natgillin/translations-raw huggingface dataset:
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Kinzalkomb. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
A risk management plan has been developed to ensure that Kinzalkomb is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila Kinzalkomb je bil pripravljen načrt obvladovanja tveganj.
Kinzalkomb is taken by mouth once a day with liquid, with or without food. 
Zdravilo Kinzalkomb se jemlje peroralno enkrat na dan s tekočino, sočasno s hrano ali brez nje.
The most common side effect with Kinzalkomb (seen in between 1 and 10 patients in 100) is dizziness. 
Najpogostejši neželeni učinek zdravila Kinzalkomb (opažen pri 1 do 10 bolnikih od 100) je omotica.
Kinzalkomb has been studied in five main studies involving a total of 2,985 patients with mild to moderate hypertension. 
Zdravilo Kinzalkomb so proučevali v petih glavnih študijah, v katerih je sodelovalo skupno 2 985 bolnikov z blago do zmerno hipertenzijo.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Kinzalkomb, including the appropriate precautions to be followed by healthcare professionals and patients. 
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
It is available as tablets (40 mg or 80 mg telmisartan and 12.5 mg hydrochlorothiazide; 80 mg telmisartan and 25 mg hydrochlorothiazide). 
Na voljo je v obliki tablet (40 mg ali 80 mg telmisartana in 12,5 mg hidroklorotiazida; 80 mg telmisartana in 25 mg hidroklorotiazida).
In patients with type 2 diabetes or in patients with moderate or severe kidney impairment, Kinzalkomb must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension). 
Pri bolnikih s sladkorno boleznijo tipa 2 ali bolnikih z zmerno ali hudo okvaro ledvic se zdravilo Kinzalkomb ne sme uporabljati v kombinaciji z zdravili, ki vsebujejo aliskiren (zdravilo za zdravljenje esencialne hipertenzije).
Other information about Kinzalkomb 
Druge informacije o zdravilu Kinzalkomb
What is the risk associated with Kinzalkomb? 
Kakšna tveganja so povezana z zdravilom Kinzalkomb?
What benefit has Kinzalkomb shown during the studies? 
Kakšne koristi je zdravilo Kinzalkomb izkazalo med študijami?
It works by increasing urine output, reducing the amount of fluid in the blood and reducing blood pressure. 
Ta povzroča povečano izločanje seča ter s tem zmanjšanje količine tekočine v krvi in znižanje krvnega tlaka.
By lowering blood pressure, the risks associated with high blood pressure, such as having a stroke, are reduced. 
Z znižanjem krvnega tlaka se zmanjša možnost tveganj, povezanih z visokim krvnim tlakom, kot je na primer možganska kap.
Care must be taken when using Kinzalkomb with other medicines that have an effect on blood potassium levels. 
Posebna pozornost je potrebna, kadar se zdravilo Kinzalkomb jemlje sočasno z drugimi zdravili, ki vplivajo na ravni kalija v krvi.
Kinzalkomb must also not be used in people who have severe liver, kidney or bile problems, blood potassium levels that are too low, or blood calcium levels that are too high. 
Zdravilo Kinzalkomb se prav tako ne sme uporabljati pri osebah, ki imajo huda obolenja jeter, ledvic ali žolčnika, ter osebah s prenizkimi ravnmi kalija v krvi ali previsokimi ravnmi kalcija v krvi.
The full EPAR for Kinzalkomb can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Kinzalkomb je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports Za več informacij o zdravljenju z zdravilom Kinzalkomb preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Kinzalkomb is used in adult patients who have essential hypertension (high blood pressure) that is not adequately controlled by telmisartan alone. 
Zdravilo Kinzalkomb se uporablja pri odraslih bolnikih, ki imajo esencialno hipertenzijo (visok krvni tlak) in pri katerih samo s telmisartanom krvnega tlaka ni mogoče ustrezno uravnavati.
In four of these studies, Kinzalkomb was compared with placebo (a dummy treatment) and with telmisartan taken alone in a total of 2,272 patients. 
