natgillin/translations-raw huggingface dataset:
Each tablet contains 20 mg of sildenafil (as the citrate). 
Jedna tableta sadrži 20 mg sildenafila (u obliku sildenafilcitrata).
A population pharmacokinetic analysis of sildenafil data from adult PAH patients in clinical trials including a 12 week study to assess the efficacy and safety of oral sildenafil 20 mg three times a day when added to a stable dose of bosentan (62.5 mg - 125 mg twice a day) indicated a decrease in sildenafil exposure with bosentan co-administration, similar to that observed in healthy volunteers (see sections 4.4 and 5.1). 
Analiza podataka o populacijskoj farmakokinetici sildenafila u odraslih bolesnika s PAH-om iz kliničkih ispitivanja, uključujući 12-tjedno ispitivanje za procjenu djelotvornosti i sigurnosti peroralnog sildenafila 20 mg tri puta dnevno koji se dodaje stabilnoj dozi bosentana (62,5 mg - 125 mg dvaput dnevno) pokazala je da se izloženost sildenafilu smanjila kod istodobne primjene bosentana, slično onome što je primijećeno u zdravih dobrovoljaca (vidjeti dijelove 4.4 i
In addition, N-desmethyl metabolite AUC and Cmax values were significantly increased by 154% and 87%, respectively in cirrhotic subjects compared to subjects with normal hepatic function. 
Osim toga, vrijednosti AUC-a i Cmax N-dezmetil metabolita bile su značajno povećane (154% odnosno 87%) u ispitanika s cirozom u odnosu na ispitanike s normalnom jetrenom funkcijom.
In addition, N-desmethyl metabolite AUC and Cmax values were significantly increased 200% and 79% respectively in subjects with severe renal impairment compared to subjects with normal renal function. 
Osim toga, vrijednosti AUC-a i Cmax N-dezmetil metabolita bile su značajno povećane (200% odnosno 79%) u ispitanika s teškim oštećenjem bubrega u odnosu na ispitanike s normalnom bubrežnom funkcijom.
For patients with a baseline 6MWD < 325 m improved efficacy was observed with higher doses (placebo-corrected improvements of 58 metres, 65 metres and 87 metres for 20 mg, 40 mg and 80 mg doses TID, respectively). 
U bolesnika čiji je početni 6MWD bio < 325 metara opažena je poboljšana djelotvornost kod primjene viših doza (poboljšanje korigirano za placebo za 58 metara pri dozi od 20 mg TID, za 65 metara pri dozi od 40 mg TID te za 87 metara pri dozi od 80 mg TID).
In volunteers with severe renal impairment (creatinine clearance < 30 ml/min), sildenafil clearance was reduced, resulting in mean increases in AUC and Cmax of 100% and 88% respectively compared to age-matched volunteers with no renal impairment. 
U dobrovoljaca s teškim oštećenjem bubrega (klirens kreatinina < 30 ml/min) klirens sildenafila je bio smanjen, što je rezultiralo srednjom vrijednošću povećanja AUC-a od 100%, a Cmax od 88% u usporedbi s dobrovoljcima bez oštećenja bubrega podudarnima s obzirom na dob.
How to take Mysildecard 
Kako uzimati Mysildecard
A white, round, biconvex film-coated tablet (approximately 6.5 mm diameter), debossed with M on one side of the tablet and SL over 20 on the other side. 
Bijela, okrugla, filmom obložena bikonveksna tableta (promjera približno 6,5 mm) s ugraviranom oznakom
Mysildecard 20 mg film-coated tablets sildenafil 
Mysildecard 20 mg filmom obložene tablete sildenafil
• Medicines containing nitrates, or nitric oxide donors such as amyl nitrate (“poppers”). 
lijekove koji sadrže nitrate ili donore dušikova oksida poput amil nitrata.
Co-administration of bosentan (a moderate inducer of CYP3A4, CYP2C9 and possibly of CYP2C19) 125 mg twice daily with sildenafil 80 mg three times a day (at steady state) concomitantly administered during 6 days in healthy volunteers resulted in a 63% decrease of sildenafil AUC. 
Istodobna primjena bosentana (umjerenog induktora CYP3A4, CYP2C9, a možda i CYP2C19) u dozi od 125 mg dva puta na dan sa sildenafilom u dozi od 80 mg tri puta na dan (u stanju dinamičke ravnoteže) tijekom 6 dana u zdravih dobrovoljaca rezultirala je smanjenjem AUC-a sildenafila od 63%.
