FrancophonIA/ELRC3.0 huggingface dataset:
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.
Danish: Dette er en undersøgelse, hvor en patient med allergi, som for øjeblikket ikke har allergisymptomer, får en bestemt dosis af et allergen (det stof, de er allergiske over for) for at fremprovokere en allergisk reaktion.
English: Other information about Emadine
Danish: Andre oplysninger om Emadine
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.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Emadine skal anvendes.
English: Emadine is not recommended for patients older than 65 years or in patients who have problems with their liver or kidneys.
Danish: Emadine anbefales ikke til patienter over 65 år eller til patienter med lever- eller nyreproblemer.
English: For more information about treatment with Emadine, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Emadine, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
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'.
Danish: Virksomheden fremlagde også resultaterne af undersøgelser, hvor patienterne fik Emadine, levocabastin eller placebo (en virkningsløs behandling), før de blev udsat for en »allergenbelastning«.
English: The bottle form of Emadine contains benzalkonium chloride, which is known to discolour soft contact lenses.
Danish: Flaskevarianten af Emadine indeholder benzalkoniumchlorid, som vides at misfarve bløde kontaktlinser.
English: The main measure of effectiveness was the reduction in itching and redness, measured on a nine-point scale over up to six weeks.
Danish: Det primære mål for virkningen var en reduktion i kløen og rødmen, som blev målt ud fra en 9-punktsskala i op til seks uger.
English: These symptoms include itching, redness and swelling.
Danish: Symptomerne er bl.a. kløe, rødme og hævelse.
English: Its effects have not been studied beyond six weeks.
Danish: Lægemidlets virkning er undersøgt i undersøgelser af højst seks ugers varighed.
English: Emadine is used in adults and children aged three years and older.
Danish: Emadine kan anvendes til voksne og børn på tre år eller derover.
English: The Committee recommended that Emadine be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af en markedsføringstilladelse for Emadine.
English: Emadine is available in a bottle and in single-dose containers.
Danish: Emadine fås i flaske og i enkeltdosisbeholdere.
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).
Danish: De hyppigste bivirkninger ved Emadine (som optræder hos mellem 1 og 2 patienter ud af 100) er øjensmerter, øjenkløe (pruritus) og konjunktival hyperæmi (øget blodtilførsel til øjet, hvilket gør øjnene røde).
English: Emadine has been compared with levocabastine (another antihistamine) in one main study involving 222 patients with seasonal conjunctivitis aged four years and over.
Danish: Emadine er blevet sammenlignet med levocabastin (et andet antihistamin) i en hovedundersøgelse med 222 patienter i alderen fire år eller derover med sæsonbetinget konjunktivitis.
English: When the receptors are blocked, histamine cannot have its effect, which leads to a decrease in the symptoms of allergy.
Danish: Når receptorerne blokeres, virker histaminet ikke, og dette fører til en reduktion af allergisymptomerne.
English: It contains the active substance emedastine (0.5 mg/ml).
Danish: Emadine er en klar øjendråbeopløsning, der indeholder det aktive stof emedastin (0,5 mg/ml).
English: For the full list of all side effects and restrictions with Emadine, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Emadine fremgår af indlægssedlen.
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.
Danish: I det lange løb faldt scoreangivelserne for kløe fra et gennemsnit på omkring 3,9 på den første dag til 0,8 for Emadine og 2,0 for levocabastin efter seks uger.
English: Emadine is used to treat the symptoms of seasonal allergic conjunctivitis (inflammation of the eyes caused by pollen in patients with hayfever).
Danish: Emadine anvendes til at behandle symptomer på sæsonbetinget allergisk konjunktivitis (betændelse i øjnene forårsaget af pollen hos patienter med høfeber).
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.
Danish: I begge patientgrupper faldt scoreangivelserne for kløe fra omkring 5,1 ved undersøgelsens start til omkring 3,8 efter fem minutter og omkring 2,7 efter to timer.
English: Similar reductions in redness scores were seen, falling from 4.5 to 3.7 after five minutes and 2.7 after two hours.
