FrancophonIA/ELRC3.0 huggingface dataset:
English: INFORMATION IN BRAILLE ZYPREXA VELOTAB 15 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU ZYPREXA VELOTAB 15 mg
English: Eli Lilly Nederland B.V. Tel: + 31(0)30 6025800
Croatian: Tel: + 31(0) 30 6025800
English: Sodium methyl parahydroxybenzoate (E219) Sodium propyl parahydroxybenzoate (E217)
Croatian: 6.1 Popis pomoćnih tvari želatina manitol (E421) aspartam (E951) natrijev metilparahidroksibenzoat (E219) natrijev propilparahidroksibenzoat (E217)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each orodispersible tablet contains 20 mg olanzapine
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna raspadljiva tableta za usta sadrži 20 mg olanzapina.
English: ZYPREXA VELOTAB 20 mg orodispersible tablets
Croatian: ZYPREXA VELOTAB 20 mg raspadljive tablete za usta olanzapin
English: Thromboembolism hypotension10
Croatian: Krvožilni poremećaji ortostatska hipotenzija10
English: INFORMATION IN BRAILLE ZYPREXA VELOTAB 10 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU ZYPREXA VELOTAB 10 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF ZYPREXA VELOTAB 20 mg ORODISPERSIBLE TABLETS
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA SA ZYPREXA VELOTAB 20 mg RASPADLJIVIM TABLETAMA ZA USTA
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ZYPREXA VELOTAB 20 mg ORODISPERSIBLE TABLETS: BLISTER FOIL LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP ZYPREXA VELOTAB 20 mg RASPADLJIVE TABLETE ZA USTA: OZNAČAVANJE NA FOLIJI BLISTERA
English: ZYPREXA VELOTAB 5 mg orodispersible tablets
Croatian: ZYPREXA VELOTAB 5 mg raspadljive tablete za usta olanzapin
English: 14 Observed for fasting normal levels at baseline (< 1.016 mmol/l) which increased to high
Croatian: 14 Uočeno za normalne početne razine triglicerida natašte (< 1,016 mmol/l) koje su porasle na visoke razine (≥ 1,467 mmol/l) i promjene u vrijednosti triglicerida natašte od početnih graničnih vrijednosti
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each orodispersible tablet contains 10 mg olanzapine
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna raspadljiva tableta za usta sadrži 10 mg olanzapina.
English: ZYPREXA VELOTAB 15 mg orodispersible tablets
Croatian: ZYPREXA VELOTAB 15 mg raspadljive tablete za usta olanzapin
English: ZYPREXA VELOTAB 10 mg orodispersible tablets
Croatian: ZYPREXA VELOTAB 10 mg raspadljive tablete za usta olanzapin
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each orodispersible tablet contains 5 mg olanzapine
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna raspadljiva tableta za usta sadrži 5 mg olanzapina.
English: What ZYPREXA VELOTAB is and what it is used for
Croatian: Pogledajte dio 4. Što se nalazi u ovoj uputi: Što je ZYPREXA VELOTAB i za što se koristi
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF ZYPREXA VELOTAB 15 mg ORODISPERSIBLE TABLETS
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA SA ZYPREXA VELOTAB 15 mg RASPADLJIVIM TABLETAMA ZA USTA
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF ZYPREXA VELOTAB 5 mg ORODISPERSIBLE TABLETS
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA SA ZYPREXA VELOTAB 5 mg RASPADLJIVIM TABLETAMA ZA USTA
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each orodispersible tablet contains 15 mg olanzapine
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna raspadljiva tableta za usta sadrži 15 mg olanzapina.
