FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Medicines Agency noted that Votubia has been shown to reduce the size of the brain tumours in adults and children with tuberous sclerosis and that this is expected to reduce the signs and symptoms of SEGA such as seizures, hydrocephalus (accumulation of fluid in the brain), and increased pressure within the brain.
Estonian: Euroopa Ravimiamet märkis, et uuringud tõendavad Votubia ajukasvajate ruumala vähendavat toimet tuberoosse skleroosiga täiskasvanutel ja lastel ning eeldatavalt leevendab see selliseid subependümaalse hiidrakulise astrotsütoomi haigusnähte ja sümptomeid nagu epilepsiaepisoodid, hüdrotsefaalia (ajuturse) ja koljusisese rõhu suurenemine.
English: The active substance in Votubia, everolimus, is an anti-tumour medicine that acts by blocking an enzyme called ‘mammalian target of rapamycin' (mTOR), which has increased activity in tumour cells of patients with SEGA or renal angiomyolipoma.
Estonian: Votubia toimeaine everoliimus on kasvajavastane aine, mis blokeerib ensüümi mTOR (imetajate rapamütsiinsihtvalk), mille aktiivsus on subependümaalse hiidrakulise astrotsütoomiga või renaalse angiomüolipoomiga patsientide kasvajarakkudes suurenenud.
English: Overall, the patients given Votubia had a 29 and 40% reduction respectively in the number of seizures during treatment, compared with a 15% reduction in those given placebo.
Estonian: Kokku vähenesid epilepsiaepisoodid Votubia kasutamisel vastavalt 29% ja 40% võrra ning platseebo korral 15% võrra.
English: The medicine is also used as an add-on treatment in patients from 2 years of age with seizures (fits) related to tuberous sclerosis that have not responded to other treatments.
Estonian: Ravimit kasutatakse ka lisaravimina vähemalt 2-aastastel tuberoosse skleroosiga seotud epilepsiaepisoodidega patsientidel, kellel ei teki muude ravimitega ravivastust.
English: The main measure of effectiveness was the proportion of patients who responded to treatment and whose kidney tumour shrank by at least half, which was seen in 42% of patients (33 out of 79) treated with Votubia, compared with none of the 39 patients who received placebo.
Estonian: Efektiivsuse põhinäitaja oli nende ravivastusega patsientide osakaal, kelle neerukasvaja vähenes vähemalt poole võrra: Votubia rühmas oli selliseid patsiente 42% (33 patsienti 79st) ja platseeborühmas 0% (0 patsienti 39st).
English: It has also shown to be effective at reducing partial-onset seizures associated with tuberous sclerosis.
Estonian: Uuringud on tõendanud ka Votubia efektiivsust tuberoosse skleroosiga seotud partsiaalsete epilepsiaepisoodide korral.
English: Two different dosage regimens of add-on treatment with Votubia (tailored to give lower or higher levels in the blood) were compared with placebo.
Estonian: Selles võrreldi Votubiat lisaravimina manustamisel kahes eri annuses (et tekitada veres väike ja suur ravimisisaldus) ja platseebot.
English: Votubia has been shown to be effective at treating patients with SEGA and renal angiomyolipoma by shrinking the volume of the tumours.
Estonian: Uuringud on tõendanud, et Votubia on subependümaalse hiidrakulise astrotsütoomiga ja renaalse angiomüolipoomiga patsientide ravis efektiivne, vähendades kasvajate mahtu.
English: The benefits of Votubia as an add-on treatment of partial onset seizures related to tuberous sclerosis that have not been sufficiently controlled by other treatments have been shown in one main study.
Estonian: Votubia kasulikkust lisaravimina patsientidel, kellel on tuberoosse skleroosiga seotud partsiaalsed epilepsiaepisoodid, mis ei allu piisavalt muudele ravimitele, tõendati ühes põhiuuringus, milles osales 366 täiskasvanut ja vähemalt 2-aastast last.
English: Although surgery remains the standard treatment for this condition, Votubia is expected to benefit patients whose tumour cannot be operated on. Votubia has also been shown to reduce the size of kidney tumours in patients with renal angiomyolipoma and has been shown to be beneficial as an add-on treatment in the management of partial-onset seizures related to tuberous sclerosis that have not sufficiently responded to other therapy.
