NILVAX COMBINATION

Main information

  • Trade name:
  • COOPERS NILVAX COMBINATION 5-IN-1 VACCINE AND BROAD SPECTRUM INJECTABLE ANTHELMINTIC
  • Pharmaceutical form:
  • MISC. VACCINES OR ANTI SERA
  • Units in package:
  • 1L, 50mL, 100mL, 250mL, 500mL
  • Class:
  • Veterinary Medicine
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • INTERVET AUSTRALIA

Documents

Localization

  • Available in:
  • COOPERS NILVAX COMBINATION 5-IN-1 VACCINE AND BROAD SPECTRUM INJECTABLE ANTHELMINTIC
    Australia
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • SHEEP - NOT LAMBS | EWE | OVINE | RAM
  • Therapeutic area:
  • vaccine,anthelmintic
  • Therapeutic indications:
  • BARBER'S POLE WORM - HAEMONCHUS SPP. | BLACK DISEASE | BLACK SCOUR WORM - TRICHOSTRONGYLUS SPP. | BLACKLEG | ENTEROTOXAEMIA (PULPY KIDNEY) | INTESTINAL THREADWORM-STRONGYLOIDES SPP. | LARGE BOWEL WORM - OESOPHAGOSTOMUM SPP. | LUNGWORM - DICTYOCAULUS SPP. | MALIGNANT OEDEMA | SMALL BROWN STOMACH WORM-OSTERTAGIA SPP. | SMALL INTESTINAL WORM - COOPERIA SPP. | STOMACH HAIR WORM | TETANUS | THIN NECKED INTESTINAL WORM | VACCINE | CLOSTRIDIUM PERFRINGENS TYPE D | EQUINE ROTAVIRUS | HAIR WORM | INTESTINAL HAIR WORM | POLE WORM | SMALL HAIR WORM | TELADORSAGIA | TETANUS VACCINATION
  • Product summary:
  • For the control of roundworms, including lungworm and the prevention of Clostridial diseases in adult sheep.DO NOT use in lambs, dogs or horses

Other information

Status

  • Source:
  • Australian Pesticides and Veterinary Medicines Authority (APVMA)
  • Authorization status:
  • Registered but not available
  • Authorization number:
  • 36163/0807
  • Authorization date:
  • 27-11-2007
  • Last update:
  • 15-06-2017

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

NILVAX

51N1

- CARTON

50ML,

100ML, 250ML,

500ML,

1L - MAIN PANEL

[Note: Text above this line not part of label text]

CAUTION

KEEP OUT OF REACH OF CHILDREN

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

FOR ANIMAL TREATMENT ONLY

COOPERS®

NILVAX®

Combination 5-in-1 vaccine and broad spectrum injectable anthelmintic

[SHEEP HEAD DIAGRAM]

ACTIVE CONSTITUENTS:

68

gIL

LEVAMISOLE as the phosphate.

Pulpy Kidney (Enterotoxaemia)

Clostridium perfringens

Type

toxoid

(>

5 U/mL

Blackleg

Clostridium eheuvoei

toxoid and inactivated cells (Pass*).

Malignant Oedema

Clostridium septicum

toxoid (> 2.5 U/mL*).

Black Disease

Clostridium novyi

Type B toxoid and inactivated cells (> 3.5 U/mL*).

Tetanus

Clostridium tetani

toxoid (> 2.5 U/mL*).

Potency Units)

Contains 0.15 mg/mL thiomersal

as preservative.

For the control

Roundworms,

including Lungworm and the prevention of

Clostridial

diseases in adult sheep.

50mL [100mL,

250mL,

500mL,

1L]

COOPERS LOGO

[Note: Text below this line not part of label text!

