NOBILIS E.COLI INAC
Land: Spanien
Sprog: engelsk
Kilde: HMA (Heads of Medicines Agencies)
Produktets egenskaber
(SPC)
04-07-2012
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Aktiv bestanddel:
E.coli Y antigenic fraction 200 µg
Tilgængelig fra:
Intervet Nederland B.V.
ATC-kode:
QI01AB05
Lægemiddelform:
Emulsion for injection
Terapeutisk gruppe:
Escherichia vaccine
Terapeutisk område:
Chicken Broilers
Autorisation dato:
2010-01-21
Produktets egenskaber
Nobilis E. coli Inac Renew al (NL/V/0017/001/R/003) Proposed SPC-labelling-leaflet Day 86
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobilis E.coli inac (AT, DE, EL, IE, NL, PT, ES, UK)
Nobilis E.Coli (BE, FR)
Nobilis E.Coli inact (IT)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Per dose of 0.5 ml:
ACTIVE SUBSTANCE:
F11-antigen suspension
containing 100 µg F11 (E.coli fimbrial antigen)
68.3 mg
FT-antigen suspension
containing 100 µg FT (E.coli flagellar toxin antigen)
68.3 mg
ADJUVANT:
214.42 mg liquid paraffin
EXCIPIENTS:
0.675 mg formalin (preservative)
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Emulsion for injection
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens (broiler-breeders)
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Partial passive immunisation of broiler chickens during their first 7 weeks of life by vaccination of the
broiler breeders as a help against postnatal colibacillosis (airsac disease and septicaemia) caused by
fimbrial F11-antigen and flagellar Ft-toxin containing E. coli.
4.3
CONTRAINDICATIONS
None
4.4
SPECIAL WARNINGS
None
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Nobilis E. coli Inac Renew al (NL/V/0017/001/R/003) Proposed SPC-labelling-leaflet Day 86
Vaccinate healthy chickens only.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL
PRODUCT TO ANIMALS
To the user:
This product contains mineral oil. Accidental injection/self injection may result in severe pain and
swelling, particularly if injected into a joint or finger, and in rare cases could result in the lo
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