LEPTOVAX

Main information

  • Trade name:
  • COOPERS LEPTOVAX LEPTO POMONA/HARDJO VACCINE FOR BEEF, DAIRY CATTLE & CALVES
  • Pharmaceutical form:
  • MISC. VACCINES OR ANTI SERA
  • Units in package:
  • 50mL,100mL,250mL,500mL,1L
  • Class:
  • Veterinary Medicine
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • INTERVET AUSTRALIA

Documents

Localization

  • Available in:
  • COOPERS LEPTOVAX LEPTO POMONA/HARDJO VACCINE FOR BEEF, DAIRY CATTLE & CALVES
    Australia
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • CALF | CATTLE - BEEF | DAIRY CATTLE | BEEF CALF | BOVINE | BREEDERS | BULLOCKS | BULLS | CALF - PODDY | CALF - PREWEANING | CALF
  • Therapeutic area:
  • vaccine
  • Therapeutic indications:
  • VACCINE | EQUINE ROTAVIRUS
  • Product summary:
  • For the prevention of leptospirosis caused by Leptospira interrogans serovars pomona and hardjo and to minimise the shedding of lepto organisms in the urine.

Other information

Status

  • Source:
  • Australian Pesticides and Veterinary Medicines Authority (APVMA)
  • Authorization status:
  • Registered but not available
  • Authorization number:
  • 36139/1299
  • Authorization date:
  • 21-12-1999
  • Last update:
  • 15-06-2017

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

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

hardjo

and to minimise the shedding of lepto organisms in the urine

(a particular public health hazard)

COOPERS LOGO

50mL

100mL

250mL

500mL

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 -

NOT INTO IT.

50mL

7.

Beef, dairy cattle and calves should be injected high on the side of the neck, behind the ear.

100mL

WITHHOLDING PERIOD NIL

250mL

DISPOSE

of empty containers and outer packaging by wrapping in paper and putting in garbage.

500mL

1L

STORE

at 2 to 8

C (REFRIGERATE, DO NOT FREEZE)

Keep out of reach of children

Protect from Light

NRA Approval No. 36139/1299

COOPERS ANIMAL HEALTH

A division of Schering-Plough Pty Ltd

(B)

EXP.

REFER TO BATCH AND EXPIRY ON TOP PANEL

11 Gibbon Road

Baulkham Hills NSW 2153

BAR CODE

leptovax.doc:10/12/99

Page 3 of 10

LEPTOVAX

CARTON - SIDE PANEL

_________________________________________________________________________________________________________

COOPERS®

For the prevention of

Leptovax ®

leptospirosis caused by Leptospira

LEPTO POMONA/HARDJO

interrogans

serovars

pomona

12 DOSES

Vaccine for Beef, Dairy Cattle

hardjo

and to minimise the

25 DOSES

& Calves

shedding of lepto organisms in the

62 DOSES

urine

(A PARTICULAR PUBLIC

125 DOSES

HEALTH HAZARD)

in beef, dairy cattle and calves

250 DOSES

_________________________________________________________________________________________________________

LEPTOVAX

CARTON - SIDE PANEL

_________________________________________________________________________________________________________

SPECIALIST ADVICE IN EMERGENCY ONLY

COOPERS®

Schering-Plough Pty Ltd

Leptovax ®

1 800 226 511

12 DOSES

LEPTO POMONA/HARDJO

ALL HOURS - AUSTRALIA WIDE

25 DOSES

Vaccine for Beef, Dairy Cattle

62 DOSES

& Calves

® Schering-Plough Pty Ltd

125 DOSES

Registered Trademark

250 DOSES

© Schering-Plough Pty Ltd 2000

_________________________________________________________________________________________________________

LEPTOVAX

CARTON - TOP PANEL

_________________________________________________________________________________________________________

COOPERS®

BATCH

EXPIRY

Leptovax ®

LEPTO POMONA/HARDJO

Vaccine for Beef, Dairy Cattle

& Calves

NOTE: 50mL = 12 DOSES, 100mL = 25 DOSES, 250mL = 62 DOSES, 500mL = 125 DOSES, 1L = 250 DOSES.

leptovax.doc:10/12/99

Page 4 of 10

LEPTOVAX

IMMEDIATE CONTAINER LABEL

____________________________________________________________________

FOR ANIMAL TREATMENT ONLY

COOPERS

Leptovax

®

LEPTO POMONA/HARDJO

Vaccine for Beef, Dairy Cattle & Calves

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

hardjo

and to minimise the shedding of lepto

organisms in the urine

(a particular public health hazard).

READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT.

WITHHOLDING PERIOD NIL

Schering-Plough Pty Ltd

50mL

11 Gibbon Road

100mL

Baulkham Hills NSW 2153

250mL

500mL

STORE

at 2 to 8

(Refrigerate. Do Not Freeze)

Protect from light

COOPERS LOGO

NRA Approval No. 36139/1299

(B)

EXP.

leptovax.doc:10/12/99

Page 5 of 10

LEPTOVAX

LEAFLET - FRONT PAGE

____________________________________________________________________

FOR ANIMAL TREATMENT ONLY

COOPERS®

Leptovax

LEPTO POMONA/HARDJO

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

hardjo

and to minimise the shedding of lepto organisms in

the urine of infected beef, dairy cattle and calves.

(A PARTICULAR PUBLIC HEALTH HAZARD)

CATTLE

HEAD

DIAGRAM

COOPERS

LOGO

leptovax.doc:10/12/99

Page 6 of 10

LEPTOVAX

LEAFLET (continued)

____________________________________________________________________

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 subcutaneously (under the skin).

A. Important points on vaccination and vaccines

Coopers Leptovax Vaccine is a potent bivalent leptospiral vaccine that will protect

your beef, dairy cattle and calves from the serious disease of Leptospirosis caused

Leptospira interrogans

serovars

pomona

hardjo,

and will also minimise

urinary shedding of Lepto organisms from chronic carriers. It is important Coopers

Leptovax Vaccine is used correctly to ensure full protection.

1.

Failure

vaccinate

recommended

times

will

allow

possible

development of “carrier” animals. These animals become chronically infected with

Leptospirosis and will contaminate the environment by shedding leptospires in their

urine.

This will allow transmission of leptospirosis to unprotected animals and also to

humans.

2.

Although steers and bulls do not exhibit many symptoms of leptospirosis

infection, they are potential carriers and should be part of a whole herd vaccination

programme.

3.

Livestock that are already infected at the time of vaccination may develop

symptoms of leptospirosis eg. late term abortion. This is due to the long incubation

period of the disease in some animals.

4.

Initial

Dose:

single

dose

Coopers

Leptovax

Vaccine

stimulates

protective antibodies in beef, dairy cattle and calves. This initial protection takes

about 10 days to develop, and will only last 6 weeks. This makes it essential to give

a booster dose (see point 5) to provide full protection.

5. First Booster Dose:

The “booster” dose of Coopers Leptovax Vaccine should be

given from 4-6 weeks after the initial dose. This rapidly results in full, potent

protection of your beef, dairy cattle and calves.

6. Annual/Seasonal Booster Dose:

The protection provided by Coopers Leptovax

Vaccine using this programme lasts 12 months, meaning your cattle only require

annual

boosters

rest

their

lives

remain

fully

protected

against

leptospirosis disease.

B. Recommended Coopers Leptovax Vaccine Vaccination Programmes

Dose: Beef, Dairy Cattle and Calves 2mL subcutaneously (under the skin).

1. BULLS

For bulls that have never been vaccinated before, or whose vaccination history is

unknown or lapsed, two doses of Coopers Leptovax Vaccine should be given 4-6

weeks apart. Annual boosters should then be given at the same time every year.

For bulls with a known complete vaccination history, annual boosters with Coopers

Leptovax Vaccine should be given at the same time every year.

leptovax.doc:10/12/99

Page 7 of 10

LEPTOVAX

LEAFLET (continued)

____________________________________________________________________

2. COWS

For cows that have never been vaccinated before, or whose vaccination history is

unknown or lapsed, two doses of Coopers Leptovax Vaccine should be given 4-6

weeks apart. Annual boosters should then be given at the same time every year.

For cows with a known complete vaccination history, annual boosters with Coopers

Leptovax Vaccine should be given at the same time every year. Annual boosters of

cows should if possible be given in the last month of pregnancy so as to optimise

protective levels of antibodies passed to the calf through the colostrum (“first milk”).

