FrancophonIA/ELRC3.0 huggingface dataset:
English: Visual field defects which can significantly affect the ability to perform hazardous activities have been frequently reported in association with vigabatrin.
Estonian: Vigabatriiniga seoses on sageli teatatud nägemisvälja defektidest, mis võivad oluliselt mõjutada autojuhtimise ja masinate käsitsemise võimet.
English: Pregnancy and breast-feeding This medicine is not intended for use in women of child-bearing potential or in breast-feeding women.
Estonian: See ravim ei ole ette nähtud kasutamiseks viljakas eas või imetavatel naistel.
English: Visual field loss (loss of sight from the edges of your child's field of vision) may occur during treatment with vigabatrin.
Estonian: Ravi ajal vigabatriiniga võib tekkida nägemisvälja defekt (nägemise kaotus nägemisvälja servades).
English: Half a tablet (500 mg)
Estonian: Pool tableti (500 mg)
English: Two tablets (100 mg)
Estonian: Kaks tabletti (100 mg)
English: What Kigabeq contains
Estonian: Kuidas Kigabeq välja näeb ja pakendi sisu
English: What Kigabeq looks like and contents of the pack Kigabeq are white oval scored soluble tablets.
Estonian: Kigabeq on saadaval valgete ovaalsete poolitusjoonega lahustuvate tablettidena.
English: Kigabeq 500 mg soluble tablets
Estonian: Kigabeq 500 mg lahustuvad tabletid
English: Four tablets (100 mg)
Estonian: Neli tabletti (100 mg)
English: HDPE bottle closed with a child resistant tamper evident PP screw cap.
Estonian: Kigabeq 100 mg lahustuvad tabletid HDPE-pudel, mis on suletud keeratava lapsekindla PP-turvakorgiga.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON CONTAINING 1 BOTTLE OF 50 SOLUBLE TABLETS OF KIGABEQ 500 MG
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED KARP, MIS SISALDAB ÜHT PUDELIT KIGABEQ 500 MG 50 LAHUSTUVA TABLETIGA
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON CONTAINING 1 BOTTLE OF 100 SOLUBLE TABLETS OF KIGABEQ 100 MG
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED KARP, MIS SISALDAB ÜHT PUDELIT KIGABEQ 100 MG 100 LAHUSTUVA TABLETIGA
English: Eye disorders visual field defect vision blurred, diplopia, nystagmus retinal disorder (such as peripheral retinal atrophy)
Estonian: Silma kahjustused nägemisväl ja defekt hägune nägemine, kahelinägemin e, nüstagm võrkkesta kahjustus (nt perifeerne võrkkesta atroofia)
English: Hepatic impairment
Estonian: nägemisnärvi atroofia
English: 1 x 500 mg tablet morning 1 x 500 mg and 1 x 100 mg tablet evening
Estonian: 1 × 500 mg tablett hommikul 1 × 500 mg ja 1 × 100 mg tablett õhtul
English: Sve rige
Estonian: II LISA
English: Table 1: Number of soluble tablets according to body weight, starting dose and dose increment in infantile spasms Body we ight (kg)
Estonian: Lahustuvate tablettide arv kehamassi, algannuse ja annuse suurendamise alusel infantiilsete spasmide korral
English: Half a tablet (100 mg)
Estonian: Pool tabletti (100 mg)
English: Two and a half tablets (100 mg)
Estonian: Kaks ja pool tabletti (100 mg)
English: Suomi/Finland ORPHELIA Pharma SAS Puh/Tel: + 33 1 42 77 08 18
Estonian: ORPHELIA Pharma SAS Puh/Tel: + 33 1 42 77 08 18
English: NAME OF THE MEDICINAL PRODUCT Kigabeq 500 mg soluble tablets vigabatrin
Estonian: Kigabeq 500 mg lahustuvad tabletid vigabatriin
English: Three and a half tablets (100 mg)
Estonian: Kolm ja pool tabletti (100 mg)
English: Four and a half tablets (100 mg)
Estonian: Neli ja pool tabletti (100 mg)
English: One and a half tablets (500 mg)
Estonian: Poolteist tabletti (500 mg)
English: PHARMACEUTICAL FORM AND CONTENTS 50 soluble tablets
Estonian: 50 lahustuvat tabletti
English: General disorders and fatigue oedema, irritability administratio n site conditions
Estonian: Üldised häired ja manustamisk oha reaktsioonid väsimus turse, ärrituvus
English: NAME OF THE MEDICINAL PRODUCT Kigabeq 100 mg soluble tablets vigabatrin
Estonian: Kigabeq 100 mg lahustuvad tabletid vigabatriin
English: PHARMACEUTICAL FORM AND CONTENTS 100 soluble tablets
Estonian: 100 lahustuvat tabletti
English: EXP
Estonian: Annus
English: M anufacture r
Estonian: TOOTJA(D)
English: Luxe mbourg/Luxemburg ORPHELIA Pharma SAS Tél/Tel: + 33 1 42 77 08 18
Estonian: ORPHELIA Pharma SAS Tél/Tel: + 33 1 42 77 08 18
English: One and a half tablets (100 mg)
Estonian: Poolteist tabletti (100 mg)
English: The recommended starting dose is 40 mg/kg/day.
