COLOMBOVAC PMV

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

INACTIVATED NEWCASTLE DISEASE VIRUS STRAIN LA SOTA

Verfügbar ab:

Zoetis Ireland Limited

ATC-Code:

QI01EA01

INN (Internationale Bezeichnung):

INACTIVATED NEWCASTLE DISEASE VIRUS STRAIN LA SOTA

Darreichungsform:

Suspension for Injection

Verschreibungstyp:

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

Therapiegruppe:

Avian

Therapiebereich:

pigeon paramyxovirus

Anwendungsgebiete:

Immunological - Inactivated vaccine

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2014-11-24

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
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 19.9 AU*
* AU: Antigen Unit
ADJUVANT(S):
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.
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.
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.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_1_
_9_
_/_
_0_
_1_
_/_
_2_
_0_
_1_
_7_
_C_
_R_
_N_
_ _
_7_
_0_
_2_
_3_
_5_
_0_
_1_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECI