FrancophonIA/ELRC3.0 huggingface dataset:
English: 4.8 Interaction with other medicinal products and other forms of interaction
Bulgarian: Interaktion med andre lægemidler og andre former for interaktion
English: Horses
Bulgarian: Heste
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Per dose of 0.2 ml vaccine:
Bulgarian: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Pr. dosis af 0,2 ml vaccine:
English: PHARMACEUTICAL FORM
Bulgarian: LÆGEMIDDELFORM
English: 4.7 Use during pregnancy, lactation or lay
Bulgarian: 4.7 Anvendelse under drægtighed, laktation eller æglægning
English: SPECIAL WARNING(S), IF NECESSARY
Bulgarian: SÆRLIG(E) ADVARSEL/ADVARSLER, OM NØDVENDIGT
English: 10 x 1 dose of vaccine 10 x 1 dose of solvent 10 applicators 10 syringes with needle
Bulgarian: 10 x 1 dosis vaccine 10 x 1 dosis solvens 10 applikator 10 sprøjter med nåle
English: Special precautions for use in animals
Bulgarian: Særlige forsigtighedsregler vedrørende brug til dyr
English: In very rare cases an abscess may develop at the injection site or in the regional lymph nodes.
Bulgarian: I meget sjældne tilfælde kan der udvikles abscesser på injektionsstedet eller i de lokale lymfeknuder.
English: Shelf life after reconstitution according to directions: 4 hours.
Bulgarian: Opbevaringstid efter rekonstituering ifølge anvisning: 4 timer.
English: Slight enlargements, which may be transient painful, of the retropharyngeal and mandibular lymph nodes may occur for a few days after vaccination.
Bulgarian: Lette forstørrelser af de retropharyngeale og mandibulære lymfeknuder, som kan være midlertidigt smertefulde, kan forekomme nogle få dage efter vaccinationerne.
English: Accidental self-injection may result in an inflammatory reaction with severe pain and swelling.
Bulgarian: Uforsætlig selvinjektion kan medføre en inflammatorisk reaktion med alvorlig smerte og hævelse.
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.
Bulgarian: I tilfælde af selvinjektion skal der straks søges lægehjælp og indlægssedlen eller etiketten bør vises til lægen, også selvom det kun drejer
English: ADVICE ON CORRECT ADMINISTRATION
Bulgarian: OPLYSNINGER OM KORREKT ANVENDELSE
English: SPECIAL STORAGE CONDITIONS
Bulgarian: SÆRLIGE OPBEVARINGSBETINGELSER
English: Slight apathy may occasionally be observed one day after vaccination.
Bulgarian: Lettere sløvhed ses lejlighedsvis dagen efter vaccination.
English: The vaccine strain is resistant to aminoglycosides, sulphonamides, flumequine and trimetroprim-sulfa combinations.
Bulgarian: Vaccinestammen er resistens overfor aminoglycocider, sulphonamider, flumequin og trimetroprimsulfa kombinationer.
English: QUANTITY OF THE ACTIVE SUBSTANCE Live Streptococcus equi.
Bulgarian: MÆNGDEN AF AKTIVT STOF (AKTIVE STOFFER) Levende Streptococcus equi
English: BATCH NUMBER Batch {number}
Bulgarian: BATCHNUMMER Batch {nummer}
English: Submucosal vaccination with 0.2 ml of reconstituted product.
Bulgarian: Submukøs vaccination med 0,2 ml opløst produkt.
English: Revaccination: Revaccinate every three months to maintain immunity.
Bulgarian: Revaccination: Revaccinér hver 3.
English: Live deletion mutant Streptococcus equi strain TW928 109.0 to 109.4 cfu
Bulgarian: Levende deletions-mutant Streptococcus equi stamme TW928 109,0 til 109,4 cfu1
English: MARKETING AUTHORISATION HOLDER
Bulgarian: INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN
English: Use during pregnancy, lactation or lay: Do not use in pregnant or lactating mares.
Bulgarian: Brug under drægtighed eller laktation: Bør ikke anvendes til drægtige eller lakterende hopper.
English: 4.6 Adverse reactions (frequency and seriousness)
Bulgarian: 4.6 Bivirkninger (forekomst og sværhedsgrad)
English: Further, an increase in rectal temperature up to 2 °C may occur on the day of vaccination.
Bulgarian: Endvidere kan den rektale temperatur stige med op til 2°C på vaccinationsdagen.
English: PACKAGE SIZE
Bulgarian: PAKNINGSSTØRRELSE
English: Special precautions for use in animals Only healthy horses should be vaccinated.
