natgillin/translations-raw huggingface dataset:
ADYNOVI 250 IU / 2 ml powder and solvent for solution for injection rurioctocog alfa pegol 
ADYNOVI 250 i.e. / 2 ml prašek in vehikel za raztopino za injiciranje rurioktokog alfa pegol
VIAL LABEL FOR THE SOLVENT (BAXJECT III SYSTEM) 
NALEPKA NA VIALI Z VEHIKLOM (sistem BAXJECT III)
Powder: White to off-white friable powder. 
Prašek: bel do belkast drobljiv prašek.
This means that it affects the activity of the immune system (the body's natural defences). 
To pomeni, da vpliva na delovanje imunskega sistema (naravnega obrambnega mehanizma telesa).
Further information on Lenalidomide Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Nadaljnje informacije o zdravilu Lenalidomide Accord so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Lenalidomide Accord is taken in repeated 28-day cycles: the patient takes the medicine once a day on certain days over 28 days. 
Zdravilo Lenalidomide Accord se jemlje v ponavljajočih se 28-dnevnih ciklusih zdravljenja: bolnik vzame zdravilo enkrat na dan na določene dni v 28 dneh.
A lower dose should be used in patients who have moderate or more severe reduction in their kidney function. 
Manjši odmerek se uporablja pri bolnikih z zmerno ali hudo oslabljenim delovanjem ledvic.
Depending on the day, the patient may take one or more medicines or may not take any medicines. 
Bolnik mora odvisno od dneva v ciklusu vzeti eno ali več zdravil oziroma na nekatere dni ne vzame nobenega zdravila.
The medicine can only be obtained with a prescription and treatment must be monitored by doctors who have experience in the use of cancer medicines. 
Predpisovanje in izdaja zdravila je le na recept, zdravljenje pa mora nadzorovati zdravnik z izkušnjami z uporabo zdravil za zdravljenje raka.
The company has also set up a pregnancy prevention programme in each Member State and will collect information on the medicine's use outside its approved uses. 
Podjetje je v vsaki državi članici tudi vzpostavilo program preprečevanja nosečnosti in bo zbiralo podatke o morebitni uporabi zdravila za neodobrene indikacije.
It will also supply cards for patients to ensure that they are informed about appropriate safety measures to be taken by each patient. 
Prav tako bo priskrbelo kartice za bolnike, s pomočjo katerih bo lahko vsak bolnik preveril, ali upošteva vse ustrezne varnostne ukrepe.
Because Lenalidomide Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's. 
Ker je zdravilo Lenalidomide Accord generično zdravilo in je bioekvivalentno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
What measures are being taken to ensure the safe and effective use of Lenalidomide Accord? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Lenalidomide Accord?
The European Medicines Agency concluded that, in accordance with EU requirements, Lenalidomide Accord has been shown to have comparable quality and to be bioequivalent to Revlimid. 
Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Lenalidomide Accord primerljivo raven kakovosti in je bioekvivalentno z zdravilom Revlimid.
Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Revlimid, and do not need to be repeated for Lenalidomide Accord. 
Študije o koristih in tveganjih učinkovine pri odobrenih načinih uporabe so že bile izvedene z referenčnim zdravilom Revlimid, zato jih ni treba ponoviti za zdravilo Lenalidomide Accord.
For more information about using Lenalidomide Accord, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Lenalidomide Accord glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Lenalidomide works in a number of different ways: it blocks the development of abnormal cells, prevents the growth of blood vessels within tumours and also stimulates specialised cells of the immune system to attack the abnormal cells. 
Lenalidomid deluje na več načinov: preprečuje razvoj nenormalnih celic, preprečuje rast krvnih žil v tumorjih in spodbuja nekatere posebne celice imunskega sistema k napadanju nenormalnih celic.
