natgillin/translations-raw huggingface dataset:
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.
Pri mešanju zdravila in pri rokovanju z medicinirano krmo nosite osebno zaščitno opremo: zaščitno obleko, neprepustne rokavice, dihalno polmasko za enkratno uporabo skladno z evropskim standardom EN 149 ali dihalno masko skladno z evropskim standardom EN 140 s filtrom EN 143.
In case of accidental ingestion seek medical advice immediately and show the label to the physician.
V primeru nenamernega zaužitja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali ovojnino.
4.7 Use during pregnancy and lactation
4. 7 Uporaba v obdobju brejosti, laktacije ali nesnosti
Use only in accordance with risk/benefit assessment by the responsible veterinarian.
Uporabite le v skladu z oceno razmerja korist / tveganje odgovornega veterinarja.
Studies in laboratory animals have not produced any evidence of teratogenicity.
Z laboratorijskimi študijami niso bili dokazani teratogeni učinki.
Maternal toxicity in rodents has been observed at doses of 400 mg tylvalosin per kg bodyweight and above.
Pri odmerkih 400 mg tylvalosina na kg telesne mase in več so bili pri glodalcih zabeleženi maternotoksični učinki.
For treatment and prevention of Swine Enzootic Pneumonia The dosage is 2.125 mg tylvalosin per kg bodyweight per day in-feed for 7 consecutive days.
Za zdravljenje in preprečevanje enzootske pljučnice pri prašičih Odmerek je 2, 125 mg tylvalosina na kg telesne mase na dan s krmo 7 dni.
For treatment of Porcine Proliferative Enteropathy (ileitis) The dosage is 4.25 mg tylvalosin per kg bodyweight per day in-feed for 10 consecutive days.
Za zdravljenje prašičje proliferativne enteropatije (ileitis) Odmerek znaša 4, 25 mg tylvalosina na kg telesne mase na dan s krmo 10 dni.
For treatment and prevention of Swine Dysentery The dosage is 4.25 mg tylvalosin per kg bodyweight per day in-feed for 10 consecutive days.
Za zdravljenje in preprečevanje dizeneterije pri prašičih Odmerek znaša 4, 25 mg tylvalosina na kg telesne mase na dan s krmo 10 dni.
In dication
Indikacija
Dose of active
Odmerek
ingredient
aktivne
Aivlosin 42.5 mg/g Premix
Aivlosin 42, 5 mg/ g predmešanica
Treatment and prevention of swine enzootic pneumonia
sestavine Zdravljenje in preprečevanje enzootske pljučnice pri prašičih
2.125 mg/kg bodyweight/day
2, 125 mg/ kg telesne mase/ dan
1 kg/tonne*
1 kg/ tono *
Treatment of PPE (ileitis)
4, 25 mg/ kg telesne mase/ dan
2 kg/tonne*
2 kg/ tono *
Treatment and prevention of swine dysentery
Zdravljenje in preprečevanje dizenterije pri prašičih
4.25 mg/kg bodyweight/day
4, 25 mg/ kg telesne mase/ dan
* Important: these inclusion rates are assumes a pig eats equivalent of 5% bodyweight per day.
* Pomembno: pri razmerjih vsebnosti se predpostavlja, da prašič na dan poje ekvivalent 5% lastne telesne mase.
In older pigs, or in pigs with reduced appetite, or on restricted feed intake, inclusion levels may need to be increased to achieve target dosage.
Pri starejših prašičih ali prašičih z zmanjšanim apetitom oziroma z omejenim prehranjevalnim režimom bo za doseganje tarčnega odmerjanja morda potrebno zvišati razmerja vsebnosti.
Dose rate (mg/kg bodyweight) x bodyweight (kg)
Razmerje v odmerku (mg/ kg telesne mase) x telesna masa (kg) Kg Predmešanice/ tono krme
Daily feed intake (kg) x Premix strength (mg/g)
Dnevna količina krme (kg) x koncentracija predmešanice (mg/ g)
As an adjunct to medication, good management and hygiene practices should be introduced in order to reduce the risk of infection and to control the build up of resistance.
Kot dodatek zdravljenju, bi morali uvesti dobro gospodarjenje in higienske prakse, da bi tako zmanjšali tveganje infekcije in za nadzor morebitne krepitve rezistence.
