natgillin/translations-raw huggingface dataset:
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). 
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).
Boehringer Ingelheim, Postbus 8037, 1802 KA Alkmaar, THE NETHERLANDS 
Boehringer Ingelheim, Postbus 8037, 1802 KA Alkmaar, NIZOZEMSKA
Bayer Hungária Ltd., 1123 Budapest, Alkotás u. 50, HUNGARY 
Bayer Hungária Ltd., 1123 Budapest Alkotás u. 50, MADŽARSKA
Globalmed Ltd, Ground Floor, 134 Church Hill, Loughton, Essex IG10 1LH, UNITED KINGDOM 
Ground Floor, 134 Church Hill, Loughton, Essex IG10 1LH, ZDRUŽENO KRALJESTVO
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). 
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.
0205IS0127F012 SCS BOEHRINGER INGELHEIM COMM.V, Vesalius Science Park, Avenue, Ariane, 16, 1200 Bruxelles, BELGIUM 
0205IS0127F012 SCS BOEHRINGER INGELHEIM COMM.V, Vesalius Science Park, Avenue, Ariane, 16, 1200 Bruxelles, BELGIJA
In the rat study, a NOEL of 0.1 mg/kg bw/day was based on foetal and maternal toxicity and teratogenicity. 
Pri podganah je bila raven NOEL 0,1 mg/kg telesne mase/dan na temelju toksičnosti in teratogenosti pri fetusu in materah.
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. 
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.
Orion Corporation, Box 65, 02101 Esbo, FINLAND 
Orion Corporation, Box 65, 02101 Esbo, FINSKA
Therefore, the CVMP concluded upon the following recommendation: 
Zaradi tega je CVMP zaključil z naslednjim priporočilom:
Pfizer Animal Health BV, Postbus 37, 2900 AA Capell a/d Ijssel, THE NETHERLANDS 
Pfizer Animal Health BV, Postbus 37, 2900 AA Capell a/d Ijssel, NIZOZEMSKA
The MAHs were invited to comment and submit any counterproposals by 16 September 2008. 
Odbor je imetnike dovoljenj za promet z zdravilom povabil, naj oddajo pripombe in morebitne protipredloge do 16. septembra 2008.
In addition, any proprietary data submitted by MAHs was evaluated in support of the products investigated in those studies. 
Poleg tega so bili v teh študijah pretehtani vsi lastniški podatki, ki so jih vložili imetniki dovoljenj za promet z zdravilom.
In the SPC for the medicinal product, Catapresin, it is stated that the active substance passes the bloodplacenta barrier. 
V povzetku glavnih značilnosti zdravila za zdravilo Catapresin je navedeno, da zdravilna učinkovina prehaja krvno maternično pregrado.
In the MRL Summary Reports for xylazine and romifidine, it is stated that the compounds have not been tested for skin sensitising potential. 
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.
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. 
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.
The CVMP further considered proprietary data provided by another MAH concerning three of the products. 
CVMP je poleg tega pretehtal lastniške podatke, ki jih je priskrbel drugi imetnik dovoljenja za promet z zdravilom za tri zdravila.
The CVMP further considered the published Maximum Residue Limit (MRL) Summary Reports for xylazine, detomidine and romifidine. 
CVMP je upošteval tudi izdana zbirna poročila o najvišji dovoljeni količini zaostankov za ksilazin, detomidin in romifidin.
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. 
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.
The CVMP concluded that these scientific recommendations concerning the precautionary measures apply also to other injectable products containing alpha2-adrenoreceptor agonists. 
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.
Quvera Ltd, Unit 8, Brember Road, Harrow, Middlesex HA2 8AX, UNITED KINGDOM 
Unit 8, Brember Road, Harrow, Middlesex HA2 8AX, ZDRUŽENO KRALJESTVO
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). 
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).
Systemic absorption of xylazine was reported in a human after ocular exposure by irrigating the eyes with xylazine. 
Pri ljudeh so poročali o sistemski absorpciji ksilazina po izpostavitvi oči z draženjem oči s ksilazinom.
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. 
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.
Orion Corporation, Orionintie 1, FUB-0220 Espoo, FINLAND 
Orion Corporation, Orionintie 1, 0220 Espoo, FINSKA
The Products listed in Annex I are approved in various MS for use via the parental route, containing alpha2adrenoreceptor agonists romifidine, xylazine, detomidine, medetomidine. 
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.
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). 
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).
Avoid skin contact and wear impermeable gloves when handling the product 3. 
Pri delu z zdravilom se izogibajte stiku s kožo in nosite neprepustne rokavice.
