BIVALENT TICK FEVER VACCINE

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

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Active ingredient:
BABESIA BOVIS; ANAPLASMA CENTRALE
Available from:
DEPARTMENT OF AGRICULTURE, FISHERIES AND FORESTRY
INN (International Name):
Anaplasma centrale(10000000u/dose)+Babesia bovis(10000000u/dose)
Pharmaceutical form:
MISC. VACCINES OR ANTI SERA
Composition:
BABESIA BOVIS VACCINE-MICROBIAL Active 0.0 P; ANAPLASMA CENTRALE VACCINE-VIRAL Active 0.0 P
Units in package:
20mL-200mL
Class:
VP - Veterinary Pesticide
Manufactured by:
DEPT AGRICULTURE, FI
Therapeutic group:
CATTLE | BEEF | BOS INDICUS | BOS TAURUS | BOVINE | BUFFALO | BULL | BULLOCK | CALF | COW | DAIRY COW | HEIFER | STEER
Therapeutic area:
IMMUNOTHERAPY
Therapeutic indications:
TICK FEVER - BOVINE ANAPLASMOSIS | TICK FEVER - BOVINE BABESIOSIS | VACCINE | ANAPLASMA MARGINALE | BABESIA BIGEMINA | BABESIA BOVIS | EQUINE ROTAVIRUS | RED WATER | REDWATER
Product summary:
Poison schedule: 0; Withholding period: WHP: Nil; Host/pest details: CATTLE: [TICK FEVER - BOVINE ANAPLASMOSIS, TICK FEVER - BOVINE BABESIOSIS, VACCINE]; For control of tick fever (Babesiosis & Anaplasmosis) in cattle.This product is contraindicated for use in cattle during late pregnancy. Caution: Avoid carcass damage. See PRECAUTIONS, etc. on label also.
Authorization status:
Registered
Authorization number:
49715
Authorization date:
2020-07-01

FOR ANIMAL TREATMENT ONLY

Bivalent Tick Fever Vaccine

Contains B bovis 1 x 10

7

,

A centrale 1 x 10

7

organisms per dose

For control of Tick Fever in Cattle

READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT

If accidental self-injection occurs, seek medical advice

Dose: 2mL. For subcutaneous or intramuscular injection

WITHHOLDING PERIOD NIL

EXPIRY DATE:

Store between 2°C to 8°C (Refrigerate. Do not freeze)

Tick Fever Centre,

280 Grindle Rd, Wacol, QLD 4076

File name

49715_

20-200mL_immediate_MPL_V02.pdf

Dimensions

95mm X 50mm

Scale

100%

Date

21/05/08 V02

APVMA

49715/20–200mL/0508

20–200mL

BIV 010–100

PANTONE 288

PANTONE 285

PANTONE 1505

4507 _6

APPROVED

LABEL

Info

pest

Verified

FOR ANIMAL TREATMENT ONLY

Bivalent Tick Fever Vaccine

Bivalent vaccine contains:

Babesia bovis 1 x 10

7

organisms per dose

Anaplasma centrale 1 x 10

7

organisms per dose

For control of tick fever (babesiosis

and anaplasmosis) in cattle

This vaccine contains live attenuated strains of tick fever

organisms. One vaccination is usually sufficient to provide

life long immunity against natural tick fever infections.

Immunity to both parasites develops within 8 weeks of

administration of the vaccine.

This vaccine is registered with the Australian Pesticides

and Veterinary Medicines Authority (Reg. No 49715)

and is manufactured in compliance with the Australian

Code of Good Manufacturing Practice for Veterinary

Preparations.

Tick Fever Centre

280 Grindle Rd.,

Wacol, QLD 4076, Australia

Telephone: (07) 3898 9655

Fax No: (07) 3898 9685

E-mail: tfc@dpi.qld.gov.au

DIRECTIONS FOR USE

Restrictions apply on the use of imidocarb in lactating

dairy cattle.

Restrictions also apply to the supply of oxytetracycline; contact

a veterinarian if this drug is to be used.

After Care

Cattle should have access to good feed, shade and water

during and after the expected reaction periods. Stress should

be avoided.

WITHHOLDING PERIOD

Nil; however, carcass quality could be affected by fever if

animals are slaughtered during vaccine reaction periods.

USER SAFETY INFORMATION

Strains of tick fever used in the Australian tick fever vaccines

are not known to be infective for humans. However, the

following people may be at increased risk after self-injection:

elderly people

people with weakened immune systems eg. people whose

immune system has been altered by diseases such as

leukaemia, lymphoma or through drugs and radiation or

HIV or AIDS sufferers.

people whose spleens have been removed.

