FrancophonIA/ELRC3.0 huggingface dataset:
English: Use of ethinylestradiol-containing medicinal products such as those contained in most combined oral contraceptives or contraceptive vaginal rings (see section 4.4 and 4.5).
Danish: Brug af lægemidler med ethinylestradiol som f.eks. de fleste kombinerede p-piller eller p-ringe (se pkt.
English: • ranolazine
Danish: • ranolazin
English: Alprazolam 0.5 mg single dose
Danish: Alprazolam 0,5 mg enkeltdosis
English: Viekirax dasabuvir paracetamol
Danish: Viekirax med dasabuvir paracetamol
English: NA If clinically indicated higher doses of omeprazole should be used.
Danish: Hvis det er klinisk indiceret, skal der bruges højere doser omeprazol
English: In the presence of paritaprevir/ritonavir, dasabuvir exposures decreased by approximately 50% to 60% while ombitasvir exposures increased by 31-47%.
Danish: Indvirkningen af paritaprevir/ritonavir på ombitasvir og dasabuvir Når paritaprevir/ritonavir var til stede, faldt eksponeringen for dasabuvir med ca. 50-60 %, mens eksponeringen for ombitasvir steg med 31-47 %.
English: Talk to your doctor or pharmacist before taking Viekirax if you: - have liver disease other than hepatitis C;
Danish: Kontakt lægen eller apotekspersonalet, før du tager Viekirax, hvis du: - har en anden leversygdom end hepatitis C; - har eller har haft en infektion med hepatitis B-virus, da din læge måske vil overvåge dig tættere.
English: global multicentre, open-label
Danish: globalt multicenter studie, ikke-blindet
English: 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)
Danish: 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)
English: In the presence of ombitasvir, paritaprevir exposures were minimally affected (5% to 27% change) while dasabuvir exposures increase by approximately 30%.
Danish: 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 %.
English: Lansoprazole
Danish: Lansoprazol
English: 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).
Danish: 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.
English: Coadministration with ethinylestradiol may increase the risk of ALT elevations (see sections 4.3 and 4.4).
Danish: Samtidig administration af ethinylestradiol kan øge risikoen for forhøjet ALAT (se pkt.
English: GT1b Arm A: Viekirax and dasabuvir + RBV Arm B: Viekirax and dasabuvir Treatment-naïve and peginterferon+ribavirin -experienced, with compensated cirrhosis
Danish: GT1b Gruppe A: Viekirax og dasabuvir med ribavirin Gruppe B: Viekirax og dasabuvir Behandlingsnaive og peginterferon/ribavirin-erfarne, med kompenseret cirrose
English: 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).
Danish: 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.
English: randomised, global multicentre, open-label
Danish: randomiseret globalt multicenter studie, ikke-blindet
English: Viekirax 12.5 mg/75 mg/50 mg film-coated tablets ombitasvir/paritaprevir/ritonavir
Danish: Viekirax 12,5 mg/75 mg/50 mg filmovertrukne tabletter ombitasvir/paritaprevir/ritonavir
English: ↑ ergot derivatives
Danish: Forventet: ↑ Sekale-derivater
English: Simvastatin, lovastatin and atorvastatin are contraindicated (see section 4.3 and 4.5).
Danish: Simvastatin, lovastatin og atorvastatin er kontraindicerede (se pkt.
English: AbbVie Deutschland GmbH & Co. KG Knollstrasse,
Danish: AbbVie Deutschland GmbH & Co.
English: ANTITPLATELET AGENTS Ticagrelor
Danish: MIDDEL TIL TROMBOSEPROFYLAKSE Ticagrelor
English: Viekirax and dasabuvir with RBV Arm A 12 Weeks N = 31
Danish: Viekirax og dasabuvir med RBV Gruppe A 12 uger N = 31
English: TURQUOISE-I: treatment-naïve or pegIFN + RBV-experienced with HIV-1 co-infection, without cirrhosis or with compensated cirrhosis
Danish: TURQUOISE-I: behandlingsnaive eller pegIFN + RBV-erfarne med samtidig HIV-1 infektion, uden eller med kompenseret cirrose
English: Viekirax is contraindicated in patients with severe hepatic impairment (Child-Pugh C) (see sections 4.3 and 5.2).
Danish: Viekirax er kontraindiceret hos patienter med svært nedsat leverfunktion (Child-Pugh C) (se pkt.
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.
