FrancophonIA/ELRC3.0 huggingface dataset:
English: The ever-increasing expectations of patients and healthcare professionals to have medicines available to treat various conditions, in combination with the continuous need for flexible and fast reaction to arising public health threats, highlights the importance of ensuring faster patient access to medicines on the market, while maintaining the quality of scientific assessment.
Estonian: Patsientide ja tervishoiutöötajate üha suurenevad ootused, et oleks saadaval ravimeid eri haiguste ravimiseks, koos pideva vajadusega paindlikumalt ja kiiremini reageerida kujunevatele rahvatervise ohtudele rõhutab veelgi, kui oluline on tagada patsientidele kiirem juurdepääs turustatavatele ravimitele, säilitades samas teadusliku hindamise kvaliteedi.
English: As a result, increased focus on ensuring that medicines tested and manufactured outside the EU meet the EU requirements will drive efforts to develop and strengthen collaboration with international partners regarding collaborative inspections, information exchange, capacity building and greater mutual reliance.
Estonian: Seetõttu tuleb veel rohkem keskenduda selle tagamisele, et väljaspool ELi katsetatud ja toodetud ravimid vastaksid ELi nõuetele, ning selleks tuleb arendada ja tugevdada koostööd rahvusvaheliste partneritega nii koostöös toimuvate inspektsioonide, teabevahetuse, suutlikkuse suurendamise kui ka suurema vastastikuse usalduseväärsuse valdkonnas.
English: In a continuous effort to meet the demands for increased efficiency of operations, while increasing the level of service the Agency provides, data management has become a key activity in creating an integrated, shared environment that provides a single, accurate, consistent source of data for the Agency, its partners and stakeholders.
Estonian: Pidevas töös toimingute suurema tõhususe nõudmistele vastamiseks, tõstes samas ameti pakutavate teenuste taset, on ametile, tema partneritele ja sidusrühmadele ühtset, täpset ja järjepidevat andmeallikat pakkuva lõimitud, ühise keskkonna loomisel muutunud põhitegevuseks andmehaldus.
English: The coming years will see an increasing need to consider aspects such as patients' values and preferences, the needs of other stakeholders (e.g. health-technology assessment bodies, or HTAs) when planning clinical research programmes and post-authorisation measures, the impact of 'real life' evidence data, and others.
Estonian: Eelolevatel aastatel suureneb vajadus arvestada kliiniliste uuringute programmide ja müügiloajärgsete meetmete kavandamisel selliseid aspekte nagu patsientide väärtused ja eelistused, teiste sidusrühmade (nt tervisetehnoloogia hindamise asutuste) vajadused, tegelikust elust saadud tõendusandmete mõju jne.
English: Increasing numbers of manufacturing sites located, and clinical trials conducted outside the EU will continue to be a trend.
Estonian: Jätkuva suundumusena paigutatakse üha enam tootmisrajatisi ja tehakse üha enam kliinilisi uuringuid väljaspool ELi.
English: The move towards developing more targeted and individualised medicines, continuous development and use of state-of-the-art knowledge and technologies in drug development, and integration of development and use of medicines and medical devices all contribute to the increasing complexity of the scientific advice and other Agency's activities.
Estonian: Liikumine rohkem sihtrühmale suunatud ja individuaalsemate ravimite arendamise poole, tipptasemel teadmiste ja tehnoloogiate pidev arendamine ja kasutamine ravimite väljatöötamises ning ravimite arendamise ja kasutamise ning meditsiiniseadmete integreerimine muudavad teadusliku nõustamise ja ameti muu tegevuse üha keerulisemaks.
English: The increasing complexity and globalisation of medicines supply chains will also require improved information exchange and closer, more streamlined cooperation among authorities, to ensure product and data integrity, and continuity of the medicines supply chain.
Estonian: Ravimite tarneahelate järjest keerulisemaks ja üleilmsemaks muutumine nõuab ka paremat teabevahetust ning tihedamat ja kooskõlastatumat koostööd ametiasutuste vahel, et tagada toodete ja andmete terviklikkus ja ravimite tarneahela järjepidevus.
