FrancophonIA/ELRC3.0 huggingface dataset:
English: VIBATIV 250 mg powder for concentrate for solution for infusion VIBATIV 750 mg powder for concentrate for solution for infusion telavancin This medicine is subject to additional monitoring.
Slovenian: VIBATIV 250 mg prašek za koncentrat za raztopino za infundiranje VIBATIV 750 mg prašek za koncentrat za raztopino za infundiranje telavancin
English: Preparation of the reconstituted concentrate (VIBATIV 250 mg vial) The contents of the vial containing 250 mg telavancin must be reconstituted with 15 ml of either dextrose 50 mg/ml (5%) solution for injection, or water for injections or sodium chloride 9 mg/ml
Slovenian: Priprava rekonstituiranega koncentrata (VIBATIV 250 mg viala) Vsebino viale z 250 mg telavancina morate rekonstituirati s 15 ml raztopine dekstroze 50 mg/ml (5 %) za injiciranje ali vode za injekcije ali raztopine natrijevega klorida 9 mg/ml (0,9 %) za injiciranje, da pridobite koncentracijo približno 15 mg/ml (skupen volumen približno 17 ml).
English: deafness
Slovenian: naglušnost
English: 1 vial (multidose)
Slovenian: 1 viala (večodmerna)
English: 3-O-desacyl-4'- monophosphoryl lipid A (MPL)
Slovenian: 3-O-desacil-4'- monofosforil lipid A (MPL)3
English: 1Human Papillomavirus = HPV adjuvanted by AS04 containing:
Slovenian: humani virus papiloma = HPV 2z adjuvansom AS04, ki vsebuje:
English: --1 1 dose (0.5 ml) contains: Human Papillomavirus1 type 16 L1 protein2,3,4
Slovenian: --1 1 odmerek (0,5 ml) vsebuje: L1 protein2,3,4 genotipa 16 humanega virusa papiloma1
English: 4L1 protein in the form of non-infectious virus-like particles (VLPs) produced by recombinant DNA technology using a Baculovirus expression system which uses Hi-5 Rix4446 cells derived from Trichoplusia ni.
Slovenian: 50 mikrogramov adsorbiran na hidratirani aluminijev hidroksid (Al(OH)3) 0,5 miligrama Al v celoti L1 protein v obliki nekužnih virusu podobnih delcev (VLPs, “virus-like particles”), pridobljenih s tehnologijo rekombinantne DNA s pomočjo bakulovirusnega ekspresijskega sistema na osnovi Hi-5 Rix4446 celic, pridobljenih iz Trichoplusia ni.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/04/043/001
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET EU/2/04/043/001
English: In very rare cases depression may develop.
Slovenian: Zelo redko se lahko razvije depresija.
English: The frequency of adverse reactions is defined using the following convention:
Slovenian: Pogostnost neželenih učinkov je določena po naslednjem dogovoru:
English: Basic vaccination performed during an outbreak is not efficacious, because immunity is insufficient until basic vaccination has been completed.
Slovenian: Osnovno cepljenje med izbruhom okužbe ni učinkovito, ker je imunost nezadostna, dokler osnovno cepljenje ni zaključeno.
English: An additional antibiotic treatment should be considered for safety reasons.
Slovenian: Iz varnostnih razlogov je treba presoditi o dodatnem antibiotičnem zdravljenju.
English: The sensitivity of the vaccine strain to antibiotics is listed above (under section 4.4).
Slovenian: Občutljivost cepnega seva za antibiotike je navedena zgoraj (v poglavju 4.4).
English: Do NOT shake.
Slovenian: NE stresajte.
English: It is recommended that all horses stabled together are vaccinated.
Slovenian: Priporočljivo je cepiti vse konje, ki so skupaj uhlevljeni.
English: DATE OF FIRST AUTHORISATION Date of first authorization: 07.05.2004 Date of last renewal: 10.04.2014
Slovenian: Datum prve odobritve dovoljenja za promet: 7. maj 2004 Datum zadnje obnovitve:
English: PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable.
