FrancophonIA/ELRC3.0 huggingface dataset:
English: In accordance with CVMP guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market (EMA/CVMP/SWP/66781/2005-Rev.1), the milk withdrawal period for cattle milk of 108 hours has been also established as the withdrawal period for sheep milk.
Estonian: Kooskõlas veterinaarravimite komitee suunisega veterinaarravimite ohutus- ja ravimijääkide andmete nõuete kohta vähekasutatavatel või vähemtähtsatel liikidel / piiratud turuga liikidel (EMA/CVMP/SWP/66781/2005-Rev.1) kehtestati veisepiima 108-tunnine keeluaeg ka lambapiima keeluajana.
English: Milk from sheep is considered a minor food commodity, and in line with the CVMP guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market (EMA/CVMP/SWP/66781/2005-Rev.1) extrapolation can be done from cow's milk to sheep milk.
Estonian: Lambapiima peetakse vähem oluliseks toiduaineks ja kooskõlas veterinaarravimite komitee suunisega veterinaarravimite ohutus- ja ravimijääkide andmete nõuete kohta vähekasutatavatel või vähemtähtsatel liikidel / piiratud turuga liikidel (EMA/CVMP/SWP/66781/2005-Rev.1) võib lehmapiima keeluaja ekstrapoleerida lambapiima keeluajaks.
English: The CVMP guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market (EMA/CVMP/SWP/66781/2005-Rev.1)1 allows extrapolation of the withdrawal period between animal species, but only from a major species to a minor species.
Estonian: Veterinaarravimite komitee suunis veterinaarravimite ohutus- ja ravimijäägiandmete nõuete kohta vähekasutatavatel või vähemtähtsatel liikidel / piiratud turuga liikidel (EMA/CVMP/SWP/66781/2005-Rev.1)1 lubab ühe loomaliigi keeluaega ekstrapoleerida teisele, kuid üksnes tähtsalt liigilt vähemtähtsale.
English: While the residue studies mentioned above were made available, milk from sheep is considered a minor food commodity, and withdrawal periods for sheep milk can be extrapolated from those for cows' milk in accordance with the CVMP guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market (EMA/CVMP/SWP/66781/2005-Rev.1).
Estonian: Kuigi esitati nimetatud ravimijäägiuuringud, võib lambapiima pidada vähem oluliseks toiduaineks ja lambapiima keeluaegu saab ekstrapoleerida lehmapiima keeluaegadest, lähtudes veterinaarravimite komitee suunisest veterinaarravimite ohutus- ja ravimijääkide andmete nõuete kohta vähekasutatavatel või vähemtähtsatel liikidel / piiratud turuga liikidel (EMA/CVMP/SWP/66781/2005Rev.1).
English: Residue depletion in sheep meat and offal
Estonian: Ravimijääkide ammendumine lamba lihast ja söödavatest kudedest
English: Milk from sheep is, however, considered a minor food commodity, and withdrawal periods for sheep milk can be extrapolated from those for cows' milk, in accordance with the CVMP guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market (EMA/CVMP/SWP/66781/2005-Rev.1).
Estonian: Lambapiima peetakse siiski vähem oluliseks toiduaineks ja lambapiima keeluaegu saab ekstrapoleerida lehmapiima keeluaegadest, lähtudes veterinaarravimite komitee suunisest veterinaarravimite ohutusja ravimijääkide andmete nõuete kohta vähekasutatavatel või vähemtähtsatel liikidel / piiratud turuga liikidel (EMA/CVMP/SWP/66781/2005-Rev.1).
English: For sheep over 50 kg, the CVMP recommends that the dose is divided over two injection sites.
Estonian: Üle 50 kg lammaste korral soovitab veterinaarravimite komitee jagada annuse kahe süstekoha vahel.
English: Cattle, sheep, pigs, dogs, cats
Estonian: Veised, lambad, sead, koerad, kassid
English: Although a number of shortcoming were identified from this study (more specifically that the number of treated animals (n=3) was below the number required in VICH GL 48, animals were very young (12 kg mean bw), and also the sampling of the injection site did not include an outer ring sample), the results showed that the injection site is the withdrawal period determining tissue and results from this residue study have been used for establishing the withdrawal periods for 49 out of the 50 products concerned.
