FrancophonIA/ELRC3.0 huggingface dataset:
English: PhotoBarr should not be used in people who may be hypersensitive (allergic) to porfimer sodium and other porphyrins, or to any of the other ingredients.
Estonian: PhotoBarri ei tohi kasutada patsiendid, kes võivad olla naatriumporfimeeri ja muude porfüriinide või selle ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised).
English: PhotoBarr should also only be used if experienced staff and material for assessing and treating anaphylaxis (severe allergic reaction) are immediately available.
Estonian: PhotoBarri tohib kasutada ainult siis, kui on olemas kogenud personal ning anafülaksiat (raske allergiline reaktsioon) saab koheselt hinnata ja ravida.
English: Adding photodynamic therapy using PhotoBarr to omeprazole treatment increased the number of patients whose dysplasia was destroyed.
Estonian: PhotoBarriga fotodünaamilise ravi lisamisel ravile omeprasooliga suurenes hävitatud düsplaasiaga patsientide arv.
English: PhotoBarr must not be used in patients with porphyria (an inability to break down porphyrins), severe problems with the liver or kidneys, varices (swollen veins) in the oesophagus or stomach, large ulcers in the oesophagus, fistulae (abnormal passageways) between the oesophagus and either the trachea (windpipe) or the bronchi (airways in the lungs), or suspected damage to major blood vessels.
Estonian: PhotoBarri ei tohi kasutada patsientidel, kellel on porfüüria (organism ei lagunda porfüriine), rasked maksa- või neeruhäired, söögitoru ja mao veenilaiendid, suured söögitoruhaavandid, fistulid (ebanormaalsed uurised) söögitoru ja kas hingetoru või bronhide vahel või suurte veresoonte kahjustuse kahtlus.
English: Why has PhotoBarr been approved?
Estonian: Miks PhotoBarr heaks kiideti?
English: For a more complete list of the side effects reported with PhotoBarr, see the package leaflet.
Estonian: PhotoBarri kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: Photodynamic therapy with PhotoBarr should only be carried out or supervised by a doctor who has experience in laser treatment using an endoscope (a thin tube used to look into the body) and who has been trained in photodynamic therapy.
Estonian: Fotodünaamilist ravi PhotoBarriga võib läbi viia sellise arsti poolt või järelevalve all, kellel on endoskoobiga (torutaoline kehaõõnte vaatlusseade) laserravi teostamise kogemus ja fotodünaamilise ravi väljaõpe.
English: What is the risk associated with PhotoBarr?
Estonian: Mis riskid PhotoBarriga kaasnevad?
English: It contains the active substance porfimer sodium.
Estonian: Ravim sisaldab toimeainena naatriumporfimeeri.
English: When PhotoBarr is injected, porfimer is absorbed into cells throughout the body.
Estonian: PhotoBarri süstimisel imendub porfimeer kogu organismi rakkudesse.
English: PhotoBarr is used in photodynamic therapy (treatment using light) for the ablation (destruction) of high-grade dysplasia (abnormal cells at high risk of turning into cancer) in patients with Barrett's oesophagus.
Estonian: PhotoBarri kasutatakse fotodünaamilises ravis (valgusravis) tugeva düsplaasia (ebanormaalsed rakud, millel on suur oht areneda vähiks) ablatsiooniks (hävitamiseks) Barretti söögitoruga patsientidel.
English: PhotoBarr is a powder that is made up into a solution for injection.
Estonian: PhotoBarr on pulber, millest valmistatakse süstelahus.
English: Treatment with PhotoBarr is a two-step process: the medicine is given first before it is activated using a laser. PhotoBarr is given by slow, careful injection into a vein at a dose of 2 mg per kilogram body weight over three to five minutes.
Estonian: PhotoBarri manustatakse aeglaselt ja ettevaatlikult veeni süstides annuses 2 mg kehakaalu kilogrammi kohta kolme kuni viie minuti jooksul.
English: What is PhotoBarr?
Estonian: Mis on PhotoBarr?
English: The effects of photodynamic therapy with PhotoBarr, used in combination with omeprazole (an antacid medicine), were compared with those of omeprazole alone.
Estonian: Uuringutes võrreldi PhotoBarriga läbi viidud fotodünaamilise ravi toimet selle kasutamisel koos omeprasooliga (teatud antatsiid ehk happevastane ravim) ainult omeprasooli toimega.
