FrancophonIA/ELRC3.0 huggingface dataset:
English: Omidria is indicated in adults for maintenance of intraoperative mydriasis, prevention of intraoperative miosis and reduction of acute postoperative ocular pain in intraocular lens replacement surgery.
Estonian: Omidria on näidustatud kasutamiseks täiskasvanutel müdriaasi säilitamiseks ja mioosi ennetamiseks silmaläätse vahetamise operatsiooni ajal ning ägeda silmavalu vähendamiseks operatsiooni järel.
English: AUC change from baseline in pupil diameter (mm) during surgery (Co-primary endpoint) [MeanSD)] Diameter < 6 mm at any time Diameter < 6 mm at cortical clean-up ≥ 2.5 mm pupillary constriction
Estonian: Diameeter < 6 mm mis tahes ajal Diameeter < 6 mm kortikaalse puhastamise ajal ≥ 2,5 mm pupillide ahenemine 2. uuring
English: Side effects affecting the body: Common side effects: - inflammation
Estonian: Organismi kahjustavad kõrvaltoimed Sageli esinevad kõrvaltoimed - põletik
English: Omidria is not recommended in women of childbearing potential not using contraception.
Estonian: Omidria kasutamine ei ole soovitatav rasestumisvastaseid vahendeid mittekasutavatel fertiilses eas naistel.
English: How Omidria is stored
Estonian: Kuidas Omidriat säilitada
English: The following instructions must be adhered to:
Estonian: Järgida tuleb allpool esitatud juhiseid.
English: Significant elevations in blood pressure have been reported following instillation of topical ocular phenylephrine.
Estonian: On teateid, et paikse fenüülefriini silma tilgutamise järel tõuseb vererõhk märgatavalt.
English: Colourless 5-mL type-1 glass vial closed with a butyl rubber stopper and a polypropylene flip-off cap.
Estonian: Värvitu 5 ml I tüüpi klaasist viaal butüülkummist punnkorgi ja polüpropüleenist eemaldatava kattega.
English: There have been reports of serious cardiovascular reactions, including ventricular arrhythmias and myocardial infarctions, in patients using ophthalmic phenylephrine.
Estonian: Patsientidel, kelle silma manustatakse fenüülefriini, on esinenud raskeid kardiovaskulaarseid kõrvaltoimeid, sh ventrikulaarne arütmia ja müokardiinfarktid.
English: Common side effects (may affect up to 1 in 10 people): - eye pain - inflammation of the front of the eye - red eyes - swelling of the cornea (the clear layer over the front of the eye) - sensitivity to light
Estonian: - silmavalu - silma eesmise osa põletik - silmade punetus - sarvkesta (silma eesmise läbipaistva kihi) turse - valgustundlikkus
English: No drug-related adverse events or pathological findings were observed, with combinations of phenylephrine and ketorolac in irrigation solution administered at concentrations up to 7200 µM phenylephrine and 900 µM ketorolac.
Estonian: Kontsentratsioonis kuni 7200 µm fenüülefriini ja 900 µm ketorolaki kombinatsiooni sisaldava loputuslahuse manustamisel ei täheldatud ühtegi ravimiga seotud kõrvalnähtu ega patoloogilist leidu.
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.
Estonian: Iga 4,0 ml lahuse viaal sisaldab 40,6 mg (10,2 mg/ml) fenüülefriini ja 11,5 mg (2,88 mg/ml) ketorolakki.
English: Omidria is not recommended during pregnancy.
Estonian: Omidria kasutamine raseduse ajal ei ole soovitatav.
English: Ketorolac is excreted in human milk after systemic administration.
Estonian: Ketorolak eritub inimese rinnapiima süsteemsel manustamisel.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED VAHEPAKEND
English: Preoperative antibiotic, anaesthetics, corticosteroid, mydriatic, and NSAID eye drops may be administered at the discretion of the treating ophthalmologist.
Estonian: Ravi läbiviiva silmaarsti otsusel võib enne operatsiooni manustada antibiootilisi, anesteetilisi, kortikosteroidseid, pupille laiendavaid ja mittesteroidseid põletikuvastaseid (NSAID) silmatilku.
