natgillin/translations-raw huggingface dataset:
One single injection of 0.05 ml per chicken egg at 18 days of embryonation, by in ovo route.
Pri in ovo vnosu - enkratno injiciranje 0, 05 ml pripravljenega cepiva na jajce 18. dan embrionalnega razvoja.
3/ 21 4.9.3 Method of administration
Pot uporabe Cepivo se injicira ali subkutano ali in ovo.
The device should be proven to safely and effectively deliver the appropriate vaccinal dose.
Naprava mora biti preverjeno varna in učinkovita za uporabo, ter mora zagotoviti ustrezno odmerjanje cepiva.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
3/ 20 4. 10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če so potrebni)
ATCvet code QI01AD15
QI01AD15
Live recombinant vaccine against Infectious Bursal Disease and Marek’ s Disease.
Živo rekombinantno cepivo proti bolezni Gumboro in Marekovi bolezni.
The vaccine strain is a recombinant Herpesvirus of turkeys (HVT) expressing the protective antigen (VP2) of the Infectious Bursal Disease Virus (IBDV) strain Faragher 52/ 70.
Sev virusa v cepivu je rekombinantni puranji herpesvirus (HVT), ki izraža zaščitne antigene (VP2) virusa infekcioznega burzitisa (IBDV) sev Faragher 52/ 70.
The vaccine induces an active immunity and a serological response against Infectious Bursal Disease and Marek’ s Disease in chickens.
Cepivo spodbudi aktivno imunost in serološki odgovor proti bolezni Gumboro in Marekovi bolezni pri piščancih.
Dimethyl sulfoxide Dilution medium
zamrznjena suspenzija virusov dimetilsulfoksid razrečilo
Sucrose Casein hydrolysate Phenol red sodium salt Salts
vehikel: saharoza hidrolizat kazeina fenol rdeče, natrijeva sol soli
Use sterile and antiseptic-free and/ or disinfectant-free equipment for injections purposes.
Za injiciranje uporabljajte le sterilne instrumente, brez aseptikov in/ ali dezinficiensov.
Do not mix with any other product except the diluent supplied for use with the product.
Ne mešajte z nobenim drugim pripravkom, razen s priloženim vehiklom.
Shelf-life of the non-reconstituted vaccine:
Rok uporabnosti nerekonstituiranega cepiva:
36 months at – 196°C Shelf-life of the reconstituted vaccine: up to 2 hours at a temperature lower than 25°C.
36 mesecev pri – 196 oC Rok uporabnosti po rekonstituciji: do dve uri pri temperaturi nižji od 25 oC.
Shelf-life of the diluent in polypropylene bottles:
Rok uporabnosti vehikla v polipropilenskih stekleničkah:
12 months at a temperature lower than 30°C.
12 mesecev pri temperaturi nižji od 30 oC.
Shelf-life of the diluent in polyvinylchloride bags:
Rok uporabnosti vehikla v polivinilkloridnih vrečkah:
36 months at a temperature lower than 30°C.
36 mesecev pri temperaturi nižji od 30 oC.
Store the reconstituted vaccine at a temperature lower than 25°C.
Rekonstituirano cepivo hranite pri temperaturi nižji od 25 °C.
Store the diluent at a temperature lower than 30°C, protected from light.
Vehikel shranjujte pri temperaturi nižji od 30 °C, zaščiteno pred svetlobo.
Avoid freezing and excessive temperatures.
Izogibajte se zmrzovanju in previsokim temperaturam.
6.5 Nature and composition of immediate packaging
4/ 20 6. 5 Vrsta ovojnine in vsebina
- (glass) ampoule of 1,000 doses of vaccine, 5-ampoule carrier.
(steklena) ampula s 1, 000 odmerki cepiva, vsebnik za 5 ampul.
Ampoule carriers are stored in canister, and in liquid nitrogen containers.
Vsebniki ampul so shranjeni v pločevinast škatli in v vsebnikih s tekočim dušikom.
- (polypropylene) bottle of 200 ml of diluent.
- (polipropilenski) vsebnik z 200 ml vehikla.
- (polyvinylchloride) bag of 200 ml of diluent
- (polivinilkloridna) vrečka z 200 ml vehikla.
- (polyvinylchloride) bag of 400 ml of diluent
- (polivinilkloridna) vrečka s 400 ml vehikla.
