FrancophonIA/ELRC3.0 huggingface dataset:
English: As for all medicines, data on the use of Stayveer are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, tehakse Stayveeri kasutamise kohta pidevat järelevalvet.
English: This medicine is the same as Tracleer, which is already authorised in the EU.
Estonian: See ravim on samane Tracleeriga, millel juba on ELis müügiluba.
English: The European Medicines Agency decided that Stayveer's benefits are greater than its risks and recommended that it can be authorised for use in the EU.
Estonian: Euroopa Ravimiamet otsustas, et Stayveeri kasulikkus on suurem kui sellega kaasnevad riskid ja ravimi kasutamise võib ELis heaks kiita.
English: What is Stayveer and what is it used for?
Estonian: Mis on Stayveer ja milleks seda kasutatakse?
English: Other information about Stayveer
Estonian: Muu teave Stayveeri kohta
English: In the larger study patients were able to walk 44 metres further.
Estonian: Suuremas uuringus paranes patsientide kõndimiskaugus 44 meetri võrra.
English: In adults, the starting dose is 62.5 mg twice a day for four weeks, which is increased to the usual dose of 125 mg twice a day.
Estonian: Täiskasvanutel on algannus 62,5 mg 2 korda ööpäevas 4 nädala jooksul, seejärel suurendatakse annust tavaannuseni 125 mg 2 korda ööpäevas.
English: Why is Stayveer authorised in the EU?
Estonian: Miks Stayveer ELis heaks kiideti?
English: Stayveer is available as film-coated tablets (62.5 mg and 125 mg).
Estonian: Stayveeri turustatakse õhukese polümeerkattega tablettidena (62,5 mg ja 125 mg).
English: The company that makes Tracleer has agreed that its scientific data can be used for Stayveer (‘informed consent').
Estonian: Tracleeri tootja on andnud nõusoleku, et tema teaduslikke andmeid võib kasutada ka Stayveeri toetuseks (teabel põhinev nõusolek).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Stayveer have also been included in the summary of product characteristics and the package leaflet.
Estonian: Stayveeri ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on samuti lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: Side effects reported with Stayveer are carefully evaluated and any necessary action taken to protect patients.
Estonian: Stayveeri kõrvalnähte hinnatakse hoolikalt ja patsientide kaitseks võetakse vajalikke meetmeid.
English: In a study in 185 patients with class II disease the distance the patients could walk over 6 minutes was similar in the Stayveer and placebo groups.
Estonian: Uuringus, milles osales 185 II klassi haigusega patsienti, oli patsientide 6 minuti kõndimiskaugus Stayveeri ja platseebo uuringurühmades sarnane.
English: For more information about using Stayveer, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet Stayveeri kasutamise kohta saate pakendi infolehelt või küsige oma arstilt või apteekrilt.
English: By expanding these blood vessels, pressure is reduced and symptoms are improved.
Estonian: Nende veresoonte laiendamisega alandatakse rõhku ning leevendatakse sümptomeid.
English: Stayveer contains the active substance bosentan.
Estonian: Stayveer sisaldab toimeainena bosentaani.
English: What are the risks associated with Stayveer?
Estonian: Mis riskid Stayveeriga kaasnevad?
English: Stayveer must not be used in patients who have certain liver problems, who are pregnant or could become pregnant and who are not using reliable contraceptive methods or who are taking ciclosporin (a medicine that acts on the immune system).
Estonian: Stayveeri ei tohi kasutada teatud maksaprobleemidega patsiendid, rasedad, rasestumisvõimelised naised, kes ei kasuta usaldusväärseid rasestumisvastaseid vahendeid, ega patsiendid, kes võtavad tsüklosporiini (immuunsüsteemi ravim).
English: The company that makes Stayveer will provide a patient alert card to remind patients of the need for regular blood tests for liver function and to use effective contraception to avoid pregnancy.
Estonian: Stayveeri tootja annab patsientidele hoiatuskaardi, mis tuletab patsientidele meelde maksatalitlust hindavate regulaarsete vereanalüüside ja raseduse vältimiseks tõhusate rasestumisvastaste vahendite kasutamise vajadust.