Side effects reported with Lenalidomide Accord are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Lenalidomide Accord, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
• on its own, in adults who have had a stem cell transplant (a procedure where the patient's bone marrow is cleared of cells and replaced by stem cells from a donor) to stop the progression of the cancer; 
• samostojno pri odraslih, pri katerih je bila opravljena presaditev matičnih celic (postopek, pri katerem iz bolnikovega kostnega mozga odstranijo celice in jih nadomestijo z matičnimi celicami darovalca) za zaustavitev napredovanja raka;
The boxes containing Lenalidomide Accord capsules also bear a warning stating that lenalidomide can be harmful to the unborn child. 
Škatle, ki vsebujejo kapsule zdravila Lenalidomide Accord, so tudi opremljene z opozorilom, da je lenalidomid lahko škodljiv za nerojene otroke.
• in combination with dexamethasone, in adults whose disease has been treated at least once in the past. 
• v kombinaciji z deksametazonom za zdravljenje odraslih, ki so se v preteklosti zaradi te bolezni zdravili vsaj enkrat.
An overview of Lenalidomide Accord and why it is authorised in the EU 
Pregled zdravila Lenalidomide Accord in zakaj je odobreno v EU
As for every medicine, the company provided studies on the quality of Lenalidomide Accord. 
Tako kot za vsako zdravilo je podjetje predložilo študije o kakovosti zdravila Lenalidomide Accord.
Lenalidomide Accord is a medicine used for the treatment of multiple myeloma, a cancer of a type of white blood cells called plasma cells. 
Lenalidomide Accord je zdravilo, ki se uporablja za zdravljenje diseminiranega plazmocitoma, tj. raka določene vrste belih krvnih celic, imenovanih plazmatke.
The company that markets Lenalidomide Accord will provide a letter and educational kits for healthcare professionals, and brochures for patients, explaining that the medicine can be harmful to the unborn child and detailing the steps that need to be taken for the medicine to be used safely. 
Podjetje, ki trži zdravilo Lenalidomide Accord, bo zdravstvenim delavcem priskrbelo dopis in izobraževalno gradivo, bolnikom pa knjižico, v katerih bo razloženo, da je zdravilo lahko škodljivo za nerojene otroke, in ki bodo vsebovali podrobnosti o varni uporabi zdravila.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lenalidomide Accord have also been included in the summary of product characteristics and the package leaflet. 
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Lenalidomide Accord upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
This means that Lenalidomide Accord contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Revlimid. 
To pomeni, da vsebuje enako učinkovino in deluje na enak način kot „referenčno zdravilo“, ki je že odobreno v EU in se imenuje Revlimid.
As for all medicines, data on the use of Lenalidomide Accord are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Lenalidomide Accord stalno spremljajo.
The dose depends on the situation in which Lenalidomide Accord is used. 
Odmerek je odvisen od okoliščin, zaradi katerih se zdravilo Lenalidomide Accord uporablja.
Lenalidomide Accord contains the active substance lenalidomide and is a ‘generic medicine'. 
Zdravilo Lenalidomide Accord vsebuje učinkovino lenalidomid in je „generično zdravilo“.
What are the benefits and risks of Lenalidomide Accord? 
Kakšne so koristi in tveganja zdravila Lenalidomide Accord?
What is Lenalidomide Accord and what is it used for? 
Kaj je zdravilo Lenalidomide Accord in za kaj se uporablja?
Other information about Lenalidomide Accord 
Druge informacije o zdravilu Lenalidomide Accord
The active substance in Lenalidomide Accord, lenalidomide, is an immunomodulating agent. 
Učinkovina v zdravilu Lenalidomide Accord, lenalidomid, je imunomodulator.
The dose should be reduced or treatment interrupted depending on whether the disease has worsened, the severity of any side effects and the levels of platelets (components that help the blood to clot) and neutrophils (a type of white blood cell that helps fight infection). 
