FrancophonIA/ELRC3.0 huggingface dataset:
English: - if you are allergic to phenylephrine or ketorolac or any of the other ingredients of this medicine
Croatian: - ako ste alergični na fenilefrin ili ketorolak ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.) - ako imate bolest oka pod nazivom glaukom uskog kuta.
English: Each 4.0 mL vial of solution contains 40.6 mg (10.2 mg/mL) of phenylephrine and 11.5 mg (2.88 mg/mL) of ketorolac.
Croatian: Svaka bočica od 4,0 mL otopine sadrži 40,6 mg (10,2 mg/mL) fenilefrina i 11,5 mg (2,88 mg/mL) ketorolaka.
English: In Study 1, the CMH weighted mean difference (Omidria - placebo) in the mean area-under-the curve (AUC) was 0.58 mm [95% confidence interval: 0.48, 0.68] (P < 0.0001).
Croatian: U ispitivanju 1, CMH ponderirana srednja razlika (Omidria - placebo) u srednjoj vrijednosti područja ispod krivulje (AUC) iznosila je 0,58 mm [95% interval pouzdanosti: 0,48; 0,68] (P < 0,0001).
English: In Study 1, the CMH weighted mean difference (Omidria - placebo) in the mean AUC was -5.20 mm [95% confidence interval: -7.31, -3.09] (P < 0.001).
Croatian: U ispitivanju 1, CMH ponderirana srednja razlika (Omidriaplacebo) u srednjem AUC iznosila je -5,20 mm [95% interval pouzdanosti: -7,31, -3,09] (P < 0,001).
English: The following information is intended for healthcare professionals only: To prepare Omidria for intraocular irrigation, dilute 4.0 mL of Omidria concentrate in 500 mL of standard ophthalmological irrigation solution.
Croatian: Da bi se lijek Omidria pripremio za intraokularno ispiranje, razrijedite 4,0 mL koncentrata u 500 mL standardne oftamološke otopine irigata.
English: In Study 2, the CMH weighted mean difference (Omidria - placebo) in the mean AUC was 0.59 mm [95% confidence interval: 0.49, 0.69] (P < 0.0001).
Croatian: U ispitivanju 2, CMH ponderirana srednja razlika (Omidria - placebo) u srednjoj vrijednosti područja ispod krivulje (AUC) iznosila je 0,59 mm [95% interval pouzdanosti: 0,49; 0,69] (P < 0,0001).
English: Omidria should not be used during breast-feeding.
Croatian: Omidria se ne smije koristiti tijekom dojenja.
English: NAME OF THE MEDICINAL PRODUCT Omidria 10 mg/mL + 3 mg/mL concentrate for solution for intraocular irrigation
Croatian: NAZIV LIJEKA Omidria 10 mg/mL + 3 mg/mL koncentrat za otopinu za irigat za oko
English: The solution should be used within 6 hours of preparation.
Croatian: 6 sati od pripreme.
English: - Especially, tell your doctor if you are taking atropine, a medicine used to dilate (widen) the pupil of the eye.Taking atropine at the same time as Omidria may increase blood pressure and cause the heart to beat faster in some patients.
Croatian: - Posebice naglasite svojem liječniku ako uzimate atropin, lijek koji se koristi za dilataciju (širenje) zjenice oka.
English: Package leaflet: Information for the user Omidria 10 mg/mL + 3 mg/mL concentrate for solution for intraocular irrigation phenylephrine/ketorolac
Croatian: Uputa o lijeku: Informacija za korisnika Omidria 10 mg/mL + 3 mg/mL koncentrat za otopinu za irigat za oko fenilefrin/ketorolak
English: Omidria is not recommended during pregnancy.
Croatian: Ne preporučuje se koristiti lijek Omidria tijekom trudnoće.
