FrancophonIA/ELRC3.0 huggingface dataset:
English: 4, 40472 Düsseldorf, GERMANY
Estonian: 4, 40472 Düsseldorf, SAKSAMAA
English: Respiratory and haemodynamic symptoms should be treated symptomatically.
Estonian: Respiratoorsete ja hemodünaamiliste sümptomite tekkimisel tuleb kasutada sümptomaatilist ravi.
English: 1, 76139 Karlsruhe, GERMANY
Estonian: 1, 76139 Karlsruhe, SAKSAMAA
English: 2.1 Systemic effect on sedation and hypotension
Estonian: 2.1 Süsteemsed toimed, näiteks sedatsioon ja hüpotensioon
English: NL Xylazine 20 Inj.
Estonian: Madalmaad Xylazine 20 Inj.
English: 161895/3 of 06.12.2002 (expired)
Estonian: 161895/3 of 06.12.2002 (aegunud)
English: It was considered that the term toxicity implies an overdose and since that will not always be the case, a modification was agreed upon.
Estonian: Leiti, et termin “toksilisus” viitab üleannustamisele, kuid kuna alati ei pruugi nii olla, lepiti kokku muudetud sõnastuses.
English: In addition, Article 78 of Directive 2001/82/EC applies only to the addition of precautionary measures in this procedure.
Estonian: Lisaks sellele kohaldatakse direktiivi 2001/82/EÜ artiklit 78 üksnes ettevaatusabinõude lisamise puhul ravimiinfosse.
English: BE Rompun Droge Stof
Estonian: Rompun Droge Stof
English: The maximal exposure was estimated to 0.3 ml Sedivet (3 mg romifidine).
Estonian: Maksimaalseks kokkupuuteks hinnati 0,3 ml Sediveti (3 mg romifidiini).
English: On 3 June 2008 the European Commission requested the Committee to complete the procedure to take into account all marketing authorisations of the 21 notified products throughout the EU.
Estonian: 3. juunil 2008 palus Euroopa Komisjon veterinaarravimite komiteel viia menetlus lõpule, et võtta arvesse 21 nimetatud ravimi müügilubasid üle kogu Euroopa Liidu.
English: The set of precautionary measures then served as basis for the proposals made by the Dutch competent regulatory authority for this procedure under Article 78 of Directive 2001/82/EC, as amended.
Estonian: Nimetatud ettevaatusabinõud olidki aluseks Madalmaade pädeva asutuse ettepanekutele seoses muudetud direktiivi 2001/82/EÜ artikli 78 kohase menetlusega.
English: The advice to doctors lists the potential clinical effects and suggested treatment.
Estonian: Arstidele ette nähtud nõuandes on loetletud võimalikud kliinilised toimed ja soovitatav ravi.
English: Xylazine, Ketamine, Atropine
Estonian: Ksülasiin, ketamiin, atropiin
English: Organização Técnica Agro Pecuária, S.A R. Alto B Vista Pavilhão 40 AgualvaCacém, 2735-340 Agualva, Cacém, Lisbon, PORTUGAL
Estonian: Organização Técnica Agro Pecuária, S.A R. Alto B Vista Pavilhão 40 Agualva-Cacém 2735-340 Agualva, Cacém, Lisbon, PORTUGAL
English: Icepharma hf., Lynhálsi 13, 110 Reykjavík, ICELAND
Estonian: Icepharma hf., Lynhálsi 13, 110 Reykjavík, ISLAND
English: NL Xylazine 5'+mg
Estonian: Madalmaad Xylazine 5'+mg
English: Bayer, Viale Certosa 130, 20156 Milano, ITALY
Estonian: Bayer, Viale Certosa 130, 20156 Milano, ITAALIA
English: DE Rompun TS
Estonian: Rompun TS
English: PT Romidys 1 mg/ml Solução Injectável para cães e gatos Romifidine
Estonian: Romidys 1 mg/ml Solução Injectável para cães e gatos
English: This resulted in the wording as proposed, which was agreed by all concerned Member States and the applicant.
