natgillin/translations-raw huggingface dataset:
If the co-administration of Atazanavir Krka with an NNRTI is required, an increase in the dose of both Atazanavir Krka and ritonavir to 400 mg and 200 mg, respectively, in combination with efavirenz could be considered with close clinical monitoring. 
Če je potrebno sočasno zdravljenje z zdravilom Atazanavir Krka in z nenukleozidnim zaviralcem reverzne transkriptaze (NNRTI; “non-nucleoside reverse transcriptase inhibitor”), je v primeru sočasne uporabe efavirenza treba razmisliti o povečanju odmerka zdravila Atazanavir Krka do 400 mg in povečanju odmerka ritonavirja do 200 mg, pri čemer je potreben skrben klinični nadzor.
If an oral contraceptive is administered with atazanavir/ritonavir, it is recommended that the oral contraceptive contain at least 30 μg of ethinyloestradiol and that the patient be reminded of strict compliance with this contraceptive dosing regimen. 
Če se peroralni kontraceptiv uporablja skupaj z atazanavirjem/ritonavirjem je priporočljivo, da peroralni kontraceptiv vsebuje vsaj
Patients should not breast-feed while taking Atazanavir Krka. 
Bolnice med zdravljenjem z zdravilom Atazanavir Krka ne smejo dojiti.
MARKETING AUTHORISATION NUMBER(S) EU/1/19/1353/003 30 hard capsules EU/1/19/1353/004 90 (3 x 30) hard capsules 
EU/1/19/1353/004 90 (3 x 30) trdih kapsul
NAME OF THE MEDICINAL PRODUCT Atazanavir Krka 300 mg hard capsules atazanavir 
IME ZDRAVILA Atazanavir Krka 300 mg trde kapsule atazanavir
HDPE tablet container with child-resistant tamper evident PP with desiccant closure: 30 hard capsules and 90 (3 x 30) hard capsules, in a box. 
Atazanavir Krka 300 mg trde kapsule Vsebnik za tablete iz HDPE z za otroke varno polipropilensko zaporko s sušilnim sredstvom, ki je ni mogoče odpreti brez vidnih poškodb: 30 trdih kapsul in 90 (3 x 30) trdih kapsul, v škatli.
Atazanavir Krka with ritonavir is contraindicated in patients with moderate hepatic insufficiency (see sections 4.2, 4.4 and 5.2). 
Uporaba zdravila Atazanavir Krka z ritonavirjem je kontraindicirana pri bolnikih z zmerno insuficienco jeter (glejte poglavja 4.2, 4.4 in 5.2).
Hard gelatine capsule, size no. 1. 
Trda želatinasta kapsula, velikost št. 1.
Treatment-Naive atazanavir Capsules/ritonavir (300 mg/100 mg once daily) n=16 
Zdravljenje bolnikov, ki še niso prejemali atazanavirja v obliki kapsul/ritonavirja (300 mg/100 mg enkrat na dan) n = 16
Musculoskeletal and connective tissue disorders uncommon: muscle atrophy, arthralgia, myalgia; rare: myopathy 
občasni: atrofija mišic, artralgija, mialgija;
The mechanism of interaction is decreased solubility of atazanavir as intra-gastric pH increases with proton pump inhibitors. 
Mehanizem interakcije je zmanjšana topnost atazanavirja zaradi zvišanja vrednosti pH
These are listed under Do not take Atazanavir Krka, at the start of Section 2. 
Druga zdravila in zdravilo Atazanavir Krka Zdravila Atazanavir Krka ne smete jemati z nekaterimi drugimi zdravili, ki so navedena na začetku poglavja 2 pod Ne jemljite zdravila Atazanavir Krka.
Atazanavir Krka 200 mg hard capsules 
Atazanavir Krka 200 mg trde kapsule
Norethindrone cmax ↑67% (↑42% Norethindrone cmin ↑262% 
Noretindron AUC ↑110 % (↑68 % Noretindron Cmax ↑67 % (↑42 % Noretindron Cmin ↑262 % (↑157 %
Based on these data and because ritonavir is not expected to have a significant impact on the pharmacokinetics of NRTIs, the co-administration of these medicinal products and atazanavir is not expected to significantly alter the exposure of the co-administered medicinal products. 
