FrancophonIA/ELRC3.0 huggingface dataset:
English: ADYNOVI 500 IU / 5 ml powder for injection rurioctocog alfa pegol IV
Estonian: ADYNOVI 500 RÜ / 5 ml süstelahuse pulber alfarurioktokog pegool IV
English: ADYNOVI 250 IU / 2 ml powder for injection rurioctocog alfa pegol IV
Estonian: ADYNOVI 250 RÜ / 2 ml süstelahuse pulber alfarurioktokog pegool IV
English: ADYNOVI 1000 IU / 5 ml powder for injection rurioctocog alfa pegol IV
Estonian: ADYNOVI 1000 RÜ / 5 ml süstelahuse pulber alfarurioktokog pegool IV
English: Population PK with sparse sampling b
Estonian: Populatsiooni farmakokineetika juhusliku valimiga b
English: ADYNOVI 500 IU / 2 ml powder and solvent for solution for injection Each vial contains nominally 500 IU human coagulation factor VIII (rDNA), rurioctocog alfa pegol, corresponding to a concentration of 250 IU/ml after reconstitution with 2 ml solvent.
Estonian: ADYNOVI 500 RÜ / 2 ml süstelahuse pulber ja lahusti Iga viaal sisaldab nominaalselt 500 RÜ inimese VIII hüübimisfaktorit (rDNA) (alfarurioktokog pegooli), mis vastab 2 ml lahustiga manustamiskõlblikuks muutmise järel kontsentratsioonile 250 RÜ/ml.
English: ADYNOVI 250 IU / 5 ml powder for injection rurioctocog alfa pegol IV
Estonian: ADYNOVI 250 RÜ / 5 ml süstelahuse pulber alfarurioktokog pegool IV
English: Do not inject a double dose to make up for a forgotten dose.
Estonian: Ärge süstige kahekordset annust, kui annus jäi eelmisel korral saamata.
English: ADYNOVI 500 IU / 2 ml powder for injection rurioctocog alfa pegol IV
Estonian: ADYNOVI 500 RÜ / 2 ml süstelahuse pulber alfarurioktokog pegool IV
English: VIAL LABEL FOR THE POWDER (BAXJECT II HI-FLOW DEVICE)
Estonian: PULBRIVIAALI SILT (SEADE BAXJECT II HI-FLOW)
English: PHARMACOLOGICAL PROPERTIES
Estonian: Farmakokineetilised omadused laste korral
English: VIAL LABEL FOR THE SOLVENT (BAXJECT II HI-FLOW DEVICE)
Estonian: LAHUSTIVIAALI SILT (SEADE BAXJECT II HI-FLOW)
English: ADYNOVI 2000 IU / 5 ml powder and solvent for solution for injection rurioctocog alfa pegol
Estonian: ADYNOVI 2000 RÜ / 5 ml süstelahuse pulber ja lahusti alfarurioktokog pegool
English: Peel-off labels are provided on the blister.
Estonian: Blistriga on kaasas äratõmmatavad kleebised.
English: ASSEMBLY LABEL (BAXJECT III SYSTEM)
Estonian: LAHUSTIVIAALI SILT (SÜSTEEM BAXJECT III)
English: EMA/554822/2018 EMEA/H/C/004857
Estonian: EMA/554822/2018 EMA/H/C/004857
English: Depending on the day, the patient may take one or more medicines or may not take any medicines.
Estonian: Sõltuvalt päevast võib patsient võtta üht või mitut ravimit või ei võta üldse ravimeid.
English: Lenalidomide Accord is taken in repeated 28-day cycles: the patient takes the medicine once a day on certain days over 28 days.
Estonian: Ravimit Lenalidomide Accord võetakse 28-päevaste tsüklitena: patsient võtab ravimit 28 päeva jooksul üks kord ööpäevas teatud päevadel.
English: Further information on Lenalidomide Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Lisateave ravimi Lenalidomide Accord kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The company has also set up a pregnancy prevention programme in each Member State and will collect information on the medicine's use outside its approved uses.