If accidental self-injection occurs, seek medical advice.

A Material Safety Data Sheet is available on the web site www.

dpi.qld.gov.au/tickfever.

To obtain further information you can visit the DPI & F

web-site: http://www.dpi.qld.gov.au/tickfever/

or Telephone: (07) 3898 9655;

A/H: (07) 389 89666

E-mail: tfc@dpi.qld.gov.au

STORAGE INSTRUCTIONS

Store between 2°C and 8°C (Refrigerate. Do not freeze).

Keep vaccine cool when not in use and protect from direct

sunlight.

Do not use vaccine after the expiry date printed on the label.

DISPOSAL OF CONTAINERS

Dispose of empty containers and outer packaging by wrapping

with paper and putting in garbage.

Discarded needles should be placed in a designated and

appropriately labelled “sharps” container. The container should

be of a type to reduce the possibility of injury to handlers during

collection and disposal. Incineration is the preferred method

of disposal. Other “sharps” should be buried at a suitable

site, such as in farm chemical disposal pit located away from

watercourses.

APVMA Approval No 49715/0508

If you have any concerns about the vaccine supplied, contact

the Tick Fever Centre and refer to the vaccine batch number

printed on the pack

APPROVED

LABEL

DIRECTIONS FOR USE

PRECAUTIONS

Do not use vaccine that is not cool on arrival

(less than 20°C).

Mix vaccine gently before use (Vaccine may vary in colour

between batches but this does not affect its efficacy).

Avoid use of disinfectants on vaccinating equipment as

residues may affect the quality of the vaccine.

Avoid use of chilled tick fever vaccine for at least 8 weeks

after administration of imidocarb, (e.g.Imizol or Imidox).

If possible avoid using simultaneously with other vaccines.

Use other vaccines 2 weeks before or 4 weeks after chilled

tick fever vaccine.

Monitor vaccinated cattle closely during reaction periods,

especially if over 9 months of age

(see monitoring and control of vaccine reactions).

Caution and close supervision is needed, especially

when bulls or pregnant cattle are being vaccinated (see

monitoring and control of vaccine reactions).

Vaccination of pregnant cattle and adult bulls

must be carried out at the owner’s risk in view

of known complications that can arise when

vaccinating these classes of stock.

Cattle older than 9 months run the risk of disease from

concurrent field infections for at least 4 weeks after

vaccination and steps should be taken to prevent exposure

to ticks during this time.

Carcass quality could be affected by fever during vaccine

reaction periods.

DOSAGE AND ADMINISTRATION

USE ALL PRODUCT IMMEDIATELY UPON OPENING

2mL per animal regardless of age or body weight.

For subcutaneous or intramuscular injection only, either behind

the ear or high on the neck.

Safe to use with tick control chemicals (dips, sprays, pour-ons)

and anthelmintics (worm drenches)

Caution: Avoid Carcass Damage

Use sterile disposable injection apparatus or sterilise all

injection apparatus by boiling for 20 minutes immediately

before use. Do not use disinfectants on apparatus and

ensure it is free of moisture before use.

Maintain cleanliness at all times.

Keep needles sharp and clean: replace frequently.

Use needles of appropriate gauge and length.

For subcutaneous administrations ensure the needle does

not exceed 15 mm.

As far as possible avoid injection of animals in wet weather

or dusty conditions.

Vaccinating with a single dose syringe

Tear off the centre foil cover to expose rubber closure on the

vaccine pack.

Pierce rubber closure of vaccine pack with needle and

withdraw one dose (2mL) of vaccine into a syringe.

Vaccinating with an automatic injector

The collapsible plastic vaccine pack is designed for use with an

automatic injector.

Connecting pack to automatic injectors:

Fit needle safely on the automatic injector as recommended

by the supplier.

Do not remove needle sheath until ready to prime.

Connect the draw-off tube firmly to the injector.

Tear off the centre foil cover to expose the vaccine pack’s

rubber closure.

Hold vaccine pack upright and place point of draw-off

spike at the centre of rubber closure.

Push draw-off overcap on to the pack so that the draw-off

spike penetrates rubber closure. Ensure rib on inside of

overcap snaps completely over metal closure.

Adjust the injector to deliver an accurate 2mL dose.

Holding the vaccine pack upside down operate the injector

until vaccine fills the barrel and the tubing is free of air

bubbles.

The vaccine pack can be tied to the operator’s forearm by

inserting cord through the holes at the base of the vaccine

pack. This allows easy, one handed administration of the

vaccine.

Check the barrel of the injector frequently to ensure no air

bubbles are present.