English: Stayveer is used to treat patients with class III pulmonary arterial hypertension (PAH) to improve exercise capacity (the ability to carry out physical activity) and reduce symptoms.
Estonian: Stayveer on ravim, mida kasutatakse III funktsionaalse klassi pulmonaalse arteriaalse hüpertensiooniga patsientide raviks, et suurendada nende koormustaluvust (füüsilist suutlikkust) ja vähendada sümptomeid.
English: The most common side effects with Stayveer (which may affect more than 1 in 10 people) are headache, fluid retention, anaemia (low levels of haemoglobin, the protein in red blood cells that carries oxygen around the body) and abnormal results of blood tests to check the liver.
Estonian: Stayveeri kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 patsiendil 10st) on peavalu, vedelikupeetus, aneemia (hapnikku organismis laiali kandva punaliblede valgu hemoglobiini vähesus) ja ebanormaalsed maksanäitajate tulemused vereanalüüsides.
English: The active substance in Stayveer, bosentan, blocks a naturally occurring hormone called endothelin-1 (ET-1), which causes blood vessels to narrow.
Estonian: Stayveeri toimeaine bosentaan blokeerib loodusliku hormooni endoteliin-1 (ET-1), mis ahendab veresooni.
English: How is Stayveer used?
Estonian: Kuidas Stayveeri kasutatakse?
English: In the first study, patients taking Stayveer had an average of 1.4 new digital ulcers after 16 weeks, compared with 2.7 in the patients taking placebo.
Estonian: Esimeses uuringus tekkis Stayveeri kasutanud patsientidel 16 nädala järel keskmiselt 1,4 uut sõrme- ja varbahaavandit ning platseebot kasutanud patsientidel 2,7 uut haavandit.
English: The second study which also looked at the effect of Stayveer on digital ulcer healing in 190 patients did not find any effect.
Estonian: Teises uuringus, milles vaadeldi ka Stayveeri toimet sõrme- ja varbahaavandite paranemisele 190 patsiendil, ei õnnestunud toimet tõendada.
English: For the full list of side effects of Stayveer, see the package leaflet.
Estonian: Stayveeri kõrvalnähtude täielik loetelu on pakendi infolehel.
English: Bosentan improves blood circulation and thereby, prevents the development of new digital ulcers.
Estonian: Bosentaan parandab vereringet ja aitab seeläbi ennetada uute sõrme- ja varbahaavandite teket.
English: Some improvement with Stayveer can also occur in patients with class II PAH.
Estonian: Stayveer võib mõnevõrra parandada ka II klassi pulmonaalse arteriaalse hüpertensiooniga patsientide seisundit.
English: In PAH, severe narrowing of the blood vessels in the lungs increases blood pressure and reduces the amount of blood entering the lungs.
Estonian: Pulmonaalse arteriaalse hüpertensiooni korral suurendab kopsuveresoonte tugev ahenemine vererõhku ning vähendab kopsudesse siseneva vere kogust.
English: An overview of Stayveer and why it is authorised in the EU
Estonian: Ülevaade ravimist Stayveer ja ELis müügiloa väljastamise põhjendus
English: Stayveer therefore prevents blood vessels from narrowing.
Estonian: Seega aitab Stayveer ennetada veresoonte ahenemist.
English: How does Stayveer work?
Estonian: Kuidas Stayveer toimib?
English: PAH is abnormally high blood pressure in the arteries of the lungs.
Estonian: Pulmonaalne arteriaalne hüpertensioon on ebanormaalselt kõrge vererõhk kopsuarterites.
English: However, Stayveer decreased the resistance to blood flow by 23%, indicating a widening of the blood vessels, compared with placebo after 6 months of treatment.
Estonian: Sellegipoolest vähendas Stayveer 6 ravikuu järel verevoolutakistust võrreldes platseeboga 23% võrra, mis tõendab veresoonte laienemist.
English: In PAH, Stayveer added to patient's current therapy was more effective than placebo (a dummy treatment) in improving the distance patients could walk in 6 minutes (a way of measuring exercise capacity) after 16 weeks of treatment.
