FrancophonIA/ELRC3.0 huggingface dataset:
English: Eviplera must not be used with the following medicines as they may lead to reduced blood levels of rilpivirine, and thereby reduce the effectiveness of Eviplera:
Estonian: Eviplerat ei tohi kasutada ka koos järgmiste ravimitega, sest need võivad vähendada vere rilpiviriinisisaldust ja seega Eviplera efektiivsust:
English: Eviplera emtricitabine / rilpivirine / tenofovir disoproxil
Estonian: Eviplera emtritsitabiin/rilpiviriin/tenofoviirdisoproksiil
English: This is a summary of the European public assessment report (EPAR) for Eviplera.
Estonian: See on ravimi Eviplera Euroopa avaliku hindamisaruande kokkuvõte.
English: Eviplera is a medicine that contains the active substances emtricitabine (200 mg), rilpivirine (25 mg) and tenofovir disoproxil (245 mg).
Estonian: Eviplera on ravim, mis sisaldab toimeainetena emtritsitabiini (200 mg), rilpiviriini (25 mg) ja tenofoviirdisoproksiili (245 mg).
English: Eviplera does not cure HIV-1 infection or AIDS, but it may slow the damage to the immune system and the development of infections and diseases associated with AIDS.
Estonian: Eviplera ei ravi HIV-nakkust ega AIDSi välja, kuid võib immuunsüsteemi kahjustumist ning AIDSiga seotud nakkuste ja haiguste tekkimist edasi lükata.
English: Other information about Eviplera
Estonian: Muu teave Eviplera kohta
English: For more information about treatment with Eviplera, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Evipleraga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: If Eviplera is given together with rifabutin, the doctor should prescribe an additional 25 mg of rilpivirine per day during rifabutin treatment.
Estonian: Kui Eviplerat võetakse koos rifabutiiniga, peab arst määrama rifabutiinikuuri ajaks täiendavad 25 mg rilpiviriini ööpäevas.
English: However, the CHMP noted that there was some risk of HIV-1 developing resistance to rilpivirine and that this risk appeared to be lower in patients with a lower viral load.
Estonian: Komitee märkis siiski, et esineb mõningane risk HIV-1 resistentsuse tekkeks rilpiviriini suhtes, aga see risk näib olevat väiksem väiksema viiruskoormusega patsientidel.
English: If patients need to stop taking one of the active substances or if they need to modify their dose, patients should be switched to separate medicines containing emtricitabine, rilpivirine or tenofovir disoproxil.
Estonian: Kui patsiendil on vaja lõpetada ühe toimeaine võtmine või kui annust on vaja kohandada, tuleb teda ravida emtritsitabiini, rilpiviriini ja tenofoviirdisoproksiili sisaldavate eraldi ravimitega.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Eviplera.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: Rarely, kidney problems may occur in patients taking tenofovir disoproxil.
Estonian: Harva võib tenofoviirdisoproksiili võtvatel patsientidel ilmneda neeruprobleeme.
English: The main measure of effectiveness was based on the reduction in viral load.
Estonian: Efektiivsuse põhinäitaja oli viiruskoormuse vähenemine.
English: It also causes fewer side effects in the early stages of treatment and offers the benefit of being taken as one tablet once per day.
Estonian: Samuti põhjustab Eviplera-ravi varajastes staadiumides vähem kõrvalnähte ja selle eelis on manustamine ühe tabletina üks kord ööpäevas.
English: Eviplera has been studied in two main studies in patients with HIV-1 who had not received HIV treatment before.
Estonian: Eviplerat uuriti kahes põhiuuringus HIV-1 nakkusega patsientidel, kes ei olnud varem HIV-ravimeid saanud.
English: What is Eviplera?
Estonian: Mis on Eviplera?
English: What is the risk associated with Eviplera?
Estonian: Mis riskid Evipleraga kaasnevad?
English: Why has Eviplera been approved?
Estonian: Miks Eviplera heaks kiideti?
English: Patients who have HIV and hepatitis B may see a worsening of their liver problems when stopping Eviplera.
Estonian: HIVi ja B-hepatiidiga patsientide maksaprobleemid võivad Eviplera kasutamise lõpetamisel süveneda.
