FrancophonIA/ELRC3.0 huggingface dataset:
English: However, one of the problems to assess the efficacy of vaccination in commercial broilers (with MDA) under laboratory conditions is that they are usually not clinically affected by a vvIBDV challenge, as Specific Pathogen Free (SPF) chickens are.
Estonian: Üks vaktsineerimise tõhususe hindamisega seotud probleeme müügiks mõeldud broileritel (kellel on MDA) laboritingimustes on asjaolu, et tavaliselt neid vvIBDV-ekspositsioon kliiniliselt ei mõjuta, erinevalt spetsiifilisest patogeenist vabadest (SPF, specific pathogen free) kanadest.
English: • Efficacy of the vaccine in the presence of a range of MDA titres (mean titre of around 500 ELISA Units as recommended) was also shown under laboratory conditions: significant reduction of the bursal lesions was shown at 14 and 32 days post challenge.
Estonian: • Laboritingimustes tõestati ka vaktsiini tõhusus mitmetes MDA tiitri vahemikes (keskmine tiiter oli ligikaudu 500 ELISA ühikut, nagu soovitatud): kloaagipauna kahjustuste olulist vähenemist näidati 14 päeva pärast vaktsineerimist ja 32 päeva jooksul.
English: monograph 01/2008:0587 showed that this vaccine strain causes significant damages to the Bursa of Fabricius, which in turn result in immunosuppression.
Estonian: monograafiale 01/2008:0587 tehtud uuring näitas, et selle vaktsiinitüvi põhjustab olulist kloaagipauna kahjustust, mis omakorda põhjustab immuunsupressiooni.
English: • Under field conditions it was shown that Poulvac Bursa Plus was able to restore performance lost due to vvIBD which had broken through the protection provided by classical vaccines containing mild or intermediate strains.
Estonian: • Välitingimustes näidati, et Poulvac Bursa Plus suutis taastada funktsiooni, mis oli kadunud vvIBD tõttu, mis olid ületanud nõrga või keskmise tugevusega tüvesid sisaldavate klassikaliste vaktsiinide poolt pakutava kaitse.
English: However, the monograph is only intended for classical strains and bursal damage is expected to be associated with intermediate plus vaccine strains.
Estonian: Monograafia kehtib siiski ainult klassikaliste tüvede korral ja arvatakse, et kloaagipauna kahjustus on seotud keskmisest tugevama toimega vaktsiinitüvede kasutamisega.
English: Belgium argued that the study conducted by the Applicant according to Ph. Eur.
Estonian: Belgia põhjendas, et taotleja poolt vastavalt Euroopa Farmakopöa (Ph.
English: Therefore, the benefits of the product have been adequately demonstrated and that any risks associated with residual virulence is a recognised risk associated with this type of product, which is only recommended for use in an environment contaminated with vvIBD.
Estonian: Seega on selle toote kasulikkus küllaldaselt tõestatud ja jääkvirulentsusega seotud riskid on toote puhul, mida soovitatakse kasutada ainult vvIBD-ga saastunud keskkonnas, teadaolevad riskid.
English: In view of the fact that no compatibility statement is claimed it is considered that sufficient information has been provided to support an absence of a negative interaction between Poulvac Bursa Plus and other vaccines.
Estonian: Arvestades asjaolu, et andmeid kokkusobivuse kohta ei nõuta, ollakse arvamusel, et esitatud on piisavalt teavet, et tõestada negatiivsete koostoimete puudumine Poulvac Bursa Plusi ja teiste vaktsiinide vahel.
English: monograph (01/2008:0587) for classical IBDV vaccines, in that there was bursal damage and an interference on the serological response to NDV, it was acknowledged that there was no requirement to comply with this monograph because the product was classified as an intermediate plus strain.
Estonian: monograafia tingimustele (01/2008:0587) selles osas, et esineb kloaagipauna kahjustus ja toime NDV vastase vaktsineerimise seroloogilisele vastusele, oldi arvamusel, et toode ei pea vastama selle monograafia tingimustele, sest see on klassifitseeritud keskmisest tugevama toimega tüvena;
English: Maximum doses of virus, at minimum passage level, were used in almost all the pivotal safety studies (4 out of 5).
