VAXSAFE MG VACCINE (LIVING)
Country: Australia
Language: English
Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)
Patient Information leaflet
(PIL)
19-06-2017
Summary of Product characteristics
(SPC)
01-07-2013
Safety Data Sheet
(SDS)
25-04-2024
Product Information
(INF)
25-04-2024
Active ingredient:
MYCOPLASMA GALLISEPTICUM STRAIN TS-11
Available from:
BIOPROPERTIES PTY. LTD.
INN (International Name):
vaccine - M. gallisepticum
Pharmaceutical form:
MISC. VACCINES OR ANTI SERA
Composition:
MYCOPLASMA GALLISEPTICUM STRAIN TS-11 VACCINE-GENERAL Active 0.0 ccu/dose
Units in package:
30 mL (1000 doses); 30 mL (2000 doses)
Class:
VM - Veterinary Medicine
Therapeutic group:
POULTRY LAYERS (EGGS FOR HUMAN CONSUMP) | CAGED LAYERS | CHICKENS | CHOOKS | HEN
Therapeutic area:
IMMUNOTHERAPY
Therapeutic indications:
CHRONIC RESPIRATORY DISEASE | MYCOPLASMA GALLISEPTICUM | VACCINE | CHRONIC RESPIRATORY DISEASE (C | EQUINE ROTAVIRUS | INFECTIOUS SINUSITIS
Product summary:
Poison schedule: 0; Withholding period: WHP: NIL.; Host/pest details: POULTRY LAYERS (EGGS FOR HUMAN CONSUMP): [CHRONIC RESPIRATORY DISEASE, MYCOPLASMA GALLISEPTICUM, VACCINE]; For the control of chronic respiratory disease (CRD) in layer chickens caused by M. gallisepticum (MG) in susceptible (MG free) chickens at risk of infection.This product is contraindicated for vaccinating unhealthy birds. This product is contraindicated for vaccination of birds undergoing medication with an antimicrobial known to inhibit M. gallisepticum multiplication, e.g. tetracycline, tiamulin, tylosin, …
Authorization status:
Registered
Authorization date:
2022-07-01
Patient Information leaflet
Product Name:
APVMA Approval No:
VAXSAFE MG VACCINE (LIVING)
35907 / 107711
Label Name:
VAXSAFE MG VACCINE (LIVING)
Signal Headings:
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
Each dose contains >10 7.0 CCU* living, attenuated,
temperature-sensitive Mycoplasma
gallisepticum vaccine Strain ts-11.
*Colour Changing Units
Claims:
Statement of Claims: An aid in the control of chronic respiratory
disease (CRD) caused by
M. gallisepticum (MG) in susceptible (MG free) chickens at risk of
infection.
Susceptible (MG free) layer flocks vaccinated with Vaxsafe® MG
vaccine prior to MG
challenge exhibit less respiratory disease, require less
anti-microbial medication and during
lay will produce more eggs than comparably challenged non-vaccinated
flocks. Safety
testing has shown M. gallisepticum Strain ts-11 to be virtually
non-pathogenic in chickens
and not readily transmitted between birds.
Net Contents:
30mL (2000 doses)
Directions for Use:
Direction for Use
Contraindications:
Contraindications:
• This product is contraindicated for vaccinating unhealthy birds.
• This product is contraindicated for vaccination of birds
undergoing medication with an
antimicrobial known to inhibit M. gallisepticum multiplication, eg,
Tetracycline, Tiamulin,
Tylosin, Enrofloxacin, Lincospectin, Gentamycin or macrolide
antibiotics.
Precautions:
Precautions:
• Vaxsafe® MG contains live organisms and correct storage and
administration are
essential for successful use.
• Do not refreeze Vaxsafe® MG after thawing.
• Withdraw antibiotics from the flock for a period equivalent to the
recommended
withholding period prior to vaccination and do not use after
vaccination.
• Where antibiotics must be used, preference should be given to
agents with low
mycoplasma activity such as penicillin, amoxycillin or neomycin. They
should not be given
within 4 weeks after vaccination.
• Do not dilute. Thawed vaccine should be used as supplied. RLP APPROVED
Dosage and
Administration:
Dosage and Administration
• Pullets are normally vaccinated
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Summary of Product characteristics
MSDS
-
MATERIAL SAFETY DATA SHEET
VAXSAFE
®
MG VACCINE (LIVING)
BIOPROPERTIES Pty Ltd
Page 1 of 4
Date of Issue: December 2011
MSDS-MG V6
BIOPROPERTIES PTY. LTD.
