WEBSTERS 3 IN 1 B12 VACCINE

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

VITAMIN B12; CLOSTRIDIUM PERFRINGENS TYPE D - ANTISERA/ANTIGEN; CORYNEBACTERIUM PSEUDOTUBERCULOSIS; CLOSTRIDIUM TETANI - TOXOID; THIOMERSAL

Available from:

VIRBAC (AUSTRALIA) PTY LTD

INN (International Name):

CLOSTRIDIUM PERFRINGENS TYPE D - ANTISERA/ANTIGEN + others

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

VITAMIN B12 VITAMIN-B12 Active 2.0 mg/ml; CLOSTRIDIUM PERFRINGENS TYPE D - ANTISERA/ANTIGEN VACCINE Active 5.0 IU/ml; CORYNEBACTERIUM PSEUDOTUBERCULOSIS VACCINE Active 1.0 IU/ml; CLOSTRIDIUM TETANI - TOXOID VACCINE-TOXOID Active 2.5 IU/ml; THIOMERSAL MERCURY Other 0.13 mg/ml

Units in package:

100mL; 200mL; 500mL

Class:

VM - Veterinary Medicine

Manufactured by:

VIRBAC

Therapeutic area:

IMMUNOTHERAPY

Product summary:

Poison schedule: 0; Withholding period: WHP: N/A (Zero Days); Host/pest details: LAMB: [CHEESY GLAND, ENTEROTOXAEMIA (PULPY KIDNEY), TETANUS, VITAMIN B12 DEFICIENCY]; SHEEP: [CHEESY GLAND, ENTEROTOXAEMIA (PULPY KIDNEY), TETANUS];

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

Product Name:
Product No:
WEBSTERS 3 IN 1 B12 VACCINE
81120/112426
Label Name:
WEBSTERS 3 IN 1 B12 VACCINE
Signal Headings:
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
Contains aluminium adjuvanted toxoid and cellular antigen from
Corynebacterium
pseudotuberculosis (ovis) 1.0 U/mL, Clostridium perfringens type D 5.0
IU/mL, Clostridium
tetani 2.5 IU/mL, 2 mg/mL vitamin B12 (hydroxocobalamin acetate) and
0.13 mg/mL of
thiomersal added as a preservative.
Claims:
For the prevention of cheesy gland (C. pseudotuberculosis), pulpy
kidney (Cl. perfringens
type D) and tetanus (Cl. tetani) in sheep and lambs.
For the treatment and prevention of vitamin B12 deficiency in sheep in
areas known or
suspected to be cobalt deficient.
Net Contents:
100mL
200mL
500mL
Directions for Use:
READ ENCLOSED LEAFLET BEFORE USING THIS PRODUCT.
Restraints:
Contraindications:
Precautions:
Side Effects:
A localised swelling at the injection site may develop which will
resolve over some weeks.
Dosage and
Administration:
Shake well before use and keep thoroughly mixed during use.
Use the contents within 50 days of first broaching the pack.
Discard the unused portion.
Handle aseptically and follow resealing and storage instructions. RLP APPROVED
Dosage: 1 mL dose by subcutaneous injection (under the skin, NOT into
the muscle).
Lambs: 1 mL dose at marking followed by a second 1 mL dose 4 to 6
weeks later. An
annual booster dose will maintain a high level of immunity.
Ewes (fully vaccinated as lambs): 1mL annual booster dose. Administer
2 to 3 weeks
before lambing if possible. This will ensure that high levels of
protective antibodies are
passed to the lambs in colostrum to protect them in their first 6
weeks of life and at marking.
Slaughter lambs from vaccinated ewes: 1 mL dose at marking. This will
usually be sufficient
to protect prime lambs from vaccinated ewes going to early slaughter.
Unvaccinated rams, ewes and wethers: all unvaccinated sheep introduced
onto a property
should be vaccinated with a 1 mL dose followed by a second 1 mL do

Summary of Product characteristics

VIRBAC (AUSTRALIA) PTY LIMITED
Chemwatch Hazard Alert Code: 0
WEBSTERS 3 IN 1 B12 VACCINE
Chemwatch: 62-7949
Version No: 5.1.1.1
Safety Data Sheet according to WHS and ADG requirements
Issue Date: 10/17/2017
Print Date: 10/18/2017
L.GHS.AUS.EN
SECTION 1 IDENTIFICATION OF THE SUBSTANCE / MIXTURE AND OF THE COMPANY
/ UNDERTAKING
PRODUCT IDENTIFIER
PRODUCT NAME
Websters 3 in 1 B12 Vaccine
SYNONYMS
APVMA No: 81120
OTHER MEANS OF IDENTIFICATION
Not Available
RELEVANT IDENTIFIED USES OF THE SUBSTANCE OR MIXTURE AND USES ADVISED
AGAINST
RELEVANT IDENTIFIED USES
Use according to manufacturer's directions.
DETAILS OF THE SUPPLIER OF THE SAFETY DATA SHEET
REGISTERED COMPANY NAME
VIRBAC (AUSTRALIA) PTY LIMITED
ADDRESS
361 Horsley Road Milperra NSW 2214 Australia
TELEPHONE
1800 242 100
FAX
[phone]
WEBSITE
www.virbac.com.au
EMAIL
[e-mail]
EMERGENCY TELEPHONE NUMBER
ASSOCIATION / ORGANISATION
POISONS INFORMATION CENTRE
EMERGENCY TELEPHONE NUMBERS
13 11 26
OTHER EMERGENCY TELEPHONE
NUMBERS
Not Available
SECTION 2 HAZARDS IDENTIFICATION
CLASSIFICATION OF THE SUBSTANCE OR MIXTURE
POISONS SCHEDULE
Not Applicable
CLASSIFICATION
[1]
Chronic Aquatic Hazard Category 4
_LEGEND:_
_1. Classified by Chemwatch; 2. Classification drawn from HSIS ; 3.
Classification drawn from EC Directive 1272/2008 - Annex VI_
LABEL ELEMENTS
HAZARD PICTOGRAM(S)
Not Applicable
SIGNAL WORD
NOT APPLICABLE
HAZARD STATEMENT(S)
H413
May cause long lasting harmful effects to aquatic life.
PRECAUTIONARY STATEMENT(S) PREVENTION
P273
Avoid release to the environment.
PRECAUTIONARY STATEMENT(S) RESPONSE
Not Applicable
PRECAUTIONARY STATEMENT(S) STORAGE
Not Applicable
PRECAUTIONARY STATEMENT(S) DISPOSAL
P501
Dispose of contents/container in accordance with local regulations.
SECTION 3 COMPOSITION / INFORMATION ON INGREDIENTS
SUBSTANCES
CONTINUED...
See section below for composition of Mixtures
MIXTURES
CAS NO
%[WEIGHT]
NAME
active ingredients, as
Not avail.
<1
Not avail.
<1
Not Available
<1
corynebacterium pseudotuberculosis
22465-48-1
<