FrancophonIA/ELRC3.0 huggingface dataset:
English: As to where the SPC in Austria and Italy include indications that cover enteric disease caused by Clostridia, CVMP concludes that no data have been provided in support of this claim.
Slovenian: V zvezi s tem, kje so v povzetku glavnih značilnosti zdravila v Avstriji in Italiji vključene enteričnih bolezni, ki jih povzročajo klostridiji, CVMP meni, da niso bili predloženi nobeni podatki, ki bi podprli to zahtevo.
English: LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATE
Slovenian: DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI , ŽIVALSKIH VRST, POTI UPORABE IN IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
English: It is also distributed in the liver and kidney tissues.
Slovenian: Porazdeli se tudi v tkiva jeter in ledvic.
English: When mixing the veterinary medicinal product and handling the medicated feed, direct contact with eyes, skin and mucous membranes should be avoided.
Slovenian: Pri mešanju zdravila za uporabo v veterinarski medicini in ravnanju z zdravilno krmno mešanico preprečite stik zdravila z očmi, kožo in sluznicami.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Active substance:
Slovenian: NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGIH SNOVI
English: The CVMP has assessed a PK/PD approach to support use in respiratory disease in rabbit and one clinical trial, as well as bibliographic and pharmacovigilance data provided by the
Slovenian: CVMP je ocenil farmakokinetični/farmakodinamični pristop za podporo uporabe pri boleznih dihal pri kuncih, eno klinično preskušanje ter bibliografske in farmakovigilančne podatke, ki so jih predložili imetniki dovoljenja za promet z zdravilom.
English: 4.11 Withdrawal period(s): for pigs the withdrawal period granted for the product varies among the Member States from 7 to 21 days before slaughter
Slovenian: 4.11 Karenca: odobrena karenca za zdravilo pri prašičih se razlikuje med državami članicami in znaša od 7 do 21 dni pred zakolom.
English: The CVMP recommends that further changes to the SPC proposed by the Marketing Authorisation Holders are made:
Slovenian: CVMP priporoča, da se v povzetek glavnih značilnosti zdravila, ki so ga predlagali imetniki dovoljenja za promet z zdravilom, vnesejo naslednje spremembe:
English: • The description of the nature and composition of immediate packaging should be harmonised.
Slovenian: • opis vrste ovojnine in vsebine stične ovojnine je treba uskladiti.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF PULMOTIL VET PREMIX
Slovenian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA PULMOTIL VET PREMIX
English: It is noted in relation to the list of excipients, that the difference in formulations of the different product strengths should be resolved by the use of separate SPCs per product strength;
Slovenian: V zvezi s seznamom pomožnih snovi je treba poudariti, da je treba razlike med formulacijami različnih jakosti zdravila odpraviti z uporabo ločenih povzetkov glavnih značilnosti zdravila za vsako posamezno jakost zdravila;
English: Shelf life of the veterinary medicinal product as packaged for sale: the proposed 2 years is acceptable.
Slovenian: Rok uporabnosti zdravila v pakiranju za prodajo: predlagani rok 2 leti je sprejemljiv.
English: - The efficacy against infections caused by Haemophilus parasuis in pigs has not been substantiated; - Contraindications should include a statement in relation to the hypersensitivity to tilmicosin; - Due to the likely variability (time, geographical) in the occurrence of the resistance of bacteria for tilmicosin, bacteriological sampling and susceptibility testing are recommended; - The special precautions to be taken by the person administering the veterinary medicinal product to animals need modification; - Information should be provided on pre-mixing before pelleting and pelleting temperature; - The inclusion rate in feed established would differ for each product strength; - The reference to rice hulls should be removed; - The shelf life after first opening of the immediate packaging should be added; - The proven shelf life after incorporation into meal or pelleted feed is 1 month; - The description of the nature and composition of immediate packaging should be harmonised; - The complete SPC should be harmonised in the framework of this referral procedure,
Slovenian: - učinkovitost proti okužbam, ki jih pri prašičih povzroča Haemophilus parasuis, ni utemeljena; - kontraindikacije morajo vsebovati izjavo v zvezi s preobčutljivostjo za tilmikozin; - zaradi verjetne (časovne, geografske) variabilnosti pojavljanja odpornosti bakterij proti tilmikozinu se priporoča odvzem bakteriološkega vzorca in preverjanje občutljivosti; - poglavje Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo, je treba popraviti; - vstaviti je treba podatke o predmešanju pred peletiranjem in o temperaturi peletiranja; - stopnja dodajanja v krmo se razlikuje pri vsaki posamezni jakosti zdravila; - odstraniti je treba sklic na luščine riža; - dodati je treba rok uporabnosti po prvem odpiranju stične ovojnine; - dokazani rok uporabnosti po dodajanju v obrok ali peletirano hrano je 1 mesec; - opis vrste ovojnine in vsebine stične ovojnine je treba uskladiti; - celoten povzetek glavnih značilnosti zdravila je treba uskladiti v okviru tega napotitvenega postopka,
English: - To avoid exposure during preparation of the medicated feed, wear overalls, safety glasses, impervious gloves and wear either a disposable half mask respirator conforming to European Standard EN149 or a non-disposable respirator to European Standard EN140 with a filter to EN143.
