FrancophonIA/ELRC3.0 huggingface dataset:
English: The CVMP at their meeting on 17-19 January 2017 decided that one further five-year renewal was required in view of the outstanding pharmacovigilance concerns regarding serious adverse events that were undergoing evaluation at the time of the renewal procedure.
Danish: CVMP har på deres møde den 17-19. januar 2017 besluttet at en yderligere 5-årig genregistrering er nødvendig, set i lyset af udestående betænkeligheder vedrørende alvorlige bivirkninger som på tidspunktet for genregistreringsproceduren stadig var under validering.
English: Such reactions may evolve to a more severe condition (anaphylaxis), which may be life-threatening.
Danish: Sådanne overfølsomhedsreaktioner kan udvikles til en mere alvorlig tilstand (anafylaksi), som kan være livstruende.
English: 4.8 Interaction with other medicinal products and other forms of interaction
Danish: 4.8 Interaktion med andre lægemidler og andre former for interaktion
English: Colourless suspension.
Danish: Farveløs suspension.
English: 0.1 mg. Colourless suspension.
Danish: 0,1 mg Farveløs suspension.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Danish: Hyppigheden af bivirkninger er defineret som: - Meget almindelig (flere end 1 ud af 10 behandlede dyr, der viser bivirkninger i løbet af en behandling) - Almindelige (flere end 1, men færre end 10 dyr af 100 behandlede dyr) - Ikke almindelige (flere end 1, men færre end 10 dyr af 1.000 behandlede dyr) - Sjældne (flere end 1, men færre end 10 dyr ud af 10.000 behandlede dyr) - Meget sjælden (færre end 1 dyr ud af 10.000 behandlede dyr, herunder isolerede rapporter)
English: MARKETING AUTHORISATION NUMBER(S) EU/2/12/143/001-005
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/12/143/001-005
English: Interaction with other medicinal products and other forms of interaction:
Danish: Interaktion med andre lægemidler og andre former for interaktion:
English: A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Danish: En eventuel beslutning om at anvende vaccinen umiddelbart før eller efter brug af et andet lægemiddel til dyr skal derfor tages med udgangspunkt i det enkelte tilfælde.
English: OTHER INFORMATION
Danish: ANDRE OPLYSNINGER
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 1 ml contains:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver dosis af 1 ml indeholder:
English: C. STATEMENT OF THE MRLs Not applicable.
Danish: C. ANGIVELSE AF MRL-VÆRDIER Ikke relevant.
English: Shelf life of the veterinary medicinal product as packaged for sale: 21 months.
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: 21 måneder.
English: Special warnings for each target species: Vaccinate healthy animals only.
Danish: Særlige advarsler for hver dyreart: Vacciner kun raske dyr.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
Danish: PAKNINGSSTØRRELSE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER
English: Do not mix with any other veterinary medicinal product except those mentioned in section 4.8.
Danish: Må ikke blandes med andre lægemidler til dyr end dem, der er nævnt i afsnit 4.8.
English: A small transient swelling at the site of injection (≤ 4 cm), which can occasionally be firm and painful on palpation, has been observed very commonly in clinical studies.
Danish: En lille forbigående hævelse på injektionsstedet (≤ 4 cm), som sommetider kan være fast og øm ved palpation, er observeret som meget almindeligt i kliniske studier.
English: Date of last renewal: 13/03/2017.
Danish: Dato for seneste fornyelse af markedsføringstilladelse: 13/03/2017.
English: 6.2 Major incompatibilities
Danish: 6.2 Væsentlige uforligeligheder
English: Special precautions for use in animals Not applicable.
Danish: Særlige forsigtighedsregler vedrørende brug til dyr Ikke relevant.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside (http://www.ema.europa.eu/)
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE
Danish: TEKSTEN “KUN TIL DYR” SAMT BETINGELSER ELLER BEGRÆNSNINGER FOR UDLEVERING OG BRUG, OM NØDVENDIGT
English: IMMUNOLOGICAL PROPERTIES
Danish: IMMUNOLOGISKE EGENSKABER
English: Incompatibilities: Do not mix with any other veterinary medicinal products except the above mentioned vaccines.
