FrancophonIA/ELRC3.0 huggingface dataset:
English: The third study compared Tyverb with placebo (a dummy treatment), both of which were taken together with letrozole (an aromatase inhibitor).
Estonian: Kolmandas uuringus võrreldi Tyverbit platseeboga (näiv ravim), kusjuures mõlemat kasutati koos letrosooliga (teatud aromataasiinhibiitor).
English: By blocking HER2 receptors, Tyverb helps to control growth of the cancer.
Estonian: Blokeerides HER2-retseptorid, aitab Tyverb piirata vähirakkude kasvu.
English: 219 of the women had cancer that was producing large quantities of HER2.
Estonian: Nendest 219 naisel oli HER2 üleekspressiooniga vähk.
English: The company that markets Tyverb will evaluate ways to predict resistance (the medicine becoming less effective) in breast cancer patients taking Tyverb with other cancer medicines.
Estonian: Tyverbi turustaja hindab, kuidas prognoosida resistentsust (ravimi efektiivsuse vähenemist) rinnavähiga patsientidel, kes võtavad Tyverbit koos muude ravimitega.
English: For the full list of side effects and restrictions with Tyverb, see the package leaflet.
Estonian: Tyverbi kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: What benefits of Tyverb have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Tyverbi kasulikkus?
English: It involved 408 women with advanced or metastatic disease that was producing large quantities of HER2 who had already been treated with anthracyclines, taxanes and trastuzumab but whose disease had got worse or come back.
Estonian: Uuringus osales 408 kaugelearenenud või metastaatilise rinnavähiga naist, kelle vähk ekspresseeris suures koguses HER2 ja keda oli juba ravitud antratsükliinide, taksaanide ja trastusumaabiga, kuid kelle haigus oli süvenenud või uuest tekkinud.
English: Tyverb in combination with other cancer medicines has been shown to improve survival of patients with breast cancer that produces large quantities of HER2, and its side effects are considered acceptable.
Estonian: On tõendatud, et Tyverb kombinatsioonis teiste vähiravimitega parandab HER2 üleekspressiooniga rinnavähiga patsientide elumust, ning selle kõrvalnähte peetakse vastuvõetavaks.
English: • in combination with trastuzumab for metastatic cancer that does not respond to hormones (hormone receptor-negative disease), and which got worse when previously treated with a combination of trastuzumab and other cancer medicines (chemotherapy);
Estonian: • Koos trastusumaabiga sellise metastaatilise vähi korral, mis ei reageeri hormoonidele (hormoonretseptor-negatiivne haigus) ja mis on süvenenud pärast varasemat ravi trastusumaabi ja teiste vähiravimite kombinatsiooniga (keemiaravi).
English: Tyverb contains the active substance lapatinib.
Estonian: Tyverb sisaldab toimeainena lapatiniibi.
English: About a quarter of breast cancers produce HER2.
Estonian: HER2 tekib ligikaudu veerandi korral rinnavähijuhtudest.
English: In addition, women taking the combination survived for 14.0 months on average, compared with 9.5 months in those taking Tyverb alone.
Estonian: Lisaks oli kombinatsioonravimit võtnud naiste üldine elumus keskmiselt 14,0 kuud ja ainult Tyverbit kasutanutel 9,5 kuud.
English: HER2 is a receptor for a substance called epidermal growth factor which stimulates the cancer cells to grow uncontrollably.
Estonian: HER2 on rakkude kontrollimatut vohamist stimuleeriva aine epidermaalse kasvufaktori (EGF) retseptor.
English: It involved 296 women with metastatic disease that was producing large quantities of HER2 and got worse despite treatment with trastuzumab and other cancer medicines (including anthracyclines and taxanes).
Estonian: Selles uuringus osales 296 metastaatilise rinnavähiga naist, kelle vähk ekspresseeris suures koguses HER2 ja kelle haigus oli vaatamata ravile trastusumaabi ja teiste vähiravimitega (sh antratsükliinid ja taksaanid) süvenenud.
English: • in combination with capecitabine (another cancer medicine) when the cancer is advanced or metastatic and got worse following previous treatment including an anthracycline and a taxane (other types of cancer medicine), and following treatment of the patient's metastatic disease with trastuzumab (another cancer medicine).
