natgillin/translations-raw huggingface dataset:
piglets over the age of 2 weeks may be vaccinated twice with one dose (2 ml), 4– 6 weeks apart.
starejše od 2 tednov, cepimo z dvakratnim dajanjem enega odmerka (2 ml) v intervalu 4 – 6 tednov.
mother (maternal antibodies).
Ta razpored cepljenja ni odvisen od tega, ali prašiči imajo protitelesa proti KPK, ki so jih dobili od matere (maternalna protitelesa).
For fattening pigs over the age of 10 weeks, just one injection with one dose is given.
Pri pitancih, ki so starejši od 10 tednov, damo le eno injekcijo z enojnim odmerkom.
The pigs may be re-vaccinated every 6 months.
Prašiče lahko ponovno cepimo vsakih 6 mesecev.
Protection from CSF starts after 2 weeks and lasts for 6 months. al
tednih in traja 6 mesecev.
It is strongly recommended to vaccinate all pigs in the herd. cin
Zelo priporočljivo je cepiti vse živali v čredi.
How does Advasure work?
Kako zdravilo Advasure deluje? ilo
When i
Zdravilo Advasure vsebuje antigen E2 (snov, ki stimulira imunski odziv) proti KPK.
this antigen is injected, this small exposure helps the pig’ s immune system to recognise and attack ed
Ko ta antigen injiciramo, nastala majhna izpostavitev pomaga imunskemu sistemu prašiča prepoznati in napasti viruse KPK.
CSF.
okužbo.
When exposed to CSF later in life, the pig will either not become infected or have a much less serious infection.
Kako je bila raziskana učinkovitost zdravila Advasure?
How has the effectiveness of Advasure been studied?
Zdravilo Advasure so preučili v zelo omejenem številu terenskih študij, saj je KPK prijavljiva bolezen.
Very limited field studies were conducted with Advasure as CSF is a notifiable disease and safety studies were conducted to assess tolerance to the vaccine and local reactions.
Opravljene so bile varnostne študije za ocenitev tolerance na cepivo in lokalnih reakcij.
All studies except one were laboratory based.
Vse študije razen ene so bile laboratorijske.
(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 Advasure has been studied in a large number of pigs using both a single or double vaccination.
(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 Zdravilo Advasure so preučili pri velikem številu prašičev z uporabo enkratnega ali dvakratnega cepljenja.
These studies included sows and gilts aged up to 40 months and also very young piglets with or without maternal antibodies.
V te študije so vključili plemenske svinje in mladice do starosti 40 mesecev ter zelo mlade pujske z maternalnimi protitelesi ali brez njih.
Advasure was also studied in fattening pigs where a single vaccination was given at age 10 weeks.
Zdravilo Advasure so preučili tudi pri pitancih, ki so jih cepili enkrat pri starosti 10 tednov.
The main measure of effectiveness was the production of antibodies to the CSF virus.
Glavno merilo učinkovitosti je bila tvorba protiteles proti virusu KPK.
What benefit has Advasure shown during the studies?
t me Kakšne koristi je zdravilo Advasure izkazalo med raziskavami?
Sows and gilts responded to both single and double vaccination with Advasure and developed enough
Tudi pri pitancih,
Fattening pigs injected at 10 weeks also responded to a single vaccination and maintained their immunity for 3 months.
pro ki so jih cepili pri starosti 10 tednov, so se protitelesa pojavila po enkratnem cepljenju, njihova imunost pa je trajala 3 mesece.
Piglets vaccinated once at 2 weeks responded whether or not they had maternal antibodies and maintained their immunity for 24 weeks.
Imunost so ohranili 24 tednov.
is Piglets given the double vaccination had higher levels of antibodies and the recommendation to vaccinate twice is justified.
Pujski, ki so prejeli dva odmerka cepiva, so imeli višje ravni protiteles, zato je priporočilo za dvakratno cepljenje utemeljeno.
or What is the risk associated with Advasure?
za Kakšna tveganja so povezana z zdravilom Advasure?
th Advasure can cause a swelling at the injection site, particularly in very young piglets, which usually disappears after one week.
nja ponavadi izgine v enem tednu po cepljenju.
