FrancophonIA/ELRC3.0 huggingface dataset:
English: diltiazem, systemic lidocaine, verapamil) - atorvastatin, pravastatin, and fluvastatin (used to lower blood cholesterol) - salmeterol (used to treat asthma) - cyclosporin, tacrolimus, and sirolimus (medicines to decrease the effects of body's immune system) - certain antibiotics (rifabutin, clarithromycin) - ketoconazole, itraconazole, and voriconazole (antifungals) - warfarin (anticoagulant, used to reduce the blood clots) - carbamazepine, phenytoin, phenobarbital, lamotrigine (antiepileptics) - irinotecan (used to treat cancer) - sedative agents (e.g. midazolam administered by injection) - buprenorphine (used to treat opioid addiction and pain).
Danish: Det er især vigtigt at nævne disse: anden medicin til behandling af hiv-infektion (f.eks. indinavir, nevirapin og efavirenz) boceprevir og sofosbuvir/velpatasvir/voxilaprevir (anvendes til at behandle hepatitis C) sildenafil, vardenafil eller tadalafil (anvendes af mænd til at behandle impotens (erektil dysfunktion)) hvis du tager p-piller samtidig med Atazanavir Krka for at undgå graviditet, er det vigtigt, at du tager dem nøjagtigt som lægen har fortalt dig, og at du ikke glemmer en dosis medicin, der bruges til at behandle sygdomme, der er forbundet med indholdet af syre i maven (f.eks. antacida (syreneutraliserende), der tages 1 time før Atazanavir Krka eller 2 timer efter Atazanavir Krka, H2-hæmmere som f.eks. famotidin og protonpumpehæmmere som f.eks. omeprazol) medicin, der sænker blodtrykket eller sænker eller ændrer hjerterytmen (amiodaron, diltiazem, systemisk lidocain, verapamil) atorvastatin, pravastatin og fluvastatin (anvendes til at sænke mængden af kolesterol i blodet) salmeterol (anvendes til at behandle astma) ciclosporin, tacrolimus og sirolimus (medicin der anvendes til at svække kroppens immunsystem) visse antibiotika (rifabutin, clarithromycin) ketoconazol, itraconazol og voriconazol (svampemidler) warfarin (blodfortyndende middel, anvendes til at mindske risiko for blodpropper) carbamazepin, phenytoin, phenobarbital, lamotrigin (anvendes mod epilepsi) irinotecan (anvendes til at behandle kræft) beroligende midler (f.eks. midazolam, som gives som indsprøjtning) buprenorphin (anvendes mod smerter og til at behandle opioidafhængighed).
English: Atazanavir Krka 300 mg hard capsules Each hard capsule contains 300 mg atazanavir (as sulphate).
Danish: Atazanavir Krka 300 mg hårde kapsler Hver hård kapsel indeholder 300 mg atazanavir (som sulfat).
English: Co-administration of atazanavir with triazolam or orally administered midazolam is contraindicated (see section 4.3), whereas caution should be used with co- administration of atazanavir and parenteral midazolam.
Danish: Samtidig administration af atazanavir og triazolam eller oralt administreret midazolam er kontraindiceret (se pkt.
English: - Atazanavir Krka may affect how well your kidneys work.
Danish: - Atazanavir Krka kan påvirke din nyrefunktion.
English: NAME OF THE MEDICINAL PRODUCT Atazanavir Krka 300 mg hard capsules atazanavir
Danish: LÆGEMIDLETS NAVN Atazanavir Krka 300 mg hårde kapsler atazanavir
English: The mechanism of efavirenz/atazanavir interaction is CYP3A4 induction.
Danish: Interaktionsmekanismen for efavirenz/atazanavir er CYP3A4-induktion.
English: Hard gelatine capsule (capsule), size no. 1.
Danish: Hård gelatinekapsel (kapsel), størrelse nr. 1.
English: Hard gelatine capsule, size no. 1.
