natgillin/translations-raw huggingface dataset:
Storbritannien Amneal Pharma Europe Limited, 70 Sir John Rogerson's Quay, Dublin 2, Ireland 
Amneal Pharma Europe Limited, 70 Sir John Rogerson's Quay, Dublin 2, Ireland
Letland sanofi-aventis Latvia SIA, Kr.Valdemara 33-8 Riga, LV 1010, Latvia 
Latvia sanofi-aventis Latvia SIA, Kr.Valdemara 33-8 Riga, LV 1010, Latvia
Grækenland IOULIA AND IRENE TSETI PHARMACEUTICAL LABORATORIES ABEE, INTERMED ABEE, Kalyftaki 27, Kifissia 14564 
IOULIA AND IRENE TSETI PHARMACEUTICAL LABORATORIES ABEE, INTERMED ABEE, Kalyftaki 27, Kifissia 14564 Greece
Grækenland SANOFI-AVENTIS AEBE 348 SYNGROU AVENUE, BUILDING A, KALLITHEA 17674 
SANOFI-AVENTIS AEBE 348 SYNGROU AVENUE, BUILDING A, KALLITHEA 17674
1526 Ljubljana 
1526 Ljubljana Slovenia
BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), INDGIVELSESVEJ(E), ANSØGER(E), INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE(R) I MEDLEMSSTATERNE 
List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration, marketing authorisation holders in the Member States
Danmark sanofi-aventis Denmark A/S, Slotsmarken 13, DK-2970 Hørsholm, Denmark 
Denmark sanofi-aventis Denmark A/S, Slotsmarken 13, DK-2970 Hørsholm, Denmark
Østrig ratiopharm Arzneimittel VertriebsGmbH, Albert-Schweitzer-Gasse 3, 1140 Wien, Austria 
Austria ratiopharm Arzneimittel VertriebsGmbH, Albert-Schweitzer-Gasse 3, 1140 Wien, Austria
Storbritannien Sandoz Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR 
Sandoz Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR
Tyskland neuraxpharm Arzneimittel GmbH Elisabeth-Selbert-Str. 23 40764 Langenfeld Germany 
Germany neuraxpharm Arzneimittel GmbH Elisabeth-Selbert-Str. 23 40764 Langenfeld Germany
Østrig sanofi-aventis GmbH, Saturn Tower, Leonard-Bernstein-Straße 10, 1220 Wien, Austria 
Austria sanofi-aventis GmbH, Saturn Tower, Leonard-Bernstein-Straße 10, 1220 Wien, Austria
Storbritannien Actavis UK Limited,Whiddon Valley, Barnstaple, North Devon EX32 8NS United Kingdom 
Actavis UK Limited,Whiddon Valley, Barnstaple, North Devon EX32 8NS United Kingdom
Storbritannien Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex BN22 9AG 
Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex BN22 9AG United Kingdom
Storbritannien Tillomed Laboratories Limited, 3 Howard Road, Eaton Socon, St Neots, Cambridgeshire PE19 8ET United Kingdom 
Tillomed Laboratories Limited, 3 Howard Road, Eaton Socon, St Neots, Cambridgeshire PE19 8ET United Kingdom
Rumænien LABORMED PHARMA S.A. B-dul Theodor Pallady nr. 44B Sector 3, Bucureşti, România 
B-dul Theodor Pallady nr. 44B Sector 3, Bucureşti, România
Storbritannien Generics [UK] Ltd. Station Close 
Czech Republic Generics [UK] Ltd. Station Close
Grækenland ITF HELLAS S.A. Areos 103 and Ag. Triados 36, Palaio Faliro 17562 
Areos 103 and Ag. Triados 36, Palaio Faliro 17562
Storbritannien Bristol Laboratories Limited, Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire HP4 
Bristol Laboratories Limited, Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire HP4 1EG United Kingdom
Holland ratiopharm Nederland B.V. 
The Netherlands ratiopharm Nederland B.V. Swensweg 5
Kampenringweg 45 D-E 2803 PE GOUDA The Netherlands 
Sanofi-Aventis Netherlands B.V. Kampenringweg 45 D-E 2803 PE GOUDA The Netherlands
Storbritannien Meda Pharmaceuticals Limited, Skyway House, Parsonage Road, Takeley, Bishops Stortford CM22 
Meda Pharmaceuticals Limited, Skyway House, Parsonage Road, Takeley, Bishops Stortford CM22 6PU United Kingdom
Storbritannien Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS United Kingdom 
Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS United Kingdom
H-1056, Budapest 
H-1056, Budapest Duna u.1
Slovenien Krka, d.d., Novo mesto Šmarješka cesta 6 
Czech Republic Krka, d.d., Novo mesto Šmarješka cesta 6
Rumænien LEK farmacevtska družba d.d. 
