FrancophonIA/ELRC3.0 huggingface dataset:
English: Open the tube by twisting the soft tip.
Slovenian: Tubo odprite tako, da zavrtite mehko konico.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/ .
Slovenian: Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) (http://www.ema.europa.eu/).
English: Avoid accidental contact to the dog's eyes.
Slovenian: Izognite se nenamernemu stiku zdravila z očmi psa.
English: Cardboard box containing 2, 12, 20 or 40 tubes (each tube containing 2.05 g of product of which a single dose of 1.2 g can be extracted).
Slovenian: Kartonska škatla, ki vsebuje 2, 12, 20 ali 40 tub (vsaka tuba vsebuje 2,05 g zdravila, iz katerega se iztisne enkratni odmerek 1,2 g).
English: The maximum clinical response may not be seen until 21 days after the second administration.
Slovenian: Do največjega kliničnega odziva lahko pride šele po 21 dneh po drugem dajanju.
English: Terbinafine:
Slovenian: terbinafin:
English: In case of parasitic otitis, an appropriate acaricidal treatment should be implemented.
Slovenian: V primeru parazitskega vnetja sluhovoda je treba uvesti ustrezno akaricidno zdravljenje.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini za oznako »EXP«.
English: Additional corticosteroid treatments should be avoided.
Slovenian: Izogibajte se dodatnemu zdravljenju s kortikosteroidi.
English: If clinical signs develop, seek veterinary advice.
Slovenian: Če se razvijejo klinični znaki, se posvetujte z veterinarjem.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose (1.2 g) contains:
Slovenian: En odmerek (1,2 g) vsebuje:
English: If hypersensitivity to any of the components occurs, the ear should be thoroughly washed.
Slovenian: Če se pojavi preobčutljivost na katerokoli sestavino, morate uho temeljito sprati.
English: These findings are considered reversible.
Slovenian: Ta opažanja so bila reverzibilna.
English: Absorption occurred primarily during the first two to four days after administration, with low plasma concentrations (1 to 42 ng/ml) of active substances.
Slovenian: Do absorpcije je v glavnem prišlo v prvih dveh do štirih dneh po vnosu, plazemske koncentracije učinkovin pa so bile majhne (1 do 42 ng/ml).
English: Florfenicol is a bacteriostatic antibiotic which acts by inhibiting protein synthesis.
Slovenian: Florfenikol je bakteriostatski antibiotik, ki zavira sintezo beljakovin.
English: The finding was not correlated with pathological or clinical signs and was reversible.
Slovenian: Ta pojav ni bil povezan s patološkimi ali kliničnimi znaki in je bil reverzibilen.
English: Terbinafine is an allylamine with a pronounced fungicidal activity.
Slovenian: Terbinafin je alilamin z izrazito fungicidno aktivnostjo.
English: Whenever possible the use of the veterinary medicinal product should be based on identification of infecting organisms and susceptibility testing.
Slovenian: Če je le mogoče, zdravilo za uporabo v veterinarski medicini uporabljajte na osnovi identifikacije povzročitelja okužbe in testiranja občutljivosti.
English: The extent of percutaneous 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, med njimi integriteta epidermalne pregrade.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 1 dose
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV 1 odmerek
English: Terbinafine has a different mode of action than azole antifungals, therefore there is no cross resistance with azole antifungals.
Slovenian: Terbinafin ima drugačen način delovanja kot azolni antimikotiki, zato ni navzkrižne odpornosti z drugimi azolnimi antimikotiki.
English: Use with precaution in dogs with suspected or confirmed endocrine disorder (i.e. diabetes mellitus; hypo- or hyper-thyroid disease, etc.).
Slovenian: Uporabljajte previdno pri psih s potrjeno endokrino motnjo (tj. sladkorno boleznijo, hipo- ali hipertiroidizmom itd.) ali sumom nanjo.
English: Accidental eye exposure may occur when the dog shakes its head during or just after administration.
Slovenian: Do nenamerne izpostavljenosti oči lahko pride, ko pes strese z glavo med ali takoj po dajanju zdravila.