English: For the full list of side effects and restrictions with Eviplera, see the package leaflet.
Estonian: Eviplera kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: The two studies evaluating the effects of switching patients to Eviplera showed that Eviplera was as effective as the previous treatment and maintained the reduction in viral load.
Estonian: Mõlemad uuringud, milles hinnati Eviplerale üleminekut, näitasid, et Eviplera oli sama efektiivne kui varasem raviskeem ning vähenenud viiruskoormus püsis.
English: By blocking this enzyme, Eviplera reduces the amount of HIV-1 in the blood and keeps it at a low level.
Estonian: Blokeerides selle ensüümi, vähendab Eviplera HIVi kogust veres ja hoiab selle sisalduse väikese.
English: Eviplera contains three active substances: emtricitabine, which is a nucleoside reverse transcriptase inhibitor; rilpivirine, which is a non-nucleoside reverse transcriptase inhibitor (NNRTI); and tenofovir disoproxil, which is a ‘prodrug' of tenofovir, meaning that it is converted into the active substance tenofovir in the body.
Estonian: Eviplera sisaldab kolme toimeainet: emtritsitabiini, mis on nukleosiidne pöördtranskriptaasi inhibiitor, rilpiviriini, mis on mittenukleosiidne pöördtranskriptaasi inhibiitor (NNRTI), ja tenofoviirdisoproksiili, mis on tenofoviiri eelravim, mis muundub organismis toimeaineks tenofoviiriks.
English: It is only used in patients where the virus has not developed resistance to certain anti-HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs), tenofovir or emtricitabine, and who have HIV levels in the blood (viral load) of no more than 100,000 HIV-1 RNA copies/ml.
Estonian: Eviplerat kasutatakse ainult patsientidel, kellel esinev viirus ei ole veel resistentne HIV-ravimite mittenukleosiidsete pöördtranskriptaasi inhibiitorite (NNRTI), tenofoviiri või emtritsitabiini suhtes ja kelle vere HIV-sisaldus (viiruskoormus) ei ole suurem kui 100 000 HIV-1 RNA koopiat/ml.
English: The second main study involving 678 patients compared rilpivirine with efavirenz, both being taken with emtricitabine and tenofovir disoproxil or two other nucleotide reverse transcriptase inhibitors.
Estonian: Teises põhiuuringus võrreldi 678 patsiendil rilpiviriini efavirensiga, kusjuures mõlemat anti koos emtritsitabiini ja tenofoviirdisoproksiiliga või koos kahe teise nukleotiidse pöördtranskriptaasi inhibiitoriga.
English: • omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole (proton pump inhibitors for reducing stomach acid);
Estonian: • omeprasool, esomeprasool, lansoprasool, pantoprasool, rabeprasool (prootonipumba inhibiitorid maohappe erituse vähendamiseks);
English: The CHMP concluded that Eviplera was as effective as combinations containing efavirenz.
Estonian: Inimravimite komitee järeldas, et Eviplera on sama efektiivne kui efavirensit sisaldavad kombinatsioonid.
English: Therefore, the CHMP considered that the benefits of Eviplera outweigh its risks in patients with a low HIV-1 viral load, and recommended that it be granted marketing authorisation for this group of patients.
Estonian: Seetõttu leidis inimravimite komitee, et väikese HIV-1 viiruskoormusega patsientidel on Eviplera kasulikkus suurem kui sellega kaasnevad riskid, ja soovitas anda selle patsiendirühma jaoks ravimi müügiloa.
English: Treatment with Eviplera should be started by a doctor who has experience in the management of HIV infection.
Estonian: Ravi Evipleraga tohib alustada vaid HIV-nakkuse ravis kogenud arst.
English: The most common side effects with Eviplera in patients who had not received previous HIV treatment (seen in more than 5 patients in 100) were nausea (feeling sick), dizziness, abnormal dreams, headache, diarrhoea and insomnia.
Estonian: Eviplera kõige sagedamad kõrvalnähud patsientidel, kes ei olnud varem HIV-ravimeid võtnud (esinenud enam kui 5 patsiendil 100st), olid iiveldus, peapööritus, ebatavalised unenäod, peavalu, kõhulahtisus ja unetus.
