VYTRATE SCOUR TREATMENT

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Patient Information leaflet (PIL)

19-06-2017

Summary of Product characteristics (SPC)

19-06-2017

Safety Data Sheet (SDS)

27-08-1996

Active ingredient:

GLYCINE; CITRIC ACID ANHYDROUS; GLUCOSE ANHYDROUS; POTASSIUM CITRATE; POTASSIUM PHOSPHATE MONOBASIC; SODIUM CHLORIDE

Available from:

ZOETIS AUSTRALIA PTY LTD

INN (International Name):

glucose(44.61g/Sc)+glycine(6.18g/Sc)+citric acid(0.48g/Sc) + others

Pharmaceutical form:

ORAL POWDER, PRE-MIX

Composition:

GLYCINE AMINO ACID-GLYCINE Active 6.18 g/sa; CITRIC ACID ANHYDROUS ACID-GENERAL Active 0.48 g/sa; GLUCOSE ANHYDROUS CARBOHYDRATE Active 44.61 g/sa; POTASSIUM CITRATE MINERAL-POTASSIUM Active 0.12 g/sa; POTASSIUM PHOSPHATE MONOBASIC MINERAL-POTASSIUM Active 4.08 g/sa; SODIUM CHLORIDE MINERAL-SODIUM-SALT Active 8.58 g/sa

Units in package:

*12x64g; *sachets; 64g sachet

Class:

VM - Veterinary Medicine

Therapeutic group:

Therapeutic area:

ALIMENTARY SYSTEM

Therapeutic indications:

DEHYDRATION | SCOURS | STRESS | SELENIUM RESPONSIVE SCOURS

Product summary:

Poison schedule: 0; Withholding period: WHP: Zero (0) days ESI: Not required; Host/pest details: CALF: [DEHYDRATION, SCOURS, STRESS]; CAT: [DEHYDRATION, SCOURS, STRESS]; DOG: [DEHYDRATION, SCOURS, STRESS]; HORSE FOAL: [DEHYDRATION, SCOURS, STRESS]; LAMB: [DEHYDRATION, SCOURS, STRESS]; PIGS: [DEHYDRATION, SCOURS, STRESS]; Poison schedule: 0; Withholding period: ; Host/pest details: CALF: [DEHYDRATION, SCOURS, STRESS]; CAT: [DEHYDRATION, SCOURS, STRESS]; DOG: [DEHYDRATION, SCOURS, STRESS]; HORSE FOAL: [DEHYDRATION, SCOURS, STRESS]; LAMB: [DEHYDRATION, SCOURS, STRESS]; PIGS: [DEHYDRATION, SCOURS, STRESS]; A non-antibiotic supportive treatment for scouring in dehydrated calves, pigs, dogs, cats, lambs & foals. A suitable first feed for bought-in-calves or stressed calves and pigs. Actively fights the dehydration that kills.Stressed and scouring animals requiring rehydration are at risk of multiple organ dysfunction. It is recommended that veterinary advice is sought when considering treating dehydrated animals.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

VYTRATE
SCOUR
TREATMENT
Relevant
Label
Particulars
05MAR14
page
1/3
[Copy
in
the
header
and
footer
will
not
appear
on
the
final
printed
label]
[J
New Product (include all applicable RLPs)
OR
x
Variation
(highlight
instructions
that
are
being
varied).
Approval
no.
of
label
being
varied:
35892/60579
...............
"
Signal
heading:
FOR ANIMAL TREATMENT ONLY
Product name:
VYTRATE®
SCOUR TREATMENT
Active constituent/s:
Active
Constituents:
1
Each duo sachet contains:
SECTION 1
+
Glycine
618g
Citric acid
0.48g
Potassium phosphate monobasic
408g
Potassium citrate
0 12g
Sodium chloride
8.58g
RLP
SECTION 2
Approved
Glucose
44.61g
Statement
of
claims:
A non-antibiotic supportive treatment for scouring or dehydrated
calves, pigs,
dogs, cats, lambs and foals. A suitable first feed for bought-in
calves or
stressed calves and pigs.
Actively fights the dehydration that kills.
VYTRATE® Reduces Scour Duration
and
Severity.
Replaces Lost Fluids and Electrolytes
NET
contents:
(64
g):
This duo sachet contains
64
g NET.
(12
_x _
64
g):
This carton contains
12
x
64
g duo sachets NET
(1
duo sachet
makes 2 litres of prepared solution)
Directions
for
Use
DIRECTIONS FOR USE
Heading:
Restraints:
---
Contraindications:
----
Precautions:
---
Side
effects:
----
Dosage
&
Dosage and administration
administration:
GENERAL DIRECTIONS
IMPORTANT-
Each sachet
is
divided into two sections.
To make
up
VYTRATE® Solution: Add the contents of Section 1
and
Section 2
of one VYTRA
TE®
sachet to 2 litres of warm water. Stir until dissolved.
Sections 1 and 2 must always
be
fed together. Keep feeding utensils clean.
500 mL of VYTRATE® solution can
be
prepared using a 5
mL
medicine spoon.
In
this case,
add
1 level spoonful of powder from section 1 to 3 heaped
spoonfuls
of
powder from section
2.
Stir until dissolved.
I
Stressed and
scouring
animals requiring rehydration are
at
risk
of
i
multiple
organ
dysfunction.
It is
strongly
recommended
that
veterinary
VYTRATE SCOUR TREATMENT
Relevant Label Particulars
05MAR14
page 2/3
[Copy
in
the header and footer

