FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, the PRAC concluded that the benefits of injectable forms of these medicines continue to outweigh their risks when used under specific conditions: these medicines should only be used to suppress premature labour for up to 48 hours, between the 22nd and the 37th weeks of pregnancy and under specialist supervision with continuous monitoring of the mother and the unborn baby.
Estonian: Seetõttu järeldas ravimiohutuse riskihindamise komitee, et nende ravimite süstitavate ravimvormide kasulikkus ületab riski kasutamisel spetsiifilistes tingimustes: ravimeid tohib kasutada ainult enneaegse sünnitustegevuse pärssimiseks kuni 48 tunni jooksul 22. kuni 37. rasedusnädalal ja spetsialisti
English: These recommendations follow a review by the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC), which looked into the known risk of cardiovascular side effects (problems affecting the heart and blood vessels) with high doses of short-acting beta-agonists when used as tocolytics (medicines that suppress labour contractions).
Estonian: Soovitused järgivad Euroopa Ravimiameti ravimiohutuse riskihindamise komitee ülevaadet lühitoimeliste beeta-agonistide suurte annuste kasutamise kohta tokolüütikumidena (ravimid, mis pärsivad tuhusid) ja sellega kaasneva teadaoleva riski kohta kardiovaskulaarsete kõrvaltoimete (südant ja veresooni mõjutavate probleemide) tekkimiseks.
English: These recommendations follow a review of available cardiovascular safety data on the medicines fenoterol, hexoprenaline, isoxsuprine, ritodrine, salbutamol and terbutaline when used in obstetric indications.
Estonian: Soovitused tulenevad fenoterooli, heksoprenaliini, isoksupriini, ritodriini, salbutamooli ja terbutaliini kardiovaskulaarsete ohutusandmete ülevaatest kasutamisel sünnitusabi näidustustel.
English: As the PRAC recommendations have been endorsed by consensus by the CMDh, they will now be implemented directly in all Member States, according to an agreed timetable.
Estonian: Et inimravimite vastastikuse tunnustamise ja detsentraliseeritud menetluste töörühm kinnitas konsensuse alusel ravimiohutuse riskihindamise komitee soovitused, rakendavad kõik liikmesriigid need otseselt kokkulepitud ajakava alusel.
English: • Although these medicines are also used for the treatment of asthma, they are usually given at lower doses for this condition; if you are being treated with short-acting beta-agonists and have any questions or concerns about your treatment, speak to your doctor or pharmacist.
Estonian: Kui teid ravitakse lühitoimeliste beeta-agonistidega ja teil on mingeid küsimusi ravi kohta, rääkige oma arsti või apteekriga.
English: They are available as tablets, oral solutions, solutions for injection or infusion, and suppositories.
Estonian: Need on müügil tablettide, suukaudsete lahuste, süstelahuste ja ravimküünaldena.
English: The PRAC concluded that there was a risk of serious cardiovascular side effects to both the mother and unborn baby when high-dose short-acting beta-agonists are used in obstetric indications, with the data suggesting these mostly occur with prolonged use.
Estonian: Ravimiohutuse riskihindamise komitee järeldas, et lühitoimeliste beeta-agonistide suurte annuste kasutamisel sünnitusabi näidustustel esineb raskete kardiovaskulaarsete kõrvaltoimete risk nii emale kui ka sündimata lapsele.
English: The CMDh is a medicines regulatory body representing the European Union (EU) Member States recommended that they remain authorised in these indications.
Estonian: 1 Inimravimite vastastikuse tunnustamise ja detsentraliseeritud menetluste töörühm on Euroopa Liidu liikmesriike esindav ravimeid reguleeriv organ.
English: Name Strength
Estonian: Tugevus
English: It contains the active substance emedastine (0.5 mg/ml).
Estonian: See sisaldab toimeainena emedastiini (0,5 mg/ml).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Emadine on 27 January 1999.
