FrancophonIA/ELRC3.0 huggingface dataset:
English: Ventricular arrhythmias have also been reported.
Slovenian: Poročali so tudi o pojavu ventrikularnih aritmij.
English: 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:
Slovenian: 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:
English: Romifidine
Slovenian: Romifidin
English: In the following, each of the proposed precautionary measures and information on human adverse reactions is evaluated separately.
Slovenian: V nadaljevanju se ločeno ovrednoti vsak predlagan varnostni ukrep in informacije o neželenih škodljivih učinkih pri ljudeh.
English: 221972/2 of 23.01.2004 (valid until 23.01.2009)
Slovenian: 221972/2 z dne 23. 1. 2004 (veljavno do 23. 1. 2009)
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.
Slovenian: Učinek je naveden v povzetku glavnih značilnosti zdravila Sedaxylan kot opozorilo pred uporabo pri samicah v visoki brejosti, še posebej pri kravah in mačkah.
English: Bayer Portugal, S.A Rua da Quinta do Pinheiro 5, 2794-003 Carnaxide PORTUGAL
Slovenian: Bayer Portugal, S.A Rua da Quinta do Pinheiro 5, 2794-003 Carnaxide, PORTUGALSKA
English: Following consideration of the data available, the CVMP agreed on the relevance of this precautionary measure, recommending the following:
Slovenian: Po pretehtanju razpoložljivih podatkov se je CVMP strinjal o pomembnosti tega varnostnega ukrepa, ki priporoča naslednje:
English: Boehringer Ingelheim, Località Prulli 103/c, 50066 Regello, FINLAND
Slovenian: Boehringer Ingelheim Località Prulli 103/c, 50066 Regello, ITALIJA
English: 221972/3 of 23.01.2004 (valid until 23.01.2009)
Slovenian: 221972/3 z dne 23. 1. 2004 (veljavno do 23. 1. 2009)
English: 2.3 Eye contact
Slovenian: 2.3 Stik z očmi
English: BOEHRINGER INGELHEIM FRANCE
Slovenian: BOEHRINGER INGELHEIM FRANCIJA
English: In the rabbit study, detomidine was non-teratogenic and non-foetotoxic up to 2 mg/kg bw.
Slovenian: V študiji pri zajcih detomidin ni bil teratogen ali fetotoksičen v odmerku do 2 mg/kg telesne mase.
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.
Slovenian: 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.
English: In addition, the SPC for Sedaxylan states that no teratogenic or foetotoxic effects have been shown.
Slovenian: Poleg tega je v povzetku glavnih značilnosti zdravila za Sedaxylan navedeno, da niso opazili nikakršnih teratogenih ali fetotoksičnih učinkov.
English: Bayer, Viale Certosa 130, 20156 Milano, ITALY
Slovenian: Bayer, Viale Certosa 130,20156 Milano, ITALIJA
English: In the mutual recognition procedure concerning another product - Sedaxylan - containing an alpha2adrenoceptor agonist, a user safety evaluation was performed.
Slovenian: V postopku vzajemnega priznavanja drugega zdravila, Sedaxylana, ki prav tako vsebuje agonist alfa-2 adrenoreceptorja, so izvedli ocenjevanje varnosti uporabnika.
English: Virbac S.A., 1ère avenue, 2065 m, L.I.D., 06516 Carros Cedex, FRANCE
Slovenian: Virbac S.A. 1ère avenue - 2065 m - L.I.D., 06516 Carros Cedex, FRANCIJA
English: 96/025/00-C ALFASAN INTERNATIONAL B.V., P.O.
Slovenian: 96/025/00-C ALFASAN INTERNATIONAL B.V.
English: 44613/22-11-00 BOEHRINGER INGELHEIM VETMEDICA GMBH., GERMANY
Slovenian: 44613/22-11-00 BOEHRINGER INGELHEIM VETMEDICA GMBH., NEMČIJA
English: Química Farmacéutica Bayer
Slovenian: 7532 A Química Farmacéutica Bayer
English: Furthermore, the results of the outcome of a European survey for alpha2-adrenoreceptor agonists were considered.
Slovenian: Nadalje je odbor pretehtal rezultate izida evropske ankete glede agonistov alfa-2 adrenoreceptorja.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Oral exposure was not reported.
Slovenian: Poročil o peroralni izpostavitvi ni bilo.
English: Aesculaap BV, Mijlstraat 35, 5281 LJ Boxtel, THE NETHERLANDS
Slovenian: Aesculaap BV, Mijlstraat 35, 5281 LJ Boxtel, NIZOZEMSKA
English: Animal Health Division, Bayer House, Strawberry Hill Newbury, Berkshire RG14 1JA, UNITED KINGDOM
Slovenian: Animal Health Division, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA, ZDRUŽENO KRALJESTVO
English: An oxytocin-like effect of xylazine on the uterus is well-known.
Slovenian: Učinek ksilazina na maternico, ki je podoben učinku oksitocina, je dobro znan.
English: Farma BV, Willeskop 206a, 4321 GW Oudewater, THE NETHERLANDS
Slovenian: Farma BV, Willeskop 206a, 4321 GW Oudewater, NIZOZEMSKA
English: 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.
Slovenian: 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.
English: In conclusion, the precautionary measures should be reflected in the product literature of the concerned veterinary medicinal products containing alpha2-adrenoreceptor agonists.
Slovenian: Previdnostni ukrepi se morajo odražati v literaturi o zadevnih veterinarskih zdravilih, ki vsebujejo agoniste alfa-2 adrenoreceptorjev.
English: Dopharma Research BV, Postbus 205, 4940 AE Raamsdonksveer, THE NETHERLANDS
Slovenian: Dopharma Research BV, Postbus 205, 4940 AE Raamsdonksveer, NIZOZEMSKA
English: 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.
Slovenian: 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.
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.
Slovenian: 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.
English: 323-03-8/01-42 VET4VET, Gerbičeva 50, 1000 Ljubljana, SLOVENIA
Slovenian: 323-03-8/01-42 VET4VET, Gerbičeva 50, 1000 Ljubljana, SLOVENIJA
English: 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.
Slovenian: 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.
English: The MAHs were invited to comment and justify any counterproposals by 16 October 2006.
Slovenian: Odbor je imetnike dovoljenj za promet z zdravilom povabil, naj oddajo pripombe in utemeljijo morebitne protipredloge do 16. oktobra 2006.
English: Chanelle Animal Health Ltd, 7 Rodney Street, Liverpool L1 9HZ, UNITED KINGDOM
Slovenian: Chanelle Animal Health Ltd, 7 Rodney Street, Liverpool L1 9HZ, ZDRUŽENO KRALJESTVO
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.
Slovenian: 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.
English: Equi Products Holland BV, Hermelijnkoog 44, 1822 CB Alkmaar, THE NETHERLANDS
Slovenian: Equi Products Holland BV, Hermelijnkoog 44, 1822 CB Alkmaar, NIZOZEMSKA
English: In the MRL Summary Report for detomidine, two oral teratology studies were reported (rat and rabbit).
Slovenian: V zbirnem poročilu o najvišji dovoljeni količini zaostankov za detomidin so poročali o dveh študijah peroralne teratologije (podgana in zajec).
English: 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.
Slovenian: 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.
English: Bayer BV Animal Health, Postbus 80, 3640 AB Mijdrecht, THE NETHERLANDS
Slovenian: Bayer BV Animal Health, Postbus 80, 3640 AB Mijdrecht, NIZOZEMSKA
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)
Slovenian: 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)
English: 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.
Slovenian: 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.
English: Pfizer Co. Ltd., 1123 Budapest, Alkotás u. 53, HUNGARY
Slovenian: Pfizer Co. Ltd., 1123 Budapest Alkotás u. 53, MADŽARSKA
English: The CVMP considered information provided by one MAH concerning the product's characteristics in relation to sensitisation and contact dermatitis.
Slovenian: 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.
English: The MRL Summary Report for detomidine does not mention this item.
Slovenian: Zbirno poročilo o najvišji dovoljeni količini zaostankov za detomidin te točke ne omenja.