Estonian: Selle tulemusena lepiti kokku esitatud hoiatuse sõnastus, millega nõustusid kõik asjaomased liikmesriigid ja müügiloa taotleja.
English: A revised list of questions addressed to the Marketing Authorisation Holders concerned was adopted on 16 July 2008.
Estonian: 16. juulil 2008 võeti vastu müügiloa hoidjatele saadetavate küsimuste ülevaadatud nimekiri.
English: NL A.A. Xylazine P.I.
Estonian: Madalmaad A.A. Xylazine P.I.
English: Precedex is a product containing dexmedetomidine, the active enantiomer of medetomidine, that is approved for use in humans in the United States.
Estonian: Precedex on ravim, mis sisaldab deksmedetomidiini, medetomidiini aktiivset stereoisomeeri, mis on Ameerika Ühendriikides heakskiidetud inimravim.
English: Treatment should be supportive with appropriate intensive therapy.
Estonian: Ravi on toetav, vajaduse korral koos sobivate intensiivravi võtete kasutamisega.
English: 221972/2 of 23.01.2004 (valid until 23.01.2009)
Estonian: 221972/2 of 23.01.2004 (kehtiv kuni 23.01.2009)
English: These products are used for sedation or analgesia in various species.
Estonian: Nimetatud ravimeid kasutatakse mitmel loomaliigil sedatiivse ja analgeetilise vahendina.
English: BOEHRINGER INGELHEIM FRANCE
Estonian: BOEHRINGER INGELHEIM PRANTSUSMAA
English: 44613/22-11-00 BOEHRINGER INGELHEIM VETMEDICA GMBH., GERMANY
Estonian: 44613/22-11-00 BOEHRINGER INGELHEIM VETMEDICA GMBH., SAKSAMAA
English: The recommendation to wear gloves when handling such a product was considered impractical for the veterinarian.
Estonian: Soovitust kanda ravimi käsitsemisel kindaid peeti veterinaararsti jaoks ebapraktiliseks.
English: Boehringer Ingelheim, Località Prulli 103/c, 50066 Regello, FINLAND
Estonian: Boehringer Ingelheim, Località Prulli 103/c, 50066 Regello, ITAALIA
English: Remove contaminated clothes that are in direct contact with skin.
Estonian: Võtke seljast ära ravimiga saastunud riided, mis on otseses kokkupuutes nahaga.
English: 221972/3 of 23.01.2004 (valid until 23.01.2009)
Estonian: 221972/3 of 23.01.2004 (kehtiv kuni 23.01.2009)
English: Since systemic effects may occur in rather low doses of romifidine in humans (0.2 mg/person), the CVMP concluded that the effects experienced by a person accidentally having injected a maximum of 0.3 ml Sedivet (3 mg romifidine) could be related to the active substance of the product.
Estonian: Et süsteemsed toimed võivad inimesel tekkida juba üsna väikeste romifidiini annuste korral (0,2 mg/isik), järeldas veterinaarravimite komitee, et kõrvaltoimed, mida täheldati endale juhuslikult maksimaalselt 0,3 ml Sediveti (3 mg romifidiini) süstinud inimesel, võivad olla seotud ravimi toimeainega.
English: FR Rompun Lyophilise
Estonian: Prantsusmaa Rompun Lyophilise
English: Authorisation number
Estonian: Müügiloa number
English: If irritation persists, seek the advice of a physician.
Estonian: Ärrituse püsimisel pöörduge arsti poole.
English: The effect is reflected in the SPC of Sedaxylan, as a warning against the use in late pregnant animals, in particular cows and cats.
Estonian: Seda toimet on käsitletud ka Sedaxylani ravimi omaduste kokkuvõttes hoiatusena mitte manustada ravimit tiinetele loomadele, eriti lehmadele ja kassidele.