Estonian: On tõendatud, et Votubia vähendab ka renaalse angiomüolipoomiga patsientide neerukasvajaid ja on kasulik lisaravimina patsientidel, kellel on tuberoosse skleroosiga seotud partsiaalsed epilepsiaepisoodid, mis ei allu muudele ravimitele piisavalt.
English: Why is Votubia authorised in the EU?
Estonian: ELis Votubiale väljastatud müügiloa põhjendus
English: Also the situation is dynamic and may change as new cases arise.
Estonian: Situatsioon on dünaamiline ja võib muutuda uute juhtude ilmnemisel.
English: de la Industria, 30 28108 Alcobendas Madrid
Estonian: de la Industria, 30 28108 Alcobendas Madriid
English: Withdrawal of the product from the market in the EU
Estonian: Toote kõrvaldamine Euroopa Liidu turult
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF MICOTIL (see Annex I)
Estonian: MICOTILI TEADUSLIKU HINDAMISE KOKKUVÕTE (vt I lisa)
English: Cattle Sheep (over 15kg)
Estonian: Veised Lambad (üle 15kg)
English: Maintaining the status quo
Estonian: Status quo säilitamine
English: They tend to be physically active and involved in handling animals every day.
Estonian: Nad on enamasti füüsiliselt aktiivsed inimesed ning tegelevad loomadega iga päev.
English: This estimate has not been independently verified.
Estonian: See hinnang ei ole seni teist, sõltumatut kinnitust leidnud.
English: D-35396 Gießen
Estonian: D-35396 Gießen Saksamaa
English: • Do not use automatic injection equipment.
Estonian: • Mitte kasutada automaatset süstimisvarustust.
English: 90027 Bernolakova, Slovak Republic
Estonian: 90027 Bernolakova, Slovakkia
English: Secondly, re-formulation would necessitate new quality, safety and efficacy studies, which might not be feasible.
Estonian: Teiseks vajaks uus tooteretsept uusi kvaliteedi-, ohutus- ning efektiivsusuuringuid, mille teostamine ei pruugi olla mõeldav.
English: • Ensure that animals are properly restrained, including those in the vicinity.
Estonian: • Loomad peavad olema kindlalt kinnitatud, kaasa arvatud läheduses olevad teised loomad.
English: Other combinations of measures would theoretically be possible, but would not present significant additional benefits to risk management, and they are therefore not discussed.
Estonian: Teised meetmete kombinatsioonid oleksid teoreetiliselt võimalikud, aga praegu ei annaks nende panus riskijuhtimisse märkimisväärset lisaväärtust, mistõttu neid siinkohal ei arutata.
English: - the Committee assessed the information provided by the Marketing Authorisation Holders in response to the list of questions agreed by the Committee on 16 June 2004 and the additional information provided on 12 July 2005;
Estonian: - komitee hindas müügiloa hoidjate poolt vastusena komitee poolt 16. juunil 2004 koostatud küsimuste nimekirjale esitatud informatsiooni ja 12. juulil 2005 esitatud lisateavet;
English: In total 520 human exposures were reported since 1999, of which 509 were accidental.
Estonian: Kokku on alates 1999. aastast teatatud 520 inimese ekspositsioonijuhust ravimile, neist 509 on olnud juhuslikud.
English: ADVICE ON CORRECT ADMINISTRATION
Estonian: NÕUANDED KORREKTSEKS MANUSTAMISEKS
English: A-1030 Wien
Estonian: A-1030 Viin
English: ANNEX IV CONDITIONS OF THE MARKETING AUTHORISATION
Estonian: IV LISA MÜÜGILOA ANDMISE TINGIMUSED
English: Wash hands after use.
Estonian: Kasutamise järel peske käsi.
English: Nevertheless, it is necessary to put in practice some measures to reduce the risks of accidental self-injection.
Estonian: Sellest hoolimata on praktikas vajalik rakendada mõningaid meetmeid juhusliku enesesüstimise ohu vähendamiseks.
English: Additional data were provided in relation to 4 studies on the likely action mechanism of tilmicosin on the heart function and on possible remedial measures.
Estonian: Täiendavaid andmeid esitati seoses 4 uuringuga tilmikosiini tõenäolise toimemehhanismi kohta südame funktsioonile ja võimalike ravimeetmete kohta.
English: It is evident that accidental injections may occur, but normally the volume injected is low.
