FrancophonIA/ELRC3.0 huggingface dataset:
English: Treated subjects (N=394) had a median age of 54 years (range: 19 to 71); 49.0% were prior pegIFN/RBV null responders; 21.8/% were prior pegIFN/RBV partial responders, and 29.2% were prior pegIFN/RBV relapsers; 57.6% were male; 8.1% were Black; 20.6% had a history of depression or bipolar disorder; 87.1% had baseline HCV RNA levels of at least 800,000 IU per mL; 17.8% had portal fibrosis (F2) and 14.5% had bridging fibrosis (F3); 58.4% had HCV genotype 1a infection; 41.4% had HCV genotype 1b infection.
Croatian: Medijan dobi liječenih ispitanika (N=394) iznosio je 54 godine (raspon: 19 do 71); 49,0% nije ostvarilo odgovor na prethodno liječenje kombinacijom pegIFN/RBV, 21,8% ostvarilo je djelomičan odgovor na prethodno liječenje kombinacijom pegIFN/RBV, a 29,2% doživjelo je relaps nakon prethodnog liječenja kombinacijom pegIFN/RBV; 57,6% ispitanika bili su muškarci; 8,1% bili su crnci; 20,6% imalo je depresiju ili bipolarni poremećaj u anamnezi; 87,1% imalo je početnu razinu HCV RNK od najmanje 800 000 IU po ml; 17,8% imalo je portalnu fibrozu (F2), a 14,5%
English: 300 mg single dose
Croatian: 300 mg pojedinačna doza paracetamol
English: Treated subjects (N = 63) had a median age of 51 years (range: 31 to 69); 24% of subjects were Black; 19% of subjects had compensated cirrhosis; 67% of subjects were HCV treatment-naïve; 33% of subjects had failed prior treatment with pegIFN/RBV; 89% of subjects had HCV genotype 1a infection.
Croatian: 19% ispitanika imalo je kompenziranu cirozu, 67% nije bilo prethodno liječeno, 33% ispitanika bilo je prethodno neuspješno liječeno pegIFN/RBV-om, 89% ispitanika imalo je infekciju HCV-om genotipa 1a.
English: ↑ telithromycin ↑ paritaprevir
Croatian: ↑ vorikonazol ↑ dasabuvir ↑ paritaprevir
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: ↑ naloxone
Croatian: ↑ dronedaron
English: Buprenorphine / naloxone
Croatian: buprenorfin/ nalokson
English: No dose adjustment needed for Viekirax with ombitasvir paritaprevir
Croatian: Nije potrebna prilagodba doze lijeka Viekirax primijenjenog s ombitasvir paritaprevir dasabuvir
English: Mechanism: OATP1B inhibition by paritaprevir and BCRP inhibition by paritaprevir, ritonavir or dasabuvir.
Croatian: Mehanizam: paritaprevir inhibira OATP1B, a paritaprevir, ritonavir ili dasabuvir inhibiraju BCRP.
English: SAPPHIRE II
Croatian: SAPPHIRE-I
English: NAME OF THE MEDICINAL PRODUCT Viekirax 12.5 mg / 75 mg / 50 mg tablets ombitasvir / paritaprevir / ritonavir
Croatian: Viekirax 12,5 mg / 75 mg / 50 mg tablete ombitasvir / paritaprevir / ritonavir
English: In a phase 2, multicentre, open-label, single arm study, 38 treatment-naïve or pegIFN/RBV treatment experienced, non-cirrhotic subjects with genotype 1 infection who were on stable doses of methadone (N=19) or buprenorphine +/- naloxone (N=19) received 12 weeks of Viekirax and dasabuvir with ribavirin.
Croatian: om genotipa 1 koji su bili na ustaljenim dozama metadona (N=19) ili buprenorfina +/- nalokson (N=19) primalo je Viekirax i dasabuvir s ribavirinom tijekom 12 tjedana.
English: 300/100 mg once daily (administered 12 hours apart)
Croatian: Kliničke napomene jedanput na dan (primijenjen u razmaku od 12 sati)
English: CYP3A4 induction by phenobarbital.
Croatian: Mehanizam: Indukcija CYP3A4 fenobarbital om.