Pelleting conditions involve a single pre-conditioning step with steam for 5 minutes and pelleting at not more than 70°C under normal conditions.
Peletiranje obsega 5- minutno predpripravo v enem koraku s paro in peletiranje pri največ 70 °C pod normalnimi pogoji.
No signs of intolerance have been observed in growing pigs at up to 10 times the recommended dosage.
4. 10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno)
2 days
2 dni.
Macrolide antibiotic, ATC vet code:
Farmakoterapevtska skupina: makrolidni antibiotik, oznaka ATC vet.:
Tylvalosin tartrate is a macrolide antibiotic that has antibacterial activity against Gram-positive, some Gram-negative organisms and mycoplasma.
Tylvalosin tartrat je makrolidni antibiotik z antibakterijskim delovanjem proti grampozitivnim in nekaterim gramnegativnim organizmom, in mikoplazmam.
Tylvalosin has a sixteen membered ring.
Tylvalosin ima šestnajstčlenski obroč.
Macrolides interfere with protein synthesis by reversibly binding to the 50S ribosome subunit.
4 Makrolidi motijo sintezo proteinov tako, da se reverzibilno vežejo na 50S ribosomsko podenoto.
4 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.
Na razvoj rezistence proti makrolidnim spojinam vpliva več mehanizmov: in sicer sprememba ribosomskega ciljnega mesta, izraba aktivnega sekretornega mehanizma in produkcija inaktiviranih encimov.
Resistance to tylvalosin by Mycoplasma hyopneumoniae and Lawsonia intracellularis has not been reported or found in the field to date.
O rezistenci Mycoplasma hyopneumoniae in Lawsonia intracellularis na tylvalosinu ni poročil, ali pa ta ni bila ugotovljena.
Generally strains of B. hyodysenteriae have higher MIC values in cases of resistance against other macrolides, such as tylosin.
Sevi B. hyodysenteriae imajo v primerih rezistence na druge makrolide, kakršen je tilozin, v splošnem višje vrednosti MIK.
Cross-resistance between tylvalosin and other macrolide antibiotics cannot be excluded.
Navzkrižne rezistence med tylvalosinom in drugimi makrolidnimi antibiotiki ni mogoče izključiti.
5.2 Pharmacokinetic properties
5. 2 Farmakokinetični podatki
Tylvalosin tartrate is rapidly absorbed after oral administration of Aivlosin.
Tylvalosin tartrat se po peroralnem dajanju zdravila Aivlosin zelo hitro absorbira.
After administration of the recommended dose lung concentrations of 0.060 – 0.066 µg/ml were found at 2 and 12 hours post-treatment.
Po dajanju priporočenega odmerka je bila v pljučih izmerjena koncentracija 0. 060- 0. 066 µg/ ml 2 uri in 12 ur po dajanju.
In vitro metabolism studies have confirmed that the parent compound is rapidly metabolised to 3-O- acetyltylosin.
In vitro študije metabolizma so potrdile, da se prvotna spojina zelo hitro presnavlja v 3- O- acetiltilozin.
In a trial with 14C aivlosin administered at 2.125 mg/kg to pigs for 7 days over 70% of the dose was excreted in the faeces, with urinary excretion accounting for 3 to 4% of the dose.
V poskusih s 14C aivlosinom, ki so ga prašiči dobivali v odmerku 2. 125 mg/ kg 7 dni, je bilo več kot 70% odmerka izločenega z blatom, 3 do 4% odmerka pa z urinom.
Magnesium trisilicate (sepiolite) (declared on labelling as carrier) Wheat feed flour Hydroxypropyl cellulose Non-fat soyabean powder
Magnezijev trisilikat (sepiolit) (na oznakah naveden kot nosilec) Pšenična krmna moka Hidroksipropilceluloza Nemasten sojin prašek
(declared on labelling as carrier)
(na oznakah naveden kot nosilec)
None known.
Niso poznane.
Shelf-life of the veterinary medicinal product as packaged for sale:
Rok uporabnosti zdravila za uporabo v veterinarski medicini v pakiranju za prodajo:
Shelf-life after incorporation into feed:
Rok uporabnosti po vmešanju v krmo:
1 month in meal or pellets
1 mesec po vmešanju v pšenično krmno moko ali v obliki peletirane krme
Do not store above 25°C Keep the container tightly closed.
