Fostera Gold PCV Metastim

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

PORCINE CIRCOVIRUS TYPE 1-TYPE 2B CHIMERA INACTIVATED; PORCINE CIRCOVIRUS TYPE 1-TYPE 2A CHIMERA INACTIVATED; THIOMERSAL

Available from:

ZOETIS AUSTRALIA PTY LTD

Pharmaceutical form:

MISC. VACCINES OR ANTI SERA

Composition:

PORCINE CIRCOVIRUS TYPE 1-TYPE 2B CHIMERA INACTIVATED VACCINE-ANTIGEN/ANTIBODY Active 1.0 RP; PORCINE CIRCOVIRUS TYPE 1-TYPE 2A CHIMERA INACTIVATED Active 1.0 RP; THIOMERSAL MERCURY Other 0.1 mg/ml

Units in package:

100 mL (50 doses); 500 mL (250 doses)

Class:

VM - Veterinary Medicine

Therapeutic area:

IMMUNOTHERAPY

Product summary:

Poison schedule: 0; Withholding period: Zero (0) days Zero (0) days; Host/pest details: PIGS (BUT NOT SOWS OR BOARS): [PREVENTION OF PORCINE CIRCOVIRUS TYPE 2]

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

Product Name:
APVMA Approval No:
Fostera Gold PCV Metastim
88614/134268
Label Name:
Fostera Gold PCV Metastim
Signal Headings:
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
Each dose contains inactivated Porcine Circovirus Type 1-Type 2a
Chimera (RP ≥ 1.0) and
inactivated Porcine Circovirus Type 1-Type 2b Chimera (RP ≥ 1.0).
Also contains: ≤ 0.1 mg/ mL thiomersal (preservative).
Claims:
For active immunisation of pigs to reduce viraemia, virus load in
lymphoid tissues, the
incidence of lesions in lymphoid tissues associated with PCV2
infection and reduction in
faecal virus shedding.
Onset of immunity:
For PCV2, 3 weeks after either a single dose (2 mL) vaccination or
completion of the two-
dose (2 x 1mL) vaccination schedule.
Duration of immunity:
For PCV2, 23 weeks after a single vaccination or a two- dose regime.
Net Contents:
100 mL (50 doses), 500 mL (250 doses)
Directions for Use:
Restraints:
Contraindications:
Precautions:
Safety studies to support the use of the product in breeding boars
have not been
conducted. No information is available on the safety and efficacy of
this vaccine when used
with other products.
Side Effects:
In a small number of pigs, a transient increase in body temperature of
up to 40.4ºC may
occur during the first 12 hours after vaccination. This usually
resolves spontaneously
within 24 hours without treatment. Immediate mild
hypersensitivity-like reactions may RLP APPROVED
occur uncommonly after vaccination, resulting in transient clinical
signs such as vomiting,
diarrhoea or depression. These clinical signs normally resolve without
treatment.
Local tissue reactions in the form of swelling at the injection site
may occur and last for up
to 2 days. The area of local reaction is usually less than 4 cm2, but
in some cases a larger
swelling may occur. Allergic reactions in pigs to vaccination,
although rare, may occur. The
antidote is adrenalin.
Dosage and
Administration:
Shake well before use. Use all product immediately after broaching the
container.
Inject intramuscularly in