Estonian: Praktiliselt kõigis kesksetes uuringutes (neljas uuringus viiest) kasutati maksimaalset viiruse annust minimaalse läbistustaseme juures.
English: This reduced serological response against NDV was however not translated into a reduction of the clinical protection against a virulent challenge.
Estonian: NDV vastase seroloogilise reaktsiooni vähenemine ei tähendanud seejuures kliinilise kaitse vähenemist viiruse ekspositsiooni suhtes.
English: The Marketing Authorisation Holder (MAH) provided 5 pivotal studies, 7 supportive studies and 3 field studies in order to assess safety of the vaccine.
Estonian: Müügiloa hoidja esitas vaktsiini ohutuse hindamiseks kokku 5 keskset uuringut, 7 toetavat uuringut ja 3 välitingimustes tehtud uuringut.
English: The level of bursal lesions seen in independent confirmatory testing of Poulvac Bursa Plus is in line with those seen following vaccination with similar products which are already authorised in several Member States and used within the EU.
Estonian: Poulvac Bursa Plusi sõltumatutes kinnitavates uuringutes täheldatud kloaagipauna kahjustuste aste on kooskõlas kahjustustega, mis tekivad mitmes liikmesriigis juba heaks kiidetud ja Euroopa Liidus kasutatavate sarnaste toodetega vaktsineerimise järel.
English: This allows the accurate dosing of the virus which, the MAH states, is not possible in very young birds by the oral route.
Estonian: See võimaldab viirust täpselt annustada, mis müügiloa hoidja vältel ei ole suukaudse manustamistee kasutamise korral väga noortel lindudel võimalik.
English: Poulvac Bursa Plus is a live vaccine against Infectious Bursal Disease Virus (IBDV), also known as Gumboro disease.
Estonian: Poulvac Bursa Plus on lindude nakkava bursiidi (teise nimetusega Gumboro haigus) viiruse (IBDV, Infectious Bursal Disease Virus) vastane elusvaktsiin.
English: Field data confirm the benefits of vaccination under practical conditions on sites which have experienced ongoing problems with vvIBD where intermediate products have not been successful at controlling the vvIBD problem.
Estonian: Väliandmed kinnitavad vaktsineerimise kasulikkust tegelikes tingimustes kohtades, milles on pidevalt esinenud probleeme vvIBD-ga ja kus keskmise tugevusega tüvesid sisaldavad tooted ei ole vvIBD probleemi ohjamisel olnud edukad.
English: • Although no compatibility is claimed, serological data have been provided to support an absence of a negative interaction between Poulvac Bursa Plus and other vaccines.
Estonian: • Kuigi andmeid kokkusobivuse kohta ei nõuta, on esitatud seroloogilised andmed negatiivsete koostoimete puudumise tõestamiseks Poulvac Bursa Plusi ja teiste vaktsiinide vahel.
English: The vaccine has a negative effect on the level of the serological response to NDV vaccination, however there was no affect on the ability of NDV vaccine to induce a protective response capable of resisting challenge with virulent NDV.
Estonian: Vaktsiinil on negatiivne toime NDV vastase vaktsineerimise seroloogilise vastuse astmele, kuid see ei mõjutanud NDV vastase vaktsiini võimet indutseerida selline kaitsev toime, mis suudab kaitsta linde virulentse NDV infektsiooni eest.
English: The potential advantage of using “intermediate plus” or “hot” strains, such as the one contained in Poulvac Bursa Plus is that they could break through higher maternally derived antibodies (MDA) levels than milder strains can do.
Estonian: Keskmisest tugevama toimega või nn kuumade tüvede (näiteks Poulvac Bursa Plusis kasutatav tüvi) kasutamise potentsiaalne eelis on see, et nad suudavad ületada suurema MDA-kontsentratsiooni kui nõrgemad tüved.
English: The breakthrough titre has been supported, which underpins the proposed recommendation for use and confirms the ability of the product to be used to overcome MDA (present at levels as specified in the SPC), an issue which typically causes problems for intermediate vaccines.
Estonian: Katsed toetavad lävitiitrit, mis põhjendab kavandatud kasutussoovitusi ja kinnitab toote võimet ületada MDA (ravimi omaduste kokkuvõttes näidatud kontsentratsioonide korral), mis on tavaliselt probleemiks keskmise tugevusega tüvesid sisaldavate vaktsiinide korral.
