FrancophonIA/ELRC3.0 huggingface dataset:
English: Elimination: Excretion of Betahistine is almost entirely (85 % - 90 %) in the urine within 24 hours Betahistin is excreted almost completely as the major metabolite in the urine.
Estonian: Beetahistiin väljutatakse peaaegu täielikult (85…90%) uriiniga 24 tunni jooksul ning peaaegu täielikult põhimetaboliidina.
English: The MAH has demonstrated that Betavert N (Hennig Arzneimittel GmbH, Germany) and the originator, Betaserc® 8 (Duphar, UK), are bioequivalent after single administration.
Estonian: Müügiloa hoidja tõestas, et Betavert N (Hennig Arzneimittel GmbH, Saksamaa) ja originaalravim Betaserc® 8 (Duphar, Ühendkuningriik) on ühekordse manustamise järel bioekvivalentsed.
English: The CHMP considered the chemicalpharmaceutical documentation and Expert Report, of Betahistine, of sufficient quality in view of the present European regulatory requirements.
Estonian: Inimravimite komitee oli arvamusel, et beetahistiini keemilis-farmatseutiline dokumentatsioon ja ekspertaruanne on Euroopa kehtivaid õigusakte arvestades küllaldase kvaliteediga.
English: Its exact biochemical mode of action as well as its receptor specificity and affinity has not been clarified until now.
Estonian: Selle täpne toimemehhanism ning spetsiifilisus ja afiinsus retseptorite suhtes ei ole seni täpselt teada.
English: Efficacy and safety of betahistine dihydrochloride in the treatment of symptoms associated with Menière's disease have been demonstrated in preclinical-and clinical trials.
Estonian: Beetahistiindihüdrokloriidi efektiivsus ja ohutus Menière'i tõvega seotud sümptomite ravis on tõestatud prekliinilistes ja kliinilistes uuringutes.
English: The binding of Betahistine to human plasma proteins has been measured by equilibrium dialysis.
Estonian: Beetahistiini seondumist inimese plasmavalkudega on mõõdetud ekviliibriumdialüüsi abil.
English: Metabolism: Betahistine dihydrochloride is rapidly metabolised in the liver to the inactive major metabolite, 2-pyridylacetic acid and to demethyl-betahistine [2-(2 aminoethylpyridine)].
Estonian: Beetahistiindihüdrokloriid metaboliseerub maksas kiiresti inaktiivseks põhimetaboliidiks 2püridüüläädikhappeks ja ühendiks demetüülbeetahistiin-[2-(2-aminoetüülpüridiin)].
English: The CHMP agreed that there were no objections to approval of Betavert N 8 mg and Betavert N 16 mg from a nonclinical point of view.
Estonian: Inimravimite komitee oli arvamusel, et ravimi Betavert N 8 mg ja Betavert N 16 mg heakskiitmisel mittemeditsiinilisi vastuväiteid ei ole.
English: Peak plasma concentrations of C14-labelled betahistine dihydrochloride are reached approximately 1 hour after oral administration in fasting volunteers.
Estonian: 14Cmärgistatud beetahistiindihüdrokloriidi tippkontsentratsioon plasmas saabub ligikaudu üks tund pärast suukaudset manustamist söömata vabatahtlikele.
English: This procedure concerns Betavert N, a generic version of betahistine dihydrochloride tablets.
Estonian: Käesolev menetlus on seotud ravimiga Betavert N, mis on beetahistiindihüdrokloriidi tablettide geneeriline variant.
English: The RMS considers that the Pharmacovigilance system as described by the MAH fulfils the requirements as described in Volume 9A of the Rules Governing Medicinal Products in the European Union and provides adequate evidence that the MAH has the services of a qualified person responsible for pharmacovigilance and has the necessary means for the notification of any adverse reaction suspected of occurring either in the Community or in a third country.
Estonian: Viiteliikmesriik on arvamusel, et müügiloa hoidja kirjeldatud ravimiohutuse järelevalve süsteem täidab nõuded, mida on kirjeldatud Euroopa Liidu ravimieeskirjade köites 9A, ja et on küllaldaselt andmeid, et müügiloa hoidja kasutab ravimiohutuse järelevalve pädeva isiku teenuseid ja et müügiloa hoidjal on olemas vahendid ühenduses või kolmandas riigis tekkinud kõrvalnähtudest teatamiseks.
