VITAMIN B12 PLUS SELENIUM INJECTION FOR CATTLE

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Patient Information leaflet (PIL)

20-06-2017

Summary of Product characteristics (SPC)

01-07-2013

Active ingredient:

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

Available from:

ELANCO AUSTRALASIA PTY LTD

INN (International Name):

hydroxocobalamin(0.675mg/mL)+cyanocobalamin(0.075mg/mL) + others

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

SELENIUM AS SODIUM SELENATE MINERAL-SELENIUM Active 5.0 mg/ml; VITAMIN B12 = CYANOCOBALAMIN VITAMIN-B12 Active 0.0675 g/ml; VITAMIN B12A = HYDROXOCOBALAMIN VITAMIN-B12 Active 0.0675 mg/ml

Units in package:

500mL

Class:

VM - Veterinary Medicine

Manufactured by:

ELANCO AUSTRALASIA

Therapeutic group:

Therapeutic area:

NUTRITION & METABOLISM

Therapeutic indications:

VITAMIN & MINERAL DEFICIENCY

Product summary:

Poison schedule: 6; Withholding period: WHP: Meat: Nil. Milk: Nil.; Host/pest details: CATTLE: [VITAMIN & MINERAL DEFICIENCY]; Poison schedule: 6; Withholding period: ; Host/pest details: CATTLE: [VITAMIN & MINERAL DEFICIENCY]; For the treatment and prevention of vitamin B12 (cobalt) and selenium deficiencies including associated productivity losses in cattle.Do not administer to cattle grazing pasture known to be high in selenium or where selenium accumulating plants are known to occur (SE Queensland)

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

Product name: Vitamin
B,?
Date:
Monday,
2
N o v e m b e r
199s
Page: 6 of 8
Pack sizes: 500 mL
Type of label: C o m p o s i
t
e :
C a r t
o n
a n d
p r i
m a r y
l
a b e l
File: VIT
B12
PLUS SE
MJ
CATTLE
Version:
1
lab 1
.doc
R e
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:
R e
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also update to code and change company details to
Novartis
(
J
B )
Text above this line is not included in the actual label
_Primary label (back)_
VITAMIN B,, PLUS SELENIUM INJECTION FOR CATTLE
DIRECTIONS FOR USE
Determine
SELENIUM STATUS OF THE HERD PRIOR TO TREATMENT. USE OF THIS PRODUCT IS
NOT
RECOMMENDED IN HERDS WHICH ARE NOT SELENIUM DEFICIENT. DO NOT
ADMINISTER TO CATTLE
GRAZING PASTURE KNOWN TO BE HIGH IN SELENIUM OR WHERE SELENIUM
ACCUMULATING PLANTS
ARE KNOWN TO OCCUR (EG SE QUEENSLAND). 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 (or equivalent) 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.
CALVES UP TO 100 KG
2 M L
GROWING CATTLE 100-300 KG
5 M L
ADULT
CATTLE
300
KG
+
10
ML
Give dose by subcutaneous injection only.
The frequency of dosing should be related to the severity of the
deficiencies, eg extreme
deficiency, repeat dose every 2-3 months.
Mild deficiency, repeat dose every 5-6 months.
Consult your animal health adviser for advice specific to your herd.
I
.
Product name: Vitamin B,l Plus Selenium Injection for Cattle
Date: Monday, 2 November 1998
Page:
1
of8
Pack sizes: 500 mL
Type of label: Composite:
Carton
and primary
label
File: VIT B12 PLUS SE INJ CATTLE
Version:
1
lab
1
.doc
Reason: Repack application
-
also update

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Summary of Product characteristics

PAGE 1 OF 3 / V3
VITAMIN B12 PLUS SELENIUM INJECTION FOR CATTLE
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.: (02) 9805 3555
FAX NO.: (02) 9888 8387

IDENTIFICATION
PRODUCT NAME: VITAMIN B12 PLUS SELENIUM INJECTION FOR CATTLE
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.
__________________________________________________________________________________________
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
0.0675
not
set
not
set
Cyanocobalamin
68-19-9
0.0075
not
set
not
set
Sodium
selenate
13410-01-0
1.2
(= 0.50% 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 IN

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