English: The growing trend for patients and healthcare professionals to use the internet, mobile communications and social media when searching for medicines-related information raises the importance of using these communication channels more widely, to ensure easy, consistent and timely access to authoritative, reliable and understandable information on medicines.
Estonian: Nii patsientide kui ka tervishoiutöötajate hulgas kasvav suundumus kasutada internetti, mobiilsidet ja sotsiaalmeediat ravimitega seotud teabe otsimiseks suurendab nende sidekanalite laiema kasutamise olulisust kerge, järjepideva ja kiire juurdepääsu tagamisel autoriteetsele, usaldusväärsele ja arusaadavale teabele ravimite kohta.
English: Factors such as advances in and growing complexity of medicines development, globalisation, the increasing role of social media as an information source, growing expectation for transparency, key legislation changes and continuous striving for increased efficiency, all impact the Agency's work.
Estonian: Ameti tööd mõjutavad kõik sellised tegurid nagu edusammud ravimite väljatöötamises ja selle üha suurem keerukus, sotsiaalmeedia kui teabeallika kasvav roll, üha suuremad ootused läbipaistvusele, olulisemate õigusaktide muudatused ning järjepidev püüd suurema tõhususe poole.
English: Transparency of the decision-making process throughout the lifecycle of medicines remains a key driver.
Estonian: Peamiseks ajendiks on jätkuvalt otsustusprotsessi läbipaistvus ravimite kogu olelusringi jooksul.
English: Growing interdependencies between committees and scientific disciplines in the decision-making further emphasise the need to continuously simplify and align processes, improve quality assurance and quality control, increase robustness of the processes and reach higher efficiency of the evaluation procedures.
Estonian: Kuna komiteed ja teadusharud sõltuvad otsuste tegemisel järjest enam üksteisest, suurendab see vajadust protsesside pideva lihtsustamise ja kooskõlastamise, kvaliteedi tagamise ja kvaliteedikontrolli täiustamise, protsesside töökindluse parandamise ning hindamismenetluste suurema tõhususe saavutamise järele.
English: The increasing workload will call for higher involvement of the NCAs.
Estonian: Suurema töökoormuse tõttu tuleb rohkem kaasata riiklikke pädevaid asutusi.
English: As a result, development of the EU Clinical Trial Portal and Database, and other associated systems, will be one of the key focus areas of the Agency in the coming years.
Estonian: Selle tulemusel on ameti eelolevate aastate põhilised töövaldkonnad ELi kliiniliste uuringute portaali ja andmebaasi ning muude seonduvate süsteemide väljatöötamine.
English: Organization (WHO), thus highlighting AMR as a global health crisis of similar importance to pandemics of an infectious disease.
Estonian: Selle probleemi tõsidust möönab ka Maailma Terviseorganisatsioon (WHO) oma antimikroobset resistentsust käsitleva ülemaailmse tegevuskava väljatöötamisega, rõhutades seega antimikroobset resistentsust kui üleilmset tervisekriisi, mis on sama tähtis kui nakkushaiguste pandeemiad.
English: The implementation of the policy on access to clinical data will also be a significant aspect of the Agency's transparency initiatives.
Estonian: Ameti läbipaistvusalgatuste oluline aspekt on kliinilistele andmetele juurdepääsu põhimõtete rakendamine.
English: Efficiency is key to the successful delivery of the Agency's activities and to coping with the growing number of responsibilities and increasing complexity of the regulatory procedures.
Estonian: Ameti tegevuse edukuse ja aina enamate kohustuste ning üha keerukamate reguleerimismenetlustega toimetuleku seisukohast on otsustavaks teguriks tõhusus.
English: substance management service
Estonian: Tegevdirektori asetäitja
English: Management Board of the EMA
Estonian: Andreas Pott, tegevdirektori asetäitja
English: International non-proprietary name (INN): deltamethrin
Estonian: Rahvusvaheline mittekaubanduslik nimetus (INN): deltametriin
English: The opinion was converted into a Decision by the European Commission on 24 September 2013.
Estonian: Arvamus vormistati Euroopa Komisjoni otsusena 24. septembril 2013.
English: For the pour-on product 24 concerned Member States are involved: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia and Spain.
