NEOVAC VACCINE

Pays: Australie

Langue: anglais

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Ingrédients actifs:

ESCHERICHIA COLI K88AC PILUS ANTIGENS; ESCHERICHIA COLI 987P PILUS ANTIGENS; ESCHERICHIA COLI K99 PILUS ANTIGENS; ESCHERICHIA COLI K88AB PILUS ANTIGENS; FORMALDEHYDE SOLUTION; THIOMERSAL

Disponible depuis:

ZOETIS AUSTRALIA PTY LTD

DCI (Dénomination commune internationale):

E.coli(12.5ug/mL)

forme pharmaceutique:

MISC. VACCINES OR ANTI SERA

Composition:

ESCHERICHIA COLI K88AC PILUS ANTIGENS VACCINE-MICROBIAL Active 12.5 ug/ml; ESCHERICHIA COLI 987P PILUS ANTIGENS VACCINE-MICROBIAL Active 12.5 ug/ml; ESCHERICHIA COLI K99 PILUS ANTIGENS VACCINE-MICROBIAL Active 12.5 ug/ml; ESCHERICHIA COLI K88AB PILUS ANTIGENS VACCINE-MICROBIAL Active 12.5 ug/ml; FORMALDEHYDE SOLUTION ALDEHYDE Other 2.5 ug/ml; THIOMERSAL MERCURY Other 0.15 mg/ml

Unités en paquet:

100mL

classe:

VM - Veterinary Medicine

Fabriqué par:

ZOETIS AUSTRALIA

Groupe thérapeutique:

PIG - PIGLET | NEONATAL PIGLET | NEW BORN PIG | SUCKER PIG

Domaine thérapeutique:

IMMUNOTHERAPY

indications thérapeutiques:

ESCHERICHIA COLI (E. COLI) | SCOURS - NEONATAL | VACCINE | EQUINE ROTAVIRUS | INCLUDING B-LACTAMASE PRODUCIN

Descriptif du produit:

Poison schedule: 0; Withholding period: WHP: Nil TRADE ADVICE (AUSTRALIA ONLY) : ESI: ESI NOT APPLICABLE; Host/pest details: PIG - PIGLET: [ESCHERICHIA COLI (E. COLI), SCOURS - NEONATAL, VACCINE]; Poison schedule: 0; Withholding period: ; Host/pest details: PIG - PIGLET: [ESCHERICHIA COLI (E. COLI), SCOURS - NEONATAL, VACCINE]; An aid in the control of neonatal scours due to E. coli.To be protected, new born piglets must obtain adequate quantities of the sow's colostrum (first milk) as soon as possible after birth.

Statut de autorisation:

Registered

Date de l'autorisation:

2023-07-01

Notice patient

+
RLP
Approved
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
0
Variation (highlight instructions that are being varied). Approval no.
of label being
varied:53610/0509
Signal
heading:
PRODUCT
NAME:
ACTIVE
CONSTITUENT/S:
STATEMENT OF
CLAIMS:
NET
CONTENTS:
DIRECTIONS
FOR
USE
Heading:
READ SAFETY DIRECTIONS
FOR ANIMAL TREATMENT ONLY
Neovac® Vaccine
Escherichia coli
K88ac, K88ab, K99 and 987P pilus antigens at 12.5
~g/mL
each
Also contains 2.5
~LimL
formaldehyde solution and
0.15 mg/mL Thiomersal.
Neovac vaccine may be used for the vaccination
of
healthy, pregnant sows and gilts
as
an
aid
in
control of neonatal scours caused
by
enterotoxigenic strains
of
Escherichia coli
having the K88ac. K88ab, K99
or
987P pili adherence factor.
100 mL
DIRECTIONS FOR USE
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT.
IMPORTANT
-
TO
BE
PROTECTED,
NEWBORN
PIGLETS
MUST
OBTAIN
ADEQUATE QUANTITIES OF THE SOW'S COLOSTRUM (FIRST MILK) AS SOON
AS POSSIBLE AFTER BIRTH.
For intramuscular injection
in
the sow
Contents must be left
in
outer package until immediately before use
Water-in-Oil Emulsion
Shake well before use and keep thoroughly mixed during use
This product can be stored and used for up
to
30 days after first opening
Handle aseptically and store refrigerated and protected from light
A.
Single Doses
Single doses of the vaccine may be withdrawn from the pack using a
sterilized hypodermic needle and syringe after disinfecting the
stopper of the vaccine
pack.
B.
Use with Automatic Vaccinator
An
automatic vaccinator may be attached to the pack
as
follows:
1.
Remove the sterilized plastic cap and tube from the pack
2. Connect the lube to the automatic vaccinator
3.
Disinfect the stopper with a suitable antiseptic, e.g. methylated
spirits
4. Screw the cap on to the plastic bottle
of
the vaccine which will cause
the needle to penetrate the stopper
5.
Prime t

Résumé des caractéristiques du produit

PRODUCT NAME: NEOVAC® VACCINE
PAGE: 1 OF 5
This revision issued: December, 2011
MATERIAL SAFETY DATA SHEET
Issued by: Pfizer 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 Australia Pty Ltd
38-42 Wharf Road
West Ryde NSW 2114
Tel: [phone]
Fax: [phone]
____________________________________
PFIZER AUSTRALIA PTY LTD
A.B.N. 50 008 422 348
CHEMICAL NATURE:
Water/oil emulsion of ingredients.
TRADE NAME:
NEOVAC® VACCINE
PRODUCT USE:
An aid in the control of E.coli scours in piglets through vaccination
of the sow.
CREATION DATE:
OCTOBER, 2004
THIS VERSION ISSUED:
DECEMBER, 2011
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.
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
: Oily emulsion.
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
SELF INJECTION: IN ALL INSTANCES OF ACCIDENTAL SELF INJECTION CONTACT
A DOCTOR AS SOON AS POSSIBLE. FURTHER
INFORMATION ON TREATMENT IS AVAILABLE FROM POISONS INFORMATION CENTRE.
PHONE 131 126.
INHALATION
SHORT TERM EXPOSURE:
Significant inhalation exposure is considered to be unlikely.
Available data indicates that this
product is not harmful. In addition product is unlikely to cause any
discomfort or irritation.
LON