POULVAC CVI/HVT VACCINE (SEROTYPES 1 AND 3, LIVE MAREK'S DISEASE VIRUSES)

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

MAREK'S DISEASE LIVE VIRUS STRAIN CVI988; HERPES VIRUS OF TURKEYS (HVT) STRAIN FC 126

Available from:

ZOETIS AUSTRALIA PTY LTD

INN (International Name):

MDV (HVT-FC 126)(1000PFU/Ds)+MDV (CVI 988)(1000PFU/Ds)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

MAREK'S DISEASE LIVE VIRUS STRAIN CVI988 VACCINE-VIRAL Active 1000.0 PFU/dose; HERPES VIRUS OF TURKEYS (HVT) STRAIN FC 126 VACCINE-VIRAL Active 1000.0 PFU/dose

Units in package:

#(amp=1000; #doses); 5x2mL Amps

Class:

VM - Veterinary Medicine

Manufactured by:

ZOETIS AUSTRALIA

Therapeutic group:

EMBRYONATED CHICKEN EGG | POULTRY CHICKS | CHICKENS | DAY OLD CHICKS | HATCHLINGS

Therapeutic area:

IMMUNOTHERAPY

Therapeutic indications:

MAREK'S DISEASE | VACCINE | EQUINE ROTAVIRUS | HERPES VIRUS OF TURKEYS (HVT)

Product summary:

Poison schedule: 0; Withholding period: WHP: NIL; Host/pest details: EMBRYONATED CHICKEN EGG: [MAREK'S DISEASE, VACCINE]; POULTRY CHICKS: [MAREK'S DISEASE, VACCINE]; For the subcutaneous vaccination of healthy one-day-old chicks or the in ovo vaccination of 18-19 day old embryonated chicken eggs to aid in the prevention of the signs and lesions of Marek's disease.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

APPENDIX2
Australian Government
Australian Pesticides
and
Veterinary Medicines Authority
TEMPLATE FOR RELEVANT LABEL PARTICULARS (RLPs)
(Veterinary
Products)
Select appropriate:
D
New
Product (include
all
applicable
RLPs)
OR
)(
Variation (highlight instructions that
are
being
varied).
Approval
no.
of
label
being
varied 53259/0802
Signal
heading:
Product
name:
Active
constituenVs:
Statement
of
claims:
Net
contents:
Directions
for
Use
Heading:
Restraints:
Contra
indications:
Precautions:
Side
effects:
Dosage
&
administration:
FOR
ANIMAL
TREATMENT
ONLY
Dn"
...,v,m/T
Vaccine
(Serotypes
1
and
3,
Live
Marek's
Disease
Viruses)
Each ampoule contains serotype 3 Marek's disease virus Herpes Virus
of
Turkeys [HVT] strain FC 126,
.::
1 ,000 pfu per dose and Chicken herpesvirus
strain CVI 988,
.::
1000 pfu per dose. The vaccine virus has been purified and
grown
in
tissue cultures derived from specific pathogen free (SPF) embryos.
The vaccine contains gentamicin as a preservative.
This product is recommended
for
the subcutaneous vaccination
of
healthy one-
day-old chicks
or
the
_in _
_ovo _
vaccination
of
18 to 19 day-old embryonated
chicken eggs to aid in the prevention
of
the signs and lesions
of
Marek's
disease.
Each cane contains 5 x 1,000 dose ampoules
DIRECTIONS FOR USE
USE
ALL
PRODUCT WITHIN 2 HOURS
OF
OPENING
Use entire contents when first opened. Read directions on leaflet
before using
this product.
NA
NA
NA
NA
~
1.
2.
3.
4.
5.
......
A,irl~ve0
for
Subcu\.g ..
~~w..>
Adm~
..
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g ...... :
Vaccinate healthy one-day-old chicks only. Flocks
in
unhealthy condition,
suffering from other diseases or parasitic conditions, may show severe
reactions.
Avoid early exposure
of
chicks to Marek's disease to allow for development
of
protection.
Use Poulvac® Marek's Diluent (Poulvac® Sterile Diluent) only. Store
the
diluent at room temperature. Avoid freezing
or
excessive temperatures (over
40°C).
Wear
protective clothing when withdrawing the vaccine ampoules from a
liquid nitrogen refrigerator. Protect hands with gloves,
wea

Summary of Product characteristics

Product Name: Poulvac® CVI-HVT Vaccine (Serotypes 1 and 3, Live
Marek's Disease Viruses)
Page: 1 of 5
This revision issued: November, 2012
SAFETY DATA SHEET
Issued by: Pfizer Animal Health 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
Pfizer Animal Health Australia Pty Ltd
38-42 Wharf Road
West Ryde NSW 2114
Tel: [phone]
Fax: [phone]
__________________________________________________________
PFIZER ANIMAL HEALTH AUSTRALIA PTY LTD
ABN 94 156 476 425
CHEMICAL NATURE:
Suspension of live viruses in water.
TRADE NAME:
POULVAC
® CVI-HVT VACCINE (SEROTYPES 1 AND 3, LIVE MAREK'S DISEASE VIRUSES)
APVMA CODE:
53259
PRODUCT USE:
V
accine to aid in the prevention of signs and lesions of Marek’s
disease in chickens
OTHER NAME:
Serotypes 1 and 3, Live Marek’s Disease Viruses
CREATION DATE:
JULY, 2012
THIS VERSION ISSUED:
NOVEMBER, 2012
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
Australia.
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.
SUSMP CLASSIFICATION:
None allocated.
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good.
UN NUMBER:
None allocated
E
E
E
M
M
M
E
E
E
R
R
R
G
G
G
E
E
E
N
N
N
C
C
C
Y
Y
Y
O
O
O
V
V
V
E
E
E
R
R
R
V
V
V
I
I
I
E
E
E
W
W
W
PHYSICAL DESCRIPTION & COLOUR
: Pinkish coloured slightly cloudy liquid when thawed.
ODOUR:
No specific odour.
MAJOR HEALTH HAZARDS:
no significant risk factors have been found for this product.
P
P
P
O
O
O
T
T
T
E
E
E
N
N
N
T
T
T
I
I
I
A
A
A
L
L
L
H
H
H
E
E
E
A
A
A
L
L
L
T
T
T
H
H
H
E
E
E
F
F
F
F
F
F
E
E
E
C
C
C
T
T
T
S
S
S
NOTE: DIFFERENT HAZARD ASSESSMENT CRITERIA OF SWA AND TGA MAY RESULT
IN SEEMING INCONSISTENCIES BETWEEN
MSDS A