English: Subjects with VAS = 0 at all times Subjects with VAS ≥ 40 at any time
Croatian: Vrijednost AUC za VAS rezultat za bol u oku za 12 sati (koprimarni ishod) [srednja vrijednost ±SD] Ispitanici s VAS = 0 u svakom trenutku Ispitanici s VAS ≥ 40 u bilo kojem trenutku
English: Inflammation
Croatian: Upala
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Omidria 10 mg/mL + 3 mg/mL concentrate for solution for intraocular irrigation phenylephrine/ketorolac
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Omidria 10 mg/mL + 3 mg/mL koncentrat za otopinu za irigat za oko fenilefrin/ketorolak
English: One 4 mL vial contains phenylephrine hydrochloride equal to 40.6 mg (10.2 mg/mL) phenylephrine and ketorolac trometamol equal to 11.5 mg (2.88 mg/mL) ketorolac.
Croatian: Jedna bočica od 4 mL sadrži količinu fenilefrinklorida jednaku 40,6 mg (10,2 mg/mL) fenilefrina i količinu ketorolakatrometamola jednaku 11,5 mg (2,88 mg/mL) ketorolaka.
English: Each 4 mL of solution in the vial contains phenylephrine hydrochloride equivalent to 40.6 mg (10.2 mg/mL) of phenylephrine and ketorolac trometamol equivalent to 11.5 mg (2.88 mg/mL) of ketorolac.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Svakih 4 mL otopine u bočici sadrži fenilefrinklorid koji odgovara 40,6 mg (10,2 mg/mL) fenilefrina i ketorolaktrometamol koji odgovara 11,5 mg (2,88 mg/mL) ketorolaka.
English: METHOD OF ADMINISTRATION Intraocular use after dilution.
Croatian: NAČIN PRIMJENE LIJEKA Primjena za oko nakon razrjeđivanja.
English: NAME OF THE MEDICINAL PRODUCT Omidria 10 mg/mL + 3 mg/mL concentrate for solution for intraocular irrigation phenylephrine/ketorolac
Croatian: Omidria 10 mg/mL + 3 mg/mL koncentrat za otopinu za irigat za oko fenilefrin/ketorolak
English: Tabulated list of adverse reactions
Croatian: Tablični popis nuspojava:
English: Further information can be found in the summary of the risk management plan.
Croatian: Dodatne informacije možete pronaći u summary of the risk management plan.
English: The doctor should confirm the need for continuing treatment at least every 6 months.
Croatian: Liječnik treba potvrditi potrebu za kontinuiranom terapijom najmanje svakih 6 mjeseci.
English: This summary was last updated in 04-2015.
Croatian: Sažetak je posljednji put ažuriran u 04.2015.
English: About 29% (44 of 154) of those given Ikervis responded, compared with 23% (21 of 91) given the vehicle.
Croatian: Otprilike 29% (44 od 154) osoba koje su primile odgovorile su na Ikervis, u usporedbi s 23% (21 od 91) koje su primile punilo.
English: The full EPAR and risk management plan summary for Ikervis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Ikervis nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It is used when treatment with artificial tears (tear substitutes) is insufficient to improve the condition.
Croatian: Koristi se ako terapija umjetnim suzama (zamjenskim suzama) nije dovoljna kako bi se poboljšalo stanje.
English: If other eye drops are used, the different medicines must be given at least 15 minutes apart.
Croatian: Ako se koriste drugi kapi za oči, različiti se lijekovi primjenjuju u razmaku od najmanje 15 minuta.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ikervis on 19 March 2015.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Ikervis vrijedi na snazi u Europskoj uniji od 19. ožujka 2015.
English: These symptoms are usually short lasting and occur at the time the eye drops are used.
Croatian: Ovi su simptomi najčešće kratkotrajni i nastupaju u trenutku kada se kapi za oči koriste.
English: It is not intended to provide practical advice on how to use Ikervis.
Croatian: Svrha sažetka nije davati praktične savjete o načinu korištenja lijeka Ikervis.
English: Other information about Ikervis
Croatian: Ostale informacije o lijeku Ikervis
English: Ikervis should be given last.