Estonian: Kuigi uuringus leiti arvukalt puudusi (ravitud loomade arv (n = 3) oli väiksem kui suunises VICH GL 48 nõutav arv, loomad olid väga noored (keskmine kehamass 12 kg) ja süstekoha proovide võtmisel ei võetud proove süstekohavälisest
English: The differences on concentrations of benzyl alcohol and propylene glycol, and on pH adjustors have been considered not to have an impact on residue absorption from the injection site.
Estonian: Bensüülalkoholi ja propüleenglükooli ning pH-regulaatorite eri kontsentratsiooniväärtused ilmselt ei mõjuta ravimijääkide imendumist süstekohast.
English: Cats, cattle, dogs, goats, pigs, sheep
Estonian: Kassid, veised, koerad, kitsed, sead, lambad
English: The formulation of 49 of the concerned products is very similar.
Estonian: Esildis hõlmab 50 ravimit, millest 49 asjaomase ravimi koostis on väga sarnane.
English: 1 CVMP guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market (EMA/CVMP/SWP/66781/2005-Rev.1)https://www.ema.europa.eu/documents/scientific-guideline/guideline-safety-residue-data-requirements-pharmaceuticalveterinary-medicinal-products-intended/limited-market_en.pdf the CVMP in the interests of protecting consumer safety in the Union, and requested the Committee to review all available residue depletion data and recommend withdrawal periods for sheep (meat and offal, and milk).
Estonian: 1 CVMP guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market (EMA/CVMP/SWP/66781/2005-Rev.1)https://www.ema.europa.eu/documents/scientific-guideline/guideline-safety-residue-data-requirements-pharmaceuticalveterinary-medicinal-products-intended/limited-market_en.pdf
English: Tiljet 200 mg/ml solution for injection for cattle, pigs, sheep and goats
Estonian: Tiljet 200 mg/ml solution for injection for cattle, pigs, sheep and goat
English: Ceva Animal Health Polska Sp. z o.o.
Estonian: Sp. z o.o.
English: Cattle, dogs, goats, pigs, sheep
Estonian: Veised, koerad, kitsed, sead, lambad
English: A GLP-compliant residue study with tylosin solution for injection, conducted in sheep via intramuscular administration was made available to CVMP.
Estonian: Veterinaarravimite komiteele edastati hea laboritava nõuetele vastav tülosiini intramuskulaarse süstelahuse ravimijääkide uuring lammastel.
English: Cattle, goats, pigs,
Estonian: Veised, lambad, sead, koerad,
English: The European Commission issued a decision on 6 October 2009.
Estonian: Euroopa Komisjon tegi otsuse 6. oktoobril 2009.
English: Dr. Karl Broich (Germany)
Estonian: Dr Karl Broich (Saksamaa)
English: Dr. Concha Prieto Yerro (Spain)
Estonian: Dr Concha Prieto Yerro (Hispaania)
English: Ref. EMA/CHMP/393579/2009 rev1 EMEA/H/A-29/1168
Estonian: London, 6.oktoober 2009 Viide: EMA/CHMP/393579/2009 rev1 EMEA/H/A-29/1168
English: The grounds for the referral were that:
Estonian: Esildise tegemise põhjused on järgmised:
English: What is Fentrix?
Estonian: Mis on Fentrix?
English: The review was carried out under an ‘Article 29' referral 1 .
Estonian: Taotlus vaadati läbi artikli 29 1 kohase esildismenetluse korras.
English: It is used to treat severe long-term (chronic) pain which can only be adequately treated with opioid painkillers (medicines that are related to morphine).
Estonian: Seda kasutatakse tugeva pikaajalise (kroonilise) valu ravis, mis allub ravile ainult opioidsete valuvaigistitega (morfiinipõhised ravimid).