Mysildecard with food and drink You should not drink grapefruit juice while you are being treated with Mysildecard. 
Ne smijete piti sok od grejpa dok se liječite lijekom Mysildecard.
Long-term Survival Data in the background epoprostenol study Patients enrolled into the epoprostenol add-on therapy study were eligible to enter a long term open label extension study. 
Podaci o dugoročnom preživljenju u populaciji prethodno neliječenih bolesnika Bolesnici uključeni u pivotalno ispitivanje bili su pogodni za ulazak u dugotrajan produžetak otvorenog ispitivanja.
The known adverse reactions headache, flushing, pain in extremity and oedema were noted in a higher frequency in sildenafil/epoprostenol treated patients compared to placebo/epoprostenol treated patients. 
Učestalost poznatih nuspojava: glavobolje, crvenila praćenog osjećajem užarenosti ili vrućine, boli u ekstremitetima i edema bila je veća u bolesnika liječenih sildenafilom/epoprostenolom u usporedbi s bolesnicima koji su primali placebo/epoprostenol.
there was no evidence of an effect of azithromycin (500 mg daily for 3 days) on the AUC, Cmax, Tmax, elimination rate constant, or subsequent half-life of sildenafil or its principal circulating metabolite. 
Za preporuke o doziranju vidjeti dio 4.2. U zdravih muških dobrovoljaca nije bilo dokaza o utjecaju azitromicina (500 mg na dan tijekom 3 dana) na AUC, Cmax, Tmax, konstantu brzine eliminacije niti kasniji poluvijek sildenafila ili njegovog glavnog metabolita u cirkulaciji.
For children and adolescents aged 1 year to 17 years old, the recommended dose is either 10 mg three times a day for children and adolescents ≤ 20 kg or 20 mg three times a day for children and adolescents > 20 kg, taken with or without food. 
Za djecu i adolescente u dobi od 1 do 17 godina preporučena doza je ili 10 mg tri puta na dan ako im je tjelesna težina ≤ 20 kg, ili 20 mg tri puta na dan ako im je tjelesna težina > 20 kg.
INFORMATION IN BRAILLE Mysildecard 20 mg tablets 
16. PODACI NA BRAILLEOVOM PISMU Mysildecard 20 mg tablete
This drug is used to treat pulmonary arterial hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high blood pressure in the lungs secondary to blood clots).PDE5 inhibitors, such as sildenafil have been shown to increase the hypotensive effects of this medicine. 
Ovaj lijek se koristi u liječenju plućne arterijske hipertenzije (kod visokog krvnog tlaka u plućima) i kronične tromboembolijske plućne hipertenzije (kod visokog krvnog tlaka u plućima kao posljedica stvaranja krvnih ugrušaka).
Patients enrolled into the pivotal study were eligible to enter a long term open label extension study. 
Bolesnici uključeni u ispitivanje dodatnog liječenja epoprostenolom bili su pogodni za ulazak u dugotrajan produžetak otvorenog ispitivanja.
A population pharmacokinetic analysis of data from a study of adult PAH patients on background bosentan therapy (62.5 mg - 125 mg twice a day) indicated an increase (20% (95% CI: 9.8 - 30.8)) of bosentan AUC with co-administration of steadystate sildenafil (20 mg three times a day) of a smaller magnitude than seen in healthy volunteers when co-administered with 80 mg sildenafil three times a day (see sections 4.4 and 5.1). 
Analiza podataka o populacijskoj farmakokinetici sildenafila iz ispitivanja u odraslih bolesnika s PAH-om kod kojih se kao osnovni lijek primjenjivao bosentan (62,5 mg - 125 mg dva puta na dan) pokazala je povećanje (20% (95% CI: 9,8 - 30,8) AUC bosentana kod istodobne primjene sildenafila u stanju dinamičke ravnoteže (20 mg tri puta na dan) u odnosu na ono zapaženo u zdravim dobrovoljcima kada se istodobno primjenjivao s 80 mg sildenafila tri puta na dan (vidjeti dijelove 4.4 i 5.1).
Survival in patients of WHO functional class II at baseline at 1, 2 and 3 years was 99%, 91%, and 84% respectively, and for patients of WHO functional class III at baseline was 94%, 90%, and 81%, respectively. 