English: Systemic absorption of all active substances was determined in multiple-dose studies after placing the veterinary medicinal product into both ear canals of healthy mixed breed dogs.
Slovenian: Sistemska absorpcija vseh učinkovin je bila določena v raziskavi z večkratnim odmerjanjem, kjer so zdravilo vnesli v oba sluhovoda zdravih psov mešancev.
English: The formulation dissolves in ear wax and is slowly eliminated from the ear mechanically.
Slovenian: Zdravilo se raztopi v ušesnem maslu in se po mehanski poti počasi izloča iz ušesa.
English: Fertility: Do not use in breeding animals.
Slovenian: Plodnost: Ne uporabite pri vzrejnih živalih.
English: The safety of the product has not been established in dogs less than 2 months of age or weighing less than 1.4 kg.
Slovenian: Varnost zdravila pri psih, mlajših od dveh mesecev ali lažjih od 1,4 kg, ni bila dokazana.
English: Its spectrum of activity includes Gram-positive and Gram-negative bacteria including Staphylococcus pseudintermedius (MIC90 of 8 µg/ml).
Slovenian: Njegov spekter delovanja zajema grampozitivne in gramnegativne bakterije, vključno s Staphylococcus pseudintermedius (MIC90 8 µg/ml).
English: Do not use in cases 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 katerokoli pomožno snov.
English: Inflammation can increase the percutaneous absorption of veterinary medicinal products.
Slovenian: Vnetje lahko poveča perkutano absorpcijo zdravila.
English: In animals with a history of chronic or recurrent otitis externa, efficacy of the product may be affected if the underlying causes of the condition such as allergy or anatomical conformation of the ear are not addressed.
Slovenian: Pri živalih z anamnezo kroničnega ali ponavljajočega se vnetja zunanjega sluhovoda je lahko učinkovitost tega zdravila zmanjšana, če primarni vzrok, kot je npr. alergija ali anatomska zgradba ušesa, ni obravnavan.
English: It is recommended not to repeat ear cleaning until 21 days after the second administration of the product.
Slovenian: Priporoča se, da čiščenja ušes ne ponovite, dokler ne mine 21 dni od drugega dajanja zdravila.
English: Elanco France S.A.S., 26 Rue de la Chapelle, 68330 Huningue, France
Slovenian: Elanco France S.A.S., 26 Rue de la Chapelle, 68330 Huningue, Francija
English: Marketing authorisation holder: Elanco GmbH, Heinz-Lohmann-Str. 4, 27472 Cuxhaven, Germany
Slovenian: Imetnik dovoljenja za promet z zdravilom: Elanco GmbH, Heinz-Lohmann-Str. 4, 27472 Cuxhaven, Nemčija
English: Auricular administration of five times the recommended dose, one week apart, for 5 consecutive weeks (a total six administrations of 5 tubes per ear or 10 tubes per dog) to mixed breed dogs weighing 10 to 14 kg resulted in clinical signs of wetness of the inner and outer pinna (attributed to presence of the product).
Slovenian: Po avrikularni uporabi petkratnega priporočenega odmerka v razmiku enega tedna pet tednov zaporedoma (skupaj šest aplikacij petih tub v eno uho oziroma 10 tub na psa) pri psih mešancih, težkih od 10 do 14 kg, so se pojavili klinični znaki mokrote notranjega in zunanjega dela uhlja (zaradi prisotnosti zdravila).
English: Single-use multi-layered aluminium and polyethylene tube with a polypropylene thermoplastic elastomer tip.
Slovenian: Večplastna aluminijasta in polietilenska tuba za enkratno uporabo s polipropilensko termoplastično elastomerno konico.
English: In clinical trials, saline only was used for ear cleaning.
Slovenian: kliničnih raziskavah se je za čiščenje ušes uporabljala le fiziološka raztopina.
English: Argenta Dundee Limited, Kinnoull Road, Dunsinane Industrial Estate, Dundee DD2 3XR, UNITED KINGDOM
Slovenian: Argenta Dundee Limited, Kinnoull Road, Dunsinane Industrial Estate, Dundee DD2 3XR, Združeno kraljestvo
English: Decreased cortisol levels were observed after product instillation in tolerance studies (before and after ACTH stimulation), indicating that betamethasone is absorbed and enters the systemic circulation.
