natgillin/translations-raw huggingface dataset:
The concentration of firocoxib required to inhibit 50% of the COX-2 enzyme (i. e., the IC50) is 0.0369 to 0.12 µM, whereas the IC50 for COX-1 is 20.14 to 33.1 µM.
V » in vitro « poskusih s celokupno krvjo konjev, firokoksib izraža 222 do 643- krat večjo selektivnost za COX- 2 kot za COX- 1. koncentracija firokoksiba, ki je potrebna, da se inhibira 50% encima COX- 2 (t. j.
Following oral administration in horses at the recommended dose of 0.1 mg per kg of bodyweight, firocoxib is rapidly absorbed, and the time to maximal concentration (Tmax) is 3.9 (± 4.4) hours.
Po peroralnem dajanju firokoksiba pri konjih v priporočenem odmerku 0, 1 mg na kg telesne teže, se firokoksib hitro absorbira in čas, v katerem je dosežena maksimalna koncentracija (Tmax), je 3, 9 (± 4. 4) ur.
The peak concentration (Cmax) is 0.075 (± 0.033) µg/ ml (equivalent to approximately 0.223 µM), area under the curve (AUC0-24) is 0.96 (± 0.26) µg x hr/ ml, and oral bioavailability is 79 (± 31) percent.
Maksimalna koncentracija (Cmax) je 0, 075 (± 0. 033) µg/ ml (enako kot približno 0. 223 µM), območje pod krivuljo (AUC0- 24) je 0, 96 (± 0. 26) µg x h/ ml in oralna biološka uporabnost je 79 (± 31) procentov.
The elimination half-life (t½) after a single dose is 29.6 (± 7.5) hours and 50.6 hours after 14 days of dosing.
Razpolovni čas eliminacije (t½) po posameznem odmerku je 29, 6 (± 7. 5) ur in 50, 6 ur po 14 dneh odmerjanja.
Titanium dioxide (E 171) Glycerol triacetate Silica, colloidal anhydrous
titanov dioksid (E 171) gliceriltriacetat silicijev dioksid, koloidni, brezvodni magnezijev subkarbonat, težki makrogol 300
4/ 17 Magnesium carbonate, heavy Macrogol 300
6. 2 Glavne inkompatibilnosti
6.2 Incompatibilities
Navedba ni smiselna.
Not applicable.
4/ 16 6. 3 Rok uporabnosti
3 years Shelf life after first opening the syringe:
3 leta Rok uporabnosti po prvem odpiranju stične ovojnine:
Each syringe contains a net weight of 7.32 g of oral paste and is labelled in 100 kg dosing increments.
Vsaka brizga vsebuje 7, 32 g peroralne paste in je označena v skladu s povišanjem odmerkov za vsakih dodatnih 100 kg telesne teže.
Each syringe is packaged in an individual carton box.
Vsaka brizga je pakirana v svojo kartonsko škatlo.
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, če obstajajo
MERIAL 29 avenue Tony Garnier FR-69007 Lyon France.
MERIAL 29 Avenue Tony Garnier FR- 69007 Lyon FRANCIJA.
5/ 17 PROHIBITION OF SALE, SUPPLY AND/ OR USE
PREPOVED PRODAJE, OSKRBE IN/ ALI UPORABE
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 (EMEA) http: // www. emea. europa. eu /
6/ 17 ANNEX II
5/ 16 DODATEK II
STATEMENT OF THE MRLs
NAVEDBA ZDRAVILA (
7/ 17 A.
6/ 16 A.
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN SPROŠČANJE SERIJE
Name and address of the manufacturer responsible for batch release
naslov izdelovalca zdravila, odgovornega za sproščanje serije
4 Chemin de Calquet 31300 Toulouse France
MERIAL 4 chemin du Calquet 31300 TOULOUSE FRANCIJA
In accordance with Council Regulation (EEC) No 2377/ 90, as amended and in accordance with Article 34.4b of Regulation (EC) No 726/ 2004 of 31 March 2004.
726/ 2004 z dne 31. marca 2004.
