FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, cefovecin exhibits in-vitro activity against Escherichia coli which is associated with canine and feline urinary tract infections.
Estonian: Lisaks toimib tsefovetsiin in-vitro Escherichia coli vastu, mida seostatakse koerte ja kasside kuseteede infektsioonidega.
English: (See also Section 4.5 ‘Special Precautions for Use'.)
Estonian: põhjustatud igemete ja periodontaalkudede raskete infektsioonide ravis (vt. ka lõik 4.5 „Erihoiatused“).
English: TARGET SPECIES Dogs and cats.
Estonian: LOOMALIIGID Koer, kass.
English: For the treatment of skin and soft tissue abscesses and wounds associated with Pasteurella multocida, Fusobacterium spp., Bacteroides spp., Prevotella oralis, β haemolytic Streptococci and/or Staphylococcus pseudintermedius.
Estonian: Pasteurella multocida, Fusobacterium spp., Bacteroides spp., Prevotella oralis'e, β-hemolüütiliste streptokokkide ja/või Staphylococcus pseudointermedius'e põhjustatud naha ja pehmete kudede abstsesside ja haavade raviks.
English: QUANTITY OF OTHER SUBSTANCES 13 mg/ml benzyl alcohol
Estonian: TOIMEAINE(TE) KOGUS 13 mg/ml bensüülalkoholi
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each 23 ml vial of lyophilised powder contains:
Estonian: TOIMEAINE JA ABIAINETE SISALDUS Iga 23 ml viaal lüofiliseeritud pulbrit sisaldab: Toimeained:
English: BATCH NUMBER
Estonian: Manustatav kogus
English: were 2.3 %, 2.7 %, 3.1 % and 1.4 %, respectively.
Estonian: Tsefovetsiinile resistentsete isolaatide osakaal E. coli'l, Prevotella oralis'el, Bacteroides spp.-l ja Proteus spp.-l oli vastavalt 2,3 %, 2,7 %, 3,1 % ja 1,4 %.
English: Shake the vial until the powder is seen to have fully dissolved.
Estonian: Loksutada viaali pulbri täieliku lahustumiseni.
English: ROUTE(S) OF ADMINISTRATION For subcutaneous use.
Estonian: MANUSTAMISVIIS(ID) Subkutaanseks manustamiseks.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL (5 ml LYOPHILISED POWDER VIAL)
Estonian: ETIKETT (5 ml LÜOFILISEERITUD PULBRI VIAAL)
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Convenia 80 mg/ml powder and solvent for solution for injection for dogs and cats
Estonian: VETERINAARRAVIMI NIMETUS Convenia 80 mg/ml pulber ja lahusti süstelahuse valmistamiseks koertele ja kassidele
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL (23 ml LYOPHILISED POWDER VIAL)
Estonian: ETIKETT (23 ml LÜOFILISEERITUD PULBRI VIAAL)
English: s.c. Read the package leaflet
Estonian: s.c. Enne ravimi kasutamist lugege pakendi infolehte.
English: Urinary tract infections in dogs and cats: A single subcutaneous injection of 8 mg/kg bodyweight (1 ml per 10 kg bodyweight).
Estonian: Kuseteede infektsioonid koertel ja kassidel: Ühekordne subkutaanne manustamine doosis 8 mg/kg kehamassi kohta (1 ml 10 kg kehamassi kohta).
English: EXPIRY DATE
Estonian: Naatriumtsitraat
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL (10 ml DILUENT VIAL)
Estonian: ETIKETT (10 ml LAHUSTI VIAAL)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL (19 ml DILUENT VIAL)
Estonian: ETIKETT (19 ml LAHUSTI VIAAL)
English: EXPIRY DATE EXP: {mm/yyyy}
Estonian: KÕLBLIKKUSAEG EXP {kuu/aasta}
English: For the treatment of skin and soft tissue infections including pyoderma, wounds and abscesses associated with Staphylococcus pseudintermedius, β-haemolytic Streptococci, Escherichia coli and/or Pasteurella multocida.
