FrancophonIA/ELRC3.0 huggingface dataset:
English: Date of first authorisation: 10/12/2019
Croatian: Datum prvog odobrenja: 10/12/2019
English: It is not associated with clinical signs.
Croatian: To nije povezano s kliničkim znakovima.
English: Plastic bottle
Croatian: Plastična bočica
English: 10 DATE OF REVISION OF THE TEXT
Croatian: 10 DATUM REDAKTURE TEKSTA
English: Read carefully the user safety warnings before use.
Croatian: Pažljivo pročitati sigurnosna upozorenja za korisnike prije primjene.
English: Macrogol 3350
Croatian: Makrogol 3350
English: In these cases, the treatment should be immediately withdrawn.
Croatian: U tim slučajevima treba odmah prekinuti terapiju.
English: Macrogol 400
Croatian: Makrogol 400
English: Treated animals should not be allowed to sleep with owners, especially children and pregnant women during all the period of the treatment.
Croatian: Tretirane životinje ne smiju spavati s vlasnicima, osobito s djecom i trudnicama, tijekom cijelog razdoblja terapije.
English: Alternate the daily application between the left and right ears.
Croatian: Dnevnu dozu primjenjivati naizmjence na lijevom i desnom uhu.
English: EXP {month/year} Once opened use within 30 days.
Croatian: Jednom otvorenu upotrijebiti unutar 30 dana.
English: Tube
Croatian: Tuba
English: The product has an expected positive effect on feed intake by stimulating the appetite but this effect was not measured in the pivotal field trial.
Croatian: Proizvod ima očekivan pozitivan učinak na unos hrane jer potiče apetit, ali taj učinak nije mjeren u glavnom terenskom ispitivanju.
English: In the case of overdose, the same effects as those observed at the recommended therapeutic dose were noted but with a higher incidence.
Croatian: U slučaju predoziranja uočeni su isti učinci kao i oni zamijećeni u preporučenoj terapijskoj dozi, ali s većom učestalošću.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Croatian: Detaljne informacije o ovom veterinarsko-medicinskom proizvodu su dostupne na mrežnom mjestu Europske agencije za lijekove (http://www.ema.europa.eu/).
English: Children must not be present when applying the treatment to the cat.
Croatian: Djeca ne smiju biti prisutna prilikom primjene proizvoda na mačku.
English: The product can be absorbed via the cutaneous or oral route and can cause drowsiness or sedation.
Croatian: Proizvod se može apsorbirati kožnim ili oralnim putem i uzrokovati pospanost ili sedaciju.
English: Given that pregnant women are considered a more sensitive population, it is recommended that pregnant women or women trying to conceive should avoid handling the product and avoid contact with treated animals throughout the treatment period.
Croatian: Budući da se trudnice smatraju osjetljivijom skupinom, preporučuje se da trudnice ili žene koje pokušavaju začeti izbjegavaju rukovanje proizvodom i kontakt s tretiranim životinjama tijekom cijelog razdoblja terapije.
English: In rare occasions, hypersensitivity reactions can occur.
Croatian: U rijetkim slučajevima mogu se javiti reakcije preosjetljivosti.
English: Thoroughly wash hands immediately after administration of the veterinary medicinal product or in case of skin contact with the product or the treated cat.
Croatian: Temeljito oprati ruke odmah nakon primjene veterinarsko-medicinskog proizvoda ili u slučaju kontakta kože s proizvodom ili tretiranom mačkom.
English: Care should be taken that other animals in the household do not come in contact with the application site until it is dry.
Croatian: Valja paziti da druge životinje u kućanstvu ne dođu u dodir s mjestom primjene proizvoda dok se ono ne osuši.
English: Mirtazapine has been identified as potentially reprotoxic in rats and rabbits.
Croatian: Mirtazapin je utvrđen kao potencijalno reprotoksičan u štakora i zečeva.
English: Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required.
Croatian: Upitajte svojeg veterinara ili ljekarnika kako odlagati VMP-ove koji vam više nisu potrebni.
English: If desired, the inner surface of the cat's ear may be cleaned by wiping with a dry tissue or cloth immediately prior to the next scheduled dose.