Extreme care should be taken when handling cows close to calving.

Seasonal Calving Herds

Annual boosters should be given at drying off 6 to 8 weeks before calving.

Non Seasonal Calving Herds

Annual boosters should be given prior to expected periods of spread. In southern

Australia the main periods are Autumn and Spring. In northern Australia it is during

the wet season.

3. CALVES

Calves born to correctly vaccinated cows will be protected via the colostrum (“first

milk”) for the first 8-10 weeks of life. This “passive immunity” is short lived, and must

be completed by a correct vaccination programme to ensure full immunity.

Calves should receive their first dose of Coopers Leptovax Vaccine from 3 months of

age on, with a second “booster” vaccination 4-6 weeks later. Annual boosters

should then be given at the same time every year.

4. STEERS

For steers that have never been vaccinated before, or whose vaccination history is

unknown or lapsed, two doses of Coopers Leptovax Vaccine should be given 4-6

weeks apart. Annual boosters should then be given at the same time every year.

For steers with a known complete vaccination history, annual boosters with Coopers

Leptovax Vaccine should be given at the same time every year.

5. HEIFERS

For heifers that have never been vaccinated before, or whose vaccination history is

unknown or lapsed, two doses of Coopers Leptovax Vaccine should be given 4-6

weeks apart. Annual boosters should then be given at the same time every year.

heifers

with

known

complete

vaccination

history,

annual

boosters

with

Coopers Leptovax Vaccine should be given at the same time every year.

C. VACCINATION PROCEDURE

CAUTION - AVOID CARCASS DAMAGE

1.

Sterilise all injection apparatus by boiling for at least 10 minutes before use.

Avoid use of strong disinfectants on apparatus.

leptovax.doc:10/12/99

Page 8 of 10

LEPTOVAX

LEAFLET (continued)

____________________________________________________________________

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 size is: 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, but not into the muscle, by raising a fold of skin

and injecting the dose under the raised skin -

NOT INTO IT.

7.

Beef, Dairy Cattle and Calves, should be injected high on the side of the

neck behind the ear. If this is not possible vaccinate subcutaneously at a site away

from bony structures.

WITHHOLDING PERIOD NIL

D. STORAGE

1.

Store at 2 to 8

C. (Refrigerate, DO NOT FREEZE). Store in a cool, dark

place.

Keep out of reach of children.

2.

Coopers Leptovax Vaccine will be adversely affected by exposure to heat and

light and by freezing.

3.

Unused Coopers Leptovax Vaccine may be safely stored in the original

container for use the following day, provided it is refrigerated after sealing.

Coopers Leptovax Vaccine has been ultrafiltered and incorporates an adjuvant to

enhance development of protection with minimum risk of damage at the site of

vaccination.

Coopers

Leptovax

Vaccine

been

manufactured

accordance

with

standards of the British Pharmacopoeia (Veterinary). Strict testing for potency,

stability and safety is carried out to ensure standardised products which will confer

rapid and prolonged protection to vaccinated stock.

N.B:

Coopers Leptovax Vaccine has been prepared under strict supervision and

has been thoroughly tested before use. Provided instructions for vaccination and

storage are followed no unfavourable result will occur. As the laboratory exercises

no control over handling or administration no responsibility can be accepted for

losses incurred through faulty use or storage.

DISPOSE

of empty containers and outer packaging by wrapping with paper and

putting in garbage.

leptovax.doc:10/12/99

Page 9 of 10

LEPTOVAX

LEAFLET (continued)

____________________________________________________________________

THE DISEASES

LEPTOSPIROSIS

Leptospirosis is the name given to the range of diseases caused by the group of

organisms called

Leptospira.

Leptospiral organisms of one type of another are

widespread in livestock producing areas of Australia, with infections occurring in

beef, dairy cattle and calves. Humans can also become infected and this is a

MAJOR RISK

to people working closely with infected animals.

The two most important Leptospirosis organisms causing disease in Australia are:

Leptospira interrogans

serovar

pomona

Leptospira interrogans

serovar

hardjo

For simplicity, these are referred to as

Lepto pomona

Lepto hardjo.

