RESPISURE ONE MYCOPLASMA HYOPNEUMONIAE VACCINE

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

MYCOPLASMA HYOPNEUMONIAE - INACTIVATED ANTIGEN; THIOMERSAL

Available from:

ZOETIS AUSTRALIA PTY LTD

INN (International Name):

vaccine - Mycoplasma hyopneum.(36100RU)

Pharmaceutical form:

MISC. VACCINES OR ANTI SERA

Composition:

MYCOPLASMA HYOPNEUMONIAE - INACTIVATED ANTIGEN VACCINE-GENERAL Active 31600.0 RU/2mL; THIOMERSAL MERCURY Other 0.1 mg/ml

Units in package:

&250 does; &500mL; *100mL; *50 does

Class:

VM - Veterinary Medicine

Manufactured by:

ZOETIS AUSTRALIA

Therapeutic group:

PIGS | BOAR | GILT | PIGLET | SOW | SWINE

Therapeutic area:

IMMUNOTHERAPY

Therapeutic indications:

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

Product summary:

Poison schedule: 0; Withholding period: WHP: Nil; Host/pest details: PIGS: [MYCOPLASMA HYOPNEUMONIAE, PNEUMONIA]; Poison schedule: 0; Withholding period: ; Host/pest details: PIGS: [MYCOPLASMA HYOPNEUMONIAE, PNEUMONIA]; For vaccination of healthy pigs at approximately 1 day of age and older, 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.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

ZOETIS AUSTRALIA PTY LTD
RESPISURE ONE MYCOPLASMA HYOPNEUMONIAE VACCINE
54654/103024
COMPANY NAME:
PRODUCT NAME: :
APVMA APPROVAL NO:
LABEL NAME:
RESPISURE ONE MYCOPLASMA HYOPNEUMONIAE VACCINE
SIGNAL HEADINGS:
FOR ANIMAL TREATMENT ONLY
CONSTITUENT
STATEMENTS:
RespiSure One contains chemically inactivated whole cell culture of
M.hyopneumoniae
(>31,600 RU), coupled with an unique oil adjuvant, Amphigen™, to
enhance and prolong
the immune response without causing detectable tissue damage at the
injection site.
Contains thiomersal
≤0.1
mg/mL.
CLAIMS:
RespiSure One is a bacterin for vaccination of healthy pigs at
approximately 1 day of
age and older, 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.
NET CONTENTS:
100 mL (50 Doses)
500 mL (250 Doses)
DIRECTIONS FOR USE:
Read the enclosed leaflet for full instructions
RESTRAINTS:
Nil
CONTRAINDICATIONS:
Nil
PRECAUTIONS:
Nil
SIDE EFFECTS:
Nil
DOSAGE AND
ADMINISTRATION:
Shake well before use. Use entire contents within 24 hours of first
opening. Discard any
unused portion.
DOSE: Inject 2 mL intramuscularly. Administer a single 2 mL dose to
piglets at
approximately 1 day of age or older. RespiSure One may also be given
as two 1 mL doses
administered 2 weeks apart. RLP APPROVED
DURATION OF IMMUNITY:
Duration of immunity in piglets vaccinated at 1-day-old has not been
established.
Duration of immunity in piglets vaccinated at 1 week of age or older
have demonstrated
efficacy for up to 25 weeks following vaccination.
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.
GENERAL DIRECTIONS:
DISEASE DESCRIPTION: Enzootic pneumonia (EP), is a widespread, chronic
disease
characterised by coughing, growth retardation, and reduced feed
efficiency. The causative
agent is M. hyopneum

Summary of Product characteristics

PRODUCT NAME: RESPISUREONE
® MYCOPLASMA HYOPNEUMONIAE VACCINE
PAGE: 1 OF 4
THIS REVISION ISSUED: JUNE, 2010
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 THE MATERIAL AND SUPPLIER
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
CHEMICAL NATURE:
Solution of inactivated (killed) Mycoplasma hyopneumoniae in sterile
water - a
bacterin type vaccine.
TRADE NAME:
RESPISURE
® ONE MYCOPLASMA HYOPNEUMONIAE VACCINE
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:
JUNE, 2010
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:
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 associ