Estonian: Resistentne partsiaalne epilepsia (fokaalse algusega episoodid) Soovitatav algannus on 40 mg/kg ööpäevas.
English: 1 x 500 mg and 2 x 100 mg tablet morning 1 x 500 mg and 2 x 100 mg tablet evening
Estonian: 1 × 500 mg ja 2 × 100 mg tablett hommikul
English: PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING LABEL FOR BOTTLE CONTAINING 50 SOLUBLE TABLETS OF KIGABEQ 500 MG
Estonian: SISEPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED KIGABEQ 500 MG 50 LAHUSTUVAT TABLETTI SISALDAVA PUDELI SILT
English: The recommended starting dose is 50 mg/kg/day.
Estonian: Infantiilsete spasmide (Westi sündroomi) monoteraapia Soovitatav algannus on 50 mg/kg ööpäevas.
English: 1 x 500 mg and 3 x 100 mg tablet morning 1 x 500 mg and 3 x 100 mg tablet evening
Estonian: 1 × 500 mg ja 3 × 100 mg tablett hommikul
English: INFORMATION IN BRAILLE Kigabeq 100 mg
Estonian: Kigabeq 100 mg
English: It is available as tablets (200 mg).
Estonian: Seda turustatakse tablettidena (200 mg).
English: The recommended dose is one tablet twice a day (every 12 hours) for 10 days.
Estonian: Soovitatav annus on üks tablett kaks korda ööpäevas (iga 12 tunni järel) 10 päeva jooksul.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Dificlir on 5 December 2011.
Estonian: Euroopa Komisjon andis Dificliri müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 5. detsembril 2011.
English: The full EPAR for Dificlir can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Dificliri kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The main measure of effectiveness was the number of patients that were cured after 10 days of treatment.
Estonian: Efektiivsuse põhinäitaja oli nende patsientide arv, kes olid pärast 10päevast ravi paranenud.
English: Other information about Dificlir
Estonian: Muu teave Dificliri kohta
English: Why has Dificlir been approved?
Estonian: Miks Dificlir heaks kiideti?
English: What is the risk associated with Dificlir?
Estonian: Mis riskid Dificliriga kaasnevad?
English: For more information about treatment with Dificlir, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Dificliriga toimuva ravi kohta lisateavet, lugege pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: When looking at the results of the two studies, 92 % of patients on Dificlir were cured compared with 90% of patients on vancomycin.
Estonian: Kahe uuringu tulemuste põhjal paranes Dificliri ravi järel 92% patsientidest, vankomütsiini korral 90%.
English: The most common side effects with Dificlir (seen in between 1 and 10 patients in 100) are nausea (feeling sick), vomiting and constipation.
Estonian: Dificliri kõige sagedamad kõrvalnähud (esinenud 1-10 patsiendil 100st) on iiveldus, oksendamine ja kõhukinnisus.
English: EPAR summary for the public fidaxomicin
Estonian: Kokkuvõte üldsusele fidaksomitsiin
English: This is a summary of the European public assessment report (EPAR) for Dificlir.