Estonian: Pulmonaalse arteriaalse hüpertensiooni ravis oli Stayveer lisatuna patsiendi tavaravile koormustaluvuse (kõndimiskaugus 6 minuti jooksul) parandamisel 16 ravinädala järel efektiivsem kui platseebo (näiv ravim).
English: The ‘class' reflects the severity of the disease: ‘class III' PAH involves marked limitation of physical activity.
Estonian: Klass väljendab haiguse raskusastet: III klassi pulmonaalse arteriaalse hüpertensiooni korral on patsiendi füüsiline suutlikkus oluliselt piiratud.
English: • caused by congenital (inborn) heart defects with shunts (abnormal passageways) causing abnormal flow of blood through the heart and lungs.
Estonian: • põhjustatud kaasasündinud südameriketest, mille korral tekib südames ja kopsudes šuntide (veresoonte ebanormaalsete ühenduste) tõttu ebanormaalne verevool.
English: ‘Class II' involves slight limitation of physical activity.
Estonian: II klassi haiguse korral on patsiendi füüsiline suutlikkus kergelt piiratud.
English: In patients with systemic sclerosis and digital ulcer disease, there is narrowing of the blood vessels of the fingers and toes leading to ulcers.
Estonian: Süsteemse skleroosi ning sõrme- ja varbahaavanditega haigusvormiga patsientidel põhjustab haavandeid sõrmede ja varvaste veresoonte ahenemine.
English: What benefits of Stayveer have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Stayveeri kasulikkus?
English: Stayveer is given to reduce the number of new digital ulcers.
Estonian: Stayveeri kasutatakse uute sõrme- ja varbahaavandite arvu vähendamiseks.
English: Stayveer can also be used in adults with systemic sclerosis in whom poor blood circulation caused by the disease has led to the development of digital ulcers (sores on the fingers and toes).
Estonian: Samuti tohib Stayveeri kasutada süsteemse skleroosiga täiskasvanutel, kellel on haigusest põhjustatud vereringehäirete tõttu tekkinud sõrme- ja varbahaavandid.
English: Stayveer can only be obtained with a prescription and treatment should only be started and monitored by a doctor who has experience in the treatment of PAH or systemic sclerosis.
Estonian: Ravi tohib alustada üksnes pulmonaalse arteriaalse hüpertensiooni või süsteemse skleroosi ravis kogenud arst ning ravi peab toimuma tema järelevalve all.
English: Stayveer was more effective than placebo at reducing the development of new digital ulcers based on two studies in a total of 312 adults.
Estonian: Kahes uuringus, milles osales kokku 312 täiskasvanut, oli Stayveer uute sõrme- ja varbahaavandite arvu vähendamisel efektiivsem kui platseebo.
English: <6 months.><…><1 year.><18 months.><2 years.><30 months.><3 years.><use immediately.>
Estonian: <6 kuud.><...><1 aasta.><18 kuud.><2 aastat.><30 kuud.><3 aastat.> <kohe kasutamiseks.>
English: <Do not use in ….>
Estonian: <Mitte kasutada...>
English: Pharmacotherapeutic group: {group}.
Estonian: Farmakoterapeutiline rühm: {rühm }
English: <Use only accordingly to the benefit-risk assessment by the responsible veterinarian.>
Estonian: <Kasutada ainult vastavalt vastutava loomaarsti tehtud kasu-riski suhte hinnangule.>
English: <<Meat and offal><Eggs><Milk> <Honey>: {X} <days><hours>.>
Estonian: <<Lihale ja söödavatele kudedele><munadele><piimale><meele>:: {X} <päeva><tundi>.>
English: <Official control authority batch release is required for this product.> [only for those immunological veterinary medicinal products which are listed for HYPERLINK "https://www.edqm.eu/en/Veterinary-OCABR-Guidelines-1531.html" \l "PSG"Official Control Authority Batch Release (OCABR) in accordance with Article 82 of Directive 2001/82/EC as amended.]