Estonian: • Koos kapetsitabiiniga (samuti vähiravim), kui vähk on kaugelearenenud või metastaatiline ja on süvenenud pärast antratsükliini ja taksaani (muud liiki vähiravimid) sisaldanud varasemat ravi ning pärast patsiendi metastaatilise haiguse ravi trastusumaabiga (samuti vähiravim).
English: The women whose cancer was producing large quantities of HER2 taking Tyverb in combination with letrozole survived for an average of 35.4 weeks without their disease getting worse.
Estonian: Naistel, kellel vähk ekspresseeris suures koguses HER2 ja kes kasutasid Tyverbit koos letrosooliga, oli keskmine progresseerumiseta elumus 35,4 nädalat.
English: An overview of Tyverb and why it is authorised in the EU
Estonian: Ülevaade ravimist Tyverb ja ELis müügiloa väljastamise põhjendus
English: It involved 1,286 women who had been through the menopause with metastatic breast cancer that was sensitive to hormones.
Estonian: Selles uuringus osales 1286 menopausijärgses eas naist, kellel rinnavähk oli metastaatiline ja hormoontundlik.
English: • in combination with an aromatase inhibitor (another type of cancer medicine) in women who have been through the menopause, when the cancer is metastatic and responds to hormones.
Estonian: • Koos aromataasiinhibiitoriga (muud liiki vähiravim) menopausijärgses eas naistel, kelle vähk on metastaatiline ja hormoontundlik.
English: Women taking Tyverb with capecitabine survived for an average of 75 weeks, and those taking capecitabine alone survived for an average of 64.7 weeks.
Estonian: Tyverbi koos kapetsitabiiniga võtnud naiste keskmine üldine elumus oli 75 nädalat ja ainult kapetsitabiini võtnud naistel 64,7 nädalat.
English: These medicines work by blocking enzymes known as protein kinases, which can be found in some receptors (targets) on the surface of cancer cells including HER2.
Estonian: Poteiinkinaasiinhibiitorid blokeerivad ensüümid proteiinkinaasid, mida on teatud vähirakkude pinnaretseptorites, sealhulgas retseptoris HER2.
English: The doctor may decide to interrupt or stop treatment in patients experiencing certain side effects, especially those affecting the heart, lungs or liver.
Estonian: Teatud kõrvalnähtude, eriti südame, kopsude või maksaga seotud kõrvalnähtude tekkimisel võib arst otsustada patsiendi ravi katkestada või lõpetada.
English: The women taking Tyverb in combination with capecitabine lived for an average of 23.9 weeks without their disease getting worse, as assessed by their doctors, compared with 18.3 weeks in the women taking capecitabine alone.
Estonian: Tyverbit koos kapetsitabiiniga kasutanud naiste progresseerumiseta elumus oli arstide hinnangul keskmiselt 23,9 nädalat ja ainult kapetsitabiini võtnud naistel 18,3 nädalat.
English: Women taking Tyverb with trastuzumab lived without their disease getting worse for 12.0 weeks on average, compared with 8.1 weeks in those taking Tyverb alone.
Estonian: Progresseerumiseta elumus oli Tyverbit koos trastusumaabiga kasutanud naistel keskmiselt 12,0 nädalat ja ainult Tyverbit kasutanutel 8,1 nädalat.
English: Palmar-plantar erythrodysaesthesia (rash and numbness on the palms and soles) is also very common when Tyverb is taken with capecitabine.
Estonian: Tyverbi võtmisel koos kapetsitabiiniga on väga sage ka palmaar-plantaarne erütrodüsesteesia (peopesade ja taldade lööve ja tuimus).
English: This means that the cancer produces a specific protein called HER2 (also known as ErbB2) in large quantities on the surface of the cancer cells.
Estonian: HER2 üleekspressioon tähendab, et vähkkasvaja toodab suures koguses vähirakkude pinnal ekspresseruvat spetsiifilist valku HER2 (ehk ErbB2).
English: The first study compared Tyverb in combination with capecitabine, with capecitabine taken alone.
Estonian: Teises uuringus võrreldi ainuravimina kasutatud Tyverbit Tyverbiga, mida kasutati koos trastusumaabiga.
English: Tyverb can only be obtained with a prescription and should only be started by a doctor who has experience in giving cancer medicines.
Estonian: Ravi peab alustama vähiravimite kasutamises kogenud arst.
English: Tyverb is a cancer medicine used to treat patients with breast cancer that has been shown to be ‘expressing' large amounts of HER2.
Estonian: Tyverb on vähiravim, mida kasutatakse HER2 üleekspressiooniga rinnavähiga patsientide raviks.
