Porcilis PCV

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

porcine circovirus type 2 ORF2 subunit antigen

Available from:

Intervet International BV

ATC code:

QI09AA07

INN (International Name):

adjuvanted inactivated vaccine against porcine circovirus

Therapeutic group:

Pigs

Therapeutic area:

Immunologicals for suidae

Therapeutic indications:

For the active immunisation of pigs to reduce the virus load in blood and lymphoid tissues and to reduce weight loss associated with porcine-circovirus-type-2 infection occurring during the fattening period.Onset of immunity: 2 weeksDuration of immunity: 22 weeks

Product summary:

Revision: 7

Authorization status:

Authorised

Authorization date:

2009-01-12

Patient Information leaflet

16
B. PACKAGE LEAFLET
17
PACKAGE LEAFLET:
Porcilis PCV 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 BV
Wim de Körverstraat 35
5831 AN Boxmeer
The NETHERLANDS
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Porcilis PCV emulsion for injection for pigs
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
Each dose of 2 ml contains:
Porcine circovirus type 2 ORF2 subunit antigen: ≥ 3720 Antigenic
Units as determined in the in vitro
potency test (AlphaLISA)
Adjuvants:
25 mg dl-α-tocopheryl acetate
346 mg light liquid paraffin.
Emulsion for injection. Opalescent white, with brown resuspendable
sediment.
4.
INDICATION(S)
For the active immunisation of pigs to reduce the virus load in blood
and lymphoid tissues and to
reduce mortality and weight loss associated with PCV2 infection
occurring during the fattening period.
Onset of immunity:
2 weeks
Duration of immunity:
22 weeks.
5.
CONTRAINDICATIONS
None
6.
ADVERSE REACTIONS
In laboratory studies and field trials:
Transient local reactions at the injection site were very commonly
observed after vaccination mainly
in the form of a hard, warm and sometimes painful swelling (diameter
up to 10 cm). These reactions
resolve spontaneously over a period of approximately 14–21 days
without any major consequence on
the general health status of the animals. Immediate systemic
hypersensitivity-like reactions were
commonly observed after vaccination, resulting in minor neurological
symptoms such as tremors
and/or excitation, which normally resolve within minutes without
requiring treatment. A transient
increase in body temperature, normally not exceeding 1 °C, was very
commonly observed until 2 days
18
after vaccination. In individual animals, an increase of rectal
temperature of 2.5 °C lasting less than
24 hours was uncommonly observed.
I

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Porcilis PCV emulsion for injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 2 ml contains:
Active substance:
Porcine circovirus type 2 ORF2 subunit antigen: ≥3720 AU*
* Antigenic Units as determined in the in vitro potency test
(AlphaLISA).
Adjuvants:
Dl-α-tocopheryl acetate
25 mg
Light liquid paraffin
346 mg
Excipients:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Emulsion for injection.
Opalescent white, with brown resuspendable sediment.
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 the virus load in blood
and lymphoid tissues and to
reduce mortality and weight loss associated with PCV2 infection
occurring during the fattening period.
Onset of immunity:
2 weeks
Duration of immunity:
22 weeks.
4.3
Contraindications
None
4.4
Special warnings for each target species
From the data provided, it can be concluded that a single dose regimen
of vaccination breaks through
up to medium levels and double dose regimen through medium to high
levels of maternally derived
antibodies in piglets.
No data are available on the use of the vaccine in breeding boars.
4.5
Special precautions for use
Special precautions for use in animals
3
Vaccinate only healthy animals.
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals
To the user:
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 insert with you. If pain persists for more than
12 hours after medical
exam