Estonian: See on ravimi Dificlir Euroopa avaliku hindamisaruande kokkuvõte.
English: The active substance in Dificlir, fidaxomicin, is an antibiotic that belongs to the class of macrocylic antibiotics.
Estonian: Dificliri toimeaine fidaksomitsiin on antibiootikum, mis kuulub uudsesse makrotsükliliste antibiootikumide klassi.
English: Dificlir must not be used in people who are hypersensitive (allergic) to fidaxomicin or any of the other ingredients.
Estonian: Dificliri ei tohi kasutada patsiendid, kes võivad olla fidaksomütsiini või selle ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised).
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Dificlir.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: What is Dificlir?
Estonian: Mis on Dificlir?
English: Dificlir is a medicine that contains the active substance fidaxomicin.
Estonian: Dificlir on ravim, mis sisaldab toimeainena fidaksomitsiini.
English: However, some antibiotics that are used to treat infections can interfere with the balance of 'good' bacteria in the gut.
Estonian: Mõned infektsiooniravi antibiootikumid võivad aga rikkuda soolebakterite tasakaalu.
English: The CHMP noted however, that there are uncertainties about the effects of Dificlir in certain groups of patients such as those with liver and kidney problems and recommended that further studies in this group should be carried out.
Estonian: Inimravimite komitee märkis siiski, et teatud patsiendirühmades, näiteks maksa- ja neeruprobleemide korral oli Dificliri mõju suhtes kahtlusi, ning komitee soovitas neid patsiendirühmi täiendavalt uurida.
English: The CHMP considered the severity of C. difficile infections and the drawbacks of current treatments and concluded that benefits of Dificlir are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee võttis arvesse bakteri Clostridium difficile infektsiooni raskust ja praeguste raviviiside puudusi ning järeldas, et Dificliri kasulikkus on suurem kui sellega seotud riskid ja soovitas anda ravimi müügiloa.
English: Dificlir has been compared with vancomycin (another antibiotic for C. difficile infections) in two main studies involving a total of 1,147 adult patients with mild to moderately severe C. difficile infection.
Estonian: Dificliri võrreldi vankomütsiiniga (teine bakteri Clostridium difficile infektsiooni antibiootikum) kahes põhiuuringus, kus osales kokku 1147 täiskasvanud patsienti, kellel oli bakteri Clostridium difficile kerge kuni mõõdukalt raske infektsioon.
English: This stops the C. difficile bacteria from growing and multiplying.
Estonian: See peatab bakteri Clostridium difficile kasvu ja paljunemise.
English: For the full list of all side effects reported with Dificlir, see the package leaflet.
Estonian: Dificliri kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: The medicine can only be obtained with a prescription.
Estonian: Dificlir on retseptiravim.
English: polymerase, which is used to produce the RNA that the bacteria need to make proteins.
Estonian: Toimeaine blokeerib bakteriaalensüümi RNA polümeraasi, mille abil tekib RNA, mida bakterid vajavad valgu tootmiseks.
English: C. difficile are bacteria that are present naturally in the gut and do not cause any problems in healthy people.
Estonian: Bakter Clostridium difficile esineb sooles looduslikult ega põhjusta tervele inimesele probleeme.
English: When it is swallowed most of the active substance does not get absorbed into the blood stream but acts locally on C. difficile bacteria in the gut.
Estonian: Neelamise järel ei imendu toimeaine verre, vaid toimib bakteri Clostridium difficile suhtes paikselt sooles.
English: The effects of Dificlir were first tested in experimental models before being studied in humans.
Estonian: Enne uuringuid inimestel kontrolliti Dificliri toimet muude katsetega.
English: Dificlir is used to treat adults with infections of the gut caused by bacteria called Clostridium difficile.
Estonian: Dificliri kasutatakse bakteri Clostridium difficile põhjustatud soolenakkuste raviks täiskasvanud patsientidel.
English: When this happens, C. difficile bacteria can multiply and produce toxins (poisons), which cause illness such as diarrhoea and fever.
