1. NAME OF THE VETERINARY MEDICINAL PRODUCT

GALLIMUNE 303 ND+IB+ART*

* for all countries except Austria, Belgium, Denmark and Sweden.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 0.3-ml dose of vaccine contains:

Active substances:

Inactivated Newcastle Disease virus, Ulster 2C strain, at least 50PD₅₀¹

Inactivated Infectious Bronchitis virus, Mass41 strain, at least 18 HI.U

Inactivated Avian Rhinotracheitis virus (Swollen Head Syndrome), VCO3 strain, at least 60 IP.U

(culture substrate: hen eggs, Vero cells)*

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 - IP: interference percentage

(1): Minimum protective dose according to monograph 0870 of Ph. Eur.

(culture substrate: hen eggs, Vero cells)*: for Germany only

Adjuvant(s):

Paraffin oil 170 to 186 mg

Excipient(s):

Thiomersal, at most 30 μg

Formaldehyde, at most 45 µg

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Water-in oil emulsion for injection.

4. CLINICAL PARTICULARS

4.1 Target species

Chickens (breeder and layer pullets).

4.2 Indications for use, specifying the target species

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

• Newcastle Disease virus in order to reduce egg drop linked to Newcastle Disease infection,

• Infectious Bronchitis virus in order to reduce egg drop linked to Infectious Bronchitis infection caused by the Mass41 strain,

• Avian pneumovirus in order to reduce respiratory signs linked to avian pneumovirus infection (Avian Rhinotracheitis).

Newcastle Disease and Infectious Bronchitis components:

• onset of immunity: 4 weeks after vaccination,

• duration of immunity: one laying period.

Avian Rhinotracheitis component:

Immunity has been demonstrated by challenge 14 weeks after vaccination and persists until the end of the laying period.

4.3 Contraindications

None

4.4 Special warnings

None.

4.5 Special precautions for use

Special precautions for use in animals

Vaccinate only healthy animals.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

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 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.

4.6 Adverse reactions (frequency and seriousness)

No palpable reactions were observed following the injection of one dose of vaccine.

In clinical studies, lesions linked to the oily adjuvant were observed histologically three weeks after injection in 87% of cases, e.g. small quantities of oily residues and occasional aseptic micro-abscesses.

4.7 Use during lay

Not to be used within 2 weeks before the onset of the laying and during the laying period.

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 made on a case by case basis.

4.9 Amounts to be administered and administration route

Administer one dose (0.3-ml) by intramuscular route from the age of 18 weeksand 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.

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

In addition to the adverse effects mentioned in paragraph «Adverse reactions (frequency and seriousness)», transitory apathy and slight oedema at injection site may occur after the administration of a double dose of vaccine.

4.11 Withdrawal period(s)

Zero days.

5. IMMUNOLOGICAL PROPERTIES

ATCvet code: QI01AA21

Inactivated vaccine in oily adjuvant against Newcastle Disease, Infectious Bronchitis and Avian Rhinotracheitis.

The vaccine stimulates active immunity of breeder and layer pullets against Newcastle Disease, Infectious Bronchitis and Avian Rhinotracheitis (Swollen Head Syndrome), subsequent to priming with live vaccines against these diseases.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Paraffin oil

Thiomersal

6.2 Incompatibilities

Do not mix with any other vaccine/immunological product.

6.3 Shelf life

Shelf-life: 18 months.

Use immediately after opening.

6.4. Special precautions for storage

Store and transport between +2°C and +8°C, protected from light. Do not freeze.

6.5 Nature and composition of immediate packaging

Nature of primary packaging elements:

• Polypropylene bottle

• Nitrile elastomer closure

• Aluminium cap

Sales presentations:

• 150-ml (500-dose) bottle.

• 150-ml (500-dose) bottle, box of 10 bottles.

• 300-ml (1,000-dose) bottle.

• 300-ml (1,000-dose) bottle, box of 10 bottles.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Any unused product or waste material should be disposed of in accordance with national requirements.

7. MARKETING AUTHORISATION HOLDER

MERIAL ANIMAL HEALTH LTD

PO Box 327

Sandringham House

Harlow Business Park

HARLOW Essex

CM19 5TG

United-Kingdom

8. MARKETING AUTHORISATION NUMBER

Vm 08327/4216

9. RENEWAL OF THE AUTHORISATION

28 July 2009

10. DATE OF REVISION OF THE TEXT

9 July 2009