natgillin/translations-raw huggingface dataset:
Mechanism: CYP2C19 induction by ritonavir. 
Mehanizam: CYP2C19 indukcija ritonavirom.
Mechanism: CYP2C19 induction by ritonavir 
Mehanizam: CYP2C19 indukcija ritonavirom
Resistance to paritaprevir and ombitasvir conferred by variants in NS3 and NS5A respectively, selected in cell culture or identified in Phase 2b and 3 clinical trials were phenotypically characterised in the appropriate genotype 1a or 1b replicons. 
NS3 ili NS5A izdvojenima u staničnoj kulturi ili identificiranima u kliničkim ispitivanjima faze 2b i 3,
Mechanism: Intestinal Pgp inhibition by paritaprevir and ritonavir. 
Mehanizam: inhibicija crijevnog Pgp paritaprevir om i ritonavirom.
Clinical monitoring and dose reduction is recommended for angiotensin receptor blockers when coadministered with Viekirax with or without dasabuvir. 
Preporučuje se kliničko praćenje i smanjenje doze za blokatore angiotenzinskih receptora kada se primjenjuju istodobno s lijekom
ANTIHISTAMINES Astemizole 
ANTIHISTAMINICI astemizol terfenadin
Mechanism: CYP3A4/Pgp inhibition by conivaptan and paritaprevir/ ritonavir/ombi tasvir 
Mehanizam: CYP3A4/Pgp inhibicija konivaptano m i paritaprevir om/ritonavir om/ombitas virom
S-warfarin paritaprevir ombitasvir 
S-varfarin paritaprevir ombitasvir dabigatran eteksilat
Viekirax and dasabuvir without ribavirin or with weight-based ribavirin for 12 weeks Treated subjects (N=419) had a median age of 50 years (range: 19 to 70), 45.8% were male; 4.8% were Black; 9.3% had a history of depression or bipolar disorder; 73.3% had baseline HCV RNA of at least 800,000 IU/mL; 20.3% had portal fibrosis (F2) and 10.0% had bridging fibrosis (F3). 
Viekirax i dasabuvir tijekom 12 tjedana bez ribavirina ili s ribavirinom čija je doza temeljena na težini Medijan dobi liječenih ispitanika (N=419) iznosio je 50 godina (raspon: 19 do 70); 45,8% bili su muškarci; 4,8% bili su crnci;; 9,3% imalo je depresiju ili bipolarni poremećaj u anamnezi; 73,3%
For patients coadministered ribavirin refer to the Summary of Product Characteristics of ribavirin. 
Za bolesnice koje istodobno primaju ribavirin, pročitajte i Sažetak opisa svojstava lijeka za ribavirin.
Mechanism: CYP3A4 inhibition by ritonavir and UGT inhibition by paritaprevir, ombitasvir and dasabuvir. 
Mehanizam: inhibicija CYP3A4 ritonavirom te inhibicija UGT-a koju uzrokuju paritaprevir, ombitasvir i dasabuvir.
Outcome for subjects without SVR12 On-treatment virologic failure Post-treatment relapse Other 
Virološki neuspjeh tijekom liječenja Relaps nakon liječenja
Ethinylestradiol-containing oral contraceptives are contraindicated (see section 4.3). 
Oralni kontraceptivi koji sadrže etinilestradiol su kontraindicirani (vidjeti dio
Viekirax and dasabuvir with investigator chosen ribavirin dose for 24 weeks 
Viekirax i dasabuvir tijekom 24 tjedna s ribavirinom čiju je dozu odredio ispitivač
Mechanism: UGT1A1 inhibition by paritaprevir, ombitasvir and dasabuvir. 
Mehanizam: UGT1A1 inhibicija paritaprevir om, ombitasviro m i dasabuviro m.
Viekirax safety and efficacy have been established in combination with dasabuvir and/or ribavirin. 
Istodobna primjena s drugim antiviroticima koji djeluju izravno na HCV Ustanovljene su sigurnost i djelotvornost lijeka Viekirax u kombinaciji s dasabuvirom i/ili ribavirinom.
