natgillin/translations-raw huggingface dataset:
Behandling af mave-tarm-infektioner med Escherichia coli eller septikæmi forårsaget af enrofloxacinfølsomme stammer af Escherichia coli. 
Treatment of Escherichia coli infections of the alimentary tract or septicaemia caused by enrofloxacin susceptible strains of Escherichia coli.
For at undgå bivirkninger, skal særlig opmærksomhed udvises ved samtidig brug af flunixin og enrofloxacin til hunde. 
Care should be taken during the concomitant use of flunixin and enrofloxacin in dogs to avoid adverse drug reactions.
- Dosering: 5 mg/kg kropsvægt subkutant én gang dagligt i op til 5 dage. 
- Dosage: 5 mg/kg bw, once daily by subcutaneous injection for up to 5 days.
Belgien Chanelle Pharmaceuticals Manufacturing Ltd. 
Belgium Chanelle Pharmaceuticals Manufacturing Ltd.
CVMP kunne godtage disse indikationer på grundlag af de foreliggende data. 
On the basis of the available data the CVMP considered that these indications can be accepted.
Kvæg, svin, får 
Cattle, pigs, sheep
Behandling af akut mycoplasma-arthritis hos kvæg yngre end 2 år, forårsaget af enrofloxacinfølsomme stammer af Mycoplasma bovis. 
Treatment of acute mycoplasma-associated arthritis due to enrofloxacin susceptible strains of Mycoplasma bovis in cattle less than 2 years old.
Behandling af luftvejsinfektioner forårsaget af enrofloxacinfølsomme stammer af Pasteurella multocida og Mannheimia haemolytica. 
Treatment of infections of the respiratory tract caused by enrofloxacin susceptible strains of Pasteurella multocida and Mannheimia haemolytica.
Der anbefales således en tilbageholdelsestid på 72 timer (3 dage) dage for mælk fra får, der er behandlet med den anbefalede dosis på 5 mg/kg kropsvægt/dag subkutant i 5 dage med styrken 50 mg/ml eller 100 mg/ml. 
A withdrawal period of 72 hours (3 days) is recommended for sheep milk for animals treated at the recommended dose of 5 mg/kg bw with the 50 mg/ml and 100 mg/ml strengths by subcutaneous injection.
0,8 ml/kg kropsvægt en gang dagligt ved intramuskulær injektion 5-10 dage i træk. 
20 mg/kg bw, corresponding to 0.8 ml/kg bw, once daily by intramuscular injection for 5 to 10 consecutive days.
Til intravenøs, subkutan og intramuskulær anvendelse. 
4.9 Amounts to be administered and administration route Intravenous, subcutaneous or intramuscular use.
CVMP kunne godtage denne indikation efter at have taget samtlige data i betragtning. 
Taking into account all data, the CVMP considered that this indication can be accepted.
Kvæg (kalve), svin, hunde 
Cattle (calves), pigs, dog
Tyskland Bayer Animal Health GmbH Kaiser-Wilhelm-Allee 50 
Germany Bayer Animal Health GmbH Kaiser-Wilhelm-Allee 50
Katte, hunde, får, kvæg, svin, geder 
Cats, dogs, sheep, cattle, pigs, goats
Behandling af mastitis forårsaget af enrofloxacinfølsomme stammer af Staphylococcus aureus og Escherichia coli. 
Treatment of mastitis caused by enrofloxacin susceptible strains of Staphylococcus aureus and Escherichia coli.
Får (styrkerne 50 mg/ml og 100 mg/ml) 
Sheep (50 mg/ml and 100 mg/ml strengths)
Der anbefales således en tilbageholdelsestid på 4 dage for kød og indmad fra kvæg, der er behandlet med den anbefalede dosis på 5 mg/kg kropsvægt/dag subkutant i 5 dage med styrken 50 mg/ml eller 100 mg/ml. 
Thus, a withdrawal period of 4 days is recommended for sheep meat and offal for animals treated at the recommended dose of 5 mg/kg bw with the 50 mg/ml and 100 mg/ml strengths by subcutaneous injection.
Danmark Bayer Animal Health GmbH Kaiser-Wilhelm-Allee 50 
Denmark Bayer Animal Health GmbH Kaiser-Wilhelm-Allee 50
Akut mycoplasma-ledbetændelse hos kvæg yngre end 2 år forårsaget af enrofloxacin-følsomme stammer af Mycoplasma bovis: 5 mg enrofloxacin/kg kropsvægt, svt. 
Acute mycoplasma-associated arthritis due to enrofloxacin susceptible strains of Mycoplasma bovis in cattle less than 2 years old: 5 mg of enrofloxacin/kg bw, corresponding to 1 ml/20 kg bw, once daily for 5 days.
CVMP kunne godtage denne indikation efter at have taget samtlige data i betragtning (kliniske, farmakokinetiske/farmakodynamiske og antimikrobielle resistensdata). 
