natgillin/translations-raw huggingface dataset:
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION isa
POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE OSKRBE IN UPORABE ris
To be supplied only on veterinary prescription. or
Izdaja zdravila za uporabo v veterinarski medicini je le na recept. o
According to Community Legislation on Classical swine fever (Council Directive 80/ 217/ EEC, as amended), in the European Union: uth
Zakonodaja Skupnosti, ki obravnava klasično prašičjo kugo (Direktiva Sveta 80/ 217/ EEG, z vsemi spremembami) v Evropski uniji določa: uth
However, the use of vaccines may be authorised in the framework of an emergency vaccination plan, implemented by the competent authority of a Member State following confirmation of disease, in accordane with Community Legislation on control and eradication of classical swine fever; gA
Vendar se uporabo cepiv lahko odobri v sklopu načrta za cepljenje v izrednih razmerah, ki ga po potrditvi bolezni izvede pristojni organ v državi članici v skladu z zakonodajo Skupnosti o nadzoru in gA
b) The storage, supply, distribution and sale of classical swine fever vaccines must be carried out under the control of and in accordance with the eventual instructions established by the competent authority of the Member State; tin
b) Skladiščenje, oskrbo, distribucijo in prodajo cepiv proti klasični prašičji kugi je treba izvajati pod nadzorstvom pristojnega organa v državi članici in v skladu z morebitnimi tin
c) Special provisions regulate the movement of pigs from areas where classical swine fever vaccine is being or has been used and the marking of pigmeat from vaccinated pigs. r ke Ma
c) Premike prašičev z območij, kjer uporabljajo ali so uporabljali cepivo proti klasični ke
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
prašičji kugi, ter označevanje mesa cepljenih prašičev urejajo posebne določbe.
According to Article 71 of Directive 2001/ 82/ EC of the European Parliament and of the Council, Member States prohibit or/ may prohibit the import, sale, supply and/ or use of Porcilis Pesti on the
POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE r
ed whole or part of their territory if it is established that:
VARNE IN UČINKOVITE UPORABE Ma
a) the administration of the product to animals will interfere with the implementation of national programmes for the diagnosis, control and elimination of animal diseases, or will cause
V skladu z 71. členom Direktive 2001/ 82/ ES evropskega parlamenta in Sveta države članice prepovejo ali lahko prepovejo uvoz, prodajo, oskrbo in/ ali uporabo Porcilisa Pesti na celotnem svojem ozemlju ali delu ozemlja, če se ugotovi, da:
nd difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals
7/ 17 a) bi uporaba izdelka pri živalih ovirala izvajanje nacionalnih programov diagnosticiranja, nadzora ali zatiranja živalskih bolezni ali da bi povzročila težave pri zagotavljanju, da ne bi prišlo do okužbe živih živali, živil ali drugih proizvodov, ki izvirajo iz zdravljenih živali.
e b) the disease to which the product is intended to confer immunity is largely absent from the territory.
b) bolezni, za katero se z izdelkom pridobi imunost, na območju skoraj ni.
Su Annex II of Council Regulation (EEC) No 2377/ 90 Pharmacologically active substance Liquid paraffin (Mineral hydrocarbons)1 Polysorbate 80 2 Sorbitan mono-oleate 3 (E494)
2377/ 90 Farmakološko aktivna snov
Animal Species All food-producing species n tio
pe tekoči parafin (ogljikovodiki mineralnega izvora) 1 polisorbat 80 2 sorbitan monooleat 3 (E494)
Other provisions
vse vrste za proizvodnjo živil
isa or uth gA tin r ke Ma
us nS o ati ris o uth gA tin ke r Ma
nd
L 291, 06. 12. 95 2 UL št.
ANNEX III
L 272, 25. 10. 96
LABELLING AND PACKAGE LEAFLET isa or uth gA tin ker Ma
8/ 17 d de n pe us nS DODATEK III o ati OZNAČEVANJE IN NAVODILO ZA UPORABO ris o uth gA tin ker Ma
10/ 17 isa LABELLING tio
OZNAČEVANJE ati
end
us
ed
pe
{50ml Bottle/ 100ml Bottle/ 250ml Bottle}
{steklenička po 50 ml / steklenička po 100 ml / steklenička po 250 ml}
nd Porcilis Pesti
n pe 2.
e sp Per dose of 2 ml:
V odmerku po 2 ml:
120 Elisa Units CSF-E2 antigen.
120 enot Elisa antigena KPK- E2
Liquid paraffin:
us Tekoči parafin:
Emulsion for injection
Emulzija za injiciranje o 4.