LEK farmacevtska družba d.d.
Rumænien SANOFI-AVENTIS ROMÂNIA S.R.L. 
SANOFI-AVENTIS ROMÂNIA S.R.L.
Edifícios Azevedos - Estrada Nacional 117-2, Alfragide 2614-504 Amadora Portugal 
Edifícios Azevedos - Estrada Nacional 117-2, Alfragide
Slovakiet sanofi-aventis Slovakia s.r.o. 
Slovak Republic sanofi-aventis Slovakia s.r.o.
Storbritannien Aventis Pharma Limited, One Onslow Street, Guildford, Surrey GU1 4SY 
Aventis Pharma Limited, One Onslow Street, Guildford, Surrey GU1 4SY United Kingdom
10 mg/ml orale dråber, opløsning 
10 mg/ml oral drops, solution oral use
Bulgarien Sanofi-Aventis Bulgaria EOOD, 103 Alexander Stamboliiski Blvd. 
Sanofi-Aventis Bulgaria EOOD, 103 Alexander Stamboliiski Blvd. Building Sofia Tower Sofia 1303
Luxembourg Apotex Europe B.V. 
Luxembourg Apotex Europe B.V. Darwinweg 20
MEDA Pharma s.r.o. 
Czech Republic MEDA Pharma s.r.o.
Zolpidem Genthion overtrukken tablet Oral anvendelse 
Zolpidem Genthion coated tablet oral use
Zolpidem Eurogenerics bruis 10 mg bruistabletten, bruistabletten brusetablet 
Zolpidem Eurogenerics bruis 10 mg bruistabletten, bruistabletten effervescent tablet oral use
Slovenien Vitabalans Oy Varastokatu 8 
Czech Republic Vitabalans Oy Varastokatu 8
Storbritannien ratiopharm GmbH Graf Arco Strasse 3 
Czech Republic ratiopharm GmbH Graf Arco Strasse 3
Storbritannien ALKALOID-INT d.o.o. 
Czech Republic ALKALOID-INT d.o.o.
Dodorest overtrukken tablet Oral anvendelse 
Dodorest coated tablet oral use
Stilnoct 5mg fiilm-coated tablets overtrukken tablet Oral anvendelse 
Stilnoct 5mg fiilm-coated tablets coated tablet oral use
Kodaňská 1441/46 110 00 Prague 10 
110 00 Prague 10
Stilnoct, tabletten 10 mg tablet 
Stilnoct, tabletten 10 mg tablet oral use
Stilnoct 10mg film-coated tablets overtrukken tablet Oral anvendelse 
Stilnoct 10mg film-coated tablets coated tablet oral use
Stilnoct overtrukken tablet Oral anvendelse 
Stilnoct tablet oral use
Zolsana 10 mg coated tablets overtrukken tablet Oral anvendelse 
Zolsana 10 mg coated tablets coated tablet oral use
overtrukken tablet Oral anvendelse 
tablet oral use
Zolsana 5 mg coated tablets overtrukken tablet Oral anvendelse 
Zolsana 5 mg coated tablets coated tablet oral use
Zolpitop overtrukken tablet Oral anvendelse 
Zolpitop coated tablet oral use
Zolpidemtartraat ADOH 10 mg, bruistabletten brusetablet 
Zolpidemtartraat ADOH bruistabletten 10 mg, bruistabletten effervescent tablet oral use
Edluar 10 mg, tablet voor sublinguaal gebruik resoriblet 
Edluar 10 mg, tablet voor sublinguaal gebruik sublingual tablet sublingual use
Edluar 5 mg, tablet voor sublinguaal gebruik resoriblet 
Edluar 5 mg, tablet voor sublinguaal gebruik sublingual tablet sublingual use
Zolpidemtartaat Actavis 5 mg, tabletten tablet 
Zolpidemtartaat Actavis 5 mg, tabletten tablet oral use
Edluar 10 mg Sublingualtabletten 10 mg resoriblet 
Edluar 10 mg Sublingualtabletten 10 mg sublingual tablet oral use
Zolpidemtartraat Actavis 10 mg, tabletten tablet 
Zolpidemtartraat Actavis 10 mg, tabletten tablet oral use
Sublingual anvendelse 
sublingual tablet sublingual use
Zolpidemtartraat ratiopharm 10 mg, tabletten tablet 
Zolpidemtartraat ratiopharm 10 mg, tabletten tablet oral use
Zolpidemtartraat ratiopharm 5 mg, tabletten tablet 
Zolpidemtartraat ratiopharm 5 mg, tabletten tablet oral use
EDLUAR 10 mg nyelvalatti tabletta 10 mg resoriblet 
EDLUAR 10 mg nyelvalatti tabletta 10 mg sublingual tablet sublingual use
Sverige ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany 
Sweden ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
Tyskland ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany 
Germany ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
INSOM 10 mg pezsgőtabletta brusetablet 
INSOM 10 mg pezsgőtabletta effervescent tablet oral use
Europa-Kommissionen vedtog en beslutning den 5. oktober 2010. 