Estonian: Sellisel juhul võib bakter Clostridium difficile hakata paljunema ja eritama toksiine, mis tekitavad haigusnähte, nagu kõhulahtisus ja palavik, ning seda nimetatakse Clostridium difficile nakkuseks.
English: How has Dificlir been studied?
Estonian: Kuidas Dificliri uuriti?
English: What benefit has Dificlir shown during the studies?
Estonian: Milles seisneb uuringute põhjal Dificliri kasulikkus?
English: What is Dificlir used for?
Estonian: Milleks Dificliri kasutatakse?
English: How is Dificlir used?
Estonian: Kuidas Dificliri kasutatakse?
English: The CHMP considered that Dificlir was effective in curing C. difficile infections and was generally well tolerated with side effects that are similar to vancomycin.
Estonian: Inimravimite komitee pidas Dificliri bakteri Clostridium difficile infektsiooni ravis efektiivseks, ravimit taluti üldiselt hästi ja kõrvalnähud olid samalaadsed kui vankomütsiini korral.
English: Dificlir was at least as effective as vancomycin in curing C. difficile infection.
Estonian: Dificlir oli bakteri Clostridium difficile infektsiooni ravis vähemalt sama efektiivne kui vankomütsiin.
English: How does Dificlir work?
Estonian: Kuidas Dificlir toimib?
English: 6 February 2012
Estonian: 6. veebruar 2012
English: The referral procedure started on 11 November 2009.
Estonian: Esildismenetlus algas 11. novembril 2009.
English: The final opinion was converted into a Decision by the European Commission on 6 February 2012.
Estonian: Lõplik arvamus kinnitati Euroopa Komisjoni otsusena 6. veebruaril 2012.
English: The Committee adopted a positive opinion by majority on 10 November 2011.
Estonian: 10. novembril 2011 võttis komitee häälteenamusega vastu positiivse arvamuse.
English: Article 34 of Directive 2001/82/EC
Estonian: Direktiivi 2001/82/EÜ artikkel 34
English: In line with the principles of referrals under Article 34(1) of Directive 2001/82/EC, on 16 September 2010 Sweden sent a revised referral notification under Article 34(1) of Directive 2001/82/EC and extended the scope of the referral procedure to all Fortekor and associated names tablet strengths and formulations.
Estonian: Direktiivi 2001/82/EÜ artikli 34 lõike 1 kohaste esildiste põhimõtete järgi esitas Rootsi 16. septembril 2010 läbivaadatud esildisteatise direktiivi 2001/82/EÜ artikli 34 lõike 1 alusel, paludes laiendada esildismenetlust kõigile ravimi Fortekor ja sarnaste nimetuste tabletitugevustele ning ravimvormidele.
English: The Committee appointed Dr Karolina Törneke as rapporteur and Dr Michael Holzhauser-Alberti as co-rapporteur.
Estonian: Veterinaarravimite komitee määras hindajaks dr Karolina Törneke ja kaashindajaks dr Michael Holzhauser-Alberti.
English: International non-proprietary name (inn): benazepril hydrochloride
Estonian: Rahvusvaheline mittekaubanduslik nimetus (INN): benasepriil-vesinikkloriid
English: referral for
Estonian: Taustteave
English: Opinion following an Article 34 referral for Fortekor and associated names EMA/965903/2011
Estonian: Arvamus pärast artikli 34 kohast esildist ravimi Fortekor ja sarnaste nimetuste kohta EMA/965903/2011
English: Written explanations were provided by the marketing authorisation holders on 24 May 2010 and 6 January 2011.
Estonian: Müügiloa hoidjad esitasid kirjalikud selgitused 24. mail 2010 ja 6. jaanuaril 2011 ning suulised selgitused 4. mail 2011.
English: Benazeprilat is a highly potent and selective inhibitor of angiotensin converting enzyme, thus preventing the conversion of inactive angiotensin I to active angiotensin II and thereby also reducing synthesis of aldosterone.
Estonian: Benaseprilaat on angiotensiini konverteeriva ensüümi selektiivne ja tugev inhibiitor, mis hoiab ära inaktiivse angiotensiin I muundumise aktiivseks angiotensiin II-ks, mis omakorda vähendab aldosterooni sünteesi.