Vsebnik shranjujte tesno zaprt.
5 6.5 Nature and contents of container
5 6. 5 Vrsta ovojnine in vsebina
One aluminium foil/polyester laminated bag containing 5 or 20 kg.
Ena vreča iz aluminijeve folije, laminirane s poliestrom, vsebuje 5 ali 20 kg Ni nujno, da so v prometu vsa navedena pakiranja.
6.6 Special precautions for the disposal of unused medicinal product or waste materials, if any
6. 6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi
NAME OR CORPORATE NAME AND ADDRESS OR REGISTERED PLACE OF BUSINESS OF THE MARKETING AUTHORISATION HOLDER
IMETNIK( I) DOVOLJENJ( A) ZA PROMET
ECO Animal Health Limited 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom
ECO Animal Health Limited 78 Coombe Road New Malden Surrey KT3 4QS Velika Britanija
DATE OF FIRST AUTHORISATION
DATUM PRIDOBITVE/ PODALJŠANJA DOVOLJENJA ZA PROMET
18.03.2009
< datum odločbe Komisije >
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/
Podrobne informacije o zdravilu so na voljo na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /.
PROHIBITION OF SALE, SUPPLY AND/OR USE
PREPOVED PRODAJE, OSKRBE IN/ ALI UPORABE
Aivlosin 8.5 mg/g Premix for medicated feeding stuff for pigs.
Aivlosin 8, 5 mg/ g predmešanica za izdelavo medicinirane krme za prašiče.
Premix for medicated feeding stuff A light yellow or light brown-yellow powder
Predmešanica za izdelavo medicinirane krme Svetlo rumen ali svetlo rjavo rumen prašek
4.5 Special warnings
4. 4 Posebna opozorila
7 4.5 Special precautions for use
7 4. 5 Posebni previdnostni ukrepi
None known
Niso znani
Dose of active ingredient
Razmerja vsebnosti v krmi
Duration of treatment
zdravljenja
In feed inclusion rate Aivlosin 8.5 mg/g Premix
Aivlosin 8, 5 mg/ g predmešanica
5 kg/tonne*
5 kg/ tono *
10
10 kg/ tono *
Macrolides interfere with protein synthesis by reversibly binding to the 50S ribosome subunit.
9 Makrolidi motijo sintezo proteinov tako, da se reverzibilno vežejo na 50S ribosomsko podenoto.
The ir effect is essentially confined to rapidly dividing organisms.
Ta učinek je omejen na hitro deleče se organizme.
9 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.
Na razvoj rezistence proti makrolidnim spojinam vpliva več mehanizmov: in sicer sprememba ribosomskega ciljnega mesta, izraba aktivnega sekretornega mehanizma in produkcija inaktiviranih encimov.
6.2 List of excipients
6. 1 Seznam pomožnih snovi
Magnesium trisilicate (sepiolite) (declared on labelling as carrier) Wheat feed flour Hydroxypropyl cellulose Non-fat soyabean powder Paraffin light liquid
Magnezijev trisilikat (sepiolit) (na oznakah naveden kot nosilec) Pšenična krmna moka Hidroksipropilceluloza Nemasten sojin prašek Lahki tekoči parafin
1 month meal, 2 weeks in pellets
1 mesec po vmešanju v pšenično krmno moko, 2 tedna v obliki peletirane krme
10 6.7 Nature and contents of container
10 6. 5 Vrsta ovojnine in vsebina
One polyethylene lined paper bag containing 5 or 20 kg.
Ena papirnata vreča s prevleko iz polietilena vsebuje 5 ali 20 kg Ni nujno, da so v prometu vsa navedena pakiranja.
6.8 Special precautions for the disposal of unused medicinal product or waste materials, if any
6. 6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/
Podrobne informacije o zdravilu so na voljo na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /
Aivlosin 8.5 mg/g Oral Powder for pigs
Aivlosin 8, 5 mg/ g peroralni prašek za prašiče
Tylvalosin (as Tylvalosin tartrate)
Zdravilna( e) učinkovina( e): tylvalosin (kot tylvalosin tartrat)
For a full list of excipients see section 6.1.
Za celoten seznam pomožnih snovi, glejte poglavje 6. 1.
