natgillin/translations-raw huggingface dataset:
(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 the effectiveness of Porcilis AR-T DF 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 bila raziskana učinkovitost zdravila Porcilis AR- T DF?
Porcilis AR-T DF has been studied in sows, where it was compared with another vaccine for progressive atrophic rhinitis.
Zdravilo Porcilis AR- T DF so preučevali pri svinjah, pri katerih so ga primerjali z drugim cepivom za progresivni atrofični rinitis.
In this study, blood was taken from piglets in each litter born from each sow, and tested for antibodies to Pasteurella multocida toxin and Bordetella bronchiseptica.
Pri tej raziskavi so pujskom iz vsakega legla vsake svinje odvzeli kri in jo testirali glede protiteles za toksin bakterije Pasteurella multocida in bakterijo Bordetella bronchiseptica.
The length of time that Porcilis AR-T DF is effective has also been studied.
Prav tako so preučili čas trajanja učinkovitosti zdravila Porcilis AR- T DF.
The main measure of effectiveness was the amount of antibodies to Bordetella bronchiseptica and also to Pasteurella multocida toxin.
Glavno merilo učinkovitosti je bila količina protiteles za bakterijo Bordetella bronchiseptica in tudi za toksin bakterije Pasteurella multocida.
What benefit has Porcilis AR-T DF shown during the studies?
Kakšne koristi je zdravilo Porcilis AR- T DF izkazalo med raziskavami?
The trials showed good protection against the clinical signs of progressive atrophic rhinitis.
Raziskave so pokazale dobro zaščito proti kliničnim znakom progresivnega atrofičnega rinitisa.
The piglets had comparable levels of antibodies against progressive atrophic rhinitis as obtained with another approved vaccine.
Pujski so imeli primerljive ravni protiteles proti progresivnemu atrofičnemu rinitisu kot so bile dosežene z drugim odobrenim cepivom.
In the study of the duration of effect, based on antibody levels, it was shown that revaccination with a single dose resulted in a clear booster response (that is, the resultant antibody levels were even higher than after the basic vaccination).
V okviru raziskave trajanja učinkovanja, temelječi na ravni protiteles, je bilo prikazano, da je revakcinacija z enim odmerkom privedla do okrepljenega odziva (to pomeni, da so bile nato ravni protiteles celo višje kot po prvem cepljenju).
What are the side effects of Porcilis AR-T DF?
Kakšni so neželeni učinki zdravila Porcilis AR- T DF?
Porcilis AR-T DF can cause a temporary increase in body temperature of 1.5 °C, and in some pigs of up to 3°C on the day of vaccination or the following day.
Zdravilo Porcilis AR- T DF utegne povzročiti prehodno povišanje telesne temperature za 1, 5 °C, pri nekaterih prašičih pa tudi za do 3 °C, na dan cepljenja ali naslednji dan.
Other side effects are reduced activity and lack of appetite in 10-20% of the pigs on the day of vaccination and/ or a temporary swelling (max diameter:
Drugi neželeni učinki so zmanjšana aktivnost in tek pri 10 do 20% prašičev na dan cepljenja in/ ali prehodna oteklina na mestu injiciranja (največji premer:
10 cm) for up to two weeks at the injection site.
10 cm), ki traja do dveh tednov.
Porcilis AR-T DF contains mineral oil.
Zdravilo Porcilis AR- T DF vsebuje tekoči parafin.
If someone is accidentally injected with this product, they must seek immediate medical advice even if only a very small amount is injected.
Če pride do nehotenega injiciranja s tem proizvodom, mora oseba nemudoma poiskati zdravniško pomoč, četudi je bila injicirana le majhna količina.
The Package Leaflet should be taken to the doctor.
K zdravniku je treba odnesti tudi Navodila za uporabo.
If pain persists for more than 12 hours after medical examination, the doctor should be contacted again.
Če bolečina traja več kot 12 ur po zdravniškem pregledu, se je potrebno ponovno zglasiti pri zdravniku.