English: Hepatobiliary disorders Transient, asymptomatic elevations of hepatic aminotransferases (ALT, AST), especially in early treatment (see section 4.4)
Croatian: Poremećaji jetre i žuči prolazni asimptomatski porasti razina aminotransferaza jetre (ALT, AST),
English: Drug
Croatian: Proizvođač
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ZYPREXA VELOTAB 15 mg ORODISPERSIBLE TABLETS: BLISTER FOIL LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP ZYPREXA VELOTAB 15 mg RASPADLJIVE TABLETE ZA USTA: OZNAČAVANJE NA FOLIJI BLISTERA
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF ZYPREXA VELOTAB 10 mg ORODISPERSIBLE TABLETS
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA SA ZYPREXA VELOTAB 10 mg RASPADLJIVIM TABLETAMA ZA USTA
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ZYPREXA VELOTAB 5 mg ORODISPERSIBLE TABLETS: BLISTER FOIL LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP ZYPREXA VELOTAB 5 mg RASPADLJIVE TABLETE ZA USTA: OZNAČAVANJE NA FOLIJI BLISTERA
English: EU/1/99/125/003 28 orodispersible tablets EU/1/99/125/011 35 orodispersible tablets EU/1/99/125/007 56 orodispersible tablets EU/1/99/125/015 70 orodispersible tablets EU/1/99/125/019 98 orodispersible tablets
Croatian: EU/1/99/125/003 28 raspadljivih tableta za usta EU/1/99/125/011 35 raspadljivih tableta za usta EU/1/99/125/007 56 raspadljivih tableta za usta EU/1/99/125/015 70 raspadljivih tableta za usta EU/1/99/125/019 98 raspadljivih tableta za usta
English: EU/1/99/125/004 28 orodispersible tablets EU/1/99/125/012 35 orodispersible tablets EU/1/99/125/008 56 orodispersible tablets EU/1/99/125/016 70 orodispersible tablets EU/1/99/125/020 98 orodispersible tablets
Croatian: EU/1/99/125/004 28 raspadljivih tableta za usta EU/1/99/125/012 35 raspadljivih tableta za usta EU/1/99/125/008 56 raspadljivih tableta za usta EU/1/99/125/016 70 raspadljivih tableta za usta EU/1/99/125/020 98 raspadljivih tableta za usta
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ZYPREXA VELOTAB 10 mg ORODISPERSIBLE TABLETS: BLISTER FOIL LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP ZYPREXA VELOTAB 10 mg RASPADLJIVE TABLETE ZA USTA: OZNAČAVANJE NA FOLIJI BLISTERA
English: EU/1/99/125/001 28 orodispersible tablets EU/1/99/125/009 35 orodispersible tablets EU/1/99/125/005 56 orodispersible tablets EU/1/99/125/013 70 orodispersible tablets EU/1/99/125/017 98 orodispersible tablets
Croatian: EU/1/99/125/001 28 raspadljivih tableta za usta EU/1/99/125/009 35 raspadljivih tableta za usta EU/1/99/125/005 56 raspadljivih tableta za usta EU/1/99/125/013 70 raspadljivih tableta za usta EU/1/99/125/017 98 raspadljivih tableta za usta
English: EU/1/99/125/002 28 orodispersible tablets EU/1/99/125/010 35 orodispersible tablets EU/1/99/125/006 56 orodispersible tablets EU/1/99/125/014 70 orodispersible tablets EU/1/99/125/018 98 orodispersible tablets
Croatian: EU/1/99/125/002 28 raspadljivih tableta za usta EU/1/99/125/010 35 raspadljivih tableta za usta EU/1/99/125/006 56 raspadljivih tableta za usta EU/1/99/125/014 70 raspadljivih tableta za usta EU/1/99/125/018 98 raspadljivih tableta za usta
English: Syndrome
Croatian: Kancerogenost
English: MARKETING AUTHORISATION NUMBER(S)
Croatian: 12. BROJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: Caution should be used if olanzapine is being administered concomitantly with medicinal products known to increase QTc interval (see section 4.4).
Croatian: Potreban je oprez ako se olanzapin primjenjuje istodobno s lijekovima za koje se zna da povećavaju
English: 0.15 mg sodium methyl parahydroxybenzoate, 0.05 mg sodium propyl parahydroxybenzoate.
Croatian: 0,05 mg natrijevog propilparahidroksibenzoata.
English: Hepatobiliary disorders
Croatian: trombocitopenija
English: België/Belgique/Belgien Eli Lilly Benelux S.A./N.V.
Croatian: Za sve informacije o ovom lijeku, obratite se lokalnom predstavniku nositelja odobrenja za stavljanje lijeka u promet: België/Belgique/Belgien Eli Lilly Benelux S.A./N.V.
English: Changes in total fasting cholesterol levels from borderline at baseline (≥ 5.17
Croatian: Promjene ukupnog kolesterola natašte od početnih graničnih vrijednosti
English: 0.30 mg sodium methyl parahydroxybenzoate, 0.10 mg sodium propyl parahydroxybenzoate.
Croatian: 0,10 mg natrijevog propilparahidroksibenzoata.
English: If you forget to take ZYPREXA VELOTAB Take your tablets as soon as you remember.
Croatian: Dok uzimate ZYPREXA VELOTAB, druge lijekove uzimajte samo ako Vam liječnik kaže da to možete.
English: Torasemide
Croatian: Torasemid
English: This summary was last updated in June 2015.
Croatian: Sažetak je posljednji put ažuriran u lipnju 2015.
English: EMA/374036/2015 EMEA/V/C/003836
Croatian: EMA/374036/2015 EMEA/H/C/003836
English: UpCard is available as tablets (0.75 mg, 3 mg, 7.5 mg and 18 mg) and can only be obtained with a prescription.
