FrancophonIA/ELRC3.0 huggingface dataset:
English: The guideline on data requirements to support in-use stability claims for veterinary vaccines*, states that “For inactivated vaccines, if the proposed in-use shelf-life is within one working day (maximum 10 hours) it is acceptable to omit the potency testing from the in-use shelf-life stability study.”
Estonian: Suunis vajalike andmete osas stabiilsusnõuete tagamiseks veterinaarravimite kasutamisel sätestab, et „inaktiveeritud vaktsiinide korral, kui etteantud kasutamistähtaeg jääb ühe tööpäeva piiresse (maksimaalselt 10 tundi), on efektiivsusuuringute tegemata jätmine kasutamistähtaja stabiilsusuuringutes aktsepteeritav.“
English: CVMP Guideline on requirements for concurrent administration of immunological veterinary medicinal products (EMEA/CVMP/550/02-FINAL) - http://www.ema.europa.eu/pdfs/vet/iwp/055002en.pdf
Estonian: * CVMP Guideline on requirements for concurrent administration of immunological veterinary medicinal products (EMEA/CVMP/550/02-FINAL) - http://www.ema.europa.eu/pdfs/vet/iwp/055002en.pdf efektiivsusparameetrite, st vireemia ja kopsukahjustuste taandumisele.
English: Following the absence of agreement between the Reference Member State (the United Kingdom acted on behalf of France as the Reference Member State in a work-sharing arrangement) and one of the Concerned Member States (Spain) at day 90 of the CMDv procedure, the matter was referred to the CVMP on 2 October 2009.
Estonian: Kokkuleppe puudumise tõttu viiteliikmesriigi (Ühendkuningriik) ja ühe asjaomase liikmesriigi (Hispaania) vahel vastastikuse tunnustamise ja detsentraliseeritud menetluse koordineerimisrühma menetluse 90. päeval suunati küsimus 2. oktoobril 2009. aastal veterinaarravimite komiteesse.
English: Intervet International B.V. represented by Intervet UK Ltd Walton Manor Walton
Estonian: represented by Intervet UK Ltd Walton Manor
English: and EU guidelines require safety studies to use animals which are seronegative for the antigens of the vaccine components.
Estonian: Euroopa Farmakopöa ja EL-i suuniste järgi tuleb ohutusuuringutes kasutada loomi, kes on vaktsiinikomponentide antigeenide suhtes seronegatiivsed.
English: For simultaneous use with Porcilis PRRS in finishing pigs from 4 weeks of age (3 weeks after priming) the vaccine may be used for reconstitution shortly before vaccination.
Estonian: Samaaegsel kasutamisel koos Porcilis PRRS`iga nuumsigadele alates 4. elunädalast (3 nädalat pärast esimest manustamist) võib vaktsiini kasutada lahustamiseks vahetult enne vaktsineerimist.
English: The marketing authorisation holder examined the repeated administration of a single dose of each vaccine administered simultaneously at an interval of 14 days in animals of 4 weeks of age.
Estonian: Müügiloa hoidja uuris kummagi vaktsiini üksikannuse üheaegset korduvmanustamist 14-päevaste intervallidega 4 nädala vanustel loomadel.
English: Porcilis M Hyo is an immunological veterinary medicinal product containing Mycoplasma hyopneumoniae and dl--tocopherol acetate as adjuvant.
Estonian: Porcilis M Hyo on immunoloogiline veterinaarravim, mis sisaldab bakterit Mycoplasma hyopneumoniae ja adjuvandina DL--tokoferoolatsetaati.
English: 2) the apparent drop over 1 hour from the titre at release (6.4/6.2 TCID50) is 0.12/
Estonian: 2) tiitri mõõdetav langus 1 tunni jooksul pärast avamist (6,4/6,2 TCID50) on 0,12/-0,02 (keskmine 0,05), mis jääb analüüsi varieeruvuse piiridesse;
English: However the argumentation provided by the marketing authorisation holder to date raises some concerns that by mixing the products some of the efficacy claims for the monovalent products would not be achieved.
Estonian: Sellele vaatamata tekitab müügiloa hoidja esitatud argumentatsioon mõningaid kahtlusi, et toodete kokkusegamisel jäävad monovalentsete toodete mõningad efektiivsusnõuded täitmata.
English: The marketing authorisation holder has complied with these requirements with the design of this study.
Estonian: Müügiloa hoidja läbi viidud uuring vastab nendele nõuetele.
