natgillin/translations-raw huggingface dataset:
The recommended posology in children of an average 0.75 mg (0.025 ml) of mepivacaine solution per kg of body weight is in line with the work-sharing procedure led by EMA in 2010 in accordance with Article 45 of the Paediatric Regulation 1901/2006 (AT/W/0002/pdWS/001). 
Povprečni priporočeni odmerek pri otrocih, ki znaša 0,75 mg (0,025 ml) raztopine mepivakaina na kilogram telesne mase, je v skladu s postopkom delitve dela, ki ga je leta 2010 vodila agencija EMA skladno s členom 45 Uredbe št. 1901/2006 o zdravilih za uporabo v pediatrični medicini (AT/W/0002/pdWS/001).
The recommendations on lower doses for patients with reduced health and pre-existing conditions such as vascular obliterations, arteriosclerosis or diabetes-related nerve damage are not supported by sufficient data and are not endorsed by the CHMP. 
Za priporočila o manjših odmerkih pri bolnikih slabšega zdravja ali s predhodnimi zdravstvenimi težavami, kot so vaskularna obliteracija, arterioskleroza ali diabetično obolenje živcev, ni zadostnih podatkov, zato jih odbor CHMP ne podpira.
The relevant posology section for the mepivacaine use in chiropody procedure will be removed as the CHMP supported the deletion of this indication. 
Ustrezno poglavje o odmerjanju glede uporabe mepivakaina v postopkih pedikure se odstrani, saj je odbor CHMP podprl izbris te indikacije.
The CHMP agreed on a common wording, on fertility, pregnancy and lactation (section 4.6) with data supported from pre-clinical studies. 
Odbor CHMP se je strinjal s skupnim besedilom glede plodnosti, nosečnosti in dojenja (poglavje 4.6), ki temelji na podatkih, podprtih s predkliničnimi študijami.
The rate of 1 ml/min is considered ideal as it does not produce tissue damage during or after anaesthesia and any serious reaction in the event of accidental intravascular injection. 
Idealna hitrost injiciranja je 1 ml/min, saj ne povzroča poškodbe tkiva med anestezijo ali po njej in resnih reakcij v primeru nenamernega injiciranja v žilo.
In section 4.4, the warnings have been re-organised in five categories: patients with cardiovascular disorders, hepatic disease, kidney disease, epileptic and elderly patients. 
V poglavju 4.4 so bila opozorila prerazporejena v pet kategorij: bolniki s srčno-žilnimi boleznimi, bolniki z obolenji jeter, bolniki z obolenji ledvic, bolniki z epilepsijo in starejši bolniki.
Sections 2 (qualitative and quantitative composition), 3 (pharmaceutical form), 4.7 (Effects on ability to drive and use machines), 5.1 (pharmacodynamic properties), 5.2 (pharmacokinetic properties), 6.1 (list of excipients), 6.2 (incompatibilities), 6.3 (shelf life), 6.4 (special precautions for storage) 6.5 (nature and contents of container) and 6.6 (Special precautions for disposal and other handling) have been updated in line with their respective harmonised Quality documentation provided in module 3 and in line with the latest QRD template. 
Poglavja 2 (Kakovostna in količinska sestava), 3 (Farmacevtska oblika), 4.7 (Vpliv na sposobnost vožnje in upravljanja strojev), 5.1 (Farmakodinamične lastnosti), 5.2 (Farmakokinetične lastnosti), 6.1 (Seznam pomožnih snovi ), 6.2 (Inkompatibilnosti), 6.3 (Rok uporabnosti), 6.4 (Posebna navodila za shranjevanje ), 6.5 (Vrsta ovojnine in vsebina) in 6.6 (Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom) so bila posodobljena v skladu z njihovo ustrezno usklajeno dokumentacijo o kakovosti (Modul 3) in najnovejšo predlogo za pregled kakovosti dokumentov.
Scandonest contains 30 mg/mL of mepivacaine hydrochloride. 
Zdravilo Scandonest vsebuje 30 mg/ml mepivakainijevega klorida.