Estonian: Staphylococcus pseudointermedius'e, β-hemolüütiliste streptokokkide, Escherichia coli ja/või Pasteurella multocida põhjustatud naha ja pehmete kudede infektsioonide, kaasa arvatud püoderma, haavade ja abstsesside raviks.
English: PACKAGE LEAFLET: Convenia 80 mg/ml powder and solvent for solution for injection for dogs and cats
Estonian: PAKENDI INFOLEHT Convenia 80 mg/ml, pulber ja lahusti süstelahuse valmistamiseks koertele ja kassidele
English: Dogs and cats.
Estonian: Koer, kass.
English: QUANTITY OF OTHER SUBSTANCES 13 mg/ml benzyl alcohol in water for injections.
Estonian: TOIMEAINE(TE) KOGUS 13 mg/ml bensüülalkoholi süstevees
English: Other information about Varuby
Estonian: Muu teave Varuby kohta
English: What measures are being taken to ensure the safe and effective use of Varuby?
Estonian: Mis meetmed võetakse, et tagada Varuby ohutu ja efektiivne kasutamine?
English: The full EPAR for Varuby can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Varuby kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What is Varuby and what is it used for?
Estonian: Mis on Varuby ja milleks seda kasutatakse?
English: Why is Varuby approved?
Estonian: Miks Varuby heaks kiideti?
English: Overall, therefore, Varuby's benefits are greater than its risks and it has been recommended for approval for use in the EU.
Estonian: Seetõttu on Varuby kasulikkus üldiselt suurem kui sellega kaasnevad riskid ja ravim soovitati kasutamiseks Euroopa Liidus heaks kiita.
English: The active substance in Varuby, rolapitant, works by blocking neurokinin-1 (NK1) receptors.
Estonian: Varuby toimeaine rolapitant blokeerib neurokiniin-1 (NK1) retseptorid.
English: The most common side effects with Varuby (which may affect between 1 and 2 people in 100) are tiredness and headache.
Estonian: Varuby kõige sagedamad kõrvalnähud (võivad esineda 1-2 patsiendil 100st) on väsimus ja peavalu.
English: Varuby contains the active substance rolapitant.
Estonian: Varuby sisaldab toimeainena rolapitanti.
English: Varuby can only be obtained with a prescription and is available as 90-mg tablets.
Estonian: Varuby on retseptiravim ja seda turustatakse 90 mg tablettidena.
English: It is not intended to provide practical advice on how to use Varuby.
Estonian: Hindamisaruandes ei anta Varuby kasutamise praktilisi nõuandeid.
English: What are the risks associated with Varuby?
Estonian: Mis riskid Varubyga kaasnevad?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Varuby have been included in the summary of product characteristics and the package leaflet.
Estonian: Varuby ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: This is a summary of the European public assessment report (EPAR) for Varuby.
Estonian: See on ravimi Varuby Euroopa avaliku hindamisaruande kokkuvõte.
English: By blocking the receptors, Varuby can prevent this effect.
Estonian: Varuby võib retseptoreid blokeerides sellist toimet ennetada.
English: Two tablets are swallowed on the first day of each cycle of chemotherapy, 2 hours or less before chemotherapy starts.
Estonian: Iga keemiaravitsükli esimesel päeval tuleb neelata 2 tabletti 2 tundi enne keemiaravi algust või hiljem.
English: Varuby produced an improvement in the control of delayed nausea and vomiting when added to other standard treatments.
Estonian: Varuby parandas hilise iivelduse ja oksendamise reguleerimist, kui ravimit lisati teistele standardravimitele.
English: There was no delayed nausea and vomiting in 71% of patients given Varuby (475 of 666) compared with 62% of those given placebo (410 of 666).
Estonian: Patsiente, kellel puudus hiline iiveldus ja oksendamine, oli Varuby uuringurühmas 71% (475 patsiendil 666st) ja platseeborühmas 62% (410 patsienti 666st).
English: In both studies, one involving 532 patients and the other involving 555 patients, participants also received dexamethasone and granisetron (a 5-HT3 receptor antagonist).
Estonian: Mõlemas uuringus (ühes 532 ja teises 555 patsienti) anti patsientidele ka deksametasooni ja granisetrooni (retseptori 5-HT3 antagonist).