English: From the studies that were presented in the safety part of the dossier, the following conclusions can be drawn:
Estonian: Dokumentatsiooni ohutust käsitlevas osas esitletud uuringute alusel saab teha alltoodud järeldused.
English: • Efficacy of the vaccine (minimum titre) has been shown using SPF chickens of the minimum age recommended: reduction of the bursal lesions and prevention of the mortality caused by a vvIBDV was achieved in those animals.
Estonian: • Vaktsiini tõhusus (minimaalne tiiter) on tõestatud, kasutades soovitatava miinimumvanusega SPF kanu: neil loomadel saavutati vvIBDV poolt põhjustatud kloaagipauna kahjustuste vähenemine ja suremuse ennetamine.
English: Until the emergence of those strains the common practice in broiler production was to vaccinate hens just before laying in order to induce a high level of passive immunity in the chicks which could protect them up to an age when infection by IBDV was less detrimental with regards to immunosuppression.
Estonian: Enne selliste tüvede ilmumist kasutati broilerikasvatuses tavaliselt kanade vaktsineerimist enne munemise algust, et tekitada tibudes suur passiivne immuunsus, mis kaitseks neid vanuseni, mil IBDVinfektsiooni immuunsupressiivne mõju ei ole enam nii kahjulik.
English: o It was accepted that the immunosuppression seen was an acknowledged risk associated with the product, which was offset against the demonstrated ability to provide protection against vvIBD in the face of MDA levels as specified in the SPC.
Estonian: o võeti teatavaks, et täheldatud immuunsupressioon on tootega seotud teadaolev risk, mida korvab tõestatud toime tagada kaitse vvIBD vastu ravimi omaduste kokkuvõttes täpsustatud MDA-kontsentratsiooni juures;
English: Efficacy of the vaccine has been adequately demonstrated in the laboratory, sufficient to confirm prevention of mortality and reduction of bursal lesions caused by vvIBDV using SPF chickens.
Estonian: Vaktsiini tõhusus on laboris küllaldaselt tõestatud, mis on piisav vvIBDV-st tingitud suremuse ennetamise ja kloaagipauna kahjustuste vähendamise kinnitamiseks SPF kanadel.
English: • Since the product has been authorised, the reported incidence of adverse reactions is zero which indicates that the safety profile is acceptable.
Estonian: • Toode on juba heaks kiidetud ning toote kohta ei ole teatatud ühestki kõrvalnähust, mis näitab, et toote ohutusprofiil on aktsepteeritav.
English: The vaccine is indicated for the active immunisation of chickens with maternal antibody levels of ≤ 500 ELISA units, to reduce mortality and bursal lesions of Gumboro disease.
Estonian: Vaktsiin on näidustatud kanade, kellel emalt saadud antikehade (MDA, maternally derived antibodies) kontsentratsioon on ≤ 500 ELISA ühikut, aktiivseks immuniseerimiseks, et vähendada Gumboro haigusest tingitud suremust ja kloaagipauna kahjustusi.
English: • When administered to SPF chickens using a 10 times overdose, the vaccine does not cause clinical signs or mortality.
Estonian: • 10kordsel üleannustamisel SPF kanadele vaktsiin kliinilisi tunnuseid ega suremust ei põhjusta.
English: Efficacy studies have been carried out both under laboratory conditions, in SPF and commercial chickens with MDA, and under field conditions.
Estonian: Tõhususe uuringud on tehtud nii labori- kui ka välitingimustes nii SPF kanadel kui ka MDAga müügiks kasvatavatel kanadel.
English: However, this effect did not affect the ability of the Newcastle Disease vaccine to protect against challenge with virulent NDV.
Estonian: Samas ei muutnud see toime Newcastle'i tõve vastase vaktsiini võimet linde kaitsta virulentse NDV eest.
English: From the studies that were provided in the efficacy part of the dossier, the following conclusions can be drawn:
Estonian: Dokumentatsiooni tõhusust käsitlevas osas esitletud uuringute alusel saab teha alltoodud järeldused.
