GASTROZINE A TRIMETHOPRIM SULFONAMIDE MIXTURE WITH ELECTROLYTES FOR ORAL USE

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Active ingredient:

GLYCINE; LYSINE-L; METHIONINE-DL; HYOSCINE METHOBROMIDE; PECTIN; KAOLIN LIGHT; BISMUTH SUBCARBONATE; CALCIUM CHLORIDE; POTASSIUM CHLORIDE; MAGNESIUM SULFATE; SODIUM ACETATE; TRIMETHOPRIM; SULFADIAZINE; VITAMIN B2 = RIBOFLAVIN; VITAMIN B1 HYDROCHLORIDE = THIAMINE HYDROCHLORIDE

Available from:

AUSRICHTER PTY LTD

INN (International Name):

trimethoprim(2g/L)+sulfadiazine(10g/L)+hyoscine methobromide(0.1g/L) + others

Pharmaceutical form:

ORAL TABLET

Composition:

GLYCINE AMINO ACID-GLYCINE Active 25.0 mg/100ml; LYSINE-L AMINO ACID-LYSINE-L Active 12.0 mg/100ml; METHIONINE-DL AMINO ACID-METHIONINE-DL Active 20.0 mg/100ml; HYOSCINE METHOBROMIDE ALKALOID Active 10.0 mg/100ml; PECTIN CARBOHYDRATE Active 1.38 g/100ml; KAOLIN LIGHT CLAY Active 11.3 g/100ml; BISMUTH SUBCARBONATE MINERAL-BISMUTH Active 770.0 mg/100ml; CALCIUM CHLORIDE MINERAL-CALCIUM-SALT Active 15.0 mg/100ml; POTASSIUM CHLORIDE MINERAL-POTASSIUM Active 20.0 mg/100ml; MAGNESIUM SULFATE MINERAL-MAGNESIUM Active 20.0 mg/100ml; SODIUM ACETATE MINERAL-SODIUM-SALT Active 25.0 mg/100ml; TRIMETHOPRIM PYRIMIDINE Active 200.0 mg/100ml; SULFADIAZINE SULFANYL Active 1.0 g/100ml; VITAMIN B2 = RIBOFLAVIN VITAMIN-B2 Active 20.0 mg/100ml; VITAMIN B1 HYDROCHLORIDE = THIAMINE HYDROCHLORIDE VITAMIN-B1 Active 20.0 mg/100ml

Units in package:

100mL; 2.5L; 250mL

Class:

VM - Veterinary Medicine

Manufactured by:

APEX LABORATORIES

Therapeutic group:

CALF | CATTLE | DOG | HORSE | HORSE FOAL | BEEF | BEEF CALF | BITCH | BOS INDICUS | BOS TAURUS | BOVINE | BUFFALO | BULL | BULLO

Therapeutic area:

ALIMENTARY SYSTEM

Therapeutic indications:

ORGANISMS SENSITIVE TO SULPHADIAZINE | ORGANISMS SENSITIVE TO TRIMETHOPRIM

Product summary:

Poison schedule: 4; Withholding period: WHP: Meat: Do not use less than 14 d ays before slaughter for human consumpt ion. Milk: Do not use in lactating or pregnant cows where milk products may b e used for human consumption. Horses: Meat withholding period: Do not use les s than 28 days before slaughter for hum an consumption. Any variation by the pr escribing veterinarian to the approved dose frequency duration, route disea se or target species may require extend ing the approved withholding period.; Host/pest details: CALF: [ORGANISMS SENSITIVE TO SULPHADIAZINE, ORGANISMS SENSITIVE TO TRIMETHOPRIM]; CATTLE: [ORGANISMS SENSITIVE TO SULPHADIAZINE, ORGANISMS SENSITIVE TO TRIMETHOPRIM]; DOG: [ORGANISMS SENSITIVE TO SULPHADIAZINE, ORGANISMS SENSITIVE TO TRIMETHOPRIM]; HORSE: [ORGANISMS SENSITIVE TO SULPHADIAZINE, ORGANISMS SENSITIVE TO TRIMETHOPRIM]; HORSE FOAL: [ORGANISMS SENSITIVE TO SULPHADIAZINE, ORGANISMS SENSITIVE TO TRIMETHOPRIM]; For the treatment of bacterial infections of the gastrointestinal tract in horses, foals, cattle, calves, and dogs due to organisms susceptible to Trimethoprim and Sulfadiazine.DO NOT USE in lactating or pregnant cows where milk or milk products may be used for human consumption.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

