ULTRAVAC SCOURSHIELD VACCINE

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

BOVINE ROTAVIRUS G10; BOVINE ROTAVIRUS G6; E. COLI STRAIN - O64:K99; BOVINE CORONAVIRUS (INACTIVATED); GENTAMICIN; FORMALDEHYDE; THIOMERSAL

Available from:

ZOETIS AUSTRALIA PTY LTD

INN (International Name):

vaccine - bovine rotavirus+vaccine - bovine coronavirus+E.coli

Pharmaceutical form:

MISC. VACCINES OR ANTI SERA

Composition:

BOVINE ROTAVIRUS G10 Active 1.0 RP/2mL D; BOVINE ROTAVIRUS G6 Active 1.3 RP/2mL D; E. COLI STRAIN - O64:K99 VACCINE-MICROBIAL Active 1.0 RP/2mL D; BOVINE CORONAVIRUS (INACTIVATED) VACCINE-VIRAL Active 1.0 RP/2mL D; GENTAMICIN ANTIBIOTIC Other 30.0 ug/ml; FORMALDEHYDE ALDEHYDE Other 0.74 mg/ml; THIOMERSAL MERCURY Other 0.1 mg/ml

Units in package:

100mL; 10x100mL; 20mL

Class:

VM - Veterinary Medicine

Manufactured by:

ZOETIS AUSTRALIA

Therapeutic group:

COW - PREGNANT | HEALTHY PREGNANT HEIFER | BOVINE | PREGNANT COW

Therapeutic area:

IMMUNOTHERAPY

Therapeutic indications:

NEONATAL CALF DIARRHEA

Product summary:

Poison schedule: 0; Withholding period: WHP: NA; Host/pest details: COW - PREGNANT: [NEONATAL CALF DIARRHEA]; HEALTHY PREGNANT HEIFER: [NEONATAL CALF DIARRHEA]; Poison schedule: 0; Withholding period: ; Host/pest details: COW - PREGNANT: [NEONATAL CALF DIARRHEA]; HEALTHY PREGNANT HEIFER: [NEONATAL CALF DIARRHEA]; For the vaccination of healthy, pregnant cows and heifers as an aid in preventing diarrhoea in their calves caused by bovine rotavirus and enterotoxigenic strains of E. coli..., and for control of diarrhoaea in their calves caused by bovine coronavirus

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

18 Wormald Street, Symonston ACT 2609
PO Box 6182, Kingston ACT 2604 Australia
Tel: [phone] Fax: [phone]
www.apvma.gov.au ABN 19 495 043 447
APPENDIX 2
TEMPLATE FOR RELEVANT LABEL PARTICULARS (RLPS) _(VETERINARY PRODUCTS)_
_Select appropriate: _

New Product (include all applicable RLPs) OR

Variation (highlight instructions that are being varied). Approval no.
of label being varied: 61027
_ _
Signal heading:
FOR ANIMAL TREATMENT ONLY
Product name:
Ultravac Scourshield Vaccine
Active constituent/s:
Inactivated Bovine Calf Scours vaccine containing Bovine rotavirus G6
≥1.3 RP/2mL,
Bovine rotavirus G10 ≥1.0 RP/2mL, Bovine coronavirus ≥1.2 RP/2mL
and E. coli K99
≥1.0 RP/2mL
0.1 mg/mL Thiomersal is added as a preservative.
Contains ≤30μg/mL Gentamicin
Contains ≤0.74mg/mL Formaldehyde
Statement of claims:
Ultravac
®
Scourshield™ vaccine may be used for the vaccination of healthy,
pregnant
cows and heifers as an aid in preventing diarrhoea in their calves
caused by bovine
rotavirus (serotypes G6 and G10) and enterotoxigenic strains of E.
coli having the
K99 pili adherence factor, and for control of diarrhoea in their
calves caused by
bovine coronavirus.
Net contents:
20 mL, 100 mL, 10 x 100 mL
Directions for Use
Heading:
DIRECTIONS FOR USE
Restraints:
Contraindications:
Precautions:
PRECAUTIONS
Interaction: No information is available on the safety and efficacy of
the concurrent
use of this vaccine with any other products
Side effects:
A transient increase in body temperature may be observed in some
animals following
vaccination. Large swelling is likely to develop at the site of
subcutaneous
vaccination and last for at least 4 weeks post vaccination.
Dosage &
administration:
Dosage and Administration:
Shake well before use and keep thoroughly mixed during use
This product can be stored and used for up to 63 days (9 weeks) after
first opening.
Store unused material upright, at 2
o
C to 8
o
C (refrigerated).
The dose on all occasions is 2 mL injected intramuscularly or
subcutaneousl

Summary of Product characteristics

PRODUCT NAME: ULTRAVAC
® SCOURSHIELD
™ VACCINE
PAGE: 1 OF 7
THIS VERSION ISSUED: 14 MARCH, 2014
SAFETY DATA SHEET
Issued by: Zoetis Australia Pty Ltd
Phone: [phone]
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA
SECTION 1 - IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND SUPPLIER
ZOETIS AUSTRALIA PTY LTD
ABN 94 156 476 425
38-42 Wharf Road
West Ryde NSW 2114 AUSTRALIA
Tel: [phone]
Fax: [phone]
Email: [e-mail]
PRODUCT IDENTIFIER:
ULTRAVAC
® SCOURSHIELD
® VACCINE
OTHER NAMES:
None
CHEMICAL FAMILY:
Not applicable.
APVMA APPROVAL NO:
65032/49934
RECOMMENDED USE:
For the vaccination of healthy, pregnant cows and heifers as an aid in
preventing
diarrhoea in their calves caused by bovine rotavirus (serotypes G6 and
G10) and
enterotoxic strains of E. coli having the K99 pili adherence factor,
and for control of
diarrhoea in their calves caused by bovine coronavirus.
RESTRICTIONS ON USE
For veterinary use only.
EMERGENCY PHONE:
1800 814 883 (ALL HOURS)
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as:
Not classified as hazardous according to the criteria of SWA.
Not a Dangerous Good according to the Australian Dangerous Goods (ADG)
Code.
RISK PHRASES:
Not Hazardous - No criteria found.
SAFETY PHRASES:
S24/25. Avoid contact with skin and eyes.
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
GHS CLASSIFICATION:
GHS LABEL ELEMENTS: NONE
SIGNAL WORD: NONE. NOT HAZARDOUS.
HAZARD STATEMENT:
None.
PRECAUTIONARY STATEMENTS
None.
PREVENTION
P102: Keep out of reach of children.
P280: Wear protective gloves, protective clothing and eye or face
protection.
RESPONSE
P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P333+P313: If skin irritation or rash occurs: Get medical advice.
STORAGE
P411: Store at temperatures not exceeding 8°C.
DISPOSAL
P501: Dispose of small quantities and empty containers by wrapping
with paper and putting in garbage. For
larger quantities, if recycling or reclaiming i