FrancophonIA/ELRC3.0 huggingface dataset:
English: Goats (50 mg/ml and 100 mg/ml strengths)
Danish: Geder (styrkerne 50 mg/ml og 100 mg/ml)
English: Meat and offal: 13 days.
Danish: Slagtning: 13 døgn
English: 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.
Danish: 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.
English: BIOLIS
Danish: Dyreart
English: - Dosage: 2.5 mg/kg bw, once daily for 3 days by intramuscular injection.
Danish: - Dosering: 2,5 mg/kg kropsvægt intramuskulært én gang dagligt i 3 dage.
English: 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.
Danish: Akut mycoplasma-ledbetændelse forårsaget af enrofloxacin-følsomme stammer af Mycoplasma bovis: 5 mg enrofloxacin/kg kropsvægt, svt.
English: On the basis of the available data the CVMP considered that this indication can be accepted.
Danish: CVMP kunne godtage denne indikation på grundlag af de foreliggende data.
English: PK/PD and antimicrobial resistance data have been taken into account to justify this indication.
Danish: For at underbygge denne indikation er PK/PD-data taget i betragtning.
English: Dogs, pigs, cattle, cats
Danish: Hunde, svin, kvæg, katte
English: Enrofloxacin 100 mg/ml (or 50 mg/ml)
Danish: Enrofloxacin 100 mg/ml (or
English: Treatment of infections of the respiratory tract caused by enrofloxacin susceptible strains of Pasteurella multocida, Mannheimia haemolytica, Mycoplasma spp.
Danish: Behandling af luftvejsinfektioner forårsaget af enrofloxacin-følsomme stammer af Pasteurella multocida, Mannheimia haemolytica, Mycoplasma spp.
English: Cattle, pigs, dogs
Danish: Kvæg, svin, hunde
English: 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.
Danish: 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.
English: Cattle, pigs, dogs, cats
Danish: Kvæg, svin, hunde, katte
English: Treatment of infections of the respiratory tract caused by enrofloxacin susceptible strains of Pasteurella multocida, Mannheimia haemolytica and Mycoplasma spp.
Danish: Behandling af luftvejsinfektioner forårsaget af enrofloxacinfølsomme stammer af Pasteurella multocida, Mannheimia haemolytica og Mycoplasma spp.
English: Treatment of skin and wound infections caused by enrofloxacin susceptible strains of Staphylococcus aureus.
Danish: Behandling af hud- og sårinfektioner forårsaget af enrofloxacinfølsomme stammer af Staphylococcus aureus.
English: Cattle, sheep, goats, pigs, dogs, cats
Danish: Kvæg, får, geder, svin, hunde, katte
English: Cats, dogs, cattle, pigs
Danish: Katte, hunde, kvæg, svin
English: Treatment of septicaemia caused by enrofloxacin susceptible strains of Escherichia coli.
Danish: Behandling af septikæmi forårsaget af enrofloxacinfølsomme stammer af Escherichia coli.
English: Treatment of infections of the respiratory tract caused by enrofloxacin susceptible strains of Pasteurella multocida, Mycoplasma spp.
Danish: Behandling af luftvejsinfektioner forårsaget af enrofloxacinfølsomme stammer af Pasteurella multocida, Mycoplasma spp.
English: Calves, pigs, dogs
Danish: Kalve, smågrise, hunde
English: Treatment of skin and wound infections caused by enrofloxacin susceptible strains of: Staphylococcus aureus.
Danish: Behandling af hud- og sårinfektioner forårsaget af enrofloxacin-følsomme stammer af Staphylococcus aureus.
English: Cattle, pigs, goats, sheep, dogs
Danish: Kvæg, svin, geder, får, hunde
English: Treatment of infections of the urinary tract caused by enrofloxacin susceptible strains of Escherichia coli.
Danish: Behandling af urinvejsinfektioner forårsaget af enrofloxacinfølsomme stammer af Escherichia coli.
English: 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.
Danish: 1 ml/5 kg kropsvægt en gang dagligt ved subkutan injektion i op til 5 dage.
English: Piglets (25 mg/ml strength)
Danish: Smågrise (styrken 25 mg/ml)
English: Pigs, cattle, dogs, cats
Danish: Svin, kvæg, hunde, katte
English: Cats, cattle, dogs, Pigs
Danish: Katte, kvæg, hunde, svin
English: - Dosage: 5 mg/kg bw, once daily for 3 days by intramuscular injection.
