FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Nacionalni pristojni organ Španije je izrazil zaskrbljenost, da nekateri vidiki kakovosti, varnosti in učinkovitosti po mešanju obeh zdravil (Porcilis PRRS in Porcilis M Hyo) niso bili ustrezno utemeljeni.
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product mentioned above.
Slovenian: O varnosti in učinkovitosti sočasne uporabe tega cepiva s katerim koli drugim zdravilom za uporabo v veterinarski medicini, razen z zgoraj navedenim, ni podatkov.
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.”
Slovenian: Smernica o zahtevah glede podatkov v podporo zahtevkov po stabilnosti cepiv za uporabo v veterinarski medicini med njihovo uporabo*, navaja, da je „pri inaktiviranih cepivih v primeru, da je predlagan rok uporabnosti krajši od enega delovnega dne (največ 10 ur), sprejemljivo, da se v študiji stabilnosti roka uporabnosti test jakosti izpusti“.
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.
Slovenian: Imetnik dovoljenja za promet z zdravilom je proučeval ponovitve enkratnih odmerkov posameznega cepiva, dajanega sočasno v intervalu 14 dneh pri živalih, starih 4 tedne.
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.
Slovenian: 4.6 Neželeni učinki (pogostost in resnost) Dan ali dva po cepljenju se lahko prehodno poveča telesna temperatura, povprečno za približno 0,3 °C, pri nekaterih prašičih do 2,0 °C.
English: It is indicated for finishing pigs from 1 week of age.
Slovenian: Indicirano je za prašiče, ki se redijo za zakol, stare od 1 tedna dalje.
English: 2.2 Justification regarding the approach followed to demonstrate the safety of the individual vaccination schemes when the two products are administered together.
Slovenian: 2.2 Utemeljitev pristopa, ki je služil za dokaz varnosti posameznih shem cepljenja pri sočasni uporabi obeh zdravil.
English: It should be administered intramuscularly (2 ml in the neck).
Slovenian: Zdravilo je treba dajati v mišico (2 ml v vrat).
English: Intervet PortugalSaúde Animal, Lda
Slovenian: Portugalska Intervet PortugalSaúde Animal, Lda Rua Agualva dos
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.
Slovenian: Medtem ko je veljalo prepričanje, da predlagani podatki niso ustrezni, saj živali niso prejele enkratnega odmerka cepiva Porcilis M Hyo v starosti 1 tedna v skladu z zasnovo te študije, zaradi česar je ostala varnost celotne sheme odmerjanja nedokazana, je imetnik dovoljenja za promet z zdravilom dokazal najslabši možni scenarij ponovitev odmerkov pri sočasni uporabi obeh cepiv pri občutljivih (seronegativnih) živalih minimalne starosti.
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.
Slovenian: Odsotnost imunološkega medsebojnega vpliva ni bila rezultat sklepanja, temveč je bila jasno dokazana s predloženimi podatki iz dodatne laboratorijske študije, ki so pokazali, da ni bistvene razlike med zaščito živali, ki so bile cepljene z mešanim zdravilom, in živali, ki so prejele samo eno cepivo.
English: Pigs should be vaccinated twice with a 3 week interval.
Slovenian: Prašiče je treba cepiti dvakrat v intervalu 3 tednov.
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.
Slovenian: Na voljo so podatki o varnosti in učinkovitosti pri prašičih od 4 tednov starosti, ki dokazujejo, da lahko cepivo mešamo s cepivom Porcilis PRRS.
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.
Slovenian: Poleg tega velja, da bi bilo treba analizirati jakost komponente Porcilis M Hyo po mešanju, da bi bilo mogoče izključiti vpliv na kakovost neposredno po mešanju (pri času t=0) in po izteku predlaganega roka uporabnosti mešanice.
English: Porcilis M Hyo is an immunological veterinary medicinal product containing Mycoplasma hyopneumoniae and dl--tocopherol acetate as adjuvant.
Slovenian: Porcilis M Hyo je imunološko zdravilo za uporabo v veterinarski medicini, ki vsebuje Mycoplasma hyopneumoniae in dl-α-tokoferolacetat kot adjuvans.