English: This is a procedure when one Member State (the ‘reference Member State', in this instance Germany) assesses a medicine with a view of granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Austria, Belgium, Italy, the Netherlands, Portugal, Slovenia and Spain).
Estonian: See on menetlus, mille käigus üks liikmesriik (viiteliikmesriik, praegusel juhul Saksamaa) hindab ravimit, et otsustada, kas anda ravimile oma riigis ja teistes liikmesriikides (asjaomased liikmesriigid, praegusel juhul Austria, Belgia, Itaalia, Madalmaad, Portugal, Sloveenia ja Hispaania) müügiluba.
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Fentrix outweigh its risks, and therefore the marketing authorisation for Fentrix should be granted in all concerned Member States.
Estonian: Praeguseks kättesaadavate andmete hindamise ning komitees toimunud teadusliku arutelu põhjal jõudis inimravimite komitee järeldusele, et Fentrixi kasulikkus on suurem kui sellega kaasnevad riskid ning seetõttu tuleb kõikides asjaomastes liikmesriikides anda ravimile müügiluba.
English: Questions and answers on the referral for Fentrix and associated names 25, 50, 70 and 100 microgram/hour fentanyl transdermal patch
Estonian: Teave järgmise ravimi esildise kohta: Fentrix ja sarnased nimetused 25, 50, 70 ja 100 mikrogrammi/tunnis fentanüüli transdermaalne plaaster
English: Why was Fentrix reviewed?
Estonian: Miks Fentrixi taotlus uuesti üle vaadati?
English: However, the Member States were not able to reach an agreement and the Spanish medicines regulatory agency referred the matter to the CHMP for arbitration on 4 May 2009.
Estonian: Liikmesriigid ei jõudnud selles küsimuses üksmeelele ja Hispaania pädev asutus tegi 4. mail 2009 Euroopa Ravimiametile esildise vahekohtumenetluse alustamiseks.
English: Helm Pharmaceuticals GmbH submitted Fentrix transdermal patch to Germany for a decentralised procedure.
Estonian: Helm Pharmaceuticals GmbH esitas Fentrixi transdermaalse plaastri Saksamaa pädevale asutusele detsentraliseeritud menetluse läbiviimiseks.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Fentrix outweigh its risks, and the marketing authorisation can be granted in Germany and in the following Member States of the EU, Austria, Belgium, Italy, the Netherlands, Portugal, Slovenia and Spain.
Estonian: Inimravimite komitee otsustas, et Fentrixi kasulikkus on suurem kui sellega kaasnevad riskid ja et ravimile võib anda müügiloa Saksamaal ning järgmistes Euroopa Liidu liikmesriikides: Austria, Belgia, Itaalia, Madalmaad, Portugal, Sloveenia ja Hispaania.
English: Fentrix is a ‘generic medicine'.
Estonian: Fentrix on geneeriline ravim.
English: Referral start date:
Estonian: Esildise tegemise kuupäev: Arvamuse esitamise kuupäev:
English: • the non-clinical local irritation and how sensitive the skin was to Fentrix were not investigated in accordance with current CHMP guidelines.
Estonian: • mittekliinilist ärrituvust ja naha tundlikkust Fentrixi suhtes ei ole uuritud kooskõlas kehtivate inimravimite komitee juhenditega.
English: The European Medicines Agency (EMEA) has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of Fentrix transdermal patch and associated names.
Estonian: Euroopa Ravimiamet on lõpetanud vahekohtumenetluse, mis algatati pärast seda, kui Euroopa Liidu liikmesriigid ei jõudnud kokkuleppele ravimi Fentrix transdermaalne plaaster ja sarnased nimetused heakskiitmises.
English: This means that Fentrix is similar to a ‘reference medicine' already authorised in the European Union (EU) called Durogesic.
Estonian: See tähendab, et Fentrix on sarnane võrdlusravimiga Durogesic, millel juba on Euroopa Liidus müügiluba.
English: Fentrix is a transdermal patch (device that delivers the drug across the skin) that contains the active substance fentanyl.