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Summary of Product characteristics

VYTRATE SCOUR TREATMENT
Page 1 of 8
Issued by: Jurox Pty Limited
Phone: 1800 023 312
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA
ISSUED:
28 JANUARY 2016
SAFETY DATA SHEET
SECTION 1: IDENTIFICATION OF CHEMICAL PRODUCT AND COMPANY
PRODUCT IDENTIFIER:
VYTRATE SCOUR TREATMENT
PRODUCT CODE:
504285 (Duo sachets, 12s)
RECOMMENDED USE:
A non-antibiotic supportive treatment for scouring or dehydrated
calves, pigs, dogs, cats, lambs and foals. A suitable first feed for
bought-in calves or stressed calves and pigs.
RESTRICTIONS ON USE:
For animal treatment only.
COMPANY IDENTIFICATION:
Jurox Pty Limited
ADDRESS:
85 Gardiner Street,
Rutherford, NSW 2320,
Australia
EMAIL:
jenq@jurox.com.au
CUSTOMER CENTRE:
1800 023 312
NATIONAL POISONS INFORMATION CENTRE:
13 1126 (Australia-wide)
EMERGENCY TELEPHONE NUMBER:
1800 023 312 (9am – 5pm, Monday to Friday)
SECTION 2: HAZARDS IDENTIFICATION
HAZARD CLASSIFICATIONS: This product has been assessed according to
GHS and is classified as non-
hazardous.
SIGNAL WORD: None.
GHS PICTOGRAMS: None.
PRECAUTIONARY STATEMENTS: None.
VYTRATE SCOUR TREATMENT
Page 2 of 8
Issued by: Jurox Pty Limited
Phone: 1800 023 312
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA
SECTION 3: COMPOSITION / INFORMATION ON INGREDIENTS
DUO SACHETS:
INGREDIENT
CAS NO.
CONTENT
_SECTION A _
Sodium chloride
7647-14-5
44%
Glycine
56-40-6
32%
Potassium phosphate monobasic
7778-77-0
21%
Citric acid monohydrate
5949-29-1
2%
Potassium citrate
866-84-2
0.6%
_SECTION B _
Glucose monohydrate
14431-43-7
100%
WHEN ONE DUO SACHET IS RECONSTITUTED IN 2 L OF WATER:
INGREDIENT
CAS NO.
CONTENT
Glucose monohydrate
14431-43-7
2.2%
Sodium chloride
7647-14-5
< 1%
Glycine
56-40-6
< 1%
Potassium phosphate monobasic
7778-77-0
< 1%
Citric acid monohydrate
5949-29-1
< 0.1%
Potassium citrate
866-84-2
< 0.1%
SECTION 4: FIRST AID MEASURES
GENERAL INFORMATION: Consult the National Poisons Centre on 13 1126 or
a doctor immediately in every case
of suspected chemical poisoning. Never give fluids or induce vomiting
if

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Safety Data Sheet

WWW.JUROX.COM.AU
Customer Service 1800 023 312
® Registered Trademark of Jurox Pty Ltd
TECHNICAL NOTES
COMPOSITION
SACHET SECTION 1
Glycine 6.18 g
Citric Acid 0.48 g
Potassium Acid Phosphate 4.08 g
Potassium Citrate 0.12 g
Sodium Chloride 8.58 g
SACHET SECTION 2
Glucose 44.61 g
DESCRIPTION
Oral rehydration therapy containing a balanced mixture of glucose,
glycine and electrolytes.
ACTIONS
Isotonic rehydration fluid and non antibiotic supportive treatment of
scouring and dehydration. Glucose and glycine are actively
absorbed by the intestine causing the absorption of water and sodium
resulting in rehydration of the scouring animal.
INDICATIONS
A non antibiotic supportive treatment for scouring or dehydrated
calves, pigs, dogs, cats, lambs and foals. A suitable first feed for
bought-in calves or stressed calves and pigs.
WITHHOLDING PERIODS
MEAT Zero (0) days
EXPORT SLAUGHTER INTERVAL
Zero (0) days
VYTRATE
®
SCOUR TREATMENT
(known as Vytrate® Sachets)
WWW.JUROX.COM.AU
Customer Service 1800 023 312
® Registered Trademark of Jurox Pty Ltd
TECHNICAL NOTES
DOSAGE AND ADMINISTRATION
RECONSTITUTION/ DILUTION
Sections 1 and 2 must be used together.
Add the contents of section 1 and section 2 to 2 litres of warm water.
Stir until dissolved.
To prepare 500 mL, add 1 level 5 mL medicine spoonful of powder from
section 1 and 3 heaped spoonfuls of powder from section 2.
Refrigerate remaining solution after use and use within 24 hours.
Prepare fresh solution daily.
CALVES
BOUGHT-IN OR STRESSED CALVES (NOT SCOURING).
Feed 2 litres of diluted solution, made up as above, as the first feed
on arrival.
For the next scheduled feed, use 1 litre diluted solution at the same
time as, but not mixed with, milk or milk replacer.
Thereafter, feed normal diet.
SCOURING CALVES
Feed 1 to 1.5 litres of diluted solution per 10 kg bodyweight daily,
divided into two or more daily doses.
If scouring is established or severe, causing dehydration, the higher
dose should be used initially and fed in three or four divided
doses. 2 litres of diluted

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