NRTI-jev ne pričakujemo, pri sočasni uporabi teh zdravil in atazanavirja ne pričakujemo,
NAME OF THE MEDICINAL PRODUCT Atazanavir Krka 150 mg hard capsules atazanavir 
IME ZDRAVILA Atazanavir Krka 150 mg trde kapsule atazanavir
The decrease in AUC, cmax, and cmin was not mitigated when an increased dose of atazanavir /ritonavir (400/100 mg once daily) was temporally separated from omeprazole by 12 hours. 
Če so povečan odmerek atazanavirja/ritonavirja (400/100 mg enkrat na dan) začasno ločili od uporabe omeprazola za 12 ur, se zmanjšanje vrednosti AUC, Cmax, in Cmin ni ublažilo.
(atazanavir 300 mg / ritonavir 100 mg once daily) 
(atazanavir 300 mg enkrat na dan z ritonavirjem 100 mg enkrat na dan)
b ATV/RTV with tenofovir disoproxil fumarate/emtricitabine (fixed dose 300 mg/200 mg tablets once daily). 
b ATV/RTV skupaj s dizoproksiltenofovirijevim fumaratom/emtricitabinom (fiksni odmerek 300 mg/200 mg tablete enkrat na dan).
Interactions with other medicinal products The combination of Atazanavir Krka with atorvastatin is not recommended (see section 4.5). 
Zdravila Atazanavir Krka ni priporočljivo uporabljati v kombinaciji z atorvastatinom (glejte poglavje 4.5).
common: jaundice; uncommon: hepatitis, cholelithiasisa, cholestasisa; rare: hepatosplenomegaly, cholecystitis a 
občasni: vnetje jeter, holelitiaza a, holestaza a;
Stop taking Atazanavir Krka and talk to your doctor immediately if you develop a severe rash or a rash with flu-like illness symptoms, blisters, fever, mouth sores, muscle or joint pain, swelling in the face, inflammation of the eye which causes redness (conjunctivitis), painful, warm, or red lumps (nodules). 
bolečina v mišicah ali sklepih, otekanje obraza, vnetje oči s posledično rdečino oči (konjunktivitis), boleči, topli ali rdeči vozliči (noduli), zdravilo Atazanavir Krka takoj prenehajte jemati in se nemudoma posvetujte z zdravnikom.
Adverse reactions were consistent between patients who received atazanavir 400 mg once daily and patients who received atazanavir 300 mg with ritonavir 100 mg once daily, except that jaundice and elevated total bilirubin levels were reported more frequently with atazanavir plus ritonavir. 
Pri bolnikih, ki so prejemali atazanavir v odmerku 400 mg enkrat na dan, in bolnikih, ki so prejemali zdravilo atazanavir v odmerku 300 mg skupaj z ritonavirjem v odmerku 100 mg enkrat na dan, so bili neželeni učinki primerljivi.
Co-administration of salmeterol and Atazanavir Krka is not recommended (see section 4.5). 
Sočasna uporaba salmeterola in zdravila Atazanavir Krka ni priporočljiva (glejte poglavje 4.5).
The mechanism of interaction is decreased solubility of atazanavir as intra-gastric pH increases with H2- blockers. 
Mehanizem interakcije je zmanjšana topnost atazanavirja zaradi zvišane vrednosti pH želodčnega soka, ki je posledica uporabe antagonista histaminskih receptorjev H2.
** When compared to rifabutin 150 mg once daily alone. 
** Pri primerjavi z uporabo samega rifabutina v odmerku 150 mg enkrat na dan. Skupna vrednost AUC rifabutina in
Talk to your doctor immediately if you get dark (tea-colored) urine, itching, yellowing of your skin or the white part of your eyes, pain around the stomach, pale colored stools or nausea. 