Slovenian: V študijah tolerance so po vkapavanju zdravila opazili zmanjšano koncentracijo kortizola (pred stimulacijo z ACTH in po njej), kar kaže na to, da se betametazon absorbira in vstopi v sistemski krvni obtok.
English: Auricular use.
Slovenian: Avrikularna uporaba.
English: <{MM/YYYY}> <{DD/MM/YYYY}> <{DD month YYYY}>
Slovenian: DATUM REVIZIJE BESEDILA {DD/MM/LLLL}
English: There were no clinical signs associated with unilateral vesicle formation within the epithelium of the tympanic membrane (also observed after six administrations, one week apart, of 1 tube per ear or 2 tubes per dog), unilateral mucosal ulceration in the lining of the middle ear cavity, or decrease in serum cortisol response below normal reference range in ACTH stimulation testing.
Slovenian: Kliničnih znakov, povezanih z enostranskim nastajanjem veziklov v epiteliju membrane bobniča (tudi po šestih aplikacijah po eno tubo na uho oziroma dve na psa v razmiku enega tedna), enostransko ulceracijo sluznice srednjega ušesa ali zmanjšanjem odziva serumskega kortizola pod normalnim referenčnim razponom pri stimulacijskem testiranju ACTH, ni bilo.
English: Do not use during pregnancy and lactation.
Slovenian: Ne uporabite v obdobju brejosti in laktacije.
English: Bacterial and fungal otitis is often secondary to other conditions.
Slovenian: Bakterijsko in glivično vnetje sluhovoda sta pogosto posledica drugih stanj.
English: Betamethasone is known to be teratogenic in laboratory species.
Slovenian: Znano je, da je betametazon za laboratorijske vrste živali teratogen.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton box
Slovenian: PODATKI NA ZUNANJI OVOJNINI Kartonska škatla
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Auricular use.
Slovenian: ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT(I) IN NAČIN UPORABE
English: Although a causal relationship with the veterinary medicinal product was not definitively established, owners should be recommended to monitor ocular signs (such as squinting, redness and discharge) in the hours and days following the product application, and to promptly consult a veterinarian in case such signs appear.
Slovenian: Čeprav vzročna povezava z zdravilom ni bila dokončno dokazana, se priporoča, da lastniki spremljajo očesne klinične znake (kot so priprte oči, pordelost in izcedek) nekaj ur in dni po dajanju zdravila in se takoj posvetujejo z veterinarjem, če se ti znaki pojavijo.
English: Before the veterinary medicinal product is applied, the external auditory canal must be examined thoroughly to ensure that the ear drum is not perforated.
Slovenian: Pred dajanjem zdravila za uporabo v veterinarski medicini je treba temeljito pregledati sluhovod, da se prepričate, da bobnič ni predrt.
English: Apply the product into the ear canal by pressing it between two fingers.
Slovenian: Zdravilo vnesite v sluhovod tako, da ga stisnete med prstoma.
English: Compatibility with ear cleaners, other than saline, has not been demonstrated.
Slovenian: Kompatibilnost s čistili za ušesa, razen s fiziološko raztopino, ni bila dokazana.
English: In case of accidental ocular exposure, flush the eyes thoroughly with water for 10 to 15 minutes.
Slovenian: V primeru, da pride do nenamerne izpostavljenosti oči, le-te temeljito spirajte z vodo 10 do 15 minut.
English: Due to the high antimicrobial concentrations achieved in the ear canal and the multifactorial nature of otitis externa, in vitro susceptibility may not be directly correlated with clinical success.
Slovenian: Zaradi visokih protimikrobnih koncentracij, doseženih v sluhovodu, in multifaktorielnih vzrokov, ki prispevajo k vnetju zunanjega sluhovoda, občutljivosti in vitro ne moremo neposredno povezati s kliničnim uspehom.
