ΠΑΡΑΡΤΗΜΑ 1: ΠΕΡΙΛΗΨΗ ΤΩΝ ΧΑΡΑΚΤΗΡΙΣΤΙΚΩΝ ΤΟΥ ΠΡΟΪΟΝΤΟΣ
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
AviPro ND HB1
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substances:
Live Newcastle Disease (ND)-Virus, strain Hitchner Β1, min 106 EID
· 50* and max
107.2 EID50*
Host system: embryonated SPF chicken eggs
* EID50= 50% embryo-infective dose the virus titre causing infection in 50% of the
embryos inoculated with the virus.
Excipients:
For a complete list of excipients please see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate for resuspension.
4.
CLINICAL PARTICULARS
4.1 Target species
Chicken.
4.2 Indications for use, specifying the target species
For active immunisation of healthy chicks and chickens against Newcastle
Disease (ND). A spray vaccination should not be carried out in flocks that are
infected with Mycoplasma gallisepticum.
4.3 Contraindications
Do not vaccinate clinically ill or weakened birds.
4.4 Special warnings
None.
4.5 Special precautions for use
Special precautions for use in animals
- Protect the vaccine solution from direct sunlight and temperatures above 25°C.
- Ensure that drinking water and drinking troughs do not contain any
residues of detergents or disinfects.
- Use the entire contents of opened containers in one single session.
- Only prepare the quantity of vaccine that can be administered within 2 hours.
Special precautions to be taken by the person administering the veterinary
medicinal product to animals
Live attenuated virus vaccine: Do not spray or spill. Wash and disinfect your hands
after application. ND viruses can cause conjunctivitis on contact with the eyes.
Therefore the person administering the product to the animals should wear
protective equipment comprising a face mask and safety visor (respiratory and eye
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protection) when spraying. If the product inadvertently comes into contact with the
eyes, seek medical advice immediately.
4.6 Adverse reactions (frequency and seriousness)
Vaccination of hens in lay may cause a transient drop in egg production.
4.7 Use during pregnancy, lactation or lay
The vaccine is intended for use in broilers and first immunization of breeders and
laying birds.
4.8 Interaction with other medicinal products and other forms of interaction
None known. Ensure that the drinking water is free from detergents and
disinfectants.
4.9 Amounts to be administered and administration route
To be administered in the drinking water or by spraying after dissolving.
One dose of the vaccine is to be administered per animal.
st
AviPro ND HB1 can be used from the 1 day of life.
A generally valid vaccine recommendation cannot be given as the vaccination
schedule must be adapted to suit individual conditions and the current situation
(e.g. epidemic).
Method of administration
a.) Administration via the drinking water
The required number of vaccine doses and the amount of water must be
determined (see below).
The entire contents of one bottle of vaccine must only be used for one stall or one
drinking system. Dose distribution can lead to dosing errors.
All of the equipment used for the vaccination (pipes, hoses and troughs, etc.) should
be thoroughly cleaned and free from cleaning and disinfectant resides.
Use only cool, clean, fresh water that is preferably chlorine- and metal ion-free.
Skimmed milk powder (2 - 4 g/litre of water) or skimmed milk (20 - 40 mlllitre of
water) can improve the quality of the drinking water and prolong the activity of the
vaccine. Add 10 minutes before administering the vaccine.
Open the vaccine vial under water and completely dissolve the contents
completely. Ensure that it is completely empty by rinsing the bottle and the rubber
stopper.
The water in the troughs must be used up prior to vaccination. All of the pipes
should be drained of normal water so that the troughs contain only vaccine
solution. Pipes filled with water must be emptied before using the vaccine
solution.
The vaccine should be administered within 2 hours. Due to the variation in the
drinking pattern of chickens, the drinking water may have to be taken away from
the animals prior to vaccination in order to guarantee that all of the animals drink
during the vaccination phase.
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Measure the quantity of water such that it can be consumed by the animals within
2 hours. The amount of water expected to be consumed within 2 hours should be
determined the day before.
As a guideline, the diluted vaccine solution should be diluted with cold, fresh water
to an end volume of 1 litrer of water per day of life and 1000 birds (e.g. 10 litres for
1000 ten-day old chickens).
In some cases, this quantity must be increased to a maximum of 40 litres per 1000
animals per day under hot climatic conditions and in the case of heavy breeds. If in
doubt, the quantity of water consumed the day before the vaccination must be
determined.
Administer diluted vaccine immediately after dissolution.
Care should be taken to ensure that all animals have adequate access to the water
troughs.
b.) Administration by spraying
The quantity of water needed for spraying depends on various factors such as the
animals' age, housing, temperature, stock density and the apparatus used to spray
the vaccine. It ranges from 250 to 1000 ml/1000 animals. Use only chlorine-free or
distilled water.
As a general rule, the finer the spray, i.e. the smaller the drops, the deeper the
virus solution penetrates the respiratory tract. This improves immunogeneity but
tolerability is reduced.
o The first vaccination is usually given as a coarse spray (droplet size > 50 μm).
o As from the 3 rd to 4th week of life, the vaccine can be administered as a fine
spray (droplet size < 50 μm).
o Use distilled water.
o Spray all animals evenly.
o Switch off or reduce the air conditioning if possible when spraying and for
approximately 20 - 30 minutes thereafter.
o Avoid upsetting the animals, e.g. by dimming the surroundings.
o Wear protective glasses and a mouth or respiratory mask.
o Only use spraying devices for ad ministering the vaccine and clean only with hot
water. Do not, under any circumstances, use disinfectants or detergents.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
An overdose is safe.
4.11 Withdrawal period
Zero days.
5.
IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: lmmunologicals for aves, domestic fowl, live viral
vaccines.
ATC vet code: QI01AD06
After administration of the vaccine virus AviPro ND HB1 spreads in the body of
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the vaccine. An immune response develops within 8 days and reaches its
maximum after another 8 days.
Chicks from immune parents receive a passive protection via the egg, which is
effective for no longer than four weeks. This can affect the development of active
immunity. The desired immunity can then be achieved by a booster jab. The
Hitchner B1 vaccine strain is avirulent for healthy animals.
6.
PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Disodium phosphate dihydrate
Sodium dihydrogen phosphate dihydrate
Sucrose
Sorbitol
Gelatin
6.2 Incompatibilities
Do not mix with any other veterinary medicinal product.
6.3 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 12 months
Shelf-life after dilution according to directions: 2 hours
6.4. Special precautions for storage
Store in a refrigerator (2°C – 8°C). Do not freeze. Protect from light.
Protect diluted vaccine from direct sunlight, temperatures above 25°C and frost.
6.5 Nature and composition of immediate packaging
EP type I glass vials with chlorobutyl - elastomer closures. The vials are sealed with
a tear-off aluminium caps.
The vaccine is available in the following packaging sizes:
Pack containing vial with 1000/2500/5000/10000 doses per vial
Bundle packs
Box containing 2 vials with 1000/2500/5000/10000 doses per vial
Box containing 10 vials with 1000/2500/5000/10000 doses
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
Dispose of waste material by boiling, incineration or immersion in an appropriate
disinfectant approved for use by the responsible authorities.
7.
MARKETING AUTHORISATION HOLDER
Lohmann Animal Health GmbH
Heinz -Lohmann-Str. 4, 27472 Cuxhaven, Germany
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8.
MARKETING AUTHORISATION NUMBER
16020
9.
DATE OF FIRST AUTHORISATION
02/02/1995
10 DATE OF REVISION OF THE TEXT
24/09/2012
PROHIBITION OF SALE, SUPPLY AND/OR USE
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