NV FOLIC ACID & VITAMIN B12 INJECTION
Country: Australia
Language: English
Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)
Patient Information leaflet
(PIL)
20-06-2017
Summary of Product characteristics
(SPC)
20-06-2017
Active ingredient:
VITAMIN B12 = CYANOCOBALAMIN; VITAMIN M = FOLIC ACID = PGA
Available from:
CEVA ANIMAL HEALTH PTY LTD
INN (International Name):
folic acid(15mg/mL)+cyanocobalamin(500ug/mL)
Pharmaceutical form:
PARENTERAL LIQUID/SOLUTION/SUSPENSION
Composition:
VITAMIN B12 = CYANOCOBALAMIN 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:
CEVA ANIMAL HEALTH
Therapeutic group:
DOG | HORSE | BITCH | CASTRATE | COLT | DONKEY | ENDURANCE HORSE | FILLY | FOAL | GELDING | HIGH PERFORMANCE HORSES | HORSES AT
Therapeutic area:
NUTRITION & METABOLISM
Therapeutic indications:
MACROCYTIC ANAEMIA
Product summary:
Poison schedule: 0; Withholding period: WHP: MEAT (HORSES): nil; Host/pest details: DOG: [MACROCYTIC ANAEMIA]; HORSE: [MACROCYTIC ANAEMIA]; Poison schedule: 0; Withholding period: ; Host/pest details: DOG: [MACROCYTIC ANAEMIA]; HORSE: [MACROCYTIC ANAEMIA]; Folic acid and vitamin B12 supplement for treatment of macrocytic anaemia in horses and dogs.
Authorization status:
Registered
Authorization date:
2023-07-01
Patient Information leaflet
INFOPEST VERIFIES THAT THIS LABEL IS CONSISTENT WITH THE
NRA APPROVED TEXT LABEL
DIRECTIONS FOR USE:
Administer by intramuscular injection.
HORSES:
5 - 10 mL
DOGS:
1 - 2 mL
Administer twice weekly or as directed by
a veterinary surgeon.
MEAT
WITHHOLDING
PERIOD
(HORSES): NIL.
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.
FOR ANIMAL TREATMENT ONLY
NV
FOLIC ACID &
VITAMIN B12
INJECTION
ACTIVE CONSTITUENTS:
FOLIC ACID
15mg/mL
CYANOCOBALAMIN
500
µ
g/mL
FOLIC ACID AND VITAMIN B12 SUPPLEMENT
FOR THE TREATMENT OF MACROCYTIC ANAEMIA
IN HORSES AND DOGS.
50 mL/100mL
STORE
below 25
°
C (Air Conditioning).
Protect from light
.
KEEP OUT OF REACH OF
CHILDREN
Batch No.:
Expiry Date:
NRA No.:51116/0200
NATURE VET PTY LIMITED
299 Castlereagh Road
Agnes Banks NSW 2753
Tel: (61) 2 4578 1022
Fax: (61) 2 4578 2913
www.naturevet.com.au
Product: Folic Vit B12 Injection
Date; 08/06/00
Container/Carton Label
Carton has centre panel repeated on front and back
Read the complete document
Summary of Product characteristics
PRODUCT NAME: FOLIC ACID AND VITAMIN B12 INJECTION
PAGE: 1 OF 5
THIS VERSION ISSUED: DECEMBER, 2014
SAFETY DATA SHEET
Issued by: Ceva Animal Health Pty Ltd
Phone: 02 9652 7000 (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: 02 9652 7000 (OFFICE HOURS)
11 MOORES RD
FAX: 02 9652 7017
GLENORIE, NSW 2157
WWW.CEVA.COM.AU
CHEMICAL NATURE:
Folic Acid and Vitamin B12 in aqueous solution.
TRADE NAME:
FOLIC ACID AND VITAMIN B12 INJECTION
PRODUCT USE:
Folic acid and vitamin B12 supplement for the treatment of macrocytic
anaemia in
horses and dogs.
CREATION DATE:
DECEMBER, 2014
THIS VERSION ISSUED:
DECEMBER, 2014
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 Australian Dangerous Goods (ADG)
Code, IATA or IMDG/IMSBC criteria.
RISK PHRASES:
Not Hazardous - No criteria found.
SAFETY PHRASES:
S25, S36. Avoid contact with eyes. Wear suitable protective clothing.
SUSMP CLASSIFICATION:
None allocated.
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good according to Australian Dangerous
Goods (ADG)
Code, IATA or IMDG/IMSBC criteria.
UN NUMBER:
None allocated
GHS SIGNAL WORD: NONE. NOT HAZARDOUS.
PREVENTION
P102: Keep out of reach of children.
P235: Keep cool.
P262: Do not get in eyes, on skin, or on clothing.
P281: Use personal protective equipment as required.
RESPONSE
P353: Rinse skin or shower with water.
P301+P330+P331: IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
P370+P378: Not combustible. Use extinguishing media suited to burning
materials.
STORAGE
P410: Protect from sunlight.
P411: Store at temperatures not exceeding 30°C.
DISPOSAL
P501: Dispose of small quantities and empty containers by wrapping
with paper and putting in garbage. For
larger quantities, if recycling or reclaiming
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