English: The National Competent Authority of Spain was concerned that some aspects regarding the quality, safety and the efficacy after mixing the two products (Porcilis PRRS and Porcilis M Hyo) were not adequately justified.
Estonian: Hispaania pädev asutus leidis, et kahe toote (Porcilis PRRS ja Porcilis M Hyo) kokkusegamise järgsed kvaliteedi, ohutuse ja efektiivsuse teatud aspektid ei ole piisavalt adekvaatselt põhjendatud.
English: The marketing authorisation holder has demonstrated that there is no immunological interference when the vaccines were mixed resulting in maintenance of the same level of efficacy by investigating one efficacy parameter, reduction in viraemia (reduction of 70-75% after simultaneous use and reduction of 72-75% after use of Porcilis PRRS alone).
Estonian: Müügiloa hoidja on näidanud, et vaktsiinide kokkusegamisel immunoloogilist interferentsi ei teki ja efektiivsus ei muutu: uuritav efektiivsusparameeter oli vireemia vähenemine (70…75%-line vähenemine kooskasutamisel ja 72…75%-line vähenemine Porcilis PRRS-i kasutamisel eraldi).
English: The marketing authorisation holder Intervet International BV submitted a Type II variation application subject to the Mutual Recognition Procedure to the Marketing Authorisations of the veterinary medicinal product Porcilis M Hyo in the framework of Article 6 of Commission Regulation (EC) No 1084/2003.
Estonian: Müügiloa hoidja Intervet International BV esitas vastavalt komisjoni määruse (EÜ) nr 1084/2003 artiklile 6 veterinaarravimi Porcilis M Hyo müügiloa II tüüpi muudatuse taotluse, mille suhtes kehtib järgsele vastastikuse tunnustamise menetlus.
English: Germany Intervet Deutschland GmbH
Estonian: Intervet Deutschland GmbH
English: The first injection can be given from an age of 1 week onwards.
Estonian: Esimese süsti võib manustada alates 1. elunädalast.
English: Pigs should be vaccinated twice with a 3 week interval.
Estonian: Sigu tuleb vaktsineerida kaks korda 3-nädalaste vahedega.
English: Nevertheless absence of immunological interference has not been inferred but has been clearly demonstrated by providing laboratory challenge data which showed that there is not significant difference in protection between animals vaccinated with the mixed products and those vaccinated with single products.
Estonian: Sellele vaatamata ei ole immunoloogilise interferentsi puudumist näidatud mitte järelduste, vaid konkreetsete nakatumiste laboriandmete põhjal, mis näitasid, et kokkusegatud toodetega ja eraldi toodetega vaktsineeritud loomade kaitsel suur erinevus puudus.
English: It should be administered intramuscularly (2 ml in the neck).
Estonian: Vaktsiini tuleb manustada lihasesse (2 ml kaela).
English: 4.9 Amounts to be administered and administration route Intramuscular injection in pigs of 2 ml per animal in the neck in the area behind the ear.
Estonian: 4.9 Annustamine ja manustamisviis Intramuskulaarne manustamine sigadele 2 ml looma kohta kaela kõrvatagusesse piirkonda
English: The inactivated vaccine is a suspension for injection.
Estonian: Inaktiveeritud vaktsiini ravimvorm on süstesuspensioon.
English: Vaccinate pigs twice with a three week interval.
Estonian: Vaktsineerida sigu kaks korda kolmenädalase intervalliga.
English: Safety and efficacy data are available in pigs from 4 weeks of age onwards, which demonstrate that this vaccine can be mixed with Porcilis PRRS.
Estonian: Andmed vaktsiini ohutuse ja efektiivsuse kohta on saadaval üle 4 nädala vanuste sigade kohta, mis tõestavad, et vaktsiini tohib kokku segada Porcilis PRRS`iga.
English: CVMP Guideline on data requirements to support in-use stability claims for veterinary vaccines (EMEA/CVMP/IWP/250147/2008-CONSULTATION) - http://www.ema.europa.eu/pdfs/vet/iwp/25014708en.pdf
Estonian: * CVMP Guideline on data requirements to support in-use stability claims for veterinary vaccines (EMEA/CVMP/IWP/250147/2008-CONSULTATION) - http://www.ema.europa.eu/pdfs/vet/iwp/25014708en.pdf hoidja tõestanud ohutust halvima juhu stsenaariumi tingimustes, kus minimaalses vanuses ja vastuvõtlikele (seronegatiivsetele) loomadele manustati korduvalt kahte vaktsiini korraga.
