Summary of Product Characteristics

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

POULVAC^®IBMM + ARK – Powder for nebulisersolution for Broiler chickens

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Quantitative composition

Active Substances:

	Global Amount per Dose
Avian Infectious Bronchitis Virus (Strain Massachusetts1263 and Strain Arkansas 3168)	103.3 EID50*

*EID₅₀: Embryo infective dose 50%

Excipients:

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Powder for nebuliser solution

4. CLINICAL PARTICULARS

4.1 Target species

Broiler chickens

4.2 Indications for use, specifying the target species

For the active immunisation of chickens to reduce the severity of upper respiratory tract infections caused by Massachusetts and 793/B/91-type strains of Avian Infectious Bronchitis virus.

The onset of immunity is from three weeks post vaccination and lasts for six weeks post vaccination.

Protection has also been demonstrated in the presence of maternally derived antibody.

4.3 Contraindications

Do not use in unhealthy birds.

Do not re-vaccinate birds.

Do not use during the laying period or in birds intended for laying or breeding.

Spray vaccination should not be used if an intercurrent infection is suspected.

4.4 Special warnings

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.

4.5 Special precautions for use

Do not vaccinate diseased birds.
The product should only be used where it has been established that 793/B/91 like infectious bronchitis serotypes are epidemiologically relevant in the area.
Care should be taken to avoid spread of the vaccine virus from vaccinates to pheasants

For the safety of eyes, nose and mouth, the use of safety goggles and dust mask is recommended. A helmet with filtered air circulation may be used instead of goggles and mask.

4.6 Adverse reactions (frequency and seriousness)

A slight transient respiratory reaction, including gasping, snicking and raling, may be observed at a rate of approximately 10% of vaccinated birds for approximately three days.

4.7 Use during pregnancy, lactation or lay

Do not use in birds intended for laying or breeding.

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 decided on a case by case basis

4.9 Amounts to be administered and administration route

Coarse spray vaccination from one day of age.

Coarse Spray:

This vaccine has been used in most types of spray equipment handsprayers (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 microns), allowing a dose of 0.5 ml per bird

The vaccine should be reconstituted with water of good quality at room temperature e.g. deionised water or good quality drinking water.

The vaccine should be dissolved as follows:

Remove the aluminium seal from the vaccine vial. To dissolve the vaccine pellet, the rubber stopper should then 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 dissolve any remaining vaccine.

The vaccine concentrate should then be added to the water in the jug, mixed well and transferred to the sprayer tank and thoroughly mixed. For the 1000 dose vial a total amount of 0.5 l water should be used. For the 5000 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 carton rings in the house to avoid loss of the vaccine virus.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

A slight transient respiratory reaction, including gasping, snicking and raling, may be observed at a rate of approximately 10% of vaccinated birds for approximately three days.

4.11 Withdrawal period

Zero days

5. IMMUNOLOGICAL PROPERTIES

To stimulate active immunity against avian infectious bronchitis, strains Massachusetts type and 793/B/91 like (Arkansas)

ATC Vet Code: QI01AD07

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Pharmatone

Bacto-Peptone

Sucrose

N-Z Amine YT

Monosodium glutamate

6.2 Incompatibilities

Do not mix with any other medicinal product.

6.3 Shelf life

2 years for the freeze dried vaccine

Shelf-life after reconstitution according to directions: 2 hours

6.4 Special precautions for storage

Store and transport refrigerated (2 ºC – 8 ºC).

Protect from light.

Do not freeze

6.5 Nature and composition of immediate packaging

Nature: Hydrolytic type I glass vials with a butylrubber (Ph Eur) stopper and aluminium cap.

Content:

6 ml glass vial containing 1,000 doses (Pack of 10 vials)
10 ml glass vial containing 5,000 doses (Pack of 10 vials)
20 ml glass vial containing 10,000 doses (Pack of 10 vials)

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 in accordance with national requirements.

7. MARKETING AUTHORISATION HOLDER

Zoetis UK Limited

5th Floor, 6 St. Andrew Street

London

EC4A 3AE

8. MARKETING AUTHORISATION NUMBER

Vm42058/4104

9. RENEWAL OF AUTHORISATION

Date: 02 June 2008

10 DATE OF REVISION OF THE TEXT

Date: November 2013

12 November 2013