Avipro Nd C131, Lyophilisate For Suspension
Revised: October 2012
AN: 00711/2012
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
AviProND C131 Lyophilisate for Suspension
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance:
1 dose contains Newcastle Disease Virus, live, strain clone 13-1 min. 106.0and max. 107.2 EID50/dose
*EID50= 50%-embryo infectious dose: the virus titre causing infection in 50% of the embryos inoculated with the virus.
Excipients:
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Lyophilisate for suspension
Appearance: off-white pellet
4. CLINICAL PARTICULARS
4.1 Target species
Chicken (from 14 days old)
4.2 Indications for use,specifying the target species
Active immunisation of chickens against Newcastle disease to reduce clinical signs and mortality.
In broilers
Onset of immunity: 3 weeks after vaccination (7 days in seronegative chickens)
Duration of immunity: 4 weeks after vaccination (based on serological levels)
In layers/breeders
Onset of immunity: 3 weeks after the first vaccination
Duration of immunity: 9 weeks after the application of the complete vaccine scheme performed accordingly with the recommended scheme described under point 4.9 (based on serological levels)
4.3 Contraindications
Do not use in unhealthy birds.
See also section 4.4 and 4.7
Special warnings for each target species
Do not use for breeders in lay.
Concurrent infections for example with Mycoplasma, E. coli, Aspergillus or Orhithobacterium rhinotracheale may cause complications.
4.5 Special precautions for use
Special precautions for use in animals
The virus is excreted with faeces up to 12 days and may spread to susceptible animals by contact infection. However, ND negative contact animals do not show sero-conversion until 15 days after contact.
Transmission of the vaccine strain to ducks, turkeys and geese is harmless. In pigeons slight pathological findings were observed in the respiratory tract, but no clinical symptoms occurred.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
ND-virus can induce conjunctivitis upon contact to eyes. Therefore during spraying eye- and inhalation protection (face mask/visors) must be worn.
Upon contact of the product to eyes seek medical advice.
Wash and disinfect hands and equipment after application.
4.6 Adverse reactions (frequency and seriousness)
6-15 days after vaccination slight reactions of the respiratory tract (coughing or sneezing) may be observed due to replication of the virus in the target cells, but this does not influence the performance of the birds. At least 15 days after vaccination, at post mortem examination specific respiratory signs were seen after application of a tenfold overdose.
4.7 Use during pregnancy, lactation or lay
Safety data demonstrate that layers can be vaccinated during the laying period according to the recommended vaccine schedule (see 4.9.).
In non-primed birds ND-vaccine virus was found in the oviduct after 10-fold over dosage. No egg transmission is observed in laying birds after basic immunisation.
Do notuse for breeders in lay.
4.8 Interaction with other medicinal products and other forms of interaction
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. 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.
4.9 Amounts to be administered and administration route
For intra-ocular application, for drinking water or spray application after dissolution.
For application to chickens starting from the 14thday of life.
Broilers:
1 vaccination.
Layers and
breeders:
Basic
immunisation scheme: 2
vaccinations with an interval of 4 weeks
Mode of
application:
Ensure that the drinking water is cold, clean, non-chlorinated and free from detergents, disinfectants and metal ions.
-
Remove sealing cap and stopper from vaccine container.
-
Suspend the vaccine in the corresponding amount of water and mix carefully.
-
Prepare only the amount of vaccine that can be consumed within 2 hours.
-
The vaccine is ready for use.
Intra-ocular administration (eye drop method)
The equipment used for eye drop application should be clean, free of detergents and disinfectants and should be used for vaccination purposes only.
For preparation of the vaccine use 34 ml of boiled and cooled drinking water per 1000 doses of vaccine.
Administer 1 droplet (corresponding to approximately 34 µl) into one eye of each bird to be vaccinated by use of a pipette or dropper.
Spray administration
The amount of drinking water to be used for spray application depends on local and husbandry conditions.
After removing the stopper under water 1000 doses of vaccine are diluted as follows:
-
500 ml for 1000 chickens up to the 4th week of life
-
750 – 1000 ml for 1000 chickens after the 4th week of life.