English: An ad-hoc expert group meeting was held on 10 October 2011 and the marketing authorisation holders attended the meeting for an oral explanation.
Estonian: Ekspertrühma kohtumine toimus 10. oktoobril 2011, kus andsid suulisi selgitusi ka müügiloa hoidjad.
English: Due to the divergent decisions taken by Member States concerning the authorisation of Fortekor and associated names (5 mg benazepril hydrochloride film-coated tablet) and differences between the summary of product characteristics of the product as authorised in the Member States, the issue was referred on 16 October 2009 by Sweden to the CVMP under Article 34(1) of Directive 2001/82/EC.
Estonian: Tingituna erinevustest liikmesriikide otsustes, millega anti ravimi Fortekor ja sarnaste nimetuste (benasepriil-vesinikkloriidi sisaldav 5 mg õhukese polümeerkattega tablett) müügiluba, ning erinevustest liikmesriikides heaks kiidetud veterinaarravimi omaduste kokkuvõttes, tegi Rootsi 16. oktoobril 2009 direktiivi 2001/82/EÜ artikli 34 lõike 1 kohase esildise veterinaarravimite komiteele.
English: Based on the assessment of the currently available data and further to a consultation with the ad-hoc expert group, the CVMP considered that the benefit-risk balance for Fortekor and associated names remains positive, except for the chronic kidney disease in dogs, subject to variation of the marketing authorisations in accordance with the recommended product information.
Estonian: Pärast olemasolevate andmete hindamist ja konsulteerimist ad hoc ekspertrühmaga järeldas veterinaarravimite komitee, et ravimi Fortekor ning sarnaste nimetuste kasulikkuse ja riski suhe on endiselt positiivne, välja arvatud koerte kroonilise neerupuudulikkuse ravis, mistõttu ravimi müügilubasid tuleb muuta ravimiteabe soovitatud sõnastuse järgi.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the amended product information in Annex III.
Estonian: Asjaomaste raviminimetuste loetelu on esitatud I lisas, teaduslikud järeldused on II lisas ja ravimi omaduste muudetud kokkuvõte III lisas.
English: Fortekor and associated names is a veterinary medicinal product containing benazepril hydrochloride presented in 2.5 mg, 5 mg and 20 mg flavoured tablets and 5 mg and 20 mg film-coated tablets intended for use in dogs and cats.
Estonian: Fortekori kasutatakse kasside ja koerte ravimiseks ning seda turustatakse 2,5 mg, 5 mg ja 20 mg maitsestatud tablettidena ning 5 mg ja 20 mg õhukese polümeerkattega tablettidena.
English: Benazepril hydrochloride is a prodrug hydrolysed in vivo to its active metabolite, benazeprilat.
Estonian: Benasepriil-vesinikkloriid on eelravim, mis in vivo hüdrolüüsitakse selle aktiivseks metaboliidiks benaseprilaadiks.
English: holders' oral explanations to the Committee, the CVMP, at its May 2011 meeting, agreed that an ad-hoc expert group should be consulted regarding the scientific evidence base for angiotensin converting enzyme inhibitor in the treatment of chronic kidney disease in dogs.
Estonian: komitee oma 2011. aasta maikuu kohtumisel, et angiotensiini konverteeriva ensüümi inhibiitorite kasutamise teaduslikku põhjendatust koerte kroonilise neerupuudulikkuse ravis tuleb arutada ad hoc ekspertrühmaga.
English: The product is intended for the treatment of heart failure in dogs and/or the treatment of chronic kidney disease in cats and dogs, and the approved indications and target species varied between the Member States.
Estonian: Ravim on näidustatud südamepuudulikkuse raviks koertel ja/või kroonilise neerupuudlikkuse raviks kassidel ja koertel.
English: Fortekor and associated names
Estonian: kohast esildist ravimi Fortekor ja sarnaste nimetuste kohta
English: Further to the marketing authorisation
Estonian: Pärast müügiloa hoidja suulisi selgitusi veterinaarravimite komiteele otsustas
English: The four remaining studies are summarised below.
Estonian: Nelja ülejäänud uuringu tulemused on kokku võetud allpool.
