SCOURBAN ORAL ANTI-DIARRHOEAL SUSPENSION

Land: Australia

Språk: engelsk

Kilde: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Informasjon til brukeren (PIL)

19-06-2017

Preparatomtale (SPC)

19-06-2017

Aktiv ingrediens:

GLYCINE; NEOMYCIN SULFATE; STREPTOMYCIN AS STREPTOMYCIN SULFATE; HYOSCINE AS HYOSCINE HYDROBROMIDE; PECTIN; KAOLIN CLAY; CALCIUM AS CALCIUM GLUCONATE; POTASSIUM AS POTASSIUM CHLORIDE; MAGNESIUM AS MAGNESIUM SULFATE; SODIUM AS SODIUM CHLORIDE; SULFADIMIDINE; SULFADIAZINE

Tilgjengelig fra:

ELANCO AUSTRALASIA PTY LTD

INN (International Name):

sulfadimidine(35.5mg/mL)+sulfadiazine(35.5mg/mL) + others

Legemiddelform:

ORAL SOLUTION/SUSPENSION

Sammensetning:

GLYCINE AMINO ACID-GLYCINE Active 627.0 mg/30ml; NEOMYCIN SULFATE ANTIBIOTIC Active 54.0 mg/30ml; STREPTOMYCIN AS STREPTOMYCIN SULFATE ANTIBIOTIC Active 182.0 mg/30ml; HYOSCINE AS HYOSCINE HYDROBROMIDE ALKALOID Active 0.95 mg/30ml; PECTIN CARBOHYDRATE Active 159.6 mg/30ml; KAOLIN CLAY CLAY Active 3.1 g/30ml; CALCIUM AS CALCIUM GLUCONATE MINERAL-CALCIUM-SALT Active 5.9 mg/30ml; POTASSIUM AS POTASSIUM CHLORIDE MINERAL-POTASSIUM Active 57.0 mg/30ml; MAGNESIUM AS MAGNESIUM SULFATE MINERAL-MAGNESIUM Active 1.77 mg/30ml; SODIUM AS SODIUM CHLORIDE MINERAL-SODIUM-SALT Active 133.0 mg/30ml; SULFADIMIDINE SULFANYL Active 1065.0 mg/30ml; SULFADIAZINE SULFANYL Active 1065.0 mg/30ml

Enheter i pakken:

100mL; 2L; 500mL; 5L

Klasse:

VM - Veterinary Medicine

Produsert av:

BAYER AUSTRALIA

Terapeutisk gruppe:

Terapeutisk område:

ALIMENTARY SYSTEM

Indikasjoner:

Produkt oppsummering:

Poison schedule: 4; Withholding period: MEAT: (horses and calves): DO NOT USE less than 14 days before slaughter for human consumption. MILK: (cattle): D O NOT USE in lactating or pregnant catt le. TRADE ADVICE EXPORT SLAUGHTER INT ERVAL (ESI): An ESI has not been establ ished for this product. Note—observing t he meat withholding period may not be su fficient to mitigate potential risks to export trade. Trade advice should be so ught from Elanco Australasia Pty Ltd on 1800 226 324 before using this product.; Host/pest details: CALF: [BACTERIAL TOXIN, ELECTROLYTE REPLACEMENT, GASTRO ENTERITIS, PNEUMONIA, REDUCTION OF INTESTINAL MOTILITY, SCOURS]; CAT: [BACTERIAL TOXIN, ELECTROLYTE REPLACEMENT, GASTRO ENTERITIS, PNEUMONIA, REDUCTION OF INTESTINAL MOTILITY, SCOURS]; DOG: [BACTERIAL TOXIN, ELECTROLYTE REPLACEMENT, GASTRO ENTERITIS, PNEUMONIA, REDUCTION OF INTESTINAL MOTILITY, SCOURS]; HORSE: [BACTERIAL TOXIN, ELECTROLYTE REPLACEMENT, GASTRO ENTERITIS, PNEUMONIA, REDUCTION OF INTESTINAL MOTILITY, SCOURS]; Poison schedule: 4; Withholding period: MEAT: (horses and calves): DO NOT USE less than 14 days before slaughter for human consumption. MILK: (cattle): D O NOT USE in lactating or pregnant catt le. TRADE ADVICE EXPORT SLAUGHTER INT ERVAL (ESI): This product does not have an ESI established. For advice on the ESI contact the manufacturer on 1800 678 368 before using this product.; Host/pest details: CALF: [BACTERIAL TOXIN, ELECTROLYTE REPLACEMENT, GASTRO ENTERITIS, PNEUMONIA, REDUCTION OF INTESTINAL MOTILITY, SCOURS]; CAT: [BACTERIAL TOXIN, ELECTROLYTE REPLACEMENT, GASTRO ENTERITIS, PNEUMONIA, REDUCTION OF INTESTINAL MOTILITY, SCOURS]; DOG: [BACTERIAL TOXIN, ELECTROLYTE REPLACEMENT, GASTRO ENTERITIS, PNEUMONIA, REDUCTION OF INTESTINAL MOTILITY, SCOURS]; HORSE: [BACTERIAL TOXIN, ELECTROLYTE REPLACEMENT, GASTRO ENTERITIS, PNEUMONIA, REDUCTION OF INTESTINAL MOTILITY, SCOURS]; An aid in the prevention and treatment of bacterial diarrhoea in horses, calves, dogs and cats.DO NOT USE in lactating or pregnant cattle

Autorisasjon status:

Registered

Autorisasjon dato:

