FrancophonIA/ELRC3.0 huggingface dataset:
English: Hyrimoz can only be obtained by prescription and treatment must be started and supervised by a doctor who has experience in the treatment of the diseases for which Hyrimoz is used.
Croatian: Hyrimoz se izdaje samo na liječnički recept, a liječenje mora započeti i nadzirati liječnik s iskustvom u liječenju bolesti za koje se Hyrimoz koristi.
English: How does Hyrimoz work?
Croatian: Kako djeluje Hyrimoz?
English: Therefore, the Agency's view was that, as for Humira, the benefits of Hyrimoz outweigh the identified risks and it can be authorised.
Croatian: Stoga je stav Agencije da korist kod lijeka Hyrimoz, kao i kod lijeka Humira, nadmašuje identificirane rizike te da lijek može biti odobren.
English: Eye specialists treating uveitis should also take advice from doctors who have experience of using Hyrimoz.
Croatian: Očni specijalisti koji liječe uveitis trebali bi također poslušati savjete liječnika s iskustvom u primjeni lijeka Hyrimoz.
English: TNF is involved in causing inflammation and is found at high levels in patients with the diseases that Hyrimoz is used to treat.
Croatian: TNF je uključen u nastajanje upale i pronađen je u velikim koncentracijama u bolesnika s bolestima koje se liječe lijekom Hyrimoz.
English: Laboratory studies comparing Hyrimoz with Humira have shown that the active substance in Hyrimoz is highly similar to that in Humira in terms of structure, purity and biological activity.
Croatian: Laboratorijska ispitivanja u kojima su uspoređivani lijekovi Hyrimoz i Humira pokazala su da je djelatna tvar u lijeku Hyrimoz vrlo slična djelatnoj tvari u lijeku Humira u pogledu strukture, čistoće i biološke aktivnosti.
English: For more information about using Hyrimoz, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Hyrimoz pogledajte uputu o lijeku ili se obratite liječniku ili ljekarniku.
English: All these data were considered sufficient to conclude that Hyrimoz will behave in the same way as Humira in terms of effectiveness and safety in its approved uses.
Croatian: Svi ti podatci smatraju se dovoljnima za donošenje zaključka da će lijek Hyrimoz za odobrene indikacije djelovati na isti način kao lijek Humira u pogledu djelotvornosti i sigurnosti.
English: What benefits of Hyrimoz have been shown in studies?
Croatian: Koje su koristi lijeka Hyrimoz dokazane u ispitivanjima?
English: Studies have also shown that giving Hyrimoz produces similar levels of the active substance in the body to giving Humira.
Croatian: Ispitivanja su dokazala i da primjena lijeka Hyrimoz dovodi do slične razine djelatne tvari u tijelu kao i primjena lijeka Humira.
English: For the full list of side effects and restrictions with Hyrimoz, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja pri primjeni lijeka Hyrimoz potražite u uputi o lijeku.
English: In addition Hyrimoz was as effective as Humira in a study involving 465 patients with moderate or severe plaque psoriasis.
Croatian: Osim toga, u ispitivanju u kojem je sudjelovalo 465 bolesnika s umjerenom do teškom plak psorijazom, lijek Hyrimoz bio je jednako djelotvoran kao lijek Humira.
English: • ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut);
Croatian: • ulceroznog kolitisa (bolesti koja uzrokuje upalu i čireve na stijenci želuca);
English: How is Hyrimoz used?
Croatian: Kako se Hyrimoz koristi?
English: These are rare and an appropriate symptomatic treatment should be administered.
Croatian: One su rijetke i potrebno je primijeniti odgovarajuće simptomatsko liječenje.
English: Date of last renewal: 23/03/2010
Croatian: Datum posljednje obnove: 23/03/2010
English: Subcutaneous use - SC
Croatian: Subkutana primjena - SC
English: A hypersensitivity reaction may occur.
Croatian: Može se javiti reakcija preosjetljivosti.
English: Two injections 21 days apart.
Croatian: dvije injekcije u razmaku od 21 dan.
English: Onset of immunity: 14 days Duration of immunity: 6 months.
Croatian: Početak imuniteta: 14 dana Trajanje imuniteta: 6 mjeseci.
