natgillin/translations-raw huggingface dataset:
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. 
CVMP je na srečanju od 12. do 14. septembra 2006 sprožil postopek za ovrednotenje zadeve skladno s členom 78(3) Direktive 2001/82/ES za ta zdravila.
It was concluded that systemic effects after dermal exposure could not be excluded. 
Zaključili so, da sistemskih učinkov po izpostavljanju kože ni mogoče izključiti.
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: 
Na podlagi obvestila, ki ga je poslal nizozemski pristojni regulacijski organ, je Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pretehtal naslednje previdnostne ukrepe:
This resulted in a set of precautionary measures, which was agreed by all concerned Member States and the applicant at the time. 
S tem so prišli do zbirke varnostnih ukrepov, s katerimi so se tisti čas strinjale vse države članice in predlagatelj.
Orion Corporation animal health 
Orion Corporation animal helth
Precedex is a product containing dexmedetomidine, the active enantiomer of medetomidine, that is approved for use in humans in the United States. 
Precedex je zdravilo, ki vsebuje deksmedetomidin, aktivni enantiomer medetomidina, ki je za humano uporabo odobren v Združenih državah.
The advice to doctors lists the potential clinical effects and suggested treatment. 
V opozorilu zdravnikom so navedeni morebitni klinični učinki in predlagani načini zdravljenja.
In the mutual recognition procedure concerning Sedaxylan, a user safety evaluation was performed. 
Pri postopku vzajemnega priznavanja za zdravilo Sedaxylan so izvedli ocenitev varnosti uporabnika.
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. 
Cilj spremembe je bil dodati serijo novih previdnostnih ukrepov, ki se tičejo varnosti uporabnika ter informacij o neželenih škodljivih učinkih pri ljudeh, k literaturi o zdravilu.
1, 76139 Karlsruhe, GERMANY 
1, 76139 Karlsruhe, NEMČIJA
The safety of Precedex during labour and delivery has not been studied. 
Varnost zdravila Precedex med porodnimi popadki in rojevanjem ni bila raziskana.
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. 
Večina teh zdravil je v obliki raztopin za injiciranje, nekatera pa so v obliki praškov, ki se jih raztopi v vodi za pripravo raztopine za injiciranje.
The proposed precautionary measures were considered relevant and proportionate, since it relates to the clinical effects, which may be expected depending on the amount injected or ingested, and because it highlights one of the main dangers for a veterinary practitioner after a self-injection or ingestion of such a product, i.e. a sedative effect in combination with driving. 
Predlagani previdnostni ukrepi so se obravnavali kot ustrezni in sorazmerni, ker se tičejo kliničnih učinkov, ki jih lahko pričakujemo v odvisnosti od vbrizgane ali zaužite količine in ker je poudarjena ena od glavnih nevarnosti za veterinarja po samoinjiciranju ali zaužitju takega zdravila, tj. učinek sedacije v kombinaciji z vožnjo.
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. 
Ker lahko pride do sistemskih učinkov pri razmeroma nizkih odmerkih romifidina pri ljudeh (0,2 mg/osebo), je CVMP zaključil, da so učinki pri osebi, ki si nenamerno vbrizga največ 0,3 ml zdravila Sedivet (3 mg romifidina), lahko povezani z zdravilno učinkovino tega zdravila.
Aimed at the user are systemic sedative and hypotensive effect, skin contact, eye contact and risks for pregnant women. 
Na uporabnika vplivajo sistemski sedacijski in hipotenzijski učinki, stik s kožo, stik z očmi in tveganja za nosečnice.
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. 
Dne 3. junija 2008 je Evropska komisija od Odbora zahtevala, naj v zaključku postopka upošteva vsa dovoljenja za promet z zdravilom za 21 prijavljenih zdravil in celotne EU.
The recommendation to wash exposed skin immediately was, however, considered a rational and proportionate measure, as was the advice to remove contaminated clothes in the absence of long term exposure studies in humans. 