- (polyvinylchloride) bag of 600 ml of diluent
- (polivinilkloridna) vrečka s 600 ml vehikla.
- (polyvinylchloride) bag of 800 ml of diluent
- (polivinilkloridna) vrečka z 800 ml vehikla
- (polyvinylchloride) bag of 1000 ml of diluent
- (polivinilkloridna) vrečka s 1000 ml vehikla
- (polyvinylchloride) bag of 1200 ml of diluent
- (polivinilkloridna) vrečka s 1200 ml vehikla
- (polyvinylchloride) bag of 1400 ml of diluent
- (polivinilkloridna) vrečka s 1400 ml vehikla
- (polyvinylchloride) bag of 1600 ml of diluent
- (polivinilkloridna) vrečka s 1600 ml vehikla
- (polyvinylchloride) bag of 1800 ml of diluent
- (polivinilkloridna) vrečka s 1800 ml vehikla
- (polyvinylchloride) bag of 2400 ml of diluent
- (polivinilkloridna) vrečka s 2400 ml vehikla
Destroy unused vaccine contents.
Uničite neporabljeno vsebino cepiva.
Empty containers or contaminated equipment should be disposed of safely by boiling, incineration or by immersion in an appropriate disinfectant approved by competent authorities.
Prazne vsebnike ali kontaminirano opremo varno odstranite s prekuhavanjem, sežigom ali potopitvijo v ustreznem dezinfekcijskem sredstvu, katerega uporabo odobrijo pristojni organi.
MERIAL 29 Avenue Tony Garnier 69007 LYON, FRANCE
MERIAL 29 avenue Tony Garnier 69007 Lyon Francija
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency, EMEA) http: // www. emea. europa. eu.
6/ 21 ANNEX II
5/ 20 DODATEK II
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK( I) DOVOLJENJ( A) ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROSTITEV SERIJE
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC ZDRAVILNE UČINKOVINE IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROSTITEV SERIJE
Mérial Laboratoire Lyon Gerland, 254 rue Marcel Merieux 69007 Lyon France
MERIAL Laboratory of Lyon Gerland 254 rue Marcel Mérieux 69007 Lyon Francija
Mérial Laboratoire Porte des Alpes Rue de l'Aviation 69800 Saint Priest France
Merial Laboratory of Lyon Porte des Alpes Rue de l' Aviation 69800 Saint Priest Francija
Veterinary medicinal product subject to prescription.
Samo za živali; uporablja se le na podlagi veterinarskega recepta
According to Article 71 of Directive 2001/ 82/ EC of the European Parliament and of the Council, Member States prohibit or may prohibit the import, sale, supply and/ or use of the veterinary medicinal product on the whole or part of their territory if it is established that:
V skladu z 71. členom Direktive 2001/ 82/ ES Evropskega parlamenta in Sveta, države članice prepovejo ali lahko prepovejo uvoz, prodajo, oskrbo in/ ali uporabo zdravila za uporabo v veterinarski medicini na celotnem svojem ozemlju ali delu ozemlja, če se ugotovi da:
the administration of the veterinary medicinal product to animals will interfere with the implementation of national programmes for the diagnosis, control and eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
a) bi uporaba zdravila za uporabo v veterinarski medicini ovirala izvajanje nacionalnih programov diagnosticiranja, nadzora ali zatiranja živalskih bolezni ali da bi povzročila težave pri zagotavljanju, da ne bi prišlo do okužbe živih živali, živil ali drugih proizvodov, ki izvirajo iz zdravljene živali
the disease to which the veterinary medicinal product is intended to confer immunity is largely absent from the territory.
b) bolezen, za katero se z zdravilom za uporabo v veterinarski medicini pridobi imunost, na območju skoraj ni.
Pharmacologically active substance
Farmakološko aktivna učinkovina
Dimethyl sulfoxide
dimetil sulfoksid
Annex II:
Dodatek II: vse živali za proizvodnjo živil
Sodium hydrogen carbonate
natrijev hidrogen karbonat klorovodikova kislina
All food producing species (For use as excipient)
Dodatek II (E500ii) Dodatek II: vse živali za proizvodnjo živil (uporablja se kot pomožna snov)
Casein hydrolysate
hidrolizat kazeina
Peptides and proteins naturally occurring - not within the scope of Council Regulation 2377/ 90.