Croatian: UpCard je dostupan kao tablete (0,75 mg, 3 mg, 7,5 mg i 18 mg) i izdaje se samo na recept.
English: It works by increasing the elimination of salt and water in the urine.
Croatian: Djeluje povećavajući eliminaciju soli i vode u urinu.
English: This decreases the overall blood volume, reducing the effort needed for the heart to pump blood and thereby improving its function.
Croatian: Time se smanjuje cjelokupni volumen krvi, što smanjuje napor potreban kako bi srce pumpalo krv te stoga poboljšava njegovu funkciju.
English: UpCard is given once daily, with or without food, with the dose adjusted to produce the required effect.
Croatian: UpCard se primjenjuje jednom dnevno, s hranom ili bez nje, a doza je prilagođena stvaranju potrebnog djelovanja.
English: It explains how the Agency assessed this veterinary medicine to recommend its authorisation in the European Union (EU) and its conditions of use.
Croatian: Objašnjava kako je Agencija ocijenila ovaj veterinarsko-medicinski proizvod kako bi preporučila njegovo odobrenje u Europskoj uniji (EU) i uvjete za njegovu primjenu.
English: Tablets should be kept in the blister packs until required, and the blisters should be kept in the outer carton.
Croatian: Tablete treba držati u blister pakiranjima sve do uporabe, a blistere treba držati u vanjskim kutijama.
English: People with known hypersensitivity (allergy) to torasemide or other sulphonamides should give the medicine with caution.
Croatian: Osobe s poznatom preosjetljivošću (alergijom) na torasemid ili druge sulfonamide trebaju oprezno primjenjivati lijek.
English: Torasemide is a diuretic medicine.
Croatian: Torasemid je dijuretik.
English: This product may increase urination and gastrointestinal disturbances if ingested.
Croatian: Ovaj VMP može povećati uriniranje i gastrointestinalne poremećaje ako se proguta.
English: Congestive heart failure is a condition, usually of older dogs, where the heart fails to pump blood efficiently around the body leading to clinical signs such as exercise intolerance (inability to carry out physical activity), difficulty breathing and fluid retention.
Croatian: Kongestivno zatajenje srca je stanje, najčešće u starijih pasa, kada srce ne može djelotvorno pumpati krv kroz tijelo što rezultira kliničkim znakovima poput nepodnošenja tjelesne aktivnosti (nesposobnost obavljanja tjelesne aktivnosti), otežanog disanja i zadržavanja tekućine.
English: Once signs of congestive heart failure have been controlled, if long-term treatment is required the lowest effective dose should be given.
Croatian: Nakon što su znakovi kongestivnog zatajenja srca pod kontrolom, potrebno je primijeniti najmanju djelotvornu dozu ako je potrebna dugoročna terapija.
English: In a field study involving 251 dogs with congestive heart failure, treatment with UpCard was compared to a standard treatment with the diuretic furosemide.
Croatian: U terenskom ispitivanju koje je obuhvatilo 251 psa s kongestivnim zatajenjem srca, terapija lijekom UpCard uspoređena je sa standardnom terapijom dijuretikom furosemidom.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that UpCard's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za veterinarsko-medicinske proizvode (CVMP) pri Agenciji odlučio je da koristi od VMP-a UpCard nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: UpCard contains the active substance torasemide.
Croatian: UpCard sadrži djelatnu tvar torasemid.
English: UpCard is a veterinary medicine used to treat signs of congestive heart failure in dogs.
Croatian: UpCard je veterinarsko-medicinski proizvod koji se koristi za liječenje znakova kongestivnog zatajenja srca u pasa.
English: The most common side effects with UpCard are kidney problems and increased thirst, water consumption and urine output, which may affect more than 1 in 10 dogs.
Croatian: Najčešće nuspojave povezane s VMP-om UpCard su problemi s funkcijom bubrega i povećana žeđ, unos vode i izbacivanje urina, što je uočeno u više od 1 na 10 pasa.
English: What is UpCard and what is it used for?
Croatian: Što je UpCard i za što se koristi?
English: It is not intended to provide practical advice on how to use UpCard.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni VMP-a UpCard.
English: Other information about UpCard
Croatian: Ostale informacije o VMP-u UpCard
English: This is a summary of the European public assessment report (EPAR) for UpCard.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za veterinarsko-medicinski proizvod UpCard.
English: The main measure of effectiveness was response to treatment after about 3 months of treatment, scoring the difficulty breathing, cough frequency, exercise intolerance and fluid retention in the abdomen.
