FrancophonIA/ELRC3.0 huggingface dataset:
English: Because the number of patients with Hunter syndrome is low, the disease is considered ‘rare', and Elaprase was designated an ‘orphan medicine' (a medicine used in rare diseases) on 11 December
Croatian: Budući da je broj bolesnika s Hunterovim sindromom nizak, dotična se bolest smatra „rijetkom” te se Elaprase označava kao lijek za liječenje rijetkih bolesti od 11. prosinca 2001.
English: Patients with Hunter syndrome do not produce an enzyme called iduronate-2-sulfatase.
Croatian: Bolesnici s Hunterovim sindromom ne proizvode enzim iduronat-2-sulfatazu.
English: Elaprase treatment should be supervised by a doctor or other healthcare professional who has experience in the management of patients with Hunter syndrome or other inherited diseases affecting the metabolism.
Croatian: Liječenje lijekom Elaprase mora nadzirati liječnik ili drugi zdravstveni radnik s iskustvom u liječenju bolesnika oboljelih od Hunterova sindroma ili drugih nasljednih metaboličkih bolesti.
English: The Committee decided that Elaprase's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Odbor je odlučio da koristi od lijeka Elaprase nadmašuju s njime povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: The company that markets Elaprase will investigate the long-term effects of the medicine, particularly on the lungs, the heart and the blood vessels, and whether the body produces antibodies that could affect the medicine's safety and effectiveness.
Croatian: Tvrtka koja lijek Elaprase stavlja u promet istražit će dugoročne učinke lijeka, napose na pluća, srce i krvne žile, te proizvodi li tijelo protutijela koja bi mogla utjecati na sigurnu i učinkovitu primjenu lijeka.
English: This enzyme is needed to break down substances in the body called glycosaminoglycans (GAGs).
Croatian: Taj je enzim potreban za razgradnju tvari u tijelu naziva glikosaminoglikani (GAG).
English: Elaprase must not be used in people who have had a severe or life-threatening allergic (anaphylactic) reaction to idursulfase or any of the other ingredients if their allergy is not controllable.
Croatian: Elaprase se ne smije primjenjivati u bolesnika koji su u prošlosti imali teške ili po život opasne alergijske (anafilaktičke) reakcije na idursulfazu ili bilo koji drugi sastojak ako njihovu alergiju nije moguće kontrolirati.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Elaprase have 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 Elaprase nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: If given to patients who have had severe allergic reactions in the past, Elaprase should be used with caution, and trained staff and equipment for emergency resuscitation should be available during infusion.
Croatian: Ako se lijek Elaprase daje bolesnicima koji su u prošlosti imali teške alergijske reakcije, treba ga davati oprezno, a tijekom infuzije mora biti dostupno stručno medicinsko osoblje i oprema za oživljavanje.
English: What is the risk associated with Elaprase?
Croatian: Koji su rizici povezani s lijekom Elaprase?
English: The most common side effects with Elaprase are related to the infusion, including skin reactions (rash or itching), fever, headache, high blood pressure and flushing.
Croatian: Najčešće nuspojave lijeka Elaprase povezane su s infuzijom, a obuhvaćaju kožne reakcije (osip ili svrbež), groznicu, glavobolju, visoki krvni tlak i crvenilo.
English: It replaces the enzyme that is missing or defective in patients with Hunter syndrome.
Croatian: Ona zamjenjuje enzim koji u bolesnika s Hunterovim sindromom nedostaje ili je oštećen.
English: Other side effects seen in more than 1 patient in 10 are wheezing, dyspnoea (difficulty breathing), abdominal pain (stomach ache), nausea (feeling sick), dyspepsia (heartburn), diarrhoea, vomiting, swelling at the site of infusion and chest pain.
Croatian: Ostale nuspojave zabilježene u više od 1 na 10 osoba jesu piskanje, dispneja (otežano disanje), abdominalna bol (bol u trbuhu), mučnina (slabost), dispepsija (žgaravica), proljev, povraćanje, oticanje na mjestu infuzije i bol u prsima.