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.
Slovenian: Ker dajanje mešanega cepiva ne spremeni zaščitne imunosti proti izidu lezije pljuč, je imetnik dovoljenja za promet z zdravilom menil, da tudi noben drug parameter učinkovitosti ne bo spremenjen, zato niso potrebni nadaljnji podatki za podporo trajanja imunosti ob dajanju mešanega cepiva.
English: 6.2 Incompatibilities Do not mix with any other veterinary medicinal product except with Porcilis PRRS.
Slovenian: Ne mešajte z nobenim drugim zdravilom za uporabo v veterinarski medicini, razen s Porcilisom PRRS.
English: GROUNDS FOR THE GRANTING OF THE VARIATION OF THE MARKETING AUTHORISATIONS
Slovenian: PODLAGA ZA ODOBRITEV SPREMEMBE DOVOLJENJ ZA PROMET
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.
Slovenian: Imetnik dovoljenja za promet z zdravilom je menil, da je na podlagi „Smernice glede zahtev za sočasno uporabo imunoloških zdravil za uporabo v veterinarski medicini“* podatke o učinkovitosti posameznih zdravil, vključno s trajanjem imunosti, mogoče uporabiti za sočasno uporabo teh zdravil, če je dokazana odsotnost imunološkega medsebojnega vpliva.
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.
Slovenian: Študije učinkovitosti, ki so vključevale ustrezne izzive za zdravili Porcilis M Hyo in Porcilis PRRS, so pokazale, da sočasna uporaba ne vpliva na parametra učinkovitosti „zmanjšanje viremije“ in „zmanjšanje lezij pljuč“.
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.
Slovenian: To je tri tedne po prvi injekciji zdravila Porcilis M Hyo, ki se daje od starosti enega tedna dalje.
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.
Slovenian: Predloženi so bili podatki iz študij laboratorijske učinkovitosti in ene terenske študije, ki so pokazali, da je zmanjšanje izida pri leziji pljuč pri prašičih, ki so prejeli mešano cepivo, podobno zmanjšanju izida pri leziji pljuč pri prašičih, ki so prejeli samo cepivo Porcilis M Hyo.
English: The youngest age for the two products to be used simultaneously is thus four weeks of age.
Slovenian: Sočasna uporaba obeh zdravil je tako mogoča od starosti štirih tednov dalje.
English: List of the names, pharmaceutical forms, strengths of the Veterinary medicinal product, animal species, routes of administration, withdrawal period, marketing authorisation holders in the Member states
Slovenian: SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, NAČINOV
English: Postfach 1130
Slovenian: Deutschland GmbH Postfach 1130
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.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predložil podatke iz študij varnosti (posamezen odmerek, preveliko odmerjanje, ponavljanje odmerkov) od starosti 4 tednov dalje za mešanico zdravil Porcilis PRRS in Porcilis M Hyo ob upoštevanju, da je starost 4 tednov najmanjša priporočljiva starost za dajanje mešanega zdravila.
English: A single dose (2 ml) of Porcilis M Hyo mixed with Porcilis PRRS is given intramuscularly in the neck.
Slovenian: Enkratni odmerek (2 ml) Porcilisa M Hyo, pomešanega s Porcilisom PRRS, damo intramuskularno na vratu.
English: Vaccinate pigs twice with a three week interval.
Slovenian: Prašiče cepimo dvakrat v presledku treh tednov.
English: Porcillis M.Hyo
Slovenian: PORCILIS M. HYO
English: - First vaccination: Porcilis M Hyo at 1 week of age.
Slovenian: - prvo cepljenje: Porcilis M Hyo pri starosti 1 tedna.
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.
Slovenian: Za zdravilo Porcilis M Hyo je imetnik dovoljenja za promet z zdravilom predložil podatke o vsebini adjuvansa (dl-α-tokoferolacetat), vrednosti pH in sterilnosti mešanice po rekonstituciji dveh serij zdravila Porcilis PRRS v dveh serijah zdravila Porcilis M Hyo po 3 urah hranjenja pri sobni temperaturi.
