Porcilis PCV ID Emulsion for Injection for Pigs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Porcine circovirus-2

Available from:

MSD Animal Health UK Limited

ATC code:

QI09AA07

INN (International Name):

Porcine circovirus-2

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:

2015-08-28

Summary of Product characteristics

Amended pages: October 2023
AN: 00940/2022 & 01210/2022
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
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:
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.
Amended pages: October 2023
AN: 00940/2022 & 01210/2022
Page 2 of 6
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:
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:
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