POULVAC CVI VACCINE (SEROTYPE 1, LIVE MAREK'S DISEASE VIRUS)

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

MAREK'S DISEASE LIVE VIRUS STRAIN CVI988

Available from:

ZOETIS AUSTRALIA PTY LTD

INN (International Name):

MDV (CVI 988)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

MAREK'S DISEASE LIVE VIRUS STRAIN CVI988 VACCINE-VIRAL Active 1000.0 PFU/dose

Units in package:

5x 1000; 5x 2000; dose 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 | HERPES VIRUS OF TURKEYS (HVT)

Product summary:

Poison schedule: 0; Withholding period: WHP: NIL; Host/pest details: EMBRYONATED CHICKEN EGG: [MAREK'S DISEASE]; POULTRY CHICKS: [MAREK'S DISEASE]; 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
AustraUan Pesticides
and
Veterinary Medicines Authority
TEMPLATE
FOR
RELEVANT
LABEL
PARTICULARS
(RLPs)
(Veterinary Products)
Select appropriate:
D
New
Product (include
all
applicable
RLPs)
OR
It
Variation (highlight instructions that
are
being
varied). Approval
no.
of
label
being
varied
56670/1003
Signal
heading:
Product
name:
Active
constituentls:
Statement
of
claims:
Net
contents:
Directions
tor
Use
Heading:
Restraints:
Contraindications:
Precautions:
Side
effects:
Dosage
&
administration:
FOR
ANIMAL
TREATMENT
ONLY
,
vuova..
CVI
Vaccine
(Serotype
1,
Live
Marek's
Disease
Virus)
Each ampoule contains serotype 1 Marek's disease virus strain CVIgaa,
~
1 ,000 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 or 2,000 dose ampoules
DIRECTIONS FOR USE
READ DIRECTIONS ON LEAFLET BEFORE USING THIS PRODUCT
USE ALL PRODUCT WITHIN 2 HOURS OF OPENING
NA
NA
NA
RLP
NA
L-ij.lj.n
uveu
Directions
for
Subcutaneous
Administration:
1.
2.
3.
4.
5.
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). Note the optimal temperature for reconstitution and use is
15-26°C.
Wear protective clothing when withdrawing the vaccine ampoules from a
liquid nitrogen refrigerator. Protect hands with gloves,
wear
long sleeves,
and use a facemask
or
goggles.
Before opening the liquid

Summary of Product characteristics

Product Name: Poulvac® CVI Vaccine (Serotype 1, Live Marek's Disease
Virus)
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:
Water solution/suspension of live virus.
TRADE NAME:
POULVAC
® CVI VACCINE (SEROTYPE 1, LIVE
MAREK'S DISEASE VIRUS)
APVMA CODE:
56670
PRODUCT USE:
V
accine to aid in the prevention of signs and lesions of Marek’s
disease in chickens
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.
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 under the ADG Code.
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, presented as frozen liquid
at -196°C
ODOUR:
Mild 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 AND LABEL. EFFECTS DESCRIBED IN THIS MSDS RELATE TO SHORT