English: Animal species
Estonian: Loomaliik Manustamisviis
English: Under laboratory conditions, efficacy against vvIBDV was shown using SPF chickens.
Estonian: Laboritingimustes on tõestatud toote tõhusus vvIBDV vastu, kasutades SPF kanasid.
English: Pharmaceutical form
Estonian: Ravimvorm
English: The onset and duration of immunity has been confirmed in commercial broiler chicks in a similar laboratory study in the presence of MDA.
Estonian: Immuunsuse algus ja kestus on MDA juuresolekul sarnases laboriuuringus kinnitatud müügiks mõeldud broileritibudel.
English: The results showed that the vaccine strain notably reduced the serological response induced by vaccination against Newcastle Disease Virus (NDV) observed in chickens previously vaccinated using Poulvac Bursa Plus.
Estonian: Tulemused näitasid, et varem Poulvac Bursa Plus vaktsiiniga vaktsineeritud kanadel vähendas vaktsiinitüvi märkimisväärselt Newcastle'i tõve viiruse (NDV, Newcastle Disease Virus) vastase vaktsinatsiooni poolt indutseeritud seroloogilist vastust.
English: These benefits have been shown in the field in circumstances where the product is intended to be used and in the face of MDA levels which must necessarily be considered typical.
Estonian: Neid kasulikke toimeid on välitingimustes näidatud situatsioonides, kus toote kasutamine on ette nähtud, ning kus arvestatakse MDA-kontsentratsioone, mistõttu neid situatsioone peab pidama tüüpilisteks kasutussituatsioonideks.
English: Benefits
Estonian: Kasulikkus
English: The effect on serology is adequately reflected in the SPC.
Estonian: Toime seroloogilisele reaktsioonile on ravimi omaduste kokkuvõttes asjakohaselt esitatud.
English: o The SPC provides adequate information to the end user to enable the appropriate use of the product, including a recommendation to only use the product where vvIBD was present.
Estonian: o ravimi omaduste kokkuvõte esitab lõppkasutajale piisavalt teavet, sealhulgas soovitus kasutada toodet ainult vvIBD olemasolul, et võimaldada toote asjakohast kasutamist, ning o taotleja esitatud ohutuse ja tõhususe andmed on piisavad, et pidada toote üldist kasulikkuse ja riski tasakaalu positiivseks.
English: For Poulvac Bursa Plus, the optimum day of vaccination recommended in the Summary of Product Characteristics (SPC) needs to be calculated using the Kouwenhoven's formula; the target maximum MDA levels at the time of vaccination is 500 ELISA Units using a commercially available kit, but whatever the vaccination day calculation reaches, it is contra-indicated to vaccinate chickens less than 10 days of age.
Estonian: MDA maksimaalne sihtväärtus vaktsineerimise ajal on 500 ELISA ühikut, mis on määratud müügil oleva komplektiga, kuid meeles tuleb pidada seda, et vaatamata sellele, missugune vaktsineerimispäev valemi abil saadakse, on alla 10päevaste kanade vaktsineerimine vastunäidustatud.
English: These have been under practical conditions, in flocks with levels of MDA which necessarily should be considered typical of situations where the product would be used.
Estonian: Katsed on tehtud praktilistes tingimustes lindlates, kus MDAkontsentratsioon on tüüpiline situatsioonidele, milles toote kasutamine ette on nähtud.
English: Recommended dose
Estonian: Soovituslik annus
English: This is an acceptable risk associated with the protection provided against vvIBD in the face of MDA.
Estonian: MDA-kontsentratsiooni arvestava kaitse tagamisel vvIBD vastu on tegemist aktsepteeritava riskiga.
English: At that time, because the hypervirulent strains were able to breakthrough high maternally derived antibodies (MDA) levels, live vaccination of broilers became necessary.
Estonian: Kuid siis tekkis vajadus ka broilerite vaktsineerimiseks elusviirusega, sest hüpervirulentsed tüved suudavad ületada suure MDAkontsentratsiooni.
English: o Although the product did not comply with Ph. Eur.
Estonian: o kuigi toode ei vasta klassikaliste IBDV-vaktsiinide Ph. Eur.
