TROY B-COMPLEX INJECTION

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

VITAMIN B12A = HYDROXOCOBALAMIN; VITAMIN B3 = NICOTINAMIDE; PANTOTHENOL-DL = PANTHENOL-DL; VITAMIN B2 PHOSPHATE SODIUM = RIBOFLAVIN PHOSPHATE SODIU; VITAMIN B1 DISULFIDE NITRATE = THIAMINE DISULFIDE NITRAT; VITAMIN B6 HYDROCHLORIDE = PYRIDOXINE HYDROCHLORIDE

Available from:

TROY LABORATORIES PTY LTD

INN (International Name):

niacinamide(60mg/mL)+pyridoxine HCl(20mg/mL)+panthenol(17mg/mL) + others

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

VITAMIN B12A = HYDROXOCOBALAMIN VITAMIN-B12 Active 200.0 ug/ml; VITAMIN B3 = NICOTINAMIDE VITAMIN-B3 Active 60.0 mg/ml; PANTOTHENOL-DL = PANTHENOL-DL VITAMIN-B5 Active 17.0 mg/ml; VITAMIN B2 PHOSPHATE SODIUM = RIBOFLAVIN PHOSPHATE SODIU VITAMIN-B2 Active 5.0 mg/ml; VITAMIN B1 DISULFIDE NITRATE = THIAMINE DISULFIDE NITRAT VITAMIN-B1 Active 15.0 mg/ml; VITAMIN B6 HYDROCHLORIDE = PYRIDOXINE HYDROCHLORIDE VITAMIN-B6 Active 20.0 mg/ml

Units in package:

100mL; 50mL

Class:

VM - Veterinary Medicine

Manufactured by:

TROY LABORATORIES

Therapeutic group:

CAT | DOG | HORSE | BITCH | CASTRATE | CAT - QUEEN | CAT - TOM | COLT | DONKEY | ENDURANCE HORSE | FILLY | FOAL | GELDING | HIGH

Therapeutic area:

NUTRITION & METABOLISM

Therapeutic indications:

VITAMIN B DEFICIENCY

Product summary:

Poison schedule: 0; Withholding period: MEAT WITHHOLDING PERIOD (HORSES): Zero ( 0) days Export Slaughter Interval (ES I): 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 t rade. Trade advice should be sought from Troy Laboratories on ([phone] before using this product.; Host/pest details: CAT: [VITAMIN B DEFICIENCY]; DOG: [VITAMIN B DEFICIENCY]; HORSE: [VITAMIN B DEFICIENCY]; Poison schedule: 0; Withholding period: MEAT WITHHOLDING PERIOD (HORSES): NIL.; Host/pest details: CAT: [VITAMIN B DEFICIENCY]; DOG: [VITAMIN B DEFICIENCY]; HORSE: [VITAMIN B DEFICIENCY]; Poison schedule: 0; Withholding period: ; Host/pest details: CAT: [VITAMIN B DEFICIENCY]; DOG: [VITAMIN B DEFICIENCY]; HORSE: [VITAMIN B DEFICIENCY]; For use in vitamin B-complex deficiencies in dogs, cats and horses.

Authorization status:

Registered

Authorization date:

2022-07-01

Patient Information leaflet

Product Name:
APVMA Approval No:
TROY B-COMPLEX INJECTION
48285/137716
Label Name:
TROY B-COMPLEX INJECTION
Signal Headings:
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
60 mg/mL nicotinamide
20 mg/mL pyridoxine hydrochloride
17 mg/mL D-panthenol
15 mg/mL thiamine (as disulphide nitrate)
5 mg/mL riboflavin (as sodium phosphate)
200 µg/mL hydroxocobalamin (as the acetate)
Claims:
For use in Vitamin B-Complex deficiencies in dog, cats and horses.
For intravenous (IV) 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 (IV) use by or under the direction of a veterinarian.
Use the contents within 24 hours of first broaching the
vial/container. Discard the unused
portion. RLP APPROVED
Administer by intramuscular (I.M.) or subcutaneous (S.C). or
intravenous (I.V.) injection.
Dogs and Cats: 0.25 - 1.0 mL/10 kg body weight daily
Horses: 0.50 - 1.0 mL/100 kg body weight
General Directions:
Withholding Periods:
MEAT WITHHOLDING PERIOD (HORSES): Zero (0) days
Trade Advice:
Export Slaughter Interval (ESI): 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
([phone]
before using this product.
Safety Directions:
First Aid Instructions:
First aid is not generally required. If in doubt, contact a Poisons
Information Centre (phone
Australia 131 126) or a doctor.
First Aid Warnings:
Additional User
Safety:
Additional information is listed in the safety data sheet.
Environmental
Statements:
Disposal:
Dispose of 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.

Summary of Product characteristics

MATERIAL SAFETY DATA SHEET
PRODUCT NAME: TROY B-COMPLEX 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 (see below).
TRADE NAME:
TROY B-COMPLEX INJECTION
PRODUCT CODE:
2961
PRODUCT USE:
B complex vitamin supplement for deficient dogs, cats and horses.
CREATION DATE:
JUNE, 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:
S2. Keep out of reach of children.
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:
Characteristic 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. In addition product is unlikely to cause any discomfort in
normal use.
LONG TERM EXPOSURE:
No data for health ef