FrancophonIA/ELRC3.0 huggingface dataset:
English: • The NexoBrid powder vial must be opened by carefully tearing off the aluminium cap and removing the rubber stopper.
Croatian: • Otvorite bočicu s praškom NexoBrid tako što ćete pažljivo ukloniti aluminijski zatvarač i gumeni čep.
English: This is to make it less likely that you develop an allergic reaction to NexoBrid.
Croatian: U slučaju dodira s kožom, isperite NexoBrid vodom da biste smanjili vjerojatnost razvoja alergijske reakcije na NexoBrid.
English: When applying a permanent skin cover (e.g., autograft) or temporary skin substitute (e.g., allograft) to a freshly enzymatically debrided area, care should be taken to clean and refresh the debrided bed by, e.g., brushing or scraping to allow dressing adherence.
Croatian: Kad se područje svježe obrađeno debridmanom enzimima pokriva trajnim kožnim presatkom (npr. vlastitom kožom) ili privremenim kožnim presatkom (npr. kožom druge osobe), potrebno je paziti da dno debridmanom obrađene rane bude očišćeno i osvježeno, npr. četkanjem ili struganjem kako bi se omogućilo prianjanje povoja.
English: Before applying NexoBrid
Croatian: Prije propisivanja NexoBrida
English: 2 g powder in a vial (glass type II) sealed with a rubber (bromobutyl), stopper and covered with a cap (aluminium), and 20 g gel in a bottle (borosilicate, glass type I), sealed with a rubber stopper and covered with a screw cap (tamper-proof polypropylene).
Croatian: 2 g praška u bočici (staklo tipa II), zatvorenoj gumom (brombutil), čepom i pokrivenoj zatvaračem (aluminij) te 20 g gela u boci (borosilikat, staklo tipa I) zatvorenoj gumenim čepom i pokrivenoj navojnim zatvaračem (polipropilenski, s evidencijom otvaranja).
English: - Conditions that could be precipitated or worsened by analgesic premedication (e.g., gastric dilatation, nausea and risk of sudden vomiting, constipation) or antibiotic prophylaxis (e.g.,
Croatian: mučnina i rizik od iznenadnog povraćanja, konstipacija) ili antibiotska profilaksa (npr. proljev).
English: In case of eye exposure, irrigate exposed eyes with copious amounts of water for at least 15 minutes.
Croatian: U slučaju izlaganja očiju, isperite izložene oči obilnom količinom vode najmanje 15 minuta.
English: In case of skin exposure, rinse NexoBrid off with water.
Croatian: U slučaju izlaganja kože, vodom isperite NexoBrid s kože.
English: There is no information on the use of NexoBrid in patients with hepatic impairment.
Croatian: Nema podataka o primjeni NexoBrida u bolesnika s oštećenjem funkcije bubrega.
English: Posology 5 g NexoBrid powder in 50 g gel is applied to a burn wound area of 250 cm
Croatian: Doziranje 5 g praška NexoBrid u 50 g gela nanosi se na područje opekline površine od 250 cm
English: Posology 2 g NexoBrid powder in 20 g gel is applied to a burn wound area of 100 cm
Croatian: Doziranje 2 g praška NexoBrid u 20 g gela nanosi se na područje opekline površine od 100 cm
English: Topically applied medicinal products (such as silver sulfadiazine or povidone-iodine) at the wound site must be removed and the wound must be cleansed prior to NexoBrid application.
Croatian: Lijekovi koji su topikalno primijenjeni (kao što su srebrni sulfadiazin ili povidon-jod) na ranu moraju se ukloniti, a rana mora biti očišćena prije primjene NexoBrida.
English: In the NexoBrid group, the event was graded as mild, moderate or severe in 0.9%, 0.9%, and 1.8% of patients, respectively.
Croatian: U skupini liječenoj NexoBridom, ovaj je događaj ocijenjen kao blag u 0,9% bolesnika, umjeren u 0,9% bolesnika i težak u 1,8% bolesnika.
English: In the NexoBrid group, the event was graded as mild, moderate or severe in 9.1%, 9.1%, and 0% of patients, respectively.