Danish: Lignende fald i scoreangivelserne for rødme blev observeret, idet de faldt fra 4,5 til 3,7 efter fem minutter og 2,7 efter to timer.
English: What is the risk associated with Emadine?
Danish: Hvilken risiko er der forbundet med Emadine?
English: For redness, the scores fell from around 2.7 to 0.5 for Emadine and to 1.1 for levocabastine.
Danish: Scoreangivelserne for rødme faldt fra omkring 2,7 til 0,5 for Emadine og til 1,1 for levocabastin.
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.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) besluttede, at fordelene ved Emadine opvejer risiciene ved symptomatisk behandling af sæsonbetinget allergisk konjunktivitis.
English: Emadine was as effective as levocabastine in reducing symptoms of seasonal conjunctivitis.
Danish: Emadine var lige så effektivt som levocabastin til at reducere symptomerne på sæsonbetinget allergisk konjunktivitis.
English: Emadine is given as one drop in the affected eye(s) twice a day.
Danish: Emadine gives som én dråbe i det eller de betændte øjne to gange dagligt.
English: Why has Emadine been approved?
Danish: Hvorfor blev Emadine godkendt?
English: What is Emadine?
Danish: Hvad er Emadine?
English: What benefit has Emadine shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Emadine?
English: What is Emadine used for?
Danish: Hvad anvendes Emadine til?
English: How has Emadine been studied?
Danish: Hvordan blev Emadine undersøgt?
English: It works by blocking the receptors that histamine normally attaches to. Histamine is a substance in the body that causes allergic symptoms.
Danish: Det virker ved at blokere de receptorer, som histaminet normalt binder sig til.
English: How is Emadine used?
Danish: Hvordan anvendes Emadine?
English: How does Emadine work?
Danish: Hvordan virker Emadine?
English: The bottles are packed individually in a carton box.
Danish: Flaskerne er pakket individuelt i æsker af karton.
English: Avoid the introduction of contamination.
Danish: Undgå kontaminering.
English: 4.8 Interaction with other medicinal product and other forms of interaction
Danish: 4.8 Interaktion med andre lægemidler og andre former for interaktion
English: DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN
English: The duration of protection is 6 months.
Danish: Beskyttelsen varer i 6 måneder.
English: Re-vaccination: Every 6 months, using a single dose.
Danish: Revaccination: Hver 6. måned, med en dosis.
English: Detailed information on this product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu/.
Danish: Nærmere oplysninger om dette veterinærlægemiddel er tilgængelige på webstedet for Det Europæiske Lægemiddelagentur (EMEA) http://www.emea.eu.int/
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:
Danish: I henhold til artikel 71 i Europaparlamentets og Rådets direktiv 2001/82/EC kan en medlemsstat forbyde import, salg, udlevering og/eller anvendelse af Porcilis Pesti på hele sit område, hvis det godtgøres at:
English: The bottles are closed with a nitryle rubber stopper and sealed with a coded aluminium cap.
Danish: Flaskerne er lukket med en nitryl gummiprop og forseglet med en kodet aluminiumkappe.
English: If you notice any serious side effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Danish: Hvis De bemærker alvorlige bivirkninger eller andre bivirkninger, som ikke er omtalt i denne indlægsseddel, bedes De kontakte Deres dyrlæge.
English: Administer one dose (2 ml) by deep intramuscular injection in the neck area behind the ear.
Danish: Indgiv en dosis (2 ml) ved dyb intramuskulær injektion i nakkemuskulaturen i området bag øret.
English: It is recommended to use a closed multiject vaccination system.
Danish: Det anbefales at bruge et lukket ”multiject” vaccinationssystem.
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.
Danish: Hjælpestofferne (inklusive adjuvanser) anført under punkt 6.1 i SPC'et er enten tilladte hjælpestoffer, hvor tabel 1 i bilaget til Kommissionens forordning (EU) Nr. 37/2010 indikerer, at MRL-værdier ikke er påkrævet, eller som ikke anses for at være omfattet af Forordning (EC) nr. 470/2009, når de anvendes i et veterinærlægemiddel.
