FrancophonIA/ELRC3.0 huggingface dataset:
English: Depending on the condition it is used to treat, Blitzima may be given with chemotherapy (other cancer medicines) or medicines used for inflammatory disorders (corticosteroids).
Croatian: Ovisno o bolesti koja se liječi, Blitzima se može primjenjivati uz kemoterapiju (drugi lijekovi za rak) ili lijekove koji se koriste za upalne poremećaje (kortikosteroidi).
English: Because Blitzima is a biosimilar medicine, the studies on effectiveness and safety of rituximab carried out with MabThera do not all need to be repeated for Blitzima.
Croatian: Budući da je lijek Blitzima biosličan lijek, ispitivanja djelotvornosti i sigurnosti provedena za lijek MabThera nije potrebno ponavljati za lijek Blitzima.
English: What are the risks associated with Blitzima?
Croatian: Koji su rizici povezani s lijekom Blitzima?
English: Doctors prescribing Blitzima for cancer will be provided with educational material reminding them of the need to use the medicine only by infusion into a vein.
Croatian: Liječnici koji propisuju lijek Blitzima dobit će edukativne materijale koji ih podsjećaju na potrebu da primjenjuju lijek samo infuzijom u venu.
English: Blitzima is a ‘biosimilar medicine'.
Croatian: Blitzima je „biosličan lijek”.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Blitzima has a highly similar structure, purity and biological activity to MabThera and is distributed in the body in the same way.
Croatian: Europska agencija za lijekove zaključila je da, u skladu sa zahtjevima EU-a za bioslične lijekove, lijek Blitzima ima vrlo sličnu strukturu, čistoću i biološku aktivnost kao i lijek MabThera te se u tijelu raspoređuje na isti način.
English: Blitzima should be given under the close supervision of an experienced healthcare professional and in a place where facilities for resuscitating patients are immediately available.
Croatian: Osim toga, lijek Blitzima potrebno je davati pod pomnim nadzorom iskusnog zdravstvenog radnika i na mjestu u kojem su izravno dostupni odjeli za oživljavanje bolesnika.
English: Therefore, the Agency's view was that, as for MabThera, the benefit outweighs the identified risk and it recommended that Blitzima be given marketing authorisation.
Croatian: Stoga je mišljenje Agencije da, kao i kod lijeka MabThera, koristi nadmašuju utvrđene rizike te je preporučila davanje odobrenja za stavljanje lijeka Blitzima u promet.
English: It is not intended to provide practical advice on how to use Blitzima.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Blitzima.
English: The active substance in Blitzima, rituximab, is a monoclonal antibody (a type of protein) designed to recognise and attach to a protein called CD20 present on the surface of B cells (types of white blood cells).
Croatian: Djelatna tvar u lijeku Blitzima je rituksimab, monoklonalno protutijelo (vrsta bjelančevine) koje prepoznaje i veže se za bjelančevine pod nazivom CD20 koji se nalaze na površini B-stanica (vrsta bijelih krvnih stanica).
English: When rituximab attaches to CD20, it causes the death of B cells, which helps in lymphoma and CLL, where B cells have become cancerous.
Croatian: Kad se rituksimab veže na bjelančevinu CD20, uzrokuje smrt B-stanica, što pomaže u bolesnika s limfomom i KLL-om kod kojih su B-stanice postale kancerogene.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Blitzima have also been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Blitzima nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: Blitzima is a medicine used in adults to treat the following blood cancers and inflammatory conditions:
Croatian: Blitzima je lijek koji se koristi za liječenje sljedećih vrsta raka krvi i upala u odraslih bolesnika:
English: Blitzima must not be used in people who are hypersensitive (allergic) to rituximab, mouse proteins or any of the other ingredients.
Croatian: Lijek Blitzima ne smiju dobivati osobe koje su preosjetljive (alergične) na rituksimab, mišje bjelančevine ili bilo koji drugi sastojak lijeka.
English: Why is Blitzima approved?
Croatian: Zašto je lijek Blitzima odobren?
English: The company that markets Blitzima will provide doctors and patients using the medicine for non-cancer conditions with educational material including information on the need to give the medicine where facilities for resuscitation are available and on the risk of infection, including PML.
Croatian: Tvrtka koja lijek Blitzima stavlja u promet, liječnicima i bolesnicima koji koriste lijek za bolesti koje nisu zloćudne dostavit će edukativni materijal, uključujući informacije o potrebi davanja lijeka na mjestima opremljenima aparatima za reanimaciju te o riziku od upale, uključujući PML.