Slovenian: DATUM REVIZIJE BESEDILA PREPOVED PRODAJE, OSKRBE IN/ALI UPORABE Navedba ni smiselna.
English: Do not use antibiotics within one week after vaccination.
Slovenian: Ne uporabite antbiotikov v enem tednu po cepljenju.
English: Special precautions for use in animals Only healthy horses should be vaccinated.
Slovenian: Posebni previdnostni ukrepi za uporabo pri živalih Cepimo samo zdrave konje.
English: Purpura haemorrhagica has not been observed in any of the safety studies performed during development of Equilis StrepE.
Slovenian: Hemoragične purpure niso zasledili v nobeni študiji varnosti, izvedeni med razvojem Equilisa StrepE.
English: The reaction is maximal at 2-3 days post vaccination with a maximum area of 3 cm by 8 cm.
Slovenian: Reakcija je največja 2 do 3 dni po cepljenju in ima največjo površino 3 krat 8 cm.
English: The duration of immunity is up to 3 months.
Slovenian: Imunost traja do 3 mesece.
English: The sensitivity of the vaccine strain to antibiotics is listed above.
Slovenian: Občutljivost cepnega seva za antibiotike je navedena zgoraj.
English: In the challenge studies performed by the company, insufficient protection was seen in approximately one quarter of horses vaccinated with the recommended dose.
Slovenian: V provokacijskih študijah, ki jih je opravila družba, so ugotovili nezadostno zaščito pri približno eni četrtini konj, ki so jih cepili s priporočenim odmerkom.
English: From literature, it is known that a very low number of horses may develop purpura haemorrhagica if they are vaccinated shortly after infection.
Slovenian: Iz literature je znano, da se pri zelo majhnem številu konj lahko razvije hemoragična purpura, če so cepljeni kmalu po okužbi.
English: Revaccination: Revaccinate every three months to maintain immunity.
Slovenian: Revakcinacija: Revakciniramo vsake tri mesece, da ohranimo imunost.
English: This swelling resolves completely within 3 weeks and normally has no effect on the appetite of the vaccinated animal and causes no apparent discomfort.
Slovenian: V 3 tednih ta oteklina povsem mine in običajno ne vpliva na apetit cepljene živali niti ne povzroča vidnega nelagodja.
English: Special care must be taken when connecting the applicator to the needle to avoid needle-stick injuries.
Slovenian: Posebno je treba paziti pri nameščanju aplikatorja na iglo, da ne pride do vboda z iglo.
English: Allow the sterile solvent to reach room temperature (15-25 °C).
Slovenian: Počakajte, da se sterilni vehikel ogreje na sobno temperaturo (15-25 °C).
English: After reconstitution use within 4 hours.
Slovenian: Po rekonstituciji uporabite v 4 urah.
English: 10 x 1 dose of vaccine 10 x 1 dose of solvent 10 applicators 10 syringes with needle
Slovenian: 10 x 1 odmerek cepiva 10 x 1 odmerek vehikla 10 aplikatorjev 10 brizg z iglo
English: As the incidence of purpura haemorrhagica is very low, its occurrence cannot be ruled out completely.
Slovenian: Ker pa je hemoragična purpura zelo redka, njenega pojava ne moremo povsem izključiti.
English: The vaccine is intended for use in horses for which a risk of Streptococcus equi infection has been clearly identified, due to contact with horses from areas where this pathogen is known to be present, e.g. stables with horses that travel to shows and/or competitions in such areas, or stables that obtain or have livery horses from such areas.
Slovenian: Cepivo je namenjeno za uporabo pri konjih, pri katerih je nevarnost okužbe s Streptococcusom equi jasno razpoznana, ker so bili v stiku s konji iz območij, za katera je znano, da je na njih prisoten ta povzročitelj, npr. hlevi s konji, ki jih vozijo na razstave ali tekmovanja na takšna območja, ali hlevi, kjer sprejemajo ali imajo v oskrbi konje s takšnih območij.
English: Allow the reconstituted vaccine to sit for 1 minute and then carefully swirl the contents to mix.