The CHMP is of the opinion that in case of vasoconstrictor contraindication there are alternative options, such as other local anaesthetics (procaine, bupivacaine and lidocaine), general anaesthesia and nitrous oxide. 
V primeru kontraindikacij za vazokonstriktor so po mnenju odbora CHMP na voljo druge možnosti, na primer drugi lokalni anestetiki (prokain, bupivakain in lidokain), splošna anestezija in dušikov oksid.
Other Sections 
Druga poglavja
Other warnings not related with the above categories were harmonised, such as for patients with coagulation disorder and coadministration of antiplatelet/anticoagulant medicines. 
Druga opozorila, ki niso povezana z zgornjimi kategorijami, so bila usklajena, na primer za bolnike z motnjami koagulacije in tiste, ki sočasno prejemajo antiagregacijska/antikoagulacijska zdravila.
Although in dental practices, local anaesthetics administrated in therapeutic dosages do not interact with standard antiepileptic drugs, the situation for patients with uncontrolled epilepsy may be different. 
Čeprav v zobozdravstvu ni medsebojnega delovanja med lokalnimi anestetiki, ki se dajejo v terapevtskih odmerkih, in standardnimi protiepileptičnimi zdravili, to pri bolnikih z nenadzorovano epilepsijo morda ne velja.
The MAH has provided a summary of the literature and studies to support the indication “anaesthesia in dental procedures”. 
Imetnik dovoljenja za promet z zdravilom je pripravil povzetek literature in študij v podporo indikaciji „anestezija pri zobozdravstvenih operacijah“.
Interactions with other medicinal products (section 4.5) have been summarised in additive interactions with other local anaesthetics, H2 antihistaminics, sedatives, antiarrhythmic drugs, CYP1A2 inhibitors and propranolol. 
Medsebojno delovanje z drugimi zdravili (poglavje 4.5) je povzeto v podpoglavjih o aditivnih medsebojnih delovanjih z drugimi lokalnimi anestetiki, antihistaminiki H2, sedativi, antiaritmiki, zaviralci CYP1A2 in propranololom.
In the presence of high blood levels, local anaesthetics cross the blood-brain barrier. 
Kadar so lokalni anestetiki v krvi prisotni v visokih ravneh, prečkajo krvno-možgansko pregrado.
This information should be reflected in the SmPC section 4.2 with a cross reference to section 4.5 (Interactions with other medicinal products). 
To informacijo je treba vključiti v poglavje 4.2 povzetka glavnih značilnosti zdravila, pri čemer se je treba sklicevati na poglavje 4.5 (Medsebojno delovanje z drugimi zdravili).
The CHMP noted that there is literature evidence that mepivacaine provides vasoconstrictive features compared with anaesthetics from other pharmaceutical groups, however this cannot consist an indication itself. 
Odbor je ugotovil, da so v literaturi dokazi o vazokonstriktivnih značilnostih mepivakaina v primerjavi z anestetiki drugih farmacevtskih skupin, vendar to samo po sebi ne predstavlja indikacije.
Changes introduced in the SmPC were consistently reflected in the labelling, with some sections left to be completed nationally. 
Spremembe, ki so jih uvedli v povzetku glavnih značilnosti zdravila, so bile dosledno vključene v označevanje, nekaj poglavij pa je treba dopolniti na nacionalni ravni.
• The Committee considered the identified divergences for Scandonest and associated names, for the indications, posology, contraindications, special warnings and precaution for use, as well as the remaining sections of the SmPC, labelling and package leaflet; 
• odbor je upošteval ugotovljene razlike za zdravilo Scandonest in povezana imena za indikacije, odmerjanje, kontraindikacije, posebna opozorila in previdnostne ukrepe ter preostala poglavja povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo;
• In addition, the Committee reviewed the documentation submitted by the MAH in support of the proposed harmonised Quality documentation (Module 3); 
• odbor je prav tako pregledal dokumentacijo, ki jo je v podporo predlagani usklajeni dokumentaciji o kakovosti (Modul 3) predložil imetnik dovoljenja za promet z zdravilom;
Mepivacaine is largely metabolised in the liver by microsomal enzymes and the principal route of excretion is via the kidney. 
