natgillin/translations-raw huggingface dataset:
QUALITATIVE AND QUANTITATIVE COMPOSITION VIBATIV 250 mg powder for concentrate for solution for infusion Each vial contains 250 mg telavancin (as hydrochloride). 
VIBATIV 250 mg prašek za koncentrat za raztopino za infundiranje Ena viala vsebuje 250 mg telavancina (v obliki klorida).
Shelf life of reconstituted concentrate: The reconstituted concentrate should be diluted immediately 
Rok uporabnosti rekonstituiranega koncentrata: Rekonstituiran koncentrat je potrebno razredčiti takoj po pripravi.
Severe 
Huje
nausea constipation, diarrhoea, vomiting abdominal pain, dry mouth, dyspepsia, flatulence, hypoaesthesia alanine aminotransferase increased, aspartate aminotransferase erythema, face oedema, hyperhidrosis, urticaria Musculoskeletal and connective tissue disorders arthralgia, back pain, muscle cramp, myalgia renal failure acute, blood creatinine increased, foamy urine (lower blood urea increased, dysuria, haematuria, microalbuminuria, oliguria, pollakiuria, renal impairment, urine odour abnormal General disorders and administration site conditions asthenia, infusion site reactions, malaise, non-cardiac chest pain, peripheral oedema, pain, pyrexia, Red Man syndrome international normalised ratio increased * Based on post-marketing reports. 
angina pektoris, atrijska fibrilacija, bradikardija, kongestivna srčna odpoved, podaljšanje popravljenega intervala QT na elektrokardiogramu, palpitacije, sinusna tahikardija, supraventrikularna ekstrasistola, ventrikularna ekstrasistola vročinski oblivi, hipertenzija, hipotenzija, flebitis dispneja, kolcanje, nazalna kongestija, faringolaringealne bolečine bolečina v predelu trebuha, suha usta, dispepsija, flatulenca, oralna zvečana vrednost alanin-aminotransferaze, zvečana vrednost eritem, obrazni edem, hiperhidroza, urtikarija Bolezni mišično-skeletnega sistema in vezivnega tkiva artralgija, bolečina v hrbtu, mišični krči, mialgija akutna ledvična odpoved, zvišan kreatinin v krvi, penast urin zvišana urea v krvi, disurija, hematurija, mikroalbuminurija, oligurija, polakiurija, ledvična okvara, nenormalen vonj urina
NAME OF THE MEDICINAL PRODUCT VIBATIV 750 mg powder for concentrate for solution for infusion 
IME ZDRAVILA VIBATIV 750 mg prašek za koncentrat za raztopino za infundiranje
Reconstitution time is not more than 5 minutes for the vial containing 250 mg and not more than 10 minutes for the vial containing 750 mg. 
Rekonstitucija traja največ 5 minut za vialo z 250 mg vsebino in največ 10 minut za vialo s 750 mg Mešanje poteka tako dolgo, dokler se vsebina viale popolnoma ne raztopi in pri pregledu s prostim
VIBATIV 250 mg powder for concentrate for solution for infusion VIBATIV 750 mg powder for concentrate for solution for infusion 
VIBATIV 250 mg prašek za koncentrat za raztopino za infundiranje VIBATIV 750 mg prašek za koncentrat za raztopino za infundiranje
clostridium colitis, urinary tract infection anaemia, leukopenia, thrombocythaemia, thrombocytopenia, eosinophil count increased, neutrophil count increased decreased appetite, hyperglycaemia, hyperkalaemia, hypoglycaemia, hypokalaemia, hypomagnesaemia agitation, anxiety, confusional state, depression ageusia, migraine, paraesthesia, parosmia, somnolence, tremor 
klostridijski kolitis, okužba urinarnega trakta anemija, levkopenija, trombocitemija, trombocitopenija, zvečano število evzinofilcev, zvečano število nevtrofilcev zmanjšan apetit, hiperglikemija, hiperkaliemija, hipoglikemija,
Vascular disorders Uncommon: 
Ušesne bolezni, vključno z motnjami labirinta Redki:
Cross hypersensitivity reactions, including anaphylaxis, have been reported in patients with a history of vancomycin allergy. 
