POULVAC I PABAC IV

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

PASTEURELLA MULTOCIDA

Available from:

ZOETIS AUSTRALIA PTY LTD

INN (International Name):

Pasteurella multocida

Pharmaceutical form:

MISC. VACCINES OR ANTI SERA

Composition:

PASTEURELLA MULTOCIDA VACCINE-GENERAL Active 0.0 Undefined

Units in package:

1000 doses; 500 mL

Class:

VM - Veterinary Medicine

Manufactured by:

ZOETIS AUSTRALIA

Therapeutic group:

POULTRY | TURKEYS | BREEDER | BREEDERS | BROILER | BROILER BREEDER | CHICKENS | CHICKS | CHOOKS | DAY OLD CHICKS | HATCHLINGS |

Therapeutic area:

IMMUNOTHERAPY

Therapeutic indications:

CHOLERA

Product summary:

Poison schedule: 0; Withholding period: WHP: N/A; Host/pest details: POULTRY: [CHOLERA]; TURKEYS: [CHOLERA]; Poison schedule: 0; Withholding period: ; Host/pest details: POULTRY: [CHOLERA]; TURKEYS: [CHOLERA]; For the vaccination of healthy chickens and turkeys as an aid in the prevention of fowl cholera.Vaccinate only healthy birds. DO NOT mix with other vaccines or products. Studies on use of this vaccine in birds during the laying period have not been conducted.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

APPENDIX 2
Australian Government
AustraUan Pesticides
and
Veterinary Medicines Authority
TEMPLATE
FOR
RELEVANT
LABEL
PARTICULARS
(RLPs)
(Veterinary
Products)
Select appropriate:
D New Product (include
all
applicable RLPs)
OR
IC
Variation (highlight instructions that are being varied). Approval
no.
of
label
being
varied 60278/53428
Signal
heading:
Product name:
Active constituent/s:
Statement
of
claims:
Net contents:
Directions
for
Use
Heading:
Restraints:
Contraindications:
Precautions:
Side
effects:
Dosage
&
administration:
RLP
·
•ilproved
FOR
ANIMAL
TREATMENT
ONLY
Poulvac"'
i
Pabac"'
IV
A liquid adjuvanted bacterin consisting
of
inactivated
Pasteurella mu/tocida,
avian isolates types
1,
3, 4 & 3x4 (9CFR 113.116, 117 & 118)
For
the
vaccination
of
healthy chickens and turkeys as an aid in
the
prevention
of
fowl cholera.
500
ml
(1000
doses)
DIRECTIONS
FOR
USE:
Do
not mix with other vaccines
or
products.
Studies
on
use of this vaccine
in
birds during
the
laying period have not
been
conducted.
N/A
N/A
I
N/A
Side effects: Local reactions in the form
of
palpable swellings
may
be
observed
at the injection site in all birds for at least 4 weeks after
vaccination.
These
reactions do not require
any
particular treatment.
Dosage
and
Administration:
Shake
well
before
use.
Use
entire
contents
within
12
hours
of
opening.
Dose:
Chickens:
Inject
0.5ml
subcutaneously
or
intramuscularly using aseptic
technique. As an aid in prevention
of
fowl cholera type
1.
Subcutaneous Injection
Vaccinate birds subcutaneously
at
6
weeks
of
age
or
older and repeat 4
weeks
later. Duration
of
immunity is
at
least 16
weeks
post-vaccination.
Intramuscular Injection
Vaccinate birds intramuscularly at 9 weeks
of
age
or
older
(duration
of
immunity
not established).
Turkeys:
Inject
0.5ml
subcutaneously using aseptic technique.
As
an aid in
prevention
of
fowl cholera types 3, 4 and 3x4, vaccinate birds 6 weeks
of
aqe
or
18 Wormald Street, Symonston
ACT
2609
PO Box 6182, Kingston
ACT
2604 Australia
Tel:
+61
2 6210 4700 Fax:
+61
2 6210 4874
www.apvma.go

Summary of Product characteristics

PRODUCT NAME: POULVAC PABAC IV
PAGE: 1 OF 6
THIS VERSION ISSUED: 5 SEPTEMBER 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
Level 6, 5 Rider Blvd
Rhodes NSW 2138 AUSTRALIA
Tel: [phone]
Fax: [phone]
Email: [e-mail]
PRODUCT IDENTIFIER:
POULVAC® I PABAC IV
APVMA APPROVAL NUMBER:
60278
OTHER NAMES:
None.
CHEMICAL FAMILY:
A liquid adjuvanted bacterin consisting of inactivated _Pasteurella
multocida_, avian
isolates.
RECOMMENDED USE:
For the vaccination of healthy chickens and turkeys as an aid in the
prevention of fowl
cholera as described on the registered 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, S36, S24/25. Do not breathe vapours or mists. Wear suitable
protective clothing. Avoid
contact with skin and eyes.
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good according to Australian Dangerous
Goods (ADG)
Code, IATA or IMDG/IMSBC criteria.
GHS CLASSIFICATION: NOT HAZARDOUS.
GHS LABEL ELEMENTS: NONE. NOT HAZARDOUS.
SIGNAL WORD: NONE. 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
P352: Wash with plenty of soap and 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 between 2°C and 8°C (refrigerate). Warm up to 24-29°C
and