English: Patients taking Varuby must not take St John's wort (a herbal medicine for mild depression) as this can reduce the effect of Varuby.
Estonian: Varubyt manustavad patsiendid ei tohi võtta naistepuna (taimne depressiooniravim), sest see võib vähendada Varuby toimet.
English: For practical information about using Varuby, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Varuby kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: How is Varuby used?
Estonian: Kuidas Varubyt kasutatakse?
English: For the full list of all side effects and restrictions with Varuby, see the package leaflet.
Estonian: Varuby kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: Adding the results from both studies together, there was no nausea and vomiting in the period from 24 to 120 hours after chemotherapy in 71% of patients (382 out of 535) given Varuby, while the figure with placebo was 60% (322 out of 535 patients).
Estonian: Mõlemas uuringus kokku oli patsiente, kellel puudus iiveldus ja oksendamine 24-120 tundi pärast keemiaravi Varuby uuringurühmades 71% (382 patsienti 535st) ja platseeborühmas 60% (322 patsienti 535st).
English: Varuby was also more effective than placebo in a third main study when used with dexamethasone and granisetron in patients given moderately emetogenic chemotherapy.
Estonian: Varuby oli platseebost efektiivsem ka kolmandas põhiuuringus, kui seda manustati koos deksametasooni ja granisetrooniga patsientidele, kes said mõõdukalt emetogeenset keemiaravi.
English: Although a number of medicines are approved in the EU for management of chemotherapy-associated nausea and vomiting significant numbers of patients still experience it, and management of nausea in particular remains a challenge.
Estonian: Kuigi Euroopa Liidus on keemiaraviga seotud iivelduse ja oksendamise reguleerimiseks heaks kiidetud mitu ravimit, esineb seda siiski paljudel patsientidel ja eriti keeruline on iivelduse reguleerimine.
English: Varuby is given with dexamethasone and a 5-HT3 receptor antagonist (two other types of medicine to prevent nausea and vomiting) but how these are given depends on the type of chemotherapy.
Estonian: Varubyt manustatakse koos deksametasooni ja 5-HT3 retseptori antagonistiga (kaks teist liiki ravimit iivelduse ja oksendamise ennetamiseks); ravimite manustamisviis sõltub keemiaravi liigist.
English: For more information about treatment with Varuby, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Varubyga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: Chemotherapy can release a substance in the body (substance P) which attaches to these receptors and stimulates delayed nausea and vomiting.
Estonian: Keemiaravi korral võib eralduda organismi aine (P-aine), mis kinnitub neile retseptoritele ja tekitab hiljem iiveldust ja oksendamist.
English: Varuby acts against delayed nausea and vomiting (when the symptoms occur 24 hours or more after the cancer treatment) and is given with other medicines that help control more immediate nausea and vomiting.
Estonian: Varuby toimib hilise iivelduse ja oksendamise korral (sümptomid ilmnevad vähemalt 24 tundi pärast vähiravi) ja seda manustatakse koos teiste ravimitega, mis aitavad reguleerida varasemat iiveldust ja oksendamist.
English: When given with medicines that work by other mechanisms to prevent immediate nausea and vomiting, Varuby can help provide prolonged control against these symptoms after chemotherapy.
Estonian: Kui Varubyt manustatakse koos ravimitega, mis ennetavad varasemat iiveldust ja oksendamist teiste mehhanismide abil, võib Varuby aidata keemiaravi järel neid sümptomeid reguleerida pikema aja kestel.
English: How does Varuby work?
Estonian: Kuidas Varuby toimib?
English: What benefits of Varuby have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Varuby kasulikkus?
English: Varuby is a medicine used to prevent nausea (feeling sick) and vomiting in adult cancer patients who are receiving chemotherapy (medicines to treat cancer).
Estonian: Varuby on ravim, mida kasutatakse iivelduse ja oksendamise ennetamiseks täiskasvanud vähipatsientidel, kes saavad keemiaravi (vähiravimeid).
English: In addition, any side effects were manageable and were similar to those usually observed with medicines for nausea and vomiting.