Estonian: Fentrix on transdermaalne plaaster (ravimi manustamiseks naha kaudu), mis sisaldab toimeainena fentanüüli.
English: The active substance in Fentrix, fentanyl, is an opioid that acts on receptors in the brain and spinal cord to prevent pain.
Estonian: Fentrixi toimeaine fentanüül on opioid, mis mõjub pea- ja seljaaju retseptoritele, vaigistades valu.
English: • that Fentrix did not show a comparable local skin tolerability to the reference medicine, Durogesic;
Estonian: • Fentrixi paikne nahataluvus ei olnud võrreldav võrdlusravimi Durogesic nahataluvusega;
English: The full list of these medicines is given in the package leaflet.
Estonian: Nende ravimite täielik loetelu on pakendi infolehel.
English: This medicine is the same as CoAprovel, which is already authorised in the European Union (EU).
Estonian: Ravim on samane CoAproveliga, millel juba on Euroopa Liidus müügiluba.
English: The full EPAR for Irbesartan Hydrochlorothiazide Zentiva can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Euroopa avaliku hindamisaruande täistekst ravimi Irbesartan Hydrochlorothiazide Zentiva kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Irbesartan on its own has been approved in the EU since 1997 under the names Karvea and Aprovel.
Estonian: Irbesartaan eraldi on olnud Euroopa Liidus ravimitena Karvea ja Aprovel heaks kiidetud alates 1997. aastast.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Irbesartan Hydrochlorothiazide Winthrop on 19 January 2007.
Estonian: Euroopa Komisjon andis ravimi Irbesartan Hydrochlorothiazide Winthrop müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 19. jaanuaril 2007.
English: The CHMP decided that Irbesartan Hydrochlorothiazide Zentiva's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee otsustas, et ravimi Irbesartan Hydrochlorothiazide Zentiva kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
English: The most common side effects with Irbesartan Hydrochlorothiazide Zentiva (seen in between 1 and 10 patients in 100) are dizziness, nausea (feeling sick) or vomiting, abnormal urination, fatigue (tiredness), and increases in blood urea nitrogen (BUN, a breakdown product of protein), creatinine (a breakdown product of muscle) and creatine kinase (an enzyme found in muscles).
Estonian: Ravimi Irbesartan Hydrochlorothiazide Zentiva kõige sagedamad kõrvalnähud (esinenud 1-10 patsiendil 100st) on peapööritus, iiveldus või oksendamine, urineerimishäired, väsimus, vere uurealämmastiku (BUN, valgu lagunemissaadus), kreatiniini (lihasest vabanev aine) ja kreatiinkinaasi (lihastes leiduv ensüüm) sisalduse suurenemine.
English: The company that makes CoAprovel has agreed that its scientific data can be used for Irbesartan Hydrochlorothiazide Zentiva.
Estonian: CoAproveli tootja on andnud nõusoleku, et tema teaduslikke andmeid võib kasutada ka ravimi Irbesartan Hydrochlorothiazide Zentiva toetuseks.
English: The name of the medicine was changed to Irbesartan Hydrochlorothiazide Zentiva on 6 February 2012.
Estonian: Ravimi nimetus muudeti 6. veebruaril 2012 Irbesartan Hydrochlorothiazide Zentiva'ks.
English: For more information about treatment with Irbesartan Hydrochlorothiazide Zentiva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate ravimiga Irbesartan Hydrochlorothiazide Zentiva toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
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 Irbesartan Hydrochlorothiazide Zentiva.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: This is a summary of the European public assessment report (EPAR) for Irbesartan Hydrochlorothiazide Zentiva.
Estonian: See on ravimi Irbesartan Hydrochlorothiazide Zentiva Euroopa avaliku hindamisaruande kokkuvõte.
English: Care must be taken when using Irbesartan Hydrochlorothiazide Zentiva with other medicines that have an effect on blood potassium levels.
Estonian: Ettevaatlik tuleb olla ravimi Irbesartan Hydrochlorothiazide Zentiva kasutamisel koos teiste ravimitega, mis võivad mõjutada vere kaaliumisisaldust.