English: NL Aescoket Plus
Estonian: Madalmaad Aescoket Plus
English: NL Xylalin
Estonian: Madalmaad Xylalin
English: The CVMP agreed on 14 September 2006 to communicate the proposed precautionary measures and information on human adverse reactions to the concerned Marketing Authorisation Holders (MAHs).
Estonian: 14. septembril 2006 otsustas veterinaarravimite komitee, et edastab pakutud ettevaatusabinõud ja teabe inimestel esineda võivate kõrvaltoimete kohta asjaomastele müügiloa hoidjatele.
English: IE Domitor Injection
Estonian: Domitor Injection
English: The competent regulatory authority for medicinal products for veterinary use of the Netherlands College Ter Beoordeling van Geneesmiddelen (Medicines Evaluation Board) Bureau Diergeneesmiddelen, notified the EMEA on 21 August 2006 in accordance with Article 78(1) of Directive 2001/82/EC, as amended by Directive 2004/28/EC, of its intention to vary 21 marketing authorisations These authorisations are for veterinary medicinal products containing an alpha2-adrenoreceptor agonist (romifidine, xylazine, detomidine or medetomidine) as the active substance and approved for use via a parenteral (injectable) route.
Estonian: Madalmaade veterinaarravimitega tegelev pädev asutus College Ter Beoordeling van Geneesmiddelen (ravimite hindamise nõukogu) Bureau Diergeneesmiddelen teatas 21. augustil 2006 direktiivi 2001/82/EÜ (mida on muudetud direktiiviga 2004/28/EÜ) artikli 78 lõike 1 kohaselt Euroopa Ravimiametile oma kavatsusest muuta kahekümne ühe, toimeainena alfa-2-adrenoretseptorite agonisti (romifidiin, ksülasiin, detomidiin või medetomidiin) sisaldava parenteraalselt (süstitaval teel) manustatava ravimi müügiluba.
English: In addition, any proprietary data submitted by MAHs was evaluated in support of the products investigated in those studies.
Estonian: Lisaks sellele hinnati kõiki müügiloa hoidjate esitatud asjakohaseid andmeid nimetatud uuringutes hinnatud ravimite kohta.
English: Precautionary measures:
Estonian: Ettevaatusabinõud
English: HU Primazin 2 % injection
Estonian: Primazin 2 % injection
English: The sentence was clearly considered a precautionary measure applicable to all alpha2-adrenoreceptor agonists and therefore not related to one specific product or substance.
Estonian: Pakutud lauset võib pidada ettevaatusabinõuks, mis kehtib kõigi alfa-2-adrenoretseptorite agonistide kohta ja mis seetõttu ei ole seotud mõne kindla ravimi või ainega.
English: Pfizer Animal Health, Ringaskiddy, Co. Cork, IRELAND
Estonian: Pfizer Animal Health, Ringaskiddy, Co. Cork, IIRIMAA
English: IS Chanazine 10%, vet.
Estonian: Chanazine 10%, vet.
English: Ventricular arrhythmias have also been reported.
Estonian: Samuti on täheldatud ventrikulaarseid arütmiaid.
English: NL Xylasan 2% Pro Inj.
Estonian: Madalmaad Xylasan 2% Pro Inj.
English: The CVMP considered the extrapolation of the proposed warnings to other alpha2-adrenoreceptor agonists justified, as all these substances have the same pharmacological mode of action and since several of the substances have shown similar effects in humans.
Estonian: Veterinaarravimite komitee leidis, et pakutud hoiatuste kasutuselevõtmine ka teiste alfa-2-adrenoretseptorite agonistide puhul on põhjendatud, sest kõigil neil ravimitel on ühesugune farmakoloogiline toimemehhanism ja mitmete nende toimeainete korral on inimestel täheldatud sarnaseid toimeid.