Firocoxib is included in Annex III of Council Regulation (EEC) No 2377/ 90 in accordance with the following table:
Firokoksib je vključen v Dodatek III Uredbe Sveta (ES) No 2377/ 90 kot je navedeno v tabeli:
Pharmacologically active substance(s)
Farmakološko aktivna snov:
Marker residue
Marker residue
MRLs
Ciljna tkiva
Target tissues
Druge določbe
Other provisions
Firokoksib
Firocoxib Firocoxib
firokoksib
Equidae
ekvidi
Muscle Fat Liver Kidney
mišice maščoba jetra ledvice
Provisional MRLs expire on 1.7.2007
Začasne vrednosti MRL veljajo do 1. 7. 2007
8/ 17 ANNEX III
7/ 16 DODATEK III
10/ 17 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
9/ 16 PODATKI NA ZUNANJI OVOJNINI
EQUIOXX 8.2 mg/ g oral paste for horses.
EQUIOXX 8. 2 mg/ g peroralna pasta za konje
PHARMACEUTICAL FORM
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI
Oral paste.
Firocoxib 8, 2 mg/ g
PACKAGE SIZE
Peroralna pasta.
1 syringe.
1 brizga.
Meat and offal:
Karenca: meso in organi:
Do not use in mares producing milk for human consumption.
26 dni Ni dovoljena uporaba pri živalih v laktaciji, katerih mleko je namenjeno prehrani ljudi.
EXP {month/ year} Once broached, use within 3 months.
EXP {mesec/ leto} Rok uporabnosti po prvem odpiranju stične ovojnine 3 mesece.
MERIAL, 29 avenue Tony Garnier, FR-69007 Lyon, France.
MERIAL, 29 avenue Tony Garnier, FR- 69007 Lyon, FRANCIJA.
Lot {number}
lot{ številka}
12/ 17 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
11/ 16 PODATKI, KI OVOJNINAH
Syringe labelling
MORAJO
1.
BITI
NAME OF THE VETERINARY MEDICINAL PRODUCT
NAVEDENI NA
EQUIOXX 8.2 mg/ g oral paste for horses
Označevanje brizge
QUANTITY OF THE ACTIVE SUBSTANCE(S)
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
KOLIČINA ZDRAVILNE UČINKOVINE (UČINKOVIN)
7.32 g of oral paste
Firocoxib 8. 2 mg/ g
Meat and offal:
Karenca: meso in notranji organi:
EQUIOXX 8.2 mg/ g oral paste for horses
13/ 16 NAVODILO ZA UPORABO EQUIOXX 8. 2 mg/ g peroralna pasta za konje
MERIAL, 4 chemin du Calquet, FR-31300 Toulouse, France.
MERIAL, 4 chemin du Calquet, FR- 31300 Toulouse, FRANCIJA.
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI
Firocoxib 8.2 mg/ g
EQUIOXX 8. 2 mg/ g peroralna pasta za konje
INDICATIONS
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SESTAVIN
Alleviation of pain and inflammation associated with osteoarthritis and reduction of associated lameness in horses.
Firocoxib 8, 2 mg/ g
Oral use.
0. 1 mg firokoksiba na kg telesne mase, enkrat dnevno največ 14 dni.
15/ 17 9.
14/ 16 Peroralna uporaba.
To deliver firocoxib at the appropriate dosage, unlock the knurled ring on the syringe plunger by rotating it ¼ turn and slide it along the plunger shaft to the appropriate dose division for the horse’ s weight.
Za določitev pravega odmerka in da se izognemo prevelikemu odmerjanju, naj bo telesna masa živali čim bolj natančno določena, Primerni odmerek firokoksiba nastavite z obročem na batu brizge tako, da ga zavrtite za ¼ kroga in ga potegnete vzdolž osi bata do primernega razdelka, glede na telesno maso konja.
Keep out of the reach and sight of children.
Zdravilo shranjujete nedosegljivo otrokom.
Replace cap after use.
Za shranjevanje ni posebnih navodil.
Do not use after the expiry date stated on the label.
Po uporabi ponovno namestite pokrovček.
Shelf-life after first opening the syringe:
Ne uporabljajte po preteku roka, ki je označen na ovojnini.
3 months.
Rok uporabnosti po prvem odpiranju stične ovojnine 3 mesece.
Pregnant women should avoid contact with the medicinal product.
Nosečnice naj se izogibajo stika z zdravilom, oziroma naj pri dajanju zdravila nosijo zaščitne rokavice.
