natgillin/translations-raw huggingface dataset:
What benefits of Bovalto Ibraxion have been shown in studies? 
Kakšne koristi je zdravilo Bovalto Ibraxion izkazalo v študijah?
For more information about treatment with Bovalto Ibraxion, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist. 
Za več informacij o zdravljenju z zdravilom Bovalto Ibraxion naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
Bovalto Ibraxion is available as an emulsion and can only be obtained with a prescription. 
Zdravilo Bovalto Ibraxion je na voljo v obliki emulzije, njegovo predpisovanje in izdaja pa sta le na recept.
Bovalto Ibraxion is a veterinary vaccine used to protect cattle against infectious bovine rhinotracheitis (IBR) virus. 
Bovalto Ibraxion je zdravilo za uporabo v veterinarski medicini, ki se uporablja za zaščito goveda pred virusom infekcioznega bovinega rinotraheitisa (IBR).
Bovalto Ibraxion is a vaccine containing a version of the IBR virus that has been made inactive so it cannot cause infection. 
Zdravilo Bovalto Ibraxion je cepivo, ki vsebuje neaktivirano različico virusa IBR, ki ne more povzročiti okužbe.
Why is Bovalto Ibraxion approved? 
Zakaj je bilo zdravilo Bovalto Ibraxion odobreno?
Bovine rhinotracheitis vaccine (inactivated) 
Bovalto Ibraxion cepivo proti bovinemu rinotraheitisu (neaktivirano)
What are the risks associated with Bovalto Ibraxion? 
Kakšna tveganja so povezana z zdravilom Bovalto Ibraxion?
Other information about Bovalto Ibraxion? 
Druge informacije o zdravilu Bovalto Ibraxion:
Bovalto Ibraxion contains the adjuvant light paraffin oil to enhance the immune response. 
Cepivo Bovalto Ibraxion vsebuje kot adjuvans lahko parafinsko olje, ki spodbuja imunski odziv.
Bovalto Ibraxion contains the active substance inactivated gene deleted IBR virus. 
Zdravilo Bovalto Ibraxion vsebuje kot zdravilno učinkovino neaktivirani virus z delecijo gena IBR.
It is not intended to provide practical advice on how to use Bovalto Ibraxion. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
How does Bovalto Ibraxion work? 
Kako zdravilo Bovalto Ibraxion deluje?
How is Bovalto Ibraxion used? 
Kako se zdravilo Bovalto Ibraxion uporablja?
What is Bovalto Ibraxion and what is it used for? 
Kaj je zdravilo Bovalto Ibraxion in za kaj se uporablja?
This product contains mineral oil. 
Ta izdelek vsebuje mineralno olje.
An alternative solution could be to retain only one production site. 
Druga možna rešitev je ohraniti zgolj eno mesto izdelave.
> 1:40 HI Units 
> 1:40 HI Enot
4.8 Interactions with other medicinal products and other forms of interaction 
4.8 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu/ 
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/
Revaccinate after 3 weeks. 
Ponovno cepljenje po treh tednih.
Applicant is asked to commit to take appropriate measures to harmonise the productions and/or to provide the adequate demonstrations/data to solve the issues. 
Predlagatelja prosimo, da sprejme ustrezne ukrepe za usklajevanje izdelovanja in/ali da priskrbi primerne predstavitve/podatke za rešitev teh vprašanj.
With regard to the differences in production and control, harmonization of the production process and the controls between both manufacturing site is strongly suggested. 
Glede na razlike v izdelovanju in kontroli, močno priporočamo uskladitev postopkov izdelave in kontrole med obema proizvodnima mestoma.
SPECIAL WARNINGS, IF NECESSARY Accidental injection is dangerous. 
POSEBNA OPOZORILA, ČE SO POTREBNA Nenamerno injiciranje je nevarno.