English: Romania Fort Dodge Animal Health
Estonian: Rumeenia Fort Dodge Animal Health
English: Belgium Fort Dodge Animal Health
Estonian: Belgia Fort Dodge Animal Health
English: Invented name
Estonian: Ravimi nimetus
English: Germany Fort Dodge Animal Health
Estonian: Saksamaa Fort Dodge Animal Health
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF POULVAC BURSA PLUS
Estonian: POULVAC BURSA PLUSI TEADUSLIKU HINDAMISE ÜLDKOKKUVÕTE 1.
English: Ireland Fort Dodge Animal Health
Estonian: Iirimaa Fort Dodge Animal Health
English: Bulgaria Fort Dodge Animal Health
Estonian: Bulgaaria Fort Dodge Animal Health
English: Slovakia Fort Dodge Animal Health
Estonian: Slovakkia Fort Dodge Animal Health
English: Greece Fort Dodge Animal Health
Estonian: Kreeka Fort Dodge Animal Health
English: Slovenia Fort Dodge Animal Health
Estonian: Sloveenia Fort Dodge Animal Health
English: Spain Fort Dodge Animal Health
Estonian: Hispaania Fort Dodge Animal Health
English: United Kingdom
Estonian: Ühendkunin griik
English: Denmark Fort Dodge Animal Health
Estonian: Madalmaad Fort Dodge Animal Health
English: The Netherlands
Estonian: Ungari
English: Tell your relatives, friends and close colleagues the following:
Estonian: Teavitage oma sugulasi, sõpru ja lähedasi kolleege alljärgnevast:
English: This helps prevent:
Estonian: See aitab vältida:
English: In most cases you will need a doctor.
Estonian: Enamikel juhtudel vajate te arstiabi.
English: Change the needle and try again.
Estonian: Vahetage nõel ja proovige uuesti.
English: Open here
Estonian: Avage siit.
English: • Contamination and/or infection
Estonian: • saastumist ja/või infektsiooni,
English: Do not share it with anyone else.
Estonian: Ärge jagage seda kellegi teisega.
English: - In your body
Estonian: - Teie kehas
English: • At the request of the European Medicines Agency
Estonian: • Euroopa Ravimiameti nõudel;
English: MedDRA system organ classes
Estonian: MedDRA organsüsteemi klassid
English: Alternatively, it may emerge gradually over a period of several weeks.
Estonian: Teise võimalusena võib see avalduda järk-järgult mitme nädala jooksul.
English: Important information for use of SoloStar:
Estonian: Oluline teave SoloStar'i kasutamiseks:
English: Some medicines cause changes in the blood sugar level (decrease, increase or both depending on the situation).
Estonian: Mõned ravimid põhjustavad vere suhkrusisalduse muutusi (tõusu, langust või mõlemat, sõltuvalt olukorrast).
English: - In your brain
Estonian: - Teie ajus
English: It is recommended that the date of the first use be noted on the label.
Estonian: Esmase kasutamise kuupäev on soovitatav märkida etiketile.
English: Make sure that you contact a doctor early.
Estonian: Võtke kindlasti arstiga aegsasti ühendust.
English: Shock
Estonian: Šokk
English: Special populations Elderly population (≧65 years old)
Estonian: Eakad (≧65-aastased)
English: The pictures below are for illustrative purposes only.
Estonian: Allpool olevad joonised on ainult illustratiivsed.
English: Your doctor or nurse should have discussed this with you previously.
Estonian: Teie arst või diabeediõde on sellest teiega varem vestelnud.
English: Generally, the greater and more rapid the decline in blood glucose, the more marked is the phenomenon of counter-regulation and its symptoms.
Estonian: Üldiselt, mida suurem ja kiirem on vere glükoosisisalduse langus, seda väljendunum on vastureaktsiooni fenomen ja selle sümptomid.
English: Insulin requirements may decrease during the first trimester and generally increase during the second and third trimesters.
Estonian: Insuliini vajadus võib väheneda esimesel trimestril ning enamasti suureneb teisel ja kolmandal trimestril.
English: Be familiar with your warning symptoms.
Estonian: Olge oma hoiatussümptomitega kursis.
English: To prevent the possible transmission of disease, each pen must be used by one patient only.
Estonian: Vältimaks võimalikku haiguste edasikandumist, võib igat pen-süstlit kasutada ainult üks patsient.