PACKAGE SIZE n tio 50 ml (25 doses) – 100 ml (50 doses) – 250 ml (125 doses) isa
VELIKOST PAKIRANJA ati 50 ml (25 odmerkov) – 100 ml (50 odmerkov) – 250 ml (125 odmerkov) ris
Pigs or uth
Prašiči o uth
Vaccine against Classical Swine Fever gA
Cepivo proti klasični prašičji kugi gA
IM injection of 2 ml tin
2 ml i. m. tin
WITHDRAWAL PERIOD ke
KARENCA ke
Withdrawal period -Zero days r
Nič dni r Ma
SPECIAL WARNING(S), IF NECESSARY Ma
POSEBNO( A) OPOZORILO( A), ČE JE/ SO POTREBNO( A)
< EXP {month/year} > Once broached, use within 3 hours.
< EXP {mesec/ leto} Odprto zdravilo uporabite v 3 urah.
nd Store in a refrigerator (2°C to 8°C).
de Shranjujte v hladilniku (2 °C do 8 °C).
sp Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements
Vsako neporabljeno zdravilo ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z
THE WORDS “ FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
BESEDILO ''SAMO ZA ŽIVALI'' TER POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, če je smiselno
For animal treatment only. n To be supplied only on veterinary prescription. tio 14.
Samo za živali Uporablja se le na osnovi recepta veterinarja. o ati 14.
THE WORDS “ KEEP OUT OF THE REACH AND SIGHT OF CHILDREN ” isa
BESEDILO ''ZDRAVILO SHRANJUJTE IZVEN DOSEGA IN POGLEDA OTROK'' ris
Keep out of the reach and sight of children. or
Zdravilo shranjujte izven dosega in pogleda otrok.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER uth
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM o uth
Intervet International B. V., NL – 5831 AN Boxmeer gA
NL – 5831 AN Boxmeer gA
EU/ 2/ 99/ 016/ 001 - EU/ 2/ 99/ 016/ 006 tin
EU/ 2/ 99/ 016/ 001 – EU/ 2/ 99/ 016/ 006 tin
MANUFACTURER’ S BATCH NUMBER
IZDELOVALČEVA ŠTEVILKA SERIJE IZDELAVE ZDRAVILA ke
< Batch > < Lot > < BN > {number} r ke Ma
< Serija > < lot > < številka serije > {številka} r Ma
12/ 17 MINIMUM PARTICULARS TO APPEAR ON Bottle Label
12/ 17 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA nalepki stekleničke
e 120 Elisa Units CSF E2 antigen/ 2ml.
pe 120 enot Elisa antigena KPK E2/ 2 ml
Su 50 ml (25 doses) – 100 ml (50 doses) – 250 ml (125 doses)
nS 50 ml (25 odmerkov) – 100 ml (50 odmerkov) – 250 ml (125 odmerkov)
n 4.
4. i. m.
tio
ati
IM injection isa
o
Withdrawal period:
Karenca: nič dni. o
BATCH NUMBER uth
ŠTEVILKA SERIJE uth
< Batch > < Lot > < BN > {number}
< Serija > < lot > < številka serije > {številka} gA
EXPIRY DATE gA
DATUM IZTEKA ROKA UPORABNOSTI
< EXP {month/year} > Once broached, use within 3 hours. tin
< EXP > {mesec/ leto} Načeto/ odprto zdravilo uporabite v 3 urah. tin
THE WORDS “ FOR ANIMAL TREATMENT ONLY” ke
BESEDILO ''SAMO ZA ŽIVALI'' ke
For animal treatment only. r Ma
Samo za živali. r Ma
PACKAGE LEAFLET tio
NAVODILO ZA UPORABO nS us pe
Su sp
NAVODILO ZA UPORABO
end
n
nd The Netherlands
pe 2.
sp Porcilis Pesti emulsion for injection
Porcilis Pesti, emulzija za injiciranje
Per dose of 2 ml:
nS V odmerku po 2 ml:
120 Elisa Units Classical Swine Fever Virus-E2 subunit antigen Liquid paraffin as adjuvant:
120 enot Elisa antigenskih podenot E2 virusa klasične prašičje kuge Tekoči parafin kot adjuvans:
Active immunisation of pigs from the age of 5 weeks onwards to prevent mortality and to reduce clinical isa
S tem se preprečuje smrtnost, zmanjšuje pa se tudi klinične znake klasične prašičje kuge.
signs of Classical Swine Fever, as well as to reduce infection with and excretion of CSF field virus.
zmanjša pa se tudi njegovo izločanje.