Pri bolnikih, ki so v preteklosti imeli alergijo na vankomicin, so poročali o navzkrižnih preobčutljivostnih reakcijah, vključno z anafilaksijo.
The powder must be reconstituted and the resulting concentrate must then be immediately diluted further prior to use. 
Posebni previdnostni ukrepi za odstranjevanje in drugo rokovanje Prašek je potrebno rekonstituirati, dobljeni koncentrat pa je potrebno pred nadaljnjo uporabo takoj
NAME OF THE MEDICINAL PRODUCT VIBATIV 250 mg powder for concentrate for solution for infusion 
IME ZDRAVILA VIBATIV 250 mg prašek za koncentrat za raztopino za infundiranje
VIBATIV 750 mg powder for concentrate for solution for infusion 
VIBATIV 750 mg prašek za koncentrat za raztopino za infundiranje
VIBATIV 250 mg powder for concentrate for solution for infusion 
VIBATIV 250 mg prašek za koncentrat za raztopino za infundiranje
VIBATIV 250 mg powder for concentrate for solution for infusion 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 (0.9%) solution for injection to obtain a concentration of approximately 15 mg/ml (total volume of approximately 17 ml). 
VIBATIV 250 mg prašek za koncentrat za raztopino za infundiranje 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 dobite koncentracijo približno 15 mg/ml (skupen volumen približno 17 ml).
The following formula can be used to calculate to volume of reconstituted VIBATIV concentrate 
Volumen rekonstituiranega koncentrata zdravila VIBATIV, potreben za pripravo odmerka, se izračuna
Cardiac disorders Uncommon: 
Srčne bolezni Občasni:
No evidence of increased bleeding risk has been observed in clinical trials with telavancin. 
V kliničnih preskušanjih telavancina niso našli dokaza za povečanje tveganja krvavitve.
VIBATIV 750 mg powder for concentrate for solution for infusion The contents of the vial containing 750 mg telavancin must be reconstituted with 45 ml of either dextrose 50 mg/ml (5%) solution for injection, or water for injections or sodium chloride 9 mg/ml (0.9%) solution for injection to obtain a concentration of approximately 15 mg/ml (total volume of 
VIBATIV 750 mg prašek za koncentrat za raztopino za infundiranje Vsebino viale s 750 mg telavancina morate rekonstituirati s 45 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 dobite koncentracijo približno 15 mg/ml (skupen volumen približno 50 ml).
The solution is to be inspected visually for particulate matter and discoloration prior to administration. 
Raztopino je treba pred uporabo pregledati s prostim očesom glede vsebnosti trdnih delcev in obarvanosti.
The following formula can be used to calculate the volume of reconstituted VIBATIV concentrate 
Volumen rekonstituiranega koncentrata zdravila VIBATIV, potreben za pripravo odmerka, se izračuna z naslednjo formulo:
750 mg telavancin (as hydrochloride) per vial After reconstitution each ml contains 15 mg of telavancin. 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 750 mg telavancina (v obliki klorida) na vialo Po rekonstituciji en ml vsebuje 15 mg telavancina.
250 mg telavancin (as hydrochloride) per vial After reconstitution each ml contains 15 mg of telavancin. 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 250 mg telavancina (v obliki klorida) na vialo Po rekonstituciji en ml vsebuje 15 mg telavancina.
dyspnoea, hiccups, nasal congestion, pharyngolaryngeal pain 
vznemirjenost, anksioznost, zmedenost, depresija agevzija, migrena, parestezija, parozmija, somnolenca, tresavica
You have to use effective contraception during 
Med zdravljenjem z zdravilom VIBATIV morate uporabljati učinkovito
A dose adjustment should be made in obese patients with BMI > 30 kg/m2 (see section 4.2). 
Pri debelih bolnikih z ITM > 30 kg/m2 je treba odmerek
Body mass index (BMI) at baseline was found to influence telavancin pharmacokinetics in the population pharmacokinetic analysis in healthy (without infection) adult subjects. 
V populacijski farmakokinetični analizi zdravih odraslih preiskovancev (brez okužbe) so ugotovili, da indeks telesne mase (ITM) ob izhodišču vpliva na farmakokinetiko telavancina.