Danish: Hård gelatinekapsel, størrelse nr. 1.
English: Atazanavir Krka 150 mg hard capsules Each hard capsule contains 150 mg atazanavir (as sulphate).
Danish: Atazanavir Krka 150 mg hårde kapsler Hver hård kapsel indeholder 150 mg atazanavir (som sulfat).
English: ANTIMYCOBACTERIAL Rifabutin 150 mg twice weekly (atazanavir 300 mg and ritonavir 100 mg once daily)
Danish: ANTIMYKOBAKTERIELLE MIDLER Rifabutin 150 mg 2 gange ugentligt (atazanavir 300 mg og ritonavir 100 mg 1 gang dagligt)
English: The mechanism of nevirapine/atazanavir interaction is CYP3A4 induction.
Danish: Interaktionsmekanismen for nevirapin/atazanavir er CYP3A4-induktion.
English: Proton pump inhibitors Omeprazole 40 mg once daily (atazanavir 400 mg once daily with ritonavir 100 mg once daily)
Danish: Protonpumpehæmmere Omeprazol 40 mg 1 gang dagligt (atazanavir 400 mg 1 gang dagligt med ritonavir 100 mg 1 gang dagligt)
English: Capsule shell of Atazanavir Krka 200 mg hard capsules Body: titanium dioxide (E171) yellow ferric oxide (E172) red ferric oxide (E172) gelatine
Danish: Kapselskal af Atazanavir Krka 200 mg hårde kapsler Krop: titandioxid (E171) gul jernoxid (E172) rød jernoxid (E172) gelatine
English: NAME OF THE MEDICINAL PRODUCT Atazanavir Krka 150 mg hard capsules atazanavir
Danish: LÆGEMIDLETS NAVN Atazanavir Krka 150 mg hårde kapsler atazanavir
English: CYP3A inhibition.
Danish: CYP3A4-hæmning.
English: Elbasvir 50 mg once daily (atazanavir 300 mg/ ritonavir 100 mg once daily)
Danish: Elbasvir 50 mg 1 gang dagligt (atazanavir 300 mg/ritonavir 100 mg 1 gang dagligt)
English: Hard gelatine capsule (capsule), size no. 0.
Danish: Hård gelatinekapsel (kapsel), størrelse nr. 0.
English: Atazanavir Krka 200 mg hard capsules
Danish: Atazanavir Krka 200 mg hårde kapsler
English: Co-administration of atazanavir with glecaprevir/pibrentasvir fixed dose combination is contraindicated because of the potential increase in the risk of ALT elevations due to a significant increase in glecaprevir and pibrentasvir plasma concentrations (see section 4.3).
Danish: Samtidig administration af atazanavir med produkter indeholdende glecaprevir/pibrentasvir i fastdosis kombination er kontraindiceret på grund af den potentielle stigning i risiko for ALAT-stigning, grundet signifikant stigning i plasmakoncentrationerne af glecaprevir og pibrentasvir (se pkt.
English: Study 045 is a randomised, multicenter trial comparing atazanavir /ritonavir (300/100 mg once daily) and atazanavir /saquinavir (400/1,200 mg once daily), to lopinavir + ritonavir (400/100 mg fixed dose combination twice daily), each in combination with tenofovir disoproxil (see sections 4.5 and 4.8) and one NRTI, in patients with virologic failure on two or more prior regimens containing at least one PI, NRTI, and NNRTI.
Danish: Voksne patienter, der tidligere har været i antiretroviral behandling Studie 045 er et randomiseret, multicenterstudie, der sammenligner atazanavir/ritonavir (300/100 mg én gang dagligt) og atazanavir/saquinavir (400/1.200 mg én gang dagligt) med lopinavir + ritonavir (400/100 mg fast dosiskombination to gange dagligt), hver i kombination med tenofovirdisoproxil (se pkt.
English: Hard gelatine capsule, size no. 0.