Why has Porcilis AR-T DF been approved?
Zakaj je bilo zdravilo Porcilis AR- T DF odobreno?
The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Porcilis AR-T DF are greater than any risks to reduce the clinical signs of progressive atrophic rhinitis in piglets.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je sklenil, da so koristi zdravila Porcilis AR- T DF pri zmanjševanju kliničnih znakov progresivnega atrofičnega rinitisa večje od morebitnih tveganj.
They recommended that Porcilis AR-T DF should be given a marketing authorisation.
Zato so priporočili, da se za zdravilo Porcilis AR- T DF podeli dovoljenje za promet.
Other information about Porcilis AR-T DF:
Druge informacije o zdravilu Porcilis AR- T DF:
The European Commission granted a marketing authorisation valid throughout the European Union for Porcilis AR-T DF to Intervet International B. V. on 16 November 2000.
Evropska komisija je dovoljenje za promet z zdravilom Porcilis AR- T DF, veljavno po vsej Evropski uniji, odobrila družbi Intervet International B. V dne 16. novembra 2000.
Information on the prescription status of this product may be found on the outer package.
Podatki o predpisovanju tega zdravila so navedeni na ovojnini.
Porcilis AR-T DF suspension for injection
Porcilis AR- T DF, suspenzija za injiciranje
Per dose of 2 ml
V odmerku po 2 ml
- Protein dO (non-toxic deletion derivative of Pasteurella multocida
- protein dO (netoksični delecijski derivat dermonekrotičnega
dermonecrotic toxin)
≥ 5, 9 log2 toksin nevtralizirajočega titra1 toksina bakterije Pasteurella multocida) ≥ 4, 2 log2 aglutinacijskega titra2
≥ 5.9 log2 TN titre 1
- inaktivirane celice bakterije Bordetella bronchiseptica
- Inactivated 1
1 Srednji toksin nevtralizirajoči titer je določen po ponovljeni vakcinaciji s polovičnim odmerkom pri kuncih.
≥ 4.2 log 2 Aggl. titre2
2 Srednji aglutinacijski titer je določen po enkratni vakcinaciji s polovičnim odmerkom pri kuncih.
- 150 mg dl-α -tocopherol acetate.
- 150 mg dl- alfa- tokoferol acetata
Per dose of 2 ml max 1.0 mg free formaldehyde.
V odmerku po 2 ml največ 1, 0 mg prostega formaldehida
Before using the vaccine allow it to reach room temperature (15°C - 25°C) and shake vigorously.
Cepivo pred uporabo ogrejte na sobno temperaturo (15 do 25 ºC) in ga dobro pretresite.
2/ 17 Special precautions to be taken by the person administering the medicinal product to animals
2/ 17 Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo
A mean transient increase in body temperature of 1.5 °C, in some pigs up to 3 °C can generally be measured on the day of vaccination or the following day.
Na splošno se lahko pri nekaterih prašičih na dan cepljenja ali naslednji dan prehodno povprečno za 1, 5 °C, pri nekaterih prašičih do 3 °C, poveča telesna temperatura.
10 cm) for up to two weeks may arise at the site of injection.
Na dan cepljenja se lahko zmanjšata aktivnost in tek pri 10 do 20% živali in se pojavi prehodna oteklina na mestu injiciranja (največji premer je 10 cm), ki traja do dveh tednov.
This product can be used during pregnancy.
Lahko se uporablja v obdobju brejosti.
It is therefore recommended that no other vaccines should be administered within 14 days before or after vaccination with this product.
Zato odsvetujemo uporabo katerega koli cepiva v obdobju 14 dni pred ali po cepljenju s tem izdelkom.
One dose of 2 ml by intramuscular injection to pigs of 18 weeks of age and older.
En odmerek po 2 ml intramuskularno prašičem, starim 18 tednov in starejšim.
Basic vaccination: 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.
Revaccination: a single injection of one dose should be carried out 2 – 4 weeks prior to each subsequent farrowing.