Vendar pa se je priporočilo glede umivanja izpostavljene kože upoštevalo kot racionalen in sorazmeren ukrep, kakor tudi nasvet glede odstranitve kontaminiranih oblek, glede na to, da ni dolgotrajnih študij pri ljudeh.
The CVMP further considered a recommendation to include a suggested antidote (atipamezole) not approved for use in humans, and, while not being in favour of recommending a treatment used only experimentally, concluded that symptoms should be treated symptomatically. 
CVMP je poleg tega pretehtal tudi priporočilo o vključitvi predlaganega antidota (atipamezol), ki ni odobren za uporabo pri ljudeh, in ker ni naklonjen priporočanju zdravljenj, uporabljenih le eksperimentalno, zaključil, da je treba simptome zdraviti simptomatsko.
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. 
Na plenarnem zasedanju v juliju 2008 se je zato CVMP dne 16. julija 2008 strinjal, da bo zaključil postopek skladno s členom 78 Direktive 2001/82/ES, kakor je bila spremenjena, za vsa dovoljenja za promet z zdravilom v EU za 21 zdravil, ki vsebujejo agoniste alfa-2 adrenoreceptorja in so bila prijavljena na začetku, ter da bo skladno s tem pregledal staro začetno mnenje.
AS Laboratórios Pfizer, Lda Lagoas Park, Edifício 10, 2740-271 Porto Salvo, PORTUGAL 
AS Laboratórios Pfizer, Lda Lagoas Park, Edifício 10 2740-271 Porto Salvo, PORTUGALSKA
161895/3 of 06.12.2002 (expired) 
161895/3 z dne 6. 12. 2002 (zapadlo)
2.2 Skin contact 
2.2 Stik s kožo
Having considered all available data, the CVMP concluded that the proposed precautionary measures regarding skin contact seem appropriate. 
Po upoštevanju vseh podatkov na voljo je CVMP zaključil, da se zdijo previdnostni ukrepi glede stika s kožo primerni.
The sentence was clearly considered a precautionary measure applicable to all alpha2-adrenoreceptor agonists and therefore not related to one specific product or substance. 
Stavek je bil očitno zasnovan kot varnostni ukrep, ki velja za vse agoniste alfa-2 adrenoreceptorja in zato ni povezan z enim določenim zdravilom ali eno snovjo.
Organização Técnica Agro Pecuária, S.A R. Alto B Vista Pavilhão 40 AgualvaCacém, 2735-340 Agualva, Cacém, Lisbon, PORTUGAL 
Organização Técnica Agro Pecuária, S.A R. Alto B Vista Pavilhão 40 Agualva-Cacém, 2735-340 Agualva, Cacém, Lisbon, PORTUGALSKA
Remove contaminated clothes that are in direct contact with skin. 
slecite onesnaženo obleko, ki je bila v neposrednem stiku s kožo.
The information on the approved United States New Drug Application (NDA) label for Precedex was considered, stating that dexmedetomidine should be used during pregnancy only if the potential benefits justify the potential risk to the foetus. 
Odbor je pretehtal podatke na odobreni vlogi za novo zdravilo (NDA) za zdravilo Precedex v Združenih državah, kjer je navedeno, da se lahko dekmedetomidin uporablja med nosečnostjo samo, če morebitne koristi upravičujejo morebitna tveganja za fetus.
ANNEX I COUNTRY, PRODUCT INVENTED NAME, ACTIVE SUBSTANCE MARKETING AUTHORISATION NUMBER, MARKETING AUTHORISATION HOLDER CONCERNED BY THE PROCEDURE 
DODATEK I DRŽAVA, IZMIŠLJENO IME ZDRAVILA, ZDRAVILNA UČINKOVINA ŠTEVILKA DOVOLJENJA ZA PROMET Z ZDRAVILOM, IMETNIK DOVOLJENJA ZA PROMET, KI GA ZADEVA POSTOPEK
Wash the exposed skin immediately after exposure with large amounts of water. 
