EQUIVAC EST EQUINE SALMONELLA TYPHIMURIUM VACCINE

מדינה: אוסטרליה

שפה: אנגלית

מקור: APVMA (Australian Pesticides and Veterinary Medicines Authority)

מרכיב פעיל:

SALMONELLA TYPHIMURIUM; THIOMERSAL; ALUMINIUM HYDROXIDE GEL

זמין מ:

ZOETIS AUSTRALIA PTY LTD

INN (שם בינלאומי):

Salmonella typhimurium (inacti

טופס פרצבטיות:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

הרכב:

SALMONELLA TYPHIMURIUM VACCINE-MICROBIAL Active 0.0 P; THIOMERSAL MERCURY Other 0.13 mg/ml; ALUMINIUM HYDROXIDE GEL MINERAL-ALUMINIUM-BASE Other 0.0 P

יחידות באריזה:

1x2mL Syr

סיווג:

VM - Veterinary Medicine

תוצרת:

ZOETIS AUSTRALIA

קבוצה תרפויטית:

HORSE FOAL | HORSE MARE (FEMALE) | FEMALE HORSE

איזור תרפויטי:

IMMUNOTHERAPY

סממני תרפויטית:

SALMONELLA TYPHIMURIUM | VACCINE | EQUINE ROTAVIRUS

leaflet_short:

Poison schedule: 0; Withholding period: WHP: MEAT - NIL; Host/pest details: HORSE FOAL: [SALMONELLA TYPHIMURIUM, VACCINE]; HORSE MARE (FEMALE): [SALMONELLA TYPHIMURIUM, VACCINE]; Poison schedule: 0; Withholding period: ; Host/pest details: HORSE FOAL: [SALMONELLA TYPHIMURIUM, VACCINE]; HORSE MARE (FEMALE): [SALMONELLA TYPHIMURIUM, VACCINE]; For the immunisation of mares and foals as an aid in the control of diseases caused by Salmonella typhimurium.Vaccination is not recommended within 4 weeks of birth. Do not vaccinate stallions and horses in training. See also SIDE EFFECTS and PRECAUTIONS on leaflet.

מצב אישור:

Registered

תאריך אישור:

2023-07-01

עלון מידע

APPENDIX 2
AUSTRALIAN
GOVERNMENT
AUSTRALIAN PESTICIDES AND
VETERINARY MEDICINES
AUTHORITY
TEMPLATE FOR RELEVANT LABEL PARTICULARS (RLPS}
(VETERINARY PRODUCTS)
Select appropriate:
C
New
Product (include all applicable RLPs)
OR
0 Variation (highlight instructions that are being varied). Approval
no. of label being varied: 38995/57147.
Signal
heading:
Product
name:
Active
constituenUs:
Statement of
claims:
Net
contents:
Directions for
Use
Heading:
Restraints:
CONTRAINDICATIONS:
PRECAUTIONS:
Side
effects:
Dosage
&
ADMINISTRATION:
FOR ANIMAL TREATMENT ONLY
KEEP OUT OF REACH OF CHILDREN
EQUIVAC® EST EQUINE SA/MONEL/A
TYPHIMURIUM
VACCINE
Equivac EST contains inactivated
Salmonella typhimurium
(2.5 x 10
9
cells/ml)
adjuvanted with aluminium hydroxide gel. Thiomersal (0.13
mg/ml)
added as a
preservative.
Each
batch
is fully
tested
before
issue and
complies
with
accepted
standards
of
potency, sterility and lack
of
non-specific toxicity.
For the immunisation of mares and foals as an aid in the control
of
diseases caused by
Salmonella typhimurium.
2
ml
dose syringe
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
+
DIRECTIONS FOR USE
Contents must
be
left
in
outer package until immediately before use
SHAKE WELL BEFORE USE
For Intramuscular Use Only
RLP
r~
-n-
N/A
Do not vaccinate stallions and horses
in
training.
Vaccination is not recommended within
4
weeks
of
expected birth.
In
some animals, the injection
of
vaccine can cause a painful swelling which appears
within 1 to 2 days and can persist for up to 2 weeks. For this reason
injection into the
rump is advised. Slight lameness may occur for a day
or
so
in
horses which react
severely
to
the vaccine but this will
not
affect feeding or general well-being. Mildly
affected animals may favour the leg on the vaccinated side.
NOTE: If the vaccine is injected
in
the neck, the horse may have difficulty with feeding,
particularly
off
the ground, for a few days.
DOSAGE FOR FOALS AND MARES:
2
ml
dose (full contents
of
one syringe) by deep intramuscular injection
PREFERABLY INTO
TH

מאפייני מוצר

Product Name: Equivac EST Equine Salmonella Typhimurium Vaccine
Page: 1 of 5
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 solution of formalin-inactivated cells of _Salmonella
typhimurium_.
TRADE NAME:
EQUIVAC EST EQUINE SALMONELLA
TYPHIMURIUM VACCINE
OTHER NAMES:
Equine Salmonella Typhimurium Vaccine
APVMA CODE:
38995
PRODUCT USE:
Vaccination
as an aid in control of disease caused by _Salmonella Typhimurium_ in
horses.
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
: Fluid bacterial vaccine 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