English: Virbac S.A., 1ère avenue, 2065 m, L.I.D., 06516 Carros Cedex, FRANCE
Estonian: 1ère avenue - 2065 m - L.I.D., 06516 Carros Cedex, PRANTSUSMAA
English: Therefore, the CVMP in the July 2008 plenary meeting agreed on 16 July 2008 to complete the procedure under Article 78 of Directive 2001/82/EC, as amended, for all marketing authorisations held in the EU for the 21 products containing alpha2-adrenoreceptor agonists initially notified and to revise the initial previous opinion accordingly.
Estonian: Seetõttu otsustas veterinaarravimite komitee 2008. aasta juulikuu plenaaristungi 16. juuli kohtumisel lõpetada muudetud direktiivi 2001/82/EÜ artikli 78 kohane menetlus kõigi Euroopa Liidu liikmesriikides müügiluba omava 21 alfa-2-adrenoretseptorite agoniste sisaldava ravimi kohta ning vaadata läbi oma esialgne arvamus.
English: In the following, each of the proposed precautionary measures and information on human adverse reactions is evaluated separately.
Estonian: Järgnevalt on eraldi hinnatud kõiki pakutud ettevaatusabinõusid ja teavet inimestel esineda võivate kõrvaltoimete kohta.
English: Both these dose levels are above the NOEL for acute pharmacologic effects.
Estonian: Mõlemad nimetatud sisaldused on suuremad kui täheldatava toimeta annus akuutse farmakoloogilise toime puhul.
English: IS Rompun, vet.
Estonian: Rompun, vet.
English: Animal Health Division, Bayer House, Strawberry Hill Newbury, Berkshire RG14 1JA, UNITED KINGDOM
Estonian: Animal Health Division, Bayer House, Strawberry Hill, Newbury Berkshire RG14 1JA, ÜHENDKUNINGRIIK
English: Aimed at the user are systemic sedative and hypotensive effect, skin contact, eye contact and risks for pregnant women.
Estonian: Kasutajaohutust puudutavad süsteemne sedatiivne ja hüpotensiivne toime, ravimi sattumine nahale ja silma ning ohud rasedatele.
English: Furthermore, the CVMP recommends inclusion of the agreed statements on precautionary measures for alpha2-adrenoreceptor agonists in the relevant guideline on Summary of Product Characteristics, to be implemented in accordance with the national regulatory framework.
Estonian: Lisaks sellele soovitab veterinaarravimite komitee lisada kõnealused kokkulepitud laused alfa-2aderenoretseptorite agonistide kasutamisel rakendatavate ettevaatusabinõude kohta ravimi omaduste kokkuvõtte asjakohasesse juhisesse, et neid rakendataks kooskõlas liikmesriikide õigusliku raamistikuga.
English: Dopharma Research BV, Postbus 205, 4940 AE Raamsdonksveer, THE NETHERLANDS
Estonian: Dopharma Research BV, Postbus 205, 4940 AE Raamsdonksveer, MADALMAAD
English: CZ Domosedan inj.
Estonian: Tšehhi Vabariik Domosedan inj.
English: The CVMP also considered other publicly available data for the scientific evaluation.
Estonian: Lisaks võttis veterinaarravimite komitee oma teaduslikus hindamises arvesse ka muud avalikku teavet.
English: Furthermore, the results of the outcome of a European survey for alpha2-adrenoreceptor agonists were considered.
Estonian: Arvesse võeti ka üleeuroopalise alfa-2-agoniste käsitleva küsitluse tulemusi.
English: In reference to information on contact hypersensitivity to detomidine and to 10 studies after subcutaneous, intramuscular, or intravenous exposure, the MAH concluded that the risk of sensitisation and contact dermatitis is minimal.
Estonian: Viidates paikse ülitundlikkuse andmete puudumisele detomidiini kasutamisel ja kümnele uuringule kokkupuute kohta pärast subkutaanset, intramuskulaarset või intravenoosset manustamist, järeldas müügiloa hoidja, et sensitisatsiooni ja kontaktdermatiidi tekkerisk on minimaalne.