English: Patients who tolerate the infusions well for several months in a clinic may be able to start having them at home. Home infusions should be supervised by a doctor or nurse.
Croatian: Bolesnici koji dobro podnose infuzije tijekom nekoliko mjeseci u klinici, mogu ih početi dobivati kod kuće.
English: The active substance in Elaprase, idursulfase, is a copy of the human enzyme iduronate-2-sulfatase.
Croatian: Djelatna tvar u lijeku Elaprase, idursulfaza, kopija je humanog enzima iduronat-2-sulfataze.
English: What information is still awaited for Elaprase?
Croatian: Koje se još informacije očekuju o lijeku Elaprase?
English: Elaprase idursulfase
Croatian: Elaprase idursulfaza
English: Elaprase is a medicine that contains the active substance idursulfase.
Croatian: Elaprase je lijek koji sadrži djelatnu tvar idursulfazu.
English: Why has Elaprase been approved?
Croatian: Zašto je lijek Elaprase odobren?
English: The medicine also produced an improvement in lung function, while the patients on placebo showed a slight worsening.
Croatian: Lijekom je također poboljšana funkcija pluća, a u bolesnika koji su primali placebo zabilježeno je blago pogoršanje.
English: What is Elaprase?
Croatian: Što je Elaprase?
English: What is Elaprase used for?
Croatian: Za što se Elaprase koristi?
English: For the full list of all side effects reported with Elaprase, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Elaprase potražite u uputi o lijeku.
English: How is Elaprase used?
Croatian: Kako se Elaprase koristi?
English: What benefit has Elaprase shown during the studies?
Croatian: Koje su koristi lijeka Elaprase utvrđene u ispitivanjima?
English: Severe allergic reactions have occurred in some patients taking Elaprase.
Croatian: U nekih bolesnika koji su primali lijek Elaprase pojavile su se teške alergijske reakcije.
English: How does Elaprase work?
Croatian: Kako djeluje Elaprase?
English: How has Elaprase been studied?
Croatian: Kako je lijek Elaprase ispitivan?
English: Overdose (symptoms, emergency procedures, antidotes), if necessary
Croatian: Predoziranje (simptomi, hitni postupci, antidoti), ako je nužno
English: Each dose of 2 ml contains:
Croatian: Svaka doza od 2 ml sadrži:
English: Carbomer 971 P NF
Croatian: Karbomer 971 P NF
English: DATE OF FIRST AUTHORISATION
Croatian: DATUM PRVOG ODOBRENJA
English: Sodium chloride solution (0.9 %)
Croatian: Otopina natrijevog klorida (0,9 %)
English: After administration of a double dose (4 ml), no adverse reactions other than those described in section 4.6 were observed.
Croatian: Nakon primjene dvostruke doze (4 ml), nisu primijećeni nikakvi neželjeni učinci osim onih već spomenutih u odjeljku 4.6.
English: 06861 Dessau-Rosslau Germany
Croatian: 06861 Dessau-Rosslau
English: Store in a refrigerator (2 ºC − 8 ºC).
Croatian: Čuvati u hladnjaku (2ºC - 8ºC).
English: Primary vaccination: see above
Croatian: Prvo cijepljenje: vidi gore
English: 7 days after primary vaccination
Croatian: 7 dana nakon prvog cijepljenja
English: Keep the vial in the outer carton in order to protect from light.
Croatian: Čuvati bočicu u vanjskom pakovanju radi zaštite od svjetla.
English: Generally, maternallyderived antibodies induced by vaccination last for approx. 5-8 weeks after birth.
Croatian: Općenito, maternalna protutijela inducirana cijepljenjem traju približno 5-8 tjedana nakon rođenja.
