FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Equisolon on 12/03/2014.
Croatian: Europska komisija dodijelila je odobrenje za stavljanje u promet koje je na snazi na teritoriju Europske unije za proizvod Equisolon dana 12/03/2014.
English: The product should not be shaken to prevent dust formation.
Croatian: Proizvod se ne smije tresti kako bi se spriječilo formiranje prašine.
English: If you need more information about your animal's medical condition or treatment, contact your veterinarian.
Croatian: Ako vam je potrebno više informacija o zdravstvenom stanju ili liječenju vaše životinje, obratite se svom veterinaru.
English: What are the precautions for the person who gives the medicine or comes into contact with the animal?
Croatian: Koje su mjere opreza za osobu koja primjenjuje veterinarsko-medicinski proizvod ili dolazi u kontakt sa životinjom?
English: If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).
Croatian: Ako želite više informacija na temelju preporuka Odbora za veterinarsko-medicinske proizvode (CVMP), pročitajte znanstvenu raspravu (također dio EPAR-a).
English: Other information about Equisolon:
Croatian: Druge informacije o VMP-u Equisolon:
English: Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.
Croatian: Cilj mu je objasniti kako procjena, koju Odbor za veterinarsko-medicinske proizvode (CVMP) provodi na temelju zaprimljene dokumentacije, dovodi do preporuka o uvjetima korištenja.
English: This decreases inflammation, thereby helping to keep the airways clear and allowing the horse to breathe more easily.
Croatian: Time se smanjuje upala, što pomaže pri održavanju zračnih putova čistima i omogućuje se konjima da lakše dišu.
English: The medicine should not be given to horses by pregnant women as there is a risk of malformation to the unborn baby.
Croatian: Trudnice ne smiju davati VMP konjima budući da postoji rizik od malformacija nerođenog djeteta.
English: This results in inflammation and blockage of the airways inside the lungs, leading to difficulty in breathing.
Croatian: Ovo rezultira upalom i blokadom zračnih putova unutar pluća, što uzrokuje poteškoće pri disanju.
English: A field study was conducted in which the same 8 horses with RAO after exposure to hay participated in 4 treatment periods receiving either no treatment or Equisolon at three different doses, each for ten days.
Croatian: Provedeno je terensko ispitivanje u kojem je 8 istih konja oboljelih od RAO-a nakon izlaganja sjenu sudjelovalo u 4 razdoblja liječenja tijekom kojih nisu primali terapiju ili su primali Equisolon u tri različite doze, i to svaku dozu tijekom deset dana.
English: RAO is a chronic (long-term) allergic condition in which horses wheeze, cough and have difficulty in breathing.
Croatian: RAO je kronično (dugoročno) alergično stanje pri kojem konji dašću, kašlju i imaju poteškoća s disanjem.
English: The use of prednisolone in horses with RAO has been well described in the scientific literature.
Croatian: Primjena prednizolona u konja oboljelih od RAO-a dobro je opisana u znanstvenoj literaturi.
English: Equisolon should be mixed with a small amount of food and given by mouth at a dose of 1 mg prednisolone per kg bodyweight once a day.
Croatian: Equisolon treba miješati s malom količinom hrane i primjenjuje se peroralno u dozi od 1 mg prednizolon po kg tjelesne težine jednom na dan.
English: In horses with RAO, the immune system (the body's natural defences) over-reacts to triggering substances (antigens) that are present in dust that the horse breathes in.
Croatian: U konja oboljelih od RAO-a, imunosni sustav (prirodna obrana tijela) prekomjerno reagira na aktivirajuće tvari (antigene) koje su prisutne u prašini koju konji udišu.
English: Treatment with prednisolone at the recommended dose of 1 mg per kg bodyweight over ten days in combination with environmental control resulted in significant improvements in fluid in the airways and clinical signs associated with RAO.