Zdravnik mora glede na poslabšanje bolezni, resnost neželenih učinkov ter število trombocitov (sestavnih delov krvi, ki pomagajo pri njenem strjevanju) in nevtrofilcev (vrste belih krvnih celic, ki pomagajo v boju proti okužbam) v krvi odmerek zmanjšati ali pa zdravljenje prekiniti.
Why is Lenalidomide Accord authorised in the EU? 
Zakaj je bilo zdravilo Lenalidomide Accord odobreno v EU?
Lenalidomide Accord is used: 
Zdravilo Lenalidomide Accord se uporablja:
Lenalidomide Accord is available as capsules of various strengths to be taken by mouth. 
Zdravilo Lenalidomide Accord je na voljo v obliki kapsul različnih jakosti, ki se jemljejo peroralno.
• in combination with melphalan (a cancer medicine) and prednisone (an anti-inflammatory medicine) for the treatment of adults with previously untreated multiple myeloma, who cannot have a stem cell transplant; 
• v kombinaciji z melfalanom (zdravilom za zdravljenje raka) in prednizonom (protivnetnim zdravilom) za zdravljenje odraslih s predhodno nezdravljenim diseminiranim plazmocitomom, pri katerih ni mogoče opraviti presaditve matičnih celic;
• in combination with dexamethasone (an anti-inflammatory medicine), for the treatment of adults with previously untreated (newly diagnosed) multiple myeloma, who cannot have a stem cell transplant; 
• v kombinaciji z deksametazonom (protivnetnim zdravilom) za zdravljenje odraslih s predhodno nezdravljenim (novo odkritim) diseminiranim plazmocitomom, pri katerih ni mogoče opraviti presaditve matičnih celic;
Therefore, the Agency's view was that, as for Revlimid, the benefit of Lenalidomide Accord outweighs the identified risk and it can be authorised for use in the EU. 
Zato je menila, da koristi zdravila Lenalidomide Accord enako kot pri zdravilu Revlimid odtehtajo znana tveganja in da se zdravilo lahko odobri v EU.
How has Lenalidomide Accord been studied? 
Kako je bilo zdravilo Lenalidomide Accord raziskano?
How does Lenalidomide Accord work? 
Kako zdravilo Lenalidomide Accord deluje?
How is Lenalidomide Accord used? 
Kako se zdravilo Lenalidomide Accord uporablja?
These measures should help protect the environment. 
Ti ukrepi pomagajo varovati okolje.
Avoid multiple vial broaching. 
Izogibajte se večkratnemu prebadanju viale.
These resolved within a maximum of 25 days. 
Te reakcije izzvenijo v največ 25 dneh.
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision. 
Imetnik dovoljenja za promet z zdravilom mora obvestiti Evropsko komisijo o načrtih trženja za zdravilo, ki je predmet tega dovoljenja.
No information is available on the use of the vaccine in seropositive animals including those with maternally derived antibodies. 
Na voljo ni nobenih informacij o uporabi cepiva pri seropozitivnih živalih vključno s tistimi z maternalnimi protitelesi.
a) The administration of the product to animals will interfere with the implementation of a national programme 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.
*(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating no presence of viral genome). 
*(Ciklična vrednost (Ct) ≥ 36 pri validirani metodi RT-PCR, kar kaže, da virusni genom ni prisoten)
Do not mix with any other veterinary medicinal product. 
Ne mešajte z nobenim drugim zdravilom.
Primary vaccination: 
Osnovno cepljenje:
The level of efficacy for other species may differ from that observed in cattle. 
Učinkovitost pri drugih vrstah se lahko razlikuje od dokazane učinkovitosti pri govedu.
*Relative Potency by a mice potency test compared to a reference vaccine that was shown efficacious in cattle. 
*Relativna potenca pri testu potence pri miših v primerjavi z referenčnim cepivom, ki je bilo učinkovito pri govedu.
The use of this veterinary medicinal product is only allowed under the particular conditions established by European Community legislation on the control of bluetongue. 