Danish: 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.
English: Viekirax is not recommended in patients with moderate hepatic impairment (Child-Pugh B).
Danish: Det anbefales ikke at bruge Viekirax til patienter med moderat nedsat leverfunktion (Child-Pugh B).
English: 60 patients were randomized and treated, and 60/60 (100%) achieved SVR12.
Danish: Behandling: Viekirax og dasabuvir uden ribavirin i 12 uger 60 patienter blev randomiseret og behandlet, og 60/60 (100 %) opnåede SVR 12.
English: 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.
Danish: ≥ 90 x 109/l og albumin ≥ 35 g/l), var recidivraten den samme for patienter behandlet i henholdsvis 12 og
English: NAME OF THE MEDICINAL PRODUCT Viekirax 12.5 mg / 75 mg / 50 mg tablets ombitasvir / paritaprevir / ritonavir
Danish: LÆGEMIDLETS NAVN Viekirax 12,5 mg/75 mg/50 mg tabletter ombitasvir/paritaprevir/ritonavir
English: Drug interactions need to be carefully taken into account in the setting of HIV co-infection (for details see section 4.5, Table 2).
Danish: Hos patienter med samtidig HIV-infektion skal der tages nøje højde for lægemiddelinteraktioner (se nærmere i pkt.
English: The safety and efficacy of Viekirax in children below 18 years have not been established.
Danish: Viekirax' sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: Relapse rates in GT1a cirrhotic subjects by baseline laboratory values are presented in Table 13.
Danish: Recidivraten hos patienter med genotype 1a og cirrose ud fra laboratorieværdier ved baseline vises i tabel
English: Viekirax + dasabuvir rosuvastatin
Danish: Viekirax med dasabuvir rosuvastatin
English: 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.
Danish: 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).
English: While no change to the pharmacokinetics of warfarin is expected, close
Danish: Selvom der ikke forventes ændringer af warfarins farmakokinetik, anbefales tæt monitorering af INR sammen med alle vitamin K-antagonister.
English: Outcome for subjects without SVR12 On-treatment VF Relapse
Danish: Samlet SVR12 Resultat for patienter uden SVR12 VF under behandlinga Recidiv b
English: For dosing recommendations with HIV antiviral agents, refer to section 4.4 (Treatment of patients with HIV co-infection) and section 4.5.
Danish: 4.4 (Behandling af patienter med samtidig HIV-infektion) og pkt.
English: Viekirax and dasabuvir with RBV for 12 weeks n/N % 95% CI
Danish: Viekirax og dasabuvir + RBV (12 uger) n/N % 95 %-KI
English: SVR12 for genotype 1-infected peginterferon+ribavirin-experienced subjects in SAPPHIRE-II
Danish: Tabel 10. SVR12 for peginterferon/ribavirin-erfarne genotype 1-smittede forsøgspersoner i SAPPHIRE II
English: Clinical Comments dasabuvir and ombitasvir and CYP3A4 inhibition by ritonavir
Danish: Klinisk kommentar dasabuvirs hæmning af UGT1A1 og ritonavirs hæmning af CYP3A4
English: Viekirax and dasabuvir for 12 weeks With RBV
Danish: Viekirax og dasabuvir (12 uger) Med RBV
English: Similar effect expected as observed with Viekirax + dasabuvir.
Danish: Samme virkning forventes som ved Viekirax med dasabuvir.
English: 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.
Danish: 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.
English: Treatment with darunavir + Viekirax without dasabuvir is not ombitasvir paritaprevir
Danish: Behandling med darunavir plus Viekirax uden dasabuvir anbefales ikke (↑ paritaprevir).
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.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 12,5 mg ombitasvir, 75 mg paritaprevir og 50 mg ritonavir.
English: Viekirax + dasabuvir duloxetine
Danish: Viekirax med dasabuvir duloxetin
English: Concomitant use is contraindicated (See section
Danish: Samtidig brug er kontraindiceret (se pkt.
English: A temporary suspension of fluvastatin and pitavastatin is recommended for the duration of treatment with Viekirax.
Danish: Det anbefales at afbryde behandlingen med fluvastatin og pitavastatin midlertidigt, så længe
English: Viekirax with dasabuvir
Danish: Viekirax med dasabuvir sofosbuvir
English: 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.
Danish: 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.
