Suvaxyn Circo
País: Unión Europea
Idioma: inglés
Fuente: EMA (European Medicines Agency)
Información para el usuario
(PIL)
06-11-2018
Ficha técnica
(SPC)
06-11-2018
Informe de Evaluación Pública
(PAR)
20-04-2018
Ingredientes activos:
porcine circovirus vaccine (inactivated, recombinant)
Disponible desde:
Zoetis Belgium SA
Código ATC:
QI09AA07
Designación común internacional (DCI):
porcine circovirus vaccine (inactivated, recombinant)
Grupo terapéutico:
Pigs (for fattening)
Área terapéutica:
Immunologicals for suidae, Inactivated viral vaccines
indicaciones terapéuticas:
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.,
Resumen del producto:
Revision: 2
Estado de Autorización:
Authorised
Fecha de autorización:
2018-02-07
Información para el usuario
15
B. PACKAGE LEAFLET
16
PACKAGE LEAFLET:
SUVAXYN CIRCO EMULSION FOR INJECTION FOR PIGS
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE,
IF DIFFERENT
Marketing authorization holder and manufacturer responsible for batch
release:
Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
BELGIUM
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Suvaxyn Circo emulsion for injection for pigs
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
One dose (2 ml) contains:
ACTIVE SUBSTANCES:
Inactivated recombinant chimeric porcine circovirus type 1containing
the porcine
circovirus type 2 ORF2 protein
2.3 – 12.4 RP*
ADJUVANT:
Squalane
Poloxamer 401
Polysorbate 80
8 µl (0.4% v/v)
4 µl (0.2% v/v)
0.64 µl (0.032%
v/v)
EXCIPIENTS:
Thiomersal
0.2 mg
*
Relative potency unit determined by ELISA antigen quantification (
_in vitro _
potency test) compared to a
reference vaccine.
White homogenous emulsion.
4.
INDICATION(S)
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: 23weeks after vaccination
5.
CONTRAINDICATIONS
None.
17
6.
ADVERSE REACTIONS
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
reactions may occur uncommonly after vaccination, resulting in
transient clinical signs such as vomiting,
diarrhea or depression. These clinical signs normally resolve without
treatment. Anaphylaxis may occur in
very rare cases. In case of such reactions, appropriate treatment is
recommended.
Local tissue reactions in the form of swelling at the injection site,
which m
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Ficha técnica
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
3
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
Not applicable.
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 reactions may occur uncommonly
after vaccination, resulting in
transient clinical signs such as vomiting, diarrhea or depression.
These clinical signs normally resolve without
treatment. Anaphylaxis may occur in very rar
Leer el documento completo
