FrancophonIA/ELRC3.0 huggingface dataset:
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
Croatian: 13. RIJEČI “ SAMO ZA PRIMJENU NA ŽIVOTINJAMA ” I UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE, ako je primjenjivo
English: Following orthopaedic surgery and depending on the response observed, treatment using the same daily dosing schedule may be continued after the first 3 days, upon judgement of the attending veterinarian.
Croatian: Nakon ortopedske operacije, ovisno o primijećenom odgovoru, liječenje se, prema istom dnevnom rasporedu, može nastaviti nakon prva 3 dana prema prosudbi odgovornog veterinara.
English: Iron oxides (E172) Caramel (E150d)
Croatian: Željezo oksidi (E172) Karamel (E150d)
English: Manufacturer for the batch release: MERIAL, 4 Chemin du Calquet, 31000 Toulouse, France
Croatian: Nositelj odobrenja za proizvodnju za puštanje proizvodne serije: MERIAL, 4 Chemin du Calquet, 31000 Toulouse, Francuska
English: As field studies were limited to 90 days, longer-term treatment should be considered carefully and regular monitoring undertaken by the veterinarian.
Croatian: Budući da su ispitivanja na terenu bila ograničena na 90 dana, dugoročno liječenje treba pažljivo razmotriti te poduzeti redovni nadzor veterinara.
English: Mode of action:
Croatian: Način djelovanja:
English: Rarely, nervous system disorders have been reported in treated dogs.
Croatian: Rijetko su zabilježeni poremećaji živčanog sustava u liječenih pasa.
English: Previcox tablets are supplied in blisters (transparent PVC /aluminium foil) or in 30 ml or 100 ml high density polyethylene bottles (with polypropylene closure).
Croatian: Previcox tablete se isporučuju u blisterima (prozirni PVC /aluminijska folija) ili u polietilenskim bočicama visoke gustoće od 30 ml ili 100 ml (s polipropilenskim zatvaračem).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton Box labelling
Croatian: PODACI NA VANJSKOM PAKOVANJU Natpis na kartonskoj kutiji
English: *The frequency of possible adverse effects is defined using the following convention: Rare (affects 1 to 10 animals in 10,000)
Croatian: *Učestalost mogućih štetnih učinaka definirana je sljedećim pravilom: Rijetko (zahvaća 1 do 10 životinja u 10.000) Vrlo rijetko (zahvaća manje od 1 životinje u 10.000)
English: The concentration of firocoxib required to inhibit 50 % of the COX-2 enzyme (i.e., the IC50) is 0.16 (± 0.05) µM, whereas the IC50 for COX-1 is 56 (± 7) µM.
Croatian: Koncentracija firokoksiba potrebna za inhibiciju 50 % enzima COX-2 (tj., IC50) je 0,16 (± 0,05) µM, dok je IC50 za COX-1 je .56 (± 7) µM.
English: Lactose Monohydrate Microcrystalline Cellulose Chartor Hickory Smoke Flavour Hydroxypropyl Cellulose Croscarmellose Sodium Magnesium Stearate Caramel (E150d) Silica, colloidal anhydrous Iron Oxides (E172)
Croatian: Laktoza monohidrat Mikrokristalna celuloza Chartor Hickory dimni okus Hidroksipropilna celuloza Kroskarmelozni natrij Magnezijev stearat Karamel (E150d)
English: Following oral administration in dogs at the recommended dose of 5 mg per kg of bodyweight, firocoxib is rapidly absorbed and the time to maximal concentration (Tmax) is 1.25 (± 0.85) hours.
Croatian: Nakon oralne primjene u pasa preporučene doze od 5 mg po kg tjelesne mase, firokoksib se brzo apsorbira i vrijeme do maksimalne koncentracije (Tmax) je 1,25 (± 0,85) sati.
English: The peak concentration (Cmax) is 0.52 (± 0.22) µg/ml (equivalent to approximately 1.5 µM), area under the curve (AUC 0-24) is 4.63 (±1.91) µg x hr/ml, and oral bioavailability is 36.9 (± 20.4) percent.