English: QI09AA03
Croatian: ATC vet kod: QI09AA03
English: PROHIBITION OF SALE; SUPPLY AND/OR USE
Croatian: ZABRANA PRODAJE; OPSKRBE I/ILI PRIMJENE
English: IDT Biologika GmbH Am Pharmapark 06861 Dessau-Rosslau Germany
Croatian: IDT Biologika GmbH Am Pharmapark 06861 Dessau-Rosslau Njemačka
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 navedene u odjeljku 6.1 su dopuštene tvari za koje je u tablici 1. Dodatka Uredbe Komisije (EU) br. 37/2010 naznačeno da se za njih ne zahtijeva određivanje DNK (MRL) ili nisu obuhvaćene odredbama Uredbe (EZ)br. 470/2009, kada se koriste u ovom veterinarskom medicinskom proizvodu.
English: Medicines should not be disposed of via wastewater or household waste.
Croatian: Lijekovi se ne smiju odlagati u otvorene vode ili kućni otpad.
English: In case of accidental self-injection only a minor injection site reaction is expected.
Croatian: U slučaju nehotičnog samoinjiciranja, očekuje se samo manja reakcija na mjestu uboda.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label and carton after EXP.
Croatian: Ne koristiti ovaj veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na naljepnici i kutiji, poslije oznake EXP.
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with the local requirements.
Croatian: Bilo koji neupotrebljeni veterinarsko-medicinski proizvod ili otpadni materijali dobiveni primjenom tih veterinarsko-medicinskih proizvoda mora se odlagati u skladu s lokalnim propisima.
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Croatian: Djelatna tvar je biološkog podrijetla namijenjena za poticanje aktivne imunosti na koju se ne primjenjuju odredbe Uredbe (EZ)br. 470/2009.
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 su dostupne na web stranici Europske agencije za lijekove http://www.ema.europa.eu/
English: It induces neutralizing and haemagglutination inhibiting antibodies against each of the three subtypes.
Croatian: Inducira stvaranje neutralizirajućih protutijela i protutijela koja sprječavaju hemaglutinaciju protiv svakog od tri podtipa.
English: Marketing authorisation holder: MERIAL
Croatian: Nositelj odobrenja za stavljanje u promet: MERIAL
English: In the latter case piglets should be vaccinated after the age of 96 days.
Croatian: U drugom slučaju prasad treba cijepiti nakon 96 dana starosti.
English: Clear, yellowish orange to pink colored suspension for injection.
Croatian: Bistra, žuto narančasta do ružičasta suspenzija za injekcije.
English: If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.
Croatian: Ako zamijetite ozbiljne nuspojave ili druge nuspojave koje nisu opisane u uputi o VMP, molimo da se javite veterinaru.
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 su dostupne na web stranici Europske agencije za lijekove (EMA) http://www.ema.europa.eu/.
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 UVETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE, ako je primjenjivo
English: Manufacturer responsible for batch release: IDT Biologika GmbH Am Pharmapark
Croatian: Nositelj odobrenja za puštanje proizvodne serije: IDT Biologika GmbH
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: EXP {month/year} Once opened, use within 10 hours.
Croatian: ROK VALJANOSTI EXP {mjesec/godina} Jednom otvoreno, primijeniti u roku 10 sati.
English: Package sizes:
Croatian: Veličine pakovanja:
English: or - Between the age of 56 and 96 days, with an interval of 3 weeks between injections to achieve duration of immunity over 4 months.
Croatian: Ili: - Između 56 i 96 dana starosti, u razmaku od 3 tjedna između injekcija za postizanje imuniteta u trajanju dužem od 4 mjeseca.
English: Pigs
Croatian: Svinje.
English: A booster is possible at each stage of pregnancy and lactation.
Croatian: Poticajna injekcija (booster) moguća je u svakom stadiju graviditeta i laktacije.
English: Duration of immunity: 4 months in pigs vaccinated between the age of 56 and 96 days and 6 months in pigs vaccinated for the first time at 96 days and above.