Croatian: Po želji se unutarnja površina uha mačke može očistiti brisanjem suhom maramicom ili krpicom neposredno prije sljedeće planirane doze.
English: Avoid contact with the treated animal for the first 12 hours after each daily application and until the application site is dry.
Croatian: Izbjegavati kontakt s tretiranom životinjom prvih 12 sati nakon svake dnevne primjene proizvoda i dok se mjesto primjene proizvoda ne osuši.
English: Do not leave the tube out of its child-proof container except during the application phase.
Croatian: Ne ostavljati tubu izvan njezina spremnika za zaštitu djece, osim u fazi primjene proizvoda.
English: Do not use in animals less than 7.5 months of age or less than 2 kg body weight.
Croatian: Ne primjenjivati u životinja mlađih od 7,5 mjeseci ili tjelesne težine manje od 2 kg.
English: These adverse events, including local reactions, resolved at the end of treatment period with no specific treatment.
Croatian: Ti štetni događaji, uključujući lokalne reakcije, povukli su se nakon terapije bez posebne dodatne terapije.
English: Pharmacotherapeutic Group: Psychoanaleptics, antidepressants ATCvet code: QN06AX11
Croatian: FARMAKOLOŠKA SVOJSTVA Farmakoterapijska grupa: Psihoanaleptici, antidepresivi ATCvet kod: QN06AX11
English: If a dose is missed, apply the veterinary medicinal product the following day and resume daily dosing.
Croatian: Ako propustite dozu, veterinarsko-medicinski proizvod primijenite sljedeći dan i nastavite svakodnevnu primjenu.
English: The plasma concentrations of mirtazapine may be also increased when used concomitantly with ketoconazole or cimetidine.
Croatian: Koncentracije mirtazapina u plazmi također se mogu povećati ako se istodobno primjenjuje s ketokonazolom ili cimetidinom.
English: C. STATEMENT OF THE MRLs
Croatian: C. IZVJEŠĆE O MRL-u
English: Do not use in breeding animals.
Croatian: Ne primjenjivati na rasplodnim životinjama.
English: 80689 Munich
Croatian: 80689 München
English: Shelf life after first opening the immediate packaging: 30 days.
Croatian: Rok valjanosti poslije prvog otvaranja unutarnjeg pakiranja: 30 dana.
English: 4.8 Interaction with other medicinal products and other forms of interaction
Croatian: 4.8 Interakcije s drugim veterinarsko-medicinskim proizvodima i drugi oblici interakcija
English: This corresponds to a 3.8 cm line of ointment (see below).
Croatian: To odgovara liniji masti dugoj 3,8 cm (vidjeti niže).
English: People with known hypersensitivity to mirtazapine should not handle the veterinary medicinal product.
Croatian: Osobe koje su preosjetljive na mirtazapin ne bi smjele rukovati veterinarsko-medicinskim proizvodom.
English: It is therefore recommended to treat the animal in the evening.
Croatian: Stoga se preporučuje da se proizvod na životinji primjenjuje navečer.
English: Klifovet AG Geyerspergerstrasse 27 80689 Muenchen Germany
Croatian: Klifovet AG Geyerspergerstrasse 27 80689 München
English: Proper diagnosis and treatment of the underlying disease is key to managing weight loss, and treatment options are dependent on the severity of weight loss and underlying disease(s).
Croatian: Pravilna dijagnoza i liječenje osnovne bolesti ključni su za upravljanje gubitkom težine, a mogućnosti terapije ovise o ozbiljnosti gubitka kilograma i osnovne(ih) bolesti.
English: In the case of contact with eyes, rinse the eyes thoroughly with clean water.
Croatian: U slučaju dodira s očima, temeljito isprati oči čistom vodom.
English: Depending on the severity of vomiting, dehydration or behavioural changes, administration of the product may be discontinued according to the benefit-risk assessment of the veterinarian.
Croatian: Ovisno o ozbiljnosti povraćanja, dehidracije ili promjena u ponašanju, primjena proizvoda može se prekinuti u skladu s procjenom veterinara u pogledu koristi i rizika.
English: When used in hypovolemic cats, supportive treatment (fluid therapy) should be implemented.
Croatian: Kad se primjenjuje u mačaka u hipovolemiji, potrebno je provesti potpornu terapiju (terapija tekućinom).
