Poulvac Pabac IV vakcina A.U.V.
Country: Hungary
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
09-11-2012
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Active ingredient:
pasteurella multocida 70 %survival X73, pasteurella multocida 70 %survivalCU, pasteurella multocida 70 %survivalP1059, pasteurella multocida 70 %survivalP1662
Available from:
Pfizer
ATC code:
QI01AB02
Pharmaceutical form:
Emulsion for injection
Therapeutic group:
Pasteurella vaccine
Therapeutic area:
Chicken Females, Other Birds, Turkeys
Authorization date:
2011-07-24
Summary of Product characteristics
ANNEX I
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
*
) ,inactivated
min. 70% survival (chickens)
* *
_Pasteurella multocida_, strain P-1059 (serovar 3
*
), inactivated min. 70% survival (turkeys)
* *
_Pasteurella multocida_, strain P-1662 (serovar 4
*
), inactivated min. 70% survival (turkeys)
* *
_Pasteurella multocida_, strain CU (serovar 3x4
*
), inactivated
min. 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
4.1
TARGET SPECIES
Chickens (future laying and future breeding hens), Ducks and Turkeys.
4.2
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
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