TROY VITAMIN B12 INJECTION

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

VITAMIN B12 = CYANOCOBALAMIN

Available from:

TROY LABORATORIES PTY LTD

INN (International Name):

cyanocobalamin(1mg/mL)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

VITAMIN B12 = CYANOCOBALAMIN VITAMIN-B12 Active 1.0 mg/ml

Units in package:

100mL; 50mL

Class:

VM - Veterinary Medicine

Manufactured by:

TROY LABORATORIES

Therapeutic group:

CAT | CATTLE | DOG | HORSE | BEEF | BITCH | BOS INDICUS | BOS TAURUS | BOVINE | BUFFALO | BULL | BULLOCK | CALF | CASTRATE | CAT

Therapeutic area:

NUTRITION & METABOLISM

Therapeutic indications:

VITAMIN B12 DEFICIENCY | ANAEMIA | COBALT DEFICIENCY

Product summary:

Poison schedule: 0; Withholding period: Meat - Zero (0) days. Milk - Zero (0) d ays. An ESI has not been established fo r this product. Note—observing the meat withholding period may not be sufficient to mitigate potential risks to export t rade. Trade advice should be sought from Troy Laboratories on 02 8808 3600 befor e using this product; Host/pest details: CAT: [VITAMIN B12 DEFICIENCY]; CATTLE: [VITAMIN B12 DEFICIENCY]; DOG: [VITAMIN B12 DEFICIENCY]; HORSE: [VITAMIN B12 DEFICIENCY]; Poison schedule: 0; Withholding period: WHP: Meat milk - Nil; Host/pest details: CAT: [VITAMIN B12 DEFICIENCY]; CATTLE: [VITAMIN B12 DEFICIENCY]; DOG: [VITAMIN B12 DEFICIENCY]; HORSE: [VITAMIN B12 DEFICIENCY]; Poison schedule: 0; Withholding period: ; Host/pest details: CAT: [VITAMIN B12 DEFICIENCY]; CATTLE: [VITAMIN B12 DEFICIENCY]; DOG: [VITAMIN B12 DEFICIENCY]; HORSE: [VITAMIN B12 DEFICIENCY]; For use in anaemias resulting from vitamin B12 deficiency.

Authorization status:

Registered

Authorization date:

2022-07-01

Patient Information leaflet

Product Name:
APVMA Approval No:
TROY VITAMIN B12 INJECTION
52509/135353
Label Name:
TROY VITAMIN B12 INJECTION
Signal Headings:
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
1 mg/mL CYANOCOBALAMIN
Claims:
For use in anaemias resulting from Vitamin B12 deficiency in horses,
cattle, dogs and cats.
For intravenous use by or under the direction of a veterinarian.
Net Contents:
50 mL
100 mL
Directions for Use:
Restraints:
Contraindications:
Precautions:
Side Effects:
Dosage and
Administration:
For intravenous use by or under the direction of a veterinarian.
Use the contents within 24 hours of first broaching the vial. Discard
the unused portion.
HORSES & CATTLE: 1 - 4 mL, S.C., I.M. or I.V.
DOGS & CATS: 0.5 - 1 mL , S.C., I.M. or I.V.
Repeat after 1 - 2 weeks RLP APPROVED
General Directions:
Caution: avoid carcase damage
1. Sterilise all injection apparatus by boiling before use. Avoid use
of strong disinfectants on
apparatus.
2. Maintain cleanliness at all times.
3. Keep needles sharp and clean. Replace frequently.
4. Use needles of appropriate gauge and length. For subcutaneous
administration, use
shortest needle possible, certainly not exceeding 15 mm.
5. As far as is possible avoid injection of animals in wet weather or
under dusty conditions.
6. Intramuscular injections should be made into muscle tissue on the
side of the neck.
Subcutaneous injections should be made under the skin high on the neck
behind the ear.
Withholding Periods:
Meat: Zero (0) days.
Milk: Zero (0) days.
Trade Advice:
An ESI has not been established for this product. Note—observing the
meat withholding
period may not be sufficient to mitigate potential risks to export
trade. Trade advice should
be sought from Troy Laboratories on 02 8808 3600 before using this
product.
Safety Directions:
First Aid Instructions:
First aid is not generally required. If in doubt, contact a Poisons
Information Centre (e.g.
phone Australia 13 11 26 or a doctor).
First Aid Warnings:
Additional User
Safety:
Environmental
Statements:
Disposal:
Dispose of conta

Summary of Product characteristics

MATERIAL SAFETY DATA SHEET
PRODUCT NAME: TROY VITAMIN B12 INJECTION
PAGE: 1 OF 4
THIS REVISION ISSUED: JULY, 2010
MATERIAL SAFETY DATA SHEET
Issued by: Troy Laboratories 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
TROY LABORATORIES AUSTRALIA PTY. LTD ABN: 21 000 283 769
TEL:
[phone]
31-35 GLENDENNING ROAD
FAX:
[phone]
GLENDENNING NSW 2761
CHEMICAL NATURE:
Water solution of vitamin B12
TRADE NAME:
TROY VITAMIN B
12 INJECTION
PRODUCT CODE:
2983
PRODUCT USE:
Treatment of anaemias resulting from Vitamin B
12
deficiency in dogs, cats, horses
and cattle.
CREATION DATE:
AUGUST, 2005
THIS VERSION ISSUED:
JULY, 2010
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
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 under the ADG Code.
UN NUMBER:
None allocated
EMERGENCY OVERVIEW
PHYSICAL DESCRIPTION & COLOUR
: Clear, dark red liquid.
ODOUR:
Mild odour.
MAJOR HEALTH HAZARDS:
no significant risk factors have been found for this product.
POTENTIAL HEALTH EFFECTS
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 long term inhalation.
SKIN CONTACT:
SHORT TERM EXPOSURE:
Available data indicates that this product is not harmful. It should
present no hazards in
normal use. However product may be mildly irritating, but is unlikely
to cause anything more than mild discomfo