COLOMBOVAC PMV
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
15-05-2024
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Active ingredient:
NEWCASTLE DISEASE VIRUS STRAIN LA SOTA INACTIVATED
Available from:
Pfizer Healthcare Ireland
ATC code:
QI01EA01
Pharmaceutical form:
Suspension for Injection
Therapeutic group:
Immunological - Inactivated vaccine
Therapeutic area:
Avian
Authorization date:
2010-09-24
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Colombovac PMV.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Inactivated Newcastle Disease Virus, strain La Sota. One dose induces a GMT-HI titre of at least 2
7.0
in chicks per 0.2
ml dose.
ADJUVANT(S):
PER 0.2 ML DOSE
Carbomer 934 P
1 mg
EXCIPIENT(S):
Thiomersal
20 µg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suspension for injection.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigeons.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of pigeons to reduce mortality and clinical signs due to paramyxovirus type 1 infection.
The onset of protection occurs one month after inoculation, the duration of protection is at least 12 months.
4.3 CONTRAINDICATIONS
Do not use in unhealthy pigeons.
Do not vaccinate during the last 2 weeks prior to mating.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 13/09/2011_
_CRN 7011253_
_page number: 1_
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Not for intramuscular injection: Intramuscular injection causes severe adverse reactions.
Maternally-derived antibody (MDA) can interfere with the development of active immunity. Where it is likely that
recent field infection or vaccination of the parent flock has stimulated a high antibody titre and consequently a high
level of MDA, the timing of the vaccination programme should be planned accordingly.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
In cases of hypersensitivity reactions treat immediately with glucocorticoid intravenously or adrenaline
intramuscularly.
The incubation period for pigeon paramyxovirosis may be a few days to several weeks. H
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