Summary of Product Characteristics

1. Name of the veterinary medicinal product

Porcilis Ery

2. Qualitative and quantitative composition of product

Per dose:

Active substance:

Erysipelothrix rhusiopathiae strain M2 (serotype 2) ≥ 1 ppd*

* ppd = pig protective dose

Excipients:

dl α-tocopherol acetate (adjuvant) 150 mg

Formaldehyde (preservative) 0.05%

3. PHARMACEUTICAL FORM

Suspension for injection.

4. CLINICAL PARTICULARS

4.1 Target species

Pigs.

4.2 Indications for use

For the active immunisation of sows, gilts, boars and growing pigs as an aid in the control of swine erysipelas.

4.3 Contraindications

Do not vaccinate unhealthy animals.

4.4 Special warnings for each target species

A good immune response is reliant on the reaction of an immunogenic agent and a fully competent immune system. Immunogenicity of the vaccine antigen will be reduced by poor storage or inappropriate administration. Immuno-competence of the animal may be compromised by a variety of factors including poor health, nutritional status, genetic factors, concurrent drug therapy and stress.

4.5 Special precautions for use

Special precaution for use in animals

None.

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

None.

4.6 Adverse reactions (frequency and seriousness)

Vaccination reactions normally consist of a slight (0.5C), transient (normal within 24 hours) rise in body temperature. A mild local swelling (less than 5 cm in diameter, normal within 3 days) and some reluctance to move may be seen in a very small proportion (<5%) of vaccinated animals.

4.7 Use during pregnancy, lactation or lay

Stress should be avoided when vaccinating animals, particularly during later stages of pregnancy.

4.8 Interaction with other medicaments 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

The dose is 2 ml per pig, given by deep intramuscular injection behind the ear.

Ensure that vaccination equipment is clean and sterile before use.

Allow vaccine to reach room temperature (15 - 25 C) before use.

Shake well before and during use.

Vaccination program

Young growing pigs

Pigs should be at least 6 weeks of age. A course of two vaccinations given 4 weeks apart, is recommended.

Breeding stock

Primary vaccination:

For the induction of protection against erysipelas, an initial course of two vaccinations, given 4 weeks apart, is recommended. Where protection against parvovirus is also required, this can be achieved with Porcilis Ery given either 4 weeks before, or 4 weeks after,administration of the Porcilis Ery+Parvo. Boars and gilts should be vaccinated against E. rhusiopathiaeat least 2 weeks before mating.

Booster vaccination:

Sows and boars should be revaccinated against erysipelas at six monthly intervals. For sows this may be during each lactation period, at weaning or during pregnancy (avoiding the last two weeks).

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

No additional symptoms at double dose.

4.11 Withdrawal periods

Zero days.

5. IMMUNOLOGICAL PROPERTIES

The active substance is inactivated antigen of Erysipelothrix rhusiopathiae which induces active immunity in vaccinated animals. The antigen is incorporated in an aqueous tocopherol based adjuvant in order to give a prolonged stimulation of immunity.

ATC Vet code: QI09AB03

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Formaldehyde, dl α-tocopherol acetate, polysorbat, simethicone, buffer

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: 2 years.

In use shelf life: 10 hours.

6.4 Special precautions for storage

Store at 2 C - 8 C. Protect from light. Do not freeze.

6.5 Nature and composition of immediate packaging

Cardbox box with glass (Type I Ph.Eur.) or PET vial containing 10, 25, 50 or 125 doses (20, 50, 100 or 250 ml respectively), closed with a rubber stopper and sealed with a colour coded aluminium cap.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal of unused veterinary medicinal product or waste material derived from the use of such products

Any unused veterinary medicinal product or waste material 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

Buckinghamshire

MK7 7AJ

8. Marketing Authorisation Number

Vm 01708/4355

9. DATE OF FIRST AUTHORISATION

Date: 07 July 1997

10. Date of revision of the text

Date:March 2015

Approved: 30 March 2015