ACN 007 303 728
36 CHARTER STREET
TELEPHONE:
03 9876 0567
RINGWOOD VIC 3134
FACSIMILE:
03 9876 0556
AUSTRALIA
EMERGENCY:
0417 548 879
WORK HAZARD ASSESSMENT
THE VACCINE IS NOT CLASSIFIED AS HAZARDOUS
TO HEALTH ACCORDING TO CRITERIA OF WORKSAFE AUSTRALIA
PRODUCT IDENTIFICATION
PRODUCT NAME:
VAXSAFE MG VACCINE (LIVING)
OTHER NAMES: MG VACCINE, TS-11 VACCINE
PRODUCT CODE: 8901 MGS
APVMA NO: 35907
UN NUMBER: None allocated.
DANGEROUS GOODS
CLASS/SUBSIDIARY RISK: None allocated.
HAZCHEM CODE: None allocated.
POISONS SCHEDULE
NUMBER: None allocated.
PRODUCT TYPE: Poultry vaccine.
CHEMICAL FAMILY: The active ingredient
consists of viable _Mycoplasma_ _gallisepticum _(MG)
suspended in a protective buffer.
USE: For the control of Chronic Respiratory Disease (CRD) in
layer chickens
caused by MG.
METHOD OF USE: Administered by eye
drop to chickens preferably between 4-12 weeks of
age.
PHYSICAL DESCRIPTION AND PROPERTIES
APPEARANCE: Frozen liquid of a pale colour in a 30 mL
plastic peel top eyedropper
bottle sufficient for 1000 doses by eye drop application.
MELTING POINT: Not relevant.
BOILING POINT: Not relevant.
VAPOUR PRESSURE: Not relevant.
VOLATILE MATERIALS: Not available.
SPECIFIC GRAVITY: Not relevant.
FLASHPOINT: Not relevant.
FLAMMABILITY LIMITS: Not relevant.
SOLUBILITY IN WATER: Fully miscible.
PH: Not available.
INGREDIENTS
Worksafe Exposure Limits
CHEMICAL NAME
CAS #
PROPORTION
BY VOLUME
ES-TWA
mg/m
3
ES-STEL
mg/m
3
_Mycoplasma gallisepticum_ (MG) in
a culture medium containing swine
s
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Safety Data Sheet
PRODUCT NAME: VAXSAFE
® MG VACCINE (LIVING)
PAGE: 1 OF 5
VERSION 7, ISSUED: NOVEMBER, 2016
SAFETY DATA SHEET
Issued by: Bioproperties Pty Ltd
Phone: 03 9876 0567 (office hours)
POISONS INFORMATION CENTRE: 13 11 26 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND)
SECTION 1 - IDENTIFICATION OF THE MATERIAL AND SUPPLIER
BIOPROPERTIES PTY LTD
PHONE: 03 9876 0567 (OFFICE HOURS)
36 CHARTER ST
FAX: 03 9876 0556
RINGWOOD, VIC 3134 AUSTRALIA
EMERGENCY: 0417 548 879 (ALL HOURS)
CHEMICAL NATURE:
Active ingredient consists of viable (MG) _Mycoplasma gallisepticum_
strain TS-11
suspended in a protective buffer.
TRADE NAME:
VAXSAFE
® MG VACCINE (LIVING)
APVMA CODE:
35907
OTHER NAMES:
MG Vaccine, ts-11 Vaccine.
PRODUCT USE:
For the control of Chronic Respiratory Disease (CRD) in layer chickens
caused by
MG (_Mycoplasma gallisepticum_).
CREATION DATE:
FEBRUARY, 2016
THIS VERSION ISSUED:
NOVEMBER, 2016
and is valid for 5 years from this date.
POISONS INFORMATION CENTRE: PHONE 13 1126 FROM ANYWHERE IN AUSTRALIA
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 Australian Dangerous Goods (ADG)
Code, IATA or IMDG/IMSBC criteria.
SUSMP CLASSIFICATION:
None allocated.
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good according to Australian Dangerous
Goods (ADG)
Code, IATA or IMDG/IMSBC criteria.
UN NUMBER:
None allocated.
GHS SIGNAL WORD: NONE. NOT HAZARDOUS.
PREVENTION
P102: Keep out of reach of children.
P262: Do not get in eyes, on skin, or on clothing.
P281: Use personal protective equipment as required.
RESPONSE
P353: Rinse skin or shower with water.
P301+P330+P331: IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
P370+P378: Not combustible. Use extinguishing media suited to burning
materials.
STORAGE
P411: For short term storage, keep below -18°C (deep freeze),
protected from light. For long term storage,
keep frozen below -70°C until the printed expiry date.
DISPOSA
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