PLEVAC PARVOVIRUS/LEPTOSPIROSIS/ERYSIPELAS VACCINE FOR PIGS

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

ERYSIPELOTHRIX RHUSIOPATHIAE; LEPTOSPIRA INTERROGANS SEROVAR POMONA; PORCINE PARVO VIRUS; FORMALDEHYDE; THIOMERSAL

Available from:

INTERVET AUSTRALIA PTY LIMITED

INN (International Name):

vaccine - erysipelas+L. pomona+porcine parvovirus

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

ERYSIPELOTHRIX RHUSIOPATHIAE VACCINE-GENERAL Active 0.0 U; LEPTOSPIRA INTERROGANS SEROVAR POMONA VACCINE-MICROBIAL Active 0.0 U; PORCINE PARVO VIRUS VACCINE-VIRAL Active 0.0 U; FORMALDEHYDE ALDEHYDE Other 0.3 mg/ml; THIOMERSAL MERCURY Other 0.1 mg/ml

Units in package:

250mL; 500mL; Dose = 4mL

Class:

VM - Veterinary Medicine

Manufactured by:

INTERVET AUSTRALIA

Therapeutic group:

PIGS | BOAR | GILT | PIGLET | SOW | SWINE

Therapeutic area:

IMMUNOTHERAPY

Therapeutic indications:

ERYSIPELAS - SWINE | LEPTOSPIROSIS - LEPTOSPIRA POMONA | PARVOVIRUS | VACCINE | EQUINE ROTAVIRUS | L. INTERROGANS SEROVAR POMONA | LEPTOSPIRA POMONA INFECTION | SWINE ERYSIPELAS

Product summary:

Poison schedule: 0; Withholding period: WHP: MEAT - NIL TRADE ADVICE: EXPORT SLAUGHTER INTERVAL (ESI): ESI ZERO(0)da ys.; Host/pest details: PIGS: [ERYSIPELAS - SWINE, LEPTOSPIROSIS - LEPTOSPIRA POMONA, PARVOVIRUS, VACCINE]; For protection against Erisipelas and Leptospira pomona infections and as an aid in the control of parvovirus infection in pigs.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

INACTIVATED ADJUVANTED VACCINE CONTAINING:
ERYSIPELOTHRIX RHUSIOPATHIAE 1 X 10
9
, ERYSIPELOTHRIX
RHUSIOATHIAE 5 X 10
8
, LEPTOSPIRA INTERROGANS POMONA
3.75 X 10
8
, PORCINE PARVOVIRUS 512 HA/ML
Preservatives: 0.1 mg/mL Thiomersal; < 1.2 mg/mL Formaldehyde
For protection against Erysipelas and Leptospira pomona infections and
as
an aid in the control of parvovirus infection in pigs.
DIRECTIONS FOR USE:
SHAKE WELL TO MIX BEFORE USE
AND KEEP MIXED DURING USE.
FOR INTRAMUSCULAR
INJECTION ONLY
DOSAGE:
WITHHOLDING PERIOD: NIL
93228390 2043 3
FOR ANIMAL TREATMENT ONLY
PARVOVIRUS/LEPTOSPIROSIS/ERYSIPELAS VACCINE FOR PIGS.
PARVOVIRUS/LEPTOSPIROSIS/ERYSIPELAS VACCINE FOR PIGS.
PARVOVIRUS/LEPTOSPIROSIS/ERYSIPELAS VACCINE FOR PIGS.
PARVOVIRUS/LEPTOSPIROSIS/ERYSIPELAS VACCINE FOR PIGS.
PARVOVIRUS/LEPTOSPIROSIS/ERYSIPELAS VACCINE FOR PIGS.
ACTIVE CONSTITUENTS:
READ THE ENCLOSED LEAFLET
BEFORE USING THIS P
RRODUCT.
4 mL by intramuscular injection
to gilts and sows.
Gilts are vaccinated at selection
then again 3-4 weeks later.
Sows (previously vaccinated) -
Vaccinate at 3 weeks before
farrowing or at weaning.
250 ML
250 ML
CA4137B/01
Client: Intervet/Schering-Plough Animal Health
Product Description: PLEvac 250mL Carton
Scale: 100%
Colour:
PMS232
100% Black
Keyline:
(not to be printed)
Uncoated/unvarnished area
Dimensions: 100 x 80 x 136mm - overall size: 372 x 331mm
Clients Code: CA4137B/01
Agency Code & Version: IVT7037 V4
Last revised: 08/11/10
Signal Heading: Lucida AK Bold 4.4 mm
Product Name: Lucida Sans AK Bold 10.8 mm
Body Text: Lucida Sans AK Roman 1.7 mm
Directions for Use: Lucida Sans AK Demi Bold 1.7 mm
Safety Directions: Lucida Sans AK Roman 1.7 mm
Intervet/Schering-Plough
Animal Health
91-105 Harpin Street
BENDIGO EAST VIC 3550
Phone: [phone]
APVMA Approval No.: 46164/50907
DISPOSAL:
Dispose of empty container by wrapping with paper and
putting in garbage.
STORAGE:
Store between 2
o
C and 8
o
C. (Refrigerate. Do not freeze).
Protect from light.
DISCARD IF PREVIOUSLY FROZEN.
WARRANTY:
Intervet Australia Pty