Slovenian: uporabite varnostna očala in nepropustne rokavice ter bodisi polovično masko z respiratorjem za enkratno uporabo, skladno z evropskim standardom EN149, bodisi respirator za večkratno uporabo, skladen z evropskim standardom EN140, ki ima nameščen filter, skladen z EN143.
English: The Marketing Authorisation Holders submitted at the request of CVMP: - an exhaustive list of differences between the SPCs of the product authorized in the member states; - a proposal for a harmonised product information (SPC, labelling and package leaflet), taking into account the latest guidance; - the available relevant data substantiating such proposed harmonised product information.
Slovenian: Imetniki dovoljenja za promet z zdravilom so na zahtevo CVMP predložili: - popoln seznam razlik med povzetki glavnih značilnosti zdravila, ki so odobreni v državah članicah; - osnutek usklajenih informacij o zdravilu (povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo) ob upoštevanju najnovejših priporočil; - razpoložljive zadevne podatke, ki utemeljujejo tako predlagane usklajene informacije o zdravilu.
English: The highest concentration in the serum (0.23 ±0.08 µg/ml) was recorded on day 10 of medication, but concentrations above the limit of quantification (0.10 µg/ml) were not found in 3 out of 20 animals examined.
Slovenian: Najvišjo koncentracijo v serumu (0,23 ± 0,08 µg/ml) so ugotovili 10. dan zdravljenja, vendar koncentracije nad mejo kvantifikacije (0,10 µg/ml) niso bile zaznane pri 3 od 20 preiskanih živalih.
English: In conclusion, the recommended shelf life after incorporation into meal or pelleted feed for both target species is 1 month.
Slovenian: Zato je priporočeni rok uporabnosti po dodajanju v obrok ali peletirano hrano za obe ciljni živalski vrsti 1 mesec.
English: • The shelf life after first opening of the immediate packaging should be added;
Slovenian: • dodati je treba rok uporabnosti po prvem odpiranju stične ovojnine;
English: Having considered the grounds for referral and the response provided by the Marketing Authorisation Holders, the CVMP concludes that the benefit/risk balance of the products is positive for use in both pigs and rabbits subject to the recommended changes of Summary of the Product Characteristics and product information (Annex III).
Slovenian: Ob upoštevanju podlage za napotitveni postopek ter odgovora imetnikov dovoljenja za promet z zdravilom CVMP meni, da je razmerje med koristmi in tveganji zdravila pozitivno za uporabo pri prašičih in kuncih ob upoštevanju priporočenih sprememb povzetka glavnih značilnosti zdravila in informacij o zdravilu (Dodatek 1).
English: After 5 days of treatment with medicated feed at a dosage of 200 ppm of Pulmotil, tilmicosin concentrations in lung tissues were of 192 ± 103 µg/g.
Slovenian: Po 5 dneh zdravljenja z zdravilno krmno mešanico z odmerkom 200 ppm zdravila Pulmotil so bile koncentracije tilmikozina v pljučnem tkivu 192 ± 103 µg/g.
English: The Marketing Authorisation Holders' proposal to harmonise the withdrawal period for both species, on the basis of the pivotal residue studies presented can be accepted:
Slovenian: CVMP lahko sprejme predlog imetnikov dovoljenja za promet z zdravilom, da se karenci za obe živalski vrsti uskladita na podlagi predloženih ključnih študij ostankov:
English: METHOD AND ROUTE(S) OF ADMINISTRATION In-feed use.