English: Tyverb in combination with another cancer medicine was shown to be more effective than the comparator treatment in three main studies involving women with breast cancer.
Estonian: Kolmes rinnavähiga naiste põhiuuringus oli Tyverb koos teise vähiravimiga efektiivsem kui võrdlusravim.
English: Why is Tyverb authorised in the EU?
Estonian: ELis Tyverbile väljastatud müügiloa põhjendus
English: Portugal capsule
Estonian: Portugal kapsel
English: Benzstraße 1
Estonian: KG Benzstraße 1
English: Benzstr.
Estonian: KG Benzstr.
English: Meda AS, Askerveien 61, Postboks 194, 1371 Asker
Estonian: Meda AS Askerveien 61 Postboks 194 1371 Asker Norway
English: SANOFI AVENTIS FRANCE 1-13 boulevard Romain Rolland
Estonian: SANOFI AVENTIS FRANCE 1-13 boulevard Romain Rolland 75014 PARIS
English: Germany ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Estonian: Saksamaa ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
English: Unit 34/35, Block A Dunboyne Business Park Dunboyne
Estonian: Meda Health Sales Ireland Limited Unit 34/35, Block A Dunboyne Business Park Dunboyne Co. Meath Ireland
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states for bromocriptine-containing medicinal products indicated in the “prevention or suppression of physiological lactation in the immediate post-partum period and in the late post-partum period”
Estonian: I lisa Ravimi nimetuste, ravimvormi, tugevuste, manustamisviisi, müügiloa hoidjate loetelu liikmesriikides
English: Gyömrõi ut 19-21 1103 Budapest Hungary
Estonian: Gyömrõi ut 19-21 1103 Budapest Ungari
English: Germany betapharm Arzneimittel GmbH
Estonian: Saksamaa betapharm Arzneimittel GmbH Kobelweg 95
English: MEDA PHARMACEUTICALS S.A., GREECE 3 Evrytanias Str., Halandri, 15231, Attiki, Greece
Estonian: 3 Evrytanias Str., Halandri 15231, Attiki
English: Belgium Meda Pharma s.a. Chaussée de la Hulpe 166 1170 Brussels
Estonian: Chaussée de la Hulpe 166 1170 Brussels Belgium
English: 170 09 Solana Box 906
Estonian: 170 09 Solna Box 906
English: Maksimirska 120/V, Zagreb
Estonian: Maksimirska 120/V Zagreb 10 000 Croatia
English: S.C. BIOFARM S.A. Str. Logofăt Tăutu nr. 99, sector 3,
Estonian: Str. Logofăt Tăutu nr. 99 sector 3, Bucureşti
English: Czech Republic Medochemie Ltd. Konstantinoupoleos Str. 1_10 3011 Limassol - Tsiflikoudia Cyprus
Estonian: Tšehhi Vabariik Medochemie Ltd. Constantinoupoleos Str. 1_10 3011 Limassol - Tsiflikoudia Cyprus
English: Czech Republic MEDA Pharma s.r.o.
Estonian: Tšehhi Vabariik MEDA Pharma s.r.o.
English: Slovak Republic MEDA Pharma s.r.o.
Estonian: Slovakkia Vabariik MEDA Pharma s.r.o.
English: Gedeon Richter Plc Gyömrői út 19-21.