Croatian: Glavna mjera djelotvornosti bio je odgovor na terapiju nakon otprilike 3 mjeseca terapije i rezultat za otežano disanje, učestalost kašljanja, nepodnošenje tjelesne aktivnosti i zadržavanje tekućine u abdomenu.
English: The study showed UpCard to be at least as effective as furosemide for treatment of signs related to congestive heart failure.
Croatian: Ispitivanjem je utvrđeno kako je UpCard barem jednako djelotvoran kao furosemid za terapiju znakova povezanih s kongestivnim zatajenjem srca.
English: What are the risks associated with UpCard?
Croatian: Koji su rizici povezani s VMP-om UpCard?
English: In case of accidental ingestion, particularly by children, medical advice should be sought immediately and the package leaflet or label shown to the doctor.
Croatian: U slučaju nehotičnog gutanja potrebno je odmah potražiti liječnički savjet te pokazati uputu o VMP-u ili etiketu liječniku.
English: Why is UpCard approved?
Croatian: Zašto je VMP UpCard odobren?
English: How does UpCard work?
Croatian: Kako djeluje UpCard?
English: The full EPAR for UpCard can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za VMP UpCard nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports Dodatne informacije o terapiji VMPom UpCard, vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti svojem veterinaru ili ljekarniku.
English: For practical information about using UpCard, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Praktične informacije o primjeni VMP-a UpCard vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti svojem veterinaru ili ljekarniku.
English: Safety information has been included in the summary of product characteristics and the package leaflet for UpCard, including the precautions to be followed by healthcare professionals and animal owners or keepers.
Croatian: U sažetku opisa svojstava VMP-a kao i u uputi o VMP-u UpCard nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici te vlasnici životinja ili uzgajivači trebaju pridržavati.
English: How is UpCard used?
Croatian: Kako se UpCard koristi?
English: What benefits of UpCard have been shown in studies?
Croatian: Koje su koristi VMP-a UpCard utvrđene u ispitivanjima?
English: For the full list of restrictions and side effects reported with UpCard, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni VMP-a UpCard potražite u uputi o VMP-u.
English: The European Commission granted a marketing authorisation valid throughout the EU for UpCard on
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za VMP UpCard na snazi u Europskoj uniji od 31/07/2015.
English: ATCvet code: QI05AA10.
Croatian: ATC vet kod: QI05AA10
English: If such a reaction occurs, appropriate treatment should be administered without delay.
Croatian: Ako do takve reakcije dođe treba bez odgađanja primijeniti odgovarajuće liječenje.
English: CONTRAINDICATIONS None.
Croatian: Nema kontraindikacija.
English: Vaccination may interfere with existing sero-epidemiological surveys.
Croatian: Cijepljenje može utjecati na postojeća seroepidemiološka ispitivanja.
English: It is therefore recommended not to vaccinate foals of less than 6 months of age.
Croatian: Stoga se ne preporučuje cijepiti ždrebad mlađu od 6 mjeseci.
English: Date of last renewal: 12/09/2013
Croatian: Datum posljednjeg produljenja odobrenja: 12/09/2013
English: For intramuscular use.
Croatian: Za intramuskularnu upotrebu.
English: The use of Equip WNV reduces the number of animals with viraemia after natural infection, but may not systematically prevent it.
Croatian: Upotreba cjepiva Equip WNV smanjuje broj životinja s viremijom nakon prirodne infekcije, ali je ne može sustavno spriječiti.
English: Rue Laid Burniat 1
Croatian: Zoetis Belgium SA Rue Laid Burniat 1
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21/11/2008
Croatian: Datum prvog odobrenja: 21/11/2008
English: The vaccine stimulates active immunity against West Nile virus.
Croatian: Cjepivo stimulira aktivan imunitet protiv virusa zapadnog Nila.
English: Following the administration of a double dose of vaccine, no adverse reactions other than those described under section 4.6 have been observed.
Croatian: Nakon davanja dvostruke doze cjepiva nisu primijećene nikakve nuspojave osim onih koje su opisane u odjeljku 4.6.
English: In very rare cases transient hyperthermia may occur for up to 2 days.
Croatian: U rijetkim slučajevima može doći do prolazne povišene tjelesne temperature u trajanju od najviše dva dana.