U bolesnika sa SZO funkcionalnim stupnjem II na početku ispitivanja jednogodišnje je preživljenje iznosilo 99%, dvogodišnje 91%, a trogodišnje 84%, dok je u bolesnika sa SZO funkcionalnim stupnjem III jednogodišnje preživljenje iznosilo 94%, dvogodišnje 90%, a trogodišnje 81%.
• Severe hepatic impairment, 
• u bolesnika s teškim oštećenjem jetre,
• Severe hypotension (blood pressure < 90/50 mmHg) at initiation. 
• u bolesnika koji kod uvođenja lijeka imaju tešku hipotenziju (krvni tlak < 90/50 mmHg).
In the pivotal placebo-controlled study of sildenafil in pulmonary arterial hypertension, a total of 207 patients were randomised to and treated with 20 mg, 40 mg, or 80 mg TID doses of sildenafil and 70 patients were randomised to placebo. 
U pivotalnom placebom kontroliranom ispitivanju sildenafila u liječenju plućne arterijske hipertenzije ukupno je 207 bolesnika randomizirano na liječenje sildenafilom u dozi od 20 mg, 40 mg ili 80 mg tri puta na dan (TID), dok je 70 bolesnika randomizirano na placebo.
The safety and efficacy of sildenafil when co-administered with other PDE5 inhibitor products, including the combined use of sildenafil for erectile dysfunction has not been studied in PAH patients and such concomitant use is not recommended (see section 4.5). 
Istovremena primjena s drugim PDE5 inhibitorima Sigurnost i djelotvornost istodobne primjene sildenafila i drugih inhibitora PDE5, uključujući i kombiniranu upotrebu sildenafila za erektilnu disfunkciju nije ispitana u bolesnika s PAH-om i ne preporučuje se takav oblik istodobne primjene (vidjeti dio 4.5).
MARKETING AUTHORISATION NUMBER(S) EU/1/16/1134/001 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/113/001
In the event of any sudden visual defect, the treatment should be stopped immediately and alternative treatment should be considered (see section 
U slučaju iznenadnog poremećaja vida liječenje lijekom Mysildecard je potrebno odmah prekinuti i razmotriti alternativno liječenje (vidjeti dio 4.3).
However, for subjects with PAH associated with connective tissue disease (36 subjects) mean changes from baseline were -18.32 m (95% CI: -65.66 to 29.02) and 17.50 m (95% CI: -9.41 to 44.41) for the sildenafil and placebo groups, respectively. 
Međutim, za ispitanike s PAH-om povezanim s bolešću vezivnog tkiva (36 ispitanika), srednje vrijednosti promjena u odnosu na početne vrijednosti bile su -18,32 m (95% CI: -65,66 do 29,02) za skupinu koja je primala sildenafil odnosno 17,50 m (95% CI: -9,41 do 44,41), za skupinu koja je primala placebo.
NAME OF THE MEDICINAL PRODUCT Mysildecard 20 mg film-coated tablets 
NAZIV LIJEKA Mysildecard 20 mg filmom obložene tablete
Musculoskeletal and connective tissue disorders Very common pain in extremity 
Poremećaji mišićno-koštanog sustava i vezivnog tkiva vrlo često bol u ekstremitetu često mialgija, bol u leđima
STATEMENT OF ACTIVE SUBSTANCE Each film-coated tablet contains 20 mg of sildenafil (as citrate). 
NAVOĐENJE DJELATNE TVARI Jedna filmom obložena tableta sadrži 20 mg sildenafila (u obliku citrata).
Co-administration of the HIV protease inhibitor ritonavir, which is a highly potent P450 inhibitor, at steady state (500 mg twice daily) with sildenafil (100 mg single dose) resulted in a 300% (4-fold)increase in sildenafil Cmax and a 1,000% (11-fold) increase in sildenafil plasma AUC. 
Istodobna primjena inhibitora HIV proteaze ritonavira, koji je vrlo snažan inhibitor citokroma P450, u stanju dinamičke ravnoteže (500 mg dva puta na dan) sa sildenafilom (jedna doza od 100 mg) povećala je Cmax sildenafila za 300% (4 puta), a AUC sildenafila u plazmi za 1000% (11 puta).
The N-desmethyl metabolite is further metabolised, with a terminal half-life of approximately 4 h. In patients with pulmonary arterial hypertension, plasma concentrations of N-desmethyl metabolite are approximately 72% those of sildenafil after 20 mg three times a day dosing (translating into a 36% contribution to sildenafil's pharmacological effects). 
