natgillin/translations-raw huggingface dataset:
The mean Tmax for milbemycin A3 and A4 5-oximes was typically 4 hours and the mean elimination half-lives were 33.9 and 77.2 hours.
Srednji Tmax za milbemicin A3 i A4 5-oksime bio je uobičajena 4 sata, a srednje poluvrijeme eliminacije bilo je 33,9 i 77,2 sata.
Special precautions for each target species:
Posebna upozorenja za svaku od ciljnih vrsta životinja:
METHOD AND ROUTE(S) OF ADMINISTRATION Administer with food.
NAČIN I PUT(EVI) PRIMJENE Primijeniti uz hranu.
The safety of this product in avermectin sensitive dogs/dogs with an MDR-1 mutation has not been sufficiently demonstrated.
Neškodljivost ovog proizvoda kod pasa osjetljivih na avermektin i pasa s mutacijom MDR-1 nije dovoljno dokazana.
A single treatment is effective for the treatment of gastrointestinal nematodes.
Jednokratno liječenje djelotvorno je protiv gastrointestinalnih nematoda.
If vomiting occurs within an hour of administration and the tablet is visible, re-dose with another full dose.
Ako se povraćanje pojavi u roku od jednog sata od primjene, a tableta je vidljiva, ponovno dajte životinji istu punu dozu.
Decreased activity was seen at the same frequency in both control and dogs treated with 3 times the maximum recommended dose.
Smanjena aktivnost je opažena u istoj učestalosti i u kontrolnih pasa i u pasa liječenih dozom 3 puta većom od maksimalno preporučene doze.
Strength and number of tablets to be administered:
Jačina i broj tableta za primjenu:
The activity of milbemycin oxime is related to its action on invertebrate neurotransmission.
Aktivnost milbemicin oksima povezana je s djelovanjem na neurotransmisiju beskralješnjaka.
The veterinary medicinal product should be administered in accordance with the following table to ensure a dose of 45 to 70 mg spinosad and 0.75 to 1.18 mg milbemycin oxime/kg bodyweight.
Veterinarsko-medicinski proizvod treba primijeniti u skladu sa sljedećom tablicom kako bi se osigurala doza od 45-70 mg spinosada i 0,75 do 1,18 mg milbemicin oksima po kilogramu tjelesne težine.
In addition, in studies containing only spinosad, AUC and Cmax values were higher in fed than fasted dogs and therefore it is recommended to treat dogs with food as this maximises the opportunity for fleas to ingest lethal amounts of spinosad.
Dodatno, u ispitivanjima koja su sadržavala samo spinosad, PIK i Cmax vrijednosti su bile veće kod sitih nego kod gladnih pasa te se prema tome preporučuje liječenje pasa uz davanje hrane jer takav način povećava mogućnosti da buhe progutaju smrtonosnu dozu spinosada.
The following list shows the code and the number of dimples marked on each strength of tablet:
Sljedeći popis navodi kodove i broj rupica zavisno o jačini tablete:
Trifexis can be used as part of the seasonal prevention of fleas (replacing treatment with a monovalent flea product) in dogs with diagnosed concurrent gastrointestinal nematode infections.
Trifexis se može upotrijebiti kao dio sezonske prevencije od buha (umjesto liječenja monovalentnim proizvodom protiv buha) kod pasa kod kojih je dijagnosticirana istovremena gastrointestinalna infestacija nematodima.
Trifexis tablets should only be used when the veterinarian has confirmed diagnosis of mixed infection (or risk of infection, where prevention applies) at the same time (see section 4).
Tablete Trifexis smiju se dati samo nakon što je veterinar potvrdio dijagnozu mješovite infestacije u isto vrijeme (ili rizika od infestacija tamo gdje je prevencija potrebna) (vidi odjeljak 4).
Approximately 90% of spinosad is comprised of spinosyns A and D. Of that 90%, the ratio of spinosyn A to A+D is 0.85 when calculated as spinosyn A/spinosyn A+D.
Od tih 90%, odnos spinosina A prema A+D je 0,85 kad se računa spinosin A/spinosin A+D.
