på mutationer ved det ribosomale målsted.
Mechanisms responsible for resistance development in Brachyspira spp to the pleuromutilin class of antibiotics are considered to be based on mutations at the ribosomal target site.
FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉET OG ETIKETTERINGEN
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND LABELLING
NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN {Implementeres nationalt}
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER {For national implementation}
- CVMP vurderede, at doseringen og administrationsvejen bør harmoniseres for hver art
- the CVMP considered that the amount to be administered and administration route should be harmonised for each species;
Visse koncentrationer af disse premixformuleringer er i øjeblikket ikke godkendt til visse arter i disse medlemsstater, f.eks. er 0,8 % koncentrationen ikke godkendt til høns og kalkuner, og 80 % koncentrationen er ikke godkendt til kaniner.
Certain concentrations of these premix formulations are not currently authorised in these Member States in certain species e.g. 0.8% concentration not authorised in chickens and turkeys, 80% concentration not authorised in rabbits.
Ved 150 mg/kg blev der ikke påvist nogen effekter på centralnervesystemet med undtagelse af sedation.
At 150 mg/kg no CNS effects were noted except for sedation.
Hos avlskalkuner på 0,025 % tiamulin var det gennemsnitlige serumniveau 0,36 µg/ml (område 0,22-0,5 µg/ml).
In breeders on 0.025% tiamulin the average serum level was 0.36μg/ml (range 0.22-0.5μg/ml).
- CVMP vurderede, at de terapeutiske indikationer bør harmoniseres for hver art, men at indikationen for tiamulin ved forebyggelse af enzootisk pneumoni ikke kan accepteres ud fra de fremsendte data
- the CVMP considered that the indications for use should be harmonised for each species but that the indication for tiamulin to be used in the prevention of enzootic pneumonia could not be accepted based on the data presented;
Tiamulin fordeles ud i hele kroppen, og det er påvist, at det koncentrerer sig i leveren og nyren (udskillelsessteder) og i lungerne (30 gange serumniveau).
Tiamulin distributes widely through the body and has been shown to concentrate in the liver and kidney (sites of excretion) and in the lung (30 times serum level).
- CVMP vurderede, at produktresuméet bør harmoniseres inden for rammerne af denne indbringelsesprocedure, mens man også bemærkede, at visse koncentrationer af premixformuleringerne i øjeblikket ikke er godkendt til visse arter i medlemsstaterne, f.eks. er 0,8 % koncentrationen ikke godkendt til høns og kalkuner, og 80 % koncentrationen er ikke godkendt til kaniner,
- the CVMP considered that the SPC should be harmonised in the framework of this referral procedure, while also noting that certain concentrations of the premix formulations are not currently authorised in Member States in certain species e.g. 0.8% concentration not authorised in chickens and turkeys, 80% concentration not authorised in rabbits;
BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉ OG ETIKETTERING
GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND LABELLING
Konklusion: CVMP har undersøgt begrundelserne for indbringelsen og de redegørelser, som indehaverne af markedsføringstilladelserne har fremsendt, og konkluderer følgende:
Conclusion: Having considered the grounds for referral and the responses provided by the Marketing Authorisation Holders, the CVMP concluded as follows:
Tiamulin synes at hæmme den mikrobielle proteinproduktion ved at producere biokemiske inaktive initieringskomplekser, som forhindrer forlængelse af polypeptidkæden.
It appears to inhibit microbial protein production by producing biochemical inactive initiation complexes, which prevent elongation of the polypeptide chain.
De kliniske tegn på akut toksicitet hos kyllinger er - vokalisation, kloniske kramper og lateral stilling.
The clinical signs of acute toxicity in chickens are - vocalization, clonic cramps and lateral recumbency.