Croatian: Ikervis se treba primjenjivati posljednji.
English: The CHMP considered that this was clinically meaningful, since none of the available medicines for the condition have been shown to reduce damage to the surface of the eye, which might help prevent the progression of the disease.
Croatian: CHMP je zaključio da je ovo klinički značajno, budući da niti jedan dostupan lijek za ovo stanje nije dokazano smanjio oštećenje na površini oka, što bi moglo pomoći pri sprječavanju progresije bolesti.
English: Why is Ikervis approved?
Croatian: Zašto je Ikervis odobren?
English: What is Ikervis and what is it used for?
Croatian: Što je Ikervis i za što se koristi?
English: What measures are being taken to ensure the safe and effective use of Ikervis?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Ikervis?
English: Applying it directly to the eye reduces inflammation and damage there but limits its effects elsewhere in the body.
Croatian: Izravna primjena na oko smanjuje upalu i oštećenje, no ograničava njegovo djelovanje drugdje u tijelu.
English: Ikervis ciclosporin
Croatian: Ikervis ciklosporin
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Ikervis's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi od lijeka Ikervis nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: This is a summary of the European public assessment report (EPAR) for Ikervis.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za Ikervis.
English: A risk management plan has been developed to ensure that Ikervis is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Ikervis.
English: The active substance in Ikervis, ciclosporin, acts on cells of the immune system (the body's natural defences) that are involved in the processes that cause inflammation.
Croatian: Djelatna tvar lijeka Ikervis, ciklosporin, djeluje na stanice imunosnog sustava (prirodnu obranu tijela) koja je uključena u postupke koji uzrokuju upalu.
English: Without sufficient protection from the tear fluid, the cornea can get damaged and become inflamed (keratitis), which can eventually lead to ulceration, infection and reduced vision.
Croatian: Bez dodatne zaštite iz tekućine za suze, rožnica se može oštetiti i upaliti (keratitis), što može naposljetku rezultirati ulceracijom, infekcijom i smanjenim vidom.
English: Regarding safety, the medicine was well tolerated, with mainly short-lasting effects on the eye at the time the eye drops are used; the risk of effects on the body as a whole was considered to be low.
Croatian: Vezano uz sigurnost, lijek je također dobro podnošen, s uglavnom manjim kratkotrajnim djelovanjima na oko u trenutku primjene kapljica za oči; zaključeno je da rizik djelovanja na tijelo kao cijelo nizak.
English: What are the risks associated with Ikervis?
Croatian: Koji su rizici povezani s lijekom Ikervis?
English: In patients with dry eye disease, either not enough tear fluid is produced to create the protective film of moisture that normally coats the surface of the eye, or abnormalities in the tear fluid cause it to dry out too quickly.
Croatian: U bolesnika s bolesti suhog oka ili se ne proizvodi dovoljno tekućine za suzu kako bi se stvorio zaštitni film vlage koji normalno prevlaći površinu oka ili abnormalnosti u tekućini suza uzrokuju prebrzo isušenje oka.
English: Ikervis contains the active substance ciclosporin.
Croatian: Ikervis sadrži djelatnu tvar ciklosporin.
English: Although Ikervis had not been shown to be any better than the vehicle in improving symptoms such as discomfort and pain, there was evidence that it could reduce the inflammation and damage to the cornea associated with keratitis.
Croatian: Iako nije utvrđeno da je lijek Ikervis bolji od bilo kojeg punila u poboljšavanju simptoma poput nelagode i boli, postoje dokazi da može smanjiti upalu i oštećenje rožnice povezano s keratitisom.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ikervis, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi za lijek Ikervis nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: The most common side effects with Ikervis (which may affect more than 1 in 10 people) are pain and irritation in the eye; other common side effects are lacrimation (excessive tears), ocular hyperaemia (red eye), and erythema (redness) of the eyelid.