English: - if you are allergic to phenylephrine or ketorolac or any of the other ingredients of this medicine
Estonian: - kui olete fenüülefriini või ketorolaki või selle ravimi mis tahes muude koostisosa(de) (loetletud lõigus 6) suhtes allergiline; - kui teil on kinnise nurga glaukoomiks nimetatav silmahaigus.
English: Side effects affecting the eye:
Estonian: Silma kahjustavad kõrvaltoimed
English: The following warnings and precautions related to topical ophthalmic use of phenylephrine and ketorolac should be considered with the use of Omidria:
Estonian: Omidria kasutamisel tuleb arvesse võtta allpool esitatud hoiatusi ja ettevaatusabinõusid, mis on seotud fenüülefriini ja ketorolaki paikse kasutamisega silmas.
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).
Estonian: 1. uuringus oli CMH kaalutud keskmine erinevus (Omidria - platseebo) kõveraaluses keskmises pindalas (AUC) -5,20 mm [95% usaldusvahemik: -7,31; -3,09] (p < 0,001).
English: A single-dose toxicology study was conducted in African green monkeys exposed to ocular irrigation solutions containing the combination of phenylehphrine and ketorolac used during lens replacement surgery.
Estonian: Neile manustati silma loputuslahust, mis sisaldas läätsevahetusravis kasutatava fenüülefriini ja ketorolaki kombinatsiooni.
English: Ocular discomfort Eye inflammation Eye irritation
Estonian: Ebamugavustunne silmas Silmapõletik
English: Package leaflet: Information for the user Omidria 10 mg/mL + 3 mg/mL concentrate for solution for intraocular irrigation phenylephrine/ketorolac
Estonian: Pakendi infoleht: teave kasutajale Omidria 10 mg/ml + 3 mg/ml intraokulaarse loputuslahuse kontsentraat Fenüülefriin/ketorolak
English: Subjects with VAS = 0 at all times Subjects with VAS ≥ 40 at any time Study 2
Estonian: AUC 12 tunni silmavalu VAS-skoor (esmane liittulemusnäitaja) [keskmine ± standardhälve] Patsiendid, kelle VAS = 0 mis tahes ajal Patsiendid, kelle VAS ≥ 40 mis tahes ajal 2. uuring
English: In Study 2, the CMH weighted mean difference (Omidria - placebo) in the mean AUC was -4.58 mm [95% confidence interval: -6.92, -2.24] (P < 0.001).
Estonian: 2. uuringus oli CMH kaalutud keskmine erinevus (Omidria - platseebo) kõveraaluses keskmises pindalas (AUC) -4,58 mm [95% usaldusvahemik: -6,92; -2,24] (p < 0,001).
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).
Estonian: 1. uuringus oli CMH kaalutud keskmine erinevus (Omidria - platseebo) kõveraaluses keskmises pindalas (AUC) 0,58 mm [95% usaldusvahemik: 0,48; 0,68] (p < 0,0001).
English: Contents of the pack and other information
Estonian: Pakendi sisu ja muu teave Mida Omidria sisaldab
English: Eye pain
Estonian: Silmalau valu
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).
Estonian: 2. uuringus oli CMH kaalutud keskmine erinevus (Omidria - platseebo) kõveraaluses keskmises pindalas (AUC) 0,59 mm [95% usaldusvahemik: 0,49; 0,69] (p < 0,0001).
English: NAME OF THE MEDICINAL PRODUCT Omidria 10 mg/mL + 3 mg/mL concentrate for solution for intraocular irrigation
Estonian: RAVIMPREPARAADI NIMETUS Omidria 10 mg/ml + 3 mg/ml intraokulaarse loputuslahuse kontsentraat
English: 6.6 Special precautions for disposal and other handling To prepare Omidria for intraocular irrigation, dilute 4.0 mL of concentrate in 500 mL of standard ophthalmological irrigation solution.
Estonian: Omidria ettevalmistamiseks silma loputamiseks lahjendada 4,0 ml Omidria kontsentraat 500 ml standardses silmaloputuslahuses.
English: The solution should be used within 6 hours of preparation.