Croatian: U skupini liječenoj NexoBridom ovaj je događaj ocijenjen kao blag u 9,1% bolesnika, umjeren u 9,1% bolesnika i težak u 0% bolesnika.
English: What NexoBrid looks like and contents of the pack NexoBrid is provided as a powder and gel for gel (powder in a vial (2 g) and gel in a bottle (20 g)), pack size of 1 (a pack contains one vial of powder and one bottle of gel)
Croatian: NexoBrid se isporučuje u obliku praška i gela za gel (prašak u bočici (2 g) i gel u boci (20 g)), veličina pakiranja: 1 (pakiranje sadrži jednu bočicu praška i jednu bocu gela).
English: Allergic reactions to bromelain have been reported in the literature (including anaphylactic reactions and other immediate-type reactions with manifestations such as bronchospasm, angiooedema, urticaria, and mucosal and gastrointestinal reactions).
Croatian: U literaturi su zabilježene alergijske reakcije na bromelain (uključujući anafilaktičke reakcije i druge reakcije ranog tipa sa znakovima kao što su bronhospazam, angioedem, urtikarija i reakcije sluznica i gastrointestianlne reakcije).
English: Deep partial-thickness wounds requiring excision/dermabrasion (surgery) Number of wounds % of wounds requiring surgery % of wound area excised or dermabraded
Croatian: Duboke opekline djelomične debljine kože koje zahtijevaju eksciziju/dermoabraziju (kiruršku obradu) Broj rana % rana koje zahtijevaju kiruršku obradu % površine rane obrađen ekscizijom ili dermoabrazijom
English: In the NexoBrid group, the event was graded as mild, moderate or severe in 30.0%, 5.6% and 1.1% of patients, respectively.
Croatian: U skupini liječenoj NexoBridom ovaj je događaj ocijenjen kao blag u 30,0% bolesnika, umjeren u 5,6% bolesnika i težak u 1,1% bolesnika.
English: As in the case of surgically debrided bed, in order to prevent desiccation and/or formation of pseudoeschar and/or infection, the debrided area should be covered immediately by temporary or permanent skin substitutes or dressings.
Croatian: Kao i u slučaju pripreme dna rane kirurškim debridmanom, područje debridmana treba odmah pokriti privremenim ili trajnim presatkom kože ili povojima kako bi se spriječilo sušenje i/ili stvaranje pseudoeshara i/ili infekcije.
English: The other ingredients are: for the powder: ammonium sulphate and acetic acid and for the gel carbomer 980, disodium phosphate anhydrous, sodium hydroxide, and water for injections.
Croatian: Ostali sastojci praška su: amonijev sulfat i acetatna kiselina, a gela: karbomer 980, natrijev hidrogenfosfat bezvodni, natrijev hidroksid i voda za injekcije.
English: Allergic reactions to bromelain include anaphylactic reactions and other immediate-type reactions with manifestations such as bronchospasm, angiooedema, urticaria, and mucosal and gastrointestinal reactions.
Croatian: Alergijske reakcije na bromelain uključuju anafilaktičke reakcije i druge vrste reakcija ranog tipa sa znakovima kao što su bronhospazam, angioedem, urtikarija i reakcije sluznica i gastrointestinalne reakcije.
English: • NexoBrid powder and gel must be mixed thoroughly until a uniform, slightly tan to slightly brown mixture is obtained.
Croatian: • Prašak NexoBrid morate temeljito miješati s gelom sve dok ne dobijete jednoliku mješavinu svijetlo bež do svijetlo smeđe boje.
English: • A dressing soaked with an antibacterial solution must be applied for an additional 2 hours.
Croatian: • Mora se staviti povoj natopljen antibakterijskom otopinom i ostaviti tako još 2 sata.
English: What NexoBrid contains - The active substance (in the powder in the vial) is a concentrate of proteolytic enzymes enriched in bromelain: 2 g, corresponding to 0.09 g/g concentrate of proteolytic enzymes enriched in bromelain after mixing.
Croatian: Što NexoBrid sadrži - Djelatna tvar (u prašku u bočici) je koncentrat proteolitičkih enzima obogaćenih bromelainom: 2 g, što odgovara 0,09 g/g koncentrata proteolitičkih enzima obogaćenih bromelainom nakon miješanja.