In very rare cases
Lahko se pojavi rahlo zvišanje telesne temperature.
au diarrhoea, anorexia (not eating), depression and vomiting may occur, which may need treatment if serious.
V zelo redkih primerih se lahko pojavijo driska, anoreksija (neješčnost), depresija in bruhanje, ki zahtevajo zdravljenje, če nastopijo v resni obliki.
Mild to moderate granulomas (small nodules) or abscesses may occur in the muscle tissue at the injection site.
V mišičnem tkivu na mestu injiciranja se lahko pojavijo blagi do srednji granulomi (majhni vozli) ali abscesi.
er vaccinated pigs should be observed for about 30 minutes after vaccination.
Čeprav to doslej še ni bilo opaženo, se lahko v zelo lje redkih primerih pojavi tudi alergična reakcija, zaradi česar je treba cepljene živali opazovati približno 30 minut po cepljenju.
In case of a reaction, appropriate treatment should be given. ng What are the precautions for the person who gives the medicine or comes into contact with the animal? lo Advasure contains mineral oil.
Živali, pri katerih se pojavi reakcija, je treba ustrezno zdraviti. vo Kakšne previdnostne ukrepe mora upoštevati oseba, ki daje zdravilo ali pride v stik z živaljo?
Accidental injection may cause severe pain and swelling, particularly if injected into a joint or finger – rarely causing the loss of a finger.
Zdravilo Advasure vsebuje mineralno olje.
If someone is accidentally injected o
Nenamerno injiciranje lahko povzroči hude bolečine in do
with this product, they must seek immediate medical advice even if only a very small amount is injected.
otekline, zlasti ob injiciranju v sklep ali prst, in lahko v izjemnih primerih privede do izgube prizadetega prsta.
The package leaflet should be taken to the doctor.
Če vam je bilo to zdravilo nenamerno injicirano, se nemudoma posvetujte z zdravnikom, četudi je bila injicirana le majhna količina.
If pain persists for more than 12 hours tn
Če bolečina ne popusti po 12 urah po zdravniškem pregledu, se ponovno posvetujte z zdravnikom. eā
Why has Advasure been approved?
Zakaj je bilo zdravilo Advasure odobreno?
The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of od
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je mnenja, da so koristni učinki av
Advasure are greater than any risks for the purpose of immunising pigs from the age of 2 weeks onwards to prevent death and to reduce clinical signs of Classical Swine Fever.
zdravila Advasure pri cepljenju prašičev, starejših od 2 tednov, za preprečevanje poginov in zmanjšanje kliničnih znamenj klasične prašičje kuge večji od z njim povezanih tveganj.
They recommended that Advasure should be given a marketing authorisation.
Odbor je zato priporočil odobritev dovoljenja za promet z zdravilom Advasure.
module 6 of this EPAR.
Razmerje med koristmi in tveganji najdete v modulu 6 tega Evropskega javnega poročila o oceni zdravila (EPAR). nim
Other information about Advasure: al
Druge informacije o zdravilu Advasure:
The European Commission granted a marketing authorisation valid throughout the European Union for Advasure (previously called Bayovac CSF E2) on 2 February 2001 and the current marketing cin
Evropska komisija je dovoljenje za promet z zdravilom Advasure (prej imenovano Bayovac CSF E2), veljavno po vsej Evropski uniji, odobrila dne 2. februarja 2001.
authorisation holder is Pfizer Ltd.
Trenutni imetnik dovoljenja za promet je družba Pfizer Ltd.
The marketing authorisation was renewed in February 2006.
Dovoljenje za promet z zdravilom je bilo obnovljeno februarja 2006. ilo
The import, sale, supply and/ or use of this veterinary medicinal product is only allowed under the i ed
Uvoz, prodaja, dobava in/ ali uporaba tega veterinarskega zdravila je dovoljena le pod posebnimi pogoji, ki jih opredeljuje zakonodaja Evropske skupnosti o nadzoru KPK (Direktiva Sveta rav
particular conditions established by European Community legislation on the control of CSF (Council Directive 80/ 217/ EEC, as amended).