(barva čaja), srbenja, rumenega obarvanja kože ali očesnih beločnic, bolečine v trebuhu,
blockers like famotidine and proton pump inhibitors like omeprazole) - medicines to lower blood pressure, to slow heart rate, or to correct heart rhythm (amiodarone, 
antacidi, ki jih je treba jemati 1 uro pred zdravilom Atazanavir Krka ali 2 uri po zdravilu Atazanavir Krka, antagonisti histaminskih receptorjev H2, kot je famotidin, in zaviralci protonske črpalke, kot je omeprazol), - zdravila za znižanje zvišanega krvnega tlaka, za upočasnitev srčnega utripa ali za uravnavanje srčnega ritma (amiodaron, diltiazem, sistemski lidokain, verapamil),
Difference estimate [95% CI] 
[95 % IZ]
c LPV/RTV with tenofovir disoproxil fumarate/emtricitabine (fixed dose 300 mg/200 mg tablets once daily). 
c LPV/RTV skupaj s dizoproksiltenofovirijevim fumaratom/emtricitabinom (fiksni odmerek 300 mg/200 mg tablete enkrat na dan).
At the time voriconazole treatment is required, a patient's CYP2C19 genotype should be performed if feasible. 
Kadar je potrebno zdravljenje z vorikonazolom, je treba, če je to možno, določiti bolnikov
c Lopinavir/RTV with tenofovir disoproxil fumarate/emtricitabine (fixed dose 300 mg/200 mg tablets once daily). 
c Lopinavir/RTV skupaj z dizoproksiltenofovirjevim fumaratom/emtricitabinom (fiksni odmerek 300 mg/200 mg tablete enkrat na dan).
- If tenofovir disoproxil or an H2-receptor antagonist is needed, a dose increase to Atazanavir Krka 
Če je uporaba kombinacije nujna, je potreben skrben klinični nadzor, odmerek atazanavirja pa je treba povečati na
Cap: titanium dioxide (E171), yellow ferric oxide (E172), red ferric oxide (E172), gelatine and ink (shellac, black ferric oxide (E172), potassium hydroxide 
Kapica: titanov dioksid (E171), rumeni železov oksid (E172), rdeči železov oksid (E172), želatina in črnilo (šelak, črni železov oksid (E172), kalijev hidroksid)
Hard gelatine capsule (capsule), size no. 0. 
Trda želatinasta kapsula (kapsula), velikost št. 0.
Capsule shell of Atazanavir Krka 200 mg hard capsules Body: titanium dioxide (E171) yellow ferric oxide (E172) red ferric oxide (E172) gelatine 
Ovojnica kapsule - Atazanavir Krka 200 mg trde kapsule Telo: titanov dioksid (E171) rumeni železov oksid (E172)
HCV Protease Inhibitors Boceprevir 800 mg three times daily (atazanavir 300 mg/ritonavir 100 mg once daily) 
Zaviralci proteaze HCV Boceprevir 800 mg trikrat na dan (atazanavir
Co-administration of atazanavir and indinavir is not recommended (see section 4.4). 
Sočasne uporabe atazanavirja in indinavirja ne priporočamo (glejte poglavje 4.4).
Absorption: in HIV-infected patients (n=33, combined studies), multiple dosing of atazanavir 300 mg once daily with ritonavir 100 mg once daily with food produced a geometric mean (CV%) for atazanavir, cmax of 4466 (42%) ng/ml, with time to cmax of approximately 2.5 hours. 
100 mg enkrat na dan skupaj s hrano geometrijska srednja vrednost Cmax (KV %) atazanavirja 4.466 (42 %) ng/ml.
Co-administration of Atazanavir Krka with proton pump inhibitors is not recommended (see section 4.5). 
Sočasna uporaba zdravila Atazanavir Krka in zaviralcev protonske črpalke ni priporočljiva (glejte poglavje 4.5).