English: Patient's previous treatment consisted either of two nucleotide reverse transcriptase inhibitors and another HIV medicine called a boosted protease inhibitor, or the medicine Atripla.
Estonian: Nende patsientide varasem raviskeem koosnes kahest nukleotiidsest pöördtranskriptaasi inhibiitorist ja teisest HIV-ravimist, nn tugevdatud proteaasiinhibiitorist, või ravimist Atripla.
English: In the first main study involving 690 patients, Eviplera was compared with a similar combination that had efavirenz in place of rilpivirine.
Estonian: Esimeses põhiuuringus, milles osales 690 patsienti, võrreldi Eviplerat samalaadse kombinatsiooniga, milles rilpiviriini asendas efavirens.
English: What benefit has Eviplera shown during the studies?
Estonian: Milles seisneb uuringute põhjal Eviplera kasulikkus?
English: • systemic dexamethasone (a steroid anti-inflammatory and immunosuppressant medicine) except when used as a single dose treatment;
Estonian: • süsteemne deksametasoon (steroidne põletikuvastane ja immunosupressiivne ravim), v.a üksikannusega ravi;
English: In the first study in previously untreated patients, 83% of the patients taking the Eviplera combination responded to treatment compared with 84% of the patients taking a combination with efavirenz.
Estonian: Esimeses varem ravimata patsientide uuringus oli patsiente, kellel tekkis ravivastus, Eviplera kombinatsiooni kasutanutest 83% ning efavirensi kombinatsiooni kasutanutest 84%.
English: Patients who attained a viral load of less than 50 HIV-1 RNA copies/ml after 48 weeks of treatment were considered to have responded to treatment.
Estonian: Ravile vastanuks loeti patsiendid, kelle viiruskoormus oli pärast 48-nädalast ravi alla 50 HIV-1 RNA koopia/ml.
English: Eviplera has also been evaluated in 532 patients who were switched from their current HIV treatment to Eviplera.
Estonian: Eviplerat hinnati ka 532 patsiendil, kes läksid varasemalt raviskeemilt üle ravile Evipleraga.
English: In patients who had received previous HIV treatment, the most common side effects (seen in more than 2 patients in 100) were tiredness, diarrhoea, nausea and insomnia.
Estonian: Varem HIV-ravimeid võtnud patsientidel olid kõige sagedamad kõrvalnähud (esinenud enam kui 2 patsiendil 100st) väsimus, kõhulahtisus, iiveldus ja unetus.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Eviplera have been included in the summary of product characteristics and the package leaflet.
Estonian: Eviplera omaduste kokkuvõttesse ja pakendi infolehele lisati ravimi ohutu ja tõhusa kasutamise teave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: Eviplera is used to treat adults infected with human immunodeficiency virus-1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Estonian: Eviplerat kasutatakse omandatud immuunpuudulikkuse sündroomi (AIDS) põhjustava inimese I tüüpi immuunpuudulikkuse viiruse (HIV-1) nakkuse raviks täiskasvanutel.
English: The Eviplera combination compared well with combinations containing efavirenz.
Estonian: Eviplera kombinatsiooni toime oli igati võrreldav efavirensi kombinatsioonide toimega.
English: All three active substances block the activity of reverse transcriptase, a viral enzyme that allows HIV-1 to replicate in the cells it has infected.
Estonian: Pöördtranskriptaas on viiruse ensüüm, mis võimaldab HIV-1 nakkusel nakatatud rakkudes paljuneda.
English: How is Eviplera used?
Estonian: Kuidas Eviplerat kasutatakse?
English: In the second study, 87% of the patients in the rilpivirine group (which included patients taking the Eviplera combination) responded to treatment.
Estonian: Teises uuringus oli patsiente, kellel tekkis ravivastus, rilpiviriinirühma patsientidest 87% (nende hulka kuulusid Eviplera kombinatsiooni kasutanud patsiendid) ning efavirensirühma patsientidest 83%.
English: What is Eviplera used for?