English: Diltiazem Verapamil
Croatian: Kliničke napomene diltiazem verapamil
English: Hepatic decompensation and hepatic failure, including liver transplantation or fatal outcomes, have been reported postmarketing in patients treated with Viekirax with and without dasabuvir and with and without ribavirin.
Croatian: Nakon stavljanja lijeka u promet, u bolesnika liječenih lijekom Viekirax u kombinaciji s dasabuvirom ili bez njega te u kombinaciji s ribavirinom ili bez njega prijavljeni su dekompenzacija jetre i zatajenje jetre, uključujući slučajeve koji su završili presađivanjem jetre ili smrtnim ishodom.
English: While no change to the pharmacokinetics of warfarin is expected, close
Croatian: Iako nije očekivana promjena farmakokinetike varfarina, preporučuje se pomni nadzor INR-a kod primjene svih antagonista vitamina K.
English: Patients who are taking ethinylestradiol-containing medicinal products (i.e. most combined oral contraceptives or contraceptive vaginal rings) must switch to an alternative method of contraception (e.g., progestin only contraception or non-hormonal methods) prior to initiating Viekirax and dasabuvir therapy (see sections 4.3 and 4.5).
Croatian: kontracepcija samo progestinom ili nehormonske metode) prije započinjanja liječenja lijekom Viekirax i dasabuvirom (vidjet dijelove 4.3 i 4.5).
English: Mechanism: CYP2C19 induction and CYP3A4 inhibition by ritonavir
Croatian: Mehanizam: ritonavir inducira CYP2C19 i inhibira CYP3A4
English: Arm A: Viekirax and dasabuvir + RBV (12 weeks)
Croatian: skupina A: Viekirax i dasabuvir + RBV (12 tjedana) skupina B: Viekirax i dasabuvir + RBV (24 tjedna)
English: Very common: may affect more than 1 in 10 people
Croatian: • Rijetke: mogu se javiti u do 1 na 1000 osoba
English: and dasabuvir
Croatian: dasabuvira
English: TURQUOISE-I: treatment-naïve or pegIFN + RBV-experienced with HIV-1 co-infection, without cirrhosis or with compensated cirrhosis
Croatian: TURQUOISE-I: ispitanici bez ciroze ili s kompenziranom cirozom, prethodno neliječeni ili prethodno liječeni pegIFN i RBV s istodobnom infekcijom HIV-om tipa 1 Dizajn:
English: If the combination is used, repeated ECG-monitoring should be done, see section 4.4.
Croatian: Ako se primjenjuje kombinacija, potrebno je redovito EKG
English: Baseline platelet count, median (× 109/L)
Croatian: Početni broj trombocita, medijan (× 109/L) < 90, n (%)
English: 2a
Croatian: Ostalo a.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film coated tablet contains 12.5 mg of ombitasvir, 75 mg of paritaprevir and 50 mg of ritonavir.
Croatian: Jedna filmom obložena tableta sadrži 12,5 mg ombitasvira, 75 mg paritaprevira i 50 mg ritonavira.
English: The mean EC50 of paritaprevir against replicons containing NS3 from a panel of treatment-naïve genotype 1a and 1b isolates in the HCV replicon cell culture assay was 0.86 nM (range 0.43 to 1.87 nM; n=11) and 0.06 nM (range 0.03 to 0.09 nM; n=9), respectively.
Croatian: 0,43 do 1,87 nM; n=11) odnosno 0,06 nM (raspon: 0,03 do 0,09 nM; n=9).
English: CYP3A4/Pgp inhibition.
Croatian: CYP3A4 inhibicija
English: Pitavastatin Mechanism: OATP1B inhibition by paritaprevir
Croatian: Mehanizam: paritaprevir inhibira OATP1B
English: NAME OF THE MEDICINAL PRODUCT Viekirax 12.5 mg / 75 mg / 50 mg film-coated tablets ombitasvir / paritaprevir / ritonavir
Croatian: Uputa o lijeku: Informacija za bolesnika Viekirax 12,5 mg/75 mg/50 mg filmom obložene tablete ombitasvir/paritaprevir/ritonavir
English: Mechanism: P-gp inhibition by paritaprevir, ritonavir and dasabuvir.
