Suvaxyn Circo Emulsion for Injection for Pigs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

recombinant Porcine Circovirus type 1 expressing the Porcine circovirus type 2 ORF2 protein

Available from:

Zoetis UK Limited

ATC code:

QI09AA07

INN (International Name):

recombinant Porcine Circovirus type 1 expressing the Porcine circovirus type 2 ORF2 protein

Pharmaceutical form:

Emulsion for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Pigs

Therapeutic area:

Inactivated Viral Vaccine

Authorization status:

Authorized

Authorization date:

2018-02-07

Summary of Product characteristics

Unlimited Renewal: February 2023
AN: 03397/2022
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Suvaxyn Circo emulsion for injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose (2 ml) contains:
ACTIVE SUBSTANCE:
Inactivated recombinant chimeric porcine circovirus type 1
containing the porcine circovirus type 2 ORF2 protein
2.3 – 12.4 RP*
ADJUVANT:
Squalane
Poloxamer 401
Polysorbate 80
EXCIPIENTS:
8 µl (0.4% v/v)
4 µl (0.2% v/v)
0.64 µl (0.032%
v/v)
Thiomersal
0.2 mg
*
Relative potency unit determined by ELISA antigen quantification (_in
vitro _potency
test) compared to a reference vaccine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Emulsion for injection.
White homogenous emulsion.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs (for fattening)
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of pigs from 3 weeks of age against porcine
circovirus type 2
(PCV2) to reduce viral load in blood and lymphoid tissues and fecal
shedding caused
by infection with PCV2.
Onset of immunity: from 3 weeks after vaccination.
Duration of immunity: 23 weeks after vaccination
Unlimited Renewal: February 2023
AN: 03397/2022
Page 2 of 5
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
None
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)
A transient increase in body temperature (on average 1°C) is very
common during the
first 24 hours after vaccination. In individual pigs the temperature
increase compared
to pre-treatment may commonly exceed 2 °C. This resolves
spontaneously within 48
hours without treatment.
Immediate mild hypersensitivity-like reacti