Estonian: Kriipsmanustatava ravimi 24 asjaomast liikmesriiki on Austria, Belgia, Bulgaaria, Eesti, Hispaania, Iirimaa, Itaalia, Island, Kreeka, Küpros, Leedu, Luksemburg, Läti, Madalmaad, Poola, Portugal, Prantsusmaa, Rumeenia, Saksamaa, Slovakkia, Sloveenia, Taani, Tšehhi Vabariik ja Ungari.
English: Article 33(4) of Directive 2001/82/EC, as amended
Estonian: Muudetud direktiivi 2001/82/EÜ artikli 33 lõige 4.
English: Potential serious risks were identified during the decentralised procedure by Germany and the Netherlands regarding the environmental safety of the product.
Estonian: Saksamaa ja Madalmaad tuvastasid detsentraliseeritud menetluse käigus võimalikud rasked riskid seoses ravimi keskkonnaohutusega.
English: Written explanations were provided by the applicant on 22 May
Estonian: Taotleja esitas kirjalikud selgitused 22. mail 2013.
English: The decentralised procedure started on 19 December 2011.
Estonian: Detsentraliseeritud menetlus algas 19. detsembril 2011.
English: The reference Member State is the United Kingdom for both products.
Estonian: Mõlema ravimi viiteliikmesriik on Ühendkuningriik.
English: The referral procedure started on 6 March 2013.
Estonian: Esildismenetlust alustati 6. märtsil 2013.
English: These are ‘hybrid' applications according to Art. 13(3) Directive 2001/82/EC, as amended, referring to the reference products Pfizer Pour On Insecticide 1% w/v Cutaneous Solution and Pfizer Spot On Insecticide 1% w/v Cutaneous Solution multidose registered in the United Kingdom.
Estonian: Need on muudetud direktiivi 2001/82/EÜ artikli 13 lõike 3 kohased hübriidtaotlused, milles viidatakse Ühendkuningriigis registreeritud võrdlusravimitele Pfizer Pour On Insecticide 1% w/v Cutaneous Solution ja Pfizer Spot On Insecticide 1% w/v Cutaneous Solution multidose.
English: The Committee appointed Dr C. Ibrahim as rapporteur and Ms H. Jukes as co-rapporteur.
Estonian: Veterinaarravimite komitee määras hindajaks C. Ibrahimi ja kaashindajaks H. Jukesi.
English: On 26 February 2013, the reference Member State, the United Kingdom, notified the European Medicines Agency that the CMD(v) had failed to reach an agreement regarding the product and referred the matter to the CVMP pursuant to Article 33(4) of Directive 2001/82/EC.
Estonian: 26. veebruaril 2013 teatas viiteliikmesriik Ühendkuningriik Euroopa Ravimiametile, et veterinaarravimite vastastikuse tunnustamise ja detsentraliseeritud menetluste kooskõlastusrühm ei saavutanud ravimi suhtes kokkulepet ning suunas direktiivi 2001/82/EÜ artikli 33 lõike 4 alusel küsimuse edasi veterinaarravimite komiteele.
English: For the spot-on product Belgium, France, Germany and the Netherlands are involved as concerned Member States.
Estonian: Täppmanustatava ravimi asjaomased liikmesriigid on Belgia, Madalmaad, Prantsusmaa ja Saksamaa.
English: On day 210, these issues remained unsolved and therefore a referral under Article 33(1) of Directive 2001/82/EC to the Coordination group for Mutual recognition and Decentralised procedures
Estonian: Need küsimused jäid 210. päeval lahenduseta ning seetõttu algatati 17. detsembril 2012 direktiivi 2001/82/EÜ artikli 33 lõike 1 kohane esildis, mis suunati veterinaarravimite vastastikuse tunnustamise ja detsentraliseeritud menetluste kooskõlastusrühmale.
English: Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle contain deltamethrin as active ingredient and is intended for use in cattle and sheep as a topical application for the treatment and prevention of infestations by lice and flies on cattle; ticks, lice, keds and established blowfly strike on sheep and lice and ticks on lambs.
Estonian: Deltanil 10 mg/ml kriipsulahus veistele ja lammastele ning Deltanil 100 mg täpilahus veistele sisaldavad toimeainena deltametriini ja on ette nähtud veistel ja lammastel paikseks kasutamiseks veistel täide ja kärbeste infestatsioonide, lammastel puukide, täide, raudkärblaste infestatsioonide ja müiaasi ning talledel täide ja puukide infestatsioonide raviks ja ennetamiseks.