English: Manufacturer of the biological active substance:
Danish: Fremstilleren af det biologisk aktive stof
English: According to Community Legislation on Classical swine fever (Council Directive 80/217/EEC, as amended), in the European Union:
Danish: I følge EU-lovgivning vedrørende Klassisk Svinepest (Rådets direktiv 80/217/EØF, med ændringer), i den europæiske union:
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;
Danish: Dog kan brugen af vacciner være tilladt i forbindelse med en nødvaccinationsplan, der er iværksat af den kompetente myndighed i et medlemsland efter diagnosticering af sygdom og i overensstemmelse med EU-lovgivning vedrørende kontrol og udryddelse af Klassisk Svinepest;
English: Polysorbate 80
Danish: Polysorbat 80 Sorbitanoleat
English: MARKETING AUTHORISATION NUMBER(S) EU/2/99/016/001 - EU/2/99/016/006
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/99/016/001 - EU/2/99/016/006
English: The onset of protection is 2 weeks.
Danish: Beskyttelsen indtræder efter 2 uger.
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.
Danish: Da sikkerheden ved at give begge vaccinationer samme sted ikke er undersøgt, tilrådes det at give 2. vaccination på et andet sted end 1. vaccination.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Intervet International B.V.,
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Intervet International B.V.,
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.
Danish: a) behandling af dyr med lægemidlet griber forstyrrende ind i gennemførelsen af et nationalt program til diagnosticering, bekæmpelse eller udryddelse af sygdomme hos dyr eller gør det vanskeligt at bekræfte, at levende dyr, levnedsmidler eller andre produkter hidrørende fra behandlede dyr ikke er kontamineret b) den sygdom, som lægemidlet er beregnet til at fremkalde immunitet mod, stort set ikke forekommer i det pågældende område.
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.
Danish: Enhver person, der påtænker at indføre, sælge, levere og/eller anvende dette veterinære lægemiddel, skal være godkendt af rette myndighed i det pågældende medlemsland.
English: Classical Swine Fever vaccine, ATC vet code: QI09AA06
Danish: Klassisk Svinepest vaccine, ATCvet-kode: QI09AA06
English: Manufacturer responsible for batch release
Danish: Fremstiller ansvarlig for batchfrigivelse
English: After administration of an overdose, local reactions at the injection site may be more pronounced.
Danish: Ved overdosering kan lokale reaktioner på injektionsstedet være mere udtalte.
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;
Danish: b) Opbevaring, udlevering, distribuering og salg af vacciner mod Klassisk Svinepest skal ske under kontrol af - og i overensstemmelse med eventuelle instruktioner udformet af den kompetente myndighed i medlemslandet;
English: The active substance stimulates active immunity against Classical Swine Fever (CSF).
Danish: Den aktive komponent stimulerer til aktiv immunitet mod Klassisk Svinepest (CSF).
English: BATCH NUMBER <Batch> <Lot> <BN> {number}
Danish: BATCHNUMMER <Batch>, <Lot>,<BN>{nummer}
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.
Danish: c) Der findes særlige forordninger, der regulerer flytning af svin fra områder, hvor vaccine mod Klassisk Svinepest anvendes eller har været anvendt, samt mærkning af svinekød fra vaccinerede svin.
English: Basic vaccination: Inject one dose per pig followed by a second injection 4 weeks after the first injection.
Danish: Basisvaccination: Indgiv en dosis pr. gris efterfulgt af endnu en vaccination 4 uger efter første vaccination.
English: Use sterile syringes and needles.
Danish: Brug sterile sprøjter og kanyler.
English: Abscesses may be observed at the injection site.
Danish: Abscesser kan forekomme på injektionsstedet.
English: a) The use of classical swine fever vaccines is prohibited.
Danish: a) Brug af vacciner mod Klassisk Svinepest er forbudt.
English: INDICATION(S) Vaccine against Classical Swine Fever
Danish: INDIKATION(ER) Vaccine mod Klassisk Svinepest
English: SPECIAL WARNING(S), IF NECESSARY Accidental self-injection is dangerous
Danish: SÆRLIG(E) ADVARSEL/ADVARSLER, OM NØDVENDIGT Selv-injektion ved uheld er farligt
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.