N-dezmetil metabolita iznose približno 72% koncentracije sildenafila nakon primjene doze od 20 mg tri puta na dan (što čini doprinos od 36% farmakološkim učincima sildenafila).
MARKETING AUTHORISATION NUMBERS EU/1/16/1134/001 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1134/001
Co-administration of the HIV protease inhibitor saquinavir, a CYP3A4 inhibitor, at steady state (1200 mg three times a day) with sildenafil (100 mg single dose) resulted in a 140% increase in sildenafil Cmax and a 210% increase in sildenafil AUC. 
Istodobna primjena inhibitora HIV proteaze sakvinavira, koji je inhibitor CYP3A4, u stanju dinamičke ravnoteže (1200 mg tri puta na dan) sa sildenafilom (jedna doza od 100 mg) povećala je Cmax sildenafila za 140%, a AUC sildenafila za 210%.
Efficacy in adult patients with PAH (when used in combination with epoprostenol) A randomised, double-blind, placebo controlled study was conducted in 267 patients with PAH who were stabilised on intravenous epoprostenol. 
Provedeno je randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje s 267 bolesnika s PAH-om koji su bili stabilizirani na intravenskoj terapiji epoprostenolom.
How to store Mysildecard 
Kako čuvati Mysildecard
Placebo-corrected treatment effects with PVR were -178 dyne.sec/cm5 (p=0.0051), -195 dyne.sec/cm5 (p=0.0017) and -320 dyne.sec/cm5 (p<0.0001) for sildenafil 20 mg, 40 mg and 80 mg TID, respectively. 
Učinci liječenja na plućni krvožilni otpor, korigirani za placebo, bili su -178 dyn.s/cm5 (p=0,0051) kod primjene sildenafila u dozi od 20 mg TID, -195 dyn.s/cm5 (p=0,0017) kod primjene sildenafila u dozi od 40 mg TID te -320 dyn.s/cm5 (p < 0,0001) kod primjene sildenafila u dozi od 80 mg TID.
Concomitant administration of sildenafil to patients taking alpha-blocker therapy may lead to symptomatic hypotension in susceptible individuals (see section 
Istodobna primjena sildenafila u bolesnika koji uzimaju alfa-blokatore može u osjetljivih osoba dovesti do simptomatske hipotenzije (vidjeti dio 4.4).
Do not take Mysildecard: • if you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 
Nemojte uzimati Mysildecard: - ako ste alergični na sildenafil ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.). - ako uzimate lijekove koji sadrže nitrate ili donore dušikova oksida poput amil nitrata.
Respiratory, thoracic and mediastinal disorders Common epistaxis, cough, nasal congestion 
Poremećaji dišnog sustava, prsišta i sredoprsja često epistaksa, kašalj, kongestija nosa
Placebo-corrected treatment effects with mPAP were -2.7 mmHg (p = 0.04), -3.0 mmHg (p = 0.01) and -5.1 mmHg (p < 0.0001) for sildenafil 20 mg, 40 mg and 80 mg TID respectively. 
Učinci liječenja na srednju vrijednost plućnog arterijskog tlaka, korigirani za placebo, bili su -2,7 mmHg (p = 0,04) kod primjene sildenafila u dozi od 20 mg TID, -3,0 mmHg (p = 0,01) kod primjene sildenafila u dozi od 40 mg TID te -5,1 mmHg (p < 0,0001) kod primjene sildenafila u dozi od 80 mg TID.
Titanium dioxide (E171) 
Film ovojnica: hipromeloza 6 mPas titanijev dioksid (E171) triacetin
• currently have a stomach ulcer, a bleeding disorder (such as haemophilia) or problems with nose bleeds. 
(leukemiju), rak koštane srži (multipli mijelom) ili bilo kakvu bolest ili deformitet penisa - trenutno imate vrijed na želucu, poremećaj krvarenja (poput hemofilije) ili tegobe s krvarenjem iz nosa.
A total of 106 out of 234 (45%) subjects were evaluable for CPET, which comprised those children ≥ 7 years old and developmentally able to perform the test. Children < 7 years (sildenafil combined dose = 47; placebo = 16) were evaluable only for the secondary endpoints. 
CPET test se mogao provesti u ukupno 106 od 234 ispitanika (45%), koji su obuhvaćali djecu u dobi od ≥ 7 godina i razvojno sposobnu za izvođenje testa.
