natgillin/translations-raw huggingface dataset:
2 years Shelf life after first opening the immediate packaging:
Rok uporabnosti po prvem odpiranju stične ovojnine:
8 hours.
8 ur.
Vials are closed with a nitryl rubber stopper and a coded aluminium cap.
Kartonske škatle z 1 vialo ali z 10 vialami iz PET po 20, 50, 100, 200 ali 500 ml Viale so zaprte z zamaški iz nitrilne gume in aluminijasto zaporko z oznako.
4/ 19 6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
6. 6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi
5/ 19 ANNEX II
5/ 18 DODATEK II
Exportstraat 39B 5831 AK Boxmeer Netherlands
Exportstraat 39B 5831 AK Boxmeer Nizozemska
The constituents of Porcilis PCV listed below are included in Annex II of Council Regulation (EEC) No.
Spodaj navedene sestavine Porcilisa PCV so vključene v Dodatek II Uredbe Sveta (ES) št.
2377/ 90 in accordance with the following table:
2377/ 90, kot je navedeno v tabeli:
Polysorbate 80 (Polyoxyethylene sorbitan monooleate)
Parafin, redko tekoči Dl- alfa- tokoferolacetat polisorbat 80 (polioksietilen sorbitan monooleat)
All food producing species
vse živalske vrste za proizvodnjo živil vse živalske vrste za proizvodnjo živil vse živalske vrste za proizvodnjo živil
Simethicone (dimethicone)
simetikon (dimetikon)
All food producing species
vse živalske vrste za proizvodnjo živil
7/ 19 ANNEX III
7/ 18 DODATEK III
9/ 19 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
9/ 18 PODATKI NA ZUNANJI OVOJNINI
Porcine Circovirus type 2 ORF2 subunit antigen: ≥ 4.5 log2 ELISA units 25 mg dl- α -tocopheryl acetate 346 mg light liquid paraffin Polysorbate 80
V odmerku po 2 ml: cirkovirus prašičev, tip 2, antigenska podenota ORF2 najmanj 4, 5 log2 enot ELISA polisorbat 80
1 vial of 10,25,50,100,250 doses 10 vials of 10,25,50,100,250 doses
1 viala po 10, 25, 50, 100, 250 odmerkov 10 vial po 10, 25, 50, 100, 250 odmerkov
Vaccine against Porcine circovirus type 2
Cepivo proti cirkovirusu prašičev tipa 2
Intramuscular use Read the package leaflet before use
Intramuskularna uporaba Pred uporabo preberite navodilo za uporabo.
Withdrawal period: zero days
Karenca: nič dni.
Shake
Pred uporabo dobro pretresite.
EXPIRY DATE
10/ 18 10.
EXP {month/ year} Once broached, use within 8 hours
EXP {mesec/ leto} Odprto zdravilo uporabite v 8 urah.
12/ 19 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE {100, 200, 500 ml bottles}
PRIMARNI OVOJNINI {viale po 100, 200, 500 ml}
PCV2 ORF2 subunit antigen: ≥ 4.5 log2 ELISA units dl-α -tocopheryl acetate light liquid paraffin Polysorbate 80
V odmerku po 2 ml: cirkovirus prašičev, tip 2, antigenska podenota ORF2 najmanj 4, 5 log2 enot ELISA polisorbat 80
1 vial of 100, 200, 500 ml (50,100,250 doses) 10 vials of 100, 200, 500 ml (50,100,250 doses)
1 viala po 100, 200 500 ml (50, 100, 250 odmerkov) 10 vial po 100, 200 500 ml (50, 100, 250 odmerkov)
13/ 19 9.
9.
EXPIRY DATE
12/ 18 10.