Estonian: Milleks Eviplerat kasutatakse?
English: How has Eviplera been studied?
Estonian: Kuidas Eviplerat uuriti?
English: The medicine can only be obtained with a prescription.
Estonian: Eviplera on retseptiravim.
English: • St John's wort (a herbal medicine to treat depression and anxiety).
Estonian: • naistepuna (taimne depressiooniravim).
English: Respect normal aseptic conditions.
Estonian: Kasutada tavalisi aseptilisi tingimusi.
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Estonian: Toimeaine, mis põhimõtteliselt on bioloogilist päritolu ja mõeldud aktiivse immuunsuse esile kutsumiseks, ei kuulu määruse (EÜ) nr 470/2009 reguleerimisalasse.
English: DATE OF REVISION OF THE TEXT
Estonian: 10 TEKSTI ÜLEVAATAMISE KUUPÄEV
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Estonian: Üksikasjalikku teavet antud veterinaarravimi kohta leiab Euroopa Ravimiameti koduleheküljelt aadressil http://www.ema.europa.eu/.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE
Estonian: MÄRGE „AINULT VETERINAARSEKS KASUTAMISEKS” NING TINGIMUSED VÕI PIIRANGUD TARNIMISE JA KASUTAMISE OSAS, kui need on kohaldatavad
English: Since stress could contribute to this adverse reaction, appropriate precautions should be taken to reduce stress as much as possible during the administration of the product.
Estonian: Et stress võib soodustada selle kõrvaltoime tekkimist, tuleb vaktsiini manustamise ajal rakendada sobivaid meetmeid, et vähendada stressi niipalju kui võimalik.
English: CEVA Sante Animale 10 avenue de la Ballastiere 33500 Libourne FRANCE
Estonian: CEVA Sante Animale 10 avenue de la Ballastiere 33500 Libourne PRANTSUSMAA
English: Disposal: read package leaflet.
Estonian: Hävitamine: lugege pakendi infolehte.
English: Tel: +33 5 57 55 40 40 Fax: +33 5 57 55 41 98
Estonian: Faks: +335 5755 4198
English: Date of last renewal: 31/07/2015
Estonian: Müügiloa viimase uuendamise kuupäev: 31.07.2015
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Estonian: Abiained, mis on loetletud ravimi omaduste kokkuvõtte lõigus 6.1, on kas lubatud ained, millele komisjoni määruse (EL) nr 37/2010 lisa tabelis 1 viidatakse kui ravimjääkide piirnorme mittenõudvatele, või määruse (EÜ) nr 470/2009 reguleerimisalasse mittekuuluvad, kui neid kasutatakse nii nagu selles veterinaarravimis
English: Whitish, opalescent, homogeneous suspension.
Estonian: Valkjas, opalestseeruv, homogeenne suspensioon.
English: Systemic signs as lethargy, malaise and/or anorexia have been observed uncommonly in post marketing safety experience.
Estonian: Süsteemseid nähte, näiteks letargiat, halba enesetunnet ja/või anoreksiat on turustamisjärgses ohutuse järelevalves aeg-ajalt täheldatud.
English: Every 9 months, as described for primary vaccination, based on a duration of immunity of 280 days.
Estonian: Iga 9 kuu järel, nagu kirjeldatud esmase vaktsineerimise kohta, põhinedes 280-päevasele immuunsuse kestvusele.
English: Onset of immunity: not established.
Estonian: Immuunsuse algus: ei ole tuvastatud.
English: There are no benefits of the vaccine (as described in the indications for cattle), when used in infected and/or pregnant cows.
Estonian: Vaktsiinil tõhususe eeliseid (nagu seda on kirjeldatud veiste näidustuse korral) nakatunud ja/või tiinetel lehmadel kasutamisel ei ole.
English: Under normal conditions the timing of vaccination should be planned so that the primary course is completed by 3 weeks before artificial insemination or mating.
Estonian: Tavatingimustes planeeritakse vaktsineerimise ajastamine selliselt, et esmane vaktsinatsioonikuur lõpetatakse 3 nädalat enne kunstlikku seemendamist või paaritamist.
English: Store and transport refrigerated (2 °C - 8 °C).