For instructions on reconstitution and dilution, see section 6.6. 
Za navodila v zvezi z rekonstitucijo in raztapljanjem zdravila glejte
• Obligation to conduct post-authorisation measures The MAH shall complete, within the stated timeframe, the below measures: 
Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okviru izvesti naslednje
The pregnancy status of women of childbearing potential has to be established prior to dosing with telavancin. 
Pred dajanjem telavancina je treba preveriti, ali je ženska v rodni dobi noseča.
Manufacturer 
Inkompatibilnosti
Whole blood (Lee-White) clotting time 
Telavancin ne vpliva na teste koagulacije Čas strjevanja polne krvi (Lee-White)
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. 
VIBATIV 250 mg prašek za koncentrat za raztopino za infundiranje VIBATIV 750 mg prašek za koncentrat za raztopino za infundiranje telavancin
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 
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).
deafness 
naglušnost
1 vial (multidose) 
1 viala (večodmerna)
1Human Papillomavirus = HPV adjuvanted by AS04 containing: 
humani virus papiloma = HPV 2z adjuvansom AS04, ki vsebuje:
--1 1 dose (0.5 ml) contains: Human Papillomavirus1 type 16 L1 protein2,3,4 
--1 1 odmerek (0,5 ml) vsebuje: L1 protein2,3,4 genotipa 16 humanega virusa papiloma1
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. 
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.
MARKETING AUTHORISATION NUMBER(S) EU/2/04/043/001 
ŠTEVILKA DOVOLJENJA ZA PROMET EU/2/04/043/001
In very rare cases depression may develop. 
Zelo redko se lahko razvije depresija.
The frequency of adverse reactions is defined using the following convention: 
Pogostnost neželenih učinkov je določena po naslednjem dogovoru:
Basic vaccination performed during an outbreak is not efficacious, because immunity is insufficient until basic vaccination has been completed. 
Osnovno cepljenje med izbruhom okužbe ni učinkovito, ker je imunost nezadostna, dokler osnovno cepljenje ni zaključeno.
An additional antibiotic treatment should be considered for safety reasons. 
Iz varnostnih razlogov je treba presoditi o dodatnem antibiotičnem zdravljenju.
The sensitivity of the vaccine strain to antibiotics is listed above (under section 4.4). 
Občutljivost cepnega seva za antibiotike je navedena zgoraj (v poglavju 4.4).
Do NOT shake. 
NE stresajte.
It is recommended that all horses stabled together are vaccinated. 
Priporočljivo je cepiti vse konje, ki so skupaj uhlevljeni.
DATE OF FIRST AUTHORISATION Date of first authorization: 07.05.2004 Date of last renewal: 10.04.2014 
Datum prve odobritve dovoljenja za promet: 7. maj 2004 Datum zadnje obnovitve:
PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable. 
DATUM REVIZIJE BESEDILA PREPOVED PRODAJE, OSKRBE IN/ALI UPORABE Navedba ni smiselna.
Do not use antibiotics within one week after vaccination. 
Ne uporabite antbiotikov v enem tednu po cepljenju.
Special precautions for use in animals Only healthy horses should be vaccinated. 
Posebni previdnostni ukrepi za uporabo pri živalih Cepimo samo zdrave konje.
Purpura haemorrhagica has not been observed in any of the safety studies performed during development of Equilis StrepE. 
Hemoragične purpure niso zasledili v nobeni študiji varnosti, izvedeni med razvojem Equilisa StrepE.
The reaction is maximal at 2-3 days post vaccination with a maximum area of 3 cm by 8 cm. 
Reakcija je največja 2 do 3 dni po cepljenju in ima največjo površino 3 krat 8 cm.
The duration of immunity is up to 3 months. 
Imunost traja do 3 mesece.
The sensitivity of the vaccine strain to antibiotics is listed above. 
Občutljivost cepnega seva za antibiotike je navedena zgoraj.
In the challenge studies performed by the company, insufficient protection was seen in approximately one quarter of horses vaccinated with the recommended dose. 
V provokacijskih študijah, ki jih je opravila družba, so ugotovili nezadostno zaščito pri približno eni četrtini konj, ki so jih cepili s priporočenim odmerkom.