THE WORDS “ FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
ESEDILO “ SAMO ZA ŽIVALI ” IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, če je navedba smiselna
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
ME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
Intervet International BV 5831 AN Boxmeer The Netherlands
Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer Nizozemska
MANUFACTURER’ S BATCH NUMBER
ZDELOVALČEVA ŠTEVILKA SERIJE
14/ 19 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS {20,50 ml vial}
13/ 18 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH {viala po 20, 50 ml
PCV2 ORF2 subunit antigen: ≥ 4.5 log2 ELISA units
KOLIČINA ZDRAVILNE( IH) UČINKOVIN( E)
20, 50ml (10, 25 doses)
20, 50 ml (10, 25 odmerkov)
16/ 19 PACKAGE LEAFLET FOR:
15/ 18 NAVODILO ZA UPORABO
PORCILIS PCV emulsion for injection for pigs
PORCILIS PCV emulzija za injiciranje za prašiče
Porcine Circovirus type 2 ORF2 subunit antigen: at least 4.5 log2 ELISA units as determined in the in vivo potency test in chickens Adjuvants:
Cirkovirus prašičev, tip 2, antigenska podenota ORF2 najmanj 4, 5 log2 enot ELISA, določeno z in vivo preskusom učinkovitosti pri piščancih Dodatki:
25 mg dl-α -tocopheryl acetate 346 mg light liquid paraffin Polysorbate 80
25 mg Dl- α- tokoferilacetata 346 mg parafina, redko tekočega polisorbat 80
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 Začetek imunosti:
2 weeks Immunity will last:
2 tedna
This will 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.
17/ 19 show a reduced feed intake for up to 5 days.
Pri nekaterih pujskih se lahko pojavi pobitost in pojedo manj krme, kar lahko traja do 5 dni.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
16/ 18 Če opazite kakršne koli resne stranske učinke ali druge učinke, ki niso omenjeni v teh navodilih za uporabo, obvestite svojega veterinarja.
The first injection (2ml) can be given from an age of 3 days, 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.
Before using the vaccine allow it to reach room temperature (15-25°C) and shake well before use.
Preden cepivo uporabite, naj se ogreje na sobno temperaturo (15– 25°C), nato ga dobre pretresite. Izogibajte se večkratnega odpiranja viale.
Avoid multiple vial broaching.
Uporabite sterilne brizge in igle.
Store in a refrigerator (2 °C – 8 °C).
Shranjujte nedosegljivo otrokom Shranjujte v hladilniku (2 °C – 8 °C).
8 hours
8 ur.
18/ 19 To the physician:
Namenjeno zdravniku:
Do not use during pregnancy and lactation.
17/ 18 Ne uporabite v obdobju brejosti in laktacije.
Following the administration of a double dose of vaccine no side effects other than those described under “ adverse reactions” have been observed.
Po dajanju dvojnega odmerka cepiva niso opazili neželenih učinkov, ki bi se razlikovali od učinkov, opisanih v odstavku ''neželeni učinki''.
Not all pack sizes may be marketed.
1 viala ali 10 vial po 20, 50, 100, 200, 500 ml (10/ 25/ 50/ 100/ 250 odmerkov) Ni nujno, da so v prometu vsa navedena pakiranja.
ed EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)
d de EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR)
EPAR summary for the public
n Povzetek EPAR za javnost
e sp This document is a summary of the European Public Assessment Report.
Njegov namen je
Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.
us pojasniti, kako je Odbor za zdravila za uporabo v veterinarski medicini (CVMP) ocenil predloženo dokumentacijo, na podlagi česar je oblikoval priporočila glede uporabe zdravila.
Su This document cannot replace a face-to-face discussion with your veterinarian.
Ta dokument ne more nadomestiti osebnega pogovora z veterinarjem.
If you need more information about your animal’ s medical condition or treatment, contact your veterinarian.
Če želite
If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
nS več informacij o podlagi za priporočila CVMP, preberite znanstveno razpravo (ki je prav tako del EPAR).
Porcilis Pesti is an emulsion for injection.
o Kaj je zdravilo Porcilis Pesti? ati Zdravilo Porcilis Pesti je emulzija za injiciranje.
