Gallivac IBD S706 NEO Effervescent tablet for use in drinking water for chickens

Quốc gia: Ai-len

Ngôn ngữ: Tiếng Anh

Nguồn: HPRA (Health Products Regulatory Authority)

Thành phần hoạt chất:

Avian infectious bursal disease virus, live

Sẵn có từ:

Boehringer Ingelheim Vetmedica GmbH

Mã ATC:

QI01AD09

INN (Tên quốc tế):

Avian infectious bursal disease virus, live

Liều dùng:

.

Dạng dược phẩm:

Effervescent tablet

Loại thuốc theo toa:

POM: Prescription Only Medicine as defined in relevant national legislation

Khu trị liệu:

avian infectious bursal disease virus (gumboro disease)

Tình trạng ủy quyền:

Authorised

Ngày ủy quyền:

2021-01-08

Đặc tính sản phẩm

Health Products Regulatory Authority
08 January 2021
CRN00974V
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Gallivac IBD S706 NEO Effervescent tablet for use in drinking water
for chickens
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of vaccine contains:
​
Active substances: ​ ​
​
Infectious Bursal Disease virus, attenuated strain S706
​10
4.0
to 10
5.3
CCID50*
​
*CCID50: Cell Culture Infective Dose 50% ​ ​
​
​
​
​
Excipients: ​
​
​
​
​
Excipient
​​qs 1 dose
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Effervescent tablet for suspension
Beige to pale orange, round tablet
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Chickens (broilers, future layers and broiler breeders).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of chickens to protect against mortality and to
reduce lesions associated with Infectious Bursal (Gumboro)
Disease.
Onset of immunity: 2 weeks after the first administration.
Duration of immunity: immunity has been shown under field conditions
to persist throughout the rearing period.
4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Due to the spread of the vaccine virus, it is recommended to separate
vaccinated and unvaccinated birds.
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
Care should be taken during resuspension of the vaccine and drinking
water application. Hands should be washed and
disinfected after vaccinating.
Health Products Regulatory Authority
08 January 2021
CRN00974V
Page 2 of 4
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Laboratory studies have shown that when the vaccine virus was
experimentally passed from bird to bird, damage to the bursa
increased. This was detected by histological examination of the
bursae. However, this is not considered to result