MRL required 
MRL ni zahtevan
The Marketing Authorisation Holder shall complete the following programme of studies, the results of which shall form the basis of the annual reassessment of the benefit/risk profile. 
Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem obdobju izvesti naslednji program študij, katerih rezultati služijo kot osnova za vsakoletno ponovno oceno razmerja korist/tveganje.
For use only as a preservative in multidose vaccines at a concentration not exceeding 
Le za uporabo v obliki konzervan sa v večodmer nih cepivih pri koncentra ciji, ki ne presega
Water in oil adjuvant 
Voda v oljnem dodatku
Duration of immunity in chickens has not been established yet. 
Čas trajanja imunske zaščite pri piščancih še ni potrjena.
According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, Member States prohibit or may prohibit the import, sale, supply and/or use of the veterinary medicinal product on the whole or part of their territory if it is established that: 
Skladno z 71. členom Direktive 2001/82/ES države članice prepovejo ali lahko prepovejo uvoz, prodajo, oskrbo in/ali uporabo zdravila za uporabo v veterinarski medicini na svojem celotnem ozemlju ali delu ozemlja, če se ugotovi da:
Do not mix with any other medicinal product. 
Ne mešajte z drugimi zdravili.
Pfizer Animal Health 2000 Rockford Road Charles City, Iowa 50616 USA 
Pfizer Animal Health 2000 Rockford Road Charles City, Iowa 50616 ZDA
QUALITY ASPECTS 
VIDIKI KVALITETE
Any person intending to import, sell, supply and/or use Poulvac FluFend H5N3 RG must consult the relevant Member States competent authority on the current vaccination policies prior to the import, sale, supply and/or use. 
Vsakdo, ki namerava uvažati, prodajati, oskrbovati in/ali uporabljati Poulvac FluFend H5N3 RG, se mora posvetovati s pristojnimi organi posamezne države članice o veljavnih programih cepljenja še pred uvozom, prodajo, oskrbo in/ali uporabo.
All food producing species 
Vse vrste za proizvodnj o živil
Pfizer Limited Ramsgate Road Sandwich, Kent CT13 9NJ United Kingdom 
Pfizer Limited Ramsgate Road Sandwich, Kent CT13 9NJ Združeno kraljestvo
In particular, a rationalization of the nature of eggs used (taking into consideration the problem of the possible presence of extraneous agents in conventional eggs and the possibility to inactivate them during the inactivation process of the Influenza virus, supported by a corresponding validation study). 
To velja še posebej pri racionalizaciji lastnosti uporabljenih jajc (ob upoštevanju problema morebitne prisotnosti tujih dejavnikov v običajnih jajcih in možnosti inaktivacije le-teh med postopkom inaktivacije virusa influence, kar podpira ustrezna validacijska študija).
The vaccination schedule should be completed at least 4 weeks before the start of laying. 
Program cepljenja bi se moral zaključiti vsaj 4 tedne pred začetkom obdobja nesnosti.
The use of this veterinary medicinal product is only allowed under the particular conditions established by European Community legislation on the control of Avian Influenza. 
Uporaba tega zdravila za uporabo v veterinarski medicini je dovoljena le pod posebnimi pogoji, ki jih določa zakonodaja Evropske skupnosti o aviarni influenci.
The vaccine is presented in boxes of 1 or 10 bottles of 500 ml. 
Cepivo je v škatlah z 1 ali 10 plastenkami po 500 ml.
PHARMACEUTICAL FORM Emulsion for injection. 
FARMACEVTSKA OBLIKA Emulzija za injiciranje.
The import, sale, supply and/or use of Poulvac FluFend H5N3 RG is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy. 
Uvoz, prodaja, oskrba in/ali uporaba Poulvac FluFend H5N3 RG je ali je lahko prepovedana v nekaterih državah članicah na njihovem celotnem ozemlju ali delu ozemlja v skladu z nacionalnim programom zdravstvenega varstva živali.
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision. 
