Hipragumboro G97
Country: Germany
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
13-03-2012
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
Infectious Bursal Disease (Gumboro) Virus 10 EID50/dose
Available from:
Laboratorios Hipra S. A.
ATC code:
QI01AD09
Pharmaceutical form:
Oral suspension
Therapeutic group:
Avian infectious bursal disease virus vaccine (Gumboro disease)
Therapeutic area:
Chicken Broilers
Authorization date:
2011-05-20
Summary of Product characteristics
Revised: May 2011
AN: 00040/2011
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT.
HIPRAGUMBORO-G97.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION.
Composition per dose:
ACTIVE SUBSTANCE:
- Live Infectious Bursal Disease Virus, strain GM97:10
2
- 10
3
EID
50
(embryo infective dose 50%).
EXCIPIENTS AND ADJUVANTS WHERE KNOWLEDGE OF THIS IS ESSENTIAL FOR
THE SAFE ADMINISTRATION OF THE MEDICINAL PRODUCT:
None.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM.
Lyophilisate for oral suspension.
Appearance: reddish tablet.
4.
CLINICAL PARTICULARS.
4.1. TARGET SPECIES.
Species: Chickens.
Category: Broilers.
4.2. INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES.
For active immunisation of broilers with insignificant levels of maternally
derived antibodies (ELISA of 500 or below) to reduce mortality, clinical
signs and bursal lesions of Gumboro disease. Such birds can be
vaccinated from one day of age. The onset of immunity is 14 days post
vaccination and the duration 43 days post vaccination.
4.3. CONTRAINDICATIONS.
Do not vaccinate sick birds.
Do not use in infected flocks showing clinical signs.
Revised: May 2011
AN: 00040/2011
Page 2 of 7
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 (see section
4.7).
4.4. SPECIAL WARNINGS FOR EACH TARGET SPECIES.
Use only in flocks with low levels of maternal antibod
Read the complete document