Croatian: Najčešće nuspojave lijeka Ikervis (mogu se javiti u više od 1 na 10 osoba) su bol i nadraženost u oku; druge uobičajene nuspojave su lakrimacija (prekomjerne suze), okularna hiperemija (crveno oko) i eritema (crvenilo) očnog kapka.
English: Ikervis can only be obtained with a prescription and treatment should only be started by a healthcare professional trained in ophthalmology (eye medicine).
Croatian: Ikervis se izdaje samo na liječnički recept, a terapiju treba započeti samo zdravstveni djelatnik obučen za oftamologiju (medicinu oka).
English: The medicine is available as single-dose eye drops and the recommended dose is one drop in each affected eye daily at bedtime.
Croatian: Lijek je dostupan kao kapi za oči za jednu dozu, te je preporučena doza jedna kapljica dnevno u svako zahvaćeno oko u vrijeme odlaska na počinak.
English: For more information about treatment with Ikervis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Ikervis pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: The benefits of Ikervis have been shown in one main study involving 246 patients with severe dry eye disease, where Ikervis was compared with the vehicle (the same eye drop formula but without any active substance).
Croatian: Koristi lijeka Ikervis koje su utvrđene u jednom glavnom ispitivanju koje je obuhvatilo 246 bolesnika s ozbiljnom bolesti suhoga oka, pri čemu je Ikervis uspoređen s punilom (ista formula kapljica za oči, no bez bilo kakve djelatne tvari).
English: The main measure of effectiveness was the proportion of patients whose condition responded to treatment after six months, as measured by a combination of damage to the cornea and a score for the level of symptoms, including discomfort and pain.
Croatian: Glavna mjera djelotvornosti bio je udio bolesnika čije je stanje odgovorilo na terapiju nakon šest mjeseci, uključujući nelagodu i bol.
English: Ikervis is a medicine used to treat severe keratitis, an inflammation of the cornea (the transparent layer covering the front of the eye) in adult patients with dry eye disease.
Croatian: Ikervis je lijek koji se koristi za liječenje ozbiljnog keratitisa, upale rožnice (prozirnog dijela koji pokriva prednji dio oka) u odraslih bolesnika s bolesti suhoga oka.
English: What benefits of Ikervis have been shown in studies?
Croatian: Koje su koristi lijeka Ikervis dokazane u ispitivanjima?
English: How does Ikervis work?
Croatian: Kako djeluje Ikervis?
English: For practical information about using Ikervis, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Ikervis pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: How is Ikervis used?
Croatian: Kako se Ikervis koristi?
English: The medicine must not be used in patients who have or are suspected to have an infection of the eye or the tissues around the eye. For the full list of restrictions, see the package leaflet.
Croatian: Lijek se ne smije koristiti u bolesnika koji imaju ili za koje se sumnja da imaju upalu oka ili tkiva oko oka.
English: The proportion of patients who responded to treatment was therefore similar in the two groups, but when only the damage to the cornea was considered, Ikervis was significantly better than the vehicle at reducing it. Levels of HLADR (a measure of inflammation in eye cells) were also reduced in patients using Ikervis compared with the dummy treatment.
Croatian: Udio bolesnika koji su odgovorili na terapiju bio je stoga sličan u obje grupe, no samo ako je se promatralo oštećenje rožnice, Ikervis je bio značajno bolji od punila pri smanjivanju.
English: For the full list of all side effects reported with Ikervis, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Ikervis potražite u uputi o lijeku.
English: This will help to protect against the disease.
Croatian: Ovo pomaže u zaštiti protiv bolesti.
English: It is available as a suspension for injection.
Croatian: Dostupan je kao suspenzija za injekciju.
English: Some animals may also have hypersensitivity (allergic) reactions.
Croatian: Pojedine životinje mogu također imati i reakcije preosjetljivosti (alergijske reakcije).
English: After vaccination, animals may have a slightly raised temperature (usually not more than 0.5°C, but in individual cases up to about 2°C) for up to three days after vaccination.