Croatian: Liječenje prednizolonom u preporučenoj dozi od 1 mg po kg tjelesne težine tijekom deset dana u kombinaciji s kontrolom okruženja rezultiralo je značajnim poboljšanjima u tekućini u zračnim putovima i kliničkim znakovima povezanima s RAO-om.
English: What is the withdrawal period?
Croatian: Što je razdoblje karencije?
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Equisolon exceed the risks for the approved indication and recommended that Equisolon be given a marketing authorisation.
Croatian: Odbor za veterinarsko-medicinske proizvode (CVMP) zaključio je da koristi od VMP-a Equisolon nadmašuju rizike za odobrene indikacije te je preporučio izdavanje odobrenja za stavljanje VMP-a u promet za VMP Equisolon.
English: It is available as a powder to be given by mouth.
Croatian: Dostupan je kao prašak koji se daje peroralno.
English: Information on the prescription status of this product may be found on the label/outer package.
Croatian: Informacije o tome je li za ovaj proizvod potreban veterinarski recept možete naći na etiketi/vanjskom dijelu pakiranja.
English: Equisolon is a veterinary medicine that contains the active substance prednisolone.
Croatian: Equisolon je veterinarsko-medicinski proizvod koji sadrži djelatnu tvar prednizolon.
English: The most common side effects (seen in more than 1 in 10 horses) with Equisolon are suppression of production of cortisol (a natural corticosteroid important in the body's response to stress), and an increase in the level of triglycerides (a type of fat) in the blood.
Croatian: Najčešće nuspojave (uočene u više od 1 na 10 konja) VMP-a Equisolon su supresija stvaranja kortizola (prirodnog kortikosteroida važnog pri odgovoru tijela na stres) i povišenje u razinama triglicerida (vrste masti) u krvi.
English: Equisolon must not be used in horses with viral or fungal infections, gastrointestinal or corneal ulcers or in pregnant mares.
Croatian: Equisolon se ne smije primjenjivati u konja s virusnim ili gljivičnim infekcijama, gastrointestinalnim čirevima ili ulkusom rožnice, odnosno u gravidnih kobila.
English: The environmental measures include keeping horses outside as much as possible or improving the ventilation in the stable, soaking hay or feeding silage (fermented grass) and using bedding with a minimum of dust in the stable.
Croatian: Mjere kontrole okruženja uključuju držanje konja vani što je više moguće ili poboljšavanje odzračivanja u staji, namakanje sjena ili hranjenje silažom (fermentirana trava) i korištenje stelje s minimalnom količinom prašine u staji.
English: The active substance in Equisolon, prednisolone, is a corticosteroid, a medicine that acts to reduce the activity of the immune system.
Croatian: Djelatna tvar u VMP-u Equisolon, prednizolon, je kortikosteroid, VMP koji djeluje tako što smanjuje aktivnost imunosnog sustava.
English: This document is a summary of the European Public Assessment Report.
Croatian: Ovaj dokument je sažetak Europskoga javnog izvješća o procjeni veterinarsko-medicinskog proizvoda.
English: Equisolon should not be used in mares producing milk for human consumption.
Croatian: Equisolon se ne smije primjenjivati u kobila koje proizvode mlijeko za uporabu u prehrani ljudi.
English: The main measures of effectiveness were clinical signs of RAO disease as well as the amount of fluid and immune cells in the airways and the air pressure in the lungs.
Croatian: Djelotvornose se mjerila na temelju kliničkih znakova RAO bolesti kao i količine tekućine i imunosnih stanica u zračnim putovima te tlaka zraka u plućima.
English: The benefit-risk balance may be found in the scientific discussion module of this EPAR.
Croatian: Omjer koristi i rizika nalazi se u modulu znanstvene rasprave ovog EPAR-a.
English: Prednisolone
Croatian: Prednizolon
English: Why has Equisolon been approved?
Croatian: Zašto je Equisolon odobren?
English: What is Equisolon?