English: a) the administration of the product to animals will interfere with the implementation of national programmes 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 veterinarsko-medicinskog proizvoda na životinjama interferirati s provedbom nacionalnog programa otkrivanja, kontrole ili eradikacije bolesti životinja ili će prouzročiti poteškoće u certificiranju odsutnosti zaraze u živim životinjama ili hrani ili drugim proizvodima dobivenim od tretiranih životinja.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/99/017/001-006
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/99/017/001-006
English: The excipients, including adjuvants, listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Croatian: Pomoćne tvari, uključujući adjuvanse, navedene u dijelu 6.1 SPC su ili dozvoljene tvari za koje je u tablici 1, Dodatka Uredbe Komisije (EU) br. 37/2010 navedeno da određivanje MRL nije nužno, ili se smatra da se na njih ne primjenjuju odredbe Uredbe (EK) br. 470/2009 kada se primjenjuju u tim veterinarsko medicinskim proizvodima.
English: Allow the vaccine to reach a temperature of 15°C-25°C.
Croatian: Neka cjepivo postigne temperaturu od 15°C - 25°C.
English: EXPIRY DATE EXP {month/year} Once broached use by: 6 hours
Croatian: ROK VALJANOSTI EXP {mjesec/godina} Jednom načeto, upotrijebiti u roku: 6 sati
English: Shelf life of the veterinary medicinal product as packaged for sale: 18 months Shelf life after first opening the immediate packaging: 6 hours
Croatian: Rok valjanosti veterinarsko-medicinskog proizvoda kad je zapakiran za prodaju: 18 mjeseci Rok valjanosti nakon prvog otvaranja unutarnjeg pakiranja: 6 sati
English: 25 doses (50 ml)
Croatian: 25 doza (50 ml)
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Croatian: Sukladno članku 71 Direktive 2001/82/EV i Europskog Parlamenta i Vijeća koja je dopunjena, države članice u skladu sa nacionalnim propisima mogu zabraniti proizvodnju, uvoz, posjedovanje, prodaju, opskrbu i/ili primjenu imunološkog veterinarsko-medicinskog proizvoda na cijelom teritoriju ili na jednom njenom dijelu ako je utvrđeno da:
English: Cattle
Croatian: Govedo
English: Use sterile syringes and needles.
Croatian: Upotrijebite sterilne štrcaljke i igle.
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) 470/2009.
Croatian: Djelatna tvar koja se sastoji od tvari biološkog podrijetla, namijenjene za stvaranje aktivne imunosti na koje se ne primjenjuju odredbe Uredbe (EK) br. 470/2009.
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/YYYY}
English: The vaccination may cause a slight rise in body temperature (less than 1°C) for a transient period (less than 48 hours after injection) without any consequence to the health or performance of the animal.
Croatian: Cijepljenje može prouzročiti mali porast tjelesne temperature (manje od 1 °C) u prolaznom razdoblju (manje od 48 sati nakon injekcije) bez ikakvih posljedica po zdravlje ili proizvodnu sposobnost životinje.
English: EU/2/99/017/001 5 doses (10 ml) EU/2/99/017/004 10 x 5 doses (10 x 10 ml) EU/2/99/017/002 10 doses (20 ml) EU/2/99/017/005 10 x 10 doses (10 x 20 ml) EU/2/99/017/003 25 doses (50 ml) EU/2/99/017/006 10 x 25 doses (10 x 50 ml)
Croatian: EU/2/99/017/001 5 doza (10 ml) EU/2/99/017/004 10 x 5 doza (10 x 10 ml) EU/2/99/017/002 10 doza (20 ml) EU/2/99/017/005 10 x 10 doza (10 x 20 ml) EU/2/99/017/003 25 doza (50 ml) EU/2/99/017/006 10 x 25 doza (10 x 50 ml)
English: Bovalto Ibraxion can be used during pregnancy and lactation.
Croatian: Bovalto Ibraxion se može primijeniti tijekom graviditeta i dojenja.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 5 doses (10 ml)
Croatian: SADRŽAJ, TEŽINA, VOLUMEN IL BROJ DOZA 5 doza (10 ml)
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 insert with you.
Croatian: Ukoliko ste nehotično injicirani ovim proizvodom, potražite hitnu medicinsku pomoć čak ako je injicirana vrlo mala količina, a sa sobom ponesite uputu o VMP.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 5 doses (10 ml)
Croatian: OSNOVNI PODACI NAPISANI NA MALIM JEDINICAMA UNUTARNJIH PAKOVANJA 5 doza (10 ml)
English: Pharmacotherapeutic group: Immunologicals, bovine rhinotracheitis virus (IBR) ATCvet code: QI02AA03
Croatian: Farmaceutska grupa: Imunološki preparat, virus zaraznog rinotraheitisa goveda (ZRG) ATCvet kod: QI02AA03
English: For use in animals from the age of 2 weeks in the absence of maternally derived antibodies against IBR virus or from the age of 3 months in the presence of maternally derived antibodies.
