Target Species
Chickens and turkeys.
Indications for use
For the active immunisation of chickens and turkeys to reduce mortality and clinical signs resulting from infection with Newcastle disease (but for use in turkeys, see comments in section 'Amounts to be administered and administration route').
Onset of immunity: 2 weeks
Duration of immunity: 6 weeks in chickens, 4 weeks in turkeys
Contraindications
None.
Special warnings for each target species
Not applicable.
Special precautions for use
Not applicable.
Operator warnings
The vaccine virus can cause conjunctivitis in humans.
Wash and disinfect hands after use.
When spraying the vaccine, to avoid hay-fever like reactions in some individuals, personal protective equipment consisting of well-fitting masks to appropriate EU standards or better and eye protection to appropriate EU standards must be worn by the operator and staff.
Adverse Reactions
Chickens and turkeys:
Very common (>1 animal / 10 animals treated): | Respiratory signs1 |
Very rare (<1 animal / 10 000 animals treated, including isolated reports): | Head shake - behavioural disorder1, 2 |
1The reaction following primary vaccination is usually mild. Symptoms may occur 4 – 7 days post vaccination and will usually disappear within 2 weeks.
2Slight.
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.
Use during pregnancy or lactation
This vaccine should not be used in birds in lay, except in an emergency. On the basis of experience with this vaccine, emergency vaccination during lay is not expected to have a negative influence on egg production when administered to animals that have been previously vaccinated with live and inactivated Newcastle disease vaccine.
Interactions
Safety and/or efficacy data are available which demonstrate that this vaccine can be mixed with the live infectious bronchitis Ma5 vaccine and live rhinotracheitis (strain 11/94) vaccines by Intervet.
Safety and/or efficacy data are available which demonstrate that this vaccine can be administered at least 7 days before the administration of infectious bursal disease vaccine (strain D78).
Vaccines which target non respiratory diseases (such as Marek’s disease vaccines) may be administered with this vaccine provided that each of the vaccines is administered using the recommended route and the recommended doses.
Safety and efficacy data are available which demonstrate that Innovax-ILT (in chicks of one day of age only) can be administered on the same day, but not mixed with this vaccine.
Safety and efficacy data are available which demonstrate that this vaccine can be administered, but not mixed to day-old chicks that are vaccinated either by the subcutaneous route or to day-old chicks that have been vaccinated by the in ovo route with Innovax-ND-IBD.
Safety and efficacy data are available which demonstrate that this vaccine can be administered, but not mixed to day-old chicks that are vaccinated either by the subcutaneous route or to day-old chicks that have been vaccinated by the in ovo route with Innovax-ND-ILT.
No information is available on the safety and efficacy of the vaccine when used with any other vaccines 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
The vaccine can be administered by oculonasal use (instillation (dropping) into the eyes and nares, coarse spray) or in drinking water use. For instillation into the eyes and nares, use Nobilis Diluent Oculo Nasal.
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.
Chickens:
The vaccine can be administered to 1-day old chicks and older chickens by coarse spray or by the intranasal/ocular route of administration.
The vaccine can be administered to 7-day and older chicks by drinking water.
Turkeys:
The vaccine has been shown to be efficacious when administered in the drinking water to antibody free turkeys of 2 weeks of age. Evidence for the safe use of this vaccine in turkeys is limited but field experience indicates that the vaccine may be safely administered to turkeys from 1 – 2 weeks of age via drinking water or coarse spray routes of administration.
Drinking water
When administering the vaccine by drinking water use cool, clean water supplemented with 2 grams of skimmed milk powder or 50 ml of liquid skimmed milk per litre to dissolve the vaccine, as it is known that this will make the virus retain its activity.
Reconstitution of vaccine:
The vials should be opened under water or the content of the cup(s) should be poured into the water. In both cases mix the water containing the vaccine well before use. All containers used should be clean and free from any traces of detergent or disinfectant. Mix thoroughly with a clean stirrer, ensuring that all vials or cups used are emptied. After reconstitution the suspension looks clear.
Offer to birds immediately.
