natgillin/translations-raw huggingface dataset:
What benefits of Vantobra have been shown in studies?
Milles seisneb uuringute põhjal Vantobra kasulikkus?
Vantobra is inhaled using a device called Tolero nebuliser, which converts the solution in the ampoule into a fine mist.
Ravimit Vantobra inhaleeritakse Tolero nebulisaatoriga, mis muudab ampullis oleva lahuse peeneks uduks.
For these patients Vantobra, which is inhaled as a solution from a nebuliser, would be a useful alternative.
Nende patsientide jaoks on kasulik alternatiiv Vantobra, mis on nebulisaatoriga inhaleeritav lahus.
How is Vantobra used?
Kuidas ravimit Vantobra kasutatakse?
Vantobra is available as a nebuliser solution in single-dose ‘ampoules'.
Ravimit Vantobra turustatakse nebuliseeritava lahusena üheannuselistes ampullides.
Side effects with Vantobra are not common.
Vantobra kasutamisel ei esine kõrvalnähte sageli.
In addition, a ‘bioequivalence' study in 58 patients with cystic fibrosis aged 6 years and above determined whether Vantobra produces similar levels of the active substance in the body as the reference medicine, Tobi.
Lisaks korraldas müügiloa taotleja bioekvivalentsuse uuringu, milles osales 58 vähemalt 6-aastast tsüstilise fibroosiga patsienti.
Beacon Pharmaceuticals Limited,
Ühendkuningriik Beacon Pharmaceuticals Limited,
Praceta do Farol, lote 101 Cascais 2750-341
Praceta do Farol, lote 101 Cascais 2750-341 Portugal
Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration and marketing authorisation holders in the member states
Nimetuste, ravimvormide, ravimite tugevuste, manustamisteede ja müügiloa hoidjate loetelu liikmesriikides
Cólquide, 6 - Portal 2, 1º-Oficina F
LABORATORIO, S.A. Cólquide, 6 - Portal 2, 1º-Oficina F
Kent DA2 6SL
Kent DA2 6SL United Kingdom
Tarchomińskie Zakłady Farmaceutyczne "Polfa" S.A. 2, A. Fleminga Str.
Tarchomińskie Zakłady Farmaceutyczne "Polfa" S.A.
Luxembourg Profile Pharma Limited Chichester Business Park City Fields Way
Ühendkuningriik Profile Pharma Limited Chichester Business Park City Fields Way
03-176 Warsaw Poland
2, A. Fleminga Str. 03-176 Warsaw Poland
Tunbridge Wells, Kent TN1 1YG
Tunbridge Wells, Kent
Colistimethat-Natrium Infectopharm I.E. Pulver zur Herstellung einer Injektionsoder Infusionslösung powder for solution for injection/infusion
Colistimethat-Natrium Infectopharm I.E. Pulver zur Herstellung einer Injektionsoder Infusionslösung
Promixin nasal use
Promixin nasaalne
Colixin 1 milijun IU prašak za otopinu za injekciju powder for solution for injection
Colixin 1 milijun IU prašak za otopinu za injekciju
COLIMYCINE 1.000.000 U.I., poudre et solvant pour solution injectable powder and solvent for solution for injection
COLIMYCINE 1.000.000 U.I., poudre et solvant pour solution injectable
55134, Kalamaria, Thessaloniki Greece
ALLERTEC HELLAS AE 74 Karamanli str. 55134, Kalamaria, Thessaloniki Greece
GES GENÉRICOS ESPAÑOLES LABORATORIO, S.A.
GES GENÉRICOS ESPAÑOLES
Tadim 1 Million I.E. Pulver zur Herstellung einer Infusionslösung powder for solution for infusion
Tadim 1 Million I.E. Pulver zur Herstellung einer Infusionslösung
COLIMYCINE 1 MUI, poudre et solvant pour inhalation par nébuliseur powder and solvent for nebuliser solution
COLIMYCINE 1 MUI, poudre et solvant pour inhalation par nébuliseur
Forest Pharma B.V. Newtonlaan 115
Forest Pharma B.V.