Izpostavljeno kožo takoj po izpostavitvi umijte z obilico vode.
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. 
CVMP je menil, da je prenos predlaganih opozoril na druge agoniste alfa2-adrenoreceptorja upravičena, ker imajo te snovi enak farmakološki način delovanja in ker je več teh snovi izkazalo podobne učinke pri ljudeh.
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. 
Ugotovitve pa so bile kljub temu zadostne za podporo opozorila o izpostavljanju oči in nasvet o primernemu ravnanju v primeru nenamerne izpostavitve oči.
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. 
V pogledu informacij o kontaktni preobčutljivosti za detomidin in 10 študij po subkutanem, intramuskularnem ali intravenskemu izpostavljanju je imetnik dovoljenja za promet z zdravilom zaključil, da je tveganje pojava preobčutljivosti in kontaktnega dermatitisa minimalno.
Xylazine induced sedation, muscle relaxation and analgesia after a single intravenous dose of 0.27 or 0.68 mg/kg bw or after a single oral dose of 0.54 mg/kg bw. 
Ksilazin je povzročil sedacijo, sproščanje mišic in analgezijo po enem samem intravenskem odmerku od 0,27 do 0,68 mg/kg telesne mase ali po enem samem peroralnem odmerku 0,54 mg/kg telesne mase.
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. 
Ker ni bilo zadostnih podatkov glede študij neželenih škodljivih učinkov pri ljudeh, CVMP ni podprl priporočila glede dodatnih podatkov o draženju, povečanju občutljivosti, kontaktnem dermatitisu in sistemskih učinkih po stiku s kožo.
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. 
Teratogenih učinkov pa niso opazili po uporabi deksmedetomidina v subkutanemu odmerku do 200 µg/kg pri podganah od 5. do 16. dne gestacije in intravenskih odmerkih do 96 µg/kg pri zajcih od 6. dne do 18. dne gestacije.
Ventricular arrhythmias have also been reported. 
Poročali so tudi o pojavu ventrikularnih aritmij.
The CVMP, having considered the risk to human health, the proposed precautionary measures and information on human adverse reactions in light of the data available, concluded that the following information should be reflected in the product literature of the concerned products within a reasonable timeframe: 
CVMP je po upoštevanju tveganj za zdravje človeka, predlaganih previdnostnih ukrepih in podatkih o neželenih učinkih pri ljudeh v pogledu razpoložljivih podatkov zaključil, da mora gradivo o zadevnih zdravilih v primernem časovnem okviru vključevati tudi naslednje informacije:
In the following, each of the proposed precautionary measures and information on human adverse reactions is evaluated separately. 
V nadaljevanju se ločeno ovrednoti vsak predlagan varnostni ukrep in informacije o neželenih škodljivih učinkih pri ljudeh.
221972/2 of 23.01.2004 (valid until 23.01.2009) 
221972/2 z dne 23. 1. 2004 (veljavno do 23. 1. 2009)
The effect is reflected in the SPC of Sedaxylan, as a warning against the use in late pregnant animals, in particular cows and cats. 
Učinek je naveden v povzetku glavnih značilnosti zdravila Sedaxylan kot opozorilo pred uporabo pri samicah v visoki brejosti, še posebej pri kravah in mačkah.
Bayer Portugal, S.A Rua da Quinta do Pinheiro 5, 2794-003 Carnaxide PORTUGAL 
Bayer Portugal, S.A Rua da Quinta do Pinheiro 5, 2794-003 Carnaxide, PORTUGALSKA
Following consideration of the data available, the CVMP agreed on the relevance of this precautionary measure, recommending the following: 
Po pretehtanju razpoložljivih podatkov se je CVMP strinjal o pomembnosti tega varnostnega ukrepa, ki priporoča naslednje:
Boehringer Ingelheim, Località Prulli 103/c, 50066 Regello, FINLAND 
Boehringer Ingelheim Località Prulli 103/c, 50066 Regello, ITALIJA
221972/3 of 23.01.2004 (valid until 23.01.2009) 
221972/3 z dne 23. 1. 2004 (veljavno do 23. 1. 2009)
2.3 Eye contact 
2.3 Stik z očmi
BOEHRINGER INGELHEIM FRANCE 
BOEHRINGER INGELHEIM FRANCIJA
In the rabbit study, detomidine was non-teratogenic and non-foetotoxic up to 2 mg/kg bw. 