English: What is PhotoBarr used for?
Estonian: Milleks PhotoBarri kasutatakse?
English: How is PhotoBarr used?
Estonian: Kuidas PhotoBarri kasutatakse?
English: What benefit has PhotoBarr shown during the studies?
Estonian: Milles seisneb uuringute põhjal PhotoBarri kasulikkus?
English: This is a disease where the lining at the lower end of the oesophagus (gullet) has changed because of damage due to acid from the stomach.
Estonian: Selle haiguse korral on söögitoru alumise osa epiteelis (pinnakoes) tekkinud maohappe kahjustava mõju tulemusena muutused.
English: How has PhotoBarr been studied?
Estonian: Kuidas PhotoBarri uuriti?
English: The medicine can only be obtained with a prescription.
Estonian: PhotoBarr on retseptiravim.
English: How does PhotoBarr work?
Estonian: Kuidas PhotoBarr toimib?
English: 7 days
Estonian: 7 ööpäeva
English: If the existing advice is not considered sufficient a proposal for revised text should be submitted.
Estonian: Kui olemasolevad soovitused ei ole piisavad, tuleb esitada teksti muutmise ettepanek.
English: Prevention and treatment of respiratory disease
Estonian: Respiratoorsete haiguse ennetamine ja ravi
English: 20041 Agrate Brianza (MB) ITALY
Estonian: 20041 Agrate Brianza (MB) ITAALIA
English: The condition of the Marketing Authorisations is described in Annex IV.
Estonian: Müügilubade tingimused on esitatud IV lisas.
English: The results of those studies should be provided to the relevant authorities for assessment not later than 12 months after the Commission Decision on this referral procedure.
Estonian: Uuringute tulemused peab esitama pädevatele asutustele kuni 12 kuud pärast komisjoni otsust selle esildismenetluse kohta.
English: National Competent Authorities, coordinated by the Reference Member State as applicable, should ensure that following conditions are fulfilled by the marketing authorisation holders:
Estonian: Riikide pädevad asutused, mida koordineerib viiteliikmesriik, kui see on asjakohane, tagavad, et müügiloa hoidjad täidavad järgmised tingimused:
English: The Committee was also asked to recommend whether the marketing authorisations should be maintained, varied, suspended or withdrawn.
Estonian: Veterinaarravimite komiteelt küsiti ka soovitust, kas müügiload tuleb säilitada, muuta, peatada või tagasi võtta.
English: During the previous referral procedure under Article 34 of Directive 2001/82/EC (EMEA/V/A/037)
Estonian: Direktiivi 2001/82/EÜ artikli 34 kohase eelmise esildismenetluse ajal (EMEA/V/A/037)
English: Homogeneity was demonstrated as the coefficient of variation was less than 5 % in all the cases tested.
Estonian: Homogeensust näitas, et variatsioonitegur oli kõigil katsejuhtudel alla 5%.
English: List of the names, pharmaceutical forms, active substance, strengths of the veterinary medicinal products, animal species, marketing authorisation holders in the Member States
Estonian: Veterinaarravimi nimetuste, ravimvormide, toimeainete, tugevuste, loomaliikide, müügiloa hoidjate loetelu liikmesriikides
English: The uptake of medicated feed depends on the clinical condition of the animals.
Estonian: Ravimsööda manustamine oleneb loomade kliinilisest seisundist.
English: The conditioning and pelleting were described.
Estonian: Koostis ja granuleerimine on kirjeldatud.
English: According to stability results, after 3 months no significant change was observed for appearance and loss on drying.
Estonian: Stabiilsusuuringute andmetel ei esinenud 3 kuu möödumisel olulisi muutusi välimuses ega massikadu kuivamisel.
English: 200 Route de Mayenne Zi des Touches 53000 Laval FRANCE
Estonian: 200 Route de Mayenne Zi des Touches 53000 Laval PRANTSUSMAA
English: ELANCO VALQUÍMICA, S.A. Avda.
Estonian: Hispaania ELANCO VALQUÍMICA, S.A. Avda.
English: LILLY France 13 Rue Pages 92158 Suresnes Cedex
Estonian: LILLY PRANTSUSMAA 13 Rue Pages 92158 Suresnes Cedex
English: Germany Lilly Deutschland GmbHAbt.