Coopers Leptovax Vaccine contains both of these important serovars in a unique,

potent vaccine that will prevent leptospirosis in beef, dairy cattle and calves. It also

minimises the

urinary

shedding

Lepto

organisms

PARTICULAR

HUMAN

HEALTH HAZARD). The source of leptospirosis infection is usually an infected

animal

which

contaminates

pasture,

drinking

water

feed

with

urine.

Leptospires survive in infected animals for long periods of time and are spread via

the urine. The organisms are also capable of surviving in the environment and soil

for several months, if the conditions are favourable. Leptospirosis occurs with warm

moist conditions and is prevalent in higher rainfall areas and irrigation districts of

Australia. It will occur in other areas during wet years.

IN BEEF, DAIRY CATTLE AND CALVES

Lepto pomona

Lepto hardjo

both cause abortions and stillbirths in beef and

dairy cattle and are associated with low calving rates and infertility in pregnant

cows. The abortions usually occur in the last trimester of pregnancy. Stillborn,

premature or weak born calves may also be seen.

In lactating cattle, an unusual form of mastitis may occur, affecting all four quarters

simultaneously. The udder is cold and soft to touch, unlike other mastitis infections.

The milk may appear normal, or be discoloured. If clinical mastitis does occur, an

increase in milk cell count can be seen and also a drop in milk production may

occur.

Lepto hardjo

primarily affects lactating and pregnant cattle while

Lepto pomona

affect all cattle and calves.

The disease caused by

Lepto pomona

is commonly referred to as “redwater” due to

the presence of broken down (haemolysed) red blood cells in the urine. Calves are

most commonly affected and will usually die. The disease is less severe in adult

cattle.

Many cattle infected with either

Lepto hardjo

Lepto pomona

show no signs of

disease. However, such animals become chronic “carriers” of Leptospirosis in their

kidneys and “shed” leptospires in their urine. This is a source of contamination of

other cattle and humans.

leptovax.doc:10/12/99

Page 10 of 10

LEPTOVAX

LEAFLET (continued)

____________________________________________________________________

The human health aspect of Leptospirosis

is an important reason for the control

of leptospirosis in cattle. People infected with leptospirosis become very sick.

Those at the greatest risk include dairy farmers and their families (especially when

working

herringbone

dairies)

people

working

closely

with

cattle

veterinarians, graziers, abattoir workers and livestock agents.

Control of Leptospirosis

The control of leptospirosis depends on the isolation of infected animals and

appropriate hygiene to prevent the spread of infection, together with a correct

vaccination

programme.

Since

leptospirosis

spreads

rapidly,

essential

vaccination is carried out as soon as possible. Where signs of leptospirosis have

been observed for a long period of time, vaccination will have less chance of

success as many carriers will be present.

Systematic use of Coopers Leptovax Vaccine in a herd will reduce the spread of

leptospiral

organisms

urine

decrease

risk

leptospirosis

transmission to other animals and also to humans. Most important to the prevention

of leptospirosis in humans is the fact that Coopers Leptovax Vaccine has been

shown to significantly reduce urinary shedding of Lepto organisms in vaccinated

animals.

References:

1. Flint, S.H. & Liardet D.M. (1980) NZ Vet J 28, 263-266. 2. Allen,

J.D. et al (1982) Aust Vet J 58, 93-96. 3. Mackintosh, C.G. et al (1980) NZ Vet J 28,

196.

Warranty

Schering-Plough Pty Ltd (SPPL) warrants that this product is of merchantable

quality and fit for its intended purpose. SPPL’s liability for any loss, including

consequential losses or injury caused by any act or omission, including negligent

acts or omissions, by SPPL or its agent, is limited to replacing or repairing the

product at the option of SPPL. If possible, a sample of any product causing

concern should be retained or delivered to SPPL within 30 days for a scientific

examination.

For further information contact Coopers Customer Service on 1 800 226 511.

SPECIALIST ADVICE IN EMERGENCY ONLY

Schering-Plough Pty Ltd

1 800 226 511

ALL HOURS - AUSTRALIA WIDE

NRA Approval No. 36139/1299

COOPERS ANIMAL HEALTH

A division of Schering-Plough Pty Ltd

11 Gibbon Road

Baulkham Hills NSW 2153

® Schering-Plough Pty Ltd Registered Trademark

© Schering-Plough Pty Ltd 2000

There are no safety alerts related to this product.

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