Estonian: Ka kõrvalnähud olid ohjatavad ning need sarnanesid teiste iiveldus- ja oksendamisvastaste ravimite kõrvalnähtudega.
English: For further information, see the summary of product characteristics (also part of the EPAR).
Estonian: Üksikasjalik teave on ravimi omaduste kokkuvõttes, mis on samuti Euroopa avaliku hindamisaruande osa.
English: In two main studies, Varuby was more effective than placebo (a dummy treatment) in preventing delayed nausea and vomiting after highly emetogenic chemotherapy.
Estonian: Varuby oli kahes põhiuuringus tugevalt emetogeense keemiaravi hilise iivelduse ja oksendamise ennetamises efektiivsem kui platseebo (näiv ravim).
English: Different chemotherapy medicines produce different degrees of nausea and vomiting, and Varuby is used in patients receiving highly or moderately emetogenic (vomit-inducing) chemotherapy.
Estonian: Varubyt kasutatakse patsientidel, kes saavad tugevalt või mõõdukalt emetogeenset (oksendamist tekitavat) keemiaravi.
English: BACKGROUND INFORMATION
Estonian: TAUSTTEAVE
English: The Rapporteur was Dr Ian Hudson and Co-Rapporteur was Dr Pierre Demolis.
Estonian: Raportöör oli dr Ian Hudson ja kaasraportöör oli dr Pierre Demolis.
English: London, 14 July 2008 EMEA/CHMP/151554/2008
Estonian: London, 14. juuli 2008 EMEA/CHMP/151554/2008
English: Article 29(4) of Directive 2001/83/EC, as amended.
Estonian: Muudetud direktiivi 2001/83/EÜ artikli 29 lõige 4.
English: Repeat use: Austria, Bulgaria, Cyprus, Spain, France, Italy, Malta and Portugal
Estonian: korduvalt: Austria, Bulgaaria, Küpros, Hispaania, Prantsusmaa, Itaalia, Malta ja Portugal.
English: The Mutual Recognition Procedure started on 2 May 2007.
Estonian: Vastastikuse tunnustamise menetlus algatati 2. mail 2007.
English: The United Kingdom referred the reasons of disagreement to the EMEA on 25 October 2007.
Estonian: Ühendkuningriik esitas lahkarvamuse põhjused EMEA-le 25. oktoobril 2007.
English: The Reference Member State was United Kingdom and the Concerned Member States were: First wave: Belgium, Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Hungary, Iceland, Ireland, Latvia, Lithuania, Luxembourg, The Netherlands, Norway, Poland, Slovak Republic, Slovenia and Sweden
Estonian: Viiteliikmesriik oli Ühendkuningriik ning asjaomased liikmesriigid olid: esimest korda: Belgia, Eesti, Iirimaa, Island, Kreeka, Leedu, Luksemburg, Läti, Madalmaad, Norra, Poola, Rootsi, Saksamaa, Slovaki Vabariik, Sloveenia, Soome, Taani, Tšehhi Vabariik ja Ungari;
English: The Marketing Authorisation Holder provided written explanations on 16 January 2008.
Estonian: Müügiloa hoidja esitas kirjalikud selgitused 16. jaanuaril
English: The final opinion was converted into a Decision by the European Commission on 11 July 2008.
Estonian: Euroopa Komisjon muutis lõpparvamuse otsuseks 11. juulil 2008.
English: A positive opinion was adopted by consensus on 19 March
Estonian: Positiivne otsus võeti konsensusega vastu 19. märtsil 2008.
English: The arbitration procedure started on 15 November 2007 with the adoption of a list of questions.
Estonian: Vahekohtumenetlus algatati 15. novembril 2007 küsimuste loetelu heakskiitmisega.
English: These Member States and the applicant / MAH were not able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State.
Estonian: Need liikmesriigid ja taotleja / müügiloa hoidja ei jõudnud üksmeelele viiteliikmesriigi välja antud müügiloa vastastikuse tunnustamise osas.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Alvesco and associated names International Non-Proprietary Name (INN): ciclesonide
Estonian: INIMRAVIMITE KOMITEE ARVAMUS PÄRAST ARTIKLI 29(4)1 ALUSEL TEHTUD ESILDIST Alvesco ja sarnased nimetused Rahvusvaheline mittekaubanduslik nimetus (INN): tsiklesoniid
English: The product contains ciclesonide which is delivered by a pressurized metered dose inhaler containing ethanolic hydrofluoroalkane-134A as a propellant.