English: No information is available on the safety and efficacy of the use of Porcilis M Hyo mixed with Porcilis PRRS in breeding animals or during pregnancy.
Estonian: Puuduvad andmed Porcilis M Hyo kasutamise ohutuse ja efektiivsuse kohta segatuna Porcilis PRRS`iga suguloomadel või tiinuse ajal.
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE PACKAGE LEAFLET
Estonian: MUUDATUSED, MIS PEAVAD OLEMA SISSE VIIDUD PAKENDI INFOLEHE VASTAVATESSE OSADESSE
English: A single dose (2 ml) of Porcilis M Hyo mixed with Porcilis PRRS is given intramuscularly in the neck.
Estonian: Ühekordne doos (2 ml) Porcilis M Hyo`d segatuna Porcilis PRRS`iga manustatakse intramuskulaarselt kaela.
English: In addition, it is considered that potency of the Porcilis M Hyo component after mixing should have been analysed in order to the exclude a quality interference right after mixing (at t=0) and after the proposed in-use shelf life.
Estonian: Märgiti ka, et pärast kokkusegamist oleks tulnud analüüsida Porcilis M Hyo efektiivsust koostisainena, et välistada kvaliteedimuutust kokkusegamisel (hetkel t = 0) ja pärast väljapakutud kasutustähtaega.
English: It is indicated for finishing pigs from 1 week of age.
Estonian: See on näidustatud sigadele alates 2. elunädalast.
English: Since the protective immunity against lung lesion score is not altered by the mixed administration, the marketing authorisation holder considered that all the other efficacy parameters will also not be altered, and therefore, no more data are required in support of the duration of immunity for the mixed administration.
Estonian: Et kokkusegatud toode ei mõjuta kaitsvat immuunsust reproduktiiv-respiratoorse sündroomi viiruse suhtes, järeldas müügiloa hoidja, et ka kõik teised efektiivsusparameetrid ei muutu, mistõttu täiendavad andmed kokkusegatud toote immuunsuse kestuse põhjendamiseks ei ole vajalikud.
English: Data on laboratory efficacy studies and on one field study were provided showing that the reduction of lung lesion score of pigs vaccinated with the mixed product is similar to the reduction of lung lesion score of pigs vaccinated with Porcilis M Hyo alone.
Estonian: Efektiivsuse laboriuuringute ja ühe väliuuringu esitatud andmed näitasid, et kokkusegatud tootega vaktsineeritud sigade reproduktiiv-respiratoorse sündroomi viiruse vähenemine oli sarnane ainult Porcilis M Hyoga vaktsineeritud sigade reproduktiiv-respiratoorse sündroomi viiruse vähenemisega.
English: GROUNDS FOR THE GRANTING OF THE VARIATION OF THE MARKETING AUTHORISATIONS
Estonian: MÜÜGILUBADE MUUTMISE ALUSED
English: According to the advised vaccination schedule, Porcilis M Hyo and Porcilis PRRS are used simultaneously for the first time at the second administration of Porcilis M Hyo.
Estonian: Soovitusliku vaktsineerimisskeemi kohaselt kasutatakse ravimeid Porcilis M Hyo ja Porcilis PRRS esimest korda korraga Porcilis M Hyo teistkordsel manustamisel.
English: Luxembourg Intervet International bv Wim de
Estonian: Luksemburg Intervet International bv Wim de
English: This is at three weeks after the first injection with Porcilis M Hyo which is to be given from one week of age onwards.
Estonian: See leiab aset kolm nädalat pärast esimest süsti ravimiga Porcilis M Hyo, mida manustatakse alates teisest elunädalast.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF PORCILIS M HYO (SEE ANNEX I)
Estonian: RAVIMI PORCILIS M HYO (VT I LISA) TEADUSLIKU HINDAMISE ÜLDKOKKUVÕTE
English: Concerning Porcilis M Hyo the marketing authorisation holder has submitted data of adjuvant content (dl--tocopherol acetate), pH and sterility of the mixture after reconstitution of 2 batches of Porcilis PRRS in 2 batches of Porcilis M Hyo after storage for 3 hours at room temperature.
Estonian: Porcilis M Hyo kohta esitas müügiloa hoidja andmed adjuvandi (DL--tokoferoolatsetaat) sisalduse, pH ja segu steriilsuse kohta pärast kahe Porcilis PRRS ravimipartii ennistamist kahe Porcilis M Hyos ravimipartiiga 3-tunnise toatemperatuuril säilitamise järel.