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Učestalost nuspojava je određena sukladno sljedećim pravilima: - vrlo česte (više od 1 na 10 životinja pokazuju nuspojavu(e) za vrijeme trajanja tretmana) - česte (više od 1 ali manje od 10 životinja na 100 životinja) - manje česte (više od 1 ali manje od 10 životinja na 1.000 životinja) - rijetke (više od 1 ali manje od 10 životinja na 10.000 životinja) - vrlo rijetke (manje od 1 životinje na 10.000 životinja, uključujući izolirane slučajeve)
A slight increase in plasma liver enzymes and haemoglobin distribution width (HDW) was observed during the study but no clinically relevant signs was attributed to these changes.
U ispitivanju su uočeni lagani porast jetrenih enzima u plazmi i širina distribucije hemoglobina (HDW), ali ovim promjenama nisu pripisani klinički značajni znaci.
Milbemycin A4 5-oxime tends to eliminate slower resulting in approximately 10-fold higher exposure than Milbemycin A3 5-oxime.
Milbemicin A4 5-oksim ima tendenciju sporije eliminacije što rezultira otprilike desetorostruko višom izloženošću nego Milbemicin A3 5-oksim.
This combination product (Trifexis) must, however, not be given for more than 6 consecutive months in any one year.
Međutim, ovaj kombinirani proizvod (Trifexis) ne smije se davati dulje od 6 mjeseci uzastopno unutar jedne godine.
Spinosad therefore has a different mode of action to other flea control or insect control products.
Spinosad prema tome ima različit način djelovanja od ostalih proizvoda za kontrolu buha ili ostalih insekata.
At acute overdoses corresponding to 3 times the maximum recommended dose, vomiting occurred in half of the animals, sometimes repeatedly.
Pri akutnom predoziranju dozom 3 puta većom od maksimalno preporučene doze, povraćanje se pojavilo kod polovice životinja, a ponekad se ponovilo i više puta.
Microcrystalline cellulose Hydroxypropyl cellulose Silica, colloidal anhydrous Croscarmellose sodium Magnesium stearate Artificial beef flavour
Mikrokristalna celuloza Hidroksipropil celuloza Bezvodni koloidni silicijev dioksid Croskarmeloza natrij Magnezijev stearat Umjetni okus govedine
Milbemycin oxime is an antiparasitic endectocide belonging to the macrocyclic lactones.
Milbemicin oksim je antiparazitski endektocid koji spada u grupu makrocikličkih laktona.
Maintenance of the efficacy of macrocyclic lactones is critical for Dirofilaria immitis control, therefore, to minimise the risk of resistance selection, it is recommended that dogs should be checked for both circulating antigens and blood microfilariae at the beginning of each season prior to starting monthly preventive treatments.
Održavanje djelotvornosti makrocikličkih laktona kritično je za kontrolu parazita Dirofilaria immitis, što znači da se radi smanjenja rizika od selekcije na otpornost preporučuje, da se psi istovremeno provjere na cirkulirajuće antigene i mikrofilariju u krvi na početku svake sezone, prije početka preventivnih mjesečnih terapija.
The use of the product should be based on the confirmed diagnosis of mixed infection (or risk of infection, where prevention applies) at the same time (see also section 4.2).
Primjena ovog proizvoda mora se bazirati na potvrđenoj dijagnozi istovremenih miješanih infestacija (ili rizika od infestacija u slučajevima prevencije) (vidi odjeljak 4.2).
Eli Lilly and Company Ltd Elanco Animal Health Priestley Road Basingstoke
Eli Lilly and Company Ltd Elanco Animal Health Priestley Road
Use with caution in dogs with pre-existing epilepsy.
Primjenjujte s oprezom u pasa s epilepsijom.
It does not interact with known binding sites of other nicotinic or GABAergic insecticides such as neonicotinides (imidacloprid or nitenpyram), fiproles (fipronil), milbemycins, avermectins (e.g. selamectin) or cyclodienes but through a novel insecticidal mechanism.