16/ 17 Concomitant treatment with molecules displaying action on renal flow (e. g. diuretics) should be subject to clinical monitoring.
15/ 16 Pri sočasnem zdravljenju z učinkovinami, ki vplivajo na delovanje ledvic (npr. diuretiki), je potrebno nadzorovati delovanje le- teh.
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 (EMEA) http: // www. emea. europa. eu /
Firocoxib is a non-steroidal anti-inflammatory drug (NSAID) belonging to the Coxib group, which acts by selective inhibition of cyclooxygenase-2 (COX-2)-mediated prostaglandin synthesis.
Firokoksib je nesteroidno protivnetno zdravilo, ki spada v skupino koksibov in delujejo po mehanizmu selektivne inhibcije sinteze prostaglandina z mediatorjem ciklooksigenazo- 2 (COX- 2).
1/ 2 EU Number
1/ 2 EU številka
Invented name
inovativno
Pharmaceutical Form
farmacevtska
Target Species
ciljna
Route of administration
način dajanja
Packaging
pakiranje
Package Size
karenca
Withdrawal period
živalska vrsta
Canine herpesvirus (F205 strain) antigens 0.3 µg to 1.75 µg*
antigen pasjega
Powder and solvent for emulsion for injection
prašek in
subcutaneous route
subkutano
10 doses
10
1 ml powder + 1 ml solvent
1 ml praška +
Not applicable
µg do 1. 75 µg *
Eurican Herpes 205
antigen pasjega
Canine herpesvirus (F205 strain) antigens 0.3 µg to 1.75 µg*
prašek in
50 doses
50
Canine herpesvirus (F205 strain) antigens 0.3 µg to 1.75 µg*
(sev F205) 0. 3
subcutaneous route
emulzijo za
1 dose
1 ml vehikla
Box of 2 x 1 bottle.
stekelničko
*expressed in µg of
injiciranje
gB glycoproteins
* izraženo v µg gB glikoproteinov
Eurican Herpes 205 contains the active substance canine herpes virus (F205 strain) antigens in a dose of 0.3 to 1.75 µg.
Eurican Herpes 205 vsebuje kot zdravilno učinkovino antigene pasjega herpesvirusa (sev F205) v odmerku od 0, 3 do 1, 75 µg.
The first injection is given either when the bitch is on heat or 7 – 10 days after the date of mating.
Prvo injekcijo damo bodisi v času, ko se psica goni, ali od 7 do 10 dni po datumu parjenja.
When injected, this small exposure helps the dog’ s immune system to synthesize antibodies against the canine herpes virus and to neutralize it.
Pri vbrizganju pride do šibke izpostavitve virusu, ki imunskemu sistemu pomaga pri tvorjenju protiteles proti pasjemu herpesvirusu in s tem tudi pri njegovi nevtralizaciji.
(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 Eurican Herpes 205 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 Eurican Herpes 205 izkazalo med raziskavami?
In the study to show the protection of puppies (from vaccinated bitches) from canine herpes virus, over 80% of the pups from the vaccinated bitches survived..
V raziskavi, katere namen je bil pokazati zaščito mladičev (zaradi cepljenja psic) pred pasjim herpesvirusom, je preživelo več kot 80% mladičev cepljenih psic.
The injection of Eurican Herpes 205 may cause temporary oedema (fluid under the skin) at the injection site in up to 10% of animals.
Injekcija zdravila Eurican Herpes 205 lahko povzroči nastanek začasnega edema (zbiranje tekočine pod kožo) na mestu vbrizganja pri največ 10% živali.
QUALITATIVE AND QUANTITATIVE COMPOSITION
0, 3 do 1, 75 µg * * izraženo v µg gB glikoproteinov
Active substance Per 1-ml dose:
Adjuvans( i):
Canine herpesvirus (F205 strain) antigens............................................. .0.3 to 1.75 µg* *expressed in µg of gB glycoproteins Adjuvant(s) Light paraffin oil...................................................................................................... ..224.8 to 244.1 mg For a full list of excipients, see section 6.1.