English: 4.6 Adverse reactions (frequency and seriousness) A mean transient temperature increase in body temperature of about 0.3C, in individual pigs up to 2.0C, may occur on the first 1 to 2 days after vaccination.
Estonian: Võib tekkida mööduv kehatemperatuuri tõus 0,3C ja mõnedel sigadel kuni 2C 1…2 päeva jooksul pärast vaktsineerimist.
English: While it was suggested that the provided data was not adequate because the animals had not received a single M Hyo vaccination at 1 week of age within the design of this study and therefore the safety of the overall schedule was unproven, the marketing authorisation holder has proven the worst case scenario of a repeated dose of simultaneous vaccination with the two vaccines in susceptible animals (seronegative) of the minimum age.
Estonian: Kuigi oli välja toodud, et esitatud andmed ei ole adekvaatsed põhjusel, et loomad ei saanud uuringuprotokolli järgi 1 nädala vanuses M Hyo vaktsiini eraldi ja seetõttu on kogu annustamisskeemi ohutus tõestamata, on müügiloa
English: The marketing authorisation holder was requested to justify why the proposed vaccination scheme (Porcilis M Hyo at 1 week of age and Porcilis M Hyo mixed with Porcilis PRRS at 4 weeks of age) was not followed to show the safety of the mixed administration.
Estonian: Müügiloa hoidjalt oli küsitud põhjendust, miks ei kasutatud väljapakutavat vaktsineerimisskeemi (Porcilis M Hyo 1 nädala vanuselt ja Porcilis M Hyo segatuna vaktsiiniga Porcilis PRRS 4 nädala vanuselt) kokkusegatud preparaadi ohutuse näitamiseks.
English: Citywest Road Dublin 24
Estonian: Magna Drive Magna Business Park Citywest Road Dublin 24
English: Intervet GmbH Siemensstrasse
Estonian: Intervet GmbH Siemensstrasse 107 1210 Wien Austria
English: As regards justifying why no potency test of the Porcilis M Hyo component has been carried out on the mixed vaccines both immediately after mixing and after the proposed in-use shelf life, the marketing authorisation holder has justified not performing a potency test for the Porcilis M Hyo component on the mixed vaccines that by provision of safety and efficacy studies using the mixed product the marketing authorisation holder has shown that there are no interactions within the mixture affecting the potency of the mixed product.
Estonian: Mis puutub põhjendusse, miks kokkusegatud vaktsiinid ei läbinud Porcilis M Hyo koostisaine efektiivsusanalüüsi ei kohe pärast kokkusegamist ega ka pärast väljapakutud kasutustähtaja lõppemist, tõi müügiloa hoidja välja argumendi, et kokkusegatud vaktsiinides ei tehtud Porcilis M Hyo komponendi efektiivsusanalüüsi.
English: The marketing authorisation holder provided data for PRRS virus titres of two batches of Porcilis PRRS reconstituted with each of ten batches of Porcilis M Hyo after 0, 1, 2 and 3 hours of storage at room temperature.
Estonian: Müügiloa hoidja esitas andmed PRRS-i viirusetiitrite kohta kahes vaktsiini Porcilis PRRS partiis, millest kumbki ennistati kümne Porcilis M Hyo partiiga pärast 0-, 1-, 2- ja 3tunnist säilitamist toatemperatuuril.
English: The marketing authorisation holder has presented data on safety studies (single dose, overdose, repeated dose) starting at 4 weeks of age with Porcilis PRRS mixed with Porcilis M Hyo, considering that 4 weeks is the youngest age recommended for the administration of the mixed product.
Estonian: Müügiloa hoidja on esitanud Porcilis PRRS-i ja Porcilis M Hyo segu ohutusuuringute andmed (üksikannuse, üleannustamise ja korduvannustamise kohta) vähemalt 4 nädala vanuste sigade kohta arvestusega, et 4 täisnädalat on minimaalne soovitatav vanus kokkusegatud toote manustamiseks.
English: - Second vaccination: Porcilis M Hyo mixed with Porcilis PRRS from 4 weeks of age.
Estonian: - teine vaktsineerimine: Porcilis M Hyo segatuna Porcilis PRRS-ga alates 5. elunädalast.
English: The product literature of Porcilis PRRS should also be consulted before administration of the mixed product.
