NV EQUI-IRON INJECTION

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

IRON AS FERRIC HYDROXIDE SUCROSE COMPOUND

Available from:

CEVA ANIMAL HEALTH PTY LTD

INN (International Name):

Fe as ferric hydroxide sucrose(20mg/mL)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

IRON AS FERRIC HYDROXIDE SUCROSE COMPOUND MINERAL-IRON-BASE Active 20.0 mg/ml

Units in package:

20mL

Class:

VM - Veterinary Medicine

Manufactured by:

CEVA ANIMAL HEALTH

Therapeutic group:

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

Therapeutic area:

NUTRITION & METABOLISM

Therapeutic indications:

ANAEMIA | IRON DEFICIENCY | IRON SUPPLEMENT | ANAEMIA

Product summary:

Poison schedule: 5; Withholding period: MEAT WITHOLDING PERIOD (HORSES): Nil; Host/pest details: HORSE: [ANAEMIA, IRON DEFICIENCY, IRON SUPPLEMENT]; Poison schedule: 5; Withholding period: ; Host/pest details: HORSE: [ANAEMIA, IRON DEFICIENCY, IRON SUPPLEMENT]; For the treatment of anaemia due to iron deficiency in horses.To be used by or under the supervision of a registered veterinary surgeon. By slow intravenous injection.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

AUSTRALIAN GOVERNMENT
AUSTRALIAN PESTICIDES AND
VETERINARY MEDICINES AUTHORITY
TEMPLATE FOR RELEVANT LABEL PARTICULARS (RLPS)
(VETERINARY PRODUCTS)
Select appropriate:
CI New Product (include all applicable RLPs) OR
El Variation. Approval no. of label being varied: 63024/20ML/1009
Signal heading:
CAUTION
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Product name:
NV Equi-lron Injection
Active constituent/s:
Iron 20mg/mL present as Ferric-Hydroxide-Sucrose complex
Statement of claims:
For the treatment of anaemia due to iron deficiency in horses. Assists
in the formation of red
blood cells and haemoglobin in horses with anaemia due to blood loss,
severe parasite
burdens, iron deficient diets, pregnant mares and adaptation to
strenuous exercise. Iron
supplementation will improve oxygen update during strenuous exercise
such as training and
racing.
Net contents:
20 nnL
Directions for Use
Heading:
DIRECTIONS FOR USE
u
Restraints:
-
Contraindications:
-
RLP
Precautions:
-
Approved
Side effects:
In extremely rare incidences anaphylactic reactions can occur.
Appropriate treatment for
anaphylactic shock should be instituted.
Dosage &
administration:
For single use only. Discard any unused product remaining in the vial.
Dose rate: Adult Horses (450 - 500kg): 20mL weekly by slow intravenous
injection or as
required.
To be used by, or under the supervision of, a registered veterinary
surgeon.
General directions:
-
Withholding Period/s:
MEAT WITHHOLDING PERIOD (HORSES): ZERO (0) DAYS
Trade Advice:
-
Safety Directions:
-
.
First Aid:
If poiSoning occurs, contact a doctor or Poisons Information Centre.
Phone Australia 13 11 26
Additional user safety:
-
Environmental
statements:
-
Disposal:
DISPOSE of empty container by wrapping with paper and putting in
garbage. Discarded
needles/sharps should immediately be placed in a designated and
appropriately labelled
'sharps' container.
Storage:
STORE below 25°C (Air Conditioning). Protect from light.
Name & address:
Ceva Animal Health Pty Ltd
11
Moores Rd
Glenorie NSW 2157
18

Summary of Product characteristics

 
PRODUCT NAME: NV EQUIIRON INJECTION
PAGE: 1 OF 5
THIS VERSION ISSUED: MARCH, 2013

SAFETY DATA SHEET 
Issued by: Ceva Animal Health Pty Ltd 
Phone: [phone] (office hours)
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND)

SECTION 1 - IDENTIFICATION OF THE MATERIAL AND SUPPLIER 
CEVA ANIMAL HEALTH PTY LTD 
PHONE: [phone] (OFFICE HOURS)
11 MOORES RD 
FAX: [phone]
GLENORIE, NSW  2157 
WWW.CEVA.COM.AU
CHEMICAL NATURE:  
Ferric hydroxide sucrose compound in water.

TRADE NAME:  
NV EQUIIRON INJECTION

PRODUCT USE:  
An injectable iron supplement for the treatment of anaemias in horses.
For animal 
treatment only.

CREATION DATE: 
MARCH, 2013 
THIS VERSION ISSUED: 
MARCH, 2013 and is valid for 5 years from this date. 
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 the Australian Dangerous Goods
(ADG) Code.

RISK PHRASES: Not Hazardous - No criteria found. 
SAFETY PHRASES: S25. Avoid contact with eyes.  
SUSMP CLASSIFICATION: S4 
ADG CLASSIFICATION: None allocated. Not a Dangerous Good under the
ADG Code. 
UN NUMBER: None allocated 
GHS SIGNAL WORD: NONE. NOT HAZARDOUS.  
HAZARD STATEMENT: 
PREVENTION 
P102: Keep out of reach of children. 
RESPONSE 
P353: Rinse skin or shower with water. 
P301+P330+P331: IF SWALLOWED: Rinse mouth. Do NOT induce vomiting. 
P332+P313: If skin irritation occurs: Get medical advice. 
P337+P313: If eye irritation persists: Get medical advice. 
P370+P378: Not combustible. Use extinguishing media suited to burning
materials.  
STORAGE 
P411+P235: Store at temperatures not exceeding 30°C. Keep cool. 
DISPOSAL 
P501: Dispose of small quantities and empty containers by wrapping
with paper and putting in garbage. For 
larger quantities, if recycling or reclaiming is not possible, use
a commercial