Estonian: Ettevõte on algatanud igas liikmesriigis ka rasestumise vältimise programmi ja kogub teavet ravimi kasutamise kohta muudel kui heakskiidetud näidustustel.
English: Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.
Estonian: Kaks ravimit on bioekvivalentsed, kui mõlemad ravimid tekitavad organismis sama toimeainesisalduse ja seetõttu on neil sama eeldatav toime.
English: Lenalidomide Accord (lenalidomide)
Estonian: Lenalidomide Accord (lenalidomiid)
English: A lower dose should be used in patients who have moderate or more severe reduction in their kidney function.
Estonian: Annust peab vähendama patsientidel, kellel on mõõdukas või raske neerupuudulikkus.
English: • in combination with dexamethasone, in adults whose disease has been treated at least once in the past.
Estonian: • koos deksametasooniga täiskasvanutel, kelle haigust on varem ravitud vähemalt ühel korral.
English: What measures are being taken to ensure the safe and effective use of Lenalidomide Accord?
Estonian: Mis meetmed võetakse, et tagada ravimi Lenalidomide Accord ohutu ja efektiivne kasutamine?
English: Lenalidomide works in a number of different ways: it blocks the development of abnormal cells, prevents the growth of blood vessels within tumours and also stimulates specialised cells of the immune system to attack the abnormal cells.
Estonian: Lenalidomiid toimib mitmel viisil: see pärsib ebanormaalsete rakkude arengut, takistab kasvaja veresoonte kasvu ning stimuleerib immuunsüsteemi erirakke ebanormaalseid rakke ründama.
English: • on its own, in adults who have had a stem cell transplant (a procedure where the patient's bone marrow is cleared of cells and replaced by stem cells from a donor) to stop the progression of the cancer;
Estonian: • ainuravimina täiskasvanutel, kellele on siiratud tüvirakke (protseduur, mille käigus patsiendi luuüdi puhastatakse rakkudest ja asendatakse doonori tüvirakkudega), et peatada vähi progresseerumine;
English: The European Medicines Agency concluded that, in accordance with EU requirements, Lenalidomide Accord has been shown to have comparable quality and to be bioequivalent to Revlimid.
Estonian: Euroopa Ravimiamet järeldas, et vastavalt ELi nõuetele on tõendatud ravimi Lenalidomide Accord võrreldav kvaliteet ja bioekvivalentsus ravimiga Revlimid.
English: For more information about using Lenalidomide Accord, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet ravimi Lenalidomide Accord kasutamise kohta vt pakendi infolehest või konsulteeri oma arsti või apteekriga.
English: The dose depends on the situation in which Lenalidomide Accord is used.
Estonian: Annus sõltub olukorrast, milles ravimit Lenalidomide Accord kasutatakse.
English: Side effects reported with Lenalidomide Accord are carefully evaluated and any necessary action taken to protect patients.
Estonian: Ravimi Lenalidomide Accord kõrvaltoimeid hinnatakse hoolikalt ja patsientide kaitseks rakendatakse vajalikke meetmeid.
English: This means that Lenalidomide Accord contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Revlimid.
Estonian: See tähendab, et Lenalidomide Accord sisaldab sama toimeainet ja toimib samamoodi nagu võrdlusravim Revlimid, millel juba on ELis müügiluba.
English: Because Lenalidomide Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Estonian: Et Lenalidomide Accord on geneeriline ravim ja võrdlusravimiga bioekvivalentne, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimil.
English: What is Lenalidomide Accord and what is it used for?
Estonian: Mis on Lenalidomide Accord ja milleks seda kasutatakse?
English: The company that markets Lenalidomide Accord will provide a letter and educational kits for healthcare professionals, and brochures for patients, explaining that the medicine can be harmful to the unborn child and detailing the steps that need to be taken for the medicine to be used safely.
Estonian: Ravimi Lenalidomide Accord turustaja edastab tervishoiutöötajatele kirja ja teabematerjalid ning patsientidele brošüürid, milles selgitatakse ravimi võimalikku kahjulikku toimet lootele ning kirjeldatakse üksikasjalikult, kuidas ravimit ohutult kasutada.
