SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Coglapix suspension for injection for pigs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One dose (2 ml) contains:

Active substances:

Actinobacillus pleuropneumoniae serotype 1(strain NT3) and

Actinobacillus pleuropneumoniae serotype 2(strains PO, U3, B4, SZ II)

expressing ApxI toxoidmin. 28.9 ELISA unit / ml*,

ApxII toxoid min. 16.7 ELISA unit / ml and

ApxIIItoxoid min. 6.8 ELISA unit / ml

* Elisa unit / ml calculated serological titre in sera of immunised rabbits

Adjuvant:

Aluminium hydroxide gel (as Al³⁺) 4.85 mg

Excipients:

Thiomersal max 0.22 mg

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Suspension for injection

Greyish-white, opaque liquid.

4. CLINICAL PARTICULARS

4.1 Target species

Pigs

4.2 Indications for use, specifying the target species

For the active immunisation of pigs as an aid to control pleuropneumonia caused by Actinobacillus pleuropneumoniae serotypes 1 and 2, by reducing the clinical signs and lung lesions associated with the disease.

Onset of immunity: 21 days following second vaccination

Duration of immunity: 16 weeks following second vaccination

4.3 Contraindications

None.

4.4 Special warnings <for each target species>

No information is available on the efficacy of the vaccine in animals with maternally derived antibodies. However, these antibodies are usually not present in piglets at the age of vaccination.

4.5 Special precautions for use

Special precautions for use in animals

Administer to healthy animals only.

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.

4.6 Adverse reactions (frequency and seriousness)

Adverse reactions to the vaccine include:

• a transient and mild swelling of maximum 2x3.2 cm is very common at the site of injection, persisting for at least 8 days.

• body temperature commonly increases of up to 1.8°C for 2 hours on days 1 or 2 after vaccination.

Vaccinated pigs may show signs of prostration for a few hours after vaccination, however, this is uncommon.

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

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

Do not use 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, preferably in the neck region.

Dose: 2ml

Vaccination schedule: 2 doses administered to animals from 7 weeks of age with an interval of 3 weeks between doses.

Shake well before use.

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

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

Administration of a double dose caused no other reactions than those described in 4.6 (adverse reactions); however, severity of the signs was increased e.g. transient and mild swelling of maximum 3x3 cm at the site of injection, regressing but persisting for at least 14 days; body temperature increases of up to 2.6°C for 2 hours on days 1 or 2 after vaccination.

4.11 Withdrawal period

Zero days.

5. IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Actinobacillus / Haemophilus vaccine.

ATCvet code: QI09AB07

The vaccine contains inactivated Actinobacillus pleuropneumoniae bacteria.The total quantity is 20 x 10⁹inactivated germs per dose.

Strain NT3 belongs to the serotype 1, expressing ApxI whereas strains SzII, PO, U3 and B4 belong to the serotype 2, expressing ApxIII. All the strains express also ApxII.

Vaccinated pigs develop active immunity against disease caused by serotype 1 or 2 of Actinobacillus pleuropneumoniae. Efficacy was demonstrated under laboratory but not under field conditions.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

sodium hydroxide

sodium chloride

water for injection

aluminium-hydroxide gel

thiomersal

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: 18 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 100 ml volume, sealed with rubber stopper and aluminium cap.

Cardboard box containing a single or 5 vaccine bottles.

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 products 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 15052/4075

9. DATE OF FIRST AUTHORISATION

21 October 2015

10. DATE OF REVISION OF THE TEXT

October 2015

Approved: 21 October 2015