Slovenian: NAČIN IN POT(I) UPORABE ZDRAVILA Za v krmo.
English: Horses fed with tilmicosin medicated feeds may present signs of toxicity with lethargy, anorexia, reduction of feed consumption, loose stools, colic, distension of the abdomen and death.
Slovenian: Pri konjih, ki zaužijejo krmne mešanice s tilmikozinom, se lahko pojavijo znaki toksičnosti z letargijo, anoreksijo, zmanjšanim vnosom krme, redkejšimi iztrebki, koliko, distenzijo abdomna in poginom.
English: Pharmaceutical form Strength
Slovenian: Farmacevtska oblika
English: • Include a new statement in relation to the prudent use: due to the likely variability (time, geographical) in the occurrence of the resistance of bacteria for tilmicosin, bacteriological sampling and susceptibility testing are recommended;
Slovenian: • vključitev nove izjave v zvezi s preudarno rabo: Zaradi verjetne (časovne, geografske) variabilnosti pojavljanja odpornosti bakterij proti tilmikozinu se priporoča odvzem bakteriološkega vzorca in preverjanje občutljivosti;
English: In respect of the benefit/risk balance for target species rabbit, the CVMP considers that benefit/risk balance is positive: - notwithstanding the fact that the clinical field study using dosage of the product have some shortcomings, the pre-clinical studies and the recent MICs data suggest the effective dosage in feed is 12.5 mg/kg for 7 days in the prevention and treatment of respiratory disease caused by Pasteurella multocida and Bordetella bronchiseptica in rabbits; - rabbit is minor species, with specific problems on availability of authorised veterinary products; - the history of use and the various management steps now set out in the harmonised SPC (bacteriological sampling and susceptibility testing are recommended).
Slovenian: V zvezi z razmerjem med koristmi in tveganji za ciljno živalsko vrsto kunec CVMP meni, da je to razmerje pozitivno: - kljub dejstvu, da ima klinična terenska študija z uporabo odmerka zdravila določene pomanjkljivosti, predklinične študije in nedavni podatki o najmanjših inhibicijskih koncentracijah (MIK) kažejo, da je za preprečevanje in zdravljenje bolezni dihal pri kuncih, ki jih povzročata Pasteurella multocida in Bordetella bronchiseptica, učinkovito odmerjanje v krmi 12,5 mg/kg v obdobju 7 dni; - kunec je manj pomembna vrsta s posebnimi težavami glede razpoložljivosti odobrenih veterinarskih zdravil; - pretekla uporaba in različne stopnje obravnave se lahko sedaj opredelijo v usklajenem povzetku glavnih značilnosti zdravila (priporočena sta odvzem bakteriološkega vzorca in preverjanje občutljivosti).
English: Horses or other Equidae, must not be allowed access to feeds containing tilmicosin.
Slovenian: Konji in drugi kopitarji ne smejo imeti dostopa do krmnih mešanic, ki vsebuje tilmikozin.
English: The maximum concentration in lung tissue (2.59±1.01 µg/ml) was recorded on day 10 of medication.
Slovenian: Najvišja koncentracija v pljučnem tkivu (2,59±1,01 µg/ml) je bila zaznana 10. dan zdravljenja.
English: Absorption: When administered to pigs via the oral route at a dose of 400 mg tilmicosin/kg feed (equivalent to approximately 21.3 mg tilmicosin/kg bodyweight/day), tilmicosin moves rapidly out of the serum into areas of low pH.
Slovenian: Absorpcija: Pri prašičih tilmikozin po peroralnem dajanju odmerka 400 mg/kg krmne mešanice (enakovredno približno 21,3 mg tilmikozina/kg telesne mase/dan) hitro preide iz seruma v področja z nizkim pH.
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary No symptoms of overdose have been seen in pigs fed a ration containing levels of tilmicosin up to 80 mg/kg bodyweight (equivalent to 2000 ppm in the feed or ten times the recommended dose) for 15 days.
Slovenian: 4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) Pri prašičih, ki so 15 dni prejemali obrok z ravnmi tilmikozina do 80 mg/kg telesne mase (enakovredno 2000 ppm v krmni mešanici ali desetkratniku priporočenega odmerka), niso opazili simptomov prevelikega odmerjanja.
