SUMMARY OF PRODUCT CHARACTERISTICS

Colombovac^® PMV

Per 0.2 ml dose

Active Substance:

Inactivated Newcastle Disease Virus, strain La Sota at least 19.9 AU*

* AU: Antigen Unit

Adjuvants:

Carbomer 934 P 1 mg

Excipients:

Thiomersal 20 µg

For a full list of excipients, see section 6.1.

Suspension for injection

Pigeons

For the active immunisation of pigeons to prevent mortality and clinical signs due to infection with paramyxovirus serotype 1 infection.

Onset of immunity: one month after inoculation

Duration of immunity: 12 months.

Do not use in unhealthy pigeons

Do not vaccinate during the last 2 weeks prior to mating

Not for intramuscular injection: Intramuscular injection causes severe adverse reactions.

Maternally derived antibody (MDA) can interfere with the development of active immunity. Where it is likely that recent field infection or vaccination of the parent flock has stimulated a high antibody titre and consequently a high level of MDA, the timing of the vaccination programme should be planned accordingly.

(i). Special precautions for use in animals

In cases of hypersensitivity reactions treat immediately with glucocorticoid intravenously or adrenaline intramuscularly.

The incubation period for pigeon paramyxovirosis may be a few days to several weeks. However, after infection with the wild virus, pigeons excrete the virus from the eye and in the droppings within 3-4 days. This means that infected birds can be a danger to others some days before their own symptoms appear. Excretion of wild virus from the infected bird continues for up to 6 weeks. This information is important since, in addition to direct bird to bird contact at competition and shows, the disease can be spread by indirect means such as hands, overalls, caps, boots and contaminated objects such as baskets and trucks.

An owner should forbid visits to the loft by anyone in contact with unvaccinated pigeons and new birds (either purchased or lent for mating) should not be brought in unless vaccinated at least 14 days previously.

(ii). Special precautions to be taken by the person administering the veterinary medicinal product to animals

In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

It is very common that vaccinated pigeons show an adverse reaction in the form of a small transient swelling at the site of injection.

Do not use in birds in lay or within 4 weeks before the onset of the laying period.

Vaccination is safe in breeding birds provided they are vaccinated before the start of 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 made on a case by case basis.

Dose: One dose (0.2 ml) per pigeon.

Administration: The vial has to be swirled several times before use.

The vaccine has to be administered by subcutaneous injection dorsally in the neck region (in the direction of the back).

Primary vaccination:

Racing pigeons

All birds in the loft should be given one vaccination annually not less than 14 days before the beginning of the racing season.

Young birds may be vaccinated with Colombovac PMV from 3 weeks of age when a single injection will provide immunity for 1 year.

Following vaccination avoid contact with birds from other lofts for at least 14 days.

Show Pigeons

All birds on the premises should be given one vaccination annually not less than 14 days before the beginning of the show season.

Young birds may be vaccinated with Colombovac PMV from 3 weeks of age when a single injection will provide immunity for 1 year. Following vaccination, avoid contact with birds from other sources for at least 14 days.

Booster vaccination:

Racing pigeons

All adult birds in the loft should be given a single booster vaccination annually. Where the annual booster vaccination may interfere with the training or racing programme, it may be brought forward prior to the commencement of each racing season.

Show Pigeons

All adult birds on the premises should be given a single booster vaccination annually.

An overdose may result in an increase of the degree of local reactions.

Zero days

To stimulate active immunity against Paramyxovirus infection type 1.

ATCVet Code: QI01EA01

Thiomersal

Carbomer 943 P
Disodium phosphate.dihydrate
Sodium dihydrogen phosphate dihydrate

Water for injection

Do not mix with any other veterinary medicinal product.

Shelf-life as packaged for sale: 18 months

Shelf-life after first opening the immediate packaging: Use immediately

6.4 Special precautions for storage

Store and transport refrigerated (2°C - 8°C).
Protect from light.
Do not freeze.

Nature: 20ml, Type hydrolytic I glass vial (Ph. Eur.)

Closure: Bromobutyl rubber stopper (Ph. Eur.), sealed by 20 mm aluminium “tear-off” cap

Contents: Either 1 x 50 doses (10 ml) or 1 x 100 doses (20 ml) Colombovac PMV.

Not all pack sizes may be marketed.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Zoetis UK Limited

5th Floor, 6 St. Andrew Street

London

EC4A 3AE

Vm 42058/4020

Date: 28 February 2005

Date: October 2014

30 October 2014