English: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Revlimid, and do not need to be repeated for Lenalidomide Accord.
Estonian: Võrdlusravimiga Revlimid on juba tehtud toimeaine heakskiidetud kasutamisviiside kasulikkuse ja riski uuringud ning neid ei ole vaja ravimiga Lenalidomide Accord korrata.
English: The boxes containing Lenalidomide Accord capsules also bear a warning stating that lenalidomide can be harmful to the unborn child.
Estonian: Ravimi Lenalidomide Accord kapslite karbile on märgitud ka hoiatus, et lenalidomiid võib kahjustada loodet.
English: As for all medicines, data on the use of Lenalidomide Accord are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, teostatakse ravimi Lenalidomide Accord kasutamise kohta pidevat järelevalvet.
English: Therefore, the Agency's view was that, as for Revlimid, the benefit of Lenalidomide Accord outweighs the identified risk and it can be authorised for use in the EU.
Estonian: Seetõttu on amet arvamusel, et nagu ka Revlimidi korral, ületab ravimi Lenalidomide Accord kasulikkus sellega kaasnevad riskid ja seda võib kasutada ELis.
English: As for every medicine, the company provided studies on the quality of Lenalidomide Accord.
Estonian: Nagu iga ravimi korral, esitas ettevõte ravimi Lenalidomide Accord kvaliteedi uuringud.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lenalidomide Accord have also been included in the summary of product characteristics and the package leaflet.
Estonian: Ravimi Lenalidomide Accord ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on samuti lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: Other information about Lenalidomide Accord
Estonian: Muu teave ravimi Lenalidomide Accord kohta
English: • in combination with melphalan (a cancer medicine) and prednisone (an anti-inflammatory medicine) for the treatment of adults with previously untreated multiple myeloma, who cannot have a stem cell transplant;
Estonian: • koos melfalaani (teatav vähiravim) ja prednisooniga (teatav põletikuvastane ravim) varem ravimata hulgimüeloomiga täiskasvanutel, kellele ei saa siirata tüvirakke;
English: The medicine can only be obtained with a prescription and treatment must be monitored by doctors who have experience in the use of cancer medicines.
Estonian: Ravi peab toimuma vähiravimite kasutamises kogenud arsti järelevalve all.
English: Lenalidomide Accord is available as capsules of various strengths to be taken by mouth.
Estonian: Ravimit Lenalidomide Accord turustatakse eri tugevustega suukaudsete kapslitena.
English: Lenalidomide Accord contains the active substance lenalidomide and is a ‘generic medicine'.
Estonian: Ravim Lenalidomide Accord sisaldab toimeainena lenalidomiidi ja on geneeriline ravim.
English: Lenalidomide Accord is used:
Estonian: Ravimit Lenalidomide Accord kasutatakse:
English: An overview of Lenalidomide Accord and why it is authorised in the EU
Estonian: Ülevaade ravimist Lenalidomide Accord ja ELis müügiloa väljastamise põhjendus
English: Lenalidomide Accord is a medicine used for the treatment of multiple myeloma, a cancer of a type of white blood cells called plasma cells.
Estonian: Lenalidomide Accord on ravim, mida kasutatakse hulgimüeloomi (plasmarakkude ehk teatud leukotsüütide vähi) raviks.
English: • in combination with dexamethasone (an anti-inflammatory medicine), for the treatment of adults with previously untreated (newly diagnosed) multiple myeloma, who cannot have a stem cell transplant;
Estonian: • koos deksametasooniga (teatav põletikuvastane ravim) varem ravimata (esmadiagnoositud) hulgimüeloomiga täiskasvanutel, kellele ei saa siirata tüvirakke;
English: The dose should be reduced or treatment interrupted depending on whether the disease has worsened, the severity of any side effects and the levels of platelets (components that help the blood to clot) and neutrophils (a type of white blood cell that helps fight infection).
Estonian: Olenevalt haiguse süvenemisest, kõrvalnähtude raskusest ning trombotsüütide (vere hüübimisel osalevad vererakud) ja neutrofiilide (infektsioonivastased leukotsüüdid) sisaldusest veres tuleb annust vajaduse korral vähendada või ravi katkestada.