Rifabutin AUC ↑48% (↑19% Rifabutin cmax ↑149% (↑103% Rifabutin cmin ↑40% (↑5% ↑87%) 
Rifabutin AUC ↑48 % (↑19 % ↑84 %)** Rifabutin Cmax ↑149 % (↑103 % Rifabutin Cmin ↑40 % (↑5 % ↑87 %)** 25-O-dezacetil-rifabutin AUC ↑990 % 25-O-dezacetil-rifabutin Cmax ↑677 % 25-O-dezacetil-rifabutin Cmin ↑1045 %
None of the de novo substitutions (see Table 4) are specific to atazanavir and may reflect reemergence of archived resistance on atazanavir + ritonavir in Study 045 treatment-experienced population. 
Razmerje spremembe dovzetnosti na celični kulturi v primerjavi z referenčnim divjim tipom je bilo določeno s testom PhenoSenseTM (Monogram Biosciences, South San Francisco, Kalifornija, ZDA) Nobena od novih substitucij (glejte preglednico 4) ni specifična za atazanavir in lahko kaže na ponoven pojav arhivirane odpornosti na atazanavir + ritonavir pri predhodno že zdravljenih bolnikih v študiji 045.
STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 200 mg atazanavir (as sulphate). 
Ena trda kapsula vsebuje 200 mg atazanavirja (v obliki sulfata).
Atazanavir AUC ↔0% (↓9% Atazanavir cmax ↑17% (↑8% Atazanavir cmin ↓42% (↓51% 
Atazanavir (popoldan): vse skupaj s hrano Atazanavir AUC ↔0 % (↓9 % ↑10 %)* Atazanavir Cmax ↑17 % (↑8 % ↑27 %)* Atazanavir Cmin ↓42 % (↓51 % ↓31 %)*
The combination of rifampicin and atazanavir is contraindicated (see section 4.3). 
Sočasna uporaba alfuzosina z atazanavirjem je kontraindicirana (glejte poglavje 4.3).
STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 300 mg atazanavir (as sulphate). 
Ena trda kapsula vsebuje 300 mg atazanavirja (v obliki sulfata).
Coadministration with atazanavir may result in increased concentrations of the PDE5 inhibitor and an increase in PDE5-associated adverse events, including hypotension, visual changes, and priapism. 
Pri sočasni uporabi z atazanavirjem se lahko koncentracije zaviralca PDE5 povečajo in pojavijo njegovi neželeni učinki, kot so hipotenzija,
All patients HIV RNA <400 copies/ml, % 
HIV RNA < 400 kopij/ml, % a
The recommended adult dose of Atazanavir Krka capsules is 300 mg once daily with 100 mg ritonavir once daily and with food, in combination with other anti-HIV medicines. 
100 mg ritonavirja enkrat na dan in skupaj s hrano, v kombinaciji z drugimi zdravili proti HIV.
Hard gelatine capsule, size no. 00. 
Trda želatinasta kapsula, velikost št. 00.
Hard gelatine capsule, size no. 0. 
Trda želatinasta kapsula, velikost št. 0.
Hard gelatine capsule (capsule), size no. 00. 
Trda želatinasta kapsula (kapsula), velikost št. 00.
ANTI-HCV AGENTS Grazoprevir 200 mg once daily (atazanavir 300 mg/ ritonavir 100 mg once daily) 
ZDRAVILA ZA ZDRAVLJENJE OKUŽBE Z VIRUSOM HEPATITISA C Grazoprevir 200 mg enkrat na dan (atazanavir 300 mg/ ritonavir 100 mg enkrat na dan)
Human experience of acute overdose with atazanavir is limited. 
Ni zadostnih izkušenj s prevelikim odmerjanjem atazanavirja pri človeku.
Mean urinary excretion of unchanged drug was 7% following 2 weeks of dosing at 800 mg once daily. 
Povprečno izločanje nespremenjenega zdravila v urinu je bilo 7 %
STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 150 mg atazanavir (as sulphate). 
NAVEDBA ENE ALI VEČ UČINKOVIN Ena trda kapsula vsebuje 150 mg atazanavirja (v obliki sulfata).