Estonian: On ilmne, et süstida võidakse juhuslikult, kuid süstitav kogus on tavaliselt väike.
English: Stawki no. 2, 21 pietro 00-193 Warsaw Poland
Estonian: Stawki no. 2, 21 pietro 00-193 Varssavi Poola
English: Iris mednarodna trgovina d.o.o Cesta v Gorice 8, SI-1000 Ljubljana, Slovenija
Estonian: Iris mednarodna trgovina d.o.o Cesta v Gorice 8, SI-1000 Ljubljana, Sloveenia
English: Harmonised, stringent user safety warnings would include:
Estonian: Ühtlustatud, ranged kasutajaohutusnõuded sisaldavad järgmist:
English: Under paragraph 5.1 “Pharmacodynamic properties”
Estonian: Lõige 5.1 "Farmakodünaamilised omadused"
English: The use of a 2 ml or smaller syringe will facilitate accurate dosing.
Estonian: 2 ml suuruse või väiksema süstla kasutamine kergendab ravimi täpset doseerimist.
English: The risk : benefit analysis for Micotil is rather complex and various risk management proposals must be carefully considered.
Estonian: Micotili riski/kasulikkuse analüüs on üsna keerukas ning erinevaid riski vähendamise ettepanekuid tuleb hoolikalt kaaluda.
English: In addition this measure would bear a high risk of being ignored.
Estonian: Lisaks esineb suur risk, et seda meedet tegelikkuses ei rakendataks.
English: RG21 6XA United Kingdom
Estonian: RG21 6XA Ühendkuningriik
English: - The educational measures for the user are a prerequisite to ensure appropriate adherence to the safety warnings.
Estonian: - Kasutajate teavitustöö on ohutusnõuete järgimise tagamise korral hädavajalik eeltingimus.
English: • Do not work alone when using Micotil.
Estonian: • Micotiliga töötades ei tohi olla üksinda.
English: Boehringer Ingelheim Vetmedica GmbH Binger Strasse 173 55216 Ingelheim Germany
Estonian: Boehringer Ingelheim Vetmedica GmbH Binger Strasse 173 55216 Ingelheim Saksamaa
English: As the dosage of the product in adult sheep is typically 1-5 ml and in adult cattle is typically 15-20 ml, it is difficult to accurately estimate the incidence of human reactions or fatalities.
Estonian: Arvestades seda, et täiskasvanud lammaste annus on tavaliselt 1-5 ml ning täiskasvanud veistel 15-20 ml, on raske täpselt hinnata kõrvaltoimete või surmajuhtude esinemist inimestel.
English: Furthermore the revised aspects of the Summary of Product Characteristics should be implemented in the labelling and product leaflet as set out below.
Estonian: Ravimiomaduste kokkuvõtte läbivaadatud aspektid tuleks välja tuua toote märgistusel ning pakendi infolehel, nagu on sätestatud allpool.
English: ELANCO ELLAS Messogion 335 Av, 15231 Athens Greece
Estonian: ELANCO ELLAS Messogion 335 Av, 15231 Ateena Kreeka
English: Tilmicosin was found to dosedependently reduce ICa amplitude with an IC50 value of 26.75 µM.
Estonian: Leiti, et tilmikosiin vähendab annusest sõltuvalt ICa amplituudi IC50 väärtust 26,75 µM võrra.
English: Very rarely the volume is higher than 1-2 ml and it is improbable that a fatality will occur.
Estonian: Väga harva on kogus üle 1-2 ml ja surmajuhtumid on ebatõenäolised.
English: These results suggest that intravenous epinephrine may be contraindicated.
Estonian: Need tulemused näitavad, et intravenoosne epinefriin võib olla vastunäidustatud.
English: Single dose All sheep indications and pneumonia in cattle:
Estonian: Üksikannus Lammastele kõikidel näidustustel ning veistele kopsupõletiku korral:
English: This option bears the following inherent risks:
Estonian: Selles võimaluses sisalduvad järgnevad riskid:
English: Of these 509 reports, 214 cases related to non-injection exposures, and 295 to injection exposures, with minor needle scratches being the most common.
Estonian: Neist 509 teatatud juhust 214 ei olnud seotud süstimisest tekkinud ekspositsiooniga ja 295 olid süstimisest tulenenud ekspositsioonid, millest kõige sagedasemad olid kerged nõelatorked.