English: Irbesartan Hydrochlorothiazide Zentiva must also not be used in patients who have severe liver, kidney or bile problems, blood potassium levels that are too low or blood calcium levels that are too high.
Estonian: Ravimit Irbesartan Hydrochlorothiazide Zentiva ei tohi kasutada ka patsiendid, kellel on raske maksa-, neeru- või sapihaigus või vere kaaliumisisaldus on liiga väike või kaltsiumisisaldus liiga suur.
English: Previously known as Irbesartan Hydrochlorothiazide Winthrop.
Estonian: Varasem nimetus Irbesartan Hydrochlorothiazide Winthrop.
English: Irbesartan Hydrochlorothiazide Zentiva is a medicine that contains two active substances, irbesartan and hydrochlorothiazide.
Estonian: Irbesartan Hydrochlorothiazide Zentiva on ravim, mis sisaldab kaht toimeainet, irbesartaani ja hüdroklorotiasiidi.
English: Irbesartan Hydrochlorothiazide Zentiva contains two active substances, irbesartan and hydrochlorothiazide.
Estonian: Irbesartan Hydrochlorothiazide Zentiva sisaldab kaht toimeainet, irbesartaani ja hüdroklorotiasiidi.
English: For the full list of all side effects reported with Irbesartan Hydrochlorothiazide Zentiva, see the package leaflet.
Estonian: Ravimi Irbesartan Hydrochlorothiazide Zentiva kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: Irbesartan Hydrochlorothiazide Zentiva is used in adults who have essential hypertension (high blood pressure) that is not adequately controlled by irbesartan or hydrochlorothiazide alone.
Estonian: Ravimit Irbesartan Hydrochlorothiazide Zentiva kasutatakse essentsiaalse hüpertensiooniga (kõrgvererõhutõvega) täiskasvanutel, kellel ainult irbesartaani või hüdroklorotiasiidiga ei teki piisavat ravivastust.
English: Irbesartan Hydrochlorothiazide Zentiva must not be used in people who are hypersensitive (allergic) to irbesartan, hydrochlorothiazide, sulfonamides, or any of the other ingredients.
Estonian: Ravimit Irbesartan Hydrochlorothiazide Zentiva ei tohi kasutada patsiendid, kes on irbesartaani, hüdroklorotiasiidi, sulfoonamiidide või selle ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised).
English: Other information about Irbesartan Hydrochlorothiazide Zentiva
Estonian: Muu teave ravimi Irbesartan Hydrochlorothiazide Zentiva kohta
English: 25 mg hydrochlorothiazide once a day are not recommended.
Estonian: Suuremaid annuseid kui 300 mg irbesartaani ja 25 mg hüdroklorotiasiidi üks kord ööpäevas ei soovitata.
English: EPAR summary for the public irbesartan / hydrochlorothiazide
Estonian: Kokkuvõte üldsusele irbesartaan / hüdroklorotiasiid
English: Irbesartan Hydrochlorothiazide Zentiva was more effective than placebo (a dummy treatment) and than hydrochlorothiazide alone in reducing diastolic blood pressure.
Estonian: Irbesartan Hydrochlorothiazide Zentiva alandas diastoolset vererõhku paremini kui platseebo (näiv ravim) ja paremini kui ainult hüdroklorotiasiid.
English: Irbesartan Hydrochlorothiazide Zentiva may be added to some other treatments for hypertension.
Estonian: Ravimit Irbesartan Hydrochlorothiazide Zentiva tohib kasutada koos mõne muu kõrgvererõhuravimiga.
English: The dose of Irbesartan Hydrochlorothiazide Zentiva to be used depends on the dose of irbesartan or hydrochlorothiazide that the patient was taking before.
Estonian: Ravimi Irbesartan Hydrochlorothiazide Zentiva annus sõltub patsiendi varasemast irbesartaani või hüdroklorotiasiidi annusest.
English: What is Irbesartan Hydrochlorothiazide Zentiva?
Estonian: Mis on Irbesartan Hydrochlorothiazide Zentiva?
