natgillin/translations-raw huggingface dataset:
For the full list of all side effects reported with DepoCyte, see the Package Leaflet.
DepoCyte kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
A patient was classified as a ‘responder' if they had no cancer cells in the spinal fluid after treatment and if their symptoms had not got worse after four weeks.
Ravivastus loeti tekkinuks, kui patsiendi seljaaju vedelikus puudusid vähirakud pärast ravi ja kui patsiendi haigus ei olnud pärast nelja nädalat progresseerunud.
What is DepoCyte?
Mis on DepoCyte?
DepoCyte is a ‘depot' injection (a type of injection where the medicine is prepared so that it is absorbed by the body very slowly).
DepoCytet süstitakse depoosüstina (süsti liik, mille korral ravim on valmistatud nii, et see imendub organismi väga aeglaselt).
In DepoCyte, cytarabine is contained in liposomes (small fatty particles), from which the medicine is released slowly.
DepoCyte sisaldab tsütarabiini liposoomides (väikesed rasvaosakesed), millest ravim aeglaselt vabaneb.
Why has DepoCyte been approved?
Miks DepoCyte heaks kiideti?
The study also looked at how long the patients lived without their nerve disease getting worse.
Uuringus jälgiti patsientide elulemust närvihaiguse süvenemiseni.
The most common side effects with DepoCyte (seen in more than 1 treatment cycle in 10) are headache, arachnoiditis (inflammation of one of the membranes protecting the spine and the brain), confusion, nausea (feeling sick), vomiting, diarrhoea, pyrexia (fever), weakness and thrombocytopenia (low blood platelet counts).To minimise the symptoms of arachnoiditis, patients should receive dexamethasone by mouth or by injection at the same time as DepoCyte and must be closely monitored.
DepoCyte kõige sagedamad kõrvalnähud (esinenud enam kui 1 ravitsükli jooksul 10st) on peavalu, arahnoidiit (selja- ja peaaju teatud kelme ehk ämblikuvõrkkesta põletik), segasus, iiveldus, oksendamine, kõhulahtisus, palavik, nõrkus ja trombotsütopeenia (vereliistakute vähesus).
It is a cytotoxic (a medicine that kills cells that are dividing, such as cancer cells), which belongs to the ‘anti-metabolite' group.
See on antimetaboliitide rühma kuuluv tsütotoksiline aine (ravim, mis hävitab jagunevaid rakke, näiteks vähirakke).
The full EPAR for DepoCyte can be found here.
Euroopa avaliku hindamisaruande täistekst DepoCyte kohta on siin.
What benefit has DepoCyte shown during the studies?
Milles seisneb uuringute põhjal DepoCyte kasulikkus?
How has DepoCyte been studied?
Kuidas DepoCytet uuriti?
The medicine must be injected ‘intrathecally' (directly into the spinal fluid in the space that surrounds the spinal cord and the brain).
Ravimit peab süstima intratekaalselt (otse seljaaju vedelikku selja- ja peaaju ümbritsevate kelmete vahele).
The patient should also receive dexamethasone (a steroid) to help control some of the medicine's side effects.
Ravimi mõningate kõrvalnähtude ärahoidmiseks peaks patsient saama ka deksametasooni (steroidi).
How is DepoCyte used?
Kuidas DepoCytet kasutatakse?
What is DepoCyte used for?
Milleks DepoCytet kasutatakse?
DepoCyte has been compared with a standard formulation of cytarabine in one main study involving 35 patients with lymphomatous meningitis.
Põhiuuringus, milles osales 35 lümfomatoosse meningiidiga patsienti, võrreldi DepoCytet tsütarabiini standardse ravimvormi kasutamisega.
This is a condition in which cells from a lymphoma (a tumour in the lymphatic system) have spread to the spinal fluid and the meninges (the membranes that surround the brain and spinal cord).
DepoCytet kasutatakse lümfomatoosse meningiidi raviks: see on seisund, mille korral lümfoomirakud (lümfisüsteemi kasvaja) on tunginud seljaaju vedelikku ja ajukelmetesse (pea- ja seljaaju ümbritsevatesse kelmetesse).