Nema međusobnog djelovanja s poznatim mjestima vezanja ostalih nikotinskih ili GABA-ergičnih insekticida kao što su neonikotinidi (imidakloprid ili nitenpiram), fiproli (fipronil), milbemicini, avermektini (npr. selamektin) ili ciklodieni, već kroz novi insekticidni mehanizam.
In a separate study with three consecutive monthly administrations, no increases in Cmax, AUC, or elimination half-lives were noted when comparing values from the third and first months.
U zasebnom ispitivanju s tri uzastopne mjesečne primjene nije primijećeno povećanje Cmax, PIK ili poluvremena eliminacije prilikom usporedbe vrijednosti iz trećeg i prvog mjeseca.
Cats in the household should be treated with a veterinary medicinal product authorised for use in that species.
Mačke u kućanstvu trebaju biti liječene veterinarskomedicinskim proizvodom dozvoljenim za primjenu u mačaka.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
U slučaju da se nehotice proguta, odmah potražite pomoć liječnika i pokažite mu uputu o VMP ili etiketu.
QUALITATIVE AND QUANTITATIVE COMPOSITION Active substances:
KVALITATIVNI I KVANTITATIVNI SASTAV DJELATNIH
In dogs, hydroxymilbemycin A4 5-oxime was detected only in plasma, but not in urine or faeces, suggesting predominant excretion of conjugated metabolites in the dog.
Kod pasa, hidroksimilbemicin A4 5-oksim otkriven je jedino u plazmi, ali ne i u mokraći ili u izmetu, što sugerira predominantno izlučivanje primarnih metabolita kod pasa.
Based on the local epidemiological situation, the veterinary medicinal product may be given at monthly intervals throughout the season at the recommended dose as outlined below.
Temeljem lokalne epidemiološke situacije, ovaj veterinarsko-medicinski proizvod može se davati u mjesečnim intervalima kroz cijelu sezonu u preporučenim dozama naznačenim u nastavku.
Prior to first use of this product, dogs in heartworm endemic areas or who have visited heartworm endemic areas must be tested for existing heartworm infection.
Prije prve primjene, psi koji žive u endemičnim područjima bolesti srčanog crva ili koji su posjetili takva područja moraju se testirati na tu bolest.
Mottled tan to brown, round, biconvex tablets with a debossed code on one side and dimples on the other side.
Išarane tablete tamnožute do smeđe boje, okrugle, bikonveksne, s utisnutim kodom na jednoj strani i rupicama na drugoj.
When Trifexis is used to replace another heartworm preventive product, the first dose of Trifexis must be given within a month of the last dose of the former medication.
Kad se Trifexis upotrebljava kao zamjena za drugi preventivni proizvod protiv bolesti srčanog crva, prva doza Trifexis-a mora se dati unutar jednog mjeseca od davanja zadnje doze prethodnog lijeka.
At doses in excess of the recommended dose, vomiting becomes a very common event.
U dozama koje prelaze preporučene, povraćanje je vrlo česta pojava.
The primary faecal and urinary metabolites in dog were identified as glucuronide conjugates of milbemycin A3 or A4 5-oximes, dealkylated milbemycin A3 or A4 5-oximes, and hydroxylated milbemycin A4 5-oxime.
Primarni fekalni i urinarni metaboliti kod pasa identificirani su kao glukuronidni konjugati milbemicina A3 ili A4 5-oksima, dealkalizirani milbemicin A3 ili A4 5-oksima i hidroksilirani milbemicin A4 5-oksim.
At three times the maximum recommended dose adverse events of potentially neurological origin e.g. decreased activity (8%), hypersalivation (17%) or stumbling (8%) were observed.
Pri predoziranju dozom 3 puta većom od maksimalno preporučene doze primijećene su nuspojave potencijalno neurološkog porijekla, npr. smanjen tek (8%), hipersalivacija (17%), posrtanje (8%).
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Ne primjenjivati u slučaju preosjetljivosti na djelatnu tvar ili na bilo koju pomoćnu tvar.
After spinosad administration, the incidence of vomiting on the day of, or the day after dosing has been observed to increase as a function of the dose.