Croatian: Za primjenu na životinjama starijim od 2 tjedna kod odsutnosti maternalnih protutijela na IBR virus ili starijim od 3 mjeseca uz prisutnost maternalnih protutijela.
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 dobivenih primjenom tih veterinarsko-medicinskih proizvoda moraju se odlagati u skladu s lokalnim propisima.
English: The presence of maternally derived antibodies against infectious bovine rhinotracheitis virus may interfere with the vaccination and requires an appropriate vaccination regimen.
Croatian: Prisutnost maternalnih protutijela protiv virusa zaraznog rinotraheitisa goveda može utjecati na djelotvornost cijepljenja te zahtijeva odgovarajući program cijepljenja.
English: The injection of the vaccine may cause a transient tissue reaction at the site of injection, which may persist for three weeks and rarely up to five weeks.
Croatian: Injiciranje cjepiva može prouzročiti prolaznu kožnu reakciju na mjestu uboda, koja može potrajati do tri tjedna, a rijetko do pet tjedana.
English: 5 doses (10 ml) 10 x 5 doses (10 x 10 ml) 10 doses (20 ml) 10 x 10 doses (10 x 20 ml) 25 doses (50 ml) 10 x 25 doses (10 x 50 ml)
Croatian: 5 doza (10 ml) 10 x 5 doza (10 x 10 ml) 10 doza (20 ml) 10 x 10 doza (10 x 20 ml) 25 doza (50 ml) 10 x 25 doza (10 x 50 ml)
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals ) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Croatian: Učestalost nuspojava je određena sukladno sljedećim pravilima: - vrlo česte (više od 1 na 10 životinja pokazuju nuspojavu(e) za vrijeme trajanja tretmana) - česte (više od 1 ali manje od 10 životinja na 100 životinja) - manje česte (više od 1 ali manje od 10 životinja na 1.000 životinja) - rijetke (više od 1 ali manje od 10 životinja na 10.000 životinja) - vrlo rijetke (manje od 1 životinje na 10.000 životinja, uključujući izolirane slučajeve).
English: Administer one dose (2 ml) by subcutaneous injection in the neck (at the front of the shoulder), according to the following regimen:
Croatian: Primijenite dozu (2 ml), supkutanom injekcijom u području vrata (s prednje strane ramena), prema sljedećem rasporedu:
English: Bovalto Ibraxion can therefore be used as a marker vaccine in association with an appropriate diagnostic test.
Croatian: Bovalto Ibraxion se, uz odgovarajući dijagnostički test, stoga može primijeniti kao marker cjepivo.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 09/03/2000
Croatian: Datum prvog odobrenja: 09/03/2000
English: The gE gene deletion allows differentiation between animals vaccinated with gE-negative vaccines (anti gE antibody negative, IBR vironeutralising antibody positive) and naturally infected animals (positive to both IBR vironeutralising antibody and anti gE antibody).
Croatian: Delecija gE gena omogućava diferencijaciju između životinja cijepljenih gE-negativnim cjepivom (protu gE protutijelo negativno, IBR vironeutralizirajuće protutijelo pozitivno) i prirodno zaraženih životinja (pozitivne na IBR vironeutralizirajuće antitijelo i na protu gE protutijelo).
English: Shake well prior to use.
Croatian: Prije primjene dobro protresti.
English: PHARMACEUTICAL FORM Emulsion for injection
Croatian: Emulzija za injekciju.
English: Type I glass bottles with a Nitrile elastomer closure and sealed with an aluminium cap Cardboard box with 1 or 10 bottles of 5 doses (1 x 10 ml or 10 x 10 ml) Cardboard box with 1 or 10 bottles of 10 doses (1 x 20 ml or 10 x 20 ml) Cardboard box with 1 or 10 bottles of 25 doses (1 x 50 ml or 10 x 50 ml)
Croatian: Tip I staklena bočica s čepom od nitrilnog elastomera i zapečaćeno aluminijskom kapicom Kartonska kutija koja sadrži 1 ili 10 bočica sa po 5 doza (1 x10 ml ili 10 x10 ml) Kartonska kutija koja sadrži 1 ili 10 bočica sa po 10 doza (1 x 20 ml ili 10 x 20 ml) Kartonska kutija koja sadrži 1 ili 10 bočica sa po 25 doza (1 x 50 ml ili 10 x 50 ml)
English: No undesirable effects other than those mentioned in section 4.6 have been observed after the administration of an overdose.
Croatian: Nakon primjene prevelike doze nisu primijećeni nikakvi neželjeni učinci osim onih već spomenutih u odjeljku 4.6.