Estonian: Gedeon Richter Plc Gyömrői út 19-21 H-1103 Budapest Hungary
English: Verovškova 57, 1000 Ljubljana, Slovenia
Estonian: 1526 Ljubljana Slovenia
English: Slovak Republic Medochemie Ltd. 1-10 Constantinoupoleos St. 3011 Limassol,
Estonian: Slovakkia Vabariik Medochemie Ltd. 1-10 Constantinoupoleos St. 3011 Limassol
English: Parlodel 10 mg 10 mg
Estonian: Parlodel 10 mg
English: MEDOCRIPTINE 2,5 mg
Estonian: MEDOCRIPTINE 2,5 mg 2.5 mg
English: Meda AS, Solvang 8, DK-3450 Allerød, Denmark
Estonian: DK-3450 Allerød Denmark
English: Parlodel 1mg Tablets
Estonian: Parlodel 1mg Tablets 1 mg
English: Medochemie Ltd Constantinoupoleos 1-10 Street
Estonian: Medochemie Ltd Constantinoupoleos 1-10 Street Lemesos 3501
English: MEDA PHARMA 25, boulevard de l'Amiral Bruix,
Estonian: 25, boulevard de l'Amiral Bruix 75016 Paris
English: 28830 San Fernando de Henares (Madrid) Spain
Estonian: Edificio Berlín 2ª planta Parque Empresarial San Fernando 28830 San Fernando de Henares Madrid
English: 89079 Ulm germany bromocriptin-ct 2,5mg Tabletten
Estonian: AbZ-Pharma GmbH Graf-Arco-Str. 3 89079 Ulm Germany bromocriptin-ct 2,5mg Tabletten
English: United Kingdom Teva UK Limited, Brampton Road,
Estonian: Teva UK Limited Brampton Road, Hampden Park Eastbourne, East Sussex BN22 9AG
English: Bromergon 2,5 mg tablete
Estonian: Bromergon 2,5 mg tablette
English: Parlodel 10mg Tablets capsule
Estonian: Parlodel 10mg Tablets 10 mg kapsel
English: Parlodel 5mg Tablets capsule
Estonian: Parlodel 5mg Tablets 5 mg kapsel
English: Parlodel 5 mg capsules
Estonian: Parlodel 5 mg capsules 5 mg
English: Parlodel 2,5 mg 2.5 mg
Estonian: Parlodel 2,5 mg
English: Kobelweg 95
Estonian: Verovškova 57
English: BromocriptinRichter 2,5 mg tabletta
Estonian: Bromocriptin-Richter 2,5 mg tabletta
English: Parlodel 2.5mg Tablets
Estonian: Parlodel 2.5mg Tablets 2.5 mg
English: BROMOCRIPTIN 2.5 mg coated tablet
Estonian: Bromocriptine 2.5mg Tablets
English: 16 December 2016 EMA/822769/2016 EMEA/H/C/004342
Estonian: 16. detsember 2016 EMA/822769/2016 EMEA/H/C/004342
English: What is Cavoley?
Estonian: Mis on Cavoley?
English: Withdrawal of the marketing authorisation application for Cavoley (pegfilgrastim) EMA/822769/2016
Estonian: Müügiloa taotluse tagasivõtmise teave: Cavoley (pegfilgrastiim) EMA/822769/2016
English: Because filgrastim is pegylated, its removal from the body is slowed down, allowing the medicine to be given less often.
Estonian: Et filgrastiim on pegüleeritud, väljub see organismist aeglasemalt ja ravimit võib anda harvemini.
English: How does Cavoley work?
Estonian: Kuidas Cavoley toimib?
English: On 16 November 2016, Gedeon Richter Plc officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Cavoley, for reducing neutropenia.
Estonian: Ettevõte Gedeon Richter Plc teatas 16. novembril 2016 ametlikult inimravimite komiteele oma soovist võtta tagasi ravimi Cavoley müügiloa taotlus.
English: A further study in patients receiving cancer medicines compared the safety and effectiveness of Cavoley and Neulasta.
Estonian: Teises uuringus, milles osalesid vähiravimeid saanud patsiendid, võrreldi Cavoley ja Neulasta ohutust ja efektiivsust.
English: This means that Cavoley was intended to be highly similar to a biological medicine (the ‘reference medicine') already authorised in the European Union called Neulasta.
Estonian: See tähendab, et Cavoley pidi olema sarnane bioloogilise ravimiga (võrdlusravimiga) Neulasta, millel juba on Euroopa Liidus müügiluba.
English: Withdrawal of the marketing authorisation application for Cavoley (pegfilgrastim)
Estonian: Müügiloa taotluse tagasivõtmise teave: Cavoley (pegfilgrastiim)
English: Neutropenia is a side effect of certain cytotoxic (cell-killing) cancer treatments because the treatments also kill white blood cells.
Estonian: Neutropeenia on teatud tsütotoksiliste (rakke hävitavate) vähiravimite kõrvalnäht, sest ravi hävitab ka valgeliblesid.
English: The company presented results of studies in healthy people designed to show that Cavoley is highly similar to its reference medicine Neulasta in terms of chemical structure, purity, the way it works and how the body handles the medicine.
Estonian: Ettevõte esitas tulemused tervetel inimestel tehtud uuringutest, mille eesmärk oli näidata, et Cavoley on keemilise struktuuri, puhtuse, toimemehhanismi ja organismis metaboliseerumise poolest sarnane võrdlusravimiga Neulasta.