English: • granulomatosis with polyangiitis (GPA or Wegener's granulomatosis) and microscopic polyangiitis (MPA), which are inflammatory conditions of the blood vessels.
Croatian: • granulomatoze s poliangitisom (GPA ili Wegenerova granulomatoza) i mikroskopskog poliangitisa
English: The reference medicine for Blitzima is MabThera.
Croatian: Referentni lijek za lijek Blitzima je MabThera.
English: For more information about treatment with Blitzima, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Blitzima pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: Other information about Blitzima
Croatian: Ostale informacije o lijeku Blitzima
English: Thus, all these data were considered sufficient to conclude that Blitzima will behave in the same way in terms of effectiveness as MabThera in its approved indications.
Croatian: Svi ti podatci stoga se smatraju dovoljnim za donošenje zaključka da će lijek Blitzima za odobrene indikacije djelovati na isti način kao i lijek MabThera u pogledu učinkovitosti.
English: In addition, Blitzima has been compared with MabThera given into a vein in a main study involving 372 patients with active rheumatoid arthritis (an inflammatory disease).
Croatian: Nadalje, lijek Blitzima uspoređen je s lijekom MabThera primjenom u venu u glavnom ispitivanju u kojem su sudjelovale 372 osobe koje boluju od reumatoidnog artritisa (upalna bolest).
English: Blitzima can only be obtained with a prescription.
Croatian: Blitzima se izdaje samo na liječnički recept.
English: Blitzima rituximab
Croatian: Blitzima rituksimab
English: Laboratory studies comparing Blitzima with MabThera have shown that the active substance in Blitzima is highly similar to that in MabThera in terms of structure, purity and biological activity.
Croatian: Laboratorijska ispitivanja u kojem su uspoređivani lijekovi Blitzima i MabThera pokazala su da je djelatna tvar u lijeku Blitzima vrlo slična djelatnoj tvari u lijeku MabThera u pogledu strukture, čistoće i biološke aktivnosti.
English: What benefits of Blitzima have been shown in studies?
Croatian: Koje su koristi od lijeka Blitzima utvrđene u ispitivanjima?
English: • follicular lymphoma and diffuse large B cell non-Hodgkin's lymphoma (two types of non-Hodgkin's lymphoma, a blood cancer);
Croatian: • folikularnog limfoma i difuznog ne-Hodgkinovog limfoma velikih B-stanica (dva oblika ne
English: Patients are also to receive an alert card to carry at all times, instructing them to contact their doctor immediately if they have any of the listed symptoms of infection.
Croatian: Bolesnici će primiti i karticu s upozorenjima koju uvijek trebaju nositi sa sobom i na kojoj piše da se u slučaju navedenih simptoma upale odmah obrate liječniku.
English: For practical information about using Blitzima, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Blitzima bolesnici trebaju pročitati u uputi o lijeku, odnosno trebaju se obratiti svojem liječniku ili ljekarniku.
English: Studies have also shown that giving Blitzima produces similar levels of the active substance in the body to giving MabThera.
Croatian: Ispitivanja su pokazala i da primjena lijeka Blitzima dovodi do slične razine djelatne tvari u tijelu kao i primjena lijeka MabThera.
English: How is Blitzima used?
Croatian: Kako se Blitzima koristi?
English: Blitzima contains the active substance rituximab.
Croatian: Blitzima sadrži djelatnu tvar rituksimab.
English: In addition, a study comparing Blitzima to MabThera in patients with rheumatoid arthritis (which can support its use in other inflammatory disorders such as GPA and MPA) showed that both medicines are similarly effective, and a supportive study in follicular lymphoma showed effectiveness in cancer.
Croatian: Nadalje, ispitivanje u kojem su uspoređeni lijekovi Blitzima i MabThera u bolesnika s reumatoidnim artritisom (što podržava njihovu primjenu kod drugih upalnih poremećaja kao što su GPA i MPA) pokazalo je da je djelotvornost oba lijeka slična.
English: For the full list of side effects reported with Blitzima, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Blitzima potražite u uputi o lijeku.
English: How does Blitzima work?
Croatian: Kako djeluje Blitzima?
English: Further evidence came from supportive studies, including one involving 121 patients with advanced follicular lymphoma, where adding Blitzima to chemotherapy medicines was at least as effective as adding Rituxan, the US version of MabThera.
