SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Ingelvac MycoFLEX suspension for injection for pigs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Inactivated Mycoplasma hyopneumoniae, J Strain Isolate B-3745.

Each dose ( 1 ml) of inactivated vaccine contains:

Active substance:

Mycoplasma hyopneumoniae: > 1 RP*

*Relative potency (ELISA test) by comparison with a reference vaccine.

Adjuvant: Carbomer: 1 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Suspension for injection.

Clear to slightly opalescent, pink to brown suspension for injection.

4. CLINICAL PARTICULARS

4.1 Target species

Pigs (fattening pigs or future breeders until first reproductive service).

4.2 Indications for use, specifying the target species

For active immunisation of pigs from 3 weeks of age to reduce lung lesions following infection with Mycoplasma hyopneumoniae.

Onset of protection occurs by 2 weeks post vaccination and lasts for at least 26 weeks.

4.3 Contraindications

None.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals

Vaccinate healthy animals only

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

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

Not applicable.

4.6 Adverse reactions (frequency and seriousness)

Adverse reactions are very rare (less than 1 animal in 10,000 animals, including isolated reports):

• anaphylactic-type reactions may occur and should be treated symptomatically (e.g. epinephrine)

• transient swelling up to four centimetres in diameter, sometimes associated with redness of the skin, may be observed at the injection site. These swellings may last up to five days.

• a transient mean increase in rectal body temperature of about 0.8 °C lasting up to 20 hours after vaccination may be observed.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)

- common (more than 1 but less than 10 animals in 100 animals)

- uncommon (more than 1 but less than 10 animals in 1,000 animals)

- rare (more than 1 but less than 10 animals in 10,000 animals)

- very rare (less than 1 animal in 10,000 animals, including isolated reports).

4.7 Use during pregnancy, lactation or lay

Not applicable.

4.8 Interaction with other medicinal products and other forms of interaction

Safety and efficacy data are available which demonstrate that this vaccine can be mixed with Boehringer Ingelheim’s Ingelvac CircoFLEX and administered at one injection site.

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

4.9 Amounts to be administered and administration route

Shake well before use.

Single intramuscular injection of one dose (1 ml), preferably in the neck of pigs from 3 weeks of age.

Avoid introduction of contamination during use.

Avoid multiple broaching.

Vaccine devices should be used in accordance with the device instructions provided by the manufacturer.

Use equipment that prevents flush back of the veterinary medicinal product.

When mixed with Ingelvac CircoFLEX:

When mixed with Ingelvac CircoFLEX the following equipment should be used:

To ensure correct mixing follow the steps as described below:

1. Connect one end of the transfer needle to the vaccine bottle of Ingelvac MycoFLEX.

2. - Connect the opposite end of the transfer needle to the vaccine bottle of Ingelvac CircoFLEX.

- Transfer the Ingelvac CircoFLEX vaccine into the vaccine bottle of Ingelvac MycoFLEX. If needed, gently press the vaccine bottle of Ingelvac CircoFLEX to facilitate the transfer.

- After the transfer of the full content of Ingelvac CircoFLEX, disconnect and discard transfer needle and empty vaccine bottle of Ingelvac CircoFLEX.

3. To ensure appropriate mixing of the vaccines, gently shake the vaccine bottle of Ingelvac MycoFLEX until the mixture is of uniform orange to reddish colour. During vaccination the uniformity of the coloured mixture should be monitored and maintained by continuous agitation.

4. Administer one single injection dose (2 ml)of the mixture intramuscularly per pig, irrespective of body weight. For administration, vaccine devices should be used in accordance with the device instructions provided by the manufacturer.

Use the entire vaccine mixture immediately after mixing. Any unused mixture or waste material should be disposed of in accordance with local requirements.

The package leaflet of Ingelvac CircoFLEX should also be consulted before the administration of the mixed product.

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

Following the administration of a 4-fold overdose of vaccine no adverse reactions other than those described under section 4.6 have been observed.

4.11 Withdrawal period

Zero days.

5. IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: immunologicals for Suidae, inactivated bacterial vaccines

ATC vet code: QI09AB13

This vaccine is designed to stimulate the development of an active immune response to Mycoplasma hyopneumoniae in pigs.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Carbomer

Sodium chloride

Water for injection

6.2 Incompatibilities

Do not mix with any other veterinary medicinal product, except with Boehringer Ingelheim´s Ingelvac CircoFLEX.

6.3 Shelf life

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

Shelf life after first opening the immediate packaging: 10 hours

6.4 Special precautions for storage

Store and transport refrigerated (2°C – 8°C).

Do not freeze.

Protect from light.

6.5 Nature and composition of immediate packaging

Cardboard box with 1 or 12 high density polyethylene bottles of 10 ml (30 ml bottles), 50 ml (120 ml bottles), 100 ml (250 ml bottles) or 250 ml (500 ml bottles) vaccine with a chlorobutyl stopper and lacquered aluminium seal.

Not all pack 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 Ltd

Ellesfield Avenue

Bracknell

Berkshire

RG12 8YS

8. MARKETING AUTHORISATION NUMBER

Vm 00015/4080

9. DATE OF FIRST AUTHORISATION

04 August 2009

10. DATE OF REVISION OF THE TEXT

February 2016

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

Approved: 24 February 2016