Estonian: Lahus tuleb ära kasutada 6 tunni vältel pärast lahjendamist.
English: One 4 mL vial contains phenylephrine hydrochloride equal to 40.6 mg phenylephrine and ketorolac trometamol equal to 11.5 mg ketorolac.
Estonian: Üks 4 ml viaal sisaldab fenüülefriinvesinikkloriidi, mis vastab 40,6 mg fenüülefriinile, ja ketorolaktrometamooli, mis vastab 11,5 mg ketorolakile.
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.
Estonian: Üks 4 ml viaal sisaldab fenüülefriinvesinikkloriidi, mis vastab 40,6 mg (10,2 mg/ml) fenüülefriinile, ja ketorolaktrometamooli, mis vastab 11,5 mg (2,88 mg/ml) ketorolakile.
English: Sodium citrate dihydrate
Estonian: Naatriumtsitraatdihüdraat
English: Omidria is used as a solution to rinse the eye (irrigation solution) during surgery to replace the lens.
Estonian: Omidriat kasutatakse silma loputamise lahusena läätsevahetusoperatsiooni ajal.
English: This is known as intraocular lens replacement.
Estonian: Siirdamisoperatsiooni nimetatakse silmaläätse vahetamiseks.
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.
Estonian: - Teatage oma arstile eelkõige siis, kui võtate atropiini, mis on silmapupillide laiendamiseks mõeldud ravim.
English: Inflammation
Estonian: Annustamine
English: 4.4 Special warnings and precautions for use
Estonian: 6.6 Erihoiatused ravimpreparaadi hävitamiseks ja käsitlemiseks
English: NAME OF THE MEDICINAL PRODUCT Omidria 10 mg/mL + 3 mg/mL concentrate for solution for intraocular irrigation Phenylephrine/ketorolac
Estonian: RAVIMPREPARAADI NIMETUS Omidria 10 mg/ml + 3 mg/ml intraokulaarse loputuslahuse kontsentraat Fenüülefriin/ketorolak
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
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE(D) Omidria 10 mg/ml + 3 mg/ml intraokulaarse loputuslahuse kontsentraat Fenüülefriin/ketorolak
English: Eyelid pain
Estonian: A91 P9KD
English: Intraoperative pupil diameter (mm) change-from-baseline
Estonian: Keskmine pupillide diameetri (mm) muutumine algväärtusest p<0,001
English: The doctor should confirm the need for continuing treatment at least every 6 months.
Estonian: Arst peab hindama ravi jätkamise vajadust vähemalt iga 6 kuu järel.
English: What measures are being taken to ensure the safe and effective use of Ikervis?
Estonian: Mis meetmed võetakse, et tagada Ikervise ohutu ja efektiivne kasutamine?
English: A risk management plan has been developed to ensure that Ikervis is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada Ikervise võimalikult ohutu kasutamine.
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.
Estonian: Euroopa avaliku hindamisaruande täistekst ja riskijuhtimiskava kokkuvõte Ikervise kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: If other eye drops are used, the different medicines must be given at least 15 minutes apart.
Estonian: Kui kasutatakse teisi silmatilku, tuleb eri ravimeid manustada vähemalt 15minutilise vahega.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ikervis on 19 March 2015.
Estonian: Euroopa Komisjon andis Ikervise müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 19. märtsil
English: Other information about Ikervis
Estonian: Muu teave Ikervise kohta
English: About 29% (44 of 154) of those given Ikervis responded, compared with 23% (21 of 91) given the vehicle.
Estonian: Ligikaudu 29% (154-st 44-l) Ikervisega ravitud patsiendil tekkis ravivastus võrreldes 23% (91-st 21-l) vehiiklit saanud osalejaga.
English: What is Ikervis and what is it used for?
Estonian: Mis on Ikervis ja milleks seda kasutatakse?
English: Applying it directly to the eye reduces inflammation and damage there but limits its effects elsewhere in the body.
Estonian: Selle tilgutamine otse silma vähendab silmapõletikku ja -kahjustusi, kuid piirab selle toimet mujal organismis.
English: It is used when treatment with artificial tears (tear substitutes) is insufficient to improve the condition.