English: What is the risk associated with Irbesartan Hydrochlorothiazide Zentiva?
Estonian: Mis riskid ravimiga Irbesartan Hydrochlorothiazide Zentiva kaasnevad?
English: Irbesartan Hydrochlorothiazide Zentiva in combination with aliskiren-containing medicines (used to treat essential hypertension) must not be used in patients with diabetes, or moderate or severe kidney impairment.
Estonian: Diabeediga või mõõduka või raske neerupuudulikkusega patsiendid ei tohi ravimit Irbesartan Hydrochlorothiazide Zentiva kasutada koos aliskireeni sisaldavate ravimitega (essentsiaalse hüpertensiooni ravimid).
English: Why has Irbesartan Hydrochlorothiazide Zentiva been approved?
Estonian: Miks Irbesartan Hydrochlorothiazide Zentiva heaks kiideti?
English: How has Irbesartan Hydrochlorothiazide Zentiva been studied?
Estonian: Kuidas ravimit Irbesartan Hydrochlorothiazide Zentiva uuriti?
English: How is Irbesartan Hydrochlorothiazide Zentiva used?
Estonian: Kuidas ravimit Irbesartan Hydrochlorothiazide Zentiva kasutatakse?
English: The studies of Karvea/Aprovel used with hydrochlorothiazide as separate tablets were used to support the use of Irbesartan Hydrochlorothiazide Zentiva.
Estonian: Ravimi Irbesartan Hydrochlorothiazide Zentiva kasutamise toetuseks kasutati uuringuid, milles Karveat või Aproveli manustati koos hüdroklorotiasiidiga, kumbagi eraldi tablettidena.
English: How does Irbesartan Hydrochlorothiazide Zentiva work?
Estonian: Kuidas Irbesartan Hydrochlorothiazide Zentiva toimib?
English: The text proposed for 4.4 was shortened in order to make it clearer.
Estonian: Lõigu 4.4 jaoks kavandatud teksti lühendati, et muuta see lihtsamini mõistetavaks.
English: The usual dose for adults is one bottle bag once daily.
Estonian: Tavaline annus täiskasvanutele on üks pudel kott üks kord päevas.
English: 7 - 21 days
Estonian: 7 - 21 päeva.
English: M1 and M2 are the only metabolites relevant in humans, both are microbiologically inactive.
Estonian: M1 ja M2 on ainsad peamised metaboliidid inimestel, mõlemad mikrobioloogiliselt inaktiivsed.
English: If you are female or elderly, you may be more sensitive to ECG changes.
Estonian: Kui te olete naine või eakas inimene, võite te olla tundlikum EKG muutuste suhtes.
English: frequency cannot be estimated from the available data
Estonian: esinemissagedust ei saa hinnata olemasolevate andmete alusel.
English: After the Commission Decision the Member State Competent Authorities, in liaison with the Reference Member State, will update the product information as required.
Estonian: Pärast komisjoni otsust ajakohastavad liikmesriigi pädevad asutused koostöös viiteliikmesriigiga tooteinfo nõuetekohaselt.
English: If any such data was necessary, the Applicant should work with already established projects, adequately designed to collect reliable data prospectively.
Estonian: Selliste andmete vajaduse korral peaks taotleja töötama juba töösse rakendatud projektidega, mis on adekvaatselt kavandatud usaldusväärsete andmete tulevaseks kogumiseks.
English: The major concern was the need for further qualification of the conditions of use.
Estonian: Peamine probleem oli vajadus täpsemalt kitsendada kasutustingimusi.
English: Octegra will always be given to you by a doctor or healthcare professional.
Estonian: Octegra't manustab teile alati kas arst või tervishoiutöötaja.
English: Changes in INR
Estonian: Muutused INR-is
English: The CHMP maintained its previous position, as no new data was provided.
Estonian: Inimravimite komitee jäi oma endisele arvamusele, sest uusi andmeid ei esitatud.
English: The following wording was adopted:
Estonian: Vastu võeti järgmine sõnastus.