Capsule shell of Atazanavir Krka 150 mg hard capsules Body: titanium dioxide (E171) gelatine 
Ovojnica kapsule - Atazanavir Krka 150 mg trde kapsule Telo: titanov dioksid (E171) želatina
- Gallbladder problems uncommonly happen in people taking atazanavir. 
- Pri osebah, ki jemljejo atazanavir, se občasno lahko pojavijo težave z žolčnikom.
If atazanavir is co-administered with irinotecan, patients should be closely monitored for adverse events related to irinotecan. 
Če se atazanavir uporablja skupaj z irinotekanom, je toksičnost irinotekana lahko poveča.
- Atazanavir Krka may affect how well your kidneys work. 
- Zdravilo Atazanavir Krka lahko vpliva na delovanje ledvic.
Capsule shell of Atazanavir Krka 300 mg hard capsules Body: titanium dioxide (E171) gelatine 
Ovojnica kapsule - Atazanavir Krka 300 mg trde kapsule Telo: titanov dioksid (E171) želatina
Diltiazem AUC ↑125% (↑109% Diltiazem cmax ↑98% (↑78% Diltiazem cmin ↑142% (↑114% 
Diltiazem AUC ↑125 % (↑109 % ↑141 %) Diltiazem Cmax ↑98 % (↑78 % ↑119 %) Diltiazem Cmin ↑142 % (↑114 % ↑173 %) Dezacetil-diltiazem AUC ↑165 % Dezacetil-diltiazem Cmax ↑172 % (↑144 % Dezacetil-diltiazem Cmin ↑121 % (↑102 %
Atazanavir AUC ↑7% (↓2% Atazanavir cmax ↑2% (↓4% ↑8%) Atazanavir cmin ↑15% (↑2% ↑29%) Elbasvir AUC: ↑376% (↑307% Elbasvir cmax: ↑315% (↑246% Elbasvir cmin: ↑545% (↑451% 
Elbasvir AUC: ↑376 % (↑307 % ↑456 %) Elbasvir Cmax: ↑315 % (↑246 % ↑397 %) Elbasvir Cmin: ↑545 % (↑451 % ↑654 %)
Atazanavir AUC ↓87% (↓92% 
Etinilestradiol AUC ↓19 % (↓25 %
Atazanavir, dosed 1 hr after ddI+d4T (fasted) Atazanavir AUC ↔3% (↓36% Atazanavir cmax ↑12% (↓33% Atazanavir cmin ↔3% (↓39% 
Atazanavir AUC ↔3 % (↓36 % ↑67 %) Atazanavir Cmax ↑12 % (↓33 % ↑18 %) Atazanavir Cmin ↔3 % (↓39 % ↑73 %)
Lopinavir/ritonavirc (400 mg/100 mg twice daily) n=443 
ATV/RTVb (300 mg/100 mg enkrat na dan) n = 120
As a general rule, it is recommended that HIV infected women not breast-feed their infants in order to avoid transmission of HIV. 
Splošno priporočilo je, da ženske, okužene z virusom HIV,
The increase in progestin exposure may lead to related side-effects (e.g. insulin resistance, dyslipidemia, acne and spotting), thus possibly affecting the compliance. 
Zaradi večje izpostavljenosti gestagenu se lahko pojavijo s tem povezani neželeni učinki (npr. odpornost proti insulinu,
Therefore, such coadministration is not recommended. 
Uporabi takih kontraceptivov se je tako treba izogibati.
Cap: titanium dioxide (E171) yellow ferric oxide (E172) red ferric oxide (E172) gelatine ink: 
Kapica: titanov dioksid (E171) rumeni železov oksid (E172)
- Kidney stones uncommonly happen in people taking atazanavir. 
- Pri osebah, ki jemljejo atazanavir, se občasno lahko pojavijo ledvični kamni.
Atazanavir concentrations were greatly decreased when coadministered with didanosine (buffered tablets) and stavudine. 
Pri sočasni uporabi z didanozinom (pufrane tablete) in s stavudinom so se koncentracije atazanavirja močno zmanjšale.