V štirih študijah so zdravilo Kinzalkomb pri skupno 2 272 bolnikih primerjali s placebom (zdravilom brez zdravilne učinkovine) in telmisartanom kot samostojnim zdravilom.
Kinzalkomb is a medicine that contains two active substances, telmisartan and hydrochlorothiazide. 
Kinzalkomb je zdravilo, ki vsebuje dve zdravilni učinkovini, telmisartan in hidroklorotiazid.
Kinzalkomb was more effective at reducing diastolic blood pressure than telmisartan taken alone and than placebo. 
Zdravilo Kinzalkomb je bilo pri zniževanju diastoličnega krvnega tlaka učinkovitejše od placeba in telmisartana, uporabljenega kot samostojno zdravilo.
The CHMP decided that Kinzalkomb's benefits are greater than its risks for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on telmisartan alone. 
CHMP je zaključil, da so koristi zdravila Kinzalkomb pri zdravljenju esencialne hipertenzije pri bolnikih, katerih krvni tlak ni zadostno uravnan samo s telmisartanom, večje od z njim povezanih tveganj.
Why has Kinzalkomb been approved? 
Zakaj je bilo zdravilo Kinzalkomb odobreno?
For the full list of all side effects reported with Kinzalkomb, see the Package Leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Kinzalkomb, glejte navodilo za uporabo.
Kinzalkomb contains two active substances, telmisartan and hydrochlorothiazide. 
Zdravilo Kinzalkomb vsebuje dve zdravilni učinkovini, telmisartan in hidroklorotiazid.
How has Kinzalkomb been studied? 
Kako je bilo zdravilo Kinzalkomb raziskano?
The dose of Kinzalkomb to be used depends on the dose of telmisartan that the patient was taking before: patients who were receiving 40 mg telmisartan should take the 40/12.5 mg tablets, and patients who were receiving 80 mg telmisartan should take the 80/12.5 mg tablets. 
Odmerek zdravila Kinzalkomb, ki ga je treba uporabiti, je odvisen od odmerka telmisartana, ki ga je bolnik jemal pred tem: bolniki, ki so predhodno jemali 40 mg telmisartana, morajo uporabljati tablete v odmerku 40 mg/12,5 mg, medtem ko morajo bolniki, ki so predhodno jemali 80 mg telmisartana, jemati tablete v odmerku 80 mg/12,5 mg. Tablete v odmerku 80 mg/25 mg se dajejo bolnikom, pri katerih krvnega tlaka ni mogoče uravnati z jemanjem tablet v odmerku 80 mg/12,5 mg ali pri katerih se je krvni tlak stabiliziral z uporabo dveh zdravilnih učinkovin, ki so ju jemali ločeno, preden so prešli na zdravilo Kinzalkomb.
The Committee recommended that Kinzalkomb be given marketing authorisation. 
Zato je priporočil, da se zanj izda dovoljenje za promet.
What is Kinzalkomb? 
Kaj je zdravilo Kinzalkomb?
What is Kinzalkomb used for? 
Za kaj se zdravilo Kinzalkomb uporablja?
How does Kinzalkomb work? 
Kako zdravilo Kinzalkomb deluje?
How is Kinzalkomb used? 
Kako se zdravilo Kinzalkomb uporablja?
ATC vet code: QS02CA91 
Oznaka ATC vet:QS02CA91
Most of the absorption occurred in the first few days after administration. 
Večji del absorbcije zdravila se je zgodil v prvih nekaj dneh po dajanju zdravila.
Therefore do not use in animals less than 4 months of age. 
Ne uporabite pri živalih mlajših od 4 mesece.
PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable. 
PREPOVED PRODAJE, OSKRBE IN/ALI UPORABE Navedba ni smiselna .
Mometasone furoate 
Mometazon furoat
See section 4.10.. 
Glej poglavje 4.10
Mometasone furoate (as monohydrate) 
Mometazon furoat (kot monohidrat)
Use of the product should be based on susceptibility testing of isolated bacteria, and/or other appropriate diagnostic tests. 
