Porcilis PCV ID

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

porcine circovirus type 2 ORF2 subunit antigen

Available from:

Intervet International B.V.

ATC code:

QI09AA07

INN (International Name):

Porcine circovirus vaccine (inactivated)

Therapeutic group:

Pigs

Therapeutic area:

Immunologicals for suidae, Inactivated viral vaccines

Therapeutic indications:

For the active immunisation of pigs to reduce viraemia, virus load in lungs and lymphoid tissues and virus shedding caused by PCV2 infection. To reduce loss of daily weight gain and mortality associated with PCV2 infection.

Product summary:

Revision: 3

Authorization status:

Authorised

Authorization date:

2015-08-28

Patient Information leaflet

14
B. PACKAGE LEAFLET
15
PACKAGE LEAFLET:
Porcilis PCV ID 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 authorisation holder and manufacturer responsible for batch
release:
Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Porcilis PCV ID emulsion for injection for pigs
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
Each dose of 0.2 ml contains:
ACTIVE SUBSTANCE:
Porcine circovirus type 2 ORF2 subunit antigen
≥
1436 AU
1
ADJUVANTS:
dl-α-tocopheryl acetate
0.6 mg
Light liquid paraffin
8.3 mg
1
Antigenic units as determined in the
_in vitro_
antigenic mass assay.
Emulsion for injection.
Homogenous, white to nearly white emulsion after shaking.
4.
INDICATION(S)
For the active immunisation of pigs to reduce viraemia, virus load in
lungs and lymphoid tissues and
virus shedding caused by PCV2 infection. To reduce loss of daily
weight gain and mortality associated
with PCV2 infection.
Onset of immunity: 2 weeks after vaccination.
Duration of immunity: 23 weeks after vaccination.
5.
CONTRAINDICATIONS
None.
6.
ADVERSE REACTIONS
Transient local reactions mostly consisting of hard non-painful
swellings of up to 2 cm diameter were
very commonly observed in laboratory studies and field trials. A
biphasic pattern of the local
16
reactions, consisting of an increase and decrease followed by another
increase and decrease of the size,
is commonly observed. In individual pigs the size may increase to 6.5
cm and redness and/or scabs
may be observed. The local reactions disappear completely within
approximately7 weeks after
vaccination.
The frequency of adverse reactions is defined using the following
convention:
-
very common (more than 1 in 10 animals treated displaying adverse
reaction(s))
-
common (more than 1 but less than 10 animals in 100 animals treated)
-
uncommon (more than 1 but less th

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Porcilis PCV ID emulsion for injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 0.2 ml contains:
ACTIVE SUBSTANCE:
Porcine circovirus type 2 ORF2 subunit antigen
≥
1436 AU
1
ADJUVANTS:
dl-α-tocopheryl acetate
0.6 mg
Light liquid paraffin
8.3 mg
1
Antigenic units as determined in the
_in vitro_
potency test (antigenic mass assay).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Emulsion for injection.
Homogenous, white to nearly white emulsion after shaking.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of pigs to reduce viraemia, virus load in
lungs and lymphoid tissues and
virus shedding caused by PCV2 infection. To reduce loss of daily
weight gain and mortality associated
with PCV2 infection.
Onset of immunity: 2 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.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Use of the vaccine in boars has not been evaluated.
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals
To the user:
3
This veterinary medicinal product contains mineral oil. Accidental
injection/self-injection may result
in severe pain and swelling, particularly if injected into a joint or
finger, and in rare cases could result
in the loss of the affected finger if prompt medical attention is not
given. If you are accidentally
injected with this product, seek prompt medical advice even if only a
very small amount is injected
and take the package leaflet with you. If pain persists for more than
12 hours after medical
examination, seek medical advice again.
To the physician:
This veterinary medicinal product contains mineral oil. Even if small
amounts have been injected,
accidenta