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Date: Saturday, May 18, 2024 14:55

Release 3.242
Poulvac IBMM + ARK Lyophilisate for suspension for spray administration for chickens
 
Species: Chickens
Therapeutic indication: Immunological veterinary medical products: For poultry
Active ingredient: Vaccine Antigens
Product:Poulvac® IBMM + ARK Lyophilisate for suspension for spray administration for chickens
Product index: Poulvac IBMM + ARK
Poultry - meat: Zero days
Poultry - eggs: Zero days
Withdrawal notes: Not to be used in birds in lay
Incorporating:
Presentation
A lyophilised vaccine containing live avian infectious bronchitis virus Massachusetts 1263 strain and Arkansas 3168 strain at 103.3 - 105.8 EID50* per dose.
*EID50: Embryo infective dose 50%
Uses
For the active immunisation of broilers to reduce the severity of upper respiratory tract infections caused by Massachusetts and 793/B/91-type strains of avian infectious bronchitis virus.
Onset of immunity: 21 days after vaccination.
Duration of immunity: 6 weeks after vaccination.
Dosage and administration
Coarse spray vaccination from one day of age.
Coarse Spray
This vaccine has been used in most types of spray equipment, hand-sprayers (e.g. ASL Polyspray 2), knapsack sprayers (e.g. Birchmeyer with 0.55 or 1.6 mm spray nozzle, Gloria with 1.0 mm nozzle) or automatic spraying equipment (e.g. Bimex). The apparatus should be set to deliver a coarse spray (droplet size of 80-160 micrometres), allowing a dose of 0.5 ml per bird.
The lyophilised vaccine should be reconstituted with water of good quality at room temperature e.g. deionised water or good quality drinking water.
The lyophilised vaccine should be reconstituted as follows:
Remove the aluminium cap from the vial. To reconstitute the lyophilised vaccine, the rubber stopper should be removed whilst the vial is immersed in a plastic measuring jug containing 0.5 litre of clean cool water.
Half fill the vial with water, replace the stopper and shake to remove any remnants in the vial.
The content of the vial should then be added to the water in the jug, mixed well and transferred to the sprayer tank and thoroughly mixed.
For the 5,000 dose vial a total amount of 2.5 L water is required and for the 10,000 dose vial a total amount of 5 L water should be used.
The chickens should be sprayed in chick boxes or brooding rings in the house to avoid loss of vaccine virus.
Contra-indications, warnings, etc
Vaccinate healthy animals only. Do not re-vaccinate birds.
Spray vaccination should not be used if an intercurrent infection is suspected.
Avian infectious bronchitis virus strains Massachusetts and Arkansas may spread to in contact birds. The duration of spreading of the vaccine virus is for up to 30 days following vaccination. It is recommended that all chickens on a site be vaccinated with this product. Do not use on mixed sites of broilers and breeders.
The product should only be used where it has been established that 793/B/91 like avian infectious bronchitis virus serotypes are epidemiologically relevant in the area.
Special precautions should be taken to avoid spread of the vaccine virus from vaccinates to pheasants.
Do not use in birds intended for laying or breeding.
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 decided on a case by case basis.
Do not mix with any other medicinal product.
Adverse reactions
Commonly a slight transient respiratory reaction, including gasping, snicking and raling, may be observed for approximately three days.
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).
Administration of a 10-fold overdose does not result in symptoms different from those mentioned above.
User Warnings
Personal protective equipment consisting of goggles and dust mask or a helmet with filtered air circulation should worn when handling the veterinary medicinal product.
Withdrawal period
Zero days.
Pharmaceutical precautions
Store and transport refrigerated (2°C - 8°C).
Protect from light. Do not freeze.
Shelf life after reconstitution according to directions: 2 hours.
Keep out of the sight and reach of children.
For animal treatment only
Legal category
Legal category: POM-V
Packaging quantities
10ml glass vial containing 5,000 doses (Pack of 10 vials)
20ml glass vial containing 10,000 doses (Pack of 10 vials)
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 local requirements.
Marketing Authorisation Number
Vm 42058/4104
Significant changes
GTIN
GTIN description:10 x 5000 dose:
GTIN:08714015016759
GTIN description:10 x 10000 dose:
GTIN:08714015006514