POULVAC NEWCASTLE V4

国家: 澳大利亚

语言: 英文

来源: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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资料单张 资料单张 (PIL)
19-06-2017
产品特点 产品特点 (SPC)
19-06-2017

有效成分:

NEWCASTLE DISEASE STRAIN V-4 VIRUS

可用日期:

ZOETIS AUSTRALIA PTY LTD

INN(国际名称):

vaccine - Newcastle disease

药物剂型:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

组成:

NEWCASTLE DISEASE STRAIN V-4 VIRUS VACCINE-VIRAL Active 0.0 P

每包单位数:

10x(1000); 10x(10000); 10x(2000); 10x(5000); dose vials

类:

VM - Veterinary Medicine

厂商:

ZOETIS AUSTRALIA

治疗组:

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

治疗领域:

IMMUNOTHERAPY

疗效迹象:

NEWCASTLE DISEASE

產品總結:

Poison schedule: 0; Withholding period: WHP:nil ESI: ESI not required; Host/pest details: POULTRY: [NEWCASTLE DISEASE]; For the prevention of Newcastle disease in poultry.

授权状态:

Registered

授权日期:

2023-07-01

资料单张

                                APPENDIX 2
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:
42019/50612.
Signal heading:
FOR ANIMAL TREATMENT ONLY
Product name:
POULVAC NEWCASTLE V4
Active constituent/s:
EACH DOSE CONTAINS NEWCASTLE DISEASE LIVE VIRUS (V4 STRAIN;
≥ 10
6.0
EID
50
),
NYSTATIN (
≤ 0.0925 UNITS) AND GENTAMICIN (
≤ 0.0925 ΜG) ARE USED AS
PRESERVATIVES
Statement of claims:
FOR THE PREVENTION OF NEWCASTLE DISEASE IN POULTRY
Net contents:
10 X 1000 [2000, 5000, 10000] DOSE VIALS
Directions for Use
Heading:
DIRECTIONS FOR USE
USE OF THIS VACCINE MAY BE RESTRICTED IN YOUR STATE OR TERRITORY.
CONTACT
YOUR LOCAL DEPARTMENT OF AGRICULTURE (OR SIMILAR) FOR DETAILS.
PLEASE NOTE THAT MANAGEMENT CONDITIONS MUST BE SATISFACTORY IF
NEWCASTLE DISEASE VACCINATION BY DRINKING WATER METHOD IS TO BE
SUCCESSFUL.
Restraints:
NIL
Contraindications:
NIL
Precautions:
NIL
Side effects:
NIL
Dosage &
administration:
DOSAGE AND ADMINISTRATION
USE ALL PRODUCT WITHIN 30 MINUTES OF RECONSTITUTION
Poulvac Newcastle V4 can be used to vaccinate day old chickens by
eyedrop,
spray or intranasal application. Chickens over 4 days of age can be
vaccinated
via the drinking water method.
CHICKENS 1 TO 5 DAYS OF AGE
•
1ST VACCINATION: Eyedrop, spray or intranasal methods from day old.
Water
vaccination from 4 days or older.
•
2ND VACCINATION: 3 weeks later usually by water but eyedrop or
intranasal
routes can be used.
OTHER AGE GROUPS
Two vaccinations three weeks apart using the drinking water method are
recommended, but other methods may be employed. Replacement birds RLP APPROVED
should be revaccinated at 14-16 weeks of age by the most appropriate
method.
REVACCINATION
Drinking water vaccination, but other methods may be employed.
METHOD OF VACCINATION
EYEDROP METHOD:
CORRECT EYEDROP DILUENT MUST BE USED
For 1000 dose vials, reconstitute as follows:
1. The vaccine is supplied as 
                                
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产品特点

                                Product Name: Poulvac® Newcastle V4
Page: 1 of 5
This revision issued: November, 2012
SAFETY DATA SHEET
Issued by: Pfizer Animal Health Australia Pty Ltd
Phone: 1800 814 883
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: 1800 814 883
Fax: (02) 9850 3399
__________________________________________________________
PFIZER ANIMAL HEALTH AUSTRALIA PTY LTD
ABN 94 156 476 425
CHEMICAL NATURE:
Live avian virus freeze dried for reconstitution and use.
TRADE NAME:
POULVAC
® NEWCASTLE V4
APVMA CODE:
42019
PRODUCT USE:
Disease prevention vaccine for poultry to provide protection against
Newcastle
Disease (ND). Should be used with specified diluent.
FOR USE ONLY WITH THE SPECIFIC PERMISSION OF THE CHIEF VETERINARY
OFFICER IN EACH STATE.
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:
S23, S24/25. Do not breathe dusts. 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
: Freeze dried vaccine plug in a glass vial.
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
NOTE: DIFFERENT HAZARD ASSESSMENT CRITERIA OF SWA AND TGA MAY RESULT
IN SEEMING INCONSISTENCIES BETWEEN
MSDS
                                
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