Kaplan-Meier estimates of survival at 3 years in patients > 20 kg in weight at baseline were 94%, 93% and 85% in the low, medium and high dose groups, respectively; for patients ≤ 20 kg in weight at baseline, the survival estimates were 94% and 93% for subjects in the medium and high dose groups respectively (see sections 4.4 and 4.8). 
Kaplan-Meierove procjene trogodišnjeg preživljenja u bolesnika tjelesne težine > 20 kg na početku ispitivanja bile su: 94% za skupinu koja je primala nisku dozu, 93% za skupinu koja je primala srednju dozu i 85% za skupinu koja je primala visoku dozu sildenafila.
In a small size placebo-controlled study of patients with documented early age-related macular degeneration (n = 9), sildenafil (single dose, 100 mg) 
U malom, placebom kontroliranom ispitivanju u bolesnika s dokumentiranom, ranom, dobno uvjetovanom degeneracijom makule (n = 9), sildenafil (jedna doza od 100 mg) nije pokazao značajne promjene u provedenim testovima vida (oštrina vida, Amslerova mreža, razlikovanje boja simulacijom semafora, Humphreyev perimetar i fotostres test).
Data from one lactating woman indicate that sildenafil and its active metabolite N-desmethylsildenafil are excreted into breast milk at very low levels. 
Podaci od jedne dojilje pokazuju da se sildenafil i njegov aktivni metabolit
A total of 234 subjects aged 1 to 17 years were treated in a randomised, double-blind, multi-centre, placebo controlled parallel group, dose ranging study. 
U randomiziranom, dvostruko slijepom, multicentričnom, placebom kontroliranom ispitivanju raspona doza s paralelnim skupinama liječena su ukupno 234 ispitanika u dobi od 1 do 17 godina.
Most patients were WHO Functional Class II (107/277, 39%) or III (160/277, 58%) with a mean baseline 6-minute walking distance of 378 meters and 326 meters respectively; fewer patients were Class I (1/277, 0.4%) or IV (9/277, 3%) at baseline. 
Većina je bolesnika imala bolest funkcionalnog stupnja II (107/277, 39%) ili III (160/277, 58%) prema klasifikaciji SZO.
Adverse reactions which occurred in > 1% of sildenafil-treated patients and were more frequent (> 1% difference) on sildenafil in the pivotal study or in the sildenafil combined data set of both the placebo-controlled studies in pulmonary arterial hypertension, at doses of 20, 40 or 80 mg TID are listed in the table below by class and frequency grouping (very common (≥1/10), common (≥1/100 to < 1/10), uncommon (≥1 /1,000 to < 1/100) and not known (cannot be estimated from the available data). 
U sljedećoj su tablici navedene nuspojave koje su nastupile u > 1% bolesnika liječenih sildenafilom i koje su se javile češće (razlika > 1%) uz primjenu sildenafila u dozama od 20, 40 ili 80 mg TID u pivotalnom ispitivanju ili u kombiniranim podacima iz oba placebom kontrolirana ispitivanja u plućnoj arterijskoj hipertenziji.
if you experience sudden decrease or loss of vision (frequency not known) if you have an erection, which lasts continuously for more than 4 hours. 
Ako iskusite bilo koju od sljedećih nuspojava, morate prestati uzimati Mysildecard i odmah se javiti liječniku (pogledajte i dio 2.): - ako osjetite iznenadno smanjenje ili gubitak vida (učestalost nepoznata) - ako imate erekciju koja traje neprekidno dulje od 4 sata.
Not known sudden hearing loss 
Poremećaji uha i labirinta često vrtoglavica nepoznato iznenadni gubitak sluha
Eye disorders Common retinal haemorrhage, visual impairment, vision blurred, photophobia, chromatopsia, cyanopsia, eye irritation, ocular hyperaemia 
Poremećaji oka često krvarenje mrežnice, oštećenje vida, zamagljen vid, fotofobija, kromatopsija, cijanopsija, iritacija oka, očna hiperemija manje često smanjena oštrina vida, diplopija, neuobičajeni osjeti u oku nepoznato nearterijska prednja ishemijska optička neuropatija*, okluzija krvnih žila mrežnice, poremećaj vidnog polja*
Local reactions may increase slightly following the second dose, in this case lasting up to 15 days. 