English: The product is considered as bioequivalent to the originator, and the benefit-risk balance is considered positive.
Estonian: Ravimit peetakse originaalravimiga bioekvivalentseks ning selle kasulikkuse ja riski suhet positiivseks.
English: The absolute bioavailability of betahistine dihydrochloride is not known.
Estonian: Beetahistiindihüdrokloriidi absoluutne biosaadavus ei ole teada.
English: The Marketing Authorisation Holder of Betavert N is Hennig Arzneimittel GmbH & Co.KG
Estonian: Ravimi Betavert N müügiloa hoidja on Hennig Arzneimittel GmbH & Co.KG.
English: The bioequivalence between Betavert N and the originator is based on Biopharmaceutics Classification System (BCS) approach (biowaiver).
Estonian: Ravimi Betavert N ja originaalravimi vaheline bioekvivalentsus tugineb biofarmatseutilise klassifikatsioonisüsteemi lähenemisel (bioloogiline asendus).
English: PK study, also, revealed no safety issues.
Estonian: Farmakokineetika uuringus ohutusprobleeme ei selgunud.
English: Betahistine is an analogue of histamine, which is indicated in the treatment of vertigo associated with functional disorders of the vestibular apparatus in the context of Meniere's symptom complex.
Estonian: Beetahistiin on histamiini analoog, mis on näidustatud vestibulaaraparaadi funktsionaalsete häiretega seotud vertiigo raviks Menière'i tõve sümptomikompleksi kontekstis.
English: The product specifications cover appropriate parameters for this dosage form.
Estonian: Ravimi dokumentatsioon hõlmab annustusviisi asjakohaseid parameetreid.
English: Pharmaceutical Form
Estonian: Ravimivorm Manustamisviis
English: The solubility of the drug substance and the fast dissolution rate of the drug product were already unquestionably proven.
Estonian: Toimeaine lahustuvus ja ravimi suur lahustumiskiirus olid juba kindlalt tõestatud.
English: A statement signed by the MAH and the qualified person for pharmacovigilance, indicating that the MAH has the services of a qualified person responsible for pharmacovigilance and the necessary means for the notification of any adverse reaction occurring either in the Community or in a third country has been provided.
Estonian: Müügiloa hoidja ja ravimiohutuse järelevalve pädeva isiku allkirjastatud tunnistus näitab, et müügiloa hoidja kasutab ravimiohutuse järelevalve pädeva isiku teenuseid ja et müügiloa hoidja on taganud vahendid ühenduses või kolmandas riigis tekkinud kõrvalnähtudest teatamiseks.
English: The CHMP asked the MAH to clearly prove the bioequivalence between Betavert N and the originator.
Estonian: Inimravimite komitee palus müügiloa hoidjal selgelt tõestada ravimi Betavert N ja originaalravimi bioekvivalentsus.
English: The solubility of the drug substance and the fast dissolution rate of the drug product have been proven.
Estonian: Ravimiaine lahustuvus ja ravimi suur lahustumiskiirus on tõestatud.
English: The evaluation of the permeability and the absorption of the active substance was derived from a bioequivalence and a mass balance study in vivo.
Estonian: Toimeaine permeaabluse ja imendumise hinnang tuletati in vivo bioekvivalentsuse ja massitasakaalu uuringutest.
English: The MAH demonstrated the bioequivalence with two types of data: an in vivo BE-study (bioequivalence study) with urine measurement and in vitro studies on BA/BE based on Biopharmaceutics Classification System (BCS).
Estonian: Müügiloa hoidja esitas bioekvivalentsuse tõestuseks kahte tüüpi andmed: in vivo bioekvivalentsuse uuringu tulemused, milles mõõdeti sisaldust uriinis, ja biofarmatseutilisel klassifikatsioonisüsteemil põhinevate in vitro biosaadavuse / bioekvivalentsuse uuringute tulemused.
English: The results of solubility study showed a high solubility of the active substance about a broad pH range.
Estonian: Lahustuvuse uuringu tulemused näitasid toimeaine head lahustuvust suures pH-vahemikus.