CYP3A4 inhibition by ritonavir and increase in paritaprevir exposures may be due to OATP/BCRP/ P-gp inhibition by ciclosporin. 
Učinak na ciklosporin posljedica je inhibicije CYP3A4 ritonavirom, dok bi povećanje izloženosti paritaprevir u moglo biti posljedica inhibicije OATPa/BCRP
Decrease digoxin dose by 30-50%. 
NP Dozu pravastatina treba smanjiti za 50%.
SVR12 for genotype 1b-infected peginterferon+ribavirin-experienced subjects in PEARL II 
Tablica 11. SVR12 za ispitanike prethodno liječene peginterferonom i ribavirinom s infekcijom genotipom 1b u ispitivanju PEARL II
↔ es citalopram 
Sdezmetilcitalopram
Posology 
buprenorfin
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. 
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%
300 mg single dose 
300 mg pojedinačna doza paracetamol
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. 
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.
↑ telithromycin ↑ paritaprevir 
↑ vorikonazol ↑ dasabuvir ↑ paritaprevir
MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET
↑ naloxone 
↑ dronedaron
Buprenorphine / naloxone 
buprenorfin/ nalokson
No dose adjustment needed for Viekirax with ombitasvir paritaprevir 
Nije potrebna prilagodba doze lijeka Viekirax primijenjenog s ombitasvir paritaprevir dasabuvir
Mechanism: OATP1B inhibition by paritaprevir and BCRP inhibition by paritaprevir, ritonavir or dasabuvir. 
Mehanizam: paritaprevir inhibira OATP1B, a paritaprevir, ritonavir ili dasabuvir inhibiraju BCRP.
SAPPHIRE II 
SAPPHIRE-I
NAME OF THE MEDICINAL PRODUCT Viekirax 12.5 mg / 75 mg / 50 mg tablets ombitasvir / paritaprevir / ritonavir 
Viekirax 12,5 mg / 75 mg / 50 mg tablete ombitasvir / paritaprevir / ritonavir
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. 
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.
300/100 mg once daily (administered 12 hours apart) 
Kliničke napomene jedanput na dan (primijenjen u razmaku od 12 sati)
CYP3A4 induction by phenobarbital. 
Mehanizam: Indukcija CYP3A4 fenobarbital om.
Diltiazem Verapamil 
Kliničke napomene diltiazem verapamil
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. 
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.
While no change to the pharmacokinetics of warfarin is expected, close 
Iako nije očekivana promjena farmakokinetike varfarina, preporučuje se pomni nadzor INR-a kod primjene svih antagonista vitamina K.
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). 
kontracepcija samo progestinom ili nehormonske metode) prije započinjanja liječenja lijekom Viekirax i dasabuvirom (vidjet dijelove 4.3 i 4.5).
Mechanism: CYP2C19 induction and CYP3A4 inhibition by ritonavir 
Mehanizam: ritonavir inducira CYP2C19 i inhibira CYP3A4
Arm A: Viekirax and dasabuvir + RBV (12 weeks) 
skupina A: Viekirax i dasabuvir + RBV (12 tjedana) skupina B: Viekirax i dasabuvir + RBV (24 tjedna)
Very common: may affect more than 1 in 10 people 
• Rijetke: mogu se javiti u do 1 na 1000 osoba
and dasabuvir 
dasabuvira
TURQUOISE-I: treatment-naïve or pegIFN + RBV-experienced with HIV-1 co-infection, without cirrhosis or with compensated cirrhosis 
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:
If the combination is used, repeated ECG-monitoring should be done, see section 4.4. 
Ako se primjenjuje kombinacija, potrebno je redovito EKG
Baseline platelet count, median (× 109/L) 
Početni broj trombocita, medijan (× 109/L) < 90, n (%)
2a 
Ostalo a.
STATEMENT OF ACTIVE SUBSTANCE(S) Each film coated tablet contains 12.5 mg of ombitasvir, 75 mg of paritaprevir and 50 mg of ritonavir. 