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.
Slovenian: Intramuskularno prašičem po 2 ml za eno žival v vrat v predel za ušesom.
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.
Slovenian: Imetnik dovoljenja za promet z zdravilom je bil pozvan, naj utemelji, zakaj ni upošteval predlagane sheme cepljenja (Porcilis M Hyo pri starosti 1 tedna ter mešanica zdravil Porcilis M Hyo in Porcilis PRRS pri starosti 4 tednov), da bi bilo mogoče pokazati varnost mešanega zdravila.
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
Slovenian: CVMP Guideline on requirements for concurrent administration of immunological veterinary medicinal products (EMEA/CVMP/550/02-FINAL) (Smernica CVMP glede zahtev za sočasno uporabo imunoloških zdravil za uporabo v veterinarski medicini) - http://www.ema.europa.eu/pdfs/vet/iwp/055002en.pdf vedno vidni vsi klinični znaki (na živali ne vplivajo drugi dejavniki) tako kot v terenskih študijah.
English: Luxembourg Intervet International bv Wim de
Slovenian: Luksemburg Intervet International bv Wim de
English: Product name
Slovenian: Lastniško ime Jakost
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).
Slovenian: - CVMP meni, da so predloženi podatki zadostno podprli varnost in učinkovitost mešanega cepiva z vidika komponente Mycoplasma hyopneumoniae; je CVMP priporočil odobritev spremembe dovoljenj za promet z zdravilom Porcilis M Hyo in povezanimi imeni (glejte Dodatek I).
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.
Slovenian: O varnosti in učinkovitosti uporabe Porcilisa M Hyo, pomešanega s cepivom Porcilis PRRS, pri vzrejnih živalih in med brejostjo ni podatkov.
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.
Slovenian: Glede na priporočeno shemo cepljenja se zdravili Porcilis M Hyo in Porcilis PRRS uporabljata sočasno od drugega dajanja zdravila Porcilis M Hyo dalje.
English: - Second vaccination: Porcilis M Hyo mixed with Porcilis PRRS from 4 weeks of age.
Slovenian: - drugo cepljenje: mešanica zdravil Porcilis M Hyo in Porcilis PRRS od starosti 4 tednov dalje.
English: Belgium Intervet International bv Wim de
Slovenian: Nizozemska Intervet International bv Wim de
English: It should be borne in mind that PRRS is a multifactorial disease and therefore all clinical signs may not always be seen in laboratory studies (animals kept free from other agents) as in field studies.
Slovenian: Zavedati se je treba, da je prašičji reprodukcijski in respiratorni sindrom (PRRS) multifaktorska bolezen, zato v laboratorijskih študijah niso
English: Rua Agualva dos Açores, n.º
Slovenian: Açores, n.º 16,
English: The Ph.Eur.
Slovenian: International B.V.
English: CARBAJOSA DE LA SAGRADA
Slovenian: CARBAJOSA DE LA SAGRADA 37188 SALAMANCA Španija
English: Porcilis PRRS
Slovenian: Porcilis PRRS Porcilis M Hyo
English: Boxmeer
Slovenian: Ciper
English: Porcilis M. Hyo, suspension injectable
Slovenian: Porcillis M.Hyo inaktivirani koncentrat celic mikoplazme
English: The product literature of Porcilis PRRS should also be consulted before administration of the mixed product.
Slovenian: Pred dajanjem mešanega cepiva je treba prebrati informacije o cepivu Porcilis PRRS.
English: Germany Intervet Deutschland GmbH
Slovenian: Unterschleißheim Nemčija
English: Porcilis M hyo, suspensão para injecção
Slovenian: PORCILIS Mhyo inaktivirani koncentrat celic mikoplazme
English: Annex I List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, marketing authorisation holders in the member states
Slovenian: SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH
English: Radlická 3185/1c 150 00 Praha 5, Czech Republic
Slovenian: Radlická 3185/1c 150 00 Praha 5,
English: Czech Republic
Slovenian: Država članica
English: (Reference is made to the pictogram of a dog in section 1).
