FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME OF THE MEDICINAL PRODUCT Dynepo 10,000 IU/0.5 ml solution for injection in a prefilled syringe Epoetin delta
Slovenian: Dynepo 10.000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi epoetin delta
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Pre-filled syringe containing 8,000 IU per 0.4 ml dose (20,000 IU/ml) of the active substance epoetin delta.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena napolnjena injekcijska brizga vsebuje 8.000 i.e. učinkovine, epoetina delta, na 0,4 ml odmerek
English: However your haemoglobin level should not consistently exceed 12 g/dl.
Slovenian: Občasno so lahko posamezne vrednosti hemoglobina nad ali pod to priporočeno ciljno koncentracijo, vendar ne smejo biti stalno nad 12 g/dl.
English: Epoetin delta
Slovenian: SHRANJEVANJE DYNEPA
English: Dose should be decreased by 25 % - 50 % or treatment temporarily withdrawn and then re-introduced with a lower dosage if: - Haemoglobin reaches ≥ 12 g/dl or - The rate of increase of haemoglobin > 2 g/dl in any 4 week period.
Slovenian: Odmerek je treba zmanjšati za 25% - 50% ali pa zdravljenje začasno prekiniti in nato znova uvesti z
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Pre-filled syringe containing 5,000 IU per 0.5 ml dose (10,000 IU/ml) of the active substance epoetin delta.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena napolnjena injekcijska brizga vsebuje 5.000 i.e. učinkovine, epoetina delta, na 0,5 ml odmerek
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Pre-filled syringe containing 1,000 IU per 0.5 ml dose (2,000 IU/ml) of the active substance epoetin delta.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena napolnjena injekcijska brizga vsebuje 1.000 i.e. učinkovine, epoetina delta, na 0,5 ml odmerek
English: In very rare cases (<1/100,000), hypersensitivity can be observed.
Slovenian: V zelo redkih primerih (< 1/100000) so opazili preobčutljivostne reakcije.
English: Do not mix with any other vaccine or immunological product.
Slovenian: Ne mešajte z nobenim drugim cepivom ali imunološkim izdelkom.
English: Mineral oil (Marcol 52)
Slovenian: Mineralno olje (Marcol 52)
English: Use sterile syringes and needles.
Slovenian: Uporabljajte sterilne brizge in igle.
English: Polysorbate 80 (Tween 80)
Slovenian: Polisorbat 80 (Tween 80)
English: * CCID50 - the quantity of virus, which infects 50 % of the cell cultures inoculated.
Slovenian: * CCID50 = količina virusa, ki inficira 50 % inokuliranih celičnih kultur
English: a) the administration of the product to animals will interfere with the implementation of a national programme for the diagnosis, control or 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.
Slovenian: a) bi uporaba zdravila ovirala izvajanje nacionalnih programov za diagnozo, nadzora ali zatiranja živalskih bolezni ali da bi povzročila težave pri zagotavljanju odsotnosti okuženosti pri živih živalih ali živilih ali drugih proizvodov, pridobljenih iz zdravljenih živali.
English: Date of last renewal: 22/08/2008
Slovenian: Datum podaljšanja dovoljenja za promet: 22/08/2008
English: One dose of 2 ml contains:
Slovenian: En odmerek (2 ml) vsebuje:
English: MARKETING AUTHORISATION NUMBER(S) EU/2/98/009/001-006
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET EU/2/98/009/001-006
English: Wash and disinfect hands and equipment after use.
Slovenian: Po dajanju si operite in razkužite roke in opremo.
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary Apart from an increase in the extent of the tissue reaction at the site of injection, no other undesirable effects have been observed.
Slovenian: 4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) Razen lokalne reakcije na mestu dajanja, ni bilo opaziti nobenih drugih neželenih učinkov.
English: Can be used during pregnancy and lactation.
Slovenian: Lahko se uporablja v času brejosti in laktacije.