Naravni peptidi in beljakovine - Ni v sklopu Uredbe Sveta 2377/ 90.
Dipotassium phosphate Potassium dihydrogen
dikalijev fosfat kalijev dihidrogen fosfat (monokalijev fosfat)
Annex II (E340ii) Annex II (E340i)
Dodatek II (E340ii) Dodatek II (E340i)
Water for injections
natrijev hidroksid voda za injiciranje
Not within the scope of Council Regulation 2377/ 90
Dodatek II( E 524) Ni v sklopu Uredbe Sveta 2377/ 90
For the following substances, the data provided by the Applicant were assessed and the substances considered not to be pharmacologically active at the doses used;
Po oceni podatkov, ki jih je predložil predlagatelj, se naslednje snovi v odmerkih, v katerih se jih uporablja, ne smatrajo kot farmakološko aktivne:
F10 HAM Medium 199 medium Phenol red Gentamicin
F10 HAM medij 199 medij Fenol rdeče Gentamicin
9/ 21 ANNEX III
8/ 20 DODATEK III
11/ 21 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
10/ 20 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
{AMPOULE 1000 doses}
AMPULA 1. 000 odmerkov
12/ 21 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE STERILE DILUENT
11/ 20 PODATKI NA STIČNI OZ.
PHARMACEUTICAL FORM
PRIMARNI OVOJNINI
PACKAGE SIZE
STERILNI VEHIKEL
1 bottle of 200 ml
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI
1 bag of 200 ml 1 bag of 400 ml 1 bag of 600 ml.
STERILNi VEHIKEL
1 bag of 800 ml.
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI
1 bag of 1000 ml.
3.
1 bag of 1200 ml.
FARMACEVTSKA OBLIKA
1 bag of 1400 ml.
4.
1 bag of 1600 ml.
VELIKOST PAKIRANJA
1 bag of 2400 ml
1 steklenica s po 200 ml 1 vrečka s po 200 ml 1 vrečka s po 400 ml 1 vrečka s po 600 ml 1 vrečka s po 800 ml 1 vrečka s po 1000 ml 1 vrečka s po 1200 ml 1 vrečka s po 1400 ml 1 vrečka s po 1600 ml 1 vrečka s po 1800 ml 1 vrečka s po 2400 ml
Read the package leaflet enclosed in the vaccine vial before use.
Pred uporabo preberite navodilo, priloženo viali s cepivom.
Store at a temperature lower than 30°C.
Shranjujte pri temperaturi do 30 oC.
Avoid freezing or excessive temperatures.
Izogibajte se zmrzovanju in visokim temperaturam.
For animal treatment only - to be supplied only on veterinary prescription.
Samo za živali; uporablja se le na podlagi veterinarskega recepta
MERIAL 29 Avenue Tony Garnier 69007 Lyon France
MERIAL 29 avenue Tony Garnier 69007 Lyon, FRANCIJA
15/ 21 PACKAGE LEAFLET (VACCINE SUSPENSION) Vaxxitek HVT+IBD
14/ 20 NAVODILO ZA UPORABO Vaxxitek HVT+IBD
Marketing authorisation holder MERIAL 29 Avenue Tony Garnier 69007 Lyon, France
MERIAL 29 avenue Tony Garnier 69007 Lyon FRANCIJA
Manufacturer for batch release MERIAL Laboratory of Lyon Porte des Alpes Rue de l’ Aviation, F-69800 Saint-Priest France
MERIAL Laboratory of Lyon Porte des Alpes Rue de l' Aviation 69800 Saint- Priest FRANCIJA
Suspension:
Suspenzija: - -
3.6 log10 PFU Excipient........................................................................................................................... qs 1 dose Diluent:
3, 6 log10 PFU q. s 1 odmerek
Diluent............................................................................................................................... qs 1 dose
Vehikel q. s 1 odmerek
16/ 21 6.
15/ 20 6.
Subcutaneous route: one single injection of 0.2 ml per chicken at the age of one day.
Pri subkutani uporabi - enkratno injiciranje 0, 2- ml pripravljenega cepiva v podkožje piščanca, starega en dan.
In ovo route: one single injection of 0.05 ml per egg at 18 days of embryonation.