A light yellow or light brown-yellow powder.
Svetlo rjav ali svetlo rjavo- rumen prašek
Treatment of Porcine Proliferative Enteropathy caused by Lawsonia intracellularis in herds where there is a diagnosis based on clinical history, post-mortem findings and clinical pathology results.
Zdravljenje prašičje proliferativne enteropatije, ki jo povzroča Lawsonia intracellularis v čredah, kjer je bila diagnoza osnovana na klinični zgodovini, ugotovitvah post mortem in rezultatih klinične patologije.
Treatment of clinical outbreaks of swine dysentery, caused by Brachyspira hyodysenteriae in herds where the disease has been diagnosed and prevention of further clinical cases.
Zdravljenje kliničnih izbruhov dizenetrije pri prašičih, ki jo povzroča Brachyspira Hydosenteriae, v čredah, kjer je bila diagnosticirana bolezen, in za preprečevanje nadaljnjih kliničnih primerov.
Acute cases and severely diseased pigs with reduced food and water intake should be treated with a suitable injectable product.
Akutne primere in hudo bolne prašiče z akutnimi infekcijami, ki manj pijejo in jedo, je treba najprej zdraviti z ustreznim zdravilom v obliki raztopine za injiciranje.
Generally, strains of B. hyodysenteriae have higher MIC values in cases of resistance against other macrolides such as tylosin.
Sevi B. hyodysenteriae imajo v primerih rezistence na druge makrolide, kakršen je tilozin, v splošnem višje vrednosti MIK.
The clinical relevance of this reduced susceptibility is not fully explored.
Klinični pomen te zmanjšanje odpornosti še ni popolnoma raziskan.
4.5 Special precautions for use
12 4. 5 Posebni previdnostni ukrepi
12 Special precautions to be taken by the person administering the medicinal product to the animals
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo
When adding the veterinary medicinal product to the individual feed ration and when handling this medicated feed, direct contact with eyes, skin and mucous membranes should be avoided.
Pri dodajanju zdravila za uporabo v veterinarski medicini posameznim krmilnim obrokom in pri rokovanju rokovanju s to krmo se je treba izogibati direktnemu stiku z očmi, kožo in sluznicami.
Personal protective equipment should be worn when handling the veterinary medicinal product or the feed with product added: 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.
Pri rokovanju z zdravilom za uporabo v veterinarski medicini ali s krmo z dodanim zdravilom nosite osebno zaščitno opremo: zaščitno obleko, neprepustne rokavice, dihalno polmasko za enkratno uporabo skladno z evropskim standardom EN 149 ali dihalno masko skladno z evropskim standardom EN 140 s filtrom EN 143.
In case of accidental ingestion seek medical advice immediately and show the label to the physician.
V primeru nenamernega zaužitja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali nalepko na zunanji ovojnini.
4.6 Adverse Reactions (frequency and seriousness)
4. 6 Neželeni učinki (pogostost in resnost)
For use in individual pigs on farms where only a small number of pigs are to receive the medicine.
Za zdravljenje posameznih prašičev na farmah, kjer se zdravilo daje le majhnemu številu prašičev.
For treatment and prevention of Enzootic Pneumonia The dosage is 2.125 mg tylvalosin per kg bodyweight per day for 7 consecutive days.
Za zdravljenje in preprečevanje enzootske pljučnice Odmerek je 2, 125 mg tylvalosina na kg telesne mase na dan 7 dni.
Secondary infection by organisms such as Pasteurella multocida and Actinobacillus pleuropneumoniae may complicate enzootic pneumonia and require specific medication.
Sekundarna infekcija zaradi organizmov kot Pasteurella multocida in Actinobalcillus pleuropneumoniae lahko povzroči zaplete pri enzootski pljučnici in zahteva posebno zdravljenje.
For treatment of Porcine Proliferative Enteropathy (ileitis) The dosage is 4.25 mg tylvalosin per kg bodyweight per day for 10 consecutive days.
Za zdravljenje prašičje proliferativne enteropatije (ileitis) Odmerek znaša 4, 25 mg tylvalosina na kg telesne mase na dan z krmo, 10 dni.
For treatment and prevention of Swine Dysentery The dosage is 4.25 mg tylvalosin per kg bodyweight per day for 10 consecutive days.