English: a) The administration of the product to animals will interfere with the implementation of a national programme for the diagnosis, control or eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
Croatian: a) će primjena veterinarsko-medicinskog proizvoda na životinjama interferirati s provedbom nacionalnog programa otkrivanja, kontrole i 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/2/08/086/004 (2 single-dose glass syringes) EU/2/08/086/005 (4 single-dose glass syringes) EU/2/08/086/006 (10 single-dose glass syringes)
Croatian: 16. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/08/086/004 (2 staklene štrcaljke s pojedinačnom dozom) EU/2/08/086/005 (4 staklene štrcaljke s pojedinačnom dozom) EU/2/08/086/006 (10 staklenih štrcaljki s pojedinačnom dozom)
English: Name and address of the manufacturer of the biological active substance: Zoetis Inc.
Croatian: Naziv i adresa proizvođača biološki djelatne tvari: Zoetis Inc.
English: Minimum essential medium (MEM) Phosphate buffered saline
Croatian: Minimalni esencijalni medij (MEM) Fosfatni pufer
English: As with any vaccine rare, occasional hypersensitivity reactions may occur.
Croatian: Kao i kod svakog drugog cjepiva, povremeno se može javiti reakcija preosjetljivosti.
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 se sastoji od tvari biološkog podrijetla, namijenjena je za stvaranje aktivne imunosti na koju se ne primjenjuju odredbe Uredbe (EZ) br. 470/2009.
English: If infection is suspected as a result of a positive IgM response, additional testing would need to be conducted to conclusively determine whether the animal was infected or vaccinated.
Croatian: Ako se zbog pozitivne IgM reakcije sumnja na infekciju, potrebno je provesti dodatne pretrage kako bi se nedvojbeno utvrdilo je li životinja zaražena ili cijepljena.
English: • Revaccination: a sufficient degree of protection should be achieved after an annual booster injection with a single 1 ml dose although this schedule has not been fully validated.
Croatian: • revakcinacija: dovoljan stupanj zaštite trebao bi se postići nakon godišnje dodatne injekcije s jednom dozom (1 ml) godišnje, iako ta shema još nije u potpunosti potvrđena.
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 trebaju se odlagati u skladu s lokalnim propisima.
English: Incompatibilities: Do not mix with any other veterinary medicinal product.
Croatian: Inkompatibilnosti: Ne miješati s drugim veterinarsko - medicinskim proizvodom.
English: • Primary vaccination course: first injection from 6 months of age, second injection 3-5 weeks later.
Croatian: • primarni ciklus cijepljenja: prvu injekciju primijeniti u starosti od 6 mjeseci, drugu injekciju 3-5 tjedana kasnije.
English: DATE OF THE REVISION OF THE TEXT 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: However, since the IgM response following vaccination is infrequent, a positive IgM-ELISA test result is a strong indicator of natural infection with West Nile virus.
Croatian: reakcija nakon cijepljenja rijetka, pozitivan rezultat IgM-ELISA testa snažan je indikator prirodne zaraze virusom zapadnog Nila.
English: Onset of immunity: 3 weeks after primary vaccination course.
Croatian: Početak imuniteta: 3 tjedna nakon primarnog ciklusa cijepljenja.
English: RP* 1.0-2.2 *Relative potency by in vitro method, compared to a reference vaccine that was shown efficacious in horses.
Croatian: RP* 1,0 - 2,2 *Relativna potentnost dobivena in vitro metodom u usporedbi s referentnim cjepivom koje se pokazalo učinkovitim kod konja.
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: PHARMACEUTICAL FORM Emulsion for injection.
Croatian: OBLIK Emulzija za injekciju.
English: Administer the entire content of the syringe (1 ml), by deep intramuscular injection in the neck region, according to the following schedule:
Croatian: Primijenite cijeli sadržaj štrcaljke dozu (1 ml) dubokom intramuskularnom injekcijom u području vrata prema sljedećoj shemi:
English: Can be used during pregnancy and lactation.
Croatian: Može se upotrebljavati tijekom graviditeta i laktacije.
English: Transient local reactions in the form of a mild, local swelling at the injection site post vaccination (maximum 1 cm in diameter) that resolve spontaneously within 1 to 2 days and that are sometimes associated with pain and mild depression were reported in very rare cases.
Croatian: Nakon cijepljenja u vrlo rijetkim slučajevima prijavljena je prolazna lokalna reakcija u obliku blage lokalne otekline na mjestu aplikacije (maksimalnog promjera 1 cm) koja će spontano nestati nakon jednog do dva dana, a ponekad je povezana s boli i blagom depresijom.
English: MARKETING AUTHORISATION NUMBERS EU/2/08/086/004-006
Croatian: EU/2/08/086/004-006
English: As a consequence, it cannot be excluded that transient immunodepression that may be observed during pregnancy could interfere with vaccine uptake.
Croatian: Zbog toga se ne može isključiti mogući utjecaj prolazne imunodepresije na unos cjepiva, koju se može uočiti tijekom graviditeta.