English: How does Lenalidomide Accord work?
Estonian: Kuidas Lenalidomide Accord toimib?
English: How has Lenalidomide Accord been studied?
Estonian: Kuidas ravimit Lenalidomide Accord uuriti?
English: It will also supply cards for patients to ensure that they are informed about appropriate safety measures to be taken by each patient.
Estonian: Tootja annab patsientidele ka ohutusmeetmete meelespea.
English: This means that it affects the activity of the immune system (the body's natural defences).
Estonian: Ravimi Lenalidomide Accord toimeaine lenalidomiid on immunomoduleeriv aine ehk aine, mis mõjutab immuunsüsteemi (organismi looduslikku kaitsesüsteemi).
English: How is Lenalidomide Accord used?
Estonian: Kuidas ravimit Lenalidomide Accord kasutatakse?
English: What are the benefits and risks of Lenalidomide Accord?
Estonian: Milles seisneb ravimi Lenalidomide Accord kasulikkus ja mis riskid ravimiga kaasnevad?
English: The active substance in Lenalidomide Accord, lenalidomide, is an immunomodulating agent.
Estonian: Lenalidomide Accord on retseptiravim.
English: Lenalidomide Accord received a marketing authorisation valid throughout the EU on 20 September
Estonian: ELis ravimile Lenalidomide Accord väljastatud müügiloa põhjendus
English: (Invented) name
Estonian: (Väljamõeldud) nimetu
English: Strength Pharmaceutical form
Estonian: Tugevus Ravimvorm Manustamiste Sisepakendi iseloomustus
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 ei kuulu Määruse (EÜ) nr 470/2009 reguleerimisalasse.
English: These resolved within a maximum of 25 days.
Estonian: Need taandusid kuni 25 päeva jooksul.
English: The level of efficacy for other species may differ from that observed in cattle.
Estonian: Efektiivsuse tase teistel liikidel võib erineda sellest, mida on täheldatud veistel.
English: *(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating no presence of viral genome).
Estonian: *(Ct (Cycling value) ≥ 36 valideeritud RT-PCR meetodil, näidates, et puudub viirusgenoom)
English: The entire content of the bottle should be used immediately after broaching and during the same procedure.
Estonian: Kogu pudeli sisu tuleb ära kasutada kohe pärast avamist ning sama protseduuri jooksul.
English: The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Estonian: Müügiloahoidja peab informeerima Euroopa Komisjoni selle otsusega autoriseeritud ravimi turundusplaanidest.
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required.
Estonian: Abiained (kaasa arvatud adjuvandid), mis on loetletud ravimi omaduste kokkuvõtte lõigus 6.1, on lubatud ained millele Komisjoni määruse (EL) nr 37/2010 lisa tabelis 1 viidatakse kui ravimjääkide piirnorme mittenõudvatele.
English: a) The administration of the product to animals will interfere with the implementation of a national programme for the diagnosis, control or eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
Estonian: a) veterinaarravimi manustamine loomadele takistab looma haiguste diagnoosimise, kontrolli või haigustõrje riiklike programmide rakendamist, või komplitseerib nakkuste puudumise tõendamist elusloomadel või toiduainetes või muudes toodetes, mis on saadud loomadelt, kellele on manustatud ravimit;
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 08/03/2012.
Estonian: ESMASE MÜÜGILOA VÄLJASTAMISE / MÜÜGILOA UUENDAMISE KUUPÄEV Esmase müügiloa väljastamise kuupäev: 08/03/2012
English: Any revaccination scheme should be agreed by the Competent Authority or by the responsible veterinarian, taking into account the local epidemiological situation.
Estonian: Iga kordusvaktsineerimise skeem peab olema kooskõlastatud pädeva asutuse või vastutava loomaarstiga, arvestades kohaliku epidemioloogilise olukorraga.
English: Local reactions may increase slightly following the second dose in this case lasting up to 15 days.
Estonian: Paiksete reaktsioonide arv võib pärast teist annust veidi suureneda ja sel juhul kestavad need kuni 15 päeva.
