SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Suvaxyn M Hyo Suspension for injection for pigs.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredient

Mycoplasma hyopneumoniae strain P-5722-3 RP 1 ^#

Constituents

Carbopol 4 mg

Thimerosal 50-115 ppm

EDTA 1.4 mg

Amaranth formerly FD & C 2 (E123) 30 g

Sodium chloride 13 mg

Water for injection ad 2 ml

^#ELISA Relative Potency unit by comparison with a reference vaccine

3. PHARMACEUTICAL FORM

Suspension for injection.

4. CLINICAL PARTICULARS

4.1 Target species

Feeder-finishing pigs.

4.2 Indications for use, specifying the target species

Active immunisation against Mycoplasma hyopneumoniae infection in pigs to reduce the frequency and severity of lung lesions.

4.3 Contraindications

The vaccination of sick animals is contra-indicated.

4.4 Special warnings for each target species

Avoid stress in the animals around the time of vaccination.

4.5 Special precautions for use

i. Special precautions for use in animals

None.

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

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

4.6 Adverse reactions (frequency and seriousness)

Occasionally a slight soft swelling of about 2cm in diameter may be observed at the site of injection, which will disappear within a few days.

4.7 Use during pregnancy, lactation or lay

Not applicable as the vaccine is only recommended for feeder-finishing pigs.

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 decided on a case by case basis.

4.9 Amounts to be administered and administration route

A dose of 2 ml must be administered intramuscularly in the neck behind the ear twice with an interval of 2 weeks, to pigs from the age of 1 week and before the age of 10 weeks.

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

The administration of an overdose may result in the same type of reaction as seen after administration of a single dose (see 5.3).

4.11 Withdrawal period(s)

Zero days.

5. IMMUNOLOGICAL PROPERTIES

The vaccine stimulates active immunity against Mycoplasma hyopneumoniae.

ATC vet code: QI09AB13

Inactivated bacterial vaccines – pigs.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Thimerosal

EDTA

Amaranth (E123)

Sodium chloride

Water for injection

Ampicillin

6.2 Incompatibilities

Do not mix with any other veterinary medicinal product.

6.3 Shelf life

Shelf life for sachets: 12 months

Shelf life for bottles: 12 months

Shelf life after opening of the container: use vaccine immediately.

6.4 Special precautions for storage

The product should be stored in the dark at a temperature of +2^oC to +8^oC.

6.5 Nature and composition of immediate packaging

Containers: Polyethylene bottles containing: 255 ml (125 doses), 105 ml (50 doses) and 22 ml (10 doses) of vaccine.

Closures: Butyl rubber stoppers with aluminium caps.

Collapsible pack: polyethylene bags containing 105 ml (50 doses).

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 material derived from such veterinary medicinal products should be disposed of in accordance with the local requirements.

7. MARKETING AUTHORISATION HOLDER

Zoetis UK Limited

5th Floor, 6 St. Andrew Street

London

EC4A 3AE

8. MARKETING AUTHORISATION NUMBER

Vm42058/4137

9. DATE OF FIRST AUTHORISATION

Date: 15 September 1995

10. DATE OF REVISION OF THE TEXT

Date:August 2014

30 October 2014