From literature, it is known that a very low number of horses may develop purpura haemorrhagica if they are vaccinated shortly after infection. 
Iz literature je znano, da se pri zelo majhnem številu konj lahko razvije hemoragična purpura, če so cepljeni kmalu po okužbi.
Revaccination: Revaccinate every three months to maintain immunity. 
Revakcinacija: Revakciniramo vsake tri mesece, da ohranimo imunost.
This swelling resolves completely within 3 weeks and normally has no effect on the appetite of the vaccinated animal and causes no apparent discomfort. 
V 3 tednih ta oteklina povsem mine in običajno ne vpliva na apetit cepljene živali niti ne povzroča vidnega nelagodja.
Special care must be taken when connecting the applicator to the needle to avoid needle-stick injuries. 
Posebno je treba paziti pri nameščanju aplikatorja na iglo, da ne pride do vboda z iglo.
Allow the sterile solvent to reach room temperature (15-25 °C). 
Počakajte, da se sterilni vehikel ogreje na sobno temperaturo (15-25 °C).
After reconstitution use within 4 hours. 
Po rekonstituciji uporabite v 4 urah.
10 x 1 dose of vaccine 10 x 1 dose of solvent 10 applicators 10 syringes with needle 
10 x 1 odmerek cepiva 10 x 1 odmerek vehikla 10 aplikatorjev 10 brizg z iglo
As the incidence of purpura haemorrhagica is very low, its occurrence cannot be ruled out completely. 
Ker pa je hemoragična purpura zelo redka, njenega pojava ne moremo povsem izključiti.
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. 
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.
Allow the reconstituted vaccine to sit for 1 minute and then carefully swirl the contents to mix. 
Rekonstituirano cepivo naj 1 minuto počaka, potem pa vsebino previdno obračajte, da se zmeša.
For the full list of excipients, see section 6.1. 
Pomožne snovi Za celoten seznam pomožnih snovi glejte poglavje 6.1.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. 
Na voljo je malo podatkov o varnosti in učinkovitosti tega cepiva ob sočasni uporabi s katerim koli drugim zdravilom za uporabo v veterinarski medicini.
Lyophilisate for suspension for injection 
Liofilizat za suspenzijo za injiciranje
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. 
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
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. 
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.
Pharmacotherapeutic group: immunological for equidae, live bacterial vaccine, ATCvet code: QI05AE. 
Farmakoterapevtska skupina: imunološko zdravilo za ekvide: živo bakterijsko cepivo Oznaka ATCvet: QI05AE
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). 
S priloženo brizgo odvzemite 0,2 ml rekonstituiranega cepiva (glejte sliko 1) in na iglo namestite aplikator (glejte sliko 2).
Do not mix with any other veterinary medicinal products except the solvent supplied for use with the vaccine. 
Ne mešajte z nobenim drugim zdravilom za uporabo v veterinarski medicini, razen z vehiklom, ki je priložen cepivu.
Accidental self-injection may result in an inflammatory reaction with severe pain and swelling. 
Nenamerno samoinjiciranje lahko povzroči vnetno reakcijo s hudo bolečino in oteklino.
To stimulate immunity against Streptococcus equi. 
Za vzbujanje imunosti proti Streptococcusu equi
The vaccine strain is sensitive to penicillins, tetracyclines, macrolides and lincomycin. 
Cepni sev je občutljiv za peniciline, tetracikline, makrolide in linkomicin.
For any information about this veterinary medicinal product, please contact the marketing authorization holder. 
Za vse nadaljnje informacije o tem zdravilu se obrnite na krajevno predstavništvo imetnika dovoljenja za promet z zdravilom.
In very rare cases an abscess may develop at the injection site or in the regional lymph nodes. 
Zelo redko se lahko na mestu vboda ali v regionalnih limfnih vozlih razvije absces.
Equilis StrepE - solvent 
Equilis StrepE - vehikel
The vaccine strain is resistant to aminoglycosides, sulphonamides, flumequine and trimetroprim-sulfa combinations. 
Cepni sev je odporen proti aminoglikozidom, sulfonamidom, flumekvinu in kombinacijam trimetoprima in sulfametoksazola.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/). 