224, 8 do 244, 1 mg Celoten seznam pomožnih snovi, glej razdelek 6. 1
Powder and solvent for emulsion for injection
Prašek in vehikel za emulzijo za injiciranje
Active immunisation of bitches to prevent mortality, clinical signs and lesions in puppies resulting from canine herpes virus infections acquired in the first few days of life.
Aktivna imunizacija psic, za preprečevanje smrtnosti, kliničnih znakov in poškodb, ki so posledica okužbe mladičev s pasjim herpesvirusom v prvih dneh življenja.
If pain persists for more than 12 hours after medical examination, seek medical advice again.
2/ 19 Če bolečina ne popusti po 12 urah po zdravniškem pregledu, se ponovno posvetujte z zdravnikom.
2/ 19 To the physician:
Namenjeno zdravniku:
The injection of the vaccine may cause a transient oedema at the site of injection in up to 10% of animals.
Vnos cepiva lahko povzroči nastanek edema prehodnega značaja na mestu injiciranja v desetih odstotkih živali.
Eurican Herpes 205 is specifically indicated during pregnancy.
Eurican Herpes 205 je posebej izdelan za uporabo v času brejosti.
No information is available on the efficacy from the concurrent use of this vaccine with any other product.
Ni podatkov o varnosti ter učinkovitosti ob sočasni uporabi tega cepiva s katerim koli drugim izdelkom.
It is therefore recommended that no other vaccines should be administered within 14 days before or after vaccination with the product.
Zato odsvetujemo uporabo katerega koli cepiva v obdobju 14 dni pred ali po cepljenju s tem izdelkom.
Two 1-ml doses of vaccine, administered by subcutaneous route, according to the following schedule:
Dva 1- ml odmerka cepiva vnesemo v podkožje, po naslednjem razporedu:
Either during heat or 7 – 10 days after the presumed date of mating.
Prva injekcija: ali v času estrusa ali 7 do 10 dni po verjetnem datumu parjenja.
1 to 2 weeks before the expected date of whelping.
1 do 2 tedna pred pričakovano kotitvijo.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
4. 10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če so potrebni)
No undesirable effects other than those observed and mentioned in the “ Adverse reactions” section have been observed after the administration of several doses.
Po vnosu večkratnih odmerkov niso opazili nobenih drugih neželenih učinkov, razen tistih navedenih v odseku „ Neželeni učinki “.
IMMUNOLOGICAL PROPERTIES
5 IMUNOLOŠKE LASTNOSTI
ATCvet code:
ATCvet oznaka:
Purified subunit vaccine for the active immunisation of pregnant bitches to induce the passive protection of puppies against herpesvirus-induced fatal neonatal disease.
Prečiščena podskupina cepiva za aktivno imunizacijo brejih psic in pasivno zaščito mladičev proti smrtnim neonatalnim boleznimm, ki jih povzroča herpes virus.
Sucrose Sorbitol Dextran 40
6. 1 Seznam pomožnih snovi
3/ 19 Casein hydrolysate Collagen hydrolysate Salts Polyoxyethylene fatty acids Ether of fatty alcohols and of polyols Triethanolamine
sahaoza sorbitol dekstran 40 3/ 19 hidrolizirani kazein hidrolizirani kolagen soli polioksietilenske maščobne kisline eter maščobnih kislin in poliolov trietanolamin
Do not mix with any other immunological product except the solvent supplied.
Ne mešajte z nobenim drugim imunološkim pripravkom, razen s priloženim vehiklom
Use immediately after reconstitution.
24 mesecev Uporabite takoj po rekonstituciji
Type I glass bottle containing powder of 1-dose and glass bottle containing 1-ml of solvent.
Steklenička iz stekla tipa I, ki vsebuje 1 odmerek praška in steklenička, ki vsebuje 1 ml vehikla.
The bottles are closed with a butyl elastomer closure and sealed with an aluminium cap Box of 2 x 1 bottle, 2 x 10 bottles and 2 x 50 bottles.
Škatla z 2 x 1 stekleničko, 2 x 10 stekleničkami in 2 x 50 stekleničkami Ni nujno, da so v prometu vsa navedena pakiranja.
MERIAL 29 Avenue Tony Garnier F-69007 Lyon FRANCE
MERIAL 29 Avenue Tony Garnier F- 69007 Lyon FRANCIJA
4/ 19 10 DATE OF REVISION OF THE TEXT
DATUM REVIZIJE BESEDILA
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. eu. int/
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 /
Not applicable.
