COOPERS LEPTOVAX LEPTO POMONA/HARDJO VACCINE FOR BEEF, DAIRY CATTLE & CALVES

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Patient Information leaflet (PIL)

19-06-2017

Summary of Product characteristics (SPC)

19-06-2017

Active ingredient:

LEPTOSPIRA INTERROGANS SEROVAR HARDJO; LEPTOSPIRA INTERROGANS SEROVAR POMONA; THIOMERSAL

Available from:

INTERVET AUSTRALIA PTY LIMITED

INN (International Name):

Leptospira interrogans

Pharmaceutical form:

MISC. VACCINES OR ANTI SERA

Composition:

LEPTOSPIRA INTERROGANS SEROVAR HARDJO VACCINE-MICROBIAL Active 0.0 P; LEPTOSPIRA INTERROGANS SEROVAR POMONA VACCINE-MICROBIAL Active 0.0 P; THIOMERSAL MERCURY Other 0.015 mg/ml

Units in package:

100mL; 1L; 250mL; 500mL; 50mL

Class:

VM - Veterinary Medicine

Manufactured by:

INTERVET AUSTRALIA

Therapeutic group:

Therapeutic area:

IMMUNOTHERAPY

Therapeutic indications:

VACCINE | EQUINE ROTAVIRUS

Product summary:

Poison schedule: 0; Withholding period: WHP: Nil; Host/pest details: CALF: [VACCINE]; CATTLE - BEEF: [VACCINE]; DAIRY CATTLE: [VACCINE]; Poison schedule: 0; Withholding period: ; Host/pest details: CALF: [VACCINE]; CATTLE - BEEF: [VACCINE]; DAIRY CATTLE: [VACCINE]; For the prevention of leptospirosis caused by Leptospira interrogans serovars pomona and hardjo and to minimise the shedding of lepto organisms in the urine.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

leptovax.doc:10/12/99
Page 1 of 10
LEPTOVAX CARTON - FRONT PANEL
_________________________________________________________________________________________________________
FOR ANIMAL TREATMENT ONLY
COOPERS
®
LEPTOVAX ®
LEPTO POMONA/HARDJO
CATTLE HEAD DIAGRAM
VACCINE FOR BEEF, DAIRY CATTLE & CALVES
ACTIVE CONSTITUENTS: _LEPTOSPIRA INTERROGANS _SEROVAR _POMONA._
_LEPTOSPIRA INTERROGANS _SEROVAR _HARDJO._
Contains 0.015 mg/mL thiomersal as preservative.
For the prevention of leptospirosis caused by
_Leptospira interrogans _
serovars
_pomona_
and
_hardjo _
and to minimise the shedding of lepto organisms in the urine
(A PARTICULAR PUBLIC HEALTH HAZARD)
COOPERS LOGO
50mL
100mL
250mL
500mL
1L
Info
PEST
✔
Verified
leptovax.doc:10/12/99
Page 2 of 10
LEPTOVAX
CARTON - REAR PANEL
_________________________________________________________________________________________________________
CATTLE HEAD DIAGRAM
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT.
DIRECTIONS FOR USE
SHAKE CONTENTS BEFORE USE.
USE ALL PRODUCT WITHIN 24 HOURS OF OPENING.
DO NOT EXPOSE DIRECTLY TO HEAT AND LIGHT DURING USE. THE USE OF AN
INSULATED CONTAINER IS RECOMMENDED DURING THE DAY TO PROTECT THE
VACCINE. IF IT
IS TO BE HUNG BESIDE THE RACE, ENSURE IT IS ON THE SHADY SIDE.
DOSE:
Beef, Dairy Cattle and Calves: 2mL by SUBCUTANEOUS INJECTION.
THE VACCINATION PROCEDURE
CAUTION: AVOID CARCASS DAMAGE
1.
Sterilise all injection apparatus by boiling for at least ten minutes
before use. Avoid use of strong disinfectants on apparatus.
2.
Maintain maximum cleanliness at all times.
3.
Keep needles sharp and clean. Change needles frequently (every 20-30
animals). Use short needles. Recommended
maximum sizes 15mm x 16 gauge for cattle and calves.
4.
Check that the equipment is functioning properly and that it is
delivering the correct dose.
5.
As far as possible avoid injection of animals during wet weather or
under dusty conditions.
6.
Inject only under the skin and not into the muscle, by raising a fold
of skin and injecting the dose under the raised skin

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Summary of Product characteristics

PRODUCT NAME: COOPERS LEPTOVAX LEPTO POMONA/HARDJO
VACCINE FOR BEEF, DAIRY CATTLE & CALVES
MATERIAL SAFETY DATA SHEET
THIS REVISION ISSUED: JULY, 2009
PAGE: 1 OF 5
MATERIAL SAFETY DATA SHEET
Issued by: Intervet Australia Pty Limited Phone: 1 800 033 461
(Business Hours)
Poisons Information Centre: 13 11 26 from anywhere in Australia, (0800
764 766 in New Zealand)
SUBSTANCE:
Water suspension of killed bacteria plus minor ingredients.
TRADE NAME:
COOPERS LEPTOVAX LEPTO POMONA/HARDJO VACCINE FOR BEEF, DAIRY
CATTLE & CALVES
RECOMMENDED USE:
Animal vaccine for the prevention of leptospirosis as described on the
product label.
APVMA NO:
36139
CREATION DATE:
July, 2009
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:
S24/25. 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:
A light brownish liquid with white precipitate.
ODOUR:
No data.
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. 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. 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:
SHORT TERM EXPOSURE
: This product may be mildly irritating to eyes, but is unlikely to
cause anything more than mild

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