Danish: Hård gelatinekapsel, størrelse nr. 0.
English: H2-Receptor antagonists Without Tenofovir disoproxil In HIV-infected patients with atazanavir/ritonavir at the recommended dose 300/100 mg once daily
Danish: Hiv-smittede patienter, der tager den anbefalede dosis atazanavir/ritonavir på 300/100 mg 1 gang dagligt
English: Serum concentrations of verapamil may be increased by atazanavir due to CYP3A4 inhibition.
Danish: Serumkoncentrationen af verapamil kan øges af atazanavir pga.
English: However, Atazanavir Krka is not recommended in patients undergoing haemodialysis (see sections 4.2 and
Danish: Dog anbefales Atazanavir Krka ikke til patienter i hæmodialysebehandling (se pkt.
English: Cap: titanium dioxide (E171), yellow ferric oxide (E172), red ferric oxide (E172), black ferric oxide (E172), gelatine and ink (shellac, titanium dioxide (E171), potassium hydroxide
Danish: Hætte: titandioxid (E171), gul jernoxid (E172), rød jernoxid (E172), sort jernoxid (E172), gelatine og blæk (shellac, titandioxid (E171), kaliumhydroxid)
English: Atazanavir Krka with ritonavir is not recommended in patients undergoing haemodialysis (see sections 4.4 and 5.2).
Danish: Atazanavir Krka med ritonavir anbefales ikke til patienter i hæmodialysebehandling (se pkt.
English: Co-administration of atazanvir with glecaprevir/pibrentasvir is contraindicated because of the potential increase in the risk of ALT elevations due to a significant increase in glecaprevir and pibrentasvir plasma concentrations (see section 4.3)
Danish: Samtidig administration af atazanavir med glecaprevir/pibrentasvir er kontraindiceret på grund af den potentielle stigning i risiko for ALAT-stigning, grundet signifikant stigning i plasmakoncentrationerne af glecaprevir og pibrentasvir se pkt.
English: HIV RNA <50 copies/ml by select baseline PI substitutions,
Danish: hiv-RNA <50 kopier/ml ved selekteret baseline PI substitutioner,f,g % (respons/evaluerbar) NA NA
English: Atazanavir Krka with ritonavir must not be used in patients with moderate to severe hepatic impairment (see sections 4.3, 4.4 and 5.2).
Danish: Atazanavir Krka med ritonavir må ikke anvendes til patienter med moderat til svært nedsat leverfunktion (se pkt.
English: Hard gelatine capsule (capsule), size no. 00.
Danish: Hård gelatinekapsel (kapsel), størrelse nr. 00.
English: How to take Atazanavir Krka
Danish: Sådan skal du tage Atazanavir Krka
English: If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicinal product.
Danish: Atazanavir Krka indeholder lactosemonohydrat Kontakt lægen, før du tager denne medicin, hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter (f.eks. lactose).
English: Hard gelatine capsule, size no. 00.
Danish: Hård gelatinekapsel, størrelse nr. 00.