English: Such cardiotoxic effects have also been observed in human beings (mainly after intentional injection but in 2 known cases outside the EU after accidental injection of Micotil).
Estonian: Selliseid kardiotoksilisi efekte on täheldatud ka inimestel (peamiselt pärast ettekavatsetud süstimist, kuid ka kahel juhul väljaspool Euroopa Liitu juhuslikul Micotili süstides).
English: Exposure assessment
Estonian: Ekspositsiooni hindamine
English: Evidence from investigations of 13 occurrences of intentional intramuscular injection suggests that 60% of people who received 10 to 12 ml of Micotil died.
Estonian: 13 tahtliku intramuskulaarse süstimise juhu uurimisel saadud tõendusmaterjal näitab, et 60% neist patsientidest, kes said Micotili 10-12 ml, suri.
English: LABELLING AND PACKAGE LEAFLET
Estonian: MÄRGISTUS JA PAKENDI INFOLEHT
English: “Special precautions to be taken by the person administering the medicinal product to animals”
Estonian: “Antud veterinaarravimit loomadele manustava isiku poolt rakendatavad spetsiaalsed ettevaatusabinõud”
English: Tilmicosin is an antimicrobial substance that is not used in human medicine and resistance in human bacteria to tilmicosin is very low (source: DANMAP).
Estonian: Tilmikosiin on antibiootikum, mida inimmeditsiinis ei kasutata ning inimpatogeenide tilmikosiiniresistentsus on väga madal (allikas: DANMAP).
English: Considering the recommendation of the Committee to restrict use to veterinary surgeons only, restriction of maximum pack size is not relevant, as the product will remain in the care of the veterinary surgeon.
Estonian: Arvestades komitee soovitust lubada ravimi kasutamine vaid veterinaararstidel, ei ole maksimaalse pakendi suuruse piirang oluline, sest toode jääb veterinaararsti hoole alla.
English: • Avoid contact with eyes.
Estonian: • Vältige ravimi sattumist silma.
English: Survival rates are greatly improved by the correct medical intervention.
Estonian: Ellujäämise tõenäosust parandab märkimisväärselt õige arstiabi.
English: Concerns were raised concerning the adequacy of the existing safety warnings and conditions for use of the product in protecting users from self-injection and its potential serious consequences as well as the need to provide adequate information for medical action in case of such an occurrence or abuse of the product (suicide).
Estonian: On väljendatud muret seoses olemasolevate ohutusalaste hoiatuste ja ravimi kasutamistingimuste piisavusega kasutajate kaitsmiseks enesesüstimise ja selle potentsiaalselt tõsiste tagajärgede eest, samuti seoses vajadusega esitada piisavat teavet meditsiinilise sekkumise kohta sellisel juhul või ravimi kuritarvitamise korral (enesetapuks).
English: Veterinary surgeons have specific training in drug safety, clinical medicine, animal husbandry, restraining and handling of animals.
Estonian: Veterinaararstid on läbinud ravimiohutuse, kliinilise meditsiini, loomapidamise ning loomade ohjamise ning kohtlemise alase erikoolituse.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Estonian: LAUSE “AINULT LOOMADE RAVIKS” NING RAVIMI VÄLJASTAMIS- JA KASUTAMISTINGIMUSED VÕI -PIIRANGUD
English: A statement in a frame with yellow background colour, saying:
Estonian: Raamitud teadaanne kollasel taustal:
English: Discussion of risk management options
Estonian: Riskijuhtimisvõimaluste arutelu
English: Cattle and calves up to 2 years of age;
Estonian: Veised ja kuni 2 a vanused vasikad;
English: Do not inject lambs weighing less than 15 kg, since there is a real risk of overdose toxicity.
Estonian: Ärge süstige alla 15 kg kaaluvaid lambaid, sest eksisteerib reaalne risk üleannustamisest tingitud toksilisuse tekkeks.
English: Apply a cold pack (not ice directly) to the injection site.
Estonian: Hoidke süstekohal külma kompressi (mitte otseselt jääd).
English: Overall, the CVMP considers the risks inherent to this option would be the lowest.
Estonian: Üldiselt hindab veterinaarravimite komitee selles variandis sisalduvaid riske teiste võimalustega võrreldes kõige madalamaks.