English: Based on the evaluation of the currently available data, the CVMP considered that the benefit-risk profile of Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle is positive.
Estonian: Olemasolevate andmete hindamisel leidis veterinaarravimite komitee, et Deltanil 10 mg/ml veiste ja lammaste kriipsulahuse ning Deltanil 100 mg veiste täpilahuse kasulikkuse ja riski profiil on positiivne.
English: Therefore, the Committee adopted by majority a positive opinion on 17 July 2013 recommending the granting of the marketing authorisations for Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle.
Estonian: Seetõttu võttis veterinaarravimite komitee 17. juulil 2013 vastu positiivse arvamuse, soovitades anda veterinaarravimite Deltanil 10 mg/ml veiste ja lammaste kriipsulahuse ning Deltanil 100 mg veiste täpilahuse müügiloa.
English: The applicant, Virbac, submitted an application for a decentralised procedure for Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle.
Estonian: Taotleja Virbac esitas Deltanil 10 mg/ml veiste ja lammaste kriipsulahuse ning Deltanil 100 mg veiste täpilahuse detsentraliseeritud menetluse taotluse.
English: Opinion following an Article 33(4)1 referral for Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle
Estonian: Arvamus pärast artikli 33 lõike 41 kohast esildist Deltanil 10 mg/ml kriipsulahus veistele ja lammastele ning Deltanil 100 mg täpilahus veistele
English: Day 60 of the CMD(v) procedure was on 14 February 2013, and since the Member States concerned failed to reach an agreement regarding the product the procedure was referred to the CVMP.
Estonian: asjaomased liikmesriigid ei jõudnud ravimi suhtes kokkuleppele, suunati menetlus edasi veterinaarravimite komiteele.
English: Opinion following an Article 33(4)0F referral for Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle EMA/539462/2013
Estonian: Arvamus pärast artikli 33 lõike 40F kohast esildist Deltanil 10 mg/ml kriipsulahus veistele ja lammastele ning Deltanil 100 mg täpilahus veistele
English: The procedure started on 5 May 2011.
Estonian: Menetlust alustati 5. mail 2011.
English: Opinion following an Article 78
Estonian: Arvamus pärast artikli 78
English: The final opinion was converted into a Decision by the European Commission on 3 November 2011.
Estonian: Lõplik arvamus kinnitati Euroopa Komisjoni otsusena 3. novembril 2011. aastal.
English: Committee for medicinal products for veterinary use (CVMP)
Estonian: Veterinaarravimite komitee (CVMP)
English: 1 Article 78 of Directive 2001/82/EC
Estonian: 1 Direktiivi 2001/82/EÜ artikkel 78
English: The rapporteur and co-rapporteur appointed were Dr JeanClaude Rouby and Dr David Murphy, respectively.
Estonian: Hindajaks määrati dr Jean-Claude Rouby ning kaashindajaks dr David Murphy.
English: A written explanation was provided by the representative of the marketing authorisation holder on 23 May 2011.
Estonian: Müügiloa hoidja esindaja esitas kirjaliku selgituse 23. mail 2011.
English: procedure for
Estonian: Taustteave
English: Due to concerns regarding reports of anaphylactic-type events following use of HIPRABOVIS PNEUMOS Emulsion for injection for cattle, France suspended the marketing authorisation for the product on 6 April 2011 triggering a procedure under Article 78 of Directive 2001/82/EC.
Estonian: Et pärast veiste süsteemulsiooni HIPRABOVIS PNEUMOS kasutamist on teatatud anafülaktilist tüüpi kõrvalnähtudest, peatas Prantsusmaa 6. aprillil 2011 vaktsiini müügiloa, alustades direktiivi 2001/82/EÜ artikli 78 kohast menetlust.
English: HIPRABOVIS PNEUMOS Emulsion for injection for cattle is an inactivated vaccine for reduction of the clinical signs and lung lesions caused by Mannheimia haemolytica serotype A1 and Histophilus somni in calves from 2 months of age.