Danish: - Dosering: 5 mg/kg kropsvægt intramuskulært én gang dagligt i 3 dage.
English: - Dosage for rodents: 10 mg/kg bw, once daily by subcutaneous injection for 5-10 consecutive days
Danish: - Dosering til gnavere: 10 mg/kg kropsvægt subkutant én gang dagligt i 5-10 på hinanden følgende dage.
English: 10 mg/kg bw, corresponding to 0.4 ml/kg bw, once daily by subcutaneous injection for 5 to 10 consecutive days.
Danish: 0,4 ml/kg kropsvægt en gang dagligt ved subkutan injektion 510 dage i træk.
English: Cattle, dogs, pigs
Danish: Kvæg, hunde, svin
English: Calves, pigs, poultry dogs, cats
Danish: Kalve, svin, fjerkræ, hunde, katte
English: Meat and offal: 6 days.
Danish: Slagtning: 6 døgn
English: Treatment of septicaemia caused by enrofloxacin susceptible strains of E. coli.
Danish: Behandling af septikæmi forårsaget af enrofloxacin-følsomme stammer af E.coli.
English: - Dosage: 5 mg/kg bw, once daily for 3 days by subcutaneous administration.
Danish: - Dosering: 5 mg/kg kropsvægt subkutant én gang dagligt i 3 dage.
English: 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.
Danish: 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.
English: Cattle, pigs, dogs, sheep, goats
Danish: Kvæg, svin, hunde, får, geder
English: Cattle, sheep, pigs, dogs
Danish: Kvæg, får, svin, hunde
English: 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.
Danish: 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
English: Sweden Bayer Animal Health GmbH Kaiser-Wilhelm-Allee 50
Danish: Bulgarien Bayer Animal Health GmbH Kaiser-Wilhelm-Allee 50
English: Cattle, pigs, sheep, goats
Danish: Kvæg, svin, får, geder
English: Cattle, sheep, goats, pigs, dogs
Danish: Kvæg, får, geder, svin, hunde
English: - Dosage: 5 mg/kg bw, once daily for 5 days
Danish: - Dosering: 5 mg/kg kropsvægt én gang dagligt i 5 dage.
English: 10 mg/kg bw, corresponding to 2 ml/5 kg bw, once daily by subcutaneous injection for 5 to 10 consecutive days.
Danish: 2 ml/5 kg kropsvægt en gang dagligt ved subkutan injektion 510 dage i træk.
English: Dogs, cats, cage birds, reptiles
Danish: Hunde, katte burfugle, krybdyr
English: 2.5 mg of enrofloxacin/kg bw, corresponding to 0.5 ml/20 kg bw, once daily by intramuscular injection for 3 days.
Danish: 0,5 ml/20 kg kropsvægt en gang dagligt ved intramuskulær injektion i 3 dage.
English: - Dosage: 5 mg/kg bw, once daily for two consecutive days Regarding E. coli, a PK/PD study was conducted at the proposed dose.
Danish: For E. coli blev der udført en PK/PD-undersøgelse ved den ansøgte dosis.
English: 5-10 mg/kg bw, corresponding to 0.2-0.4 ml/kg bw, once daily by intramuscular injection for 5 consecutive days.
Danish: 0,2-0,4 ml/kg kropsvægt en gang dagligt ved intramuskulær injektion 5 dage i træk.
English: 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.
Danish: 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.
English: 5 mg of enrofloxacin/kg bw, corresponding to 1 ml/20 kg bw, once daily by subcutaneous injection for 3 days.
Danish: 1 ml/20 kg kropsvægt en gang dagligt ved subkutan injektion i 3 dage.
English: Dogs, cattle and pigs
Danish: Hunde, kvæg, svin
English: Meat and offal: 4 days.
Danish: Slagtning: 6 døgn Mælk: 4 døgn
English: Mode of action
Danish: Virkningsmåde
English: Rodents, reptiles and ornamental birds
Danish: Gnavere, krybdyr og prydfugle
English: 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.
Danish: Infektioner i fordøjelseskanalen eller septikæmi forårsaget af Escherichia coli: 5 mg enrofloxacin/kg kropsvægt, svt.
English: 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.
Danish: 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.
English: 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.