Danish: Uforligeligheder: Må ikke blandes med andre lægemidler til dyr end de ovenfor nævnte vacciner.
English: Overdose (symptoms, emergency procedures, antidotes):
Danish: Overdosis (symptomer, nødforanstaltninger, modgift):
English: In very rare cases, clinical signs of immune-mediated haemolytic anaemia, immune-mediated thrombocytopenia, or immune-mediated polyarthritis have been reported.
Danish: I meget sjældne tilfælde er rapporteret kliniske tegn på immun-medieret hæmolytisk anæmi, immunmedieret thrombocytopeni eller immun-medieret polyarthritis.
English: 5 x 1 ml (1 dose) 10 x 1 ml (1 dose) 25 x 1 ml (1 dose) 50 x 1 ml (1 dose) 10 ml (10 doses)
Danish: 5x 1 ml (1 dosis) 10x 1 ml (1 dosis) 25x 1 ml (1 dosis) 50x 1 ml (1 dosis) 1x 10 ml (10 doser)
English: Ask your veterinary surgeon how to dispose of medicines no longer required.
Danish: Kontakt din dyrlæge vedrørende bortskaffelse af lægemidler, der ikke længere findes anvendelse for.
English: BATCH NUMBER Lot {number}
Danish: BATCHNUMMER Batch, {nummer}
English: Pharmacotherapeutic group: Immunologicals for Canidae, inactivated bacterial vaccines.
Danish: Farmakoterapeutisk gruppe: Immunologisk inaktiverede bakterielle vacciner til canidae.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Danish: DATO FOR SENESTE GODKENDELSE AF INDLÆGSSEDLEN Nærmere oplysninger om dette veterinærlægemiddel er tilgængelige på webstedet for Det Europæiske Lægemiddelagentur (EMA) http://www.ema.europa.eu/.
English: MANUFACTURER'S BATCH NUMBER Lot {number}
Danish: FREMSTILLERENS BATCHNUMMER Batch {nummer}
English: In case of ocular irritation seek medical advice immediately and show the package leaflet or the label to the physician.
Danish: I tilfælde af øjenirritation skal der straks søges lægehjælp, og indlægsseddel eller etiket bør vises lægen.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE
English: A mild and transient increase in body temperature (≤ 1 °C) has been observed very commonly in clinical studies for a few days after vaccination, with some pups showing less activity and/or a reduced appetite.
Danish: Let forbigående øget kropstemperatur (≤ 1°C) er observeret som meget almindeligt i kliniske studier i få dage efter vaccination, hvorfor nogle hvalpe kan vise nedsat aktivitet og ædelyst.
English: For example, local swelling, which can be up to 5 cm in diameter and which may take over 5 weeks to completely disappear, may be observed at the site of injection.
Danish: Eksempelvis kan lokal hævelse på injektionsstedet blive op til 5 cm i diameter og være mere end 5 uger om at forsvinde helt.
English: 6.5 Nature and composition of immediate packaging
Danish: 6.5 Den indre emballagens art og indhold
English: Subcutaneous use.
Danish: Til subkutan anvendelse.
English: Type I glass vial of 1 ml (1 dose) or 10 ml (10 doses) closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap.
Danish: Type I hætteglas af 1 ml (1 dosis) eller 10 ml (10 doser) lukket med halogenobutyl gummiprop og forseglet med en kodet aluminiumshætte.
English: ANNEX IV GROUNDS FOR ONE ADDITIONAL RENEWAL
Danish: BILAG IV ÅRSAG TIL EN YDERLIGERE FORNYELSE AF MARKEDSFØRINGSTILLADELSEN
English: SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use.
