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Date: Wednesday, April 30, 2025 9:17

Release 2.30
NEMOVAC lyophilisate for oculonasal suspension/use in drinking water (Northern Ireland)
 
Species: Chickens
Therapeutic indication: Immunological veterinary medical products: For chickens
Active ingredient: Vaccine Antigens
Product:Nemovac
Product index: Nemovac
Poultry - meat: Zero days
Poultry - eggs: See note
Withdrawal notes: Do not use in chickens in lay
Incorporating:
Qualitative and quantitative composition
Each dose of reconstituted vaccine contains:
Active substance: Live avian pneumovirus PL21 strain, at least 2.3 log10 CCID50*
*CCID50 = 50% cell culture infective dose.
Qualitative composition of excipients and other constituents
Casein hydrolysate
Bovine albumin
Povidone
Sucrose
Mannitol
Monopotassium phosphate
Dipotassium phosphate
Potassium glutamate
Pale Pellet
Pharmaceutical form
Please see QUALITATIVE AND QUANTITATIVE COMPOSITION section
Clinical particulars
Target species
Chickens
Indications for use
For broiler chickens:
For active immunisation of chickens from 7 to 14 days of age to reduce upper respiratory signs associated with avian pneumovirus infection (Swollen Head Syndrome).
Onset of immunity: 17 days after vaccination.
Duration of immunity: 5 weeks after vaccination.
For breeder and layer pullets:
Priming for active immunisation of pullets from 14 weeks of age before booster vaccination with an inactivated vaccine containing avian pneumovirus to reduce respiratory signs associated with avian pneumovirus infection.
For onset of immunity and duration of immunity of full schedule, see SPC of the inactivated booster vaccine.
Contraindications
None
Special warnings
Vaccinate healthy animals only.
Special precautions for use
Special precautions for safe use in the target species:
The product is a live vaccine and is excreted from vaccinated birds and so spreads to unvaccinated chickens and turkeys. Reversion to virulence trials carried out in the laboratory have shown that the strain does not revert to virulence neither in chickens nor in turkeys. However, precautionary measures have to be followed in order to diminish the spread, see sections 3.9 and 5.5.
It is advised not to vaccinate in the presence of other sensitive species (guinea fowl, pheasant), taking into account the spread of the vaccine strain and the lack of safety data for these species.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Care should be taken during reconstitution and administration of the vaccine.
Wash hands and wear disposable gloves during reconstitution and administration of the vaccine.
Hands should be washed and disinfected after vaccinating.
Special precautions for the protection of the environment:
Not applicable.
Adverse reactions
None known.
In layer and breeder pullets, refer to the SPC of the inactivated booster vaccine.
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 the national competent authority via the national reporting system. See the package leaflet for respective contact details
Use during pregnancy, lactation or lay
Laying birds:
Do not use in birds in lay.
Interaction with other medicinal products and other forms of interaction
Safety and efficacy data are available which demonstrate that the simultaneous use of the vaccine and Infectious Bursal Disease, Infectious Bronchitis and Newcastle Disease vaccines may slightly decrease or transiently delay the humoral response of animals to NEMOVAC. The simultaneous use of the vaccine and Infectious Bronchitis vaccine may decrease and/or delay the Infectious Bronchitis seroconversion. Therefore, no other vaccine should be used simultaneously with the product.
Administration routes and dosage
Broiler chickens:
One dose of vaccine to be administered from 7 and 14 days of age when levels of maternally derived antibodies are low, or at 14 days of age when levels of maternally derived antibodies are likely to be high.
Breeder/layer pullets:
One dose of vaccine to be administered at 14 weeks of age before booster vaccination with inactivated vaccine prior to the onset of lay.
Apply the usual aseptic precautions to all administration procedures.
Calculate the number of vials of vaccine required to vaccinate all the birds. Treat all water to come into contact with the vaccine with skimmed milk powder at a rate of 2.5 g per litre. Use only clean, antiseptic and disinfectant free drinking water.
Half fill a plastic (non-metallic) container in which a vaccine vial can be submerged with the clean treated drinking water.
Remove the metal caps from each of the vaccine bottles, submerge each one individually and remove the rubber cap. Rinse the bottle, remove the cap and bottle and discard appropriately. Repeat for each bottle.
Administration by oral route (broilers and pullets)
For 1,000 birds, reconstitute the freeze-dried pellet corresponding to 1,000 doses in a small quantity of non-chlorinated drinking water and subsequently dilute it into a volume of non-chlorinated drinking water to be consumed within 1 to 2 hours. Birds may have drinking water withdrawn for 1-2 hours before administering vaccine.
Administration by spray route (pullets)
For 1,000 birds, reconstitute the freeze-dried pellet corresponding to 1,000 doses into 1 ml of non-chlorinated water and subsequently dilute it into the volume of non-chlorinated water according to the type of sprayer used (pressure-sprayer or sprayer with rotary cone, for further information on sprayer equipment, contact the manufacturer).
Spray the vaccine solution above the birds using a sprayer capable of producing droplets with a mean diameter of 80-150 μm.
For proper vaccine distribution, make sure that birds are evenly distributed during spraying.
The ventilation system of the poultry house should be inoperative during the spray administration.
The reconstituted product appears as a pale suspension.
Overdose
None known.
Withdrawal period
Zero days.
Pharmaceutical particulars
Major incompatibilities
Only disinfectant-free and/or antiseptic-free water should be used for the preparation of vaccine solution.
Do not mix with any other veterinary medicinal product.
Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 18 months.
Shelf-life after reconstitution according to directions: 2 hours.
Special precautions for storage
Store and transport refrigerated (2 °C – 8 °C).
Do not freeze.
Protect from light.
After reconstitution, do not store above 25 °C.
Broached vials should not be stored.
Immediate packaging
Type of immediate packaging:
Type I glass vial, with butyl elastomer closure and aluminium cap.
Plastic box with 1 or 10 vials of 1,000 doses.
Plastic box of 1 or 10 vials of 2,000 doses.
Plastic box of 1 or 10 vials of 5,000 doses.
Not all pack sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal products 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.
Marketing Authorisation Number
Vm 08327/3006
Significant changes
Legal category
Legal category: POM-V
GTIN
GTIN description:Nemovac 1000 dose vial
GTIN:3661103034032
GTIN description:Nemovac 5000 dose vial
GTIN:3661103000396