CD4 Mean Change from Baseline, cells/mm All patients 
Srednja sprememba števila celic CD4 od izhodišča, celice/mm
EXPIRY DATE 
občasni: dispneja
3rd Trimester (n=20) 
Nova substitucija zaviralca proteaz (n = 35)
Atazanavir Krka should be discontinued if severe rash develops. 
Atazanavir Krka prekiniti.
Atazanavir cmin: ↑713% (↑359% 
Atazanavir AUC: ↑250 % (↑144 % Atazanavir Cmax: ↑120 % (↑56 % Atazanavir Cmin: ↑713 % (↑359 %
Capsule shell of Atazanavir Krka 300 mg hard capsules Body: titanium dioxide (E171) and gelatine 
Ovojnica kapsule - Atazanavir Krka 150 mg trde kapsule: Telo:titanov dioksid (E171) in želatina
Capsule shell of Atazanavir Krka 150 mg hard capsules: 
Ovojnica kapsule - Atazanavir Krka 200 mg trde kapsule:
The mechanism of amiodarone or systemic lidocaine/atazanavir interaction is 
Mehanizem interakcije med amiodaronom in sistemskim lidokainom ter atazanavirjem je zavrtje CYP3A.
Buprenorphine, once daily, stable maintenance dose (atazanavir 300 mg once daily with ritonavir 100 mg once daily) 
Metadon, stabilni vzdrževalni odmerek (atazanavir 400 mg enkrat na dan)
the clarithromycin/atazanavir interaction is CYP3A4 inhibition. 
Mehanizem interakcije klaritromicin/atazanavir je zaviranje CYP3A4.
Atazanavir Krka may affect how well your kidneys work. 
Zdravilo Atazanavir Krka lahko vpliva na delovanje ledvic.
Efavirenz 600 mg once daily (atazanavir 400 mg once daily with ritonavir 200 mg once daily) 
Atazanavir (popoldan): vse skupaj s hrano na dan (atazanavir 400 mg enkrat na dan z ritonavirjem 200 mg enkrat na dan)
Irinotecan 
Kinidin
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). 
- Če je potrebna uporaba dizoproksiltenofovirata ali antagonista receptorjev H2, je treba razmisliti o povečanju odmerka zdravila Atazanavir Krka na 400 mg z ritonavirjem 100 mg ob sočasnem spremljanju koncentracij zdravila (glejte poglavji 4.6 in 5.2).
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. 
Sočasna uporaba atazanavirja s triazolamom ali peroralnim midazolamom je kontraindicirana (glejte poglavje 4.3).
Tenofovir disoproxil fumarate Cmin 
Dizoproksiltenofovirjev fumarat AUC Dizoproksiltenofovirjev fumarat Cmax Dizoproksiltenofovirjev fumarat Cmin
Grazoprevir concentrations were greatly increased when coadministered with atazanavir/ritonavir. 
Izjema sta bila le zlatenica in zvišanje vrednosti celotnega bilirubina, ki sta bila pri uporabi atazanavirja skupaj z ritonavirjem pogostejša.
Atazanavir Krka with ritonavir should be used with caution in patients with mild hepatic impairment. 
Pri bolnikih z blago okvaro jeter je treba zdravilo Atazanavir Krka z ritonavirjem uporabljati previdno.
Reduced plasma concentrations of atazanavir may be the consequence of increased gastric pH if antacids, including buffered medicinal products, are administered with atazanavir. 
Pri sočasni uporabi atazanavirja in antacidov, vključno z zdravili, ki vsebujejo pufre, se zaradi zvišanja vrednosti pH
Rare (may affect up to 1 in 1,000 people): - gait disturbance (abnormal manner of walking) - oedema (swelling) - hepatosplenomegaly (enlargement of the liver and spleen) - myopathy (aching muscles, muscle tenderness of weakness, not caused by exercise) - kidney pain 
- hepatosplenomegalija (povečanje jeter in vranice); - miopatija (bolečina, občutljivost ali slabost mišic, ki ni posledica telesnega napora); - bolečine v ledvicah.
