SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Nobilis E.coli inac Emulsion for injection for chickens

2. 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: 0.675 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Emulsion for injection.

A homogeneous, white to nearly white emulsion.

4. CLINICAL PARTICULARS

4.1 Target species

Chickens (broilerbreeders)

4.2 Indications for use, specifying the target species

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-antigen containing Esherichia coli (E.coli).

Onset of immunity: 1 day of age (offspring)

Duration of immunity: 7 weeks (offspring)

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 Not applicable.

Special precautions to be taken by the person administering the veterinary medicinal product to animals To the user:

This veterinary medicinal 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 veterinary medicinal 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 veterinary medicinal product contains mineral oil. Even if small amounts have been injected, accidental injection with this veterinary medicinal 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.

Special precautions for the protection of the environment: Not applicable.

4.6 Adverse reactions (frequency and seriousness)

Chickens:

-

Very common (>1 animal / 10 animals treated):	Injection site granuloma1
Common (1 to 10 animals / 100 animals treated):	Injection site necrosis1, injection site abscess1

¹ Five weeks after vaccination these local reactions are considerably decreased.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See also the last section of the package leaflet for contact details.

4.7 Use during pregnancy, lactation or lay

Laying birds:

Do not use in birds in lay.

4.8 Interaction with other medicinal products and other forms of interaction

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 bursitis, avian tenosynovitis and Newcastle disease. The vaccine should be given at different.

No information is available on the safety and efficacy of this vaccine when used with any other 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.

4.9 Amounts to be administered and administration route

Intramuscular or subcutaneous use.

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 °C - 25 °C).

Shake well before use.

Use sterile vaccination equipment.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

As compared to the single dose reaction, effects after administration of a double dose have the same character, but they are more severe.

4.11 Withdrawal period(s)

Meat and offal: 35 days. Eggs: zero days.

5. IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Immunological for Aves, inactivated bacterial vaccines for domestic fowls, Escherichia ATCvet code: QI01AB05

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.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Polysorbate 80

Sorbitan oleate

Sodium chloride

Formalin

Water for injections

6.2 Major incompatibilities

Do not mix with any other veterinary medicinal product.

6.3 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.

6.4 Special precautions for storage

Store in a refrigerator (2°C - 8°C).

Do not freeze.

Protect from light.

6.5 Nature and composition of immediate packaging

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)or 500 ml (1000 doses)

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Medicines should not be disposed of via wastewater.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

The Netherlands

8. MARKETING AUTHORISATION NUMBER

Vm 06376/5011

9. DATE OF FIRST AUTHORISATION

30 December 1994

10. DATE OF REVISION OF THE TEXT

December 2024

11. CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS

Veterinary medicinal product subject to prescription.

Approved 10 December 2024