Uporaba tega cepiva je dovoljena le pod posebnimi pogoji zakonodaje EU o kontroli bolezni modrega jezika.
The excipients (including adjuvants) listed in section 6.1 of the SPC are allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required. 
SPC so dovoljenje snovi, za katere tabela 1 priloge Uredbe Komisije (EU) št. 37/2010 določa, da MRL ni potreben.
In this category of animals the vaccine should be used only according to the benefit/risk assessment by the responsible veterinarian and/or national Competent Authorities on the current vaccination policies against bluetongue virus (BTV). 
Pri tej kategoriji živali uporabite cepivo le v skladu z oceno razmerja korist/tveganje odgovornega veterinarja in/ali v skladu s trenutnimi smernicami pristojnih državnih organov za cepljenje proti virusu modrikastega jezika (BT).
Any revaccination scheme should be agreed by the Competent Authority or by the responsible veterinarian, taking into account the local epidemiological situation. 
Za vsak program ponovnega cepljenja se je potrebno dogovoriti s pristojnimi nacionalnimi organi ali odgovornim veterinarjem, upoštevajoč pri tem epidemiološko situacijo.
Local reactions may increase slightly following the second dose in this case lasting up to 15 days. 
Lokalne reakcije se lahko nekoliko povečajo po drugem odmerku in trajajo do 15 dni.
Interaction with other medicinal products and other forms of interaction: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. 
Medsebojno delovanje z drugimi zdravili in druge oblike interakcij: Ni podatkov o varnosti ter učinkovitosti ob uporabi tega cepiva s katerim koli drugim zdravilom za uporabo v veterinarski medicini.
Shelf life of the veterinary medicinal product as packaged for sale: 1 year. 
Rok uporabnosti zdravila v pakiranju za prodajo: 1 leto.
Shelf life after first opening the immediate packaging: use immediately after broaching. 
Rok uporabnosti po prvem odpiranju stične ovojnine: porabite takoj po načetju.
High density polyethylene (HDPE) vials of 20, 100 or 240 ml with chlorobutyl elastomer rubber stopper and aluminium seal containing 10, 50 or 120 doses of vaccine. 
20 ml, 100 ml ali 240 ml-viale iz polietilena visoke gostote (HDPE) z zamaškom iz klorobutilnega elastomera in aluminijsko zaporko, ki vsebujejo 10, 50 ali 120 odmerkov cepiva.
A transient increase in rectal temperature, not exceeding 2.7 C, was commonly observed during the 48 hours following vaccination in field safety studies. 
Prehodno povišanje rektalne temperature, ki ne presega 2,7 °C je bilo pogosto opaženo 48 ur po cepljenju v terenskih varnostnih študijah.
In order to avoid accidental contamination of the vaccine during use, it is recommended to use a multiinjection type vaccination system when larger dose presentations are used. 
Da bi se izognili naključni kontaminaciji cepiva med uporabo, je pri večjih pakiranjih priporočljivo uporabljati sistem multiinjekcijskega cepljenja.
Potassium dihydrogen phosphate Disodium hydrogen phosphate dihydrate Sodium chloride 
Kalijev dihidrogenfosfat Natrijev hidrogenfosfat dihidrat Natrijev klorid
Per dose of 2 ml: 
V odmerku 2 ml:
To stimulate active immunity against bluetongue virus, serotypes 1 and 8 in cattle. 
Za stimulacijo aktivne imunosti proti virusu bolezni modrikastega jezika, serotipa 1 in 8, pri govedu.
METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular use. 
NAČIN IN POT(I) UPORABE Intramuskularma uporaba.
PACKAGE LEAFLET: Zulvac 1+8 Bovis Suspension for injection for cattle 
NAVODILO ZA UPORABO Zulvac 1+8 Bovis Suspenzija za injiciranje za govedo
The entire content of the bottle should be used immediately after broaching and during the same procedure. 