The European Commission issued a decision on 5 October 2010.
Virksomheden ønskede, at markedsføringstilladelsen skulle anerkendes i Bulgarien, Tyskland, Frankrig, Irland og Italien ("de berørte medlemsstater"). 
The company wanted the authorisation to be recognised in Bulgaria, Germany, France, Ireland and Italy (the ‘concerned Member States').
Kristina Dunder (Sverige) 
Kristina Dunder (Sweden)
Daniela Melchiorri (Italien) 
Daniela Melchiorri (Italy)
Hvad er Norsed Combi D? 
What is Norsed Combi D?
Begrundelserne for indbringelsen var betænkeligheder med hensyn til dokumentationen for virkningen af dette kombinationslægemiddel, gyldigheden af påstandene om, at denne måde at kombinere aktive stoffer på ville være til fordel for patienterne sammenlignet med de enkelte aktive stoffer, og gyldigheden af påstandene om, at lægemidlet skabte bedre overensstemmelse (patienternes evne til at overholde behandlingen). 
The grounds for the referral were concerns over the evidence provided of the efficacy of this combination medicine, the validity of claims that this way of combining active substances would bring a benefit to patients compared with the individual active substances, and the validity of claims that the medicine improved compliance (the ability of patients to stick to their treatment).
Medlemsstaterne kunne imidlertid ikke nå til enighed, og den regulerende myndighed for lægemidler i Sverige indbragte den 29. april 2010 sagen for CHMP med henblik på voldgift. 
However, the Member States were not able to reach an agreement and the Swedish medicines regulatory agency referred the matter to the CHMP for arbitration on 29 April 2010.
Hvorfor blev Norsed Combi D vurderet igen? 
Why was Norsed Combi D reviewed?
5. oktober 2010 
5 October 2010
20. maj 2010 
20 May 2010
Når aktiviteten af disse celler hæmmes, sker der mindre tab af knoglemasse. 
Blocking the action of these cells leads to less bone loss.
På baggrund af en vurdering af de tilgængelige data og den videnskabelige diskussion i udvalget konkluderede CHMP, at fordelene ved Norsed Combi D er større end risiciene, og at markedsføringstilladelsen for Norsed Combi D derfor bør udstedes i alle de berørte medlemsstater. 
Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Norsed Combi D outweigh its risks, and therefore the marketing authorisation for Norsed Combi D should be granted in all concerned Member States.
Det bruges til at reducere risikoen for frakturer i hoften og ryggraden. 
It is used to reduce the risk of fractures (in the hip and spine.
De aktive stoffer i brusegranulatet tilfører calcium og D-vitamin, som er nødvendige for normal knogledannelse. 
The active substances in the effervescent granules provide calcium and vitamin D, which are needed for normal bone formation.
Det Europæiske Lægemiddelagentur (EMA) har gennemført en voldgiftsprocedure efter en uoverensstemmelse mellem Den Europæiske Unions medlemsstater vedrørende markedsføringstilladelsen for lægemidlet Norsed Combi D. EMA's Udvalg for Humanmedicinske Lægemidler (CHMP) har konkluderet, at fordelene ved Norsed Combi D er større end risiciene, og at den markedsføringstilladelse, der er udstedt i Sverige, kan anerkendes i andre EU-medlemsstater. 