80/ 217/ EGS, kot je bila spremenjena).
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.
Uvoz, prodaja, dobava in/ ali uporaba tega veterinarskega zdravila so dovoljeni le z odobritvijo pristojnega organa posamezne države članice.
This summary was last updated in December 2006.
Ta povzetek je bil nazadnje posodobljen decembra 2006.
ised or th au ANNEX I
t me pro za nja lje DODATEK I
ng lo o tn uc od Pr al icin ed M
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA vo do eā av nim ilo rav Zd
Advasure emulsion for injection.
Advasure emulzija za injiciranje
2.
t me 2.
Per dose of 2 ml:
Vsebnost na odmerek 2 ml
ed Active substance:
pro Zdravilna učinkovina:
is E2 glycoprotein of Classical Swine Fever (CSF) virus minimum 32 µg
glikoprotein E2 virusa klasične prašičje kuge, vsaj 32 µg
or Adjuvant:
Pomožne snovi:
Mineral oil
za sestava adjuvansa – emulzija olje- olje mineralno olje
au Emulsifiers Phosphate buffered saline
nja emulgatorji fiziološka raztopina s fosfatnim pufrom
Preservative:
Konzervans:
er Thiomersal
lje
maximum 1:10,000
tiomersal
3.
vo
ng lo o
10. 000
Emulsion for injection. tn
Celoten seznam pomožnih snovi, glej razdelek 6. 1. do
CLINICAL PARTICULARS uc
FARMACEVTSKA OBLIKA
4.1 Target species od
Emulzija za injiciranje eā
Pigs.
4.
4.2 Indications for use, specifying the target species Pr
Prašiči. nim
Active immunisation of pigs, over the age of 2 weeks, against Classical Swine Fever (CSF), to prevent mortality, reduce clinical signs of the disease and the excretion of field virus. al
4. 2 Indikacije za uporabo, opredelitev ciljne živalske vrste
The onset of protection is 2 weeks.
Zaščita nastopi po 2 tednih.
The duration of protection is 6 months. cin
Zaščita traja 6 mesecev. ilo
4.3 Contraindications i ed
4. 3 Kontraindikacije rav
4.4 Special warnings for each target species M
Posebna opozorila za vsako ciljno živalsko vrsto Zd
It is strongly recommended to vaccinate all pigs in the herd.
Prašiče je potrebno cepiti pravočasno pred pričakovano možnostjo okužbe, najbolje pred vhlevitvijo ali premikom v novo čredo. Priporočamo, da se cepijo vse živali v čredi.
4.5 Special precautions for use
2/ 20 4. 5 Posebni previdnostni ukrepi
2/ 20 Special precautions for use in animals
Posebni previdnostni ukrepi za uporabo pri živalih
See section 4.4.
t me Glej poglavje 4. 4.
In case of accidental self-injection, seek medical advice immediately and show the package insert to a
pro V primeru nenamernega samo- injiciranja, se takoj posvetujte z zdravnikom in mu pokažite navodilo za uporabo.
ed physician.
Namenjeno uporabniku:
is This product contains mineral oil.
Ta izdelek vsebuje mineralno olje.
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
Nenamerno injiciranje/ samo- injiciranje lahko povzroči hude
or affected finger if prompt medical attention is not given.
za 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.
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
Če vam je bil ta proizvod nenamerno injiciran, se takoj posvetujte z zdravnikom, čeprav je bila
th insert with you.
nja injicirana le majhna količina, in mu pokažite navodila za uporabo.
This product contains mineral oil.
Zdravniku: lje To izdelek vsebuje mineralno olje.
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
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.
er the loss of a digit.
4. 6.
Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.
Stranski učinki (pogostost in resnost) do
4..6 Adverse reactions (frequency and seriousness) ng lo Swelling at the injection site may occur, which usually disappears spontaneously within approximately one week after vaccination.
Na mestu injiciranja se pojavi lokalna oteklina, ki izgine sama od sebe približno v enem tednu po cepljenju.
Other side o
Pogosteje se pojavlja pri zelo mladih živalih.
effects such as a slight increase in body temperature can occur.