The duration of protection is 6 months. or
Zaščita traja 6 mesecev. o uth
CONTRAINDICATIONS uth
KONTRAINDIKACIJE
None
Niso znane. gA
ADVERSE REACTIONS gA
NEŽELENI UČINKI
Since safety after giving both inoculations at the same tin
Po drugem cepljenju je možna prehodna hipertermija. tin
site has not been examined, it is advised to carry out the second vaccination at a different site than the first vaccination.
Varnost dajanja obeh odmerkov na isto mesto ni raziskana, zato je drugi odmerek priporočljivo dati na drugo mesto kot prvič.
After administration of an overdose, local reactions at the injection site may be more pronounced. ke
Po vnosu prevelikega odmerka so lahko lokalne reakcije na mestu vboda izrazitejše. ke
If you notice any serious side effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon. r Ma
Če opazite kakršnekoli druge stranske učinke, obvestite svojega veterinarja. r Ma
DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION
ODMEREK ZA POSAMEZNE ŽIVALSKE VRSTE TER NAČIN UPORABE IN DAJANJA ZDRAVILA
ed Vaccination scheme:
d Intramuskularno
Basic vaccination:
de Shema cepljenja:
Inject one dose per pig followed by a second injection 4 weeks after the first injection.
Osnovno cepljenje: en odmerek za enega prašiča, nato drugi odmerek 4 tedne po prvem Revakcinacija: enkratni odmerek vsakih 6 mesecev
Re-vaccination:
n pe 9.
Every 6 months, using a single dose.
NASVET O PRAVILNI UPORABI ZDRAVILA
ADVICE ON CORRECT ADMINISTRATION
Injicirajte 2 ml cepiva globoko intramuskularno v vratni predel za ušesom.
e Allow the vaccine to reach a temperature of 15°C-25°C and shake well before use.
Uporabite sterilne brizge in
Use sterile syringes and needles.
Priporočamo uporabo zaprtega sistema za cepljenje z večtočkovnim vbrizgom.
Zero days
Nič dni 11.
Keep out of the reach and sight of children. isa
o
Do not freeze.
Zdravilo ne sme zmrzniti. ris
Shelf-life after first broaching the bottle:
Rok uporabnosti po prvem odpiranju stekleničke:
Do not use after the expiry date which is stated on the label. or
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na nalepki. o
SPECIAL WARNINGS uth
POSEBNA OPOZORILA uth
If you are accidentally injected with this gA
Nenamerno injiciranje/ samoinjiciranje lahko povzroči hude bolečine in otekline, zlasti ob injiciranju v sklep ali prst, in lahko v izjemnih primerih, če ni gA
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 izdelek nenamerno injiciran, se takoj posvetujte z zdravnikom, čeprav je bila injicirana le majhna količina, in mu pokažite navodila za uporabo.
If pain persists for more than 12 hours after medical examination, seek medical advice again. tin
Če bolečina ne popusti po 12 urah po zdravniškem pregledu, se ponovno posvetujte z zdravnikom. tin
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 ke
and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.
Potreben je strokoven, TAKOJŠEN, kirurški poseg ter morda tudi takojšnja incizija in izpiranje injiciranega mesta, zlasti če so prizadete tudi kite ali mehka tkiva prsta. r
The product can be used during pregnancy but may not prevent transplacental transmission of Classical Ma
Lahko se uporablja v obdobju brejosti, vendar pa ne prepreči transplacentarnega prenosa naravnega virusa klasične prašičje kuge z matere na zarodke.
It is therefore recommended that no other vaccines can be administered concurrently with the product.
Zato sočasnega dajanja z drugimi cepivi ne priporočamo.
16/ 17 The import, sale, supply and/ or use of this veterinary medicinal product is only allowed under the particular conditions established by European Community legislation on the control of CSF (Council Directive 80/ 217/ EEC, as amended).
16/ 17 Uvoz, prodaja, oskrba ali uporaba tega zdravila za uporabo v veterinarski medicini so dovoljeni samo pod določenimi pogoji, ki jih predpisuje zakonodaja Evropske skupnosti za nadzor nad KPK (Direktiva Sveta 80/ 217/ EGS, z vsemi spremembami).