Estonian: Euroopa Komisjon andis Emadine müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 27. jaanuaril 1999.
English: The results of the allergen challenge tests supported these results.
Estonian: Allergeeniga sihiliku kokkupuute uuringud toetasid neid tulemusi.
English: Similar results were seen in adults and in children.
Estonian: Täiskasvanute ja laste tulemused olid sarnased.
English: The full EPAR for Emadine can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Emadine kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Its effects have not been studied beyond six weeks.
Estonian: Ravimi toimet on uuritud ainult kuni 6 nädala jooksul.
English: Emadine emedastine
Estonian: Emadine emedastiin
English: The main measure of effectiveness was the reduction in itching and redness, measured on a nine-point scale over up to six weeks.
Estonian: Efektiivsuse põhinäitaja oli sügeluse ja punetuse vähenemine, mõõdetuna kuni 6 nädala jooksul 9-punktisel skaalal.
English: The Committee recommended that Emadine be given marketing authorisation.
Estonian: Komitee soovitas anda Emadine müügiloa.
English: Emadine is used in adults and children aged three years and older.
Estonian: Emadinet kasutatakse täiskasvanutel ja vähemalt 3-aastastel lastel.
English: Emadine is not recommended for patients older than 65 years or in patients who have problems with their liver or kidneys.
Estonian: Emadinet ei soovitata kasutada üle 65-aastastel ega maksa- või neeruprobleemidega patsientidel.
English: These symptoms include itching, redness and swelling.
Estonian: Need sümptomid on näiteks sügelus, punetus ja turse.
English: When the receptors are blocked, histamine cannot have its effect, which leads to a decrease in the symptoms of allergy.
Estonian: Kui retseptorid on blokeeritud, ei saa histamiin mõjuda ja selle tõttu allergiasümptomid vähenevad.
English: Emadine is available in a bottle and in single-dose containers.
Estonian: Emadinet turustatakse pudelis ja üheannuselistes pakendites.
English: The most common side effects with Emadine (which may affect between 1 and 2 patients in 100) are eye pain, eye pruritus (itchy eye) and conjunctival hyperaemia (increased blood flow to the eye, leading to redness).
Estonian: Emadine kõige sagedamad kõrvalnähud (võivad esineda 1-2 patsiendil 100st) on silmavalu, silmakihelus ja sidekesta hüpereemia (silma verevarustuse suurenemine, mis põhjustab silma punetuse).
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Emadine.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: Other information about Emadine
Estonian: Muu teave Emadine kohta
English: Emadine is given as one drop in the affected eye(s) twice a day.
Estonian: Emadinet tilgutatakse haigestunud silma (silmadesse) üks tilk kaks korda ööpäevas.
English: For more information about treatment with Emadine, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Emadinega toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: What is Emadine?
Estonian: Mis on Emadine?
English: The bottle form of Emadine contains benzalkonium chloride, which is known to discolour soft contact lenses.
Estonian: Pudelis turustatav Emadine sisaldab bensalkooniumkloriidi, mis muudab pehmete kontaktläätsede värvust.
English: Emadine has been compared with levocabastine (another antihistamine) in one main study involving 222 patients with seasonal conjunctivitis aged four years and over.
Estonian: Emadinet võrreldi levokabastiiniga (samuti antihistamiin) ühes põhiuuringus, milles osales 222 vähemalt 4-aastast hooajalise konjunktiviidiga patsienti.
English: The company also presented the results of studies in which patients received Emadine, levocabastine or placebo (a dummy treatment) before being subjected to an ‘allergen challenge'.
Estonian: Ettevõte esitas ka tulemusi uuringutest, kus patsientidele manustati enne sihilikku kokkupuudet allergeeniga Emadinet, levokabastiini või platseebot (näiv ravim).
English: Emadine is a clear eye drop solution.
Estonian: Emadine on selge silmatilgalahus.
English: The active substance in Emadine, emedastine, is an antihistamine.