Croatian: Mehanizam: inhibicija Pgp-a paritaprevir om, ritonavirom i dasabuviro m
English: Mechanism: CYP3A4 inhibition by cobicistat
Croatian: Mehanizam: CYP3A4 inhibicija kobicistato m
English: • Monitor for clinical signs and symptoms of hepatic decompensation (such as ascites, hepatic encephalopathy, variceal haemorrhage).
Croatian: • Potreban je nadzor zbog moguće pojave kliničkih znakova i simptoma dekompenzacije jetre
English: Paritaprevir had an EC50 value of 5.3 nM against the 2a-JFH-1 replicon cell line, and EC50 values of 19, 0.09, and 0.68 nM against replicon cell lines containing NS3 from a single isolate each of genotype 3a, 4a, and 6a, respectively
Croatian: Vrijednost EC50 paritaprevira protiv stanične linije replikona 2a-JFH-1 iznosila je 5,3 nM, dok su vrijednosti EC50
English: Mechanism: CYP3A4 induction by phenytoin.
Croatian: Mehanizam: Indukcija CYP3A4 fenitoinom
English: SVR12 % (n/N)
Croatian: SVR12 % (n/N) Ishodi za ispitanike bez SVR12
English: Expected: ↑ sildenafil
Croatian: ↑ sildenafil
English: Viekirax and dasabuvir with RBV 12 weeks
Croatian: Viekirax i dasabuvir s RBV-om
English: Clinical trials in subjects with genotype 4 chronic hepatitis C PEARL- I- genotype 4, treatment-naïve or pegIFN + RBV experienced without cirrhosis Design:
Croatian: PEARL- I - ispitanici s infekcijom genotipom 4, prethodno neliječeni ili prethodno liječeni pegIFN i RBV bez ciroze
English: Expected
Croatian: Vidjeti
English: Co-administration of Viekirax with or without dasabuvir with medicinal products that are primarily metabolized by UGT1A1 result in increased plasma concentrations of such medicinal products; routine clinical monitoring is recommended for narrow therapeutic index medicinal products (i.e. levothyroxine).
Croatian: povećava koncentracije tih lijekova u plazmi; preporuča se rutinsko kliničko praćenje za lijekove s uskim terapijskim indeksom (tj. levotirkosin).
English: Viekirax and dasabuvir without ribavirin or with weight-based ribavirin for 12 weeks Treated subjects (N=305) had a median age of 54 years (range: 19 to 70); 65.2% were male; 11.8% were Black; 20.7% had a history of depression or bipolar disorder; 86.6% had baseline HCV RNA levels of at least 800,000 IU/mL; 18.4% had portal fibrosis (F2) and 17.7% had bridging fibrosis (F3).
Croatian: Viekirax i dasabuvir tijekom 12 tjedana s ribavirinom čija je doza temeljena na težini Medijan dobi liječenih ispitanika (N=631) iznosio je 52 godine (raspon: 18 do 70); 54,5% bili su muškarci; 5,4% bili su crnci; 15,2% imalo je depresiju ili bipolarni poremećaj u anamnezi; 79,1%
English: ANTIFUNGALS Ketoconazole 400 mg once daily
Croatian: IMUNOSUPRESIVI ciklosporin 30 mg jedanput na dan pojedinačna doza Mehanizam:
English: Mechanism: CYP3A4 induction by carbamazepine
Croatian: Mehanizam: Indukcija CYP3A4 karbamazep inom.