Any person intending to import, sell, supply and/ or use the veterinary medicinal product must be authorised by the competent authority of the Member State.
Osebe, ki se nameravajo ukvarjati z uvozom, prodajo, oskrbo ali uporabo zdravila za uporabo v veterinarski medicini, morajo imeti pooblastilo pristojnega organa v državi članici.
nd Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
n Vsako neporabljeno zdravilo ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z lokalnimi zahtevami.
sp 09/ 06/ 2000
us 09/ 06/ 2000
Su Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. eu. int/
nS Evropske agencije za zdravila (European Medicines Agency, EMEA) http: // www. emea. eu. int /
n For animal treatment only. tio As a consequence of the subunit nature of the vaccine, vaccination does not induce production of antibodies against CSF virus antigen, other than E2. isa
Samo za živali. ati Ker je uporabljena podenota, cepljenje ne povzroči nastanka protiteles proti drugim antigenom virusa KPK, razen proti E2.
50 ml/ 100 ml/ 250 ml multidose glass bottle 50 ml/ 100 ml/ 250 ml multidose PET bottle
50 ml/ 100 ml/ 250 ml, večodmerna plastenka iz PET
Not all pack sizes may be marketed. or uth gA tin r ke Ma
Ni nujno, da so v prometu vsa navedena pakiranja. o uth gA tin ke r Ma
Porcilis Porcoli emulsion for injection
Porcilis Porcoli, emulzija za injiciranje
F4ab (K88ab) fimbrial adhesin F4ac (K88ac) fimbrial adhesin F5 (K99) fimbrial adhesin F6 (987P) fimbrial adhesin LT toxoid
Zdravilne učinkovine najmanj 100 SR801 fimbrijski adhezin F4ab (K88ab) fimbrijski adhezin F4ac (K88ac) fimbrijski adhezin F5 (K99) fimbrijski adhezin F6 (987P) toksoid LT
at least 100 SR801 at least 100 SR80 at least 100 SR80 at least 100 SR80 at least 100 SR80
najmanj 100 SR80 najmanj 100 SR80 najmanj 100 SR80 najmanj 100 SR80
Liquid paraffin
Tekoči parafin
For a full list of excipients, see section 6.1
Celoten seznam pomožnih snovi, glej razdelek 6. 1.
For passive immunisation of piglets by active immunisation of sows and gilts to reduce mortality and clinical signs of neonatal enterotoxicosis, caused by those E. coli, which express the adhesins F4ab (K88ab), F4ac (K88ac), F5 (K99) or F6 (987P), during the first days of life.
S tem se zmanjša smrtnost in klinični znaki neonatalne enterotoksikoze pujskov prve dni po rojstvu, ki jo povzročajo sevi E. coli, ki izločajo adhezine F4ab (K88ab), F4ac (K88ac), F5 (K99) ali F6 (987P).
4.5 Special precautions for use
4. 2 Posebni previdnostni ukrepi
Not applicable.
Uporabite sterilne brizge in igle.
1 SR80= sero-response in 80% of vaccinated rabbits
1 SR80 = serološki odziv pri 80% vakciniranih kuncev
2/ 34 Special precautions to be taken by the person administering the veterinary medicinal product to animals
2/ 34 Posebni varnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo
4.6 Adverse reactions (frequency and seriousness)
4. 6 Stranski učinki (pogostnost in resnost)
Mild, transient clinical reactions (fever, lethargy) may occur in the first 24 hours after vaccination.
Prvih 24 ur po cepljenju se lahko pojavijo blage in prehodne klinične reakcije (vročina, letargija).
For some weeks after vaccination a swelling may be present at the site of injection.
Oteklina na mestu injiciranja lahko vztraja nekaj tednov po cepljenju.
Local tissue reactions in the form of abscesses may frequently occur.
Pogosto so možne lokalne tkivne reakcije v obliki abscesov.
Six weeks after vaccination these local reactions are considerably decreased.
Te reakcije se šest tednov po cepljenju znatno zmanjšajo.
No information is available on the safety and efficacy from concurrent use of this vaccine with any other.
O varnosti in učinkovitosti sočasne uporabe cepiva z drugimi cepivi ni podatkov.
It is therefore recommended that no other vaccine should be administered concurrently with the product.
Zato sočasne uporabe drugih cepiv ne priporočamo.
Before using the vaccine allow it to reach room temperature (15-25°C) and shake vigorously before use.