28 x 1 tablets
Blister (polüamiid/alumiinium/PVC) 28 x 1 tabletti
Dose adjustments might be necessary in these patients.
Nendel patsientidel võib olla vajalik annust kohandada.
Gabapentin - Respiratory depression without concomitant opioid use (EPITT no 18814)
Gabapentiin - respiratoorne depressioon ilma samaaegse opioidravita (EPITT nr 18 814)
Adopted at the 6-9 June 2017 PRAC
Vastu võetud ravimiohutuse riskihindamise komitee 6.-9. juuni 2017 koosolekul
- if you have nervous system disorders, respiratory disorders, or you are more than 65 years old, your doctor may prescribe you a different dosing regimen
− kui teil on närvisüsteemi häired, hingamishäired või kui olete üle 65-aastane, võib arst teile määrata teistsuguse annustamisskeemi
Contact your doctor immediately if you experience any of the following symptoms after taking this medicine as they can be serious:
Pöörduge otsekohe oma arsti poole, kui teil esineb ravimi võtmise järel mis tahes järgmisi sümptomeid, sest need võivad olla rasked:
Special warnings and precautions for use Concomitant use with opioids
Erihoiatused ja ettevaatusabinõud kasutamisel Kasutamine koos opioididega
In particular, tell your doctor (or pharmacist) if you are taking or have been recently taking any medicines for convulsions, sleeping disorders, depression, anxiety, or any other neurological or psychiatric problems.
Eriti teatage oma arstile (või apteekrile), kui te võtate või olete hiljuti võtnud mis tahes ravimeid krampide, unehäirete, depressiooni, ärevuse või muude neuroloogiliste või psühhiaatriliste probleemide vastu.
Gabapentin has been associated with severe respiratory depression.
Gabapentiini on seostatud raske respiratoorse depressiooniga.
- breathing problems, which if severe you may need emergency and intensive care to continue breathing normally
− hingamisprobleemid, mis raskel juhul võivad normaalse hingamise säilitamiseks vajada erakorralist abi või intensiivravi
Undesirable effects Respiratory, thoracic and mediastinal disorders Frequency ‘rare': Respiratory depression
Respiratoorsed, rindkere ja mediastiinumi häired Esinemissagedus „harv“: Respiratoorne depressioon
What you need to know before you take <brand name> Warnings and precautions
2. Mida on vaja teada enne <tootenimetuse> võtmist Hoiatused ja ettevaatusabinõud
Patients with compromised respiratory function, respiratory or neurological disease, renal impairment, concomitant use of CNS depressants and the elderly might be at higher risk of experiencing this severe adverse reaction.
Selle raske kõrvalnähu tekkerisk võib olla suurem patsiendil, kellel on hingamishäireted, hingamiselundite või neuroloogiline haigus, neerukahjustus või kes kasutab samaaegselt kesknärvisüsteemi depressante ja eakatel patsientidel.
Talk to your doctor or pharmacist before taking <brand name>
Enne <kaubanduslik nimetus omastavas käändes> võtmist pidage nõu oma arsti või apteekriga,
Rare (may affect up to 1 in 1,000 people):
Harv (võivad esineda kuni 1 inimesel 1000st): − Hingamisraskused, pindmine hingamine (respiratoorne depressioon)
Summary of product characteristics 4.4.
Ravimi omaduste kokkuvõte
EU/1/18/1277/001 Mylotarg
EU/1/18/1277/001
Intravenous use vial (glass)
Viaal (klaas)
Pack size
Intravenoosne
Treatment should be continued for as long as the patient benefits from it.
Ravi tuleb jätkata, kuni sellest on patsiendile kasu.
The patches can be worn during bathing and hot weather.
Plaastit tohib kanda ka vees ja kuuma ilmaga.
The patches should not be cut into pieces.
Plaastrit ei tohi tükeldada.
The full EPAR and risk management plan summary for Rivastigmine 3M Health Care Ltd can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Euroopa avaliku hindamisaruande täistekst ja riskijuhtimiskava kokkuvõte ravimi Rivastigmine 3M Health Care Ltd kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Treatment should be started with the 4.6-mg-per-24-hours patch, with the dose increased to the higher strength 9.5 mg/24-h patch after at least four weeks if the lower dose is well tolerated.