MONITORING AND CONTROL OF

VACCINE REACTIONS

While the majority of animals show no visible reactions, some

may develop severe illness and require treatment. The vaccine

is safest when used in calves 3-9 months of age.

It is advisable to monitor animals older than

9 months of age for rises in body temperature

(resting early morning temperature) between days

10 and 21 after vaccination.

Treat animals promptly if fever exceeds 40.5°C or other signs

of severe reactions are apparent

Persistent high fever may result in temporary sterility in bulls

and abortion

Pregnant cattle should be closely supervised and treated at the

first sign of fever to minimise the risk of abortion.

Babesia reactions may occur between days 10 and 21.

Clinical signs are: fever and/or general signs of ill

health and/or red urine and/or anaemia.

Anaplasma reactions may occur from days 30 to 60

and monitoring for anaemia and/or weight loss is

recommended.

Use imidocarb for treatment of Babesia reactions at dose

rates recommended by the manufacturer. For treatment of

Anaplasma vaccine reaction, imidocarb or oxytetracycline

antibiotic can be used.

Animals treated with imidocarb should be revaccinated, but

no sooner than 8 weeks after treatment as imidocarb may

eliminate the parasites before lasting immunity develops.

APPROVED

LABEL

File name

49715_45076_leaflet_MPL_V02.pdf

Dimensions

297mm X 210mm

Scale

100%

Date

21/05/08 V02

PANTONE 021

PANTONE 288

TICK FEVER CENTRE, WACOL MSDS Bivalent

MATERIAL SAFETY DATA SHEET

BIVALENT TICK FEVER VACCINE

Ref: MSDS2

Rev:6

Date ofIssue: 4/09/08

Page 1 of 5

Department ofPrimaryIndustriesandFisheries,Queensland

Biosecurity

Tick FeverCentre

280GrindleRoad, Wacol Queensland4076Australia

Telephone:+61 738989655

Fax:+61738989685

E-mail: tfc@dpi.qld.gov.au

Web-site:http://www.dpi.qld.gov.au/tickfever/

IDENTIFICATION

Product Name : BIVALENT TICK FEVER VACCINE

Other Names: Bivalent chilled vaccine

Manufacturer’s Product Code : BIV/10, 20, 25, 50, 100.

UN Number: None allocated

Dangerous Goods Class and None allocated, no subsidiary risk

Subsidiary Risk

Hazchem Code: None allocated

Poisons Schedule Number: Not scheduled

Use: For control of Tick Fever(Bovine Babesiosis and

Anaplasmosis)by vaccination in cattle.

Physical Description/Properties:

Appearance: Liquid blood based vaccinepacked in polypropylene

pillow packs

Boiling Point No data. Expected to be about 100 0

C

Vapour Pressure: No data

Specific Gravity: Approximately 0.97

Flammability: Does not burn

Corrosiveness: Not corrosive

TICK FEVER CENTRE, WACOL MSDS Bivalent

MATERIAL SAFETY DATA SHEET

BIVALENT TICK FEVER VACCINE

Ref: MSDS2

Rev:6

Date ofIssue: 4/09/08

Page 2 of 5

Other Properties:

Ingredients: Contains live attenuated tick fever organisms (Babesia bovis

and Anaplasma centrale) in bovine blood diluted with a cell

free diluent. The diluent consists of 10% bovine serumin an

isotonic balanced salt solution.

Each 2 mL dose of bivalent vaccinecontains:

(i) Mixed bovine blood containing Babesia bovis&

Anaplasma centrale(10 7 of each organism)

Maximum blood = 1.20 mL

Minimum blood = 0.03 mL

Average blood = 0.05 mL

(ii) Heparin = 0.5units

(iii) Antibiotics: benzylpenicillin = 1000 units

streptomycin sulphate = 1.0 mg

(vi) Vaccine diluent (isotonicbalancedsaltsolution

containing 10% bovineserum)to 2 mL.

Vaccine Diluent Formulation

Sodium Chloride (NaCl) 119.8 mM

MagnesiumChloride(MgCl

) 1.5 mM

Glucose(C

H

O

) 5.6mM

Disodium hydrogen orthophosphate (Na

HPO4) 17.8 mM

Potassium Dihydrogen orthophosphate (KH

PO4) 5.1mM

Sodium hydrogen carbonate (Na HCO

)6.1mM

Benzylpenicillin 500,000 units/litre

Streptomycin sulphate 500 mg/litre

Sterile bovine serum 100 mLs/litre

TICK FEVER CENTRE, WACOL MSDS Bivalent

MATERIAL SAFETY DATA SHEET

BIVALENT TICK FEVER VACCINE

Ref: MSDS2

Rev:6

Date ofIssue: 4/09/08

Page 3 of 5

HEALTH HAZARD INFORMATION

HEALTH EFFECTS No specific data are available for the product for chronic

exposure symptoms. The vaccineis non toxic and the live

organisms contained in the vaccine are harmless to humans.