Takoj po odpiranju in med istim postopkom porabite naenkrat celotno vsebino stekleničke.
Avoid bubble formation, as this can be irritating at the site of injection. 
Izogibajte se nastanku zračnih mehurčkov, saj le-ti lahko povzročijo draženje na mestu dajanja.
Manufacturer responsible for batch release: Zoetis Manufacturing & Research Spain, S.L. 
Proizvajalec, odgovoren za sproščanje serij: Zoetis Manufacturing & Research Spain, S.L.
Revaccination: 
Ponovno cepljenje:
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 08/03/2012. 
Datum pridobitve dovoljenja za promet: 08/03/2012 Datum podaljšanja dovoljenja za promet: 13/12/2016
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Outer carton 1 x 20 ml, 1 x 100 ml or 240 ml 
PODATKI NA ZUNANJI OVOJNINI Kartonska škatla 1 x 20 ml, 1 x 100 ml ali 1 x 240 ml
Off-white or pink liquid 
Belkasta ali roza obarvana tekočina.
The safety and the efficacy of the vaccine have not been established in breeding males. 
Varnost in učinkovitost zdravila ni bila ugotovljena pri plemenskih živalih.
Lactation: Can be used during lactation. 
Brejost : Lahko se uporablja v obdobju brejosti .
2nd injection: 3 weeks after 1st injection. 
2. injekcija: 3 tedne po prvem cepljenju
For active immunisation of cattle from 3 months of age for the prevention* of viraemia caused by bluetongue virus (BTV), serotypes 1 and 8. 
Za aktivno imunizacijo goveda, starejšega od 3 mesecev, za preprečitev* viremije, ki jo povzroča virus modrikastega jezika (BT), serotipa 1 in 8.
Shake gently immediately before use. 
Neposredno pred uporabo rahlo pretresite.
Name and address of the manufacturer of the biological active substance Zoetis Manufacturing & Research Spain, S.L. 
Ime in naslov proizvajalca (proizvajalcev) biološke (bioloških) učinkovine (učinkovin) Zoetis Manufacturing & Research Spain, S.L.
Aluminium hydroxide, saponin and thiomersal. 
Aluminijev hidroksid, saponin in tiomersal.
Administer one dose of 2 ml according to the following vaccination scheme: 1st injection: from 3 months of age. 
Dajte en odmerek (2 ml) v skladu z naslednjim programom cepljenja:
Pack of 1 bottle of 10 doses (20 ml). 
Pakiranje z 1 vialo z 10 odmerki (20 ml).
PACKAGE SIZE 20 ml (10 doses) 100 ml (50 doses) 240 ml (120 doses) 
20 ml (10 odmerkov) 100 ml (50 odmerkov) 240 ml (120 odmerkov)
Zero days. 
KARENCA Nič dni
Official control authority batch release is required for this product. 
Za to zdravilo je potreben postopek uradne kontrole in sproščanja (OCABR postopek).
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Vial label 100 ml or 240 ml 
PODATKI NA STIČNI OVOJNINI Nalepka na viali 100 ml ali 240 ml
Duration of immunity: 12 months after completion of the primary vaccination course. 
Trajanje imunosti: 12 mesecev po končanem osnovnem cepljenju .
PACKAGE SIZE 100 ml (50 doses) 240 ml (120 doses) 
100 ml (50 odmerkov) 240 ml (120 odmerkov)
Do not use after the expiry date which is stated on the carton and label after EXP. Once broached use immediately. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini po {EXP}.
Pack sizes 
VELIKOST PAKIRANJA
Pack of 1 bottle of 120 doses (240 ml). 
Pakiranje z 1 vialo s 120 odmerki (240 ml).
IMMUNOLOGICAL PROPERTIES Pharmacotherapeutic group: Inactivated viral vaccines - Bluetongue virus ATCvet code: QI02AA08. 