English: Cavoley was developed as a ‘biosimilar' medicine.
Estonian: Cavoley töötati välja bioloogiliselt sarnase ravimina.
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that having considered the CHMP's conclusion, it has decided to withdraw the application but to continue developing the product and follow the CHMP's advice to eliminate the remaining uncertainty.
Estonian: Ettevõtte kirjas, milles ta teatab Euroopa Ravimiametile oma taotluse tagasivõtmisest, märgib ettevõte, et pärast inimravimite komitee järelduste kaalumist otsustati taotlus tagasi võtta, kuid jätkata ravimi arendamist ja järgida inimravimite komitee soovitust kõrvaldada kahtlused.
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Cavoley could not have been approved for reducing neutropenia.
Estonian: Tuginedes esitatud andmete analüüsile ja ettevõtte vastustele inimravimite komitee esitatud küsimustele, nägi komitee taotluse tagasivõtmise ajal põhjust ettevaatlikkuseks ja oli esialgsel seisukohal, et ravimi Cavoley kasutamist ei saa neutropeenia vähendamiseks heaks kiita.
English: The company informed the CHMP that there are no ongoing clinical trials or compassionate-use programmes for Cavoley.
Estonian: Ettevõte teatas inimravimite komiteele, et Cavoleyga ei viida läbi kliinilisi uuringuid ega eriloaga kasutamise programme.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the company had not demonstrated that Cavoley is highly similar to Neulasta.
Estonian: Seetõttu oli inimravimite komitee müügiloa taotluse tagasivõtmise ajal arvamusel, et ettevõte ei olnud tõendanud Cavoley sarnasust Neulastaga.
English: Cavoley was to be used to reduce the duration of neutropenia and the occurrence of febrile neutropenia (neutropenia with fever).
Estonian: Cavoleyd kavatseti kasutada neutropeenia kestuse ja febriilse neutropeenia (palavikuga neutropeenia) esinemissageduse vähendamiseks.
English: What was Cavoley expected to be used for?
Estonian: Milleks kavatseti Cavoleyd kasutada?
English: Cavoley was to be used in cancer patients to reduce neutropenia (low levels of neutrophils).
Estonian: Cavoleyd kavatseti kasutada vähipatsientidel neutropeenia (neutrofiilide vähesuse) vähendamiseks.
English: The CHMP was concerned that study results had not shown that Cavoley was handled by the body in the same way as the reference medicine Neulasta.
Estonian: Inimravimite komiteed tegi ettevaatlikuks asjaolu, et uuringutulemused ei tõendanud, kas organism metaboliseerib Cavoleyd samal viisil kui võrdlusravimit Neulasta.
English: Cavoley is a medicine that contains the active substance pegfilgrastim, which stimulates the production of neutrophils (a type of white blood cell that fights infections).
Estonian: Cavoley on on toimeainena pegfilgrastiimi sisaldav ravim, mis stimuleerib neutrofiilide (teatud infektsioonivastaste valgeliblede) teket.
English: The active substance in Cavoley, pegfilgrastim, consists of filgrastim that has been 'pegylated' (attached to a chemical called polyethylene glycol).
Estonian: Cavoley toimeaine pegfilgrastiim koosneb pegüleeritud (polüetüleenglükooliga (PEG) kaetud) filgrastiimist.
English: The vaccine is then ready to use.
Estonian: Vaktsiin on siis valmis kasutamiseks.
English: ATCvet code: QI01BD03.
Estonian: ATCvet kood: QI01BD03.
English: Do not use in birds in lay (see section 4.3).
Estonian: Mitte kasutada munevatel lindudel (vt lõik 4.3.
English: Any person intending to manufacture, import, possess, sell, supply and use this veterinary medicinal product must first consult the relevant Member State's competent authority on the current vaccination policies, as these activities may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Estonian: Iga isik, kes kavatseb toota, importida, omandada, müüa, tarnida ja/või kasutada seda veterinaarravimit, peab eelnevalt konsulteerima vastava liikmesriigi vastutava ametkonnaga vaktsineerimispoliitika osas sest need tegevused võivad olla teatud liikmesriikide territooriumil või osal nende territooriumist siseriiklike õigusaktide kohaselt keelatud.
English: Protect from light.
Estonian: Hoida kaitstuna valguse eest.
English: Store and transport refrigerated (2° C - 8° C).
Estonian: Hoida ja transportida külmas (2°C - 8°C).