English: One vial contains 2 g of concentrate of proteolytic enzymes enriched in bromelain, corresponding to 0.09 g/g concentrate of proteolytic enzymes enriched in bromelain after mixing (or 2 g/22 g gel).
Croatian: Jedna bočica sadrži 2 g koncentrata proteolitičkih enzima obogaćenih bromelainom, što odgovara 0,09 g/g koncentrata proteolitičkih enzima obogaćenih bromelainom nakon miješanja (ili 2 g/22 g gela).
English: Carbomer 980 disodium phosphate anhydrous Sodium hydroxide Water for injections
Croatian: Gel karbomer 980 natrijev hidrogenfosfat, bezvodni natrijev hidroksid voda za injekcije
English: NexoBrid 2 g powder and gel for gel Concentrate of proteolytic enzymes enriched in bromelain
Croatian: NexoBrid 2 g prašak i gel za gel koncentrat proteolitičkih enzima obogaćenih bromelainom
English: Mixed wounds (deep partial and full thickness) Non-autografted mixed wounds
Croatian: Mješovite rane (duboke rane djelomične i pune debljine kože)
English: Deep partial-thickness wounds autografted* Number of wounds % of wounds autografted % of wound area autografted (mean ± SD)
Croatian: Duboke opekline djelomične debljine kože pokrivene presatkom vlastite kože* Broj rana % rana pokrivenih presatkom % područja rane pokriveno presatkom (srednja vrijednost ± SD)
English: What NexoBrid contains - The active substance (in the powder in the vial) is a concentrate of proteolytic enzymes enriched in bromelain: 5 g, corresponding to 0.09 g/g concentrate of proteolytic enzymes enriched in bromelain after mixing.
Croatian: Što NexoBrid sadrži - Djelatna tvar (u prašku u bočici) je koncentrat proteolitičkih enzima obogaćenih bromelainom: 5 g, što odgovara 0,09 g/g koncentrata proteolitičkih enzima obogaćenih bromelainom nakon miješanja.
English: One vial contains 5 g of concentrate of proteolytic enzymes enriched in bromelain, corresponding to 0.09 g/g concentrate of proteolytic enzymes enriched in bromelain after mixing (or 5 g/55 g gel).
Croatian: Jedna bočica sadrži 5 g koncentrata proteolitičkih enzima obogaćenih bromelainom, što odgovara 0,09 g/g koncentrata proteolitičkih enzima obogaćenih bromelainom nakon miješanja (ili 5 g/55 g gela).
English: NexoBrid 5 g powder and gel for gel Concentrate of proteolytic enzymes enriched in bromelain
Croatian: NexoBrid 5 g prašak i gel za gel koncentrat proteolitičkih enzima obogaćenih bromelainom
English: (mean ± SD) Time to complete wound closure (time from ICF**) Number of patients Days to closure of last wound (mean ± SD) Time to successful eschar removal Number of patients Days (mean ± SD) from injury Days (mean ± SD) from consent Patients not reported to have successful eschar removal Measured at first session, if there was more than one surgery session.
Croatian: Dani do zatvaranja posljednje rane (srednja vrijednost ± SD) Vrijeme do uspješnog odstranjenja eshara Broj bolesnika Dani (srednja vrijednost ± SD) od ozljede Dani (srednja vrijednost ± SD) od pristanka Bolesnici u kojih nije zabilježeno uspješno uklanjanje eshara
English: • The wound must be wiped thoroughly first with a large sterile dry gauze or napkin, followed by a sterile gauze or napkin that has been soaked with sterile isotonic sodium chloride 9 mg/ml
Croatian: • Rana se mora temeljito obrisati prvo velikom sterilnom suhom gazom ili ubrusom, a nakon toga sterilnom gazom ili ubrusom natopljenim sterilnom izotoničnom otopinom natrijevog klorida od
English: Powder and gel to be mixed before application.
Croatian: Prije primjene treba pomiješati prašak i gel.
English: An aseptic technique must be used when mixing the powder with the gel.
Croatian: Kod miješanja praška s gelom mora se koristiti aseptička tehnika.
English: Aseptic technique must be used when mixing NexoBrid powder with the gel.