English: Cap: titanium dioxide (E171) yellow ferric oxide (E172) red ferric oxide (E172) gelatine ink:
Danish: Hætte: titandioxid (E171) gul jernoxid (E172) rød jernoxid (E172) gelatine blæk:
English: Table 1: Dose for paediatric patients (6 years to less than 18 years of age and weighing at least 15 kg) for Atazanavir Krka capsules with ritonavir Body Weight (kg)
Danish: 6 år til under 18 år og med en legemsvægt på mindst 15 kg) Legemsvægt (kg)
English: All patients HIV RNA <400 copies/ml, %
Danish: hiv-RNA <50 kopier/ml, % a Alle patienter hiv-RNA <400 kopier/ml, % a Alle patienter
English: Cap: titanium dioxide (E171), yellow ferric oxide (E172), red ferric oxide (E172), gelatine and ink (shellac, black ferric oxide (E172), potassium hydroxide
Danish: Hætte: titandioxid (E171), gul jernoxid (E172), rød jernoxid (E172), gelatine og blæk (shellac, sort jernoxid (E172), kaliumhydroxid)
English: Tenofovir disoproxilfumarate AUC ↑37% (↑30% ↑45%) Tenofovir disoproxil fumarate Cmax
Danish: Tenofovirdisoproxilfumarat AUC ↑37% Tenofovirdisoproxilfumarat Cmax ↑34% Tenofovirdisoproxilfumarat Cmin ↑29%
English: ACID REDUCING AGENTS
Danish: Nedsat leverfunktion
English: Glecaprevir AUC : ↑553% Glecaprevir cmax : ↑306% (↑215% Glecaprevir cmin : ↑1330% (↑885% Pibrentasvir AUC : ↑64% (↑48% Pibrentasvir cmax : ↑29% (↑15% Pibrentasvir cmin: ↑129% (↑95%
Danish: Glecaprevir AUC: ↑553% (↑424% ↑714%) Glecaprevir Cmax: ↑306% (↑215% ↑423%) Glecaprevir Cmin: ↑1330% (↑885%
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 200 mg atazanavir (as sulphate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hård kapsel indeholder 200 mg atazanavir (som sulfat).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 300 mg atazanavir (as sulphate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hård kapsel indeholder 300 mg atazanavir (som sulfat).
English: What Atazanavir Krka is and what it is used for
Danish: Atazanavir Krka indeholder:
English: Desacetyl-diltiazem AUC ↑165% Desacetyl-diltiazem cmax ↑172% Desacetyl-diltiazem cmin ↑121%
Danish: Desacetyl-diltiazem Cmin ↑121% (↑102%
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 150 mg atazanavir (as sulphate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hård kapsel indeholder 150 mg atazanavir (som sulfat).
English: Capsule shell of Atazanavir Krka 150 mg hard capsules Body: titanium dioxide (E171) gelatine
Danish: Kapselskal af Atazanavir Krka 150 mg hårde kapsler Krop: titandioxid (E171) gelatine
English: - medicines containing St. John's wort (Hypericum perforatum, a herbal preparation) - triazolam and oral (taken by mouth) midazolam (used to help you sleep and/or to relieve anxiety) - simvastatin and lovastatin (used to lower blood cholesterol).
Danish: - quetiapin (bruges til at behandle skizofreni, bipolar lidelse (maniodepressiv sygdom) og moderat til svær depresssion); lurasidon (bruges til behandling af skizofreni) - medicin, der indeholder perikon (Hypericum perforatum, naturlægemiddel) - triazolam og oralt (indtaget gennem munden) midazolam (bruges som sovemedicin eller til at behandle angst) - simvastatin og lovastatin (bruges til at sænke mængden af kolesterol i blodet) - produkter indeholdende grazoprevir, inklusive elbasvir/grazoprevir i fastdosis-kombination, og glecaprevir/pibrentasvir i fastdosis-kombination (bruges til behandling af kronisk hepatitis C infektion).
English: The mechanism of interaction is CYP3A4 inhibition.
Danish: Interaktionsmekanismen er CYP3A4-hæmning.
English: Atazanavir Krka with ritonavir is contraindicated in patients with moderate hepatic insufficiency (see sections 4.2, 4.4 and 5.2).
Danish: Atazanavir Krka med ritonavir er kontraindiceret hos patienter med moderat nedsat leverfunktion (se pkt.
English: Capsule shell of Atazanavir Krka 300 mg hard capsules Body: titanium dioxide (E171) and gelatine
Danish: Kapselskal af Atazanavir Krka 300 mg hårde kapsler Krop: titandioxid (E171) og gelatine
English: Cap: titanium dioxide (E171) yellow ferric oxide (E172) red ferric oxide (E172) black ferric oxide (E172) gelatine ink:
Danish: Hætte: titandioxid (E171) gul jernoxid (E172) rød jernoxid (E172) sort jernoxid (E172) gelatine blæk:
English: the clarithromycin/atazanavir interaction is CYP3A4 inhibition.
