FrancophonIA/ELRC3.0 huggingface dataset:
English: <Conditions to the Marketing Authorisation(s)>
Croatian: <Uvjeti odobrenja za stavljanje lijeka u promet>
English: <Package Leaflet>
Croatian: <Uputa o lijeku>
English: 10000 units (50 mg)/10 ml; 10 ml (1000
Croatian: 10 000 jedinica (50 mg)/10 ml; 10 ml (1 000
English: 8000 units (40 mg)
Croatian: 8 000 jedinica (40 mg)/8 ml;
English: Powder and solvent for solution for injection
Croatian: Naziv lijeka Jačina
English: 8000 units (40 mg)/8 ml; 8 ml (1000 U/ml5 mg/ml)
Croatian: 8 ml (1 000 U/ml - 5 mg/ml)
English: Pack size
Croatian: Farmaceutski oblik
English: Date of first authorisation: 15/05/2017.
Croatian: Datum prvog odobrenja: 15/05/2017
English: In the absence of safety data it is not recommended to use the product in calves less than 4 weeks old.
Croatian: Zbog nedostatka podataka o sigurnosti nije preporučljivo koristiti proizvod u teladi mlađe od 4 tjedna.
English: Ceva Santé Animale 10 av. de La Ballastière 33500 Libourne FRANCE
Croatian: Ceva Santé Animale 10 av. de La Ballastière 33500 Libourne FRANCUSKA
English: Bovine 200
Croatian: Govedo 200
English: Meat and offal: 56 days.
Croatian: Meso i jestive iznutrice: 56 dana.
English: MRLs (µg/kg)
Croatian: MRL (µg/kg)
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 dostupne su na web stranici Europske agencije za lijekove ( http://www.ema.europa.eu/.)
English: The injection should only be given in the neck area.
Croatian: Injekciju treba primijeniti samo u području vrata.
English: Use only according to the benefit-risk assessment by the responsible veterinarian.
Croatian: Primijeniti samo nakon procjene odnosa koristi/rizika od strane odgovornog veterinara.
English: The impact of this difference on anti-inflammatory effects has not been investigated in field trials.
Croatian: Utjecaj te razlike na protuupalni učinak nije istražen u terenskim uvjetima.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
Croatian: RIJEČI “SAMO ZA PRIMJENU NA ŽIVOTINJAMA” I UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE ILI PRIMJENE, ako je primjenjivo
English: The active substances in Zeleris are allowed substances as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Croatian: Djelatne tvari u Zeleris su dozvoljene tvari kako je navedeno u tablici 1, Dodatka Uredbe Komisije (EU) br. 37/2010:
English: The genes corresponding to these mechanisms are coded on mobile genetic elements such as plasmids, transposon or genes cassettes.
Croatian: Geni koji odgovaraju na ove mehanizme su kodirani na promjenjivim genetičkim elementima kao što su plazmidi, transpozoni i genske kasete.
English: The expiry date refers to the last day of that month.
Croatian: Rok valjanosti se odnosi na zadnji dan tekućeg mjeseca
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton after "EXP".
Croatian: Ne koristite veterinarska-medicinski proizvod poslije isteka roka valjanosti naznačenog na kutiji poslije "EXP".
English: Ask your veterinary surgeon how to dispose of medicines no longer required.
Croatian: Pitajte vašeg veterinara kako odlagati veterinarska-medicinske proizvode koji vam više nisu potrebni.
English: It reduces leukocyte infiltration into the inflamed tissue.
Croatian: Smanjuje infiltraciju leukocita u upalom zahvaćeno tkivo.
English: During injection of this product animals may exhibit signs of moderate pain, manifested as movement of the head or neck.
Croatian: Tijekom ubrizgavanja ovog proizvoda životinja može pokazivati znakove umjerene boli koji se manifestiraju micanjem glave i vrata.
English: Florfenicol
Croatian: Florfenikol
English: Meloxicam Meloxicam Bovine 20
Croatian: Meloksikam Meloksikam Govedo 20
English: The extent of these adverse effects was dose-dependent.
Croatian: Opseg štetnih učinaka ovisan je o dozi.
English: Otherwise, the use of a multiple-dose syringe is recommended.