The vaccine is not classified as hazardous according to the

criteria of Worksafe Australia.

However the following people may be at increased risk after

self-injection:

Elderly Persons

Persons with weakened immune systems eg. Persons

whose immune systemhas been altered by diseases such as

leukaemia, lymphomaor through drugs and radiation or

HIV or AIDS sufferers; and

Persons whose spleen has been removed.

Acute Swallowing, skin contact, eye contact or inhalation:

According to the present state ofknowledge provided that this

product is handled correctly,there is no known danger to

humans. The product contains low levels of Benzylpenicillin

and Streptomycin Sulphate antibiotics and individuals allergic

to these antibiotics should avoid self-injection or ingestion.

FIRST AID

WARNING: You should seekmedical adviceif accidental self-injection occurs

Self injection: Accidental self-injection may lead toan inflammatory

response and medical adviceshould be sought on the

managementof deep injections,particularly those near a joint

or associated with bruising. If possible the application of

gentle squeezing pressure withabsorbent material (eg facial

tissues) 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.

TICK FEVER CENTRE, WACOL MSDS Bivalent

MATERIAL SAFETY DATA SHEET

BIVALENT TICK FEVER VACCINE

Ref: MSDS2

Rev:6

Date ofIssue: 4/09/08

Page 4 of 5

Swallowed: If in mouth, thoroughly washmouth with water, then give

somewater to drink. Further measures should not be

necessary.

Eye: If this product comes into contact with eyes, hold open and

wash well with clean running water. Ensure irrigation under

eyelids by occasionally lifting them. Do not try to remove

contact lenses unless trained.

Skin: If this product comes into contact with skin, wash skin with

soap and water.

Advice to Doctor: Accidentalselfinjection may lead to an inflammatory

response and deep injections, particularly those near a joint or

associated with bruising should be treated medically or

surgically. The vaccine containslowlevels of the antibiotics

Benzylpenicillin and Streptomycin Sulphate as preservatives

(approximately 500 units of benzylpenicillin and 0.5 mg

streptomycin sulphate per mLof vaccine).

There is no convincing evidence that the organisms used in the

vaccine (Babesia bovis and Anaplasma centrale) are infective

for humans. However related organisms present overseas

includingBabesia microtiandBabesia divergenshave been

shown to be able to infect and causedisease especially in

elderly and immune compromisedindividuals. The organisms

are intra-erythrocytic parasites and the disease syndrome can

resemble malaria. More information on the zoonotic disease

seen in the United States can be found on the web-site

“http://www.riaes.org/resources/ticklab/babesia.html”

PRECAUTIONSFOR USE

Exposure Standards: None available

Engineering Controls: Not applicable

Personal Protection: Avoid self-injection

Flammability: Does not burn

TICK FEVER CENTRE, WACOL MSDS Bivalent

MATERIAL SAFETY DATA SHEET

BIVALENT TICK FEVER VACCINE

Ref: MSDS2

Rev:6

Date ofIssue: 4/09/08

Page 5 of 5

SAFE HANDLING INFORMATION

Storage and Transport: Store at 2 0

to8 0

C (refrigerate, do not freeze)

Spills: N/A non hazardous

Disposal: Dispose of empty containersand outer packaging by

wrapping with paper and putting in garbage. Discarded

needles should be placed in a designated and appropriately

labelled ‘sharps’ container. The container should be of a type

to reduce the possibility ofinjury to handlers during collection

and disposal. Incineration isthe preferred method of disposal,

otherwise ‘sharps’ should be buried at a suitable site, such as

on farmchemical disposal pit located away from watercourses.

Fire/Explosion Hazard: N/A

OTHER INFORMATION

This MSDS has been prepared in accord withthe Worksafe Australia‘National Code for

Preparation of Material Safety Data Sheets, 1994’.

CONTACT POINT

Contact an adviser at: Department ofPrimaryIndustriesandFisheries,Queensland

Biosecurity

Tick FeverCentre

280 GrindleRoad

Wacol Queensland4076 Australia

Telephone: +61 7 3898 9655

Fax: +61 7 3898 9685

E-mail: tfc@dpi.qld.gov.au

Web-site: http://www.dpi.qld.gov.au/tickfever/

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