PREPOVED PRODAJE, OSKRBE IN/ ALI UPORABE Navedba ni smiselna.
5/ 19 ANNEX II
5/ 19 DODATEK II
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC( IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (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 zdravila, odgovornega za sprostitev serije
7/ 19 ANNEX III
7/ 19 DODATEK III
9/ 19 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
9/ 19 PODATKI NA ZUNANJI OVOJNINI
Canine herpesvirus (F205 strain) antigens............................................. .0.3 to 1.75 µg* *expressed in µg of gB glycoproteins Light paraffin oil
v 1- ml odmerku: antigeni pasjega herpesvirusa (sev F205) * izraženo v µg gB glikoproteinov Lahko parafinsko olje
1 dose: powder (1 bottle) + solvent (1 bottle) 50 doses: powder (50 bottles) + solvent (50 bottles)
1 odmerek: prašek (1 steklenička) + vehikel (1 steklenička) 50 odmerkov: prašek (50 stekleničk) + vehikel (50 stekleničk)
Active immunisation of bitches to prevent mortality, clinical signs and lesions in puppies resulting from canine herpes virus infections acquired in the first few days of life.
Aktivna imunizacija psic za preprečevanje smrtnosti, kliničnih znakov in poškodb, ki so posledica okužbe mladičev s pasjim herpesvirusom v prvih dneh življenja.
Accidental injection is dangerous – read the package leaflet before use.
Nenamerno injiciranje je nevarno – pred uporabo glej navodila.
EXP {month/ year} Use immediately after reconstitution.
EXP {mesec/ leto} Uporabite takoj po rekonstituciji
MERIAL 29 Avenue Tony Garnier F-69007 Lyon France
MERIAL 29 Avenue Tony Garnier F- 69007 Lyon FRANCIJA
EU/ 2/ 01/ 029/ 002 50 doses: powder (50 bottles) + solvent (50 bottles) EU/ 2/ 01/ 029/ 003 1 dose: powder (1 bottle) + solvent (1 bottle)
EU/ 2/ 01/ 029/ 002 50 odmerkov: prašek (50 stekleničk) + vehikel (50 stekleničk) EU/ 2/ 01/ 029/ 003 1 odmerek: prašek (1 steklenička) + vehikel (1 steklenička)
11/ 19 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
11/ 19 PODATKI NA ZUNANJI OVOJNINI
Canine herpesvirus (F205 strain) antigens............................................. .0.3 to 1.75 µg* *expressed in µg of gB glycoproteins Light paraffin oil
v 1 ml odmerku: antigeni pasjega herpesvirusa (sev F205) * izraženo v µg gB glikoproteinov Lahko parafinsko olje
10 doses: powder (10 bottles) + solvent (10 bottles)
10 odmerkov: prašek (10 stekleničk) + vehikel (10 stekleničk)
EXP {month/ year} Use immediately after reconstitution.
EXP {mesec/ leto} Uporabite takoj po rekonstituciji.
EU/ 2/ 01/ 029/ 001 10 doses: powder (10 bottles) + solvent (10 bottles)
EU/ 2/ 01/ 029/ 001 10 odmerkov: prašek (10 stekleničk) + vehikel (10 stekleničk)
13/ 19 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
13/ 19 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Withdrawal period:
Karenca: ni smiselna.
14/ 19 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
14/ 19 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
WITHDRAWAL PERIOD
KARENCA( E)
16/ 19 PACKAGE LEAFLET Eurican Herpes 205 powder and solvent for emulsion for injection
16/ 19 NAVODILO ZA UPORABO Eurican Herpes 205, prašek in vehikel za emulzijo za injiciranje
MERIAL, 29 Avenue Tony Garnier, F-69007 Lyon, France
Imetnik dovoljenja za promet z zdravilom MERIAL, 29 Avenue Tony Garnier, F- 69007 Lyon, Francija
MERIAL, Laboratoire Porte des Alpes, Rue de l’ Aviation, F-69800 Saint Priest, France
Ime in naslov izdelovalca zdravila, odgovornega za sprostitev serije MERIAL, Laboratoire Porte des Alpes, Rue de l' Aviation, F- 69800 Saint Priest, Francija
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGE( IH) SNOVI
Canine herpesvirus (F205 strain) antigens............................................. .0.3 to 1.75 µg* *expressed in µg of gB glycoproteins Light paraffin oil
0, 3 do 1, 75 µg * * izraženo v µg gB glikoproteinov Lahko parafinsko olje
Active immunisation of bitches to prevent mortality, clinical signs and lesions in puppies resulting from canine herpes virus infections acquired in the first few days of life.
