1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Ecoporc SHIGA suspension for injection for pigs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each dose of 1 ml contains:

Active substance:

Genetically modified recombinant Stx2e antigen: ≥ 3.2 x 10⁶ ELISA units

Adjuvant:

Aluminium (as hydroxide) max. 3.5 mg

Excipient:

Thiomersal max. 0.115 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Suspension for injection.

Appearance after shaking: yellowish to brownish, homogenous suspension.

4. CLINICAL PARTICULARS

4.1 Target species

Pigs.

4.2 Indications for use, specifying the target species

Active immunisation of piglets from the age of 4 days, to reduce the mortality and clinical signs of oedema disease caused by Stx2e toxin produced by E. coli (STEC).

Onset of immunity: 21 days after vaccination

Duration of immunity: 105 days after vaccination

4.3 Contraindications

Do not use in cases of hypersensitivity to the active substance, to the adjuvant or to any of the excipients.

4.4 Special warnings for each target species

Vaccinate healthy animals only.

4.5 Special precautions for use

Special precautions for use in animals

Not applicable.

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

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

4.6 Adverse reactions (frequency and seriousness)

Commonly very small local reactions such as mild swelling at the injection site (maximum of 5 mm) may be observed, but these reactions are transient and subside within a short time (up to seven days) without treatment.

Commonly a slight rise in body temperature (maximum of 1.7 °C) may occur after injection. However, these reactions subside within a short time (maximum of two days) without treatment.

Clinical signs such as temporary mild behavioural disturbances can uncommonly be observed after application of Ecoporc SHIGA.

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

- very common (more than 1 in 10 animals treated displaying adverse reaction(s))

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

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

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

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

4.7 Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation.

Pregnancy and lactation: The use is not recommended during pregnancy and lactation.

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. The preferred application site is the neck muscle behind the ear. It is recommended to use a needle appropriate for the age of the piglets (preferred size 21G length 16 mm).

Prior to administration, shake the vaccine carefully.

A single intramuscular injection (1 ml) to pigs from the age of 4 days.

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

Following the administration of a double dose of vaccine no adverse reactions other than those described in section 4.6 have been observed.

4.11 Withdrawal period(s)

Zero days.

5. IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Immunologicals for suidae, inactivated bacterial vaccines. ATC vet code: QI09AB02.

The vaccine consisting of genetically modified recombinant Stx2e stimulates an active immunity against Shiga toxin 2e produced by the causative agent of oedema disease in pigs.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Aluminium hydroxide (Al(OH)₃)

Thiomersal

Water for injections

Glutaraldehyde

6.2 Major 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: 3 years Shelf life after first opening the immediate packaging: 24 hours

Between the withdrawals, the vaccine should be stored at 2 °C – 8 °C.

6.4. Special precautions for storage

Store in a refrigerator (2 °C – 8 _°C).

Do not freeze.

Protect from light.

6.5 Nature and composition of immediate packaging

PET bottle containing 50 ml or 100 ml closed with a bromobutyl rubber stopper and sealed with an aluminium tear-off cap.

Pack sizes:

Cardboard box with 1 PET bottle of 50 doses (50 ml) or 100 doses (100 ml).

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 Santé Animale

10 av. de La Ballastière

33500 Libourne

France

8. MARKETING AUTHORISATION NUMBER(S)

EU/2/13/149/001

EU/2/13/149/002

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 10/04/2013 Date of latest renewal: 20/03/2018

10. DATE OF REVISION OF THE TEXT

{MM/YYYY}

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.