Jedna filmom obložena tableta sadrži 12,5 mg ombitasvira, 75 mg paritaprevira i 50 mg ritonavira.
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. 
0,43 do 1,87 nM; n=11) odnosno 0,06 nM (raspon: 0,03 do 0,09 nM; n=9).
CYP3A4/Pgp inhibition. 
CYP3A4 inhibicija
Pitavastatin Mechanism: OATP1B inhibition by paritaprevir 
Mehanizam: paritaprevir inhibira OATP1B
NAME OF THE MEDICINAL PRODUCT Viekirax 12.5 mg / 75 mg / 50 mg film-coated tablets ombitasvir / paritaprevir / ritonavir 
Uputa o lijeku: Informacija za bolesnika Viekirax 12,5 mg/75 mg/50 mg filmom obložene tablete ombitasvir/paritaprevir/ritonavir
Mechanism: P-gp inhibition by paritaprevir, ritonavir and dasabuvir. 
Mehanizam: inhibicija Pgp-a paritaprevir om, ritonavirom i dasabuviro m
Mechanism: CYP3A4 inhibition by cobicistat 
Mehanizam: CYP3A4 inhibicija kobicistato m
• Monitor for clinical signs and symptoms of hepatic decompensation (such as ascites, hepatic encephalopathy, variceal haemorrhage). 
• Potreban je nadzor zbog moguće pojave kliničkih znakova i simptoma dekompenzacije jetre
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 
Vrijednost EC50 paritaprevira protiv stanične linije replikona 2a-JFH-1 iznosila je 5,3 nM, dok su vrijednosti EC50
Mechanism: CYP3A4 induction by phenytoin. 
Mehanizam: Indukcija CYP3A4 fenitoinom
SVR12 % (n/N) 
SVR12 % (n/N) Ishodi za ispitanike bez SVR12
Expected: ↑ sildenafil 
↑ sildenafil
Viekirax and dasabuvir with RBV 12 weeks 
Viekirax i dasabuvir s RBV-om
Clinical trials in subjects with genotype 4 chronic hepatitis C PEARL- I- genotype 4, treatment-naïve or pegIFN + RBV experienced without cirrhosis Design: 
PEARL- I - ispitanici s infekcijom genotipom 4, prethodno neliječeni ili prethodno liječeni pegIFN i RBV bez ciroze
Expected 
Vidjeti
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). 
povećava koncentracije tih lijekova u plazmi; preporuča se rutinsko kliničko praćenje za lijekove s uskim terapijskim indeksom (tj. levotirkosin).
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). 
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%
ANTIFUNGALS Ketoconazole 400 mg once daily 
IMUNOSUPRESIVI ciklosporin 30 mg jedanput na dan pojedinačna doza Mehanizam:
Mechanism: CYP3A4 induction by carbamazepine 
Mehanizam: Indukcija CYP3A4 karbamazep inom.
Mechanism: OATP1B/BC RP inhibition by paritaprevir 
Mehanizam: paritaprevir inhibira OATP1B/ BCRP
TURQUOISE-III: treatment-naïve or pegIFN + RBV-experienced with compensated cirrhosis 
TURQUOISE-III: ispitanici s kompenziranom cirozom, prethodno neliječeni ili prethodno liječeni pegIFN i RBV Dizajn:
↑ dabigatran etexilate 
↑ dabigatran eteksilat
OPIOIDS Methadone 
ANTITUMORSKI LIJEKOVI enzalutamid mitotan
Cyclobenzapr ine 5 mg single dose 
Očekuje se sličan učinak kao kod primjene kombinacije ciklobenzap rin 5 mg pojedinačna doza
↑ digoxin 
↑ nalokson
Duloxetine 60 mg single dose 
DIURETICI furosemid pojedinačna doza od 20 mg
20-120 mg once daily 
OPIOIDI metadon 20-120 mg jedanput na dan5
Quetiapine 
pitavastatin
↑ repaglinide 
↑ amlodipin
Viekirax without dasabuvir atazanavir 
Viekirax bez dasabuvira escitalopram
Efavirenz/ emtricitabine/ tenofovir disoproxil fumarate mg once daily 
Očekuje se sličan učinak kao kod primjene kombinacije efavirenz/ emtricitabin /tenofovir dizoproksil fumarat
Retreatment 
Supstitucija
Mechanism: CYP3A4 and/or P-gp inhibition by itraconazole, posaconazole and paritaprevir/ ritonavir/ombi tasvir 
Mehanizam: itrakonazol, posakonazol i paritaprevir/ ritonavir/om bitasvir inhibiraju CYP3A4 i/ili P-gp.