Estonian: See toode sisaldab tsiklesoniidi, mis on pakitud mõõdetavate doosidega surveinhalaatorisse, mis propellandina sisaldab etanoolhüdrofluoroalkaan-134A.
English: In light of this, the applicant/MAH proposed a study which would resolve the outstanding question on the long term use of 320 µg and 640 µg daily.
Estonian: Selle valguses esitles taotleja / müügiloa hoidja uuringu projekti, mis lahendaks aktuaalse probleemi ööpäevase annuse 320 µg või 640 µg pikaajalise kasutamise kohta.
English: During their March 2008 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Alvesco and associated names, that the objections raised by France should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Estonian: 2008. aasta märtsi kohtumisel otsustas inimravimite komitee, et Alvesco ja sarnaste nimetuste kasulikkuse ja riski suhe on esitatud üldandmeid ja komitees peetud teaduslikku arutelu arvesse võttes soodne, mistõttu Prantsusmaa tõstatatud küsimused ei saa olla müügiloa andmisel takistuseks ning et parandada tuleb viiteliikmesriigis kehtivat ravimi omaduste kokkuvõtet, märgistust ja pakendi infolehte.
English: The data supporting this application, as interpreted according with the CHMP guidance, did not support authorization of regular daily doses in excess of 160 µg in the treatment populations, and this was considered to be of serious public health concern.
Estonian: Seda taotlust põhjendavad andmed ei toetanud, hinnatuna inimravimite komitee suuniste kohaselt, kõrgemate igapäevaste regulaarselt kasutatavate annuste kui 160 µg heakskiitmist ravipopulatsioonis ning seega peeti seda oluliseks rahvatervise probleemiks.
English: Altana Pharma AG submitted applications for mutual recognition of Alvesco and associated names, 40µg, 80 µg and 160 µg pressurised inhalation, solution on the basis of the marketing authorisation granted by United Kingdom on 14 April 2004.
Estonian: Altana Pharma AG esitas Alvesco ja sarnaste nimetuste, 40 µg, 80 µg ja 160 µg survemahutis inhalatsioonilahuse vastastikuse tunnustamise taotluse, tuginedes Ühendkuningriigis 14. aprillil 2004 antud müügiloale.
English: Additionally, the applicant/MAH was requested to commit to obtaining scientific advice in relation to exploring a suitable study design, and executing such study(ies) to provide further information on the use of the higher dose of Alvesco in the control of severe asthma.
Estonian: Lisaks taotleti seda, et taotleja / müügiloa hoidja otsiks teaduslikku abi sobiva uuringudisaini selgitamiseks ja selle uuringu läbiviimiseks, et saada lisateavet Alvesco kõrgemate annuste kasutamise kohta raskekujulise astma ravis.
English: The applicant/MAH also accepted an updated wording for Section 5.1, which includes more detail on Study M1-140, at the end of the CMDh procedure, and a fully updated Package Leaflet.
Estonian: Taotleja / müügiloa hoidja nõustus vastastikuse tunnustamise menetluse lõpus ka lõigu 5.1 uuendatud sõnastusega, mis kirjeldab üksikasjalikumalt uuringut M1-150, ning täielikult uuendatud pakendi infolehega.
English: Significant difference have been identified with regard to the currently approved posology for the control of exacerbations in severe asthma, and the need for a study comparing 160 µg, 320 µg and 640 µg/daily to demonstrate a reduction in the frequency of exacerbations in patients with severe asthma at the higher doses.
Estonian: Tuvastati olulised erinevused praegu kehtivate raskekujulise astma raviks heakskiidetud annuste osas ning tuvastati vajadus uuringu järele, milles võrreldakse 160 µg, 320 µg ja 640 µg manustamist ööpäevas, ning tõestatakse ägenemiste esinemissageduse vähenemine kõrgemate annuste kasutamisel raskekujulise astmaga patsientidel.