Nakon primjene spinosada primijećen je porast učestalosti povraćanja na dan primjene ili dan nakon nje, ovisno o dozi.
In the majority of cases, vomiting was transient and mild and did not require symptomatic treatment.
U većini slučajeva, povraćanje je bilo prolazno i blago, te nije zahtijevalo simptomatsku terapiju.
Chewable tablets.
Tablete za žvakanje.
Excretion is primarily via faeces, and also to a lesser extent in the urine.
Izlučuje se primarno preko izmeta i također u manjem obimu u mokraći.
Adverse reactions seen during the course of this study included vomiting, diarrhoea, skin lesions, salivation, tremors, decreased activity, coughing and vocalization.
Nuspojave uočene za vrijeme ispitivanja uključivale su povraćanje, proljev, ozljede kože, salivaciju, tremor, smanjenu aktivnost, kašalj i vokalizaciju.
After treatment of the nematode infection, further flea prevention should be continued with a monovalent product.
Nakon liječenja infekcije nematodima, daljnju prevenciju od buha preporučuje se provoditi monovalentnim proizvodom.
It is recommended to observe the treated dog up to 24 hours post-administration of the product for possible adverse reactions (see section 4.6).
Preporučuje se promatranje liječenog psa do 24 sata nakon primjene proizvoda radi mogućih nuspojava (vidi odjeljak 4.6).
It is recommended to observe the treated dog up to 24 hours post-administration of the product for possible adverse reactions (see section 6).
Preporučuje se promatranje liječenog psa do 24 sata nakon primjene proizvoda radi mogućih nuspojava (vidi odjeljak 6).
It is active against mites, larval and adult stages of nematodes as well as larvae of Dirofilaria immitis.
Djelotvoran je protiv grinja, odraslih nematoda i nematoda u stadiju ličinki kao i ličinki Dirofilaria immitis.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Outer carton
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU
Fleas may be observed for a period of time after administration of the veterinary medicinal product due to the emergence of adult fleas from pupae already present in the environment.
Buhe se mogu održati određeno vrijeme nakon primjene veterinarsko-medicinskog proizvoda zahvaljujući pojavi odraslih jedinki iz kukuljica koje se već nalaze u okolišu.
PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable.
11. ZABRANA PRODAJE, OPSKRBE I/ILI PRIMJENE
Neurotoxicity characterised by transient mild depression, ataxia, trembling, mydriasis, and excessive salivation has been observed in dogs given higher dose multiples of milbemycin oxime alone (5 to 10 mg/kg).
Neurotoksičnost karakterizirana blagom prolaznom depresijom, ataksijom, drhtavicom, midrijazom i prekomjernom salivacijom primijećena je kod pasa kojima su davane visoke višestruke doze samo milbemicin oksima (5 do 10 mg/kg).
Regular monthly treatments with the insecticidal active substance, spinosad, break the fleas' life cycle and may be used to control the flea population in contaminated households.
Redovno mjesečno liječenje insekticidnom djelatnom tvari spinosad, prekida životni ciklus buha i može se upotrijebiti za kontrolu populacije buha u kontaminiranim kućanstvima.
Milbemycin A3 and A4 5-oximes are rapidly absorbed and extensively distributed in dogs after oral administration.
Milbemicin A3 i A4 5-oksimi brzo se apsorbiraju i široko raspodjeljuju kod pasa nakon peroralne primjene.
Hypersalivation, muscle tremors, ataxia and seizures were uncommon.
Hipersalivacija, tremor mišića, ataksija i epileptički napadaji manje su česti.
Do not use this veterinary medicinal product after the expiry date which is stated on the blister after EXP.
Ne koristite veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na kutiji.
Manufacturer responsible for batch release: Eli Lilly and Company Ltd Speke Operations
Proizvođač odgovoran za puštanje serije u promet: Eli Lilly and Company Ltd Speke Operations
Based on the local epidemiological situation and the decision of the prescribing veterinarian, the veterinary medicinal product may be given at monthly intervals throughout the season at the recommended dose as outlined below.