English: 100 g tilmicosin per 1000 g Member State Marketing Authorisation Holder
Slovenian: 100 g tilmikozina na 1000 g Država članica Imetnik dovoljenja za promet
English: Not to be incorporated into feeds containing Bentonite.
Slovenian: Zdravila ne smete vmešati v krmne mešanice, ki vsebujejo bentonit.
English: This referral was related to the divergent national decisions taking by member states in relation with the SPC of the products Pulmotil 40 VET Premix, Pulmotil 100 VET Premix, Pulmotil 200 VET Premix and associated name, raised by Belgium.
Slovenian: Ta napotitveni postopek je sprožila Belgija in se nanaša na različne nacionalne odločitve držav članic glede povzetkov glavnih značilnosti zdravil Pulmotil 40 VET Premix, Pulmotil 100 VET Premix, Pulmotil 200 VET Premix in z njim povezanih imen.
English: Inappropriate use of the product may increase the prevalence of bacteria resistant to tilmicosin and may decrease the effectiveness of treatment with tilmicosin related substances.
Slovenian: Posebni previdnostni ukrepi za uporabo pri živalih Neprimerna raba zdravila lahko poveča pogostnost bakterij, odpornih proti tilmikozinu, in zmanjša učinkovitost zdravljenja z zdravili, podobnimi tilmikozinu.
English: In the event of accidental skin contact, wash thoroughly with soap and water.
Slovenian: V primeru nenamernega stika s kožo temeljito sperite z milom in vodo.
English: Tilmicosin degrades/declines slowly in the soil.
Slovenian: Tilmikozin v prsti razpada počasi.
English: Due to the likely variability (time, geographical) in the occurrence of the resistance of bacteria for tilmicosin, bacteriological sampling and susceptibility testing are recommended
Slovenian: Zaradi verjetne variabilnosti (trajanje, geografsko) pojavljanja bakterij, odpornih proti tilmikozinu, se priporoča odvzem vzorca za bakteriologijo in določanje občutljivosti.
English: Quantifiable levels of tilmicosin were found in lung tissue with the maximum concentration (1.43±1.13 µg/ml) being recorded on day 10 of medication.
Slovenian: V pljučnem tkivu so bile izmerljive ravni tilmikozina, najvišja koncentracija (1,43±1,13 µg/ml) pa je bila zaznana 10. dan zdravljenja.
English: Elimination: Following oral administration, tilmicosin is excreted mainly via the bile into the faeces but a small proportion is excreted via the urine.
Slovenian: Izločanje: Tilmikozin se po peroralnem dajanju izloča predvsem prek žolča v iztrebke, manjši delež pa se izloči s sečem.
English: • The shelf life after incorporation into meal or pelleted feed: 1 month;
Slovenian: • rok uporabnosti po dodajanju v obrok ali peletirano hrano: 1 mesec;
English: The CVMP accepts that a claim for efficacy at a dose of 8 to 16 mg/kg bw/day of tilmicosin (equivalent to 200 to 400 ppm in the feed) for a period of 15 to 21 days for prevention and treatment of respiratory infections in pigs has been demonstrated.
Slovenian: CVMP se strinja, da je bila zahteva o učinkovitosti pri odmerku 8 do 16 mg tilmikozina na kg telesne mase dnevno (enakovredno 200 do 400 ppm v krmi) v obdobju od 15 do 21 dni za preprečevanje in zdravljenje bolezni dihal pri prašičih dokazana.
English: 8-16 mg/kg bodyweight/day
Slovenian: 8-16 mg/kg telesne mase/dan
English: The sudden decline in potency after one month at 25 ºC for tilmicosin in pelleted feeds with levels of wheat higher than 30% is troubling.
Slovenian: Težava je v nenadnem padcu aktivnosti tilmikozina po enem mesecu v peletirani krmi z ravnijo pšenice več kot 30 %.
English: In order to obtain a correct dosage the concentration of tilmicosin has to be adjusted accordingly.
Slovenian: Koncentracijo tilmikozina morate prilagoditi tako, da dosežete pravilni odmerek.
English: Therefore, to protect soil and ground water, pig manure not to be spread onto the grass land and when spread onto arable land plough to a depth of 30 cm. Environmental assessments have demonstrated that the use of Pulmotil Premix as indicated is not expected to have any impact on the environment.