Colistimethate sodium 1 million international units powder for solution for injection or infusion powder for solution for injection/infusion
Colistimethate sodium 1 million international units powder for solution for injection or infusion
Colistimetato de sodio GES 1 MUI polvo para solución inyectable/para inhalación por nebulizador powder for solution for injection, powder for nebuliser solution
Colistimetato de sodio GES 1 MUI polvo para solución inyectable/para inhalación por nebulizador
Pulver zur Herstellung einer Lösung für einer Infusionslösung powder for solution for infusion
Pulver zur Herstellung einer Lösung für einer Infusionslösung
Colixin 1 MUI polvo para solución inyectable o para solución para inhalación por nebulizador powder for solution for injection, powder for nebuliser solution
Colixin 1 MUI polvo para solución inyectable o para solución para inhalación por nebulizador
powder for solution for infusion
powder for solution for injection
Colomycin Injection 2 million international units powder for soln for inj, infusion or inhalation powder for solution for injection
Colomycin Injection 2 million international units powder for soln for inj, infusion or inhalation
Pulver zur Herstellung einer Injektions-/Infusionslösung powder for solution for injection/infusion
Pulver zur Herstellung einer Injektions-/Infusionslösung
powder for solution for injection/infusion/ inhalation
Powder for solution for injection, infusion or inhalation
Colomycin Injection 1million International Units powder for solution for injection, infusion or inhalation powder for solution for injection/infusion/ inhalation
Colomycin Injection 1million International Units powder for solution for injection, infusion or inhalation
Colistimethatnatrium "Xellia" 1000000 I.U.
Colistimethatnatrium "Xellia" 1000000 RÜ süste-/infusioonilahuse pulber intravenoosne
Belgium Forest Laboratories UK Ltd. Riverbridge House
Ühendkuningriik Forest Laboratories UK Limited Riverbridge House Anchor Boulevard
Crossways Business Park Dartford
Crossways Business Park Dartford, Kent DA2 6SL United Kingdom
Colomycin Injection 1 million international units powder for soln for inj, infusion or inhalation powder for solution for injection, infusion or inhalation intramuscular use, intravenous use, inhalation use
Colomycin Injection 1 million international units powder for soln for inj, infusion or inhalation
powder for solution for injection, injection or inhalation intramuscular use, intravenous use, inhalation use
1000000 RÜ süstelahuse pulber, infusioon või inhalatsioon intramuskulaarne, intravenoosne, inhalatsioon
Promixin 1 million international units (IU) powder for solution for infusion powder for solution for injection intramuscular use, intravenous use
Promixin 1 million international units (IU) powder for solution for infusion
Colistin ForestTrockenstechampullen mit Lösungsmittel powder and solvent for suspension for injection, nebuliser solution intramuscular use, intravenous use, inhalation use
1000000 RÜ süstesuspensiooni pulber ja lahusti, nebuliseeritav lahus intramuskulaarne, intravenoosne, inhalatsioon
The antibodies will help to protect against the disease.
Antikehad aitavad kaitsta haiguse eest.
Long-term antibody levels were similar with both schedules.
Pikaajaline antikehade sisaldus oli sarnane mõlema skeemi korral.
Vaccination must be postponed in people with recent severe fever.
Vaktsineerimine tuleb edasi lükata patsientidel, kellel on hiljuti olnud kõrge palavik.
Ixiaro received a marketing authorisation valid throughout the EU on 31 March 2009.
Ixiaro on saanud müügiloa, mis kehtib kogu ELis, 31. märtsil 2009.
Further information on Ixiaro can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Ixiaro.
Lisateave Ixiaro kohta on ameti veebilehel: ema.europa.eu/medicines/human/EPAR/Ixiaro.
• The third main study involved 1,869 children aged between 2 months and 18 years.
• Kolmandas põhiuuringus osales 1869 last vanuses 2 kuud kuni 18 aastat.
What measures are being taken to ensure the safe and effective use of Ixiaro?
Mis meetmed võetakse, et tagada Ixiaro ohutu ja efektiivne kasutamine?
The second dose should be given at least one week before potential exposure to the virus.
Teine annus tuleb manustada vähemalt üks nädal enne võimalikku kokkupuudet viirusega.
The European Medicines Agency decided that Ixiaro's benefits are greater than its risks and it can be authorised for use in the EU.
Euroopa Ravimiamet otsustas, et Ixiaro kasulikkus on suurem kui sellega kaasnevad riskid ja et ravimi kasutamise võib ELis heaks kiita.