Bulgarian: til brug hos dyr: Kun raske heste bør vaccineres.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Bulgarian: FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: Figure 3
Bulgarian: Figur 3
English: Equilis StrepE - solvent
Bulgarian: SOLVENS NAVN Equilis StrepE - solvens
English: The abscesses drain purulent material from 2 weeks after vaccination, but heal without intervention within a month thereafter.
Bulgarian: Der løber pus fra bylden i to uger efter vaccination, men den heles uden behandling inden for en måned herefter.
English: Lyophilisate: off-white or cream coloured pellet Solvent: clear colourless solution
Bulgarian: Lyofilisat: Råhvid eller cremefarvet pellet Solvens: Klar farveløs opløsning
English: Figure 1
Bulgarian: Figur 1
English: Onset of immunity: 2 weeks after basic vaccination.
Bulgarian: Immunitetens indtræden: 2 uger efter basisvaccination.
English: MANUFACTURER'S BATCH NUMBER Batch {number}
Bulgarian: FREMSTILLERENS BATCHNUMMER Batch {nummer}
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.
Bulgarian: 10 hætteglas med lyofilisat og 10 hætteglas med 0,5 ml solvens, alle i 3 ml hætteglas af Type I glas, lukket med en halogenobutyl gummiprop
English: INDICATION
Bulgarian: INDIKATIONER
English: This product contains a live bacterial deletion mutant with a limited growth potential in mammalian tissue.
Bulgarian: Dette produkt indeholder en levende bakteriel deletions-mutant med begrænset vækstpotentiale i væv hos pattedyr.
English: Figure 2
Bulgarian: Figur 2
English: CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 1 dose
Bulgarian: PAKNINGSSTØRRELSE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER
English: WITHDRAWAL PERIOD Withdrawal period: zero days.
Bulgarian: TILBAGEHOLDELSESTID Tilbageholdelsestid: 0 dage.
English: ROUTE OF ADMINISTRATION For submucosal use.
Bulgarian: INDGIVELSESVEJ(E) Til submukøs anvendelse.
English: NAO-1 stabiliser
Bulgarian: NAO-1-stabilisator Vand til injektionsvæsker
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Bulgarian: Ikke anvendte veterinærlægemidler, samt affald heraf bør destrueres i henhold til lokale retningslinier.
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Bulgarian: ingen oplysninger om sikkerhed og virkning ved brug af vaccinen
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Bulgarian: Særlige forholdsregler der skal træffes af personer, der administrerer lægemidlet
English: For any information about this veterinary medicinal product, please contact the marketing authorization holder.
Bulgarian: De bedes kontakte indehaveren af markedsføringstilladelsen, hvis De ønsker yderligere oplysninger om dette lægemiddel.
English: Pharmacotherapeutic group: immunological for equidae, live bacterial vaccine, ATCvet code: QI05AE.
Bulgarian: til heste: levende bakteriel vaccine ATCvet-kode: QI05 AE
English: A slight cloudy discharge commonly occurs from the mucosal injection site at 3 or 4 days post vaccination.
Bulgarian: Et lettere uklart eksudat ses almindeligvis fra injektionsstedet på slimhinden på 3. eller 4. dagen efter vaccination.
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).
Bulgarian: Træk 0,2 ml opløst vaccine op med den vedlagte sprøjte (se figur 1) og sæt applikatoren på kanylen (se figur 2).
English: After vaccination a diffusely swollen reaction, which may be warm or painful, develops at the injection site within 4 hours.
Bulgarian: Efter vaccination dannes der indenfor 4 timer en diffus hævelse, der kan være varm eller smertefuld, på injektionsstedet.
English: 4.5 Special precautions for use
Bulgarian: 4.5 Særlige forsigtighedsregler vedrørende brugen
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCE 0.2 ml dose:
Bulgarian: ANGIVELSE AF AKTIV STOFFER OG ANDRE STOFFER 0,2 ml dosis:
English: In the challenge studies performed by the company, insufficient protection was seen in approximately one quarter of horses vaccinated with the recommended dose.
Bulgarian: I de challenge studier, der er udført af firmaet, fandtes utilstrækkelig beskyttelse hos ca.
English: Anti-inflammatory therapy is indicated even if only a very small amount of the product in injected.
Bulgarian: selv om kun en lille mængde af produktet er injiceret.
English: To the physician:
Bulgarian: Til lægen:
English: − very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)
Bulgarian: som: - Meget almindelig (mere end 1 ud af 10 dyr, der viser bivirkninger
English: Basic vaccination: Horses from 4 months of age onwards receive two vaccinations of one dose with a 4 week interval.
