natgillin/translations-raw huggingface dataset:
Amiodaron, dronedaron mod uregelmæssig hjerterytme astemizol, terfenadin mod allergisymptomer - fås i håndkøb atorvastatin, lovastatin, simvastatin mod forhøjet kolesterol carbamazepin, phenytoin, phenobarbital mod epilepsi cisaprid til lindring af visse maveproblemer clarithromycin, fusidinsyre, rifampicin, telithromycin mod bakterieinfektioner colchicin hos patienter, som har alvorlige problemer med deres lever eller nyrer mod urinsyregigt conivaptan til normalisering af natrium i blodet efavirenz, etravirin, lopinavir/ritonavir, saquinavir, tipranavir, nevirapin, indinavir, cobicistat mod hiv-infektion enzalutamid mod prostatakræft ergotamin, dihydroergotamin mod migræne ergonovin, methylergometrin i forbindelse med fødsler ethinylestradiol-holdige lægemidler som f.eks. de fleste p-piller og p-ringe som prævention itraconozol, ketoconazol, posaconazol, voriconazol mod svampeinfektioner midazolam, triazolam (når de tages gennem munden) 
These medicines may be available without a prescription atorvastatin, lovastatin, simvastatin to lower blood cholesterol carbamazepine, phenytoin, phenobarbital for epilepsy cisapride for relieving certain stomach problems clarithromycin, fusidic acid, rifampicin, telithromycin for bacterial infections colchicine in patients who have severe problems with their liver or kidneys for treating gout attacks conivaptan for making the sodium levels in the blood normal efavirenz, etravirine, lopinavir/ritonavir, saquinavir, tipranavir, nevirapine, indinavir, cobicistat for HIV infection enzalutamide for prostate cancer ergotamine, dihydroergotamine for migraine headaches ergonovine, methylergometrine used in childbirth ethinylestradiol-containing medicines such as those contained in most contraceptive pills and vaginal rings used for contraception for contraception itraconozole, ketoconozole, posaconazole, voriconazole for fungal infections midazolam, triazolam (when taken by mouth) for anxiety or trouble sleeping mitotane for symptoms of malignant tumours of the adrenal glands pimozide, lurasidone for schizophrenia quetiapine for schizophrenia, bipolar disorder and major depressive disorder quinidine for abnormal heart rhythms or malaria ranolazine for chronic angina (chest pain)
Indvirkningen af ombitasvir på paritaprevir/ritonavir og dasabuvir Når ombitasvir var til stede, faldt eksponeringen for paritaprevir minimalt (ændring på 5-27 %), mens eksponeringen for dasabuvir steg med ca. 30 %. 
In the presence of ombitasvir, paritaprevir exposures were minimally affected (5% to 27% change) while dasabuvir exposures increase by approximately 30%.
Samtidig administration af Viekirax med eller uden dasabuvir og lægemidler, der er stærke hæmmere af CYP3A, forventes at øge paritaprevir plasmakoncentration og må derfor ikke administreres samtidig med Viekirax (se pkt. 
Co-administration of Viekirax with or without dasabuvir with medicinal products that are strong inhibitors of CYP3A4 is expected to increase paritaprevir plasma concentrations and must not be co-administered with Viekirax (see section 4.5).
Samtidig administration af ethinylestradiol kan øge risikoen for forhøjet ALAT (se pkt. 
Coadministration with ethinylestradiol may increase the risk of ALT elevations (see sections 4.3 and 4.4).
GT1b Gruppe A: Viekirax og dasabuvir med ribavirin Gruppe B: Viekirax og dasabuvir Behandlingsnaive og peginterferon/ribavirin-erfarne, med kompenseret cirrose 
GT1b Arm A: Viekirax and dasabuvir + RBV Arm B: Viekirax and dasabuvir Treatment-naïve and peginterferon+ribavirin -experienced, with compensated cirrhosis
Lever og galdeveje: Der er observeret dekompenseret leversygdom og leversvigt under behandling med Viekirax med eller uden dasabuvir og med eller uden ribavirin (se pkt. 