Danish: Interaktionsmekanismen for clarithromycin/atazanavir er CYP3A4-hæmning.
English: For patients not taking tenofovir disoproxil, if atazanavir 300 mg/ritonavir 100 mg and H2-receptor antagonists are co-administered, a dose equivalent to famotidine 20 mg twice daily should not be exceeded.
Danish: H2-receptorantagonister administreres samtidigt, bør en dosis svarende til famotidin 20 mg 2 gange dagligt ikke overskrides.
English: - If tenofovir disoproxil or an H2-receptor antagonist is needed, a dose increase to Atazanavir Krka
Danish: - Hvis det er nødvendigt at anvende tenofovirdisoproxil eller en H2-receptorantagonist, bør det overvejes at øge dosis af Atazanavir Krka til 400 mg med 100 mg ritonavir under TDM
English: The mechanism of
Danish: Samtidig administration af
English: Atazanavir, dosed 1 hr after ddI+d4T (fasted) Atazanavir AUC ↔3% (↓36% Atazanavir cmax ↑12% (↓33% Atazanavir cmin ↔3% (↓39%
Danish: Atazanavir AUC ↔3% (↓36% ↑67%) Atazanavir Cmax ↑12% (↓33% ↑18%) Atazanavir Cmin ↔3% (↓39% ↑73%)
English: 4.94 log10 copies/ml (range 2.6 to 5.88 log10 copies/ml) b atazanavir /RTV with tenofovir disoproxil fumarate/emtricitabine (fixed dose 300 mg/200 mg tablets once daily).
Danish: a Gennemsnitligt CD4-celletal ved baseline var 214 celler/mm3 (i området 2 til 810 celler/mm3) og gennemsnitligt plasma-hiv-1-RNA ved baseline var 4,94 log10 kopier/ml (i området 2,6 til 5,88 log10 kopier/ml) b Atazanavir/RTV med tenofovirdisoproxilfumarat/emtricitabin (fast dosis på 300 mg/200 mg tabletter én gang dagligt).
English: Atazanavir AUC ↔6% (↓10%
Danish: ritonavir AUC ↓ 36%
English: Capsule shell of Atazanavir Krka 300 mg hard capsules Body: titanium dioxide (E171) gelatine
Danish: Kapselskal af Atazanavir Krka 300 mg hårde kapsler Krop: titandioxid (E171)
English: The mechanism of diltiazem/atazanavir interaction is CYP3A4 inhibition.
Danish: Interaktionsmekanismen for diltiazem/atazanavir er CYP3A4-hæmning.
English: Ethinyloestradiol AUC ↓19% Ethinyloestradiol cmax ↓16% Ethinyloestradiol cmin ↓37%
Danish: Ethinylestradiol AUC ↓19% (↓25% ↓13%) Ethinylestradiol Cmax ↓16% (↓26% ↓5%) Ethinylestradiol Cmin ↓37% (↓45% ↓29%)
English: If the combination is judged unavoidable, close clinical monitoring is recommended in combination with an increase in the dose of atazanavir to 400 mg with 100 mg of ritonavir; doses of proton pump inhibitors comparable to omeprazole 20 mg should not be exceeded (see section 4.4).
Danish: Hvis kombination vurderes at være nødvendig, anbefales omhyggelig monitorering og dosisøgning af atazanavir til 400 mg med 100 mg ritonavir.
English: The proportion of patients with HIV RNA < 400 copies/ml were 53% and 43% for ATV/RTV and 54% and 46% for LPV/RTV at weeks 48 and 96 respectively.