Danish: En lokal, og i de fleste tilfælde forbigående, hævelse på injektionsstedet kan forekomme op til 4 uger efter indgift af hver vaccinedosis.
English: 120 Elisa Units CSF-E2 antigen.
Danish: 120 Elisa enheder CSF-E2 antigen.
English: MANUFACTURER'S BATCH NUMBER <Batch> <Lot> <BN> {number}
Danish: FREMSTILLERENS BATCHNUMMER <Batch>, >Lot>, <BN> {nummer}
English: Liquid paraffin : 941.4 mg
Danish: Paraffinolie: 941,4 mg
English: Pigs.
Danish: Svin
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).
Danish: Import, salg, levering og/eller anvendelse af Porcilis Pesti er kun tilladt under de særlige betingelser fastsat i den Europæiske Unions lovgivning vedrørende kontrol af CSF (Rådets direktiv 80/217/EEC med senere ændringer).
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.
Danish: Klassisk Svinepest virus E2 subunit antigenet er inkorporeret i en emulsion for at forlænge stimulationen af dyrets immunsystem.
English: Shelf-life after first broaching the bottle: 3 hours.
Danish: Opbevaringstid efter første åbning af beholderen: 3 timer.
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).
Danish: Import, salg, levering og/eller anvendelse af dette veterinære lægemiddel er kun tilladt under de særlige betingelser fastsat i den Europæiske Unions lovgivning vedrørende kontrol af CSF (Rådets direktiv 80/217/EEC med senere ændringer).
English: EXPIRY DATE <EXP {month/year}> Once broached, use within 3 hours.
Danish: UDLØBSDATO <EXP> {måned/år} Anvendes inden 3 timer efter åbning.
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator (2°C to 8°C).
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i køleskab (2ºC til 8C).
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Per dose of 2 ml:
Danish: ANGIVELSE AF AKTIVE STOFFER OG ANDRE STOFFER Pr. dosis af 2 ml:
English: 120 Elisa Units Classical Swine Fever Virus-E2 subunit antigen Liquid paraffin as adjuvant: 941.4 mg
Danish: 120 Elisa enheder Klassisk Svinepest virus - E2 subunit antigen Paraffinolie som adjuvans: 941,4 mg
English: Active immunisation of pigs from the age of 5 weeks onwards to prevent mortality and to reduce clinical signs of Classical Swine Fever, as well as to reduce infection with and excretion of CSF field virus.
Danish: Til aktiv immunisering af svin fra 5-ugers alderen for at forebygge dødelighed og reducere de kliniske symptomer ved Klassisk Svinepest, samt reducere infektionstryk og udskillelse af CSF vild-virus.
English: 4.2 Indications for use, specifying the target species Active immunisation of pigs from the age of 5 weeks onwards to prevent mortality and to reduce clinical signs of Classical Swine Fever, as well as to reduce infection with and excretion of CSF field virus.
Danish: 4.2 Terapeutiske indikationer med angivelse af dyrearter, som lægemidlet er beregnet til Til aktiv immunisering af svin fra 5-ugers alderen for at forebygge dødelighed og reducere de kliniske symptomer ved Klassisk Svinepest, samt reducere infektionstryk og udskillelse af CSF vild-virus.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each dose of 2 ml contains:
Danish: ANGIVELSE AF DE(T) AKTIVE STOF(FER) OG ANDRE INDHOLDSSTOFFER Hver dosis af 2 ml indeholder:
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) 120 Elisa Units CSF E2 antigen/2ml.
Danish: MÆNGDEN AF AKTIVT STOF (AKTIVE STOFFER) 120 Elisa enheder CSF E2 antigen/2 ml.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/99/016/001-006
Danish: EU/2/99/016/001-006
English: Excipients: For a full list of excipients, see section 6.1
Danish: Se afsnit 6.1 for en fuldstændig fortegnelse over hjælpestoffer.