English: Kepro BV, Maadgenburgstraat 38, 7421 ZE Deventer, THE NETHERLANDS
Slovenian: Kepro BV, Maadgenburgstraat 38, 7421 ZE Deventer, NIZOZEMSKA
English: Avoid skin, eye or mucosal contact.
Slovenian: Izogibajte se stiku s kožo, očmi ali sluznico.
English: Although the exact accidental injected exposure (dose) of the reported human adverse reaction (Hoyer, M.J., 2006) was unknown, it was concluded that the observed clinical effects - on day 1 being loss of consciousness (arousable), hallucinations, low heart rate and low blood pressure, vasoconstriction, and vasodilation; and on day 2 drowsiness, mild headache, loss of memory and tiredness - can be attributable to the product (Sedivet).
Slovenian: Čeprav v primeru nenamernega vbrizganja pri ljudeh (Hoyer, M.J., 2006), ko so poročali o pojavu neželenih škodljivih učinkov, izpostavitev (odmerek) ni bila natančno znana, so zaključili, da lahko opažene klinične učinke - na 1. dan vključujejo izgubo zavesti (razburljivost), halucinacije, nizek srčni utrip in nizek krvni tlak, vazokonstrikcijo in vazodilatacijo; na 2. dan so neželeni učinki vključevali zaspanost, blag glavobol, izgubo spomina in utrujenost - pripišemo zdravilu (Sedivet).
English: Boehringer Ingelheim, Postbus 8037, 1802 KA Alkmaar, THE NETHERLANDS
Slovenian: Boehringer Ingelheim, Postbus 8037, 1802 KA Alkmaar, NIZOZEMSKA
English: Bayer Hungária Ltd., 1123 Budapest, Alkotás u. 50, HUNGARY
Slovenian: Bayer Hungária Ltd., 1123 Budapest Alkotás u. 50, MADŽARSKA
English: Globalmed Ltd, Ground Floor, 134 Church Hill, Loughton, Essex IG10 1LH, UNITED KINGDOM
Slovenian: Ground Floor, 134 Church Hill, Loughton, Essex IG10 1LH, ZDRUŽENO KRALJESTVO
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).
Slovenian: CVMP se je dne 14. septembra 20006 strinjal, da zadevnim imetnikom dovoljenja za promet z zdravilom sporoči predloge previdnostnih ukrepov in informacije o neželenih učinkih pri ljudeh.
English: 0205IS0127F012 SCS BOEHRINGER INGELHEIM COMM.V, Vesalius Science Park, Avenue, Ariane, 16, 1200 Bruxelles, BELGIUM
Slovenian: 0205IS0127F012 SCS BOEHRINGER INGELHEIM COMM.V, Vesalius Science Park, Avenue, Ariane, 16, 1200 Bruxelles, BELGIJA
English: In the rat study, a NOEL of 0.1 mg/kg bw/day was based on foetal and maternal toxicity and teratogenicity.
Slovenian: Pri podganah je bila raven NOEL 0,1 mg/kg telesne mase/dan na temelju toksičnosti in teratogenosti pri fetusu in materah.
English: The CVMP considered that the proposed advice to doctors lists the most common pharmacological effects of alpha2-adrenoreceptor agonists, as could also be extracted from the MRL Summary Reports cited under section 2.1.
Slovenian: CVMP je upošteval, da predlagani nasvet za zdravnike navaja najbolj pogoste farmakološke učinke agonistov alfa-2 adrenoreceptorja, kakor jih je mogoče izluščiti tudi iz poglavja 2.1 zbirnega poročila o najvišji dovoljeni količini zaostankov.
English: Orion Corporation, Box 65, 02101 Esbo, FINLAND
Slovenian: Orion Corporation, Box 65, 02101 Esbo, FINSKA
English: Therefore, the CVMP concluded upon the following recommendation:
Slovenian: Zaradi tega je CVMP zaključil z naslednjim priporočilom:
English: Pfizer Animal Health BV, Postbus 37, 2900 AA Capell a/d Ijssel, THE NETHERLANDS
Slovenian: Pfizer Animal Health BV, Postbus 37, 2900 AA Capell a/d Ijssel, NIZOZEMSKA
English: The MAHs were invited to comment and submit any counterproposals by 16 September 2008.
