natgillin/translations-raw huggingface dataset:
A 10 ml vial of Type II hydrolytic glass containing 500, 1 000, 2 500, 5 000 or 10 000 doses of freeze- dried vaccine.
Viala po 10 ml iz stekla 2. hidrolitične skupine, ki vsebuje 500, 1000, 2500, 5000 ali 10000 odmerkov liofiliziranega cepiva.
The vial is closed with a halogenobutyl rubber bung and sealed with a coded aluminium cap.
Viala je zaprta z zamaškom iz sintetične gume in s tesnilno aluminijasto zaporko s šifro.
The product is presented as a single vial or in multipacks of 10 vials of the same dosage.
Izdelek je na voljo v ovojnini z eno vialo ali z 10 vialami z enakimi odmerki.
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials, derived from the use of such products
4/ 17 6. 6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi
Wim de Körverstraat 35 5831 AN BOXMEER The Netherlands
Wim de Körverstraat 35 5831 AN BOXMEER Nizozemska
9 June 1998
9. junij 1998
The import, sale, supply and/ or use of Nobilis IB 4-91 is/ or may be prohibited in certain Member States on the whole or part of its territory pursuant to national animal health policy.
Uvoz, prodaja, oskrba in/ ali uporaba Nobilisa IB 4- 91 je ali je lahko prepovedana v nekaterih državah članicah na njihovem celotnem ozemlju ali delu ozemlja v skladu z nacionalnim programom zdravstvenega varstva živali.
Any person intending to import, sell, supply and/ or use Nobilis IB 4-91 has to consult the relevant Member State’ s competent authorities on the current vaccination policies prior to the import, sale, supply and/ or use.
Vsakdo, ki namerava uvažati, prodajati, oskrbovati in/ ali uporabljati Nobilis IB 4- 91, se mora posvetovati s pristojnimi organi posamezne države članice o veljavnih programih cepljenja še pred uvozom, prodajo, oskrbo in/ ali uporabo.
5/ 17 ANNEX II
5/ 17 DODATEK II
Intervet International Wim de Körverstraat 35, 5831 AN Boxmeer, The Netherlands
Intervet International Wim de Körverstraat 35, 5831 AN Boxmeer, Nizozemska
Veterinary Medicinal product subject to medical prescription.
Izdaja zdravila je le na veterinarski recept.
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 Nobilis IB 4-91 on the whole or part of their territory if it is established that: 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.
Skladno z 71. členom Direktive 2001/ 82/ ES Evropskega parlamenta in Sveta, države članice prepovejo ali lahko prepovejo uvoz, prodajo, oskrbo in/ ali uporabo Nobilisa IB 4- 91 na svojem celotnem ozemlju ali delu ozemlja, če se ugotovi da: 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 proizvodih, pridobljenih iz zdravljenih živali. b) bolezen, za katero se z zdravilom za uporabo v veterinarski medicini pridobi imunost, na območju skoraj ni prisotna.
7/ 17 ANNEX III
7/ 17 DODATEK III
9/ 17 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
9/ 17 PODATKI NA ZUNANJI OVOJNINI
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
NAVEDBA ZDRAVILNEIH UČINKOVIN IN DRUGIH SNOVI
Live attenuated Infectious Bronchitis Virus strain 4-91 ≥ 3.6 log10 EID50. *
Živi, oslabljeni sev virusa kužnega bronhitisa perutnine 4- 91: ≥ 3, 6 log10 EID50 *
* EID50 = 50% Embryo infective dose
* EID50 = 50- odstotni infektivni odmerek za zarodke
1 x 500/ 1000/ 2500/ 5000/ 10000 doses 10 x 500/ 1000/ 2500/ 5000/ 10000 doses
1 x 500/ 1000/ 2500/ 5000/ 10000 odmerkov 10 x 500/ 1000/ 2500/ 5000/ 10000 odmerkov
Vaccine against avian Infectious Bronchitis
Cepivo proti kužnemu bronhitisu perutnine
For intranasal/ ocular, spray or drinking water administration.
Za intranazalno/ okularno dajanje, razprševanje ali dajanje v vodi za pitje.