Estonian: Saksamaa Lilly Deutschland GmbHAbt.
English: In order to obtain a correct dosage the concentration of tilmicosin has to be adjusted accordingly.
Estonian: Õige annuse saamiseks tuleb tilmikosiini kontsentratsiooni kohandada.
English: de la Industria 30 28108 Alcobendas Madrid
Estonian: 28108 Alcobendas
English: 34 Rue Jean Monnet Zi D'Etriche 49500 Serge FRANCE
Estonian: 34 Rue Jean Monnet Zi D'Etriche 49500 Serge PRANTSUSMAA
English: Sick animals hereby consume less, being acceptable at 100 g per day.
Estonian: Haiged loomad söövad siiski vähem, ligikaudu 100 g ööpäevas.
English: Thus, one rabbit of 1.5 kg can consume in average 180 g of feed per day.
Estonian: 1,5 kg küülik sööb seega ööpäevas keskmiselt 180 g sööta.
English: Regarding the target species feeding behaviour, it is known that rabbits feed frequently (up to 30 times per day of 2-8 g of feed over 4-6 minute periods
Estonian: Sihtliigi toitumisviisi alusel on teada, et küülikud söövad sageli (kuni 30 korda päevas 2-8 g sööta korraga iga 4-6 minuti järel
English: Even though it was confirmed that no overage was used in the formulation, no justification was found for those results and it was considered that the results do not fall into the normal range observed in other feed studies.
Estonian: Kuigi selgus, et segu valmistamisel ei olnud ravimit liiga palju, jäid nende tulemuste põhjuseid leidmata ning järeldati, et tulemused ei ole teistes uuringutes vaadeldud normaalvahemikus.
English: This was further supported considering further data provided in which no such problems were presented thus far with pilot scale batches.
Estonian: Seda toetasid ka hiljem esitatud lisaandmed, kus selliseid probleeme võrreldes proovipartiidega ei esinenud.
English: The marketing authorisation holders were requested to provide the following:
Estonian: Müügiloa hoidjatel paluti esitada järgmine teave.
English: Regarding meal feeds, mean content was not in the range of 90-110% of the nominal content (180220 ppm), since concentration values were higher than the expected nominal concentration of 200 ppm ± 10% (values rate between 198.1 - 243.6 ppm).
Estonian: Toidusöödasegude korral ei olnud keskmine sisaldus 90-110% piires nimisisaldusest (180-220 ppm), kuid kontsentratsioon oli suurem kui eeldatav nimikontsentratsioon 200 ppm ±10% (väärtuste vahemik 198,1-243,6 ppm).
English: The pharmacokinetic parameters confirm the effective dose of tilmicosin.
Estonian: Farmakokineetilised omadused kinnitavad tilmikosiini efektiivset annust.
English: This discussion should be supported with the appropriate data, i.e. data confirming the pelleting conditions suitability and demonstrating that these conditions do not affect the shelf-life granted for the medicated feedingstuff (1 month).
Estonian: Arvamust peavad toetama asjakohased andmed, nt granuleerimismeetodite sobivust kinnitavad andmed ja andmed, et need meetodid ei vähenda ravimsööda kinnitatud kõlblikkusaega (1 kuu).
English: D-61352 Bad Homburg GERMANY
Estonian: D-61352 Bad Homburg SAKSAMAA
English: The marketing authorisation holders reported that the administration of feed to the food producing rabbits is via complete feedingstuff.
Estonian: Müügiloa hoidjad teatasid, et toiduloomadest küülikute söötmine toimub komplekssöödaga.
English: These higher values require further consideration as they would lead to higher than target dose.
Estonian: Suurem kontsentratsioon vajab edasist uurimist, sest see võib põhjustada suuremat sihtannust.
English: This was considered acceptable, as homogeneity of medicated feedingstuffs is reached with low concentrations of medicated pre-mixes.
Estonian: Seda peeti vastuvõetavaks, sest ravimsöötade homogeensus saavutatakse ravimsööda eelsegude väikese kontsentratsiooniga.
English: As outlined in the CVMP's Note for guidance (EMEA/CVMP/080/95) a description should be provided of how the pre-mix is to be incorporated into the feedingstuff.
Estonian: Veterinaarravimite komitee suunise (EMEA/CVMP/080/95) järgi tuleb kirjeldada, kuidas eelsegu söödasegule lisatakse.