Revakcinacija: en odmerek 2 do 4 tedne pred vsako naslednjo prasitvijo.
Apart from a higher average transient increase in body temperature on the day of vaccination or the following day, no adverse reactions other than already mentioned under point 4.6 can be expected.
Razen večjega povprečnega porasta telesne temperature na dan cepljenja ali naslednji dan ni pričakovati drugih neželenih učinkov kot tistih, opisanih v 4. 6.
Pharmacotherapeutic group: inactivated bacterial vaccine.
Farmakoterapevtska skupina: inaktivirano bakterijsko cepivo
To stimulate active immunity in order to provide passive immunity to atrophic rhinitis.
Spodbujanje aktivne imunosti za razvoj pasivne imunosti pri potomcih proti progresivnemu atrofičnemu rinitisu
The
Cepivo vsebuje netoksični rekombinantni derivat toksina Pasteurelle multocide in inaktivirane celice Bordetelle bronchiseptice.
3/ 17 immunogens are incorporated in an adjuvant based on dl-α -tocopherol.
Imunogeni so vgrajeni v adjuvans na osnovi dl- alfa- tokoferola.
Neonatal piglets derive passive immunity via ingestion of colostrum from vaccinated sows/ gilts.
Novorojeni pujski pridobijo pasivno imunost s kolostrumom cepljenih svinj/ mladic.
6.1 Incompatibilities
6. 1 Glavne inkompatibilnosti
Shelf-life after first opening the vial:
Rok uporabnosti po prvem odpiranju viale:
10 hours.
10 ur.
6.3 Special precautions for storage
6. 3 Posebna navodila za shranjevanje
6.4 Nature and composition of immediate packaging
6. 4 Vrsta in vsebina vsebnika
Cardboard box containing one 20 or 50 ml multi-dose vial of hydrolytic Type I glass or polyethylene terephthalate [PET], closed with a halogenobutyl rubber stopper and sealed with an aluminium cap.
Zloženka z eno večodmerno vialo po 20 ali 50 ml iz stekla 1. hidrolitične skupine ali iz polietilen tereftalata [PET], zaprto z zamaškom iz sintetične gume in aluminijasto zaporko.
6.5 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
6. 5 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi, če obstajajo
DATE OF THE FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATUM PRIDOBITVE/ PODALJŠANJA DOVOLJENJA ZA PROMET
16 November 2000 Date of last renewal:
16. november 2000 Datum zadnjega podaljšanja:
PROHIBITION OF SALE, SUPPLY AND/ OR USE
4/ 17 PREPOVED PRODAJE, OSKRBE IN/ ALI UPORABE
The import, sale, supply and/ or use of Porcilis AR-T DF 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 Porcilisa AR- T DF 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 Porcilis AR-T DF 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 Porcilis AR- T DF, 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 SUBSTANCES AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC BIOLOŠKIH ZDRAVILNIH UČINKOVIN IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROSTITEV SERIJE
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY AND USE
POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDEOSKRBE IN UPORABE
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 s členom 71 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:
7/ 17 The MRL status of the excipients is as follows:
7/ 17 Status pomožnih snovi glede na MRL:
Annex II of Council Regulation (EEC) No 2377/ 90 Substance Sodium chloride Formaldehyde dl-α -tocopherol acetate Simethicone (Dimethicone) Disodium phosphate dihydrate
2377/ 90
MRL status All food-producing animals
Status glede na MRL Vse živali, namenjene za proizvodnjo živil
Comments OJ No.
UL št.
L 290 of 5.12.95 OJ No.
L 290 z dne 05. 12. 95 UL št.
L 122 of 12.05.99 OJ No L 290 of 5.12.95 OJ No L 272 of 25.10.96
L 122 z dne 12. 05. 99 UL št.
OJ No L 272 of 25.10.96
L 290 z dne 05. 12. 95
Polysorbate 80
natrijev hidrogenfosfat dihidrat kalijev dihidrogenfosfat polisorbat 80
OJ No L 290 of 05.12.95
L 290 z dne 05. 12. 95
8/ 17 ANNEX III
8/ 17 DODATEK III
10/ 17 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
10/ 17 PODATKI NA ZUNANJI OVOJNINI
Per dose of 2 ml:
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI
- ≥ 5.9 log2 TN titre1 Protein dO
- ≥ 5, 9 log2 toksin nevtralizirajočega titra1 proteina dO
Titre1 inactivated B. bronchiseptica cells
- ≥ 4, 2 log2 aglutinacijskega titra1 inaktiviranih celic bakterije Bordetella bronchiseptica
1 See package leaflet.
1 Glejte navodila za uporabo.
150 mg dl-α -tocopherol acetate
150 mg dl- alfa- tokoferol acetata
20 ml (10 doses) Glass vial 50 ml (25 doses) Glass vial 20 ml (10 doses) PET vial 50 ml (25 doses) PET vial
20 ml (10 odmerkov), steklena viala 50 ml (25 odmerkov) steklena viala 20 ml (10 odmerkov), viala iz PET 50 ml (25 odmerkov), viala iz PET
i. m. injection of 2 ml Read the package leaflet before use.
Pred uporabo preberite navodila za uporabo.
SPECIAL WARNING(S), IF NECESSARY
POSEBNO( A) OPOZORILO( A), ČE JE( SO) POTREBNA
EXP {month/ year} Once broached, use within 10 hours.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
THE WORDS “ FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
BESEDILO ''SAMO ZA ŽIVALI'' TER POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
THE WORDS “ KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
BESEDILO ''ZDRAVILO SHRANJUJTE IZVEN DOSEGA IN POGLEDA OTROK''
12/ 17 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
12/ 17 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
20 ml (10 doses of 2 ml) 50 ml (25 doses of 2 ml)
20 ml (10 odmerkov po 2 ml) 50 ml (25 odmerkov po 2 ml)
i. m. injection
i. m.
EXP {month/ year} Once broached, use within 10 hours.
EXP {mesec/ leto} Načeto/ odprto zdravilo uporabite v 10 urah.
Porcilis AR-T DF suspension for injection for pigs
Porcilis AR- T DF, suspenzija za injiciranje za prašiče
Protein dO (non-toxic deletion derivative of Pasteurella multocida) dermonecrotic toxin)
- protein dO (netoksični delecijski derivat dermonekrotičnega
≥ 5.9 log2 TN titre 1
≥ 5, 9 log2 toksin nevtralizirajočega titra1 toksina bakterije Pasteurella multocida) ≥ 4, 2 log2 aglutinacijskega titra2
- inactivated Bordetella bronchiseptica cells.
- inaktivirane celice bakterije Bordetella bronchiseptica
1
1 Srednji toksin nevtralizirajoči titer je določen po ponovljeni vakcinaciji s polovičnim odmerkom pri kuncih.
Adjuvant Per dose of 2 ml
Adjuvans V odmerku po 2 ml
Preservatives Per dose of 2 ml max 1.0 mg free formaldehyde.
Konzervansi V odmerku po 2 ml Največ 1, 0 mg prostega formaldehida
For the reduction of clinical signs of progressive atrophic rhinitis in piglets by passive oral immunisation with colostrum from dams actively immunised with the vaccine.
Zmanjšanje kliničnih znakov progresivnega atrofičnega rinitisa pujskov s pasivno peroralno imunizacijo prek kolostruma aktivno imuniziranih mater
A mean transient increase in body temperature of 1.5°C, in some pigs up to 3 °C can generally be measured on the day of vaccination or the following day.
Na splošno se lahko pri nekaterih prašičih na dan cepljenja ali naslednji dan prehodno povprečno za 1, 5 °C, pri nekaterih prašičih do 3 °C, poveča telesna temperatura.