Croatian: Inače, preporuča se korištenje šprice za više doza.
English: Florfenicol is a synthetic broad-spectrum antibiotic effective against most Gram-positive and Gramnegative bacteria isolated from domestic animals.
Croatian: Florfenikol je sintetički antibiotik širokog spektra učinkovit protiv većine gram-pozitivnih i gramnegativnih bakterija izoliranih iz domaćih životinja.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Croatian: DATUM PRVOG ODOBRENJA / PRODULJENJA ODOBRENJA
English: Do not use in pregnant cows, which are intended to produce milk for human consumption, within 2 months of expected parturition.
Croatian: Ne primjenjivati na gravidnim životinjama koje su namijenjene za proizvodnju mlijeka za ljudsku upotrebu u periodu od 2 mjeseca od očekivanog poroda.
English: Do not use in adult bulls intended for breeding.
Croatian: Ne primjenjivati na odraslim bikovima namijenjenim za rasplod.
English: The in vitro Minimum Inhibitory Concentration (MIC) distribution values for these field isolates are presented in the table below.
Croatian: In vitro minimalne inhibicijske koncentracije (MIC) za terenske izolate prikazane su u tablici ispod.
English: Surveillance data of the susceptibility of target field isolates from cattle, collected between 2004 and 2012 across Europe, show consistent efficacy of florfenicol with no finding of resistant isolates.
Croatian: Podaci o osjetljivosti terenskih izolata izdvojenih iz goveda, prikupljeni između 2004 i 2012 godine diljem Europe, pokazuju konstantnu učinkovitost florfenikola bez nalaza rezistentnih sojeva.
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 veterinary surgeon.
Croatian: Ako zamijetite bilo koju nuspojavu, čak i one koje nisu navedene u ovoj uputi o VMP, molimo obavijestite svog veterinara.
English: Clear yellow solution.
Croatian: Bistro žuta otopina.
English: People with known hypersensitivity to florfenicol, meloxicam or to any of the excipients should avoid contact with the veterinary medicinal product.
Croatian: Osobe preosjetljive na florfenicol, meloksikam ili na bilo koje od pomoćnih tvari trebaju izbjegavati kontakt s veterinarsko-medicinskim proizvodom.
English: MANUFACTURER'S BATCH NUMBER
Croatian: BROJ PROIZVODNJE SERIJE PROIZVOĐAČA
English: Marketing authorisation holder and manufacturer responsible for batch release: Ceva Santé Animale
Croatian: Nositelj odobrenja za stavljanje u promet i proizvođač odgovoran za puštanje serije u promet: Ceva Santé Animale
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals treated in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Croatian: Učestalost nuspojava je određena sukladno sljedećim pravilima: - vrlo česte (više od 1 na 10 tretiranih životinja pokazuju nuspojavu(e)) - česte (više od 1 ali manje od 10 životinja na 100 tretiranih životinja) - manje česte (više od 1 ali manje od 10 životinja na 1.000 tretiranih životinja) - rijetke (više od 1 ali manje od 10 životinja na10.000 tretiranih životinja) - vrlo rijetke (manje od 1 životinje na 10.000 tretiranih životinja, uključujući izolirane slučajeve).
English: The safety of the veterinary medicinal product has not been established in breeding, pregnant and lactating animals.
Croatian: Neškodljivost veterinarsko-medicinskog proizvoda nije utvrđena za vrijeme rasploda, graviditeta i laktacije.
English: Sum of florfenicol and its metabolites measured as florfenicolamine
Croatian: Florfenikol i njegovih metaboliti mjere se kao florfenikolamin
English: Range (µg/ml) MIC50 (µg/ml) MIC90 (µg/ml)
Croatian: Raspon(µg/ml) MIC50 (µg/ml) MIC90 (µg/ml)
English: Whenever possible, the veterinary medicinal product should only be used based on susceptibility testing.
Croatian: Kad god je moguće, veterinarsko-medicinski proizvod treba koristiti na temelju antibiograma.
English: Official, national and regional antimicrobial policies should be taken into account when the veterinary medicinal product is used.