Hepatobiliary Disorders: Hepatic decompensation, hepatic failure have been observed during treatment with Viekirax with and without dasabuvir and with or without ribavirin (see section 4.4).
randomiseret globalt multicenter studie, ikke-blindet 
randomised, global multicentre, open-label
Viekirax 12,5 mg/75 mg/50 mg filmovertrukne tabletter ombitasvir/paritaprevir/ritonavir 
Viekirax 12.5 mg/75 mg/50 mg film-coated tablets ombitasvir/paritaprevir/ritonavir
Forventet: ↑ Sekale-derivater 
↑ ergot derivatives
Simvastatin, lovastatin og atorvastatin er kontraindicerede (se pkt. 
Simvastatin, lovastatin and atorvastatin are contraindicated (see section 4.3 and 4.5).
MIDDEL TIL TROMBOSEPROFYLAKSE Ticagrelor 
ANTITPLATELET AGENTS Ticagrelor
Viekirax og dasabuvir med RBV Gruppe A 12 uger N = 31 
Viekirax and dasabuvir with RBV Arm A 12 Weeks N = 31
TURQUOISE-I: behandlingsnaive eller pegIFN + RBV-erfarne med samtidig HIV-1 infektion, uden eller med kompenseret cirrose 
TURQUOISE-I: treatment-naïve or pegIFN + RBV-experienced with HIV-1 co-infection, without cirrhosis or with compensated cirrhosis
Viekirax er kontraindiceret hos patienter med svært nedsat leverfunktion (Child-Pugh C) (se pkt. 
Viekirax is contraindicated in patients with severe hepatic impairment (Child-Pugh C) (see sections 4.3 and 5.2).
De behandlede patienter (N = 63) havde en gennemsnitsalder på 51 år (interval: 31-69), 24 % var sorte, 19 % havde kompenseret cirrose, 67 % var HCV-behandlingsnaive, 33 % havde oplevet behandlingssvigt med pegIFN/RBV, og 89 % havde HCV genotype 1a-infektion. 
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.
Det anbefales ikke at bruge Viekirax til patienter med moderat nedsat leverfunktion (Child-Pugh B). 
Viekirax is not recommended in patients with moderate hepatic impairment (Child-Pugh B).
Behandling: Viekirax og dasabuvir uden ribavirin i 12 uger 60 patienter blev randomiseret og behandlet, og 60/60 (100 %) opnåede SVR 12. 
60 patients were randomized and treated, and 60/60 (100%) achieved SVR12.
≥ 90 x 109/l og albumin ≥ 35 g/l), var recidivraten den samme for patienter behandlet i henholdsvis 12 og 
In subjects with all three favourable baseline laboratory values (AFP < 20 ng/mL, platelets ≥ 90 x 109/L, and albumin ≥ 35 g/L), relapse rates were similar in subjects treated for 12 or 24 weeks.
LÆGEMIDLETS NAVN Viekirax 12,5 mg/75 mg/50 mg tabletter ombitasvir/paritaprevir/ritonavir 
NAME OF THE MEDICINAL PRODUCT Viekirax 12.5 mg / 75 mg / 50 mg tablets ombitasvir / paritaprevir / ritonavir
Hos patienter med samtidig HIV-infektion skal der tages nøje højde for lægemiddelinteraktioner (se nærmere i pkt. 
Drug interactions need to be carefully taken into account in the setting of HIV co-infection (for details see section 4.5, Table 2).
Viekirax' sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt. 
The safety and efficacy of Viekirax in children below 18 years have not been established.
Recidivraten hos patienter med genotype 1a og cirrose ud fra laboratorieværdier ved baseline vises i tabel 
Relapse rates in GT1a cirrhotic subjects by baseline laboratory values are presented in Table 13.
Viekirax med dasabuvir rosuvastatin 
Viekirax + dasabuvir rosuvastatin
Farmakokinetikken for kombinationen af ombitasvir 25 mg, paritaprevir 200 mg og ritonavir 100 mg med dasabuvir 400 mg blev undersøgt hos patienter med let nedsat leverfunktion (Child-Pugh A), moderat nedsat leverfunktion (Child-Pugh B) og svært nedsat leverfunktion (Child-Pugh C). 
Pharmacokinetics of the combination of ombitasvir 25 mg, paritaprevir 200 mg, and ritonavir 100 mg, with dasabuvir 400 mg were evaluated in subjects with mild (Child-Pugh A), moderate (Child-Pugh B) and severe (Child-Pugh C) hepatic impairment.