English: Prior pegIFN/RBV relapser
Danish: Tidligere ikke-respondere på pegIFN/RBV
English: Diazepam2 mg single dose
Danish: Tacrolimus 2 mg enkeltdosis
English: ↓ voriconazole ↑ paritaprevir
Danish: ↑ voriconazole ↑ dasabuvir ↑ paritaprevir
English: No dose adjustment is necessary for methadone and Viekirax with or without dasabuvir.
Danish: Dosisjustering er ikke nødvendig for metadon og Viekirax med eller uden dasabuvir.
English: The magnitude of interaction was similar to that observed with Viekirax + dasabuvir.
Danish: Interaktionen var af samme størrelsesorden som for Viekirax med dasabuvir.
English: ANTI-GOUT Colchicine
Danish: MIDLER MOD URINSYREGIGT Colchicin
English: ↔ lopinavir The magnitude of interaction was similar to that observed with Viekirax + dasabuvir.
Danish: ↔ lopinavir Interaktionen var af samme størrelsesorden som for Viekirax med dasabuvir.
English: Purpose of the medicine
Danish: LÆGEMIDLETS NAVN
English: NA
Danish: Ikke
English: The recommended dose of atazanavir is 300 mg, without ritonavir, in combination with Viekirax with dasabuvir.
Danish: Den anbefalede dosis atazanavir er 300 mg, uden
English: NA No dose adjustment required for carisoprodol; increase dose if clinically indicated.
Danish: Dosisjustering er ikke nødvendig for for carisoprodol; øgning af dosis, hvis klinisk indiceret ombitasvir paritaprevir ↔ dasabuvir
English: Mechanism: CYP2C19 induction by ritonavir.
Danish: Mekanisme: Ritonavirs inducerende virkning på CYP2C19 .
English: Not studied: Similar effect is expected as observed with Viekirax + dasabuvir.
Danish: Ikke undersøgt: Samme virkning forventes som observeret for Viekirax med dasabuvir.
English: ↑ quetiapine ↑ lurasidone
Danish: ↑quetiapin ↑ lurasidon
English: Viekirax without dasabuvir omeprazole
Danish: Viekirax uden dasabuvir emtricitabin
English: 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.
Danish: 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.
English: ↑ pravastatin The magnitude of interaction was similar to that observed with Viekirax + dasabuvir.
Danish: ↑ pravastatin Interaktionen var af samme størrelsesorden som for Viekirax med dasabuvir.
English: Post Marketing Adverse Reactions
Danish: Bivirkninger observeret efter markedsføring
English: Viekirax is not recommended in patients with moderate hepatic impairment (Child-Pugh B) (see sections 4.4 and 4.8).
Danish: Det anbefales ikke at bruge Viekirax til patienter med moderat nedsat leverfunktion (Child-Pugh B) (se pkt.
English: 30 mg once daily single dose3
Danish: 30 mg enkeltdosis én gang dagligt
English: Mechanism: CYP3A4 and/or P-gp inhibition by itraconazole, posaconazole and paritaprevir/ ritonavir/ombi tasvir
Danish: Mekanisme: Itraconazols, posaconazols og paritaprevir/ ritonavir/ ombitasvirs hæmning af CYP3A4 og/eller P-gp.
English: Overall SVR12 Outcome for subjects without SVR12 On-treatment VF Relapse Other * Ombitasvir tablets, paritaprevir tablets and ritonavir capsules administered separately.
Danish: Andetc * Ombitasvir-tabletter, paritaprevir-tabletter og ritonavir-kapsler givet separat.
English: 2 mg single dose
Danish: 2 mg enkelt dosis
English: HERBAL PRODUCTS St. John's Wort (hypericum perforatum)
Danish: NATURLÆGEMIDLER Prikbladet perikon (hypericum perforatum)
English: Mechanism: CYP3A4 induction enzalutamide or mitotane.
Danish: Mekanisme: enzalutamid eller mitotans inducerende virkning på CYP3A4
English: ↑ paritaprevir ↑ dasabuvir
Danish: ↓ voriconazole ↑ paritaprevir ↑ dasabuvir
English: Increase in raltegravir exposures may be due to UGT1A1 inhibition by paritaprevir, ombitasvir.
Danish: Mekanisme: Øget raltegravireksponering kan skyldes paritaprevir, ombitasvir og dasabuvirs hæmning af UGT1A1.
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).
Danish: 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).
English: CYP3A4 inhibition by protease inhibitors.