Pred uporabo počakajte, da se cepivo ogreje na sobno temperaturo (15- 25 ºC) in ga dobro pretresite.
Intramuscular injection in sows and gilts of 2 ml per animal in the neck in the area behind the ear.
Intramuskularno svinjam in mladicam po 2 ml cepiva za eno žival v vrat v predel za ušesom.
Sows and gilts which have not been vaccinated with the product should be given two injections with an interval of six weeks.
Osnovno cepljenje: svinjam in mladicam, ki še niso bile cepljene, dajemo dva odmerka v presledku šest tednov.
A single injection should be given prior to each farrowing.
Revakcinacija: en odmerek pred vsako prasitvijo.
Generally speaking this means every 5 to 6 months.
Na splošno to pomeni vsakih 5 do 6 mesecev.
It is preferable to vaccinate sows and gilts during the second half of the pregnancy, but not within two weeks before the expected date of farrowing.
Svinje in mladice je bolje cepiti v drugi polovici brejosti, toda ne pozneje kot dva tedna pred pričakovano prasitvijo.
No other undesirable effects observed at double dose when compared with one dose of vaccine.
Po dvojnem odmerku niso zasledili nikakršnih drugačnih neželenih učinkov kot po enem odmerku cepiva.
3/ 34 4.11 Withdrawal period
4. 11 Karenca
5.
3/ 34 5.
Vaccine to stimulate active immunity in order to provide passive immunity to the progeny against E. coli fimbrial adhesins F4ab, F4ac, F5 and F6.
Cepivo za spodbujanje aktivne imunosti za razvoj pasivne imunosti potomcev proti fimbrijskim adhezinom E. coli F4ab, F4ac, F5 in F6.
The fimbrial adhesins F4ab, F4ac, F5, and F6 are responsible for the virulence of E. coli strains, which cause neonatal enterotoxicosis in piglets.
Fimbrijski adhezini F4ab, F4ac, F5 in F6 povzročajo virulenco sevov E. coli, ki so povzročitelji neonatalne enterotoksikoze pujskov.
The immunogens are incorporated in a water-in-oil emulsion in order to enhance a prolonged stimulation of immunity.
Imunogeni so vgrajeni v emulzijo vode v olju, kar podaljša stimulativni učinek na razvoj imunosti.
Progeny of vaccinated sows and gilts derive a passive immunity via the colostrum.
Potomci cepljenih svinj in mladic pridobijo pasivno imunost s kolostrumom.
Liquid paraffin Polysorbate 80 Sodium Chloride Sorbitan mono-oleate Water for injection
tekoči parafin polisorbat 80 natrijev klorid sorbitan monooleat voda za injekcije
Broached vials:
2 leti Odprte viale:
Cardboard box with 1 PET or glass (hydrolytic Type II) vial of 20 or 50 ml with a nitryl rubber stopper and a coded aluminium cap.
Zloženka z 1 vialo iz PET ali stekleno vialo (hidrolitične skupine II) po 20 ali 50 ml z zamaškom iz nitrilne gume in aluminijasto zaporko s šifro.
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products, if any
6. 6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi, če obstajajo
Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands.
Wim de Körverstraat 35 5831 AN Boxmeer Nizozemska
8.
4/ 34 8.
EU/ 2/ 96/ 001/ 001-002 & EU/ 2/ 96/ 001/ 009-010
EU/ 2/ 96/ 001/ 001- 002 in EU/ 2/ 96/ 001/ 009- 010
- F4ab (K88ab) fimbrial adhesin - F4ac (K88ac) fimbrial adhesin - F5 (K99) fimbrial adhesin - F6 (987P) fimbrial adhesin - LT toxoid 1
≥ 9, 0 log2 titra protiteles1 fimbrijski adhezin F4ab (K88ab) ≥ 5, 4 log2 titra protiteles1 fimbrijski adhezin F4ac (K88ac) ≥ 6, 8 log2 titra protiteles1 fimbrijski adhezin F5 (K99) ≥ 7, 1 log2 titra protiteles1 fimbrijski adhezin F6 (987P) ≥ 6. 8 log2 titra protiteles1 toksoid LT 1 srednji titer protiteles po cepljenju miši z 1/ 20 odmerka za svinje
Adjuvant: dl-α -tocopherol acetate
Adjuvans dl- alfa- tokoferol acetat
For the passive immunisation of piglets by active immunisation of sows/ gilts to reduce mortality and clinical signs such as diarrhoea due to neonatal enterotoxicosis during the first days of life, caused by those E. coli strains, which express the fimbrial adhesins F4ab (K88ab), F4ac (K88ac), F5 (K99) or F6 (987P).