Ravi tuleb alustada 4,6 mg / 24 h plaastriga ja annust suurendatakse vähemalt nelja nädala pärast, võttes kasutusele suurema tugevusega 9,5 mg / 24 h plaastri, kui patsient talub väiksemat annust hästi.
The patches are applied to clean, dry, hairless, intact skin on the back, upper arm or chest, and are replaced every 24 hours.
Plaaster kinnitatakse seljale, õlavarrele või rindkerele puhtale kuivale karvadeta ja tervele nahale ning plaastrit vahetatakse iga 24 tunni järel.
In patients with Alzheimer's dementia, certain nerve cells die in the brain, resulting in low levels of the neurotransmitter acetylcholine (a substance that allows nerve cells to communicate with each other).
Alzheimeri dementsusega patsientidel hävivad ajus teatud närvirakud, mille tulemusena väheneb neurotransmitteri (keemiline aine, mis vahendab signaale närvirakkude vahel) atsetüülkoliini sisaldus.
Treatment should continue as long as the medicine has a benefit, but the dose can be reduced or treatment interrupted if the patient has side effects.
Raviga tuleb jätkata, kuni ravimist kasu, kuid kõrvalnähtude tekkimisel tohib patsiendi annust vähendada või ravi katkestada.
Rivastigmine 3M Health Care Ltd is used to treat patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour.
Ravimit Rivastigmine 3M Health Care Ltd kasutatakse patsientide ravis, kellel on kerge kuni mõõdukalt raske Alzheimeri dementsus - see on progresseeruv ajuhäire, mis kahjustab järk-järgult mälu, vaimseid võimeid ja käitumist.
A risk management plan has been developed to ensure that Rivastigmine 3M Health Care Ltd is used as safely as possible.
Töötati välja riskijuhtimiskava, et tagada ravimi Rivastigmine 3M Health Care Ltd võimalikult ohutu kasutamine.
This means that Rivastigmine 3M Health Care Ltd is similar to a ‘reference medicine' already authorised in the European Union (EU) called Exelon.
See tähendab, et Rivastigmine 3M Health Care Ltd on sarnane võrdlusravimiga Exelon, millel juba on Euroopa Liidus müügiluba.
Treatment should only be started if a caregiver is available who will regularly give and monitor the use of Rivastigmine 3M Health Care Ltd by the patient.
Ravi tohib alustada üksnes juhul, kui on olemas hooldaja, kes annab patsiendile regulaarselt ravimit Rivastigmine 3M Health Care Ltd ja jälgib, kuidas patsient seda kasutab.
Patients can be switched from rivastigmine capsules or oral solution to the patches.
Patsiendid tohivad rivastigmiini kapslitelt või suukaudselt lahuselt üle minna plaastritele.
Rivastigmine 3M Health Care Ltd can only be obtained with a prescription and is available as transdermal patches, which release either 4.6 or 9.5 mg rivastigmine across the skin over 24 hours.
Rivastigmine 3M Health Care Ltd on retseptiravim ja seda turustatakse transdermaalsete plaastritena, millest vabaneb ööpäeva jooksul naha kaudu 4,6 või 9,5 mg rivastigmiini.
The Committee recommended that Rivastigmine 3M Health Care Ltd be approved for use in the EU.
Komitee soovitas Rivastigmine 3M Health Care Ltd kasutamise Euroopa Liidus heaks kiita.
By blocking these enzymes, Rivastigmine 3M Health Care Ltd allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer's dementia.
Neid ensüüme blokeerides suurendab Rivastigmine 3M Health Care Ltd atsetüülkoliini sisaldust ajus, mis aitab vähendada Alzheimeri dementsuse sümptomeid.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Rivastigmine 3M Health Care Ltd has been shown to have comparable quality and to be bioequivalent to Exelon.
Inimravimite komitee järeldas, et vastavalt Euroopa Liidu nõuetele on tõendatud ravimi Rivastigmine 3M Health Care Ltd võrreldav kvaliteet ja bioekvivalentsus ravimiga Exelon.
Because Rivastigmine 3M Health Care Ltd is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Et Rivastigmine 3M Health Care Ltd on geneeriline ravim ja võrdlusravimiga bioekvivalentne, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimil.
