Revised: April 2013

AN. 01041/2012

SUMMARY OF PRODUCT CHARACTERISTICS

1.NAME OF THE VETERINARY MEDICINAL PRODUCT

Nobilis Reo ERS inac, emulsion for injection for chickens

2.QUALITATIVE AND QUANTITATIVE COMPOSITION

Per dose of 0.5 ml:

Active substance:

Inactivated Reovirus strain ERS inducing  6.7 log2 and ≤ 10.0 log2 antibody ELISA units

Adjuvant:

Light liquid paraffin, 215 mg

For the full list of excipients, see section 6.1

3.PHARMACEUTICAL FORM

Emulsion for injection, white to nearly white (after shaking)

4.CLINICAL PARTICULARS

4.1Target species

Chicken

4.2Indications for use, specifying the target species

Active immunisation of chickens as an aid in the protection of their progeny against weight gain losses due to enteric Reovirus (ERS) infection, and reduction of virus replication in target organs.

Onset of immunity: 4 weeks after two vaccinations

Duration of immunity: 47 weeks after two vaccinations

4.3Contraindications

None

4.4Special warnings

None

4.5Special precautions for use

Special precautions for use in animals

Vaccinate healthy birds only. For birds in lay please see section 4.7.

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

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 insert 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 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.

4.6Adverse reactions (frequency and seriousness)

A slight transient swelling (< 1 cm) may occur at the site of vaccination and may last up to three weeks.

4.7Use during pregnancy, lactation or lay

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

4.8Interaction with other medicinal products and other forms of interaction

Safety and efficacy data are available which demonstrates that this vaccine can be administered the same day but not mixed with Intervet’s inactivated vaccines containing Reovirus strains 1733 and 2408.

No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the products mentioned above. 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.

4.9Amounts to be administered and administration route

Each chicken should be intramuscularly vaccinated twice with 0.5 ml of vaccine in the thigh or breast muscle. Nobilis Reo ERS inac should be given to chickens from 7 weeks of age onwards but not later than 4 weeks before the expected onset of lay. The interval between the two vaccinations should be approximately 11 weeks.

Before using the vaccine allow it to reach ambient temperature (15 – 25°C).

Shake the bottle vigorously before use and periodically during use.

Make sure that vaccination equipment is clean and sterile before use.

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

No other effects than mentioned in section “Adverse reactions” were observed following the administration of a double dose of vaccine.

4.11Withdrawal period

Zero days.

5.IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Inactivated viral vaccines, ATCvet code: QI01AA04

Nobilis Reo ERS inac is an inactivated vaccine that contains the ERS strain of avian Reovirus. The antigen is suspended in the aqueous phase of a water-in-oil emulsion serving as adjuvant. The vaccine is intended to stimulate active immunity in chickens by transferring passive immunity to the progeny.

6.PHARMACEUTICAL PARTICULARS

6.1List of excipients

Light liquid paraffin

Polysorbate 80

Sorbitan oleate

Water for injection

6.2Incompatibilities

Do not mix with any other veterinary medicinal product.

6.3Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale:

2 years

Once broached, use within 3 hours.

6.4Special precautions for storage

Store in a refrigerator (2°C -8°C).

Do not freeze.

Protect from light.

6.5Nature and composition of immediate packaging

Bottle of polyethylene terephthalate (PET). The bottles are closed with a nitryl rubber stopper and sealed with a coded aluminium cap, containing 500 ml (1,000 doses) of vaccine. Presentations: 1 bottle of 500 ml (1000 ds) or 12 bottles of 500 ml (1000 ds).

Not all pack sizes may be marketed.

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

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

7.MARKETING AUTHORISATION HOLDER

Intervet UK Ltd

Walton Manor

Walton

Milton Keynes

Buckinghamshire

MK7 7AJ

8.MARKETING AUTHORISATION NUMBER

Vm 01708/4540

9.DATE OF FIRST AUTHORISATION

6 June 2008

10.DATE OF REVISION OF THE TEXT

April 2013

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable

Approved: 22/04/2013

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