Mepivakain se v glavnem presnavlja v jetrih z mikrosomskimi encimi, njegova glavna pot izločanja pa je skozi ledvice.
On 25 August 2017 Septodont on behalf of all marketing authorisation holders (MAHs) presented to the European Medicines Agency a referral under Article 30 of Directive 2001/83/EC, in order to harmonise the national summary of product characteristics (SmPC), labelling, package leaflet and quality Module 3 of the medicinal products Scandonest and associated names (see Annex I of CHMP opinion). 
Družba Septodont je 25. avgusta 2017 v imenu vseh imetnikov dovoljenja za promet z zdravilom Evropski agenciji za zdravila predložila napotitev v skladu s členom 30 Direktive 2001/83/ES, da bi uskladili povzetek glavnih značilnosti zdravila, označevanje, navodilo za uporabo in dokumentacijo o kakovosti (Modul 3) zdravila Scandonest in povezanih imen (glejte Prilogo I k mnenju odbora CHMP).
Therefore, the CHMP concluded in the inclusion of the contraindications summarised below: - Hypersensitivity to the active substance (or any local anaesthetics agent of the amide type) or to any of the excipients listed in section 6.1, - Children below 4 years of age (ca. 20 kg body weight), - Severe disorders of atrioventicular conduction not compensated by pace maker, - Poorly controlled epileptic patient. 
Odbor CHMP je zato sklenil, da se vključijo kontraindikacije, povzete v nadaljevanju: - preobčutljivost za učinkovino (ali kateri koli lokalni anestetik amidnega tipa) ali katero koli pomožno snov, navedeno v poglavju 6.1; - otroci, mlajši od štirih let (približno 20 kg telesne mase); - hude motnje atrioventrikularnega prevajanja, kadar se ne uporablja srčni spodbujevalnik; - bolniki s slabo nadzirano epilepsijo.
If sedatives are used to reduce patient anxiety, lower doses of the anaesthetic should be used, since there is increased risk of adverse effects when central nervous system (CNS) depressants are combined. 
Če se sočasno uporabljajo sedativi za zmanjšanje bolnikove anksioznosti, je treba uporabiti manjše odmerke anestetika, saj pri kombinirani uporabi depresorjev centralnega živčnega sistema obstaja večje tveganje neželenih učinkov.
Mepivacaine is an intermediate-acting local anaesthetic, which inhibits the conduction of nerve impulses by decreasing sodium (Na+) flow during propagation of the nerve action potential. 
Mepivakain je lokalni anestetik s srednjeročnim učinkom, ki zavira prevajanje živčnih impulzov, tako da zmanjšuje pretok natrija (Na+) med širjenjem akcijskega potenciala v živcu.
The statement regarding the risk of possible accumulation of the product leading to toxicity in special populations (elderly and patients with renal and hepatic impairment) has been however endorsed by the CHMP. 
Je pa podprl trditev glede tveganja morebitnega kopičenja zdravila, ki lahko vodi do toksičnosti pri določenih populacijah (starejših in bolnikih z okvaro ledvic in jeter).
{(Invented) name and associated names, strength pharmaceutical form} is a local anaesthetic indicated for the local and loco-regional anaesthesia in dental surgery in adults, adolescents and children above 4 years of age (c.a. 
Zdravilo {(izmišljeno) ime in povezana imena, jakost, farmacevtska oblika} je lokalni anestetik, indiciran za lokalno ali lokoregionalno anestezijo pri zobozdravstvenih operacijah pri odraslih, mladostnikih in otrocih, starejših od štirih let (telesna masa približno 20 kg).
Therefore, the CHMP recommended that the statement regarding mepivacaine's use when vasoconstrictor is contraindicated should be moved from section 4.1 to 5.1 (pharmacodynamic properties) of the SmPC. 
Zato je priporočil, da se trditev o uporabi mepivakaina v primeru kontraindikacije vazokonstriktorja prestavi iz poglavja 4.1 v poglavje 5.1 (farmakodinamične lastnosti) povzetka glavnih značilnosti zdravila.