Bulgarian: Vaccinationsprogram: Basisvaccination: Heste fra 4 måneder vaccineres to gange med én dosis med 4 ugers mellemrum.
English: 4.4 Special warnings
Bulgarian: 4.4 Særlige advarsler
English: In rare cases, inappetence, fever, shivering and diffuse oedematous swellings (e.g. facial oedema, swollen muzzle/upper lip) may be observed.
Bulgarian: I sjældne tilfælde kan der observeres appetitløshed, feber, kulderystelser og spredte ødematøse hævelser (f.eks.
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.
Bulgarian: Vaccineorganismen kan skabe et lille betændt område på injektionsstedet, hvilket forårsager en erosion af læbens slimhinde med efterfølgende udskillelse af væske og inflammatoriske celler.
English: For immunisation of horses against Streptococcus equi to reduce clinical signs and occurrence of lymph node abscesses.
Bulgarian: Til immunisering af heste mod Streptococcus equi for at reducere kliniske symptomer og forekomst af lymfeknudeabscesser.
English: The vaccine strain is a deletion mutant with a limited growth potential in mammalian tissue.
Bulgarian: Vaccinestammen er en deletions-mutant med begrænset vækstpotientale i væv hos pattedyr.
English: Name and address of the manufacturer of the biological active substance Intervet International B.V.
Bulgarian: Navn og adresse på fremstilleren af det biologisk aktive stof Intervet International B.V.
English: THE WORDS "FOR ANIMAL TREATMENT ONLY"
Bulgarian: TEKSTEN “TIL DYR”
English: Lyophilisate for suspension for injection
Bulgarian: til injektionsvæske, suspension
English: Solvent: This medicinal product does not require any special storage conditions.
Bulgarian: Beskyttes mod lys. Solvens: Ingen særlige forholdsregler vedrørende opbevaringen.
English: − rare (more than 1 but less than 10 animals in 10,000 animals)
Bulgarian: i løbet af en behandling) - Almindelige (mere end 1, men mindre end 10 dyr i 100 dyr) - Ualmindelige (mere end 1, men mindre end 10 dyr i 1.000 dyr) - Sjældne (mere end 1, men mindre end 10 dyr ud af 10.000 dyr) - Meget sjælden (mindre end 1 dyr ud af 10.000 dyr, herunder isolerede rapporter)
English: WITHDRAWAL PERIOD Zero days.
Bulgarian: TILBAGEHOLDELSESTID 0 dage.
English: PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection Lyophilisate: off-white or cream-coloured pellet Solvent: clear colourless solution
Bulgarian: Lyofilisat og solvens til injektionsvæske, suspension Lyofilisat: Råhvid eller cremefarvet pellet Solvens: Klar farveløs opløsning
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Equilis StrepE
Bulgarian: VETERINÆRLÆGEMIDLETS NAVN Equilis StrepE
English: The frequency of adverse reactions is defined using the following convention:
Bulgarian: Hyppigheden af bivirkninger er defineret
English: Do not use in pregnant or lactating mares.
Bulgarian: ikke anvendes til drægtige eller lakterende hopper.
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator (2 °C - 8 °C).
Bulgarian: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i køleskab (2°C - 8°C).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton box
Bulgarian: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDERKARTON
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.
Bulgarian: ikke det vaccinerede dyrs appetit og forårsager intet tydeligt ubehag.
English: 6.1 List of excipients
Bulgarian: 6.1 Fortegnelse over hjælpestoffer
English: After reconstitution use within 4 hours.
Bulgarian: Opløst vaccine bør anvendes inden for 4 timer.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Equilis StrepE - solvent
Bulgarian: VETERINÆRLÆGEMIDLETS NAVN Equilis StrepE - solvens
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.
Bulgarian: Aktiv substans som principielt er af biologisk oprindelse hvis formål er at producere aktiv immunitet falder
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.
Bulgarian: ikke er påkrævet eller som ikke anses for at være omfattet af Forordning (EF) nr. 470/2009, når de anvendes i et veterinærlægemiddel.
English: PARTICULARS TO APPEAR ON THE INNER BOX WITH SOLVENT
Bulgarian: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE MED SOLVENS
English: Special care must be taken when connecting the applicator to the needle to avoid needle-stick injuries.
Bulgarian: Når man anbringer applikatoren på kanylen, skal der udvises særlig forsigtighed for at undgå
English: Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Bulgarian: Opbevaringstid for veterinærlægemidlet i salgspakning: 3 år. Opbevaringstid efter rekonstituering ifølge anvisning: 4 timer.