Use clean cold water, which is free of iron and chlorine. Where water sanitisers are used consult MSD Animal Health technical staff. Chlorine at levels as low as 1 ppm is known to have a detrimental effect on vaccine virus stability, therefore the use of liquid skimmed milk is recommended to prolong the life of the virus. By adding 2 grams skimmed milk powder per litre water the virus retains its activity much longer. This may be added to the water at the rate of 500 ml (approximately 1 pint) per 10 litres of water. After mixing well, the solution should be allowed to stand for 15 – 30 minutes before adding the vaccine. Only skimmed milk should be used, as the fat in whole milk may block the automatic drinking systems as well as reduce vaccine virus efficacy.
Ensure uptake of all the vaccine medicated water in 2 hours. Depending on the weather conditions, it may be advisable to deprive the birds of water prior to vaccination. A sufficient number of water containers to provide adequate drinking space is essential. These should be clean and free from traces of detergents and disinfectants. Dissolve 1 000 doses in as many litres of water as the age of the birds in days, to a maximum of 40 litres.
The vaccine should be given in the early morning as this is the main period of drinking or the cool period on a hot day. When vaccinating larger flocks, it is advisable to start by dissolving only part of the vaccine. If vaccine is administered through a central water supply or a proportioner, great care should be taken. For numbers of birds between standard dosages, the next higher dosage should be chosen.
The vaccine can be administered by oculonasal use (instillation (dropping) into the eyes and nares, coarse spray) or in drinking water use. For instillation into the eyes and nares, use Nobilis Diluent Oculo Nasal.
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.
Chickens:
The vaccine can be administered to 1-day old chicks and older chickens by coarse spray or by the intranasal/ocular route of administration.
The vaccine can be administered to 7-day and older chicks by drinking water.
Turkeys:
The vaccine has been shown to be efficacious when administered in the drinking water to antibody free turkeys of 2 weeks of age. Evidence for the safe use of this vaccine in turkeys is limited but field experience indicates that the vaccine may be safely administered to turkeys from 1 – 2 weeks of age via drinking water or coarse spray routes of administration.
Drinking water
When administering the vaccine by drinking water use cool, clean water supplemented with 2 grams of skimmed milk powder or 50 ml of liquid skimmed milk per litre to dissolve the vaccine, as it is known that this will make the virus retain its activity.
Reconstitution of vaccine:
The vials should be opened under water or the content of the cup(s) should be poured into the water. In both cases mix the water containing the vaccine well before use. All containers used should be clean and free from any traces of detergent or disinfectant. Mix thoroughly with a clean stirrer, ensuring that all vials or cups used are emptied. After reconstitution the suspension looks clear.
Offer to birds immediately.
Use clean cold water, which is free of iron and chlorine. Where water sanitisers are used consult MSD Animal Health technical staff. Chlorine at levels as low as 1 ppm is known to have a detrimental effect on vaccine virus stability, therefore the use of liquid skimmed milk is recommended to prolong the life of the virus. By adding 2 grams skimmed milk powder per litre water the virus retains its activity much longer. This may be added to the water at the rate of 500 ml (approximately 1 pint) per 10 litres of water. After mixing well, the solution should be allowed to stand for 15 – 30 minutes before adding the vaccine. Only skimmed milk should be used, as the fat in whole milk may block the automatic drinking systems as well as reduce vaccine virus efficacy.
Ensure uptake of all the vaccine medicated water in 2 hours. Depending on the weather conditions, it may be advisable to deprive the birds of water prior to vaccination. A sufficient number of water containers to provide adequate drinking space is essential. These should be clean and free from traces of detergents and disinfectants. Dissolve 1 000 doses in as many litres of water as the age of the birds in days, to a maximum of 40 litres.
The vaccine should be given in the early morning as this is the main period of drinking or the cool period on a hot day. When vaccinating larger flocks, it is advisable to start by dissolving only part of the vaccine. If vaccine is administered through a central water supply or a proportioner, great care should be taken. For numbers of birds between standard dosages, the next higher dosage should be chosen.
Overdose
The reactions seen after administration of an overdose are generally similar to the reactions seen after a single dose (but in rare cases the reactions may be somewhat more pronounced).
Withdrawal period
Zero days.