Estonian: Veiste süsteemulsioon HIPRABOVIS PNEUMOS on inaktiveeritud vaktsiin bakterite Mannheimia haemolytica serotüüp A1 ja Histophilus somni põhjustatud kliiniliste nähtude ning kopsukahjustuste vähendamiseks vähemalt 2 kuu vanustel vasikatel.
English: The Committee, adopted on 14 July 2011, an opinion recommending the suspension of the marketing authorisations for HIPRABOVIS PNEUMOS Emulsion for injection for cattle and associated names until the marketing authorisation holder proposes appropriate measures to mitigate the risk of occurrence of such adverse events and demonstrates a favourable benefit-risk balance for the product when used according to the recommendations of the summary of product characteristics The list of product names concerned is given in Annex I. The scientific conclusions and grounds for suspension of the marketing authorisations are provided in Annex II.
Estonian: Komitee võttis 14. juulil 2011 vastu arvamuse, milles soovitas peatada veiste süsteemulsiooni HIPRABOVIS PNEUMOS ja sarnaste nimetuste müügiload, kuni müügiloa hoidja kavandab sobivad meetmed selliste kõrvalnähtude esinemisriski vähendamiseks ning näitab, et vaktsiini kasutamisel ravimi omaduste kokkuvõtte soovituste kohaselt on kasulikkuse ja riski suhe tasakaalus.
English: HIPRABOVIS PNEUMOS Emulsion for injection for cattle and associated names
Estonian: kohast menetlust veiste süsteemulsiooni HIPRABOVIS PNEUMOS ja sarnaste nimetuste kohta
English: Based on the rapporteurs' assessment of the data available from pharmacovigilance reports and a laboratory study, the CVMP concluded that the underlying cause of the adverse events observed has yet to be determined; the data evaluated indicated an association between vaccination of cattle with HIPRABOVIS PNEUMOS Emulsion for injection for cattle and the occurrence of anaphylactic-type events; no corrective measures could be recommended; and the benefit-risk balance for the product was unfavourable.
Estonian: Hinnatud andmed näitasid, et veiste vaktsineerimine HIPRABOVIS PNEUMOSega ja anafülaktilist tüüpi kõrvalnähud on seotud; parandusmeetmeid ei ole võimalik soovitada ning vaktsiini kasulikkuse ja riski suhe on ebasoodne.
English: The text was valid at that time.
Estonian: See tekst kehtis sel ajal.
English: This increase is not generally important for most patients.
Estonian: See tõus ei ole enamike patsientide puhul üldiselt oluline.
English: The absolute bioavailability is approximately 100%.
Estonian: Absoluutne biosaadavus on ligikaudu 100%.
English: Hertfordshire EN11 9BU United Kingdom
Estonian: Hertfordshire EN11 9BU Ühendkuningriik
English: Children and adolescents under 16 years of age.
Estonian: Lapsed ja alla 16-aastased noorukid.
English: The following additional safety results were observed in the study:
Estonian: Uuringus pandi tähele täiendavalt järgnevaid ohutusalaseid tulemusi:
English: Therefore, this SPC may not necessarily represent the current text.
Estonian: Seega ei pruugi käesolev ravimi omaduste kokkuvõte (SPC) tingimata kajastada praegust teksti.
English: Therefore, the combination should be administered with caution, especially in the elderly.
Estonian: Seetõttu tuleb sellist kombinatsiooni manustada ettevaatusega, eriti vanuritele.
English: Patients were treated for a median duration of 11 months.
Estonian: Patsiente raviti keskmiselt 11 kuud.
English: 11415 Tallinn Estonia
Estonian: 11415 Tallinn Eesti
English: The potential for human risk in pregnancy is unknown.
Estonian: Oht inimese raseduse puhul ei ole teada.
English: Bottles: Keep the container tightly closed.
Estonian: Hoida pakend tihedalt suletuna.
English: These data are not considered clinically significant.
Estonian: Neid andmeid ei loeta kliiniliselt olulisteks.
English: Patients with hypertension whose blood pressure has not been adequately controlled.
Estonian: Hüpertensiooniga patsiendid, kelle vererõhk ei ole raviga hästi kontrollitud.