Slovenian: Če se raztrese po orni zemlji, je treba orati do globine 30 cm. Ocene okolja so pokazale, da ni pričakovati, da bi zdravilo Pulmotil Premix, uporabljeno v skladu z indikacijami, imelo vpliv na okolje.
English: When administered at a dose of 200 mg tilmicosin/kg feed (equivalent to approximately 11.0 mg/kg/day), plasma concentrations above the limit of quantification (0.10 µg/ml) were found in 3 out of 20 animals examined.
Slovenian: Pri dajanju odmerka 200 mg tilmikozina/kg krmne mešanice (enakovredno približno 11,0 mg/kg/dan) pri 3 od 20 preiskanih živalih niso bile zaznane koncentracije v plazmi nad mejo kvantifikacije (0,10 µg/ml).
English: 2 kg, 5 kg and 10 kg 200g/kg: 1 kg and 10 kg
Slovenian: Predmešanica 200 g/kg: 1 kg in 10 kg
English: Distribution: Following oral administration, tilmicosin is distributed throughout the body with especially high levels found in lungs.
Slovenian: Porazdelitev: Tilmikozin se po peroralnem dajanju porazdeli po celotnem telesu, posebno visoke ravni pa so v pljučih.
English: Efficacy in rabbits
Slovenian: Učinkovitost pri kuncih
English: For products containing 200g tilmicosin/kg:
Slovenian: Za zdravila, ki vsebujejo 200 g tilmikozina/kg:
English: 12 mg/kg bodyweight/day
Slovenian: 12 mg/kg telesne mase/dan
English: Pigs Rabbits
Slovenian: Prašiči Kunci
English: Under practical conditions, the management of respiratory disease outbreaks recognises that acutely ill animals are inappetant and require parenteral therapy.
Slovenian: 4.4 Posebna opozorila za vsako ciljno živalsko vrsto Kadar je praktično, je treba pri obvladovanju izbruhov bolezni dihal upoštevati, da so akutno bolne živali neješče, zato potrebujejo parenteralno terapijo.
English: WITHDRAWAL PERIOD Pigs: 21 days
Slovenian: KARENCA Prašiči: 21 dni Kunci: 4 dni
English: Product containing 200g tilmicosin/kg is packed in either:
Slovenian: Zdravila, ki vsebujejo 200 g tilmikozina/kg, so pakirana v:
English: PHARMACEUTICAL FORM Premix for medicated feeding stuff.
Slovenian: FARMACEVTSKA OBLIKA Predmešanica za zdravilno krmno mešanico.
English: Shelf life after incorporation into meal or pelleted feed: 1 month.
Slovenian: Rok uporabnosti po vključitvi v obrok ali peletirano hrano: 1 mesec.
English: PHARMACEUTICAL FORM Premix for medicated feeding stuff
Slovenian: FARMACEVTSKA OBLIKA Predmešanica za zdravilno krmno mešanico
English: Pigs and rabbits
Slovenian: Prašiči in kunci
English: Macrolides, such as tilmicosin, may also cause hypersensitivity (allergy) following injection, inhalation, ingestion or contact with skin or eye. Hypersensitivity to tilmicosin may lead to cross reactions to other macrolides and vice versa.
Slovenian: Makrolidi, kot je tilmikozin, lahko povzročajo tudi preobčutljivost (alergijo) po injiciranju, vdihavanju, zaužitju ali pri stiku s kožo ali očmi.
English: the CVMP has recommended the amendment of the Marketing Authorisations for which the Summary of Product Characteristics is set out in Annex III for Pulmotil 40 VET Premix, Pulmotil 100 VET Premix, Pulmotil 200 VET Premix and associated names.
Slovenian: je CVMP priporočil dopolnitev dovoljenj za promet z zdravili Pulmotil 40 VET Premix, Pulmotil 100 VET Premix, Pulmotil 200 VET Premix in z njim povezana imena, katerih povzetek glavnih značilnosti zdravila in označevanja so navedeni v Dodatku III.
English: Rabbits: Pasteurella multocida, Staphylococcus aureus and Bordetella bronchoseptica
Slovenian: Prašiči: Mycoplasma hyopneumoniae, Pasteurella multocida, Actinobacillus pleuropneumoniae Kunci: Pasteurella multocida, Staphylococcus aureus in Bordetella bronchoseptica
English: Paper/polyethylene/aluminium/polyethylene/paper bags containing 2 kg, 5 kg or 10 kg of product.
