Poulvac Pabac IV

Country: Bretland

Tungumál: enska

Heimild: VMD (Veterinary Medicines Directorate)

Virkt innihaldsefni:

Pasteurella multocida

Fáanlegur frá:

Zoetis UK Limited

ATC númer:

QI01AB02

INN (Alþjóðlegt nafn):

Pasteurella multocida

Leyfisstaða:

Expired

Vara einkenni

AN: 00753/2013
Revised: October 2013
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
POULVAC PABAC IV [POULVAC iP (Spain only)] emulsion for injection in
chickens,
ducks, and turkeys
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Per dose of 0.5 ml
ACTIVE SUBSTANCES:
_Pasteurella multocida_, strain X-73 (serovar 1
*
),inactivatedmin. 70% survival (chickens)
* *
_Pasteurella multocida_, strain P-1059 (serovar 3
*
), inactivatedmin. 70% survival (turkeys)
* *
_Pasteurella multocida_, strain P-1662 (serovar 4
*
), inactivatedmin. 70% survival (turkeys)
* *
_Pasteurella multocida_, strain CU (serovar 3x4
*
), inactivatedmin. 70% survival (turkeys)
* *
*
according to Heddleston classification
**
in vaccinated birds, following virulent challenge, according to Ph.
Eur. 1945
requirements
ADJUVANT:
Light liquid paraffin
0.325 ml
Sorbitan sesquioleate
0.025 ml
Polysorbate 80
0.004 ml
EXCIPIENTS:
Formaldehyde
traces
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Emulsion for injection
White creamy emulsion, with no extraneous particles.
A separation of the emulsion can occur over time, leading to a
biphasic appearance
where the upper layer appears as a white to an off-white milky
suspension and the
bottom layer appears as a grey to tan aqueous phase.
4.
CLINICAL PARTICULARS
5.1
TARGET SPECIES
Chickens (future laying and future breeding hens), Ducks and Turkeys.
5.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In chickens (future laying and future breeding hens) and ducks:
- active immunization in order to reduce mortality caused by
Pasteurella multocida
serovar 1 (Heddleston classification).
Page 1 of 6
AN: 00753/2013
Revised: October 2013
Onset of immunity against serovar 1 is of 2 weeks from administration
of the second
dose.
Duration of immunity is of 16 weeks post basic vaccination (future
laying and future
breeding hens) or 9 weeks post basic vaccination (ducks).
In turkeys:
- active immunization in order to reduce mortality caused by
Pasteurella multocida
serov