What measures are being taken to ensure the safe and effective use of Rivastigmine 3M Health Care Ltd?
Mis meetmed võetakse, et tagada ravimi Rivastigmine 3M Health Care Ltd ohutu ja efektiivne kasutamine?
The European Commission granted a marketing authorisation valid throughout the European Union for Rivastigmine 3M Health Care Ltd on 3 April 2014.
Euroopa Komisjon andis ravimi Rivastigmine 3M Healt Care Ltd müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 03. aprillil 2014.
For practical information about using Rivastigmine 3M Health Care Ltd, patients should read the package leaflet or contact their doctor or pharmacist.
Kui vajate ravimi Rivastigmine 3M Health Care Ltd kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
Rivastigmine 3M Health Care Ltd is a medicine that contains the active substance rivastigmine.
Rivastigmine 3M Health Care Ltd on ravim, mis sisaldab toimeainena rivastigmiini.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Rivastigmine 3M Health Care Ltd, including the appropriate precautions to be followed by healthcare professionals and patients.
Selle alusel lisati ravimi Rivastigmine 3M Health Care Ltd omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
What is Rivastigmine 3M Health Care Ltd and what is it used for?
Mis on Rivastigmine 3M Health Care Ltd ja milleks seda kasutatakse?
Other information about Rivastigmine 3M Health Care Ltd
Muu teave ravimi Rivastigmine 3M Health Care Ltd kohta
For more information about treatment with Rivastigmine 3M Health Care Ltd, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Kui vajate ravimiga Rivastigmine 3M Health Care Ltd toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
Rivastigmine 3M Health Care Ltd rivastigmine
Rivastigmine 3M Health Care Ltd rivastigmiin
Treatment with Rivastigmine 3M Health Care Ltd should be started and supervised by a doctor who has experience in the diagnosis and treatment of Alzheimer's dementia.
Ravi ravimiga Rivastigmine 3M Health Care Ltd tohib alustada üksnes Alzheimeri dementsuse diagnoosimise ja ravis kogenud arst ning see peab toimuma tema järelevalve all.
Rivastigmine 3M Health Care Ltd is a ‘generic medicine'.
Rivastigmine 3M Health Care Ltd on geneeriline ravim.
This is a summary of the European public assessment report (EPAR) for Rivastigmine 3M Health Care Ltd.
See on ravimi Rivastigmine 3M Health Care Ltd Euroopa avaliku hindamisaruande kokkuvõte.
It is not intended to provide practical advice on how to use Rivastigmine 3M Health Care Ltd.
Hindamisaruandes ei anta ravimi Rivastigmine 3M Health Care Ltd kasutamise praktilisi nõuandeid.
Because Rivastigmine 3M Health Care Ltd is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Exelon.
Et Rivastigmine 3M Health Care Ltd on geneeriline ravim, piirdusid patsiendiuuringud katsetega, milles näidati ravimi Rivastigmine 3M Health Care Ltd bioekvivalentsust võrdlusravimiga Exelon.
Why is Rivastigmine 3M Health Care Ltd approved?
Miks Rivastigmine 3M Health Care Ltd heaks kiideti?
The active substance in Rivastigmine 3M Health Care Ltd, rivastigmine works by blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase.
Ravimi Rivastigmine 3M Health Care Ltd toimeaine rivastigmiin toime seisneb atsetüülkoliini lagundavate ensüümide atsetüülkoliinesteraasi ja butürüülkoliinesteraasi blokeerimises.
How does Rivastigmine 3M Health Care Ltd work?
Kuidas Rivastigmine 3M Health Care Ltd toimib?
How has Rivastigmine 3M Health Care Ltd been studied?
Kuidas ravimit Rivastigmine 3M Health Care Ltd uuriti?
Therefore, the CHMP's view was that, as for Exelon, the benefit outweighs the identified risk.
Seetõttu on inimravimite komitee arvamusel, et nagu Exeloni korral, ületab ravimi Rivastigmine 3M Health Care Ltd kasulikkus sellega kaasnevad riskid.
How is Rivastigmine 3M Health Care Ltd used?