Porcilis Pesti contains Classical Swine Fever Virus -E2 subunit antigen. isa
Zdravilo Porcilis Pesti vsebuje virus klasične prašičje kuge – antigenska podenota E2.
What is Porcilis Pesti used for?
Za kaj se zdravilo Porcilis Pesti uporablja? ris
Porcilis Pesti is used to immunise healthy pigs from the age of 5 weeks onwards to prevent death and or
Zdravilo Porcilis Pesti se uporablja za imunizacijo zdravih prašičev, starih 5 tednov in več.
to reduce clinical signs of Classical Swine Fever (CSF).
S tem se preprečuje smrtnost in zmanjšujejo klinični znaki klasične prašičje kuge (KPK).
It is also used to reduce infection with CSF and excretion of CSF virus into the environment. uth
Uporablja se tudi za zmanjševanje okuženosti s KPK in izločanja virusa KPK v okolico. o uth
Protection from CSF starts after 2 weeks and lasts for 6 months. gA
Zaščita pred KPK začne učinkovati po 2 tednih in traja 6 mesecev. gA
When this antigen is injected, this small exposure helps the pig’ s immune system to recognise and attack CSF.
Po injiciranju tega antigena, ta majhna izpostavitev pripomore k temu, da imunski sistem prašiča prepozna in napade KPK.
When exposed to CSF later in life, the pig will either not become infected or have a much tin
Če bo prašič bolezni KPK izpostavljen pozneje v življenju, se ne bo okužil tin
less serious infection.
ali pa bo imel bistveno manj resno okužbo.
How has Porcilis Pesti been studied? ke
Kako je bilo zdravilo Porcilis Pesti raziskano? ke
The field trials confirm the results obtained in the laboratory safety experiments and show that the product is safe for the target animal (piglets from 5 weeks of age r
Terenske študije potrjujejo rezultate laboratorijskih preizkusov varnosti in kažejo, da je izdelek varen za ciljne živali (pujski od 5 meseca r
onwards) and in the most sensitive category of animals (pregnant sows).
dalje) in najobčutljivejšo kategorijo živali (breje svinje).
(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 What benefit has Porcilis Pesti shown during the studies?
(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 Kakšne koristi je zdravilo Porcilis Pesti izkazalo med raziskavami?
Viraemia was only prevented by two injections (as recommended in the vaccination schedule for
Viremijo je bilo mogoče preprečiti z dvema injekcijama (kot je priporočeno v shemi cepljenja z zdravilom Porcilis
ed Porcilis Pesti).
d Pesti).
What is the risk associated with Porcilis Pesti?
de Kakšna tveganja so povezana z zdravilom Porcilis Pesti?
nd Porcilis Pesti can cause a swelling at the injection site for up to 4 weeks after each injection of the vaccine.
Zdravilo Porcilis Pesti lahko povzroči oteklino na mestu injiciranja, ki lahko traja do 4 tedne po
It is recommended that the second vaccination is given at
Priporočljivo je, da se drugo cepljenje
e a different site than the first vaccination.
pe ne izvede na istem mestu kot prvo.
sp What are the precautions for the person who gives the medicine or comes into contact with the animal?
Kakšne previdnostne ukrepe mora upoštevati oseba, ki daje zdravilo ali pride v stik z živaljo?
Su Porcilis Pesti contains mineral oil.
us Zdravilo Porcilis Pesti 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 tega izdelka, mora ta oseba nemudoma poiskati
The package leaflet should be taken to the doctor.
nS zdravniško pomoč, tudi če je bila injicirana le zelo majhna količina.