Reduced activity and lack of appetite in 10-20%
Na dan cepljenja se lahko
10 cm) for up to two weeks may arise at the site of injection.
15/ 17 zmanjšata aktivnost in tek pri 10 do 20% živali in se pojavi prehodna oteklina na mestu injiciranja (največji premer je 10 cm), ki traja do dveh tednov.
- Before using the vaccine allow it to reach room temperature (15°C - 25°C).
- Cepivo pred uporabo ogrejte na sobno temperaturo (15 ºC do 25 ºC).
- Shake vigorously before use and at intervals during use.
- Pred uporabo in občasno med njo dobro pretresite.
- Avoid introduction of contamination.
- Pazite, da ne bi prišlo do kontaminacije.
- Vaccinate only healthy animals.
- Cepite samo zdrave živali.
16/ 17 Do not mix with any other veterinary medicinal products.
16/ 17 Ne mešajte z drugimi zdravili za uporabo v veterinarski medicini.
In case of accidental self-injection, seek medical advice immediately and show the package insert or the label to the physician.
V primeru nenamernega samoinjiciranja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali nalepko na zunanji ovojnini.
The import, sale, supply and/ or use of this veterinary medicinal product 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 tega zdravila za uporabo v veterinarski medicini 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 the veterinary medicinal product 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 to zdravilo za uporabo v veterinarski medicini, se mora posvetovati s pristojnimi organi posamezne države članice o veljavnih programih cepljenja še pred uvozom, prodajo, oskrbo in/ ali uporabo.
The immunogens are incorporated in an adjuvant based on dl-α -tocopherol.
Imunogeni so vgrajeni v adjuvans na osnovi dl- alfa- tokoferola.
Neonatal piglets derive passive immunity via ingestion of colostrum from vaccinated sows/ gilts.
Novorojeni pujski pridobijo pasivno imunost s kolostrumom cepljenih svinj ali mladic.
This helps to reduce the amount of virus in the animal’ s blood and lymphoid tissues and to reduce weight loss associated with PCV2 infection occurring during the fattening period.
S tem pomagamo zmanjšati količino virusov v krvi živali in njenih limfnih tkivih ter zmanjšati hujšanje pri okužbi s PCV2 v obdobju pitanja.
Measures of effectiveness that were 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Merila učinkovitosti, ki so jih opazovali, so bila povečanje telesne mase, smrtnost ter 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
The trials showed that vaccination of pigs with Porcilis PCV helps to reduce the amount of virus in the animal’ s blood and lymphoid tissues and to reduce weight loss associated with PCV2 infection occurring during the fattening period.
Preskušanja so pokazala, da cepljenje prašičev z zdravilom Porcilis PCV pomaga zmanjšati količino virusov v krvi živali in njenih limfnih tkivih ter zmanjšati hujšanje pri okužbi s PCV2 v obdobju pitanja.
Immediate systemic hypersensitivity- like reactions may occur after vaccination, resulting in minor neurological symptoms such as tremors and/ or excitation, which normally resolve within minutes without requiring treatment.
Po cepljenju se lahko pojavijo takojšnje sistemske, preobčutljivostnim podobne reakcije z blagimi nevrološkimi simptomi v obliki tremorja in/ ali razdraženosti, ki običajno minejo v nekaj minutah brez zdravljenja.
Occasionally, an increase of rectal temperature up to 2.5 °C lasting less than 24 hours may occur.
Občasno se lahko za do 2, 5 °C poveča rektalna temperatura, kar traja manj kot 24 ur.
Accidental injection/ self injection may result in severe pain and swelling, particularly if injected into a joint or finger, and, in rare cases, could result in the loss of the affected finger if prompt medical attention is not given.
Nenamerno injiciranje/ samoinjiciranje lahko povzroči hude bolečine in otekline, zlasti ob injiciranju v sklep ali prst, in lahko v izjemnih primerih, če ni zagotovljena takojšnja zdravniška oskrba, pripelje do izgube prizadetega prsta.
This summary was last updated in January 2009.