English: The active substance Betahistine hydrochloride is described in Ph.Eur.
Estonian: Toimeainet beetahistiinhüdrokloriidi on kirjeldatud Euroopa Farmakopöas.
English: Germany HENNIG ARZNEIMITTEL GmbH & Co. KG
Estonian: HENNIG ARZNEIMITTEL GmbH & Co.
English: The originator product is Betaserc® 8 available in 8 mg tablets.
Estonian: Originaalravimit Betaserc® 8 turustatakse 8 mg tablettidena.
English: The determination of 2-Pyridylacetic acid (PAA), the active metabolite of betahistine, from urine samples was not considered as up-to-date method, the measurement of PAA in human plasmas would have considered more appropriate.
Estonian: Beetahistiini toimiva metaboliidi 2-püridüüläädikhappe (PAA) kontsentratsiooni määramist uriinis ei peetud nüüdisaegseks meetodiks.
English: The Marketing Authorisation Holder of the originator is Solvay Pharma B.V. settled in Netherlands.
Estonian: Originaalravimi müügiloa hoidja Solvay Pharma B.V.
English: Pharmacodynamic, pharmacokinetic and toxicological properties of betahistine are well known.
Estonian: Beetahistiini farmakodünaamilised, farmakokineetilised ja toksikoloogilised omadused on hästi teada.
English: Absorption: following oral administration, betahistine dihydrochloride is rapidly and completely absorbed.
Estonian: Suukaudse manustamise järel imendub beetahistiindihüdrokloriid kiiresti ja täielikult.
English: Betahistine is excreted in breast milk in concentrations similar to those found in plasma.
Estonian: Beetahistiin eritub rinnapiima plasmakontsentratsiooniga sarnases kontsentratsioonis.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS / MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Estonian: LISA I RAVIMI(TE) NIMETUSTE, RAVIMVORMI(DE), TUGEVUS(T)E, MANUSTAMISVIISI(DE), TAOTLEJA(TE), MÜÜGILOA HOIDJA(TE) LOETELU LIIKMESRIIKIDES
English: Based on these, the CHMP proposed a re-test period of 5 years for betahistine hydrochloride.
Estonian: Nendele andmetele tuginedes soovitas inimravimite komitee beetahistiinhüdrokloriidi jaoks korraldada korduskatseid iga 5 aasta järel.
English: The CHMP has recommended the granting of the Marketing Authorisation(s) for Betavert N and associated names (see Annex I).
Estonian: Inimravimite komitee soovitas ravimile Betavert N ja sarnastele nimetustele (vt I lisa) anda müügiloa.
English: This was done by a bioequivalence study investigating urine levels of the main metabolite and by supportive in vitro studies, performed in the course of the national authorisation procedure, leading to the conclusion that it is justified to waive for further bioequivalence studies in human volunteers.
Estonian: Müügiloa andmise riikliku menetluse kulgu järgides tehti ka toetavad in vitro uuringud, mille alusel jõuti järeldusele, et õigustatud on loobumine täiendavatest bioekvivalentsuse uuringutest vabatahtlikel.
English: The BCS-studies of betahistine substance and formulations presented herein along with the properties of the drug substance (therapeutic index, safety and complete absorption) and the formulations (composition) provided robust support for waiving in vivo BE studies for Betavert N. Moreover, betahistine fulfils the regulatory requirements for granting a biowaver, being assigned to the group of compounds with high solubility and complete absorption - accordant with Class I of BCS.
Estonian: Beetahistiini ja käesolevas dokumendis käsitletud preparaatide ja ravimi omaduste (terapeutiline indeks, ohutus ja täielik imendumine) ning koostise analüüsimisel biofarmatseutilise klassifikatsioonisüsteemi kohastes uuringutes saadi kindlaid andmeid, millega põhjendada ravimi Betavert N in vivo bioekvivalentsuse uuringutest loobumist.
English: The CHMP concluded that betahistine dihydrochloride can be classified as Class I according to Biopharmaceutics Classification System.
Estonian: Inimravimite komitee otsustas, et beetahistiindihüdrokloriidi võib biofarmatseutilise klassifikatsioonisüsteemi järgi klassifitseerida I klassi ravimiks.