Croatian: Kod primjene veterinarsko-medicinskog proizvoda u obzir treba uzeti službenu, nacionalnu i regionalnu antimikrobnu politiku.
English: This veterinary medicinal product does not require any special storage conditions.
Croatian: Ovaj veterinarsko-medicinski proizvod ne zahtijeva nikakve posebne uvijete čuvanja.
English: Do not use in case of hypersensitivity to the active substances or to any of the excipients.
Croatian: Ne primjenjivati u slučaju preosjetljivosti na djelatne tvari ili na bilo koje od pomoćnih tvari.
English: Meloxicam is extensively bound to plasma proteins (97%) and is distributed in all well-perfused organs.
Croatian: Meloksikam se veže za proteine plazme (97%) i najviše koncentracije su u dobro prokrvljenim organima.
English: PROHIBITION OF SALE, SUPPLY AND/OR USE
Croatian: ZABRANA OPSKRBE, PRODAJE ILI PRIMJENE
English: Overdose (symptoms, emergency procedures, antidotes), if necessary In pre-ruminant calves, repeated administration of the recommended dose once per week for three weeks was well tolerated as well as a single administration of 3 times (3x) the recommended dose.
Croatian: Predoziranje (simptomi, hitni postupci, antidoti), ako je nužno Telad koja još siše dobro je podnijela aplikaciju preporučene doze jednom tjedno kroz tri tjedna, kao i jednokratnu aplikaciju 3 puta veću od preporučene doze.
English: Dimethyl sulfoxide Glycerol formal, stabilised
Croatian: Glicerol formal, stabilizirani
English: Cattle.
Croatian: Govedo.
English: Florfenicol is largely distributed in the whole body and has a low plasma protein binding (approximately 20%).
Croatian: Florfenikol se distribuira po cijelom tijelu i slabo se veže za proteine plazme (oko 20%).
English: For the full list of excipients, see section 6.1
Croatian: Pomoćne tvari: Potpuni popis pomoćnih tvari vidi u odjeljku 6.1.
English: ANNEX III LABELLING AND PACKAGE LEAFLET
Croatian: ANNEX III OZNAČAVANJE I UPUTA O VMP
English: STATEMENT OF THE MRLs
Croatian: C. IZVJEŠĆE O MRL
English: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Croatian: U slučaju nehotičnog samoinjiciranja odmah potražiti pomoć liječnika i pokazati mu uputu o VMP-u ili etiketu.
English: Species
Croatian: Vrsta
English: Not for animals from which milk is produced for human consumption
Croatian: Nije za životinje koje proizvode mlijeko za ljudsku upotrebu
English: Milk: Not authorised for use in lactating animals producing milk for human consumption.
Croatian: Mlijeko: nije odobrena primjena na životinjama koje proizvode mlijeko za ljudsku upotrebu.
English: Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, anti-exudative, analgesic and antipyretic effects.
Croatian: Meloksikam je nesteroidni protuupalni lijek (NSPUL) iz grupe oksikama čije se djelovanje temelji na inhibiciji sinteze prostaglandina, što dovodi do protuupalnog, antieksudativnog, analgetskog i antipiretičkog učinka.
English: To a minor extent it also inhibits collagen-induced thrombocyte aggregation.
Croatian: U manjoj mjeri inhibira kolagenom inducirano nakupljanje trombocita.
English: For the 250 ml vials, the rubber stopper may safely be punctured up to 20 times.
Croatian: Kod bočica od 250 mL, gumeni čep može sigurno biti probušen i do 20 puta.
English: Resistance to florfenicol is mainly mediated by an efflux system due to a specific (Flo-R) or multidrug transporter (AcrAB-TolC).
Croatian: Otpornost na florfenikol uglavnom je posredovana aktivnošću sustava efluks pumpe uslijed specifičnog (Flo-R) ili višestrukog prijenosnika za lijekove (AcrAB-TolC).
English: The bioavailability of meloxicam in this combination product is lower compared to the use of meloxicam when administered on its own.
Croatian: Bioraspoloživost meloksikama u kombiniranom proizvodu je niža i protuupalni učinak može trajati kraće u usporedbi s upotrebom meloksikama kao samostalne tvari.