Imetnik tega dovoljenja za promet mora o načrtih prometa z zdravilom, ki je bilo odobreno s tem odlokom, obvestiti Evropsko Komisijo.
The level of efficacy attained may vary depending on the degree of antigenic homology between the vaccine strain and circulating field strains. 
Nivo dosežene učinkovitosti lahko variira glede na stopnjo antigenske homolognosti med sevom v cepivu in sevi v okolju.
Keep in the original container in order to protect from light. 
Shranjujte v originalni ovojnini za zaščito pred svetlobo.
ADVICE ON CORRECT ADMINISTRATION Do not mix with any other medicinal product. 
NASVET O PRAVILNI UPORABI ZDRAVILA Ne mešajte z drugimi zdravili.
Excludes aromatic and unsaturated compounds 
Izključene aromatičn e in nesaturira ne sestavine
Pharmacotherapeutic group: Inactivated recombinant vaccine, ATC vet code: QI01AA23 
Farmakoterapevtska skupina: Inaktivirano rekombinantno cepivo, ATCvet oznaka: QI01AA23
The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009. 
D. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN ZAOSTANKOV ZDRAVILA (MRL) Zdravilna učinkovina biološkega izvora namenjena za vzpodbudo aktivne imunosti ni vključena v Uredbo(ES) št. 470/2009.
Even if small amounts have been injected, accidental injection with this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit. 
Čeprav je bila injicirana le majhna količina, lahko nenamerno injiciranje tega izdelka povzroči močno oteklino, ki lahko na primer privede do ishemične nekroze ter celo do izgube prsta.
The entire content of the bottle should be used within 2 hours after broaching the container. 
Vsebino plastenke morate porabiti v dveh urah po predrtju vsebnika.
Avoid stress in the birds around the time of vaccination. 
V času cepljenja ptice varujte pred stresom.
1) There are important outstanding issues regarding the differences of production and control between the manufacturing sites (including the nature of the eggs used) and the lack of a validation study for the potency test on finished product (it appears that final product tests are only done at Weesp but in-process tests such as titration and HA quantification need to be equivalent too). 
1) Obstajajo pomembna nerešena vprašanja glede razlik med izdelavo in nadzorom v različnih proizvodnih obratih (vključno z lastnostmi uporabljenih jajc) in ni validacijske študije za test moči (potency test) na končnem izdelku (zdi se, da se testi končnega cepiva izvajajo le v
PACKAGE SIZE 500 ml 
VELIKOST PAKIRANJA 500 ml
A transient local site reaction (swelling) may occasionally occur as is normal with oil adjuvanted vaccines. 
Občasno se lahko pojavi prehodna lokalna reakcija (otekanje), kot je običajno za cepiva, kjer je dodatek olje.
White Oil 
Belo olje
Mineral hydrocarbons, low to high viscosity including microcrystalline waxes, approximately C10-C60, aliphatic, branched aliphatic and alicyclic compounds 
Hidrokarbon, mineralni, nizke do visoke viskoznosti vključuje voske, mikrokristalinične, okoli C10-C60, alifatične, razvejane alifatične in aliciklične sestavine
DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION 
ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POTI IN NAČIN UPORABE ZDRAVILA
Name and address of the manufacturer of the biological active substance(s) 
Ime in naslov izdelovalca(izdelovalcev) biološke zdravilne učinkovine (zdravilnih učinkovin).
Chickens and ducks. 
Piščanci in race.
Emulsion for injection for chickens and ducks 
Emulzija za injiciranje za piščance in race
3 weeks of age or older: 0.5 ml intramuscularly in the breast muscle. 
