PORCILIS PCV M HYO

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

PORCINE CIRCOVIRUS TYPE 2 ORF2 SUBUNIT ANTIGEN; MYCOPLASMA HYOPNEUMONIAE - INACTIVATED ANTIGEN

Available from:

INTERVET AUSTRALIA PTY LIMITED

INN (International Name):

porcine circovirus type 2+vaccine - Mycoplasma hyopneum.

Pharmaceutical form:

VACCINE OR ANTISERA

Composition:

PORCINE CIRCOVIRUS TYPE 2 ORF2 SUBUNIT ANTIGEN VACCINE-VIRAL Active 1414.0 AU/mL; MYCOPLASMA HYOPNEUMONIAE - INACTIVATED ANTIGEN VACCINE-GENERAL Active 2.69 RP

Units in package:

10x100mL; 10x20mL; 10x500mL; 10x50mL; 1x100mL; 1x200mL; 1x20mL; 1x500mL; 1x50mL

Class:

VM - Veterinary Medicine

Manufactured by:

INTERVET AUSTRALIA

Therapeutic area:

IMMUNOTHERAPY

Product summary:

Poison schedule: 0; Withholding period: WHP: 0 DAYS; Host/pest details: PIG: [MYCOPLASMA HYOPNEUMONIAE, PREVENTION OF PORCINE CIRCOVIRUS TYPE 2]; Poison schedule: 0; Withholding period: ; Host/pest details: PIG: [MYCOPLASMA HYOPNEUMONIAE, PREVENTION OF PORCINE CIRCOVIRUS TYPE 2]; For the active immunisation of pigs against PCV2 infection; To aid in the prevention of enzootic pneumonia of swine caused by M. hypopneumoniae; To reduce the severity of lung lesions caused by M. hypopneumoniae; To reduce associated weight loss . . .Vaccinate only healthy animals. Use during pregnancy or lactation has not been determined. Refer to Side Effects information on label/leaflet also.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

Product Name:
APVMA Approval No:
PORCILIS PCV M HYO
82241/140074
Label Name:
PORCILIS PCV M HYO
Signal Headings:
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
Each dose of 2 mL contains:
Active constituents:
Porcine circovirus type 2 (PCV2) ORF 2 subunit antigen: ≥ 2828 AU*
Mycoplasma hyopneumoniae J strain inactivated: ≥ 2.69 RPU**
Also contains (Adjuvants):
0.268 mL Light mineral Oil
1.64 - 2.40 mg Aluminium hydroxide
* Antigenic units
** Relative potency units
Claims:
For the active immunisation of pigs to reduce viraemia, virus load in
lungs and lymphoid
tissues, virus shedding caused by porcine circovirus type 2 (PCV2)
infection, and severity
of lung lesions caused by
Mycoplasma hyopneumoniae
infection.
To aid in the prevention of enzootic pneumonia of swine caused by
Mycoplasma
hyopneumoniae.
To reduce the loss of daily weight gain during the finishing period in
face of infections with
Mycoplasma hyopneumoniae
and/or PCV2 (as observed in field studies).
Onset of immunity with single dose vaccination
PCV2: 2 weeks after vaccination.
M. hyopneumoniae
: 4 weeks after vaccination.
Onset of immunity with two dose vaccination
PCV2: 18 days after first vaccination.
M. hyopneumoniae
: 3 weeks after the second vaccination.
Duration of immunity (single and flexible vaccination schedules)
PCV2: 22 weeks after (the last) vaccination.
M. hyopneumoniae
: 21 weeks after (the last) vaccination
Net Contents:
20 mL, 50 mL, 100 mL, 200 mL, 500 mL RLP APPROVED
[10x] 20 mL, 50 mL, 100 mL, 200 mL, 500 mL
Directions for Use:
Restraints:
DO NOT mix with any other vaccine or immunobiological product, except
Porcilis Lawsonia
Inactivated Vaccine for Pigs (APVMA No. 91351).
Contraindications:
Precautions:
Use with caution in pregnant or lactating sows as the safety of this
product has not been
determined.
Side Effects:
In laboratory and field trials:
A transient increase in body temperature very commonly occurs on the
day of vaccination.
This resolves spontaneously after 1 to 2 days without treatment.
Mild systemic reactions