Za zdravljenje in preprečevanje dizenetrije pri prašičih Odmerek znaša 4, 25 mg tylvalosina na kg telesne mase na dan z krmo 10 dni.
This is achieved by thoroughly mixing Aivlosin 8.5 mg/g Oral Powder into the daily ration for each individual pig.
To dosežemo tako, da Aivlosin 8, 5 mg/ g peroralni prašek vmešamo v dnevno količino krme za vsakega prašiča posebej.
Scoops of 3 sizes are provided for measuring the correct amount of Aivlosin 8. 5 mg/g Oral Powder for mixing with the daily ration, according to the schedule below.
Za odmerjanje ustreznega odmerka peroralnega praška Aivlosin 8, 5 mg/ g, ki se po spodaj navedenem razporedu vmeša v dnevni obrok, so na voljo lopatice treh velikosti.
The feed containing the oral powder should be provided as the sole ration for the periods recommended above.
Krma, ki vsebuje peroralni prašek, mora biti edina krma, ki jo prašiči prejemajo v trajanju, priporočenem zgoraj
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.
13 Prašiča, ki ga zdravimo, je treba stehtati in oceniti količino krme, ki jo bo zaužil, ob predpostavki, da je dnevna količina zaužite krme 5% telesne mase.
Consideration must be given to pigs whose daily feed intake is reduced or restricted.
Pozorni morate biti na prašiče, pri katerih je dnevna količina krme zmanjšana ali omejena.
The correct quantity of Aivlosin 8.5 mg/g Oral Powder should be added to the estimated quantity of daily ration for each pig, in a bucket or similar receptacle, and thoroughly mixed.
Ustrezno količino peroralnega praška Aivlosin 8, 5 mg/ g je treba dodati ocenjeni dnevni količini krme za vsakega prašiča posebej količini v vedru ali podobni posodi in dobro premešati.
13 The product should only be added to dry non-pelleted feed.
Zdravilo se sme dodajati samo suhi nepeletirani krmi.
Swine Enzootic Pneumonia 2. 125 mg/kg bodyweight
Enzootična pljučnica pri prašičih 2, 125 mg/ kg telesne mase
PPE (ileitis) & Swine Dysentery 4.25 mg/kg bodyweight
PPE (ileitis) in Griža pri prašičih 4, 25 mg/ kg telesne mase
Bodyweight range (kg) 6.5 - 12
Interval telesne mase (kg)
Scoop size 5 ml
Velikost Število Interval telesne Velikost lopatice lopatic mase (kg) lopatice
Number of Bodyweight scoops range (kg) 1 6.5-12 13-24
Število lopatic 1
Scoop size 10 ml 10 ml
5 ml 1 6. 5 - 12 10 ml 13 - 24 10 ml
13 - 2 4 2 5 - 48 49 - 72 73 - 9 6
49 - 72
1 25-48 2 49-72 3 73-96 4
49 - 72 73 - 96
4 6 8
3 4
5 97-115 6 116-145 7 146-175 8 176-200
5 6 7 8
A level scoop of the product should be measured
Opomba: količino zdravila v lopatici morate izmeriti.
As an adjunct to medication, good management and hygiene practices should be introduced in order to reduce the risk of infection and to control the potential build up of resistance.
Kot dodatek zdravljenju, bi morali uvesti dobro gospodarjenje in higienske navade, da bi tako zmanjšali tveganje infekcije in za nadzor morebitne krepitve rezistence.
Two days
2 dni.
Macrolides interfere with protein synthesis by reversibly binding to the 50S ribosome subunit.
14 Makrolidi motijo sintezo proteinov tako, da se reverzibilno vežejo na 50S ribosomsko podenoto.
Resistance to tylvalosin by Mycoplasma hyopneumoniae and Lawsonia intracellularis has not been reported or found in the field to date.
O rezistenci Mycoplasma. hyopneumoniae in Lawsonia intracellularis na tylvalosin ni poročil, ali pa ta ni bila ugotovljena.
No breakpoint for Brachyspira hyodysenteriae has been
Za Brachyspira hyodysenteriae ni bilo ugotovljene nobene točke spremembe.
Generally, strains of b. hyodysenteriae have higher MIC values in cases of resistance against other macrolides, such as tylosin.