English: Product trade name
Estonian: Toote kaubanduslik nimetus
English: Under paragraph 4.9 “Amounts to be administered and administration route”
Estonian: Lõige 4.9 " Annustatavad kogused ja manustamisviis"
English: Eli Lilly Italia S.p.A Elanco Animal Health Via Gramsci, 733 Sesto Fiorentino, 50019 Firenze Italy
Estonian: Eli Lilly Italia S.p.A Elanco Animal Health Via Gramsci, 733 Sesto Fiorentino, 50019 Firenze Itaalia
English: Given the diversity of farming conditions throughout the different EU Member States concerned by the referral, the various capabilities of farmers in the EU Member States concerned, as well as the recent trends in farming of more suckler animals and scarcity of labour in some EU Member States, the CVMP does not concur with the view of the representative of the MAHs that all ‘professional' farmers may be regarded as experienced and competent.
Estonian: Arvestades Euroopa Liidu liikmesriigiti erinevaid loomakasvatustingimusi, loomakasvatajate erinevaid võimalusi asjassepuutuvates liikmesriikides ning viimasel ajal suurenenud imetavate loomade hulka ning põllumajandustööjõu puudust mõnes liikmesriigis, ei nõustu veterinaarravimite komitee müügiloa hoidjate esindaja arvamusega, et kõik loomakasvatajad on kogenud ning kompetentsed.
English: Such a volume restriction would necessitate additional administrations to the same animal.
Estonian: Selline ühekordse manustamiskoguse piiramine tähendaks mitme süsti tegemist ühele ja samale loomale.
English: It noted that a lower strength product would firstly lead to an increase in the number of administrations necessary to achieve a therapeutic dose.
Estonian: Märgiti, et madalama kontsentratsiooniga ravim tähendaks esiteks terapeutilise annuse saavutamiseks vajalike manustamiskordade arvu suurenemist.
English: In view of the benefits afforded by the product as set out above and on the basis of the evidence provided by the representative of the MAHs the CVMP is of the opinion that this approach is however not proportionate.
Estonian: Arvestades tootest saadavat tulu ning tuginedes müügiloa hoidjate esindaja poolt esitatud tõendusmaterjalile, arvab veterinaarravimite komitee, et mainitud lähenemine ei ole siiski proportsionaalne.
English: Bearing the aforesaid in mind, based on the data provided by the representative of the MAHs on world-wide sales of Micotil since 1999 and the 2 cases of accidental fatal injections in human beings reported to date in the USA, the risk of an accidental human fatality may be estimated as less than 1 per 60 million administrations1.
Estonian: Arvestades eespool mainitut ning tuginedes müügiloa hoidjate esindaja poolt esitatud Micotili ülemaailmset müüki puudutavale statistikale alates 1999. aastast ning võttes arvesse ka kahte surmavat juhuslikku süstimisjuhtu inimestel, millest teatati Ameerika Ühendriikidest, on risk juhusliku surmajuhtumi tekkeks inimesel väiksem kui üks 60 miljoni manustamise kohta1.
English: Cattle (not to be used in lactating cows)
Estonian: Veised (kasutamine keelatud lakteerivatel lehmadel)
English: the CVMP recommends by a majority of 18 out of 27 votes that the warnings relative to user safety of the nationally granted Marketing Authorisations be harmonised and that the conditions of use be harmonised to ‘For use by veterinary surgeons only'; the revised aspects of the Summary of Product Characteristics are set out in Annex III and the conditions considered essential for the safe use of the product, as referred to in Article 36(4) of Directive 2001/82/EC as amended, are set out in Annex IV.
Estonian: soovitab veterinaarravimite komitee 18 häälega 27st ühtlustada siseriiklikult väljastatavate müügilubade tingimuste kasutajaohutust puudutav osa ning kasutustingimused (“Kasutusõigus ainult veterinaararstidel”); ravimiomaduste kokkuvõtte läbivaadatud aspektid on esitatud III lisas ning toote ohutu kasutamise puhul oluliseks peetavad tingimused, nagu on osutatud muudetud direktiivi 2001/82/EÜ artikli 36 lõikes 4, on esitatud IV lisas.
English: Qualitative risk assessment
Estonian: Kvalitatiivse riski hindamine
English: For the EU the average bovine weight was put on 150 kg (90% of the sales) whereas the average ovine weight was kept at 30 kg.