Estonian: Emadine toimeaine emedastiin on antihistamiin.
English: Similar reductions in redness scores were seen, falling from 4.5 to 3.7 after five minutes and 2.7 after two hours.
Estonian: Samamoodi täheldati ka punetuspunktide vähenemist, mis vähenesid 4,5 punktilt 5 minutiga 3,7 punktini ja 2 tunniga 2,7 punktini.
English: In both groups of patients, itching scores fell from around 5.1 at the start of the study, to around 3.8 after five minutes and around 2.7 after two hours.
Estonian: Mõlemas patsiendirühmas vähenesid sügelusskaala punktid ligikaudu 5,1 punktilt ravi alguses 5 minutiga ligikaudu 3,8 punktini ja 2 tunniga ligikaudu 2,7 punktini.
English: If more than one type of eye treatment is being used, each one should be given at least 10 minutes apart and any eye ointments should be given last.
Estonian: Mitme silmaravimi kasutamisel tuleb jätta nende manustamise vahele vähemalt 10 minutit.
English: Emadine is used to treat the symptoms of seasonal allergic conjunctivitis (inflammation of the eyes caused by pollen in patients with hayfever).
Estonian: Emadinet kasutatakse hooajalise allergilise konjunktiviidi (heinanohuga patsientidel õietolmust põhjustatud silmapõletik) sümptomite raviks.
English: For the full list of all side effects and restrictions with Emadine, see the package leaflet.
Estonian: Emadine kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: What is the risk associated with Emadine?
Estonian: Mis riskid Emadinega kaasnevad?
English: In the long term, the itching scores fell from an average of around 3.9 on the first day, falling to 0.8 for Emadine and 2.0 for levocabastine after six weeks.
Estonian: Sügeluspunktid vähenesid pikema aja jooksul keskmiselt ligikaudu 3,9 punktilt esimesel päeval 6 nädalaga Emadine kasutamisel 0,8 punktini ja levokabastiini kasutamisel ligikaudu 2,0 punktini.
English: Why has Emadine been approved?
Estonian: Miks Emadine heaks kiideti?
English: It works by blocking the receptors that histamine normally attaches to. Histamine is a substance in the body that causes allergic symptoms.
Estonian: See blokeerib retseptorid, millega tavaliselt seondub histamiin (organismi aine, mis tekitab allergiasümptomeid).
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Emadine's benefits are greater than its risks for the symptomatic treatment of seasonal allergic conjunctivitis.
Estonian: Inimravimite komitee otsustas, et Emadine kasulikkus hooajalise allergilise konjunktiviidi ravis on suurem kui sellega kaasnevad riskid.
English: For redness, the scores fell from around 2.7 to 0.5 for Emadine and to 1.1 for levocabastine.
Estonian: Punetuspunktid vähenesid ligikaudu 2,7 punktilt Emadine korral 0,5 punktini ja levokabastiini korral 1,1 punktini.
English: This is a test where patients with an allergy who are not currently showing any allergic symptoms receive a defined dose of an allergen (the substance that they are allergic to) to trigger an allergic reaction.
Estonian: Uuringus manustati allergiapatsientidele, kellel uuringu alguses allergiasümptomid puudusid, allergiareaktsiooni tekitamiseks teatav annus allergeeni (ainet, mille suhtes on patsient allergiline).
English: This is a summary of the European public assessment report (EPAR) for Emadine.
Estonian: See on ravimi Emadine Euroopa avaliku hindamisaruande kokkuvõte.
English: What benefit has Emadine shown during the studies?
Estonian: Milles seisneb uuringute põhjal Emadine kasulikkus?
English: Emadine was as effective as levocabastine in reducing symptoms of seasonal conjunctivitis.
Estonian: Emadine vähendas hooajalise konjuktiviidi sümptomeid vähemalt sama efektiivselt kui levokabastiin.
English: What is Emadine used for?
Estonian: Milleks Emadinet kasutatakse?
English: How is Emadine used?