The 7-day accelerated vaccination course did not produce lower protection than the standard 4-week vaccination course.
7-päevane kiirvaktsineerimine ei põhjustanud nõrgemat kaitset kui 4-nädalane tavavaktsineerimine.
Other information about Ixiaro
Muu teave Ixiaro kohta
It is transmitted by mosquitoes and is most common in Asia, particularly in rural areas.
Haigust kannavad edasi sääsed ja enamasti esineb haigus Aasias, eelkõige maapiirkondades.
This was compared with 94% of the people receiving the comparator vaccine (347 out of 370).
Võrdlusvaktsiiniga vaktsineeritutest oli selliseid 94% (347 inimest 370st).
Children and adolescents may also receive a booster dose one to two years after the initial vaccination.
Lapsed ja noorukid tohivad samuti saada korduvannuse 1-2 aastat pärast algset vaktsineerimist.
Ixiaro (Japanese encephalitis vaccine (inactivated, adsorbed))
Ixiaro (Jaapani entsefaliidi vaktsiin (inaktiveeritud, adsorbeeritud))
As for all medicines, data on the use of Ixiaro are continuously monitored.
Nagu kõigi ravimite puhul, teostatakse Ixiaro kasutamise kohta pidevat järelevalvet.
This means that the virus is fixed onto aluminium compounds, to stimulate a better response.
See tähendab, et viirus on parema immuunvastuse tekitamiseks kinnitatud alumiiniumiühenditele.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ixiaro have been included in the summary of product characteristics and the package leaflet.
Ixiaro ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
The Agency noted that the production of the only other vaccine for protection against Japanese encephalitis that was in use outside Asia had been discontinued.
Amet märkis, et on lõpetatud ainsa teise väljaspool Aasiat kasutatud Jaapani entsefaliidi eest kaitsva vaktsiini tootmine.
When a person is given the vaccine, the immune system identifies the inactivated virus as ‘foreign' and makes antibodies against it.
Kui inimesele manustatakse vaktsiini, peab immuunsüsteem inaktiveeritud viirust võõraks ja tekitab selle vastu antikehi.
Side effects reported with Ixiaro are carefully evaluated and any necessary action taken to protect patients.
Ixiaro kõrvaltoimeid hinnatakse hoolikalt ja patsientide kaitseks rakendatakse vajalikke meetmeid.
• The second main study in 660 adults compared a rapid vaccination course (2 doses given 7 days apart) with the standard vaccination course (2 doses given 4 weeks apart).
• Teises põhiuuringus, milles osales 660 täiskasvanut, võrreldi kiirvaktsineerimist (2 annust 7-päevase vahega) tavavaktsineerimisega (2 annust 4-nädalase vahega).
Before vaccination, most of the people in the study had no protective levels of antibodies against the virus.
Enne vaktsineerimist ei olnud enamikul uuringus osalenutest viirusvastaseid antikehi kaitsvas koguses.
Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend against a disease.
Vaktsiinid n-ö õpetavad immuunsüsteemi (organismi looduslikud kaitsemehhanismid) kaitsma organismi haiguse eest.
For more information about using Ixiaro, see the package leaflet or contact your doctor or pharmacist.
Lisateavet Ixiaro kasutamise kohta vt pakendi infolehest või konsulteeri oma arsti või apteekriga.
What is Ixiaro and what is it used for?
Mis on Ixiaro ja milleks seda kasutatakse?
Vaccination with Ixiaro should be considered for people who are at risk of exposure to the Japanese encephalitis virus through travel or work.
Ixiaroga vaktsineerimist tuleb kaaluda inimestel, kellel on reisimise või töö tõttu Jaapani entsefaliidi viirusega kokkupuute risk.
Japanese encephalitis can be fatal or lead to long-term disability.
Jaapani entsefaliit võib lõppeda surmaga või tekitada pikaajalise puude.
The virus in Ixiaro is grown in mammal cells (‘Vero cells') under laboratory conditions.
Ixiaros sisalduvat viirust kasvatatakse laboritingimustes imetajate rakkudes (nn Vero rakud).
In addition, the company presented the results of studies looking at the level of protection in adults and in children for up to 3 years after vaccination with Ixiaro, and at the response to booster doses.