Slovenian: 1. vreče iz polietilena/poliamida/polietilena (notranja plast) z 10 kg zdravila ali 2. vreče iz papirja/polietilena/aluminija/polietilena/papirja z 2 kg, 5 kg ali 10 kg zdravila.
English: Distribution: Following oral administration, tilmicosin is distributed throughout the body with especially high levels found in the lung and in lung tissue macrophages.
Slovenian: Porazdelitev: Tilmikozin se po peroralnem dajanju porazdeli po celotnem telesu, posebno visoke ravni pa so v pljučih in makrofagih pljučnega tkiva.
English: 40 g/kg Premix:
Slovenian: Predmešanica 40 g/kg:
English: The following indication can be accepted: Prevention and treatment of respiratory disease caused by Actinobacillus pleuropneumoniae, Mycoplasma hyopneumoniae, Pasteurella multocida and other organisms sensitive to tilmicosin in pigs.
Slovenian: Lahko se sprejme naslednja indikacija: Preprečevanje in zdravljenje bolezni dihal, ki jih povzročajo Actinobacillus pleuropneumoniae, Mycoplasma hyopneumoniae, Pasteurella multocida in drugi za tilmikozin občutljivi organizmi, pri prašičih.
English: a) The indication for use in rabbits: prevention and treatment of respiratory disease caused by Pasteurella multocida and Bordetella bronchiseptica susceptible to tilmicosin.
Slovenian: a) indikacijo za uporabo pri kuncih: preprečevanje in zdravljenje bolezni dihal, ki jih povzročajo za tilmikozin občutljivi sevi Pasteurella multocida in Bordetella bronchiseptica.
English: Pigs, Rabbits
Slovenian: prašiči, kunci
English: Do not use in case of hypersensitivity to tilmicosin or to any of the excipients 4.4 Special warnings for each target species
Slovenian: Ne uporabite v primeru preobčutljivosti za tilmikozin ali katero koli pomožno snov.
English: Withdrawal periods
Slovenian: Rok uporabnosti
English: Kg Premix/tonne feed = Dose rate (mg/kg bodyweight) x bodyweight (kg) Daily feed intake (kg) x premix strength (g/kg)
Slovenian: = odmerek (mg/kg telesne mase) x telesna masa (kg) dnevni vnos krmne meš.
English: • The reference to rice hulls should be removed from the SPC.
Slovenian: • iz povzetka glavnih značilnosti zdravila se odstrani sklic na luščine riža.
English: b) The amounts to be administered and administration route: administered in the feed at 12 mg/kg bodyweight/day of tilmicosin (equivalent to 200 ppm in the feed) for 7 days.
Slovenian: b) odmerjanje in pot uporabe: dajanje tilmikozina v krmo v koncentraciji 12 mg na kg telesne mase (enakovredno 200 ppm v krmi) v obdobju 7 dni.
English: 4.7 Use during pregnancy, lactation or lay
Slovenian: 4.7 Uporaba v obdobju brejosti, laktacije ali nesnosti Varnost tilmikozina pri vzrejnih merjascih ni bila ugotovljena.
English: Pigs: Prevention and treatment of respiratory disease caused by Actinobacillus pleuropneumoniae, Mycoplasma hyopneumoniae, Pasteurella multocida and other organisms sensitive to tilmicosin.
Slovenian: Prašiči: preprečevanje in zdravljenje bolezni dihal, ki jih povzročajo Actinobacillus pleuropneumoniae, Mycoplasma hyopneumoniae, Pasteurella multocida in drugi organizmi, ki so občutljivi za tilmikozin.
English: EXP Once opened, use within 3 months Once incorporated into meal or pelleted feed, use within 1 month
Slovenian: Zdravilo, vmešano v obrok ali peletirano hrano, uporabite v 1 mesecu.
English: 2 kg, 5 kg and 10 kg 100 g/kg Premix:
Slovenian: 2 kg, 5 kg in 10 kg
English: 200 g/kg For a full list of excipients see section 6.1
Slovenian: Za celoten seznam pomožnih snovi glejte poglavje 6.1.