POULVAC NEWCASTLE IK VACCINE (INACTIVATED)

Land: Australien

Sprog: engelsk

Kilde: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Aktiv bestanddel:

INACTIVATED NEWCASTLE DISEASE VIRUS ANTIGEN

Tilgængelig fra:

ZOETIS AUSTRALIA PTY LTD

INN (International Name):

Newcastle disease virus (I)

Lægemiddelform:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Sammensætning:

INACTIVATED NEWCASTLE DISEASE VIRUS ANTIGEN VACCINE-VIRAL Active 0.0 EID/50

Enheder i pakken:

(500mL); 1000 Doses

Klasse:

VM - Veterinary Medicine

Fremstillet af:

ZOETIS AUSTRALIA

Terapeutisk gruppe:

POULTRY - SEE LABEL | CHICKEN

Terapeutisk område:

IMMUNOTHERAPY

Terapeutiske indikationer:

NEWCASTLE DISEASE

Produkt oversigt:

Poison schedule: 0; Withholding period: WHP: NIL; Host/pest details: PIGEON: [MAINTENANCE OF HEALTH, PARVOVIRUS]; POULTRY - SEE LABEL: [NEWCASTLE DISEASE]; Poison schedule: 0; Withholding period: ; Host/pest details: PIGEON: [MAINTENANCE OF HEALTH, PARVOVIRUS]; POULTRY - SEE LABEL: [NEWCASTLE DISEASE]; For vaccination of healthy chickens 3 weeks of age or older, as an aid in the prevention of Newcastle disease. For active immunization of healthy pigeons 8 weeks of age or older, as an aid in the control of Pigeon Paramyxovirus.

Autorisation status:

Registered

Autorisation dato:

2023-07-01

Indlægsseddel

APPENDIX 2
Australian Government
Australian Pesticides
and
Veterinary Medicines Authority
+
RLP
Approved
TEMPLATE FOR RELEVANT
LABEL
PARTICULARS (RLPs)
(Veterinary
Products)
Select appropriate:
Cl
New Product (include all applicable RLPs)
OR
)(
Variation (highlight instructions that are being varied). Approval
no.
of label being varied
59138/62153
Signal
heading:
Product name:
Active constituent/s:
Statement
of
claims:
Net
contents:
Directions for Use
Heading:
Restraints:
Contraindications:
Precautions:
Side
effects:
Dosage
&
administration:
FOR
ANIMAL
TREATMENT ONLY
POULVAC
NEWCASTLE
iK
VACCINE (INACTIVATED)
Contains Newcastle Disease virus LaSota strain (inactivated).
Each dose contains no less than
10
7
'
8
EID
50
Newcastle virus
For vaccination of healthy chickens
3
weeks
of
age or older, as
an
aid in the
prevention of Newcastle disease.
For active immunization of healthy pigeons
8
weeks of age
or
older, as
an
aid in
the
control of Pigeon Paramyxovirus.
500
mL
(1
000
doses)
DIRECTIONS FOR USE .
Vaccinate healthy birds only.
Do not mix with other vaccines or products.
If birds are vaccinated during
lay,
a drop
in
egg production may occur.
As with any oil emulsion product, post-vaccination reactions may
occur.
These
may
include:
swelling
at
the site of injection, granulomas at the site of injection (which may
cause processing plant condemnations), stiff necks, swollen heads,
transient
inappetence, and dehydration. Such reactions may be aggravated by
improper
vaccination techniques. Some birds may show signs
of
general malaise.
Dosage
and
Administration:
SHAKE WELL BEFORE USE.
Use entire contents within
24
hours
of
openin-g.
Dose
for
Chickens:
0.5
mL
subcutaneously or intramuscularly using aseptic technique.
Dose
for
Pigeons:
0.5
mL
subcutaneously using aseptic technique.
28
days later:
0.5
mL subcutaneously using aseptic technique.
Intramuscular:
Ensure that the needle is
in
the thickest part
of
the muscle, avoiding
bone
or
other structures.
Subcutaneous: Vaccinate midway between the bird's head and the base of

Produktets egenskaber

Product Name: Poulvac® Newcastle iK Vaccine
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:
Water suspension of killed viruses.
TRADE NAME:
POULVAC
® NEWCASTLE IK VACCINE
APVMA CODE:
59138
PRODUCT USE:
Vaccine
to aid in prevention of Newcastle 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:
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
: Liquid suspension in a 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 AND LABEL. EFFECTS DESCRIBED IN THIS MSDS RELATE TO SHORT TERM
EMERGENCY SITUATIONS, SUCH AS ACCIDENTS
AND SPILLS WITH THE POTENTIAL FOR GROSS OVEREXPOSURE, AND TO LONG TERM
INDUSTRIAL AND MANUFACTURING EXPOSURE