RESPISURE MYCOPLASMA HYOPNEUMONIAE VACCINE

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

M. HYOPNEUMONIAE - INACTIVATED WHOLE CELL CULTURE; THIOMERSAL

Available from:

ZOETIS AUSTRALIA PTY LTD

INN (International Name):

vaccine - Mycoplasma hyopneum.

Pharmaceutical form:

MISC. VACCINES OR ANTI SERA

Composition:

M. HYOPNEUMONIAE - INACTIVATED WHOLE CELL CULTURE VACCINE-GENERAL Active 6000.0 RU/do; THIOMERSAL MERCURY Other 0.1 mg/ml

Units in package:

#10x100mL; #50 Doses; #Vials; *125 Doses; *4 x 250mL; *Vials; 12 x 500mL; 250 Doses; Vials

Class:

VM - Veterinary Medicine

Manufactured by:

ZOETIS AUSTRALIA

Therapeutic group:

PIGS | BOAR | GILT | PIGLET | SOW | SWINE

Therapeutic area:

IMMUNOTHERAPY

Therapeutic indications:

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

Product summary:

Poison schedule: 0; Withholding period: WHP: Nil TRADE ADVICE: EXPORT SLAUGHT ER INTERVAL (ESI): ESI not applicable.; Host/pest details: PIGS: [MYCOPLASMA HYOPNEUMONIAE, VACCINE]; Poison schedule: 0; Withholding period: ; Host/pest details: PIGS: [MYCOPLASMA HYOPNEUMONIAE, VACCINE]; An aid in the prevention of enzootic pneumonia of pigs caused by M. hyopneumoniae.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

APPENDIX2
Australian
Government
Australian Pesticides and
Veterinary Medicines Authority
TEMPLATE FOR RELEVANT
LABEL
PARTICULARS (RLPs)
(Veterinary
Products)
Select appropriate:
[J
New Product (include all applicable RLPs)
OR
IC
Variation (highlight instructions that
are
being varied). Approval
no.
of label
being
varied 50168/0405
Signal
heading:
Product
name:
Active
constituent/s:
Statement
of
claims:
Net
contents:
Directions
for
Use
Heading:
Restraints:
Contraindications:
Precautions:
Side
effects:
Dosage
&
administration:
General
directions:
FOR
ANIMAL
TREATMENT
ONLY
RespiSure®
Mycoplasma hyopneumoniae
Vaccine
RespiSure contains chemically inactivated whole cell culture
of
M.
hyopneumoniae
(>6,000RU), coupled with an unique oil adjuvant, AmphigenTM,
to enhance and prolong the immune response without causing detectable
tissue
damage
at
the
injection site.
Contains thiomersal
S0.1
mg/ml.
RespiSure is a bacterin for vaccination
of
healthy pigs as an aid in the
prevention
of
chronic pneumonia caused by
Mycoplasma hyopneumoniae.
An
aid in the prevention
of
enzootic pneumonia
of
pigs caused by
M.
hyopneumoniae.
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DIRECTIONS
FOR
USE
READ
ENCLOSED LEAFLET BEFORE USING THIS
PRODUCT
Shake
well before use. Use entire contents when first opened.
NA
NA
~
....
NA
RLP
NA
A.
p
\.JJ.
u
""
u.
DOSE: Inject 2 mL intramuscularly at approximately
1
week
of
age. Repeat in 2
weeks. Administer a single 2-mL dose to piglets at approximately one
week
of
age with a booster dose 2 weeks later.
NOTE: Some animals may be unable to develop
or
maintain adequate
immune
response following vaccination if they are incubating a disease, are
malnourished
or
parasitised, or are stressed
due
to shipment
or
adverse
environmental conditions.
DISEASE
DESCRIPTION: Enzootic pneumonia (EP), is a widespread, chronic
disease characterised by coughing, growth retardation, and reduced
feed
efficiency.
The
causative agent is
M.
hyopneumonia~;
however, the naturally
occurring disease often results from

Summary of Product characteristics

PRODUCT NAME: RESPISURE VACCINE FOR MYCOPLASMA HYOPNEUMONIAE
PAGE: 1 OF 4
THIS REVISION ISSUED: MAY, 2009
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 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:
Solution of inactivated (killed) Mycoplasma Hyopneumoniae in sterile
water - a
bacterin type vaccine.
TRADE NAME:
RESPISURE VACCINE FOR MYCOPLASMA HYOPNEUMONIAE
PFIZER MSDS CODE:
MSDS050
PRODUCT USE:
Animal vaccine for Mycoplasma Hyopneumoniae pneumonia in pigs. For use
as
described on the product label.
CREATION DATE:
JUNE, 2004
THIS VERSION ISSUED:
MAY, 2009
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as:
Not classified as hazardous according to the criteria of ASCC
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:
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
: Clear, colourless liquid.
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