Estonian: <Selle ravimi puhul on vajalik partii ametlik kasutamiseks vabastamine.> [only for those immunological veterinary medicinal products which are listed for HYPERLINK "https://www.edqm.eu/en/Veterinary-OCABR-Guidelines-1531.html" \l "PSG"Official Control Authority Batch Release (OCABR) in accordance with Article 82 of Directive 2001/82/EC as amended.]
English: <Store in a refrigerator (2 (C - 8 (C).>
Estonian: <Hoida külmkapis (2(C - 8(C).>
English: Personnel involved in attending vaccinated {species} should follow general hygiene principles (changing clothes, wearing gloves, cleaning and disinfection of boots) and take particular care in handling animal waste and bedding materials from recently vaccinated {species}.>
Estonian: Vaktsineeritud {liike} hooldav personal peab järgima üldise hügieeni põhimõtteid (rõivaste vahetamine, kinnaste kandmine, jalatsite puhastamine ja desinfitseerimine) ning olema eriti hoolikas hiljuti vaktsineeritud {liikide} väljaheidete ja allapanu koristamisel>.
English: <PHARMACOLOGICAL><IMMUNOLOGICAL> PROPERTIES
Estonian: <FARMAKOLOOGILISED> <IMMUNOLOOGILISED> OMADUSED
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, omada, 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: · CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Estonian: · VETERINAARRAVIMI OHUTU JA EFEKTIIVSE KASUTAMISE TINGIMUSED JA PIIRANGUD
English: <The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.>
Estonian: <Ravimi trükitud pakendi infolehel peab olema vastava ravimipartii vabastamise eest vastutava tootja nimi ja aadress.>
English: <Accidental injection is dangerous.>
Estonian: <Juhuslik süstimine on ohtlik.>
English: <Vaccinate healthy animals only.>
Estonian: <Vaktsineerida ainult terveid loomi.>
English: <None known.>
Estonian: <Ei ole teada.>
English: <This veterinary medicinal product does not require any special temperature storage conditions.>*****
Estonian: <Veterinaarravim ei vaja säilitamisel temperatuuri eritingimusi.>*****
English: {(Invented) name of veterinary medicinal product <strength> pharmaceutical form}
Estonian: {Veterinaarravimi (väljamõeldud) nimetus <tugevus> ravimvorm}
English: <The periodic safety update report (PSUR) cycle should be restarted for submission of 6 monthly reports (covering all authorised presentations of the product) for the next two years, followed by yearly reports for the subsequent two years and thereafter at 3 yearly intervals.>[Only applicable, if justified after authorisation.]
Estonian: <Ravimi perioodilise ohutusaruande(PSUR) tsüklid tuleb määrata järgnevaks kaheks aastaks iga 6 kuu järel esitamiseks (peab hõlmama müügiloaga ravimi kõik ravimvorme ja tugevusi), edasised aruanded kahe järgneva aasta jooksul igal aastal esitamiseks ja seejärel 3 aastase intervalliga esitamiseks.
English: <Store in a refrigerator.>
Estonian: <Hoida külmkapis.>
English: <Do not use in <birds in lay><breeding birds> <and within 4 weeks before the start of the laying period>.>
Estonian: <Mitte kasutada <munevatel lindudel> <sugulindudel> <ja 4 nädala jooksul enne munemisperioodi algust.>>
English: <Do not mix with any other veterinary medicinal product<, except <solvent or other component> <recommended><supplied> <for use with the veterinary medicinal product>.>
Estonian: <Mitte segada teiste veterinaarravimitega>, välja arvatud <lahusti või mõne teise komponendiga>, mis on <soovitatud kasutamiseks>< tarnitud> <koos selle veterinaarravimiga>.>
English: <In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.>
Estonian: <Sobivusuuringute puudumise tõttu ei tohi seda veterinaarravimit teiste veterinaarravimitega segada.>
English: <Zero days.>
Estonian: <0 päeva.>
English: The active substance being a principle of biological origin intended to <produce> <active><passive><diagnose a state of> immunity is not within the scope of Regulation (EC) No 470/2009.
