Introduction

Company name: Fort Dodge Animal Health

Address: Flanders Road

Hedge End

Southampton SO30 4QH

Telephone: 01489 781711

Fax: 01489 788306

Presentation

White creamy emulsion with no extraneous particles.

Per dose of 0.5 ml:

Pasteurella multocida, strain X-73 (serovar 1*), inactivated min. 70% survival (chickens)**

Pasteurella multocida, strain P-1059 (serovar 3*), inactivated min. 70% survival (turkeys)**

Pasteurella multocida, strain P-1662 (serovar 4*), inactivated min. 70% survival (turkeys)**

Pasteurella multocida, strain CU (serovar 3x4*), inactivated min. 70% survival (turkeys)**

* according to Heddleston classification

** in vaccinated birds, following virulent challenge, according to Ph. Eur. 1945 requirements

Light liquid paraffin 0.325 ml

Sorbitan sesquioleate 0.025 ml

Polysorbate 80 0.004 ml

Formaldehyde traces

Excipient qs 1 dose (0.5 ml)

Uses

In chickens (future laying and future breeding hens) and ducks:

- active immunisation in order to reduce mortality caused by Pasteurella multocida serovar 1 (Heddleston classification).

Onset of immunity against serovar 1 is of 2 weeks from administration of the second dose. Duration of immunity is of 16 weeks post basic vaccination (future laying and future breeding hens) or 9 weeks post basic vaccination (ducks).

In turkeys:

- active immunisation in order to reduce mortality caused by Pasteurella multocida serovar 3, 4 and 3x4 (Heddleston classification).

Onset of immunity against serovars 3, 4 and 3x4 is of 2 weeks from administration of the second dose.

Duration of immunity is of 6 weeks post basic vaccination.

Dosage and administration

One dose of 0.5 ml by sub-cutaneous route only (at the base of the neck).

Chickens (future laying and future breeding hens): First injection at 6 weeks.

Booster: 4 weeks later.

Ducks: First injection at 3 weeks.

Booster: 3 weeks later.

Turkeys: First injection at 6 weeks.

Booster: 4 weeks later.

Advice on correct administration:

Before administration, allow the vaccine to warm to room temperature and shake well.

Administer under aseptic conditions. Inject at the base of the neck.

The use of a closed multi-dose injection system is recommended for administration of the product to minimise the risk of contamination.

Any unused product must be discarded within 3 hours of broaching.

Contra-indications, warnings, etc

Do not vaccinate unhealthy birds.

Do not use in birds in lay.

Adverse Reactions:

In chickens: local reactions in the form of palpable swellings may be observed at the injection site in all birds. These swellings can be large (over 3cm) and, in some birds (at least 5%), the local reactions may persist for more than 4 weeks after vaccination and the endpoint of these reactions is not known.

In turkeys: local reactions in the form of palpable swellings may be observed at the injection site in all birds. These swellings can be large (over 4.5 cm) and, in some birds (at least 10%), the local reactions may persist for more than 4 weeks after vaccination and the endpoint of these reactions is not known.

In ducks: local reactions in the form of palpable swellings may be observed at the injection site in all birds. These swellings can be large (over 6cm) and, in some birds (at least 28%), the local reactions may persist for more than 4 weeks after vaccination and the endpoint of these reactions is not known.

A transient reduction in weight gain can be observed in chickens, ducks and turkeys for up to 4 weeks following vaccination. These reactions do not require any particular treatment. If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.

Special Warnings:

No information is available on the safety and efficacy of this vaccine with any other vaccines. It is therefore recommended that no other vaccines should be administered within 14 days before or after vaccination with this product. No information is available on the possible interferences from the presence of maternal antibodies on the response to vaccination with Poulvac Pabac IV. It is therefore not recommended to use this vaccine in birds with maternal antibodies. Do not mix with any other vaccine or immunological product.

To the user:

This product contains mineral oil. Accidental injection/self injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given.

If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package insert with you. If pain persists for more than 12 hours after medical examination, seek medical advice again.

To the Physician:

This product contains mineral oil. Even if small amounts have been injected, accidental injection with this product that contains oil can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit. Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.

Withdrawal Period: Zero days

Pharmaceutical precautions

Store and transport refrigerated (2°C - 8°C).

Do not freeze. Protect from light.

Use immediately after broaching.

Keep out of the reach and sight of children.

Legal category

POM-VPS

Packaging Quantities

Box of 10 polyethylene bottles of 1000 doses (500ml).

Box of 1 polyethylene bottle of 1000 doses (500ml).

Box of 10 polyethylene bottles of 200 doses (100ml)

Not all pack sizes may be marketed.

Further information

For Animal Treatment Only.

Inactivated vaccine for chickens, turkeys and ducks containing serovars 1,3,4 and 3x4 of Pasteurella multocida.

Disposal:
Any unused product or waste material should be disposed of in accordance with the local requirements.

Marketing authorisation number

Vm 01596/4360.

Significant Changes

Poulvac Pabac IV

Fort Dodge Animal Health

New product

12/10/2007