Kuidas ravimit Rivastigmine 3M Health Care Ltd kasutatakse?
Article 35 of Directive 2001/82/EC, as amended.
Muudetud direktiivi 2001/82/EÜ artikkel 35.
The CVMP was requested to give its opinion on the matter.
Veterinaarravimite komiteel paluti esitada oma arvamus küsimuse kohta.
The final opinion was converted into a Decision by the European Commission on 1 October 2009.
Lõplik arvamus kinnitati Euroopa Komisjoni otsusena 1. oktoobril 2009.
International Non-Proprietary Name (INN): Ivermectin
Rahvusvaheline mittekaubanduslik nimetus (INN): ivermektiin
The re-examination procedure started on 15 April 2009.
Taasläbivaatamise menetlus algas 15. aprillil 2009.
On 9 December 2008 and 14 January 2009 two Marketing Authorisation Holders provided oral explanations at their request.
9. detsembril 2008 ja 14. jaanuaril 2009 esitasid kaks müügiloa hoidjat oma taotluse põhjal suulised selgitused.
Oral explanations were given on 12 May 2009.
Suulised selgitused anti 12. mail 2009.
On 4 June 2008 the National Competent Authorities of the Member States were requested to provide the missing information for the outstanding 120 Marketing Authorisations.
4. juunil 2008 paluti liikmesriikide pädevatel asutustel esitada puuduv teave ülejäänud 120 müügiloa kohta.
On 21 May 2008 the EMEA received a total of 19 written explanations from the Marketing Authorisation Holders (either as a group of or individual Marketing Authorisation Holders).
21. mail 2008 sai EMEA kokku 19 kirjalikku selgitust müügiloa hoidjatelt (nii rühmadena kui ka üksikute müügiloa hoidjatena).
The Committee appointed Dr G. J. Schefferlie as rapporteur and Dr J. G. Beechinor, Prof C. Friis, Prof R. Kroker and Dr B. Urbain as co-rapporteurs.
Komitee määras ettekandjaks dr G. J. Schefferlie ning kaasettekandjaiks dr J. G. Beechinori, prof C. Friisi, prof R. Krokeri ja dr B. Urbaini.
National Marketing Authorisations for injectable products containing ivermectin for use in cattle have been granted in all the Member States of the European Union via different authorisation procedures (mutual recognition procedures or national procedures) and under various legal bases.
Kõigis Euroopa Liidu liikmesriikides on olemas kariloomadel kasutatavate ivermektiini sisaldavate süsteravimite riiklikud müügiload, mis on antud mitmesuguste heakskiidumenetluste teel (vastastikuse tunnustamise menetlused ja riiklikud menetlused) ning mitmesugustel juriidilistel alustel.
Ref. EMEA/471056/2009
1. oktoober 2009 Viide: EMEA/471056/2009
The referral procedure started on 16 January 2008.
Esildise menetlemine algas 16. jaanuaril 2008.
The submitted information concerned 173 of the 293 Marketing Authorisations involved in this referral procedure.
Esitati teave 293 käesolevas esildismenetluses käsitletavast müügiloast 173 müügiloa kohta.
Written explanations were provided by the Marketing Authorisation Holders on 13 November 2008.
Müügiloa hoidjad esitasid kirjalikud selgitused 13. novembril 2008.
The detailed grounds for the re-examination were submitted by Norbrook Laboratories Ltd on 14 April 2009.
Norbrook Laboratories Ltd esitas uue läbivaatamise üksikasjalikud põhjendused 14. aprillil 2009.
The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the amended Summary of Product Characteristics, package leaflet and label in the Annex III.
Asjaomased raviminimetused on esitatud I lisas, teaduslikud järeldused II lisas ning muudetud ravimi omaduste kokkuvõte, märgitus ja pakendi infoleht III lisas.
On 25 February 2009, Norbrook Laboratories Ltd, notified the EMEA of its intention to request the reexamination of the CVMP opinion of 11 February 2009.
25. veebruaril 2009 teatas Norbrook Laboratories Ltd Euroopa Ravimiametile oma kavatsusest paluda veterinaarravimite komitee arvamuse uut läbivaatamist.