Estonian: Euroopa Liidu puhul arvestati veise keskmiseks kaaluks 150 kg (90% müügist) ning lamba keskmiseks kaaluks 30 kg.
English: The primary cardiac effects are increased heart rate (tachycardia) and decreased contractility (negative inotrophy).
Estonian: Südamele avalduvad mõjud on eelkõige pulsisageduse tõus (tahhükardia) ja südame kontraktiilsuse vähenemine (negatiivne inotroopne toime).
English: DO NOT GIVE ADRENALIN OR BETA-ADRENERGIC ANTAGONISTS SUCH AS PROPRANOLOL.
Estonian: MITTE MANUSTADA ADRENALIINI EGA BEETAADRENERGILISI ANTAGONISTE, NÄITEKS PROPANOLOOLI.
English: Although the actual role of CaCl2 infusion following tilmicosin exposure in humans is inconclusive because of the limited data available, it is suggested that CaCl2 infusion may help to reverse the induced changes in blood pressure and heart rate in humans.
Estonian: Kuigi CaCl2 infusiooni tegelik roll inimestele pärast tilmikosiiniga kokkupuutumist ei ole kättesaadavate andmete piiratuse tõttu lõplikult kindlaks määratud, arvatakse, et CaCl2 infusioon võib aidata inimeste vererõhus ja pulsisageduses esilekutsutud muutusi tagasi pöörata.
English: The representative of the MAHs further identified a report of accidental injection in humans where CaCl2 had been used as part of the emergency treatment of the patient.
Estonian: Müügiloa hoidjate esindaja teatas ka ühest inimese juhusliku süstimise juhust, mille puhul CaCl2 oli kasutatud ühe osana patsiendi ravimiseks hädaolukorras.
English: As tilmicosin persists in tissues for several days, the cardiovascular system should be closely monitored and supportive treatment provided.
Estonian: Kuna tilmikosiin püsib kudedes mitu päeva, tuleb südant ja veresoonkonda hoolikalt jälgida ja kasutada sümptomaatilist ravi.
English: When administered by injection, tilmicosin has been fatal in various species, including primates (in monkeys 30 mg/kg bw were shown to be fatal), mainly due to its cardio-toxic effects.
Estonian: Süstides on tilmikosiin osutunud surmavaks ravimiks mitmetel liikidel, sealhulgas ka primaatidel (ahvidel on letaalne annus 30 mg kehakaalu kilogrammi kohta), peamiselt oma kardiotoksiliste efektide tõttu.
English: Overall risk assessment
Estonian: Üldine riski hindamine
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, ANIMAL SPECIES AND MARKETING AUTHORISATION HOLDERS IN THE CONCERNED MEMBER STATES
Estonian: I LISA RAVIMITE NIMEDE, FARMATSEUTILISE VORMI, TOIMEAINE SISALDUSE, MANUSTAMISTEEDE, LOOMALIIKIDE LOETELU NING MÜÜGILOA HOIDJATE LOETELU ASJASSEPUUTUVATES LIIKMESRIIKIDES
English: The risk of serious signs of toxicity and death in human beings appear to be linked to plasma concentrations around 5 µg/ml, whereas plasma concentrations of 1-2 µg/ml did not lead to fatalities.
Estonian: Tõsiste toksiliste reaktsioonide teket inimesel ning surma seostatakse ravimi ligikaudu 5 µg/ml plasmakontsentratsioonidega, plasmakontsentratsioonid 1-2 µg/ml ei põhjustanud surmajuhtumeid.
English: Additional recommendation to any of the options 3. to 5. regarding limitation of the volume of Micotil to be held per syringe or of maximum pack size or re-formulation of the product
Estonian: Lisasoovitused võimalustele 3 kuni 5 korraga süstlasse võetava Micotili koguse ning maksimaalse lubatud pakendi suuruse või uue tooteretsepti kohta.
English: The results of an additional study with administration of epinephrine as a treatment for combating intravenous tilmicosin toxicity in swine strongly suggest that intravenous administration of epinephrine may be contraindicated due to the rate of deaths in the treated group.
Estonian: Täiendava uuringu tulemused epinefriini manustamisega tilmikosiini intravenoosse manustamise tagajärjel tekkinud toksilisuse raviks sigadel näitavad kindlalt, et epinefriini intravenoosne manustamine võib olla surmajuhtumite sageduse tõttu ravitud rühmas vastunäidustatud.