Croatian: Što je Equisolon?
English: What is the risk associated with Equisolon?
Croatian: Koji su rizici povezani s VMP-om Equisolon?
English: It is also the time allowed after administration of the medicine before milk can be used for human consumption.
Croatian: To je također razdoblje koje treba proći od primjene VMP-a prije nego što se mlijeko može koristiti u prehrani ljudi.
English: The withdrawal period for Equisolon for meat is ten days.
Croatian: Karencija za meso u slučaju primjene VMP-a Equisolon iznosi deset dana.
English: In addition to treatment with prednisolone, the exposure to organic dust was reduced by substituting hay with silage and by improving the ventilation in the stable.
Croatian: Uz liječenje prednizolonom, izlaganje organskoj prašini smanjeno je zamjenom sjena sa silažom, te se tako poboljšala ventilacija u staji.
English: Equisolon is used to treat recurrent airway obstruction (RAO or heaves) in horses in combination with environmental measures.
Croatian: Equisolon se koristi za liječenje rekurentne opstrukcije dišnih putova (RAO ili plućna bolest) u konja u kombinaciji s mjerama kontrole okruženja.
English: For a full list of all side effects reported with Equisolon, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih s VMP-om Equisolon dostupan je u uputi o VMP-u.
English: What is Equisolon used for?
Croatian: Za što se Equisolon koristi?
English: What benefit has Equisolon shown during the studies?
Croatian: Koje su koristi VMP-a Equisolon utvrđene tijekom ispitivanja?
English: The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat used for human consumption.
Croatian: Razdoblje karencije je razdoblje koje treba proći od primjene VMP-a do klanja životinje i uporabe mesa u prehrani ljudi.
English: How does Equisolon work?
Croatian: Na koji način Equisolon djeluje?
English: How has Equisolon been studied?
Croatian: Kako je Equisolon ispitivan?
English: EPAR summary for the public
Croatian: Sažetak Europskoga javnog izvješća o procjeni (EPAR)
English: Protect from light.
Croatian: Zaštiti od svjetla.
English: ATCvet code: QI07AB01.
Croatian: ATCvet kod: QI07AB01.
English: However, these reactions may be more severe and/or last longer.
Croatian: Ipak, ove reakcije mogu biti izraženije i/ili trajati dulje.
English: If such reactions occur appropriate treatment is recommended.
Croatian: Ako primijete navedene reakcije preporuča se odgovarajući tretman.
English: Date of last renewal: 13/03/2017.
Croatian: Datum zadnje obnove: 13/03/2017.
English: Can be used during pregnancy.
Croatian: Može se primijeniti tijekom graviditeta.
English: These measures should help to protect the environment.
Croatian: Ove mjere pomažu u zaštiti okoliša.
English: Duration of immunity: 1 year.
Croatian: Trajanje imunosti: 1 godina.
English: Avoid accidental self-injection or contact with the eyes.
Croatian: Izbjegavati slučajno samoinjiciranje ili kontakt s očima.
English: Ask your veterinary surgeon how to dispose of medicines no longer required.
Croatian: Upitajte svojeg veterinara kako zbrinuti lijekove koji vam više nisu potrebni.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
Croatian: SADRŽAJ: TEŽINA, VOLUMEN ILI BROJ DOZA
English: Not all pack sizes may be marketed.
Croatian: Ne moraju sve veličine pakovanja biti u prometu.
English: Interaction with other medicinal products and other forms of interaction:
Croatian: Interakcija s drugim medicinskim proizvodima i drugi oblici interakcije:
English: 6.2 Major incompatibilities
Croatian: 6.2 Glavne inkompatibilnosti
English: None.
Croatian: Nema.
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator.
Croatian: 11. POSEBNI UVJETI ČUVANJA Čuvati u hladnjaku.
English: 1 Antigenic mass ELISA units.
Croatian: 1 Antigena masa ELISA jedinice.
