HIPRAGUMBORO CW
Country: France
Language: English
Source: HMA (Heads of Medicines Agencies)
Patient Information leaflet
(PIL)
16-03-2012
Summary of Product characteristics
(SPC)
16-03-2012
Active ingredient:
Live Infectious Bursal Disease Virus, strain CH/80 3.5 log10 CCID50, Live Infectious Bursal Disease Virus, strain CH/80 5.5 log10 CCID50
Available from:
Laboratorios Hipra S. A.
ATC code:
QI01AD09
Pharmaceutical form:
Oral lyophilisate
Therapeutic group:
avian infectious bursal disease virus (gumboro disease)
Therapeutic area:
Chicken Broilers
Authorization date:
2011-06-14
Patient Information leaflet
_ [Version 7.3, 04/2010] _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
HIPRAGUMBORO CW
Lyophilisate for oral suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
COMPOSITION PER DOSE:
ACTIVE SUBSTANCE:
Live Infectious Bursal Disease Virus, strain CH/80…………….. 10
3.5
– 10
5.5
CCID
50
(cell
culture infective dose 50%).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate for oral suspension.
Appearance: brown freeze-dried tablet.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens: broilers.
4.2
INDICATIONS FOR USE,SPECIFYING THE TARGET SPECIES
For active immunisation of broilers with maternally derived antibodies (MDA ELISA
breakthrough titre of 115) to prevent clinical signs and to reduce loss of weight and bursal
damage caused by Gumboro Disease. The onset of immunity is 14 days and the duration of
30 days post vaccination.
4.3
CONTRAINDICATIONS
Do not use in sick birds.
Since no studies to demonstrate the safety of this vaccine when it is administered to layers
and breeders have been carried out, its use is not recommended for these categories of the
target species.
4.4
SPECIAL WARNINGS
The optimal day of vaccination is calculated according to the Deventer’s formula, using 115
as the ELISA breakthrough titre value.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
- The vaccine strain is excreted up to a maximum of 10 days; thus, during this time, it may
spread to unvaccinated chickens.
- Appropriate veterinary and
Read the complete document
Summary of Product characteristics
_ [Version 7.3, 04/2010] _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
HIPRAGUMBORO CW
Lyophilisate for oral suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
COMPOSITION PER DOSE:
ACTIVE SUBSTANCE:
Live Infectious Bursal Disease Virus, strain CH/80…………….. 10
3.5
– 10
5.5
CCID
50
(cell
culture infective dose 50%).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate for oral suspension.
Appearance: brown freeze-dried tablet.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens: broilers.
4.2
INDICATIONS FOR USE,SPECIFYING THE TARGET SPECIES
For active immunisation of broilers with maternally derived antibodies (MDA ELISA
breakthrough titre of 115) to prevent clinical signs and to reduce loss of weight and bursal
damage caused by Gumboro Disease. The onset of immunity is 14 days and the duration of
30 days post vaccination.
4.3
CONTRAINDICATIONS
Do not use in sick birds.
Since no studies to demonstrate the safety of this vaccine when it is administered to layers
and breeders have been carried out, its use is not recommended for these categories of the
target species.
4.4
SPECIAL WARNINGS
The optimal day of vaccination is calculated according to the Deventer’s formula, using 115
as the ELISA breakthrough titre value.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
- The vaccine strain is excreted up to a maximum of 10 days; thus, during this time, it may
spread to unvaccinated chickens.
- Appropriate veterinary and
Read the complete document