English: The Reference Member State was Ireland and the Concerned Member States were Austria, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Greece, Spain, Finland, France, Hungary, Iceland, Latvia, Lithuania, Malta, The Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia and Sweden.
Estonian: Viiteliikmesriik oli menetluses Iirimaa ning asjaomased liikmesriigid olid Austria, Bulgaaria, Küpros, Tšehhi Vabariik, Taani, Eesti, Kreeka, Hispaania, Soome, Prantsusmaa, Ungari, Island, Läti, Leedu, Malta, Madalmaad, Norra, Poola, Portugal, Rumeenia, Slovakkia, Sloveenia ja Rootsi.
English: Special warnings, if necessary
Estonian: ERIHOIATUS(ED), KUI VAJALIK
English: Therefore, this scenario was not considered for sheep.
Estonian: Seetõttu ei arvestatud seda stsenaariumit lammaste puhul.
English: Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ United Kingdom
Estonian: Pfizer Limited Veterinary Medical Research & Development Sandwich Kent CT13 9NJ Ühendkuningriik
English: Although this study was well conducted other studies cannot be disregarded unless there is a sound reason for doing so (e.g. evidence of mistakes).
Estonian: Vaatamata sellele, et see uuring oli hästi läbi viidud, ei saa ka teisi uuringuid tähelepanuta jätta, välja arvatud juhul, kui selleks on selged põhjused (näiteks tõendid vigade kohta uuringu läbiviimisel).
English: No data on the nature and rates of metabolites are available.
Estonian: Andmed metaboliitide iseloomu ja määrade kohta puuduvad.
English: Benefits have not been subject of this referral; they were considered in the preceding decentralised procedure.
Estonian: Kasulikkus ei olnud käesoleva esildismenetluse teemaks, seda on käsitletud eelneva detsentraliseeritud menetluse käigus.
English: During the decentralised procedure it was agreed that the authorisation of the generic product under the name "Dectomax" will not be issued until the reference product under the name "Dectomax" has either been withdrawn or renamed.
Estonian: Detsentraliseeritud menetluse ajal lepiti kokku, et geneerilise ravimi müügiluba nimetuse all „Dectomax“ ei anta välja enne, kui võrdlusravimi müügiluba nimetuse all „Dectomax“ on kas tagasi võetud või ära muudetud.
English: Add the following text in the relevant sections of the product information:
Estonian: Lisada järgnev tekst ravimiinfo asjakohastele lõikudele:
English: The study report provided is very brief and the animal weights were not provided.
Estonian: Esitatud uuringuaruanne on väga lühike ja selles ei ole esitatud loomade kehakaalu.
English: The valid Summary of Product Characteristics, Labelling and Package Leaflet are the final versions achieved during the Coordination Group procedure with the following amendments:
Estonian: Kehtiv ravimi omaduste kokkuvõte, pakendi märgistus ja pakendi infoleht on lõplikud versioonid, milleni jõuti koordinatsioonirühma protseduuril, järgnevate muudatustega:
English: It is noted that the study (2002) predates the introduction of that guideline (2005).
Estonian: Samas tuleb märkida, et nimetatud uuring viidi läbi enne (2002. aastal), kui vastav juhis kehtima hakkas (2005. aastal).
English: Before addressing the issues of disagreement the following two changes to the initial application that were made during the decentralised procedure and the CVMP referral procedure should be noted:
Estonian: Enne erimeelsuse aluseks olevate küsimuste käsitlemist on oluline mainida kahte muudatust, mis tehti esialgsesse taotlusse detsentraliseeritud menetluse ja inimravimite komitee algatatud esildismenetluse ajal:
English: All except one were GLP studies and were carried out with the same formulation (plus or minus radioactive tracer).
Estonian: Kõik uuringud peale ühe vastasid hea laboritava (GLP) nõuetele ning viidi läbi sama ravimvormiga (koos radioaktiivselt märgistatud jäljega või ilma).
English: The weights of animals were below 250 kg. Only injection sites (500-600 g) were sampled.
Estonian: Loomade kaal uuringus oli alla 250 kg. Proove (500-600 g) võeti üksnes süstekohast.