English: Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic disorders, or when there is evidence of ulcerogenic gastrointestinal lesions.
Croatian: Ne primjenjivati na životinjama s oštećenom jetrenom, srčanom ili bubrežnom funkcijom ili hemoragijskim poremećajima, te kod dijagnosticiranih ulceroznih lezija probavnog sustava.
English: Each ml contains:
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV 1 mL sadržava:
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
Croatian: 14. DATUM KADA JE UPUTA O VMP ZADNJI PUT ODOBRENA
English: Do not administer concurrently with glucocorticoids, other non-steroidal anti-inflammatory drugs or with anticoagulant agents.
Croatian: Ne primjenjivati istodobno s glukokortikoidima, drugim nesteroidnim protuupalnim lijekovima ili antikoagulansima.
English: Fertility Do not use in adult bulls intended for breeding (see section 4.3).
Croatian: Plodnost: Ne primjenjivati na rasplodnim životinjama (vidi odjeljak 4.3.).
English: Resistance to florfenicol in the target pathogens has only been reported on rare occasions, and was associated with efflux pump and the presence of the floR gene.
Croatian: O stečenoj otpornosti ciljanih bakterija na florfenikol rijetko je izvješćivano, a vezana je uz efluks pumpu i prisutnost floR gena.
English: To ensure a correct dosage, bodyweight should be determined as accurately as possible to avoid underdosing.
Croatian: Tjelesnu masu životinje treba odrediti što je moguće točnije kako bi se osigurala primjena točne doze.
English: Fertility Do not use in adult bulls intended for breeding (see section “Contraindications”).
Croatian: Plodnost: Ne primjenjivati na rasplodnim životinjama (vidi odjeljak "kontraindikacije")
English: Translucent multi-layered plastic vials (polypropylene/ethylene vinyl alcohol/polypropylene) with chlorobutyl rubber stoppers and aluminium and plastic flip capsules, containing 50 ml, 100 ml or 250 ml.
Croatian: Prozirne višeslojne plastične bočice (polipropilen / etilen vinil alkohol / polipropilen), s klorbutilnim gumenim čepovima te aluminijskim i plastičnim flip kapsulama od 50 mL, 100 mL ili 250 mL.
English: Subcutaneous use.
Croatian: Za subkutanu primjenu.
English: Repeated weekly administration of overdoses (3x and 5x the recommended dose) in calves was associated with decreased milk consumption, decreased weight gain, loose faeces or diarrhoea.
Croatian: Davanje tri i pet puta veće doze od preporučene doze teladi dovelo je do smanjene konzumacije mlijeka, smanjenog prirasta, mekog izmeta i proljeva.
English: Cardboard box with 1 vial of 50 ml, 100 ml or 250 ml.
Croatian: Kartonska kutija s 1 bočicom od 50 ml, 100 ml ili 250 ml.
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Croatian: 6.6 Posebne mjere opreza prilikom odlaganja neupotrebljivog veterinarsko-medicinskog proizvoda ili otpadnih materijala dobivenih primjenom tih proizvoda Bilo koji neupotrebljeni veterinarsko-medicinski proizvod ili otpadni materijali dobiveni primjenom tih veterinarsko-medicinskih proizvoda trebaju se odlagati u skladu s lokalnim propisima.
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIAL, IF ANY
Croatian: POSEBNE MJERE OPREZA PRI ODLAGANJU NEUPOTREBLJENIH PROIZVODA ILI OTPADNIH MATERIJALA, AKO IH IMA
English: Macroscopic intestinal lesions were observed post-mortem (presence of fibrin, abomasal ulcers, haemorrhagic dots and thickening of the abomasal wall).
Croatian: Razudbom nakon uginuća nađene su makroskopske lezije probavnog sustava (prisutnost fibrina, čirevi na sirištu, hemoragična žarišta i zadebljanje stijenke sirišta).
English: However, a clear antipyretic effect has been demonstrated in the first 48 hours after administration.
Croatian: Međutim, u prvih 48 sati nakon primjene postoji potpun antipiretički učinak.