Further to the resignation of Prof R. Kroker as CVMP member, Dr C. Ibrahim was appointed to replace him and took over the co-rapporteurship.
Pärast prof R. Krokeri loobumist veterinaarravimite komitee liikmeks olekust määrati teda asendama dr C. Ibrahim, kellest sai samuti kaasettekandja.
On 17 September 2008 the CVMP considered that there were still issues with regard to some products which needed further clarification and therefore the Committee requested the relevant Marketing Authorisation Holders to address the outstanding issues in writing.
17. septembril 2008 otsustas veterinaarravimite komitee, et teatud ravimite suhtes oli ikka veel lahendamata probleeme, mille tõttu nõudis komitee asjaomastelt müügiloa hoidjatelt esitada käsitlemata probleemide kohta kirjalikud selgitused.
Based on the evaluation of the currently available data and the rapporteurs' assessment, the CVMP considered that its opinion of 11 February 2009 should be revised.
Seni kättesaadavate andmete ja ettekandjate hindamisaruannete põhjal leidis veterinaarravimite komitee, et komitee 11. veebruari 2009 arvamust tuleb muuta.
Eighteen Member States responded and submitted information concerning 103 of the outstanding 120 Marketing Authorisations.
Vastas 18 liikmesriiki, esitades teabe 120 ülejäänud müügiloast 103 müügiloa kohta.
OPINION FOLLOWING AN ARTICLE 351 REFERRAL FOR Injectable veterinary medicinal products containing ivermectin that are indicated for use in cattle at dose of 200 μg ivermectin per kg bodyweight
ARVAMUS PÄRAST ARTIKLI 351 KOHAST ESILDIST Ivermektiini sisaldavad süstitavad veterinaarravimid, mis on näidustatud kariloomadele annuses 200 μg ivermektiini kehakaalu kg kohta
During its 10-12 March 2009 meeting, the CVMP, appointed Dr A. Holm as rapporteur and Dr M. Holzhauser-Alberti as co-rapporteur for the re-examination of the above mentioned opinion.
10.-12. märtsi 2009 koosolekul määras veterinaarravimite komitee dr A. Holmi arvamuse uue läbivaatamise ettekandjaks ja dr M. Holzhauser-Alberti kaasettekandjaks.
Therefore, the Committee adopted by written procedure an opinion on 5 June 2009 recommending the variation the existing Marketing Authorisations in line with the proposed amendments of the Summary of Product Characteristics, labelling and package leaflet.
Seetõttu võttis komitee 5. juunil 2009 kirjaliku menetluse teel vastu arvamuse, milles soovitas muuta senist müügiluba kooskõlas ravimi omaduste kokkuvõtte, märgistuse ja pakendi infolehe soovitatud muudatustega.
Ivermectin belongs to the macrocyclic lactone class of endectocides with activity against a wide rage of internal and external parasites.
Ivermektiin kuulub makrotsüklilistest laktoonidest endektotsiidide rühma ning sellel on lai toimespekter sise- ja välisparasiitide vastu.
With regard to the products containing ivermectin in combination with clorsulon as a second active substance a withdrawal period of 66 days for cattle was recommended.
Süstitavate veterinaarravimite jaoks, mis sisaldavad ivermektiini ja teise toimeainena klorsulooni, soovitati kariloomade keeluajaks 66 päeva.
Therefore, the Committee adopted an opinion on 11 February 2009 recommending the variation of the existing Marketing Authorisations in accordance with the recommended amendments to the Summary of Product Characteristics.
veebruaril 2009 vastu arvamuse, milles soovitas muuta olemasolevaid müügilube kooskõlas ravimi omaduste kokkuvõtte soovitatud muudatustega.
Based on the evaluation of the currently available data and the rapporteurs' assessment, the CVMP considered that a single withdrawal period of 49 days should be established for all concerned injectable products for cattle containing ivermectin.
Kättesaadavate andmete ja ettekandjate hindamisaruannete põhjal leidis veterinaarravimite komitee, et kõigi asjaomaste ivermektiini sisaldavate süstitavate veterinaarravimite jaoks, mis on näidustatud kariloomadele, tuleb kehtestada ühetaoline keeluaeg 49 päeva.