V študiji pri zajcih detomidin ni bil teratogen ali fetotoksičen v odmerku do 2 mg/kg telesne mase.
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. 
Ugotovitve so bile pomembne za bolj normalno izpostavitev, do katere pride v situacijah, ko zdravilo po nesreči brizgne v oči, tj. ko se igla loči od injekcijske brizge.
In addition, the SPC for Sedaxylan states that no teratogenic or foetotoxic effects have been shown. 
Poleg tega je v povzetku glavnih značilnosti zdravila za Sedaxylan navedeno, da niso opazili nikakršnih teratogenih ali fetotoksičnih učinkov.
Bayer, Viale Certosa 130, 20156 Milano, ITALY 
Bayer, Viale Certosa 130,20156 Milano, ITALIJA
In the mutual recognition procedure concerning another product - Sedaxylan - containing an alpha2adrenoceptor agonist, a user safety evaluation was performed. 
V postopku vzajemnega priznavanja drugega zdravila, Sedaxylana, ki prav tako vsebuje agonist alfa-2 adrenoreceptorja, so izvedli ocenjevanje varnosti uporabnika.
Virbac S.A., 1ère avenue, 2065 m, L.I.D., 06516 Carros Cedex, FRANCE 
Virbac S.A. 1ère avenue - 2065 m - L.I.D., 06516 Carros Cedex, FRANCIJA
44613/22-11-00 BOEHRINGER INGELHEIM VETMEDICA GMBH., GERMANY 
44613/22-11-00 BOEHRINGER INGELHEIM VETMEDICA GMBH., NEMČIJA
Química Farmacéutica Bayer 
7532 A Química Farmacéutica Bayer
Furthermore, the results of the outcome of a European survey for alpha2-adrenoreceptor agonists were considered. 
Nadalje je odbor pretehtal rezultate izida evropske ankete glede agonistov alfa-2 adrenoreceptorja.
Medetomidine, structurally related to detomidine, at an intravenous dose 0.67 µg/kg bw caused hypotension and sedation that lasted for at least 8 hours, as reported in the MRL Summary Report for detomidine. 
Medetomidin, ki je strukturno soroden detomidinu, je pri intravenskem odmerku 0,67 µg/kg telesne mase povzročil hipotenzijo in sedacijo, ki sta trajali vsaj 8 ur, kot so poročali v zbirnem poročilu o najvišji dovoljeni količini zaostankov za detomidin.
In reference to the MRL Summary Report for detomidine, the effects of detomidine on pregnant cows seemed less than those described for xylazine, but in horses treated with 20 µg/kg bw, 4 out of 10 pregnancies showed diverse abnormalities with unclear significance. 
Kar se tiče zbirnega poročila o najvišji dovoljeni količini zaostankov za detomidin, so se zdeli učinki detomidina na breje krave manj izraženi kot tisti, ki so bili opisani pri uporabi ksilazina, vendar pa je 4 od 10 konj, ki so jih zdravili z 20 µg/kg telesne mase, pokazalo različne abnormalnosti z nejasnim pomenom.
Oral exposure was not reported. 
Poročil o peroralni izpostavitvi ni bilo.
Aesculaap BV, Mijlstraat 35, 5281 LJ Boxtel, THE NETHERLANDS 
Aesculaap BV, Mijlstraat 35, 5281 LJ Boxtel, NIZOZEMSKA
Animal Health Division, Bayer House, Strawberry Hill Newbury, Berkshire RG14 1JA, UNITED KINGDOM 
Animal Health Division, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA, ZDRUŽENO KRALJESTVO
An oxytocin-like effect of xylazine on the uterus is well-known. 
