TRIMAZINE BOLUS A SULPHONAMIDE TRIMETHOPRIM PREPARATION

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

Active ingredient:

TRIMETHOPRIM; SULFADIAZINE

Available from:

AUSRICHTER PTY LTD

INN (International Name):

trimethoprim(200mg/Bs)+sulfadiazine(1000mg/Bs)

Pharmaceutical form:

ORAL BOLUS + INTRA VAGINAL/UTERINE

Composition:

TRIMETHOPRIM PYRIMIDINE Active 200.0 mg/Tb; SULFADIAZINE SULFANYL Active 1000.0 mg/Tb

Units in package:

50 Tablets

Class:

VM - Veterinary Medicine

Manufactured by:

APEX LABORATORIES

Therapeutic group:

Therapeutic area:

ANTIBIOTIC+GENITOURINARY

Therapeutic indications:

Product summary:

Poison schedule: 4; Withholding period: WHP:Meat: DO NOT USE less than 14 days for cattle and sheep or 15 days for pig s before slaughter for human consumptio n. Milk: DO NOT USE lactating or pregna nt cattle or sheep where milk or milk products may be used for human consumpt ion. Horses: MEAT WITHHOLDING PERIOD:28 days before slaughter for human consum ption.; Host/pest details: CALF: [BACTERIAL INFECTION]; COW: [BACTERIAL INFECTION]; HORSE FOAL: [BACTERIAL INFECTION]; HORSE MARE (FEMALE): [BACTERIAL INFECTION]; PIG SOW (FEMALE): [BACTERIAL INFECTION]; SHEEP EWE (FEMALE): [BACTERIAL INFECTION]; Systemic treatment of susceptible gram-pos. and gram-neg. bacterial infections due to Trimethoprim and Sulfadiazine sensitive micro-organisms in foals and calves. For prevention/treatment of postparturient bacterial infections in mares, cows, sows & ewes.DO NOT USE in lactating or pregnant cattle or sheep where milk or milk products may be used for human consumption

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

Apex Laboratories Pty Ltd
Trirnazine
Bolus A Sulphonamide Trimethoprim Preparation
Specification No: LB-TRIMAZBOLID
Supercede
LB-TRI MAZBOLIC
Page 1 of
1
24
September
2001
Label:Self adhesive
MADE IN
AUSTRALIA
FROM
LOCAL AND
IMPORTED
iNGREDIENTS
APEX lABORATORIES
PTY
LTD
6
I
Chivers Rd Somersby NSW
2250
Australia.
Dispose of
empty
containers
by
wrapping
with
paper
and
putting
in
gorbage.
Store
below
30'C
(Room
Temperature)
N:R.A.
APPROVED
LABEL
(TEXT)
Label
No:
.~:?.~:\':th~.Q..\..·
D
te
o
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U.Q.\
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a.
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Signature:
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DIRECTIONS
FOR
USE:
DO
NOT
USE
in lactating or
pregnant cottle or sheep where
milk or milk products may be used
FOR
HUMAN
CONSUMPTION.
ORAL
DOSE:
CALVES,
FOALS
and
PIGS
1
Bolus/40Kg
Bodyweight
Repeat
daily
until
2
days
after
clinical
signs
have
subs.cec
In
the
case
of
Salmonellosis
and
Bacterial
Pneumonia
in calves.
treatment
should
be
continued
for
at
least
5
days.
Bolus
may
be
given
by
hand
balling
gun
or
dispersed in drinking
water.
INTRAUTERINE:
MARES
AND COWS.
2 -
4
BOLUSES
SOWS AND
EWES.
1 - 2
BOLUSES.
Repeat
as
required.
May
be
inserted
whole
into
uterus or dispersed
with
worm
water
and
administered
through
a
catheter.
Any
variation
by
the
prescribing
veterinarian
to
the
approved
dose,
frequency,
duration,
route,
disease
or
target
species
may
require
extending
the
approved
withholding
period.
50
TABLETS
Intrauterine: For
prevention
and
treatment
of
postparturient
bacterial
intections,
in mares.
cows,
sows
and
ewes.
TRIMAZINE
BOLUS
A SULPHONAMIDE
TRIMETHOPRIM
PREP
ARATION
PRESCRIPTION
ANIMAL
REMEDY
KEEP
OUT
OF
REACH
OF
CHILDREN
FOR
ANIMAL
TREATMENT
ONLY
Systemic
treatment
of
susceptible
gram-
positive
and
gram-negative
bocteriol
infections
due
to Trimethoprim
and
Sulfadiazine sensitive
micro-
organisms
in calves,
foals
and
pigs.
Each bolus
contains:
TRIMETHOPRIM
200mg
SULFADIAZINE
1000mg
Expiry:
NRA: 35694/
\00
(
Batch:
WITHHOLDING
PERIOD:
MEAT:
DO
NOT
USE
less
than
14
days for cattle and sheep or
15
doys for pigs, before slaughter for
HUMAN CONSUMPTION.
MilK:
DO
NOT
USE
In

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Summary of Product characteristics

MATERIAL SAFETY DATA SHEET
TRIMAZINE BOLUS
CLASSIFIED AS HAZARDOUS ACCORDING TO THE CRITERIA OF NOHSC
Product Name
Trimazine Bolus
Recommended Use
Treatment of bacterial infections sensitive to Trimethoprim and
Sulfadiazine.
Supplier Details
Apex Laboratories Pty. Ltd.
ACN Number
000 397 240
Street
61 Chivers Road
Suburb
Somersby
State
NSW
Country
Australia
Post Code
2250
Phone
+61 2 4372 1661 (Business hours – 8.30am – 5.00pm)
Fax
+61 2 4372 1668 (fax)
Website
http://www.apexlabs.com.au
Emergency contact
As above or Poisons Information Centre 131126 (Australia)
Classification
Classified as hazardous according to the criteria of NOHSC
Risk Phrases
R42 May cause sensitisation by inhalation
Safety Phrases
None allocated
ADG Class
None allocated
Hazchem Code
None allocated
Poisons Schedule
S4
INGREDIENTS
CAS NO
PROPORTION
TWA MG/M3
STEL MG/M3
Trimethoprim
738-70-5
10-<30%
not set
not set
Sulfadiazine
68-35-9
>60%
not set
not set
Other non hazardous ingredients
NA
to 100%
NA
NA
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/m3. 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.
Ingestion
If swallowed rinse mouth out with water, give water to drink and seek
medical advice. Induce vomiting.
Eye
Generally not required. If irritation does occur irrigate with copies
quantities of luke warm water for 10 minutes and seek medical advice.
Skin
Generally not required. If concerned wash well with soap and water and
seek medical advice.
Inhalation
Generally not required. If concerned move to fresh air and seek
medical
advice.
1 of 4
MSDS|TRIMAZINE BOLUS
Apex Laboratories Pty. Ltd. | ACN 000 397 2

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