Za uporabo tega zdravila se odločamo na osnovi testa občutljivosti izoliranih bakterij in/ali katerega drugega primernega diagnostičnega testa.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary 
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) , če je potrebno
Studies with a range of proprietary ear cleaners have shown no chemical incompatibilities. 
Študije z različnimi sredstvi za čiščenje useš niso pokazale kemične inkompatibilnosti.
No data available.. 
Podatki niso na voljo.
Plasticised hydrocarbon gel (5% polyethylene in 95% mineral oil) 
Plastificiran ogljikovodikov gel (5% polietilen in 95% mineralno olje) 6.2 Inkompatibilnosti
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu 
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency, (EMA) http://www.ema.europa.eu
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23/06/2008 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve pridobitve dovoljenja za promet: 23/06/2008
Do not use during the whole or part of the pregnancy. 
Ne uporabite v celotnem ali delnem obdobju brejosti.
Interaction with other medicinal products and other forms of interaction: No data available. 
Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Podatki niso na voljo
One drop contains 267 µg orbifloxacin, 27 µg mometasone furoate and 27 µg posaconazole. 
Ena kapljica vsebuje 267 µg orbifloksacina, 27 µg mometazon furoata in 27 µg posakonazola.
Treatment should continue for 7 consecutive days. 
Zdravilo dajemo sedem zaporednih dni.
Malassezia pachydermatis resistance to azoles, including posaconazole, has not been reported. 
Rezistenca Malassezia pachydermatis na azole vključno s posakonazolom ni bila ugotovljena.
OTHER INFORMATION Not all pack sizes may be marketed. 
DRUGE INFORMACIJE Ni nujno, da so v prometu vsa pakiranja.
Inflammation can increase the percutaneous absorption of veterinary medicinal products. 
Vnetje lahko poveča perkutano absorbcijo zdravila.
The rapidity and extent of killing are directly proportional to the drug concentration. 
Hitrost in obseg uničenih bakterij sta v direktni povezavi s koncentracijo zdravila.
Date of last renewal: 23/06/2013 
Datum zadnjega podaljšanja dovoljenja za promet: 23/06/2013
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE 
BESEDILO “SAMO ZA ŽIVALI” IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, če je navedba smiselna
Mometasone furoate is a corticosteroid with high topical potency but little systemic effect. 
Mometazon furoat je kortikosteroid z visoko lokalno učinkovitostjo in majhnim sistemskim učinkom.
Posaconazole is 40 - 100 times more potent in vitro against Malassezia pachydermatis than clotrimazole, miconazole and nystatin. 
Posakonazol je in vitro 40-100 krat bolj učinkovit proti Malassezia pachydermatis kot klotrimazol, mikonazol in nistatin.
Minimum Inhibitory Concentrations vs. Orbifloxacin - Summary Pathogen 
Minimalna inhibitorna koncentracija vs. Orbifloksacin - Povzetek
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu/. 
DATUM ZADNJE ODOBRITVE NAVODIL ZA UPORABO Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency, EMA) http://www.ema.europa.eu
Pseudomonas aeruginosa Staphylococcus intermedius Streptococcus ß-haemolyticus G 19 
Staphylococcus intermedius 171 0.125 Streptococcus ß-haemolyticus G
Orbifloxacin 
Orbifloksacin
Fluoroquinolones are known to cross the placenta and to be distributed into milk. 
Znano je, da fluorkinoloni prehajajo skozi placento in se izločajo v mleko.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements. 
Vsako neporabljeno zdravilo za uporabo v veterinarski medicini ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z lokalnimi predpisi .
Vet Pharma Friesoythe Sedelsberger Straße 2 26169 Friesoythe Germany 
26169 Friesoythe Nemčija
Studies to determine the effect of orbifloxacin on fertility in dogs have not been conducted. 
Študije, ki bi pokazale, kakšen je vpliv orbifloksacina na plodnost, niso bile narejene.
Cross-resistance across the fluoroquinolone class of antibiotics is common. 
Navskrižna rezistenca med antibiotiki iz skupine fluorkinolonov je običajen pojav.