The revised therapeutic indications in section 4.1 of the SmPC are: 
Spremenjene terapevtske indikacije v poglavju 4.1 povzetka glavnih značilnosti zdravila se glasijo:
No clinical data on fertility and nursing mothers are available on humans. 
Pri ljudeh ni kliničnih podatkov o plodnosti in doječih materah.
Only the most major changes have been discussed in details below. 
Spodaj so podrobno obravnavane le najpomembnejše spremembe, usklajena pa so bila vsa poglavja informacij o zdravilu.
Mepivacaine is contraindicated in patients with a history of hypersensitivity to the product, to any other amide anaesthetics or to any of the excipients. 
Mepivakain je kontraindiciran pri bolnikih z anamnezo preobčutljivosti za zdravilo, druge amidne anestetike ali katero koli pomožno snov.
Therefore, mepivacaine is contraindicated in patients with atrioventricular disorders not compensated by a pacemaker. 
Zato je mepivakain kontraindiciran pri bolnikih z atrioventrikularnimi motnjami, kadar se ne uporablja srčni spodbujevalnik.
Consequently, metabolism and elimination of mepivacaine can be significantly altered by the presence of hepatic or renal diseases. 
Posledično lahko bolezni jeter ali ledvic bistveno vplivajo na presnovo in izločanje mepivakaina.
The finished product is presented as a solution for injection containing 30 mg/ml of mepivacaine hydrochloride as active substance. 
Končno zdravilo je v obliki raztopine za injiciranje, ki kot učinkovino vsebuje 30 mg/ml mepivakainijevega klorida.
The CHMP recommended the variation to the terms of the marketing authorisations for which the summary of product characteristics, labelling and package leaflets are set out in Annex III for Scandonest and associated names (see Annex I). 
je odbor CHMP priporočil spremembo pogojev dovoljenj za promet z zdravilom Scandonest in povezanimi imeni, za katera so v Prilogi III navedeni povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo (glejte Prilogo I).
Information for medical staff on how to avoid a blood vessel penetration during injection as well as instructions to avoid injections to inflamed or infected tissues are maintained in the SmPC. 
V povzetku glavnih značilnosti zdravila so ohranjeni informacije za zdravstveno osebje glede preprečevanja, da bi igla med injiciranjem prodrla v žilo, in navodila o preprečevanju injiciranja v vneto ali okuženo tkivo.
As the drug concentration rises in the brain, the excitatory pathways are inhibited and CNS depression occurs. 
Z višjo koncentracijo zdravila v možganih se zavirajo ekscitatorne poti in pojavi se depresija osrednjega živčnega sistema.
The package leaflet (PL) was amended in accordance with the changes made to the SmPC. 
Navodilo za uporabo je bilo spremenjeno skladno s spremembami v povzetku glavnih značilnosti zdravila.
Whereas 
Odmerjanje
20 kg of body weight). 
300 mg.
A harmonised version of section 4.8 of adverse events has been agreed by the CHMP after assessing data from global pharmacovigilance database and literature and in line with data assessed in previous periodic update assessment reports (PSURs). 
Po oceni podatkov iz svetovne zbirke podatkov o farmakovigilanci in literature ter v skladu s podatki, ki so bili ocenjeni v predhodnih redno posodobljenih poročilih o varnosti zdravila (PSUR), je odbor CHMP sprejel usklajeno različico poglavja 4.8 o neželenih dogodkih.
A harmonised description of the symptoms and the management of overdose has been agreed in accordance with the EMA SmPC guideline (2009). 
V skladu s smernicami agencije EMA za povzetek glavnih značilnosti zdravila (2009) je bil sprejet usklajen opis simptomov in obravnave prevelikega odmerjanja.
Section 4.2 - Posology and methods of administration Posology 
Poglavje 4.2 - Odmerjanje in načini uporabe
Therefore, care should be taken to ensure that each piglet ingests a sufficient quantity of colostrum. 
Zato je treba paziti, da vsak pujsek dobi zadostno količino kolostruma.
Aqueous, white to nearly white. 
Vodna, bela do skoraj bela.
ATC vet code: QI09AB08. 
Oznaka ATCvet: QI09AB08.