Croatian: Pokazalo se da je dodavanje lijeka Blitzima lijekovima za kemoterapiju barem jednako djelotvorno kao dodavanje lijeka Rituxan, američke verzije lijeka MabThera.
English: The local reactions disappear completely within approximately 5 weeks after vaccination.
Croatian: Lokalne reakcije potpuno nestaju unutar približno 5 tjedana nakon cijepljenja.
English: ATCvet code: QI09AA07
Croatian: ATCvet kod: QI09AA07
English: In individual pigs this temperature may increase up to 2 °C.
Croatian: U pojedinih svinja ova temperatura može se povećati do 2°C.
English: No data available.
Croatian: Nisu dostupni podaci.
English: Detailed information on this 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 (EMEA) (http://www.ema.europa.eu/).
English: If pain persists for more than 12 hours after medical examination, seek medical advice again.
Croatian: Ako bol potraje više od 12 sati nakon liječničkog pregleda, ponovo potražite pomoć liječnika
English: A biphasic pattern of the local reactions, consisting of an increase and decrease followed by another increase and decrease of the size, is commonly observed.
Croatian: Često se opaža bifazični obrazac lokalnih reakcija, koji se sastoji od povećanja i smanjenja koje prati drugo povećanje i smanjenje veličine.
English: Shelf-life of the veterinary medical product as packaged for sale: 2 years.
Croatian: Rok valjanosti veterinarsko-medicinskog proizvoda kad je zapakiran za prodaju: 2 godine.
English: Moreover, a transient increase in body temperature on the day of vaccination of about 0.2 °C is common.
Croatian: Štoviše, uobičajeno je prolazno povećanje tjelesne temperature na dan cijepljenja od oko 0,2°C.
English: Homogenous, white to nearly white emulsion after shaking.
Croatian: Homogena, bijela do gotovo bijela emulzija nakon protresanja.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/015/187/001-004
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/015/187/001-004
English: The animals return to normal within 1-2 days after the peak temperature is observed.
Croatian: Temperatura se vraća na normalne vrijednosti unutar 1-2 dana nakon uočene vršne vrijednosti temperature.
English: Duration of immunity: 23 weeks after vaccination.
Croatian: Trajanje imuniteta: 23 tjedna nakon cijepljenja.
English: 10 ml 20 ml 10 x 10 ml 10 x 20 ml
Croatian: 10 x 10 ml 10 x 20 ml
English: Cardboard box with 1 or 10 glass vials.
Croatian: Kartonska kutija s 1 ili 10 staklenih bočica.
English: In addition, to reduce loss of daily weight gain and mortality associated with PCV2 infection.
Croatian: Nadalje, da se smanji gubitak dnevnog prirasta i mortaliteta koji su povezani s PCV2 infekcijom.
English: Before use allow the vaccine to reach room temperature.
Croatian: Prije primjene pustite da se cjepivo dosegne sobnu temperaturu.
English: Avoid multiple broaching.
Croatian: Izbjegavajte probijanje više puta.
English: Transient local reactions mostly consisting of hard non-painful swellings of a diameter of up to 2 cm are very common.
Croatian: Vrlo su česte prolazne lokalne reakcije koje se uglavnom sastoje od tvrdih, bezbolnih oteklina promjera do 2 cm.
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 kakve nuspojave, čak i one koje nisu opisane u uputi o VMP ili mislite da je proizvod nedjelotvoran, molimo da se javite veterinaru.
English: Name and address of the manufacturer of the biological active substance
Croatian: Naziv i adresa proizvođača biološki djelatnih tvari
English: In the event that the crust is rubbed off, some small skin damage may be commonly observed.
Croatian: U slučaju da se krasta otrgne često su uočena manja oštećenja kože.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED DD/MM/YYYY
Croatian: 14. DATUM KADA JE UPUTA O VMP ZADNJI PUTA ODOBRENA DD/MM/GGGG
English: 8.3 mg Antigenic units as determined in the in vitro potency test (antigenic mass assay).
Croatian: 8,3 mg Antigenske jedinice kao što je određeno u in vitro ispitivanju potentnosti (analiza antigenske mase).
English: The product literature of Porcilis M Hyo ID ONCE should be consulted.
Croatian: Treba pregledati podatke o proizvodu Porcilis M Hyo ID ONCE.
English: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals 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: - 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 na 10.000 tretiranih životinja) - vrlo rijetke (manje od 1 životinje na 10.000 tretiranih životinja, uključujući izolirane slučajeve)
English: Cardboard box with 1 or 10 PET vials.