Na splošno imajo sevi b. hyodysenteriae pri primerih rezistence proti drugim makrolidom, kakršen je tilozin, večje MIK vrednosti.
The clinical relevance of this reduced susceptibility is not fully explored.
Klinični pomen te zmanjšane občutljivosti ni bil popolnoma raziskan.
Magnesium trisilicate (sepiolite) Wheat feed flour Hydroxypropyl cellulose Non-fat soyabean powder Paraffin light liquid
Magnezijev trisilikat (sepiolit) Pšenična krmna moka Hidroksipropilceluloza Nemasten sojin prašek Lahki tekoči parafin
3 years Feed to which the oral powder has been added should be replaced if not consumed within 24 hours.
Krmo, ki ji je dodan peroralni prašek je treba zamenjati, če ni porabljena v 24 urah.
One polyethylene lined paper bag containing 1 or 3 kg.
Ena papirnata vreča s prevleko iz polietilena vsebuje 1 kg ali 3 kg zdravila.
Scoops of 5 ml, 10 ml and 25 ml are attached.
Lopatice po 5 ml, 10 ml in 25 ml so priložene.
Aivlosin 625 mg/g Granules for use in drinking water for chickens
Aivlosin 625 mg/ g Zrnca za uporabo v vodi za pitje za piščance
Tylvalosin (as tylvalosin tartrate)
Tilvalozin v obliki tilvalozinijevega tartrata
For a full list of excipients, see section 6.1
Za celoten seznam pomožnih snovi, glejte poglavje 6. 1.
Granules for use in drinking water, White granules.
Zrnca za uporabo v vodi za pitje Bela zrnca.
Treatment and prevention of respiratory disease associated with Mycoplasma gallisepticum in chickens.
Zdravljenje in preprečevanje z Mycoplasma gallisepticum povezanih bolezni dihal pri piščancih.
As an aid in the prevention strategy to reduce the clinical signs and mortality from respiratory disease in flocks, where infection in ovum with Mycoplasma gallisepticum is likely because the disease is known to exist in the parent generation.
Kot pripomoček v strategiji preventive za zmanjševanje kliničnih znakov in smrtnosti zaradi bolezni dihal pri jatah, pri katerih je verjetna infekcija in ovo z Mycoplasma gallisepticum, ker je znano, da bolezen obstaja v roditeljski generaciji.
The prevention strategy should include efforts to eliminate the infection from the parent generation.
Strategija preventive naj vključuje poskuse odstranitve infekcije iz roditeljske generacije.
Tylvalosin has been shown to cause hypersensitivity reactions in laboratory animals; therefore, people with known hypersensitivity to tylvalosin tartrate should avoid contact with the veterinary medicinal product.
Izkazalo se je, da tilvalozin pri laboratorijskih živalih povzroča preobčutljivostne reakcije; zato naj se osebe z znano preobčutljivostjo na tilvalozin tartrat izogibajo stiku z zdravilom za uporabo v veterinarski medicini.
17 When mixing the veterinary medicinal product and handling the medicated water, direct contact, with eyes, skin and mucous membranes should be avoided.
17 Pri mešanju zdravila za uporabo v veterinarski medicini in rokovanju z vodo s primešanim zdravilom se izogibajte neposrednemu stiku z očmi in sluznicami.
Personal protective equipment consisting of impervious gloves and a half-mask respirator conforming to European Standard EN 149 or a non- disposable respirator conforming to European Standard EN 140, with a filter conforming to European Standard EN 143 should be worn when mixing the veterinary medicinal product.
Pri mešanju zdravila za uporabo v veterinarski medicini je treba nositi osebno zaščitno opremo, ki jo sestavljajo delovna obleka, neprepustne rokavice in respiratorna polobrazna maska v skladu z evropskim standardom EN 149 ali respirator za večkratno uporabo v skladu z evropskim standardom EN 140 s filtrom v skladu z evropskim standardom EN 143.
Wash contaminated skin.
Onesnaženo kožo umijte.
The safety of the veterinary medicinal product has not been established during lay.
4. 7 Uporaba v obdobju brejosti, laktacije ali nesnosti
4.8 Interaction with other medicinal products and other forms of interaction
Varnost zdravila v obdobju nesnosti ni bila ugotovljena.