English: Consequently the drug product is eligible for BCS based biowaiver approach.
Estonian: Seega saab ravimi korral kasutada ka biofarmatseutilisel klassifikatsioonisüsteemil põhinevat bioloogilise asenduse lähenemist.
English: The control tests and specifications for drug substance product were adequately drawn up.
Estonian: Asjakohaselt olid korraldatud ravimi kontrollanalüüsid ja koostatud dokumentatsioon.
English: The CHMP, considered these data, concluded that betahistine dihydrochloride can be assigned to the highly soluble class according to Biopharmaceutics Classification System, Class I.
Estonian: Võttes arvesse neid andmeid, otsustas inimravimite komitee, et beetahistiindihüdrokloriidi võib määrata biofarmatseutilise klassifikatsioonisüsteemi I klassi kohaselt hästi lahustuvate ühendite klassi.
English: Non-clinical pharmacodynamic, pharmacokinetic and toxicological properties of betahistine dihydrochloride are also well known.
Estonian: Beetahistiindihüdrokloriidi mittekliinilised farmakodünaamilised, farmakokineetilised ja toksikoloogilised omadused on hästi teada.
English: Only traces of desmethylbetahistine dihydrochloride are recovered in the urine.
Estonian: Uriinis on tuvastatavad vaid desmetüülbeetahistiindihüdrokloriidi jäljed.
English: In conclusuion, considering the absorption correlated with high permeability, the allocation of betahistine dihydrochloride to BCS Class I is considered justified by the CHMP.
Estonian: Võttes arvesse suure permeaablusega seotud imendumist, peab inimravimite komitee õigustatuks beetahistiindihüdrokloriidi määramise biofarmatseutilise klassifikatsioonisüsteemi I klassi ravimiks.
English: Distribution: The human volume of distribution of betahistine dihydrochloride is not known.
Estonian: Beetahistiindihüdrokloriidi jaotusruumala inimesel ei ole teada.
English: The issue was referred to the CMD(h) and an assessment was carried out by the RMS.
Estonian: Asi esitati inimravimite vastastikuse tunnustamise ja detsentraliseeritud menetluse koordineerimisrühmale ning viiteliikmesriik viis läbi hindamise.
English: Drug substance
Estonian: Toimeaine
English: Content (concentration)
Estonian: Pakendid sisu (kontsentratsio on)
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration
Estonian: Ravimvorm Manustamisviis Sisepakendi iseloomustus
English: This does not affect the health or performance of the animal.
Estonian: See ei mõjuta loomade tervist ega füüsilisi näitajaid.
English: The name of the medicine was changed to Bovalto Ibraxion on 10 August 2016.
Estonian: Ravimi nimetus muudeti 10. augustil 2016 Bovalto Ibraxioniks.
English: Accidental injection may cause severe pain and swelling, particularly if injected into a joint or finger -this could result in the loss of a finger if prompt medical attention is not given.
Estonian: Juhuslik enesesüstimine võib põhjustada tugevat valu ja turset, eriti kui süstitakse liigesesse või sõrme, mis võib viia vigastatud sõrme kaotuseni, kui viivitamatult ei pöörduta arsti poole.
English: The vaccine is given into the neck at the front of the shoulder.
Estonian: Vaktsiini süstitakse õla ette kaela.
English: The full EPAR for Bovalto Ibraxion can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Bovalto Ibraxioni kohta on ameti veebilehel: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Ibraxion may cause a slight rise in body temperature (less than 1°C) for less than 48 hours after injection.
Estonian: Bovalto Ibraxion võib tekitada kehatemperatuuri kerget tõusu (vähem kui 1°C) vähem kui 48 tunni jooksul pärast süstimist.
English: The European Commission granted a marketing authorisation valid throughout the EU for Bovalto Ibraxion on 9 March 2000.
Estonian: Euroopa Komisjon andis Bovalto Ibraxioni müügiloa, mis kehtib kogu Euroopa Liidus, 9. märtsil 2000.
English: Protection starts 2 weeks after vaccination and lasts for 6 months.
Estonian: Kaitse haiguse vastu tekib 2 nädalat pärast vaktsineerimist ning püsib 6 kuud.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Bovalto Ibraxion's benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Veterinaarravimite komitee järeldas, et Bovalto Ibraxioni kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas vaktsiini kasutamise Euroopa Liidus heaks kiita.