English: The effects of mirtazapine on glucose regulation have not been evaluated.
Croatian: Nisu ispitani učinci mirtazapina na regulaciju glukoze.
English: In case of oral ingestion, in addition to effects cited above (except local reactions), salivation and tremors may rarely occur.
Croatian: U slučaju unosa oralnim putem, osim navedenih učinaka (s izuzetkom lokalnih reakcija), rijetko se mogu pojaviti slinjenje i tremor.
English: Mirtazapine may increase sedative properties of benzodiazepines and of other substances with sedative properties (antihistamines H1, opiates).
Croatian: Mirtazapin može povećati sedativna svojstva benzodiazepina i drugih tvari sa sedativnim svojstvima (antihistaminici H1, opijati).
English: Do not use during pregnancy and lactation (see section 4.3).
Croatian: Ne primjenjivati tijekom graviditeta i laktacije (vidjeti odjeljak 4.3.).
English: Do not use in breeding animals (see section 4.3).
Croatian: Ne primjenjivati na rasplodnim životinjama (vidjeti odjeljak 4.3.).
English: The efficacy of the veterinary medicinal product has not been established in cats less than 3 years of age.
Croatian: Učinkovitost veterinarsko-medicinskog proizvoda nije utvrđena u mačaka mlađih od 3 godine.
English: Each plastic bottle with a child resistant cap contains 1 tube (5 g) .
Croatian: Svaka plastična bočica sa sigurnosnim zatvaračem za djecu sadrži jednu tubu (5 g).
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
Croatian: PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE U PROMET B. UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE C. IZVJEŠĆE O MRL-u
English: If skin or eye irritation occurs or in case of accidental ingestion, seek immediately medical advice and show the label to the physician.
Croatian: Ako dođe do nadraženosti kože ili oka ili slučajnog gutanja, odmah potražite liječnički savjet i pokažite etiketu liječniku.
English: Inhibition of 5-HT2 and histamine H1 receptors may account for the orexigenic effects of the molecule.
Croatian: Inhibicija 5-HT2 i H1 receptora za histamin može biti posljedica oreksigenih učinaka molekule.
English: Step 4: Using your finger, gently rub ointment on inside surface of cat's ear (pinna) spreading it evenly over the surface.
Croatian: Korak 4.: Prstom nježno utrljati mast na unutarnju površinu uha mačke (ušna školjka) te je ravnomjerno rasporediti po površini.
English: PROHIBITION OF SALE, SUPPLY AND/OR USE
Croatian: ZABRANA PRODAJE, OPSKRBE ILI PRIMJENE
English: The veterinary medicinal product should not be applied on damaged skin.
Croatian: Veterinarsko-medicinski proizvod ne smije se primjenjivati na oštećenoj koži.
English: Step 1: Put on impermeable gloves
Croatian: Korak 1.: Staviti nepropusne rukavice
English: The efficacy of the product was only demonstrated with a 14-day administration corresponding to the current recommendations.
Croatian: Učinkovitost proizvoda utvrđena je samo tijekom 14-dnevne primjene u skladu s trenutačnim preporukama.
English: Repetition of the treatment has not been investigated and as such should only be done after benefit-risk balance assessment by the veterinarian.
Croatian: Ponavljanje terapije nije ispitano i trebalo bi se provoditi tek nakon što veterinar procijeni omjer koristi i rizika.
English: Step 1: Put on impermeable gloves.
Croatian: Korak 1.: Staviti nepropusne rukavice.
English: 27 80689 Munich Germany
Croatian: 27 80689 München
English: In the case of use in cats with diabetes mellitus, glycaemia should be regularly monitored.
Croatian: U slučaju primjene u mačaka koje boluju od diabetes mellitus, trebalo bi redovito pratiti glikemiju.
English: To apply the veterinary medicinal product:
Croatian: Za primjenu veterinarsko-medicinskog proizvoda:
English: Avoid hand to mouth and hand to eye contact until hands have been thoroughly washed.
Croatian: Izbjegavati dodir ruku s ustima ili očima prije nego što ih temeljito operete.