English: This product is a fixed combination of three active substances: antibiotic, antifungal and corticosteroid.
Slovenian: To zdravilo je fiksna kombinacija treh zdravilnih učinkovin: antibiotika, antimikotika in kortikosteroida.
English: Clean the ears before the initial treatment is applied.
Slovenian: Ušesa pred prvim dajanjem zdravila očistite.
English: Appropriate diagnosis should be used and therapy of causative conditions should be investigated before antimicrobial treatment is considered.
Slovenian: Pred protimikrobnim zdravljenjem je treba izvesti ustrezno diagnostiko in predvideti zdravljenje vzroka.
English: These findings don't affect hearing and are reversible.
Slovenian: Pojava ne prizadaneta sluha in sta reverzibilna.
English: Do not use in pregnant or breeding animals.
Slovenian: Ne uporabite pri brejih ali vzrejnih živalih.
English: Deafness or impaired hearing, usually temporary, have been reported after use in very rare cases in dogs, mainly in elderly animals, in post authorisation experience.
Slovenian: Glede na izkušnje po pridobitvi dovoljenja za promet so v zelo redkih primerih poročali o gluhosti ali okvari sluha, večinoma začasni, po uporabi zdravila pri psih, predvsem pri starejših živalih.
English: Additionally, dogs showed slightly elevated red blood cell count, hematocrit, total protein, albumin and alanine aminotransferase.
Slovenian: zvišane vrednosti hematokrita, skupnih beljakovin, albumina in alanin-aminotransferaze.
English: Prolonged or intensive use of the product may cause blistering of the tympanic membrane epithelium or mucosal ulceration in the lining of the middle ear cavity.
Slovenian: Dolgotrajna ali intenzivna uporaba zdravila lahko povzroči mehurje na epiteliju bobniča ali ulceracijo sluznice srednjega ušesa.
English: In case of accidental skin contact, wash exposed skin thoroughly with water.
Slovenian: V primeru nenamernega stika s kožo izpostavljeni predel temeljito sperite z vodo.
English: The veterinary medicinal product is a fixed combination of three active substances (corticosteroid, antifungal and antibiotic):
Slovenian: Zdravilo je fiksna kombinacija treh zdravilnih učinkovin (kortikosteroida, antimikotika in antibiotika):
English: If accidental ocular exposure does occur, the eyes should be flushed thoroughly with water for 10 to 15 minutes.
Slovenian: V primeru, da pride do nenamerne izpostavljenosti oči, le-te temeljito izpirajte z vodo 10 do 15 minut.
English: Reversibility of the epithelial tympanic membrane blistering is also likely through epithelial migration, a natural self-cleaning and self-repair mechanism for the tympanic membrane and ear canal.
Slovenian: Reverzibilnost pojava mehurjev na epitelni membrani bobniča je verjetno prav tako posledica epitelne migracije, ki je naravni mehanizem samoočiščenja in samoobnavljanja bobniča in sluhovoda.
English: Do not use in pregnant or breeding animals (see section 4.7).
Slovenian: Ne uporabite pri brejih ali vzrejnih živalih (glejte poglavje 4.7).
English: Introduce this flexible soft tip into the ear canal.
Slovenian: Prožno konico vstavite v sluhovod.
English: If treatment with this product is discontinued, the ear canals should be cleaned before treatment with an alternative product is initiated.
Slovenian: Če zdravljenje z zdravilom prekinete, morate pred uvedbo drugega zdravila sluhovod očistiti.
English: Excipient: Butylhydroxytoluene (E321):
Slovenian: Pomožna snov: butilhidroksitoluen (E321)
English: Use of the veterinary medicinal product deviating from the instructions given in the package leaflet may increase the prevalence of bacteria resistant to florfenicol and fungi resistant to terbinafine, and may decrease the effectiveness of treatment with other antibiotics and antifungal agents.
