Nobilis OR Inac

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

inactivated whole cell suspension of Ornithobacterium rhinotracheale serotype A, strain B3263/91

Available from:

Intervet International BV

ATC code:

QI01AB07

INN (International Name):

adjuvanted inactivated vaccine against Ornithobacterium rhinotracheale serotype A

Therapeutic group:

Chicken

Therapeutic area:

Immunologicals for aves

Therapeutic indications:

For passive immunisation of broilers induced by active immunisation of female broiler breeders to reduce infection with Ornithobacterium rhinotracheale serotype A when this agent is involved. Under field conditions passive immunity is transferred during lay for 43 weeks after the last vaccination of broiler breeders, resulting in a duration of passive immunity in broilers of at least 14 days after hatching.,

Product summary:

Revision: 7

Authorization status:

Withdrawn

Authorization date:

2003-01-24

Patient Information leaflet

Medicinal product no longer authorised
15
B. PACKAGE LEAFLET
Medicinal product no longer authorised
16
PACKAGE LEAFLET
Nobilis OR inac emulsion for injection for chickens
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE IN THE EEA
Marketing authorisation holder and manufacturer:
Intervet International
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobilis OR inac emulsion for injection for chickens
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Per dose of 0.25 ml:
Inactivated whole cell suspension of _Ornithobacterium rhinotracheale_
serotype A strain B3263/91 1 x
10
7
cells *
* inducing a mean titre in the chickens of the potency test of at
least 11.2 (log
2
).
Light liquid paraffin: 107.21 mg
Traces of formaldehyde
4.
INDICATION(S)
For passive immunisation of broilers induced by active immunisation of
female broiler breeders to
reduce infection with _Ornithobacterium rhinotracheale_ serotype A
when this agent is involved.
Under field conditions passive immunity is transferred during lay for
43 weeks after the last
vaccination of broiler breeders, resulting in a duration of passive
immunity in broilers of at least 14
days after hatching.
5.
CONTRAINDICATIONS
Do not use for birds in lay
6.
ADVERSE REACTIONS
In laboratory studies, a local transient swelling was found at post
mortem examination in up to 40% of
the birds for at least 14 days after subcutaneous vaccination. Under
field conditions, sporadic local and
systemic clinical reactions have been reported.
If you notice any serious effects or other effects not mentioned in
this leaflet, please inform your
veterinary surgeon.
Medicinal product no longer authorised
17
7.
TARGET SPECIES
Chickens
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Single dose of 0.25 ml.
Subcutaneous injection in the neck or intramuscular injection in the
breast of the chicken.
9.
ADVICE ON CORRECT ADMINISTRATION

Summary of Product characteristics

Medicinal product no longer authorised
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobilis OR inac emulsion for injection for chickens
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Per dose of 0.25 ml:
ACTIVE SUBSTANCE
Inactivated whole cell suspension of _Ornithobacterium rhinotracheale_
serotype A, strain B3263/91 1 x
10
7
cells *
* inducing a mean titre in the chickens of the potency test of at
least 11.2 (log
2
).
ADJUVANT
Light liquid paraffin:
107.21 mg
EXCIPIENTS
Traces of formaldehyde
For a list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Emulsion for injection
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For passive immunisation of broilers induced by active immunisation of
female broiler breeders to
reduce infection with _Ornithobacterium rhinotracheale_ serotype A
when this agent is involved.
Under field conditions passive immunity is transferred during lay for
43 weeks after the last
vaccination of broiler breeders, resulting in a duration of passive
immunity in broilers of at least 14
days after hatching.
4.3
CONTRAINDICATIONS
Do not use in birds in lay.
4.4
SPECIAL WARNINGS
None
Medicinal product no longer authorised
3
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Allow vaccine to reach room temperature (15-25°C) before using the
vaccine.
Shake well before use.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO
ANIMALS
To the user:
This product contains mineral oil. Accidental injection/self injection
may result in severe pain and
swelling, particularly if injected into a joint or finger, and in rare
cases could result in the loss of the
affected finger if prompt medical attention is not given.
If you are accidentally injected with this product, seek prompt
medical advice even if only a very
small amount is injected and take the package insert with you.
If pain persists for mo