Suvaxyn Circo Emulsion for Injection for Pigs

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: VMD (Veterinary Medicines Directorate)

Δραστική ουσία:

Porcine circovirus-2

Διαθέσιμο από:

Zoetis UK Limited

Φαρμακολογική κατηγορία (ATC):

QI09AA07

INN (Διεθνής Όνομα):

Porcine circovirus-2

Φαρμακοτεχνική μορφή:

Emulsion for injection

Τρόπος διάθεσης:

POM-V - Prescription Only Medicine – Veterinarian

Θεραπευτική ομάδα:

Pigs

Θεραπευτική περιοχή:

Inactivated Viral Vaccine

Καθεστώς αδειοδότησης:

Authorized

Ημερομηνία της άδειας:

2018-02-07

Αρχείο Π.Χ.Π.

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