Selvom der ikke forventes ændringer af warfarins farmakokinetik, anbefales tæt monitorering af INR sammen med alle vitamin K-antagonister. 
While no change to the pharmacokinetics of warfarin is expected, close
Samlet SVR12 Resultat for patienter uden SVR12 VF under behandlinga Recidiv b 
Outcome for subjects without SVR12 On-treatment VF Relapse
4.4 (Behandling af patienter med samtidig HIV-infektion) og pkt. 
For dosing recommendations with HIV antiviral agents, refer to section 4.4 (Treatment of patients with HIV co-infection) and section 4.5.
Viekirax og dasabuvir + RBV (12 uger) n/N % 95 %-KI 
Viekirax and dasabuvir with RBV for 12 weeks n/N % 95% CI
Tabel 10. SVR12 for peginterferon/ribavirin-erfarne genotype 1-smittede forsøgspersoner i SAPPHIRE II 
SVR12 for genotype 1-infected peginterferon+ribavirin-experienced subjects in SAPPHIRE-II
Klinisk kommentar dasabuvirs hæmning af UGT1A1 og ritonavirs hæmning af CYP3A4 
Clinical Comments dasabuvir and ombitasvir and CYP3A4 inhibition by ritonavir
Viekirax og dasabuvir (12 uger) Med RBV 
Viekirax and dasabuvir for 12 weeks With RBV
Samme virkning forventes som ved Viekirax med dasabuvir. 
Similar effect expected as observed with Viekirax + dasabuvir.
I TURQUOISE I var SVR12-raterne hos HCV-forsøgspersoner med samtidig HIV-I-infektion konsistente med SVR12-raterne hos forsøgspersonerne i fase 3-studier, der kun var inficeret med HCV. 7 ud af 7 forsøgspersoner med genotype 1b-infektion og 51 ud af 56 forsøgspersoner med genotype 1a-infektion opnåede SVR12. 
In TURQUOISE-I, the SVR12 rates in HCV/HIV-1 co-infected subjects were consistent with SVR12 rates in the phase 3 trials of HCV mono-infected subjects.
Behandling med darunavir plus Viekirax uden dasabuvir anbefales ikke (↑ paritaprevir). 
Treatment with darunavir + Viekirax without dasabuvir is not ombitasvir paritaprevir
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 12,5 mg ombitasvir, 75 mg paritaprevir og 50 mg ritonavir. 
STATEMENT OF ACTIVE SUBSTANCE(S) Each film coated tablet contains 12.5 mg of ombitasvir, 75 mg of paritaprevir and 50 mg of ritonavir.
Viekirax med dasabuvir duloxetin 
Viekirax + dasabuvir duloxetine
Samtidig brug er kontraindiceret (se pkt. 
Concomitant use is contraindicated (See section
Det anbefales at afbryde behandlingen med fluvastatin og pitavastatin midlertidigt, så længe 
A temporary suspension of fluvastatin and pitavastatin is recommended for the duration of treatment with Viekirax.
Viekirax med dasabuvir sofosbuvir 
Viekirax with dasabuvir
De behandlede patienter (N = 631) havde en median alder på 52 år (interval: 18-70); 54,5 % var mænd; 5,4 % var sorte; 15,2 % havde depression eller bipolar lidelse i anamnesen; 79,1 % havde et HCV-rnaniveau på mindst 800.000 IE/ml ved baseline; 15,4 % havde portal fibrose (F2), og 8,7 % havde bridging fibrose (F3); 67,7 % havde HCV genotype 1a-infektion; 32,3 % havde HCV genotype 1b-infektion. 
Treated subjects (N=631) had a median age of 52 years (range: 18 to 70); 54.5% were male; 5.4% were Black; 15.2% had a history of depression or bipolar disorder; 79.1% had baseline HCV RNA levels of at least 800,000 IU/mL; 15.4% had portal fibrosis (F2) and 8.7% had bridging fibrosis (F3); 67.7% had HCV genotype 1a infection; 32.3% had HCV genotype 1b infection.
