SUMMARY OF PRODUCT CHARACTERISTICS

Porcilis M Hyo ID ONCE emulsion for injection for pigs

IT: Porsilis M Hyo ID ONCE

HU: Porcilis M Hyo ID ONCE vakcina A.U.V.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substance:

Per dose of 0.2 ml:

Inactivated whole cell concentrate of Mycoplasma hyopneumoniaestrain 11: 6.5 log₂Ab titre*

Adjuvant:

34.6 mg light liquid paraffin

2.5 mg dl--tocopheryl acetate

For a list of excipients, see section 6.1.

* Mean antibody titre (Ab) obtained after inoculation of mice with a 1/1000 pig dose.

3. PHARMACEUTICAL FORM

Emulsion for injection

4. CLINICAL PARTICULARS

4.1 Target species

Pig (finishing pigs)

4.2 Indications for use, specifying the target species

For the active immunisation of finishing pigs to reduce pulmonary lesions and the decrease in daily weight gain during the finishing period due to infection caused byMycoplasma hyopneumoniae.

Onset of immunity: 3 weeks after vaccination.

Duration of immunity: 22 weeks after vaccination.

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 administration/self administration may result in severe pain and swelling, particularly if administered 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 administered with this product, seek prompt medical advice even if only a very small amount is administered and take the package leaflet 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 administered, accidental administration 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 administration area, especially where there is involvement of finger pulp or tendon.

4.6 Adverse reactions (frequency and seriousness)

A mean transient increase in body temperature of about 0.7^oC, in individual pigs up to 2^oC, may occur on the day of vaccination. The animals return to normal 1 to 2 days after the peak temperature is observed. In individual animals mild systemic reactions may be observed on the day of vaccination consisting of a tendency of the animal to lie down and minor signs of discomfort. Transient local reactions mostly consisting of hard non-painful button-like swellings of a diameter of up to 3 cm can be observed in the majority of the animals. In individual pigs redness and/or a biphasic pattern of the local reactions, consisting of an increase and decrease followed by another increase and decrease of the size, may be observed. The local reactions disappear completely within approximately 7 weeks after vaccination.

4.7 Use during pregnancy, lactation or lay

Not applicable.

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

Intradermal administration of 0.2 ml per animal preferably at the sides of the neck or along the muscles of the back using a intradermal device. A small, transient, intradermal lump observed after the intradermal application is indicative of the appropriate vaccination technique.

Vaccination scheme:

Vaccinate once from an age of 2 weeks onwards.

Before using the vaccine allow it to reach room temperature (15-25C) and shake well before use.

Avoid introduction of contamination.

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

No adverse reactions other than those mentioned under section 4.6 have been observed after administration of a double dose. However, these reactions may be more pronounced. A mean transient temperature increase of 1.0°C may be observed. Local reactions may be observed with a maximum diameter of up to 7 cm. The local reactions disappear completely within approximately 9 weeks after vaccination.

4.11 Withdrawal period

Zero days.

5. IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Inactivated bacterial vaccine

ATCvet code: QI09AB13

Porcilis M HYO ID ONCE is an inactivated bacterial vaccine containing whole cell concentrate of Mycoplasma hyopneumoniaestrain 11. This antigen is incorporated in an adjuvant based on a combination of light liquid paraffin and dl-α-tocopheryl acetate in order to give a prolonged stimulation of immunity. The product stimulates the development of active immunity in pigs against Mycoplasma hyopneumoniae.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Light liquid paraffin

dl--tocopheryl acetate

Polysorbate 80

Simethicone

Disodium phosphate dihydrate

Sodium dihydrogen phosphate dihydrate

Water for injections

6.2 Incompatibilities

Do not mix with any other veterinary medicinal product.

6.3 Shelf life

Shelf-life of the veterinary medical product as packaged for sale: 2 years

Shelf-life after first opening the immediate packaging: 3 hours.

6.4. Special precautions for storage

Store refrigerated (2 °C – 8 °C). It has been demonstrated that transport at 30°C for 3 days has no impact on the quality of the product.Do not freeze.

Protect from direct sunlight

6.5 Nature and composition of immediate packaging

Cardboard boxes with 1, 5 or 10 glass vials (type I, Ph.Eur.) containing 5, 10 or 20 ml corresponding to 25*, 50*and 100 doses respectively.

Vials are closed with a nitryl rubber stopper (type I, Ph. Eur.) and sealed with a coded aluminium cap.

Not all pack sizes may be marketed.

*10 ml vials are used for the 25 and 50 doses presentation.

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

Intervet UK Ltd.

Walton Manor

Walton

Milton Keynes

MK7 7AJ

UK

8. MARKETING AUTHORISATION NUMBER

Vm 01708/4562

9. DATE OF FIRST AUTHORISATION

24January 2012

10. DATE OF REVISION OF THE TEXT

January 2012

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.