The birds are sprayed uniformly with a distance of 30 – 40 cm.
During and after vaccination ventilation should be switched off in order to avoid turbulences.
For primary vaccination during the 1stweeks of life a coarse spray having a droplet size of 100 µm and more should be used to avoid penetration into the lower parts of the respiratory tract and increased vaccination reactions.
Drinking water administration
all equipment used for vaccination (tubes, drinkers etc.) are carefully cleaned and are free of detergents and disinfectants.
Estimate the amount of water according to the number of birds to be vaccinated (see 5.) Only cold clean water of drinking water quality should be used.
The addition of skimmed milk powder (2 – 4 g/l water) or skimmed milk (20 – 40 ml/l water) may positively influence the stability of the vaccine. Skimmed milk powder or skimmed milk must be carefully mixed with the water before dilution of the vaccine.
Remove aluminium-cap. Open the stopper of vaccine bottle under water and dilute the contents completely.
For easy handling the vaccine should be prepared in a small container (about 1 litre). Rinse the vial carefully and empty it completely. The vaccine suspension is then diluted in a larger vessel (5 – 10 l) and mixed well again.
The complete content of the vaccine vials should be used for one flock or drinking water system only. Splitting of the diluted vaccine may lead to dosage errors.
To the Vaccine suspension fresh cold water is added that – as a rule of thumb -1000 vaccine doses are suspended in one litre of water per day of life for 1000 birds: i.e. for 1000 chickens at the age of 15 days 15 litres of water are necessary. In case of doubt the uptake of water should be established the day before vaccination.
The water present in the drinking water should be consumed before vaccination. Pipes still filled with water must be drained before application of the vaccine suspension. The vaccine should be consumed within 2 hours. Since drinking behaviour of chickens is varying it may be necessary to withdraw the drinking water for 2-3 hours before vaccination to ensure that all birds will drink during the vaccination phase. Every bird should receive an adequate dose of the vaccine.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
No other signs than mentioned under 4.6. are seen after administration of ten times the maximum dose via the recommended routes.At least 15 days after vaccination, at post mortem examination specific respiratory signs were seen after application of a tenfold overdose.
4.11 Withdrawal period(s)
Zero days
5. IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group:Immunologicals, immunologicals for aves, domestic fowl, live viral vaccines, Newcastle disease virus/paramyxovirus
ATC vet-Code:QI01AD06
The component of the vaccine is a live, lentogenic ND-strain which stimulates active immunity against Newcastle Disease.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Peptone
Magnesium sulphate
Sucrose
Gelatine
6.2 Incompatibilities
Do not mix with any substance other than water and skimmed milk or skimmed milk powder, or the solvent indicated for eye-drop administration where it is authorised.
Ensure that the drinking water is cold, clean, non-chlorinated and free from detergents, disinfectants and metal ions.
6.3 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 1 year
Shelf-life after dilution or reconstitution according to directions: 2 hours
The complete content of opened containers should be used at once.
6.4. Special precautions for storage
Store in a refrigerator (2 C – 8 C). Protect from direct sunlight. Do not freeze.
6.5 Nature and composition of immediate packaging
Crimp vials made of glass type I (Ph.Eur.) with Chlorobutyl-Elastomer closure.
The vials are sealed with aluminium tear-off crimp caps.
The vaccine is available in the following packaging sizes:
Box with vial with 500 doses
Box with ten vials with 500 Doses
Box with vial with 1000 doses
Box with ten vials with 1000 Doses
Box with vial with 2500 doses
Box with ten vials with 2500 Doses
Box with vial with 5000 doses
Box with ten vials with 5000 Doses
Box with vial with 10000 doses
Box with ten vials with 10000 Doses
Potentially not all packaging sizes are placed into the market.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.
7. MARKETING AUTHORISATION HOLDER
Lohmann Animal Health GmbH
Heinz-Lohmann-Strasse 4,
D-27472 Cuxhaven
8. MARKETING AUTHORISATION NUMBER
Vm16894/4007
9. DATE OF FIRST AUTHORISATION
Date:22 August 2007
10. DATE OF REVISION OF THE TEXT
Date:October 2012
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
APPROVED 28/11/12
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