Peale selle esitas turustaja uuringute tulemused, milles vaadeldi kaitsetaset täiskasvanutel ja lastel kuni 3 aasta jooksul pärast Ixiaroga vaktsineerimist ning reaktsiooni korduvannustele.
• The first study involved 867 healthy adults and compared Ixiaro with another vaccine for Japanese encephalitis containing viruses grown in mouse brains.
• Esimeses uuringus, milles osales 867 tervet täiskasvanut, võrreldi Ixiarot teise Jaapani entsefaliidi vaktsiiniga, mis sisaldas hiire ajus kasvatatud viirust.
These additional studies showed that protection against Japanese encephalitis virus lasted for at least 2 to 3 years in most people vaccinated with Ixiaro.
Lisauuringud tõendasid, et kaitse Jaapani entsefaliidi viiruse vastu kestis enamikul Ixiaroga vaktsineeritutel vähemalt 2-3 aastat.
In adults, the second dose can be given up to 11 months after the first.
Teise annuse tohib manustada täiskasvanutele kuni 11 kuu jooksul pärast esimest annust.
In adults, including those aged above 65 years, and children aged 3 years and older, a full dose of Ixiaro (0.5 ml) should be given, and an additional 0.5 ml dose should be given four weeks later.
Täiskasvanutele, sh üle 65-aastastele, ja vähemalt 3-aastastele lastele tuleb manustada Ixiaro täisannus (0,5 ml) ning 4 nädala pärast lisaannus (0,5 ml).
Adults from 18 to 65 years can also receive a rapid vaccination course, where the second dose is given seven days after the first dose.
18-65-aastastele täiskasvanutele tohib teha ka kiirvaktsineerimist, mille korral manustatakse teine annus 7 päeva pärast esimest.
Ixiaro contains small amounts of the virus that causes Japanese encephalitis, which has been inactivated (killed) so that it cannot cause the disease.
Ixiaro sisaldab väheses koguses Jaapani entsefaliidi viirust, mis on inaktiveeritud (surmatud), nii et see ei saa haigust tekitada.
The most common side effects with Ixiaro in adults (which may affect more than 1 in 10 people) are headache, myalgia (muscle pain), pain and tenderness at the injection site and tiredness.
Täiskasvanutel on Ixiaro kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 patsiendil 10st) peavalu, müalgia (lihasevalu), süstekoha valu ja valulikkus ning väsimus.
Four weeks after the final injection, 96% of these people who received both doses of Ixiaro had developed protective levels of antibodies (352 out of 365).
Viimasest süstist 4 nädala möödumisel oli Ixiaro mõlema annuse saanutest neid, kellel tekkis kaitsvas koguses antikehi, 96% (352 inimest 365st).
A booster dose should also be considered for adults aged above 65 years before any further exposure to the Japanese encephalitis virus.
Korduvannust tuleb kaaluda ka üle 65-aastastel enne nende võimalikku kokkupuudet Jaapani entsefaliidi viirusega.
What are the risks associated with Ixiaro?
Mis riskid Ixiaroga kaasnevad?
In children aged between 2 months and 3 years, half the adult dose of Ixiaro (0.25 ml) should be given, and an additional 0.25 ml dose should be given four weeks later.
2 kuu kuni 3 aasta vanustele lastele tuleb manustada pool Ixiaro täiskasvanu annust (0,25 ml) ning 4 nädala pärast tuleb manustada lisaannus (0,25 ml).
Adults from 18-65 years who are likely to be exposed to the Japanese encephalitis virus again or who are at continuous risk of the disease should receive a booster dose of Ixiaro one to two years later and a second booster dose 10 years after the first booster.
18-65-aastastele täiskasvanutele, kes tõenäoliselt puutuvad Jaapani entsefaliidi viirusega uuesti kokku või kellel on pidev kokkupuuterisk, tuleb 1-2 aasta pärast manustada esimene korduvannus ja 10 aastat pärast esimest teine korduvannus.
Ixiaro must not be used in people who are hypersensitive (allergic) to any residual substances in the vaccine such as protamine sulphate.
Ixiarot ei tohi kasutada patsiendid, kes on ülitundlikud (allergilised) vaktsiini mis tahes jääkainete suhtes (näiteks protamiinsulfaat).
How does Ixiaro work?