The product should only be used after it has been established that IBV variant strain 4-91 is epidemiologically relevant in the area.
Cepivo smemo uporabiti, ko je dokazana epidemiološka pomembnost variantnega seva virusa kužnega bronhitisa 4- 91 na območju, kjer ga bomo uporabili.
THE WORDS "KEEP OUT OF THE REACH AND SIGHT OF CHILDREN"
BESEDILO “ ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM ”
11/ 17 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
11/ 17 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
QUANTITY OF ACTIVE SUBSTANCE
KOLIČINA ZDRAVILNE( IH) UČINKOVIN( E)
> 3.6 log10 EID50 IBV per dose
≥ 3, 6 log10 EID50 IBV v odmerku
500/ 1000/ 2500/ 5000/ 10000 doses
500/ 1000/ 2500/ 5000/ 10000 odmerkov
intranasal/ ocular, spray or drinking water
Intranazalno/ okularno, razprševanje ali v vodi za pitje
13/ 17 PACKAGE LEAFLET FOR:
13/ 17 NAVODILO ZA UPORABO
Nobilis IB4-91, lyophilisate for suspension
Nobilis IB 4- 91, liofilizat za suspenzijo
Live attenuated Infectious Bronchitis Virus variant strain 4-91 ≥ 3.6 log10 EID50. *
Živo, oslabljeno cepivo za piščance proti variantnemu sevu kužnega bronhitisa 4- 91 ≥ 3, 6 log10 EID50 *
* EID50 = 50% Embryo infective dose: the titre required to infect 50% of the embryos inoculated with the virus.
* EID50 = 50- odstotni infektivni odmerek za zarodke: titer virusa, ki povzroči okužbo pri 50% inokuliranih zarodkov.
Future layers and breeders should not be vaccinated before 3 weeks of age.
Bodočih nesnic in matične jate ne smemo cepiti pred 3. tednom starosti.
Nobilis IB 4-91 given at day-old can adversely affect the efficacy of Turkey Rhinotracheitis (TRT) vaccine given within 7 days; therefore this vaccination scheme is contraindicated.
Nobilis IB 4- 91 lahko pri enodnevnih piščancih zmanjša učinkovitost cepiva proti rinotraheitisu puranov 7 dni po dajanju, zato je takšna shema cepljenja kontraindicirana.
Vaccination with Nobilis IB 4-91 may induce mild respiratory signs which may persist for a few days depending on the health and condition of the chickens.
Cepljenje z Nobilisom IB 4- 91 lahko povzroči blage respiratorne znake bolezni, ki lahko trajajo več dni, odvisno od zdravstvenega in splošnega stanja piščancev.
At least 3.6 log10 EID50 (1 dose) per animal by either spray vaccination, drinking water or intranasal/ ocular administration.
Najmanj 3, 6 log10 EID50 (1 odmerek) za eno žival za cepljenje z razprševanjem, z dajanjem cepiva v vodi za pitje, intranazalno ali okularno.
The appropriate number of vials should be opened under the water.
Ustrezno število vial odpremo pod vodo.
For administration of the vaccine, as a general rule, dissolve 1 000 doses in one litre per age in days up to a maximum volume of 20 litres per 1 000 doses.
Po splošnem navodilu ga pripravimo tako, da raztopimo 1000 odmerkov v enem litru vode na starost v dnevih, do največjega volumna 20 litrov na 1000 odmerkov.
Ocular/ intranasal administration or coarse spray give the best responses and these should be the methods of choice, especially when vaccinating young chickens.
Po okularnem ali intranazalnem dajanju ter škropljenju z večjimi kapljicami je odzivnost najboljša, zato so ti načini izbirni načini dajanja, zlasti pri cepljenju mladih piščancev.
15/ 17 Only healthy chickens should be vaccinated.
15/ 17 Cepimo samo zdrave piščance.
Chickens should be vaccinated against other prevalent IBV serotypes (e. g.
