TROY FOLIC-B12 INJECTION

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

VITAMIN B12A ACETATE = HYDROXOCOBALAMIN ACETATE; VITAMIN M = FOLIC ACID = PGA

Available from:

TROY LABORATORIES PTY LTD

INN (International Name):

folic acid(15mg/mL)+hydroxocobalamin acetate(500ug/mL)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

VITAMIN B12A ACETATE = HYDROXOCOBALAMIN ACETATE VITAMIN-B12 Active 500.0 ug/ml; VITAMIN M = FOLIC ACID = PGA VITAMIN-M Active 15.0 mg/ml

Units in package:

100mL; 50mL

Class:

VM - Veterinary Medicine

Manufactured by:

TROY LABORATORIES

Therapeutic group:

DOG | HORSE | BITCH | CASTRATE | COLT | DONKEY | ENDURANCE HORSE | FILLY | FOAL | GELDING | HIGH PERFORMANCE HORSES | HORSES AT

Therapeutic area:

NUTRITION & METABOLISM

Therapeutic indications:

VITAMIN & MINERAL DEFICIENCY

Product summary:

Poison schedule: 0; Withholding period: WHP: MEAT WITHHOLDING PERIOD (HORSES) NIL; Host/pest details: DOG: [VITAMIN & MINERAL DEFICIENCY]; HORSE: [VITAMIN & MINERAL DEFICIENCY]; Poison schedule: 0; Withholding period: ; Host/pest details: DOG: [VITAMIN & MINERAL DEFICIENCY]; HORSE: [VITAMIN & MINERAL DEFICIENCY]; For use in anaemias resulting from vitamin B12 and folic acid deficiencies in horses and dogs.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

LABEL IMAGE PROUDLY SUPPLIED BY
[e-mail]
..
Draft Text label:
Troy Folfc-B12 Injection
Immediate Label: Ancillary Panel
Text
appearing
above the Header and below the Footer lines is not included in the
label
DIRECTIONS FOR
USE:
FOR
(INTRAVENOUS)
USE
ONLY
BY
OR
UNDER
the
direction
of
a
registered
VETERINARY SURGEON.
HORSES:
5-10mL,
i.m.
or i.v.
DOGS:
1-2mL, i.m,
or i.v.
Repeat once or twice weekly,
or as required.
MEAT
WITHHOLDING
PERIOD
(HORSES):
NIL
TROY
LABORATORIES PTY.
LIMITED
98
LONG ST,
SMITHFIELD,
NSW
2164
AUSTRALIA
Dispose of empty container by wrapping with paper and putting in
garbage.
Protect from light
Store below 25°C (air conditioning).
NRA
Approval
No.:
_404361_
_0803_
Batch:
25 July 2003
Expiry:
Page 2
of4
·
.
Draft Text
Label:
Troy Folic-B12lnjeclion
Carton:
Main Panel
Text
appearing above the Header and below the Footer
lines is not included in the label
FOR ANIMAL TREATMENT ONLY
TROY
FOLlC-B12 INJECTION
ACTIVE CONSTITUENTS:
15 mg/mL FOLIC ACID
500
~g/mL
HYDROXOCOBALAMIN ACETATE
FOR USE IN ANAEMIAS RESULTING FROM VITAMIN
812
AND FOLIC ACID
DEFICIENCIES IN HORSES AND DOGS
50
mL/100
mL
25 July 2003
Page
3 of 4
·
.
Draft Text
Label:
Troy Folic-B12
Injection
Carton:
Ancillary Panel
Text appearing above the Headerand below the Footer lines is nol
included
in the label
DIRECTIONS FOR USE:
FOR (INTRAVENOUS) USE
ONLY
BY OR UNDER
the
direction
of
a
registered
VETERINARY SURGEON.
HORSES:
5-10mL,
i.m. or i.v.
DOGS:
1-2mL,
i.rn,
or i.v.
Repeat once or twice weekly,
or as required.
MEAT WITHHOLDING PERIOD (HORSES):
NIL
TROY
LABORATORIES PTY.
LIMITED
98
LONG ST,
SMITHFIELD,
NSW 2164 AUSTRALIA
Dispose of empty container by wrapping with paper and putting in
garbage.
Protect from light
Store below 25°C (air conditioning).
NRA Approval
No.:
_404361_
_0130:3,_
Batch:
25 July 2003
Expiry
Page 4 of
4

Summary of Product characteristics

MATERIAL SAFETY DATA SHEET
PRODUCT NAME: TROY FOLIC-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 ingredients.
TRADE NAME:
TROY FOLIC-B
12 INJECTION
PRODUCT CODE:
40436
PRODUCT USE:
For use in anaemias resulting from Vitamin B
12
and folic acid deficiencies in dogs and
horses.
CREATION DATE:
JULY, 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 reddish-yellow 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 discom