Danish: Mekanisme: Proteasehæmmeres hæmning af CYP3A4.
English: No dose adjustment needed for dolutegravir when coadministered with Viekirax with or without dasabuvir.
Danish: Dosisjustering er ikke nødvendig for dolutegravir ved samtidig administration med Viekirax med eller uden dasabuvir.
English: Mechanism: CYP3A4/Pgp inhibition by ketoconazole and paritaprevir/ ritonavir/ ombitasvir
Danish: Mekanisme: Ketoconazols og paritaprevir/ ritonavir/omb itasvirs hæmning af CYP3A4 og P-gp.
English: Viekirax and dasabuvir without ribavirin or with weight-based ribavirin for 12 weeks
Danish: randomiseret, globalt multicenter studie, ikke-blindet Behandling: Viekirax og dasabuvir uden ribavirin eller med ribavirin baseret på vægt i 12 uger
English: Viekirax + dasabuvir atazanavir
Danish: Viekirax med atazanavir
English: Hepatic impairment
Danish: Virologisk svigt under behandling
English: Posology
Danish: Karateristika
English: NA Reduce pravastatin dose by
Danish: Nedsat nyrefunktion
English: Mechanism: OATP1B/BC RP inhibition by paritaprevir
Danish: Mekanisme: Paritaprevirs hæmning af OATP1B/ BCRP.
English: ↑ voriconazole
Danish: ↑ranolazin
English: Retreatment
Danish: Opbevaring
English: 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.
Danish: OATP1B1/B 3 og CYP3A og den yderligere ritonavirdosis' hæmning af CYP3A.
English: Viekirax and dasabuvir with weight-based ribavirin for 12 or 24 weeks
Danish: Viekirax og dasabuvir med ribavirin 12-uger-gruppen
English: CYP3A4 inhibition by ritonavir.
Danish: Ritonavirs hæmning af CYP3A4.
English: Viekirax and dasabuvir + ribavirin
Danish: Viekirax og dasabuvir med ribavirin
English: MA (EU) number (Invented) name Strength
Danish: 1 inhalator (60 doser) 3 inhalatorer (3x120 doser) 3 inhalatorer (3x60 doser)
English: Immediate Packaging
Danish: Inhalator Inhalator Inhalator
English: Pharmaceutical Form
Danish: Styrke
English: MA (EU) Number
Danish: MF (EU)-nummer Særnavn
English: Vaccination may interfere with existing sero-epidemiological surveys.
Danish: Vaccination kan interferere med igangværende seroepidemiologiske undersøgelser.
English: If clinical signs are present, their duration and severity are reduced.
Danish: Hvis kliniske symptomer er til stede, vil varighed og sværhedsgrad blive reduceret.
English: After inoculation, the virus does not multiply in the horse but expresses the protective proteins.
Danish: Efter inokulering multipliceres virus ikke hos hest men afgiver beskyttende proteiner.
English: Date of first authorisation: 05/08/2011 Date of last renewal: 17/05/2016
Danish: Dato for første markedsføringstilladelse: 05/08/2011 Dato for seneste fornyelse af markedsføringstilladelse: 17/05/2016
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.
Danish: • Revaccination: efter årlig revaccination med en enkelt dosis skulle tilstrækkelig grad af beskyttelse opnås, skønt dette program ikke er blevet fuldstændig valideret.
English: 1 x 1 dose 2 x 1 dose 5 x 1 dose 10 x 1 dose
Danish: 1 x 1 dosis 2 x 1 dosis 5 x 1 dosis 10 x 1 dosis
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).
Danish: 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)
English: In order to achieve full protection, the full vaccination course of two doses must be given.
Danish: For at opnå fuld beskyttelse er det nødvendigt at give hele vaccinationsprogrammet på 2 doser.
English: Store and transport refrigerated (2 °C-8 °C).
Danish: Opbevares og transporteres nedkølet (2 °C-8 °C).
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Danish: Yderligere information om dette veterinærlægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
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
Danish: 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
English: Shelf life of the veterinary medicinal product as packaged for sale: 27 months.
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: 27 måneder.
English: Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.
Danish: Affaldsmateriale skal destrueres ved kogning, forbrænding eller opblanding i et egnet desinfektionsmiddel, som er godkendt til brug af den relevante kompetente myndighed.
English: To stimulate active immunity against West Nile virus.
Danish: For at stimulere aktiv immunitet mod West Nile virus.