Nobilis IB 4- 91 je namenjen samo za zaščito piščancev proti respiratornim znakom bolezni, ki jo povzroča variantni sev virusa kužnega bronhitisa perutnine 4- 91, in ga ne smemo uporabljati kot nadomestilo za druga cepiva, pripravljena iz virusov kužnega bronhitisa.
Massachusetts) according to the local IB vaccination programme.
Massachusetts) v skladu z nacionalnim programom cepljenja proti kužnemu bronhitisu.
Do not mix or administer with other products.
Cepiva ne smete mešati ali ga dajati z drugimi zdravili.
Wash and disinfect hands and equipment after vaccinating.
Po cepljenju si umijte in razkužite roke in opremo.
The vaccine should be used within 2 hours after reconstitution and should not be stored.
Po rekonstituciji je treba cepivo uporabiti v 2 urah in ga ne smete shranjevati.
The product should only be used after it has been established that IBV variant strain 4-91 is epidemiologically relevant in the area.
Izdelek smemo uporabiti, ko je dokazana epidemiološka pomembnost variantnega seva virusa kužnega bronhitisa 4- 91 na območju, kjer ga bomo uporabili.
Care should be taken to avoid spread of a vaccine virus from vaccinated chickens to pheasants.
Paziti je treba, da se cepni virus ne bi s cepljenih živali prenesel na fazane.
Active immunisation against avian Infectious Bronchitis virus variant strain IB 4-91 which causes infectious bronchitis in chickens.
Aktivna imunizacija piščancev proti kužnemu bronhitisu, ki ga povzroča variantni sev IB 4- 91.
1/ 10 x 500/ 1000/ 2500/ 5000/ 10000 doses Not all pack sizes my be marketed.
1/ 10 x 500/ 1000/ 2500/ 5000/ 10000 odmerkov Ni nujno, da so v prometu vsa navedena pakiranja.
Nobivac Bb is a vaccine that contains a live bacterium Bordetella bronchiseptica strain B-C2.
Zdravilo Nobivac Bb je cepivo, ki vsebuje živo bakterijo Bordetella bronchiseptica, sev B- C2.
Cats are vaccinated by giving a 0.2-ml dose into one nostril.
Cepljenje mačk se izvede z dajanjem 0, 2 ml odmerka v eno nosnico.
Nobivac Bb contains a type of live B. bronchiseptica called strain B-C2.
Zdravilo Nobivac Bb vsebuje vrsto žive B. bronchiseptice, imenovane sev B- C2.
When a cat is given the vaccine, the immune system recognises the bacteria as ‘ foreign’ and makes a special type of antibodies against them.
Ko mačka prejme cepivo, imunski sistem prepozna bakterije kot tujke in proti njim razvije posebno vrsto protiteles.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Nobivac Bb been studied?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kako je bilo zdravilo Nobivac Bb raziskano?
The European Commission granted a marketing authorisation valid throughout the European Union for Nobivac Bb to Intervet International B. V. on 10 September 2002.
Evropska Komisija je dovoljenje za promet z zdravilom Nobivac Bb, veljavno po vsej Evropski uniji, odobrila družbi Intervet International B. V. dne 10. septembra 2002.
Information on the prescription status of this product may be found on the label/ outer package.
Podatki o predpisovanju tega zdravila so navedeni na nalepki na škatli zdravila.
EU/ 2/ 02/ 034/ 001 Nobivac Bb
EU/ 2/ 02/ 034/ 001 Nobivac Bb ≥106. 3 in ≤108.. 3
≥ 106.3 and ≤ 108..3 CFU of live Bordetella bronchiseptica bacteria strain B-C2 per dose
intranazalno
Powder and solvent for suspension for nasal administration
prašek: viala
Cats
prašek:
Nasal use
navedba ni
Powder: vial (glass) Solvent: vial (glass)
(steklena) topilo: viala (steklena)
Powder:
topilo:
5 vials 5 vials
5 vial
Not Applicable
smiselna
Active substance ≥ 106,3 and ≤ 108,3 CFU of live Bordetella bronchiseptica bacteria strain B-C2, per 0.2 ml dose of reconstituted suspension.