Proton pump inhibitors Omeprazole 40 mg once daily (atazanavir 400 mg once daily with ritonavir 100 mg once daily) 
Omeprazol 40 mg enkrat na dan (atazanavir 400 mg enkrat na dan z ritonavirjem 100 mg enkrat na dan)
Osteonecrosis 
paragevzija
The efficacy of atazanavir /ritonavir in combination with 
Zaradi zaviralnega učinka atazanavirja na
Further information on Nasym can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/nasym. 
Nadaljnje informacije o zdravilu Nasym so na voljo na spletni strani agencije: ema.europa.eu/medicines/veterinary/EPAR/nasym.
The European Medicines Agency decided that Nasym's benefits are greater than its risks and it can be authorised for use in the EU. 
Evropska agencija za zdravila je odločila, da so koristi zdravila Nasym večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
This overview was last updated in May 2019. 
Ta povzetek je bil nazadnje posodobljen 05-2019.
Nasym is a vaccine. 
Zdravilo Nasym je cepivo.
Other information about Nasym 
Druge informacije o zdravilu Nasym
What benefits of Nasym have been shown in studies? 
Kakšne koristi zdravila Nasym so se pokazale v študijah?
An overview of Nasym and why it is authorised in the EU 
Pregled zdravila Nasym in zakaj je odobreno v EU
Why is Nasym authorised in the EU? 
Zakaj je zdravilo Nasym odobreno v EU?
Nasym received a marketing authorisation valid throughout the EU on 29 July 2019. 
Zdravilo Nasym je pridobilo dovoljenje za promet, veljavno po vsej Evropski uniji, 29/07/2019.
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. 
Ko je žival ponovno izpostavljena temu ali podobnemu virusu, ta protitelesa skupaj z drugimi mehanizmi imunskega sistema uničijo virus in pripomorejo k zaščiti pred boleznijo.
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. 
Najpogostejši nezaželen učinek zdravila Nasym (ki lahko prizadene največ 1 žival od 10) je rahla sprememba v konsistenci iztrebkov.
What is Nasym and what is it used for? 
Kaj je zdravilo Nasym in za kaj se uporablja?
These studies involved non-vaccinated animals given a dummy vaccination and all animals were artificially exposed to bovine respiratory syncytial virus. 
Te študije so vključevale necepljene živali, ki so bile cepljene s cepivom brez učinkovine, vse živali pa so bile umetno izpostavljene bovinemu respiratornemu sincicijskemu virusu.
The withdrawal period for meat from cattle treated with Nasym is ‘zero' days, which means that there is no mandatory waiting time. 
Karenca za meso goveda, zdravljenega z zdravilom Nasym, je nič dni, kar pomeni, da ni obvezne čakalne dobe.
When an animal is given the vaccine, the animal's immune system recognises the virus as ‘foreign' and makes antibodies against it. 
Ko žival prejme cepivo, imunski sistem prepozna virus kot „tujek“ in proti njemu tvori protitelesa.
For cattle from 9 days of age, the vaccine is sprayed into each of the animal's nostrils using an intranasal applicator. 
Govedu od devet dni starosti se cepivo naprši v vsako nosnico z intranazalnim aplikatorjem.
What are the risks associated with Nasym? 
Kakšna tveganja so povezana z zdravilom Nasym?
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. 
Učinkovitost zdravila Nasym so dokazali v sedmih laboratorijskih študijah, v katerih je cepljenje govedi z zdravilom Nasym v obliki nosnega pršila ali injekcije v mišico zmanjšalo tako izločanje virusa kot znake respiratorne bolezni, kot so pospešeno dihanje, oteženo dihanje, izcedek iz oči in vnete oči.
Nasym contains a strain of bovine respiratory syncytial virus that is weakened and does not cause the disease. 
Zdravilo Nasym vsebuje sev bovinega respiratornega sincicijskega virusa, ki je oslabljen in ne povzroča bolezni.
Nasym (bovine respiratory syncytial virus vaccine, live) EMA/287041/2019 
Zdravilo Nasym (cepivo proti bovinemu respiratornemu sincicijskemu virusu, živo) EMA/422471/2019