The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Norsed Combi D. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Norsed Combi D outweigh its risks, and that the marketing authorisation granted in Sweden can be recognised in other Member States of the EU.
Det består af tabletter, der indeholder 35 mg risedronatnatrium, sammen med breve af brusegranulat, der indeholder 1000 mg calcium som calciumcarbonat og 880 IE colecalciferol. 
It consists of tablets containing 35 mg risedronate sodium, together with sachets of effervescent granules containing 1000 mg calcium as calcium carbonate and 880 IU colecalciferol.
Norsed Combi D anvendes til behandling af osteoporose (en sygdom, som gør knoglerne skrøbelige) hos postklimakterielle kvinder. 
Norsed Combi D is used for the treatment of osteoporosis (a disease that makes bones fragile) in women who have been through the menopause.
Det hæmmer aktiviteten af osteoklasterne, som er de celler, der er med til at nedbryde knoglevævet. 
It stops the action of the osteoclasts, the cells that are involved in breaking down the bone tissue.
Det aktive stof i tabletterne, risedronatnatrium, er et bifosfonat. 
The active substance in the tablets, risedronate sodium, is a bisphosphonate.
Norsed Combi D er et lægemiddel, der indeholder de tre aktive stoffer risedronatnatrium, calciumcarbonat og colecalciferol. 
Norsed Combi D is a medicine that contains three active substances, risedronate sodium, calcium carbonate and colecalciferol.
ansøgte om gensidig anerkendelse for Norsed Combi D på baggrund af den første markedsføringstilladelse, der blev udstedt af Sverige den 3. oktober 2006. 
Sanofi-aventis S.p.A. submitted Norsed Combi D for mutual recognition on the basis of the initial authorisation granted by Sweden on 3 October 2006.
Medrapportør: 
Co-rapporteur:
MF (EU)-nummer (Særnavn) navn Styrke Lægemiddelform Administration 
MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size
Disse foranstaltninger skal hjælpe med til at beskytte miljøet. 
These measures should help to protect the environment.
Deres virkning er i alt væsentligt begrænset til hurtigtdelende organismer. 
Their effect is essentially confined to rapidly dividing organisms.
Behandling af PPE (ileitis) 
Treatment of PPE (ileitis)
Tylvalosin har en sekstenleddet ring. 
Tylvalosin has a sixteen membered ring.
Åbnede poser må ikke opbevares. 
Opened bags should not be stored.
Hvor fødeindtagelsen er reduceret, anvendes den følgende formel: 
Where feed intake is reduced, use the following formula:
Spørg din dyrlæge, hvordan du bortskaffer lægemidler, der ikke længere er påkrævet. 
Ask your veterinary surgeon how to dispose of medicines no longer required.
For at opnå den korrekte dosis skal koncentrationen af Aivlosin justeres i overensstemmelse hermed. 
In order to obtain the correct dose, the concentration of Aivlosin has to be adjusted accordingly.
Yderligere én årlig periodisk sikkerhedsindberetning (PSUR) er påkrævet, og derefter skal PSUR'er indsendes med tre års mellemrum, medmindre andet kræves. 
One additional yearly periodic safety update report (PSUR) is required, and thereafter PSURs shall be submitted at three-yearly intervals, unless otherwise required.
Bakterier kan udvikle resistens over for antimikrobielle stoffer. 
Bacteria can develop resistance to antimicrobial substances.
Hold posen tæt tillukket. 
Keep the bag tightly closed.
Vask kontamineret hud. 
Wash contaminated skin.
Yderligere information om dette veterinærlægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside (http://www.ema.europa.eu). 
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu).
Der skal tages hensyn til svin, hvis daglige foderration er nedsat eller begrænset. 
Consideration must be given to pigs whose daily feed intake is reduced or restricted.
Efter åbning anvendes straks 
Once opened use immediately.
• ANDRE BETINGELSER: 
OTHER CONDITIONS:
Beregn den totale mængde nødvendigt produkt ved hjælp af den følgende formel: 
Calculate the total amount of product required with the formula:
Hold beholderen tæt tillukket. 
Keep the container tightly closed.
Den vigtigste metabolit af tylvalosin er 3-acetyltylosin (3AT), som også er mikrobiologisk aktiv. 