Slovenian: Odbor je imetnike dovoljenj za promet z zdravilom povabil, naj oddajo pripombe in morebitne protipredloge do 16. septembra 2008.
English: In addition, any proprietary data submitted by MAHs was evaluated in support of the products investigated in those studies.
Slovenian: Poleg tega so bili v teh študijah pretehtani vsi lastniški podatki, ki so jih vložili imetniki dovoljenj za promet z zdravilom.
English: In the SPC for the medicinal product, Catapresin, it is stated that the active substance passes the bloodplacenta barrier.
Slovenian: V povzetku glavnih značilnosti zdravila za zdravilo Catapresin je navedeno, da zdravilna učinkovina prehaja krvno maternično pregrado.
English: In the MRL Summary Reports for xylazine and romifidine, it is stated that the compounds have not been tested for skin sensitising potential.
Slovenian: V zbirnih poročilih o najvišji dovoljeni količini zaostankov za ksilazin in romifidin je navedeno, da pri spojinah niso testirali morebitnega potenciala za povečanje preobčutljivosti kože.
English: In the Summary of Product Characteristics (SPC) for a medicinal product for use in humans, Catapresan, containing the alpha2-adrenoreceptor agonist clonidine (injectable and tablets), the dermal adverse reactions after an unknown route of exposure are listed as skin-rash, urticaria, pruritus, and hairloss with an incidence rate of 1/100 - 1/10000 in patients.
Slovenian: V povzetku glavnih značilnosti zdravila za zdravilo za uporabo v humani medicini, Catapresan, ki vsebuje agonist alfa-2 adrenoreceptorja klonidin (v obliki za injiciranje in v obliki tablet), so navedene neželene kožne reakcije, kot so kožni izpuščaj, urtikarija, pruritus in izguba las v deležu pogostnosti 1/100-1/10.000 pri bolnikih, pot izpostavitve pa ni bila znana.
English: The CVMP further considered proprietary data provided by another MAH concerning three of the products.
Slovenian: CVMP je poleg tega pretehtal lastniške podatke, ki jih je priskrbel drugi imetnik dovoljenja za promet z zdravilom za tri zdravila.
English: The CVMP further considered the published Maximum Residue Limit (MRL) Summary Reports for xylazine, detomidine and romifidine.
Slovenian: CVMP je upošteval tudi izdana zbirna poročila o najvišji dovoljeni količini zaostankov za ksilazin, detomidin in romifidin.
English: In the case of accidental oral intake or self-injection, seek medical advice immediately and show the package insert to the physician but DO NOT DRIVE as sedation and changes in blood pressure may occur.
Slovenian: v primeru nenamernega peroralnega zaužitja ali samoinjiciranja takoj poiščite zdravniško pomoč in zdravniku pokažite navodilo za uporabo zdravila, vendar SE NE PELJITE SAMI, ker lahko pride do sedacije in sprememb v krvnem tlaku.
English: The CVMP concluded that these scientific recommendations concerning the precautionary measures apply also to other injectable products containing alpha2-adrenoreceptor agonists.
Slovenian: CVMP je zaključil, da znanstvena priporočila glede previdnostnih ukrepov veljajo za vsa druga zdravila, ki jih lahko vbrizgamo, in ki vsebujejo agoniste alfa-2 adrenoreceptorja.
English: Quvera Ltd, Unit 8, Brember Road, Harrow, Middlesex HA2 8AX, UNITED KINGDOM
Slovenian: Unit 8, Brember Road, Harrow, Middlesex HA2 8AX, ZDRUŽENO KRALJESTVO
English: Ventricular arrhythmias are stated to have been reported, probably after accidental self-injection, but such was not reported in the published report on the human adverse reaction (Hoyer, M.J., 2006).