Croatian: Kod miješanja praška NexoBrid s gelom mora se koristiti aseptička tehnika.
English: Wound Type
Croatian: Vrsta rane
English: Uncommon (1/1,000 to <1/100)
Croatian: Manje često (1/1000 i <1/100)
English: The major constituent is stem bromelain.
Croatian: Glavni sastojak je bromelain iz stabljike ananasa.
English: After applying NexoBrid
Croatian: Nakon primjene NexoBrida
English: All topically applied antibacterial medicinal products must be removed before applying NexoBrid.
Croatian: Prije primjene NexoBrida moraju se ukloniti svi topikalno primijenjeni antibakterijski lijekovi.
English: The powder is off-white to light tan.
Croatian: Prašak je bjelkaste do bež boje.
English: • All topically applied antibacterial medicinal products must be removed before applying NexoBrid.
Croatian: • Prije primjene NexoBrida moraju se ukloniti svi topikalno primijenjeni antibakterijski lijekovi.
English: Excipients: Carbomer 980, disodium phosphate anhydrous, sodium hydroxide, water for injections.
Croatian: Pomoćne tvari: karbomer 980, natrijev hidrogenfosfat bezvodni, natrijev hidroksid, voda za injekcije
English: Excipients for the gel: Carbomer 980, disodium phosphate anhydrous, sodium hydroxide, water for injections.
Croatian: Pomoćne tvari u gelu: karbomer 980, natrijev hidrogenfosfat bezvodni, natrijev hidroksid, voda za injekcije.
English: • Dressing soaked with an antibacterial solution must be applied for 2 hours.
Croatian: • Mora se staviti povoj natopljen antibakterijskom otopinom i ostaviti na rani 2 sata.
English: Powder and gel for gel.
Croatian: Prašak i gel za gel.
English: • A total wound area of not more than 15% TBSA can be treated by NexoBrid.
Croatian: • NexoBridom se može liječiti rana čija cjelokupna površina nije veća od 15% cjelokupne površine tijela.
English: Size: % mean TBSA Depth: Superficial (%TBSA) DPT (% TBSA) FT (% TBSA) Incidence of autograft
Croatian: Dubina: površinski (% ukupne površine tijela) duboka djelomična debljina (% ukupne površine tijela) puna debljina (% ukupne površine tijela)
English: How NexoBrid is stored
Croatian: Kako čuvati NexoBrid
English: Mixed wounds (with partial and full-thickness area) autografted NexoBrid (Number of wounds)
Croatian: Mješovite rane (s područjima djelomične i pune debljine kože) prekrivene presatkom vlastite kože
English: % of wounds requiring surgery % of wound area excised or dermabraded
Croatian: Broj rana % rana koje zahtijevaju kiruršku obradu % površine rane obrađen ekscizijom ili dermabrazijom
English: General principles of proper burn wound care must be adhered to when using NexoBrid.
Croatian: Kod primjene NexoBrida morate se pridržavati općih načela ispravne njege opeklina.
English: • Wounds with areas of full thickness and deep burn should be autografted as soon as possible after NexoBrid debridement.
Croatian: • Rane s opekotinama pune debljine kože ili dubokim opekotinama trebaju se nakon debridmana
English: If you get any side effects, talk to your doctor or nurse.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ili medicinsku sestru.
English: NexoBrid showed no genotoxic activity when investigated in the standard set of in vitro and in vivo studies.
Croatian: Kad se provjeravao standardnim in vitro i in vivo ispitivanjima, NexoBrid nije pokazao genotoksično djelovanje.
English: 5 g NexoBrid powder mixed in 50 g gel is applied to a burn wound area of 250 cm It should be left for 4 hours, and then be removed.
Croatian: 5 g praška NexoBrid pomiješanih u 50 g gela nanosi se na površinu opekline od 250 cm
English: Time to complete wound closure (time from ICF**) Number of patients Days to closure of last wound (mean ± SD) Time to successful eschar removal Number of patients Days (mean ± SD) from injury Days (mean ± SD) from consent Patients not reported to have successful eschar removal 1 Measured at first session, if there was more than one surgery session.