TURQUOISE-II - treatment-naïve or pegIFN + RBV-experienced with compensated cirrhosis 
TURQUOISE-II - ispitanici s kompenziranom cirozom, prethodno neliječeni ili prethodno liječeni pegIFN i RBV
Trazodone 
paritaprevir trazodon
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). 
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
SVR12 window. 
CYP2D6.
Coadministration with enzyme inducers may increase the risk of adverse events and ALT elevations (see Table 2). 
Farmakodinamičke interakcije Istodobna primjena s induktorima enzima može povećati rizik od nuspojava i porasta razine ALT-a
Mechanism: CYP3A4/Pgp inhibition by ketoconazole and paritaprevir/ ritonavir/ ombitasvir 
Mehanizam: ketokonazol i paritaprevir/ ritonavir/om bitasvir inhibiraju CYP3A4/Pgp.
AGATE-1 -treatment-naïve or pegIFN +RBV experienced patients with compensated cirrhosis 
I - ispitanici prethodno neliječeni ili prethodno liječeni pegIFN i RBV s kompenziranom cirozom Dizajn:
(0.81-0.96) (0.88-1.02) monitoring of INR is recommended with all vitamin K antagonists. 
(0,92-1,38) (1,21-1,59) kombinaciji s dasabuvirom ili bez njega.
↑ levothyroxine 
↑ levotiroksin
Viekirax + dasabuvir dolutegravir 
Viekirax bez dasabuvira buprenorfin
If clinical signs are present, their duration and severity are reduced. 
Ako su klinički znakovi prisutni, njihovo trajanje i ozbiljnost se smanjuju.
ATC vet code: QI05AX. 
ATC vet kod: QI05AX.
After inoculation, the virus does not multiply in the horse but expresses the protective proteins. 
Nakon inokulacije virus se u konju ne množi, ali izražava zaštitne proteine.
Carbomer ......................................................................................................................................... 4 mg 
Karbomer ......................................................................................................................................... 4 mg
Date of first authorisation: 05/08/2011 Date of last renewal: 17/05/2016 
Datum prvog odobrenja: 05/08/2011 Datum posljednjeg produljenja odobrenja: 17/05/2016
1 dose 
1 doza.
1 x 1 dose 2 x 1 dose 5 x 1 dose 10 x 1 dose 
1 x 1 doza 2 x 1 doza 5 x 1 doza 10 x 1 doza
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 
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
Protect from light 
Zaštiti od svjetla
Shelf life of the veterinary medicinal product as packaged for sale: 27 months. 
Rok valjanosti veterinarsko-medicinskog proizvoda kad je zapakiran za prodaju: 27 mjeseci.
Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP. 
Ne primjenjivati ovaj veterinarsko-medicinski proizvod poslije isteka roka valjanosti koji je naznačen na etiketi nakon EXP.
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. 
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
In order to achieve full protection, the full vaccination course of two doses must be given. 
Za postizanje potpune zaštite, moraju se dati dvije doze cjepiva.
Vaccination may interfere with existing sero-epidemiological surveys. 
Cijepljenje može utjecati na postojeća sero-epidemiološke ispitivanja.
A hypersensitivity reaction may occur in rare cases, which may require appropriate symptomatic treatment. 
Može se rijetko javiti hipersenzibilna reakcija, koja može zahtijevati odgovarajući simptomatski tretman.