Starost treh tednov ali več: 0,5 ml intramuskularno v prsno mišico.
a) the administration of the veterinary medicinal product to animals will interfere with the implementation of national programmes for the diagnosis, control and 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 b) the disease to which the veterinary medicinal product is intended to confer immunity is largely absent from the territory. 
a) bi uporaba zdravila za uporabo v veterinarski medicini 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 izdelkih, pridobljenih iz zdravljenih živali,
E. SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER 
E. POSEBNE ZAHTEVE, KI JIH MORA IZPOLNJEVATI IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
Onset of immunity: 3 weeks after the second injection. 
Nastop imunosti: Tri tedne po drugi injekciji.
If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you. 
Če vam je bil ta proizvod nenamerno injiciran, se takoj posvetujte z zdravnikom, čeprav je bila injicirana le majhna količina, in mu pokažite navodila za uporabo.
1 year. 
Nič dni.
MARKETING AUTHORISATION NUMBER(S) EU/2/06/060/001-002 
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/06/060/001-002
The following constituents of Poulvac FluFend H5N3 RG are included in Table 1 (Allowed substances) of the annex to Commission Regulation (EU) No 37/2010 as follows: 
Naslednje sestavine zdravila Poulvac FluFenf H5N3 RG so vključene v tabeli 1 priloge Uredbe Komisije (EU) št. 37/2010:
Manufacturer for the batch release: Pfizer Global Manufacturing Weesp CJ van Houtenlaan 36 
Izdelovalec, odgovoren za sproščanje serije: Pfizer Global Manufacturing Weesp CJ van Houtenlaan 36
Polyoxyethylen e sorbitan monooleate and trioleate 
Polioksietilen sorbitan monooleat in trioleatkrmni
One dose of 0.5 ml contains: 
1 odmerek (0,5 ml) vsebuje:
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT 
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER IMETNIKA DOVOLJENJA ZA PROIZVODNJO ZDRAVILA, ODGOVORNEGA ZA SPROSTITEV SERIJ V EGP, ČE STA RAZLIČNA
For disposal read the package leaflet. 
Za navodilo o pravilnem odstranjevanju preberite navodilo za uporabo.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES One dose of 0.5 ml contains: 
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI 1 odmerek (0,5 ml) vsebuje:
NAME OF THE VETERINARY MEDICINAL PRODUCT Poulvac FluFend H5N3 RG 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Poulvac FluFend H5N3 RG
Sorbitan sesquioleate 
Sorbitan seskvioleat
White oil is a mineral hydrocarbon, Arlacel 83V is sorbitan sesquioleate, Tween 80 is polyoxyethylene sorbitan monooleate, sodium phosphate dibasic (E339) and potassium phosphate monobasic (E340) are substances with E numbers. 
Belo olje je hidrokarbon, mineralni, Arlacel 83V je sorbitan seskvioleat, Tween 80 je polioksietilen sorbitan monooleat, dvobazni natrijev fosfat (E339) in enobazni kalijev fosfat sta snovi s številko E. Navedene sestavine zdravila Poulvac FluFend H5N3 RG so vključene v tabelo 1 (dovoljene snovi) priloge Uredbe Komisije (EU) št. 37/2010:
MARKETING AUTHORISATION NUMBER EU/2/06/060/001-002 
ŠTEVILKA(E) V REGISTRU SKUPNOSTI ZDRAVIL EU/2/06/060/001-002
MANUFACTURER'S BATCH NUMBER Lot (Number) 
IZDELOVALČEVA ŠTEVILKA SERIJE IZDELAVE ZDRAVILA Serija> <lot><številka serije>{številka}
No Entry 
Ni vnosa
PACKAGE SIZE 1 x 500 ml 10 x 500 ml 
VELIKOST PAKIRANJA 1 x 500 ml
THE WORDS ‘FOR ANIMAL TREATMENT ONLY' AND CONDITIONS OF RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE 
BESEDILO “SAMO ZA ŽIVALI” IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, če je navedba smiselna
At one day old: 0.2 ml subcutaneously in the neck. 
Pri starosti enega dne: 0,2 ml podkožno v vrat.