Temeljem lokalne epidemiološke situacije i odluke veterinara koji provodi liječenje, veterinarskomedicinski proizvod može se davati u mjesečnim intervalima kroz cijelu sezonu u preporučenim dozama naznačenim u nastavku.
Further information for the prescribing veterinarian:
Daljnje informacije za veterinara koji propisuje veterinarsko-medicinski proizvod:
Dogs travelling to a heartworm region should start medication within a month after arrival there.
Psima koji putuju u područja u kojima postoji bolest srčanog crva, lijek se mora primijeniti unutar mjesec dana od dolaska u takva područja.
In rats dosed with milbemycin A4 5-oxime, the main metabolites identified in urine and faeces were mono-, di-, and trihydroxy milbemycin A4 5-oximes.
U ispitivanjima s milbemicin A4 5-oksimom na miševima, glavni metaboliti identificirani u mokraći i izmetu bili su mono-, di- i trihidroksi milbemicin A4 5-oksimi.
Marketing authorisation holder: Eli Lilly and Company Ltd Elanco Animal Health Priestley Road
Nositelj odobrenja za stavljanje u promet: Eli Lilly and Company Ltd Elanco Animal Health Priestley Road
At acute overdoses corresponding to 1.5 times the maximum recommended dose, vomiting occurred in 17% of the dogs, and hypersalivation occurred in 8% of the dogs.
Pri akutnom predoziranju dozom 1,5 puta većom od maksimalno preporučene doze, povraćanje se pojavilo kod 17 % pasa, a hipersalivacija kod 8 % pasa.
The flea preventive effect against re-infestations is a result of the adulticidal activity and the reduction in egg production and persists for up to 4 weeks after a single administration of the veterinary medicinal product.
Preventivno djelovanje protiv ponovljene infestacije buhama rezultat je adulticidnog djelovanja i smanjenja proizvodnje jajašaca i traje do 4 tjedna nakon jednokratne primjene ovog veterinarskomedicinskog proizvoda.
THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only.
RIJEČI „SAMO ZA PRIMJENU NA ŽIVOTINJAMA“
Spinosad is excreted in the colostrum and milk of lactating bitches.
Spinosad se izlučuje kroz kolostrum i mlijeko kuja koje doje.
PHARMACEUTICAL FORM Chewable tablets
OBLIK Tablete za žvakanje
After oral administration of 45 mg spinosad and 0.75 mg milbemycin oxime/kg bodyweight to fed dogs, spinosyns A and D are rapidly absorbed and extensively distributed.
Nakon peroralne primjene 45 mg spinosada i 0,75 mg milbemicin oksima po kg tjelesne težine kod sitih pasa, spinosini A i D brzo se apsorbiraju i široko raspodjeljuju.
In case of adverse clinical signs, treat symptomatically.
U slučaju štetnih kliničkih znakova, životinju liječiti simptomatski.
NAME OF THE MARKETING AUTHORISATION HOLDER Eli Lilly and Company Ltd
NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET Eli Lilly and Company Ltd
Laboratory studies on the effect of spinosad and milbemycin oxime in rats and rabbits have neither produced any evidence of teratogenic, foetotoxic or maternotoxic effects, nor any effect on the reproductive capacity in males and females.
Laboratorijski pokusi o utjecaju spinosada i milbemicin oksima na miševima i kunićima nisu dali nikakav dokaz teratogenog, fetotoksičnog niti maternotoksičnog učinka kao ni utjecaj na reproduktivnu sposobnost kod mužjaka ili ženki.
If a dose is missed, administer the veterinary medicinal product with the next offering of food.
Ako ste zaboravili primijeniti dozu, dajte veterinarsko-medicinski proizvod uz naredni obrok hrane.
Cartons containing a blister pack with 1, 3 or 6 chewable tablets.
Blister pakovanje s 1, 3 ili 6 tableta za žvakanje u kutiji.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
12. POSEBNE MJERE OPREZA PRI ODLAGANJU NEUPOTREBLJENIH PROIZVODA ILI OTPADNIH MATERIJALA, AKO IH IMA
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Bilo koji neupotrebljeni veterinarsko-medicinski proizvod ili otpadni materijali dobiveni primjenom tih veterinarsko-medicinskih proizvoda treba odlagati u skladu s lokalnim propisima.