English: • Inject one dose per gilt before the first mating, or
Slovenian: • Injicirajte en odmerek na mladico pred prvim parjenjem, ali
English: Mannide mono oleate (Arlacel A)
Slovenian: Manidijev monooleat (Arlacel A)
English: Excipient: Thiomersal
Slovenian: Pomožne snovi: Tiomersal
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 07/08/1998
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 07/08/1998
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Powder:
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA
English: The presence of maternal antibodies against Aujeszky's disease virus may have a negative influence on the result of vaccination.
Slovenian: Prisotnost maternalnih protiteles proti Aujeszkyjevi bolezni lahko negativno učinkuje na rezultat cepljenja.
English: For the full list of excipients, see section 6.1.
Slovenian: 0,15 mg Za celoten seznam pomožnih snovi, glejte poglavje 6.1.
English: Disodiumhydrogenphosphate Sodiumhydrogenphosphate Mannitol
Slovenian: Dinatrijev hidrogenfosfat Natrijev hidrogenfosfat Manitol
English: MANUFACTURER'S BATCH NUMBER Lot: {number} for the powder:
Slovenian: IZDELOVALČEVA ŠTEVILKA SERIJE Lot:{številka} za prašek:
English: Shelf-life after reconstitution according to directions: 1 hour.
Slovenian: Rok uporabnosti po rekonstituciji v skladu z navodili: 1 ura.
English: Each piglet of vaccinated gilts or sows should ingest a sufficient quantity of colostrum and milk.
Slovenian: Vsak novorojeni pujsek cepljene svinje ali mladice naj dobi določeno količino kolostruma in mleka.
English: Apart from an increase in the extent of the tissue reaction at the site of injection, no other undesirable effects have been observed.
Slovenian: Razen lokalne reakcije na mestu dajanja, ni bilo opaziti nobenih drugih neželenih učinkov.
English: 17 µl
Slovenian: 17 μl
English: 7-ml vials of Type I hydrolytic glass containing 10, 50 or 100 doses of freeze-dried powder.
Slovenian: 7 ml viala iz hidrolitičnega stekla (tip I), ki vsebuje 10, 50 ali 100 odmerkov liofiliziranega praška.
English: CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 10 doses
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV 10 odmerkov
English: Therefore, the product is suitable to be used in eradication programmes against Aujeszky's disease field virus in pigs based on the presence or absence of antibodies against the gE-antigen of that virus.
Slovenian: Tako je pripravek primeren za uporabo za program eradikacije proti virusom Aujeszkyjeve bolezni pri prašičih, temelječ na prisotnosti ali odsotnosti specifičnih protiteles proti gE-antigenu tega virusa.
English: In general these reactions disappear within 3 weeks after the first vaccination.
Slovenian: Na splošno ta oteklina izgine v 3 tednih po prvem cepljenju.
English: The immunity lasts for 3 months after basic vaccination.
Slovenian: Imunost traja 3 mesece po osnovnem cepljenju.
English: If you are accidentally injected with this veterinary medicinal product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you.
Slovenian: Če vam je bilo to zdravilo nenamerno injicirano, se takoj posvetujte z zdravnikom, čeprav je bila injicirana le majhna količina, in mu pokažite navodila za uporabo.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton label 1 x 10 doses, 1 x 50 doses, 1 x 100 doses, 10 x 10 doses, 10 x 50 doses, 10 x 100 doses
Slovenian: Kartonska nalepka 1 x 10 odmerkov, 1 x 50 odmerkov, 1 x 100 odmerkov, 10 x 10 odmerkov, 10 x 50 odmerkov, 10 x 100 odmerkov
English: Re-vaccination of breeding pigs (gilts, sows and boars):
Slovenian: Re-vakcinacija plemenskih prašičev (mladic, svinj in merjascev):
English: 425 µl,
Slovenian: 425 μl
English: The bottles are closed with a butyl rubber stopper and sealed with an aluminium cap.
Slovenian: Stekleničke so zaprte z gumijastim zamaškom iz butila, zaščitenim z aluminijasto kapico.
English: Aluminium hydroxide, Mineral oil (Marcol 52), Mannide mono oleate (Arlacel A), Polysorbate 80 (Tween 80), Thiomersal.
Slovenian: Aluminijev hidroksid, mineralno olje (Marcol 52), manidijev monooleat (Arlacel A), polisorbat 80 (Tween 80), tiomersal
English: A second dose may be injected 3-4 weeks after the first injection.