Učinek ksilazina na maternico, ki je podoben učinku oksitocina, je dobro znan.
Farma BV, Willeskop 206a, 4321 GW Oudewater, THE NETHERLANDS 
Farma BV, Willeskop 206a, 4321 GW Oudewater, NIZOZEMSKA
The pharmacovigilance data evaluated by the Dutch competent regulatory authority that resulted in its intention to vary the authorisations is a published suspected adverse reaction (SAR) in a human being, reporting cardiovascular and central nervous system effects over a period of 3 days after accidental selfinjection of Sedivet (Reference: Hoyer, Mark J. Alpha2-agonisten, alledaagse verdovingsmiddelen in de diergeneeskunde praktijk, maar verre van ongevaarlijk - de gevolgen van een accidentele zelfinjectie. 
Farmakovigilančni podatek, ki ga je ovrednotil nizozemski pristojni regulatorni organ, zaradi česar je nato želel spremeniti dovoljenja, je bil objavljen sum na neželene učinke pri ljudeh, ki so poročali o učinkih v krvožilnem in osrednjem živčnem sistemu v obdobju treh dni po nenamernem samoinjiciranju zdravila Sedivet (Referenca: Hoyer, Mark J. Alpha2-agonisten, alledaagse verdovingsmiddelen in de diergeneeskunde praktijk, maar verre van ongevaarlijk - de gevolgen van een accidentele zelfinjectie.
In conclusion, the precautionary measures should be reflected in the product literature of the concerned veterinary medicinal products containing alpha2-adrenoreceptor agonists. 
Previdnostni ukrepi se morajo odražati v literaturi o zadevnih veterinarskih zdravilih, ki vsebujejo agoniste alfa-2 adrenoreceptorjev.
Dopharma Research BV, Postbus 205, 4940 AE Raamsdonksveer, THE NETHERLANDS 
Dopharma Research BV, Postbus 205, 4940 AE Raamsdonksveer, NIZOZEMSKA
In general, it was concluded that xylazine hydrochloride is moderately irritating to the human skin after prolonged exposure although no reports on skin irritation were, however, available nor were reports on sensitisation of xylazine. 
Splošna ugotovitev je bila, da je ksilazin hidroklorid zmerno dražeč za človeško kožo po dolgotrajnejši izpostavitvi, čeprav ni bilo poročil o draženju kože, pa tudi ni bilo poročil o pojavu preobčutljivosti na ksilazin.
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. 
CVMP poleg tega priporoča vključitev stavkov glede previdnostnih ukrepov pri agonistih alfa-2 adrenoreceptorjev, o katerih so prišli do soglasja, v povzetek glavnih značilnosti zdravila, kar se izvede skladno z nacionalnim regulativnim okvirom.
323-03-8/01-42 VET4VET, Gerbičeva 50, 1000 Ljubljana, SLOVENIA 
323-03-8/01-42 VET4VET, Gerbičeva 50, 1000 Ljubljana, SLOVENIJA
In another reproductive study when dexmedetomidine was administered subcutaneously to pregnant rats from gestation day 16 through nursing, it caused lower pup weights at 8 and 32 µg/kg as well as foetal and embryocidal toxicity of second generation offspring at a dose of 32 µg/kg. 
V drugi reproduktivni študiji so brejim podganam subkutano dajali deksmedetomidin od 16. dne do konca dojenja, kjer je zdravilo povzročilo manjše mase mladičev od 8 do 32 µg/kg ter tudi fetalno in embrionalno toksičnost mladičev druge generacije pri odmerku 32 µg/kg.
The MAHs were invited to comment and justify any counterproposals by 16 October 2006. 
Odbor je imetnike dovoljenj za promet z zdravilom povabil, naj oddajo pripombe in utemeljijo morebitne protipredloge do 16. oktobra 2006.
Chanelle Animal Health Ltd, 7 Rodney Street, Liverpool L1 9HZ, UNITED KINGDOM 
Chanelle Animal Health Ltd, 7 Rodney Street, Liverpool L1 9HZ, ZDRUŽENO KRALJESTVO
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. 