Slovenian: (sklic na piktogram psa v poglavju 1).
English: Date of first authorisation: 10/12/2019.
Slovenian: Datum pridobitve dovoljenja za promet: 10/12/2019.
English: 2 tubes 10 tubes 20 tubes
Slovenian: 2 tubi 10 tub 20 tub
English: The maximum clinical response may not be seen until 28 days after administration.
Slovenian: Do največjega kliničnega odziva lahko pride šele po 28 dneh po dajanju zdravila.
English: 1 dose (1 ml) contains:
Slovenian: En odmerek (1 ml) vsebuje:
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Slovenian: - zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali) - pogosti (pri več kot 1, toda manj kot 10 živali od 100 zdravljenih živali) - občasni (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali) - redki (pri več kot 1, toda manj kot 10 živali od 10.000 zdravljenih živali) - zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri)
English: ATCvet code: QS02CA91
Slovenian: Oznaka ATC vet: QS02CA91
English: Shake well before use for 5 seconds.
Slovenian: Pred uporabo dobro stresajte 5 sekund.
English: Shelf life of the veterinary medicinal product as packaged for sale: 18 months
Slovenian: Rok uporabnosti zdravila v pakiranju za prodajo: 18 mesecev
English: In cases of parasitic otitis, an appropriate acaricidal treatment should be implemented.
Slovenian: V primeru parazitarnega vnetja sluhovoda je treba uvesti ustrezno akaricidno zdravljenje.
English: EU/2/19/246/001 (2 tubes) EU/2/19/246/002 (10 tubes) EU/2/19/246/003 (20 tubes)
Slovenian: EU/2/19/246/002 (10 tub) EU/2/19/246/003 (20 tub)
English: Do not use in case of hypersensitivity to the active substances, to other corticosteroids or to any of the excipients.
Slovenian: Ne uporabite v primerih preobčutljivosti na učinkovine, na druge kortikosteroide ali na katero koli pomožno snov.
English: Like other corticosteroids, it has antiinflammatory and anti-pruritic properties.
Slovenian: Kot ostali kortikosteroidi ima protivnetne in antipruritične lastnosti.
English: Mometasone furoate is a corticosteroid with high potency.
Slovenian: Mometazonfuroat je kortikosteroid z visoko jakostjo.
English: May be harmful after ingestion.
Slovenian: Lahko je škodljivo po zaužitju.
English: Studies to determine the effect on fertility in dogs have not been conducted.
Slovenian: Študije, ki bi pokazale, kakšen je vpliv na plodnost pri psih, niso bile narejene.
English: Clear, colourless to yellow, slightly viscous liquid.
Slovenian: Bistra, brezbarvna do rumena, rahlo viskozna tekočina.
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.
Slovenian: Da bi se izognili tveganju za lastnike se priporoča, da zdravilo daje veterinar ali pa pod njegovim neposrednim nadzorom.
English: The extent of transcutaneous absorption of topical medications is determined by many factors including the integrity of the epidermal barrier.
Slovenian: Obseg perkutane absorpcije topikalnih zdravil določajo številni dejavniki vključno z integriteto epidermalne pregrade.
English: Whenever possible, the use of the veterinary medicinal product should be based on identification of infecting organisms and susceptibility testing.
Slovenian: Kadarkoli je možno, mora uporaba tega zdravila temeljiti na identifikaciji organizma odgovornega za okužbo in testiranju občutljivosti.
English: Pack sizes: 2, 10 or 20 tubes.
Slovenian: Pakiranje: 2, 10 ali 20 tub.
English: The recommended dosage is 1 single-dose container (i.e. 1 ml of solution) per infected ear.
Slovenian: Priporočen odmerek je 1 enoodmerni vsebnik (tj. 1 ml raztopine) v vsako prizadeto uho.
English: Insert the applicator nozzle into the affected external ear canal and squeeze the entire contents into the ear.
Slovenian: Šobo aplikatorja vstavite v prizadet zunanji ušesni kanal in iztisnite celotno vsebino v uho.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the outer carton and container label after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na zunanji škatli in ovojnini po EXP.
