Hipracox Broilers
Country: Greece
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
16-03-2012
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Active ingredient:
Eimeria Acervulina 300 IU, Eimeria Maxima 200 IU, Eimeria Mitis 300 IU, Eimeria Praecox 300 IU, Eimeria Tenella 250 IU
Available from:
Laboratorios Hipra S. A.
ATC code:
QI01AN01
Pharmaceutical form:
Oral suspension
Therapeutic group:
Coccidia vaccine
Therapeutic area:
Chicken Broilers
Authorization date:
2011-11-05
Summary of Product characteristics
Issued: August 2011
AN: 01345/2010
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
HIPRACOX BROILERS Oral suspension for chickens.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Composition per dose (0.007 ml) of HIPRACOX BROILERS:
1. ACTIVE SUBSTANCES:
- Each 0.007 ml dose of vaccine contains the following numbers of sporulated
oocysts derived from five precocious attenuated lines of coccidia:
_Eimeria acervulina, _strain 003............. 300
– 390 *
_Eimeria maxima, _strain 013 ................. 200
– 260 *
_Eimeria mitis, _strain 006....................... 300
– 390 *
_Eimeria praecox, _strain 007................. 300
– 390 *
_Eimeria tenella, _strain 004 ................... 250
– 325 *
* According to in vitro procedures of the manufacturer at the time of blending
and at release.
2. EXCIPIENTS AND ADJUVANTS:
Diluent for coarse spray only: UNIFLOCK (0.02 ml/dose)
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Slightly brownish to white turbid oral suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chicken (broilers).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of broiler chicks to reduce intestinal colonisation, intestinal
lesions and clinical signs of Coccidiosis caused by _Eimeria acervulina_, _Eimeria _
_maxima,_ _Eimeria mitis, Eimeria praecox_ and _Eimeria tenella_.
The onset of immunity is 14 days post-vaccination and the duration of protection
is maintained at least for 42 days post-vaccination.
4.3
CONTRAINDICATIONS
None.
Issued: August 2011
AN: 01345/2010
Page 2 of 6
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