English: Do not mix with any other veterinary medicinal product except those mentioned in section 4.8.
Croatian: Ne miješati s bilo kojim drugim veterinarsko-medicinskim proizvodima osim onih navedenih u odjeljku 4.8.
English: Thiomersal
Croatian: Tiomersal
English: Onset of immunity: 3 weeks.
Croatian: Početak imunosti: 3 tjedna.
English: 4.7 Use during pregnancy, lactation or lay
Croatian: 4.7 Primjena tijekom graviditeta, laktacije ili nesenja
English: 4.8 Interaction with other medicinal products and other forms of interaction
Croatian: 4.8 Interakcije s drugim medicinskim proizvodima i drugi oblici interakcija
English: Colourless suspension.
Croatian: Bezbojna suspenzija.
English: Shelf life of the veterinary medicinal product as packaged for sale: 21 months.
Croatian: Rok valjanosti veterinarsko-medicinskog proizvoda kad je zapakiran za prodaju:21 mjesec.
English: IMMUNOLOGICAL PROPERTIES
Croatian: IMUNOLOŠKA SVOJSTVA
English: C. STATEMENT OF THE MRLs Not applicable.
Croatian: C. IZVJEŠĆE O MRL Nije primjenjivo.
English: Dogs.
Croatian: Psi.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16/07/2012.
Croatian: Datum prvog odobrenja: 16/07/2012.
English: The CVMP at their meeting on 17-19 January 2017 decided that one further five-year renewal was required in view of the outstanding pharmacovigilance concerns regarding serious adverse events that were undergoing evaluation at the time of the renewal procedure.
Croatian: Na sastanku CVMP, od 17 - 19 siječnja 2017., odlučeno je da je potrebno jedno dodatno produljenje zbog neriješenih pitanja farmakovigilancije, vezanih uz ozbiljne nuspojave koje su bile u tijeku procjene, u vrijeme produljenja odobrenja.
English: Detailed information on this veterinary medicinal 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: Water for injections
Croatian: Voda za injekcije
English: Store in a refrigerator (2 °C - 8 °C).
Croatian: Čuvati u hladnjaku (2 °C - 8 °C).
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 nuspojave, čak i one koje nisu opisane u priloženoj uputi ili mislite da proizvod nije djelotvoran , molimo javite se veterinaru.
English: Such reactions may evolve to a more severe condition (anaphylaxis), which may be life-threatening.
Croatian: Takve reakcije mogu se pojaviti kao prolazna akutna reakcija preosjetljivosti koja može evoluirati u ozbiljnije stanje (anafilaksu) te može biti životno ugrožavajuća.
English: Name and address of the manufacturer of the biological active substances
Croatian: Naziv i adresa proizvođača biološki djelatnih tvari
English: Any such swelling will either have disappeared or be clearly diminished by 14 days post-vaccination.
Croatian: Oteklina će se znatno smanjiti ili će sasvim nestati do 14 dana poslije cijepljenja.
English: In case of ocular irritation seek medical advice immediately and show the package leaflet or the label to the physician.
Croatian: U slučaju iritacije očiju odmah potražite liječničku pomoć i pokažite liječniku uputu ili naljepnicu koja se nalazi u pakiranju.
English: 5 x 1 ml (1 dose) 10 x 1 ml (1 dose) 25 x 1 ml (1 dose) 50 x 1 ml (1 dose) 10 ml (10 doses)
Croatian: 5x 1 ml (1 doza) 10x 1 ml (1 doza) 25x 1 ml (1 doza) 50x 1 ml (1 doza)
English: INDICATION(S)
Croatian: INDIKACIJA(E)
English: Pharmacotherapeutic group: Immunologicals for Canidae, inactivated bacterial vaccines.
Croatian: Farmakoterapijska grupa: imunološki pripravak za kanide, inaktivirano bakterijsko cjepivo.