Lokalne reakcije mogu se malo pojačati nakon druge doze, što u ovom slučaju može trajati do 15 dana.
Local reactions at the injection site are common and normally resolve within 4 weeks. 
Lokalne reakcije u mjestu injekcije su uobičajene i normalno nestaju u roku od 4 tjedna.
Cattle may show a temporary increase in body temperature (no more than 2.7 °C) in the 48 hours following vaccination. 
U goveda se može manifestirati privremeno povišenje tjelesne temperature (ne veće od 2,7°C) tijekom 48 sati nakon cijepljenja.
The European Medicines Agency (EMA) reviewed additional information submitted according to an agreed timetable on the quality, safety and efficacy of the vaccine. 
Europska agencija za lijekove (EMA) pregledala je dodatne informacije dostavljene u skladu s usuglašenim rasporedom o kvaliteti, sigurnosti i djelotvornosti cjepiva.
Protection starts three weeks after the last injection and lasts for one year. 
Zaštita započinje tri tjedna nakon posljednje injekcije i traje godinu dana.
The vaccine also contains ‘adjuvants' (aluminium hydroxide and saponin) to enhance the immune response. 
Cjepivo također sadrži dodatne tvari (aluminij hidroksid i saponin) za jači imunološki odgovor.
The vaccine is given to young animals as two injections under the skin. 
Cjepivo se daje mladim životinjama kao dvije potkožne injekcije.
Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease. 
Cjepiva djeluju tako da „uče” imunološki sustav (prirodnu obranu tijela) kako da se brani protiv bolesti.
The first injection is given from three months of age and the second injection is given three weeks later. 
Prva se injekcija daje nakon tri mjeseca starosti, a druga se injekcija daje tri tjedna nakon prve injekcije.
Zulvac 1+8 Bovis was initially authorised under ‘exceptional circumstances'. 
Zulvac 1+8 Bovis prvotno je odobren u „iznimnim okolnostima”.
The vaccine is used to prevent viraemia (the presence of viruses in the blood) in cattle from three months of age. 
Cjepivo se koristi za sprječavanje viremija (prisutnosti virusa u krvi) u goveda nakon tri mjeseca starosti.
The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat or milk used for human consumption. 
Razdoblje karencije je rok koji mora proći između primjene lijeka i klanja životinja te uporabe mesa ili mlijeka za ljudsku konzumaciju.
Another laboratory study in cattle looked at how long the vaccine was able to protect against bluetongue infection. 
Drugo laboratorijsko ispitivanje u goveda istražilo je koliko dugo cjepivo može štititi protiv upale plavog virusa.
Inactivated adjuvanted vaccine against bluetongue disease virus, serotypes 1 and 8 
Inaktivirano adjuvantno cjepivo protiv virusa bolesti plavog jezika, serotipovi 1 i 8
The withdrawal period for Zulvac 1 + 8 Bovis for meat and milk is zero days. 
Razdoblje karencije za Zulvac 1 + 8 Bovis za meso i mlijeko iznosi nula dana.
A field study was also conducted investigating the safety of the vaccine in dairy cows, including pregnant and lactating cows. 
Provedeno je i terensko ispitivanje, u kojem je istražena sigurnost cjepiva u mliječnih krava, uključujući i gravidne krave te krave u laktaciji.
The field study showed that the vaccine can be used safely in pregnant and lactating cows. 
Terensko ispitivanje dokazalo je da se cjepivo može sigurno koristiti u gravidnih krava i krava u laktaciji.
In 2013 the CVMP considered that the submitted data were adequate for the authorisation of Zulvac 1+8 Bovis to convert to a normal status. 
U 2013. godini CVMP je zaključio da su dostavljeni podaci primjereni za promjenu statusa odobrenja za stavljanje u promet VMP-a Zulvac 1+8 Bovis u normalan status.
The studies looked at the strength of vaccine required to protect against bluetongue infection, and at the safety of the vaccine. 
Ispitivanja su istražila jačinu cjepiva potrebnog za zaštitu protiv upale plavog jezika i sigurnost cjepiva.
The studies showed that the vaccine is safe and that it prevents viraemia caused by bluetongue virus serotypes 1 and 8 in cattle from three months of age. 
Ispitivanjima je utvrđeno da je cjepivo sigurno, te da sprječava viremije uzrokovane virusom plavog jezika serotipove 1 i 8 u goveda nakon tri mjeseca starosti.