Therefore, concomitant treatment with other P-gp substrates could lead to enhanced toxicity.
Pgp supstratima može uzrokovati pojačanu toksičnost.
AUC values increased approximately linearly while Cmax increased slightly less than linearly with increasing dose-rates over the intended therapeutic dose range.
PIK je narasla uglavnom linearno dok je Cmax s povećanim rasponima doza u odnosu na namjeravani terapijski raspon doze porastao nešto manje nego linearno.
Milbemycin oxime, like avermectins and other milbemycins, increases nematode and insect membrane permeability to chloride ions via glutamate-gated chloride ion channels (related to vertebrate GABA and glycine receptors).
Milbemicin oksim, kao i avermektini i drugi milbemicini, povećavaju propusnost membrane nematoda i insekata preko kloridnih ionskih kanala koji se otvaraju i zatvaraju pomoću glutamata (povezani s GABA i glicinskim receptorima kod kralješnjaka).
In studies performed with spinosad only, the primary biliary, faecal and urinary metabolites in both rat and dog were identified as the demethylated spinosyns, glutathione conjugates of the parent compounds and N-demethylated spinosyns A and D. Excretion is primarily via the bile and faeces, and to a lesser extent in the urine.
U ispitivanjima koja su sadržavala samo spinosad, primarni bilijarni, fekalni i urinarni metaboliti u miševa i pasa identificirani su kao demetilirani spinosini, konjugati glutationa izvornih spojeva i Ndemetiliranih spinosina A i D.
Safe use in overdose situations up to 3.6 times the recommended dose has been demonstrated following 6 monthly administrations.
Dokazana je sigurna primjena kod predoziranja, s do 3,6 puta višom dozom od preporučene, nakon 6 mjeseci primjene.
At doses of 30 to 60 mg spinosad and 0.5 to 1 mg milbemycin oxime per kg bodyweight, lethargy, anorexia/decreased appetite, diarrhoea, pruritus, dermatitis and reddening of the skin and pinna were commonly seen.
Pri dozama od 30 do 60 mg spinosada i 0,5 do 1 mg milbemicin oksima po kg tjelesne težine, letargija, anoreksija/smanjen tek, proljev, pruritus, dermatitis i crvenilo kože i uške česte su nuspojave.
Dogs living in non-heartworm endemic areas:
Psi koji žive u neendemičnim područjima bolesti srčanog crva:
Accidental ingestion may cause adverse reactions.
Slučajno gutanje može izazvati nuspojave.
No studies have been performed in sick or convalescent dogs, therefore the product should only be used based on a benefit-risk assessment of the responsible veterinarian.
Nisu provedena ispitivanja na bolesnim psima ili na psima koji se oporavljaju, stoga se ovaj proizvod smije primijeniti samo nakon procjene odnosa koristi/rizika od strane odgovornog veterinara.
Method of administration:
Način i putevi primjene:
Laboratory studies (in rats and rabbits) on the effect of spinosad and milbemycin oxime have neither produced any evidence of teratogenic, foetotoxic or maternotoxic effects, nor any effect on the reproductive capacity in males and females.
Laboratorijski pokusi o utjecaju spinosada i milbemicin oksima (na miševima i kunićima) nisu dali nikakav dokaz teratogenog, fetotoksičnog niti maternotoksičnog učinka, kao ni utjecaj na reproduktivnu sposobnost kod mužjaka ili ženki.
Vomiting was seen in both treated and control dogs with similar frequencies.
Na liječenim i kontrolnim psima povraćanje je primijećeno sa sličnom učestalošću.
Dogs living in heartworm endemic areas:
Psi koji žive u endemičnim područjima bolesti srčanog crva:
Milbemycin oxime
Milbemicin oksim
This product should therefore only be used during pregnancy and lactation according to the benefit-risk assessment of the responsible veterinarian.
Stoga se ovaj proizvod smije primijeniti za vrijeme graviditeta i laktacije samo nakon procjene odnosa koristi/rizika od strane odgovornog veterinara.