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Date: Saturday, May 18, 2024 8:44

Release 2.60
Nobilis® E Coli Inac emulsion for injection for chickens
 
Species: Chickens, Poultry
Therapeutic indication: Immunological veterinary medical products: For poultry, For chickens
Active ingredient: Vaccine Antigens
Product:Nobilis® E Coli Inac emulsion for injection for chickens
Product index: Nobilis® E Coli Inac
Poultry - meat: 35 days
Poultry - eggs: Zero days
Incorporating:
Qualitative and quantitative composition
Each dose (0.5 ml) of vaccine contains:
Active substance:
F11-antigen (E.coli fimbrial antigen) 100 μg
FT-antigen (E.coli flagellar toxin antigen) 100 μg
Adjuvant:
Liquid paraffin: 214.42 mg
Excipient:
Formalin (preservative): 0.675 mg
Pharmaceutical form
A homogeneous, white to nearly white emulsion.
Clinical particulars
Target species
Chickens (broiler-breeders).
Indications for use
Partial passive immunisation of broiler chickens during their first 7 weeks of life by vaccination of the broiler breeders as a help against postnatal colibacillosis (airsac disease and septicaemia) caused by fimbrial F11-antigen and flagellar Ft-toxin containing E. coli.
Contraindications
None.
Special warnings for each target species
Vaccinate healthy animals only.
Special precautions for use
Not applicable.
Operator warnings
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 leaflet with you. If pain persists for more than 12 hours after medical examination, seek medical advice again.
To the physician:
This product contains mineral oil. Even if small amounts have been injected, accidental injection with this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit. Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.
Adverse reactions
Local tissue reactions of a granulomatous nature are very commonly observed and
necrosis or abscesses may commonly occur. Five weeks after vaccination these local
reactions are considerably decreased.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Use during pregnancy or lactation
Do not use in birds in lay.
Interactions
Data are available which demonstrate that this vaccine can be administered on the same day but not mixed with other inactivated vaccines of the same company against avian infectious bronchitis, avian infectious bursal disease, avian tenosynovitis and Newcastle disease. The product should be administered at different sites of injection. No information is available on the safety and efficacy of this vaccine when used with any veterinary medicinal product except the products mentioned above. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Amounts to be administered and administration route
Intramuscular or subcutaneous injection in broiler breeder hens. Vaccination scheme: Two injections of 0.5 ml, with an interval of at least 6 weeks. First vaccination at 6-12 weeks of age, revaccination at 14-18 weeks of age. Before use allow the vaccine to reach room temperature (15-25 °C). Shake well before use. Use sterile vaccination equipment.
Overdose
As compared to the single dose reaction, effects after administration of a double dose have the same character, but they are more severe.
Withdrawal periods
Meat and offal: 35 days
Eggs: zero days.
Pharmacological particulars
ATC Vet Code: QI01AB05
Pharmacotherapeutic group
Active immunization of broiler breeders in order to provide passive immunity to broiler chickens against postnatal colibacillosis.
Immunological for Aves, inactivated bacterial vaccines for domestic fowls, Escherichia.
Pharmacodynamic properties
The E.coli antigens are incorporated in a water in oil emulsion in order to enhance and
prolong the production of antibodies against E. coli fimbrial antigen and E coli flagellar toxin antigen.
Pharmaceutical particulars
Excipients
Liquid paraffin
Polysorbate
Sorbitan mono-oleate
Sodium chloride
Formalin
Water for injections.
Major incompatibilities
Do not mix with any other veterinary medicinal product.
Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf-life after first opening the immediate packaging: 10 hours.
Special precautions for storage
Store in a refrigerator (2 °C - 8 °C). Do not freeze. Protect from light.
Immediate packaging
Lyophilisate container:
Glass Type II vial or PET vial, closed with a nitryl rubber stopper and sealed with a coded aluminium cap.
Pack sizes:
Cardboard box with one glass vial or PET vial of 250 ml (500 doses).
Cardboard box with one glass vial or PET vial of 500 ml (1000 doses).
Not all pack sizes may be marketed.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Marketing Authorisation Number
UK: Vm 01708/4266
Significant changes
Date of the first authorisation or date of renewal
1 October 2005.
Date of revision of the text
August 2020.
Any other information
For animal treatment only. Keep out of the sight and reach of children.
Legal category
Legal category: POM-V
GTIN
GTIN description:Nobilis E.Coli Inac 1x1000ds/500ml:
GTIN:08713184011824