Croatian: Nakon cijepljenja, životinje mogu imati blago povišenu temperaturu (najčešće ne više od 0,5°C, no u pojedinačnim slučajevima i do 2°C) i do tri dana nakon cijepljenja.
English: In all studies the vaccinated cattle and sheep were compared with animals that were not immunised (controls).
Croatian: U svim ispitivanjima cijepljena goveda i ovce uspoređene su sa životinjama koje nisu bile imunizirane (kontrole).
English: The vaccine also contains ‘adjuvants' (aluminium hydroxide and saponin) to enhance the immune response.
Croatian: Cjepivo sadrži također „adjuvans” (aluminij hidroksid i saponin) kako bi se pojačao imunosni odgovor.
English: In the future, if the animals are exposed to the same type of bluetongue virus, the immune system will be able to produce antibodies more quickly.
Croatian: U budućnosti, ako životinje budu izložene istom tipu virusa plavog jezika, imunosni sustav moći će brže proizvoditi protutijela.
English: The virus exists in several forms (serotypes) throughout the world; the type used in Bovilis BTV8 is serotype 8.
Croatian: Virus postoji u nekoliko oblika (serotipova) diljem svijeta; tip koji se koristi u Bovilis BTV8 je serotip 8.
English: Bovilis BTV8 was initially authorised under ‘exceptional circumstances'.
Croatian: Bovilis BTV8 je prvotno odobren pod „iznimnim okolnostima”.
English: This means that it was not possible at the time of the initial authorisation to obtain complete information about Bovilis BTV8.
Croatian: To znači da u trenutku prvotnog odobrenja nije bilo moguće dobiti potpune informacije o VMP-u Bovilis BTV8.
English: The European Medicines Agency (EMA) reviewed additional information according to an agreed timetable on the quality, safety and efficacy of the vaccine.
Croatian: Europska agencija za lijekove (EMA) pregledala je dodatne informacije o kvaliteti, sigurnosti i djelotvornosti cjepiva sukladno dogovorenom rasporedu.
English: One injection is enough to vaccinate sheep, but cattle will need a second injection approximately three weeks later.
Croatian: Jedna je injekcija dovoljna za cijepljenje ovaca, no govedima se mora dati druga injekcija nakon otprilike tri tjedna.
English: The vaccine is given to young animals as an injection under the skin.
Croatian: Cjepivo se primjenjuje u mladih životinja kao potkožna injekcija.
English: When it is given to cattle and sheep, the animals' immune system recognises the virus as ‘foreign' and produce antibodies against it.
Croatian: Ako se daje govedima i ovcama, imunosni sustav životinja prepoznaje virus kao „strano tijelo” i proizvodi protutijela protiv virusa.
English: The main measure of effectiveness was the level of the bluetongue virus in the blood (viraemia) of animals.
Croatian: Glavna mjera djelotvornosti bila je koncentracija virusa plavog jezika u krvi (viremija) u životinja.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Bovilis BTV8 on 06/09/2010.
Croatian: Europska komisija dodijelila je odobrenje za stavljanje u promet koje je na snazi na teritoriju Europske unije za proizvod Bovilis BTV8 dana 06.09.2010.
English: The vaccine is used to prevent viraemia (the presence of viruses in the blood) in sheep and to limit viraemia in cattle.
Croatian: Cjepivo se koristi za sprječavanje viremije (prisutnosti virusa u krvi) u ovaca i za ograničavanje viremije u goveda.
English: Inactivated adjuvanted vaccine against bluetongue virus serotype 8
Croatian: Inaktivirano adjuvantno cjepivo protiv virusa plavog jezika serotipa 8
English: The efficacy of the vaccine in cattle and sheep was studied in a number of laboratory trials; in cattle from six weeks of age and in sheep from one month of age..
Croatian: Djelotvornost cjepiva u goveda i ovaca ispitana je nizom laboratorijskih testiranja; u goveda u dobi od šest tjedana starosti i u ovaca u dobi od mjesec dana starosti.