Slovenian: Navedeno je, da obstajajo poročila o ventrikularnih aritmijah, do katerih je po vsej verjetnosti prišlo po nenamernem samoinjiciranju, vendar o tem niso poročali v izdanem poročilu o neželenih škodljivih učinkih pri ljudeh (Hoyer, M.J., 2006).
English: Systemic absorption of xylazine was reported in a human after ocular exposure by irrigating the eyes with xylazine.
Slovenian: Pri ljudeh so poročali o sistemski absorpciji ksilazina po izpostavitvi oči z draženjem oči s ksilazinom.
English: If pregnant women handle the product, special caution should be observed not to self-inject as uterine contractions and decreased foetal blood pressure may occur after accidental systemic exposure.
Slovenian: Če z zdravilom delajo nosečnice, morajo biti posebej previdne, da zdravila ne bi vbrizgale vase, ker lahko po neželeni sistemski izpostavitvi pride do materničnih krčev in zmanjšanega krvnega tlaka fetusa.
English: Orion Corporation, Orionintie 1, FUB-0220 Espoo, FINLAND
Slovenian: Orion Corporation, Orionintie 1, 0220 Espoo, FINSKA
English: The Products listed in Annex I are approved in various MS for use via the parental route, containing alpha2adrenoreceptor agonists romifidine, xylazine, detomidine, medetomidine.
Slovenian: Zdravila, ki so navedena v Dodatku I, so odobrena za parenteralno uporabo v različnih državah članicah, in vsebujejo agoniste alfa-2 adrenoreceptorja romifidin, ksilazin, detomidin in medetomidin.
English: The pharmacovigilance data evaluated included the published suspected adverse reaction (SAR) in a human being, reporting cardiovascular and central nervous system effects (Hoyer, M.J., 2006).
Slovenian: Ocenjeni farmakovigilančni podatki so vključevali objavljene neželene škodljive učinke, za katere so sumili, da se lahko pojavijo pri človeku, in za katera so obstajala poročila o učinkih na krvožilni in osrednji živčni sistem (Hoyer, M.J., 2006).
English: Avoid skin contact and wear impermeable gloves when handling the product 3.
Slovenian: Pri delu z zdravilom se izogibajte stiku s kožo in nosite neprepustne rokavice.
English: Bayer HealthCare AG, Animal Health Division, 51368, Leverkusen, GERMANY
Slovenian: Bayer HealthCare AG, Animal Health Division, 51368, Leverkusen, NEMČIJA
English: Novivet BV, Albert Cuyplaan 2B, 7482 JA Haaksbergen, THE NETHERLANDS
Slovenian: Novivet BV, Albert Cuyplaan 2B, 7482 JA Haaksbergen, NIZOZEMSKA
English: • Irritation, sensitisation, contact dermatitis and systemic effects cannot be excluded after skin contact.
Slovenian: • po stiku s kožo ni mogoče izključiti pojava draženja, povečanja občutljivosti, kontaktnega dermatitisa in sistemskih učinkov.
English: CEVA Santé BV, Tiendweg 8c ,2671 SB Naaldwijk, THE NETHERLANDS
Slovenian: CEVA Santé BV, Tiendweg 8c, 2671 SB Naaldwijk, NETHERLANDS
English: Chanelle Pharmaceuticals Manufacturing Ltd., Dublin Road, Loughrea Co. Galway, IRELAND
Slovenian: Chanelle Pharmaceuticals Manufacturing Ltd., Dublin Road, Loughrea Co. Galway, IRSKA
English: If irritation persists, seek the advice of a physician.
Slovenian: Če ostane draženje prisotno, poiščite zdravniško pomoč.
English: The NOEL was 0.5 mg/kg bw/day based on maternal toxicity.
Slovenian: Meja ravni brez opaznih učinkov je bila 0,5 mg/kg telesne mase/dan na osnovi toksičnosti pri materah.
English: Wirtz Farma BV, Albert Cuyplaan 2B, 7482 JA Haaksbergen, THE NETHERLANDS
Slovenian: Wirtz Farma BV, Albert Cuyplaan 2B, 7482 JA Haaksbergen, NIZOZEMSKA