Croatian: Dani do zatvaranja posljednje rane (srednja vrijednost ± SD) Vrijeme do uspješnog uklanjanja eshara Broj bolesnika Dani (srednja vrijednost ± SD) od ozljede Dani (srednja vrijednost ± SD) od informiranog pristanka
English: PSURs
Croatian: PSUR-evi
English: 2 g NexoBrid powder mixed in 20 g gel is applied to a burn wound area of 100 cm It should be left for 4 hours, and then be removed.
Croatian: 2 g praška NexoBrid pomiješanih u 20 g gela nanosi se na površinu opekline od 100 cm
English: NAME AND ADDRESS OF MARKETING AUTHORISATION HOLDER
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: Mixed wounds (with partial and full-thickness area) requiring excision/dermabrasion (surgery) NexoBrid
Croatian: Duboke opekline djelomične i/ili pune debljine kože koje zahtijevaju eksciziju/dermabraziju (kiruršku obradu)
English: - Signs of local and systemic inflammatory and infectious processes.
Croatian: - znakova lokalnih i sistemskih upalnih i infektivnih procesa. - stanja koja može izazvati ili pogoršati premedikacija analgeticima (npr. dilatacija želuca,
English: • Pain management must be used as commonly practiced for an extensive dressing change; it should be initiated at least 15 minutes prior to NexoBrid application.
Croatian: • Preventivno liječenje boli mora se primijeniti prema uobičajenoj praksi kod opsežne promjene povoja.
English: All mixed burns baseline characteristics
Croatian: Početne karakteristike svih mješovitih opeklina
English: Topically applied medicinal products (such as silver sulfadiazine or povidone-iodine) at the wound site must be removed and the wound cleansed prior to NexoBrid application.
Croatian: Prije primjene NexoBrida, lijekovi topikalno primijenjeni (kao što su sulfadiazin srebro ili povidon jod) na mjesto rane moraju se ukloniti i rana se mora očistiti.
English: Autografted mixed wounds
Croatian: Mješovite rane pokrivene presatkom vlastite kože
English: How NexoBrid is used
Croatian: Kako primjenjivati NexoBrid
English: Chemin de la Chatanérie 2 1023 Crissier-Lausanne SWITZERLAND
Croatian: Chemin de la Chatanérie 2 1023 Crissier-Lausanne ŠVICARSKA
English: ATCvet code: QI02AT01.
Croatian: ATC vet kod: QI02AT01
English: * microagglutination method
Croatian: * metoda mikroaglutinacije
English: For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
Croatian: Za bilo kakve informacije o ovom veterinarsko-medicinskom proizvodu, molimo kontaktirajte lokalnog predstavnika nositelja odobrenja stavljanja u promet.
English: The product is produced from colostrum collected from cows kept under field conditions.
Croatian: Proizvod se dobiva od kolostruma prikupljenog od krava držanih u vanjskim uvjetima.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/99/011/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/99/011/001
English: This should be borne in mind when planning vaccination programmes for calves, which receive Locatim.
Croatian: Ovo treba imati na umu kada se planira program vakcinacije za telad koja prima Locatim.
English: The excipients 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 navedene u dijelu 6.1 SPC su dozvoljene tvari za koje je u tablici 1, Dodatka Uredbe Komisije (EU) br. 37/2010 navedeno da određivanje MRL nije nužno.
English: Date of last renewal: 05/12/2008.
Croatian: Datum posljednjeg produljenja odobrenja: 05/12/2008.
English: FRANCE
Croatian: FRANCUSKA
English: Merial Laboratoire Porte des Alpes Rue de l'Aviation 69800 Saint Priest FRANCE
Croatian: Merial Laboratoire Porte des Alpes Rue de l'Aviation 69800 Saint Priest FRANCUSKA
English: If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.
Croatian: Ako primijetite ozbiljne nuspojave ili druge nuspojave koje nisu spomenuti ovdje, molimo Vas da obavijestite svog veterinara.
English: Methyl parahydroxybenzoate ≤ 0.8 mg/ml.
Croatian: Metil parahidroksibenzoat ≤ 0.8 mg/ml.
English: LIECHTENSTEIN
Croatian: FÜRSTENTUM LIECHTENSTEIN
English: In the absence of information specifically demonstrating the safety of more than one repeated dose, it is recommended that calves should only be dosed once.