The major metabolite of tylvalosin is 3-acetyltylosin (3-AT), which is also microbiologically active.
Indtagelsen af medicineret vand afhænger af dyrenes kliniske tilstand. 
The intake of medicated water depends on the clinical condition of the animals.
Tmax for tylvalosin er cirka 2,2 timer; den terminale eliminationshalveringstid er cirka 2,2 timer. 
The tmax for tylvalosin is about 2.2 hours; the terminal half-life for the elimination is approximately 2.2 hours.
Der er ikke fastlagt nogen tærskelværdi for Brachyspira hyodysenteriae. 
No breakpoint for Brachyspira hyodysenteriae has been established.
10 dage 
10 days
De binder sig til donorstedet og forhindrer den translokation, der er nødvendig for fortsat vækst af peptidkæden. 
They bind to the donor site and prevent the translocation necessary for keeping the peptide chain growing.
ATCvet-kode: QJ01FA92 
ATCvet code: QJ01FA92.
Dato for første markedsføringstilladelse: 9. september 2004. 
Date of first authorisation: 9 September 2004.
Det svin, der skal behandles, skal vejes, og den mængde foder, svinet sandsynligvis vil indtage, skal estimeres ud fra det daglige foderindtag svarende til 5% af legemsvægten. 
The pig to be treated should be weighed and the amount of feed that the pig is likely to consume should be estimated, based on a daily feed intake equivalent to 5% of bodyweight.
Disse undersøgelser viste en beskeden, men statistisk signifikant reduktion i forekomsten af lavere respiratoriske læsioner (lunge og luftsæk) og kliniske tegn hos kalkuner behandlet med tylvalosin sammenlignet med negative kontroller. 
These studies demonstrated a modest but statistically significant reduction in the incidence of lower respiratory lesions (lung and air sac) and clinical signs in turkeys treated with tylvalosin compared with negative controls.
Den kliniske relevans af denne nedsatte følsomhed er ikke undersøgt fuldt ud. 
The clinical relevance of this reduced susceptibility is not fully explored.
Tylvalosin (som tylvalosintartrat) 
Tylvalosin (as tylvalosin tartrate)
Strategien for Mycoplasma gallisepticum-infektion bør omfatte bestræbelser på at eliminere patogenet fra forældregenerationen. 
The strategy for Mycoplasma gallisepticum infection should include efforts to eliminate the pathogen from the parent generation.
Behandlings -varighed 
Duration of treatment
Metabolismeundersøgelser in vitro har bekræftet, at udgangsstoffet hurtigt metaboliseres til 3-Oacetyltylosin. 
In vitro metabolism studies have confirmed that the parent compound is rapidly metabolised to 3-Oacetyltylosin.
Muskler Hud og fedt Lever 
Muscle Skin and fat Liver
Foderet med det orale pulver skal være den eneste foderration i de ovenfor anbefalede perioder. 
The feed containing the oral powder should be provided as the sole ration for the periods recommended above.
Laboratorieundersøgelser af dyr har ikke afsløret en teratogen virkning. 
Laboratory studies in animals have not produced any evidence of a teratogenic effect.
Foderlægemidlet kan derefter granuleres. 
Medicated feed may then be pelleted.
Oralt pulver. 
Oral powder.
I feltstudier, hvor effekten af behandling og metafylakse på mycoplasmose undersøgtes, fik alle fugle (cirka 3 uger gamle) produktet, når der var kliniske tegn i 2-5% af flokken. 
In field studies investigating the effect of treatment and metaphylaxis on mycoplasmosis, all birds (approximately 3 weeks old) received the product when clinical signs were evident in 2 - 5% of the flock.
BATCH NUMMER 
BATCH NUMBER
Foder med tilsat oralt pulver skal udskiftes, hvis det ikke er spist inden 24 timer. 
Feed to which the oral powder has been added should be replaced if not consumed within 24 hours.
Foderlægemidlet skal gives som eneste ration. 
The medicated feed should be fed as the sole ration.
Veterinærlægemidlet må kun tilsættes til tørfoder, der ikke er granuleret. 
The veterinary medicinal product should only be added to dry non-pelleted feed.
OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE/INDRE POSE 
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE/INNER BAG
Tylvalosin (som tylvalosintartrat) 625 mg/g. 
Tylvalosin (as tylvalosin tartrate) 625 mg/g.
Alle fugle i den berørte flok skal behandles. 