Danish: SÆRLIG(E) ADVARSEL/ADVARSLER, OM NØDVENDIGT Læs indlægssedlen inden brug.
English: Shelf life after reconstitution of Nobivac vaccines according to directions: 45 mins.
Danish: Opbevaringstid efter rekonstituering af Nobivac vacciner: 45 min.
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the products mentioned above.
Danish: Der foreligger ingen oplysninger om sikkerhed og effekt af vaccinen ved samtidig brug med andre lægemidler til dyr end dem, der er nævnt ovenfor.
English: No adverse reactions other than those mentioned in section 6 were observed after the administration of a double dose of vaccine.
Danish: Der blev ikke set andre bivirkninger end dem nævnt under afsnit 6 efter administration af dobbelt dosis vaccine.
English: No adverse reactions other than those mentioned in section 4.6 were observed after the administration of a double dose of vaccine.
Danish: Der blev ikke set andre bivirkninger end dem nævnt under afsnit 4.6 efter administration af dobbelt dosis vaccine.
English: Pregnancy: Can be used during pregnancy.
Danish: Drægtighed: Kan anvendes under drægtighed.
English: 4.11 Withdrawal period
Danish: 4.11 Tilbageholdelsestid
English: Can be used during pregnancy.
Danish: Kan anvendes under drægtighed.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Nobivac L4
Danish: VETERINÆRLÆGEMIDLETS NAVN Nobivac L4
English: Revaccination: Dogs should be re-vaccinated annually with one dose (1 ml) of vaccine.
Danish: Revaccination: Hunde bør revaccineres årligt med en dosis (1 ml).
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each dose of 1 ml contains:
Danish: ANGIVELSE AF DE AKTIVE STOFFER OG ANDRE INDHOLDSSTOFFER Hver dosis af 1 ml indeholder:
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER ETIKET
English: (*) In case of high level of maternally derived antibodies, first vaccination is recommended at 9 weeks of age.
Danish: (*) I tilfælde af højt niveau af maternelt deriverede antistoffer, anbefales første vaccination ved 9 ugers alderen.
English: Vaccination scheme: Basic vaccination: The first vaccination can be administered from 6 to 9(*) weeks of age and the second vaccination from 10 to 13 weeks of age.
Danish: Basisvaccination: Den første vaccination kan gives fra 6-9(*) ugers alderen og den anden fra 10-13 ugers alderen.
English: (just for 10 ml vials)
Danish: (kun for 10 ml hætteglas)
English: The mixed vaccines should be at room temperature (15°C - 25°C) before they are administered by subcutaneous injection.
Danish: De opblandede vacciner skal opnå rumtemperatur (15°C - 25°C) inden de administreres ved subkutan injektion.
English: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The NETHERLANDS
Danish: Wim de Körverstraat 35 5831 AN Boxmeer Holland
English: Thiomersal
Danish: Hjælpestof: Thiomersal
English: When mixed with these Nobivac vaccines, the demonstrated safety and efficacy claims for Nobivac L4 are no different from those described for Nobivac L4 alone.
Danish: Når Nobivac L4 blandes med disse Nobivac vacciner er oplysningerne om sikkerhed og effekt ikke forskellig fra dem beskrevet ved at anvende Nobivac L4 alene.
English: Pack sizes:
Danish: Pakningsstørrelser:
English: CONTRAINDICATIONS
Danish: KONTRAINDIKATIONER
English: EXP {month/year}
Danish: {måneder/år}
English: Once broached, use within 10 hours.
Danish: Efter anbrud/åbning anvendes inden 10 timer.
English: Shelf life after first opening the immediate container: 10 hours.
Danish: Opbevaringstid efter første åbning af beholderen: 10 timer.
English: Vaccinate healthy animals only.
Danish: Kun raske dyr må vaccineres.
English: MARKETING AUTHORISATION NUMBER(S)
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE)
English: SC
Danish: s.c.
