LEPTOSHIELD VACCINE

Land: Australien

Sprog: engelsk

Kilde: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Aktiv bestanddel:

LEPTOSPIRA INTERROGANS SEROVAR POMONA FORMOL CULTURE; LEPTOSPIRA BORGPETERSENII SEROVAR HARDJO TYPE HARDJOBOVI; THIOMERSAL

Tilgængelig fra:

ZOETIS AUSTRALIA PTY LTD

INN (International Name):

vaccine - leptospirosis

Lægemiddelform:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Sammensætning:

LEPTOSPIRA INTERROGANS SEROVAR POMONA FORMOL CULTURE VACCINE-MICROBIAL Active 0.0 P; LEPTOSPIRA BORGPETERSENII SEROVAR HARDJO TYPE HARDJOBOVI VACCINE-MICROBIAL Active 0.0 P; THIOMERSAL MERCURY Other 0.1 mg/ml

Enheder i pakken:

100mL; 250mL; 500mL; 50mL

Klasse:

VM - Veterinary Medicine

Fremstillet af:

ZOETIS AUSTRALIA

Terapeutisk gruppe:

CATTLE | DEER | GOAT | SHEEP | BEEF | BILLY | BOS INDICUS | BOS TAURUS | BOVINE | BUCK | BUFFALO | BULL | BULLOCK | CALF | CAPRA

Terapeutisk område:

IMMUNOTHERAPY

Terapeutiske indikationer:

LEPTOSPIROSIS | URINARY SHEDDING | L. HARDJO | L. INTERROGANS | L. POMONA | L. TARASSOVI

Produkt oversigt:

Poison schedule: 0; Withholding period: WHP:NIL ESI: ESI not applicable; Host/pest details: CATTLE: [LEPTOSPIROSIS, URINARY SHEDDING]; DEER: [LEPTOSPIROSIS]; GOAT: [LEPTOSPIROSIS]; SHEEP: [LEPTOSPIROSIS]; Poison schedule: 0; Withholding period: ; Host/pest details: CATTLE: [LEPTOSPIROSIS, URINARY SHEDDING]; DEER: [LEPTOSPIROSIS]; GOAT: [LEPTOSPIROSIS]; SHEEP: [LEPTOSPIROSIS]; For the prevention of leptospiroses in cattle, sheep and goats. As an aid in the control of leptospirosis in deer. For the prevention of urinary shedding in cattle when used prior to natural challenge & to prevent the risk of human leptospiral infection.

Autorisation status:

Registered

Autorisation dato:

2023-07-01

Indlægsseddel

•
•
APPENDIX 2
Australian Government
Austrafian Pesticides
and
Veterinary Medicines Authority
TEMPLATE FOR RELEVANT LABEL PARTICULARS (RLPs)
(Veterinary Products)
Select appropriate:
IJ New Product (include all applicable RLPs)
OR
!&I
Variation (highlight instructions that are being
varied). Approval
no.
of label being
varied:
51075/1 [2,3,4]/0509
Signal heading:
Product name:
Active
constituentls:
Statement of
claims:
Net contents:
Directions for Use
Heading:
FORANIMAL TREATMENT ONLY
Leptoshield® Vaccine
Leptoshield vaccine contains
Leptospira borgpetersenii
serovar
Hardjo
type
Hardjobovis
:::
500 x
10
6
organisms/ml
and
Leptospira interrogans
serovar
Pomona
.:::
500 x
10
6
organisms/ml (as formol
cultures) with
0.1
mg/ml
Thiomersal added.
For the prevention
of
leptospirosis in cattle, sheep and
goats
caused
by
Leptospira
borgpetersenii
serovar
Hardjo
and
_L. _
interrogans
serovar
Pomona
and as an aid in the control
of
leptospirosis
in deer caused by
the named leptospires.
For the prevention
of
urinary shedding
of
the named leptospires
in
cattle
when used
prior
to
natural challenge and
to
prevent the
risk
of
human
leptospiral
infection
associated
with
shedding
of
the named
leptospires
in the urine and
from
the reproductive
tract
of
cattle.
For
the
prevention
of
reproductive
tract
colonisation
and
placental
and
foetal
infection
with
L.
Hardjo.
APVMA
No.
51075/60361
'
~~
Leptoshield
is
available
in
semi-rigid packs of
50ml,
100ml,
250ml
and 500
ml.
DIRECTIONS FOR
USE
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
This vaccine is compatible
with
the Zoetis
Quickshot
Vaccinator.
It
is
important
that
the vaccine is kept properly mixed before and
during
use.
Shake the vaccine container at regular intervals
to
sustain
mixing.
This
product
can
be stored and
used
for
up
to
30
days
after
first
opening.
On each subsequent reuse, swab the opening
with
a
suitable
disinfectant
(for
example, methylated
spirits)
both before and
after
using.
A
sterile
needle and syringe
must
be used each time
product
is removed.
18 Wor

Produktets egenskaber

PRODUCT NAME: LEPTOSHIELD
® VACCINE
PAGE: 1 OF 5
THIS REVISION ISSUED: APRIL, 2010
MATERIAL SAFETY DATA SHEET
Issued by: Pfizer Australia Pty Ltd
Phone: [phone]
SECTION 1 - IDENTIFICATION OF CHEMICAL PRODUCT AND COMPANY
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
SUBSTANCE:
Water solution of ingredients.
TRADE NAME:
LEPTOSHIELD
® VACCINE
PFIZER MSDS CODE:
0503
PRODUCT USE:
For the prevention of leptospirosis in cattle.
CREATION DATE:
OCTOBER, 2004
THIS VERSION ISSUED:
APRIL, 2010
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.
SUSDP CLASSIFICATION:
S2 (NZ)
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
: Aqueous liquid suspension.
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
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.
LONG TERM EXPOSURE:
No data for health effects associated with long term inhalation.
SKIN CONTACT:
SHORT TERM EXPOSURE:
Available data indicates that this product is not harmful. It should
present no hazards in
normal use. However product may be mildly irritating, but is unlikely
to cause anythin