English: An additional antibiotic treatment should be considered for safety reasons.
Bulgarian: sikkerhedsgrunde skal en supplerende antibiotisk behandling overvejes. Vaccinestammens følsomhed over for antibiotika er nævnt ovenfor.
English: Aseptically reconstitute the lyophilisate with 0.3 ml of the sterile solvent provided.
Bulgarian: Opløs lyofilisatet aseptisk med 0,3 ml af den medfølgende sterile solvens. Lad den rekonstituerede vaccine henstå 1 minut
English: The sensitivity of the vaccine strain to antibiotics is listed above (under section 4.4).
Bulgarian: sikkerhedsgrunde skal en supplerende antibiotisk behandling overvejes. Vaccinestammens følsomhed over for antibiotika er nævnt ovenfor i afsnit 4.4.
English: Interaction with other medicinal products and other forms of interaction:
Bulgarian: og andre former for interaktion:
English: Vaccination scheme:
Bulgarian: Vaccinen er beregnet
English: A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Bulgarian: til dyr. En eventuel beslutning om at anvende vaccinen umiddelbart før eller efter brug af et andet lægemiddel
English: Lyophilisate: Store in a refrigerator (2 °C - 8 °C).
Bulgarian: Lyofilisat: Opbevares i køleskab (2°C - 8°C).
English: 4.11 Withdrawal period(s)
Bulgarian: 4.11 Tilbageholdelsestid
English: WITHDRAWAL PERIOD
Bulgarian: UDLØBSDATO
English: Marketing authorization holder and manufacturer responsible for batch release: Intervet International B.V.
Bulgarian: Indehaver af markedsføringstilladelsen og fremstiller ansvarlig for batchfrigivelse: Intervet International B.V.
English: THE WORDS "KEEP OUT OF THE SIGHT AND REACH OF CHILDREN"
Bulgarian: TEKSTEN “OPBEVARES UTILGÆNGELIGT FOR BØRN”
English: THE WORDS "KEEP OUT OF THE SIGHT AND REACH OF CHILDREN" Keep out of the sight and reach of children.
Bulgarian: TEKSTEN “OPBEVARES UTILGÆNGELIGT FOR BØRN” Opbevares utilgængeligt for børn.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For administration submucosally to the inside of the upper lip. Read the package leaflet before use.
Bulgarian: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Til submukøs anvendelse i overlæbens inderside.
English: 4.9 Amounts to be administered and administration route
Bulgarian: 4.9 Dosering og indgivelsesvej
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.
Bulgarian: til brug til heste, som tydeligvis risikerer infektion med Streptococcus equi på grund af kontakt med heste fra områder med kendt forekomst af smitte.
English: STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT(S) Per dose of 0.2 ml vaccine:
Bulgarian: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER OG HJÆLPESTOFFER Pr. dosis af 0,2 ml vaccine:
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCTS OR WASTE MATERIALS
Bulgarian: 6.6 Eventuelle særlige forholdsregler ved bortskaffelse af ubrugte veterinærlægemidler eller affaldsmaterialer fra brugen af
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
Bulgarian: EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE, OM NØDVENDIGT
English: Therefore only a single dose of vaccine is needed to restore immunity.
Bulgarian: En priming-effekt varer i op til seks måneder efter basisvaccination, hvorfor der kun behøves en enkelt vaccinedosis for at gendanne immuniteten.
English: In addition to the clinical signs given under section 6, vaccination with a ten times overdose may induce an abscess in one of the submandibular lymph nodes.
Bulgarian: ti gange overdosis medføre en byld i en af de submandibulære lymfeknuder.
English: PARTICULARS TO APPEAR ON THE INNER BOX WITH LYOPHILISATE
Bulgarian: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE MED LYOFILISAT
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Intervet International B.V.
Bulgarian: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Intervet International B.V.
English: EXPIRY DATE EXP: {month/year}
Bulgarian: UDLØBSDATO EXP {MM/ÅÅÅÅ}
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription.
Bulgarian: BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG BRUG.
English: Name and address of the manufacturer responsible for batch release Intervet International B.V.
Bulgarian: Navn og adresse på fremstilleren ansvarlig for batchfrigivelse Intervet International B.V.
English: For animal treatment only.
Bulgarian: Til dyr.
English: METHOD AND ROUTE OF ADMINISTRATION
Bulgarian: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E)
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only.