English: This line coincides with the appropriate length of ointment to be applied:
Croatian: Linija se podudara s odgovarajućom duljinom masti koja se primjenjuje:
English: EU/2/19/247/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/19/247/001
English: Step 3: Apply even pressure on tube and squeeze a 3.8 cm line of ointment onto your index finger using the measured line on the bottle or in this leaflet as a guide.
Croatian: Korak 3.: Primijeniti ravnomjerni pritisak na tubu i istisnuti liniju od 3,8 cm masti na kažiprst, služeći se izmjerenom linijom na bočici ili u ovoj uputi.
English: The known symptoms of a mirtazapine overdose of > 2.5 mg/kg in cats include: vocalization and behavioural changes, vomiting, ataxia, restlessness, and tremors.
Croatian: Poznati simptomi predoziranja mirtazapinom od > 2,5 mg/kg u mačaka uključuju: vokalizaciju i promjene u ponašanju, povraćanje, ataksiju, nemir i tremor.
English: Bioavailability following topical administration was 34% (6.5 to 89%) compared to oral administration during the first 24 hours and 65% (40.1 to 128.0%) based on AUC0-∞.
Croatian: Bioraspoloživost nakon topikalne primjene bila je 34 % (6,5 do 89 %) u usporedbi s oralnom primjenom tijekom prva 24 sata i 65 % (40,1 do 128,0 %) na temelju AUC0-∞.
English: In case of an overdose, symptomatic/supportive treatment should be instituted if needed.
Croatian: U slučaju predoziranja potrebno je započeti simptomatsku/potpornu terapiju.
English: Mirtazapine-induced weight gain may be secondary to changes in leptin and the tumour necrosis factor (TNF).
Croatian: Dobivanje na težini izazvano mirtazapinom može biti sekundarno zbog promjena u leptinu i faktoru tumorske nekroze (TNF).
English: Each dose of 0.1 g contains:
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Svaka doza od 0,1 g sadrži:
English: The tube must be placed in the child-proof container after application, which must be closed immediately.
Croatian: Tuba se nakon primjene proizvoda mora staviti u spremnik za zaštitu djece, koji se mora odmah zatvoriti.
English: In the case of hepatic disease, elevated hepatic enzyme levels may be observed.
Croatian: U slučaju bolesti jetre mogu se primijetiti povišene vrijednosti jetrenih enzima.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
Croatian: DATUM KADA JE UPUTA O VMP-u ZADNJI PUTA ODOBRENA
English: Mirtazapine is an α2-adrenergic receptor antagonist nor-adrenergic and serotonergic antidepressant drug.
Croatian: Mirtazapin je antagonist α2-adrenergičkih receptora te noradrenergični i serotonergički antidepresiv.
English: This veterinary medicinal product may cause eye and skin irritation.
Croatian: Ovaj veterinarsko-medicinski proizvod može izazvati nadraženost očiju i kože.
English: The line below coincides with the appropriate length of ointment to be applied:
Croatian: Linija u nastavku podudara se s odgovarajućom duljinom masti koja se primjenjuje:
English: The mean terminal half-life of mirtazapine was 19.9 h (± 3.70) and the mean AUC0-24 was 400 ng*h/ml (±100).
Croatian: Srednja vrijednost terminalnog poluživota mirtazapina iznosila je 19,9 h (± 3,70), a srednja vrijednost AUC0-24 iznosila je 400 ng*h/ml (± 100).
English: The median accumulation between first and 35th dose was 3.71X (based on AUC ratio) and 3.90X (based on Cmax ratio).
Croatian: Srednja vrijednost akumulacije između prve i 35. doze iznosila je 3,71X (na temelju omjera AUC) i 3,90X (na temelju omjera Cmax).
English: The efficacy and safety of the veterinary medicinal product has not been established in cats weighing less than 2.1 kg or more than 7.0 kg (see also section 4.9).
Croatian: Učinkovitost i neškodljivost veterinarsko-medicinskog proizvoda nisu utvrđene u mačaka lakših od 2,1 kg ili težih od 7,0 kg (vidjeti također odjeljak 4.9.).
English: The management of any chronic disease associated with weight loss should include providing appropriate nutrition and monitoring body weight and appetite.
Croatian: Upravljanje bilo kojom kroničnom bolešću povezanom s gubitkom kilograma trebalo bi uključivati osiguravanje odgovarajuće prehrane i praćenje tjelesne težine i apetita.