File Name:

Nilvax 5in1 Label

EOSL

Schering-Plough Label

&

Printer

Version:

Page 1 of 11

(Approved) 6 Aug 07.doc

Specifications:

(6/8/2007)

Prepared By:

L. Wirth

CCP TBD

[Text

in italics

Preparation Date:

6/812007

square brackets not

pert

label

Last

Revised:

2712/2004

texfl

Info

pest

Verified

NILVAX

51N1

- CARTON

50ML, 100ML, 250ML, 500ML, 1L - REAR PANEL

[Note: Text above this line not part

label text]

DO NOT USE IN LAMBS

COOPERS®

NILVAX®

Combination

5-in-1

vaccine

broad

spectrum

injectable

anthelmintic

READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT.

DIRECTIONS FOR USE

Restraints:

DO NOT use in lambs,

dogs

horses.

Shake

contents

before use.

Precautions:

Exercise care in handling weak,

pregnant and young animals to avoid unnecessary stress.

Avoid yarding

animals off-feed overnight,

and ensure animals have access to water

when yarded prior to injection.

Recommended dose should not be exceeded, except under veterinary supervision.

7.0mL

8.0mL

61-70kg

71-80kg

31-40kg

4.0mL

41-50kg

5.0mL

51-60kg

6.0mL

Sheep in excess of 80kg should be treated at the rate

of 1mL per 1

liveweighl.

Dose SUbcutaneously:

Sheep

The heaviest sheep in a mob should be weighed.

Dose the mob to the heaviest animal

by liveweight in

each group (ewes, rams, wethers), do not underdoes.

CAUTION:

AVOID CARCASS .DAMAGE

Sterilise all

injection apparatus by boiling for

least

ten minutes before use.

Avoid use of

strong

disinfectants on apparatus.

Maintain maximum cleanliness at all times.

Keep needles sharp and clean.

Change needles frequently (every 20-30 animals).

Use short

needles.

Recommended maximum sizes 15mm x 18 gauge.

Check that the equipment is functioning properly and that it is delivering the correct dose.

As far as possible avoid injection of animals during wet weather or under dusty conditions.

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.

Adult sheep should be injected high on the side of the neck, behind the ear.

WITHHOLDING

PERIOD

DO NOT USE less than

days before slaughter

human consumption.

{Note:

Text below this line not

Dart

label text!

File Name:

Nilvax 5in1 Label

EOSL

Schering-Plough Label

&

Printer

Version:

Page 2 of

(Approved) 6 Aug 07.doc

Specifications:

(6/8/2007)

Prepared

L, Wirth

CCP TBD

[Text in italics

Preparation Date:

6/812007

square brackets not part of

Jabel

Last

Revised:

27/212004

te~n

NILVAX

51N1

- CARTON

50ML,

100ML,

250ML,

500ML,

1L - REAR PANEL

(continued)

[Note:

Text above this line not part

labe/ text]

SAFETY DIRECTIONS:

Poisonous if

swallowed.

irritate the eyes and skin.

Avoid contact

with

eyes and skin.

Wear rubber

gloves.

FIRST AID:

poisoning

occurs,

contact

doctor

Poisons

Information

Centre (Phone

131126).

Additional

information is listed in the Material

Safety Data Sheet.

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

STORE at 2 to 8°C (REFRIGERATE,

DO NOT FREEZE)

Protect from Light

APVMA Approval

36163/50/0807

[APVMA Approval

36163/100/0807]

[APVMA Approval

36163/250/0807]

[APVMA Approval

36163/500/0807]

[APVMA

Approval

36163/1/08071

COOPERS

ANIMAL HEALTH

A Division of

Schering-Plough Pty Ltd

Level

66 Waterioo Road,

North Ryde NSW

2113

50mL

[100mL

250mL

500mL

EXP.