Estonian: Toimeaine, mis põhimõtteliselt on bioloogilist päritolu ja mõeldud <aktiivse> <passiivse> immuunsuse <esile kutsumiseks> <diagnoosimiseks> ei kuulu Määruse (EÜ) nr 470/2009 reguleerimisalasse.
English: · <SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES>
Estonian: · <ERIKOHUSTUSED <TINGIMUSLIKU MÜÜGILOA> <ERANDLIKEL ASJAOLUDEL VÄLJAANTUD MÜÜGILOA> JÄRGSETE MEETMETE TÄITMISEKS>
English: <The <vaccine><immunological veterinary medicinal product> can be pathogenic for humans.
Estonian: < <vaktsiin> <immunoloogiline veterinaarravim> võib olla inimesele patogeenne.
English: <Not authorised for use in animals producing milk for human consumption.>
Estonian: <Ei ole lubatud kasutamiseks loomadel, kelle piima tarvitatakse inimtoiduks.>
English: <Not for use in birds producing or intended to produce eggs for human consumption.>
Estonian: <Mitte kasutada lindudel, kelle mune tarvitatakse või kavatsetakse tarvitada inimtoiduks.>
English: <For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
Estonian: <Lisaküsimuste tekkimisel veterinaarravimi kohta pöörduge palun müügiloa hoidja kohaliku esindaja poole.>
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (HYPERLINK "http://www.ema.europa.eu/"http://www.ema.europa.eu/).
Estonian: Üksikasjalikku teavet antud veterinaarravimi kohta leiab Euroopa Ravimiameti koduleheküljelt HYPERLINK "http://www.ema.europa.eu" http://www.ema.europa.eu/.
English: <Duration of immunity: {x years}>
Estonian: <Immuunsuse kestus: {x aastat}>
English: <Store and transport refrigerated (2 (C - 8 (C).>*
Estonian: <Hoida ja transportida külmas (2(C - 8(C).>*
English: <Onset of immunity: {x weeks}>
Estonian: <Immuunsuse teke: {x nädalat}>
English: DescriptionDue date>>
Estonian: KirjeldusKuupäev>>
English: <Environmental properties>
Estonian: <Keskkonnaomadused>
English: <Disposal: read package leaflet.>
Estonian: <Hävitamine: vt pakendi infolehte.>
English: <Adjuvant
:>
Estonian: <Adjuvant<adjuvandid>:>
English: <Laboratory studies in {species} have shown evidence of <teratogenic>, <foetotoxic>, <maternotoxic> effects.>
Estonian: <Laboratoorsed uuringud {liigid} on näidanud <teratogeenset>, <fetotoksilist>, <maternotoksilist> toimet.>
English: <Shelf life after first opening the immediate packaging: >
Estonian: <Kõlblikkusaeg pärast vahetu pakendi esmast avamist:>
English: <Do not use in pregnant animals which are intended to produce milk for human consumption within {X} months of expected parturition.>
Estonian: <Mitte kasutada tiinetel loomadel, kelle piima kavatsetakse tarvitada inimtoiduks, {X} kuud enne oodatavat poegimist.>
English: <Do not use in cases of hypersensitivity to the active substance(s)<, to the adjuvant(s)> or to any of the excipient(s).>
Estonian: <Mitte kasutada, kui esineb ülitundlikkust toimeaine(te), <adjuvandi (adjuvantide)> või ravimi ükskõik millis(t)e abiaine(te) suhtes.>
English: During this time, the contact of immunosuppressed and unvaccinated {species} with vaccinated {species} should be avoided.>
Estonian: Selle aja jooksul tuleb vältida immuunpuudulikkusega ja vaktsineerimata {liikide} kokkupuudet vaktsineeritud {liikidega}.>
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 veterinaarravim või selle jäätmed tuleb hävitada vastavalt kohalikule seadusandlusele.>
English: <Laboratory studies in {species} have not produced any evidence of <teratogenic>, <foetotoxic>, <maternotoxic> effects.>
Estonian: <Laboratoorsed uuringud {liigid} ei ole näidanud <teratogeenset>, <fetotoksilist>, <maternotoksilist> toimet.>
English: <The MAH shall complete, within the stated timeframe, the following measures:
Estonian: <Müügiloa hoidja viib ettenähtud aja jooksul läbi järgmised meetmed:
English: <No data available.>
Estonian: <Andmed puuduvad.>
English: Do not use this veterinary medicinal product after the expiry date which is stated on the <label><carton><bottle><...> <after {abbreviation used for expiry date}>.