Sodium chloride Disodium phosphate dihydrate Potassium dihydrogen phosphate Water for injections 
Natrijev klorid Dinatrijev fosfatdihidrat Kalijev dihidrogenfosfat Voda za injekcije
To stimulate active immunity against West Nile virus. 
Za stimulaciju aktivnog imuniteta protiv virusa zapadnog Nila.
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. 
Međutim, kako IgM odgovor nakon cijepljenja nije čest, pozitivan rezultat IgM-ELISA testa je čvrst indikator prirodne infekcije virusom zapadnog Nila.
Pharmacotherapeutic group: Immunologicals for equidae, other immunologicals. 
Farmakoterapijska grupa: imunološki lijekovi za ekvide, drugi imunološki lijekovi.
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. 
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.
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. 
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.
Homogeneous opalescent suspension for injection Each dose of 1 ml contains: 
Homogena opalescentna suspenzija za injekciju Svaka doza od 1 ml sadrži:
Store and transport refrigerated (2 °C-8 °C). 
Čuvati i prevoziti rashlađeno (2 C-8 C).
Active immunisation of horses from 5 months of age against West Nile disease by reducing the number of viraemic horses. 
Aktivna imunizacija konja starijih od 5 mjeseci protiv groznice zapadnog Nila smanjenjem broja viremičnih konja.
• 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. 
• Docjepljivanje: dostatna bi se zaštita trebala postići docjepljivanjem godišnjom poticajnom injekcijom od jedne doze iako ovaj raspored nije u potpunosti validiran.
Apathy, usually resolving within two days, and reduced appetite may be observed in rare cases the day after vaccination. 
Apatija koja obično prestaje za dva dana i smanjeni tek mogu se primijetiti rijetko, dan nakon cijepljenja.
Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities. 
Odlagati otpadne materijale uranjanjem u kipuću vodu, spaljivati, uranjati u prikladno dezinfekcijsko sredstvo odobreno za upotrebu od strane nadležnog tijela.
• Primary vaccination course: first injection from 5 months of age, second injection 4-6 weeks later, 
• Prvo cijepljenje: prva injekcija u dobi 5 mjeseci, druga injekcija 4- 6 tjedana kasnije.
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. 
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.
Type I glass vial, with a butyl elastomer closure, sealed with an aluminium cap. 
Tip I staklena bočica zatvorena gumenim čepom i aluminijskom kapicom.
DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION 
DOZIRANJE ZA SVAKU CILJNU VRSTU ŽIVOTINJA, NAČIN I PUTEVI
Box of 1, 2, 5 or 10 vial(s) of 1 dose. 
Kutija s 1, 2, 5 ili 10 bočica sa po jednom dozom.
Administer one dose of 1 ml, by intramuscular injection, preferably in the neck region, according to the following schedule: 
Primijenite dozu od 1 ml, intramuskularno , najbolje u području vrata, prema sljedećem rasporedu:
Laboratoire Porte des Alpes Rue de l'Aviation 69800 Saint Priest France 
Laboratoire Porte des Alpes Rue de l'Aviation 69800 Saint Priest Francuska
PACKAGE SIZE 
VELIČINA PAKIRANJA
Onset of immunity: 4 weeks after the first dose of the primary vaccination course. 
Početak imuniteta: 4 tjedna nakon prve doze primarnog cijepljenja.
Homogeneous opalescent suspension. 
Homogena opalescentna suspenzija.
Duration of immunity: 1 year after a full primary vaccination course of two injections. 
Trajanje imuniteta: 1 godina nakon potpunog primarnog cijepljenja s dvije doze.
As a consequence, these proteins induce protective immunity against equine West Nile disease. 
Posljedica toga je da ti proteini induciraju zaštitni imunitet protiv virusa zapadnog Nila.
However the vaccine has also been shown to be safe in a field study including animals of 2 months of age. 
Međutim, cjepivo se također pokazalo neškodljivim u terenskom ispitivanju na životinjama starim 2 mjeseca.