English: Mechanism: OATP1B/BC RP inhibition by paritaprevir
Croatian: Mehanizam: paritaprevir inhibira OATP1B/ BCRP
English: TURQUOISE-III: treatment-naïve or pegIFN + RBV-experienced with compensated cirrhosis
Croatian: TURQUOISE-III: ispitanici s kompenziranom cirozom, prethodno neliječeni ili prethodno liječeni pegIFN i RBV Dizajn:
English: ↑ dabigatran etexilate
Croatian: ↑ dabigatran eteksilat
English: OPIOIDS Methadone
Croatian: ANTITUMORSKI LIJEKOVI enzalutamid mitotan
English: Cyclobenzapr ine 5 mg single dose
Croatian: Očekuje se sličan učinak kao kod primjene kombinacije ciklobenzap rin 5 mg pojedinačna doza
English: ↑ digoxin
Croatian: ↑ nalokson
English: Duloxetine 60 mg single dose
Croatian: DIURETICI furosemid pojedinačna doza od 20 mg
English: 20-120 mg once daily
Croatian: OPIOIDI metadon 20-120 mg jedanput na dan5
English: Quetiapine
Croatian: pitavastatin
English: ↑ repaglinide
Croatian: ↑ amlodipin
English: Viekirax without dasabuvir atazanavir
Croatian: Viekirax bez dasabuvira escitalopram
English: Efavirenz/ emtricitabine/ tenofovir disoproxil fumarate mg once daily
Croatian: Očekuje se sličan učinak kao kod primjene kombinacije efavirenz/ emtricitabin /tenofovir dizoproksil fumarat
English: Retreatment
Croatian: Supstitucija
English: Mechanism: CYP3A4 and/or P-gp inhibition by itraconazole, posaconazole and paritaprevir/ ritonavir/ombi tasvir
Croatian: Mehanizam: itrakonazol, posakonazol i paritaprevir/ ritonavir/om bitasvir inhibiraju CYP3A4 i/ili P-gp.
English: TURQUOISE-II - treatment-naïve or pegIFN + RBV-experienced with compensated cirrhosis
Croatian: TURQUOISE-II - ispitanici s kompenziranom cirozom, prethodno neliječeni ili prethodno liječeni pegIFN i RBV
English: Trazodone
Croatian: paritaprevir trazodon
English: Treated subjects (N=179) had a median age of 57 years (range: 26 to 70); 35.2% were prior pegIFN/RBV null responders; 28.5% were prior pegIFN/RBV partial responders, and 36.3% were prior pegIFN/RBV relapsers; 54.2% were male; 3.9% were Black; 12.8% had a history of depression or bipolar disorder; 87.7% had baseline HCV RNA levels of at least 800,000 IU/mL; 17.9% had portal fibrosis (F2) and 14.0% had bridging fibrosis (F3).
Croatian: Viekirax i dasabuvir tijekom 12 tjedana bez ribavirina ili s ribavirinom čija je doza temeljena na težini Medijan dobi liječenih ispitanika (N=179) iznosio je 57 godina (raspon: 26 do 70); 35,2% nije ostvarilo odgovor na prethodno liječenje kombinacijom pegIFN/RBV, 28,5% ostvarilo je djelomičan odgovor na prethodno liječenje kombinacijom pegIFN/RBV, a 36,3% doživjelo je relaps nakon prethodnog liječenja kombinacijom pegIFN/RBV; 54,2% ispitanika bili su muškarci; 3,9% bili su crnci; 12,8% imalo je depresiju ili bipolarni poremećaj u anamnezi; 87,7% imalo je početne razine
English: SVR12 window.
Croatian: CYP2D6.
English: Coadministration with enzyme inducers may increase the risk of adverse events and ALT elevations (see Table 2).
Croatian: Farmakodinamičke interakcije Istodobna primjena s induktorima enzima može povećati rizik od nuspojava i porasta razine ALT-a
English: Mechanism: CYP3A4/Pgp inhibition by ketoconazole and paritaprevir/ ritonavir/ ombitasvir
Croatian: Mehanizam: ketokonazol i paritaprevir/ ritonavir/om bitasvir inhibiraju CYP3A4/Pgp.
English: AGATE-1 -treatment-naïve or pegIFN +RBV experienced patients with compensated cirrhosis
Croatian: I - ispitanici prethodno neliječeni ili prethodno liječeni pegIFN i RBV s kompenziranom cirozom Dizajn:
English: (0.81-0.96) (0.88-1.02) monitoring of INR is recommended with all vitamin K antagonists.
Croatian: (0,92-1,38) (1,21-1,59) kombinaciji s dasabuvirom ili bez njega.
English: ↑ levothyroxine
Croatian: ↑ levotiroksin
English: Viekirax + dasabuvir dolutegravir
Croatian: Viekirax bez dasabuvira buprenorfin
English: If clinical signs are present, their duration and severity are reduced.
Croatian: Ako su klinički znakovi prisutni, njihovo trajanje i ozbiljnost se smanjuju.