Bayer HealthCare AG, Animal Health Division, 51368, Leverkusen, GERMANY 
Bayer HealthCare AG, Animal Health Division, 51368, Leverkusen, NEMČIJA
Novivet BV, Albert Cuyplaan 2B, 7482 JA Haaksbergen, THE NETHERLANDS 
Novivet BV, Albert Cuyplaan 2B, 7482 JA Haaksbergen, NIZOZEMSKA
• Irritation, sensitisation, contact dermatitis and systemic effects cannot be excluded after skin contact. 
• po stiku s kožo ni mogoče izključiti pojava draženja, povečanja občutljivosti, kontaktnega dermatitisa in sistemskih učinkov.
CEVA Santé BV, Tiendweg 8c ,2671 SB Naaldwijk, THE NETHERLANDS 
CEVA Santé BV, Tiendweg 8c, 2671 SB Naaldwijk, NETHERLANDS
Chanelle Pharmaceuticals Manufacturing Ltd., Dublin Road, Loughrea Co. Galway, IRELAND 
Chanelle Pharmaceuticals Manufacturing Ltd., Dublin Road, Loughrea Co. Galway, IRSKA
If irritation persists, seek the advice of a physician. 
Če ostane draženje prisotno, poiščite zdravniško pomoč.
The NOEL was 0.5 mg/kg bw/day based on maternal toxicity. 
Meja ravni brez opaznih učinkov je bila 0,5 mg/kg telesne mase/dan na osnovi toksičnosti pri materah.
Wirtz Farma BV, Albert Cuyplaan 2B, 7482 JA Haaksbergen, THE NETHERLANDS 
Wirtz Farma BV, Albert Cuyplaan 2B, 7482 JA Haaksbergen, NIZOZEMSKA
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. 
Pristojni regulativni organ Nizozemske College Ter Beoordeling van Geneesmiddelen (Odbor za nadzor zdravil) Bureau Diergeneesmiddelen za zdravila za uporabo v veterinarski medicini je agencijo EMEA dne 21. avgusta 2006 skladno s členom 78(1) Direktive 2001/82/ES, kakor je bila spremenjena z Direktivo 2004/28/ES, obvestil o svoji nameri spremeniti 21 dovoljenj za promet z zdravilom.
Alfasan Nederland BV, Postbus 78, 3440 AB Woerden, THE NETHERLANDS 
Alfasan Nederland BV, Postbus 78, 3440 AB Woerden, NIZOZEMSKA
Boehringer Ingelheim España S.A., Prat de la Riva s/n., 08190 Sant Cugat del Valles. 
1107 ESP Boehringer Ingelheim España S.A. Prat de la Riva s/n. 08190 Sant Cugat del Valles, Barcelona, ŠPANIJA
In addition, the following information concerning human adverse reactions was considered by the CVMP: 
Poleg tega je CVMP pretehtal tudi informacije glede neželenih škodljivih učinkov pri ljudeh:
0187IS0155F012 BAYER N.V., Louizalaan 143, 1050 Brussel, BELGIUM 
0187IS0155F012 BAYER N.V., Louizalaan 143, 1050 Brussel, BELGIJA
Pfizer Luxembourg SARL PFIZER, podružnica Ljubljana, Letališka 3 c, 1000 Ljubljana, SLOVENIA 
5363-959/2004 Pfizer Luxembourg SARL PFIZER, podružnica Ljubljana, Letališka 3 c, 1000 Ljubljana, SLOVENIJA
In conclusion, the CVMP agreed on the following recommendation: 
Zaradi tega se je CVMP strinjal z naslednjim priporočilom:
0187IS0120F012 BAYER N.V., Louizalaan 143, 1050 Brussel, BELGIUM 
0187IS0120F012 BAYER N.V., Louizalaan 143, 1050 Brussel, BELGIJA
Having considered the matter, the CVMP concluded on the following recommendation: 
Po premisleku je CVMP zaključil z naslednjim priporočilom:
Detomodine 
Detomodin
No information on the risks for pregnant women was available in the reported human adverse reaction (Hoyer, M.J., 2006). 
Med poročili o neželenih škodljivih učinkih pri ljudeh ni bilo podatkov o tveganjih za nosečnice (Hoyer, M.J., 2006).
Boehringer Ingelheim Vetmedica GmbH 
CY004V-E Boehringer Ingelheim Vetmedica GmbH
Orion Corporation Orion Pharma, Tengstromink 8, Box 65, Turku, 0101, FINLAND 
Orion Corporation Orion Pharma, Tengstromink 8, Box 65, Turku, 0101, FINSKA
<The substance> is an alpha2-adrenoreceptor agonist, symptoms after absorption may involve clinical effects including dose-dependent sedation, respiratory depression, bradycardia, hypotension, a dry mouth, and hyperglycaemia. 