Zdravilna učinkovina ≥ 106, 3 in ≤ 108, 3 CFU živih bakterij Bordetella bronchiseptica, sev B- C2, v odmerku po 0, 2 ml rekonstituirane suspenzije
Solvent Water for injections
Topilo Voda za injekcije
For a list of excipients, see section 6.1.
Pomožne snovi Za seznam pomožnih snovi glejte poglavje 6. 1.
Lyophilisate and solvent for suspension for nasal administration.
Liofilizat in topilo za suspenzijo za intranazalno uporabo
Onset of immunity was established in 8 week old cats as early as 72 hours after vaccination.
Pri 8 mesecev starih mačkah se je imunost razvila že 72 ur po cepljenju.
From literature it is considered that this type of intranasal vaccine is able to induce an immune response without interference from maternally derived antibodies.
Po podatki v literaturi na imunsko reakcijo, ki jo spodbudi ta vrsta intranazalnega cepiva, ne vplivajo protitelesa, ki jih mladiči pridobijo od matere.
None known.
4. 3 Kontraindikacije
Vaccinated animals can spread the Bordetella bronchispetica vaccine strain for six weeks; in individual cases for at least one year.
Cepljene živali lahko širijo cepni sev Bordetelle bronchiseptice šest tednov; v posameznih primerih najmanj eno leto.
2 4.5 Special precaution(s) for use
2 4. 5 Posebni previdnostni ukrepi
Sneezing by cats after administration does not adversely affect the efficacy of the product.
Kihanje po dajanju cepiva ne zmanjša njegove učinkovitosti.
Do not administer during antibiotic treatment or in conjunction with any other intranasal products.
Cepiva ne smemo dajati med zdravljenjem z antibiotiki ali hkrati z drugimi izdelki za intranazalno dajanje.
Occasionally sneezing, coughing, mild and transient discharge from the eyes or nose.
Občasno kihanje, kašelj, blag in prehoden izcedek iz oči ali nosu.
In animals, which show more severe signs, appropriate antibiotic treatment may be indicated.
Pri živalih, ki imajo resnejše znake, je včasih indicirano ustrezno antibiotično zdravljenje.
No information is available on the safety and efficacy from the 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 within 14 days before or after vaccination with the product.
Zato 14 dni pred cepljenjem s tem izdelkom in 14 dni po njem ni priporočljivo uporabiti drugih cepiv.
One dose, of 0.2 ml of reconstituted vaccine at least 72 hours prior to period of anticipated risk.
En odmerek po 0, 2 ml rekonstituiranega cepiva najmanj 72 ur pred obdobjem povečane nevarnosti okužbe.
Allow the solvent to reach room temperature (15 - 25°C).
Počakajte, da se topilo ogreje na sobno temperaturo (15 do 25 ºC).
Aseptically reconstitute the freeze-dried vaccine with 0.3 ml of the sterile solvent provided.
Aseptično rekonstituirajte liofilizirano cepivo z 0, 3 ml priloženega sterilnega topila.
Shake well after addition of the solvent.
Po dodajanju topila dobro pretresite.
Withdraw 0.2 ml of reconstituted vaccine into a 1 ml or 2 ml syringe, remove the needle and administer the whole contents of the syringe into one of the cat’ s nostrils.
Odvzemite 0, 2 ml rekonstituiranega cepiva z 1 - ali 2- mililitrsko brizgo, snemite iglo in mački vse cepivo v brizgi vbrizgajte v eno nosnico.
Occasionally sneezing, coughing, mild and transient discharge from the eyes or nose, particularly in very young susceptible kittens.
Občasno kihanje, kašelj in blag in prehoden izcedek iz oči ali nosu, zlasti pri zelo mladih občutljivih mladičih.
In animals, which show more severe signs, appropriate antibiotic treatment may be indicated.
Pri živalih, pri katerih se pojavijo resnejši znaki, je včasih indicirano ustrezno antibiotično zdravljenje.
Gelatin, sorbitol, phosphate buffers.
Želatina, sorbitol, fosfatni pufri.
In the absence of incompatibility studies, do not mix with any other product except the solvent supplied for use with the vaccine.