Pri in ovo vnosu - enkratno injiciranje 0, 05 ml pripravljenega cepiva na jajce 18. dan embrionalnega razvoja.
• Wear protective gloves and spectacles during the ampoule thawing and opening operations. • Remove from the liquid nitrogen container only those ampoules which are to be used immediately. • Thaw rapidly the contents of the ampoules by agitation in water at 25-30°C.
Nato takoj nadaljujte z naslednjim korakom.
Proceed immediately to next step. • As soon as they are thawed, open ampoules holding them at arm’ s length in order to prevent any risk of injury should an ampoule break. • Once the ampoule is opened, draw up the contents into a 5 ml sterile syringe. • Transfer the suspension into the diluent (Do not use if cloudy). • Draw up 2 ml of the contents of the diluent into the syringe. • Rinse the ampoule with these 2 ml and then transfer the rinsing liquid into the diluent.
Pri tem jih držite na oddaljenosti dolžine roke, da bi lahko preprečili možnost poškodbe, če bi se ampula zlomila.
Repeat the rinsing operation once or twice.
Ko je ampula odprta, vsebino napolnite v 5- ml sterilno brizgo.
Repeat the thawing, opening, transfer and rinsing operations for the appropriate number of ampoules to be reconstituted in the diluent; either 1 ampoule per 200 ml of diluent for subcutaneous administration, or 4 ampoules per 200 ml of diluent for in ovo administration. • The diluted vaccine prepared as described is mixed by gentle agitation so as to be ready for use.
Odtajanje, odpiranje in izpiranje vsebine ampule z vehiklom ponovite glede na potrebno število ampul, ali 1 ampulo za 200 ml vehikla za vnos v podkožje ali 4 ampule za 200 ml vehikla za vnos in ovo.
It should be used immediately after the preparation (all of the diluted vaccine should be used up within one hour).
Razredčeno cepivo, ki je pripravljeno, kot je bilo opisano, zmešajte z rahlim pretresanjem in že je pripravljeno za uporabo.
This is why the vaccine suspension should only be prepared as and when required
Uporabiti ga je treba takoj po pripravi (celotno količino razredčenega cepiva morate porabiti v eni uri).
11.
16/ 20 11.
Store the vaccine in liquid nitrogen.
Zdravilo shranjujte nedosegljivo otrokom Cepivo shranjujte v tekočem dušiku.
Open ampoules holding them at arm’ s length in order to prevent any risk of injury should an ampoule break.
Ampule odpirajte tako, da jih držite na oddaljenosti dolžine roke, da bi lahko preprečili možnost poškodbe, če bi se ampula zlomila.
Destroy unused vaccine contents.
Uničite neporabljeno cepivo.
Empty containers or contaminated equipment should be disposed of safely, by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.
Prazne vsebnike ali kontaminirano opremo varno odstranite s prekuhavanjem, sežigom ali potopitvijo v ustreznem dezinfekcijskem sredstvu, katerega uporabo odobrijo pristojni organi.
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency, EMEA) http: // www. emea. eu. int /
The vaccine induces an active immunity and a serological response against Infectious Bursal Disease and Marek’ s Disease in chickens.
17/ 20 Cepivo spodbudi aktivno imunost in serološki odgovor proti bolezni Gumboro in Marekovi bolezni pri piščancih.
- (glass) ampoule of 1,000 doses of vaccine, 5-ampoule carrier.
- (steklena) ampula s 1, 000 odmerki cepiva, vsebnik za 5 ampul.
- (polypropylene) bottle of 200 ml of diluent.
- (polipropilenska) steklenica z 200 ml vehikla.
- (polyvinylchloride) bag of 800 ml of diluent
- (polivinilkloridna) vrečka z 800 ml vehikla.
- (polyvinylchloride) bag of 1000 ml of diluent
- (polivinilkloridna) vrečka s 1000 ml vehikla.
- (polyvinylchloride) bag of 1200 ml of diluent
- (polivinilkloridna) vrečka s 1200 ml vehikla.
- (polyvinylchloride) bag of 1400 ml of diluent
- (polivinilkloridna) vrečka s 1400 ml vehikla.
- (polyvinylchloride) bag of 1600 ml of diluent
- (polivinilkloridna) vrečka s 1600 ml vehikla.
