POULVAC I IBD

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

INFECTIOUS BURSAL DISEASE VIRUS (IBD) STRAIN V877

Available from:

ZOETIS AUSTRALIA PTY LTD

INN (International Name):

IBDV vaccine

Pharmaceutical form:

MISC. VACCINES OR ANTI SERA

Composition:

INFECTIOUS BURSAL DISEASE VIRUS (IBD) STRAIN V877 VACCINE-VIRAL Active 0.0 USP

Units in package:

500mL

Class:

VM - Veterinary Medicine

Manufactured by:

ZOETIS AUSTRALIA

Therapeutic group:

POULTRY | BREEDERS | BROILER | CHICKENS | CHICKS | CHOOKS | DAY OLD CHICKS | HATCHLINGS | LAYERS

Therapeutic area:

IMMUNOTHERAPY

Therapeutic indications:

INFECTIOUS BURSAL DISEASE | BURSAL DISEASE

Product summary:

Poison schedule: 0; Withholding period: WHP:Nil; Host/pest details: POULTRY: [INFECTIOUS BURSAL DISEASE]; Poison schedule: 0; Withholding period: ; Host/pest details: POULTRY: [INFECTIOUS BURSAL DISEASE]; For vaccination of poultry following priming with a live avian infectious bursal disease virus vaccine. An aid in prevention of the signs and lesions associated with avian infectious bursal disease in the progeny of vaccinated poultry.Vaccinate healthy birds only. DO NOT mix with other vaccines or products.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

(
(
APPENDIX 2
Australian Government
Australian Pesticides
and
Veterinary Medicines Authority
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 54684/1208
Signal
heading:
Product
name:
Active
constituenVs:
Statement
of
claims:
Net
contents:
Directions
for
Use
Heading:
Restraints:
Contraindications:
Precautions:
Side
effects:
Dosage
&
administration:
FOR
ANIMAL
TREATMENT
ONLY
Poulvac®
i
IBD
l;omalns
avian infectious bursal
virus("
10"·"
TCID,nl. grown on tissue
culture, chemically inactivated and emulsified
in
an oil base. Contains
gentamicin added
as
a preservative.
For
vaccination
of
poultry
•unuvv"'IJ
priming with a live avian ",
bursal
disease virus vaccine. An aid
in
prevention
of
the signs and lesions associated
with avian infectious bursal disease in the progeny
of
vaccinated poultry.
500
m L (
1000
doses)
DIRECTIONS
FOR
USE
Vaccinate healthy birds only.
NA
~
NA
RJ.P
Precautions:
-'"'1-'P"
u
;cu
Do
not
mix with other vaccines
or
products.
If
it is desired to vaccinate birds during lay, a drop in egg production
may
occur
.
Side
effects:
As
with any oil emulsion product, post-vaccination reactions may
occur. These may include: swelling at the site
of
injection, granulomas
at
the
site
of
injection (which may cause processing plant condemnations), stiff
necks,
swollen heads, transient inappetence, and dehydration. Such reactions
may
be
aggravated by improper vaccination techniques.
Dosage
and
Administration:
This vaccine is
recommended
for the active protection
of
healthy chickens
against the signs and lesions associated with avian infectious bursal
disease.
This
vaccine
will
confer passive protection
of
progeny from the
signs
and
lesions associated with avian infectious bursal disease when
administered to
primed birds vaccinated approximately 4 weeks prior
to
laying (around
16-22
weeks
of
age). For best protection, prime the b

Summary of Product characteristics

PRODUCT NAME: POULVAC I IBD
PAGE: 1 OF 5
THIS VERSION ISSUED: JUNE, 2013
SAFETY DATA SHEET
Issued by: Zoetis Australia Pty Ltd
Phone: [phone]
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND)
SECTION 1 - IDENTIFICATION OF THE MATERIAL AND SUPPLIER
Zoetis Australia Pty Ltd
38-42 Wharf Road
West Ryde NSW 2114
Tel: [phone]
Fax: [phone]
____________________________________
ZOETIS AUSTRALIA PTY LTD
ABN 94 156 476 425
CHEMICAL NATURE:
Infectious Bursal Disease killed virus vaccine in a suitable medium.
TRADE NAME:
POULVAC I IBD
APVMA CODE:
54684
PRODUCT USE:
Animal vaccine for use as described on the product label.
CREATION DATE:
JUNE, 2013
THIS VERSION ISSUED:
JUNE, 2013
and is valid for 5 years from this date.
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:
S23, S25, S36. Do not breathe mists. Avoid contact with eyes. Wear
suitable protective clothing.
SUSMP CLASSIFICATION:
None allocated.
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
UN NUMBER:
None allocated
GHS SIGNAL WORD: NONE. NOT HAZARDOUS.
PREVENTION
P102: Keep out of reach of children.
RESPONSE
P353: Rinse skin or shower with water.
P301+P330+P331: IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
P332+P313: If skin irritation occurs: Get medical advice.
P337+P313: If eye irritation persists: Get medical advice.
P370+P378: Not combustible. Use extinguishing media suited to burning
materials.
STORAGE
P402+P404: Store in a dry place. Store in a closed container.
P403+P235: Store in a well-ventilated place. Keep cool.
DISPOSAL
P501: Dispose of small quantities and empty containers by wrapping
with paper and putting in garbage. For
larger quantities, if recycling or reclaiming is not possible, use a
commercial waste disposa