<Spojina> je agonist alfa-2 adrenoreceptorja, simptomi po absorpciji lahko obsegajo klinične učinke, ki vključujejo od odmerka odvisno sedacijo, respiratorno depresijo, bradikardijo, hipotenzijo, suha usta in hiperglikemijo.
ADVICE TO DOCTORS: <The substance> is an alpha2-adrenoreceptor agonist whose toxicity may cause clinical effects including sedation, respiratory depression and coma, bradycardia and hypotension and hyperglycaemia. 
NASVET ZA ZDRAVNIKE: <Spojina> je agonist alfa-2 adrenoreceptorja, njegova toksičnost pa lahko ima klinične učinke, vključno s sedacijo, respiratorno depresijo in komo, bradikardijo, hipotenzijo ter hiperglikemijo.
Icepharma hf., Lynhálsi 13, 110 Reykjavík, ICELAND 
IS/2/01/003/01 Icepharma hf., Lynhálsi 13, 110 Reykjavík, ISLANDIJA
In the case of accidental contact of the product with eyes, rinse abundantly with fresh water. 
V primeru nenamernega stika zdravila z očmi, jih izperite z obilico sveže vode.
BOX 78, 3440 AB Woerden, THE NETHERLANDS 
P.O. BOX 78, 3440 AB Woerden, NIZOZEMSKA
Boehringer Ingelheim Ltd, Ellesfield, Avenue Bracknell, Berkshire RG12 8YS, UNITED KINGDOM 
Ellesfield, Avenue Bracknell, Berkshire RG12 8YS, ZDRUŽENO KRALJESTVO
Advice to doctors: <The substance> is an alpha2-adrenoreceptor agonist, symptoms after absorption may involve clinical effects including dose-dependent sedation, respiratory depression, bradycardia, hypotension, a dry mouth, and hyperglycaemia. 
Nasvet za zdravnike: <Spojina> je agonist alfa-2 adrenoreceptorja, simptomi po absorpciji lahko obsegajo klinične učinke, ki vključujejo od odmerka odvisno sedacijo, respiratorno depresijo, bradikardijo, hipotenzijo, suha usta in hiperglikemijo.
However, foetal toxicity, as evidenced by increased postimplantation losses and reduced live pups, was observed in rats at subcutaneous dose of 200 µg/kg. 
Kljub temu so pri subkutanemu odmerku 200 µg/kg za podgane opazili fetalno toksičnost, o kateri so pričali povečana izguba po vgnezdenju zarodka in manjše število mladičev, ki preživijo.
96/039/01-C BOEHRINGER INGELHEIM VETMEDICA GMBH, Binger Strasse 173, 55216 Ingelheim am Rhein, GERMANY 
96/039/01-C BOEHRINGER INGELHEIM VETMEDICA GMBH, Binger Strasse 173, 55216 Ingelheim am Rhein, NEMČIJA
Marketing Authorisation number Marketing Authorisation Holder 
Številka dovoljenja za promet z zdravilom
Having considered the data and the comments from the MAHs, the CVMP agreed on the following recommendation: 
CVMP se je ob upoštevanju podatkov in pripomb imetnikov dovoljenja za promet z zdravilom strinjal z naslednjim priporočilom:
Romifidine Chlorhydrate 
Romifidin klorohidrat
NRP/VFP-00544-05 Alfasan International B.V., Kuipersweg 9, P.O. 
NRP/VFP-00544-05 Alfasan International B.V., Kuipersweg 9, P.O. Box 78, 3440 AB Woerden, THE NIZOZEMSKA
NRP/VFP-01453-07 Alfasan International B.V., Kuipersweg 9, P.O. 
NRP/VFP-01453-07 Alfasan International B.V., Kuipersweg 9, P.O. Box 78, NL-3440 AB Woerden, THE NIZOZEMSKA
In the case of accidental projection of the product into the eyes, rinse abundantly with fresh water. 
V primeru nenamernega brizga zdravila v oči jih izperite z obilico sveže vode.