Why has Porcilis Pesti been approved? n tio The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Porcilis Pesti are greater than any risks to immunise pigs from the age of 5 weeks onwards to prevent death isa
Zakaj je bilo zdravilo Porcilis Pesti odobreno? o Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je sklenil, da so koristi zdravila Porcilis ati Pesti pri imunizaciji prašičev, starih 5 tednov in več, pri preprečevanju smrtnosti in zmanjšanju kliničnih znakov klasične prašičje kuge večje od morebitnih tveganj.
and to reduce clinical signs of Classical Swine Fever.
Zato je priporočil, da se za zdravilo Porcilis Pesti odobri dovoljenje za promet.
They recommended that Porcilis Pesti should be given a marketing authorisation.
Razmerje med koristmi in tveganji najdete v ris
The benefit-risk balance may be found in module 6 of this EPAR.
modulu 6 tega Evropskega javnega poročila o oceni zdravila (EPAR).
Other information about Porcilis Pesti: or
Druge informacije o zdravilu Porcilis Pesti: o
The European Commission granted a marketing authorisation valid throughout the European Union for Porcilis Pesti to Intervet International B. V. on 9 February 2000, which was renewed in February 2005. uth
Dovoljenje je bilo podaljšano uth
The import, sale, supply and/ or use of Porcilis Pesti is only allowed under the particular conditions established by European Community legislation on the control of CSF (Council Directive 80/ 217/ EEC, as amended).
Uvoz, prodaja, dobava in/ ali uporaba zdravila Porcilis Pesti so dovoljeni samo pod posebnimi pogoji, določenimi z zakonodajo Evropske skupnosti o nadzoru KPK (Direktiva Sveta 80/ 217/ EGS, z vsemi gA
must be authorised by the competent authority of the Member State.
Vsakdo, ki želi uvažati, prodajati, dobavljati in/ ali uporabljati zdravilo za uporabo v veterinarski medicini, mora dobiti dovoljenje pristojnega organa države članice. tin
This summary was last updated in December 2006. tin r ke Ma
Ta povzetek je bil nazadnje posodobljen 12- 2006. ke r Ma
SUMMARY OF PRODUCT CHARACTERISTICS isa or uth gA tin ker Ma
d de n pe us nS DODATEK I o ati POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA ris o uth gA tin ker Ma
Porcilis Pesti emulsion for injection
Porcilis Pesti, emulzija za injiciranje
Active substance:
de Zdravilna učinkovina:
Classical Swine Fever Virus (CSFV) -E2 subunit antigen:
Virus klasične prašičje kuge (KPK) – antigenska podenota E2:
120 Elisa Units (EU) per dose of 2 ml
120 enot Elisa (EU) v odmerku po 2 ml
nd Adjuvant:
n Adjuvans:
941.4 mg liquid paraffin per dose of 2 ml
pe 941, 4 mg tekočega parafina v odmerku po 2 ml
e For a full list of excipients, see section 6.1
Celoten seznam pomožnih snovi, glej razdelek 6. 1.
Su Emulsion for injection.
nS Emulzija za injiciranje
4.
4. 1 Prašiči
CLINICAL PARTICULARS
KLINIČNI PODATKI Ciljna živalska vrsta
n 4.1 Target species tio Pigs. isa
ati
4.2 Indications for use, specifying the target species
4. 2 Indikacije za uporabo, opredelitev ciljne živalske vrste ris
Active immunisation of pigs from the age of 5 weeks onwards to prevent mortality and to reduce clinical signs of Classical Swine Fever, as well as to reduce infection with and excretion of CSF field virus. or
Prav tako se zmanjša okuženost z naravnim virusom KPK, o
The onset of protection is 2 weeks.
Zaščita se razvije v 2 tednih. uth
The duration of protection is 6 months. uth
Zaščita traja 6 mesecev.
4.3 Contraindications
4. 3 Kontraindikacije gA
None gA
Niso znane.
