POULVAC HVT CF VACCINE (SEROTYPE 3, LIVE MAREK'S DISEASE VIRUS)

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

MAREK'S DISEASE VIRUS, SEROTYPE 3, HVT STRAIN FC 126; GENTAMICIN

Available from:

ZOETIS AUSTRALIA PTY LTD

INN (International Name):

MDV (HVT-FC 126)(1000PFU/Ds)

Pharmaceutical form:

MISC. VACCINES OR ANTI SERA

Composition:

MAREK'S DISEASE VIRUS, SEROTYPE 3, HVT STRAIN FC 126 VACCINE-GENERAL Active 1000.0 PFU/dose; GENTAMICIN ANTIBIOTIC Other 0.0 P

Units in package:

#10x1000; #dose vial; *1x1000; *dose vial

Class:

VM - Veterinary Medicine

Manufactured by:

ZOETIS AUSTRALIA

Therapeutic group:

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: POULTRY CHICKS: [MAREK'S DISEASE]; Poison schedule: 0; Withholding period: ; Host/pest details: POULTRY CHICKS: [MAREK'S DISEASE]; For the subcutaneous vaccination of healthy 1-day old chicks 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

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
IC
Variation (highlight instructions
that
are
being
varied}.
Approval
no.
of
label
being
varied
53275/1104
Signal heading:
Product name:
Active constituenUs:
Statement
of
claims:
Net contents:
Directions for Use
Heading:
FOR ANIMAL TREATMENT
ONLY
Pou
HVT CF
Vaccine
(Serotype
3,
Live
Marek's
Disease
Each
i
contains
eel
serotype
Marek's
sease
(Herpes Virus
Turkeys [HVT] strain FC 126,
~
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.
product
is
recommended
one-
day-old chicks to aid in the prevention
of
the signs and lesions of Marek's
disease.
1
, 000 ( 1
OX
1
000) dose vials
DIRECTIONS FOR USE
READ ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
USE ALL PRODUCT WITHIN 2 HOURS OF OPENING
Restraints:
NA
Contraindications:
NA
Precautions:
Side effects:
Dosage
&
administration:
NA
NA
RLP
Approved
1.
Vaccinate healthy one-day-old chicks only. Flocks in unthrifty
condition,
suffering from other diseases or parasitic conditions, may show severe
reactions.
2.
Avoid early exposure of chicks to Marek's disease to allow
for
development
of
protection.
3.
Poulvac® Marek's Diluent (Poulvac® Sterile Diluent) is recommended
as
vaccine diluent. Store the diluent at room temperature. Avoid freezing
or
excessive temperatures (over 40°C).
4.
For subcutaneous route of vaccination, use 200 mLs of diluent per 1
,000
doses of vaccine. Ensure diluent
is
at room temperature when mixing with
vaccine virus.
Do
not use chilled diluent for this step.
5.
Using a sterile mixing syringe with a 38mm 18-gauge (18G X 1
Y:.")
needle,
draw up a small amount of diluent.
6.
Gently inject the diluent into the vial and swirl to thoroughly mix
the
contents. Draw the contents from the vaccine vial

Summary of Product characteristics

Product Name: Poulvac® HVT CF Vaccine (Serotype 3, Live Marek’s
Disease Virus)
Page: 1 of 4
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:
Live freeze-dried virus vaccine.
TRADE NAME:
POULVAC
® HVT CF VACCINE (SEROTYPE 3, LIVE
MAREK’S DISEASE VIRUS)
APVMA CODE:
53275
PRODUCT USE:
Vaccine to aid in p
revention of the 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
Australia.
Not a Dangerous Good according to the Australian Dangerous Goods (ADG)
Code.
RISK PHRASES:
Not Hazardous - No criteria found.
SAFETY PHRASES:
Not Hazardous - No criteria found.
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
: Freeze dried plug.
ODOUR:
No data.
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
THERE APPEARS TO BE NO EVIDENCE OF MAREK’S DISEASE INFECTING HUMANS.
HOWEVER, AVOID CONTACT.
INHALATION:
SHORT TERM EXPOSURE:
Significant inhalation exposure is considered to be unlikely.
Available data indicates that thi