Lahko se pojavijo tudi drugi stranski učinki, kot je na primer rahlo povišanje telesne temperature.
In very rare cases diarrhoea, anorexia, tn
V zelo redkih primerih se lahko pojavi tudi eā
depression and vomiting may be observed.
driska, anoreksija, depresija in bruhanje.
Symptomatic treatment should be considered when serious side effects are observed.
V primeru pojava resnejših stranskih učinkov je potrebno prizadete živali zdraviti simptomatsko.
As part of the immune reaction following vaccination, mild to moderate granulomas may occur in the uc
Kot del imunskega odgovora po cepljenju se lahko v mišičnini na mestu aplikacije pojavijo blagi do av
muscle tissue at the injection site.
srednji granulomi.
In some cases also formation of abscesses was observed.
V posamičnih primerih se lahko izoblikujejo tudi abscesi.
In those cases, od
Čeprav do sedaj še ni bilo opaženo, se lahko zelo redko pojavi tudi preobčutljivostna reakcija, zaradi česar je potrebno živali opazovati do 30 minut po cepljenju.
appropriate treatment should be administered.
Vse živali, ki kažejo znamenja preobčutljivosti, je potrebo ustrezno zdraviti. nim
4.7 Use during pregnancy, lactation or lay Pr
Uporaba v obdobju brejosti, laktacije ali nesnosti
Can be used during pregnancy.
Cepivo se lahko uporablja v času brejosti.
However it may not prevent transplacental al
Cepivo po dveh cepljenjih svinj preprečuje transplacentarni prenos nizko virulentnih sevov virusa na zarodke, ne prepreči pa transplacentarnega prenosa visoko virulentnih sevov. ilo
The use of immunosuppressive veterinary medicinal products (e. g. corticosteroids) or modified live i ed
4. 8 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij rav
Porcine Reproductive and Respiratory Syndrome (PRRS) vaccines within 7 days before and 7 days after application of Advasure may interfere with the induction of immunity and should therefore be avoided.
Izogibamo se sočasni uporabi imunosupresivnih zdravil (npr. kortikosteroidov) ali cepljenju z modificirano živo vakcino prašičjega reprodukcijskega in respiratornega sindroma (PRRS) 7 dni pred in 7 dni po cepljenju z Advasure cepivom, saj lahko to ovira razvoj imunosti.
The dosage for pigs, over the age of 2 weeks, is 2 ml of the vaccine.
Odmerjanje Odmerek za prašiče, starejše od 2 tednov, je 2 ml.
3/ 20 Mode of administration:
3/ 20 Način uporabe:
In emergency situations the basic immunisation consists of one intramuscular injection with one dose (2 ml) for all pigs over the age of 2 weeks, irrespective of the level of maternal antibodies.
V nujnih situacijah je osnovni program imunizacije enkratno intramuskularno dajanje enega odmerka (2 ml) vsem prašičem, starejšim od 2 tednov, ne glede na nivo maternalnih protiteles.
Depending on the infection pressure and the disease situation sows and piglets over the age of 2 weeks (irrespective of the level of maternal antibodies) may be vaccinated twice with one dose (2 ml), 4– 6 weeks apart.
Glede na jakost okužbe in stanje obolenja lahko plemenske svinje in pujske starejše od 2 tednov (ne glede na nivo maternalnih protiteles) ponovno cepimo z dvakratnim dajanjem enega odmerka (2 ml) v
For fattening pigs over the age of 10 weeks, however, one intramuscular injection with one dose is administered.
Pri pitancih, ki so starejši od 10 tednov, damo le enkrat enojen odmerek
ed Re-vaccination:
Ponovno cepljenje:
One dose (2 ml) at 6 months intervals.
En odmerek (2 ml) vsakih 6 mesecev.
is The vaccine is to be administered aseptically by intramuscular injection closely behind the ear.
pro Cepimo aseptično intramuskularno tik za bazo uhlja.
or 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
4. 10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če so potrebni)
th An overdose of the product can result in a moderate swelling at the injection site that can persist for 2- 3 weeks.
za Preveliko odmerjanje cepiva lahko na mestu injiciranja povzroči srednje močno oteklino, ki lahko ostane 2 – 3 tedne.
au 4.11 Withdrawal period(s)
nja 4. 11 Karenca( e)
er Zero days.