English: If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Danish: Dette gælder også bivirkninger, der ikke allerede er anført i denne indlægsseddel eller hvis du mener, at dette lægemiddel ikke har virket efter anbefalingerne.
English: STATEMENT OF ACTIVE SUBSTANCES Read the package leaflet before use.
Danish: ANGIVELSE AF AKTIVE STOFFER Læs indlægssedlen inden brug.
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Danish: Ikke anvendte veterinærlægemidler, samt affald heraf bør destrueres i henhold til lokale retningslinjer.
English: The product information of the relevant Nobivac vaccines should be consulted before administration of the mixed product.
Danish: Læs produktresumeet til de relevante Nobivac vacciner inden anvendelse af blandet produkt.
English: PHARMACEUTICAL FORM Suspension for injection.
Danish: LÆGEMIDDELFORM Injektionsvæske, suspension.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous use.
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Subkutan anvendelse.
English: PHARMACEUTICAL FORM Suspension for injection
Danish: LÆGEMIDDELFORM Injektionsvæske, suspension
English: PACKAGE SIZE
Danish: PAKNINGSSTØRRELSE
English: Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with vaccines of the Nobivac series containing Bordetella bronchiseptica and/or parainfluenza virus components for intranasal administration.
Danish: Der foreligger oplysninger om sikkerhed og virkning, som viser, at vaccinen kan gives samme dag som, men ikke blandet med Nobivac-vacciner indeholdende Bordetella bronchiseptica og/eller parainfluenzavirus komponenter til intranasal administration.
English: WITHDRAWAL PERIOD(S) Not applicable.
Danish: TILBAGEHOLDELSESTID(er) Ikke relevant
English: When mixed with Nobivac vaccines containing canine parainfluenza virus at annual revaccination, it has been established that there is no interference with the anamnestic response induced by the injectable canine parainfluenza virus component.
Danish: Når Nobivac L4 blandes med Nobivac vacciner som indeholder hundeparainfluenzavirus ved årlig revaccination, er det påvist, at der ingen interferens er med det anamnestiske respons induceret ved injektion med hundeparainfluenzavirus komponenten.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN SAMT PÅ DEN INDEHAVER AF VIRKSOMHEDSGODKENDELSE, SOM ER ANSVARLIG FOR BATCHFRIGIVELSE, HVIS FORSKELLIG HERFRA
English: Cardboard box with 1 vial of 10 ml (10 doses).
Danish: Karton med 1 hætteglas af 10 ml (10 doser).
English: 1 Antigenic mass ELISA units.
Danish: (stamme Gr-01-005) 1 Antigen masse ELISA-enheder.
English: 290-1000 U1
Danish: 290-1000 E1
English: Plastic box with 5, 10, 25 or 50 vials of 1 ml (1 dose).
Danish: Plastikæske med 5, 10, 25 eller 50 hætteglas af 1 ml (1 dosis).
English: Sodium chloride Potassium chloride Disodium phosphate dihydrate Potassium dihydrogen phosphate
Danish: Dinatriumphosphatdihydrat Kaliumdihydrogenphosphat Vand til injektionsvæsker
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only.
Danish: TEKSTEN ”TIL DYR” Kun til dyr.
English: Plastic box with 5, 10, 25 or 50 vials of 1 ml Cardboard box with 1 vial of 10 ml
Danish: Plastikæske med 5, 10, 25 eller 50 hætteglas af 1 ml Karton med1 hætteglas af 10 ml
English: To stimulate active immunity in dogs against L. interrogans serogroup Canicola serovar Canicola, L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni, L. interrogans serogroup Australis serovar Bratislava, and L. kirschneri serogroup Grippotyphosa serovar Bananal/Lianguang.
