SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Hyogen emulsion for injection for pigs

FI, SE: Hyobloc

DK: Mhyogen

BE, NL: Hyogen J5

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One dose (2 ml) contains:

Active substance:

Inactivated

Mycoplasma hyopneumoniae 2940 strain: min. 5.5 EU *

Adjuvants:

Light liquid paraffin 187 μl

Escherichia coliJ5 LPS 1184-38000 Endotoxin unit

Excipient:

Thiomersal 50 µg

* Mean antibody titre – expressed in M. hyopneumoniaeELISA Unit – obtained 28 days after the immunisation of rabbits with half of pig vaccine dose (1ml).

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Emulsion for injection

Off-white, homogeneous emulsion.

4. CLINICAL PARTICULARS

4.1 Target species

Pigs for fattening

4.2 Indications for use, specifying the target species

For the active immunization of fattening pigs from 3 weeks of age to reduce the occurrence and severity of lung lesions caused by Mycoplasma hyopneumoniae infection.

Onset of immunity: 3 weeks after the vaccination

Duration of immunity: 26 weeks after vaccination

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 only healthy animals.

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

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

To the user:

This veterinary medicinal product contains mineral oil. Accidental injection/self-injection may result in severe pain and swelling, particularly if injected 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 injected with this veterinary medicinal product, seek prompt medical advice even if only a very small amount is injected 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 veterinary medicinal product contains mineral oil. Even if small amounts have been injected, accidental injection with this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit. Expert and 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.

4.6 Adverse reactions (frequency and seriousness)

On the day of vaccination a transient mean increase in body temperature of about 1.3C is very common. In an individual pig this increase might reach 2oC, but in all cases body temperature is back to normal the next day.

A local reaction at the site of injection in the form of a swelling of a diameter up to 5 cm can be very common, which can last for three days. These reactions are of transient nature and do not need further treatment.

Immediate mild hypersensitivity-like reactions may occur uncommonly after vaccination, resulting in transient clinical signs such as vomiting. These clinical signs normally resolve without treatment

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

.

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

For intramuscular use.

Vaccinate pigs in the side of their neck.

Administer a single dose of 2 ml from 3 weeks of age.

The data available are not sufficient to exclude the interaction of maternally derived antibodies with vaccine uptake. Interaction with maternal-derived antibodies is known and should be taken into consideration. It is recommended to delay vaccination in piglets with residual MDA at the age of 3 weeks.

Shake well before use.

Use sterile syringe and needle, respect aseptic conditions of vaccination.

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

As the vaccine is inactivated, studies investigating the safety of an overdose administration are not required.

4.11 Withdrawal period(s)

Zero days.

5. IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Pig / Inactivated bacterial vaccines / mycoplasma

ATCvet code: QI09AB13

Inactivated bacterial vaccine, containing whole cell concentrate of Mycoplasma hyopneumoniae strain 2940. This antigen is incorporated in an adjuvant for stimulation of immunity, based on a combination of light liquid paraffin and cell free Escherichia coliJ5 LPS. The product stimulates the development of active immunity in pigs against Mycoplasma hyopneumoniae.

Under experimental conditions reduction of M. hyopneumoniaecolonization was demonstrated 44-50 days post vaccination.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

light liquid paraffin

sorbitan trioleate

Polysorbate 80

Escherichia coliJ5 LPS

thiomersal

sodium chloride

potassium chloride

disodium phosphate dihydrate

potassium dihydrogen phosphate

water for injection

6.2 Incompatibilities

Do not mix with any other veterinary medicinal product.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 15 months

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

Low density polyethylene bottle of 50, 100 or 250 ml volume, sealed with rubber stopper and aluminium cap.

1x50 ml, 1x100 ml, 1x250 ml, 5x50 ml, 5x100 ml or 5x250 ml in a carton box.

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

Ceva Animal Health Ltd

Unit 3, Anglo Office Park

White Lion Road

Amersham

Buckinghamshire

HP7 9FB

8. MARKETING AUTHORISATION NUMBER

Vm 15052/4078

9. DATE OF FIRST AUTHORISATION

11 June 2015

10. DATE OF REVISION OF THE TEXT

October 2016

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

06 October 2016