Danish: Andelen af patienter med hiv-RNA <400 kopier/ml var 53% og 43% for ATV/RTV og 54% og 46% for LPV/RTV ved henholdsvis uge 48 og 96. g Selekterede substitutioner inkluderer alle ændringer ved position L10, K20, L24, V32, L33, M36, M46, G48, I50, I54, L63,
English: Sofosbuvir AUC : ↑40% (↑25% Sofosbuvir cmax :↑29% (↑9% Velpatasvir AUC: ↑93% (↑58% Velpatasvir cmax : ↑29% (↑7% Voxilaprevir AUC : ↑331% Voxilaprevir cmax : ↑342% (↑265%
Danish: Sofosbuvir AUC: ↑40% (↑25% ↑57%) Sofosbuvir Cmax: ↑29% (↑9% ↑52%)
English: Week 48 Week 96 Week 48 Week 96 Week 48 Week 96
Danish: Tidsgennemsnitlig forskel ATV/RTV-LPV/RTV [97,5% KId] Uge 48 Uge 96 Uge 48 Uge 96 Uge 48 Uge 96 hiv-RNA Middelændring fra baseline, log10 kopier/ml Alle patienter
English: Norethindrone cmax ↑67% (↑42% Norethindrone cmin ↑262%
Danish: Norethindron AUC ↑110% (↑68% ↑162%) Norethindron Cmax ↑67% (↑42% ↑196%) Norethindron Cmin ↑262% (↑157% ↑409%)
English: Respiratory, thoracic and meadiastinal disorders uncommon: dyspnoea
Danish: Luftveje, thorax og mediastinum:
English: Atazanavir cmin: ↑713% (↑359%
Danish: Voxilaprevir Cmax: ↑342% (↑265% ↑435%)
English: Efavirenz 600 mg once daily (atazanavir 400 mg once daily with ritonavir 200 mg once daily)
Danish: Atazanavir (aften): alle administreret med dagligt (atazanavir 400 mg 1 gang dagligt med ritonavir 200 mg 1 gang dagligt)
English: postpartuma (n=36)
Danish: (n=36)
English: The mechanism of interaction is CYP3A4 inhibition by atazanavir and/or ritonavir.
Danish: Interaktionsmekanismen er atazanavir og/eller ritonavir-hæmning af CYP3A4.
English: Tenofovir disoproxil fumarate Cmin
Danish: Uden tenofovirdisoproxil
English: Further information on Nasym can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/nasym.
Danish: Yderligere oplysninger om Nasym findes på agenturets websted under: ema.europa.eu/medicines/veterinary/EPAR/nasym.
English: Nasym is a vaccine.
Danish: Nasym er en vaccine.
English: The withdrawal period for meat from cattle treated with Nasym is ‘zero' days, which means that there is no mandatory waiting time.
Danish: Tilbageholdelsestiden for kød fra kvæg, der behandles med Nasym, er "nul" dage, hvilket vil sige, at der ikke er nogen påkrævet ventetid.
English: Other information about Nasym
Danish: Andre oplysninger om Nasym
English: The most common side effect with Nasym (which may affect up to 1 in 10 animals) is a slight change in the consistency of the faeces.
Danish: Den hyppigste bivirkning ved Nasym (som kan optræde hos op til 1 ud af 10 dyr) er en let forandring i konsistensen af fæces.
English: When the animal comes into contact again with this or a similar virus, these antibodies together with other components of the immune system will be able to kill the viruses and help protect against the disease.
Danish: Når dyret igen kommer i kontakt med denne eller en lignende virus, vil disse antistoffer sammen med andre komponenter i immunsystemet være i stand til at dræbe virusset og hjælpe med at beskytte mod sygdommen.
English: The European Medicines Agency decided that Nasym's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur besluttede, at fordelene ved Nasym opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: What is Nasym and what is it used for?
Danish: Hvad er Nasym, og hvad anvendes det til?
English: Why is Nasym authorised in the EU?
Danish: Hvorfor er Nasym godkendt i EU?
English: These studies involved non-vaccinated animals given a dummy vaccination and all animals were artificially exposed to bovine respiratory syncytial virus.