Paraffin, Liquid 
Parafin, tekoči
The underlying cause should be identified and treated. 
Potrebno je ugotoviti in zdraviti primarni vzrok vnetja.
Pharmacotherapeutic group: Otologic - Corticosteroids and anti-infectives in combination. 
Farmakoterapevtska skupina: Zdravila za ušesne bolezni - Kortikosteroidi v kombinaciji z antimikrobnimi učinkovinami.
Such impairment disrupts replication of the bacterial cell, leading to rapid cell death. 
Zaradi tega je prekinjena produkcija bakterijske celice, kar privede do njenega hitrega uničenja.
SPECIAL STORAGE CONDITIONS Store in the original carton. 
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v originalni ovojnini.
PACKAGE SIZE 17.5 mL 
VELIKOST PAKIRANJA 17.5 ml
It is prudent to reserve fluoroquinolones for the treatment of clinical conditions, which have responded poorly or are expected to respond poorly to other classes of antibiotics. 
Pomembno je, da uporabimo fluorkinolone za zdravljenje takšnih kliničnih stanj, ki so slabo reagirala oz. predvidevamo, da bodo slabo reagirala na zdravljenje z drugimi skupinami antibiotikov.
Resistance to fluoroquinolones occurs by chromosomal mutation with three mechanisms: Decrease of the bacterial wall permeability, expression of efflux pump, or mutation of enzymes responsible for the molecule's binding site. 
Do rezistence na fluorkinolone pride zaradi treh mehanizmov, ki sodelujejo pri mutaciji kromosomov: zmanjšanje prepustnosti bakterijske stene, delovanja efflux črpalke in pa mutacije encima odgovornega za vezavo molekul.
In in vitro tests, posaconazole has shown fungicidal activity against most of the approximately 7,000 strains of yeast and filamentous fungi tested. 
In vitro poskusi so pokazali, da posakonazol deluje na večino od približno 7000 sevov kvasovk in gliv, ki so bile testirane.
The extent of percutaneous absorption of topical medications is determined by many factors including the integrity of the epidermal barrier. 
Obseg perkutane absorbcije lokalnega zdravila je odvisna od številnih dejavnikov, med njimi tudi od nepoškodovanosti kože.
packl sizes: 8.8 mL (7.5 g), 17.5 mL (15 g) and 35.1 mL (30 g) 
Velikosti pakiranja: 8,8 ml (7,5 g) ; 17,5 ml (15 g) in 35,1 ml.(30 g) Ni nujno, da so v prometu vsa pakiranja.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 17.5 mL 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV 17.5 ml
Administration of the recommended dose (4 drops per ear) 5 times daily for 21 consecutive days to dogs weighing 7.6 to 11.4 kg bodyweight caused a slight decrease in serum cortisol response after adrenocorticotropic hormone (ACTH) administration in an ACTH stimulation test. Discontinuation of treatment will result in a complete return to normal adrenal response. 
Uporaba priporočenega odmerka (4 kapljice na uho) petkrat dnevno 21 zaporednih dni, je pri psih težkih 7,6 do 11,4 kg po adrenokortikotropični hormonski stimulaciji povzročila rahel padec serumske koncentracije kortizola.
Excess hair around the treatment area should be cut. 
Odstranite dlake na mestu zdravljenja.
MANUFACTURER'S BATCH NUMBER Batch {number} 
IZDELOVALČEVA ŠTEVILKA SERIJE IZDELAVE ZDRAVILA Številka serije
Orbifloxacin has in vitro activity against a wide range of Gram-positive and Gram-negative organisms. 
Orbifloksacin deluje in vitro na številne grampozitivne in gramnegativne bakterije.
Shelf life of the veterinary medicinal product as packaged for sale: 2 years Shelf life after first opening the immediate packaging: 8.8 mL: 7 days 
Rok uporabnosti zdravila po prvem odpiranju vsebnika: 8,8 ml: 7 dni
The safety of the veterinary medicinal product has not been established during pregnancy or lactation. 
Varnost zdravila v obdobju brejosti in laktacije ni bila ugotovljena.