Estonian: Hoida ja transportida külmas (2°C...8°C).
English: Administer the vaccine as follows: Cattle: 4 ml in the neck region.
Estonian: Vaktsiini manustatakse alljärgnevalt: Veised: 4 ml kaelapiirkonda.
English: EU/2/10/110/001 (40 ml) EU/2/10/110/002 (100 ml)
Estonian: MÜÜGILOA NUMBER EU/2/10/110/001 (40 ml) EU/2/10/110/002 (100 ml)
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Estonian: Andmed antud vaktsiini ohutuse ja tõhususe kohta selle kasutamisel koos teiste veterinaarravimitega puuduvad.
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Estonian: Kasutamata veterinaarravimid või nende jäätmed tuleb hävitada vastavalt kohalikule seadusandlusele.
English: Meat, milk and offal: Zero days.
Estonian: Lihale, piimale ja söödavatele kudedele: 0 päeva.
English: Shelf life after first opening the immediate packaging: 10 hours.
Estonian: Kõlblikkusaeg pärast vahetu pakendi esmast avamist: 10 tundi.
English: Diarrhoea has been observed rarely in post marketing safety experience.
Estonian: Kõhulahtisust on turustamisjärgses ohutuse järelevalves täheldatud harva.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after {EXP}.
Estonian: Pärast etiketil märgitud kõlblikkusaja lõppu (EXP) mitte kasutada.
English: For the active immunisation of cattle to lower the risk for non-infected animals vaccinated when nonpregnant to become shedder (5 times lower probability in comparison with animals receiving a placebo), and to reduce shedding of Coxiella burnetii in these animals via milk and vaginal mucus.
Estonian: Veiste aktiivseks immuniseerimiseks, et vähendada riski mittenakatunud loomadel, keda vaktsineeriti siis, kui mittetiined loomad nakkust levitasid (tõenäosus on 5 korda väiksem kui platseebo puhul) ja Coxiella burnetii levimust nendel loomadel piima ja tupelima kaudu.
English: Under field conditions, vaccination with COXEVAC has commonly been followed by a decrease in milk production in goats.
Estonian: Välitingimustes on COXEVACiga vaktsineerimisele tavaliselt järgnenud kitsede piimatoodangu vähenemine.
English: MANUFACTURER'S BATCH NUMBER
Estonian: TOOTJAPOOLNE PARTII NUMBER Lot:
English: It is advisable to vaccinate all the animals in the herd at the same time.
Estonian: Soovitatav on vaktsineerida kõik karja loomad ühel ja samal ajal.
English: > 72 QF Units* *QF (Q fever) Unit: relative potency of phase I antigen measured by ELISA in comparison with a reference item.
Estonian: >72 QF ühikut* *QF (Q-palaviku) ühik: suhteline tõhusus I faasi antikehade suhtes, määratakse ELISA testiga, kasutatakse võrdlusainet.
English: Lactation: The vaccine can be used during lactation.
Estonian: Laktatsioon: Vaktsiini võib kasutada laktatsiooni perioodil.
English: Two doses should be given subcutaneously with an interval of 3 weeks.
Estonian: Kaks annust manustatakse nahaalusi 3-nädalase ajavahemikuga.
English: A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Estonian: Seetõttu tuleb selle vaktsiini kasutamine otsustada igal erineval juhul eraldi nii enne kui ka pärast ükskõik millise veterinaarravimi manustamist.
English: In the case that it is decided to vaccinate the whole herd, it is advisable to vaccinate the male animals at the same time.
Estonian: Kui on otsustatud vaktsineerida kogu kari, soovitatakse samal ajal vaktsineerida ka isasloomad.
English: Duration of immunity: one year after completion of the primary vaccination course.
Estonian: Immuunsuse kestus: üks aasta pärast esmase vaktsineerimiskuuri lõpetamist.
English: The vaccine contains phase I Coxiella burnetii as active ingredient inducing active immunity against Q fever in cattle and goats.
Estonian: Vaktsiin sisaldab toimeainena I faasi Coxiella burnetii'd, et indutseerida aktiivset immuunsust Q-palaviku vastu veistel ja kitsedel.