Slovenian: Naslednji odmerek aplicirajte 3-4 tedne po prvem cepljenju.
English: 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.
Slovenian: Potreben je strokoven, TAKOJŠEN, kirurški poseg, ter morda tudi takojšnja incizija in izpiranje injiciranega mesta, zlasti če so prizadete tudi kite ali mehka tkiva prsta.
English: For whole herd vaccination, an injection of one dose may be administered per gilt, sow and boar every 4 months.
Slovenian: Za cepljenje cele črede se priporoča injicirati po en odmerek na mladico, svinjo in merjasca vsake 4
English: To reconstitute the vaccine, inject 3 ml of solvent into the small vial with the powder.
Slovenian: Za rekonstitucijo cepiva injicirajte 3 ml vehikla v vialo s praškom.
English: Basic vaccination of fattening pigs and breeding pigs (gilts, sows and boars):
Slovenian: Osnovno cepljenje prašičev pitancev in plemenskih prašičev (mladic, svinj in merjascev):
English: SPECIAL WARNING(S) Accidental injection is dangerous - see package insert before use.
Slovenian: POSEBNO(A) OPOZORILO(A) Nenamerno injiciranje je nevarno - pred uporabo preberite priložena navodila.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER SUBSTANCE(S)
Slovenian: NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGIH SESTAVIN
English: The vials are closed with a butyl rubber stopper and sealed with an aluminium cap.
Slovenian: Viale so zaprte z gumijastim zamaškom iz butila, zaščitenim z aluminijasto kapico.
English: • Inject one dose per fattening pig from the age of 10 weeks.
Slovenian: • Z enim odmerkom cepiva cepite prašiče pitance pri starosti 10 tednov.
English: 46 µl,
Slovenian: 46 μl
English: Any person intending to manufacture, import, possess, sell, supply and use Suvaxyn Aujeszky 783 + O/W must consult the relevant Member State's competent authority on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use.
Slovenian: Vsakdo, ki namerava izdelovati, uvažati oziroma vnašati, posedovati, prodajati, oskrbovati in/ali uporabljati Suvaxyn Aujeszky 783 + O/W, se mora posvetovati s pristojnim organom posamezne države članice o veljavnih programih cepljenja še pred izdelavo, uvozom oziroma vnosom, posedovanjem, prodajo, oskrbo in/ali uporabo.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Live attenuated Aujeszky's disease virus
Slovenian: KOLIČINA ZDRAVILNE(IH) UČINKOVIN(E) Živ, atenuiran virus Aujeszkyjeve bolezni
English: SPECIAL STORAGE CONDITIONS Store and transport refrigerated (2 ºC - 8 ºC).
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte in prevažajte v hladilniku (2 °C - 8 °C).
English: Zoetis Belgium SA Teл: +359 2 4775791
Slovenian: Република България Zoetis Belgium SA Teл: +359 2 4775791
English: Shake gently to dissolve the vaccine and transfer the dissolved vaccine into the vial with the solvent.
Slovenian: Nežno pretresite, da se cepivo raztopi in prenesite raztopljeno cepivo nazaj v stekleničko z vehiklom.
English: Progeny of vaccinated gilts and sows derive a passive immunity via the colostrum and milk.
Slovenian: Potomci cepljenih svinj razvijejo pasivno imunost preko kolostruma in mleka.
English: BATCH NUMBER Lot {number}
Slovenian: ŠTEVILKA SERIJE Lot {številka}:
English: Cardboard box with 1 vial of powder and 1 bottle of solvent or 10 vials of powder and 10 bottles of solvent for injection.
Slovenian: Kartonska škatla z 1 vialo praška in 1 stekleničko vehikla ali z 10 vialami s praškom in 10 stekleničkami vehikla.
English: For intramuscular use.
Slovenian: Za intramuskularno dajanje.
English: Shelf-life of the veterinary medicinal product as packaged for sale (powder): 2 years.
Slovenian: Rok uporabnosti zdravila v pakiranju za prodajo (prašek): 2 leti.