Povzetek je bil nazadnje posodobljen 01- 2009.
Route of administration
Način uporabo zdravila
≥ 4.5 log 2 ELISA units
≥ 4, 5 log2 emulzija za enot ELISA injiciranje
Pig
prašič
Vial (PET)
viala (PET)
Zero days
nič d ni
Each dose of 2 ml contains:
KAKOVOSTNA IN KOLIČINSKA SESTAVA
Porcine circovirus type 2 ORF2 subunit antigen: at least 4.5 log2 ELISA units*
Cirkovirus prašičev, tip 2, antigenska podenota ORF2: najmanj 4, 5 log2 enot ELISA *
* Antibody titre obtained according to the in vivo potency test in chickens.
* Titer protiteles je določen z in vivo preskusom učinkovitosti pri piščancih.
Adjuvants Dl-α -tocopheryl acetate
Dl- α- tokoferilacetat
Light liquid paraffin
Parafin, redko tekoči
For the active immunisation of pigs to reduce the virus load in blood and lymphoid tissues and to reduce weight loss associated with PCV2 infection occurring during the fattening period
Za aktivno imunizacijo prašičev z namenom zmanjšati virusno breme v krvi in limfnih tkivih ter hujšanje pri okužbi s PCV2 v obdobju pitanja
22 weeks
22 tednov
From the data provided, it can be concluded that a full dose regimen of vaccination breaks through medium to high levels of maternally derived antibodies in piglets.
Na podlagi pridobljenih podatkov lahko sklepamo, da je po cepljenju z odmerkom po celotni shemi cepljenja raven materinih protiteles pri pujskih srednja do visoka.
2/ 19 4.5 Special precautions for use
2/ 18 4. 5 Posebni previdnostni ukrepi
Accidental injection/ self injection may result in severe pain and swelling, particularly if injected into a joint or finger, and, in rare cases, could result in the loss of the affected finger if prompt medical attention is not given.
Nenamerno injiciranje/ samoinjiciranje lahko povzroči hude bolečine in otekline, zlasti ob injiciranju v sklep ali prst, in lahko v izjemnih primerih, če ni zagotovljena takojšnja zdravniška oskrba, privede do izgube prizadetega prsta.
Immediate systemic hypersensitivity-like reactions may occur after vaccination, resulting in minor neurological symptoms such as tremors and/ or excitation, which normally resolve within minutes without requiring treatment.
Po cepljenju se lahko pojavijo takojšnje sistemske, preobčutljivostnim podobne reakcije z blagimi simptomi v obliki tremorja ali razdraženosti, ki običajno minejo v nekaj minutah brez zdravljenja.
3/ 19 Vaccination Administer one dose of 2 ml by intramuscular injection in the neck, in the area behind the ear, according to the following schedule:
Cepljenje Cepite z enim odmerkom po 2 ml intramuskularno na vratu v predelu za ušesom po naslednji shemi:
The first injection (2 ml) can be given from an age of 3 days, with the second injection (2 ml) 2-3 weeks later.
Prvi odmerek (2 ml) lahko dajemo od starosti 3 dni, drugega (2 ml) pa 2 do 3 tedne pozneje.
4.10 Overdose (symptoms, emergency procedures, antidotes) (if necessary)
3/ 18 4. 10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno)
Following the administration of a double dose of vaccine no side effects other than those described in section 4.6 have been observed.
Po dajanju dvojnega odmerka cepiva niso opazili neželenih učinkov, ki bi se razlikovali od učinkov, opisanih v poglavju 4. 6.
Inactivated Porcine circovirus vaccine.
Farmakoterapevtska skupina: inaktivirano cepivo proti cirkovirusu prašičev
Vaccine to stimulate active immunity against Porcine circovirus type 2
Cepivo za vzbujanje aktivne imunosti proti cirkovirusu prašičev tipa 2
Polysorbate 80 Simethicon Water for injections
Polisorbat 80 simetikon voda za injekcije