Sorbitan sesquioleate Polysorbate 80 
Sorbitan seskvioleat Polisorbat 80
For active immunisation of chickens and ducks against avian influenza virus type A, subtype H5. 
Aktivna imunizacija piščancev in rac proti virusu aviarne influence tipa A, podtipa H5.
No information is available on the safety of this vaccine for birds in lay. 
O varnosti tega cepiva za ptice v obdobju nesnosti ni podatkov.
Only substances approved as additives in foodstuffs for human 
Ni vnosa Ni vnosa številko odobreni kot dodatki za živila v prehrani ljudi proizvodnj o živil
NAME OF THE VETERINARY MEDICINAL PRODUCT Poulvac FluFend H5N3 RG emulsion for injection for chickens and ducks 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Poulvac FluFend H5N3 RG emulzija za injiciranje za piščance in race
To induce serological response against N3 neuraminidase which can act as a marker to Differentiate Infected from Vaccinated Animals (DIVA strategy). 
Cepivo je namenjeno spodbujanju aktivne imunosti pri piščancih in racah proti virusu aviarne influence podtipa H5 in sproženju serološkega odziva proti N3 neuraminidazi, ki lahko služi kot marker za razlikovanje med okuženimi in cepljenimi živalmi (t.i. strategija DIVA)
Duration of immunity in ducks: 14 weeks after the second injection. 
Čas trajanja imunske zaščite pri racah: 14 tednov od druge injekcije
No information is available on the interference of maternally derived antibodies on vaccination for both target species. 
Za obe ciljni vrsti ni podatkov o vplivih materinih protiteles na cepljenje.
SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER 
POSEBNE ZAHTEVE, KI JIH MORA IZPOLNITI IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
TARGET SPECIES Chickens and ducks 
CILJNE ŽIVALSKE VRSTE Piščanci in race
SPECIAL STORAGE CONDITIONS Store and transport refrigerated (2° to 8°C). 
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte in prevažajte pri temperaturi (2 C - 8 C).
MRLs Target tissues 
MRL Ciljna tkiva
Name and address of the manufacturer responsible for batch release 
Ime in naslov izdelovalca (izdelovalcev) zdravila, odgovornega za sproščanje serije
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE 
C. POGOJI TER OMEJITVE DOVOLJENJA ZA PROMET Z ZDRAVILOM GLEDE VARNE IN UČINKOVITE UPORABE
Chickens: Reduction of mortality and virus excretion after challenge. 
Piščanci: Zmanjšanje smrtnosti in izločanja virusa po izpostavljenost.
6.5 Nature and composition of immediate packaging 500 ml of vaccine in high-density polyethylene bottles, closed with a nitrile rubber stopper and aluminium cap. 
500 ml cepiva v plastenkah iz polietilena visoke gostote, z nitrilnim gumijastim zamaškom in aluminijasto zaporko
For animal treatment only 
Samo za živali.
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH 
A. IZDELOVALEC(IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
EXPIRY DATE EXP (month/year) Once broached, use within 2 hours. 
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP {mesec/leto}
Store and transport refrigerated (2ºC - 8ºC). 
Shranjujte in prevažajte v hladilniku (2 C - 8 C).
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE 
IZDELOVALEC(IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY 
6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi, če obstajajo
Reduction of mortality and virus excretion after challenge. 
Zmanjšanje smrtnosti in izločanje virusa po izpostavljenost.
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE 
POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE VARNE IN UČINKOVITE UPORABE
Inactivated recombinant avian influenza virus of H5N3 subtype (strain rg-A/ck/VN/C58/04) 
Neaktiviran rekombinantni virus aviarne influence podtipa H5N3 (sev rg-A/ck/VN/C58/04)
Reduction of clinical signs and virus excretion after challenge. 
Zmanjšanje pojava kliničnih znakov in izločanja virusa po izpostavljenost.
A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis Following the administration of a double dose in chickens and ducks, no adverse reactions other than those described in section 6 have been observed. 