Croatian: U nedostatku podataka koji izričito ukazuju na neškodljivost više od jedne ponovljene doze, preporučuje se davanje samo jedne doze.
English: This product may contain antibodies against BVD virus.
Croatian: Ovaj proizvod može sadržavati protutijela za virus BVD-a.
English: The active substance being a principle of biological origin intended to produce passive immunity is not within the scope of Regulation (EC) No 470/2009.
Croatian: Djelatna tvar koja se sastoje od tvari biološkog podrijetla, namijenjene za stvaranje pasivne imunosti na koje se ne primjenjuju odredbe Uredbe (EK) br. 470/2009.
English: The product should be administered neat or diluted in milk or in milk replacer within the first 12 hours of the calf's life, preferably, as soon as it is receptive.
Croatian: Proizvod se daje u čistom obliku ili razrijeđen u mlijeku ili zamjeni za mlijeko unutar prvih 12 sati teletova života, po mogućnosti čim postane receptivno.
English: If the calf is reluctant to take the product, it may be administered via an ordinary syringe placed in the mouth.
Croatian: Ako tele oklijeva uzeti otopinu, može se dati običnom špricom u usta.
English: Transient effects of temperature increase and respiration rate increase have been seen when the product is administered in a double dose.
Croatian: Prolazni učinak povećane temperature i ubrzanog disanja zabilježeni su kod davanja dvostruke doze.
English: Pregnancy and lactation: The product is not intended for use during pregnancy and lactation.
Croatian: Graviditet i laktacija: Nije namijenjen za primjenu za vrijeme graviditeta ili laktacije.
English: Shelf life of the veterinary medicinal product as packaged for sale: 30 months.
Croatian: 6.3 Rok valjanosti Rok valjanosti veterinarsko-medicinskog proizvoda kad je zapakiran za prodaju: 30 mjeseci.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Djelatne tvari
English: The product is not intended for use during pregnancy and lactation.
Croatian: Ovaj proizvod nije namijenjen za primjenu za vrijeme graviditeta ili laktacije.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
Croatian: DATUM KADA JE UPUTA O VMP ZADNJI PUTA ODOBRENA
English: Special precautions for use in animals: This product may contain antibodies against BVD virus.
Croatian: Posebne mjere opreza prilikom primjene: Ovaj proizvod može sadržavati protutijela za virus BVD-a.
English: a) the administration of the product to animals will interfere with the implementation of a national programme for the diagnosis, control or 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 nacionalnih programa za otkrivanje, kontrolu ili iskorjenjivanje bolesti životinja ili će prouzročiti poteškoće u certificiranju odsutnosti zaraze u živih životinja ili hrani ili drugim proizvodima dobivenim od tretiranih životinja. b) je bolest, za koju je proizvod namijenjen da pruži imunost, u velikoj mjeri odsutna s odnosnog područja.
English: Reduction of mortality caused by enterotoxicosis associated with E. coli F5 (K99) adhesin during the first days of life as a supplement to colostrum from the dam.
Croatian: Smanjenje smrtnosti uzrokovane enterotoksikozom povezanom s adhezinom E. coli F5 (K99) za vrijeme prvih dana života kao dopuna maternalnom kolostrumu.
English: Consequently, in addition to antibodies to E. coli F5 (K99) it also contains antibodies to other organisms, as a result of vaccination and/or exposure of the donor cows to organisms in their environment.
Croatian: Osim protutijela za E. coli F5 (K99), kolostrum također sadrži protutijela za druge mikroorganizme, što je rezultat cijepljenja i/ili izloženosti krave donatora mikroorganizmima u njihovom okolišu.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottle
Croatian: OSNOVNI PODACI KOJI SE MORAJU NALAZITI NA MALIM UNUTARNJIM PAKOVANJIMA
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 29/03/1999.
Croatian: Datum prvog odobrenja: 29/3/1999.
English: In the absence of compatibility studies this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Croatian: U nedostatku studija inkompatibilnosti, ovaj se veterinarsko-medicinski proizvod ne smije miješati s drugim veterinarsko-medicinskim proizvodima.