Croatian: Vršna koncentracija (Cmax) je 0,52 (± 0,22) µg/ml (približno jednako 1,5 µM), područje ispod krivulje (AUC 0-24) je 4,63 (± 1,91) µg x hr/ml, a oralna biodostupnost je 36,9 (± 20,4) posto.
English: Previcox Chewable tablets are scored to facilitate accurate dosing and contain caramel and smoke flavours to facilitate administration to dogs.
Croatian: Previcox tablete za žvakanje imaju razdjelni urez kako bi se olakšalo točno doziranje i sadrži karamel i arome dima za lakše davanje psima.
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: Bilo koji neupotrebljeni veterinarsko-medicinski proizvod ili otpadni materijali dobiveni primjenom tih veterinarsko-medicinskih proizvoda moraju se odlagati u skladu s lokalnim propisima.
English: Concurrent use of other active substances that have a high degree of protein binding may compete with firocoxib for binding and thus lead to toxic effects.
Croatian: Kod istovremene primjene drugih djelatnih tvari s visokim stupnjem vezanja proteina može doći do kompetitivnosti u vezanju s firokoksibom što može dovesti do toksičnih učinaka.
English: In those target animal safety studies, clinical signs of toxicity were reversible in some dogs following cessation of therapy.
Croatian: U tim ispitivanjima neškodljivosti za ciljne životinje, klinički znaci toksičnosti su se u nekih pasa vratili nakon prekida liječenja.
English: As with other NSAIDs, serious adverse effects can occur and, in very rare cases, may be fatal.
Croatian: Kao i kod drugih nesteroidnih protuupalnih lijekova, može doći do teških nuspojava, koje u vrlo rijetkim slučajevima mogu izazvati smrt.
English: If clinical signs of overdosing are observed, discontinue treatment.
Croatian: Ako se uoče znaci predoziranja, prekinite liječenje.
English: Do not use in animals less than 10 weeks of age or less than 3 kg body weight.
Croatian: Ne primjenjivati na životinje mlađe od 10 tjedana ili s manje od 3 kg tjelesne mase.
English: Relief of post-operative pain:
Croatian: Ublažavanje postoperacijskih bolova:
English: COX-2 is also thought to be involved in ovulation, implantation and closure of the ductus arteriosus, and central nervous system functions (fever induction, pain perception and cognitive function).
Croatian: COX-2 se također smatra da sudjeluje u ovulaciji, implantaciji i zatvaranju ductus arteriosus, i u funkcijama središnjeg živčanog sustava (početak povišene temperature, prepoznavanje boli i kognitivne funkcije).
English: Firocoxib is metabolised predominantly by dealkylation and glucuronidation in the liver.
Croatian: Firokoksib se većinom metabolizira dealkilacijom i glukuronidacijom u jetri.
English: Appropriate laboratory testing is recommended prior to treatment in order to detect subclinical (asymptomatic) renal or hepatic disorders that may predispose to adverse effects.
Croatian: Prije liječenja se preporučuju odgovarajuće laboratorijske pretrage kako bi se otkrili subklinički (asimptomatični) poremećaji bubrega i jetre koji bi mogli biti preduvjet za štetne učinke.
English: Concomitant treatment with molecules displaying action on renal flow, e.g. diuretics or Angiotensin Converting Enzyme (ACE) inhibitors, should be subject to clinical monitoring.
Croatian: Istodobno liječenje molekulama koje utječu na protok tvari kroz bubrege, npr. diuretici ili inhibitori enzima konvertaze angiotenzina (ACE), treba klinički nadzirati.
English: Administer 5 mg per kg bodyweight once daily as presented in the table below for up to 3 days as needed, starting approximately 2 hours prior to surgery.
Croatian: Primijeniti 5 mg na kg tjelesne mase jednom dnevno kako je prikazano u donjoj tablici, do 3 dana prema potrebi, s početkom oko 2 sata prije operacije.
English: Laboratory studies in rabbits have shown evidence of maternotoxic and foetotoxic effects at dose rates approximating the recommended treatment dose for the dog.
Croatian: Laboratorijskim pokusima na zečevima dokazan je fetotoksični i maternotoksični učinak pri dozama približnim onima preporučenim za liječenje pasa.
English: It is possible that a proportion of such cases had sub-clinical renal or hepatic disease prior to the commencement of therapy.
