Avishield ND
Active substance
ATC code
Species
Chickens and turkeys.
Indications
For active immunisation of chickens to reduce mortality and clinical signs due to infection with
Newcastle disease virus.
Onset of immunity: 21 days post vaccination.
Duration of immunity: 35 days post vaccination.
For active immunisation of turkeys to prevent mortality and clinical signs due to infection with
Newcastle disease virus.
Onset of immunity: 21 days post vaccination.
Duration of immunity has not been established.
Dose to be administered and administration route
Chickens: 1 dose by coarse spray or oculonasal use from the age of 1 day. The vaccine can be administered in drinking water at the time when birds are drinking continuously from the drinking system.
Turkeys: 1 dose by coarse spray, oculonasal use or in drinking water use from the age of 14 days.
Method of application depends on the epizootiological situation, age, category and number of animals. The veterinarian should determine the optimum vaccination schedule according to the local situation taking into account the information provided in section 3.4.
It is extremely important that all birds receive the full dose of vaccine. Details presented below should be strictly followed to achieve this.
After reconstitution the vaccine appears as a clear to slightly opalescent suspension.
If prolonged immunity is required, chickens can be revaccinated after 35 days.
Revaccination in turkeys has not been investigated.
1. Oculonasal use
Reconstitute 1 000 doses of the vaccine in 100 ml distilled water.
A dose of reconstituted vaccine is 0.1 ml, i.e. two drops, irrespective of poultry age, weight and type. Instil one drop into an eye and one drop into the nostril.
2. In drinking water use
Reconstitute the vaccine in cool and clean water without traces of chlorine, other disinfectants or impurities in a number of doses corresponding to the number of birds to be vaccinated.
The vaccine should be reconstituted immediately before use.
The volume of water for reconstitution depends on the age of the birds, the breed, the management practice and weather conditions.
In order to determine the quantity of water in which vaccine will be reconstituted for the vaccination of chickens in a younger age category (until the third week of life), the following guideline applies:
- multiplying the number of birds in the thousands with the day of life (e.g. 1 thousand chickens in the 7th day of life = 1 x 7 = 7 L)
It is important to reconstitute the vaccine in the amount of water which will be drunk within 1.5 - 2.5 hours (taking into account the different types of drinking systems for poultry).
In order to make the birds thirsty, withdraw the supply of drinking water up to 2 hours prior to vaccination (depending on the air temperature).
Always make sure that there is food available when vaccinating. Birds will not drink if they have no food to eat. The drinking system should be clean, without traces of chlorine, other disinfectants or impurities.
3. Coarse spray
It is recommended to reconstitute 1 000 doses of the vaccine in 150 - 300 ml of distilled water. The number of doses to be used corresponds to the number of birds in the flock. The volume of water for reconstitution should be sufficient to ensure an even distribution when sprayed onto the birds, and will vary according to the age of the birds being vaccinated and the management system.
The reconstituted vaccine suspension should be spread evenly over the correct number of chickens, at a distance of 30 – 40 cm using a coarse spray, preferably when the chickens are sitting together in dim light. The spray apparatus should be free from sediments, corrosion and traces of disinfectants and ideally should be used for vaccination purposes only. During and after vaccination ventilation should be switched off in order to avoid turbulences.
Adverse reactions
Chickens:
|
Very common (>1 animal / 10 animals treated): |
Respiratory signsa |
a After oculonasal use. These symptoms could last at least two weeks.
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.
Dispensing
POM-V - Prescription Only Medicine – Veterinarian
TRUSTED SOURCE
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Avishield ND, lyophilisate for oculonasal suspension/use in drinking water, for chickens and turkeys
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose contains:
Active substance:
Live, lentogenic Newcastle disease virus, strain La Sota 106.0 to 107.0 TCID50
TCID50 = 50% Tissue culture infective dose
Excipients
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Lyophilisate for oculonasal suspension/use in drinking water. Cream coloured lyophilisate.
4. CLINICAL PARTICULARS
4.1 Target species
Chickens and turkeys.
4.2 Indications for use, specifying the target species
For active immunisation of chickens to reduce mortality and clinical signs due to infection with Newcastle disease virus.
Onset of immunity: 21 days post vaccination.
Duration of immunity: 35 days post vaccination.
For active immunisation of turkeys to prevent mortality and clinical signs due to infection with Newcastle disease virus.
Onset of immunity: 21 days post vaccination.
Duration of immunity has not been investigated.
4.3 Contraindications
None.
4.4 Special warnings for each target species
Vaccinate healthy animals only.
The vaccine strain can spread to susceptible, unvaccinated birds for at least 10 days following vaccination. The spread does not induce clinical signs.
Vaccine virus can disseminate to the trachea, spleen, kidneys, lung, caecal tonsils, duodenum and brains of chickens without inducing pathological changes to these organs.
Maternally Derived Antibodies (MDA) can interfere with the development of active immunity.
Where it is likely, for example, that a recent field infection or vaccination of the parent flock has stimulated a high antibody titre and consequently a high level of MDA, the vaccination programme should be planned accordingly.