UK Domosedan 10 mg/ml Injection 
UK Domosedan 10 mg/ml Injection Detomidin hidroklorid
Pfizer Animal Health, Ringaskiddy, Co. Cork, IRELAND 
10019/025/001 Pfizer Animal Health, Ringaskiddy, Co. Cork, IRSKA
Box 65, 02201 Espoo, FINLAND 
Orion oyj, P.O. Box 65, 02201 ESPOO, FINSKA
0419IS0003F012 PFIZER ANIMAL HEALTH S.A., Rue Laid Burniat 1, 1348 Louvain La Neuve, BELGIUM 
0419IS0003F012 PFIZER ANIMAL HEALTH S.A., Rue Laid Burniat 1, 1348 Louvain La Neuve, BELGIJA
Bayer Vital GmbH, 51368 Leverkusen, GERMANY 
6293841.00.00 Bayer Vital GmbH, 51368 Leverkusen, NEMČIJA
0419IS0001F012 PFIZER ANIMAL HEALTH S.A. Rue Laid Burniat 1, 1348 Louvain La Neuve, BELGIUM 
0419IS0001F012 PFIZER ANIMAL HEALTH S.A., Rue Laid Burniat 1, 1348 Louvain La Neuve, BELGIJA
96/731/96-C Pfizer Animal Health S.A., Rue Laid Burniat 1, 1348 Louvain-la-Neuve, BELGIUM 
96/731/96-C PFIZER ANIMAL HEALTH S.A., Rue Laid Burniat 1, 1348 Louvain La Neuve, BELGIJA
96/730/96-C Pfizer Animal Health S.A., Rue Laid Burniat 1, 1348 Louvain-la-Neuve, BELGIUM 
96/730/96-C PFIZER ANIMAL HEALTH S.A., Rue Laid Burniat 1, 1348 Louvain La Neuve, BELGIJA
Boehringer Ingelheim Vetmedica GmbH, Binger Strasse 173, 55216 Ingelheim am Rhein, GERMANY 
BOEHRINGER INGELHEIM VETMEDICA GMBH, Binger Strasse 173, 55216 Ingelheim am Rhein, NEMČIJA
No information on eye exposure was available in the reported human adverse reaction (Hoyer, M.J., 2006). 
Med poročili o neželenih škodljivih učinkih pri ljudeh ni bilo podatkov o izpostavitvi oči (Hoyer, M.J.,
BOEHRINGER INGELHEIM VETMEDICA GMBH, Binger Str. 173, 55218 Ingelheim, GERMANY 
Boehringer Ingelheim Vetmedica GmbH, Binger Str. 173, 55218 Ingelheim, NEMČIJA
No information on skin exposure was available in the reported human adverse reaction (Hoyer, M.J., 2006). 
Med poročili o neželenih škodljivih učinkih pri ljudeh ni bilo podatkov o izpostavitvi kože (Hoyer, M.J.,
Detomodine hydrochloride 
Detomidin hidroklorid
Boehringer Ingelheim Vetmedica GmbH, Binger Str. 173, 55218 Ingelheim, GERMANY 
Boehringer Ingelheim Vetmedica GmbH, Binger Str. 173, 55218 Ingelheim, NIZOZEMSKA
Xylazine hydrochloride 
Ksilazin hidroklorid
Detomidine chlorhydrate 
Detomidin klorohidrat
Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, Co. Galway, IRELAND 
10987/030/001 Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, Co. Galway, IRSKA
CY004V-E 
ALFASAN INTERNATIONAL B.V.
Medetomidine Chlorhydrate 
Medetomidin klorohidrat
ALFASAN INTERNATIONAL B.V. Kuipersweg 9, 3449 Ja Woerden, THE NETHERLANDS 
Kuipersweg 9, 3449 JA Woerden, NIZOZEMSKA
Duration of immunity: at least 6 months. 
Trajanje imunosti: najmanj 6 mesecev.
Do not touch! 
Ne dotikajte se!
The vaccination area should be as large as possible (preferably larger than 5,000 km2). 
Območje cepljenja naj bo čim večje (po možnosti večje od 5.000 km2).
The efficacy of the vaccine was demonstrated in laboratory studies. 
Učinkovitost cepiva je bila dokazana v laboratorijskih študijah.
No field studies were conducted. 
Terenskih študij niso izvedli.
Handle the baits with care. 
Z vabami ravnajte previdno.
Interaction with other medicinal products and other forms of interaction: Not known. 
Medsebojno delovanje z drugimi zdravili in druge oblike interakcij: Niso znani.
If you notice any side effects, even those not listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon. 
Če opazite kakršne koli stranske učinke, tudi tiste, ki niso navedeni v tem navodilu za uporabo ali mislite, da zdravilo ni delovalo, obvestite svojega veterinarja.