English: On the basis of the notification sent by the Dutch competent regulatory authority, the matters considered by the Committee for Medicinal Products for Veterinary Use (CVMP) were the following proposed precautionary measures:
Estonian: Madalmaade pädeva asutuse saadetud kirja alusel arutas veterinaarravimite komitee järgmisi ettevaatusabinõusid.
English: ANNEX I COUNTRY, PRODUCT INVENTED NAME, ACTIVE SUBSTANCE MARKETING AUTHORISATION NUMBER, MARKETING AUTHORISATION HOLDER CONCERNED BY THE PROCEDURE
Estonian: I LISA MENETLUSEGA SEOTUD RIIGID, RAVIMITE NIMETUSED, TOIMEAINED, MÜÜGILOA NUMBRID JA MÜÜGILOA HOIDJAD
English: NL Rompun droog
Estonian: Madalmaad Rompun droog
English: Remove contaminated clothes.
Estonian: Võtke ravimiga saastunud riided kohe seljast ära.
English: This resulted in a set of precautionary measures, which was agreed by all concerned Member States and the applicant at the time.
Estonian: Selle hindamise alusel lisati ravimiinfosse mitu ettevaatusabinõu, millega kõik asjaomased liikmesriigid ja müügiloa taotleja sel ajal nõustusid.
English: Aesculaap BV, Mijlstraat 35, 5281 LJ Boxtel, THE NETHERLANDS
Estonian: Aesculaap BV, Mijlstraat 35 5281 LJ Boxtel, MADALMAAD
English: The findings were considered relevant for the more normal exposure occurring in a situation where medicine may accidentally splash into the eyes, e.g. when a syringe detaches from the needle.
Estonian: Antud leidu peeti ülekantavaks ka tavalisemale olukorrale, kus ravim võib kogemata silma pritsida, näiteks kui nõel tuleb süstla küljest lahti.
English: Following this request, the CVMP during its meeting of 15-17 July 2008 restarted the procedure for evaluating the products indicated by the Member States.
Estonian: Selle nõude kohaselt taasalgatas veterinaarravimite komitee 2008. aasta 15.-17. juuli kohtumisel kõigi Euroopa Liidu liikmesriikides müügiluba omavate asjaomaste ravimite hindamismenetluse.
English: An oxytocin-like effect of xylazine on the uterus is well-known.
Estonian: Ksülasiini oksütotsiini taoline toime on hästi tuntud.
English: Chanelle Animal Health Ltd, 7 Rodney Street, Liverpool L1 9HZ, UNITED KINGDOM
Estonian: Chanelle Animal Health Ltd, 7 Rodney Street, Liverpool L1 9HZ, ÜHENDKUNINGRIIK
English: RO Xylazine 2% xylazine
Estonian: Xylazine 2% xylazine
English: It was concluded that systemic effects after dermal exposure could not be excluded.
Estonian: Jõuti järeldusele, et süsteemset toimet ravimi kokkupuutel nahaga ei saa välistada.
English: PFIZER GLOBAL MANUFACTURING, Rue Laid Burniat 1, 1348 Louvain La Nueve, BELGIUM (Variation IA,1 - pending Pfizer Animal Health MA EEIG Ramsgate Road, Sandwich, Kent CT13 9NJ UNITED KINGDOM)
Estonian: PFIZER GLOBAL MANUFACTURING, Rue Laid Burniat 1, 1348 Louvain La Nueve, BELGIA (Muutus IA,1 on menetlemisel- Pfizer Animal Health MA EEIG Ramsgate Road, Sandwich, Kent CT13 9NJ, ÜHENDKUNINGRIIK)
English: Romifidine
Estonian: Romifidiin
English: In the absence of sufficient data concerning the human adverse reactions studies the CVMP did not support a recommendation concerning addition of information on irritation, sensitisation, contact dermatitis and systemic effects after skin contact.