0 dni.
5.
lje 5.
IMMUNOLOGICAL PROPERTIES ng lo ATCvet code:
IMUNOLOŠKE LASTNOSTI vo ATCvet oznaka:
QI09AA06
QI09AA06
Summary presentation of the active ingredients: o
Povzetek opisa aktivne snovi: do
The Classical Swine Fever (CSF, Hog Cholera) virus, a member of the Pestivirus genus, codes for a tn
Virus klasične prašičje kuge (KPK), ki sodi v rod Pestivirus, kodirajo številni strukturni in nestrukturni glikoproteini, kot so E2, E1, Erns, gp54 in gp80.
E2, E1, Erns, gp54 and gp80.
Glikoprotein E2 štejemo za glavno imunogeno komponento virusa KPK, proti kateremu so usmerjena nevtralizacijska protitelesa.
The E2 glycoprotein is considered to be the main immunogen of the CSF virus against which the neutralising antibodies are directed.
Gen, ki kodira glikoprotein E2 (E2 gen) je konzervativna regija.
The gene coding for the E2 glycoprotein (E2 gene) is a rather conserved uc
Glikoprotein E2 je imunološko navzkrižno reaktiven eā
The E2 glycoprotein is considered to be immunologically cross-reactive with all field strains.
z vsemi. kliničnimi izolati.
The vaccine od
Gen za glikoportein E2 je bil vstavljen v genom virusa žuželk (baculovirus) Cepivo vsebuje le E2, ne av
Pr
pa tudi druge proteine virusa KPK.
The vaccine, as formulated with the mineral oil and the emulsifiers, induces protection in pigs against clinical signs caused by the Classical Swine Fever (CSF) virus.
Cepivo, proizvedeno z dodatkom mineralnih olj in emulgatorjev, pri prašičih prepreči pojav kliničnih nim
As a consequence of the subunit nature al
znamenj klasične prašičje kuge.
of the vaccine, vaccination does not induce production of antibodies against CSF virus antigens, other than E2. cin
Zaradi sestave cepiva cepljenje ne spodbudi tvorbe protiteles proti drugim antigenom virusa KPK razen proti glikoproteinu E2.
PHARMACEUTICAL PARTICULARS i ed
FARMACEVTSKI PODATKI ilo
M
Fiziološka raztopina s fosfatnim pufrom. rav
6.2 Incompatibilities
6. 2 Glavne inkompatibilnosti
Do not mix with any other vaccine or immunological product.
Zd
6.3 Shelf life
4/ 20 6. 3 Rok uporabnosti
14 months
14 mesecev.
4/ 20 After first broaching the container, the contents may be used for up to 8 hours if stored at 2°C-8°C.
8 ur, če se hrani pri temperaturi 2°C – 8°C.
6.4.
t 6. 4.
Do not freeze.
me Shranjujte pri temperaturi 2°C – 8°C.
Protect from light.
Zdravilo ne sme zmrzniti!
6.5 Nature and composition of immediate packaging
pro Zaščitite pred svetlobo.
ed Multidose containers with appropriate overfill:
6. 5 Vrsta in vsebina vsebnika
- 1 glass vial, type 2, containing 20 ml (10 doses) vaccine, closed with rubber stopper and sealed
Steklena viala z več odmerki in ustreznim presežkom v vsebniku:
with an aluminium seal, packed as 54 vials in 1 styrofoam box
1 steklena viala stekla tipa 2 z 20 ml (10 odmerki) cepiva, zaprta z gumijastim čepom aluminjasto zaporko, pakirani v stiroporne škatle s 54 vialami.
is
in
- 1 glass vial, type 1, containing 50 ml (25 doses) vaccine, closed with rubber stopper and sealed
1 steklena viala stekla tipa 1 s 50 ml (25 odmerki) cepiva, zaprta z gumijastim čepom aluminjasto zaporko, pakirani v stiroporne škatle s 35 vialami.
