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Date: Wednesday, April 30, 2025 11:27

Release 2.40
Nobilis® ND C2 Lyophilisate for oculonasal suspension for chickens
 
Species: Chickens
Therapeutic indication: Immunological veterinary medical products: For chickens
Active ingredient: Vaccine Antigens
Product:Nobilis® ND C2 Lyophilisate for oculonasal suspension for chickens
Product index: Nobilis® ND C2
Poultry - meat: Zero days
Incorporating:
Qualitative and quantitative composition
Per dose of reconstituted vaccine:
Active substance:
Live attenuated Newcastle disease virus (NDV) strain C2: 5.7 - 7.5 log10 EID50*
*EID50 = 50% Embryo infective dose: the virus titre required to produce infection in 50% of the embryos inoculated.
For the full list of excipients, see section “Pharmaceutical particulars”.
Pharmaceutical form
Lyophilisate:
Vials: white/off-white coloured pellet.
Cups: white/off-white, predominantly sphere shaped.
Clinical particulars
Target Species
Chickens.
Indications for use
Active immunisation of chickens against Newcastle disease virus to reduce clinical signs and mortality.
Onset of immunity: 2 weeks after vaccination of seronegative animals.
Duration of immunity: 5 weeks after vaccination of seronegative animals.
Onset of protection is demonstrated at 2 weeks after vaccination of animals with maternally derived antibodies.
Duration of immunity is in accordance with the vaccination programme.
Contraindications
Do not vaccinate clinically ill (especially respiratory disease) or stressed birds.
Special warnings for each target species
Vaccinate healthy animals only.
Special precautions for use
The vaccine virus may spread to unvaccinated birds up to 10 days post vaccination. This spread does not induce clinical signs but may lead to seroconversion in unvaccinated chickens.
Operator warnings
The vaccine can be pathogenic for humans. Since this vaccine has been prepared with live, attenuated viruses, appropriate measures should be taken to prevent contamination of the handler and other people that collaborate in the process.
In case of spray administration, personal protective equipment consisting of masks with eye protection should be worn when handling the veterinary medicinal product.
Wash and disinfect hands and equipment after vaccination.
Adverse Reactions
Very common
(>1 animal / 10 animals treated):
Head shake - behavioural disorder1,
Blinking1.
1 May be observed when ice-cold vaccine is administered via the eye/nose drop method.
Use during pregnancy or lactation
Do not use in birds in lay or within 4 weeks before the start of the laying period (as the safety of this has not been investigated).
Interactions
Safety and efficacy data are available which demonstrate that this vaccine can be administered to 1 day old chicks on the same day, but not mixed with Innovax-ILT or the Nobilis live vaccines against rhinotracheitis (strain 11/94). Marek's disease (strains CVI988-FC126) or infectious bronchitis (strain IB Ma5) are compatible with Nobilis ND C2 when not mixed and given on day 1. The efficacy of the Marek and IB Ma5 vaccines has not been investigated.
Safety and efficacy data are available which demonstrate that the Nobilis live vaccine against Infectious bursal disease vaccine (strain D78) can be given 7 days after Nobilis ND C2.
Safety and efficacy data are available which demonstrate that Nobilis ND C2 can be administered to day-old chicks that are vaccinated either by the subcutaneous or in ovo route with Innovax-ND-IBD.
Safety and efficacy data are available which demonstrate that Nobilis ND C2 can be administered to day-old chicks that are vaccinated either by the subcutaneous or in ovo route with Innovax-ND-ILT.
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.
Amounts to be administered and administration route
For oculonasal use via intranasal/ocular or coarse spray administration.
Single vaccination with one dose per animal from 1 day of age onwards.
The vaccine may be delivered as a freeze-dried cake in a glass vial or as freeze-dried spheres in cups. In case of the product presented in cups, do not use the product if the contents are brownish and stick to the container as this indicates that the integrity of the container has been breached. Each container should be used immediately and completely after opening. After reconstitution the suspension looks clear.