Farmakoterapevtska skupina: Inaktivirana virusna cepiva - virus bolezni modrikastega jezika.
Onset of immunity: 21 days after completion of the primary vaccination course. 
Začetek imunosti: 21 dni po končanem osnovnem cepljenju.
2nd injection: after 3 weeks. 
1. injekcija: od 3 meseca starosti.
Inactivated bluetongue virus, serotype 1, strain BTV-1/ALG2006/01 E1, Inactivated bluetongue virus, serotype 8, strain BTV-8/BEL2006/02. 
Inaktiviran virus modrega jezika, serotip 1, sev BTV-1/ALG2006/01 E1 Inaktiviran virus modrega jezika, serotip 8, sev BTV-8/BEL2006/02
Pack of 1 bottle of 50 doses (100 ml). 
Pakiranje z 1 vialo s 50 odmerki (100 ml).
If used in other domestic and wild ruminant species that are considered at risk of infection, its use in these species should be undertaken with care and it is advisable to test the vaccine on a small number of animals prior to mass vaccination. 
Če se cepivo uporablja pri drugih domačih in divjih vrstah prežvekovalcev, ki jih ogroža okužba, je potrebna previdnost.
Local reactions of up to 5 cm diameter were very commonly observed and reactions > 5 cm diameter were commonly observed after repeated administration of a single dose in field safety studies. 
Lokalne reakcije v velikosti do 5 cm v premeru so bile zelo pogosto opažene in reakcije v velikosti >5 cm v premeru so bile pogosto opažene po večkratnem dajanju enkratnega odmerka v v terenskih varnostnih študijah.
Adjuvants: Aluminium hydroxide 
Aluminijev hidroksid
MARKETING AUTHORISATION NUMBER(S) EU/2/12/139/001 (20 ml) 
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/12/139/001 (20 ml)
A transient increase in rectal temperature, not exceeding 2 °C, may occur in 10% of the animals during the 24 hours following administration of two-fold overdose. 
Po dajanju dvojnega odmerka se pri 10 % živali v 24 urah po injiciranju lahko pojavi prehodno povišanje rektalne temperature do 2°.
EXPIRY DATE EXP {month/year} Once broached use immediately. 
EXP {mesec/leto}
MARKETING AUTHORISATION NUMBER(S) EU/2/12/139/001 
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/12/139/001
QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2 ml dose contains: 
Vsak 2 ml odmerek vsebuje:
MARKETING AUTHORISATION NUMBER(S) EU/2/12/139/002 
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/12/139/002
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each 2 ml dose contains: 
Vsak odmerek (2 ml) vsebuje:
A transient increase in rectal temperature, not exceeding 2 C, may occur in 10% of the animals during the 24 hours following administration of a two-fold overdose. 
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi), (če je potrebno) Po dajanju dvojnega odmerka se pri 10 % živali v 24 urah po injiciranju lahko pojavi prehodno povišanje rektalne temperature do 2 °C.
Local reactions of < 2 cm diameter were very commonly observed while reactions of up to 5 cm diameter were commonly observed after administration of a single dose in field safety studies. 
Lokalne reakcije, manjše od 2 cm v premeru so bile zelo pogosto opažene, medtem ko so bile reakcije do 5 cm v premeru opažene pogosto po enkratnem odmerku v terenskih varnostnih študijah.
Special warnings for each target species: 
Posebna opozorila za vsako ciljno živalsko vrsto: Cepite samo zdrave živali.
Active substance(s): 
NAVEDBA UČINKOVIN(E) IN
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial label 20 ml 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 20 ml (10 doses) 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV
Packaging Content Package size Withdrawal period 
Način uporabe Pakiranje Vsebina Velikost pakiranja
This has been subject to previous reviews leading to risk minimisation measures at national level. 
To je bil tudi predmet predhodnih preučevanj, ki so privedli do ukrepov za zmanjšanje tveganj na nacionalnih ravneh.