Croatian: Kartonska kutija s 1 ili 10 PET bočica.
English: Onset of immunity: 2 weeks after vaccination.
Croatian: Početak imuniteta: 2 tjedna nakon cijepljenja.
English: 1Antigenic units as determined in the in vitro antigenic mass assay.
Croatian: 1Antigenske jedinice kao što je određeno u in vitro ispitivanju antigene mase.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS Each dose of 0.2 ml contains:
Croatian: NAVOĐENJE DJELATNE(IH) TVARI I DRUGIH SASTOJAKA Svaka doza od 0,2 ml sadrži:
English: Shelf-life after first opening the vial: 8 hours.
Croatian: Rok valjanosti poslije prvog otvaranja bočice: 8 sati.
English: Once broached use within 8 hours.
Croatian: EXP Jednom otvoren, upotrijebiti unutar 8 sati.
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 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 na 10.000 tretiranih životinja) - vrlo rijetke (manje od 1 životinje na 10.000 tretiranih životinja, uključujući izolirane slučajeve).
English: dl-α-tocopheryl acetate
Croatian: dl-α- tokoferil acetat
English: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Croatian: Wim de Körverstraat 35 5831 AN Boxmeer NIZOZEMSKA
English: If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you.
Croatian: Ukoliko ste nehotično injicirani ovim veterinarsko-medicinskim proizvodom, potražite hitnu medicinsku pomoć čak ako je injicirana vrlo mala količina i sa sobom ponesite uputu o VMP.
English: Porcine circovirus type 2 ORF2 subunit antigen
Croatian: Cirkovirus svinja tip 2, ORF2 subjedinični antigen
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation:
Croatian: Datum prvog odobrenja:
English: Light liquid paraffin
Croatian: Lagani tekući parafin
English: The product stimulates the development of active immunity against porcine circovirus type 2 in pigs.
Croatian: Proizvod stimulira razvoj aktivnog imuniteta protiv cirkovirusa svinja tipa 2.
English: Adjuvants: dl-α-tocopheryl acetate
Croatian: Adjuvansi: dl-α-tokoferil acetat
English: Pharmacotherapeutic group: immunologicals for Suidae, inactivated viral vaccines for pigs.
Croatian: Farmakoterapijska grupa: imunološki pripravak za svinje, inaktivirano virusno cjepivo za svinje.
English: For intradermal use.
Croatian: Za intradermalnu primjenu.
English: In individual pigs the size may increase to 4 cm and redness may be observed.
Croatian: U pojedinih svinja veličina se može povećati na 4 cm i može doći do crvenila.
English: In the case both vaccines are used on the same day the size of the local reactions may increase up to 6 cm in individual pigs and may last 7 weeks and are very commonly accompanied by redness and crusts..
Croatian: U slučaju primjene oba cjepiva na isti dan, veličina lokalnih reakcija može se povećati do 6 cm u pojedinih svinja i može trajati 7 tjedana, a često su praćene crvenilom i krastom.
English: Simethicone
Croatian: Simetikon
English: Safety and efficacy of Porcilis PCV ID have been demonstrated using the device IDAL.
Croatian: Neškodljivost i djelotvornost Porcilisa PCV ID dokazana je primjenom aplikatora IDAL®.
English: PET (polyethylene terephthalate) vial of 20 ml closed with a nitryl-based rubber stopper and sealed with an aluminium cap.
Croatian: PET (polietilen tereftalat) bočica od 20 ml, zatvorena nitrilnim gumenim čepom i zabrtvljena aluminijskim poklopcem.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 0.2 ml contains:
Croatian: Svaka doza od 0,2 ml sadrži:
English: For the active immunisation of pigs to reduce viraemia, virus load in lungs and lymphoid tissues and virus shedding caused by PCV2 infection.
Croatian: Za aktivnu imunizaciju tovnih svinja u svrhu smanjivanja viremije, količine virusa u plućima i limfoidnim tkivima te otpuštanja virusa uzrokovano PCV2 infekcijom.
English: Even if small amounts have been administered, accidental administration with this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit.
Croatian: U slučaju nehotičnog injiciranja ovim proizvodom, čak ako je injicirana i vrlo mala količina, ona može prouzročiti intenzivno oticanje, koje, na primjer može rezultirati ishemičnom nekrozom i čak gubitkom prsta.
