VITAMIN B12 PLUS SELENIUM INJECTION FOR SHEEP

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

SELENIUM AS SODIUM SELENATE; VITAMIN B12 = CYANOCOBALAMIN; VITAMIN B12A = HYDROXOCOBALAMIN

Available from:

ELANCO AUSTRALASIA PTY LTD

INN (International Name):

hydroxocobalamin(1.72mg/mL)+cyanocobalamin(0.2mg/mL) + others

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

SELENIUM AS SODIUM SELENATE MINERAL-SELENIUM Active 2.0 mg/ml; VITAMIN B12 = CYANOCOBALAMIN VITAMIN-B12 Active 0.2 mg/ml; VITAMIN B12A = HYDROXOCOBALAMIN VITAMIN-B12 Active 1.72 mg/ml

Units in package:

500mL

Class:

VM - Veterinary Medicine

Manufactured by:

ELANCO AUSTRALASIA

Therapeutic group:

SHEEP | EWE | HOGGET | LAMB | OVINE | RAM | WEANER | WETHER

Therapeutic area:

NUTRITION & METABOLISM

Therapeutic indications:

SELENIUM DEFICIENCY | VITAMIN B12 DEFICIENCY | ANAEMIA | COBALT DEFICIENCY | WHITE MUSCLE DISEASE

Product summary:

Poison schedule: 6; Withholding period: WHP: Nil; Host/pest details: SHEEP: [SELENIUM DEFICIENCY, VITAMIN B12 DEFICIENCY]; Poison schedule: 6; Withholding period: ; Host/pest details: SHEEP: [SELENIUM DEFICIENCY, VITAMIN B12 DEFICIENCY]; For the treatment and prevention of Vitamin B12 and selenium deficiencies in sheep.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

INFOPEST VERIFIES THAT THIS LABEL IS CONSISTENT WITH THE NRA
APPROVED TEXT LABEL OF 23/8/99 ________
_PRIMARY CARTON LABEL (FRONT)_
POISON
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
VITAMIN B
12 PLUS SELENIUM INJECTION FOR SHEEP
Active constituents: 1.92 mg /mL Vitamin B
12
(as 1.72 mg/mL Hydroxocobalamin and 0.20 mg/mL Cyanocobalamin)
2.0 mg/mL Selenium as Sodium Selenate
For the treatment and prevention of Vitamin B12 and selenium
deficiencies
500 ML
NOVARTIS ANIMAL HEALTH AUSTRALASIA PTY LIMITED
A.C.N. 076 745 198
140-150 Bungaree Road
PENDLE HILL NSW 2145
in sheep.
_PRIMARY CARTON LABEL (BACK PANEL)_
VITAMIN B
12 PLUS SELENIUM INJECTION FOR SHEEP
DIRECTIONS FOR USE
•
DETERMINE SELENIUM STATUS OF THE FLOCK PRIOR TO TREATMENT.
•
USE OF THIS PRODUCT IS NOT RECOMMENDED IN FLOCKS WHICH ARE NOT
SELENIUM DEFICIENT.
•
DO NOT ADMINISTER TO SHEEP GRAZING PASTURE KNOWN TO BE HIGH IN
SELENIUM OR WHERE
SELENIUM ACCUMULATING PLANTS ARE KNOWN TO OCCUR.
•
TO AVOID OVERDOSING, DO NOT USE WITH OTHER SELENISED PRODUCTS, EG.
VACCINE, PELLETS,
FERTILISER, ORAL DRENCH OR OTHER INJECTABLE PRODUCTS.
CAUTION: AVOID CARCASS 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 shortest needles possible . For subcutaneous injection, 18 g by 15
mm should suffice.
5.
Avoid injection in wet weather or dusty conditions.
6.
Subcutaneous injections should be made under the skin, high on the
neck behind the ear.
DOSAGE AND ADMINISTRATION
LAMBS (UNDER 15 KG)
1 ML
WEANERS AND ADULTS
2 ML
Give dose by subcutaneous injection only.
The frequency of dosing should be related to the severity of the
deficiencies. For instance, for
sheep in extremely deficient areas, repeat dose every 2-3 months.
In less deficient areas, repeat dose every 5-6 months or as found
necessary.
Consult your animal health adviser for advice specific to your flock. WITHHOLDING PERIODS: NIL NOTE: THE

Summary of Product characteristics

 
PAGE 1 OF 3 / V3 
VITAMIN B12 PLUS SELENIUM INJECTION FOR SHEEP 
DATE OF ISSUE: 27 OCTOBER 2008 
MATERIAL SAFETY DATA SHEET 
STATEMENT OF HAZARDOUS NATURE: 
CLASSIFIED AS HAZARDOUS ACCORDING TO THE CRITERIA OF WORKSAFE
AUSTRALIA.  
COMPANY DETAILS: 
NOVARTIS ANIMAL HEALTH AUSTRALASIA PTY LIMITED

A.C.N. 076 745 198 
54 WATERLOO ROAD,  
NORTH RYDE NSW 2113 

TELEPHONE NO.: [phone] 
FAX NO.: [phone] 

IDENTIFICATION 
PRODUCT NAME: VITAMIN B12 PLUS SELENIUM INJECTION FOR SHEEP 
OTHER NAMES: None. 
PRODUCT CODE: None. 
UN NO: None allocated. 
HAZCHEM CODE: None allocated. 
DANGEROUS GOODS CLASS: None allocated. 
SUB RISK CLASS: None allocated. 
PACKAGING GROUP: None allocated. 
POISON SCHEDULE: S6. 
CHEMICAL FAMILY: Vitamin / trace element preparation. 
USES: Treatment of cobalt and selenium deficiency in sheep. 
__________________________________________________________________________________________  
PHYSICAL DESCRIPTION & PROPERTIES 
APPEARANCE & ODOUR: Liquid. No data re odour. 
MELTING/SOFTENING POINT: Approximately 0°C. 
BOILING POINT AND VAPOUR PRESSURE: Approximately 100°C at 100kPa. 
VOLATILE MATERIALS: Water component. 
FLASHPOINT: Does not burn. 
SPECIFIC GRAVITY: No data. 
SOLUBILITY IN WATER: Completely soluble. 
CORROSIVENESS: Not corrosive. 
________________________________________________________________________________  
Ingredients 
Worksafe Exposure Limits 
Chemical Entity 
CAS No 
Proportion, %w/v 
TWA, mg/m
3
 STEL, 
mg/m
3

Hydroxocobalamin
 13422-51-0 
0.18

not set 
not set 
Cyanocobalamin
 68-19-9 
0.02

not set 
not set 
Sodium selenate 
13410-01-0

0.479 (= 0.20% Se)  0.2 
not set

Other non hazardous ingredients 
secret 
to 100 
not set 
not set 

This is a commercial product whose exact ratio of
components may vary. Trace quantities of impurities are also
likely. 
HEALTH HAZARD INFORMATION 
HEALTH EFFECTS: 
No specific data is available for the