English: The CVMP concluded that the benefits of Bovilis BTV8 exceed the risks and recommended that Bovilis BTV8 be given a marketing authorisation.
Croatian: CVMP je zaključio da koristi VMP-a Bovilis BTV8 nadmašuju s njim povezane rizike i preporučio je izdavanje odobrenja za stavljanje u promet VMP-a Bovilis BTV8.
English: The withdrawal period for both sheep and cattle for meat and milk is zero days.
Croatian: Razdoblje karencije kako za ovce tako i za goveda za meso i mlijeko iznosi nula dana.
English: The risk of bluetongue transmission to cattle following vaccination with Bovilis BTV8 was further investigated in two epidemiological models.
Croatian: Rizik od prijenosa plavog jezika na goveda nakon cijepljenja VMP-om Bovilis BTV8 dalje je ispitan na dva epidemiološka modela.
English: The studies showed that the vaccine is safe for both sheep and cattle and that it prevents viraemia in sheep from one month of age when infected with bluetongue virus serotype 8, whereas Bovilis BTV8 reduces viraemia in cattle from six weeks of age.
Croatian: Ispitivanjima je utvrđeno da je cjepivo sigurno kako za ovce tako i za goveda te da sprječava viremiju u ovaca u dobi od mjesec dana starosti u slučaju infekcije virusom plavog jezika serotip 8, dok VMP Bovilis BTV8 smanjuje viremiju u goveda u dobi od šest tjedana starosti.
English: There can also be a temporary swelling at the injection site, lasting for up to three weeks in sheep and six weeks in cattle.
Croatian: Može se pojaviti i privremeno oticanje na mjestu injekcije, koje može potrajati i do tri tjedna u ovaca te šest tjedana u goveda.
English: The first injection is given from one month of age in sheep and from six weeks of age in cattle.
Croatian: Prva se injekcija daje u dobi od jednog mjeseca starosti u ovaca te od šest tjedana starosti u goveda.
English: The safety of the vaccine was studied in laboratory safety studies carried out with an overdose of Bovilis BTV8 in young lambs and calves and in pregnant ewes and cows.
Croatian: Sigurnost cjepiva ispitana je u laboratorijskim ispitivanjima sigurne primjene provedenima s prekomjernom dozom lijeka Bovilis BTV8 u mlade janjadi i teladi te u gravidnih ovaca i krava.
English: Bovilis BTV8 is used in cattle and sheep to protect them against bluetongue disease, an infection caused by the bluetongue virus which is transmitted by midges.
Croatian: Bovilis BTV8 koristi se u goveda i ovaca za zaštitu od bolesti plavog jezika, infekcije koju uzrokuje virus plavog jezika koji se prenosi mušicama.
English: Bovilis BTV8 contains bluetongue virus that has been inactivated so that it cannot cause the disease.
Croatian: Bovilis BTV8 sadrži virus plavog jezika koji je inaktiviran tako da ne može uzrokovati bolest.
English: The benefit-risk balance may be found in the scientific discussion module of this EPAR.
Croatian: Omjer koristi i rizika dostupan je u modulu znanstvene rasprave koji je dio ovog EPAR-a.
English: Bovilis BTV8 was shown to be safe for use in pregnant ewes and cattle.
Croatian: Dokazano je da je Bovilis BTV8 siguran za primjenu u gravidnih ovaca i krava.
English: Bovilis BTV8 is a vaccine that contains an inactivated (killed) bluetongue serotype 8 virus as the active substance.
Croatian: Bovilis BTV8 je cjepivo koje sadrži inaktivirani (ubijeni) virus plavog jezika serotipa 8 kao djelatnu tvar.
English: 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.
Croatian: Razdoblje karencije je razdoblje koje treba proći od primjene VMP-a do klanja životinje i uporabe mesa ili mlijeka u prehrani ljudi.