Po vnosu dvojnega odmerka pri piščancih in racah niso zasledili drugačnih neželenih učinkov, kot so opisani v poglavju 6.
Inactivated recombinant avian influenza virus of H5N3 subtype (strain rg-A/ck/VN/C58/04) > 1:40 HI units per dose 
Inaktivirani rekombinantni virus aviarne influence podtipa H5N3 (sev rg-A/ck/VN/C58/04) > 1:40 HI Enot v odmerku
Ducks: Reduction of clinical signs and virus excretion after challenge. 
Race: Zmanjšanje pojava kliničnih znakov in izločanja virusa po izpostavljenost.
Store and transport refrigerated (2° to 8°C). 
Shranjujte in prevažajte pri temperaturi (2 C - 8 C).
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE 
POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE OSKRBE IN UPORABE
THE WORDS ‘FOR ANIMAL TREATMENT ONLY' AND CONDITIONS OF 
BESEDILO “SAMO ZA ŽIVALI” IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE 
B POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE OSKRBE IN UPORABE
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary Following the administration of a double dose in chickens and ducks, no adverse reactions other than those described in section 4.6 have been observed. 
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi), če je potrebno
THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN” Keep out of the reach and sight of children 
BESEDILO “ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM ” Zdravilo shranjujte nedosegljivo otrokom.
Phosphate Buffer Saline 
Fosfatni pufer s soljo
Food additives (substances with a valid E number approved as additives in 
Samo snovi odobrene kot dodatki za živila za prehrano ljudi z izjemo prezervati vov navedenih v dodatku III
Revaccinate after 3 weeks: 0.5 ml subcutaneously in the neck The vaccination schedule should be completed at least 4 weeks before the start of laying. 
Ponovno cepljenje po treh tednih: 0,5 ml subkutano v vrat.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL 
Ni nujno, da so v prometu vsa navedena pakiranja
Chickens 
Piščanci
Excipients: 
Race:
STATEMENT OF THE MRLs 
NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN ZAOSTANKOV ZDRAVILA ( MRL)
Animal 
Race
In general the Core Safety Profile, dated 2 April 2009 was considered. 
Na splošno je bil upoštevan Glavni varnostni profil z dne 2. aprila 2009.
In addition minor typographic errors were corrected. 
Poleg tega so bile popravljene tudi manjše tipografske napake.
QUALITY - MODULE 3 
KAKOVOST - MODUL 3
There are differences between all Member States concerning the individual paragraphs in this section. 
Med državami članicami obstajajo razlike med posameznimi odstavki v tem poglavju.
So a warning has been added in this section. 
Zato je bilo v to poglavje dodano opozorilo.
This section was partly restructured according to guidelines. 
To poglavje je bilo v skladu s smernicami deloma spremenjeno.
A harmonised Module 3 was also adopted. 
Sprejet je bil tudi usklajen modul 3.
Additional data were available from a compassionate use study (EU, 2006). 
Na voljo so bili tudi dodatni podatki iz študije sočutne uporabe (EU, 2006).
Section 4.8 - Undesirable effects 
Poglavje 4.8 - Neželeni učinki
In most patients, symptoms should resolve within days after the start of effective therapy. 
Pri večini bolnikov naj bi simptomi izginili v nekaj dneh po začetku učinkovitega zdravljenja.
Acute oral candidiasis may occur in up to 5% of newborn infants. 
Akutna oralna kandidiaza se lahko pojavi pri do 5 % novorojenčkov.
In addition the paediatric indications have been clarified. 
Poleg tega so pojasnili tudi pediatrične indikacije.
The proposed text for the pharmokinetics in children is the wording that was agreed during the EU work sharing project. 
Predlagano besedilo za farmakokinetiko pri otrocih je besedilo, ki je bilo dogovorjeno v skupnem delovnem projektu EU.