Date of first authorisation: 14/06/2012 Date of last renewal: 29/03/2017 
Datum pridobitve dovoljenja za promet: 14. 06. 2012 Datum zadnjega podaljšanja dovoljenja za promet: 29. 03. 2017
The active substances being a principle of biological origin intended to produce passive immunity are not within the scope of Regulation (EC) No 470/2009. 
Učinkovine biološkega izvora, namenjene vzbujanju pasivne imunosti, niso vključena v Uredbo (ES) št. 470/2009.
Reduced activity and lack of appetite on the day of vaccination commonly occurred and/or a sometimes painful and hard swelling up to 10 cm diameter for up to 25 days were very commonly observed at the site of injection. 
Zmanjšana aktivnost in pomanjkanje apetita sta se pogosto pojavila na dan cepljenja in/ali včasih trde in boleče otekline s premerom do 10 cm, ki so trajale do 25 dni, so bile zelo pogosto opažene na mestu injiciranja.
Pharmacotherapeutic group: Immunologicals for Suidae, inactivated bacterial vaccine. 
Farmakoterapevtska skupina: imunološka zdravila za suidae, inaktivirano bakterijsko cepivo.
2 International units of beta antitoxin according to Ph. Eur. 
2 Internacionalne enote beta antitoksina po Ph. Eur.
Administer 1 dose (2 ml) of vaccine per animal in the neck in the area behind the ear. 
Dajte 1 odmerek (2 ml) cepiva na žival v vrat v predel za ušesom.
In post marketing experience: Hypersensitivity reactions may occur in very rare cases. 
Preobčutljivostne reakcije se lahko pojavijo v zelo redkih primerih.
No adverse reactions other than those mentioned in section 4.6 have been observed. 
Zasledili niso nikakršnih neželenih učinkov, ki bi se razlikovali od tistih, ki so našteti v poglavju 4.6.
An increase in body temperature up to 2°C was very commonly observed on the day of vaccination. 
Prehodno povišanje telesne temperature za približno 2 ºC je bilo zelo pogosto opaženo na dan cepljenja.
Before use allow the vaccine to reach room temperature. 
Pred uporabo naj se cepivo ogreje na sobno temperaturo.
Do not use this veterinary medicinal product after the expiry date which is stated on the label. 
Tega zdravila za uporabo v veterinarski medicini ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na nalepki.
The excipients (including adjuvants) listed in section 6.1 of the SPC are allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product. 
SPC so dovoljene snovi, za katere tabela 1 priloge Uredbe Komisije (EU) št.37/2010 določa, da MRL ni potreben ali pa, kot so uporabljene v tem cepivu za uporabo v veterinarski medicini, niso vključene v Uredbo (ES) št.
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports). 
Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (pojavijo se pri več kot 1 živali od 10 živali v teku enega zdravljenja) - pogosti (pojavijo se pri več kot 1 živali toda manj kot pri 10 živalih od 100 živali) - občasni (pojavijo se pri več kot 1 živali toda manj kot pri 10 živalih od 1000 živali) - redki (pojavijo se pri več kot 1 živali toda manj kot pri 10 živalih od 10.000 živali) - zelo redki (pojavijo se pri manj kot 1 živali od 10.000 živali, vključujoč posamezne primere)
Protection of piglets is achieved by colostrum intake. 
Zaščita pujskov je dosežena z zaužitjem kolostruma.
Shelf life of the veterinary medicinal product as packaged for sale: 2 years Shelf life after first opening the vial: 10 hours 
Rok uporabnosti zdravila za uporabo v veterinarski medicini v pakiranju za prodajo: 2 leti Rok uporabnosti po prvem odpiranju viale: 10 ur
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable 
BESEDILO ''SAMO ZA ŽIVALI'' IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, če je smiselno
Each dose of 2 ml contains: 
V odmerku po 2 ml:
Revaccination: A single revaccination is carried out 2 to 4 weeks before the expected date of farrowing. 
Revakcinacija: En odmerek 2 do 4 tedne pred pričakovano prasitvijo.
Vaccination results in an antibody response with neutralizing activity against LT toxin. 
