Hipracox Broilers dw
Country: Portugal
Language: English
Source: HMA (Heads of Medicines Agencies)
Patient Information leaflet
(PIL)
09-05-2012
Summary of Product characteristics
(SPC)
09-05-2012
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
Authorization date:
2007-10-24
Patient Information leaflet
Revised: August 2012
AN: 01471/2011
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Name of the product in United Kingdom: HIPRACOX BROILERS dw
Name of the product in Spain: HIPRACOX agua de bebida.
Name of the product in Portugal: HIPRACOX ab.
Name of the product in France: HIPRACOX eb.
Name of the product in Sweden: HIPRACOX ad.
All other CMS: HIPRACOX dw.
Oral suspension for use in drinking water for chickens.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Composition per dose (0.007 ml):
- 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.
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).
Revised: August 2012
AN: 01471/2011
Page 2 of 6
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 acervulin
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Summary of Product characteristics
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Name of the product in United Kingdom: HIPRACOX BROILERS dw
Name of the product in Spain: HIPRACOX agua de bebida.
Name of the product in Portugal: HIPRACOX ab.
Name of the product in France: HIPRACOX eb.
Name of the product in Sweden: HIPRACOX ad.
All other CMS: HIPRACOX dw.
Oral suspension for use in drinking water.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Composition per dose (0.007 ml): :
- 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
For full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Oral suspension for use in drinking water.
4. CLINICAL PARTICULARS
4.1. TARGET SPECIES.
Chicken (broilers).
4.2. INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIE S.
For active immunisation of broiler chicks to reduce intestinal colonisation, intestinal
lesions and clinical signs of Coccidiosis caused by _Eimeria acervulina_, _E. maxima,_
_E. mitis, E. praecox_ and _E. tenella_.
The onset of immunity is 14 days post-vaccination and the duration of protection is
maintained at least for 28 days.
4.3. CONTRAINDICATIONS.
None.
4.4.
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