Other products
Nobilis IB + ND + EDS
Active substance
ATC code
Species
Chickens (breeders and layers).
Indications
The vaccine is recommended for the vaccination of laying and breeding birds to:
- Prevent egg production losses caused by infection with the Massachusetts serotype of avian infectious bronchitis virus (IBV) and reduce infection in primed birds.
- Prevent mortality and clinical signs and reduction of infection caused by Newcastle disease virus (NDV).
- Prevent egg production losses and egg quality defects caused by infection with eggdrop syndrome ’76 virus (EDSV).
Onset of immunity: Active immunity develops within 4 weeks.
Duration of immunity: One laying period (for avian infectious bronchitis and Newcastle disease viruses, this requires birds to have been adequately primed with live vaccines against these pathogens during the growing phase).
Dose to be administered and administration route
Intramuscular or subcutaneous use.
Dose: 0.5 ml per bird.
Intramuscular injection in the thigh or chest muscle, or by subcutaneous injection in the back of the neck, using a medium sized needle (20 G x ½”).
The veterinary medicinal product should be given to birds around 14 – 20 weeks of age but not less than 4 weeks before the expected start of lay.
Priming with live vaccines for avian infectious bronchitis and Newcastle disease viruses is necessary unless serological tests indicate otherwise. The interval between priming and booster should not be less than 4 weeks and preferably more than 6 weeks.
Allow the vaccine to reach ambient temperature (15 – 25 °C) before use.
The vaccine may occasionally separate into two layers on storage. This in no way affects its potency. Shake the bottle vigorously before and periodically during use.
An automatic injection system, incorporating a means to prevent back-flushing and hence possible contamination of the vaccine, should be used for administration.
Ensure that vaccination equipment is clean and sterile before use. Do not use vaccination equipment with rubber parts as the excipient may attack certain types of rubber.
Adverse reactions
Chickens (breeders and layers):
| Very common (>1 animal / 10 animals treated): |
Injection site swelling1 |
1 Mild, may be observed at the injection site 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 the package leaflet for respective contact details.
Dispensing
POM-VPS - Prescription Only Medicine – Veterinarian, Pharmacist, SQP
TRUSTED SOURCE
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobilis IB+ND+EDS emulsion for injection for chickens
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.5 ml dose contains:
Active substances:
Avian infectious bronchitis virus, type Massachusetts, strain M41, inactivated ≥ 6.0 log2 HI* units Newcastle disease virus, strain Clone 30, inactivated ≥ 4.0 log2 HI* units per1/50th dose or
≥ 50 PD50 units per dose
Eggdrop syndrome-1976 virus, strain BC14, inactivated ≥ 6.5 log2 HI* units
|
* HI = haemagglutination inhibition. ** PD50 = 50% protective dose. Adjuvant: |
|
|
Liquid paraffin |
215 mg |
Excipients:
|
Qualitative composition of excipients and other constituents |
|
Polysorbate 80 |
|
Sorbitan oleate |
|
Glycine |
|
Water for injections |
Homogenous white to nearly white oily emulsion.
3. CLINICAL INFORMATION
3.1 Target species
Chickens (breeders and layers).
3.2 Indications for use for each target species
The vaccine is recommended for the vaccination of laying and breeding birds to:
- Prevent egg production losses caused by infection with the Massachusetts serotype of avian infectious bronchitis virus (IBV) and reduce infection in primed birds.
- Prevent mortality and clinical signs and reduction of infection caused by Newcastle disease virus (NDV).
- Prevent egg production losses and egg quality defects caused by infection with eggdrop syndrome ’76 virus (EDSV).
Onset of immunity: Active immunity develops within 4 weeks.
Duration of immunity: One laying period (for avian infectious bronchitis and Newcastle disease viruses, this requires birds to have been adequately primed with live vaccines against these pathogens during the growing phase).
3.3 Contraindications None.
3.4 Special warnings
Vaccinate healthy animals only.
A good immune response is reliant on the reaction of an immunogenic agent and a fully competent immune system. Immunogenicity of the vaccine antigen will be reduced by poor storage or inappropriate administration. Immunocompetence of the animal may be compromised by a variety of factors including poor health, nutritional status, genetic factors, concurrent drug therapy and stress. Under certain conditions, for example extreme disease pressure, fully immune birds may succumb to disease. Therefore, successful vaccination may not be synonymous with full protection in the face of a disease challenge.
3.5 Special precautions for use
Special precautions for safe use in the target species: 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.
3.6 Adverse events
Chickens (breeders and layers):
1 Mild, may be observed at the injection site 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 the package leaflet for respective contact details.
3.7 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.
3.8 Interaction with other medicinal products and other forms of interaction
Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with Nobilis TRT inac, an Intervet inactivated vaccine containing TRT antigen strain But1#8544 (subgroup A).
|
Very common (>1 animal / 10 animals treated): |
Injection site swelling1. |
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product mentioned above. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case-bycase basis.
3.9 Administration routes and dosage
Intramuscular or subcutaneous use.
Dose: 0.5 ml per bird.
Intramuscular injection in the thigh or chest muscle, or by subcutaneous injection in the back of the neck, using a medium sized needle (20 G x ½”).
The veterinary medicinal product should be given to birds around 14 – 20 weeks of age but not less than 4 weeks before the expected start of lay.
Priming with live vaccines for avian infectious bronchitis and Newcastle disease viruses is necessary unless serological tests indicate otherwise. The interval between priming and booster should not be less than 4 weeks and preferably more than 6 weeks.
Allow the vaccine to reach ambient temperature (15 – 25 °C) before use.
The vaccine may occasionally separate into two layers on storage. This in no way affects its potency. Shake the bottle vigorously before and periodically during use.
An automatic injection system, incorporating a means to prevent back-flushing and hence possible contamination of the vaccine, should be used for administration.
Ensure that vaccination equipment is clean and sterile before use. Do not use vaccination equipment with rubber parts as the excipient may attack certain types of rubber.
3.10 Symptoms of overdose (and where applicable, emergency procedures and antidotes)
After administration of a two-fold overdose the reactions are not different from those observed after a single dose. No effects other than those described in section 3.6.
3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable.
3.12 Withdrawal periods
Zero days.
4. IMMUNOLOGICAL INFORMATION
4.1 ATCvet code: QI01AA13.
To stimulate active immunity against avian infectious bronchitis, Newcastle disease and eggdrop syndrome ’76 viruses.
5. PHARMACEUTICAL PARTICULARS
5.1 Major incompatibilities
Do not mix with any other veterinary medicinal product.
5.2 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.
5.3 Special precautions for storage
Store in a refrigerator (2 °C – 8 °C).
Do not freeze.
Protect from light.
5.4 Nature and composition of immediate packaging
Cardboard box containing a PET bottle with 500 ml (1 000 doses) of the vaccine.
The bottles are closed with a nitryl rubber stopper and sealed with a coded aluminium cap.
5.5 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 or household waste.
Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.
6. NAME OF THE MARKETING AUTHORISATION HOLDER
Intervet International B.V.
7. MARKETING AUTHORISATION NUMBER
Vm 06376/4132
8. DATE OF FIRST AUTHORISATION
19 October 2005
9. DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS
December 2025
10. CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT
Veterinary medicinal product subject to prescription.
Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.
Approved: 13 April 2026