Croatian: Moguće je da se u dijelu takvih slučajeva radi o subkliničkim bolestima bubrega ili jetre koje su postojale prije početka liječenja.
English: Pre-treatment with other anti-inflammatory substances may result in additional or increased adverse effects and accordingly a treatment-free period with such drugs should be observed for at least 24 hours before the commencement of treatment with Previcox.
Croatian: Prethodno liječenje bilo kojim protuupalnim supstancama može za posljedicu imati dodatne ili pojačane štetne učinke pa je stoga potrebno provesti najmanje 24 sata bez takvih lijekova prije početka liječenja Previcoxom.
English: These reactions are generally of a transitory nature and are reversible when the treatment is stopped.
Croatian: Te su reakcije uglavnom prolazne i nestaju po prestanku liječenja.
English: Coxibs therefore display analgesic, anti-inflammatory and antipyretic properties.
Croatian: Koksibi stoga imaju analgetska, protuupalna i antipiretička svojstva.
English: Half tablets should be returned to the original market container and may be stored for up to 7 days.
Croatian: Polovine tableta treba vratiti u originalni spremnik te se mogu čuvati do 7 dana.
English: For the reduction of post-operative pain and inflammation, the animals can be dosed starting approximately 2 hours before surgery for up to 3 consecutive days as needed.
Croatian: Za smanjenje postoperacijske boli i upale doziranje može početi oko 2 sata prije operacije, do 3 dana uzastopno prema potrebi.
English: Gastrointestinal tract ulceration may be exacerbated by corticosteroids in animals given non-steroidal anti-inflammatory drugs.
Croatian: Ulceracije gastrointestinalnog trakta mogu se pogoršati uz davanje kortikosteroida, životinjama kojima su davani nesteroidni protuupalni lijekovi.
English: Special precautions for use in animals The recommended dose, as indicated in the dosing table, should not be exceeded.
Croatian: Preporučena doza, kako je naznačeno u tablici doziranja, ne smije se prekoračiti.
English: Do not use in animals suffering from gastrointestinal bleeding, blood dyscrasia or haemorrhagic disorders.
Croatian: Ne primjenjivati na životinje koje pate od gastrointestinalnog krvarenja, krvne diskrazije ili poremećaja krvarenja.
English: Pain and inflammation associated with osteoarthritis.
Croatian: Bol i upala povezane s osteoartritisom
English: Avoid use in any dehydrated, hypovolaemic or hypotensive animals, as there is a potential risk of increased renal toxicity.
Croatian: Izbjegavajte primjenu u dehidriranih, hipovolemičnih ili hipotenzivnih životinja, budući da postoji potencijalna opasnost od povećane toksičnosti u bubrezima.
English: Tan-brown, round, convex, engraved scored tablets.
Croatian: Tamno smeđe, okrugle, konveksne, tablete s ugraviranim razdjelnim zarezom.
English: Pharmacotherapeutic group: Anti-inflammatory and anti-rheumatic products, non-steroids.
Croatian: Farmakoterapijska grupa: Protuupalni i protureumatski proizvodi, nesteroidi.
English: In order to protect from moisture, store in the original package.
Croatian: Čuvati u originalnom pakovanju radi zaštite od vlage.
English: Each tablet contains: Firocoxib
Croatian: Jedna tableta sadrži: Firokoksib
English: Following multiple oral administrations, the steady state is reached by the third daily dose.
Croatian: stabilno se stanje postiže trećinom dnevne doze.
English: The treatment should be discontinued if any of these signs are observed: repeated diarrhoea, vomiting, faecal occult blood, sudden weight loss, anorexia, lethargy, degradation of renal or hepatic biochemistry parameters.
Croatian: Liječenje treba prekinuti ako se primijeti bilo koji od ovih znakova: opetovani proljev, povraćanje, prikrivenu krv u stolici, iznenadni gubitak težine, anoreksiju, letargiju, snižavanje biokemijskih parametara bubrega ili jetre.
English: In dogs seven months of age at the start of treatment at dose rates greater than or equal to 25 mg/kg/day (5 times the recommended dose) for six months, gastrointestinal adverse effects, i.e. vomiting were observed.