Danish: I disse studier indgik ikke-vaccinerede dyr, der fik en virkningsløs vaccination, og alle dyrene blev kunstigt eksponeret for bovin respiratorisk syncytialvirus.
English: An overview of Nasym and why it is authorised in the EU
Danish: Oversigt over Nasym, og hvorfor det er godkendt i EU
English: What are the risks associated with Nasym?
Danish: Hvilke risici er der forbundet med Nasym?
English: For the full list of side effects and restrictions of Nasym, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Nasym fremgår af indlægssedlen.
English: When an animal is given the vaccine, the animal's immune system recognises the virus as ‘foreign' and makes antibodies against it.
Danish: Når et dyr får vaccinen, opfatter dyrets immunsystem virussen som "fremmed" og danner antistoffer mod den.
English: The medicine can only be obtained with a prescription and is available as a lyophilisate (a freeze dried powder) and solvent to make either a nasal spray or an injection.
Danish: Lægemidlet fås kun på recept og findes som et lyofilisat (et frysetørret pulver) og opløsningsmiddel til fremstilling af enten en næsespray eller en injektionsvæske.
English: For cattle from 9 days of age, the vaccine is sprayed into each of the animal's nostrils using an intranasal applicator.
Danish: For kvæg i alderen ni dage og derover sprayes vaccinen ind i begge dyrets næsebor ved anvendelse af en intranasal applikator.
English: Nasym (bovine respiratory syncytial virus vaccine, live) EMA/287041/2019
Danish: Nasym (bovin respiratorisk syncytialvirus-vaccine, levende) EMA/422475/2019
English: Nasym is a vaccine used to protect cattle against bovine respiratory syncytial virus, a disease that affects their airways.
Danish: Nasym er en vaccine, der anvendes til at beskytte kvæg mod bovin respiratorisk syncytialvirus, en sygdom, der påvirker deres luftveje.
English: For cattle from 10 weeks of age, the vaccine is given as a single injection into the muscle followed by a second injection into the muscle 4 weeks later.
Danish: For kvæg i alderen 10 uger og derover gives vaccinen som en enkelt injektion i musklen efterfulgt af en anden injektion i musklen fire uger senere.
English: Nasym (bovine respiratory syncytial virus vaccine, live)
Danish: Nasym (bovin respiratorisk syncytialvirus-vaccine, levende)
English: Nasym reduces shedding of virus and respiratory signs such as raised breathing rate, difficulty breathing, watery eyes and runny nose.
Danish: Nasym reducerer udskillelse af virus og respiratoriske tegn såsom forhøjet vejrtrækningshastighed, vejrtrækningsbesvær, rindende øjne og løbende næse.
English: Nasym contains a strain of bovine respiratory syncytial virus that is weakened and does not cause the disease.
Danish: Nasym indeholder en stamme af bovin respiratorisk syncytialvirus, der er svækket og ikke forårsager sygdom.
English: Nasym contains bovine respiratory syncytial virus strain Lym-56.
Danish: Nasym indeholder bovin respiratorisk syncytialvirus-stammen Lym-56.
English: The effectiveness of Nasym has been shown in 7 laboratory studies in which vaccination of cattle with Nasym, either using the nasal spray route or injection into the muscle, reduced both shedding of virus and signs of respiratory disease, such as increased rate of breathing, difficulty in breathing and watery or mucky eyes.
Danish: Nasyms virkning er blevet påvist i syv laboratorieforsøg, hvor vaccination af kvæg med Nasym indgivet enten som næsespray eller injektion i musklen reducerede udskillelse af virus og tegn på respiratorisk sygdom såsom forhøjet vejrtrækningshastighed, vejrtrækningsbesvær og rindende eller pusfyldte øjne.
English: Nasym received a marketing authorisation valid throughout the EU on 29 July 2019.
Danish: Nasym modtog en markedsføringstilladelse med gyldighed i hele Den Europæiske Union den