Croatian: Trajanje imuniteta: 4 mjeseca kod svinja cijepljenih u dobi između 56 i 96 dana i 6 mjeseci kod svinja cijepljenih prvi puta u dobi od 96 dana i starijih.
English: DD/MM/YYYY
Croatian: D.D.MM.YYYY
English: On very rare occasions, a slight transient rectal temperature increase might occur after vaccination (“very rare” corresponds to a frequency of adverse reactions less than 1 animal in 10,000 animals, including isolated reports).
Croatian: U vrlo rijetkim slučajevima nakon cijepljenja može doći do malog povišenja rektalne temperature (¨vrlo rijetko¨ odgovara učestalosti nuspojava manjoj od 1 životinje na 10.000, uključujući izolirane slučajeve).
English: Shelf-life after first opening the container: 10 hours.
Croatian: Rok valjanosti poslije prvog otvaranja spremnika: 10 sati.
English: Immunologicals, Inactivated viral vaccines
Croatian: cjepiva, inaktivirano virusno cjepivo
English: Special warnings for the target species
Croatian: Posebna upozorenja za svaku od ciljnih vrsta životinja
English: Pregnancy and lactation: The vaccine can be used during pregnancy and lactation.
Croatian: Graviditet i laktacija: Može se primijeniti tijekom graviditeta i laktacije.
English: Maternally-derived immunity in the piglets interacts with antibody induction.
Croatian: Maternalna imunost u prasadi utječe na indukciju protutijela.
English: Adverse reactions (frequency and seriousness)
Croatian: 4.6. Nuspojave (učestalost i ozbiljnost)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box for 20ml, 50 ml, 100 ml
Croatian: PODACI NA VANJSKOM PAKOVANJU Kartonska kutija za 20 ml, 50 ml, 100 ml
English: For intramuscular use.
Croatian: Za intramuskularnu primjenu.
English: Active immunisation of pigs from the age of 56 days onwards including pregnant sows against swine influenza caused by subtypes H1N1, H3N2 and H1N2 to reduce clinical signs and viral lung load after infection.
Croatian: Aktivna imunizacija svinja starijih od 56 dana, uključujući i gravidne krmače, protiv influence svinja uzrokovane podtipovima H1N1, H3N2 i H1N2 za smanjenje kliničkih znakova i prisutnosti virusa u plućima nakon infekcije.
English: The vaccine stimulates an active immunity against Swine Influenza A virus subtypes H1N1, H3N2 and H1N2.
Croatian: Cjepivo stimulira aktivni imunitet na virus influence svinja A, podtipove H1N1, H3N2 i H1N2.
English: Gilts and sows:
Croatian: Nazimice i krmače:
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial of 20 ml and 50 ml
Croatian: OSNOVNI PODACI NAPISANI NA MALIM JEDINICAMA UNUTARNJIH PAKOVANJA Bočica od 20 ml i 50 ml
English: Gripovac 3 Suspension for injection for pigs
Croatian: UPUTA O VMP Gripovac 3 Injekcijska suspenzija za svinje
English: Onset of immunity:
Croatian: Početak imuniteta:
English: Indication for use, specifying the target species
Croatian: 4.2. Indikacije za primjenu, navesti ciljne vrste životinja
English: Pharmacotherapeutic group:
Croatian: IMUNOLOŠKA SVOJSTVA Farmakoterapijska grupa:
English: In particular cases of multiple contacts of the sows with antigens (field infections + vaccination) the antibodies transmitted to the piglets may last until week 12 of life.
Croatian: U određenim slučajevima višekratnog kontakta krmača s antigenima (prirodna infekcija + cijepljenje) protutijela koja se prenose na prasad mogu trajati do starosti od 12 tjedana.
English: GMNU = Geometric mean of neutralizing units induced in Guinea pigs after twice immunisation with 0.5 ml of this vaccine.
Croatian: GMNU = Geometrijska sredina neutralizirajućih jedinica inducirana kod zamorčadi nakon dvokratne imunizacije s 0,5 ml ovog cjepiva
English: When vaccination is performed 14 days prior to farrowing with one dose (2 ml), it provides maternally-derived immunity to the piglets which protects them from clinical signs of influenza at least until day 33 after birth.