It has been shown in laboratory studies that MDA interfere with vaccination by the spray and oral route and can result in up to 55% unprotected birds 3 - 4 weeks post vaccination. Better protection in these studies was seen by oculonasal delivery but the onset of immunity was delayed by a week.
Influence of MDA on vaccination in turkeys has not been investigated.
4.5 Special precautions for use
Special precautions for use in animals
All birds in the flock should be vaccinated at the same time.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Care should be taken when handling and administering the vaccine.
Newcastle disease virus can cause a mild transient conjunctivitis in the person administering the vaccine. Personal protective equipment consisting of a mask and eye protection should be worn when handling the veterinary medicinal product. Wash and disinfect hands after administration of the vaccine.
4.6 Adverse reactions (frequency and seriousness)
Respiratory disturbances after oculonasal use occur very commonly. These symptoms could last at least two weeks.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
4.7 Use during pregnancy, lactation or lay
Laying birds:
Do not use in birds in lay and within 4 weeks before the start of the laying period.
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
Chickens: 1 dose by coarse spray or oculonasal use from the age of 1 day. The vaccine can be administered in drinking water at the time when birds are drinking continuously from the drinking system.
Turkeys: 1 dose by coarse spray, oculonasal use or in drinking water use from the age of 14 days.
Method of application depends on the epizootiological situation, age, category and number of animals. The veterinarian should determine the optimum vaccination schedule according to the local situation taking into account the information provided in section 4.4.
It is extremely important that all birds receive the full dose of vaccine. Details presented below should be strictly followed to achieve this.
If prolonged immunity is required, chickens can be revaccinated after 35 days. Revaccination in turkeys has not been investigated.
1. Oculonasal use
Reconstitute 1,000 doses of the vaccine in 100 ml distilled water.
A dose of reconstituted vaccine is 0.1 ml, i.e. two drops, irrespective of poultry age, weight and type. Instil one drop into the eye and one drop into the nose opening.
2. In drinking water use
Reconstitute the vaccine in cool and clean water without traces of chlorine, other disinfectants or impurities in a number of doses corresponding to the number of birds to be vaccinated.
The vaccine should be reconstituted immediately before use.
The volume of water for reconstitution depends on the age of the birds, the breed, the management practice and weather conditions.
In order to determine the quantity of water in which vaccine will be reconstituted for the vaccination of chickens in a younger age category (until the third week of life), the following guideline applies:
- multiplying the number of birds in the thousands with the day of life (e.g. 1 thousand chickens in the 7th day of life = 1 x 7 = 7 L)
It is important to reconstitute the vaccine in the amount of water which will be drunk within 1.5–2.5 hours (taking into account the different types of drinking systems for poultry).
In order to make the birds thirsty, withdraw the supply of drinking water up to 2 hours prior to vaccination (depending on the air temperature).
Always make sure that there is food available when vaccinating. Birds will not drink if they have no food to eat. The drinking system should be clean, without traces of chlorine, other disinfectants or impurities.
3. Coarse spray
It is recommended to reconstitute 1,000 doses of the vaccine in 150–300 ml of distilled water. The number of doses to be used corresponds to the number of birds in the flock. The volume of water for reconstitution should be sufficient to ensure an even distribution when sprayed onto the birds, and will vary according to the age of the birds being vaccinated and the management system.
The reconstituted vaccine suspension should be spread evenly over the correct number of chickens, at a distance of 30–40 cm using a coarse spray, preferably when the chickens are sitting together in dim light. The spray apparatus should be free from sediments, corrosion and traces of disinfectants and ideally should be used for vaccination purposes only. During and after vaccination ventilation should be switched off in order to avoid turbulences.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Slightly open mouth breathing was seen very commonly 5–9 days post vaccination after application of a tenfold overdose by coarse spray; these symptoms disappeared within 10 days.
4.11 Withdrawal period(s) Zero days.
5. IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: immunologicals for Aves, live viral vaccines for domestic fowl.
ATCvet code: QI01AD06.
To stimulate active immunity against Newcastle disease virus. In the absence of a field infection with Newcastle disease, efficacy by challenge was not demonstrated under field conditions.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Povidone K-25
Bacto peptone
Monosodium glutamate
Potassium dihydrogen phosphate
Potassium hydroxide
Dextran 40000
6.2 Major incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years. Shelf life after reconstitution according to directions: 3 hours.
6.4 Special precautions for storage
Store in a refrigerator (2 ºC – 8 ºC). Protect from light.
6.5 Nature and composition of immediate packaging
The vaccine is filled into colourless glass vials (type I), which are closed with rubber stoppers and sealed with aluminium caps.
Pack sizes:
Cardboard or plastic box with 10 vials of 1,000 doses of vaccine.
Cardboard or plastic box with 10 vials of 2,500 doses of vaccine.
Cardboard or plastic box with 10 vials of 5,000 doses of vaccine. Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
Genera Inc.
Svetonedeljska cesta 2, Kalinovica
10436 Rakov Potok
Croatia
8. MARKETING AUTHORISATION NUMBER
Vm 43676/4000
9. DATE OF FIRST AUTHORISATION
26 April 2016
10. DATE OF REVISION OF THE TEXT
February 2021
Approved 25 February 2021
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| EAN | 3858888793746 |