Slovenian: Uporaba zdravila za uporabo v veterinarski medicini, ki odstopa od navodil v Povzetku glavnih značilnosti zdravila, lahko poveča razširjenost bakterij, odpornih proti florfenikolu, in glivic, odpornih proti terbinafinu, ter lahko zmanjša učinkovitost zdravljenja z drugimi antibiotiki in antimikotiki.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Auricular use
Slovenian: NAČIN IN POT(I) UPORABE
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Tube
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
English: In case of accidental ingestion by humans, seek medical advice immediately and show the package leaflet or the label to the physician.
Slovenian: V primeru nenamernega zaužitja s strani ljudi se takoj posvetujte z zdravnikom in mu pokažite navodilo za uporabo ali ovojnino.
English: The safety of this medicine has not been established in pregnancy and lactating bitches.
Slovenian: Varnost zdravila pri brejih psicah in psicah v obdobju laktacije ni bila ugotovljena.
English: Do not use if the eardrum is perforated.
Slovenian: Ne uporabite, če je bobnič predrt.
English: The veterinary medicinal product may be irritating to eyes.
Slovenian: To zdravilo za uporabo v veterinarski medicini lahko draži oči.
English: Fertility Do not use in breeding animals (see section 4.3).
Slovenian: Plodnost: Ne uporabite pri vzrejnih živalih (glejte poglavje 4.3).
English: Pharmacotherapeutic group: Otologicals - Corticosteroids and anti-infectives in combination.
Slovenian: FARMAKOLOŠKE LASTNOSTI Farmakoterapevtska skupina: Zdravila za ušesne bolezni - kortikosteroidi v kombinaciji s protimikrobnimi učinkovinami
English: The decreased adrenal and thymus weights accompanied by atrophy of the adrenal cortex and lymphoid depletion of the thymus correlated with the decreased cortisol levels, and were consistent with the pharmacologic effects of betamethasone.
Slovenian: Zmanjšanje mase nadledvične žleze in ščitnice, ki ga spremljata atrofija skorje nadledvične žleze in izguba limfatičnega tkiva ščitnice, je bilo povezano z zmanjšanimi ravnmi kortizola in v skladu s farmakološkimi učinki betametazona.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT OSURNIA ear gel for dogs terbinafine/florfenicol/betamethasone acetate
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI OSURNIA gel za uho za pse terbinafin/florfenikol/betametazonacetat (terbinafinum/florfenicolum/betamethasoni acetas)
English: OSURNIA ear gel for dogs is available in the following pack sizes: 1 cardboard box containing 2 tubes, 1 cardboard box containing 12 tubes 1 cardboard box containing 20 tubes 1 cardboard box containing 40 tubes Not all pack sizes may be marketed.
Slovenian: OSURNIA gel za uho za pse je na voljo v naslednjih velikostih pakiranja: Ena kartonska škatla, ki vsebuje 2 tubi.
English: In very rare cases, eye disorders such as keratoconjunctivitis sicca and corneal ulcers have been reported in treated dogs, in absence of eye contact with the product.
Slovenian: V zelo redkih primerih so pri zdravljenih psih, pri katerih ni prišlo do stika zdravila z očmi, poročali o obolenjih oči, kot so 'suho oko' (keratoconjunctivitis sicca) in razjede na roženici.
English: Administer one tube per infected ear.
Slovenian: V vsako vneto uho dajte eno tubo.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT OSURNIA ear gel for dogs
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI OSURNIA gel za uho za pse
English: It selectively inhibits the early synthesis of ergosterol, which is an essential component of the membrane of yeasts and fungi including Malassezia pachydermatis (MIC90 of 2 µg/ml).
Slovenian: Selektivno zavira zgodnjo sintezo ergosterola, ki je glavna komponenta membrane kvasovk in glivic, vključno z glivico Malassezia pachydermatis
English: Betamethasone acetate belongs to the diesters class of the glucocorticosteroids with a potent intrinsic glucocorticoid activity which relieves both inflammation and pruritus leading to an improvement of clinical signs observed in otitis externa.
Slovenian: Betametazonacetat je glukokortikosteroid iz skupine diestrov z močno intrinzično glukokortikoidno aktivnostjo, ki lajša vnetje in pruritus ter tako izboljša klinične znake vnetja sluhovoda.