Kuidas Ixiaro toimib?
For the full list of side effects of Ixiaro, see the package leaflet.
Ixiaro kõrvalnähtude täielik loetelu on pakendi infolehel.
They also showed that a booster dose might be needed to maintain high levels of protection, which may be necessary for people at high risk of exposure to the virus.
Samuti tõendati uuringutes, et viirusega kokkupuute suure riskiga isikud võivad suurema kaitsetaseme saavutamiseks vajada korduvvaktsineerimist.
Anyone who has an allergic reaction after the first dose of Ixiaro should not receive the second dose.
Kui Ixiaro esimene annus tekitab allergilise reaktsiooni, ei tohi teist annust manustada.
Ixiaro is a vaccine that helps protect adults and children aged 2 months and older against Japanese encephalitis, a disease that causes inflammation of the brain.
Ixiaro on vaktsiin, mida kasutatakse täiskasvanute ja vähemalt 2-kuuste laste kaitseks Jaapani entsefaliidi (peaaju põletikku tekitava haiguse) eest.
What benefit of Ixiaro have been shown in studies?
Milles seisneb uuringute põhjal Ixiaro kasulikkus?
An overview of Ixiaro and why it is authorised in the EU
Ülevaade ravimist Ixiaro ja ELis müügiloa väljastamise põhjendus
Ixiaro can only be obtained with a prescription.
Ixiaro on retseptiravim.
How is Ixiaro used?
Kuidas Ixiarot kasutatakse?
In children, fever, diarrhoea, influenza-like illness, irritability, and reactions at the injection site (such as redness,
Lastel on kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 lapsel 10st) palavik, kõhulahtisus, gripilaadne haigus, ärrituvus ning süstekoha reaktsioonid (näiteks punetus, valu ja valulikkus).
It is recommended that individuals who receive the first dose of Ixiaro should receive both doses.
Ixiaro esimese annuse saanud isikutele on soovitatav manustada ka teine annus.
99% to 100% of children who received both doses of Ixiaro had developed protective levels of antibodies against the Japanese encephalitis virus 4 weeks after the final injection.
Mõlemad Ixiaro annused saanud lastest oli neid, kellel tekkis 4 nädalat pärast viimast vaktsineerimist kaitsev kogus antikehi Jaapani entsefaliidi viiruse vastu, 99-100%.
Ixiaro is given by injection into a muscle, preferably into the shoulder muscle, or into the thigh muscle in young children.
Vaktsiini süstitakse lihasesse, eelistatavalt deltalihasesse (õlavarde) või väikelastel reielihasesse.
In future, the immune system will be able to produce antibodies quickly and in large numbers when it is exposed to Japanese encephalitis virus again.
Kui immuunsüsteem puutub hiljem Jaapani entsefaliidi viirusega uuesti kokku, tekib kiiresti palju antikehi.
On average, the levels of antibodies were over 2 times higher in the people receiving Ixiaro than in those receiving the comparator vaccine.
Ixiarot saanutel oli antikehade sisaldus keskmiselt üle 2 korra suurem kui võrdlusvaktsiini saanutel.
Ixiaro (given as 2 doses 4 weeks apart) was as effective as the comparator vaccine at triggering the production of antibodies against the Japanese encephalitis virus.
4-nädalase vahega 2 annusena manustatud Ixiaro tekitas Jaapani entsefaliidi viiruse vastaseid antikehi sama efektiivselt kui võrdlusvaktsiin.
Ixiaro has been shown to trigger the production of antibodies against the Japanese encephalitis virus in 3 main studies:
3 põhiuuringus tõendati, et Ixiaro vallandab antikehade tekke Jaapani entsefaliidi viiruse vastu.
Ixiaro can be injected under the skin in people who have a bleeding disorder such as low blood platelet counts or haemophilia.
Patsientidel, kellel on hüübimishäired, näiteks trombotsüütide (vereliistakute) vaegus või hemofiilia, tohib Ixiarot süstida naha alla.
20 May 2019
20. mai 2019
What is closantel?
Mis on klosanteel?
The European Commission issued a decision on 20 May 2019.
Euroopa Komisjon tegi otsuse 20. mail 2019.
Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/126)
Direktiivi 2001/82/EÜ artikli 35 kohase esildismenetluse (EMEA/V/A/126) tulemused
In addition, cattle may also be treated topically on their skin.
