SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCT

Ingelvac® M. hyo emulsion for injection for pigs.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Inactivated whole culture of Mycoplasma hyopneumoniae, J Strain, Isolate B-3745.

One dose of 2 ml vaccine contains:

Active substance

Mycoplasma hyopneumoniae: > 1 : 80 *

* antibody titre elicited with ½ dose

(rabbits/ELISA assay)

Adjuvant

Montanide ISA 708 1.30ml (65%)

Excipients

For a full list of excipients, please see 6.1

3. PHARMACEUTICAL FORM

Emulsion for injection. White opaque emulsion.

4. CLINICAL PARTICULARS

4.1 Target Species

Fattening pigs.

4.2 Indications for use, specifying the target species

For active immunisation of pigs from three weeks of age to reduce lung lesions following infection with Mycoplasma hyopneumoniae

Onset of protection occurs by two weeks post vaccination and lasts for at least 118 days.

4.3 Contraindications

None.

4.4 Special warnings

None.

4.5 Special Precautions for Use

Special precautions for use in animals

Vaccinate only clinically healthy animals.

In case of anaphylactic reactions, the administration of epinephrine is recommended.

The application of the vaccine should be performed according to the requirements of Good Veterinary Practice. Injections with Ingelvac M Hyo done improperly can cause injection site lesions, such as granulomas or abcesses.

Special Precautions to be taken by the person administering the product to

animals

Self injection may result in pain and swelling and may persist for several days.

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

4.6 Adverse reactions (frequency and seriousness)

Depression and reduction of appetite may occur after administration. These clinical signs generally disappear wit in a few days.

Swelling of about two centimetres in diameter, which may be of hard consistency, may be observed at the site of injection in about 2.4% of the cases. These swellings will disappear within one to two days.

In very rare cases granulomatous reactions at the injection site have been observed at the slaughterhouse, which were mainly caused by an improper injection technique. (See 4.5)

4.7 Use during Pregnancy, Lactation and Lay

Do not use during pregnancy and lactation

4.8 Interaction with other vaccines and other forms of interaction

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 the product.

4.9 Amounts to be administered and administration route.

Warm to room temperature prior to use. The minimum needle diameter recommended is 1.2 mm.

Shake well before use.

The vaccination dose is 2 ml, irrespective of body weight.

A single dose should be administered by deep intramuscular injection in the neck to pigs of three to ten weeks of age.

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

No adverse reactions other than those listed in section 4.6 have been observed following administration of twice the recommended dose.

4.11 Withdrawal Periods

Zero days.

5. IMMUNOLOGICAL PROPERTIES

The vaccine is designed to stimulate the development of an active immune response to Mycoplasma hyopneumoniae.

ATC Vet code : QI09AB13 (Mycoplasma vaccine)

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Montenide ISA 708

Hank’s Balanced Salt Solution

Water for Injection in bulk.

6.2 Incompatibilities

Do not mix with any other vaccine orimmunological product

6.3 Shelf Life

Shelf-life of the veterinary medicinal product as packaged for sale : 2 years (100ml)

: 1 year (20ml)

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

6.4 Special precautions for storage

Store and transport refrigerated (+2ºC - +8ºC).

Do not freeze.

6.5 Nature and composition of immediate packaging

High density polyethylene vial of 20 ml (10 doses) or 100 ml (50 doses), closed with a chlorobutyl stopper with lacquered aluminium seal in cardboard boxes.

Not all package sizes may be marketed

6.6 Special 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

Boehringer Ingelheim Limited

Ellesfield Avenue

Bracknell

Berkshire RG12 8YS

UK

8. MARKETING AUTHORISATION NUMBERS

Vm 00015/4067

VPA 10007/038/01

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

UK : 21 02 2002/18 01 2007

IE : 04 07 2002/18 01 2007

10 DATE OF LAST REVISION

November 2007