None tin
Jih ni. tin
4.5 Special precautions for use
4. 5 Posebni previdnostni ukrepi ke
Special precautions for use in animals ke
Posebni previdnostni ukrepi za uporabo pri živalih
Not applicable
Navedba ni smiselna. r Ma
Special precautions to be taken by the person administering the veterinary medicinal product to r
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo
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 injicirana le majhna
2/ 17 leaflet with you.
2/ 17 količina, in mu pokažite navodila za uporabo.
Even if small amounts have been injected, accidental injection with
Čeprav je bila injicirana le majhna količina, lahko nenamerno
ed this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit.
d injiciranje tega izdelka povzroči močno oteklino, ki lahko na primer privede do ishemične nekroze ter celo do izgube prsta.
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.
Potreben je strokoven, TAKOJŠEN, kirurški poseg ter morda tudi takojšnja
nd 4.6 Adverse reactions (frequency and seriousness)
4. 6 Stranski učinki (pogostost in resnost)
A local and in most cases transient swelling at the injection site may occur up to 4 weeks after
n Do 4 tedne po vsakem odmerku cepiva se lahko pojavi lokalna in večinoma prehodna oteklina na
e administration of each dose of the vaccine.
pe mestu injiciranja.
Since safety after giving both inoculations at the same
Varnost dajanja obeh odmerkov na isto mesto ni raziskana, zato je drugi odmerek priporočljivo dati na drugo mesto kot prvič.
sp site has not been examined, it is advised to carry out the second vaccination at a different site than the first vaccination.
us 4. 7 Uporaba v obdobju brejosti, laktacije ali nesnosti
Su 4.7 Use during pregnancy, lactation or lay
Lahko se uporablja v obdobju brejosti, vendar pa ne prepreči transplacentarnega prenosa naravnega
Can be used during pregnancy but may not prevent transplacental transmission of Classical swine fever field virus from the sow to foetuses.
nS virusa klasične prašičje kuge z matere na zarodke.
4.8 n Interaction with other medicinal product and other forms of interaction tio No information is available on the safety and efficacy from the concurrent use of this vaccine with any other.
4. 8 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij o O varnosti in učinkovitosti sočasne uporabe cepiva z drugimi cepivi ni podatkov.
It is therefore recommended that no other vaccines can be administered concurrently with the product. isa
Zato sočasnega dajanja z drugimi cepivi ne priporočamo. ati 4. 9 Odmerjanje in način uporabe ris
Shake well before use. or
Pred uporabo dobro pretresite.
Intramuscular injection of one dose (2 ml) in the neck in the area behind the ear.
Intramuskularno en odmerek (2 ml) v vrat v predel za ušesom Shema cepljenja:
Inject one dose per pig followed by a second injection 4 weeks after the first
Osnovno cepljenje: en odmerek za enega prašiča, nato drugi odmerek 4 tedne po prvem o
Every 6 months, using a single dose.
Revakcinacija: enkratni odmerek vsakih 6 mesecev uth
Allow the vaccine to reach a temperature of 15°C-25°C before use.
Cepivo pred uporabo ogrejemo na sobno temperaturo 15 ºC- 25 ºC.
Avoid the introduction of contamination. gA
Pazite, da ne bi prišlo do kontaminacije.
It is recommended to use a closed multiject vaccination system.
Priporočamo uporabo zaprtega sistema za cepljenje z večtočkovnim vbrizgom. gA
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary tin
4. 10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če so potrebni)
After administration of an overdose, local reactions at the injection site may be more pronounced.
Po vnosu prevelikega odmerka so lahko lokalne reakcije na mestu vboda izrazitejše. tin
4.11 Withdrawal period(s) ke
4. 11 Karenca
Zero days r Ma
Nič dni ke
IMMUNOLOGICAL PROPERTIES
IMUNOLOŠKE LASTNOSTI r
Classical Swine Fever vaccine, ATC vet code:
Cepivo proti klasični prašičji kugi, oznaka ATCvet:
QI09AD04 The active substance stimulates active immunity against Classical Swine Fever (CSF).