Tidligere ikke-respondere på pegIFN/RBV 
Prior pegIFN/RBV relapser
Tacrolimus 2 mg enkeltdosis 
Diazepam2 mg single dose
↑ voriconazole ↑ dasabuvir ↑ paritaprevir 
↓ voriconazole ↑ paritaprevir
Dosisjustering er ikke nødvendig for metadon og Viekirax med eller uden dasabuvir. 
No dose adjustment is necessary for methadone and Viekirax with or without dasabuvir.
Interaktionen var af samme størrelsesorden som for Viekirax med dasabuvir. 
The magnitude of interaction was similar to that observed with Viekirax + dasabuvir.
MIDLER MOD URINSYREGIGT Colchicin 
ANTI-GOUT Colchicine
↔ lopinavir Interaktionen var af samme størrelsesorden som for Viekirax med dasabuvir. 
↔ lopinavir The magnitude of interaction was similar to that observed with Viekirax + dasabuvir.
LÆGEMIDLETS NAVN 
Purpose of the medicine
Ikke 
NA
Den anbefalede dosis atazanavir er 300 mg, uden 
The recommended dose of atazanavir is 300 mg, without ritonavir, in combination with Viekirax with dasabuvir.
Dosisjustering er ikke nødvendig for for carisoprodol; øgning af dosis, hvis klinisk indiceret ombitasvir paritaprevir ↔ dasabuvir 
NA No dose adjustment required for carisoprodol; increase dose if clinically indicated.
Mekanisme: Ritonavirs inducerende virkning på CYP2C19 . 
Mechanism: CYP2C19 induction by ritonavir.
Ikke undersøgt: Samme virkning forventes som observeret for Viekirax med dasabuvir. 
Not studied: Similar effect is expected as observed with Viekirax + dasabuvir.
↑quetiapin ↑ lurasidon 
↑ quetiapine ↑ lurasidone
Viekirax uden dasabuvir emtricitabin 
Viekirax without dasabuvir omeprazole
De behandlede forsøgspersoner havde en median alder på 56 år (interval: 32-81), 50 % var behandlingsnaive, 28 % var tidligere ikke-respondere på pegIFN/RBV; 10 % var tidligere delvise respondere på pegIFN/RBV, 13 % havde tidligere recidiv efter pegIFN/RBV-behandling; 70 % var mænd, 17 % var sorte, 73 % havde et HCV-rna-niveau på mindst 800.000 IE/ml ved baseline; 17 % havde et trombocyttal på under 90 x 109/l og 4 % havde albuminniveau på under 3,5 mg/dl. 
Viekirax with weight-based ribavirin for 12 or 16 weeks Subjects had a median age of 56 years (range: 32 to 81); 50% were treatment-naïve, 28% were prior pegIFN/RBV null responders; 10% were prior pegIFN/RBV partial responders, 13% were prior pegIFN/RBV relapsers; 70% were male; 17% were Black; 73% had baseline HCV RNA levels of at least 800,000 IU per mL; 17% had platelet counts of less than 90 x 109 per L; and 4% had albumin less than 3.5 mg per dL.
↑ pravastatin Interaktionen var af samme størrelsesorden som for Viekirax med dasabuvir. 
↑ pravastatin The magnitude of interaction was similar to that observed with Viekirax + dasabuvir.
Bivirkninger observeret efter markedsføring 
Post Marketing Adverse Reactions
Det anbefales ikke at bruge Viekirax til patienter med moderat nedsat leverfunktion (Child-Pugh B) (se pkt. 
Viekirax is not recommended in patients with moderate hepatic impairment (Child-Pugh B) (see sections 4.4 and 4.8).
30 mg enkeltdosis én gang dagligt 
30 mg once daily single dose3
Mekanisme: Itraconazols, posaconazols og paritaprevir/ ritonavir/ ombitasvirs hæmning af CYP3A4 og/eller P-gp. 
Mechanism: CYP3A4 and/or P-gp inhibition by itraconazole, posaconazole and paritaprevir/ ritonavir/ombi tasvir
Andetc * Ombitasvir-tabletter, paritaprevir-tabletter og ritonavir-kapsler givet separat. 
Overall SVR12 Outcome for subjects without SVR12 On-treatment VF Relapse Other * Ombitasvir tablets, paritaprevir tablets and ritonavir capsules administered separately.