English: SPECIAL WARNING(S) Special precautions for use in animals Not applicable.
Croatian: 12. POSEBNO(A) UPOZORENJE(A) Posebne mjere opreza prilikom primjene na životinjama
English: Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the administration area, especially where there is involvement of finger pulp or tendon.
Croatian: HITNO je potreban, stručni kirurški pregled koji može zahtijevati preventivnu inciziju i ispiranje injiciranog područja, napose u području jagodice prsta ili tetiva.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intradermal use
Croatian: NAČIN I PUT(EVI) PRIMJENE
English: Vaccination scheme: Vaccinate once from an age of 3 weeks onwards.
Croatian: Cijepite jedanput u dobi od 3 tjedna na dalje.
English: Safety and efficacy data are available which demonstrate that this vaccine can be given with Porcilis M Hyo ID ONCE on the same day from 3 weeks of age, either at different sites (e.g. alternate sides of the neck), or at the same site providing that intradermal administration of each vaccine is separated by at least 3 cm.
Croatian: Porcilis M Hyo ID ONCE isti dan u dobi od 3 tjedna starosti, bilo na različita mjesta aplikacije (različita mjesta na vratu) ili isti dan na isto mjesto, primjenjujući intradermalno svako cjepivo s razmakom od 3 cm.
English: Intradermal administration of 0.2 ml per animal, preferably at the sides of the neck, along the muscles of the back or in the hind leg using a multi-dose needle-free injection device for intradermal application of liquids suitable to deliver a “jet-stream” volume of vaccine (0.2ml ± 10%) through the epidermal layers of the skin.
Croatian: Intradermalna primjena 0,2 ml po životinji, najbolje sa strane vrata, duž mišića leđa ili stražnje noge koristeći višedozni pribor za intradermalnu aplikaciju s odgovarajućom tekućinom za davanje
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis PCV ID
Croatian: Porcilis PCV ID
English: PACKAGE LEAFLET: Porcilis PCV ID emulsion for injection for pigs
Croatian: UPUTA O VMP: Porcilis PCV ID emulzija za injekciju, za svinje
English: PCV2 ORF2 subunit antigen ≥1436 AU
Croatian: Jedna doza od (0,2) ml sadrži: PCV2 ORF2 subjedinični antigen ≥1436 AU
English: Glass vial (type I) of 10 ml closed with a nitryl-based rubber stopper and sealed with an aluminium cap.
Croatian: 6.5 Osobine i sastav unutarnjeg pakovanja Staklena bočica (tip I) od 10 ml, zatvorena nitrilnim gumenim čepom i zabrtvljena aluminijskim poklopcem.
English: OTHER INFORMATION The vaccine stimulates active immunity against porcine circovirus type 2
Croatian: Cjepivo stimulira razvoj aktivnog imuniteta protiv cirkovirusa svinja tipa 2.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis PCV ID emulsion for injection for pigs
Croatian: Porcilis PCV ID emulzija za injekciju, za svinje
English: 4.2 Indications for use, specifying the target species For the active immunisation of fattening pigs to reduce viraemia, virus load in lungs and lymphoid tissues and virus shedding caused by PCV2 infection.
Croatian: INDIKACIJE Za aktivnu imunizaciju svinja za smanjenje viremije, količine virusa u plućima i limfoidnim tkivima te otpuštanja virusa uzrokovano PCV2 infekcijom.
English: WITHDRAWAL PERIOD(S) Zero days.
Croatian: Karencija: nula dana.
English: Pack size:
Croatian: Veličine pakovanja:
English: 4.5 Special precautions for use
Croatian: 4.5 Posebne mjere predostrožnosti za primjenu Posebne mjere opreza prilikom primjene na životinjama
English: Sodium chloride Potassium chloride Disodium phosphate dehydrate Potassium dihydrogen phosphate dl-α-tocopheryl acetate Light liquid paraffin Water for injections
Croatian: Natrijev klorid Kalijev klorid Dinatrijev fosfat dihidrat
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIALS OF 10 AND 20 ML
Croatian: OSNOVNI PODACI KOJI SE MORAJU NALAZITI NA MALIM UNUTARNJIM PAKOVANJIMA
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Intervet International B.V.5831 AN Boxmeer
Croatian: Wim de Korverstraat 35 5831 AN Boxmeer
English: TARGET SPECIES Pigs (for fattening)
Croatian: CILJNE VRSTE ŽIVOTINJA
English: (picture 2)
Croatian: (slika 2)