Slovenian: Rekonstituirano cepivo naj 1 minuto počaka, potem pa vsebino previdno obračajte, da se zmeša.
English: For the full list of excipients, see section 6.1.
Slovenian: Pomožne snovi Za celoten seznam pomožnih snovi glejte poglavje 6.1.
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Slovenian: Na voljo je malo podatkov o varnosti in učinkovitosti tega cepiva ob sočasni uporabi s katerim koli drugim zdravilom za uporabo v veterinarski medicini.
English: Lyophilisate for suspension for injection
Slovenian: Liofilizat za suspenzijo za injiciranje
English: 6.5 Nature and composition of immediate packaging Each package of Equilis StrepE contains: 10 vials with lyophilisate and 10 vials of 0.5 ml solvent, each in 3 ml Type I glass vials closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap, 10 applicators, 10 syringes with needle.
Slovenian: Eno pakiranje Equilisa StrepE vsebuje: 10 vial z liofilizatom in 10 vial z 0,5 ml vehikla v 3mililitrskih vialah iz stekla tipa I, zaprtih z zamaški iz umetne gume in zaporka iz aluminija s šifro; 10
English: In case of accidental self-injection, seek medical advice immediately and show the package insert or the label to the physician even if only a very small amount is injected.
Slovenian: V primeru nenamernega samo-injiciranja se takoj posvetujte z zdravnikom in mu pokažite navodilo za uporabo ali ovojnino, tudi če je bila injicirana le zelo majhna količina.
English: Pharmacotherapeutic group: immunological for equidae, live bacterial vaccine, ATCvet code: QI05AE.
Slovenian: Farmakoterapevtska skupina: imunološko zdravilo za ekvide: živo bakterijsko cepivo Oznaka ATCvet: QI05AE
English: Withdraw 0.2 ml of the reconstituted vaccine into the syringe provided (see Figure 1) and connect the applicator to the needle (see Figure 2).
Slovenian: S priloženo brizgo odvzemite 0,2 ml rekonstituiranega cepiva (glejte sliko 1) in na iglo namestite aplikator (glejte sliko 2).
English: Do not mix with any other veterinary medicinal products except the solvent supplied for use with the vaccine.
Slovenian: Ne mešajte z nobenim drugim zdravilom za uporabo v veterinarski medicini, razen z vehiklom, ki je priložen cepivu.
English: Accidental self-injection may result in an inflammatory reaction with severe pain and swelling.
Slovenian: Nenamerno samoinjiciranje lahko povzroči vnetno reakcijo s hudo bolečino in oteklino.
English: To stimulate immunity against Streptococcus equi.
Slovenian: Za vzbujanje imunosti proti Streptococcusu equi
English: The vaccine strain is sensitive to penicillins, tetracyclines, macrolides and lincomycin.
Slovenian: Cepni sev je občutljiv za peniciline, tetracikline, makrolide in linkomicin.
English: For any information about this veterinary medicinal product, please contact the marketing authorization holder.
Slovenian: Za vse nadaljnje informacije o tem zdravilu se obrnite na krajevno predstavništvo imetnika dovoljenja za promet z zdravilom.
English: In very rare cases an abscess may develop at the injection site or in the regional lymph nodes.
Slovenian: Zelo redko se lahko na mestu vboda ali v regionalnih limfnih vozlih razvije absces.
English: Equilis StrepE - solvent
Slovenian: Equilis StrepE - vehikel
English: The vaccine strain is resistant to aminoglycosides, sulphonamides, flumequine and trimetroprim-sulfa combinations.
Slovenian: Cepni sev je odporen proti aminoglikozidom, sulfonamidom, flumekvinu in kombinacijam trimetoprima in sulfametoksazola.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Slovenian: Evropske agencije za zdravila (European Medicines Agency) http://www.ema.europa.eu/.
English: Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Slovenian: Rok uporabnosti zdravila za uporabo v veterinarski medicini v pakiranju za prodajo: 3 leta
English: Shedding of the vaccine strain from the injection site can be observed for a period of four days after vaccination.