Posaconazole is a broad-spectrum triazole antifungal agent. 
Posakonazol je antimikotik iz skupine triazolov s širokim spektrom delovanja.
17.5 mL and 35.1 mL: 28 days 
17,5 ml in 35,1 ml :28 dni.
The external ear canal should be meticulously cleaned and dried before treatment. 
Sluhovod mora biti pred dajanjem zdravila čist in suh.
The mechanism by which posaconazole exerts fungicidal action involves the selective inhibition of the enzyme lanosterol 14-demethylase (CYP51) involved in ergosterol biosynthesis in yeasts and filamentous fungi. 
Njegovo delovanje je vezano na selektivno inhibicijo encima lanosterol 14-demetilaza (CYP51), ki sodeluje pri biosintezi ergosterola pri kvasovkah in glivicah.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Orbifloxacin 
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI
Shelf-life after first opening the bottle: 
Rok uporabnosti zdravila po prvem odpiranju vsebnika:
Treatment of acute otitis externa and acute exacerbations of recurrent otitis externa, associated with bacteria susceptible to orbifloxacin and fungi susceptible to posaconazole, in particular Malassezia pachydermatis. 
Zdravljenje akutnih vnetij zunanjega sluhovoda pri psih in akutnih poslabšanj kroničnih vnetij, ki jih povzročajo za orbifloksacin občutljivi mikroorganizmi in glivice, občutljive za posakonazol, predvsem kvasovka Malassezia pachydermitis.
Do not use in case of hypersensitivity to the active substances, to any of the ingredients, to corticosteroids, to other azole antifungal agents or to other fluoroquinolones. 
Ne uporabite v primeru preobčutljivosti na zdravilno učinkovino, katero koli učinkovino v zdravilu ali na kortikosteroide, na druga protiglivična zdravila iz skupine azolov ali druge fluorkinolone.
Do not use in case of hypersensitivity to any of the ingredients of the veterinary medicinal product, to corticosteroids, to other azole antifungal agents or to other fluoroquinolones. 
Ne uporabite v primeru preobčutljivosti na katero koli zdravilno učinkovino v zdravilu ali na kortikosteroide, druga protiglivična zdravila iz skupine azolov ali druge fluorkinolone.
Prolonged and intensive use of topical corticosteroids preparation is known to trigger local and systemic effects, including suppression of adrenal function, thinning of the epidermis and delayed healing. 
Dolgotrajna in intezivna uporaba lokalnih kortikosteroidov lahko povzroči lokalne ali sistemske učinke, kot so supresija delovanja nadledvične žleze ter tanjšanje in slabše celjenje kože.
Laboratory studies in puppies have shown evidence of arthropathy after systemic administration of orbifloxacin. 
Laboratorijske študije, ki so jih opravili na mladičih, so pokazale, da orbifloksacin, če ga uporabljamo sistemsko, povzroča artropatije.
METHOD AND ROUTE OF ADMINISTRATION For auricular use only. 
NAČIN UPORABE IN DAJANJA Samo za avrikularno uporabo.
Special warnings for each target species: 
Posebna opozorila za ciljno živalsko vrsto
Like other topical corticosteroids, it has anti-inflammatory and anti-pruritic properties. 
Kot drugi lokalni kortikosteroidi deluje protivnetno in lajša srbenje.
The in vitro activity of orbifloxacin against pathogens isolated from clinical cases of canine otitis externa in an EU field trial conducted in 2000 - 2001 was: 
V klinični študiji opravljeni pri psih, v letih 2000-2001 na območju EU je bil učinek orbifloksacina in vitro na bakterije, ki so bile izolirane pri vnetjih zunanjega sluhovoda sledeč:
Store in the original bottle and carton. 
Shranjujte v originalnem vsebniku in ovojnini.
Quinolone class veterinary medicinal products have been associated with cartilage erosions in weightbearing joints and other forms of arthropathy in immature animals of various species. 
Zdravila za uporabo v veterinarski medicini iz skupine kinolonov povezujejo z erozijo hrustanca na sklepih nog in drugimi artropatijami pri še nerazvitih živalih(mladičih) različnih vrst.