2 mg enkelt dosis 
2 mg single dose
NATURLÆGEMIDLER Prikbladet perikon (hypericum perforatum) 
HERBAL PRODUCTS St. John's Wort (hypericum perforatum)
Mekanisme: enzalutamid eller mitotans inducerende virkning på CYP3A4 
Mechanism: CYP3A4 induction enzalutamide or mitotane.
↓ voriconazole ↑ paritaprevir ↑ dasabuvir 
↑ paritaprevir ↑ dasabuvir
Mekanisme: Øget raltegravireksponering kan skyldes paritaprevir, ombitasvir og dasabuvirs hæmning af UGT1A1. 
Increase in raltegravir exposures may be due to UGT1A1 inhibition by paritaprevir, ombitasvir.
De behandlede patienter (N = 305) havde en median alder på 54 år (interval: 19-70); 65,2 % var mænd; 11,8 % var sorte; 20,7 % havde depression eller bipolar lidelse i anamnesen;; 86,6 % havde et HCV-rnaniveau på mindst 800.000 IE/ml ved baseline; 18,4 % havde portal fibrose (F2), og 17,7 % havde bridging fibrose (F3). 
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).
Mekanisme: Proteasehæmmeres hæmning af CYP3A4. 
CYP3A4 inhibition by protease inhibitors.
Dosisjustering er ikke nødvendig for dolutegravir ved samtidig administration med Viekirax med eller uden dasabuvir. 
No dose adjustment needed for dolutegravir when coadministered with Viekirax with or without dasabuvir.
Mekanisme: Ketoconazols og paritaprevir/ ritonavir/omb itasvirs hæmning af CYP3A4 og P-gp. 
Mechanism: CYP3A4/Pgp inhibition by ketoconazole and paritaprevir/ ritonavir/ ombitasvir
randomiseret, globalt multicenter studie, ikke-blindet Behandling: Viekirax og dasabuvir uden ribavirin eller med ribavirin baseret på vægt i 12 uger 
Viekirax and dasabuvir without ribavirin or with weight-based ribavirin for 12 weeks
Viekirax med atazanavir 
Viekirax + dasabuvir atazanavir
Virologisk svigt under behandling 
Hepatic impairment
Karateristika 
Posology
Nedsat nyrefunktion 
NA Reduce pravastatin dose by
Mekanisme: Paritaprevirs hæmning af OATP1B/ BCRP. 
Mechanism: OATP1B/BC RP inhibition by paritaprevir
↑ranolazin 
↑ voriconazole
Opbevaring 
Retreatment
OATP1B1/B 3 og CYP3A og den yderligere ritonavirdosis' hæmning af CYP3A. 
Mechanism: Increase in paritaprevir exposures may be due to inhibition of OATP1B1/B3 and CYP3A by atazanavir and CYP3A by the additional dose of ritonavir.
Viekirax og dasabuvir med ribavirin 12-uger-gruppen 
Viekirax and dasabuvir with weight-based ribavirin for 12 or 24 weeks
Ritonavirs hæmning af CYP3A4. 
CYP3A4 inhibition by ritonavir.
Viekirax og dasabuvir med ribavirin 
Viekirax and dasabuvir + ribavirin
1 inhalator (60 doser) 3 inhalatorer (3x120 doser) 3 inhalatorer (3x60 doser) 
MA (EU) number (Invented) name Strength
Inhalator Inhalator Inhalator 
Immediate Packaging
Styrke 
Pharmaceutical Form
MF (EU)-nummer Særnavn 
MA (EU) Number
Vaccination kan interferere med igangværende seroepidemiologiske undersøgelser. 
Vaccination may interfere with existing sero-epidemiological surveys.
Hvis kliniske symptomer er til stede, vil varighed og sværhedsgrad blive reduceret. 
If clinical signs are present, their duration and severity are reduced.
Efter inokulering multipliceres virus ikke hos hest men afgiver beskyttende proteiner. 
After inoculation, the virus does not multiply in the horse but expresses the protective proteins.
Dato for første markedsføringstilladelse: 05/08/2011 Dato for seneste fornyelse af markedsføringstilladelse: 17/05/2016 
Date of first authorisation: 05/08/2011 Date of last renewal: 17/05/2016
• Revaccination: efter årlig revaccination med en enkelt dosis skulle tilstrækkelig grad af beskyttelse opnås, skønt dette program ikke er blevet fuldstændig valideret. 