English: The withdrawal period for meat and milk from cattle treated with Bovalto Ibraxion is ‘zero' days, which means there is no mandatory waiting time.
Estonian: Bovalto Ibraxioniga ravitud veiste liha ja piima keeluaeg on 0 päeva, mis tähendab, et keeluaega ei ole.
English: Field studies were conducted in around 300 cattle of various ages in both an IBR contaminated and an IBR free environment.
Estonian: Ligikaudu 300 eri vanuses veisega tehti väliuuringuid nii IBR-saastatud kui ka IBR-saastevabas keskkonnas.
English: The virus in the vaccine has also been modified to allow vaccinated animals to be distinguished from naturally infected animals so allowing better disease management.
Estonian: vaktsineeritud loomade eraldamist loomulikult nakatunud loomadest ja seeläbi võimaldada paremat haiguse ravi.
English: If someone is accidentally injected with this product, they must seek medical attention immediately even if only a very small amount is injected.
Estonian: Ravimi juhusliku süstimise korral inimesele tuleb otsekohe pöörduda arsti poole, isegi kui süstitud kogus oli väga väike.
English: This summary was last updated in August 2016.
Estonian: Kokkuvõtte viimane uuendus: 08-2016.
English: Two injections are given 3 weeks apart to calves from age 2 weeks provided they have not acquired antibodies against IBR virus from the mother.
Estonian: Alates 2-nädalastele vasikatele tehakse kaks süsti 3-nädalase vahega, kui vasikad ei ole omandanud emalt IBR-viiruse vastaseid antikehi.
English: In the future, if the animals are exposed to the active virus the immune system will be able to respond more quickly.
Estonian: Kui loomad puutuvad hiljem aktiivse viirusega uuesti kokku, tekivad antikehad kiiremini.
English: The injection of Bovalto Ibraxion may cause a temporary tissue reaction at the site of injection, which may last for three weeks and rarely up to five weeks.
Estonian: Bovalto Ibraxioni süstimine võib tekitada mööduva koeärrituse süstekohal, mis võib kesta 3 nädalat ja harvadel juhtudel kuni 5 nädalat.
English: Bovalto Ibraxion is an emulsion containing mineral oil.
Estonian: Bovalto Ibraxion on mineraalõli sisaldav emulsioon.
English: For practical information about using Bovalto Ibraxion, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Estonian: Kui loomaomanikud või -pidajad vajavad Bovalto Ibraxioni kasutamise praktilisi nõuandeid, peavad nad lugema pakendi infolehte või pöörduma oma veterinaararsti või apteekri poole.
English: This is a summary of the European public assessment report (EPAR) for Bovalto Ibraxion.
Estonian: See on vaktsiini Bovalto Ibraxion Euroopa avaliku hindamisaruande kokkuvõte.
English: It is not intended to provide practical advice on how to use Bovalto Ibraxion.
Estonian: Hindamisaruandes ei anta Bovalto Ibraxioni kasutamise praktilisi nõuandeid.
English: What are the risks associated with Bovalto Ibraxion?
Estonian: Mis riskid Bovalto Ibraxioniga kaasnevad?
English: Bovalto Ibraxion is a vaccine containing a version of the IBR virus that has been made inactive so it cannot cause infection.
Estonian: Bovalto Ibraxion on vaktsiin, mis sisaldab IBR-viiruse varianti, mis on inaktiveeritud, nii et see ei saa nakkust tekitada.
English: Bovalto Ibraxion is a veterinary vaccine used to protect cattle against infectious bovine rhinotracheitis (IBR) virus.
Estonian: Bovalto Ibraxion on veterinaarvaktsiin, mida kasutatakse veiste kaitseks veiste infektsioosse rinotrahheiidi (IBR) viiruse vastu.
English: IBR virus infections affect the airways with nasal discharge, conjunctivitis (inflammation of the eye) and coughing.
Estonian: IBR-viirusnakkused mõjutavad hingamisteid, tekitades limaeritust ninast, samuti konjunktiviiti (silma sidekesta põletik) ja köha.