English: Prolonged and intensive use of topical corticosteroids preparation is known to trigger systemic effects, including suppression of adrenal function (see section 4.10).
Slovenian: Znano je, da ima dolgotrajna in intenzivna uporaba topikalnih kortikosteroidnih pripravkov sistemske učinke, med njimi supresijo delovanja nadledvične žleze (glejte poglavje 4.10).
English: Treatment of acute otitis externa, and acute exacerbation of recurrent otitis externa associated with Staphylococcus pseudintermedius and Malassezia pachydermatis.
Slovenian: Zdravljenje akutnega vnetja zunanjega sluhovoda ter akutnega poslabšanja ponavljajočega se vnetja zunanjega sluhovoda, povezanega z bakterijo Staphylococcus pseudintermedius in glivico Malassezia pachydermatis.
English: Appropriate measures (e.g. wearing safety glasses during administration, massaging the ear canal well after administration to ensure even distribution of product, restraining the dog after administration) are needed to avoid exposure to the eyes.
Slovenian: Da se izognete izpostavljenosti oči, so potrebni ustrezni ukrepi (npr. nošenje zaščitnih očal med dajanjem zdravila, masiranje ušesnega kanala po dajanju zdravila, da se zagotovi enakomerna porazdelitev zdravila, fiksacija psa po dajanju zdravila).
English: Name and address of the manufacturers responsible for batch release
Slovenian: Ime in naslov proizvajalca zdravila, odgovornega za sproščanje serij
English: Special warnings for each target species
Slovenian: 4.4 Posebna opozorila za vsako ciljno živalsko vrsto
English: 1 mg equivalent to Betamethasone base 0.9 mg
Slovenian: 1 mg kar ustreza bazi betametazona
English: PHARMACEUTICAL FORM Ear gel.
Slovenian: FARMACEVTSKA OBLIKA Gel za uho.
English: PACKAGE LEAFLET: OSURNIA ear gel for dogs
Slovenian: NAVODILO ZA UPORABO OSURNIA gel za uho za pse
English: If symptoms develop, seek medical advice and show the package leaflet or the label to the physician.
Slovenian: Če se razvijejo klinični znaki, se takoj posvetujte z zdravnikom in mu pokažite navodilo za uporabo ali ovojnino.
English: Prolonged and intensive use of topical corticosteroids preparation is known to trigger systemic effects, including suppression of adrenal function.
Slovenian: Znano je, da ima dolgotrajna in intenzivna uporaba topikalnih kortikosteroidnih pripravkov sistemske učinke, med njimi supresijo delovanja nadledvične žleze.
English: Prolonged and intensive use of topical corticosteroids preparation is known to trigger systemic effects, including suppression of adrenal function (see section Overdose).
Slovenian: Znano je, da ima dolgotrajna in intenzivna uporaba topikalnih kortikosteroidnih pripravkov sistemske učinke, med njimi supresijo delovanja nadledvične žleze (glejte poglavje »Preveliko odmerjanje«).
English: Use of the veterinary medicinal product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to florfenicol and fungi resistant to terbinafine and may decrease the effectiveness of treatment with other antibiotics and antifungal agents.
Slovenian: lahko poveča razširjenost bakterij, odpornih proti florfenikolu, in glivic, odpornih proti terbinafinu, ter lahko zmanjša učinkovitost zdravljenja z drugimi antibiotiki in antimikotiki.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) One dose (1.2 g) contains 10 mg terbinafine, 10 mg florfenicol and 1 mg betamethasone acetate Excipient: 1 mg butylhydroxytoluene (E 321)
Slovenian: En odmerek (1,2 g) vsebuje 10 mg terbinafina, 10 mg florfenikola in 1 mg betametazonacetata.
English: STATEMENT OF ACTIVE SUBSTANCES 1 dose: 10 mg terbinafine, 10 mg florfenicol, 1 mg betamethasone acetate
Slovenian: En odmerek: 10 mg terbinafina, 10 mg florfenikola, 1 mg betametazonacetata.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
Slovenian: B. POGOJI TER OMEJITVE GLEDE OSKRBE IN UPORABE Rp-Vet.