Bulgarian: TEKSTEN ”TIL DYR” Til dyr.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Lyophilisate vial
Bulgarian: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Lyofilisat hætteglas
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS
Bulgarian: EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE
English: MINIMUM PARTICULARS ON IMMEDIATE PACKAGING OF THE SOLVENT Solvent vial
Bulgarian: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER SOLVENS HÆTTEGLAS
English: The onset of immunity is established as two weeks after vaccination.
Bulgarian: Immuniteten indtræder 2 uger efter basisvaccination.
English: Incompatibilities:
Bulgarian: Uforligeligheder
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Equilis StrepE, lyophilisate and solvent for suspension for injection, for horses
Bulgarian: VETERINÆRLÆGEMIDLETS NAVN Equilis StrepE, lyofilisat og solvens til injektionsvæske, suspension, til hest
English: This product contains a live auxotrophic deletion mutant Streptococcus equi vaccine strain with attenuated virulence.
Bulgarian: Dette produkt indeholder en levende auxotrofisk deletions-mutant Streptococcus equi vaccine-stamme med svækket virulens. Efter uforsætlig injektion kan dette produkts vaccinekomponenter imidlertid skabe en betændt reaktion med intens og smertefuld hævelse.
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.
Bulgarian: til Til immunisering af heste mod Streptococcus equi for at reducere kliniske symptomer og forekomst af lymfeknudeabscesser.
English: THE WORDS "FOR ANIMAL TREATMENT ONLY" For animal treatment only.
Bulgarian: TEKSTEN “TIL DYR” Til dyr. Kræver recept.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Equilis StrepE, lyophilisate and solvent for suspension for injection
Bulgarian: VETERINÆRLÆGEMIDLETS NAVN Equilis StrepE, lyofilisat og solvens til injektionsvæske, suspension
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.
Bulgarian: Ud over de kliniske symptomer, der er nævnt i sektion 4.6, kan en
English: BATCH NUMBER Lot {number}
Bulgarian: BATCHNUMMER Batch {nummer} UDLØBSDATO EXP {MM/ÅÅÅÅ}
English: Lyophilisate:
Bulgarian: Der foreligger
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).
Bulgarian: ind i overlæbens inderside indtil applikatoren hviler på læben.
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/).
Bulgarian: DATO FOR SENESTE ÆNDRING AF INDLÆGSSEDLEN Yderligere information om dette lægemiddel er
English: MARKETING AUTHORISATION NUMBER(S)
Bulgarian: NUMMER (NUMRE) I EU-REGISTRET FOR LÆGEMIDLER
English: PACKAGE LEAFLET FOR: Equilis StrepE, lyophilisate and solvent for suspension for injection, for horses
Bulgarian: Equilis StrepE, lyofilisat og solvens til injektionsvæske, suspension
English: 6.2 Incompatibilities
Bulgarian: Væsentlige uforligeligheder
English: EXPIRY DATE Exp {month/year}
Bulgarian: EXP {MM/ÅÅÅÅ}
English: ROUTE OF ADMINISTRATION See package leaflet.
Bulgarian: INDGIVELSESVEJ(E) Se indlægssedlen.
English: Excipients:
Bulgarian: til dyr:
English: 3 micrograms Conjugated to meningococcal protein2 50 micrograms adsorbed on aluminium phosphate (0.17 mg Al adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.15 mg Al 3 produced in yeast (Saccharomyces cerevisiae) cells by recombinant DNA technology 4 produced in Vero cells or equivalent antigenic quantity determined by a suitable immunochemical method.
Bulgarian: адсорбиран върху алуминиев фосфат (0,17 mg Al 2адсорбиран върху аморфен алуминиев хидроксифосфат сулфат (0,15 mg Al3+) 3произведен в клетки на дрожди (Saccharomyces cerevisiae) чрез рекомбинантна ДНК технология произведен върху Vero клетки или еквивалентно количество на антигена, определено чрез подходящ имунохимичен метод.
English: Poliovirus (Inactivated)4: Type 1 (Mahoney)
Bulgarian: Полиовирус (инактивиран)4 Тип 1 (Mahoney)
English: 50 (5x10) pre-filled syringes (multipack)
Bulgarian: 50 (5 х 10) предварително напълнени спринцовки (групова опаковка)
English: --1 One dose (0.5 ml) contains: Diphtheria Toxoid1:
Bulgarian: Една доза (0,5 ml) съдържа: Дифтериен токсоид1
English: Hepatitis B surface antigen2,3:
Bulgarian: Повърхностен антиген на хепатит B2,3