                                Apex Laboratories Ply Ltd
Gastrozine A Trimethoprim Sulfonamide
Mixture
with electrolytes for oral use
Specification
No:
LB-GASTR0100/D
Supercede:
LB-GASTR0100/C
Page
1
of
1
5
November
2001
Label:Self Adhesive
PRESCRIPTION
ANIMAL
REMEDY
KEEP
OUT
OF
REACH
OF
CHILDREN
FOR
ANIMAL
TREATMENT
ONLY
Each I
OOmL
contains:
TRIMETHOPRIM
SULFADIAZINE
HYOSCINE
METHOBROMIDE
KAOLIN
LIGHT
PECTIN
BISMUTH
SUBCARBONATE
POTASSIUM
CHLORIDE
MAGNESIUM
SULFATE
CALCIUM
CHLORIDE
SODIUM
ACETATE
GLYCINE
RACEMETHIONINE
I-LYSINE
THIAMINE
HYDROCHLORIDE
RIBOFLAVINE
200mg
Ig
10mg
11.3g
1.38g
770mg
20mg
20mg
15mg
25mg
25mg
20mg
12mg
20mg
20mg
GASTROZINE
A
TRIMETHOPRIM
SULFONAMIDE
MIXTURE
with Electrolytes for Oral
Use
ACTIVE
CONSTITUENTS:
See side
panel
for
active
constituents.
INDICATIONS:
BACTERIAL
INFECTIONS
OF
THE
GASTROINTESTINAL
TRACT
IN
HORSES,
FOALS,
CAmE,
CALVES,
AND
DOGS
DUE
TO
ORGANISMS
SUSCEPTIBLE
TO
TRIMETHOPRIM
AND
SULFADIAZINE.
(100mL/250mL/2.5L)
DIRECTIONS
FOR
USE:
DO
NOT
USE
in
lactating
or pregnant
cows where milk or milk products
may
be used for human consumption
25 mL/10 kg
body
weight
daily.
Can
be
given in
divided
doses
or as
recommended
by a veterinary surgeon
SHAKE
WELL
BEFORE
USE.
WITHHOLDING
PERIODS:
MEAT:
DO
NOT
USE
less than
14
days
before slaughfer for
human
consumption.
MILK:
DO
NOT
USE
in lactating or
pregnant cows where
milk
or milk
products
may
be
used for human
consumption
HORSES:
MEAT
WITHHOLDING
PERIOD:
DO
NOT
USE
less than
28
days before
slaughter for human consumption.
Any variation
by
the prescribing
veterinarian to the
approved
dose,
frequency, duration, route,
disease or
forget species
may
require extending
the
approved
Withholding period
MADEIN
AUSTRALIA
FROM
LOCALAND
IMPORTED
INGREDIENTS
F:lwordIREGOILABELSIG281
LAB.
DOC
N.R.A.
APPROVED
LABEL
(TEXT)
Label
No:
,~?~~.
                                
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Summary of Product characteristics

                                Gastrozine – A Trimethoprim Sulphonamide Mixture
Page 1 of 5
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MATERIAL SAFETY DATA SHEET
GASTROZINE
NOT CLASSIFIED AS HAZARDOUS ACCORDING TO THE CRITERIA OF NOHSC
SECTION I
IDENTIFICATION OF THE MATERIAL AND SUPPLIER
Product Name
Gastrozine – A trimethoprim sulfonamide mixture with electrolytes
for
oral use
Recommended Use
Treatment of bacterial gastrointestinal infections in cattle, horses
and
dogs.
Supplier details
Apex Laboratories Pty Ltd
ACN 000 397 240
61 Chivers Road
Somersby NSW 2250
+61 2 4372 1661 (Business hours – 8.30am – 5.30pm)
+61 2 4372 1668 (fax)
www.apexlabs.com.au
Emergency contact
As above or Poisons Information Centre 131126 (Australia)
SECTION II
HAZARD IDENTIFICATION
Classification
Not classified as hazardous according to the criteria of NOHSC
Risk Phrases
None allocated
Safety Phrases
None allocated
ADG Class
None allocated
Hazchem Code
None allocated
Poisons Schedule
S4
SECTION III
COMPOSITION
Ingredients
CAS No
Proportion
TWA
mg/m
3
STEL
mg/m
3
Sulfadiazine
68-35-9
<10%
not set
not set
Trimethoprim
738-70-5
<10%
not set
not set
Hyoscine Methobromide
114-49-8
<10%
not set
not set
Benzoic Acid
65-85-0
<10%
not set
not set
Calcium Chloride
10043-52-4
<10%
not set
not set
Other non hazardous ingredients
to 100%
The TWA exposure value is the average airborne concentration of a
particular substance when calculated over a
normal 8 hour working day for a 5 day working week over an entire
working lifetime. The TWA exposure standard
set by Worksafe Australia for dusts not otherwise specified is 10mg/m
3
. The STEL (Short Term Exposure Limit) is an
exposure value that should not be exceeded for more than 15 minutes
and should not be repeated for more than 4
times per day. There should be at least 60 minutes between successive
exposures at the STEL.
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