Croatian: U pasa koji su bili stari sedam mjeseci na početku liječenja, pri dozama jednakim ili većim od 25 mg/kg/dan (peterostruka preporučena doza) tijekom šest mjeseci, primijećeni su gastrointestinalni štetni učinci, tj. povraćanje.
English: For oral use as per table below.
Croatian: Za oralnu primjenu prema donjoj tablici.
English: In in-vitro canine whole blood assays, firocoxib exhibits approximately 380-fold selectivity for COX-2 over COX-1.
Croatian: U in-vitro testiranjima krvi psa, firokoksib pokazuje približno 380 puta veću selektivnost za COX-2 u odnosu na COX-1.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottle label
Croatian: OSNOVNI PODACI KOJI SE MORAJU NALAZITI NA MALIM UNUTARNJIM PAKOVANJIMA
English: As anaesthetic drugs may affect renal perfusion, the use of parenteral fluids during surgery should be considered to decrease potential renal complications when using NSAIDs peri-operatively.
Croatian: Budući da anestetici mogu djelovati na perfuziju bubrega, tijekom operacija treba razmotriti primjenu parenteralnog nadomještanja tekućine kako bi se umanjila mogućnost komplikacija s bubrezima kod perioperativne primjene nesteroidnih protuupalnih lijekova.
English: Do not use concomitantly with corticosteroids or other non-steroidal anti-inflammatory drugs (NSAIDs).
Croatian: Ne primjenjivati istovremeno s kortikosteroidima ili drugim nesteroidnim protuupalnim lijekovima (NSAIDs).
English: Administer 5 mg per kg bodyweight once daily as presented in the table below.
Croatian: Primijeniti 5 mg na kg tjelesne mase jednom dnevno kako je prikazano u donjoj tablici.
English: If adverse reactions like vomiting, repeated diarrhoea, faecal occult blood, sudden weight loss, anorexia, lethargy, degradation of renal or hepatic biochemistry parameters occur, use of the product should be stopped and the advice of a veterinarian should be sought.
Croatian: Ako dođe do nuspojava kao što su opetovani proljev, povraćanje, prikrivena krv u stolici, iznenadni gubitak težine, anoreksija, letargija, snižavanje biokemijskih parametara bubrega ili jetre, primjenu proizvoda treba prekinuti i potražiti savjet veterinara.
English: In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Croatian: U slučaju nehotičnog gutanja, odmah potražite pomoć liječnika i pokažite mu uputu o VMP ili etiketu.
English: For the relief of pain and inflammation associated with osteoarthritis in dogs.
Croatian: Za olakšanje bolova i upala povezanih s osteoartritisom u pasa.
English: For the relief of post-operative pain and inflammation associated with soft-tissue, orthopaedic and dental surgery in dogs.
Croatian: Za olakšanje postoperativnih bolova i upala povezanih s operacijama na mekom tkivu, ortopedskim i operacijama na zubima u pasa.
English: Firocoxib is a non-steroidal anti-inflammatory drug (NSAID) belonging to the Coxib group, which acts by selective inhibition of cyclooxygenase-2 (COX-2) - mediated prostaglandin synthesis.
Croatian: Firokoksib je nesteroidni protuupalni lijek (NSAID) koji pripada u skupinu Koksiba, koja djeluje selektivnom inhibicijom ciklooksigenaze-2 (COX-2) - u sintezi prostaglandina.
English: Firocoxib is a non-steroidal anti-inflammatory drug (NSAID) that acts by selective inhibition of cyclooxygenase-2 (COX-2) - mediated prostaglandin synthesis.
Croatian: Firokoksib je nesteroidni protuupalni lijek (NSAID) koji djeluje selektivnom inhibicijom ciklooksigenaze-2 (COX-2) - u sintezi prostaglandina.
English: Previcox must not be administered in conjunction with other NSAIDs or glucocorticosteroids.
Croatian: Previcox se ne smije primjenjivati zajedno s drugim nesteroidnim protuupalnim lijekovima ili glukokortikosteroidima.
English: In dogs ten weeks of age at the start of treatment at dose rates equal or greater to 25 mg/kg/day (5 times the recommended dose) for three months, the following signs of toxicity were observed: bodyweight loss, poor appetite, changes in the liver (accumulation of lipid), brain (vacuolisation), duodenum (ulcers) and death.