English: Florfenicol is a bacteriostatic antibiotic which acts by inhibiting protein synthesis, through binding to and acting on the 50S ribosomal subunit of bacteria.
Slovenian: Florfenikol je bakteriostatski antibiotik, ki deluje z zaviranjem sinteze beljakovin, preko vezave in delovanja na 50S ribosomalno podenoto bakterije.
English: After 3 weekly administrations of up to 5x the recommended posology, the test product induced slight erythema in one or both ears that returned to normal within 48 hours.
Slovenian: Po 3-eh tednih dajanja do 5x priporočenega odmerjanja, je testirano zdravilo izzvalo rahlo rdečino v enem ali obeh ušesih, ki so se vrnila v normalno stanje po 48-ih urah.
English: Other potentially treatment-related effects included mild changes to aspartate aminotransferase (AST), total protein, cholesterol, inorganic phosphorus, creatinine and calcium.
Slovenian: Drugi možni z zdravljenjem povezani učinki so vključevali rahle spremembe aspartat aminotransferaze (AST), celokupnih proteinov, holesterola, anorganskega fosforja, kreatinina in kalcija.
English: Bacterial and fungal otitis is often secondary to other conditions.
Slovenian: Bakterijsko in glivično vnetje sluhovoda je pogosto sekundarno zaradi drugih stanj.
English: Restrain the dog's head to prevent shaking, for 2 minutes.
Slovenian: Zadržite glavo psa, da mu preprečite tresenje z glavo za 2 minuti.
English: The veterinary medicinal product is a fixed combination of three active substances (corticosteroid, antifungal and antibiotic).
Slovenian: Zdravilo je fiksna kombinacija treh učinkovin (kortikosteroida, antimikotika in antibiotika).
English: Single treatment.
Slovenian: Enkratno zdravljenje.
English: Inflammation can increase the transcutaneous absorption of veterinary medicinal products across the skin adjacent to the external opening of the ear canal.
Slovenian: Vnetje lahko poveča perkutano absorpcijo zdravila preko kože v bližini odpiranja zunanjega ušesnega kanala.
English: Propylene carbonate Propylene glycol Ethanol (96 per cent) Macrogol 8000
Slovenian: Seznam pomožnih snovi propilen karbonat propilenglikol etanol, 96-odstotni makrogol 8000
English: The safety of the veterinary medicinal product has not been established in dogs less than 3 months of age.
Slovenian: Varnost zdravila pri psih, mlajših od treh mesecev, ni bila dokazana.
English: After application, gently massage the base of the ear for 30 seconds to allow distribution of the solution.
Slovenian: Po dajanju zdravila 30 sekund nežno masirajte bazo ušesa, da omogočite porazdelitev raztopine.
English: Although no potential for skin irritation was indicated by experimental studies, contact of the product with the skin should be avoided.
Slovenian: Čeprav eksperimentalne študije niso pokazale možnosti za draženje kože, se moramo izogibati izpostavljenosti zdravila s kožo.
English: Terbinafine hydrochloride is an allylamine with a pronounced fungicidal activity.
Slovenian: Terbinafinijev klorid je alilamin z izrazito fungicidno aktivnostjo.
English: Its spectrum of activity includes Gram-positive and Gram-negative bacteria including Staphylococcus pseudintermedius (MIC90 of 2 μg/ml).
Slovenian: Njegov spekter delovanja zajema grampozitivne in gramnegativne bakterije, vključno s Staphylococcus pseudintermedius (MIC90 pri 2 μg/ml).
English: Terbinafine hydrochloride has a different mode of action to azole antifungals, therefore there is no cross-resistance with azole antifungals.
Slovenian: Terbinafinijev klorid ima drugačen način delovanja kot azolni antimikotiki, zato ni navzkrižne odpornosti z drugimi azolnimi antimikotiki.
English: Ears must be cleaned before administration of the product.
Slovenian: Ušesa je potrebno pred prvim dajanjem zdravila očistiti.