Nobilis OR inac, emulsion for injection for chickens

Introduction

Company name: MSD Animal Health

Address: Walton Manor

Walton

Milton Keynes

MK7 7AJ

Telephone: 01908 685685 (Customer Support Centre)

Fax: 01908 685555

Email: vet-support.uk@merck.com

Website: www.msd-animal-health.co.uk

Presentation

Per dose of 0.25 ml:

Inactivated whole cell suspension of Ornithobacterium rhinotracheale serotype A strain B3263/91, 1 x 107 cells *

* inducing a mean titre, in the chickens of the potency test, of at least 11.2 (log2).

Light liquid paraffin: 107.21 mg and traces of formaldehyde.

Uses

For passive immunisation of broilers induced by active immunisation of female broiler breeders to reduce infection with Ornithobacterium rhinotracheale serotype A when this agent is involved.

Under field conditions passive immunity is transferred during lay for 43 weeks after the last vaccination of broiler breeders, resulting in a duration of passive immunity in broilers of at least 14 days after hatching.

Dosage and administration

Subcutaneous injection in the neck or intramuscular injection in the breast of the chicken.

Vaccination scheme

The vaccination scheme consists of two injections with a dose of 0.25 ml, administered subcutaneously in the neck or intramuscularly in the breast. The first injection can be administered at an age of 6 - 12 weeks. The second injection has to be administered at least 6 weeks later, at an age of 14 - 18 weeks.

Allow the vaccine to reach room temperature (15-25°C) before using the vaccine. Shake well before use.

Use sterile vaccination equipment.

Contra-indications, warnings, etc

Do not use for birds in lay.

In laboratory studies, a local transient swelling was found at post mortem examination in up to 40% of the birds for at least 14 days after subcutaneous vaccination. Under field conditions, sporadic local and systemic clinical reactions have been reported.

If you notice any other side effects, please inform your veterinary surgeon.

No other undesirable effects have been observed after administration of a double dose when compared with a single dose of vaccine. Occasionally hardened minor local swellings (0.5 – 2.0 cm) were observed which disappeared within 21 days after vaccination.

No information is available on the safety and efficacy from the concurrent use of this vaccine with any other. It is therefore recommended that no other vaccines should be administered within 14 days before or after vaccination with this product.

A good immune response is reliant on the reaction of an immunogenic agent and a fully competent immune system. Immunogenicity of the vaccine antigen will be reduced by poor storage or inappropriate administration. Immunocompetence of the animal may be comprised by a variety of factors including poor health, nutritional status, genetic factors, concurrent drug therapy and stress.

Under certain conditions, for example extreme disease pressure and variant challenge, fully immune birds may succumb to disease. Therefore, successful vaccination may not be synonymous with full protection in the face of a disease challenge.

Withdrawal periods

Zero days.

Operator warnings

To the user:

This product is a mineral oil-based compound. Accidental injection/self injection may result in severe pain and swelling and could result in the loss of the affected finger or thumb if prompt medical attention is not given.

Ensure that the method of restraint, handling and administration, e.g. by the use of guarded needles, minimises the risk of accidental injection/self injection.

If you are accidentally injected with this product, go AT ONCE to the nearest accident and emergency (casualty) department of a hospital and show the information printed below to the doctor (or nurse) on duty.

Seek prompt medical advice even if only a very small amount is injected.

If pain persists for more than 12 hours after medical examination, seek further medical advice.

To the doctor:

Even if very tiny amounts have been injected, accidental injection with this oil-based product can cause intense swelling which may, for example, result in ischaemic necrosis and 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.

For animal treatment only. Keep out of reach and sight of children.

Pharmaceutical precautions

Store and transport at +2°C to +8°C. Do not freeze.

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

Legal category

POM-V

Packaging Quantities

250 ml PET bottles containing 1000 doses.

Further information

Nil.

Marketing authorisation number

EU/2/02/036/001.

GTIN (Global Trade Item No)

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