SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Porcilis APP Suspension for injection

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 2 ml dose: contains:

Active substance(s):

600 mg Actinobacillus pleuropneumoniae antigen concentrate containing:

OMP [outer membrane protein] 50 units*

Apx I toxoid 50 units

Apx II toxoid 50 units

Apx III toxoid 50 units

* units relative to an internal standard determined to be efficacious in pigs.

Adjuvant

dl-α-tocopherol 150 mg

Excipients

Formaldehyde (preservative) 0.02 % w/v

For a full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

Suspension for injection.

4. CLINICAL PARTICULARS

4.1 Target Species

Pigs (weaned piglets).

4.2 Indications for use, specifying the target species

For the active immunization of weaned piglets to reduce mortality, clinical signs and lesions of pleuropneumonia caused by Actinobacillus pleuropneumoniae.

Onset of immunity: 2 weeks after completion of the vaccination scheme.

Duration of immunity: 11 weeks after completion of the vaccination scheme.

4.3 Contraindications

None.

4.4 Special warnings for each target species

Only healthy animals should be vaccinated.

4.5 Special precautions for use

Special precautions for use in animals

It is not advisable to vaccinate animals immediately before and after feeding.

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

In the case of accidental self-injection or ingestion seek medical advice immediately and show the package leaflet or the label to the physician. If spilled on the skin, wash with soap and water.

4.6 Adverse reactions (frequency and seriousness)

Mild to moderate injection site reactions may occur in some animals, these resolve within 5 days post-vaccination. Transient increases in temperature (up to 2 °C), anorexia, decreased activity/depression, lower appetite, vomiting, increases in respiration rate with a change towards abdominal breathing and dyspnea may be observed after vaccination. These reactions are transient and resolve within 24 hours after vaccination.

In addition to these reactions, more severe reactions such as anaphylaxis may occasionally occur.

4.7 Use during pregnancy, lactation or lay

Do not use during pregnancy or 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

Dose: 2 ml

Route of administration: Deep intramuscular injection.

Allow the vaccine to reach ambient temperature (between 15 °C to 25 °C) before use.

Shake bottle vigorously before and at intervals during use.

Clean and sterile vaccination equipment should be used.

The use of automatic vaccination equipment is recommended.

Maximum protection should be achieved before the start of the fattening period.

Pigs may be vaccinated from 6 weeks of age.

Two doses at least 4 weeks apart are required.

It is advised to give these at 6 and 10 weeks of age.

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

No reactions other than those in Section 4.6 were observed following a double dose, however the severity of clinical signs was increased.

4.11 Withdrawal Period(s)

Zero days.

5. PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Immunologicals for Suidae; Inactivated bacterial vaccines; Actinobacillus vaccine.

ATC vet code: QI09AB07

The active ingredients (Apx I, Apx II, Apx III and OMP) induce antibodies, which help to protect pigs against pleuropneumonia caused by Actinobacillus pleuropneumoniae.

The antigens are incorporated in an aqueous adjuvant in order to enhance stimulation of immunity.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

dl-α-tocopherol acetate

Polysorbate 80

Simethicone

Sodium chloride

Formaldehyde

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: 2 years.

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

6.4 Special precautions for storage

Store in a refrigerator (2 °C to 8 °C).

Do not freeze.

Protect from light.

6.5 Nature and composition of immediate packaging

Carton with one glass bottle type I (Ph. Eur.) or PET bottle with halogenated rubber stoppers and aluminium closures, containing 20, 50, 100 or 250 ml (10, 25, 50 or 125 doses).

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials

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

Intervet UK Ltd

Walton Manor

Walton

Milton Keynes

MK7 7AJ

8. MARKETING AUTHORISATION NUMBER

Vm 01708/4606

9. DATE OF THE FIRST AUTHORISATION

11 February 2014

10. DATE OF REVISION OF THE TEXT

February 2014

APPROVED 11/02/2014