PORCILIS PCV IDAL EMULSION FOR INJECTION FOR PIGS

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

PORCINE CIRCOVIRUS TYPE 2 ORF2 SUBUNIT ANTIGEN

Available from:

INTERVET AUSTRALIA PTY LIMITED

Pharmaceutical form:

MISC. VACCINES OR ANTI SERA

Composition:

PORCINE CIRCOVIRUS TYPE 2 ORF2 SUBUNIT ANTIGEN VACCINE-VIRAL Active 7180.0 AU/mL

Units in package:

10x10mL; 10x20mL; 1x10mL; 1x20mL

Class:

VM - Veterinary Medicine

Therapeutic area:

IMMUNOTHERAPY

Product summary:

Poison schedule: 0; Withholding period: Zero (0) days.; Host/pest details: PIGS: [PREVENTING WEIGHT LOSS, PREVENTION OF PORCINE CIRCOVIRUS TYPE 2, REDUCTION OF PCV2 VIRAEMIA]

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

Product Name:
APVMA Approval No:
PORCILIS PCV IDAL EMULSION FOR INJECTION FOR PIGS
84901/111721
Label Name:
PORCILIS PCV IDAL EMULSION FOR INJECTION FOR PIGS
Signal Headings:
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
Each dose of 0.2 mL contains:
Active Constituent: Porcine circovirus type 2 (PCV2) ORF 2 subunit
antigen: ≥ 1436 AU
Claims:
For the active immunisation of pigs against PCV2 infection.
To reduce PCV2 associated viraemia, virus load in lungs, tonsils and
lymphoid tissues.
To reduce shedding caused by PCV2 infection, and thereby minimise
environmental
contamination.
To reduce weight loss and mortality associated with PCV2 infection.
Onset of immunity: 2 weeks after vaccination.
Duration of immunity: 23 weeks after vaccination.
Porcilis PCV IDAL is effective in the presence of maternally derived
antibodies to PCV2.
Net Contents:
1 x 10 mL
1 x 20 mL
10 x 10 mL
10 x 20 mL
Directions for Use:
READ THE ENCLOSED LEAFLET FOR FULL INSTRUCTIONS.
SHAKE WELL BEFORE USE
Use the entire contents within 8 hours of opening.
Restraints:
DO NOT mix with any other veterinary medicinal product.
Contraindications:
Precautions:
Vaccinate healthy animals only.
Safety studies to support the use of the product in breeding animals
and pregnant females
have not been conducted.
No information is available on the safety and efficacy of this vaccine
when used with any
other veterinary medicinal product. A decision to use this vaccine
before or after any other
veterinary medicinal product therefore needs to be made on a case by
case basis. RLP APPROVED
Side Effects:
Transient local reactions are common and usually consist of a hard
non-painful swelling
of up to 2 cm diameter. Occasionally the swellings may increase up to
4 cm diameter and
may be associated with redness. The swellings may recur after
initially subsiding and will
disappear completely within approximately 5 weeks.
Dosage and
Administration:
Before use allow the vaccine to reach room temperature. Shake well
before use.
FOR INTRADERMAL USE ONLY.
Intradermal admi