Estonian: Enne kokku segatud preparaadi manustamist tuleb tutvuda Porcilis PRRS`i tootealase kirjandusega.
English: Agualva-Cacém Portugal
Estonian: Unterschleißheim Saksamaa
English: Member State/EEA
Estonian: Liikmesriik/EEA Müügiloa hoidja Nimetus Tugevus
English: The efficacy studies using appropriate challenges for Porcilis M Hyo and Porcilis PRRS have shown that there is no affect of simultaneous administration on the efficacy parameters of reduced viraemia and a reduction in lung lesions.
Estonian: Ravimite Porcilis M Hyo ja Porcilis PRRS vastavad efektiivsusuuringud on näidanud, et nende koosmanustamisel puudub negatiivne mõju
English: 5831 AN
Estonian: 5831 AN Boxmeer Holland
English: A transient swelling/redness (max. diameter 5 cm) may occur at the injection site diminishing over a period of maximally 14 days.
Estonian: Süstekohal võib tekkida kuni 14 päeva jooksul mööduv turse/punetus (maks.
English: Rua Agualva dos Açores, n.º
Estonian: Intervet PortugalSaúde Animal, Lda Rua Agualva dos Açores, n.º 16, 2735 - 557 AgualvaCacém
English: CARBAJOSA DE LA SAGRADA
Estonian: CARBAJOSA DE LA SAGRADA 37188 SALAMANCA Hispaania
English: The marketing authorisation holder considered that, based on the “Guideline on requirements for concurrent administration of immunological veterinary medicinal products*, the efficacy data of the individual products, including duration of immunity, can be applied for the concurrent use of them if absence of immunological interference is demonstrated.
Estonian: mille põhjal individuaalsete toodete efektiivsusandmeid, sealhulgas immuunsuse kestust, on võimalik üle kanda nende toodete kooskasutamisel kehtivatesse tingimustesse juhul, kui on ära näidatud immunoloogilise interferentsi puudumine.
English: The marketing authorisation holder has provided data of the PRRS virus titration after mixing Porcilis PRRS with Porcilis M Hyo at 0, 1, 2 and 3 hours.
Estonian: Müügiloa hoidja on esitanud andmed PRRS-viiruse tiitrimise kohta 0, 1, 2 ja 3 tundi pärast ravimite Porcilis PRRS ning Porcilis M Hyo kokkusegamist.
English: Estonia
Estonian: Eesti Vabariik
English: The specific claims for finishing pigs to improve the rearing results have not been demonstrated.
Estonian: Spetsiifilisi nõudeid nuumsigade kasvatamise parendamiseks ei ole siiani näidatud, samuti ei ole näidatud Porcilis PRRS-i immuunsuse kestust toodete koosmanustamisel.
English: The proposed vaccination scheme for finishing pigs with the mixed product is: first administration of Porcilis M Hyo from one week of age followed by the administration of Porcilis PRRS mixed with Porcilis M Hyo from 4 weeks of age.
Estonian: Väljapakutud skeem, kuidas kokkusegatud tootega nuumsigu vaktsineerida, on järgmine: alates teisest elunädalast manustatakse ravimit Porcilis M Hyo , seejärel alates viiendast elunädalast ravimite Porcilis PRRS ja Porcilis M Hyo segu.
English: Boxmeer
Estonian: Walton
English: - First vaccination: Porcilis M Hyo at 1 week of age.
Estonian: Kokkusegatud toote väljapakutud vaktsineerimisskeem on järgmine: - esimene vaktsineerimine: Porcilis M Hyo 1 nädala vanuses;
English: Intervet Ireland Limited, Magna Drive Magna Business Park
Estonian: Intervet Ireland Limited,
English: Porcilis PRRS
Estonian: Sealjuures tuleb kasutada järgnevat juhendit: Porcilis PRRS
English: Belgium Intervet International bv Wim de
Estonian: Ühendkuningriik Intervet International B.V.
English: Whereas: - the CVMP considered that stability of the mixed product up to 1 hour after mixing as claimed on the Summary of Product Characteristics was supported by the data provided, - the CVMP considered that the safety and efficacy of the mixed vaccine regarding the Mycoplasma hyopneumoniae component were sufficiently supported by the data provided, the CVMP has recommended the granting of the variation of the Marketing Authorisations for Porcilis M Hyo and associated names (see Annex I).
