Each 0.3 ml dose of vaccine contains:

Active substances: Inactivated Newcastle Disease virus, Ulster 2C strain, at least 50PD50*; Inactivated Infectious Bronchitis virus, Mass41 strain, at least 18 HI.U; Inactivated Egg Drop Syndrome virus (EDS76), V127 strain, at least 180 HI.U; Inactivated Avian Rhinotracheitis virus (Swollen Head Syndrome), VCO3 strain, at least 0.76 ODD.

The concentrations are expressed by the antibody titre obtained during the potency test. One unit (U) corresponding to an antibody titre of 1. HI: haemagglutination inhibiting - ODD : Optical Density Difference*Minimum protective dose according to monograph 0870 of Ph. Eur.

Adjuvant: Paraffin oil 170 to 186 mg

Excipients: Thiomersal, at most 30 μg, Formaldehyde, at most 90 μg

Whitish homogeneous emulsion for injection.

Chickens (breeder and layer pullets).

Booster immunisation of breeder and layer pullets after vaccination with live vaccines against:

Active immunisation of breeder and layer pullets in order to reduce egg drop linked to infection with Egg Drop Syndrome virus EDS76 without priming.

Newcastle Disease, Infectious Bronchitis and Egg Drop Syndrome components:

Avian Rhinotracheitis component:

None.

Vaccinate healthy animals only.

Not applicable.

To the user: This veterinary medicinal 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 leaflet with you. If pain persists for more than 12 hours after medical examination, seek medical advice again.

To the physician: This veterinary medicinal product contains mineral oil. Even if small amounts have been injected, accidental injection with this product can cause intense swelling which may, for example, result in ischaemic necrosis and even 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.

No palpable reactions were observed following the injection of one dose of vaccine. Lesions linked to the oily adjuvant were histologically observed very commonly (in 87% of cases) three weeks after injection in clinical studies (e.g. small quantities of oily residues and occasional aseptic micro-abscesses).

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).

Do not use in birds in lay and within 4 weeks before the start of the laying period.

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.

Administer one dose (0.3 ml) by intramuscular route from the age of 18 weeks and at least 4 weeks after the priming with live vaccines against Newcastle Disease (strain Hitchner B1 or VG/GA), Infectious Bronchitis (strain Mass H120), and avian pneumovirus (strain PL21).

Shake well before use. Apply usual aseptic procedures. Do not use syringes with natural rubber or butyl elastomer pistons. Equipment including needles and syringes must be sterile before use.

Transitory apathy and slight oedema at injection site may occur after the administration of a double dose of vaccine.

Zero days.

Paraffin oil, thiomersal, formaldehyde, ester of fatty acids and ethoxylated polyols, ester of fatty acids and polyols, water for injections.

Do not mix with any other vaccine/immunological product.

Shelf life of the veterinary medicinal product as packaged for sale: 18 months. Shelf life after first opening the immediate packaging: use immediately.

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

Polypropylene bottles containing 1,000 doses.

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