17493 Greifswald - Insel Riems Germany 
17493 Greifswald - Insel Riems Nemčija
QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose (1.7 ml) contains: 
KAKOVOSTNA IN KOLIČINSKA SESTAVA 1 odmerek (1,7 ml) vsebuje:
Stability after distribution in the environment was shown for 7 days at temperatures up to 25 °C. 
Stabilnost po polaganju v okolje je bila dokazana za 7 dni pri temperaturah do 25 °C.
A differentiation of this vaccine virus from any other rabies virus strains is possible, including its parental strain, for example by PCR methods. 
Diferenciacija tega virusa cepiva od vseh drugih sevov virusa stekline je možna, vključno s starševskim sevom, na primer z metodami PCR.
EXP {month/year} 
EXP: {mesec/leto}
Restricted to duly designated competent authorities. 
Omejeno na ustrezno imenovane pristojne organe.
a) the administration of the product to animals will interfere with the implementation of a national programmes for the diagnosis, control or eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals. 
a) bi uporaba zdravila ovirala izvajanje nacionalnih programov za diagnozo, nadzor ali zatiranje živalskih bolezni ali da bi povzročila težave pri zagotavljanju odsotnosti okuženosti pri živih živalih ali živilih ali drugih proizvodih, pridobljenih iz zdravljenih živali.
According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that: 
Skladno z 71. členom Direktive 2001/82/ES Evropskega parlamenta in Sveta z vsemi dopolnitvami in spremembami lahko država članica, skladno z nacionalno zakonodajo, prepove proizvajanje, uvoz/vnos, posedovanje, prodajo, oskrbo in/ali uporabo imunološkega zdravila za uporabo v veterinarski medicini na svojem celotnem ozemlju ali delu ozemlja, če ugotovi, da:
b) the disease to which product is intended to confer immunity is largely absent from the territory in question. 
b) bolezen, za katero se z zdravilom pridobi imunost, na zadevnem območju skoraj ni prisotna.
Therefore the recommendations / request of the duly designated competent authority are followed concerning distribution rate, vaccination area, distribution/baiting method and other local/areal conditions as specified by the competent authority. 
Zato se upoštevajo priporočila /zahtevki ustrezno imenovanega pristojnega organa glede gostote polaganja, območja cepljenja, načina polaganja vab in drugi lokalni/terenski pogoji, ki jih opredeli pristojni organ.
Pregnancy and lactation: Can be used during pregnancy. 
Brejost in laktacija: Lahko se uporablja v obdobju brejosti.
The vaccination campaigns in rabies-free areas should be designed in such a way that the area covers a 50 km belt ahead of the rabies front. 
Kampanje cepljenja na območjih, kjer stekline ni, morajo biti zasnovane tako, da območje pokriva 50 km pas pred območjem s steklino.
As each of these modifications on the genome were shown to further attenuate the SAD B19 virus strain, their multiple effect helps to avoid the reversion to the parental strain. 
Ker se je pokazalo, da vsaka od modifikacij genoma nadalje oslabi sev virusa SAD B19, njihov večkratni učinek pomaga preprečiti vračanje v starševski sev.
Proposed first aid measures immediately after direct human exposure to the vaccine fluid should follow the recommendations of the WHO as outlined in the “WHO Guide for Rabies Pre- and PostExposure Prophylaxis (PEP) in Humans”. 
Predlagani ukrepi prve pomoči takoj po izpostavljenosti človeka tekočini cepiva naj sledijo priporočilom SZO, navedenim v "WHO Guide for Rabies Pre- and Post-Exposure Prophylaxis (PEP) in Humans" ("Smernice SZO za preprečevanje stekline pred izpostavljenostjo in po njej pri ljudeh").
Vaccination should not be attempted when temperatures are expected to reach 25 °C or more, and never during the summer season. 
Cepitev naj se ne izvaja, če se pričakujejo temperature 25 °C ali več, in nikoli med poletno sezono.
The administration of the vaccine at 10 times the recommended dose induced no undesirable effects. 
Dajanje 10-kratnega priporočenega odmerka cepiva ni povzročilo neželenih učinkov.
A higher distribution density is recommended in areas with a high population density of foxes/raccoon dogs. 
Večja gostota polaganja se priporoča na območjih z veliko gostoto populacije lisic/rakunastih psov.
The distribution rate depends on the topography, on the population density of the target species and on the epizootiological situation. 
Gostota polaganja je odvisna od topografije, gostote populacije ciljne živalske vrste in od epizootiološke situacije.
Distribution of baits manually or by air. 
Vaba se polaga ročno ali iz zraka.
Store and transport frozen, below -15 °C. 
Shranjujte in prevažajte zamrznjeno pri temperaturi pod -15 °C.