English: Bovine rhinotracheitis vaccine (inactivated)
Estonian: Bovalto Ibraxion veiste rinotrahheiidi vaktsiin (inaktiveeritud)
English: Bovalto Ibraxion contains the adjuvant light paraffin oil to enhance the immune response.
Estonian: Bovalto Ibraxion sisaldab immuunvastuse tugevdamiseks adjuvanti (kerget parafiinõli).
English: Why is Bovalto Ibraxion approved?
Estonian: Miks Bovalto Ibraxion heaks kiideti?
English: When there are antibodies the vaccine should be given to calves from age 3 months.
Estonian: Antikehade korral süstitakse vaktsiini vasikatele alates 3. elukuust.
English: When Bovalto Ibraxion is given to cattle the animals' immune system recognises the inactive virus as ‘foreign' and makes antibodies against it.
Estonian: Kui veistele manustatakse vaktsiini Bovalto Ibraxion, peab loomade immuunsüsteem viirust võõraks ja tekitab selle vastu antikehi.
English: Other information about Bovalto Ibraxion?
Estonian: Muu teave Bovalto Ibraxioni kohta
English: Cattle vaccinated with Bovalto Ibraxion had protective levels of antibodies to IBR virus at 2 weeks after vaccination and the duration of protection was shown to last 6 months.
Estonian: Bovalto Ibraxioniga vaktsineeritud veistel tekkis pärast IBR-viiruse vastast vaktsineerimist kaitsval määral antikehi, mis kestsid 6 kuud.
English: How does Bovalto Ibraxion work?
Estonian: Kuidas Bovalto Ibraxion toimib?
English: What benefits of Bovalto Ibraxion have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Bovalto Ibraxioni kasulikkus?
English: How is Bovalto Ibraxion used?
Estonian: Kuidas Bovalto Ibraxioni kasutatakse?
English: Bovalto Ibraxion is available as an emulsion and can only be obtained with a prescription.
Estonian: Vaktsiini Bovalto Ibraxion turustatakse emulsioonina ja see on retseptivaktsiin.
English: Bovalto Ibraxion contains the active substance inactivated gene deleted IBR virus.
Estonian: Bovalto Ibraxioni toimeaine on veiste infektsioosse rinotrahheiidi inkativeeritud viiruse eemaldatud geen.
English: What is Bovalto Ibraxion and what is it used for?
Estonian: Mis on Bovalto Ibraxion ja milleks seda kasutatakse?
English: A booster injection is given at 6 month intervals.
Estonian: Revaktsineerimine tehakse 6 kuud pärast esmast vaktsineerimist.
English: An alternative solution could be to retain only one production site.
Estonian: Alternatiivne lahendus oleks jätta ainult üks tootmiskoht.
English: Applicant is asked to commit to take appropriate measures to harmonise the productions and/or to provide the adequate demonstrations/data to solve the issues.
Estonian: Hageja on palunud endale võtta asjakohaseid meetmeid, et ühtlustada lavastused ja / või pakkuda piisavat meeleavaldused / data küsimuste lahendamiseks.
English: QUALITY ASPECTS
Estonian: KVALITEEDIASPEKTID
English: Keep in the original container in order to protect from light.
Estonian: Hoida originaalpakendis, et kaitsta valguse eest.
English: With regard to the differences in production and control, harmonization of the production process and the controls between both manufacturing site is strongly suggested.
Estonian: Mis puudutab erinevusi tootmist ja kontrolli ühtlustamine tootmisprotsessi ja kontrolli vahel nii tootvas on tugevalt soovitatud.
English: White Oil
Estonian: Valge õli
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Estonian: Aktiivse immuunsuse tekitamiseks mõeldud bioloogilist päritolu põhikomponendina ei kuulu toimeaine määruse nr. 470/2009 (EÜ) haldusalasse.
English: Excludes aromatic and unsaturated compounds
Estonian: Välistab aromaatsed ja küllastumata ühendid
English: The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Estonian: Müügiloa hoidja peab informeerima Euroopa Komisjoni käesoleva meditsiinilise toote turustamisplaanidest.
English: The entire content of the bottle should be used within 2 hours after broaching the container.
Estonian: Kogu pudeli sisu tuleb ära kasutada 2 tunni jooksul pärast pudeli avamist.