NOAH Compendium

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Date: Tuesday, December 1, 2020 8:36

Release 2.76
Avishield® IB H120, Lyophilisate for Oculonasal Suspension/Use in Drinking Water for Chickens
 
Species: Chickens
Therapeutic indication: Immunological veterinary medical products: For chickens
Active ingredient: Vaccine Antigens
Product:Avishield® IB H120, Lyophilisate for Oculonasal Suspension/Use in Drinking Water for Chickens
Product index: Avishield IB H120, Lyophilisate for Oculonasal Suspension/Use in Drinking Water for Chickens
Withdrawal notes: Zero days
Qualitative and quantitative composition
Each dose contains: Active substance:
Attenuated live virus of avian infectious bronchitis,
Massachusetts serotype, strain H-120: 103.5 to 104.5 EID50*
*EID50 = 50% Embryo infective dose
Pharmaceutical form
Lyophilisate for oculonasal suspension/use in drinking water. Cream coloured lyophilizate.
Clinical particulars
Target species
Chickens (broilers and future layers/breeders).
Indications for use
For active immunisation of chickens (broiler and future layers/breeders) in order to reduce the detrimental effect resulting from the infection by avian infectious bronchitis virus, serotype Massachusetts on the ciliary activity, which may be manifested in respiratory clinical signs.
Onset of immunity: 3 weeks after vaccination
Duration of immunity: 8 weeks after vaccination
Special warnings for each target species
Vaccinate healthy animals only.
Special precautions for use in animals
All the birds in the flock should be vaccinated at the same time.
The vaccine strain can spread to susceptible, unvaccinated chickens for a minimum of 10 days following vaccination. It is possible that the vaccine virus can be spread to non-target susceptible species. Appropriate veterinary and husbandry measures should be taken to avoid spread of the vaccine strain to unvaccinated birds or susceptible species as much as possible.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Care should be taken when reconstituting and administering the vaccine . Wash and disinfect hands and equipment after administration of the vaccine. When spraying the vaccine, personal protective equipment consisting of masks with eye protection should be worn by the operator and staff.
Adverse reactions
Transient respiratory disturbances, including tracheal rales have been observed very commonly for 3-10 days post vaccination. These did resolve spontaneously and did not need treatment.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions)
- 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
Use during pregnancy and lactation
Laying birds:
Do not use in birds in lay or within 4 weeks before the start of the laying period.
Interactions
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.
Amounts to be administered and administration route
Coarse spray and oculonasal route: from one day of age
Drinking water route: from 7 days of age
By spraying:
It is recommended to resuspend 1000 doses of the vaccine in 150 - 300 ml of distilled water. The number of doses diluted corresponds to the number of birds in a 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 (targeted average droplet size of 150 - 170 microns), 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.
Administration in the drinking water:
Suspend 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.
Vaccine should be suspended immediately before use.
The volume of water for reconstitution depends on the age of the birds, breeds, the management practice and weather conditions.
In order to determine the quantity of water in which vaccine will be suspended for the vaccination of chickens in a younger age category (until third week of life), the following are guidelines:
- multiplying the number of birds in the thousands with the day of life (e.g. 1 thousand of chickens in the 7th day of life = 1 x 7 = 7 L).
It is important to dissolve 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 immunisation (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.
Oculo-nasal administration:
Suspend 1000 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. In case of chickens aged from 1 to 14 days of smaller breeds, 25 μl-drops should be used. Two drops per eye (0.05 ml altogether) and two drops per nostril (0.05 ml altogether) should be administered then.
Overdose
No adverse reactions other than those listed in Adverse reactions have been observed following the administration of 10 times the recommended dose of vaccine.
Withdrawal periods
Zero days.
Pharmacological particulars
Pharmacotherapeutic group: Immunologicals, immunologicals for aves, domestic fowl, live viral vaccines, avian infectious bronchitis virus
ATCvet code: QI01AD07
To stimulate active immunity in chickens against strains of avian infectious bronchitis virus belonging to Massachusetts serotype.
Pharmaceutical particulars
Incompatibilities
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: 3 hours.
Special precautions for storage
Store and transport refrigerated (2 °C – 8 °C).
Protect from light.
Do not freeze.
Immediate packaging
The vaccine is filled into colourless glass vials (type I), which are closed with brombutyl rubber stoppers and sealed with aluminium caps.
Carton box with 10 vials of 1000 doses of vaccine.
Carton box with 10 vials of 2500 doses of vaccine.
Carton box with 10 vials of 5000 doses of vaccine.
Not all pack sizes may be marketed.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with national requirements.

Marketing Authorisation Holder (if different from distributor)
Genera Inc., Svetonedeljska cesta 2, Kalinovica, 10436 Rakov Potok, Croatia.
Marketing Authorisation Number
Vm 43676/4002
Significant changes
Date of the first authorisation or date of renewal
13 February 2018
Date of revision of the text
February 2020
Any other information
For animal treatment only. To be supplied only on veterinary prescription. Keep out of the sight and reach of children.
Legal category
Legal category: POM-V
GTIN
GTIN description:Avishield IB H120, Lyophilisate for Oculonasal Suspension/Use in Drinking Water for Chickens 2500:
GTIN:03858888798437
GTIN description:Avishield IB H120, Lyophilisate for Oculonasal Suspension/Use in Drinking Water for Chickens 5000:
GTIN:03858888798444