English: ATC vet code: QI05AX.
Croatian: ATC vet kod: QI05AX.
English: After inoculation, the virus does not multiply in the horse but expresses the protective proteins.
Croatian: Nakon inokulacije virus se u konju ne množi, ali izražava zaštitne proteine.
English: Carbomer ......................................................................................................................................... 4 mg
Croatian: Karbomer ......................................................................................................................................... 4 mg
English: Date of first authorisation: 05/08/2011 Date of last renewal: 17/05/2016
Croatian: Datum prvog odobrenja: 05/08/2011 Datum posljednjeg produljenja odobrenja: 17/05/2016
English: 1 dose
Croatian: 1 doza.
English: 1 x 1 dose 2 x 1 dose 5 x 1 dose 10 x 1 dose
Croatian: 1 x 1 doza 2 x 1 doza 5 x 1 doza 10 x 1 doza
English: EU/2/11/129/001 1 x 1 dose EU/2/11/129/002 2 x 1 dose EU/2/11/129/003 5 x 1 dose EU/2/11/129/004 10 x 1 dose
Croatian: EU/2/11/129/001 1 x 1 doza EU/2/11/129/002 2 x 1 doza EU/2/11/129/003 5 x 1 doza EU/2/11/129/004 10 x 1 doza
English: Protect from light
Croatian: Zaštiti od svjetla
English: Shelf life of the veterinary medicinal product as packaged for sale: 27 months.
Croatian: Rok valjanosti veterinarsko-medicinskog proizvoda kad je zapakiran za prodaju: 27 mjeseci.
English: 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 koji je naznačen na etiketi nakon EXP.
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: In order to achieve full protection, the full vaccination course of two doses must be given.
Croatian: Za postizanje potpune zaštite, moraju se dati dvije doze cjepiva.
English: Vaccination may interfere with existing sero-epidemiological surveys.
Croatian: Cijepljenje može utjecati na postojeća sero-epidemiološke ispitivanja.
English: A hypersensitivity reaction may occur in rare cases, which may require appropriate symptomatic treatment.
Croatian: Može se rijetko javiti hipersenzibilna reakcija, koja može zahtijevati odgovarajući simptomatski tretman.
English: Sodium chloride Disodium phosphate dihydrate Potassium dihydrogen phosphate Water for injections
Croatian: Natrijev klorid Dinatrijev fosfatdihidrat Kalijev dihidrogenfosfat Voda za injekcije
English: To stimulate active immunity against West Nile virus.
Croatian: Za stimulaciju aktivnog imuniteta protiv virusa zapadnog Nila.
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: Međutim, kako IgM odgovor nakon cijepljenja nije čest, pozitivan rezultat IgM-ELISA testa je čvrst indikator prirodne infekcije virusom zapadnog Nila.
English: Pharmacotherapeutic group: Immunologicals for equidae, other immunologicals.
Croatian: Farmakoterapijska grupa: imunološki lijekovi za ekvide, drugi imunološki lijekovi.
English: The manufacture, import, possession, sale, supply and/or use of Proteq West Nile may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Croatian: Proizvodnja, uvoz, prodaja, posjedovanje, opskrba i/ili primjena Proteq West Nile može biti zabranjena u državi članici na cijelom teritoriju ili na jednom njegovom dijelu sukladno nacionalnim propisima.
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 je sumnja na infekciju rezultat pozitivnog IgM odgovora, potrebno je provesti dodatno ispitivanje kako bi se ustanovilo je li životinja zaražena ili je cijepljena.
English: Homogeneous opalescent suspension for injection Each dose of 1 ml contains:
Croatian: Homogena opalescentna suspenzija za injekciju Svaka doza od 1 ml sadrži:
English: Store and transport refrigerated (2 °C-8 °C).
Croatian: Čuvati i prevoziti rashlađeno (2 C-8 C).
English: Active immunisation of horses from 5 months of age against West Nile disease by reducing the number of viraemic horses.
Croatian: Aktivna imunizacija konja starijih od 5 mjeseci protiv groznice zapadnog Nila smanjenjem broja viremičnih konja.
English: • Revaccination: a sufficient degree of protection should be achieved after an annual booster injection with a single dose although this schedule has not been fully validated.