Slovenian: Izločanje cepnega seva iz mesta injiciranja je mogoče opaziti štiri dni po cepljenju.
English: Solvent: This medicinal product does not require any special storage conditions.
Slovenian: Vehikel: Posebne razmere za shranjevanje niso potrebne.
English: PACKAGE SIZE 10 x 1 dose
Slovenian: 10 x 1 odmerek
English: Shelf life after reconstitution according to directions: 4 hours.
Slovenian: Rok uporabnosti po rekonstituciji v skladu z navodili: 4 ure.
English: In addition to the clinical signs given under section 4.6, vaccination with a ten times overdose may induce an abscess in one of the submandibular lymph nodes.
Slovenian: Poleg kliničnih znakov, ki so opisani v poglavju 4.6, lahko cepljenje z 10-krat prevelikim odmerkom povzroči tudi absces submandibularnega limfnega vozla.
English: Ensure that the lyophilisate is completely reconstituted before use.
Slovenian: Pred uporabo preverite, da je liofilizat povsem rekonstituiran.
English: Intervet International B.V. Wim de Körverstraat 35 NL - 5831 AN Boxmeer The Netherlands
Slovenian: Wim de Körverstraat 35 NL - 5831 AN Boxmeer Nizozemska
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Equilis StrepE
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI
English: ADVICE ON CORRECT ADMINISTRATION
Slovenian: NASVET O PRAVILNI UPORABI ZRAVILA
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC BIOLOŠKE AKTIVNE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROSTITEV SERIJE
English: This medicinal product does not require any special storage conditions.
Slovenian: Posebne razmere za shranjevanje niso potrebne.
English: − common (more than 1 but less than 10 animals in 100 animals)
Slovenian: - pogosti (pojavijo se pri več kot 1 toda pri manj kot 10 živalih od 100 živali)
English: 4.2 Indications for use, specifying the target species For immunisation of horses against Streptococcus equi to reduce clinical signs and occurrence of lymph node abscesses.
Slovenian: 4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Imunizacija konjev proti Streptococcusu equi za zmanjšanje kliničnih znakov in nastanka abscesov limfnih vozlov.
English: The abscesses drain purulent material from 2 weeks after vaccination, but heal without intervention within a month thereafter.
Slovenian: Iz abscesa se 2 tedna po cepljenju izloča gnojen izcedek, nato se v enem mesecu brez intervencije zaceli.
English: For immunisation of horses against Streptococcus equi to reduce clinical signs and occurrence of lymph node abscesses.
Slovenian: Imunizacija konjev proti Streptococcusu equi za zmanjšanje kliničnih znakov in nastanka abscesov limfnih vozlov.
English: Live deletion mutant Streptococcus equi strain TW928 109.0 to 109.4 cfu
Slovenian: Živi delecijski mutant seva Streptococcus equi TW928 109,0 do 109,4 CFU1
English: − very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)
Slovenian: - zelo pogosti (pojavijo se pri več kot 1 živali od 10 živali v teku enega zdravljenja)
English: However, the bacterial compounds of this product can cause an inflammatory reaction with intense and painful swelling after accidental injection.
Slovenian: Toda bakterijske spojine v proizvodu lahko v primeru nenamernega injiciranja povzročijo vnetno reakcijo z močno in bolečo oteklino.
English: THE WORDS "FOR ANIMAL TREATMENT ONLY"
Slovenian: BESEDILO ''SAMO ZA ŽIVALI''
English: Slight apathy may occasionally be observed one day after vaccination.
Slovenian: Občasno se lahko naslednji dan po cepljenju pojavi blaga apatija.
English: The vaccine organism may establish a small suppurative inflammation locally at the injection site, leading to a disruption of the overlaying lip mucosa and subsequent discharge fluid and inflammatory cells.
Slovenian: Na mestu vboda lahko cepni mikroorganizem povzroči manjše lokalno gnojno vnetje, zaradi katerega lahko pride do razkroja sluznice ustnice nad mestom vboda ter izločanja tekočine in vnetnih celic.