Danish: Akut mastitis forårsaget af Escherichia coli: 5 mg enrofloxacin/kg kropsvægt, svt.
English: 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.
Danish: Akut yverbetændelse forårsaget af Escherichia coli: 5 mg enrofloxacin/kg kropsvægt, svt.
English: 5 mg of enrofloxacin/kg body weight (bw), corresponding to 1 ml/20 kg bw, once daily for 3-5 days.
Danish: 1 ml/20 kg kropsvægt en gang dagligt 5 dage.
English: None known
Danish: Ingen kendte.
English: Member State/EEA
Danish: Medlemsstat /EEA
English: antibacterial for systemic use
Danish: antibakterica til systemisk brug
English: The prevention strategy should include efforts to eliminate the infection from the parent generation.
Danish: Forebyggelsesstrategien bør omfatte bestræbelser for at eliminere infektionen fra forældregenerationen.
English: ATCvet code:
Danish: ATCvet-kode:
English: If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of target bacteria.
Danish: Hvis dette ikke er muligt, bør behandlingen være baseret på lokal (regional, bedriftsniveau) epidemiologisk information om følsomheden hos målbakterier.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF TIAMUTIN PREMIX AND ASSOCIATED NAMES (see Annex I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF TIAMUTIN PREMIX OG TILKNYTTEDE NAVNE (se bilag I)
English: Premier Shukuroglou Hellas S.A
Danish: Grækenland Premier Shukuroglou Hellas S.A
English: The Marketing Authorisation Holders were requested:
Danish: Indehaverne af markedsføringstilladelserne blev anmodet om:
English: 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.
Danish: 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.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
Danish: TEKSTEN "KUN TIL DYR" SAMT BETINGELSER ELLER BEGRÆNSNINGER FOR
English: The intake of medicated feed depends on the clinical condition of the animals.
Danish: Indtaget af foderlægemiddel afhænger af dyrenes kliniske tilstand.
English: A minimum lethal dose has not been established in pigs.
Danish: En mindste dødelig dosis er ikke fastsat hos grise.
English: 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.
Danish: 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.
English: Preventive medication with tiamulin should be given for 2-4 weeks.
Danish: Forebyggende medicin med tiamulin bør gives i 2-4 uger.
English: Tiamulin, which has not been absorbed or metabolised, passes down the intestines to the colon and concentrates there.
Danish: Tiamulin, som ikke er absorberet eller omsat, passerer ned gennem tarmene til tyktarmen og koncentreres der.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES To be completed nationally
Danish: ANGIVELSE AF AKTIVE STOFFER OG ANDRE STOFFER Udfyldes nationalt
English: If signs of an interaction do occur, administration of contaminated feed should be stopped immediately.
Danish: Hvis der forekommer tegn på en interaktion, bør indgiften af det kontaminerede foder straks standses.
English: Premixes with tiamulin are marketed in 20 European Member States under a variety of invented names (see Annex I).
Danish: Premix med tiamulin markedsføres i 20 EU-medlemsstater under en række forskellige handelsnavne (se bilag I).
English: In case of reduced feed intake, the inclusion levels in feed may need to be increased to achieve target dosage.
Danish: I tilfælde af nedsat foderindtag kan det være nødvendigt at øge inklusionsniveauerne i foderet for at opnå måldosis.
English: Severe growth depression or death may result.
Danish: Dette kan medføre svær væksthæmning eller dødsfald.
English: 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.
Danish: 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.
English: Tiamulin is well absorbed in chickens (70-95%) after oral administration.
Danish: Tiamulin absorberes godt hos kyllinger (70-95 %) efter oral indgift.
English: The authorised premix-formulations are based on tiamulin hydrogen fumarate in a concentration of:
Danish: De godkendte premixformuleringer er baseret på tiamulinhydrogenfumarat i en koncentration på:
English: To ensure a correct dosage body weight should be determined as accurately as possible to avoid underdosing.
Danish: For at sikre den korrekte dosis skal legemsvægten bestemmes så nøjagtigt som muligt med henblik på at undgå underdosering.
English: 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.
Danish: 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.
English: Inclusion levels in the higher range will in most cases be needed to avoid underdosing.
Danish: Inklusionsniveauer i det højere område vil i de fleste tilfælde være nødvendige for at undgå underdosering.