Treat all the birds in the affected flock.
De betragtes generelt som bakteriostatiske. 
They are generally considered bacteriostatic.
(som en sammenfoldet seddel vedhæftet direkte på den indre pakning eller som bagetiket på poser med 400 g) 
(attached as concertina label directly to the immediate package or as a back label for the 400 g sachet for one language)
Der bør ikke være andre tilgængelige drikkevandskilder under behandlingen. 
No other source of drinking water should be available during treatment.
Tylvalosins virkning over for O. rhinotracheale hos kalkuner blev vist i en challenge-model ved hjælp af co-infection med aviær metapneumovirus og en enkelt stamme af O. rhinotracheale under strengt kontrollerede forhold. 
Efficacy of tylvalosin against O. rhinotracheale in turkeys was demonstrated in a challenge model using co-infection with avian metapneumovirus and a single strain of O. rhinotracheale under strictly controlled conditions.
PPE (ileitis) & svinedysenteri 
PPE (ileitis) and swine dysentery
Der er ikke udført effektstudier under 'i marken'. 
Efficacy studies under field conditions have not been conducted.
Efter indgivelse af den anbefalede dosis blev der fundet lungekoncentrationer på 0,060-0,066 µg/ml 2 og 12 timer efter behandling. 
After administration of the recommended dose lung concentrations of 0.060-0.066 µg/ml were found at 2 and 12 hours post-treatment.
Hvidt granulat. 
White granules.
Fås i pakningsstørrelser indeholdende 5 kg eller 20 kg produkt. 
Available in pack sizes containing 5 kg or 20 kg of product.
Der menes at være flere mekanismer, der er ansvarlige for resistensudvikling over for makrolidforbindelser: nemlig ændring af det ribosomale målsted, brug af aktiv udstrømningsmekanisme og produktion af inaktiverende enzymer. 
It is considered that there are multiple mechanisms responsible for resistance development to macrolide compounds: namely alteration of the ribosomal target site, utilisation of active efflux mechanism and production of inactivating enzymes.
Medicinering bør kun anvendes til kortsigtet bedring af kliniske tegn i avlsflokke, mens der ventes på, at diagnosen Mycoplasma gallisepticum-infektion bekræftes. 
Medication should only be used for short-term amelioration of clinical signs in breeder flocks whilst awaiting confirmation of diagnosis of Mycoplasma gallisepticum infection.
Dette opnås ved at tilsætte Aivlosin til cirka 200-500 g foder og derefter blande denne præmikstur grundigt sammen med resten af den daglige ration. 
This is achieved by thoroughly mixing Aivlosin into approximately 200-500 g of feed and then thoroughly mixing this pre-mixture into the remainder of the daily ration.
1 kg/ton* 
1 kg/tonne*
Tylvalosin Sum af tylvalosin og 3-Oacetyltylosin 
Sum of tylvalosin and 3-Oacetyltylos in
Dato for seneste fornyelse af markedsføringstilladelse: 9. september 2014 
Date of last renewal: 9 September 2014
Start behandlingen snarest muligt efter konstatering af kliniske tegn på mycoplasmose. 
Treat as soon as possible after clinical signs suggestive of mycoplasmosis are observed.
Dette efterfølges af yderligere en behandling med 25 mg tylvalosin pr. kg legemsvægt pr. dag i drikkevand i 3 på hinanden følgende dage i risikoperioden, dvs. på tidspunkter for behandlingstress som f.eks. ved vaccinationer (typisk når fuglene er 2-3 uger gamle). 
This is followed by a second treatment with 25 mg tylvalosin per kg bodyweight per day in drinking water for 3 consecutive days at the period of risk, i.e. at times of management stress such as administration of vaccines (typically when birds are 2-3 weeks old).
Infektion med Mycoplasma gallisepticum reduceres, men elimineres ikke, ved brug af den anbefalede dosis. 
Infection with Mycoplasma gallisepticum is reduced but not eliminated at the recommended dose.
2 kg/ton* 
2 kg/tonne*
Sekundær infektion med organismer såsom Pasteurella multocida og Actinobacillus pleuropneumoniae kan komplicere enzootisk pneumoni og kræve særlig medicinering. 
Secondary infection by organisms such as Pasteurella multocida and Actinobacillus pleuropneumoniae may complicate enzootic pneumonia and require specific medication.