Croatian: Kada se cijepljenje provodi 14 dana prije prasenja s jednom dozom (2 ml), prasad stječe maternalnu imunost koja štiti od kliničkih znakova influence, najmanje 33 dana po rođenju.
English: Active immunisation of pregnant sows after finished primary immunisation by administration of a single dose 14 days prior to farrowing to develop high colostral immunity which provides clinical protection of piglets for at least 33 days after birth.
Croatian: Aktivna imunizacija gravidnih krmača po završetku primarne imunizacije, primjenom jedne doze 14 dana prije prasenja za postizanje visokog kolostralnog imuniteta što prasadi osigurava kliničku zaštitu još najmanje 33 dana nakon rođenja.
English: Zero days
Croatian: Nula dana.
English: Store in a refrigerator.
Croatian: 11. POSEBNI UVIJETI ČUVANJA Čuvati u hladnjaku
English: Bromobutyl rubber stoppers
Croatian: Čepovi: čepovi od bromobutilne gume.
English: FRANCE
Croatian: Francuska
English: France
Croatian: FRANCUSKA
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Croatian: NAVOĐENJE DJELATNIH I DRUGIH TVARI
English: Strains of inactivated Influenza A virus/swine/ Bakum/IDT1769/2003 (H3N2) ≥ 10.53 log2 GMNU, Haselünne/IDT2617/2003(H1N1) ≥ 10.22 log2 GMNU, Bakum/1832/2000 (H1N2) ≥ 12.34 log2 GMNU
Croatian: A /svinja/ Bakum/IDT1769/2003 (H3N2) ≥ 10.53 log2 GMNU*, Haselünne/IDT2617/2003(H1N1) ≥ 10.22 log2 GMNU*, Bakum/1832/2000 (H1N2) ≥ 12.34 log2 GMNU*
English: Use during pregnancy,lactation or lay
Croatian: Primjena tijekom graviditeta laktacije ili nesenja
English: On very rare occasions, a slight transient rectal temperature increase might occur after vaccination.
Croatian: Ponekad, u vrlo rijetkim slučajevima nakon cijepljenja može doći do malog povišenja rektalne temperature.
English: When a single dose of the vaccine is administered 14 days prior to farrowing as a booster to previously vaccinated sows, the vaccine stimulates active immunity in order to provide maternally-derived immunity to the progeny against Swine Influenza A virus subtypes H1N1, H3N2 and H1N2.
Croatian: Kada se cijepljenje provodi 14 dana prije prasenja kao docjepljivanje prethodno cijepljenih krmača, cjepivo potiče aktivni imunitet kako bi se postigla maternalna imunost na virus influence svinja A, podtipove H1N1, H3N2 i H1N2.
English: Strains of inactivated Influenza A virus/swine (H3N2) ≥ 10.53 log2 GMNU, (H1N1) ≥ 10.22 log2 GMNU, (H1N2) ≥ 12.34 log2 GMNU
Croatian: A /svinja (H3N2) ≥ 10,53 log2 GMNU, (H1N1) ≥ 10,22 log2 GMNU, (H1N2) ≥ 12,34 log2 GMNU
English: B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY AND USE
Croatian: UVIJETI ILI OGRANIČENJA ODOBRENJA ZA STAVLJANJE U PROMET U POGLEDU OPSKRBE I PRIMJENE
English: Special precautions for use in animals
Croatian: Posebne mjere opreza za primjenu na životinjama
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Croatian: UVIJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE
English: Suspension for injection
Croatian: OBLIK Suspenzija za injekcije.
English: Incompatibilities: Do not mix with any other medicinal product.
Croatian: Ne miješati ni s jednim drugim medicinskim proizvodom.