English: Re-vaccination: One dose should be given yearly.
Estonian: Revaktsineerimine: Igal aastal tuleb manustada üks annus.
English: The manufacture, import, possession, sale, supply and/or use of COXEVAC may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Estonian: COXEVACi tootmine, import, omamine, müük, tarnimine ja /või kasutamine on või võib olla teatud liikmesriikide territooriumil või osal nende territooriumist siseriiklike õigusaktide kohaselt keelatud.
English: For the active immunisation of goats to reduce abortion caused by Coxiella burnetii and to reduce shedding of the organism via milk, vaginal mucus, faeces and placenta.
Estonian: Kitsede aktiivseks immuniseerimiseks, et vähendada Coxiella burnetii infektsioonist tingitud aborte ning vähendada mikroorganismi levimust piima, tupelima, rooja ja platsenta kaudu.
English: Store and transport refrigerated.
Estonian: SÄILITAMISE ERITINGIMUSED Hoida ja transportida külmas.
English: Manufacturer responsible for batch release: CEVA-Phylaxia Veterinary Biologicals Co. Ltd. Szállás u. 5
Estonian: Partii väljastamise eest vastutav tootja: CEVA-Phylaxia Veterinary Biologicals Co. Ltd. Szállás u. 5.
English: Duration of immunity: 280 days after completion of the primary vaccination course.
Estonian: Immuunsuse kestvus: 280 päeva pärast esmase vaktsineerimiskuuri lõpetamist.
English: Goats: 2 ml in the neck region.
Estonian: Kitsed:2 ml kaelapiirkonda.
English: > 72 QF Units/ml
Estonian: > 72 QF ühikut/ ml
English: EU/2/10/110/001-002
Estonian: MÜÜGILOA NUMBER EU/2/10/110/001-002
English: Cattle from 3 months of age:
Estonian: Veised alates 3. elukuust:
English: No efficacy data are available concerning the use of COXEVAC in male animals.
Estonian: Puuduvad tõhususe andmed COXEVACi kasutamise kohta isasloomadel.
English: Date of first authorisation: 30/09/2010.
Estonian: ESMASE MÜÜGILOA VÄLJASTAMISE / MÜÜGILOA UUENDAMISE KUUPÄEV Esmase müügiloa väljastamise kuupäev: 30.09.2010.
English: The biological significance of the levels of reduction shown in shedding in cattle and goats is not known.
Estonian: Haigestumise taseme vähenemise bioloogiline olulisus nakkuse leviku ajal veistel ja kitsedel ei ole teada.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Estonian: B. MÜÜGILOA TINGIMUSED VÕI PIIRANGUD TARNIMISE VÕI KASUTAMISE OSAS
English: However, in safety laboratory trials, the use of the vaccine in males proved to be safe.
Estonian: Laboratoorsetes ohutusuuringutes on aga tõestatud, et vaktsiin on isasloomadele ohutu.
English: Inactivated Coxiella burnetii, strain Nine Mile
Estonian: Toimeaine: inaktiveeritud Coxiella burnetii, tüvi Nine Mile
English: However, in safety laboratory trials, the use of COXEVAC in males proved to be safe.
Estonian: Laboratoorsetes ohutusuuringutes on aga tõestatud, et COXEVAC on isasloomadele ohutu.
English: EXP {month/year} Once broached, use within 10 hours.
Estonian: EXP: Pärast korgi läbistamist kasutada 10 tunni jooksul.
English: Cattle and goats
Estonian: LOOMALIIGID Veised ja kitsed
English: It was very common to observe in laboratory trials a slight increase of rectal temperature for 4 days post-vaccination.
Estonian: Väga sageli võis laboratoorsetes uuringutes rektaalne temperatuur 4 päeva jooksul pärast vaktsineerimist vähesel määral tõusta.
English: EU/2/10/110/002
Estonian: MÜÜGILOA NUMBER EU/2/10/110/002
English: Pack sizes: 40 ml or 100 ml in a plastic LDPE bottle.
Estonian: Pakendi suurused: 40 ml või 100 ml plastpudelis (LDPE).