Estonian: Ärge kasutage veterinaarravimit pärast kõlblikkusaega, mis on märgitud <sildil><karbil><pudelil><...> <pärast {kõlblikkusaja lühend}.
English: <Do not use {name of product} if you notice {description of the visible signs of deterioration}.>
Estonian: <Mitte kasutada, kui täheldate {ravimi nimetus} juures {nähtavate riknemise tunnuste kirjeldus}.>
English: OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION>
Estonian: MUUD TINGIMUSED JA NÕUDED MÜÜGILOALE>
English: <<Accidental administration> <Contact with the mucosa> is dangerous.>
Estonian: <<Juhuslik manustamine> <Kokkupuude limaskestaga> on ohtlik.>
English: <Do not use within {X} weeks of the start of the laying period.>
Estonian: <Mitte kasutada {X} nädala jooksul enne munemisperioodi algust.>
English: HYPERLINK "http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2014/08/WC500170559.pdf" http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2014/08/WC500170559.pdf]
Estonian: PARTII NUMBER[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website HYPERLINK "http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2014/08/WC500170559.pdf" http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2014/08/WC500170559.pdf]
English: <Shelf life after incorporation into meal or pelleted feed: ….>
Estonian: < Kõlblikkusaeg pärast sööda või pelleteeritud sööda sisse segamist: ...>
English: <Medicines should not be disposed of via wastewater or <household waste>.>
Estonian: <Kasutamata jäänud ravimeid ega jäätmematerjali ei tohi ära visata kanalisatsiooni kaudu <ega koos majapidamisprügiga>.>
English: <The use is not recommended (during the whole or part of the pregnancy).>
Estonian: <Kasutamine ei ole soovitatav (kogu tiinuse ajal või tiinuse teatud järgus).>
English: <Shelf life after incorporation into meal or pelleted feed: >
Estonian: <Kõlblikkusaeg pärast sööda või pelleteeritud sööda sisse segamist: >
English: · <OBLIGATION TO CONDUCT POST-AUTHORISATION MEASURES>
Estonian: · <MÜÜGILOA JÄRGSED KOHUSTUSED>
English: The Committee for Medicinal Products for Veterinary Use has recommended the inclusion of {name of the active substance(s)} in {name of the product} in table 1 (Allowed substances) of the annex to Commission Regulation (EU) No 37/2010 as follows:
Estonian: Veterinaarravimite komitee on soovitanud lisada {toimeaine(te) nimetus(ed)} {preparaadi nimi} Komisjoni määruse (EL) nr 37/2010 lisa tabelisse 1 (lubatud ained) järgmiselt:
English: <Alternatively you can report via your national reporting system {national system details}.> [For MRP/DCP only]
Estonian: <Võite ka ise teavitada HYPERLINK "http://www.ravimiamet.ee" www.ravimiamet.ee kaudu.> [For MRP/DCP only]
English: <Do not use (during the whole or part of the pregnancy).>
Estonian: <Mitte kasutada (kogu tiinuse ajal või tiinuse teatud järgus).>
English: <Can be used during pregnancy.>
Estonian: <Lubatud kasutada tiinuse ajal.>
English: <The use is not recommended during <pregnancy><lactation>.>
Estonian: <Kasutamine <tiinuse> <laktatsiooni> ajal ei ole soovitatav.>
English: Marketing authorisation holder <and manufacturer responsible for batch release>:
Estonian: <Müügiloa hoidja> <ja partii vabastamise eest vastutav tootja>:
English: <Store and transport frozen {temperature range}.>**
Estonian: <Hoida ja transportida külmutatult {temperatuuri vahemik}.>**
English: <Laying birds:>
Estonian: <Munevad kanad>