English: Active substance: Classical Swine Fever Virus (CSFV) -E2 subunit antigen: 120 Elisa Units (EU)
Danish: Klassisk Svinepest virus (CSFV)-E2 subunit antigen: 120 Elisa Units (EU) Adjuvans:
English: Before use, allow the vaccine to reach room temperature.
Danish: Lad vaccinen opnå stuetemperatur før brug.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis Pesti emulsion for injection for pigs
Danish: VETERINÆRLÆGEMIDLETS NAVN Porcilis Pesti injektionsvæske, emulsion til grise
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Danish: Særlige forsigtighedsregler for personer, som indgiver lægemidlet til dyr Til brugeren:
English: Shelf life of the veterinary medicinal product as packaged for sale: 12 months Shelf life after first broaching the bottle: 3 hours.
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: 12 måneder.
English: As a consequence of the subunit nature of the vaccine, vaccination does not induce production of antibodies against CSF virus antigen, other than E2.
Danish: Som følge af at vaccinen er en subunitvaccine, vil vaccination ikke føre til dannelse af antistoffer mod andre CSF virusantigener end E2.
English: Can be used during pregnancy but may not prevent transplacental transmission of Classical swine fever field virus from the sow to foetuses.
Danish: Kan anvendes under drægtighed, men det forhindrer nødvendigvis ikke transplacental overførsel af Klassisk Svinepest vildvirus fra soen til fostrene.
English: The product can be used during pregnancy but may not prevent transplacental transmission of Classical swine fever field virus from the sow to foetuses.
Danish: Lægemidlet kan anvendes under drægtighed, men forhindrer nødvendigvis ikke transplacental overførsel af Klassisk Svinepest vildvirus fra soen til fostrene.
English: Adjuvant: 941.4 mg liquid paraffin
Danish: 941,4 mg paraffinolie
English: C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
Danish: C. BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN HERUNDER BEGRÆNSNINGER VEDRØRENDE SIKKER OG EFFEKTIV BRUG
English: 6.5 Nature and composition of immediate packaging Bottles of type I hydrolytic glass or polyethylene terephthalate (PET) containing 50 ml for 25 doses, 100 ml for 50 doses and 250 ml for 125 doses presentation.
Danish: Flasker af hydrolytisk glas type I eller polyethylen terephthalate (PET) indeholdende 50 ml svarende til 25 doser, 100 ml svarende til 50 doser eller 250 ml svarende til 125 doser.
English: MINIMUM PARTICULARS TO APPEAR ON Bottle Label {50ml/100ml/250ml }
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ flakseetiket {50 ml / 100 ml / 250 ml}
English: PACKAGE SIZE 50 ml (25 doses) - 100 ml (50 doses) - 250 ml (125 doses)
Danish: PAKNINGSSTØRRELSE 50 ml (25 doser) - 100 ml (50 doser) - 250 ml (125 doser)
English: 50 ml/100 ml/250 ml multidose glass bottle
Danish: 50 ml/100 ml/250 ml multidosis glasflaske
English: 50 ml/100 ml/250 ml multidose PET bottle
Danish: 50 ml/100 ml/250 ml multidosis PET-flaske
English: Each dose of 2 ml contains:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver dosis af 2 ml indeholder:
English: Transient hyperthermia may occur post the second dose.
Danish: Forbigående feber kan forekomme efter 2. vaccination.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE {50ml Bottle/ 100ml Bottle/250ml Bottle}
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE 50 ml flaske / 100 ml flaske / 250 ml flaske
English: ROUTE(S) OF ADMINISTRATION IM injection
Danish: INDGIVELSESVEJ(E) i.m.
English: METHOD AND ROUTE(S) OF ADMINISTRATION IM injection of 2 ml
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) i.m.
English: {DD/MM/YYYY}
Danish: DATO FOR ÆNDRING AF TEKSTEN dd/mm/åååå
English: Special precautions for use in animals
Danish: 4.5 Særlige forsigtighedsregler vedrørende brugen Særlige forsigtighedsregler vedrørende brug til dyr Vacciner kun raske dyr.
English: Patients should be made aware of this.
Danish: Patienter skal være gjort klar over dette.