Summary of Product characteristics

PRODUCT NAME: PLE -
PAR
VOVIRUS/ERYSIPELAS/LEPTOSPIROSIS VACCINE FOR PIGS
MATERIAL SAFETY DATA SHEET
THIS REVISION ISSUED: JULY, 2009
PAGE: 1 OF 5
MATERIAL SAFETY DATA SHEET
Issued by: Intervet Australia Pty Limited Phone: [phone]
(Business Hours)
Poisons Information Centre: 13 11 26 from anywhere in Australia, (0800
764 766 in New Zealand)
SUBSTANCE:
Water solution of ingredients and suspension of inactivated virus and
bacteria.
TRADE NAME:
PLE - PARVOVIRUS/ERYSIPELAS/LEPTOSPIROSIS VACCINE FOR PIGS
PRODUCT CODE:
not available
RECOMMENDED USE:
FOR PROTECTION AGAINST ERYSIPELAS AND _LEPTOSPIRA POMONA_ INFECTIONS
AND AS AN AID
IN THE CONTROL OF PARVOVIRUS INFECTION IN PIGS.
APVMA NO:
46164
CREATION DATE:
February, 2007
THIS VERSION ISSUED:
July, 2009
and is valid for 5 years from this date.
STATEMENT OF HAZARDOUS NATURE:
THIS PRODUCT IS CLASSIFIED AS:
Not classified as hazardous according to the criteria of SWA.
Not a Dangerous Good according to the Australian Dangerous Goods (ADG)
Code.
RISK PHRASES:
Not Hazardous - No criteria found.
SAFETY PHRASES:
S37, S24/25. Wear suitable gloves. Avoid contact with skin and eyes.
SUSDP CLASSIFICATION:
None allocated.
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
UN NUMBER:
None allocated
PHYSICAL DESCRIPTION & COLOUR:
White turbid liquid.
ODOUR:
No odour.
MAJOR HEALTH HAZARDS:
no significant risk factors have been found for this product.
INHALATION:
SHORT TERM EXPOSURE:
Available data indicates that this product is not harmful. However
product may be mildly
irritating, although unlikely to cause anything more than mild
transient discomfort.
LONG TERM EXPOSURE:
No data for health effects associated with long term inhalation.
SKIN CONTACT:
SHORT TERM EXPOSURE:
Available data indicates that this product is not harmful. It should
present no hazards in
normal use. In addition product is unlikely to cause any discomfort in
normal use.
LONG TERM EXPOSURE:
No data for health effects associated with long term skin exposure.
EYE CONTACT:
POTENTIAL H