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Croatian: Bilo koji neupotrebljeni veterinarsko-medicinski proizvod ili otpadni materijali dobiveni primjenom tih veterinarsko-medicinskih proizvoda treba odlagati u skladu s lokalnim propisima.
English: Do not freeze.
Croatian: Čuvati od zamrzavanja.
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 prema slijedećim pravilima: - vrlo česte (više od 1 u 10 tretiranih životinja pokazuju nuspojave) - česte (više od jedne ali manje od 10 životinja od 100 tretiranih životinja) - manje česte (više od 1 ali manje od 10 životinja na 1000 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: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the products mentioned above.
Croatian: Ne postoje dostupni podaci o neškodljivosti i djelotvornosti ovog cjepiva kada se primjenjuje s bilo kojim drugim veterinarsko-medicinskim proizvodom osim gore navedenim proizvodima.
English: ANNEX IV GROUNDS FOR ONE ADDITIONAL RENEWAL
Croatian: OSNOVA ZA JEDNO DODATNO PRODULJENJE
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL
Croatian: OSNOVNI PODACI NAPISANI NA MALIM JEDINICAMA UNUTARNJIH PAKOVANJA ETIKETA
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE
Croatian: RIJEČI “SAMO ZA PRIMJENU NA ŽIVOTINJAMA” I UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE, ako je primjenjivo
English: PACKAGE SIZE
Croatian: VELIČINA PAKOVANJA
English: Vaccinate healthy animals only.
Croatian: Cijepiti samo zdrave životinje.
English: THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” Keep out of the sight and reach of children.
Croatian: I POGLEDA DJECE” Čuvati izvan pogleda i dosega djece.
English: TARGET SPECIES
Croatian: CILJNE VRSTE ŽIVOTINJA
English: A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Croatian: Stoga se odluka o primjeni ovog cjepiva prije, odnosno poslije primjene bilo kojeg drugog veterinarsko-medicinskog proizvoda mora donositi od slučaja do slučaja.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Croatian: Posebne mjere predostrožnost koje mora poduzeti osoba koja primjenjuje veterinarsko-medicinski proizvod na životinjama
English: PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable.
Croatian: ZABRANA PRODAJE, OPSKRBE I/ILI PRIMJENE
English: When mixed with these Nobivac vaccines, the demonstrated safety and efficacy claims for Nobivac L4 are no different from those described for Nobivac L4 alone.
Croatian: Kada se primjenjuju pomiješana cjepiva prikazani podaci o neškodljivosti i djelotvornosti Nobivaca L4 nisu različiti od onih navedenih samo za cjepivo Nobivac L4.
English: 4.6 Adverse reactions (frequency and seriousness)
Croatian: 4.6 Nuspojave (učestalost i ozbiljnost)
English: OTHER INFORMATION
Croatian: 15. OSTALE INFORMACIJE
English: Shelf life after first opening the immediate container: 10 hours.
Croatian: Rok valjanosti poslije prvog otvaranja unutarnjeg spremnika: 10 sati.
English: To be supplied only on veterinary prescription.
Croatian: Može se izdavati samo na veterinarski recept.
English: Revaccination: Dogs should be re-vaccinated annually with one dose (1 ml) of vaccine.
Croatian: Revakcinacija: pse treba nadocijepiti svake godine s jednom dozom (1 ml) cjepiva.
English: 6.5 Nature and composition of immediate packaging
Croatian: 6.5 Osobine i sastav unutarnjeg pakovanja
English: In case of high level of maternally derived antibodies, first vaccination is recommended at 9 weeks of age.
Croatian: U slučaju visoke razine maternalnih antitijela, prvo cijepljenje se preporučuje u dobi od 9 tjedana.
English: (*) In case of high level of maternally derived antibodies, first vaccination is recommended at 9 weeks of age.
Croatian: (*) U slučaju visoke razine maternalnih antitijela, prvo cijepljenje se preporučuje u dobi od 9 tjedana.