S tem se zmanjša smrtnost in klinični znaki, kot je driska zaradi neonatalne enterotoksikoze prve dni po rojstvu, ki jo povzročajo sevi E. coli, ki izločajo fimbrijske adhezine F4ab (K88ab), F4ac (K88ac), F5 (K99) ali F6 (987P).
None
Ni posebnih opozoril.
Before using the vaccine allow it to reach room temperature (15-25 °C) and shake well before use.
Pred uporabo počakajte, da se cepivo ogreje na sobno temperaturo (15- 25 ºC) in ga dobro pretresite.
6/ 34 Avoid introduction of contamination.
6/ 34 Pazite, da ne bi prišlo do kontaminacije.
In the case of accidental self-injection, seek medical advice immediately and show the package leaflet or label to the physician.
V primeru nenamernega samo- injiciranja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali nalepko na zunanji ovojnini.
Reduced feed intake and listlessness may occur in approximately 10% of the animals on the day of vaccination, but returns to normal within 1-3 days.
Na dan cepljenja se lahko pojavita zmanjšan tek in ravnodušnost pri 10 do 20% živali, kar se normalizira v 1- 3 dneh.
A transient swelling and redness at the injection site may be observed in approximately 5% of the animals.
Pri približno 5% živali se lahko na mestu injiciranja pojavita prehodna oteklina in rdečina.
Intramuscular injection in sows/ gilts of 2 ml of the vaccine per animal in the neck in the area behind the ear.
Intramuskularno svinjam in mladicam po 2 ml cepiva za eno žival v vrat v predel za ušesom.
Sows/ gilts which have not yet been vaccinated with the product shall be given an injection preferably 6 to 8 weeks before the expected date of farrowing followed by a second injection 4 weeks later.
Osnovno cepljenje: svinjam in mladicam, ki z izdelkom še niso bile cepljene, je najbolje dati prvi odmerek 6 do 8 tednov pred pričakovano prasitvijo in drugi odmerek 4 tedne pozneje.
A single revaccination shall be carried out during the second half of each subsequent pregnancy, preferably 2 to 4 weeks before the expected date of farrowing.
Revakcinacija: en odmerek v drugi polovici vsake naslednje brejosti, najbolje 2 do 4 tedne pred pričakovano prasitvijo.
No undesirable effects other than those observed and mentioned in the “ Adverse reactions” section have been observed.
Niso zasledili nikakršnih drugačnih neželenih učinkov kot tistih, ki so navedeni v razdelku Stranski učinki.
Vaccine to stimulate active immunity of sows/ gilts in order to provide passive immunity to their progeny against E. coli strains that express the fimbrial adhesins F4ab, F4ac, F5 and F6.
Cepivo za spodbujanje aktivne imunosti svinj ali mladic za razvoj pasivne imunosti potomcev proti sevom E. coli, ki izločajo fimbrijske adhezine F4ab, F4ac, F5 in F6.
The fimbrial adhesins F4ab, F4ac, F5, and F6 are responsible for the adhesion and the virulence of E. coli strains, which cause neonatal enterotoxicosis in piglets.
7/ 34 Fimbrijski adhezini F4ab, F4ac, F5 in F6 povzročajo adhezijo in virulenco sevov E. coli, ki so povzročitelji neonatalne enterotoksikoze pujskov.
Neonatal piglets derive passive immunity via ingestion of colostrum from vaccinated sows/ gilts.
Potomci cepljenih svinj in mladic pridobijo pasivno imunost s kolostrumom.
Polysorbate 80 Potassium Chloride Potassium Dihydrogen Phosphate Simethicone emulsion Sodium chloride Disodium Phosphate Dihydate DL-Alpha-Tocopherol Acetate Water for injection
polisorbat 80 kalijev klorid kalijev dihidrogen fosfat simetikon, emulzija natrijev klorid dinatrijev fosfat dihidrat DL- alfa- tokoferol acetat voda za injekcije
Shelf-life after first opening:
2 leti Rok uporabnosti po prvem odpiranju:
9.
8/ 34 9.
9/ 34 ANNEX II
9/ 34 DODATEK II
Box 31, 5830 AA Boxmeer, The Netherlands.
Box 31 5830 AA Boxmeer Nizozemska