Taking into account all data available (clinical, PK/PD and antimicrobial resistance data), the CVMP considered that this indication can be accepted.
Dyrearter, som lægemidlet er beregnet til, indikationer og dosering 
Target species, indications and posology
- Dosering: 10 mg/kg kropsvægt subkutant én gang dagligt i 5-10 på hinanden følgende dage. 
- Dosage: 10 mg/kg bw, once daily for 5 to 10 consecutive days by subcutaneous administration.
S.c.: 12 døgn 
SC: Meat and offal: 12 days.
Tyskland Chanelle Pharmaceuticals Manufacturing Ltd. 
Germany Chanelle Pharmaceuticals Manufacturing Ltd.
Geder (styrkerne 50 mg/ml og 100 mg/ml) 
Goats (50 mg/ml and 100 mg/ml strengths)
Slagtning: 13 døgn 
Meat and offal: 13 days.
Dette er den anbefalede tilbageholdelsestid for kød og indmad fra kvæg, der er behandlet med den anbefalede dosis på 5 mg/kg kropsvægt/dag subkutant i 5 dage enten med styrken 50 mg/ml eller 100 mg/ml. 
This is recommended as the withdrawal period for cattle meat and offal for animals treated at the recommended dose of 5 mg/kg bw/day for 5 days with either the 50 mg/ml or 100 mg/ml strenghts and administered subcutaneously.
Dyreart 
BIOLIS
- Dosering: 2,5 mg/kg kropsvægt intramuskulært én gang dagligt i 3 dage. 
- Dosage: 2.5 mg/kg bw, once daily for 3 days by intramuscular injection.
Akut mycoplasma-ledbetændelse forårsaget af enrofloxacin-følsomme stammer af Mycoplasma bovis: 5 mg enrofloxacin/kg kropsvægt, svt. 
Acute mycoplasma-associated arthritis due to enrofloxacin susceptible strains of Mycoplasma bovis: 5 mg of enrofloxacin/kg bw, corresponding to 1 ml/10 kg bw, once daily for 5 days.
CVMP kunne godtage denne indikation på grundlag af de foreliggende data. 
On the basis of the available data the CVMP considered that this indication can be accepted.
For at underbygge denne indikation er PK/PD-data taget i betragtning. 
PK/PD and antimicrobial resistance data have been taken into account to justify this indication.
Hunde, svin, kvæg, katte 
Dogs, pigs, cattle, cats
Enrofloxacin 100 mg/ml (or 
Enrofloxacin 100 mg/ml (or 50 mg/ml)
Behandling af luftvejsinfektioner forårsaget af enrofloxacin-følsomme stammer af Pasteurella multocida, Mannheimia haemolytica, Mycoplasma spp. 
Treatment of infections of the respiratory tract caused by enrofloxacin susceptible strains of Pasteurella multocida, Mannheimia haemolytica, Mycoplasma spp.
Kvæg, svin, hunde 
Cattle, pigs, dogs
Behandling af mave-tarm-infektioner og luftvejsinfektioner, hvor de kliniske erfaringer, om muligt støttet af følsomhedsbestemmelse for den patogene organisme, taler for, at enrofloxacin bør foretrækkes. 
Rodents, reptiles and ornamental birds (25 mg/ml strength) Treatment of infections of the alimentary and respiratory tracts where clinical experience, if possible supported by sensitive testing of the causal organism, indicates enrofloxacin as the substance of choice.
Kvæg, svin, hunde, katte 
Cattle, pigs, dogs, cats
Behandling af luftvejsinfektioner forårsaget af enrofloxacinfølsomme stammer af Pasteurella multocida, Mannheimia haemolytica og Mycoplasma spp. 
Treatment of infections of the respiratory tract caused by enrofloxacin susceptible strains of Pasteurella multocida, Mannheimia haemolytica and Mycoplasma spp.
Behandling af hud- og sårinfektioner forårsaget af enrofloxacinfølsomme stammer af Staphylococcus aureus. 
Treatment of skin and wound infections caused by enrofloxacin susceptible strains of Staphylococcus aureus.
Kvæg, får, geder, svin, hunde, katte 
Cattle, sheep, goats, pigs, dogs, cats
Katte, hunde, kvæg, svin 
Cats, dogs, cattle, pigs
Behandling af septikæmi forårsaget af enrofloxacinfølsomme stammer af Escherichia coli. 
Treatment of septicaemia caused by enrofloxacin susceptible strains of Escherichia coli.
Behandling af luftvejsinfektioner forårsaget af enrofloxacinfølsomme stammer af Pasteurella multocida, Mycoplasma spp. 
Treatment of infections of the respiratory tract caused by enrofloxacin susceptible strains of Pasteurella multocida, Mycoplasma spp.
Kalve, smågrise, hunde 
Calves, pigs, dogs
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.