Croatian: U pasa koji su bili stari deset tjedana na početku liječenja, pri dozama jednakim ili većim od 25 mg/kg/dan (peterostruka preporučena doza) tijekom tri mjeseca, primijećeni su sljedeći znaci toksičnosti: gubitak tjelesne mase, slab tek, promjene na jetri (nakupljanje lipida), mozgu
English: Body weight (kg) Number of chewable tablets by size mg/kg range
Croatian: Broj tableta za žvakanje prema njihovoj veličini raspon mg/kg
English: Do not use in pregnant or lactating bitches.
Croatian: Ne smije se primjenjivati u gravidnih ili kuja u laktaciji.
English: Administer 5 mg per kg bodyweight once daily.
Croatian: Primijenite 5 mg po kg tjelesne mase jednom dnevno.
English: At dose rates equal or greater to 15 mg/kg/day (3 times the recommended dose) for six months, similar clinical signs were observed, albeit that the severity and frequency were less and duodenal ulcers were absent.
Croatian: Slični klinički znaci su uočeni kod doza jednakih ili većih od 15 mg/kg/dan (trostruka preporučena doza) tijekom šest mjeseci, no bili su slabijeg intenziteta i rjeđi, a čirevi na dvanaesniku su izostali.
English: COX-2 is the isoform of the enzyme that has been shown to be induced by pro-inflammatory stimuli and has been postulated to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever.
Croatian: COX-2 je izoformni oblik enzima za koji se pokazalo da inducira protuupalne stimulanse te je primarno odgovoran za stvaranje prostanoidnih medijatora boli, upala i povišene temperature.
English: COX-2 is the isoform of the enzyme that has been postulated to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever.
Croatian: COX-2 je izoformni oblik enzima za koji se pokazalo da je primarno odgovoran za stvaranje prostanoidnih medijatora boli, upala i povišene temperature.
English: Firocoxib 57 mg Firocoxib 227 mg
Croatian: Firokoksib 57 mg Firokoksib 227 mg
English: Peri-operative pain management.
Croatian: Perioperacijsko liječenje boli.
English: Therefore, appropriate laboratory testing to establish baseline renal or hepatic biochemistry parameters is recommended prior to and periodically during administration.
Croatian: Stoga se prije primjene i povremeno tijekom primjene preporučuju odgovarajuće laboratorijske pretrage kako bi se ustanovili početni biokemijski parametri za bubrege ili jetru.
English: Oral use
Croatian: Oralna primjena
English: Concurrent administration of potentially nephrotoxic drugs should be avoided as there might be an increased risk for renal toxicity.
Croatian: Istovremenu primjenu potencijalno nefrotoksičnih lijekova treba izbjegavati zbog mogućeg povećanja opasnosti od nefrotoksičnosti.
English: Elimination is principally in the bile and gastrointestinal tract.
Croatian: Izlučuje se uglavnom kroz žuč i probavni trakt.
English: Concurrent administration of potentially nephrotoxic drugs should be avoided.
Croatian: Istovremenu primjenu potencijalno nefrotoksičnih lijekova treba izbjegavati.
English: Firocoxib
Croatian: Firokoksib
English: A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: NOSITELJ(I) ODOBRENJA ZA PROIZVODNJU ODGOVORAN(I) ZA PUŠTANJE SERIJE U PROMET
English: Renal and/or hepatic disorders have been reported in very rare cases in dogs administered the recommended treatment dose.
Croatian: Zabilježeni su vrlo rijetki slučajevi poremećaja bubrega i jetre u pasa kod kojih je primijenjena preporučena doza lijeka.
English: ADVERSE REACTIONS*
Croatian: NUSPOJAVE*
English: Firocoxib 57 mg
Croatian: Firokoksib 57 mg.
English: Firocoxib 227 mg
Croatian: Firokoksib 227 mg.
English: Use this product under strict veterinary monitoring where there is a risk of gastrointestinal bleeding, or if the animal previously displayed intolerance to NSAIDs.