English: For Mannheimia haemolytica, Pasteurella multocida and Histophilus somni the following florfenicol breakpoints have been determined by CLSI (Clinical and Laboratory Standards institute) for bovine respiratory pathogens: susceptible ≤ 2 µg/ml, intermediate : 4 µg/ml, resistant : ≥ 8 µg/ml.
Croatian: Za bakterije Mannheimia haemolytica, Pasteurella multocida i Histophilus somni utvrđene su sljedeće granične vrijednosti za florfenikol prema CLSI (Clinical and Laboratory Standards institute), za respiratorne infekcije goveda: osjetljivo ≤ 2µg/ml, umjereno osjetljivo 4µg/ml, rezistentno ≥ 8µg/ml.
English: Antiinfectious agents/Antibi otics
Croatian: Antiinfektivne tvari/Antibiotici
English: These effects were transitory and usually resolved without any treatment within 5 to 15 days, but could persist up to 49 days.
Croatian: Subkutana primjena vrlo često uzrokuje upalne promjene na mjestu injekcije (uglavnom oteklinu, otvrdnuće, toplinu i bolnost) koje bez tretiranja nestaju kroz 5 do 15 dana, ali mogu biti prisutne do 49 dana.
English: Use during pregnancy, lactation or lay
Croatian: Primjena tijekom graviditeta, laktacije ili nesenja:
English: Laboratory tests have shown that florfenicol is active against the most commonly isolated bacterial pathogens involved in bovine respiratory disease which include Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.
Croatian: Laboratorijski testovi su pokazali da je florfenikol učinkovit protiv većine uobičajenih patogenih bakterija odgovornih za pojavu respiratorne bolesti goveda što uključuje Mannheimia haemolytica, Pasteurella multocida i Histophilus somni.
English: No entry Antiinflammatory agents/Nonsteroidal antiinflammatory agents
Croatian: Protuupalne tvari/Nesteroidne protuupalne tvari
English: The single dose volume should not exceed 15 ml per injection site.
Croatian: Najveći volumen koji se smije primijeniti na jedno mjesto je 15 ml.
English: Target tissues
Croatian: Ciljna tkiva
English: Florfenicol is considered to be a bacteriostatic agent, but in vitro studies demonstrate its bactericidal activity against Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.
Croatian: Djelovanje florfenikola je bakteriostatsko međutim, in vitro testovima dokazan je baktericidni učinak protiv Mannheimia haemolytica, Pasteurella multocida i Histophilus somni.
English: In pre-ruminant calves, repeated administration of the recommended dose once per week for three weeks was well tolerated, as well as a single administration of 3 times (3x) the recommended dose.
Croatian: Telad koja još siše dobro je podnijela aplikaciju preporučene doze jednom tjedno, kroz tri tjedna, kao i jednokratnu aplikaciju 3 puta veću od preporučene doze.
English: 1 ml contains 400 mg of florfenicol and 5 mg of meloxicam.
Croatian: 1 ml sadržava 400 mg florfenikola i 5 mg meloksikama.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box of 50 ml, 100 ml and 250 ml vials
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU Kartonska kutija od 50 ml, 100 ml i 250 ml
English: 5.2 Pharmacokinetic particulars
Croatian: 5.1 Farmakodinamička svojstva
English: Meloxicam also has anti-endotoxic properties, because it has been shown to inhibit production of thromboxane B2 induced by E. coli endotoxin after administration in calves, lactating cows and pigs.
Croatian: Meloksikam ima i anti - endotoksična svojstva jer se pokazalo da inhibira stvaranje tromboksana B2, izazvano unosom endotksina E.
English: Therefore, the veterinary medicinal product should not be administered by pregnant women.
Croatian: Trudnice ne bi trebale primjenjivati veterinarsko-medicinski proizvod.
English: Efficacious plasma levels of florfenicol are maintained above the MIC90 of 1 µg/ml, 0.5µg/mL and 0.2 µg/ml for 72 h, 120 h and 160 h, respectively.
Croatian: Srednje razine u serumu zadržale su se iznad MIC90 za 1µg/ml nakon 72 h, 0,5 µg/ml nakon 120 h i 0,2 µg/ml nakon 160 h.
English: Repeated weekly administration of a 5x dose was fatal in 7 out of 8 calves after the third administration.