English: Dispose of waste material in accordance with local requirements
Danish: Affaldsmateriale skal destrueres i overensstemmelse med de lokale krav.
English: - the CVMP considered that the withdrawal periods should be harmonised for each species as follows: Pigs
Danish: - CVMP vurderede, at tilbageholdelsestiderne bør harmoniseres for hver art, som følger: Svin
English: 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).
Danish: CVMP har anbefalet ændringen af markedsføringstilladelserne, for hvilke produktresuméet og etiketteringen fremgår af bilag III for Tiamutin Premix og tilknyttede navne (se bilag I).
English: It is sound clinical practice to base treatment on susceptibility testing of the bacteria isolated from the animal.
Danish: Det er god klinisk praksis at basere behandlingen på følsomhedsbestemmelse af bakterier isoleret fra dyret.
English: At 55 mg/kg given for 14 days a transient salivation and slight gastric irritation occurred.
Danish: Ved 55 mg/kg givet i 14 dage forekom der forbigående spytsekretion og let gastrisk irritation.
English: MANUFACTURER'S BATCH NUMBER {For national implementation}
Danish: FREMSTILLERENS BATCHNUMMER {Implementeres nationalt}
English: Prevention should be administered during 3 - 4 weeks from the first week after weaning.
Danish: Forebyggelse skal administreres i 3-4 uger fra den første uge efter fravænning.
English: Resistance to tiamulin may be associated with decreased susceptibility to other pleuromutilins.
Danish: Resistens over for tiamulin kan være forbundet med nedsat følsomhed over for andre pleuromutiliner.
English: As regards harmonisation of indications and based on the efficacy data provided it is agreed to harmonise the indications as follows:
Danish: Med hensyn til harmonisering af indikationer og på grundlag af de indsendte effektdata vedtages det at harmonisere indikationerne, som følger:
English: Rabbits There are no pharmacokinetic data available for rabbits.
Danish: Kaniner Der forefindes ingen tilgængelige data for kaniner.
English: In turkeys serum levels of tiamulin are similar to chickens.
Danish: Tiamulin-niveauerne i serum hos kalkuner svarer til niveauerne hos kyllinger.
English: PHARMACOLOGICAL PROPERTIES Pharmacotherapeutic group:
Danish: FARMAKOLOGISKE EGENSKABER Farmakoterapeutisk gruppe:
English: Clinically relevant resistance to tiamulin requires combinations of mutations around the tiamulin binding site.
Danish: Klinisk relevant resistens over for tiamulin kræver kombinationer af mutationer omkring bindingsstedet for tiamulin.
English: Treatment should be administered until 2 - 3 days after clinical signs has resolved.
Danish: Behandlingen bør indgives indtil 2-3 dage efter, at de kliniske tegn er ophørt.
English: Hoge Mauw 900, 2370 Arendonk BELGIUM
Danish: Leo Aerden Hoge Mauw 900, 2370 Arendonk BELGIUM
English: 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.
Danish: 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.
English: 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).
Danish: 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).
English: Tiamulin is well absorbed in the pig (over 90%) following oral administration and widely distributed through the body.
Danish: Tiamulin absorberes godt hos grise (over 90 %) efter oral indgift og fordeles i hele kroppen.
English: 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.
Danish: Forskellene i dosering i de nationalt godkendte produktresuméer betød, at dette spørgsmål også skulle behandles i denne indbringelsesprocedure.
English: Refer to section 4.8 for information regarding interaction between tiamulin and ionophores
Danish: Se afsnit 4.8 for oplysninger vedrørende interaktion mellem tiamulin og ionophor-præparater
English: 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.
Danish: 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:
English: LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: LISTE OVER VETERINÆRLÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM, STYRKER, DYREART, INDGIVELSESVEJ OG INDEHAVERE AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATEN
English: On rare occasions erythema or mild oedema of the skin may occur in pigs following the use of tiamulin.
Danish: I sjældne tilfælde kan der forekomme erytemer eller milde ødemer på huden hos grise efter brug af tiamulin.
English: Consideration should be given to official guidance on the incorporation of medicated premixes in final feeds.
Danish: Officiel vejledning vedrørende iblanding af medicineret premix i det færdige foder bør tages i betragtning.
English: Amount of THF (mg/g) per premix formulation
Danish: THF-mængde (mg/g) pr. premixformulering