English: INDICATION(S) Active and passive immunisation of pigs against Aujeszky's disease.
Slovenian: INDIKACIJE Aktivna in pasivna imunizacija prašičev proti Aujeszkyjevi bolezni.
English: Lot: {number} for the solvent:
Slovenian: Lot:{številka} za vehikel:
English: 20 ml, 100 ml or 200 ml bottles of Type I hydrolytic glass containing solvent for the 10-doses, 50doses or 100-doses presentation or Type II glass rinsed with WFI containing solvent for the 50-doses and 100-doses presentation.
Slovenian: 20 ml, 100 ml ali 200 ml stekleničke iz hidrolitičnega stekla (tip I), ki vsebujejo vehikel za 10, 50 ali 100 odmerkov cepiva ali iz stekla (tip II), ki so sprane z vodo za injekcije in vsebujejo vehikel za 50 in 100 odmerkov cepiva .
English: The manufacture, import, possession, sale, supply and/or use of Suvaxyn Aujeszky 783 + O/W may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Slovenian: Izdelava, uvoz/vnos, posedovanje, prodaja, oskrba in/ali uporaba Suvaxyn Aujeszky 783 + O/W je lahko v državi članici prepovedana na njenem celotnem ozemlju ali delu ozemlja v skladu z nacionalno zakonodajo.
English: Aluminium hydroxide Mineral oil (Marcol 52) Mannide mono oleate (Arlacel A) Polysorbate 80 (Tween 80) Thiomersal
Slovenian: Mineralno olje (Marcol 52) Manidijev monooleat (Arlacel A) Polisorbat 80 (Tween 80) Tiomersal
English: Manufacturer responsible for the batch release: Zoetis Manufacturing & Research Spain, S.L.
Slovenian: Izdelovalec, odgovoren za sproščanje serij: Zoetis Manufacturing & Research Spain, S.L.
English: Shelf-life of the veterinary medicinal product as packaged for sale (solvent): 2 years.
Slovenian: Rok uporabnosti zdravila v pakiranju za prodajo (vehikel): 2 leti.
English: Administer by intramuscular injection of 1 dose (2 ml) per pig in the neck in the area behind the ear.
Slovenian: En odmerek (2 ml) na prašiča aplicirajte intramuskularno v vratni predel za ušesom.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intramuscular use of 1 dose (2 ml) per pig.
Slovenian: NAČIN IN POT UPORABE 1 odmerek (2 ml) na prašiča apliciramo intramuskularno.
English: 100 doses
Slovenian: 100 odmerkov
English: EXPIRY DATE EXP {month/year}
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP{ mesec/leto}
English: By reconstitution of the immunogen in the oil emulsion, the stimulation of immunity after injection is prolonged.
Slovenian: Po predhodni rekonstituciji zdravilne učinkovine v oljno emulzijo, se po injiciranju prolongira stimulacija imunosti.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC BIOLOŠKE ZDRAVILNIH UČINKOVIN IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
English: The active substance stimulates active immunity against Aujeszky's disease in pigs.
Slovenian: Zdravilna učinkovina povzroči nastanek aktivne imunosti proti Aujeszkyjevi bolezni pri prašičih.
English: Slight, transient and local reactions up to 2 cm in diameter after first vaccination and up to 5 cm after second vaccination may occur up to 50 % of the pigs.
Slovenian: Pri približno 50 % živali se lahko po cepljenju pokaže škodljiva reakcija v obliki 2 cm velike otekline po prvem cepljenju in 5 cm velike otekline po drugem cepljenju.
English: Use within one hour after reconstitution.
Slovenian: Po rekonstituciji je uporabno 1 uro.
English: • Inject one dose per gilt or sow during each gestation at 3-6 weeks before the expected date of farrowing.
Slovenian: • Injicirajte en odmerek na mladico ali svinjo v obdobju 3-6 tednov pred pričakovano gonitvijo • Injicirajte en odmerek na merjasca najmanj vsakih 6 mesecev.
English: Name and address of the manufacturers of the biological active substances Zoetis Manufacturing & Research Spain, S.L.