Intranasal/Oculonasal administration
Reconstitute the vaccine with the appropriate amount of a suitable diluent and administer by means of a standardised dropper (of which the droplet size is known and consistent). Sterile distilled water or phosphate buffered saline can be used. The amount of diluent required for eye- or nose-drop administration depends on the number of doses and the droplet size, but approximately 35 ml per 1000 doses is used. One drop should be applied into one nostril or one eye. Ensure that the nasal drop is inhaled before freeing the bird.
Course spray administration
Reconstitute the vaccine in cool, clean water, to which 2% skimmed milk may be added. The vials should be opened under water or the content of the cup(s) should be poured into water. Chlorinated water should not be used. In both cases mix the water containing vaccine well before use. The volume of solvent for reconstitution should be sufficient to ensure an even distribution when sprayed onto the birds. This will vary according to the age of the birds being vaccinated and the management system, but 250 to 500 ml of water per 1000 doses is suggested. The vaccine suspension should be sprayed evenly over the birds at a distance of 30-40 cm, preferably when the birds are sitting together in dim light. If applicable, reduce or stop ventilation to prevent loss of spray.
The water and spray apparatus should be free from sediments, corrosion and traces of disinfectants or antiseptics and ideally should be used for vaccination purposes only.
Vaccination programme
The vaccine can be given from 1 day of age onwards. Because the immunity which is induced by vaccination with Nobilis ND C2 is not long lasting, an extended vaccination programme should be followed. To maintain a required level of immunity, chickens should receive a secondary vaccination 2-3 weeks after administration of this vaccine, with a live vaccine containing the more immunogenic Clone 30 strain.
Overdose
No other signs than after a single dose are seen after administration of ten times the maximum dose via the recommended routes.
Withdrawal period(s):
Zero days.
Pharmacological particulars
ATCvet code: QI01AD06
Pharmacotherapeutic group:
Live Newcastle disease virus vaccine.
To stimulate immunity against Newcastle disease in chickens.
The attenuated C2 strain is lentogenic and of low pathogenicity and is therefore suitable from 1 day of age.
Priming effect of ND C2 has been demonstrated exclusively by secondary vaccination of chickens with the live NDV vaccine containing the more immunogenic Clone 30 strain.
Pharmaceutical particulars
Excipients
Sorbitol
Hydrolysed gelatine
Pancreatic digest of casein
Disodium phosphate dihydrate
Purified water
Major incompatibilities
Do not use with any other veterinary medicinal product.
Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf-life after reconstitution according to directions: 3 hours.
Special precautions for storage
Store in a refrigerator (2 °C - 8 °C).
Do not freeze.
Protect from light.
Store below 25 °C after reconstitution.
Immediate packaging:
Glass vial (hydrolytic glass type I or glass type II), closed with a with halogenobutyl rubber stopper and metal cap.
Sealed aluminium laminate cup with a polypropylene (cup) and polypropylene/polyethylene (lid) contact layer.
Pack sizes:
Cardboard box with 1 or 10 vial(s) of 500 doses, 1000 doses, 2500 doses, 5000 doses, 10 000 doses or 25 000 doses.
PET plastic boxes with 12 cups of 1000 doses, 2500 doses, 5000 doses or 10 000 doses.
Not all pack sizes may be marketed.
Disposal
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.
Marketing Authorisation Holder (if different from distributor)
Marketing Authorisation Number
UK(GB): Vm 01708/5088
UK(NI): Vm 01708/3020
Significant changes
Date of the first authorisation or date of renewal
25 April 2005
Date of revision of the text
April 2024
Any other information
For animal treatment only. Keep out of the sight and reach of children.
Any person intending to manufacture, import, possess, sell, supply and use this veterinary medicinal product must first consult the relevant Member State’s competent authority on the current vaccination policies, as these activities may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Legal category
Legal category: POM-V
GTIN
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