SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Nobilis RT+IBmulti+G+ND emulsion for injection for chickens

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 0.5 ml dose contains:

Active substance(s):

Inactivated viral antigens of:

ART strain But1# 8544: inducing ≥ 9.5 log₂ ELISA units*

IBV strain M41(Massachusetts): inducing ≥ 5.5 log₂ VN units*

IBV strain 249g (D274/D207): inducing ≥ 4.0 log₂ VN units*

IBDV strain D78: inducing ≥ 14.5 log₂ VN units*

NDV strain Clone 30: inducing ≥ 4.0 log₂ HI units per 1/50^th dose*

or containing ≥ 50 PD₅₀ 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 (IBV);

- reduction of egg drop and eggshell defects caused by the D274/D207 serotype of infectious bronchitis virus (IBV);

- reduction of infection caused by Newcastle disease virus (NDV);

- prevention of respiratory signs and reduction of egg drop and eggshell defects turkey rhinotracheitis (TRT) virus;

- passive immunisation of the progeny of the vaccinated birds against infectious bursal disease virus (IBDV).

Onset of immunity:

• IBV, NDV, ARTV: 4 weeks post-vaccination

• IBDV in progeny: 1 day of age

Duration of immunity:

• IBV, NDV, ARTV: one laying period.

• IBDV in progeny: 4 weeks of age.

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

Vaccination with inactivated vaccine will not completely prevent shedding of wild type virus after infection. Therefore this vaccine is only meant to reduce the clinical signs and not as a tool for eradication of the diseases

Special precautions to be take 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 leafletwith 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.

Other precautions

None

4.6 Adverse reactions (frequency and seriousness) Chickens (future breeders):

Very common (>1 animal / 10 animals treated):

Injection site swelling1

¹ A mild swelling which may be observed for 2 weeks.

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 its local representative or the national competent authority via the national reporting system. See section “Contact details” of the package leaflet.

4.7 Use during pregnancy, lactation or lay

Laying birds:

Do not use in birds in lay and within 4 weeks before the start of the laying period.

4.8 Interaction with other medicinal products and other forms of interaction

No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product needs to be made on a case by case basis.

4.9 Amount(s) to be administered and administration route

The vaccine should be given tochickens around 14-20 weeks of age but not later than 4 weeks before the expected onset of lay.

If live vaccines were used to prime chickens against Infectious Bronchitis, Rhinotracheitis, Newcastle Disease and Infectious Bursal Disease, the vaccine should be given at least 4 weeks after the administration of the live vaccines. Administer one dose of 0.5 ml vaccine per chickens via intramuscular injection in the thigh or chest muscle.

Before using the vaccine allow it to reach ambient temperature (15 °C – 25 °C).

Shake the bottle vigorously before use and periodically during use.

Ensure that vaccination equipment is clean and sterile before use.

Do not use vaccination equipment with rubber parts as the excipient may damage certain types of rubber.

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

After administration of a double dose the reactions are not different from those observed after a single dose.

4.11 Withdrawal period(s)

Zero days

5. IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Inactivated viral vaccine

ATCvet code: QI01AA06.

The antigens are inactivated with formalin or β-propiolactone and suspended in the aqueous phase of an water in oil adjuvant emulsion, in order to enhance a prolonged stimulation of immunity.

The vaccine is intended to stimulate active immunity against avian rhinotracheitis virus, against the Massachusetts and D274/D207 serotypes of infectious bronchitis virus and against Newcastle disease; and to stimulate active immunity against Infectious Bursal (Gumboro) Disease to provide passive immunity to the progeny. An enhanced immune response is obtained when the product is used for booster immunisation after priming the birds with live vaccines, if available, against Infectious Bronchitis, Rhinotracheitis, Newcastle Disease and Infectious Bursal Disease. The best results will be obtained if vaccination with the inactivated vaccine takes place at least 4 weeks after administration of the live primer.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Polysorbate 80

Sorbitan mono-oleate

Glycine

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: 3 hours.

6.4 Special precautions for storage

Store in a refrigerator (2°C - 8°C).

Protect from light. Do not freeze.

6.5 Nature and composition of immediate packaging

Bottle of polyethylene terephthalate (PET), closed with a nitryl rubber stopper and sealed with a colour coded aluminium cap.

Pack sizes:

Cardboard box with one bottle 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 product or waste material should be disposed of in accordance with national requirements.

7. MARKETING AUTHORISATION HOLDER

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

The Netherlands

8. MARKETING AUTHORISATION NUMBER

Vm 06376/5012

9. DATE OF FIRST AUTHORISATION

27 April 2000

10. DATE OF REVISION OF THE TEXT

December 2024

PROHIBITION OF SALE, SUPPLY AND/OR USE

Any person intending to manufacture, import, possess, distribute, sell, supply and use this veterinary medicinal product must first consult the relevant competent authority on the current vaccination policies, as these activities may be prohibited in a country on the whole or part of its territory pursuant to national legislation.

11. CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ or ‘PID’ on www.gov.uk.

Approved 10 December 2024