Quinolone class drugs have been associated with cartilage erosions in weight-bearing joints and other forms of arthropathy in immature animals of various species. 
Kinolone povezujejo z erozijo hrustanca na sklepih nog in drugimi artropatijami pri še nerazvitih živalih(mladičih) različnih vrst.
4.1 Target species 
KLINIČNI PODATKI 4.1 Ciljna živalska vrsta
The bactericidal action of orbifloxacin results from interference with the enzymes DNA topoisomerase II (DNA-gyrase) and DNA topoisomerase IV which are needed for the synthesis and maintenance of bacterial DNA. 
Orbifloksacin je sintetični širokospektralni baktericidni antibiotik derivat kinolonske karboksilne kisline iz vrste fluorkinolonov.Baktericidno delovanje orbifloksacina je posledica motenega delovanja encima DNA topoizomeraze II (DNA giraza) in encima DNA topoizomeraze IV, ki sta potrebna za sintezo in vzdrževanje bakterijske DNA.
Heavy reliance on a single class of antibiotic may result in the induction of resistance in a bacterial population. 
Posebni previdnostni ukrepi za uporabo pri živalih V kolikor uporabljamo le eno skupino antibiotikov lahko bakterije na ta antibiotik razvijejo rezistenco.
Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands 
5831 AN Boxmeer
Do not use after the expiry date, which is stated on the label. 
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti.
PACKAGE SIZE 8.8 mL 
Plastenka 8.8 ml
Bacterial and fungal otitis is often secondary in nature. 
Bakterije in glivice so pogosto le sekundarni vzrok, ki povzroči vnetje zunanjega sluhovoda.
C. STATEMENT OF THE MRLs Not applicable. 
KARENCA Navedba ni smiselna.
PHARMACEUTICAL FORM Ear drops suspension White to off-white viscous suspension 
Bela do sivo bela viskozna suspenzija
The use of the veterinary medicinal product is not recommended during lactation. 
Uporaba ni priporočljiva v obdobju laktacije.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY 
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEPORABLJENEGA ZDRAVILA ALI ODPADNIH SNOVI,ČE OBSTAJAJO
After application, the base of the ear may be massaged briefly and gently to allow the veterinary medicinal product to penetrate the lower part of the ear canal. 
Po dajanju zdravila zmasirajte bazo ušesa, da se omogoči delovanje zdravila za uporabo v veterinarski medicini tudi v globljih delih sluhovoda.
In case of accidental exposure, rinse the affected area with copious quantities of water. 
V kolikor pridejo kapljice v stik s kožo, to mesto speremo z veliko količino vode.
MARKETING AUTHORISATION NUMBER(S) EU/2/08/081/001 
ŠTEVILKA DOVOLJENJA ZA PROMET EU/2/08/081/001
MARKETING AUTHORISATION NUMBER(S) EU/2/08/081/002 
ŠTEVILKA DOVOLJENJA ZA PROMET EU/2/08/081/002 EU/2/08/081/003
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Box 17.5 mL and 35.1 mL 
PODATKI NA ZUNANJI OVOJNINI PODATKI NA STIČNI OZ. PRIMARNI OVOJNINI škatle 17.5 in 35.1 ml
With dogs weighing less than 2 kg, apply 2 drops to the ear once a day. 
Psom s telesno maso manj kot 2 kg dajemo 2 kapljici zdravila v sluhovod enkrat dnevno.
White HDPE bottle with a white LDPE cap, a natural or white LDPE applicator and a sheath. 
Bela plastenka iz polietilena visoke gostote z zamaškom iz belega polietilena nizke gostote, z nastavkom za dajanje v uho iz polietilena nizke gostote, bele ali naravne barve s pokrovčkom.
6.1 List of excipients 
6.1 Seznam pomožnih snovi lavrinska kislina
Dogs weighing 15 kg or more, apply 8 drops to the ear once a day. 
Psom s telesno maso 15 kg in več dajemo 8 kapljic zdravila v sluhovod enkrat dnevno.