English: Administer one dose of 2 ml according to the following vaccination scheme: 1st injection: from 3 months of age.
Estonian: Manustada üks 2 ml annus järgmise vaktsineerimisskeemi kohaselt: 1. süstimine: alates 3. elukuust,
English: *Relative Potency by a mice potency test compared to a reference vaccine that was shown efficacious in cattle.
Estonian: * Suhteline potentsus hiire potentsustestiga võrrelduna referensvaktsiiniga, mis oli veistel efektiivne.
English: Avoid multiple vial broaching.
Estonian: Vältida viaali korgi mitmekordset nõelaga läbistamist.
English: In this category of animals the vaccine should be used only according to the benefit/risk assessment by the responsible veterinarian and/or national Competent Authorities on the current vaccination policies against bluetongue virus (BTV).
Estonian: Selle kategooria loomadel tuleb seda vaktsiini kasutada ainult vastavalt vastutava loomaarsti tehtud kasu-riski suhte hinnangule ja/või riikliku pädeva asutuse kehtivatele bluetongue viiruse (BTV) vastase vaktsineerimise eeskirjadele.
English: Date of latest renewal: 13/12/2016
Estonian: Müügiloa viimase uuendamise kuupäev: 13/12/2016
English: The use of this veterinary medicinal product is only allowed under the particular conditions established by European Community legislation on the control of bluetongue.
Estonian: Selle veterinaarpreparaadi kasutamine on lubatud vaid vastavatel tingimustel Euroopa Komisjoni õigusaktide järgi Bluetongue tõrjes.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2 ml dose contains:
Estonian: KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS Iga 2 ml annus sisaldab:
English: 2nd injection: after 3 weeks.
Estonian: 2. süstimine: 3 nädala pärast.
English: Shake gently immediately before use.
Estonian: Vahetult enne kasutamist õrnalt loksutada.
English: Avoid bubble formation, as this can be irritating at the site of injection.
Estonian: Vältida mullide tekkimist, sest see võib ärritada süstekohta.
English: Off-white or pink liquid
Estonian: Valkjas või roosa vedelik.
English: No information is available on the use of the vaccine in seropositive animals including those with maternally derived antibodies.
Estonian: Teave kasutamise kohta seropositiivsetel, sealhulgas maternaalsete antikehadega loomadel puudub.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Estonian: TEKSTI LÄBIVAATAMISE KUUPÄEV Üksikasjalikku teavet antud veterinaarravimi kohta leiab Euroopa Ravimiameti koduleheküljelt http://www.ema.europa.eu/.
English: Interaction with other medicinal products and other forms of interaction: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Estonian: Koostoimed teiste ravimitega ja muud koostoimed Andmed antud vaktsiini ohutuse ja efektiivsuse kohta selle kasutamisel koos teiste veterinaarravimitega puuduvad.
English: Do not use after the expiry date which is stated on the carton and label after EXP. Once broached use immediately.
Estonian: Ärge kasutage veterinaarravimit pärast kõlblikkusaega, mis on märgitud sildil pärast EXP Pärast esmast avamist kasutada koheselt.
English: Shelf life after first opening the immediate packaging: use immediately after broaching.
Estonian: Kõlblikkusaeg pärast vahetu pakendi esmast avamist: kasutada kohe.
English: Aluminium hydroxide, saponin and thiomersal.
Estonian: Alumiiniumhüdroksiid, saponiin ja tiomersaal.
English: The safety and the efficacy of the vaccine have not been established in breeding males.
Estonian: Selle vaktsiini ohutus ja efektiivsus suguisastel ei ole tõestatud.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular use.
Estonian: MANUSTAMISVIIS JA -TEE(D) Intramuskulaarne kasutamine.
English: Excipient(s): Thiomersal
Estonian: Abiaine(d): Tiomersaal
English: If used in other domestic and wild ruminant species that are considered at risk of infection, its use in these species should be undertaken with care and it is advisable to test the vaccine on a small number of animals prior to mass vaccination.