English: Store and transport refrigerated (2°C- 8°C), Do not freeze.
Croatian: Čuvati i prevoziti rashlađeno (2 °C - 8 °C), Čuvati od zamrzavanja.
English: Accidental injection/self injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given.
Croatian: Nehotična injekcija/ samoinjiciranje može prouzročiti jaku bol i otjecanje, naročito ako se injicira u zglob prsta, a u rijetkim slučajevima može rezultirati gubitkom zahvaćenog prsta ukoliko nije pružena hitna medicinska pomoć.
English: STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
Croatian: NAVOĐENJE DJELATNIH I DRUGIH TVARI
English: Disposal: read package leaflet.
Croatian: Zbrinjavanje: pročitati uputu
English: Active immunisation of cattle to reduce the clinical signs of infectious bovine rhinotracheitis (IBR) and field virus excretion.
Croatian: Aktivna imunizacija goveda za smanjenje kliničkih znakova zaraznog rinotraheitisa goveda (ZRG) i izlučivanja virusa u okoliš.
English: Polyoxyethylene oleate Polyoxyethylene oleic alcohol Potassium chloride, Sodium chloride, Potassium dihydrogen phosphate, Disodium phosphate dihydrate, Magnesium chloride, Calcium chloride
Croatian: Kalijev dihidrogenfosfat, Dinatrij-fosfat dihidrat, Magnezijev klorid,
English: Laboratoire Porte des Alpes Rue de l'Aviation-69800 Saint Priest France
Croatian: Rue de l'Aviation-69800 SAINT PRIEST FRANCUSKA
English: Laboratoire Porte des Alpes Rue de l'Aviation-69800 Saint Priest FRANCE
Croatian: Rue de l'Aviation-69800 Saint Priest Francuska
English: The manufacture, import, possession, sale, supply and/or use of Bovalto Ibraxion may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Croatian: Proizvodnja, uvoz, posjedovanje, prodaja, opskrba i/ili primjena Bovalto Ibraxion-a može biti zabranjena u državi članici na cijelom teritoriju ili na jednom njenom dijelu sukladno nacionalnim odredbama.
English: Bovalto Ibraxion is a gene specific deleted (gE), inactivated and adjuvanted (o/w emulsion) vaccine which acts by the active immunisation of cattle characterised by the production of Infectious Bovine Rhinotracheitis (IBR) vironeutralising antibodies.
Croatian: Bovalto Ibraxion je cjepivo koje ima deleciju specifičnog gena (gE), inaktivirano i adjuventirano (o/v emulzija) koje aktivno imunizira govedo tako da stvara vironeutralizirajuća protutijela protiv zaraznog rinotraheitisa goveda (IBR).
English: Light paraffin oil Benzyl alcohol
Croatian: Lako parafinsko ulje
English: Shake well prior to use.Allow the vaccine to reach a temperature of 15 -25ºC.
Croatian: Neka cjepivo postigne temperaturu od 15 - 25 °C.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) For 1 dose of 2 ml: gE deleted inactivated IBR virus, at least ................................................ 0.75 VN.U
Croatian: Za 1 dozu od 2 ml: gE deletirani inaktivirani ZRG virus, najmanje .................................... 0,75 VN.U*
English: The import, possession, sale, supply and/or use of this veterinary medicinal product may be prohibited in a Member State on the whole or part of its territory, see package leaflet for further information.
Croatian: Uvoz, posjedovanje, prodaja, opskrba i/ili primjena ovog veterinarsko-medicinskog proizvoda može biti zabranjena u državi članici na njenom teritoriju ili na jednom njenom dijelu, pročitati uputu o
English: PACKAGE LEAFLET FOR Bovalto Ibraxion emulsion for injection
Croatian: UPUTA O VMP ZA Bovalto Ibraxion emulzija za injekciju
English: No undesirable effects other than those mentioned in the “Adverse reactions” section have been observed after the administration of an overdose.
Croatian: Nakon primjene prevelike doze nisu primijećeni nikakvi neželjeni učinci osim onih već spomenutih u odjeljku “Nuspojave”.
English: SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
Croatian: 12. SPECIFIČNE MJERE PREDOSTROŽNOSTI ZA ODLAGANJE NEUPOTREBLJENIH PROIZVODA ILI OTPADNIH MATERIJALA, AKO IH IMA
English: a booster injection should be administered at 6 month intervals.
Croatian: docijepiti treba u razmacima od 6 mjeseci.
English: Any person intending to manufacture, import, possess, sell, supply and/or use Bovalto Ibraxion must consult the relevant Member State's competent authority on the current vaccination policies prior to the manufacture, import, possession,sale, supply and/or use.
