Hipracox Broilers Oral suspension for chicken

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Eimeria acervulina, strain 003; Eimeria maxima, strain 013; Eimeria mitis, strain 006; Eimeria praecox, strain 007; Eimeria tenella, strain 004

Saatavilla:

Laboratorios Hipra S.A.

ATC-koodi:

QI01AN01

INN (Kansainvälinen yleisnimi):

Eimeria acervulina, strain 003; Eimeria maxima, strain 013; Eimeria mitis, strain 006; Eimeria praecox, strain 007; Eimeria tenella, strain 004

Annos:

.

Lääkemuoto:

Oral suspension

Prescription tyyppi:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeuttinen ryhmä:

Chickens

Terapeuttinen alue:

coccidia

Käyttöaiheet:

Immunological - Live Vaccine

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2007-10-31

Valmisteyhteenveto

Health Products Regulatory Authority
15 January 2022
CRN00CRJG
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Hipracox Broilers Oral suspension for chicken
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 (0.02ml /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.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
The vaccine will not protect species other than chickens against
Coccidiosis and is only effective against the _Eimeria_ species
indicated.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Health Products Regulatory Authority
15 January 2022
CRN00CRJG
Page 2 of 5
Chickens must be strictly floor-reared on litter.
Do not vaccinate unhealthy or stressed birds.
For the drin