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Slovenian: (EU) št.37/2010 določa, da MRL ni potreben ali pa, kot so uporabljene v tem zdravilu za uporabo v veterinarski medicini, niso vključene v Uredbo(ES) št. 470/2009.
English: This product contains a live auxotrophic deletion mutant Streptococcus equi vaccine strain with attenuated virulence.
Slovenian: Zdravilo vsebuje živi avksotrofni delecijski mutant cepnega seva Streptococcusa equi z oslabljeno virulenco.
English: In rare cases, inappetence, fever, shivering and diffuse oedematous swellings (e.g. facial oedema, swollen muzzle/upper lip) may be observed.
Slovenian: Redko lahko zasledimo anoreksijo, vročino, tresenje in difuzne edematozne otekline (npr. facialni edem, otekel gobec/ gornja ustnica).
English: CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 1 dose
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV
English: This product contains a live bacterial deletion mutant with a limited growth potential in mammalian tissue.
Slovenian: Zdravilo vsebuje živi bakterijski delecijski mutant z omejenim potencialom za rast v tkivu sesalcev.
English: It is able to multiply locally at the submucosal injection site during a short period and is shed into the oro-nasal cavity during a few days, but the vaccine strain does not survive on the oro-nasal mucosa and does not disseminate systemically at the recommended dose.
Slovenian: Na mestu submukoznega injiciranja se lahko krajši čas lokalno razmnožuje in nekaj dni širi v ustno in nosno votlino, vendar na sluznici ustne in nosne votline ne preživi in se pri uporabi priporočenega odmerka ne širi v organizem.
English: Restrain the animal's head, lift the upper lip and insert the needle into the inside of the upper lip until the applicator rests on the lip. Administer the whole contents of the syringe into the inside of the upper lip (see Figure 3).
Slovenian: Konju zadržite glavo, dvignite zgornjo ustnico in iglo vbodite na notranji strani zgornje ustnice tako globoko, da se aplikator dotakne njene površine.
English: Lyophilisate: Store in a refrigerator (2 °C - 8 °C).
Slovenian: Liofilizat: Shranjujte v hladilniku (2 °C-8 °C).
English: Vaccination scheme:
Slovenian: Revakcinacija:
English: Basic vaccination: Horses from 4 months of age onwards receive two vaccinations of one dose with a 4 week interval.
Slovenian: Shema cepljenja: Osnovno cepljenje: konje od 4 mesecev starosti dalje cepimo dvakrat s po enim odmerkom s 4
English: PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection Lyophilisate: off-white or cream-coloured pellet Solvent: clear colourless solution
Slovenian: Liofilizat in vehikel za suspenzijo za injiciranje Liofilizat: peleta belkaste ali krem barve Vehikel: bistra brezbarvna raztopina
English: Onset of immunity: 2 weeks after basic vaccination.
Slovenian: Imunost se razvije dva tedna po osnovnem cepljenju.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Per dose of 0.2 ml vaccine:
Slovenian: V odmerku po 0,2 ml cepiva:
English: The vaccine strain is a deletion mutant with a limited growth potential in mammalian tissue.
Slovenian: Cepni sev je delecijski mutant z omejeno potencialno rastjo v tkivu sesalcev.
English: Anti-inflammatory therapy is indicated even if only a very small amount of the product in injected.
Slovenian: Čeprav je bila injicirana le zelo majhna količina proizvoda, je indicirana protivnetna terapija.
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: C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN ZAOSTANKOV ZDRAVILA (MRL) Učinkovina biološkega izvora, namenjena vzbujanju imunosti, ni vključena v Uredbo(ES) št.
English: Therefore only a single dose of vaccine is needed to restore immunity.
Slovenian: Imunski odziv na osnovno cepljenje se ohrani do šest mesecev, zato je za obnovitev imunosti potreben samo en odmerek cepiva.
English: DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION Submucosal vaccination of 0.2 ml of reconstituted product.
