SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Porcilis Ery + Parvo

2. QUALITATIVE AND QUANTITATIVE COMPOSITION OF PRODUCT

Per dose

Active substance

Erysipelothrix rhusiopathiae strain M2 (serotype 2) 1ppd¹

Porcine Parvovirus (PPV) strain 014 ≥ 552 EU²

¹One pig protective dose

²Antigenic ELISA

Excipients:

dl α-tocopherol (adjuvant) 150 mg

Formaldehyde (preservative) 0.05%

For a full list of excipients see section 6.1.

3. PHARMACEUTICAL FORM

Suspension for injection.

4. CLINICAL PARTICULARS

4.1 Target species

Pig (sows and gilts).

4.2 Indications for use

For the active immunisation of sows and gilts as an aid in the control of swine erysipelas and for the protection of embryos and foetuses against PPV infection.

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. Immunocompetence 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 precautions 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 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

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

Allow vaccine to reach room temperature (15 °C - 25 °C) before use. Shake well before and during use.

Vaccination programme

Gilts should be vaccinated against E. rhusiopathiae and porcine parvo virus (PPV) before first mating. A single injection, not less than 2 weeks before mating is sufficient to protect the following pregnancy from damage due to PPV. For the induction of protection against erysipelas, an initial course of two vaccinations is recommended. This can be achieved with the single component erysipelas vaccine given either 4 weeks before, or 4 weeks after the administration of Porcilis Ery+Parvo.

Sows should be revaccinated against erysipelas during each lactation period (i.e. at no more than 6 month intervals) and against parvovirus annually.

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

No additional symptoms at double dose.

4.11 Withdrawal periods

Zero days.

5. IMMUNOLOGICAL PROPERTIES

ATC Vet:QI09AL01: Inactivated bacterial and inactivated viral vaccines. Porcine parvovirus and Erysipelothrix

The active substances are inactivated antigens of Erysipelothrix rhusiopathiae and Porcine parvovirus which induce active immunity in vaccinated animals. The antigens are incorporated in an aqueous tocopherol based adjuvant in order to give a prolonged stimulation of immunity.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Formaldehyde

dl α-Tocopherol acetate

Polysorbate

Simethicone

Buffer

6.2 Incompatibilities

Do not mix with any veterinary medicinal product.

6.3 Shelf life

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

Shelf life after first opening of the immediate packaging: 10 hours.

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

Cardboard 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 01708/4334

9. DATE OF FIRST AUTHORISATION

16 July 1997

10. Date of revision of the text

January 2016

Prohibition of sale supply and/or use

Not applicable

Approved: 27 January 2016