English: Av. Da Siderurgia Nacional 4745-457 S. Mamede do Coronado Portugal
Estonian: Da Siderurgia Nacional 4745-457 S. Mamede do Coronado Portugal
English: This USR was initiated on 16 February 2005 and finalised on 17 February 2005.
Estonian: See kiireloomuline ohutuspiirang algatati 16. veebruaril 2005 ja vormistati lõplikult 17. veebruaril 2005.
English: However, current estimates are based on limited data and the extent of under-reporting is unquantifiable.
Estonian: Samas tuginevad praegused hinnangud piiratud andmetele ning reaktsioonidest teatamata jätmise määra pole võimalik kvantitatiivselt kindlaks teha.
English: Five metabolites have been identified in man.
Estonian: Inimesel on leitud viis metaboliiti.
English: Puławska 303 02-785 Warszawa Poland
Estonian: Puławska 303 02-785 Warszawa Poola
English: <INVENTED NAME> tablets contain lactose.
Estonian: <VÄLJAMÕELDUD NIMETUS> tabletid sisaldavad laktoosi.
English: Aluminum/aluminium blisters in packs containing 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 98 or 100 tablets.
Estonian: Alumiinium/alumiinium blistrid pakendites, mis sisaldavad 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 98 või 100 tabletti.
English: If blood pressure rises significantly, alternative treatment should be considered.
Estonian: Kui vererõhk tõuseb olulisel määral, tuleks kaaluda teist ravi.
English: Congestive heart failure (NYHA II-IV).
Estonian: Südame paispuudulikkus (NYHA II-IV).
English: None of these metabolites inhibit COX-1.
Estonian: Ükski metaboliit ei inhibeeri COX-1.
English: 2003 PC Haarlem The Netherlands
Estonian: 2003 PC Haarlem Holland
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES AND NORWAY AND ICELAND
Estonian: LISA I RAVIMPREPARAATIDE NIMED, RAVIMVORMID, TUGEVUSED, MANUSTAMISVIIS JA MÜÜGILOA HOIDJAD LIIKMESRIIKIDES NING NORRAS JA ISLANDIL
English: Via Benedetto Croce, 37 I-56125 Pisa Italy
Estonian: Via Benedetto Croce, 37 I-56125 Pisa Itaalia
English: Less than 2% was recovered as unchanged drug.
Estonian: Alla 2% ravimist leiti muutumatul kujul.
English: [Very Common (>1/10) Common (>1/100, <1/10) Uncommon (>1/1000, <1/100) Rare (>1/10,000, <1/1,000) Very rare (<1/10,000) including isolated cases]
Estonian: (Väga sage (>1/10), sage (>1/100, <1/10), aeg-ajalt (>1/1000, <1/100), harv (>1/10000, <1/1000), väga harv (<1/10000, sealhulgas üksikjuhud))
English: It may also play a role in ulcer healing.
Estonian: Sellel võib olla roll ka haavaparanemises.
English: Two isoforms, COX-1 and COX-2, have been identified.
Estonian: On identifitseeritud kaks isovormiCOX-1 ja COX-2.
English: Via G. Fabbroni, 6 I-00191 Roma Italy
Estonian: Via G. Fabbroni, 6 I-00191 Roma Itaalia
English: These beneficial effects were observed as early as the second day of therapy and maintained for up to 52 weeks.
Estonian: Ravimi toimet täheldati juba teisel ravipäeval ja see jäi püsima kuni 52 nädala jooksul.
English: Pregnancy and lactation (see sections 4.6 and 5.3).
Estonian: Rasedus ja imetamine (vt lõigud 4.6 ja 5.3).
English: The gastrointestinal and cardiovascular safety data are summarized below.
Estonian: Mao-sooletrakti ja kardiovaskulaarset ohutust puudutav teave on kokkuvõetud allpool.
English: The CHMP confirmed changes to the Product Information already introduced through a type II variation adopted in May 2005 further to the February USR and requested further changes.
Estonian: Inimtervishoius kasutatavate ravimite komitee kinnitas muutused, mis olid tooteinfosse sisse viidud juba mais 2005 veebruarikuise ohutuspiirangu alusel vastu võetud II tüüpi muudatuse kaudu, ning taotles edasiste muutuste tegemist.