- (polyvinylchloride) bag of 1800 ml of diluent
- (polivinilkloridna) vrečka s 1800 ml vehikla.
- (polyvinylchloride) bag of 2400 ml of diluent
- (polivinilkloridna) vrečka s 2400 ml vehikla.
19/ 21 PACKAGE LEAFLET (STERILE DILUENT) STERILE DILUENT
18/ 20 NAVODILO ZA UPORABO STERILNI VEHIKEL
MERIAL 29 avenue Tony Garnier 69007 Lyon, France
Imetnik dovoljenja za promet z zdravilom MERIAL 29 avenue Tony Garnier 69007 Lyon, FRANCIJA
MERIAL Laboratory of Lyon Porte des Alpes Rue de l’ Aviation, F-69800 Saint-Priest France
Izdelovalec odgovoren za sprostitev serije MERIAL, Laboratoire Porte des Alpes Rue de l' Aviation F- 69800 Saint- Priest, FRANCIJA
Read the package leaflet enclosed in the vaccine vial.
Preberite Navodilo za uporabo, ki je priloženo viali s cepivom.
• Wear protective gloves and spectacles during the ampoule thawing and opening operations. • Remove from the liquid nitrogen container only those ampoules which are to be used immediately. • Thaw rapidly the contents of the ampoules by agitation in water at 25-30°C.
Nato takoj nadaljujte z naslednjim korakom. • Ko so ampule odtajane, jih takoj odprite.
Proceed immediately to next step. • As soon as they are thawed, open ampoules holding them at arm’ s length in order to prevent any risk of injury should an ampoule break. • Once the ampoule is opened, draw up the contents into a 5 ml sterile syringe.
19/ 20
20/ 21 • Transfer the suspension into the diluent. • Draw up 2 ml of the contents of the diluent into the syringe. • Rinse the ampoule with these 2 ml and then transfer the rinsing liquid into the diluent.
Odtajanje, odpiranje in izpiranje vsebine ampule z vehiklom ponovite glede na potrebno število ampul, ali 1 ampulo za 200 ml vehikla za vnos v podkožje ali 4 ampule za 200 ml vehikla za vnos in ovo.
Repeat the rinsing operation once or twice. • Repeat the thawing, opening, transfer and rinsing operations for the appropriate number of ampoules to be reconstituted in the diluent; either 1 ampoule per 200 ml of diluent for subcutaneous administration, or 4 ampoules per 200 ml of diluent for in ovo administration. • The diluted vaccine prepared as described is mixed by gentle agitation so as to be ready for use.
Razredčeno cepivo, ki je pripravljeno, kot je bilo opisano, zmešajte z rahlim pretresanjem in že je pripravljeno za uporabo.
Store at a temperature lower than 30°C.
Zdravilo shranjujte nedosegljivo otrokom Shranjujte pri temperaturi nižji od 30 oC.
Avoid freezing or excessive temperatures
Izogibajte se zamrzovanju in prekomernim temperaturam.
Any unused container or waste materials should be disposed of in accordance with the local requirements.
Vsako neporabljeno zdravilo ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z lokalnimi predpisi.
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency, EMEA) http: // www. emea. eu. int /
This diluent may be used with the following products:
Vehikel se lahko uporablja z naslednjimi proizvodi:
QUESTIONS AND ANSWERS ON THE RECOMMENDATION FOR REFUSAL OF A MARKETING AUTHORISATION APPLICATION for VERAFLOX International Non-proprietary Name (INN): pradofloxacin
VPRAŠANJA IN ODGOVORI GLEDE PRIPOROČILA ZA ZAVRNITEV VLOGE ZA DOVOLJENJE ZA PROMET za zdravilo VERAFLOX Mednarodno nelastniško ime (INN): pradofloksacin
On 17 May 2006 the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Veraflox 15 mg, 60 mg & 120 mg Tablets for Cats and Dogs, and Veraflox 25 mg/ ml Oral Suspension for Cats.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je v negativnem mnenju z dne 17. maja 2006 priporočil zavrnitev dovoljenja za promet z zdravilom Veraflox - 15 mg, 60 mg in 120 mg tablete za pse in mačke ter Veraflox - 25 mg/ ml peroralna suspenzija za mačke.
Veraflox Oral Suspension contains 25 mg/ ml pradofloxacin.