Croatian: Davanje pet puta veće doze od preporučene dovelo je do uginuća u 7 od 8 teladi nakon treće aplikacije.
English: After subcutaneous administration of the product at recommended dose of 1 ml/10 kg bodyweight maximum mean plasma concentration (Cmax) of 4.6 mg/l and 2.0 mg/l occurred 10 hours (h) and 7 h after dosing for florfenicol and meloxicam respectively.
Croatian: Nakon subkutanog davanja preporučene doze proizvoda od 1 ml/10 kg tjelesne mase najviša srednja koncentracija u serumu (Cmax) od 4,6 mg/l postigne se za 10 sati za florfenikol, odnosno 2,0 mg/l za 7 sati za meloksikam.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial 50 ml
Croatian: OSNOVNI PODACI KOJI SE MORAJU NALAZITI NA MALIM UNUTARNJIM PAKOVANJIMA
English: EU/2/17/210/001 EU/2/17/210/002 EU/2/17/210/003
Croatian: EU/2/17/210/002
English: A single subcutaneous injection at a dosage of 40 mg florfenicol/kg bodyweight and 0.5 mg meloxicam / kg bodyweight (i.e. 1 ml/10 kg bodyweight).
Croatian: Doza od 40 mg/kg tjelesne mase florfenikola i 0,5 mg/kg tjelesne mase meloksikama (tj. 1 ml/10 kg tjelesne mase).
English: Mannheimia haemolytica, Pasteurella multocida and Histophilus somni susceptible to florfenicol.
Croatian: Za prevenciju respiratorne bolesti goveda (BRD) povezane s vrućicom uzrokovanom Mannheimia haemolytica, Pasteurella multocida i Histophilus somni osjetljivih na florfenikol.
English: Pack size: 1 vial per cardboard box
Croatian: Kartonska kutija s 1 bočicom.
English: Florfenicol is mainly excreted via the urine and to a small extent via the faeces with a half-life of about 60 h. Meloxicam excretion is equally divided between urine and faeces, with a half-life of about 23 h.
Croatian: Veći dio florfenikola se eliminira putem mokraće, a manji dio preko izmeta s poluvremenom izlučivanja od oko 60 sati.
English: Repeated weekly administration of a 3x dose was fatal in 1 out of 8 calves after the third administration.
Croatian: Davanje tri puta veće doze od preporučene dovelo je do uginuća jednog od 8 teladi nakon treće aplikacije.
English: Pharmacotherapeutic group: Antibacterials for systemic use, amphenicols, combinations.
Croatian: Farmakoterapijska grupa: antibiotici za sustavnu primjenu (florfenikol), kombinacija amfenikola ATCvet kod: QJ01BA99
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Vial of 100 ml and 250 ml
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKOVANJU Bočice od 100 ml i 250 ml
English: Florfenicol acts by inhibiting protein synthesis at the ribosomal level and its action is bacteriostatic and time-dependent.
Croatian: Florfenikol djeluje bakteriostatski inhibirajući sintezu bjelančevina na razini ribosoma.
English: Zeleris 400 mg/ml + 5 mg/ml solution for injection for cattle florfenicol / meloxicam
Croatian: Zeleris 400 mg/ml + 5 mg/ml otopina za injekciju, za goveda florfenikol / meloksikam
English: florfenicol 400 mg/ml meloxicam 5 mg/ml
Croatian: SASTAV DJELATNIH TVARI florfenikol, 400 mg/ml meloksikam, 5 mg/ml
English: PACKAGE LEAFLET Zeleris 400 mg/ml + 5 mg/ml solution for injection for cattle
Croatian: UPUTA O VMP: Zeleris 400 mg/ml + 5 mg/ml otopina za injekciju, za goveda
English: 400 mg/ml florfenicol 5 mg/ml meloxicam
Croatian: SASTAV DJELATNIH TVARI 400 mg/ml florfenikol, 5 mg/ml meloksikam
English: Dose dependent maternotoxic and foetotoxic effects have been observed after oral administration of meloxicam to pregnant rats.
Croatian: Ovisno o dozi, nakon oralne primjene meloksikama, uočeni su uterotoksični i fetotoksični učinci.