Zaradi pomanjkanja študij kompatibilnosti tega zdravila ne smemo mešati z drugimi zdravili, razen s topilom, ki je priloženo cepivu.
After reconstitution the product should be used within 4 hours.
Po rekonstituciji je treba izdelek porabiti v 4 urah.
Store at 2 - 8°C.
Shranjujte pri temperaturi 2 °C do 8 °C.
One 3 ml unit-dose vial (glass Type I) of lyophilisate sealed with a halogenobutyl rubber stopper and an aluminium cap, supplied with a vial (glass Type I) of 0.5 ml sterile solvent.
Ena viala po 3 ml (iz stekla tipa 1) liofilizata, zaprta z zamaškom iz sintetične gume in aluminijasto zaporko, in ena viala (iz stekla tipa 1) po 0, 5 ml sterilnega topila.
5 unit-dose vials of lyophilisate and 5 vials of solvent per carton.
Zloženke s 5 vialami z liofilizatom in 5 vialami s topilom.
Wim de Körverstraat 35 PO Box 31 NL - 5830 AA Boxmeer The Netherlands
Wim de Körverstraat 35 PO Box 31 NL – 5830 AA Boxmeer Nizozemska
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA), http: / /www. emea. europa. eu/.
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency, EMEA) http: // www. emea. europa. eu /.
The import, sale, supply and/ or use of Nobivac Bb for cats 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 Nobivaca Bb za mačke je ali je lahko prepovedana v nekaterih državah članicah na njihovem celotnem ozemlju ali delu ozemlja v skladu z nacionalnim programom zdravstvenega varstva živali.
Any person intending to import, sell, supply and/ or use Nobivac Bb for cats must consult the relevant Member State’ s 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 Nobivac Bb za mačke, se mora posvetovati s pristojnimi organi posamezne države članice o veljavnih programih cepljenja še pred uvozom, prodajo, oskrbo in/ ali uporabo.
Manufacturer of the biological active substance
Izdelovalec biološke zdravilne učinkovine
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 mora obvestiti Evropsko komisijo o načrtih trženja zdravila, za katerega je bila izdana ta odločba.
According to Article 71 of Directive 2001/ 82/ EEC 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 Evropskega parlamenta in Sveta, 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:
10 PARTICULARS TO APPEAR ON THE OUTER PACKAGE PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
PRIMARNI OVOJNINI
Carton label:
Nalepka na zloženki:
Per 0.2 ml dose of reconstituted suspension: ≥ 106,3 and ≤ 108,3 CFU of live Bordetella bronchiseptica bacteria strain B-C2.
V odmerku po 0, 2 ml rekonstituirane suspenzije: ≥ 106, 3 in ≤ 108, 3 CFU živih bakterij Bordetella bronchiseptica, sev B- C2
5 unit-dose vials of lyophilisate and 5 vials of solvent.
5 vial z liofilizatom in 5 vial s topilom.
Read the package leaflet before use for correct administration, disposal of waste materials and special warnings for immunecompromised humans.
Za intranazalno dajanje Pred uporabo preberite v priloženem navodilu poglavja o pravilnem dajanju, odlaganju odpadnih snovi in posebnih opozorilih za osebe z zmanjšano imunostjo.
Read the package leaflet before use for correct administration, disposal of waste materials and special warnings for immunecompromised humans.
Pred uporabo preberite v priloženem navodilu poglavja o pravilnem dajanju, odlaganju odpadnih snovi in posebnih opozorilih za osebe z zmanjšano imunostjo.
PO Box 31 NL - 5830 AA Boxmeer
PO Box 31 NL – 5830 AA Boxmeer
Lot/ Batch {number}
Lot/ serija {številka}
12 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
12 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Label for the vaccine vial:
Nalepka na viali s cepivom:
≥ 106,3 and ≤ 108,3 CFU/ dose B. bronchiseptica
≥ 106, 3 in ≤ 108, 3 CFU bakterij Bordetella bronchiseptica v odmerku
1 dose.
1 odmerek
Nasal administration.
