LEPTO-ERYVAC VACCINE

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

ERYSIPELOTHRIX RHUSIOPATHIAE; LEPTOSPIRA BORGPETERSENII SEROVAR TARASSOVI; LEPTOSPIRA INTERROGANS SEROVAR POMONA; THIOMERSAL

Available from:

ZOETIS AUSTRALIA PTY LTD

INN (International Name):

E.rhusiopathiae+L. pomona+L. tarassovi

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

ERYSIPELOTHRIX RHUSIOPATHIAE VACCINE-GENERAL Active 0.0 P; LEPTOSPIRA BORGPETERSENII SEROVAR TARASSOVI VACCINE Active 0.0 P; LEPTOSPIRA INTERROGANS SEROVAR POMONA VACCINE-MICROBIAL Active 0.0 P; THIOMERSAL MERCURY Other 0.1 mg/ml

Units in package:

100mL; 250mL; 500mL

Class:

VM - Veterinary Medicine

Manufactured by:

ZOETIS AUSTRALIA

Therapeutic group:

PIGS | BOAR | GILT | PIGLET | SOW | SWINE

Therapeutic area:

IMMUNOTHERAPY

Therapeutic indications:

ERYSIPELAS INFECTION | LEPTOSPIROSIS - LEPTOSPIRA POMONA | LEPTOSPIROSIS - LEPTOSPIRA TARASSOVI | URINARY SHEDDING | VACCINE | EQUINE ROTAVIRUS | L. INTEROGANS SEROVAR TARASSOV | L. INTERROGANS SEROVAR POMONA | LEPTOSPIRA POMONA INFECTION

Product summary:

Poison schedule: 0; Withholding period: Zero (0) days EXPORT SLAUGHTER INTERVAL (ESI): Zero (0) days; Host/pest details: PIGS: [ERYSIPELAS INFECTION, LEPTOSPIROSIS - LEPTOSPIRA POMONA, LEPTOSPIROSIS - LEPTOSPIRA TARASSOVI, URINARY SHEDDING, VACCINE]; Poison schedule: 0; Withholding period: WHP: Nil. TRADE ADVICE (AUSTRALIA ONLY ): ESI: ESI NOT APPLICABLE; Host/pest details: PIGS: [ERYSIPELAS INFECTION, LEPTOSPIROSIS - LEPTOSPIRA POMONA, LEPTOSPIROSIS - LEPTOSPIRA TARASSOVI, URINARY SHEDDING, VACCINE]; Poison schedule: 0; Withholding period: ; Host/pest details: PIGS: [ERYSIPELAS INFECTION, LEPTOSPIROSIS - LEPTOSPIRA POMONA, LEPTOSPIROSIS - LEPTOSPIRA TARASSOVI, URINARY SHEDDING, VACCINE]; For the control of swine erysipelas and the prevention of leptospirosis in pigs caused by leptospira interrogans, serovars pomona, and tarassovi. Minimises urinary shedding of leptospires.Allergic shock reactions may occur on rare occasions.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

Product Name:
APVMA Approval No:
LEPTO-ERYVAC VACCINE
53384/139247
Label Name:
LEPTO-ERYVAC VACCINE
Signal Headings:
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
Erysipelothrix rhusiopathiae ≥ 40 IU/dose, Leptospira interrogans
serovar Pomona ≥
400 x 10^6 organisms/mL and Leptospira borgpetersenii serovar
Tarassovi ≥ 400 x 10^6
organisms/mL (as formol cultures).
Also contains: 0.1 mg/mL thiomersal (preservative)
Claims:
For the control of swine erysipelas caused by Erysipelothrix
rhusiopathiae and the
prevention of leptospirosis in pigs caused by Leptospira interrogans
serovars Pomona and
Leptospira borgpetersenii serovar Tarassovi
Minimises urinary shedding of leptospires.
Net Contents:
100 mL (40 doses)
250 mL (100 doses)
500 mL (200 doses)
Directions for Use:
Restraints:
Contraindications:
Precautions:
Side Effects:
Some swelling usually develops at the site of vaccination and may last
for some months
before gradually subsiding. On rare occasions, allergic shock
reactions have occurred. RLP APPROVED
Dosage and
Administration:
Use the contents within 30 days of first broaching the vial/container.
Discard the unused
portion.
Shake well before use and keep thoroughly mixed during use.
Contents must be refrigerated in outer package until immediately
before use.
Refer to the Resealing section for further information on storage and
handling after
opening.
On each subsequent reuse, swab the opening with a suitable
disinfectant (e.g., methylated
spirits) both before and after using. A sterile needle and syringe
must be used each time
product is removed.
When not in use during any given vaccination session, place the
vaccine pack into its
original cardboard carton and place in either a portable cooler with
an ice brick or in a
refrigerator between 2 °C and 8 °C.
For subcutaneous use only.
Dose: 2.5 mL injected subcutaneously (under the skin), high on the
neck behind the ear
(i.e., under the skin on the side of the neck, just behind and below
the base of the ear). Do
not inject at any other site.
Give two d

Summary of Product characteristics

PRODUCT NAME: LEPTO-ERYVAC
® FOR PIGS
PAGE: 1 OF 5
THIS REVISION ISSUED: APRIL, 2010
MATERIAL SAFETY DATA SHEET
Issued by: Pfizer Australia Pty Ltd
Phone: [phone]
SECTION 1 - IDENTIFICATION OF CHEMICAL PRODUCT AND COMPANY
Pfizer Australia Pty Ltd
38-42 Wharf Road
West Ryde NSW 2114
Tel: [phone]
Fax: [phone]
____________________________________
PFIZER AUSTRALIA PTY LTD
A.B.N. 50 008 422 348
SUBSTANCE:
Aqueous solution of ingredients.
TRADE NAME:
LEPTO-ERYVAC
® FOR PIGS
PFIZER MSDS CODE:
0709
PRODUCT USE:
For the prevention of leptospirosis and erysipelas in pigs.
CREATION DATE:
OCTOBER, 2004
THIS VERSION ISSUED:
APRIL, 2010
and is valid for 5 years from this date.
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as:
Not classified as hazardous according to the criteria of SWA
Australia.
Not a Dangerous Good according to the Australian Dangerous Goods (ADG)
Code.
RISK PHRASES:
Not Hazardous - No criteria found.
SAFETY PHRASES:
Not Hazardous - No criteria found.
SUSDP CLASSIFICATION:
S2 (NZ)
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good.
UN NUMBER:
None allocated
E
E
E
M
M
M
E
E
E
R
R
R
G
G
G
E
E
E
N
N
N
C
C
C
Y
Y
Y
O
O
O
V
V
V
E
E
E
R
R
R
V
V
V
I
I
I
E
E
E
W
W
W
PHYSICAL DESCRIPTION & COLOUR
: Aqueous liquid suspension.
ODOUR:
No data.
MAJOR HEALTH HAZARDS:
no significant risk factors have been found for this product.
P
P
P
O
O
O
T
T
T
E
E
E
N
N
N
T
T
T
I
I
I
A
A
A
L
L
L
H
H
H
E
E
E
A
A
A
L
L
L
T
T
T
H
H
H
E
E
E
F
F
F
F
F
F
E
E
E
C
C
C
T
T
T
S
S
S
INHALATION
SHORT TERM EXPOSURE:
Significant inhalation exposure is considered to be unlikely.
Available data indicates that this
product is not harmful. In addition product is unlikely to cause any
discomfort or irritation.
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. However product may be mildly irritating, but is unlike