English: In very rare cases, clinical signs of immune-mediated haemolytic anaemia, immune-mediated thrombocytopenia, or immune-mediated polyarthritis have been reported.
Croatian: U vrlo rijetkim slučajevima prijavljeni su klinički znakovi imunološki posredovane hemolitičke anemije, imunološki posredovane trombocitopenije ili imunološki posredovanog poliartritisa.
English: Before use, ensure that the vaccine is at room temperature (15°C - 25°C).
Croatian: Prije primjene, osigurati da cjepivo postigne sobnu temperaturu (15°C - 25°C).
English: METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous use.
Croatian: NAČIN I PUT(EVI) PRIMJENE Subkutana primjena.
English: Type I glass vial of 1 ml (1 dose) or 10 ml (10 doses) closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap.
Croatian: Staklena bočica tip I, od 1ml (1 doza) ili 10 ml (10 doza) začepljena s halogenbutil gumenim čepom i zapečaćena s označenom aluminijskom kapicom.
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Croatian: DOZIRANJE ZA SVAKU CILJNU VRSTU ŽIVOTINJA, NAČIN I PUT(EVI) PRIMJENE
English: 4.4 Special warnings for each target species
Croatian: 4.4 Posebna upozorenja za svaku ciljnu vrstu životinja
English: 0.1 mg. For the full list of excipients, see section 6.1.
Croatian: Potpuni popis pomoćnih tvari vidi u odjeljku 6.1.
English: EXPIRY DATE EXP {month/year} Once broached, use within 10 hours.
Croatian: EXP {mjesec/godina} Jednom otvoreno, primijeniti unutar 10 sati.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/12/143/001-005
Croatian: EU/2/12/143/001-005
English: CONTRAINDICATIONS
Croatian: KONTRAINDIKACIJE
English: The mixed vaccines should be at room temperature (15°C - 25°C) before they are administered by subcutaneous injection.
Croatian: Pomiješana cjepiva trebaju biti na sobnoj temperaturi (15°C - 25°C) prije subkutane primjene injekcijom.
English: A mild and transient increase in body temperature (≤ 1 °C) has been observed very commonly in clinical studies for a few days after vaccination, with some pups showing less activity and/or a reduced appetite.
Croatian: Prolazno, blago povećanje tjelesne temperature (≤ 1°C) često se pojavljuje nekoliko dana nakon cijepljenja uz smanjenu aktivnost i/ili smanjen apetit kod nekih štenaca.
English: Dogs
Croatian: Psi
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX
Croatian: PODACI NA VANJSKOM PAKOVANJU KUTIJA
English: 4.2 Indications for use, specifying the target species
Croatian: 4.2 Indikacije za primjenu, navesti ciljne vrste životinja
English: The product information of the relevant Nobivac vaccines should be consulted before administration of the mixed product.
Croatian: Informacije o cjepivima Nobivaca treba provjeriti prije primjene pomiješanih proizvoda.
English: Inactivated Leptospira strains: - L. interrogans serogroup Canicola serovar Portland-vere (strain Ca-12-000)
Croatian: Inaktivirani sojevi Leptospira : - L. interrogans, serogrupa Canicola, serovar Portland-vere (soj Ca-12-000)
English: - L. kirschneri serogroup Grippotyphosa serovar Dadas (strain Gr-01-005)
Croatian: - L. kirschneri, serogrupa Grippotyphosa, serovar Dadas (soj Gr-01-005)
English: 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Croatian: 6.6 Posebne mjere predostrožnosti za odlaganje neupotrebljenog veterinarsko-medicinskog proizvoda ili otpadnih materijala dobivenih primjenom tih proizvoda
English: Cardboard box with 1 vial of 10 ml (10 doses).
Croatian: Kartonska kutija s 1 bočicom od 10 ml (10 doza).