Danish: Til stimulering af aktiv immunitet hos hunde mod L. interrogans serogruppe Canicola serovar Canicola, L. interrogans serogruppe Icterohaemorrhagiae serovar Copenhageni, L. interrogans serogruppe Australis serovar Bratislava og L. kirschneri serogruppe Grippotyphosa serovar Bananal/Lianguang.
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Danish: DOSERING FOR HVER DYREART, ANVENDELSESMÅDE OG INDGIVELSESVEJ Til subkutan anvendelse.
English: 650-1300 U1
Danish: 650-1300 E1
English: Marketing authorisation holder and manufacturer responsible for batch release:
Danish: Indehaver af markedsføringstilladelsen og fremstiller ansvarlig for batchfrigivelse:
English: 500-1700 U1
Danish: 500-1700 E1
English: ADVICE ON CORRECT ADMINISTRATION Before use, ensure that the vaccine is at room temperature (15°C - 25°C).
Danish: OPLYSNINGER OM KORREKT ANVENDELSE Det skal sikres at vaccinen har rumtemperatur (15°C - 25°C) før brug.
English: 4.2 Indications for use, specifying the target species
Danish: 4.2 Terapeutiske indikationer med angivelse af dyrearter, som lægemidlet er beregnet til
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLERE AF DE BIOLOGISK AKTIVE STOFFER OG INDEHAVER AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
English: 6.1 List of excipients
Danish: 6.1 Fortegnelse over hjælpestoffer
English: Administer two vaccinations of 1 dose (1 ml) of vaccine with an interval of 4 weeks to dogs from 6 weeks of age onwards.
Danish: Til hunde på 6 uger eller ældre gives to vaccinationer af en dosis (1 ml ) med et interval af 4 uger.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Nobivac L4 suspension for injection for dogs
Danish: VETERINÆRLÆGEMIDLETS NAVN Nobivac L4, injektionsvæske, suspension til hunde
English: For simultaneous use, 1 dose of a Nobivac vaccine containing canine distemper virus, canine adenovirus type 2, canine parvovirus and/or canine parainfluenza virus components should be reconstituted with 1 dose (1 ml) of Nobivac L4.
Danish: Ved samtidig anvendelse af 1 dosis Nobivac vaccine indeholdende hundesygevirus, hundens type-2 adenovirus, hundeparvovirus og/eller hundeparainfluenzavirus komponenter, skal den rekonstitueres med 1 dosis (1 ml) Nobivac L4.
English: For simultaneous use, 1 dose of a Nobivac vaccine containing canine distemper virus, canine adenovirus type 2, canine parvovirus, and/or canine parainfluenza virus components should be reconstituted with 1 dose (1 ml) of Nobivac L4.
Danish: Ved samtidig anvendelse af 1 dosis Nobivac vaccine indeholdende hundesygevirus, hundens type-2 adenovirus, hundeparvovirus, og/eller hundeparainfluenzavirus komponenter, skal den rekonstitueres med 1 dosis (1 ml) Nobivac L4.
English: MARKETING AUTHORISATION HOLDER
Danish: INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN
English: In vitro and in vivo data in non-target species suggests that the vaccine may provide a degree of crossprotection against L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae and L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa.
Danish: In vitro og in vivo data fra andre dyrearter end hund antyder at vaccinen kan give nogen grad af krydsbeskyttelse mod L. interrogans serogruppe Icterohaemorrhagiae serovar Icterohaemorrhagiae og L. kirschneri serogruppe Grippotyphosa serovar Grippotyphosa.
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with vaccines of the Nobivac series containing canine distemper virus, canine adenovirus type 2, canine parvovirus and/or canine parainfluenza virus components for subcutaneous administration.
Danish: Der foreligger oplysninger om sikkerhed og virkning, som viser, at vaccinen kan blandes og anvendes med Nobivac-vacciner indeholdende hundesygevirus, hundens type-2 adenovirus, hundeparvovirus og/eller hundeparainfluenzavirus komponenter til subkutan anvendelse.