Croatian: Ako postoji rizik od od gastrointestinalnog krvarenja ili ako je životinja ranije pokazala da ne podnosi nesteroidne protuupalne lijekove, primijenite ovaj proizvod pod strogim nadzorom veterinara.
English: Previcox 57 mg chewable tablets for dogs Previcox 227 mg chewable tablets for dogs
Croatian: Previcox 57 mg tablete za žvakanje za pse Previcox 227 mg tablete za žvakanje za pse
English: EU/2/04/045/003 10 tablets EU/2/04/045/004 30 tablets EU/2/04/045/006 180 tablets EU/2/04/045/009 60 tablets
Croatian: EU/2/04/045/004 30 tableta.
English: EU/2/04/045/001 10 tablets EU/2/04/045/002 30 tablets EU/2/04/045/005 180 tablets EU/2/04/045/008 60 tablets
Croatian: EU/2/04/045/002 30 tableta.
English: PACKAGE LEAFLET Previcox 57 mg chewable tablets for dogs Previcox 227 mg chewable tablets for dogs
Croatian: UPUTA O VMP Previcox 57 mg tablete za žvakanje za pse Previcox 227 mg tablete za žvakanje za pse
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS {NATURE/TYPE}
Croatian: OSNOVNI PODACI NAPISANI NA BLISTERIMA
English: Previcox 227 mg chewable tablets for dogs
Croatian: Previcox 227 mg tablete za žvakanje za pse.
English: Previcox 57 mg chewable tablets for dogs
Croatian: Previcox 57 mg tablete za žvakanje za pse.
English: Chewable tablet
Croatian: Tableta za žvakanje.
English: 10 tablets 30 tablets 60 tablets 180 tablets
Croatian: 180 tableta.
English: Previcox 227 mg chewable tablets Firocoxib
Croatian: Previcox 227 mg tablete za žvakanje.
English: ANNEX II A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE D. STATEMENT OF THE MRLs
Croatian: DODATAK II A. NOSITELJ(I) ODOBRENJA ZA PROIZVODNJU ODGOVORAN(I) ZA PUŠTANJE SERIJE U PROMET
English: Previcox 57 mg chewable tablets Firocoxib
Croatian: Previcox 57 mg tablete za žvakanje.
English: SPECIAL STORAGE PRECAUTIONS
Croatian: Posebne mjere opreza za primjenu na životinjama
English: - 2nd injection: after 3-4 weeks.
Croatian: - Druga injekcija: nakon 3-4 tjedna.
English: a) the administration of the product to animals will interfere with the implementation of a national programme for the diagnosis, control and eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
Croatian: a) će primjena proizvoda na životinjama interferirati s provedbom nacionalnog programa otkrivanja, kontrole i eradikacije bolesti životinja ili će prouzročiti poteškoće u certificiranju odsutnosti zaraze u živim životinjama ili hrani ili drugim proizvodima dobivenim od tretiranih životinja.
English: In cattle and sheep - 1st injection: from 1 month of age in naive animals (or from 2.5 months of age in young cattle and sheep born to immune animals).
Croatian: Za goveda i ovce - Prva injekcija: od 1 mjeseca starosti (ili od 2,5 mjeseca starosti u mladih goveda i ovaca rođenih od imunih životinja).
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal product on the whole or part of their territory if it is established that:
Croatian: Sukladno članku 71. Direktive 2001/82/EK i Europskog Parlamenta i Vijeća s izmjenama i dopunama države članice u skladu sa nacionalnim zakonodavstvom mogu zabraniti proizvodnju, uvoz, posjedovanje, prodaju, opskrbu i/ili primjenu imunoloških veterinarsko-medicinskih proizvoda na cijelom svom teritoriju ili na jednom njegovom dijelu ako je utvrđeno da:
English: The duration of immunity for cattle and sheep is 1 year after the primary vaccination course.
Croatian: Trajnost imuniteta kod goveda i ovaca je 1 godinu nakon prvog cijepljenja.
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required.
Croatian: Pomoćne tvari (uključujući adjuvanse) navedene u odjeljku 6.1 Sažetka opisa svojstava su dopuštene tvari za koje, kako je navedeno u tablici 1, Dodatka Uredbe Komisije (EU) br. 37/2010. za koje se MRL ne zahtijeva.