Slovenian: Ime in naslov izdelovalca biološke zdravilne učinkovine (zdravilnih učinkovin): Zoetis Manufacturing & Research Spain, S.L.
English: Powder for emulsion for injection:
Slovenian: Prašek za pripravo emulzije za injiciranje:
English: 4.2 Indications for use, specifying the target species Active immunisation of pigs from the age of 10 weeks to prevent the mortality and clinical signs of Aujeszky's disease and to reduce the excretion of Aujeszky's disease field virus.
Slovenian: 4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Aktivna imunizacija prašičev, starih 10 tednov z namenom zmanjšanja pogina in klinične manifestacije zaradi Aujeszkyjeve bolezni ter za redukcijo prisotnosti virusa Aujeszkyjeve bolezni v okolju.
English: - Active immunity: The onset of immunity is from 3 weeks after basic vaccination.
Slovenian: - Aktivna imunost: Razvije se v 3 tednih po cepljenju.
English: The gE- (glycoprotein E negative) characteristic of the vaccine virus makes it possible to distinguish between antibodies induced by vaccination with this product and those induced by field infection with Aujeszky's disease virus, if the vaccine is used in association with an appropriate diagnostic test.
Slovenian: gE- (Glikoprotein E negativen) je značilen za cepivo in se odlikuje ravno v tem, da omogoča s specifičnim diagnostičnim testom potrditev prisotnosti protiteles, nastalih zaradi cepljenja in izključitev protiteles, pridobljenih z okužbo virusov Aujeszkyjeve bolezni iz okolja.
English: MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: IZDELOVALEC BIOLOŠKE ZDRAVILNIH UČINKOVIN IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
English: Name and address of the manufacturers responsible for batch release Zoetis Manufacturing & Research Spain, S.L.
Slovenian: Ime in naslov izdelovalca zdravila, odgovornega za sproščanje serije: Zoetis Manufacturing & Research Spain, S.L.
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Slovenian: NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) Učinkovina biološkega izvora namenjena vzbujanju aktivne imunosti, ni vključena v Uredbo(ES) št. Pomožne snovi (vključno z dodatki), navedene v poglavju 6.1.
English: ANNEX III LABELLING AND PACKAGE INSERT
Slovenian: OZNAČEVANJE IN NAVODILO ZA UPORABO
English: Solvent for emulsion for injection:
Slovenian: Vehikel za pripravo emulzije za injiciranje:
English: ATCvet code: QI09 AD01.
Slovenian: Farmakoterapevtska skupina: Oznaka ATCvet: QI 09 AD 01
English: 1 vial with powder for injection (10 doses) and 1 bottle of solvent for injection (20 ml).
Slovenian: 1 prebodna viala s praškom (10 odmerkov) in 1 prebodna steklenička z vehiklom (20 ml).
English: A transient increase in body temperature, up to about 40,5 oC and lasting for up to 2 days, may occur in a small number of pigs after vaccination.
Slovenian: Pri manjšem številu cepljenih živali lahko naraste telesna temperatura do 40,5 ˚C.
English: Active immunisation of pigs from the age of 10 weeks to prevent the mortality and clinical signs of Aujeszky's disease and to reduce the excretion of Aujeszky's disease field virus.
Slovenian: Aktivna imunizacija prašičev, starih 10 tednov z namenom zmanjšanja pogina in klinične manifestacije zaradi Aujeszkyjeve bolezni ter za redukcijo prisotnosti virusa Aujeszkyjeve bolezni v okolju.
English: ROUTE OF ADMINISTRATION For intramuscular use.
Slovenian: POT UPORABE ZDRAVILA Za intramuskularno dajanje.
English: PHARMACEUTICAL FORM Powder and solvent for emulsion for injection
Slovenian: Prašek in vehikel za pripravo emulzije za injiciranje
English: 20 ml 100 ml 200 ml
Slovenian: 200 ml
English: 10 vials with powder for injection (each containing 100 doses) and 10 bottles of solvent for injection (each containing 200 ml).
Slovenian: 10 prebodnih vial s praškom (v vsaki je 100 odmerkov) in 10 prebodnih stekleničk z vehiklom (vsaka vsebuje 200 ml)
English: 10 vials with powder for injection (each containing 50 doses) and 10 bottles of solvent for injection (each containing 100 ml).