• 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.
1 x 1 dosis 2 x 1 dosis 5 x 1 dosis 10 x 1 dosis 
1 x 1 dose 2 x 1 dose 5 x 1 dose 10 x 1 dose
Hyppigheden af bivirkninger er defineret som: - Meget almindelige (mere end 1 ud af 10 dyr, der viser bivirkninger i løbet af en behandling) - Almindelige (mere end 1, men færre end 10 dyr ud af 100 dyr) - Ualmindelige (mere end 1, men færre end 10 dyr ud af 1.000 dyr) - Sjældne (mere end 1, men færre end 10 dyr ud af 10.000 dyr) - Meget sjældne (færre end 1 dyr ud af 10.000 dyr, herunder isolerede rapporter) 
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).
For at opnå fuld beskyttelse er det nødvendigt at give hele vaccinationsprogrammet på 2 doser. 
In order to achieve full protection, the full vaccination course of two doses must be given.
Opbevares og transporteres nedkølet (2 °C-8 °C). 
Store and transport refrigerated (2 °C-8 °C).
Yderligere information om dette veterinærlægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu. 
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
EU/2/11/129/001 1 x 1 dosis EU/2/11/129/002 2 x 1 dosis EU/2/11/129/003 5 x 1 dosis EU/2/11/129/004 10 x 1 dosis 
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
Opbevaringstid for veterinærlægemidlet i salgspakning: 27 måneder. 
Shelf life of the veterinary medicinal product as packaged for sale: 27 months.
Affaldsmateriale skal destrueres ved kogning, forbrænding eller opblanding i et egnet desinfektionsmiddel, som er godkendt til brug af den relevante kompetente myndighed. 
Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.
For at stimulere aktiv immunitet mod West Nile virus. 
To stimulate active immunity against West Nile virus.
Aktiv immunisering af heste fra 5-måneders alderen mod West Nile sygdom ved at nedsætte antallet af viræmiske heste. 
Active immunisation of horses from 5 months of age against West Nile disease by reducing the number of viraemic horses.
Hjælpestofferne (inklusive adjuvanser) som er anført i punkt 6.1 af SPC'et er enten tilladte hjælpestoffer, hvor tabel 1 i bilaget til Kommissionens forordning (EU) Nr. 37/2010 indikerer at MRL-værdier ikke er påkrævet eller som ikke anses for at være omfattet af Forordning (EF) nr. 470/2009, når de anvendes i et veterinærlægemiddel. 
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.
Administrer 1 dosis (1 ml) ved intramuskulær injektion, gerne i halsregionen, i henhold til følgende program: 
Administer one dose of 1 ml, by intramuscular injection, preferably in the neck region, according to the following schedule:
I henhold til artikel 71 i Europa-Parlamentets og Rådets direktiv 2001/82/EF, med senere ændringer, kan en medlemsstat i overensstemmelse med medlemsstatens nationale lovgivning forbyde fremstilling, indførsel, besiddelse, salg, levering og/eller anvendelse af veterinærlægemidlet på hele eller en del af sit område, hvis det godtgøres: 
According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
En beslutning om at anvende vaccinen før eller efter brug af et andet lægemiddel til dyr skal derfor tages med udgangspunkt i det enkelte tilfælde. 
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.
Ved mistanke om infektion efter et positivt IgM-svar vil det være nødvendigt at udføre yderligere testning for endeligt at kunne afgøre, om dyret var inficeret eller vaccineret. 
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.
Hver dosis á 1 ml indeholder: 
Each dose of 1 ml contains:
Enhver, som har til hensigt at fremstille, indføre, besidde, sælge, levere og/eller anvende Proteq West Nile, skal rådføre sig med den relevante medlemsstats kompetente myndighed vedrørende gældende vaccinationspolitik forinden fremstilling, indførsel, besiddelse, salg, levering og/eller anvendelse finder sted. 
Any person intending to manufacture, import, possess, sell, supply and use Proteq West Nile must consult the relevant Member State's competent authority on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use.
• Basisvaccination: første injektion fra 5-måneders alderen, anden injektion 4-6 uger senere. 
• Primary vaccination course: first injection from 5 months of age, second injection 4-6 weeks later,