English: Denmark Elanco Animal Health Eli Lilly Danmark A/S Nybrovej 110
Estonian: Elanco Animal Health Eli Lilly Danmark A/S Nybrovej 110
English: DK-2800 Kongens
Estonian: DK-2800 Kongens Lyngby
English: states that the daily dose of the medicated pre-mix must be contained in at least half the daily ration of the animals under treatment.
Estonian: 1 märgitakse, et ravimsööda eelsegu ööpäevane annus peab sisalduma vähemalt pooles ravitavate loomade ööpäevases söödakoguses.
English: Whilst the demonstration of homogeneity was considered acceptable, the higher than expected values need explanation, taking into account that if those meal feeds were administered to animals, the concentration in those feeds would be higher than the target dose of 200 ppm.
Estonian: Kuigi homogeensust peeti vastuvõetavaks, vajavad eeldatavast suuremad väärtused selgitust, sest nende segude manustamisel loomadele on nende segude kontsentratsioon suurem kui sihtannus 200 ppm.
English: No data on incorporation were provided for Tilmicosin 40 g pre-mix.
Estonian: Tilmikosiini 40 g eelsegu segamise kohta andmeid ei esitatud.
English: The average size of a feed mixer can vary from 3 to 5 tons and complete medicated rabbit feedingstuff is produced in the same size mixers.
Estonian: Söödaseguri keskmine suurus on 3-5 tonni ja küülikute valmis ravimsööta toodetakse samade seguritega.
English: The incorporation rate of Tilmicosin 40 g pre-mix in the feed would be 5 kg per ton (the requirement of the European Pharmacopoeia monograph on pre-mixes for medicated feedingstuffs for veterinary use).
Estonian: Söödale lisatav tilmikosiini 40 g eelsegu kogus on 5 kg tonni kohta (Euroopa Farmakopöa nõue ravimsöötade eelsegude veterinaarse kasutamise kohta).
English: The relevant advice given in the product literature should be provided along with a discussion of whether this is in line with CVMP's Note for guidance (EMEA/CVMP/080/95).
Estonian: Esitada tuleb asjakohased nõuanded ravimi dokumentatsioonist koos arvamusega, kas need on kooskõlas veterinaarravimite komitee suunisega (EMEA/CVMP/080/95).
English: Germany Lilly Deutschland GmbH Abt. Elanco Animal Health Werner-Reimers-Str. 2-4
Estonian: Saksamaa Lilly Deutschland GmbH Abt. Elanco Animal Health Werner-Reimers-Str. 2-4
English: CVMP Note for Guidance on additional quality requirements for products intended for incorporation into animal feedingstuffs (mediciated premixes)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004466.pdf
Estonian: Veterinaarravimite komitee suunis loomade toidusöödasegudesse lisatavate ravimite (ravimsööda eelsegude) täiendavate kvaliteedinõuete kohta, http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004466.pdf
English: The CVMP therefore requests that conditioning/pelleting stability studies with three batches of medicated rabbit feeds are carried out in order to confirm whether or not the high tilmiscosin valuies are typical results (see Annex IV).
Estonian: Veterinaarravimite komitee nõuab seetõttu granuleerimise stabiilsusuuringute korraldamist küülikute ravimsööda kolme partiiga, et kinnitada, kas tilmikosiini sisalduse väärtused on tüüpilised tulemused või mitte (vt IV lisa).
English: Note: The text in grey shading below is not applicable for MICLOZAN 200 pre-mix (see Annex I):
Estonian: Märkus: hallil taustal tekst ei kehti eelsegu MICLOZAN 200 kohta (vt I lisa):
English: kg pre-mix/ton feed = Dose rate (mg/kg bodyweight) x bodyweight (kg) Daily feed intake (kg) x pre-mix strength (g/kg)
Estonian: kg eelsegu tonni sööda kohta = annus (mg kehamassi kg kohta) × kehamass (kg) sööda tarbimine ööpäevas (kg) × eelsegu tugevus (g/kg)
English: The testing of only one strength was considered valid because the concentration of tilmicosin in the final medicated feeding stuffs would be 200 ppm in all cases, as the homogenicity of the other medicated premixes was sufficiently justified.