Estonian: Kuna inimestel esinevate kõrvaltoimete uuringud ei andnud piisavalt asjakohaseid andmeid, ei toetanud veterinaarravimite komitee soovitust lisada ravimiinfosse teave nahaärrituse, sensitisatsiooni, kontaktdermatiidi ja süsteemsete toimete kohta pärast ravimi kokkupuudet nahaga.
English: UK Domitor Injection (Strength 1 mg/ml)
Estonian: Domitor Injection (Strength 1 mg/ml)
English: 323-03-8/01-42 VET4VET, Gerbičeva 50, 1000 Ljubljana, SLOVENIA
Estonian: 323-03-8/01-42 VET4VET, Gerbičeva 50 1000 Ljubljana, SLOVEENIA
English: The CVMP concluded that these scientific recommendations concerning the precautionary measures apply also to other injectable products containing alpha2-adrenoreceptor agonists.
Estonian: Veterinaarravimite komitee otsustas, et kõnealused teaduslikud soovitused ettevaatusabinõude kohta kehtivad ka muude süstitavate ravimite puhul, mis sisaldavad alfa-2-adrenoretseptorite agoniste.
English: IS Domosedan, vet.
Estonian: Domosedan, vet.
English: The objective of the variations was to add a set of new precautionary measures concerning user safety, and information on human adverse reactions, to the product literature.
Estonian: Muudatuste eesmärk oli lisada ravimiinfosse mitu kasutajaohutust käsitlevat ettevaatusabinõu ning teavet inimestel esineda võivate kõrvaltoimete kohta.
English: Farma BV, Willeskop 206a, 4321 GW Oudewater, THE NETHERLANDS
Estonian: Farma BV, Willeskop 206a 4321 GW Oudewater, MADALMAAD
English: The CVMP during its meeting of 12-14 September 2006 initiated a procedure for evaluating the matter under Article 78(3) of Directive 2001/82/EC for these products.
Estonian: 2006. aasta 12.-14. septembri kohtumisel algatas veterinaarravimite komitee direktiivi 2001/82/EÜ artikli 78 lõike 3 kohaselt nimetatud ravimeid puudutavate asjaolude hindamismenetluse.
English: It was considered difficult to assess whether the results on corneal effects of xylazine in the studies using mice and rats are relevant for humans.
Estonian: Veterinaarravimite komitee leidis, et on raske hinnata, kas hiirte ja rottide uuringutes täheldatud ksülasiini toime silma sarvkestale omab tähendust ka inimeste puhul.
English: The findings were, however, considered sufficient to support a warning against eye exposure and advice on how to act in the case of accidental eye exposure.
Estonian: Siiski peeti seda leidu piisavaks, et toetada ravimiinfosse hoiatuse lisamist ravimi sattumise kohta silma ning nõuandeid, mida sellisel juhul teha.
English: Box 65, 02201 Espoo, FINLAND
Estonian: Box 65, 02201 Espoo, SOOME
English: Kepro BV, Maadgenburgstraat 38, 7421 ZE Deventer, THE NETHERLANDS
Estonian: Kepro BV, Maadgenburgstraat 38, 7421 ZE Deventer, MADALMAAD
English: Equi Products Holland BV, Hermelijnkoog 44, 1822 CB Alkmaar, THE NETHERLANDS
Estonian: Equi Products Holland BV, Hermelijnkoog 44, 1822 CB Alkmaar, MADALMAAD
English: Most of these products are presented as solutions for injection, and some are presented as powders to be dissolved in water for solution for injection.
Estonian: Enamik neist ravimitest on saadaval valmis süstelahuse kujul, mõned süstelahuse valmistamise pulbrina turustatavad ravimid tuleb enne manustamist süstevees lahustada.
English: In the MRL Summary Reports for xylazine and romifidine, it is stated that the compounds have not been tested for skin sensitising potential.
Estonian: Ksülasiini ja romifidiini ravimijääkide piirnormide koondaruannetes on märgitud, et nimetatud ühendeid ei ole naha sensitisatsiooni põhjustada võiva toime suhtes testitud.