2023-07-01

Informasjon til brukeren

COMPANY NAME:
BAYER AUSTRALIA
LTD
(ANIMAL HEALTH)
PRODUCT NAME:
SCOURBAN ORAL ANTI-DIARRHOEAL SUSPENSION
ELABEL APPLICATION
NO:
DC12-62114253E17
APVMA APPROVAL
NO:
36026/100547
LABEL NAME:
SCOURBAN ORAL ANTI-DIARRHOEAL SUSPENSION
SIGNAL HEADINGS:
PRESCRIPTION ANIMAL REMEDY
KEEP
OUT
OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
CONSTITUENT
STATEMENTS:
54 mg/30ml NEOMYCIN SULFATE
182 mg/30ml STREPTOMYCIN
AS
STREPTOMYCIN SULFATE
0.95 mg/30ml HYOSCINE AS HYOSCINE HYDROBROMIDE
159.6 mg/30ml PECTIN
5.9 mg/30ml CALCIUM AS CALCIUM GLUCONATE
57 mg/30ml POTASSIUM
AS
POTASSIUM CHLORIDE
1.77 mg/30ml MAGNESIUM AS MAGNESIUM SULFATE
133 mg/30ml SODIUM AS SODIUM CHLORIDE
1065 mg/30ml SULFADIMIDINE
1065 mg/30ml SULFADIAZINE
{Also Contains)
627 mg/30ml GLYCINE
3.1
g/30ml KAOLIN CLAY
•
RLP
APPROVED
CLAIMS:
An aid in the prevention and treatment of bacterial diarrhoea in
horses, calves, dogs and
cats.
I
DIRECTIONS FOR USE:
RESTRAINTS:
For the treatment
of
gastroenteritis and scour/pneumonia complex caused by sensitive
bacterial organisms. For restoring electrolyte loss, reducing
intestinal motility and
elimination
of
bacterial toxins.
100mL
2L
500mL
5L
DO NOT USE
in
lactating or pregnant cattle.
CONTRAINDICATIONS:
\ PRECAUTIONS:
DOSAGE AND
ADMINISTRATION:
GENERAL DIRECTIONS:
WITHHOLDING
PERIODS:
TRADE ADVICE:
FIRST AID
INSTRUCTIONS:
\ FIRST AID WARNINGS:
I
Environmental
STATEMENTS:
DISPOSAL:
This product is contraindicated for use
in
animals with known sulfonamide sensitivity,
li
ver
damage
or
blood dyscrasias.
SHAKE WELL BEFORE USE
For oral use only. Treat twice daily
Small animals 2mU3kg Bwt
Calves and horses
30ml/25kg
Bwt
When treating salmonellosis and bacterial pneumonias continue
treatment for a minimum
of
5 days.
MEAT: (horses
and
calves): DO NOT USE less than 14 days before slaughter for human
consumption.
MILK: (cattle): DO NOT USE in lactating or pregnant cattle.
Any variation by the prescribing veterinarian to the allowed dose,
frequency, duration,
route, disease or target species may require extending the approved
wit

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Preparatomtale

Page 1 of 8
SAFETY DATA SHEET
A18298/04/AUS
SCOURBAN ORAL ANTI-DIARRHOEAL SUSPENSION
SECTION 1 – IDENTIFICATION, CONTACTS
Bayer Australia Ltd
875 Pacific Highway
Pymble NSW 2073
EMERGENCY TELEPHONE NUMBER
1800 033 111
24 hour Emergency Service Australia Wide, Toll Free
CONTACT POINT (FOR NON-EMERGENCY CALLS)
Animal Health Division
(02) 9391 6000
Full Product Name
SCOURBAN ORAL ANTI-DIARRHOEAL SUSPENSION
Other Names
Nil.
Product Use
FOR ANIMAL TREATMENT ONLY
For treatment of bacterial diarrhoea in horses, calves, dogs and cats.
Creation Date
10
th
January 2012
Revision Date
26 May 2015
SECTION 2 – HAZARDS IDENTIFICATION
Hazard Classification
CLASSIFIED AS A HAZARDOUS SUBSTANCE
NOT CLASSIFIED AS DANGEROUS GOODS when transported by
road or rail within Australia under Special Provision AU01 of the
Australian Dangerous Goods Code, 7th Edition.
CLASSIFIED AS DANGEROUS GOODS when transported by sea or
air.
Poison Schedule S4
Risk Phrases
R50/53 Very toxic to aquatic organisms, may cause long term adverse
effects in the aquatic environment.
Safety Phrases
S60 This material and its container must be disposed of as hazardous
waste. S61 Avoid release to the environment. Refer to special
instructions/ Safety Data Sheet.
RISK
&
SAFETY
PHRASES
ARE
NOT
REQUIRED
ON
PACKAGES
INTENDED
FOR
END
USERS.
APPROPRIATE
SAFETY
DIRECTIONS
AND
FIRST
AID
STATEMENTS
ARE
SHOWN
ON
THE
PRODUCT
LABEL.
A18298/04/AUS SCOURBAN ORAL ANTIDIARRHOEAL SUSPENSION
Page
2
of
8
SECTION 3 – COMPOSITION
INGREDIENTS
CAS NO.
PROPORTION
(% W/V)
Sulfadimidine (sulfamethazine)
57-68-1
<5%
Sulfadiazine
68-35-9
<5%
Streptomycin sulphate
3810-74-0
<1%
Neomycin sulphate
1405-10-3
<1%
Sodium chloride
7647-14-5
<1%
Calcium gluconate
299-28-5
<1%
Magnesium sulphate, heptahydrate
10034-99-8
<1%
Potassium chloride
7447-40-7
<1%
Hyoscine hydrobromide
114-49-8
<1%
Pectin
9000-69-5
<1%
Kaolin
1332-58-7
10%
Glycine
56-40-6
<5%
Water and other inert ingredients of a non-hazardous
nature
-
balance to 100%
SECTION 4 – FIRST AID MEASURES
Label Regulated First
Aid Statement
I

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