Estonian: Kuidas Emadinet kasutatakse?
English: How has Emadine been studied?
Estonian: Kuidas Emadinet uuriti?
English: How does Emadine work?
Estonian: Kuidas Emadine toimib?
English: Avoid the introduction of contamination.
Estonian: Vältida saastumist.
English: The duration of protection is 6 months.
Estonian: Kaitse kestab 6 kuud.
English: Shake well before use.
Estonian: Enne tarvitamist hästi loksutada.
English: If you notice any serious side effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Estonian: Kui täheldate tõsiseid kõrvaltoimeid või muid toimeid, mida pole käesolevas pakendi infolehes mainitud, palun teavitage sellest oma veterinaararsti.
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.
Estonian: Bioloogilist päritolu aktiivset immuunsust toetav aktiivaine ei kuulu määruse (EÜ) nr 470/2009 reguleerimisalasse.
English: Classical Swine Fever vaccine, ATC vet code: QI09AA06
Estonian: Klassikalise sigade katku vaktsiin, ATC vet kood: QI09AA06
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council, Member States prohibit or/ may prohibit the import, sale, supply and/or use of Porcilis Pesti on the whole or part of their territory if it is established that:
Estonian: Vastavalt Euroopa Parlamendi ja nõukogu direktiivi nr 2001/82/EÜ artiklile 71 keelustavad või võivad keelustada liikmesriigid Porcilis Pesti impordi, müügi, tarnimise ja/või kasutamise oma territooriumil või osal oma territooriumist, kui on tuvastatud, et:
English: The onset of protection is 2 weeks.
Estonian: Kaitse ilmneb 2 nädalaga.
English: Detailed information on this product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu/.
Estonian: Üksikasjalikku teavet antud veterinaarravimi kohta leiab Euroopa Ravimiameti (EMA) koduleheküljelt aadressil http://www.ema.europa.eu/.
English: SPECIAL WARNING(S), IF NECESSARY Accidental self-injection is dangerous
Estonian: ERIHOIATUS(ED), KUI VAJALIK Juhuslik vaktsiini enesele süstimine on ohtlik.
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 are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Estonian: Abiained (sealhulgas adjuvandid), mis on loetletud ravimi omaduste kokkuvõtte punktis 6.1. on kas lubatud ained, millele Komisjoni määruse (EL) nr 37/2010 lisa tabelis 1 viidatakse kui ravimjääkide piirnorme mittenõudvatele, või loetakse neid määruse (EÜ) nr 470/2009 reguleerimisalasse mittekuuluvateks, kui neid kasutatakse nii nagu selles veterinaarravimis.
English: It is recommended to use a closed multiject vaccination system.
Estonian: Soovitav on kasutada mitmedoosilist suletud vaktsineerimissüsteemi.
English: According to Community Legislation on Classical swine fever (Council Directive 80/217/EEC, as amended), in the European Union:
Estonian: Vastavalt Ühenduse seadusandlusele sigade klassikalise katku kohta (Nõukogu määrus 80/217/EEC parandusega) Euroopa Liidus:
English: The bottles are closed with a nitryle rubber stopper and sealed with a coded aluminium cap.
Estonian: Pudelid on suletud nitriilkummist korgiga, mis on kaetud kodeeritud alumiiniumkapsliga.
English: The bottles are packed individually in a carton box.
Estonian: Pudelid on pakendatud ühekaupa pappkarpi.
English: Administer one dose (2 ml) by deep intramuscular injection in the neck area behind the ear.
Estonian: Manustada üks doos (2 ml) sügava lihasesisese süstena kaelapiirkonda kõrva taha.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/99/016/001 - EU/2/99/016/006
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/2/99/016/001 - EU/2/99/016/006
English: DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Estonian: ESMASE MÜÜGILOA VÄLJASTAMISE / MÜÜGILOA UUENDAMISE KUUPÄEV
English: After administration of an overdose, local reactions at the injection site may be more pronounced.