Estonian: - veterinaarravimite komitee leidis, et esitatud andmetega on piisavalt tõendatud kokkusegatud vaktsiini Mycoplasma hyopneumoniae koostisosa ohutus ja efektiivsus,
English: Annex I List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, marketing authorisation holders in the member states
Estonian: Lisa I Ravimpreparaadi nimi, ravimvorm, tugevus, manustamistee, müügiloa hoidja erinevates liikmesriikides
English: (Reference is made to the pictogram of a dog in section 1).
Estonian: (Viide koera piktogrammile lõigus 1).
English: Water, purified
Estonian: Vesi, puhastatud
English: EU/2/19/246/001 (2 tubes) EU/2/19/246/002 (10 tubes) EU/2/19/246/003 (20 tubes)
Estonian: EU/2/19/246/001 (2 tuubi) EU/2/19/246/002 (10 tuubi) EU/2/19/246/003 (20 tuubi)
English: Date of first authorisation: 10/12/2019.
Estonian: Esmase müügiloa väljastamise kuupäev: 10/12/2019
English: 1 dose (1 ml) contains:
Estonian: 1 annus (1 ml) sisaldab:
English: ATCvet code: QS02CA91
Estonian: ATCvet kood: QS02CA91
English: The maximum clinical response may not be seen until 28 days after administration.
Estonian: Maksimaalne kliiniline vastus ei pruugi ilmneda enne 28 päeva möödumist manustamisest.
English: Single treatment.
Estonian: Ühekordne ravi.
English: Additional corticosteroid treatments should be avoided.
Estonian: Täiendavat kortikosteroidravi tuleb vältida.
English: In case of accidental ocular exposure, flush the eyes thoroughly with water for 10 to 15 minutes.
Estonian: Juhuslikul ravimi silma sattumisel loputada silmi hoolikalt veega 10 kuni 15 minutit.
English: Do not use in dogs with generalised demodicosis.
Estonian: Mitte kasutada generaliseerunud demodekoosiga koertel.
English: Auricular use.
Estonian: Aurikulaarne kasutamine.
English: Restrain the dog's head to prevent shaking, for 2 minutes.
Estonian: Hoida koera pead paigal raputamise vältimiseks 2 minutit.
English: If hypersensitivity to any of the components occurs, the ear should be thoroughly washed.
Estonian: Kui ilmneb ülitundlikkus ükskõik millise koostisaine suhtes, peab kõrva põhjalikult pesema.
English: Shake well before use for 5 seconds.
Estonian: Enne kasutamist loksutada hoolikalt 5 sekundi vältel.
English: After the administration, wet ears or clear discharge can be observed which is not related to the disease pathology.
Estonian: Pärast manustamist võib täheldada kõrvade märgumist või selget eritist, mis ei ole seotud haiguse patoloogiaga.
English: Pack sizes: 2, 10 or 20 tubes.
Estonian: Pakendi suurused: 2, 10 või 20 tuubi.
English: Propylene carbonate Propylene glycol Ethanol (96 per cent) Macrogol 8000
Estonian: Propüleenkarbonaat Propüleenglükool Etanool (96 protsenti) Makrogool 8000
English: Clear, colourless to yellow, slightly viscous liquid.
Estonian: Selge, värvitu kuni kollane, kergelt viskoosne vedelik.
English: The safety of the veterinary medicinal product has not been established in dogs less than 3 months of age.
Estonian: Veterinaarravimi ohutus ei ole kindlaks määratud alla 3 kuu vanustel koertel.
English: Like other corticosteroids, it has antiinflammatory and anti-pruritic properties.
Estonian: Nagu teistel kortikosteroididel on tal põletiku- ja sügelemisvastased omadused.
English: It is recommended not to repeat ear cleaning until 28 days after administration of the product.
Estonian: Soovitatav on kõrvade puhastamist mitte korrata varem kui 28 päeva pärast ravimi manustamist.
English: The extent of transcutaneous absorption of topical medications is determined by many factors including the integrity of the epidermal barrier.
Estonian: Lokaalsete ravimite transkutaanse imendumise ulatus on mõjutatud mitmetest faktoritest, kaasa arvatud epidermaalse barjääri terviklikkus.
English: To avoid this risk for the owners, it is recommended that this veterinary product is administered only by veterinarians or under their close supervision.
Estonian: Vältimaks ohtu loomaomanikele on soovitav, et seda veterinaarravimit manustaks ainult loomaarst või see toimuks tema hoolika järelevalve all.
English: Carton containing 2, 10 or 20 blisters.
Estonian: Karbis sisaldub 2, 10 või 20 blistrit.