Zdravilna učinkovina spodbudi aktivno imunost proti klasični prašičji kugi (KPK).
ed Polysorbate 80 Sorbitan oleate
Polisorbat 80
6.2 Incompatibilities
d Sorbitan oleat
nd Do not mix with any other vaccine or immunological product.
de 6. 2 Glavne inkompatibilnosti
e 6.3 Shelf life
Ne mešajte z drugimi cepivi ali imunološkimi pripravki.
sp 3 years.
n 6. 3 Rok uporabnosti
Shelf life after first broaching the bottle:
pe 3 leta Rok uporabnosti po prvem odpiranju stekleničke:
Su 6.4 Special precautions for storage
us 6. 4 Posebna navodila za shranjevanje
6.5 Nature and composition of immediate packaging
nS 6. 5 Vrsta in vsebina vsebnika
The bottles are packed individually in a carton box. isa
Stekleničke iz stekla 1. hidrolitične skupine ali polietilen tereftalata (PET) po 50 ml za 25 odmerkov, po 100 ml za 50 odmerkov in po 250 ml za 125 odmerkov o Stekleničke so zaprte z zamaškom iz nitrilne gume in zaporko iz aluminija s šifro. ati Stekleničke so pakirane posamezno v zloženkah.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products or
6. 6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi, če obstajajo ris
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements. uth
Vsako neporabljeno zdravilo ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z lokalnimi zahtevami. o uth
Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands tin
5831 AN Boxmeer Nizozemska
MARKETING AUTHORISATION NUMBER(S)
ŠTEVILKA( E) DOVOLJENJ( A) ZA PROMET tin
DATE OF THE FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION r Ma
DATUM PRIDOBITVE/ PODALJŠANJA DOVOLJENJA ZA PROMET r
06/ 2005
06/ 2005 Ma
4/ 17 Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. eu. int/
4/ 17 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. eu. int /
PROHIBITION OF SALE, SUPPLY AND/ OR USE
d PREPOVED PRODAJE, OSKRBE IN/ ALI UPORABE
ed The import, sale, supply and/ or use of Porcilis Pesti is only allowed under the particular conditions established by European Community legislation on the control of CSF (Council Directive 80/ 217/ EEC, as amended).
de Uvoz, prodaja, oskrba in/ ali uporaba Porcilisa Pesti je dovoljena 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
Vsakdo, ki namerava uvažati, prodajati, oskrbovati in/ ali uporabljati zdravilo za
nd must be authorised by the competent authority of the Member State.
n uporabo v veterinarski medicini, mora imeti pooblastilo pristojnega organa v državi članici.
5/ 17 ed
5/ 17 d de n pe us nS DODATEK II
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR isa
IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE o (ZDRAVILNIH UČINKOVIN) IN IMETNIK (I) DOVOLJENJ( A) ZA IZDELAVO ati ZDRAVILA, ODGOVOREN ZA SPROSTITEV SERIJE
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE or
POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE OSKRBE IN UPORABE ris
CONDITIONS OR RESTRICTIONS OF THE MARKETING uth
POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE VARNE IN UČINKOVITE UPORABE o
AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN ZAOSTANKOV ZDRAVILA uth
STATEMENT OF THE MRLs gA tin ker Ma
(MRL) gA tin ker Ma
Manufacturer of the biological active substance:
d Izdelovalec biološke zdravilne učinkovine:
ed Nobilon International BV Exportstraat 39b 5830 AH Boxmeer
de Nobilon International BV Exportstraat 39b 5830 AH Boxmeer
nd The Netherlands
n Nizozemska
or
pe ali
e Intervet International B. V.
Intervet International B. V.
sp Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
us NL- 5831 AN Boxmeer Nizozemska
Su Manufacturer responsible for batch release
nS Izdelovalec, odgovoren za sprostitev serije:
Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer n The Netherlands tio B.
Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer o Nizozemska ati B.