Estonian: Üledoseerimise järgselt võivad lokaalsed reaktsioonid süstekohal olla rohkem väljendunud.
English: a) The use of classical swine fever vaccines is prohibited.
Estonian: a) Klassikalise sigade katku vaktsiini kasutamine on keelatud.
English: Use sterile syringes and needles.
Estonian: Kasutada steriilseid nõelu ja süstlaid.
English: Shelf-life after first broaching the bottle: 3 hours.
Estonian: Kõlblikkusaeg pärast pudeli esmakordset avamist: 3 tundi.
English: Each dose of 2 ml contains:
Estonian: Iga doos (2 ml) sisaldab:
English: 4.8 Interaction with other medicinal product and other forms of interaction
Estonian: Koostoimed teiste ravimitega ja teised koostoimed
English: Excipients: For a full list of excipients, see section 6.1
Estonian: Abiaine(d): Abiainete terviklik loetelu on esitatud punktis 6.1.
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator (2°C to 8°C).
Estonian: SÄILITAMISE ERITINGIMUSED Hoida külmkapis (2C-8C).
English: MARKETING AUTHORISATION NUMBER(S) EU/2/99/016/001-006
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/2/99/016/001-006
English: The active substance stimulates active immunity against Classical Swine Fever (CSF).
Estonian: Toimeaine stimuleerib aktiivset immuunsust sigade klassikalise katku (SKK) vastu.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Intervet International B.V.,
Estonian: MÜÜGILOA HOIDJA NIMI JA AADRESS Intervet International B.V.
English: Polysorbate 80
Estonian: Polüsorbaat 80 Sorbitaanoleaat
English: However, the use of vaccines may be authorised in the framework of an emergency vaccination plan, implemented by the competent authority of a Member State following confirmation of disease, in accordance with Community Legislation on control and eradication of classical swine fever;
Estonian: Samas võib olla vaktsineerimine lubatud hädaabi vaktsineerimisplaani raames kohaldatuna liikmesriigi kompetentse ameti poolt haigusjuhtumi esinemisel ja vastavuses Ühenduse seadusandlusega kontrollimaks ja kõrvaldamaks sigade klassikalist katku;
English: a) the administration of the product to animals will interfere with the implementation of national programmes for the diagnosis, control and elimination of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals b) the disease to which the product is intended to confer immunity is largely absent from the territory.
Estonian: a) veterinaarravimi manustamine loomadele segab veterinaarhaiguste diagnoosimise, kontrolli ja haigustõrje riiklike programmide rakendamist, või komplitseerib nakkuste puudumise tõendamist elusloomadel või toiduainetes või muudes toodetes, mis on saadud loomadelt, kellele on manustatud ravimit;
English: b) The storage, supply, distribution and sale of classical swine fever vaccines must be carried out under the control of and in accordance with the eventual instructions established by the competent authority of the Member State;
Estonian: b) Sigade klassikalise katku vaktsiini hoidmine, hankimine, levitamine ja müük peab toimuma liikmesriigi kompetentse ameti kontrolli ja juhendite alusel;
English: Before use, allow the vaccine to reach room temperature.
Estonian: Enne kasutamist lasta vaktsiinil soojendada toatemperatuurini.
English: A local and in most cases transient swelling at the injection site may occur up to 4 weeks after administration of each dose of the vaccine.
Estonian: Süstekohal võib esineda kuni 4 nädalat pärast iga vaktsiinidoosi manustamist lokaalne ja enamasti mööduv turse.
English: Since safety after giving both inoculations at the same site has not been examined, it is advised to carry out the second vaccination at a different site than the first vaccination.
Estonian: Kaks korda samasse süstekohta manustamise ohutust ei ole uuritud, seetõttu soovitatakse teistkordsel vaktsiini manustamisel kasutada erinevat süstekohta kui esimesel vaktsineerimisel.