English: If contact with your skin occurs wash with soap and water.
Croatian: U slučaju dodira s vašom kožom, oprati je sapunom i vodom.
English: Vomiting, polyuria associated with reduced urine specific gravity, elevated blood urea nitrogen (BUN) and dehydration were commonly observed in safety and clinical studies.
Croatian: Povraćanje, poliurija povezana sa smanjenom specifičnom težinom urina, povišen dušik iz ureje u krvi (BUN) i dehidracija često su primijećeni u ispitivanjima neškodljivosti i kliničkim ispitivanjima.
English: Limited data are available on the reproductive toxicity of mirtazapine.
Croatian: O reproduktivnoj toksičnosti mirtazapina dostupni su ograničeni podaci.
English: The therapy with mirtazapine should not replace necessary diagnostics and/or treatment regimens needed to manage the underlying disease(s) causing unintended weight loss.
Croatian: Terapija mirtazapinom ne bi trebala zamijeniti nužnu dijagnostiku niti režime terapije koji su potrebni za upravljanje osnovnom bolešću ili bolestima koje dovode do neželjenog gubitka težine.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU
English: The tube must be stored in the child resistant bottle with cap and returned to the bottle and capped immediately after every use.
Croatian: Tuba se mora čuvati u bočici sa sigurnosnim zatvaračem za djecu te se nakon svake primjene mora odmah vratiti u bočicu i zatvoriti zatvarač.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Croatian: OSNOVNI PODACI KOJI SE MORAJU NALAZITI NA MALOM UNUTARNJEM PAKIRANJU
English: In the case of contact with the skin, wash thoroughly with soap and warm water.
Croatian: U slučaju dodira s kožom, temeljito je oprati sapunom i toplom vodom.
English: The efficacy and safety of the veterinary medicinal product has not been established in cats weighing less than 2.1 kg or more than 7.0 kg (see “Dosage for each species, route(s) and method of administration”).
Croatian: Učinkovitost i neškodljivost veterinarsko-medicinskog proizvoda nisu utvrđene u mačaka težine manje od 2,1 kg ili veće od 7,0 kg (vidjeti „Doziranje za svaku ciljnu vrstu životinja, način i put(evi) primjene”).
English: The efficacy and safety of the veterinary medicinal product has not been established in cats with severe renal disease and/or neoplasia.
Croatian: Učinkovitost i neškodljivost veterinarsko-medicinskog proizvoda nisu utvrđene u mačaka s teškom bubrežnom bolešću ili neoplazijom.
English: Non-greasy, homogeneous, white to off-white ointment.
Croatian: Nemasna, homogena mast bijele do prljavo bijele boje.
English: Mirtazapine is a potent antagonist of 5-HT2 and 5-HT3 receptors in the central nervous system (CNS), and a potent inhibitor of histamine H1 receptors.
Croatian: Mirtazapin je potentan antagonist 5-HT2 i 5-HT3 receptora u središnjem živčanom sustavu i potentan inhibitor H1 receptora za histamin.
English: Impermeable disposable protective gloves should be provided at the point of sale with the product and must be worn when handling and administering the veterinary medicinal product.
Croatian: Na prodajnom mjestu zajedno s proizvodom trebalo bi osigurati nepropusne zaštitne rukavice za jednokratnu uporabu koje se moraju nositi prilikom rukovanja i primjene veterinarsko-medicinskog proizvoda.
English: PACKAGE SIZE
Croatian: Veličina pakiranja
English: In a crossover study conducted with the product at 0.5 mg/kg in eight cats to determine the relative bioavailability of oral and transdermal 2% mirtazapine, the mean terminal half-life (25.6 ± 5.5 hours) with topical administration was over 2X longer than the mean terminal half-life (8.63 ±3.9 hours) with oral administration.
Croatian: U unakrsnom ispitivanju proizvoda pri 0,5 mg/kg na osam mačaka kako bi se utvrdila relativna bioraspoloživost oralnog i transdermalnog 2% mirtazapina, srednja vrijednost terminalnog poluživota (25,6 ± 5,5 sati) kod topikalne je primjene bila više od dvaput dulja nego srednja vrijednost terminalnog poluživota (8,63 ± 3,9 sati) kod oralne primjene.