English: Alvesco and associated names, 40 µg, 80 µg and 160 µg pressurised inhalation, solution is a glucocorticoid used to treat obstructive airway disease.
Estonian: Alvesco ja sarnased nimetused, 40 µg, 80 µg ja 160 µg survemahutis inhalatsioonilahus on glükokortikosteroid, mida kasutatakse hingamisteede obstruktsiooniga (ahenemisega) kulgevate haiguste raviks.
English: The list of the product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics in Annex III.
Estonian: Asjaomaste toodete nimetuste loetelu on esitatud I lisas.
English: In particular, the proposed wording for Section 4.2 at the end of CMDh procedure was amended to reflect that in severe asthmatics, a 12 week study provided by the applicant/MAH has shown that a dose of 640µg/d (given 320µg/d twice daily) demonstrated a reduction in the frequency of exacerbations but without an improvement in lung function.
Estonian: uuringuga tõendatud, et annuse 640 µg ööpäevas (manustatuna 320 µg kaks korda ööpäevas) kasutamisel saavutati ägenemiste esinemissageduse vähenemine, kuid ilma kopsufunktsiooni paranemiseta.
English: Long-term safety data in children and adolescents are not available.
Estonian: Puuduvad pikaajalised ohutusalased andmed laste ja noorukite kohta.
English: The primary objective was to assess the efficacy and safety of this combination regimen over 12 months.
Estonian: Esmaseks eesmärgiks oli hinnata selle ravikombinatsiooni kuuri ohutust ja efektiivsust 12 kuu jooksul.
English: • Ensure that the Package Leaflet in all languages contains a statement referring to the fact that Arimidex should not be given to children.
Estonian: • tagama, et pakendi infolehtede kõikides keeleversioonides on teave, et Arimidexit ei tohi anda lastele.
English: The National Health Authorities, coordinated by the Reference Member State, shall ensure the following conditions are fulfilled by the Marketing Authorisation Holder:
Estonian: Riikide tervishoiuasutused, kelle tegevust koordineerib viiteliikmesriik, tagavad järgmiste tingimuste täitmise müügiloa hoidja poolt
English: Palazzo Volta - Via F. Sforza 20080 - Basiglio (Milano) Italia
Estonian: Palazzo Volta - Via F. Sforza 20080 - Basiglio (Milano) Itaalia
English: Measured mean plasma concentrations were 44.4 (± 14.7) ng/ml and 165 (±90) ng/ml respectively.
Estonian: Mõõdetud keskmisteks plasma kontsentratsioonideks olid vastavalt 44,4 (±14,7) ng/ml ja 165 (±90) ng/ml.
English: The number of children treated was too limited to draw any reliable conclusions on safety.
Estonian: Ravi saanud laste hulk oli liiga väike, et saada usaldusväärset ohutusalast kokkuvõtet.
English: • Submit a Risk Management Plan (or its update) for Arimidex at National level, taking into account the new paediatric data and the CHMP recommendations.
Estonian: • esitama riiklikul tasandil riskijuhtimise kava (või selle viimase versiooni) Arimidexi kohta, võttes arvesse uusi pediaatrilisi andmeid ja inimravimite komitee soovitusi;
English: Thirteen out of the 14 patients enrolled completed 12 months of combination treatment (one patient was lost to follow-up).
Estonian: Kolmteist patsienti 14-st lõpetasid 12-kuulise kombineeritud ravikuuri (üks patsient ei ilmunud järelkontrolli).
English: ANNEX III CONDITIONS OF THE MARKETING AUTHORISATION
Estonian: III LISA MÜÜGILOA TINGIMUSED
English: The reduction was transient as all mating and fertility parameters were similar to control group values following a 9-week treatment-free recovery period.
Estonian: Vähenemine oli ajutine, kuna kõik paaritumisvõime ja fertiilsuse parameetrid sarnanesid vastavate kontrollrühma parameetritega pärast 9nädalast ravivaba taastusperioodi.
English: Only 14 subjects on anastrozole completed 36 months.
Estonian: Ainult 14 anastrosooliga ravitud isikut lõpetasid 36 kuud kestnud ravikuuri.