English: Liquid paraffin : 941.4 mg
Estonian: Vedel parafiin : 941,4 mg
English: Re-vaccination: Every 6 months, using a single dose.
Estonian: Revaktsineerimine: iga 6 kuu järel üks doos.
English: BATCH NUMBER <Batch> <Lot> <BN> {number}
Estonian: PARTII NUMBER <Partii> <Saadetis> <BN>{number}
English: The import, sale, supply and/or use of Porcilis Pesti is only allowed under the particular conditions established by European Community legislation on the control of CSF (Council Directive 80/217/EEC, as amended).
Estonian: Porcilis Pesti import, turustamine, tarnimine ja/või kasutamine on lubatud ainult Euroopa Ühenduse SKK tõrjet reguleerivas seadusandluses (nõukogu direktiiv 80/217/EEC) sätestatud eritingimustel.
English: The import, sale, supply and/or use of this veterinary medicinal product is only allowed under the particular conditions established by European Community legislation on the control of CSF (Council Directive 80/217/EEC, as amended).
Estonian: Selle veterinaarravimi import, turustamine, tarnimine ja/või kasutamine on lubatud ainult Euroopa Ühenduse SKK tõrjet reguleerivas seadusandluses (nõukogu Direktiiv 80/217/EEC koos parandustega) sätestatud eritingimustel.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis Pesti emulsion for injection for pigs
Estonian: VETERINAARRAVIMI NIMETUS Porcilis Pesti süsteemulsioon sigadele
English: As a consequence of the subunit nature of the vaccine, vaccination does not induce production of antibodies against CSF virus antigens, other than E2.
Estonian: Vaktsiinile iseloomuliku alaühikuid sisaldava koostise tõttu, ei indutseeri vaktsineerimine antikehade teket muude SKK viiruse antigeenide kui vaid E2 suhtes.
English: Active substance: Classical Swine Fever Virus (CSFV) -E2 subunit antigen: 120 Elisa Units (EU)
Estonian: Toimeaine: Sigade klassikalise katku viiruse (SKKV) E2 alaühiku antigeeni: 120 Elisa ühikut (EÜ)
English: The product contains Classical Swine Fever virus E2 immunogen incorporated in an emulsion in order to prolong stimulation of the immune system of the target species.
Estonian: Preparaat sisaldab SKK viiruse E2 immunogeeni, mis imuunsüsteemi stimuleeriva toime pikendamiseks sihtliikidel on viidud emulsiooni.
English: MANUFACTURER'S BATCH NUMBER <Batch> <Lot> <BN> {number}
Estonian: TOOTJAPOOLNE PARTII NUMBER <Partii> <Saadetis> <BN> {number}
English: Adjuvant: 941.4 mg liquid paraffin
Estonian: Adjuvant: 941,4 mg vedelat parafiini
English: Store in a refrigerator (2°C to 8°C).
Estonian: Hoida külmkapis (2C-8C).
English: 120 Elisa Units CSF-E2 antigen.
Estonian: 120 Elisa ühikut SKK E2 antigeeni.
English: c) Special provisions regulate the movement of pigs from areas where classical swine fever vaccine is being or has been used and the marking of pig meat from vaccinated pigs.
Estonian: c) Piirkondades, kus kasutatakse või on kasutatud sigade klassikalise katku vastast vaktsiini, reguleerivad sigade liikumist erilised ettevaatusabinõud ja vaktsineeritud sigade liha erimärgistatakse.
English: Any person intending to import, sell, supply and/or use the veterinary medicinal product must be authorised by the competent authority of the Member State.
Estonian: Iga isik, kes plaanib importida, turustada, tarnida, ja/või kasutada Porcilis Pesti süsteemulsiooni peab omama liikmesriigi vastava ametkonna poolt välja antud tegevusluba.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) 120 Elisa Units CSF E2 antigen/2ml.
Estonian: TOIMEAINE(TE) KOGUS 120 Elisa ühikut SKK E2 antigeeni/2 ml