Estonian: Seda kasutatakse siis, kui ravi kunstlike pisaratega (pisaraasendusainetega) ei ole haigusest paranemiseks piisav.
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.
Estonian: Inimravimite komitee otsustas, et Ikervise kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: Ikervis should be given last.
Estonian: Ikervist tuleb manustada viimasena.
English: Why is Ikervis approved?
Estonian: Miks Ikervis heaks kiideti?
English: Ikervis contains the active substance ciclosporin.
Estonian: Ikervis sisaldab toimeainena tsüklosporiini.
English: These symptoms are usually short lasting and occur at the time the eye drops are used.
Estonian: Need sümptomid on tavaliselt lühiajalised ja ilmnevad ravimi silma tilgutamisel.
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.
Estonian: Seoses ohutusega leiti, et ravimit talutakse hästi ja see tekitab peamiselt lühiajalisi kõrvalnähte silma tilgutamise ajal; kogu organismi mõjutavate kõrvalnähtude riski peeti väikeseks.
English: Ikervis ciclosporin
Estonian: Ikervis tsüklosporiin
English: This is a summary of the European public assessment report (EPAR) for Ikervis.
Estonian: See on ravimi Ikervis Euroopa avaliku hindamisaruande kokkuvõte.
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.
Estonian: Inimravimite komitee pidas seda kliiniliselt tähtsaks, sest ei ole tõendeid, et seni selle haiguse ravis kättesaadavad ravimid vähendaksid silmapinna kahjustust, mis võib aidata vältida haiguse süvenemist.
English: It is not intended to provide practical advice on how to use Ikervis.
Estonian: Hindamisaruandes ei anta Ikervise kasutamise praktilisi nõuandeid.
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.
Estonian: Kuigi ei tõendatud, et Ikervis on vehiiklist parem selliste sümptomite nagu ebamugavuse ja valu leevendamisel, on tõendeid, et Ikervis võib vähendada keratiidiga seotud sarvkestapõletikku ja -kahjustust.
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.
Estonian: Ikervise toimeaine tsüklosporiin avaldab toimet immuunsüsteemi (organismi looduslik kaitsemehhanism) rakkudele, mis on seotud põletikku tekitavate protsessidega.
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.
Estonian: Ilma pisaravedeliku piisava kaitseta võib sarvkest kahjustuda ja muutuda põletikuliseks (keratiit) ning see võib põhjustada haavandeid, infektsiooni ja nägemise halvenemist.
English: What are the risks associated with Ikervis?
Estonian: Mis riskid Ikervisega kaasnevad?
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).
Estonian: Ikervise kasulikkust tõendati ühes põhiuuringus, milles osales 246 raskekujulise kuiva silma haigusega patsienti ja milles Ikervist võrreldi vehiikliga (sama silmatilgakoostis, kuid ilma toimeaineta).
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.
Estonian: Efektiivsuse põhinäitaja oli nende patsientide osakaal, kellel tekkis ravivastus kuue kuu järel, mõõdetuna sarvkestakahjustuse ja sümptomite, sh ebamugavuse ja valu taseme kombinatsioonina.
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.
Estonian: Selle alusel lisati Ikervise omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: How is Ikervis used?
Estonian: Kuidas Ikervist kasutatakse?
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.
Estonian: Kuiva silma haigusega patsientidel ei teki piisavalt palju pisaravedelikku tavaliselt silmapinda katva kaitsva niiskuskihi loomiseks või põhjustavad probleemid pisaravedelikuga silma liiga kiiret kuivamist.
English: Ikervis can only be obtained with a prescription and treatment should only be started by a healthcare professional trained in ophthalmology (eye medicine).
Estonian: Ikervis on retseptiravim ja ravi peab alustama oftalmoloogia (silmaravimite) väljaõppega tervishoiutöötaja.
English: For practical information about using Ikervis, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Ikervise kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
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.
Estonian: Ikervis on ravim, mida kasutatakse raske keratiidi (silma eesmise läbipaistva kihi, sarvkesta põletik) raviks kuiva silma haigusega täiskasvanud patsientidel.
English: For more information about treatment with Ikervis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Ikervisega toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
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.