English: PACKAGE LEAFLET: Nobivac L4 suspension for injection for dogs
Danish: INDLÆGSSEDDEL Nobivac L4, injektionsvæske, suspension til hunde
English: THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” Keep out of the sight and reach of children.
Danish: TEKSTEN “OPBEVARES UTILGÆNGELIGT FOR BØRN” Opbevares utilgængeligt for børn.
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE, OM NØDVENDIGT
English: SPECIAL STORAGE PRECAUTIONS
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VEDRØRENDE OPBEVARING
English: Before use, ensure that the vaccine is at room temperature (15°C - 25°C).
Danish: Det skal sikres at vaccinen har rumtemperatur (15°C - 25°C) før brug.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) See package leaflet.
Danish: MÆNGDEN AF AKTIVT STOF (AKTIVE STOFFER) Læs indlægssedlen inden brug.
English: Name and address of the manufacturer responsible for batch release
Danish: Navn og adresse på fremstilleren ansvarlig for batchfrigivelse Intervet International B.V.
English: Name and address of the manufacturer of the biological active substances
Danish: Navn og adresse på fremstilleren af de biologisk aktive stoffer Intervet International B.V.
English: - L. kirschneri serogroup Grippotyphosa serovar Dadas (strain Gr-01-005)
Danish: (stamme As-05-073) - L. kirschneri serogruppe Grippotyphosa serovar Dadas
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription.
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER FOR MARKEDSFØRINGSTILLADELSEN VEDRØRENDE UDLEVERING OG BRUG
English: Inactivated Leptospira strains: - L. interrogans serogroup Canicola serovar Portland-vere (strain Ca-12-000)
Danish: Inaktiveret Leptospira stammer: - L. interrogans serogruppe Canicola serovar Portland-vere 3550-7100 E1
English: 0.1 mg. For the full list of excipients, see section 6.1.
Danish: 0,1 mg Alle hjælpestoffer er anført under pkt.
English: Avoid accidental self-injection or contact with the eyes.
Danish: Særlige forsigtighedsregler for personer, som indgiver lægemidlet til dyr Undgå uheld med selvinjektion eller kontakt med øjnene.
English: - L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni (strain Ic-02-001)
Danish: (stamme Ca-12-000) - L. interrogans serogruppe Icterohaemorrhagiae serovar
English: ROUTE(S) OF ADMINISTRATION
Danish: INDGIVELSESVEJ(E)
English: Dogs
Danish: Holland
English: ADVERSE REACTIONS
Danish: SÆRLIGE ADVARSLER
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Danish: Særlige forholdsregler der skal træffes af personer, der administrerer lægemidlet til dyr: Undgå uheld med selvinjektion eller kontakt med øjnene.
English: - L. interrogans serogroup Australis serovar Bratislava (strain As-05-073)
Danish: Copenhageni (stamme Ic-02-001) - L. interrogans serogruppe Australis serovar Bratislava
English: For active immunisation of dogs against: - L. interrogans serogroup Canicola serovar Canicola to reduce infection and urinary excretion - L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni to reduce infection and urinary excretion - L. interrogans serogroup Australis serovar Bratislava to reduce infection - L. kirschneri serogroup Grippotyphosa serovar Bananal/Lianguang to reduce infection and urinary excretion.
Danish: Til aktiv immunisering af hunde mod: - L. interrogans serogruppe Canicola serovar Canicola for at begrænse infektion og udskillelse i urin.
English: TARGET SPECIES
Danish: DYREARTER Hunde
English: London, 26 June 2008 Doc.
Danish: London, 26. juni 2008 Dok.
English: What is Spanidin?
Danish: Hvad er Spanidin?
English: QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for SPANIDIN
Danish: SPØRGSMÅL OG SVAR VEDRØRENDE TILBAGETRÆKNINGEN AF ANSØGNINGEN OM MARKEDSFØRINGSTILLADELSE for SPANIDIN