Colombovac PMV

Երկիր: Իռլանդիա

Լեզու: անգլերեն

Աղբյուրը: HPRA (Health Products Regulatory Authority)

Ակտիվ բաղադրիչ:

Inactivated newcastle disease virus strain la sota

Հասանելի է:

Zoetis Belgium S.A.

ATC կոդը:

QI01EA01

INN (Միջազգային անվանումը):

Inactivated newcastle disease virus strain la sota

Դոզան:

.

Դեղագործական ձեւ:

Suspension for injection

Ռեկվիզորի տեսակը:

POM (E): Prescription Only Exempt as defined in relevant national legislation

Թերապեւտիկ խումբ:

Other Birds

Թերապեւտիկ տարածք:

pigeon paramyxovirus

Թերապեւտիկ ցուցումներ:

Immunological - Inactivated Vaccine

Լիազորման կարգավիճակը:

Authorised

Հաստատման ամսաթիվը:

2014-11-24

Ապրանքի հատկությունները

Health Products Regulatory Authority
11 October 2017
CRN000TYW
Page 1 of 5
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Colombovac PMV
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
PER 0.2 ML DOSE
ACTIVE SUBSTANCE:
Inactivated Newcastle Disease Virus, strain La Sota at least 19.9AU*
* AU: Antigen Unit
ADJUVANT(S):
Carbomer 934 P1 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.
Onset of immunity one month after inoculation. Duration of immunity12
months.
4.3 CONTRAINDICATIONS
Do not use in unhealthy pigeons.
Do not vaccinate during the last 2 weeks prior to mating.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Not for intramuscular injection: Intramuscular injection causes severe
adverse
reactions.
Health Products Regulatory Authority
11 October 2017
CRN000TYW
Page 2 of 5
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. However, after infection with the wild virus, pigeons excrete
the virus from the
eye and in the droppings within 3-4 days. This means that infected
birds can be a
danger to others some days before their own symptoms appear. Excretion
of wild
virus from the infected bird continues for up to 6 weeks. This
information is
important since, in addition to direct bird to bird cont