English: Special precautions for the disposal of unused veterinary medicinals product or waste materials derived from the use of such products
Croatian: Posebne mjere opreza za odlaganje neupotrebljenog veterinarsko-medicinskog proizvoda ili otpadnih materijala dobivenih primjenom tih proizvoda
English: A transient slight swelling may occur on very rare occasions after vaccination at the site of injection, regressing within 2 days.
Croatian: Nakon cijepljenja se u vrlo rijetkim slučajevima može na mjestu uboda javiti prolazni mali otok koji se povlači za 2 dana.
English: Withdrawal period: zero days
Croatian: KARENCIJA Karencija: nula dana
English: 20 ml (10 doses), 50 ml (25 doses), 100 ml (50 doses)
Croatian: VELIČINA PAKOVANJA 20 ml (10 doza), 50 ml (25 doza), 100 ml (50 doza)
English: 100 ml (50 doses)
Croatian: 50 ml (25 doza).
English: Strains of inactivated Influenza A virus/swine/ Bakum/IDT1769/2003 (H3N2)
Croatian: A /svinja/ Bakum/IDT1769/2003 (H3N2)
English: Amounts to be administered and administration route
Croatian: Količine koje se primjenjuju i način primjene
English: ≥ 12.34 log2 GMNU GMNU = Geometric mean of neutralizing units induced in Guinea pigs after twice immunisation with 0.5 ml of this vaccine
Croatian: ≥ 12,34 log2 GMNU GMNU = Geometrijska sredina neutralizirajućih jedinica inducirana kod zamorčadi nakon dvokratne imunizacije s 0,5 ml ovog cjepiva Adjuvans: Karbomer 971 P NF
English: Date of first authorisation: 14/01/2010 Date of last renewal : DD/MM/YYYY
Croatian: Datum zadnje obnove odobrenja: DD.MM.YYYY
English: For animal treatment only.To be supplied only on veterinary prescription.
Croatian: Izdaje se samo na veterinarski recept.
English: Gripovac 3 suspension for injection for pigs
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Gripovac 3 injekcijska suspenzija za svinje.
English: Disposal: read package leaflet
Croatian: Odlaganje: pročitati uputu o VMP .
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Vial of 100 ml
Croatian: PODACI NA UNUTARNJEM PAKOVANJU Bočica od 100 ml
English: Contraindications
Croatian: INDIKACIJE
English: Veterinary medicinal product subject to prescription
Croatian: Veterinarsko-medicinski proizvod koji se izdaje na recept.
English: Special precautions for storage
Croatian: Posebne mjere opreza za čuvanje
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
Croatian: SADRŽAJ: TEŽINA, VOLUMEN IL BROJ DOZA 20 ml (10 doza),
English: List of excipients
Croatian: I SAŽETAK OPISA SVOJSTAVA
English: STATEMENT OF ACTIVE SUBSTANCES
Croatian: Popis pomoćnih tvari
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) BIOLOŠKI DJELATNE(IH) TVARI I PROIZVOĐAČ ODGOVORAN(I) ZA PUŠTANJE SERIJE U PROMET
English: Target species
Croatian: 4.1. Ciljne vrste životinja
English: Name and address of the manufacturer(s) responsible for batch release
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije u promet
English: Caps:
Croatian: Prasad:
English: IM Read the package leaflet before use.
Croatian: POSEBNA UPOZORENJA, UKOLIKO JE POTREBNO Pročitati uputu o VMP prije primjene.
English: Cardboard box with 1 glass or PET vial of 10 doses (20 ml), 25 doses (50 ml) or 50 doses (100 ml) with a rubber stopper and flanged cap.
Croatian: Kartonska kutija s 1 staklenom bočicom od 10 doza (20 ml), 25 doza (50 ml) ili 50 doza (100 ml) s gumenim čepom i rubnim zatvaračem.
English: Glass vials: 20 ml vials, glass type I 50 ml vials, glass type II 100 ml vials, glass type II
Croatian: 50 ml bočice, staklo tip II,