Nobilis RT+IBmulti+ND+EDS
Country: Spain
Language: English
Source: HMA (Heads of Medicines Agencies)
Patient Information leaflet
(PIL)
13-10-2012
Summary of Product characteristics
(SPC)
13-10-2012
Active ingredient:
ARTV strain BUT#8544 0 ELISA, EDS 76 strain BC 14 0 HI, IBV strain 249g 0 VN, IBV strain M41 0 VN
Available from:
Intervet Intenational BV
ATC code:
QI01AA
Pharmaceutical form:
Emulsion for injection
Therapeutic group:
Inactivated viral vaccines
Therapeutic area:
Chicken Layers
Authorization date:
2012-02-28
Patient Information leaflet
Nobilis RT +IBmulti+G+ND
DE/V/0212/001/R/002 - Day 87
SUMMARY OF PRODUCT CHARACTERISTICS
Nobilis RT +IBmulti+G+ND
DE/V/0212/001/R/002 - Day 87
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobilis RT+IBmulti+G+ND (AT, BE, DE, EL, ES, IE, IT, LU, NL, PT, UK)
Nobilis RT-IBmulti-G-ND (DK)
Nobilis RT Repro (FR)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Per dose of 0.5 ml:
ACTIVE SUBSTANCE(S):
ART strain But1#8544 :
inducing
9.5 log
2
ELISA units*
IBV strain M41(Massachusetts):
inducing
5.5 log
2
VN units*
IBV strain 249g (D274/D207):
inducing
4.0 log
2
VN units*
IBDV strain D78:
inducing
14.5 log
2
VN units*
NDV strain Clone 30:
inducing
4.0 log
2
HI units per 1/50
th
dose*
or containing
50 PD
50
units
* serological response in chickens
ADJUVANT:
Liquid paraffin: 215 mg
EXCIPIENTS:
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Emulsion for injection (water-in-oil)
White to nearly white oily emulsion.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens (future breeders)
4.2
INDICATIONS FOR USE , SPECIFYING THE TARGET SPECIES
Active immunisation of breeder chickens for:
- reduction of infection and prevention of egg drop caused by the Massachusetts serotype of
Infectious Bronchitis virus;
- reduction of egg drop and egg shell defects caused by the D274/D207 serotype of Infectious
Bronchitis virus;
- reduction of infection caused by Newcastle Disease virus;
- prevention of respiratory signs and reduction of egg drop and egg shell defects related to
A
Read the complete document
Summary of Product characteristics
Nobilis RT +IBmulti+G+ND
DE/V/0212/001/R/002 - Day 87
SUMMARY OF PRODUCT CHARACTERISTICS
Nobilis RT +IBmulti+G+ND
DE/V/0212/001/R/002 - Day 87
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobilis RT+IBmulti+G+ND (AT, BE, DE, EL, ES, IE, IT, LU, NL, PT, UK)
Nobilis RT-IBmulti-G-ND (DK)
Nobilis RT Repro (FR)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Per dose of 0.5 ml:
ACTIVE SUBSTANCE(S):
ART strain But1#8544 :
inducing
9.5 log
2
ELISA units*
IBV strain M41(Massachusetts):
inducing
5.5 log
2
VN units*
IBV strain 249g (D274/D207):
inducing
4.0 log
2
VN units*
IBDV strain D78:
inducing
14.5 log
2
VN units*
NDV strain Clone 30:
inducing
4.0 log
2
HI units per 1/50
th
dose*
or containing
50 PD
50
units
* serological response in chickens
ADJUVANT:
Liquid paraffin: 215 mg
EXCIPIENTS:
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Emulsion for injection (water-in-oil)
White to nearly white oily emulsion.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens (future breeders)
4.2
INDICATIONS FOR USE , SPECIFYING THE TARGET SPECIES
Active immunisation of breeder chickens for:
- reduction of infection and prevention of egg drop caused by the Massachusetts serotype of
Infectious Bronchitis virus;
- reduction of egg drop and egg shell defects caused by the D274/D207 serotype of Infectious
Bronchitis virus;
- reduction of infection caused by Newcastle Disease virus;
- prevention of respiratory signs and reduction of egg drop and egg shell defects related to
A
Read the complete document