Estonian: Ikervise kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 patsiendil 10st) on silmavalu jaärritus; muud sagedad kõrvalnähud on pisaravoolu suurenemine, silma hüpereemia (silma punetus) ja lau erüteem (lau punetus).
English: How does Ikervis work?
Estonian: Kuidas Ikervis toimib?
English: The medicine is available as single-dose eye drops and the recommended dose is one drop in each affected eye daily at bedtime.
Estonian: Ravimit turustatakse üheannuseliste silmatilkadena ja soovitatav annus on üks tilk ööpäevas kummassegi kahjustatud silma enne magamaminekut.
English: For the full list of all side effects reported with Ikervis, see the package leaflet.
Estonian: Ikervise kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
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.
Estonian: Seega oli nende patsientide osakaal, kellel tekkis ravivastus, kahes rühmas sarnane, kuid kui vaadeldi ainult sarvkestakahjustust, oli Ikervis selle vähendamisel oluliselt parem kui vehiikel.
English: What benefits of Ikervis have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Ikervise kasulikkus?
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.
Estonian: Ravimit ei tohi kasutada patsiendid, kellel on või võib olla silma- või silmaümbruskoepõletik.
English: Some animals may also have hypersensitivity (allergic) reactions.
Estonian: Mõnel loomal võib esineda ka ülitundlikkusreaktsioone (allergiat).
English: In all studies the vaccinated cattle and sheep were compared with animals that were not immunised (controls).
Estonian: Kõikides uuringutes võrreldi vaktsineeritud veiseid ja lambaid immuniseerimata loomadega (kontrollrühm).
English: This summary was last updated in January 2014.
Estonian: Kokkuvõtte viimane uuendus: 01-2014.
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.
Estonian: Kuni kolme ööpäeva vältel pärast vaktsineerimist võib loomadel esineda normaalsest veidi kõrgem kehatemperatuur (üldiselt kuni 0,5 °C, harva kuni 2 °C üle normaaltemperatuuri).
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Estonian: Vaktsiinid nn õpetavad immuunsüsteemi (organismi looduslikke kaitsemehhanisme) kaitsma organismi haiguse eest.
English: One injection is enough to vaccinate sheep, but cattle will need a second injection approximately three weeks later.
Estonian: Lammaste vaktsineerimiseks piisab ühest süstist, kuid veistele tuleb ligikaudu kolme nädala möödudes teha ka teine süst.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Bovilis BTV8 on 06/09/2010.
Estonian: Euroopa Komisjon andis vaktsiini Bovilis BTV8 müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 6. septembril 2010.
English: The withdrawal period for both sheep and cattle for meat and milk is zero days.
Estonian: Liha ja piima keeluaeg on nii lammaste kui ka veiste korral null päeva.
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.
Estonian: Võib esineda ka süstekoha ajutist turset, mis võib lammastel kesta kuni kolm nädalat ja veistel kuni kuus nädalat.
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.
Estonian: Kui loomad puutuvad hiljem lammaste katarraalse palaviku viirusega uuesti kokku, tekivad antikehad kiiremini.
English: The main measure of effectiveness was the level of the bluetongue virus in the blood (viraemia) of animals.
Estonian: Efektiivsuse põhinäitaja oli lammaste katarraalse palaviku viiruse sisaldus (vireemia) loomade veres.
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.
Estonian: Uuringud näitasid, et vaktsiin on lammastele ja veistele ohutu ning ennetab vireemia teket lammaste katarraalse palaviku serotüübiga 8 nakatunud vähemalt ühe kuu vanustel lammastel ning Bovilis BTV8 vähendab vireemiat vähemalt kuue nädala vanustel veistel.
English: The vaccine is used to prevent viraemia (the presence of viruses in the blood) in sheep and to limit viraemia in cattle.
Estonian: Vaktsiini kasutatakse vireemia (viiruse esinemine veres) ennetamiseks lammastel ja vireemia vähendamiseks veistel.
English: Bovilis BTV8 was initially authorised under ‘exceptional circumstances'.
Estonian: Bovilis BTV8 kiideti heaks esialgu erandkorras.