Cepljenja sproži nastanek protiteles, ki nevtralizirajo LT toksin.
Pigs (sows and gilts) 
Prašiči (svinje in mladice)
100, 200 and 250 ml 
100, 200 in 250 ml
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/).
≥ 20 IU 
≥ 20 IE
≥20 IU2 
≥20 IE2
EU/2/12/141/004 EU/2/12/141/005 EU/2/12/141/006 EU/2/12/141/007 EU/2/12/141/008 EU/2/12/141/009 
EU/2/12/141/005 EU/2/12/141/006 EU/2/12/141/007 EU/2/12/141/008 EU/2/12/141/009
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. 
Zato se za uporabo tega cepiva pred uporabo katerega koli drugega zdravila ali po njem odločamo od primera od primera.
Shelf life after first opening the container: 10 hours. 
Rok uporabnosti po prvem odpiranju vsebnika: 10 ur
1 Mean antibody titre (Ab) obtained after vaccination of mice with a 1/20 or 1/40 sow dose 
1 Srednji titer protiteles po cepljenju miši z 1/20 ali 1/40 odmerka za svinje.
A slight redness and/or roughness may transiently occur after a double dose vaccination. 
Po dvojnem odmerku cepiva se lahko prehodno pojavi rahla rdečina in/ali hrapavost.
EXP {month/year} Once broached, use within 10 hours. 
Načeto vialo porabite v 10 urah.
Walton Manor, Walton, Milton Keynes 
Walton Manor, Walton, Milton Keynes Buckinghamshire, MK7 7AJ, Združeno kraljestvo
Pig pictogram 
Piktogram prašiča
LT toxoid 
LT toksoid
Shake vigorously before use and at intervals during use. 
Pred uporabo in v razmakih med uporabo dobro pretresite.
THE WORDS “FOR ANIMAL TREATMENT ONLY” 
BESEDILO ''SAMO ZA ŽIVALI'' Samo za živali
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. 
Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Ni podatkov o varnosti in učinkovitosti ob uporabi tega cepiva s katerim koli drugim zdravilom za uporabo v veterinarski medicini.
150 mg For the full list of excipients, see section 6.1 
Za celoten seznam pomožnih snovi glejte poglavje 6.1
Sodium chloride Potassium chloride Disodium hydrogen phosphate Potassium dihydrogenphosphate Simethicone 
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi natrijev klorid kalijev klorid dinatrijev hidrogenfosfat kalijev dihidrogenfosfat Simetikon
Porcilis ColiClos suspension for injection for pigs 
Porcilis ColiClos suspenzija za injiciranje za prašiče
E.coli: fimbrial adhesins, LT toxoid C. perfringens toxoid 
E.coli: fimbrijski adhezini, LT toksoid C. perfringens: toksoid
C. perfringens type C toxoid 
C. perfringens: toksoid tip C
Porcilis ColiClos suspension for injection 
Porcilis ColiClos suspenzija za injiciranje
- LT toxoid 
- toksoid LT
20 ml (10 doses) 50 ml (25 doses) 
20 ml (10 odmerkov) 50 ml (25 odmerkov)
For the passive immunisation of progeny by active immunisation of sows and gilts to reduce mortality and clinical signs during the first days of life, caused by those E. coli strains, which express the adhesins F4ab (K88ab), F4ac (K88ac), F5 (K99) or F6 (987P) and caused by C. perfringens type C. 
S tem se zmanjša smrtnost in klinični znaki v prvih dnevih po rojstvu, ki jo povzročajo sevi E.coli, ki izločajo fimbrijske adhezine F4ab (K88ab), F4ac (K88ac), F5 (K99) ali F6 (987P) in ki jih povzroča tip C C. perfringens.
Name and address of the manufacturers responsible for batch release 
Ime in naslov izdelovalca, odgovornega za sprostitev serije
Clostridium perfringens component: - Type C (strain 578) beta toxoid 
Komponenta C. perfringens: - beta toksoid tip C (sev 578)
THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” 
BESEDILO ''ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM''
dl-α-tocopheryl acetate 
dl-α-tokoferilacetat