Slovenian: 10 prebodnih vial s praškom (v vsaki je 50 odmerkov) in 10 prebodnih stekleničk z vehiklom (vsaka vsebuje 100 ml)
English: Live attenuated Aujeszky's disease virus, strain NIA3-783: ≥ 105.2 CCID50* per 2 ml dose of reconstituted emulsion.
Slovenian: Živ, atenuiran virus Aujeszkyjeve bolezni, sev NIA3-783: ≥105.2.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Slovenian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo Po dajanju si operite in razkužite roke in opremo.
English: Shelf life after reconstitution: Use within one hour.
Slovenian: Rok uporabe po rekonstituciji: 1 ura.
English: Passive immunisation of piglets from vaccinated gilts and sows to reduce mortality and clinical signs of Aujeszky's disease and to reduce the excretion of Aujeszky's disease field virus.
Slovenian: Pasivna imunizacija pujskov, katerih matere so bile cepljene, z namenom zmanjšanja pogina in manifestacije kliničnih znakov zaradi Aujeszkyjeve bolezni in za zmanjšanje prisotnosti virusa v okolju.
English: To avoid foaming, shake gently the vial after reconstitution of the freeze-dried component in the liquid component.
Slovenian: Da preprečite penjenje, pretresite raztopljeni prašek v vehiklu zelo nežno.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Suvaxyn Aujeszky 783 + O/W, solvent for injection for pigs
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Suvaxyn Aujeszky 783 + O/W, vehikel za pripravo emulzije za injiciranje Za prašiče.
English: PACKAGE LEAFLET Suvaxyn Aujeszky 783 + O/W, powder and solvent for emulsion for injection for pigs
Slovenian: Suvaxyn Aujeszky 783 + O/W, prašek in vehikel za pripravo emulzije za injiciranje za prašiče
English: SPECIAL STORAGE PRECAUTIONS Keep out of the sight and reach of children.
Slovenian: Shranjujte nedosegljivo otrokom.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vials for the powder: 10 doses, 50 doses, 100 doses
Slovenian: Viala za prašek: 10 odmerkov, 50 odmerkov, 100 odmerkov 1.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottles for the solvent: 10 doses, 50 doses, 100 doses
Slovenian: Steklenička z vehiklom: 10 odmerkov, 50 odmerkov, 100 odmerkov 1.
English: One dose (2 ml) of reconstituted emulsion containing ≥ 105.2 CCID50 of live attenuated Aujeszky's disease virus strain NIA3-783 for each pig.
Slovenian: Živ, atenuiran virus Aujeszkyjeve bolezni, sev NIA3-783: 105.2.
English: SCIENTIFIC CONCLUSIONS FOR AMENDMENT OF PRODUCT INFORMATION
Slovenian: ZNANSTVENI ZAKLJUČKI ZA DOPOLNILO DOVOLJENJA ZA PROMET
English: The CHMP confirmed changes to the Product Information already introduced through a type II variation adopted in April 2005 further to the February USR and requested further changes.
Slovenian: CHMP je potrdil spremembe informacij o zdravilu, že vnešene z variacijo tipa II, sprejeto aprila 2005, po februarskem nujnem varnostnem ukrepu in zahteval še nadaljnje spremembe.
English: Further to the assessment of the data on serious skin reactions, parecoxib is associated with very rare occurrence of serious skin reactions, as evidenced in post-marketing surveillance.
Slovenian: Po vrednotenju podatkov o hudih kožnih reakcijah je parekoksib povezan z zelo redkim pojavljanjem hudih kožnih reakcij, kakor je razvidno iz postmarketinškega nadzora.
English: Further to a request from the European Commission, the scope of the ongoing class review was broadened to include the assessment of serious skin reactions in addition to the cardiovascular safety aspects.
Slovenian: Na zahtevo Evropske komisije se je obseg revizije skupine zdravil v teku še razširil, tako da poleg vidikov kardiovaskularne varnosti zajema tudi vrednotenje hudih kožnih reakcij.