Estonian: Kontrollimine ainult ühe tugevusega loeti lubatuks, sest tilmikosiini kontsentratsioon valmis ravimsöötades peab alati olema 200 ppm, mida piisavalt põhjendas teiste ravimsöötade homogeensus.
English: CVMP opinion following an Article 34 referral on Pulmotil 40 VET Premix, Pulmotil 100 VET Premix, Pulmotil 200 VET Premix and associated names (2009)http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/Pulmotil_Premix_34/WC500036654 .pdf
Estonian: Veterinaarravimite komitee arvamus seoses artikli 34 kohase esildisega ravimite Pulmotil 40 VET Premix, Pulmotil 100 VET Premix, Pulmotil 200 VET Premix ja sarnaste nimetuste kohta (2009), http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/Pulmotil_Premix_34/WC500036654 .pdf
English: Note: The text in grey shading below is not applicable for MICLOZAN 200 premix (see Annex I of the opinion)
Estonian: Märkus: hallil taustal tekst ei kehti eelsegu MICLOZAN 200 kohta (vt arvamuse I lisa)
English: The results of a mixing uniformity study (with tilmicosin 100 g and 200 g pre-mixes) the homogeneity results obtained from ten analysed samples per batch, showed no samples out of the 85-115% range of the mean content.
Estonian: Segamise ühetaolisuse uuringust (tilmikosiini 100 g ja 200 g eelsegudega) saadud homogeensuse tulemused sama partii 10 analüüsitud proovi kohta näitasid, et ükski proov ei olnud väljaspool keskmise sisalduse 85-115% vahemikku.
English: The pre-mixes for medicated feedingstuffs containing 40 g, 100 g or 200 g of tilmicosin per kg premix, are veterinary medicinal products which are indicated in pigs for the prevention and treatment of respiratory disease caused by Actinobacillus pleuropneumoniae, Mycoplasma hyopneumoniae, Pasteurella multocida and other organisms sensitive to tilmicosin.
Estonian: Ravimsööda eelsegud, mis sisaldavad 40 g, 100 g või 200 g tilmikosiini eelsegu kg kohta, on veterinaarravimid, mis on näidustatud bakterite Actinobacillus pleuropneumoniae, Mycoplasma hyopneumoniae, Pasteurella multocida ja teiste tilmikosiini suhtes tundlike mikroorganismide põhjustatud hingamisteede haiguste raviks ning profülaktikaks sigadel.
English: The CVMP's Note for guidance on additional quality requirements for products intended for incorporation into animal feedingstuffs (medicated pre-mixes) (EMEA/CVMP/080/95)
Estonian: Veterinaarravimite komitee suunises söödasegudesse lisatavate ravimite täiendavate kvaliteedinõuete kohta (ravimsööda eelsegud) (EMEA/CVMP/080/95)
English: Taking into account the characteristics of a rabbit feed used to prepare pelleted medicated feedingstuffs, it was concluded that the maximum limit of cereal meals that can be used in commercial feedingstuffs for fattening rabbits should be less than 30% (the inclusion of 30% of wheat meal is not appropriate due to the risk of triggering severe enteric problems).
Estonian: Arvestades granuleeritud ravimsööda valmistamiseks kasutatud küülikusööda omadusi, järeldati, et küülikute nuumsöötade maksimaalne teraviljasisaldus peab olema alla 30% (30% nisusisaldus ei sobi raskete seedimisprobleemide tekkeriski tõttu).
English: Mean content in pelleted feeds was in the range of 90-110% of the nominal content therefore, the homogeneity of those medicated feeds is considered demonstrated.
Estonian: Granuleeritud söötade keskmine sisalduse vahemik oli 90110% nimisisaldusest ja seega olid need ravimsöödad homogeensed.
English: 4.9 Amounts to be administered and administration route:
Estonian: 4.9 Annustamine ja manustamisviis
English: Pellet storage stability was evaluated by examining the difference in the level of tilmicosin assay over a 12 week period at 25 °C/60% relative humidity (RH) and 40 °C/70% RH.
Estonian: Graanulite säilivust hinnati tilmikosiini sisalduse erinevus analüüsimisel 12 nädala jooksul tingimustel 25 °C ja 60% RH ning 40 °C ja 70% RH.
English: Concentrations are 10 - 13% higher than the expected nominal concentration of 200 mg/kg.