Slovenian: 4.9 Odmerjanje in pot uporabe Submukozno cepljenje z 0,2 ml rekonstituiranega cepiva.
English: Furthermore, an increase in rectal temperature up to 2.5 °C may occur on the day of vaccination.
Slovenian: Na dan cepljenja se lahko za največ 2,5 °C poveča rektalna temperatura.
English: Aseptically reconstitute the freezedried vaccine with 0.3 ml of the sterile solvent provided.
Slovenian: Aseptično rekonstituirajte liofilizirano cepivo z 0,3 ml priloženega sterilnega vehikla.
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCTS OR WASTE MATERIALS
Slovenian: POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEPORABLJENEGA ZDRAVILA ALI ODPADNIH SNOVI
English: MARKETING AUTHORISATION HOLDER
Slovenian: DATUM PRIDOBITVE DOVOLJENJA ZA PROMET
English: Aseptically reconstitute the lyophilisate with 0.3 ml of the sterile solvent provided.
Slovenian: Liofilizat aseptično rekonstituirajte z 0,3 ml priloženega sterilnega vehikla.
English: THE WORDS "KEEP OUT OF THE SIGHT AND REACH OF CHILDREN"
Slovenian: BESEDILO ''ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM''
English: ROUTE OF ADMINISTRATION See package leaflet.
Slovenian: POT UPORABE ZDRAVILA Glejte priloženo navodilo.
English: After vaccination a diffusely swollen reaction, which may be warm or painful, develops at the injection site within 4 hours.
Slovenian: Po cepljenju se na mestu vboda v 4 urah pojavi reakcija v obliki difuzne otekline, ki je lahko topla ali boleča.
English: Use during pregnancy, lactation or lay: Do not use in pregnant or lactating mares.
Slovenian: 4.7 Uporaba v obdobju brejosti, laktacije ali nesnosti Ne uporabite pri brejih kobilah ali kobilah v obdobju laktacije.
English: Further, an increase in rectal temperature up to 2 °C may occur on the day of vaccination.
Slovenian: Na dan cepljenja se lahko za največ 2 °C poveča rektalna temperatura.
English: QUANTITY OF THE ACTIVE SUBSTANCE Live Streptococcus equi.
Slovenian: Živi Streptococcus equi
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCE 0.2 ml dose:
Slovenian: V odmerku po 0,2 ml:
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Equilis StrepE, lyophilisate for suspension for injection, for horses
Slovenian: Equilis StrepE, liofilizat za suspenzijo za injiciranje, za konje
English: THE WORDS "KEEP OUT OF THE SIGHT AND REACH OF CHILDREN" Keep out of the sight and reach of children.
Slovenian: BESEDILO ''ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM'' Zdravilo shranjujte nedosegljivo otrokom.
English: PARTICULARS TO APPEAR ON THE INNER BOX WITH LYOPHILISATE
Slovenian: Za dajanje submukozno na notranjo stran zgornje ustnice
English: Lyophilisate: off-white or cream coloured pellet Solvent: clear colourless solution
Slovenian: 1 Colony forming units - kolonijske enote Liofilizat: peleta belkaste ali krem barve Vehikel: bistra brezbarvna raztopina
English: PACKAGE LEAFLET FOR: Equilis StrepE, lyophilisate and solvent for suspension for injection, for horses
Slovenian: Equilis StrepE, liofilizat in vehikel za suspenzijo za injiciranje, za konje
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST REVISED Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Slovenian: Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani
English: ROUTE OF ADMINISTRATION For submucosal use.
Slovenian: Za submukozno uporabo
English: Marketing authorization holder and manufacturer responsible for batch release: Intervet International B.V.
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec, odgovoren za sprostitev serije Intervet International B.V.
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi
English: Slight enlargements, which may be transient painful, of the retropharyngeal and mandibular lymph nodes may occur for a few days after vaccination.
Slovenian: Nekaj dni po cepljenju so lahko blago povečani retrofaringealni in mandibularni limfni vozli, kar lahko spremlja prehodna bolečina.