SUVAXYN MH - ONE VACCINE (INACTIVATED)

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

MYCOPLASMA HYOPNEUMONIAE - INACTIVATED ANTIGEN; THIOMERSAL

Available from:

VIRBAC (AUSTRALIA) PTY LTD

INN (International Name):

vaccine - Mycoplasma hyopneum.

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

MYCOPLASMA HYOPNEUMONIAE - INACTIVATED ANTIGEN VACCINE-GENERAL Active 0.0 ml; THIOMERSAL MERCURY Other 0.1 mg/ml

Units in package:

100mL; 500mL

Class:

VM - Veterinary Medicine

Therapeutic group:

PIG - ADULT

Therapeutic area:

IMMUNOTHERAPY

Therapeutic indications:

LUNG LESIONS | MYCOPLASMA HYOPNEUMONIAE | REDUCTION OF LUNG LESIONS | RESPIRATORY DISEASE | SWINE ENZOOTIC PNEUMONIA

Product summary:

Poison schedule: 0; Withholding period: ; Host/pest details: PIG - ADULT: [LUNG LESIONS, MYCOPLASMA HYOPNEUMONIAE]; For the single dose vaccination of healthy pigs 21days or older as an aid in the reduction of lung lesions, a pathological sign of Mycoplasma hyopnuemoniae.See PRECAUTIONS and GENERAL DIRECTIONS (To avoid carcass damage) on label.

Authorization status:

Stopped

Authorization date:

2018-06-30

Patient Information leaflet

·""·
FORT
Dodge
(Australia)
PTY LIMITED
PAGE
1
of
_2 _
PRODUCT
NAME:
SUVAXYN
MH-ONE
VACCINE
(INACTIVATED)
APVMA NUMBER:
55742/60537
VERSION
DATE:
27/09/2013
PACK
SIZES:
500ml
(250 doses)
TEMPLATE
FOR
RELEVANT
LABEL
PARTICULARS
(RLPS)
(VETERINARY
PRODUCTS)
Select appropriate:
[J
New Product (include all applicable RLPs)
OR
-~'
Variation
(highlight
instructions
that
are
being
varied).
Approval
no.
of
label
being
varied:
................
.
Signal
heading:
FOR ANIMAL TREATMENT ONLY.
Product
name:
SUVAXYN® MH-ONE VACCINE (INACTIVATED)
Active
constituenUs:
A
liquid
adjuvanted
bacterin
consisting
of
inactivated
Mycoplasma
hyopneumoniae
(6
x 10
9
DCE* per dose).
Contains thiomersal
0.1
mg
/ml
as a preservative.
Statement
of
claims:
For the single dose vaccination
of
healthy pigs
21
days or older as an aid
in
the
reduction of lung lesions, a pathological sign of
Mycoplasma hyopneumoniae.
Net
contents:
500ml(250
doses)
100ml(50
doses)
A
Directions
for
Use
DIRECTIONS FOR USE:
..
Heading:
T>Tn
~~
Restraints:
NIA
Approved
CONTRAINDICATIONS:
N/A
PRECAUTIONS:
Do
not mix with other vaccines or products
Studies to support reduction
of
Mycoplasma induced growth suppression and
use
of
the product
in
pregnant sows have not been conducted. Vaccination of
breeding sows may increase the level of maternal antibody conferred
to
sucker
pigs. Maternal antibodies in piglets may interfere with effective
vaccination.
Side
effects:
Allergic reactions in pigs although rare, may occur. The antidote is
adrenaline.
Dosage
&
Shake well before use. Use entire contents immediately.
ADMINISTRATION:
DOSE:
2
ml
intramuscularly using aseptic technique.
SUCKING PIGS:
Inject 2
ml
at
21
days of age or older. A second dose
is
not
required.
INTRODUCED GROWERS AND BREEDERS:
Inject 2
ml
at time of arrival.
General
directions:
TO AVOID CARCASS DAMAGE:
1.
Sterilise all injection apparatus by boiling before use. Avoid use of
strong
disinfectants
on
apparatus.
2.
Maintain cleanliness at all times.
3.
Keep needles sharp
and
clean.
4.
Use needles
of
appropriate ga

Summary of Product characteristics

VIRBAC (AUSTRALIA) PTY. LTD.
MATERIAL SAFETY DATA SHEET
Product Name:
Suvaxyn
®
MH-One Vaccine (Inactivated)
PAGE: 1 OF 5
DATE OF ISSUE
1 FEBRUARY 2010
EMERGENCY: VIRBAC: 02 9772 9772 OR 1800 242 100 (BUSINESS HOURS ONLY)
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND)
SECTION 1 - IDENTIFICATION OF CHEMICAL PRODUCT AND COMPANY
COMPANY:
VIRBAC (AUSTRALIA) PTY. LTD
ABN 77 003 268 871
ADDRESS
361 Horsley Rd, Milperra, NSW 2214, Australia
Locked Bag 6000, Milperra Business Centre, NSW 1891, Australia
TELEPHONE:
[phone] or 1800 242 100
FAX:
[phone]
EMERGENCY PHONE
As above during business hours; answering machine after hours
SUBSTANCE:
Water suspension of inactivated antigens, and other minor ingredients.
TRADE NAME:
SUVAXYN
® MH-ONE VACCINE (INACTIVATED)
APVMA CODE:
55742
PRODUCT USE:
Vaccination of healthy pigs as an aid in reduction of lung lesions
caused by
_Mycoplasma hyopneumoniae_.
CREATION DATE:
FEBRUARY, 2010
REVISION DATE:
DECEMBER, 2010
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as:
Not classified as hazardous according to the criteria of ASCC.
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:
None allocated.
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
UN NUMBER:
None allocated
EMERGENCY OVERVIEW
PHYSICAL DESCRIPTION & COLOUR
: Brown coloured aqueous suspension.
ODOUR:
No data.
MAJOR HEALTH HAZARDS:
no significant risk factors have been found for this product.
POTENTIAL HEALTH EFFECTS
NOTE: DIFFERENT HAZARD ASSESSMENT CRITERIA OF ASCC 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.
SEE PRODUCT LABEL