Coglapix Suspension for Injection for Pigs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Actinobacillus pleuropneumoniae

Available from:

Ceva Animal Health Ltd

ATC code:

QI09AB07

INN (International Name):

Actinobacillus pleuropneumoniae

Pharmaceutical form:

Suspension for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Pigs

Therapeutic area:

Inactivated Bacterial Vaccine

Authorization status:

Authorized

Authorization date:

2015-10-21

Summary of Product characteristics

Revised: September 2022
AN: 01488/2022
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Coglapix suspension for Injection for Pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2 ml dose contains:
ACTIVE SUBSTANCES:
_Actinobacillus pleuropneumoniae _inactivated serotype 1(strain NT3)
and
_Actinobacillus pleuropneumoniae _inactivated serotype 2(strains PO,
U3, B4, SZ II)
expressing
ApxI toxoid min. 28.9 ELISA unit / ml*
ApxII toxoid min. 16.7 ELISA unit / ml
ApxIII toxoid min. 6.8 ELISA unit / ml
* Elisa unit / ml calculated serological titre in sera of immunised
rabbits
ADJUVANT:
Aluminium hydroxide (Al
3+
)
4.85 mg
EXCIPIENT:
Thiomersal
max 0.22 mg
For the 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
Revised: September 2022
AN: 01488/2022
Page 2 of 5
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.
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, 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