EQUIMUNE MYCOBACTERIAL CELL WALL FRACTION IMMUNOSTIMULANT

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

MYCOBACTERIUM CELL WALL FRACTION; GENTAMICIN

Available from:

NOVAVIVE AUSTRALASIA PTY LTD

INN (International Name):

mycobacterial cell wall extr(1mg/mL)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

MYCOBACTERIUM CELL WALL FRACTION UNGROUPED Active 1.0 mg/ml; GENTAMICIN ANTIBIOTIC Other 30.0 ug/ml

Units in package:

10 x 1.5mL; Vials

Class:

VM - Veterinary Medicine

Manufactured by:

NOVAVIVE AUSTRALASIA

Therapeutic group:

HORSE | COLT | DONKEY | ENDURANCE HORSE | FILLY | FOAL | GELDING | HIGH PERFORMANCE HORSES | HORSES AT STUD | MARE | PACER | POL

Therapeutic area:

IMMUNOTHERAPY

Therapeutic indications:

EQUINE RESPIRATORY TRACT INFECTIONS VIRA | INFECTIONS OF VIRAL ORIGIN

Product summary:

Poison schedule: 0; Withholding period: WHP: MEAT: 28 days.; Host/pest details: HORSE: [EQUINE RESPIRATORY TRACT INFECTIONS VIRA]; Poison schedule: 0; Withholding period: ; Host/pest details: HORSE: [EQUINE RESPIRATORY TRACT INFECTIONS VIRA]; An immunotherapeutic agent for use by or under the direction of a registered Veterinarian as an aid in the treatment of Equine Respiratory Tract Infections of viral origin.Cortisone reduces the production of IL-1. Concurrent use of corticosteroids, ACTH and other products known to be immunosuppresive is not recommended.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

COMPANY NAME:
PRODUCT NAME:
APVMA APPROVAL NO:
LABEL NAME:
EQUIMUNE MYCOBACTERIAL CELL WALL FRACTION IMMUNOSTIMULANT
SIGNAL HEADINGS:
FOR ANIMAL TREATMENT ONLY
CONSTITUENT
STATEMENTS:
1 mg/mL MYCOBACTERIUM CELL WALL FRACTION
Contains 30 µg/mL GENTAMICIN as a preservative
CLAIMS:
An immunotherapeutic agent for use by or under the direction of a
registered Veterinarian
as an aid in the treatment of Equine Respiratory Tract Infections of
viral origin.
NET CONTENTS:
10 x 1.5mL single dose vials
DIRECTIONS FOR USE:
FOR USE ONLY BY, OR UNDER THE DIRECTION OF, A REGISTERED VETERINARY
SURGEON.
Roll the vial gently between hands to ensure homogeneous suspension
before injecting.
Airspace has been provided in vial to facilitate mixing.
FOR INTRAVENOUS USE ONLY
Administer the total contents of one vial (1.5 mL) by intravenous
injection into the jugular
vein.
RESTRAINTS:
CONTRAINDICATIONS:
Cortisone reduces the production of IL-1.1 Concurrent use of
corticosteroids, ACTH and
other products known to be immunosuppressive is not recommended.
Horses with a history of hyper-immune disease (vaccine bumps,
allergies etc.) should
be closely monitored, by a veterinarian. In the event of urticaria,
edema, pneumonitis or
persistent fever, treat appropriately. Do not repeat treatment with
Equimune® in horses,
which develop these symptoms.
Many factors influence the efficacy of immunotherapy in animals.
Concurrent disease,
stresses due to shipping or weaning, nutritional status, parasitism,
environmental
conditions and concurrent therapeutic regimens are important
considerations.
PRECAUTIONS:
1. In the event of an anaphylactic reaction, administer adrenaline.
2. KEEP OUT OF REACH OF CHILDREN.
NOVAVIVE AUSTRALASIA PTY LTD
EQUIMUNE MYCOBACTERIAL CELL WALL FRACTION IMMUNOSTIMULANT
51105/106194 RLP APPROVED
3. Immune stimulation regimens have the potential to stimulate
hypersensitivity reactions.
These may be manifested as a persistent fever, with or without
pulmonary involvement.
Veterinary attention should be sought if these symptoms occ

Summary of Product characteristics

PRODUCT NAME: EQUIMUNE I.V. MYCOBACTERIAL CELL WALL FRACTION
IMMUNOSTIMULANT FOR HORSES 
PAGE: 1 OF 4 
THIS REVISION ISSUED: AUGUST, 2008 
MATERIAL SAFETY DATA SHEET 
Issued by: Bioniche Animal Health (A/Asia) 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 
BIONICHE ANIMAL HEALTH (A/ASIA) PTY. LTD. 
PHONE: [phone]
PO BOX 2258 
FAX: [phone]
CAULFIELD, VIC AUSTRALIA 3161 
TOLL FREE: 1800 032 355
SUBSTANCE:  
Active ingredient is a Mycobacterial Cell Wall Fraction. Stabilised
with Gentamicin.

TRADE NAME:  
EQUIMUNE I.V. MYCOBACTERIAL CELL WALL FRACTION IMMUNOSTIMULANT 
FOR HORSES

PRODUCT USE:  
Treatment of equine respiratory tract infection of viral origin. May
only be used by a 
registered veterinary surgeon.

CREATION DATE: 
APRIL, 2007 
REVISION DATE: 
AUGUST, 2008 
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: S25. Avoid contact with eyes.  
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: Clear, milky coloured emulsion. 
ODOUR: No odour. 
MAJOR HEALTH HAZARDS: no significant risk factors have been found for
this product. 
POTENTIAL HEALTH EFFECTS 
INHALATION: 
SHORT TERM EXPOSURE: Available data indicates that this product
is not harmful. However product may be mildly 
irritating, although unlikely to cause anything more than mild
transient discomfort. 

LONG TERM EXPOSURE: No data for health effects associated with long
term inhalation. 

SKIN CONTACT: 
SHORT TERM