Estonian: Teistel nakatumise riskigrupis olevatel mäletsejalisetel (kodu- ja metsloomadel) tuleb vaktsiini kasutada ettevaatlikult ja seda on soovitatav enne massvaktsineerimisi väikesel arvul loomadel testida.
English: Active substance(s):
Estonian: Toimeaine(d):
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 20 ml (10 doses)
Estonian: PAKENDI SISU KAALU, MAHU VÕI ANNUSTE ARVU JÄRGI 20 ml (10 annust)
English: Per dose of 2 ml:
Estonian: Ühe 2 ml annuse kohta:
English: 2nd injection: 3 weeks after 1st injection.
Estonian: 2. süstimine: 3 nädalat pärast 1. süsti.
English: Official control authority batch release is required for this product.
Estonian: Selle ravimi puhul on vajalik partii ametlik kasutamiseks vabastamine.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Zulvac 1+8 Bovis suspension for injection for cattle
Estonian: VETERINAARRAVIMI NIMETUS Zulvac 1+8 Bovis, süstesuspensioon veistele
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Outer carton 1 x 20 ml, 1 x 100 ml or 240 ml
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED Väline pappkarp 1 x 20 ml, 1 x 100 ml või 240 ml
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Estonian: A. BIOLOOGILISE TOIMEAINE TOOTJA JA RAVIMIPARTII VABASTAMISE EEST VASTUTAV TOOTJA
English: Onset of immunity: 21 days after completion of the primary vaccination course.
Estonian: Immuunsuse teke: 21 päeva pärast esmase vaktsineerimiskuuri lõpetamist.
English: Aluminium hydroxide Saponin
Estonian: Alumiiniumhüdroksiid Saponiin
English: Name and address of the manufacturer of the biological active substance Zoetis Manufacturing & Research Spain, S.L.
Estonian: Bioloogilise toimeaine tootj nimi ja aadress Zoetis Manufacturing & Research Spain, S.L.
English: A.
Estonian: i.m.
English: Potassium dihydrogen phosphate Disodium hydrogen phosphate dihydrate Sodium chloride
Estonian: Kaaliumdivesinikfosfaat Dinaatriumvesinikfosfaatdihüdraat Naatriumkloriid
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Vial label 100 ml or 240 ml
Estonian: SISEPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED Viaali etikett 100 ml ja 240 ml
English: IMMUNOLOGICAL PROPERTIES Pharmacotherapeutic group: Inactivated viral vaccines - Bluetongue virus ATCvet code: QI02AA08.
Estonian: IMMUNOLOOGILISED OMADUSED Farmakoterapeutiline rühm: inaktiveeritud viirusvaktsiin - bluetongue viirus.
English: Potassium chloride
Estonian: Kaaliumkloriid
English: A transient increase in rectal temperature, not exceeding 2.7 C, was commonly observed during the 48 hours following vaccination in field safety studies.
Estonian: Ohutuse väliuuringutes täheldati 48 tunni jooksul pärast vaktsineerimist sageli rektaaltemperatuuri mööduvat tõusu kuni 2,7 °C.
English: PACKAGE SIZE 100 ml (50 doses) 240 ml (120 doses)
Estonian: PAKENDI SUURUS(ED) 100 ml (50 annust ) 240 ml (120 annust)
English: PACKAGE SIZE 20 ml (10 doses) 100 ml (50 doses) 240 ml (120 doses)
Estonian: PAKENDI SUURUS(ED) 20 ml (10 annust) 100 ml (50 annust ) 240 ml (120 annust)
English: EU/2/12/139/002 (100 ml) EU/2/12/139/003 (240 ml)
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/2/12/139/001 (20 ml) EU/2/12/139/002 (100 ml) EU/2/12/139/003 (240 ml)
English: Revaccination:
Estonian: Kordusvaktsineerimine:
English: Pack of 1 bottle of 10 doses (20 ml).
Estonian: Karp 1 pudeliga, mis sisaldab 10 annust (20 ml).
English: Lactation: Can be used during lactation.
Estonian: Laktatsioon Lubatud kasutada laktatsiooni ajal.