DUVAXYN EHV 1,4 INACTIVATED ADJUVANTED EQUINE HERPES VACCINE

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Patient Information leaflet (PIL)

19-06-2017

Summary of Product characteristics (SPC)

19-06-2017

Active ingredient:

EQUINE HERPES VIRUS 1 (EHV-1) 438/77 STRAIN; EQUINE HERPES VIRUS 4 (EHV-4) 405/76 STRAIN

Available from:

ZOETIS AUSTRALIA PTY LTD

INN (International Name):

EHV-1+EHV-4

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

EQUINE HERPES VIRUS 1 (EHV-1) 438/77 STRAIN VACCINE Active 0.0 P; EQUINE HERPES VIRUS 4 (EHV-4) 405/76 STRAIN VACCINE Active 0.0 P

Units in package:

10 x 1dose; Vial=1.5mL

Class:

VM - Veterinary Medicine

Manufactured by:

ZOETIS AUSTRALIA

Therapeutic group:

Therapeutic area:

IMMUNOTHERAPY

Therapeutic indications:

Product summary:

Poison schedule: 0; Withholding period: Zero (0) days; Host/pest details: HORSE: [ANTIBIOTIC - ANTI-INFECTIVE]; Poison schedule: 0; Withholding period: WHP: MEAT:Nil.; Host/pest details: HORSE: [ANTIBIOTIC - ANTI-INFECTIVE]; Poison schedule: 0; Withholding period: ; Host/pest details: HORSE: [ANTIBIOTIC - ANTI-INFECTIVE]; For the vaccination of horses and ponies for reduction in the clinical signs of the respiratory diseases caused by EHV-1 and EHV-4. For use as an aid in the control of EHV-1 abortion when used in conjunction with appropriate management practices.Animals that have received immunosuppressive drugs (eg. glucocorticoids) should not be vaccinated until an interval of at least 4 weeks has elapsed.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

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APPENDIX 2
AUSTRALIAN GOVERNMENT
AUSTRALIAN PESTICIDES
AND
VETERINARY MEDICINES ANTHORITY
TEMPLATE FOR RELEVANT LABEL PARTICULARS (RLPS)
(VETERINARY PRODUCTS)
Select appropriate:
0
New Product (include all applicable RLPs)
OR
0
Variation (highlight instructions that are being varied). Approval no.
of
label being varied: 48485/0507.
Signal
heading:
Product
name:
Active constituenl/s:
Statement of
claims:
Net
contents:
Directions for
Use
Heading:
Restraints:
Contraindications:
PRECAUTIONS:
Side
effects:
Dosage
&
ADMINISTRATION:
+
RLP
Approved
FOR ANIMAL TREATMENT ONLY
DUVAXYN® EHV 1,4 INACTIVATED ADJUVANTED EQUINE HERPES VACCINE
DUVAXYN® EHV
1
,
4
is
an inactivated adjuvanted liquid vaccine
in
a glass vial and
presented
in
a form for administration to horses and ponies. Each single vial
contains
one dose (1.5
ml)
of
an inactivated aqueous solution
of
equine herpesvirus 1 (EHV-1.
RP~1)
and equine herpesvirus
4
(EHV-4,
RP~1)
grown on continuous cell lines.
The adjuvant carbomer
is
used
in
the formulation to stimulate the immune system.
For the vaccination of healthy horses and ponies for reduction
in
the clinical signs
of
the respiratory diseases caused
by
EHV-1 and EHV-4. For use as an aid
in
the
control
of
EHV-1 abortion when used
in
conjunction with appropriate management
practices. Pregnant mares vaccinated with this product may still
abort.
10 x 1 dose
(1.5ml)
vials
READ ATTACHED LEAFLET BEFORE USING THIS PRODUCT
DIRECTIONS FOR USE
FOR USE BY
OR
UNDER THE DIRECT SUPERVISION OF A REGISTERED VETERINARY SURGEON.
N/A
Do not vaccinate sick horses and ponies.
Animals that have received immunosuppressive drugs (eg
glucocorticoids) should not
be vaccinated until an interval
of
at least 4 weeks has elapsed.
The vaccine is safe for administration to pregnant mares but the
handling
of
mares
during pregnancy carries its own inherent risks.
After administration
of
any vaccine, a systemic reaction can occasionally occur. Local
reactions may occur following vaccination and are usually transient.
In
cases
of
local
reactio

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Summary of Product characteristics

Product Name: Duvaxyn® EHV 1,4 Inactivated Adjuvanted Equine Herpes
Vaccine
Page: 1 of 4
This revision issued: October, 2015
SAFETY DATA SHEET
Issued by: Zoetis 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
ZOETIS AUSTRALIA PTY LTD
ABN 94 156 476 425
Level 6, 5 Rider Blvd
Rhodes NSW 2138 AUSTRALIA
Tel: 1800 814 883
Fax: (02) 8876 0444
Email: australia.animalhealth@zoetis.com
CHEMICAL NATURE:
Suspension of equine herpes virus (inactivated).
TRADE NAME:
DUVAXYN
® EHV 1,4 INACTIVATED ADJUVANTED
EQUINE HERPES VACCINE
OTHER NAMES:
Duvaxyn EHV
APVMA CODE:
48485
PRODUCT USE:
Vaccination of horses against disease caused by equine herpes viruses.
CREATION DATE:
JULY, 2012
THIS VERSION ISSUED:
OCTOBER, 2015
and is valid until December, 2017.
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
: Duvaxyn EHV1,4 is presented in glass vials containing 1.5 ml (1
dose).
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 GRO

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