Peroralna suspenzija Veraflox vsebuje 25mg/ ml pradofloksacina.
What documentation did the Company present to support its application to the CVMP?
Katero dokumentacijo je podjetje predložilo CVMP v podporo svoji vlogi?
The CVMP was therefore of the opinion that Veraflox’ s benefits had not been shown to be greater than its risks.
CVMP je bil posledično mnenja, da ni bilo dokazano, da bi bile koristi zdravila Veraflox večje od z njim povezanih tveganj.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 47 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged What are the consequences for animals of the refusal for Veraflox?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 47 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kakšne so posledice zavrnitve dovoljenja za promet z zdravilom Veraflox za živali?
Recombinant Omega interferon of feline origin 5 MU1
rekombinantni
Powder and solvent for suspension for injection
Prašek in vehikel
Dogs, Cats
Psi, mačke.
Subcutaneous
Intrakavenska
Powder: vial (glass) Solvent: vial
Praškaste: viala
Powder:
Praškaste:
5 MU1 Solvent:
5
5 vials + 5 vials
uporaba
(glass)
z zamaškom)
Recombinant Omega interferon of feline origin 10 MU1
rekombinantni
Subcutaneous use
Intrakavenska
Powder: vial (glass) Solvent: vial (glass)
Praškaste: viala
10 MU1 Solvent:
10
5 vials + 5 vials
5 viala + 5 viala
N/ A
Omega
Powder and solvent
omega interferon mačjega izvora
Powder: vial
za suspenzijo za
Powder:
uporaba Mačke:
10
10 ME * / vialo
Recombinant Omega interferon
rekombinantni
for suspension for
Prašek in vehikel
Intravenous use
Intrakavenska
(glass) Solvent: vial
Praškaste: viala
MU1 Solvent:
Praškaste:
1 ml
10
2 vials + 2 vials
2 viala + 2 viala
of feline origin
omega interferon mačjega izvora
injection
za suspenzijo za
Cats:
uporaba Mačke:
(glass)
ME *
10 MU1
10 ME * / vialo
Powder: vial (glass)
Praškaste: viala
10 MU1
10
N/ A
ME *
of feline origin 10 MU1
10 ME * / vialo
for suspension for injection
injiciranje.
Cats:
uporaba
Solvent: vial (glass)
Vehikla: viala (steklenička z zamaškom
Solvent:
Vehikla:
1 MU:
* ME:
Million Units
Milijonov Enot
Virbagen Omega contains the active substance recombinant omega interferon of feline origin (from cats) at 5 MU/ vial or 10 MU/ vial.
Zdravilo Vibragen Omega vsebuje zdravilno učinkovino rekombinantni omega interferon mačjega izvora v količini 5 ME/ vialo ali 10 ME/ vialo.
Virbagen Omega is also used to treat cats infected with FeLV (feline leukaemia virus) and/ or FIV (feline immunodeficiency virus), in non-terminal cats from the age of 9 weeks.
Zdravilo Vibragen Omega se uporablja tudi za zdravljenje mačk okuženih s FeLV (virus mačje levkemije) in/ ali FIV (virusa mačje imunske pomanjkljivosti) pri mačkah, ki niso v stadiju pred smrtjo in so stare 9 tednov ali več.
The suspension should be injected intravenously (into a vein) once daily for 3 consecutive days.
Suspenzijo morate vbrizgati intravensko (v veno) enkrat dnevno 3 dni zapored.
The dose is 2.5 MU/ kg bodyweight.
Odmerek znaša 2, 5 ME/ kg telesne teže.
The suspension should be injected subcutaneously (under the skin) once daily for 5 consecutive days.
Suspenzijo morate vbrizgati subkutano (pod kožo) enkrat dnevno 5 dni zapored.
The dose is 1 MU/ kg bodyweight.
Odmerek znaša 1 ME/ kg telesne teže.
The active substance of Virbagen Omega, omega interferon, is produced by a method known as ‘ recombinant technology’.
Zdravilna učinkovina zdravila Virbagen Omega je omega interferon, ki se proizvaja z metodo imenovano "tehnologija rekombinantne DNA".
Virbagen Omega 2.5 MU/ kg was given intravenously for 3 days.
Zdravilo Vibragen Omega 2, 5 ME/ kg so dajali intravensko 3 dni.
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