English: Diethylene glycol monoethyl ether Caprylocaproyl polyoxyglycerides Oleyl alcohol
Croatian: Dietilen glikol monoetil eter Kaprilokaproil polioksigliceridi Oleil alkohol
English: The recommended fixed dose has been tested in cats weighing between 2.1 kg and 7.0 kg
Croatian: Preporučena fiksna doza ispitana je na mačkama težine između 2,1 kg i 7,0 kg
English: The exact mechanism by which mirtazapine induces weight gain appears to be multifactorial.
Croatian: Čini se da je točan mehanizam kojim mirtazapin potiče dobivanje na težini višefaktorski.
English: In these special cases, biochemical hepatic and renal parameters should be regularly monitored during the treatment.
Croatian: U tim posebnim slučajevima, tijekom terapije trebalo bi redovito pratiti biokemijske jetrene i bubrežne parametre.
English: If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinarian.
Croatian: Ako zamijetite bilo koju nuspojavu, čak i one koje nisu navedene u ovoj uputi o VMP-u ili mislite da veterinarsko-medicinski proizvod ne djeluje, molimo vas da obavijestite svog veterinara.
English: Mirtazapine (as hemihydrate) 2 mg
Croatian: Mirtazapin (kao hemihidrat) 2 mg
English: The only effect tested under field practice was on bodyweight: client-owned cats presented with a weight loss ≥ 5%, deemed clinically significant by the investigator, gained a statistically significant (p<0.0001) amount of weight, after 14 days of product administration (3.39% weight gain or average of 130 grams) compared to those cats administered placebo (0.09% weight gain or average of 10 grams).
Croatian: Jedini učinak ispitan u terenskoj praksi odnosi se na tjelesnu težinu: u kućnih mačaka koje su imale gubitak tjelesne težine ≥ 5 %, što ispitivač smatra klinički značajnim, zamijećeno je statistički značajno dobivanje na težini (p <0,0001) nakon 14 dana primjene proizvoda (3,39 % povećanja težine ili prosječno 130 grama) u usporedbi s mačkama koje su primale placebo (povećanje težine od 0,09 % ili prosječno 10 grama).
English: The recommended fixed dose has been tested in cats weighing between 2.1 kg and 7.0 kg.
Croatian: Preporučena fiksna doza ispitana je na mačkama težine između 2,1 kg i 7,0 kg.
English: Butylhydroxytoluene (E321) Dimethicone
Croatian: Butilhidroksitoluen (E321) Dimetikon
English: Aniserve GmbH Geyerspergerstr.
Croatian: Klifovet AG Geyerspergerstr.
English: In the target animal safety study, where cats received a higher dose (2.8 to 5.4 mg) than the label dose (2 mg) once daily for 42 days, steady state was achieved within 14 days.
Croatian: U ispitivanju neškodljivosti za ciljne vrste životinja, pri čemu su mačke primale veću dozu (2,8 do 5,4 mg) od doze u uputi (2 mg) jednom dnevno tijekom 42 dana, stanje dinamičke ravnoteže postignuto je u roku od
English: Application site reaction(s) (erythema, crust/scab, residue, scaling/dryness, flaking, head shaking, dermatitis or irritation, alopecia, and pruritus) and behavioural changes (increased vocalisation, hyperactivity, disoriented state or ataxia, lethargy/weakness, attention seeking and aggression) occurred very commonly in safety and clinical studies.
Croatian: Reakcije na mjestu primjene proizvoda (eritem, krusta/krasta, rezidue, ljuskanje/suhoća, prhutanje, tresenje glave, dermatitis ili iritacija, alopecija i pruritus) i promjene u ponašanju (povećana vokalizacija, hiperaktivnost, dezorijentiranost ili ataksija, letargija/slabost, traženje pažnje i agresija)
English: For bodyweight gain in cats experiencing poor appetite and weight loss resulting from chronic medical conditions (see section 5.1).
Croatian: Za porast tjelesne težine u mačaka koje imaju slab apetit i gube na težini zbog kroničnih oboljenja (vidjeti odjeljak 5.1.). 4.3 Kontraindikacije