REFER

TO BATCH AND EXPIRY ON TOP PANEL

Barcode

label

item

codes to be assigned

[Note:

Text be/ow this line not part of labe/ text/

File Name:

Nilvax 5in1 Label

EOSL

Schering-Plough Label

&

Printer

Version:

Page 3 of

(Approved) 6 Aug 07.doc

Specifications:

(6/6/2007)

Prepared By:

L. Wirth

CCP TBO

[Text

in italics and

Preparation Date:

6/8/2007

square brackets not

part

label

Last

Revised:

27/2/2004

texfi

NILVAX

51N1

- CARTON

50ML,

100ML,

250ML,

500ML,

1L -

SIDE PANEL

[Note:

Text

above

this

line

notpartof

label

text]

USE IN

LAMBS

COOPERS®

NILVAX®

Combination 5-in-1 vaccine and

broad spectrum injectable

anthelmintic

NILVAX

51N1

- CARTON

COOPERS®

NILVAX®

Combination 5-in-1 vaccine and

broad spectrum injectable

anthelmintic

For control

Roundworms,

including Lungworm and for

immunity against

Pulpy Kidney

(Clostridium perfringens Type

Blackleg

(Clostridium chauvoei)

Malignant Oedema

(Clostridium septicum)

Black Disease

(Clostridium novyiType

Tetanus

(Clostridium tetam)

in adult sheep.

50ML,

100ML,

250ML,

500ML -

SIDE PANEL

SPECIALIST ADVICE IN EMERGENCY

ONLY

Schering-Plough Pty Ltd

1800

226 511

HOURS -

AUSTRALIA WIDE

® Schering-Plough

Animal

Health

Corporation

Registered

Trademark

® Yellow (PANTONE® 123) the predominant colour of Coopers packaging is a Registered Trademark of Schering-

Plough Animai Health Corporation.

PANTONE is a registered trademark of Pantone, Inc.

Schering-Plough

Pty Ltd

2007

NILVAX

51N1

- CARTON

50ML,

100ML,

250ML,

500ML -

TOP PANEL

BATCH

EXPIRY

DO NOT USE IN

LAMBS

COOPERS®

NILVAX®

Combination 5-in-1 vaccine and broad spectrum injectable anthelmintic

rNote:

Text

below

this

line

notoeri of

label

textl

File Name:

Nilvax 5in1 Label

EOSL

Schering-Plough Label

&

Printer

Version:

Page 4 of

(Approved) 6 Aug 07.doc

Specifications:

(6/8/2007)

Prepared By:

L. Wirth

CCP TSD

[Text

in italics

Preparation Date:

6/812007

square brackets not part

label

Last Revised:

2712/2004

texn

NILVAX

51N1

-IMMEDIATE CONTAINER

50ML, 1

OOML,

250ML, 500ML, 1L -

MAIN PANEL

[Note: Text above this line not part

iabei text]

CAUTION

KEEP OUT OF REACH OF CHILDREN

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

FOR ANIMAL TREATMENT ONLY

COOPERS®

NILVAX®

Combination

5-in-1

vaccine and broad spectrum injectable anthelmintic

ACTIVE CONSTITUENTS:

LEVAMISOLE as the phosphate.

Pulpy

Kidney (Enterotoxaemia)

Clostridium perfringens

Type 0 toxoid

(>

5 U/mL*).

Blackleg

Clostridium chauvoei

toxoid and inactivated cells (Pass*).

Malignant Oedema

Clostridium sept/cum

toxoid

(>

2.5 U/mL*).

Black

Disease

Clostridium

novyiType

B toxoid and inactivated cells

(>

3.5 U/mL*).

Tetanus

Clostridium tetani

toxoid

(>

2.5 U/mL*).

(* = Potency Units)

Contains 0.15 mg/mL thiomersal

as preservative.

For the control of Roundworms, including Lungworm and the prevention of Clostridial diseases

in adult sheep.

READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT.

DIRECTIONS FOR USE

Restraints:

DO NOT use in lambs,

dogs

horses.

Shake

contents

before use.

Precautions:

Exercise care in handling

weak,

pregnant

and young animals to avoid unnecessary stress.

Avoid yarding animals off-feed overnight,

and ensure animals have access to water

when

yarded prior

to injection.

Recommended dose should not

be exceeded,

except

under

veterinary supervision.

7.0mL

8.0mL

61-70kg

71-80kg

31-40kg

4.0mL

41-50kg

5.0mL

51-60kg

6.0mL

Sheep in excess of 80kg should be treated at the rate

of 1mL per 10kg liveweighl.

Dose subcutaneously:

Sheep

WITHHOLDING PERIOD

DO NOT USE less than 3 days before

slaughter

human

consumption.

INote: Text beiow this line not part

iabei textl

File Name:

Nilvax

51n1

Label EOSL

Scherlng-Plouqh Label

&

Printer

Version:

Page 5 of 11

(Approved) 6 Aug 07.doc

Specifications:

(6/8/2007)

Prepared

Wirth

CCP TBD

[Text

in italics

Preparation Date:

6/8/2007

square brackets not

parl

label

Last Revised:

27/212004

lexO

NILVAX

51N1

-IMMEDIATE

CONTAINER (continued)

50ML,

100ML,

250ML,

500ML,

1L -

MAIN PANEL

[Note: Text above this line not part

label text]

SAFETY DIRECTIONS:

Poisonous if swallowed.

May irritate the eyes and skin.

Avoid

contact with eyes and skin.

Wear rubber gloves.

FIRST AID:

If

poisoning occurs,

contact

a doctor

or

Poisons Information Centre

(Phone 131126).

Additional

information is listed in the Material

Safety Data Sheet.

STORE

at 2 to 8°C (REFRIGERATE,

FREEZE)

Protect from Light

APVMA Approval

36163/5010807

[APVMA Approval

36163/10010807]

[APVMA Approval

36163/25010807]

[APVMA Approval

36163/50010807]

[APVMA Approval

36163/1/0807]

COOPERS ANIMAL HEALTH

A Division of

Schering-Plough Pty Ltd

Level

4, 66 Waterloo Road, North Ryde

2113

50mL [100mL, 250mL, 500mL, 1L]

EXP.

COOPERS LOGO

[Note: Text below this line not part

label text!

File Name:

Nilvax 5in1 Label

EOSL

Schertnp-Plouqh

Label

&

Printer

Version:

Page6of11

(Approved) 6 Aug 07.doc

Specifications:

(6/8/2007)

Prepared

By:

L. Wirth

CCP TBD

[Textin

italics

and

Preparation

Date:

6/812007

square

brackets

not part of label

Last

Revised:

2712/2004

texfi

NILVAX

51N1

LEAFLET

[Note: Text above this line not part

label text]

50ML,

100ML,

250ML,

500ML,

CAUTION

KEEP OUT OF REACH OF CHILDREN

READ SAFETY DIRECTIONS BEING OPENING OR USING

FOR ANIMAL TREATMENT

ONLY

[SHEEP HEAD DIAGRAM]

COOPERS®

Nilvax"

Combination

5-in-1

vaccine

broad

Spectrum

injectable

anthelmintic

ACTIVE CONSTITUENTS:

LEVAMISOLE as

phosphate.

Pulpy

Kidney

(Enterotoxaemia)

Clostridium perfringens

Type D toxoid

(>

5 U/mL*).

Blackleg

Clostridium chauvoei

toxoid and inactivated cells (Pass*).

Malignant

Oedema

Clostridium septicum

toxoid (> 2.5 U/mL*).

Black

Disease

Clostridium

novyi

Type B toxoid and inactivated cells

(>

3.5 U/mL*).

Tetanus

Clostridium

tetanitoxoid(>

2.5 U/mL*).

Potency Units)

Contains 0.15

mg/mL

thiomersal

as preservative.

For the control

Roundworms,

including Lungworm and the prevention of

Clostridiai

diseases

in adult sheep.

NOT FOR USE IN LAMBS

COOPERS LOGO

[Note'

Text below this line not part of/abel text]

File Name:

Nilvax 5in1 Label EOSL

Schering-Plough Label

&

Printer

Version:

Page 7 of 11

(Approved) 6 Aug 07.doc

Specifications:

(6/8/2007)

Prepared

L. Wirth

CCP TBD

[Text in italics

Preparation Date:

61812007

square brackets not part

of label

Last

Revised:

271212004

texfi

NILVAX

51N1

LEAFLET

50ML, 100ML, 250ML, 500ML, 1L

(continued)

{Note:

Text above this line not part

iabel text]

COOPERS®

NILVAX®

Combination

5-in-1

vaccine and broad spectrum injectable anthelmintic

Coopers Nilvax is a combination of

levamisole phosphate (the active ingredient of

Niiverm)

Tasvax

5-in-1

clostridiai

vaccine.

When used in adult

sheep,

levamisole phosphate is

effective

against:

Mature and immature

Haemonchus

spp.

(Barber's Pole Worm),

Ostertagia spp.

(Smali

Brown Stomach Worm),

Trichostrongylus

axei

(Stomach Hair Worm),

Trichostrongylus

spp.

(Black Scour

Worm),

Cooperia

spp.

(Smali

Intestinal

Worm),

Nematodirus

spp.

(Thin-

necked Intestinal

Worm),

Strongyloides

(no common name),

Oesophagostomum

spp.

(Nodule and Large Bowel Worms) and

Dictyocaulus

spp. (Large Lung Worm).

Controls both susceptible and benzimidazole and ivermectin resistant

strains of

above

species.

Internal

parasites

develop

resistance

drenches

(anthelmintics).

drench

(anthelmintic) failure with this preparation is suspected,

seek veterinary confirmation and

notify the manufacturer.

vaccine

component

Coopers

Nilvax

gives

protection

against

Pulpy

Kidney

(Enterotoxaemia), Blackleg, Malignant Oedema, Tetanus and Black Disease.

Indications

Coopers Nilvax is suitable for

use in adult

sheep when treatment

roundworms and

lungworm is required at

the same time as a protection against

the five major

clostridial

diseases.

The most critical time for this is prior to lambing when vaccination of the ewe prior

to lambing wili

give protection to the newborn lamb for

about

10 weeks through the

colostrum.

has now also been shown that

drenching six weeks prior

to lambing can

improve lamb survival and increase lamb weights at weaning.

Coopers Nlivax may also be used in adult rams and wethers.

Reference:

Froyd G. (1973) Helminthogia,

377-384.

DIRECTIONS FOR USE

Restraints:

DO NOT use in lambs,

dogs

or horses.

Shake contents before use.

Precautions:

Exercise care in handling weak,

pregnant and young animals to avoid unnecessary stress.

Avoid yarding animals

off-feed

overnight,

and ensure animals have access to water when

yarded prior

to injection.

Recommended dose should not

be exceeded,

except

under

veterinary supervision.

Dose subcutaneously:

Sheep

31-40kg

4.0mL

41-50kg

5.0mL

51-60kg

6.0mL

61-70kg

7.0mL

71-80kg

8.0mL

Sheep in excess of 80kg should be treated at the

rate of 1mL per 10kg liveweight.

The heaviest sheep in a mob should be weighed.

Dose the mob to the heaviest animal

liveweightin each group (ewes,

rams,

wethers), do not underdose.

{Note:

Text below this line not Dart

label text!

File Name:

Nilvax 5in1 Label EOSL

Schering-PJough

Label

&

Printer

Version:

Page 8 of 11

(Approved) 6 Aug 07.doc

Specifications;

(6/8/2007)

Prepared By:

L. Wirth

CCP TBD

[Text

in Italics

Preparation Date:

6/812007

square brackets not part

label

Last Revised:

2712/2004

texfi

NILVAX

51N1

LEAFLET

50ML, 100ML, 250ML, 500ML, 1L (continued)

[Note: Text above this line not part

label text]

Rams

and Wethers:

Rams

and wethers

previously vaccinated should be

vaccinated twice at intervals of at least 4 weeks.

Annual

booster should be given.

Ewes:

Ewes not previousiy vaccinated shouid be vaccinated twice 4 to 6 weeks apart.

The second shot should be timed to be given up to 6 weeks prior to lambing.

This wili

protect

lambs until

approximately

8-10 weeks of

age.

ewes have been previously vaccinated

correctly against

those diseases for

which protection is required,

then only the pre-lambing

vaccination is required.

VACCINATION PROCEDURE

CAUTION: AVOID CARCASS DAMAGE

Sterilise all

injection apparatus by boiling for at least ten minutes before use.

Avoid use of

strong disinfectants on apparatus.

Maintain maximum cleanliness at ali times.

Keep needles sharp and clean.

Change needles frequently (every

20-30 animals).

short needles.

Recommended maximum sizes 15mm x 18 gauge for sheep.

Check that the equipment is functioning properiy and that it is delivering the correct dose.

As far as possible avoid injection of animals during wet weather or under dusty conditions.

Inject only under the skin and not into the muscie, by raising a fold of skin and injecting the

dose under the raised skin

-NOT INTO IT.

Adult sheep should be injected high on the side of the neck, behind the ear.

WITHHOLDING PERIOD

DO NOT USE less than 3 days before slaughter

human consumption.

SAFETY DIRECTIONS:

Poisonous

swallowed.

May irritate the eyes and skin.

Avoid

contact

with

eyes and skin.

Wear

rubber

gloves.

FIRST AID:

poisoning

occurs,

contact

doctor

Poisons

Information

Centre

(Phone 131126).

Additionai

information is listed in the Material Safety Data Sheet.

STORAGE

Store at 2 to 8°C (Refrigerate, DO NOT FREEZE).

Coopers Nilvax will

be adversely affected by exposure to heat

and light

and by

freezing.

Do not expose directly to heat and light during use.

The use of an insulated container

is recommended during the day to protect

Coopers Nilvax.

Coopers Nilvax is to be hung

beside the race, ensure it is on the shady side.

Do not use Coopers Nilvax that has been open more than 24 hours.

DISPOSAL

Dispose of

empty containers and outer

packaging by wrapping in paper

and putting in

garbage.

rNote:

Text below this line not

Dart

label textl

File Name:

Nilvax

5in1

Label EOSL

Scherlng-Plough Label

&

Printer

Version:

Pagegof11

(Approved) 6 Aug 07.doc

Specifications:

(6/8/2007)

Prepared

Wirth

CCP TBD

[Text

in italics

Preparation Date:

6/812007

square brackets not

part

label

Last Revised:

2712/2004

texfi

NILVAX

51N1

LEAFLET

50ML, 100ML, 250ML, 500ML,

(continued)

{Note: Text above this tine not part

labei text]

THE DISEASES

Obtain veterinary advice for

accurate diagnosis,

and then use an appropriate vaccination

programme.

BLACK DISEASE

Black disease is generally seasonai

in appearance and is caused by infection with

Clostridium

novyi

Type B.

Black disease is an acute infectious disease of

widespread occurrence,

especially in areas where liver fluke are prevalent.

Black disease germs live in the

sailor

the livers of sheep in a resting form, or spore.

Where damage has occurred in the liver due to

fluke invasion, the germs grow rapidly and in so doing produce a powerfui and deadly poison.

Sheep affected with Black Disease will

suddenly lie down and die,

apparently painlessly and

without warning.

The only method of

prevention of

Black Disease losses where fluke is prevalent

is by

vaccination.

N.B.

Treatment for liver fluke and measures to control the snails which act as the intermediate

host to the liver fluke should also be carried out.

TO PROTECT AGAINST SWELLED-HEAD IN RAMS (caused by

Clostridium

novyiType

Vaccinate at

4-6 months of

age with a

5in1

vaccine,

followed by a booster

dose after

interval

4 to 6 weeks.

Revaccinate annually,

or once rams are over 30kg bodyweight with

Nilvax, 4 weeks before expected loss.

BLACKLEG/MALIGNANT OEDEMA

(both sometimes called Blood Poisoning)

Blackleg/Malignant

Oedema is caused by an infection to wounds with

Clostridium

chauvoei

and/or

Clostridium septicum.

These organisms contaminate the soil

and are very resistant.

They may attack singly or

in combination.

Young stock,

thriving on good pasture,

are very

susceptible.

The disease occurs most commonly after injuries caused quite often by shearing,

marking,

dipping, lambing etc.

Some symptoms are rapid breathing, depression, iameness in

one or more legs.

The skin becomes purple and when touched may impart a crackling feeling

due to the presence of gas in the tissue.

In all

areas where this disease occurs or is likely to

occur, regular vaccination programmes should be adopted.

PULPY KIDNEY

(Enterotoxaemia)

Pulpy Kidney is caused by infection of

Clostridium

perfringens

Type D.

The bacteria causing

this disease are normally present in the bowels of

healthy sheep.

The germ, given favourable

conditions such as a change from dry to lush feed or lush to dry feed,

in effect,

any type of

sudden change in the food intake,

grows rapidly and in so doing,

produces a very strong

poison,

which is quickly fatal.

Symptoms in young lambs are convulsions,

clamping of

jaws,

rolling eyes and the head drawn backward.

In adult

sheep,

where the onset

disease is slower,

the symptoms are not

as violent.

A staggering gait

may be noticed and

some scouring Is apparent

just

before death.

must

be remembered that

deaths occur

suddenly,

therefore protection by vaccination is the only sure method of

prevention.

Annual

revaccination is advisable on heavily infected properties.

{Note: Text below this tine not Dart

iabel text]

File Name:

Nilvax

5in1

Label EOSL

Scherinq-Plouqh

Label

&

Printer

Version:

Page 10 of

(Approved) 6 Aug 07.doc

Specifications:

(6/8/2007)

Prepared

By:

L. Wirth

CCP TBO

[Text

in Italics and

Preparation

Date:

6/812007

sq~t1are

brackets

not part of label

Last

Revised:

2712/2004

NILVAX

51N1

LEAFLET

50ML, 100ML, 250ML,

500ML,

(continued)

[Note:

Text above this line not

parl

label

text]

TETANUS

Tetanus is caused by infection with

Clostridium tetani.

The germ lives mainly in the soil,

manure and dust.

It exists in a spore form which is extremely resistant and may remain in this

resting form for

many years.

The germ can enter

the body at

any point

where there is a

wound and upon entry quickly grows,

producing a deadly poison which affects the nervous

system.

There is a gradual

onset

of stiffness followed by tetanic spasm of muscles.

The signs

are evident

in the gait,

eyelids,

ears,

nostrils and tail.

The muscles do not

relax completely

between spasms.

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,

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

days for a scientific

examination.

further

information contact Coopers Customer Service on 1 800 226 511.

SPECIALIST ADVICE IN EMERGENCY

ONLY

Schering-Plough Pty Ltd

1800226511

HOURS·

AUSTRALIA

WIDE

APVMA Approval

36163/0807

COOPERS

ANIMAL

HEALTH

A Division of Schering-Plough Pty Ltd

Level

4, 66

Waterloo Road,

North Ryde NSW

2113

Schering-Plough Animal

Health

Corporation Registered Trademark

Yellow

(PANTONE®

123)

predominant

colour

Coopers

packaging

is a

Registered

Trademark

Schering-

Piough

Animal

Health

Corporation.

PANTONE

is a

registered

trademark

Pantone,

Inc.

Schering-Plough Pty Ltd 2007

[Note'

Text below this line not parl

label

text]

File Name:

Nilvax 5in1 Label

EOSL

Schering-Plough Label

&

Printer

Version:

Page 11 of

(Approved) 6 Aug 07.doc

Specifications:

(6/8/2007)

Prepared

L. Wirth

CCP TBD

[Text

in italics and

Preparation Date:

6/812007

square brackets not part

of label

Last

Revised:

2712/2004

texn