Za intranazalno dajanje
(not applicable - will not be mentioned)
(navedba ni smiselna – ne bo navedeno)
For animal treatment
Samo za živali.
Label for the solvent vial:
Nalepka na viali s topilom:
Solvent for Nobivac Bb
Topilo za Nobivac Bb
15 PACKAGE LEAFLET Nobivac Bb for cats
15 NAVODILO ZA UPORABO
Wim de Körverstraat 35 PO Box 31 NL - 5830 AA Boxmeer The Netherlands
Wim de Körverstraat 35 PO Box 31 NL - 5830 AA Boxmeer Nizozemska
STATEMENT OF THE ACTIVE AND OTHER SUBSTANCE(S) AND OTHER INGREDIENT(S)
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SESTAVIN
Contains ≥ 106,3 and ≤ 108,3 CFU of live Bordetella bronchiseptica strain B-C2, per 0.2 ml dose of reconstituted suspension.
Vsebuje ≥ 106, 3 in ≤ 108, 3 CFU živih bakterij Bordetella bronchiseptica, sev B- C2, v odmerku po 0, 2 ml rekonstituirane suspenzije
For active immunisation of cats, of 1 month of age or older, to reduce clinical signs of Bordetella bronchiseptica associated upper respiratory tract disease.
Aktivna imunizacija mačk, starih 1 mesec ali starejših, za zmanjšanje kliničnih znakov obolenja zgornjih dihalnih poti, ki ga povzroča bakterija Bordetella bronchiseptica
In animals, which show more severe signs, appropriate antibiotic treatment may be indicated.
Pri živalih z resnejšimi znaki je včasih potrebno ustrezno antibiotično zdravljenje.
One dose, of 0.2 ml of reconstituted vaccine at least 72 hours prior to period of anticipated risk.
En odmerek po 0, 2 ml rekonstituiranega cepiva najmanj 72 ur pred obdobjem povečane nevarnosti okužbe
For nasal administration.
Za intranazalno dajanje.
The head of the cat should be held with its nose pointing upward and its mouth closed, so that it is forced to breathe through its nostrils.
Mački držite glavo tako, da bo nos obrnjen navzgor in usta zaprta in bo prisiljena dihati skozi nos.
Store at 2 - 8°C.
Shranjujte pri temperaturi 2 do 8 ºC.
Do not administer during antibiotic treatment, or in conjunction with any other intranasal product.
Cepiva ne smemo dajati med zdravljenjem z antibiotiki ali hkrati z drugimi izdelki za intranazalno dajanje.
17 Although the risk of immunocompromised humans becoming infected with Bordetella bronchiseptica is extremely low, it is advised that cats that are in close contact with immunocompromised humans are not vaccinated with this vaccine.
17 Čeprav je nevarnost, da bi se osebe z zmanjšano imunsko odpornostjo okužile z Bordetello bronchiseptico izjemno majhna, ne priporočamo cepljenja mačk, ki so v tesnem stiku z njimi.
Detailed information on this product is available on the website of the European Medicines Agency (EMEA), http: / /www. emea. europa. eu/.
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency, EMEA) http: // www. emea. europa. eu /.
Presentation:
Pakiranje:
Carton box with 5 vials of freeze-dried vaccine and 5 vials of sterile solvent.
Kartonska škatla s 5 vialami z liofiliziranim cepivom in 5 vialami s sterilnim topilom.
18 ANNEX IV
18 DODATEK IV
The authorisation requires a further renewal for the following reasons:
Dovoljenje za promet je treba ponovno obnoviti iz naslednjih razlogov:
- Limited exposure due to limited marketing.
- omejena izpostavljenost zaradi omejenega trženja
The vaccine also contains an ‘ adjuvant ’ (a compound called saponin) to stimulate a better response.
Cepivo vsebuje tudi adjuvans (spojino saponin) za stimulacijo boljšega odziva.
When a dog is given the vaccine, the immune system recognises the antigens as ‘ foreign’ and makes antibodies against them.
Ko pes dobi cepivo, imunski sistem prepozna antigene kot tujke in tvori protitelesa proti njim.