Estonian: Kontsentratsioon on 10-13% suurem eeldatavast nimikontsentratsioonist 200 mg/kg.
English: Shelf life after incorporation into meal or pelleted feed: 3 months
Estonian: Kõlblikkusaeg pärast ravimi segamist toidusöödasegu või granuleeritud söödaga: 3 kuud
English: The pharmakokinetic/pharmacodynamic study and MIC data to support use in respiratory disease in rabbits at dose of 12.5 mg/kg bw/day for 7 days (submitted previously) were referenced in the answers to the CVMP list of questions and were found to be acceptable.
Estonian: Farmakokineetilise ja farmakodünaamilise uuringu ning MIC-andmed, mis toetavad ravimi kasutamist küülikutel annuses 12,5 mg/kg 7 ööpäeva jooksul (esitatud varem), on loetletud veterinaarravimite komitee küsimustele antud vastuste loetelus ning neid peeti piisavaiks.
English: Confirmation should be provided that this requirement will be fulfilled by all of the pack sizes for all the different strengths.
Estonian: Selle nõude täitmise kohta kõigi pakendi suuruste ja kõigi ravimi tugevuste korral on vaja esitada kinnitus.
English: The marketing authorisation holders should conduct conditioning/pelleting stability studies with three batches of medicated rabbit feeds (manufactured using tilmicosin 200 g per kg pre-mix) in order to confirm that if meal rabbit feed was correctly formulated with a concentration of 200 ppm, tilmicosin content in the pelleted feed would still be within the specification range of ±15 % of nominal value over a period of 3 months.
Estonian: Müügiloa hoidjad peavad korraldama eeltöötlemise/granuleerimise stabiilsusuuringud küülikute ravimsööda kolme partiiga (mis on valmistatud tilmikosiini 200 g eelsegust), et kinnitada, kas küülikute toidusöödasegu õigel koostamisel kontsentratsiooniga 200 ppm püsib tilmikosiini sisaldus granuleeritud söödas 3 kuu jooksul lubatud vahemikus ±15% nimiväärtusest.
English: The high values of tilmicosin in the medicated feed prior to the pelleting process need further explanation.
Estonian: Tilmikosiini suurt sisaldust ravimsöödas enne granuleerimist tuleb veel selgitada.
English: On 8 April 2011, the European Commission initiated a referral under Article 35 of Directive 2001/82/EC, as amended, for all pre-mixes for medicated feedingstuff containing 40, 100 or 200 g tilmicosin per kg pre-mix and administered to rabbits.
Estonian: 8. aprillil 2011 tegi Euroopa Komisjon muudetud direktiivi 2001/82/EÜ artikli 35 kohase esildise kõigi küülikutele manustatavate 40 g, 100 g või 200 g tilmikosiini eelsegu kg kohta sisaldavate ravimsöötade eelsegude suhtes.
English: “To ensure through dispersion of the product, it should first be mixed with a suitable quantity of feed ingredients (20 - 50 kg) before incorporation into the finished feed.
Estonian: Ravimi põhjaliku segunemise tagamiseks tuleb enne kogu söödakogusele lisamist eelsegu segada väiksema söödakogusega (20-50 kg).
English: Taking into account that stability results on medicated pelleted rabbit feeds were similar to those obtained for medicated pelleted pig feeds, a shelf life period of 3 months after incorporation into feeding stuffs was considered acceptable.
Estonian: Arvestades, et küülikute granuleeritud ravimsöötade stabiilsuskatsete tulemused sarnanesid sigade granuleeritud ravimsöötade tulemustega, leiti, et 3kuuline kõlblikkusaeg pärast söödale lisamist on vastuvõetav.
English: The CVMP also considered that rabbits are minor species, with specific problems concerning availability of authorised veterinary products for this species and considered the history of use and the various management steps now set out in the harmonised SPC (bacteriological sampling and susceptibility testing are recommended).
Estonian: Lisaks leidis veterinaarravimite komitee, et küülik on vähelevinud loomaliik, kelle korral on müügiloaga veterinaarravimite turustamisel eriprobleeme, ning võttis arvesse, et ravimi kasutamine ja eri raviastmed on nüüd sätestatud ravimi omaduste ühtlustatud kokkuvõttes (soovitatakse bakterioloogiliste proovide võtmist ja ravimitundlikkuse määramist).