Croatian: • Docjepljivanje: dostatna bi se zaštita trebala postići docjepljivanjem godišnjom poticajnom injekcijom od jedne doze iako ovaj raspored nije u potpunosti validiran.
English: Apathy, usually resolving within two days, and reduced appetite may be observed in rare cases the day after vaccination.
Croatian: Apatija koja obično prestaje za dva dana i smanjeni tek mogu se primijetiti rijetko, dan nakon cijepljenja.
English: Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.
Croatian: Odlagati otpadne materijale uranjanjem u kipuću vodu, spaljivati, uranjati u prikladno dezinfekcijsko sredstvo odobreno za upotrebu od strane nadležnog tijela.
English: • Primary vaccination course: first injection from 5 months of age, second injection 4-6 weeks later,
Croatian: • Prvo cijepljenje: prva injekcija u dobi 5 mjeseci, druga injekcija 4- 6 tjedana kasnije.
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 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. b) je bolest za koju je odnosni proizvod namijenjen da pruži imunost, odsutna s odnosnog područja.
English: Type I glass vial, with a butyl elastomer closure, sealed with an aluminium cap.
Croatian: Tip I staklena bočica zatvorena gumenim čepom i aluminijskom kapicom.
English: DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
Croatian: DOZIRANJE ZA SVAKU CILJNU VRSTU ŽIVOTINJA, NAČIN I PUTEVI
English: Box of 1, 2, 5 or 10 vial(s) of 1 dose.
Croatian: Kutija s 1, 2, 5 ili 10 bočica sa po jednom dozom.
English: Administer one dose of 1 ml, by intramuscular injection, preferably in the neck region, according to the following schedule:
Croatian: Primijenite dozu od 1 ml, intramuskularno , najbolje u području vrata, prema sljedećem rasporedu:
English: Laboratoire Porte des Alpes Rue de l'Aviation 69800 Saint Priest France
Croatian: Laboratoire Porte des Alpes Rue de l'Aviation 69800 Saint Priest Francuska
English: PACKAGE SIZE
Croatian: VELIČINA PAKIRANJA
English: Onset of immunity: 4 weeks after the first dose of the primary vaccination course.
Croatian: Početak imuniteta: 4 tjedna nakon prve doze primarnog cijepljenja.
English: Homogeneous opalescent suspension.
Croatian: Homogena opalescentna suspenzija.
English: Duration of immunity: 1 year after a full primary vaccination course of two injections.
Croatian: Trajanje imuniteta: 1 godina nakon potpunog primarnog cijepljenja s dvije doze.
English: As a consequence, these proteins induce protective immunity against equine West Nile disease.
Croatian: Posljedica toga je da ti proteini induciraju zaštitni imunitet protiv virusa zapadnog Nila.
English: However the vaccine has also been shown to be safe in a field study including animals of 2 months of age.
Croatian: Međutim, cjepivo se također pokazalo neškodljivim u terenskom ispitivanju na životinjama starim 2 mjeseca.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial Label
Croatian: OSNOVNI PODACI NAPISANI NA MALIM JEDINICAMA UNUTARNJIH PAKOVANJA
English: The vaccine strain vCP2017 is a recombinant canarypox virus expressing the preM/E genes of West Nile virus.
Croatian: Cjepni soj vCP2017 je rekombinant s virusom boginja kanarinca koji izražava M/E gene virusa zapadnog Nila.
English: 6.5 Nature and composition of immediate packaging
Croatian: 6.5 Osobine i sastav unutarnjeg pakiranja
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: The safety of the vaccine has been demonstrated in foals from 5 months of age.
Croatian: Neškodljivost cjepiva bila je dokazana na ždrebadi starijoj od 5 mjeseci.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reactions 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)
English: Pregnancy and lactation: This vaccine can be used during pregnancy and lactation.
Croatian: Ovo cjepivo se može primijeniti tijekom graviditeta i dojenja.
English: Pain and local hyperthermia can occur in rare cases.
Croatian: U rijetkim slučajevima mogu se javiti bol i lokalna hipertermija.
English: Special precautions for use in animals:
Croatian: Posebne mjere opreza za primjenu na životinjama: