SINGVAC SINGLE SHOT 5 IN 1 VACCINE FOR SHEEP AND LAMBS

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Active ingredient:
CLOSTRIDIUM CHAUVOEI - TOXOID; CLOSTRIDIUM NOVYI TYPE B - TOXOID; CLOSTRIDIUM PERFRINGENS TYPE D TOXOID; CLOSTRIDIUM SEPTICUM - TOXOID; CLOSTRIDIUM TETANI - TOXOID; THIOMERSAL
Available from:
Virbac (Australia) Pty Ltd
INN (International Name):
Cl perfringens toxoid (D)+Cl septicum - toxoid+Cl novyi type B + others
Pharmaceutical form:
MISC. VACCINES OR ANTI SERA
Composition:
CLOSTRIDIUM CHAUVOEI - TOXOID VACCINE-TOXOID Active 0.0 U; CLOSTRIDIUM NOVYI TYPE B - TOXOID VACCINE-TOXOID Active 3.5 IU/ml; CLOSTRIDIUM PERFRINGENS TYPE D TOXOID VACCINE-TOXOID Active 5.0 IU/ml; CLOSTRIDIUM SEPTICUM - TOXOID VACCINE-TOXOID Active 2.5 IU/ml; CLOSTRIDIUM TETANI - TOXOID VACCINE-TOXOID Active 2.5 IU/ml; THIOMERSAL MERCURY Other 0.13 g/L
Units in package:
200mL; 500mL
Class:
VM - Veterinary Medicine
Therapeutic group:
LAMB | SHEEP | EWE | HOGGET | LAMB | OVINE | RAM | WEANER | WETHER
Therapeutic area:
IMMUNOTHERAPY
Therapeutic indications:
BLACK DISEASE | BLACKLEG | ENTEROTOXAEMIA (PULPY KIDNEY) | MALIGNANT OEDEMA | TETANUS | VACCINE | CLOSTRIDIUM PERFRINGENS TYPE D | EQUINE ROTAVIRUS | TETANUS VACCINATION
Product summary:
Poison schedule: 0; Withholding period: WHP: NIL ESI: Not Required; Host/pest details: LAMB: [BLACK DISEASE, BLACKLEG, ENTEROTOXAEMIA (PULPY KIDNEY), MALIGNANT OEDEMA, TETANUS, VACCINE]; SHEEP: [BLACK DISEASE, BLACKLEG, ENTEROTOXAEMIA (PULPY KIDNEY), MALIGNANT OEDEMA, TETANUS, VACCINE]; Poison schedule: 0; Withholding period: ; Host/pest details: LAMB: [BLACK DISEASE, BLACKLEG, ENTEROTOXAEMIA (PULPY KIDNEY), MALIGNANT OEDEMA, TETANUS, VACCINE]; SHEEP: [BLACK DISEASE, BLACKLEG, ENTEROTOXAEMIA (PULPY KIDNEY), MALIGNANT OEDEMA, TETANUS, VACCINE]; For the prevention of pulpy kidney(enterotoxaemia)(Cl. perfringens type D), blackleg (Cl chauvoei), malignant oedema (Cl. septicum), black disease (Cl.novyi type B) and tetanus (Cl tetani) for sheep and lambs.NOT TO BE USED IN CATTLE.
Authorization status:
Registered
Authorization number:
49947
Authorization date:
2020-07-01

.

Virbac (Australia)

Limited

Page

Product Name:

Singvac Single Shot 5 in 1 Vaccine

Sheep and Lambs

APVMA Number:

49947/60410

Version Date:

17 October 2013

Pack sizes:

ml/500

TEMPLATE

RELEVANT

LABEL

PARTICULARS

(RLPs)

(Veterinary

Products)

Select appropriate:

New Product (include all applicable RLPs) OR

x Variation (highlight instructions that are being varied). Approval

of label being varied

49947/1007

Signal

heading:

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

A.pprov

FOR ANIMAL TREATMENT ONLY

Product

name:

SingVac""

SINGLE SHOT 5

1 VACCINE

FOR SHEEP AND

LAMBS

Active constituenUs:

A water

oil emulsion of purified toxoids of

perfringens

Type D (5.0 IU/mL),

septicum

(2.5 IU/ml),

novyi

Type 8 (3.5

IU/ml)

tetani

(2.5

IU/ml)

combined with

the formal treated cells

chauvoei

0361

Contains 0.13 g/L thiomersal

Statement

claims:

For the prevention of pulpy kidney (enterotoxaemia)

(Clostridium perfringens

Type D),

blackleg

(C/.

chauvoe1),

malignant oedema

(C/.

septicum),

black disease

(CI.

novyi

Type

tetanus

(CI.

tetam)

for sheep

lambs.

A vaccine for the active immunisation of sheep and lambs against pulpy kidney

(enterotoxaemia, caused by

Clostridium perfringens

Type D), blackleg (caused by

Clostridium chauvoe1),

malignant oedema (caused by

Clostridium septicum),

black disease

(caused by

Clostridium novyi

Type

tetanus (caused by

Clostridium tetani).

Net contents:

200ml

Directions for Use

READ ENCLOSED LEAFLET BEFORE USING THIS PRODUCT

Heading:

DIRECTIONS FOR USE:

NOT TO BE USED

CATTLE

Restraints:

Contraindications:

Precautions:

Side

effects:

Note: Because

single shot formulation

this vaccine, local swellings occur at the

injection site

a proportion of animals.

Such swellings are sterile

will normally regress

spontaneously.

is strongly recommended that the vaccine is administered under the skin

the neck behind the ear

minimise the effect of such swellings.

Dosage

&

SHAKE WELL BEFORE

AND KEEP THOROUGHLY MIXED DURING USE.

administration:

SINGVAC® VACCINE IS A WATER

OIL EMULSION AND AN OIL COMPATIBLE

VACCINATOR SUCH AS THE SINGVAC® VACCINATOR IS REQUIRED TO BE USED

WHEN ADMINISTERING THE VACCINE.

Dosage and route

administration: Administer 1

of vaccine under the skin

neck behind the ear.

not vaccinate into the muscle.

vaccinate

into

brisket

thigh.

Lambs: 1

dose at marking

second dose

required

the first year).

annual booster dose with 1

of SingVac® Single Shot 5

1 Vaccine

with the

recommended dose of Websters 5

1 Vaccine is required to maintain Immunity.

Ewes

(fully

vaccinated as lambs):

annual booster dose with the recommended

dose ofWebsters 5

1 Vaccine.

Administer

6 weeks before lambing if possible

protect lambs until marking.

Virbac (Australia) Pty Limited

Page

Product Name:

Singvac Single ShotS in 1 Vaccine

Sheep and Lambs

APVMA Number:

49947/60410

Version Date:

17 October

2.013

Pack sizes:

Slaughter

lambs

from

vaccinated

ewes:

dose at marking.

Unvaccinated rams, ewes and wethers: all sheep introduced onto a property should

be vaccinated with a 1

dose immediately. An annual booster dose with 1

SingVac® Single Shot 5

1 Vaccine or with the recommended dose

Websters 5

1 Vaccine is required.

Rams: An annual booster dose of 1

of SingVac® Single Shot 5

1 Vaccine or the

recommended dose of Websters 5

1 Vaccine should

given before or at joining.

administration

concurrent

Injections

should

a separate

site.

VACCINATION PROGRAMME

Primary

Vaccination

A single dose

will generate protective levels of circulating antibodies for 12 months.

No second dose is required for animals receiving their first vaccination.

Immunity develops

within 28 days after vaccination.

Annual

Vaccination

annual booster dose with 1

of SingVac® Single Shot 5

1 Vaccine or with the

recommended dose of Websters 5

1 Vaccine is required to maintain immunity.

General direcf1ons:

CAUTION:

AVOID

CARCASS

DAMAGE

Sterilise all injection apparatus by boiling (or equivalent) before use.

Avoid use

strong disinfectants

apparatus.

Maintain cleanliness

all times;

Keep needles sharp and clean, replace frequently;

Use shortest needle possible, certainly not exceeding

As far as possible avoid injection

animals during wet weather or under dusty

conditions;

This product should

injected only under the skin;

If possible, inject high

the neck behind the ear.

Withholding

Period/s:

ZERO (0) DAYS

Trade Advice:

Safety Directions:

Avoid contact with eyes and skin.

First

Aid:

If poisoning occurs, contact a doctor or Poisons Information Centre.

Phone 131126.

If skin

contact occurs, remove contaminated clothing and wash skin thoroughly.

Additional user

Take Care to Avoid Self-Injection

safety:

Accidental self-administration may result

local bruising, pain and swelling.

the event of

self-administration, seek medical attention and show the package leaflet or the label,

Medical Practitioner

Environmental

statements:

Disposal:

Dispose of empty containers

outer packaging by wrapping with paper and putting

garbage. Discarded needles should immediately be placed

a designated and appropriately

labelled "sharps" container. The container should

of a type to reduce the possibility of

injury to handlers during collection and disposal. Incineration is the preferred method of

disposal; otherwise "sharps" should

buried at a suitable site, such as an

farm chemical

disposal pit located away from watercourses

Storage:

Store between

and 8°C. (Refrigerate. Do not freeze).

Protect from light.

For overniQht

storaQe,

disconnect and empty the svrinqe and draw-off

awratus

from the

Virbac {Australia)

Limited

Page

Product Name:

Singvac Single Shot 5 in 1 Vaccine

Sheep and Lambs

APVMA Number:

49947/60410

Version Date:

17 October 2013

Pack sizes:

200 mL/ 500

pack and store the vaccine between 2°C

8°C.

(Refrigerate.

not freeze).

Resterilise.

the injection apparatus before reassemblinQ the following day.

Name & address:

VIRBAC (AUSTRALIA) PTY. LIMITED

Horsley Road, Milperra NSW 2214

Freecall Customer Service Line: 1800 009 847

www.virbac.com.au

The following is for APVMA use only:

APVMA approval no.

APVMA

No: 49947/60410

abcdefg

FORT DODGE AUSTRALIA Pty Limited

ACN 000 074 902

MATERIAL SAFETY

1 Maitland Place

DATA SHEET

Baulkham Hills NSW 2153

Telephone: (02) 9899 0444

Facsimile:

(02) 9899 2151

Emergency: 1800 033 111

WORK HAZARD ASSESSMENT

Not classified as hazardous according to the criteria of Worksafe Australia.

l IDENTIFICATION

Product Name: SingVac

Single Shot 5 in 1 Vaccine for

Sheep and Lambs (49947).

Other Names:

Single Shot 5 in 1 Vaccine

Product Code:

None.

UN No:

None allocated

Hazchem Code:

None allocated

Dangerous Goods Class:

None allocated

Sub Risk Class:

None allocated

Packaging Group:

None allocated

Poison Schedule:

Not scheduled.

Chemical Family:

Water solution of ingredients (see below). Inactivated bacterial water in oil emulsion

vaccine for sheep and lambs.

Uses:

Disease prevention by vaccination in sheep and lambs.

Physical Appearance & Properties

Appearance & Odour:

Oil emulsion bacterial vaccine in a plastic pillow pack. No data re odour.

Melting/softening point:

Approximately 0°C.

Boiling point and vapour pressure: Approximately 100°C at 100kPa.

Volatile materials:

Water component.

Flashpoint:

Does not burn.

Specific gravity:

No data.

Solubility in water:

Completely soluble.

Corrosiveness:

Not corrosive.

Ingredients

Worksafe Exposure Limits

Chemical Entity

CAS No

Proportion, %

TWA, mg/m

STEL, mg/m

Formaldehyde inactivated antigens of:

Clostridium perfringens Type D

not set

see label

not set

not set

Clostridium septicum

not set

see label

not set

not set

Clostridium novyi Type B

not set

see label

not set

not set

Clostridium tetani

not set

see label

not set

not set

Clostridium chauvoei anaculture (formalin-inactivated)

not set

see label

not set

not set

Other non hazardous ingredients

secret

<1

not set

not set

Water

7732-18-5

to 100

not set

not set

This is a commercial product whose exact ratio of components may vary. Trace quantities of impurities are also likely.

ll HEALTH HAZARD DATA

Issued by: Fort Dodge Australia Pty Limited

Product: SingVac Single Shot 5 in 1 Vaccine for Sheep and Lambs

(49947).

Phone: (02)9899 0444

Page 1 of 4

Issued: 4 Jul 2002

Revision 2

MATERIAL SAFETY DATA SHEET

Issued by: Fort Dodge Australia Pty Limited

Product: SingVac Single Shot 5 in 1 Vaccine for Sheep and Lambs

(49947).

Phone: (02)9899 0444

Page 2 of 4

Issued: 4 Jul 2002

Revision 2

Health Effects:

No specific data is available for the product for chronic exposure symptoms. The

ingredients are not listed as carcinogenic in Worksafe’s document “Exposure Standards

for Atmospheric Contaminants in the Occupational Environment” (May 1995), nor in

NOHSC’s “List of Designated Hazardous Substances” (April 1999).

Acute Effects:

Swallowed:

Data suggests that this product should present no significant problems to typical persons

in normal use.

Eye:

Data suggests that this product should present no significant problems to typical persons

in normal use.

Skin:

Data suggests that this product should present no significant problems to typical persons

in normal use.

Inhalation:

Data suggests that this product should present no significant problems to typical persons

in normal use.

First Aid:

If poisoning occurs, contact a Doctor or Poisons Information Centre. Phone 13 1126 from

anywhere in Australia. If possible have this MSDS or product label with you.

Swallowed:

If swallowed, do NOT induce vomiting. Wash mouth with water and give a glass of water

to drink.

Accidental self-injection:

If possible the application of gentle squeezing pressure with absorbent material (e.g.

facial tissue) at the injection site will swab up unabsorbed vaccine. Strong squeezing of

the site should be avoided. The damaged area should be thoroughly cleansed and a

topical antiseptic applied.

Eyes:

If product gets in eyes, wash eyes to remove material. No further measures should

normally be required.

Skin:

If product gets on skin, wash skin to remove material. No further measures should

normally be required.

Inhalation:

No first aid measures normally required. However, if vapours or mists have been inhaled,

and irritation has developed, remove to fresh air and observe until recovered. If irritation

becomes painful or persists more than about 30 minutes, seek medical advice.

Advice to Doctor:

Treat self injection symptomatically. Accidental self injection may lead to an inflammatory

response. Deep injections, particularly those near a joint or associated with bruising

should be treated medically or surgically.

lll PRECAUTIONS FOR USE

Exposure Standards:

A time weighted average (TWA) concentration for an 8 hour day, and 5 day week has not

been established by Worksafe Australia for any of the major ingredients in this product.

There is a blanket limit of 10mg/m

for dusts or mists when limits have not otherwise been

established. The nature of this product makes it unlikely that this level will be approached

in normal use.

Engineering Controls:

In industrial situations, concentration values below the TWA value should be maintained.

Values may be reduced by process modification, use of local exhaust ventilation,

capturing substances at the source, or other methods. If you believe air borne

concentrations of mists, dusts or vapours are high, you are advised to modify the process

or environment to reduce the problem.

Personal Protection:

Respiratory Protection:

It is usually safe to not use a dust mask or respirator protection on account of this product.

However, if the product is being used in dusty or confined conditions, use of a mask or

respirator may be preferred. For help in selecting suitable equipment, consult AS/NZS

1715.

Protective Gloves:

Protective gloves are not normally necessary when using this product. However, it is

always prudent to wear gloves. For help in selecting suitable equipment, consult AS 2161.

MATERIAL SAFETY DATA SHEET

Issued by: Fort Dodge Australia Pty Limited

Product: SingVac Single Shot 5 in 1 Vaccine for Sheep and Lambs

(49947).

Phone: (02)9899 0444

Page 3 of 4

Issued: 4 Jul 2002

Revision 2

Eye Protection:

Protective eyewear is not normally necessary when using this product. However, it is

always prudent to use protective eyewear. Consult AS1336 and AS/NZS 1337 for advice

on Industrial Eye Protection.

Clothing:

This product is essentially safe to use without special protective clothing. However, its use

is recommended as a good industrial practice. Consult AS2919 for advice on Industrial

Clothing.

Safety Boots:

Wearing safety boots in industrial situations is advisory. Consult AS/NZS2210 for advice

on Occupational Protective Footwear.

Always wash hands before smoking, eating or using the toilet. Wash contaminated

clothing and other protective equipment before storing or re-using.

lV SAFE HANDLING INFORMATION

Storage & Transport

This product has no UN classification. Not a Scheduled Poison. Containers should be

kept closed in order to minimise contamination. Store & transport between 2°C and 8°C.

(DO NOT FREEZE). All opened and unused vaccine should be discarded after 24 hours.

Keep from extreme heat and open flames, and make sure that the product does not come

into contact with substances listed under "Materials to avoid" below.

Spills & Disposals

Minor spills do not normally need any special cleanup measures. In the event of a major

spill, prevent spillage from entering drains or water courses. No special protective clothing

is normally necessary. However use judgement and take care. Stop leak if safe to do so,

and contain spill. Absorb onto sand, vermiculite or other suitable absorbent material.

Sweep up and shovel or collect recoverable product into labelled containers for recycling

or salvage. After spills, wash area preventing runoff from entering drains. If a significant

quantity of material enters drains, advise emergency services. Full details regarding

disposal of used containers, spillage and unused material may be found on the label. If

there is any conflict between this MSDS and the label, instructions on the label prevail.

Dispose of only in accord with all regulations.

Fire & Explosion Hazard

There is no risk of an explosion from this product under normal circumstances if it is

involved in a fire.

Flashpoint:

Does not burn.

Flammability limits:

Not applicable. This product does not burn.

Extinguishing Media:

This product does not burn. Use extinguishing media suited to the materials that are

burning.

Special Fire Fighting procedures: When fighting fires involving significant quantities of this product, wear safety boots,

non-flammable overalls, gloves, hat and preferably, goggles.

Unusual Fire & Explosion Hazards: This product is unlikely to decompose at temperatures normally achieved in a fire.

Likely to decompose only after heating to dryness followed by further strong heating.

Stability:

This product is unlikely to spontaneously decompose.

Polymerisation:

This product is unlikely to spontaneously polymerise.

Decomposition Products:

No significant quantities of decomposition products are expected at temperatures

normally achieved in a fire.

Materials to avoid:

No particular incompatibilities.

MATERIAL SAFETY DATA SHEET

Issued by: Fort Dodge Australia Pty Limited

Product: SingVac Single Shot 5 in 1 Vaccine for Sheep and Lambs

(49947).

Phone: (02)9899 0444

Page 4 of 4

Issued: 4 Jul 2002

Revision 2

V OTHER INFORMATION

This MSDS is prepared in accord with the Worksafe Australia document “National Code of Practice for the Preparation

of Material Safety Data Sheets”, 1994.

Contact Point:

Technical Services Manager

FORT DODGE AUSTRALIA Pty Limited

1 Maitland Place

Baulkham Hills NSW 2153

Telephone:

(02)9899 0444

Facsimile:

(02)9899 2151

Emergency:

1800 033 111

Poisons Information Centre:

13 1126 (from anywhere in Australia)

Please read all labels carefully before using product.

DISCLAIMER: This MSDS summarises our best knowledge of the health and safety hazard information of the product and how to safely handle and

use the product in the workplace. Each user should read this MSDS and consider the information in the context of how the product will be handled

and used in the workplace including in conjunction with other products. If clarification or further information is needed to ensure that an appropriate

risk assessment can be made, the user should contact this company.

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