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Date: Wednesday, April 30, 2025 6:38

Description: MSD-AH
Release 2.36
Nobilis® IB+ND+EDS emulsion for injection (UK)
 
Product:Nobilis® IB+ND+EDS emulsion for injection (UK)
Product index: Nobilis® IB+ND+EDS emulsion for injection (UK)
Poultry - meat: Zero days
Incorporating:Nobilis® IB+ND+EDS emulsion for injection (UK)
Qualitative and quantitative composition
Active substances:
Inactivated avian infectious bronchitis virus, strain M41 6.0 log2 HI units
Inactivated Newcastle disease virus, strain Clone 30 4 log2 HI units per 1/50 dose or 50 PD50 units per dose
Inactivated egg drop syndrome virus, strain BC14 ≥ 6.5 log2 HI units
Adjuvant:
Liquid paraffin 215 mg.
For the full list of excipients, see section “Pharmaceutical Particulars”.
Pharmaceutical form
Emulsion for injection.
Clinical particulars
Target Species:
Chickens (breeders and layers).
Indications for use:
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 egg drop 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).
Contraindications:
None.
Special warnings for each target species:
Vaccinate healthy birds 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. Immuno-competence 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.
Special precautions for use:
None.
Operator warnings:
To the user:
This veterinary medicinal product contains mineral oil. Accidental 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 veterinary medicinal 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:
A mild transient swelling may be observed at the injection site for 2 weeks.
Use during pregnancy or lactation:
Do not use in birds in lay or within 4 weeks before the onset of the laying period.
Interactions:
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).
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 decided on a case-by-case basis.
Amounts to be administered and administration route:
Dose: 0.5 ml per bird.
Routes of administration: 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”).
Nobilis IB+ND+EDS should be given to birds around 14–20 weeks of age but not less than 4 weeks before the expected onset 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.
Overdose:
No particular symptoms are observed after administration of a double dose.
No effects other than those described in section Adverse Reactions.
Withdrawal periods:
Zero days.
Pharmacological particulars
ATCvet code: QI01AA13.
Pharmacotherapeutic group: Immunologicals for Aves, domestic fowl, inactivated viral vaccines.
To stimulate active immunity against avian infectious bronchitis, Newcastle disease and egg drop syndrome ’76 viruses.
Pharmaceutical particulars
Excipients:
Light liquid paraffin
Polysorbate 80
Sorbitan oleate
Glycine
Formaldehyde
Water for injections
Major incompatibilities:
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
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.
Special precautions for storage:
Store in refrigerator (2 °C – 8 °C). Do not freeze.
Protect from light.
Immediate packaging:
Cardboard box containing a PET bottle with 500 ml (1,000 doses) of the vaccine.
The bottles are closed with a nitrile rubber stopper and sealed with a coded aluminium cap.
Disposal:
Any unused veterinary medicinal product or waste material derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
Intervet International B.V., represented by MSD Animal Health UK Limited.
Marketing Authorisation Number
Vm 06376/4132
Significant changes
Date of the first authorisation or date of renewal
19 October 2005
Date of revision of the text
January 2025.
Any other information
Legal category
Legal category: POM-V
GTIN
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