Croatian: Tko namjerava proizvoditi, uvesti, posjedovati, prodavati, opskrbljivati i/ili primjenjivati Bovalto Ibraxion mora konzultirati nadležno tijelo odnosne države članice u pogledu važećih odredbi o cijepljenju prije proizvodnje, uvoza, posjedovanja, prodaje, opskrbe i/ili primjene.
English: Manufacturer responsible for batch release MERIAL
Croatian: Proizvođač odgovoran za puštanje proizvodne serije: MERIAL
English: Even if small amounts have been injected, accidental injection 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 gubitkom prsta.
English: Shelf life after first opening the container: 6 hours Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Croatian: Ne primjenjivati ovaj veterinarsko medicinski proizvod poslije isteka roka valjanosti naznačenog na etiketi, nakon EXP.
English: SPECIAL WARNING(S), IF NECESSARY Accidental injection is dangerous.
Croatian: Nehotično injiciranje je opasno.
English: ADVICE ON CORRECT ADMINISTRATION See above.
Croatian: SAVJETI ZA ISPRAVNU PRIMJENU
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Croatian: Posebna mjere opreza za osobu koja primijenjuje veterinarsko medicinski proizvod na životinji: Korisniku:
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURRER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) BIOLOŠKI DJELATNE(IH) TVARI I PROIZVOĐAČ ODGOVORAN(I) ZA PUŠTANJE SERIJE U PROMET
English: Triethanolamine
Croatian: KARENCIJA
English: Marketing authorisation holder MERIAL
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE U PROMET MERIAL
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES For 1 dose of 2 ml: .gE deleted inactivated IBR virus, at least ............................................................................ 0.75 VN.U* .light paraffin oil ......................................................................................................... 449.6 to 488.2 mg * VN.U: Vironeutralising antibody titre after vaccine injection in guinea pigs
Croatian: gE deletirani inaktivirani ZRG virus, najmanje .................................................................... 0,75 VN.U* adjuvans: lako parafinsko ulje ..................................................................................... 449,6 do 488,2 mg
English: MERIAL,Laboratoire Lyon Gerland 254, Avenue Marcel Mérieux-69007 Lyon FRANCE
Croatian: 254, Avenue Marcel Mérieux-69007 LYON
English: 4.5 Special precautions for use
Croatian: 6.4 Posebne mjere opreza za čuvanje
English: Type I glass bottles with a Nitrile elastomer closure and sealed with an aluminium cap Cardboard box with 1 or 10 bottles of 5 doses Cardboard box with 1 or 10 bottles of 10 doses Cardboard box with 1 or 10 bottles of 25 doses
Croatian: Kartonska kutija koja sadrži 1 ili 10 bočica sa po 25 doza.
English: Special precautions for use in animals
Croatian: Posebna mjere opreza za primjenu kod životinja:
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Croatian: 15. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET MERIAL
English: Revaccination:
Croatian: Inkopatibilnost:
English: 29 avenue Tony Garnier 69007 LYON France
Croatian: 29 avenue Tony Garnier 69007 LYON FRANCUSKA
English: 29 avenue Tony Garnier 69007 LYON FRANCE
Croatian: 29 avenue Tony Garnier 69007 LYON Francuska
English: WITHDRAWAL PERIOD Withdrawal period: Zero days
Croatian: KARENCIJA Karencija: Nula dana
English: 29 avenue Tony Garnier -69007 Lyon France
Croatian: 29 avenue Tony Garnier-69007 LYON Francuska
English: CLINICAL PARTICULARS
Croatian: Kalcijev klorid
English: Each dose of 2 ml contains: gE deleted inactivated IBR virus, at least ............................................................................. 0.75 VN.U* * VN.U: Vironeutralising antibody titre after vaccine injection in guinea pigs.
Croatian: Svaka doza od 2 ml sadrži: gE deletirani inaktivirani ZRG virus, najmanje .................................................................... 0,75 VN.U*
English: Adjuvant light paraffin oil .......................................................................................................... 449.6 to 488.2 mg
Croatian: Adjuvans lako parafinsko ulje ..................................................................................................... 449,6 do 488,2 mg
English: Active substance
Croatian: Djelatna tvar
English: This summary was last updated in 01-2015.
Croatian: Ovaj sažetak je posljednji put ažuriran u 01. 2015.
English: Rixubis nonacog gamma
Croatian: Rixubis nonakog gama
English: Other information about Rixubis
Croatian: Ostale informacije o lijeku Rixubis
English: The full EPAR and risk management plan summary for Rixubis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Rixubis nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.