English: SoloStar is designed to work accurately and safely.
Estonian: SoloStar on kavandatud töötama korralikult ja ohutult.
English: Please note: The needles shown are for illustrative purposes only.
Estonian: Tähelepanu: näidatud nõelad on ainult illustratiivsed.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) ) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Estonian: Müügiloa hoidja peab esitama asjaomase ravimi perioodilisi ohutusaruandeid kooskõlas direktiivi 2001/83/EÜ artikli 107c punktis 7 sätestatud ja Euroopa ravimite veebiportaalis avaldatud liidu kontrollpäevade loetelu (EURD loetelu) nõuetega.
English: These symptoms often develop before the symptoms of a low sugar level in the brain.
Estonian: Need sümptomid tekivad tavaliselt enne, kui sümptomid, mis on tingitud madalast suhkrutasemest ajus.
English: Then eat something that has a long-acting effect in raising your blood sugar (such as bread or pasta).
Estonian: Seejärel sööge midagi, millel on pikaajaline veresuhkru taset tõstev toime (nt leib või pasta).
English: Always tell people who are caring for you or treating you that you require insulin.
Estonian: Alati informeerige teie eest hoolitsevaid või teid ravivaid inimesi oma insuliinivajadusest.
English: The insulin requirement is often increased.
Estonian: Tihti on suurenenud insuliinivajadus.
English: • ensuring that pen and needle work properly
Estonian: • tagab, et pen-süstel ja nõel töötavad korralikult,
English: Inform your doctor if you are planning to become pregnant, or if you are already pregnant.
Estonian: Informeerige oma arsti plaanist rasestuda või sellest, kui olete juba rase.
English: This helps prevent contamination, and potential needle blocks.
Estonian: See aitab vältida saastumist ja võimalikku nõela ummistumist.
English: It is essential for patients with pre-existing or gestational diabetes to maintain good metabolic control throughout pregnancy.
Estonian: Tavalise või rasedusdiabeediga patsientidel on hädavajalik säilitada head metaboolset kontrolli kogu raseduse jooksul.
English: It should be handled with care.
Estonian: Seda peab käsitsema ettevaatlikult.
English: You should know these factors so that you are able to react correctly to changes in your blood sugar level and to prevent it from becoming too high or too low.
Estonian: Te peaksite olema nendest teguritest teadlik ning võimeline õigesti reageerima muutustele oma veresuhkru tasemes, et vältida selle tõusmist liiga kõrgele või langemist liiga madalale.
English: It is specially stabilised to minimise loss of efficacy which may result from mechanical and thermal stress in such pumps.
Estonian: Ta on eriliselt stabiliseeritud, et vältida efektiivsuse langust, mis selliste pumpade korral võib olla tingitud mehhaanilisest või termilisest kahjustusest.
English: Problems with the pen?
Estonian: Probleemid pen-süstliga?
English: Therefore, no specific frequency can be presented.
Estonian: Seetõttu ei ole võimalik esitada täpset esinemissagedust.
English: However, it must be noted that the pharmacokinetics of insulin do not reflect its metabolic action.
Estonian: Kuid tuleb meeles pidada, et insuliini farmakokineetika ei peegelda selle metaboolset toimet.
English: Keep this possible problem in mind in all situations where you might put yourself and others at risk (such as driving a car or using machines).
Estonian: Pidage seda võimalikku probleemi meeles olukordades, kus te võite ennast ja teisi ohustada (nt autojuhtimine ja masinatega töötamine).
English: This medicine contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially ‘sodium-free'.
Estonian: Ravim sisaldab vähem kui 1 mmol naatriumi (23 mg) annuse kohta, st see on põhimõtteliselt „naatriumivaba”.
English: You normally should be able to recognise when your blood sugar is falling too much so that you can take the right actions.
Estonian: Tavaliselt peaksite ära tundma, kui teie veresuhkur langeb liiga madalale, ning olema võimeline õigeid meetmeid rakendama.
English: The warning symptoms of hypoglycaemia may be changed, be less pronounced or be absent in certain risk groups.
Estonian: Hüpoglükeemia hoiatussümptomid võivad muutuda, olla vähem väljendunud või puududa teatud riskigruppides.