PESTIGARD VACCINE

Land: Australien

Sprog: engelsk

Kilde: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Aktiv bestanddel:

INACTIVATED BOVINE PESTIVIRUS - BEGA STRAIN; INACTIVATED BOVINE PESTIVIRUS - TRANGIE STRAIN; THIOMERSAL

Tilgængelig fra:

ZOETIS AUSTRALIA PTY LTD

INN (International Name):

bovine viral diarrhoea

Lægemiddelform:

MISC. VACCINES OR ANTI SERA

Sammensætning:

INACTIVATED BOVINE PESTIVIRUS - BEGA STRAIN VACCINE-VIRAL Active 0.0 P; INACTIVATED BOVINE PESTIVIRUS - TRANGIE STRAIN VACCINE-VIRAL Active 0.0 P; THIOMERSAL MERCURY Other 0.1 mg/ml

Enheder i pakken:

!100 DOSES; !50mL; #250 DOSES; #50mL; *500 DOSES; *50mL

Klasse:

VM - Veterinary Medicine

Fremstillet af:

ZOETIS AUSTRALIA

Terapeutisk gruppe:

CATTLE | BEEF | BOS INDICUS | BOS TAURUS | BOVINE | BUFFALO | BULL | BULLOCK | CALF | COW | DAIRY COW | HEIFER | STEER

Terapeutisk område:

IMMUNOTHERAPY

Terapeutiske indikationer:

BOVINE PESTIVIRUS

Produkt oversigt:

Poison schedule: 0; Withholding period: WITHOLDING PERIOD: Nil EXPORT SLAUGHTE R INTERVAL (ESI): ESI not applicable.; Host/pest details: CALVES FROM 3 MONTHS OF AGE: [BOVINE PESTIVIRUS]; CATTLE: [BOVINE PESTIVIRUS]; For the active immunisation of cattle against BVDV (also known as Bovine Pestivirus) and to reduce reproductive losses due to BVDV. For the prevention of nasal shedding of BVDV.

Autorisation status:

Registered

Autorisation dato:

2023-07-01

Indlægsseddel

For Official Use Only
E-LABEL APPLICATION (DRAFT)
COMPANY NAME:
ZOETIS AUSTRALIA PTY LTD
PRODUCT NAME:
PESTIGARD VACCINE
ELABEL APPLICATION NO:
DC13-98701581E54
APVMA APPROVAL NO:
53867/101097
PRODUCT NO:
53867
VERSION NO:
4.0
APPLICATION STARTED:
2014-Nov-06 11:38:23
VERSION CREATED:
2015-Jan-12 13:32:50
STARTED BY:
Janet Mosbey
PRINTED:
2015-Jan-12 13:36:05
LABEL NAME:
PESTIGARD VACCINE
SIGNAL HEADINGS:
FOR ANIMAL TREATMENT ONLY
CONSTITUENT
STATEMENTS:
#10^6.7 TCID50/dose of Bega and #10^7.5 TCID50/dose of Trangie,
Australian strains of
Bovine Viral Diarrhoea Virus (BVDV).
0.1 mg/ml Thiomersal is added as a preservative.
CLAIMS:
For the active immunisation of cattle against BVDV (also known as
Bovine Pestivirus) and
to reduce reproductive losses due to BVDV. For the prevention of nasal
shedding of BVDV
NET CONTENTS:
50 [100, 250, 500] mL
DIRECTIONS FOR USE:
DIRECTIONS FOR USE
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
RESTRAINTS:
NA
CONTRAINDICATIONS:
NA
PRECAUTIONS:
NA
SIDE EFFECTS:
Side effects:
Some swelling may develop at the site of vaccination, which may last
for several weeks
before gradually subsiding.
Following vaccination with this product, a transient febrile response
in animals may be
observed. This response could contribute to a sudden drop in milk
production by affected
dairy cattle
DOSAGE AND
ADMINISTRATION:
This section contains file attachment.
FILE NAME: Dosage and administration Pestigard Jan 15.docx
FILE SIZE: 70470 bytes RLP APPROVED
For Official Use Only
GENERAL DIRECTIONS:
INDICATIONS FOR USE
Pestigard is an orange/pink aqueous suspension containing inactivated,
Bega and Trangie
strains of Australian Bovine Viral Diarrhoea Virus (BVDV), also known
as Bovine Pestivirus,
with immunostimulating complex. As an inactivated vaccine, Pestigard
can be used in both
infected and non-infected herds for the routine immunisation of all
classes and all ages
of cattle, including pregnant cows, against infection with BVDV.
Immunisation to reduce
reproductive loss however, can only be effective w

Produktets egenskaber

PRODUCT NAME: PESTIGARD® VACCINE
PAGE: 1 OF 6
THIS VERSION ISSUED: 19 FEBRUARY 2015
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
Level 6, 5 Rider Blvd
Rhodes NSW 2138 AUSTRALIA
Tel: [phone]
Fax: [phone]
Email: [e-mail]
PRODUCT IDENTIFIER:
PESTIGARD® VACCINE
OTHER NAMES:
None.
APVMA APPROVAL NO:
53867
CHEMICAL FAMILY:
Inactivated Bovine viral diarrhoea virus – Bega and Trangie strains
in an aqueous
medium.
RECOMMENDED USE:
Animal vaccine for use as described on the product label.
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 Australian Dangerous Goods (ADG)
Code, IATA or IMDG/IMSBC criteria.
RISK PHRASES:
Not Hazardous - No criteria found.
SAFETY PHRASES:
S23, S25, S36. Do not breathe mists. Avoid contact with eyes. Wear
suitable protective clothing.
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good according to Australian Dangerous
Goods (ADG)
Code, IATA or IMDG/IMSBC criteria.
GHS LABEL ELEMENTS: NONE
SIGNAL WORD: NONE – NOT HAZARDOUS.
GHS CLASSIFICATION: NOT HAZARDOUS.
PREVENTION
P102: Keep out of reach of children.
P262: Do not get in eyes, on skin, or on clothing.
P281: Use personal protective equipment as required.
RESPONSE
P353: Rinse skin or shower with water.
P301+P330+P331: IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
P370+P378: Not combustible. Use extinguishing media suited to burning
materials.
STORAGE
P410: Protect from sunlight.
P411: Store at temperatures preferably between 2 and 8°C, but do not
freeze.
P403+P233: Store in a well-ventilated place. Keep container tightly
closed.
DISPOSAL
P501: Dispose of small quantit