Na koncu je CVMP glede nujnosti zadeve zaključil, da čeprav so ti novi stavki očitno potrebni, glede na dolgotrajno prisotnost zdravil z agonisti alfa-2 adrenoreceptorja na trgu, urgentni ukrepi niso sorazmerni.
Equi Products Holland BV, Hermelijnkoog 44, 1822 CB Alkmaar, THE NETHERLANDS 
Equi Products Holland BV, Hermelijnkoog 44, 1822 CB Alkmaar, NIZOZEMSKA
In the MRL Summary Report for detomidine, two oral teratology studies were reported (rat and rabbit). 
V zbirnem poročilu o najvišji dovoljeni količini zaostankov za detomidin so poročali o dveh študijah peroralne teratologije (podgana in zajec).
The CVMP considered published data on the effects of xylazine hydrochloride on intrauterine pressure in the cow, the oxytocic effect of xylazine on the canine uterus, effects of detomidine, romifidine and xylazine on intrauterine pressure and sedation in horses, and the effects of xylazine on intrauterine pressure, uterine blood flow, maternal and foetal cardiovascular and pulmonary function in pregnant goats. 
CVMP je pretehtal objavljene podatke o učinkih ksilazin hidroklorida na intrauterini tlak pri kravah, na oksitocinski učinek ksilazina na maternico psic, učinke detomidina, romifidina in ksilazina na tlak v maternici in sedacijo konj ter učinke ksilazina na intramaternični tlak, maternični krvni pretok ter kardiovaskularno in pljučno funkcijo fetusa pri brejih kozah.
Bayer BV Animal Health, Postbus 80, 3640 AB Mijdrecht, THE NETHERLANDS 
Bayer BV Animal Health, Postbus 80, 3640 AB Mijdrecht, NIZOZEMSKA
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) 
PFIZER GLOBAL MANUFACTURING, Rue Laid Burniat 1, 1348 Louvain La Nueve, BELGIUM (Sprememba IA,1 - v postopku Pfizer Animal Health MA EEIG Ramsgate Road, Sandwich, Kent CT13 9NJ ZDRUŽENO KRALJESTVO)
The CVMP considered publicly available data on systemic toxicity after ocular exposure to xylazine hydrochloride in a human; corneal toxicity of xylazine and clonidine, in combination with ketamine, in the rat; and acute reversible cataract induced by xylazine and by ketamine-xylazine anesthesia in rats and mice. 
CVMP je pretehtal javno razpoložljive podatke o sistemski toksičnosti po izpostavitvi človeških oči ksilazin hidrokloridu; kornealni toksičnosti ksilazina in klonidina v kombinaciji s ketaminom pri podganah; in akutni reverzibilni katarakti, ki jo sprožita ksilazin in anestezija s ketamin ksilazinom pri podganah in miših.
Pfizer Co. Ltd., 1123 Budapest, Alkotás u. 53, HUNGARY 
Pfizer Co. Ltd., 1123 Budapest Alkotás u. 53, MADŽARSKA
The CVMP considered information provided by one MAH concerning the product's characteristics in relation to sensitisation and contact dermatitis. 
CVMP je pretehtal informacije, ki jih je priskrbel eden od imetnikov dovoljenja za promet z zdravilom glede lastnosti zdravila v povezavi s povečanjem občutljivosti in kontaktnim dermatitisom.
The MRL Summary Report for detomidine does not mention this item. 
Zbirno poročilo o najvišji dovoljeni količini zaostankov za detomidin te točke ne omenja.
Kepro BV, Maadgenburgstraat 38, 7421 ZE Deventer, THE NETHERLANDS 
Kepro BV, Maadgenburgstraat 38, 7421 ZE Deventer, NIZOZEMSKA
Avoid skin, eye or mucosal contact. 
Izogibajte se stiku s kožo, očmi ali sluznico.