English: Teratogenic effects were, however, not observed following administration of dexmedetomidine at subcutaneous doses up to 200 µg/kg in rats from day 5 to day 16 of gestation and intravenous doses up to 96 µg/kg in rabbits from day 6 to day 18 of gestation.
Estonian: Samas ei täheldatud teratogeenseid toimeid deksmedetomidiini subkutaansel manustamisel rottidele annuses kuni 200 µg/kg tiinuse 5.-16. päeval ega intravenoossel manustamisel küülikutele annuses kuni 96 µg/kg tiinuse 6.-18. päeval.
English: In the MRL Summary Report for detomidine, two oral teratology studies were reported (rat and rabbit).
Estonian: Detomidiini ravimijääkide piirnormide koondaruandes kirjeldatakse kaht suukaudse teratogeense toime uuringut (rotid ja küülikud).
English: The CVMP concluded that the recommended general statements on precautionary measures are final recommendations given in response to the notification received from the Netherlands.
Estonian: Veterinaarravimite komitee otsustas, et soovitatavad üldlaused ettevaatusabinõude kohta on veterinaarravimite komitee lõplikud soovitused vastusena Madalmaade pädeva asutuse ettepanekutele.
English: In addition, the SPC for Sedaxylan states that no teratogenic or foetotoxic effects have been shown.
Estonian: Lisaks sellele märgitakse Sedaxylani ravimi omaduste kokkuvõttes, et ravimi kasutamisel ei ole teratogeenseid ega fetotoksilisi toimeid täheldatud.
English: Globalmed Ltd, Ground Floor, 134 Church Hill, Loughton, Essex IG10 1LH, UNITED KINGDOM
Estonian: Ground Floor, 134 Church Hill, Loughton, Essex IG10 1LH, ÜHENDKUNINGRIIK
English: In the rabbit study, detomidine was non-teratogenic and non-foetotoxic up to 2 mg/kg bw.
Estonian: Küülikute uuringus ei täheldatud detomidiinil teratogeenset ega fetotoksilist toimet annuste puhul kuni 2 mg/kg kehakaalu kohta.
English: 0205IS0127F012 SCS BOEHRINGER INGELHEIM COMM.V, Vesalius Science Park, Avenue, Ariane, 16, 1200 Bruxelles, BELGIUM
Estonian: 0205IS0127F012 SCS BOEHRINGER INGELHEIM COMM.V, Vesalius Science Park, Avenue, Ariane, 16, 1200 Brüssel, BELGIA
English: In the mutual recognition procedure concerning Sedaxylan, a user safety evaluation was performed.
Estonian: Kasutajaohutust hinnati Sedaxylani vastastikuse tunnustamise menetluse raames.
English: If symptoms occur, seek the advice of a physician.
Estonian: Sümptomite püsimisel pöörduge arsti poole.
English: The MAHs were invited to comment and submit any counterproposals by 16 September 2008.
Estonian: Müügiloa hoidjatel paluti saata oma märkused ja vastuargumendid hiljemalt 16. septembriks 2008.
English: Such effects had never been reported after use of the product (detomidine).
Estonian: Neid toimeid ei olnud ravimi kasutamisel mitte kunagi täheldatud.
English: Finally, having considered the urgency of the matter, the CVMP concluded that since products containing alpha2-adrenoreceptor agonists have been on the market for a long time, although these new statements are clearly needed, urgent measures were not considered proportional.
Estonian: Nimetatud ettevaatusabinõude lisamise kiireloomulisuse kaalumisel otsustas veterinaarravimite komitee järgmist: kuna alfa-2-adrenoretseptorite agoniste sisaldavad ravimid on olnud turul juba pikka aega ja ehkki need ettevaatusabinõud on kindlasti vajalikud, ei pea veterinaarravimite komitee kiireloomulisi meetmeid muutuste sisseviimiseks proportsionaalseks võimaliku ohu suurusega.