Peale selle võib veiseid ravida paikselt naha kaudu.
Consequently, on 5 February 2018, the United Kingdom initiated a procedure under Article 35 of Directive 2001/82/EC for the aforementioned veterinary medicinal products.
Seetõttu algatas Ühendkuningriik eespool nimetatud veterinaarravimite kohta 5. veebruaril 2018 direktiivi 2001/82/EÜ artikli 35 kohase menetluse.
Withdrawal period refers to the minimum period of time from administering the last dose of veterinary medicinal product and the production of meat or other animal-derived products for food.
Keeluaeg on minimaalne aeg, mis peab jääma veterinaarravimi viimase annuse manustamisest liha või muude loomset päritolu toodete toiduks tootmiseni.
The CVMP recommended that variations to the terms of the marketing authorisations for the aforementioned veterinary medicinal products are required in order to amend the product information accordingly.
Veterinaarravimite komitee soovitas muuta eespool nimetatud veterinaarravimite müügilubade tingimusi, et muuta vastavalt nende ravimiteavet.
Why were solutions for injection containing 50 mg closantel per ml (as a single active substance) reviewed?
Miks vaadati läbi 50 mg/ml klosanteeli (ainsa toimeainena) sisaldavad süstelahused?
On 21 February 2019, the European Medicines Agency (the Agency) completed a review of the consumer safety of the withdrawal periods (meat and offal) for sheep for veterinary medicinal products containing 50 mg closantel per ml (as a single active substance) presented as solutions for injection.
21. veebruaril 2019 lõpetas Euroopa Ravimiamet (edaspidi „amet“) läbivaatamismenetluse, mis käsitles lammastele (liha ja rups) kehtestatud keeluaegade tarbijaohutust 50 mg/ml klosanteeli (ainsa toimeainena) sisaldavate veterinaarravimite korral, mida kasutatakse süstelahusena.
Closantel is intended for use in cattle and sheep for the treatment and control of adult and immature flukes, nematodes and larval stages of some arthropods and is administered subcutaneously by injection or as an oral solution.
Klosanteel on ette nähtud kasutamiseks veistel ja lammastel täiskasvanud maksakaanide ja nende vastsete, ümarusside ja teatud lülijalgsete vastsestaadiumide vastaseks raviks ja tõrjeks ning seda manustatakse subkutaanse süstena või suukaudse lahusena.
The CVMP was requested to review all available residue depletion data and recommend withdrawal periods for meat and offal derived from treated sheep.
Veterinaarravimite komiteel paluti läbi vaadata kõik olemasolevad ravimijääkide kadumise andmed ning soovitada ravitud lammaste liha ja rupsi keeluajad.
The United Kingdom noted that, for veterinary medicinal products containing closantel presented as solutions for injection, there are different approved withdrawal periods for sheep across the European Union e.g. sheep meat and offal, from 28 days to 107 days.
Ühendkuningriik märkis, et süstelahusena kasutatavate klosanteeli sisaldavate veterinaarravimite korral lammaste (näiteks lammaste liha ja rupsi) jaoks heakskiidetud keeluajad Euroopa Liidus on erinevad, st 28 päevast 107 päevani.
Based on the evaluation of the currently-available data, the CVMP concluded that the overall benefitrisk balance for veterinary medicinal products containing 50 mg closantel per ml (as a single active substance) presented as solutions for injection for subcutaneous use in sheep, is positive and agreed that the withdrawal periods (meat and offal) for sheep should be harmonised and amended to provide assurance for consumer safety.
Tuginedes praegu kättesaadavate andmete hindamisele, järeldas veterinaarravimite komitee, et lammastel subkutaanse süstelahusena kasutatavate 50 mg/ml klosanteeli (ainsa toimeainena) sisaldavate veterinaarravimite üldine kasulikkuse ja riski suhe on positiivne, ja nõustus, et lammaste (liha ja rups) keeluaegu tuleb tarbijaohutuse tagamiseks ühtlustada ja muuta.
Proprietary data and scientific references on residue depletion were provided by the marketing authorisation holders.
Müügilubade hoidjad esitasid ravimijääkide organismist kadumise kohta avaldamata andmed ja teaduskirjanduse viited.