Aktivna imunizacija psic in posledično preprečevanje smrtnosti, kliničnih znakov in poškodb, ki so posledica okužbe mladičev s pasjim herpesvirusom v prvih dneh življenja.
These are rare and appropriate symptomatic treatment should be administered.
Lahko se pojavijo preobčutljivostne reakcije, ki pa so redke in jih je treba ustrezno simptomatično zdraviti.
The injection of the vaccine may cause a transient oedema at the site of injection in up to 10% of animals.
Vnos cepiva lahko povzroči edem na vbodnem mestu pri 10% živali.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Če opazite kakršnekoli druge stranske učinke, obvestite svojega veterinarja.
Keep out of the reach and sight of children Store in a refrigerator (2 °C – 8 °C).
Shranjujte v hladilniku (2 °C – 8 °C).
Do not use after the expiry date stated on the label.
Uporabite takoj po rekonstituciji Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na nalepki.
• Vaccinate only healthy animals. • Do not mix with any other immunological product except the solvent supplied. • Eurican Herpes 205 is specifically indicated during pregnancy. • No information is available on the efficacy from the concurrent use of this vaccine with any other product.
• Cepite le zdrave živali.. • Ne mešajte z nobenim drugim imunološkim izdelkom, razen s priloženim vehiklom. • Eurican Herpes 205 je posebej izdelan za uporabo v času brejosti. • Ni podatkov o varnosti in učinkovitosti ob sočasni uporabi tega cepiva s katerimkoli drugim izdelkom.
It is therefore recommended that no other vaccines should be administered within 14 days before or after vaccination with the product • No undesirable effects other than those observed and mentioned in the “ Adverse reactions” section have been observed after the administration of several doses. • To the user:
Zato odsvetujemo uporabo kateregakoli cepiva v obdobju 14 dni pred ali po cepljenju s tem izdelkom. • Po vnosu večkratnih odmerkov niso opazili nobenih drugih neželenih učinkov, razen tistih navedenih v odseku „ Neželeni učinki “. • Namenjeno uporabniku:
If pain persists for more than 12 hours after medical examination, seek medical advice again. • To the physician:
Če bolečina ne popusti po 12 urah po zdravniškem pregledu, se ponovno posvetujte z zdravnikom. • Namenjeno zdravniku:
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. eu. int/
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 /
Box of 2 x 1 bottle, 2 x 10 bottles and 2 x 50 bottles.
Šktla s po 2x1 stekleničko, 2x10 stekleničk in 2x50 stekleničk.
Fevaxyn Pentofel contains the following inactivated viruses:
Zdravilo Fevaxyn Pentofel je cepivo za mačke v obliki raztopine za injiciranje v napolnjeni injekcijski brizgi.
Feline Panleukopenia Virus, Feline Rhinotracheitis Virus, Feline Calicivirus, Feline Leukaemia Virus, and the inactivated bacterium Feline Chlamydia psittaci.
Zdravilo Fevaxyn Pentofel vsebuje naslednje inaktivirane viruse: virus mačje panleukopenije, virus mačjega rinotraheitisa, mačji calicivirus, virus mačje leukemije in inaktivirano bakterijo mačje Chlamydia psittaci.
Fevaxyn Pentofel is used to immunise healthy cats of 9 weeks or older against Feline Panleukopenia and Feline Leukaemia and against respiratory diseases caused by Feline Rhinotracheitis virus, Feline Calicivirus and Feline Chlamydia psittaci.
Zdravilo Fevaxyn Pentofel se uporablja za imunizacijo zdravih mačk, starih 9 tednov ali več, proti mačji panleukopeniji in mačji leukemiji ter proti boleznim dihal, ki jih povzročajo virusi mačjega rinotraheitisa, mačji calicivirusi in mačja Chlamydia psittaci.