English: b) the disease to which the product is intended to confer immunity is largely absent from the territory in question
Estonian: b) haigust, mille suhtes preparaat annab immuunsuse, kõnealusel territooriumil üldiselt ei esine.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 11/04/2014
Estonian: ESMASE MÜÜGILOA VÄLJASTAMISE / MÜÜGILOA UUENDAMISE KUUPÄEV Esmase müügiloa väljastamise kuupäev: 11/04/2014
English: Laboratoire Porte des Alpes Rue de l'Aviation 69800 Saint Priest FRANCE
Estonian: Laboratoire Porte des Alpes Rue de l'Aviation 69800 Saint Priest Prantsusmaa
English: C T C G C C C A A T A The vaccine strain can be found in the spleen for at least 35 days.
Estonian: C A C G C C C A A C A Hanede parvoviirus C T C G C C C A A T A Vaktsiini tüve võib leida põrnast vähemalt 35 päeva jooksul.
English: The entire flock should be vaccinated to lower the risk of any circulation of the vaccine strain and virus recombination.
Estonian: Vaktsineerima peab kogu linnukarja, et alandada riski vaktsiinitüve tsirkuleerimiseks ning viiruse rekombinatsiooniks.
English: Detailed information of 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 (http://www.ema.europa.eu/).
English: SPECIAL STORAGE CONDITIONS Store below 25° C.
Estonian: SÄILITAMISE ERITINGIMUSED Hoida temperatuuril kuni 25°C .
English: Subcutaneous use.
Estonian: Subkutaanselt kasutamiseks.
English: The concentrate is opalescent and homogeneous.
Estonian: Kontsentraat on opalestsentne ja homogeenne.
English: ANNEX IV GROUNDS FOR ONE ADDITIONAL RENEWAL
Estonian: IV LISA MÜÜGILOA ÜHE TÄIENDAVA UUENDAMISE PÕHJUSED
English: After mixing, connect the bag to a high-speed, automated or semi-automated injection system.
Estonian: Peale segunemist ühendage kott automaatse või poolautomaatse kiirsüstlaga.
English: 2,500 doses
Estonian: 2500 doosi
English: C A C G C C C A A C A
Estonian: C A C G C C C A A C A Hanede parvoviirus C T C G C C C A A T A
English: Then remove the trocar from both containers.
Estonian: Siis eemaldage troakaar mõlemast mahutist.
English: Casein hydrolysate Aluminium hydroxide
Estonian: Kaseiinihüdrolüsaat Alumiiniumhüdroksiid
English: Antigen concentrate:
Estonian: Antigeeni kontsentraat:
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
Estonian: VABASTAMISE EEST VASTUTAV(AD) TOOTJA(D) B. TARNIMIS- JA KASUTAMISTINGIMUSED VÕI PIIRANGUD C. RAVIMJÄÄKIDE PIIRNORMID
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each reconstituted dose of 0.2 ml contains:
Estonian: KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS Iga lahustatud doos 0,2 ml sisaldab:
English: The demonstrated duration of immunity protects the birds during the period when they are most susceptible to Muscovy duck parvovirosis and Derzsy's disease.
Estonian: Näidatud immuunsuse kestus kaitseb linde perioodil, mil nad on kõige vastuvõtlikumad muskuspartide parvoviroosile ning Derzsy haigusele.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 500 doses
Estonian: PAKENDI SISU KAALU, MAHU VÕI ANNUSTE ARVU JÄRGI 500 doosi
English: Sodium chloride Potassium chloride Potassium dihydrogen phosphate Disodium phosphate dehydrate Water for injections.
Estonian: Naatriumkloriid Kaaliumkloriid Kaaliumdivesinikfosfaat Dinaatriumfosfaatdehüdraat Süstevesi
English: Gently shake the bag to mix the antigen concentrate with the diluent.
Estonian: Raputage õrnalt kotti, et antigeeni kontsentraat seguneks lahustiga.
English: Due to the limited period the veterinary medicinal product Parvoduk has been placed on the market and the consequently limited post-marketing safety information, the CVMP at their meeting on 6-8 November 2018 decided that one five-year renewal is required.
Estonian: Seoses veterinaarravimi Parvoduc limiteeritud turuloleku ajaperioodiga ja sellest tulenevalt müügiloa saamise järgsete piiratud ohutusalaste andmete olemasolu tõttu otsustas CVMP 6.