with an aluminium seal, packed as 35 vials in 1 styrofoam box
in
or
nja -
- 1 glass vial, type 1, containing 100 ml (50 doses) vaccine, closed with rubber stopper and sealed
1 steklena viala stekla tipa 1 s 100 ml (50 odmerki) cepiva, zaprta z gumijastim čepom aluminjasto zaporko, pakirani v stiroporne škatle z 12 vialami.
with an aluminium seal, packed as 12 vials in 1 styrofoam box
in
th
-
- 1 glass vial, type 1, containing 250 ml (125 doses) vaccine, closed with rubber stopper and
1 steklena viala tipa 1 z 250 ml (125 odmerki) cepiva, zaprta z gumijastim čepom aluminjasto zaporko, pakirani v stiroporne škatle z 10 vialami. lje
sealed with an aluminium seal, packed as 10 vials in 1 styrofoam box
in
au 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
6. 6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi, če obstajajo vo Vsako neporabljeno zdravilo za uporabo v veterinarski medicini ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z nacionalnimi zahtevami. do
er Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements. ng lo 7.
7.
MARKETING AUTHORISATION HOLDER
IMETNIK( I) DOVOLJENJ( A) ZA PROMET eā
Sandwich tn
Sandwich Kent, CT13 9NJ av
Kent, CT13 9NJ United Kingdom uc
Združeno kraljestvo
MARKETING AUTHORISATION NUMBER(S) od
ŠTEVILKA( E) DOVOLJENJ( A) ZA PROMET nim
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATUM PRIDOBITVE/ PODALJŠANJA DOVOLJENJA ZA PROMET ilo
02-02-2001 / 13-02-2006 al cin
02- 02- 2001 / 13- 02- 2006 rav
PROHIBITION OF SALE, SUPPLY AND/ OR USE M
13- 02- 2006 Zd
5/ 20
5/ 20 PREPOVED PRODAJE, OSKRBE IN/ ALI UPORABE
or
t uporabljati to zdravilo za uporabo v veterinarski medicini mora pridobiti dovoljenje pristojnega organa
is
me posamezne države članice.
ed
pro za nja lje vo do eā av nim ilo rav Zd
th au ANNEX II
6/ 20 t me pro za nja lje DODATEK II vo A.
er
B.
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND ng MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE lo
POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE VARNE IN UČINKOVITE UPORABO av
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE o tn
NAVEDBA ZDRAVILA (MRL) nim
C.
NAJVIŠJIH
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE uc
DOVOLJENIH
D.
KOLIČIN
STATEMENT OF THE MRLs od Pr al
ZAOSTANKOV
icin ed M
ilo rav Zd
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
(ZDRAVILNIH UČINKOVIN) IN IMETNIK( I) DOVOLJENJ( A) ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROSTITEV SERIJE
Name and address of the manufacturer(s) of the biological active substance(s)
Ime in naslov izdelovalca( izdelovalcev) biološke zdravilne učinkovine (zdravilnih učinkovin).
Box 65
t me ID- DLO Edelhertweg 15, P. O.
ed 8200 AB Lelystad The Netherlands
Box 65 8200 AB Lelystad Nizozemska
is Name and address of the manufacturer(s) responsible for batch release
pro Ime in naslov izdelovalca (izdelovalcev) zdravila, odgovornega za sprostitev serije
or Bayer AG Business Group Animal Health
Bayer AG
th Osterather Strasse 1a D-50739 Köln
za Business Group Animal Health Osterather Strasse 1aD- 50739 Köln Nemčija
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
nja B POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE OSKRBE IN UPORABE
According to Community Legislation on Classical swine fever (Council Directive 80/ 217/ EEC, as amended), in the European Union: o
lje Izdaja zdravila za uporabo v veterinarski medicini je le na recept.
However, the use of vaccines may be tn
V skladu z zakonodajo o Klasični prašičji kugi (Direktiva 80/ 217/ EEC) v Evropski Uniji: vo a) Uporaba vakcin klasične prašičje kuge je prepovedana.