Evropske agencije za zdravila (European Medicines Agency) http://www.ema.europa.eu/.
Shelf life of the veterinary medicinal product as packaged for sale: 3 years. 
Rok uporabnosti zdravila za uporabo v veterinarski medicini v pakiranju za prodajo: 3 leta
Shedding of the vaccine strain from the injection site can be observed for a period of four days after vaccination. 
Izločanje cepnega seva iz mesta injiciranja je mogoče opaziti štiri dni po cepljenju.
Solvent: This medicinal product does not require any special storage conditions. 
Vehikel: Posebne razmere za shranjevanje niso potrebne.
PACKAGE SIZE 10 x 1 dose 
10 x 1 odmerek
Shelf life after reconstitution according to directions: 4 hours. 
Rok uporabnosti po rekonstituciji v skladu z navodili: 4 ure.
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. 
Poleg kliničnih znakov, ki so opisani v poglavju 4.6, lahko cepljenje z 10-krat prevelikim odmerkom povzroči tudi absces submandibularnega limfnega vozla.
Ensure that the lyophilisate is completely reconstituted before use. 
Pred uporabo preverite, da je liofilizat povsem rekonstituiran.
NAME OF THE VETERINARY MEDICINAL PRODUCT Equilis StrepE 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI
ADVICE ON CORRECT ADMINISTRATION 
NASVET O PRAVILNI UPORABI ZRAVILA
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
A. IZDELOVALEC BIOLOŠKE AKTIVNE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROSTITEV SERIJE
This medicinal product does not require any special storage conditions. 
Posebne razmere za shranjevanje niso potrebne.
− common (more than 1 but less than 10 animals in 100 animals) 
- pogosti (pojavijo se pri več kot 1 toda pri manj kot 10 živalih od 100 živali)
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. 
4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Imunizacija konjev proti Streptococcusu equi za zmanjšanje kliničnih znakov in nastanka abscesov limfnih vozlov.
The abscesses drain purulent material from 2 weeks after vaccination, but heal without intervention within a month thereafter. 
Iz abscesa se 2 tedna po cepljenju izloča gnojen izcedek, nato se v enem mesecu brez intervencije zaceli.
For immunisation of horses against Streptococcus equi to reduce clinical signs and occurrence of lymph node abscesses. 
Imunizacija konjev proti Streptococcusu equi za zmanjšanje kliničnih znakov in nastanka abscesov limfnih vozlov.
Live deletion mutant Streptococcus equi strain TW928 109.0 to 109.4 cfu 
Živi delecijski mutant seva Streptococcus equi TW928 109,0 do 109,4 CFU1
− very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment) 
- zelo pogosti (pojavijo se pri več kot 1 živali od 10 živali v teku enega zdravljenja)
However, the bacterial compounds of this product can cause an inflammatory reaction with intense and painful swelling after accidental injection. 
Toda bakterijske spojine v proizvodu lahko v primeru nenamernega injiciranja povzročijo vnetno reakcijo z močno in bolečo oteklino.
THE WORDS "FOR ANIMAL TREATMENT ONLY" 
BESEDILO ''SAMO ZA ŽIVALI''
Slight apathy may occasionally be observed one day after vaccination. 
Občasno se lahko naslednji dan po cepljenju pojavi blaga apatija.
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. 
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.
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. 
(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.
This product contains a live auxotrophic deletion mutant Streptococcus equi vaccine strain with attenuated virulence. 
Zdravilo vsebuje živi avksotrofni delecijski mutant cepnega seva Streptococcusa equi z oslabljeno virulenco.
In rare cases, inappetence, fever, shivering and diffuse oedematous swellings (e.g. facial oedema, swollen muzzle/upper lip) may be observed. 
Redko lahko zasledimo anoreksijo, vročino, tresenje in difuzne edematozne otekline (npr. facialni edem, otekel gobec/ gornja ustnica).
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 1 dose 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV
This product contains a live bacterial deletion mutant with a limited growth potential in mammalian tissue. 
Zdravilo vsebuje živi bakterijski delecijski mutant z omejenim potencialom za rast v tkivu sesalcev.