BIMOTRIM INJECTION

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

TRIMETHOPRIM; SULFADOXINE

Available from:

BIMEDA (AUSTRALIA) PTY. LIMITED

INN (International Name):

sulfadoxine(200mg/mL)+trimethoprim(40mg/mL)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

TRIMETHOPRIM PYRIMIDINE Active 40.0 mg; SULFADOXINE SULFANYL Active 200.0 mg

Units in package:

100mL

Class:

VM - Veterinary Medicine

Manufactured by:

BIMEDA (AUSTRALIA)

Therapeutic group:

CATTLE | DOG | GOAT | HORSE | PIGS | SHEEP | BEEF | BILLY | BITCH | BOAR | BOS INDICUS | BOS TAURUS | BOVINE | BUCK | BUFFALO |

Therapeutic area:

ANTIBIOTIC & RELATED

Therapeutic indications:

ORGANISMS SENSITIVE TO SULFADOXINE | ORGANISMS SENSITIVE TO TRIMETHOPRIM

Product summary:

Poison schedule: 4; Withholding period: WITHHOLDING PERIODS: MEAT: DON NOT U SE LESS THAN 14 DAYS (CATTLE SHEEP G OATS AND PIGS) 28 DAYS (HORSES) BEFORE SLAUGHTER FOR HUMAN CONSUMPTION. MI LK: CATTLE- MILK COLLECTED FROM COWS WI THIN 72 HOURS (6 MILKINGS) FOLLOWING TR EATMENT MUST NOT BE RUSED FOR HUMAN CON SUMPTION OR PROCESSING OR FED TO BOBBY CALVES. MILK: SHEEP & GOATS: DO NOT USE IN FEMALE SHEEP OR GOATS WHICH ARE PRODUCING OR MAY IN THE FUTURE PRODUCT MILIK OR MILK PRODUCTS FOR HUM AN CONSUMPTION. TRADE ADVICE: EXPO RT SLAUGHTER INTERVAL (ESI): THIS PRODU CT DOES NOT HAVE AN ESI ESTABLISHED. FO R ADVICE ON THE ESI CONTACT THE DISTR IBUTOR ON 02 8090 7187 BEFORE USING TH IS PRODUCT.; Host/pest details: CATTLE: [ORGANISMS SENSITIVE TO SULFADOXINE, ORGANISMS SENSITIVE TO TRIMETHOPRIM]; DOG: [ORGANISMS SENSITIVE TO SULFADOXINE, ORGANISMS SENSITIVE TO TRIMETHOPRIM]; GOAT: [ORGANISMS SENSITIVE TO SULFADOXINE, ORGANISMS SENSITIVE TO TRIMETHOPRIM]; HORSE: [ORGANISMS SENSITIVE TO SULFADOXINE, ORGANISMS SENSITIVE TO TRIMETHOPRIM]; PIGS: [ORGANISMS SENSITIVE TO SULFADOXINE, ORGANISMS SENSITIVE TO TRIMETHOPRIM]; SHEEP: [ORGANISMS SENSITIVE TO SULFADOXINE, ORGANISMS SENSITIVE TO TRIMETHOPRIM]; Poison schedule: 4; Withholding period: WITHHOLDING PERIODS: MEAT: DON NOT U SE LESS THAN 14 DAYS (CATTLE SHEEP G OATS AND PIGS) 28 DAYS (HORSES) BEFORE SLAUGHTER FOR HUMAN CONSUMPTION. MI LK: CATTLE- MILK COLLECTED FROM COWS WI THIN 72 HOURS (6 MILKINGS) FOLLOWING TR EATMENT MUST NOT BE RUSED FOR HUMAN CON SUMPTION OR PROCESSING OR FED TO BOBBY CALVES. MILK: SHEEP & GOATS: DO NOT USE IN FEMALE SHEEP OR GOATS WHICH ARE PRODUCING OR MAY IN THE FUTURE PRODUCT MILIK OR MILK PRODUCTS FOR HUM AN CONSUMPTION. TRADE ADVICE: EXPO RT SLAUGHTER INTERVAL (ESI): THIS PRODU CT DOES NOT HAVE AN ESI ESTABLISHED. FO R ADVICE ON THE ESI CONTACT THE DISTR IBUTOR ON 02 8090 7187 BEFORE USING TH IS PRODUCT.; Host/pest details: CATTLE: [ORGANISMS SENSITIVE TO SULFADOXINE, ORGANISMS SENSITIVE TO TRIMETHOPRIM]; DOG: [ORGANISMS SENSITIVE TO TRIMETHOPRIM]; GOAT: [ORGANISMS SENSITIVE TO TRIMETHOPRIM]; HORSE: [ORGANISMS SENSITIVE TO TRIMETHOPRIM]; PIGS: [ORGANISMS SENSITIVE TO TRIMETHOPRIM]; SHEEP: [ORGANISMS SENSITIVE TO SULFADOXINE]; Poison schedule: 4; Withholding period: ; Host/pest details: CATTLE: [ORGANISMS SENSITIVE TO SULFADOXINE, ORGANISMS SENSITIVE TO TRIMETHOPRIM]; DOG: [ORGANISMS SENSITIVE TO TRIMETHOPRIM]; GOAT: [ORGANISMS SENSITIVE TO TRIMETHOPRIM]; HORSE: [ORGANISMS SENSITIVE TO TRIMETHOPRIM]; PIGS: [ORGANISMS SENSITIVE TO TRIMETHOPRIM]; SHEEP: [ORGANISMS SENSITIVE TO SULFADOXINE]; For the treatment and control of bacterial infections susceptible to sulfadoxine/trimethoprim combination in cattle, sheep, goats, pigs, dogs and horses.DO NOT USE in female sheep or goats which are producing or may in the future produce milk or milk products for human consumption. See also WITHHOLDING PERIODS.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

Product: Bimotrim Injection
Vial and Carton Labels: Main Panel
Text above the header line and below the footer line is not included
in
the label.
PRESCRIPTION ANIMAL REMEDY
KEEP
OUT
OF REACH OF CHILDREN
FOR ANIMAL TREATMENT
ONLY
BIMOTRIM INJECTION
Each
ml
contains SULFADOXINE
BP
200
mg
TRIMETHOPRIM BP 40
mg
For the treatment and control of bacterial infections susceptible to
sulfadoxine/trimethoprim
combination
in
cattle, sheep, goats, pigs, dogs and horses.
100
ML
13 Mar 13
Bimotrim Injection Labei_RLP _V01
Page 1
of
4
Product: Bimotrim Injection
Vial and Carton Labels: Ancillary Panels
Text above the header line and below the footer line
is
not included
in
the label.
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT.
DIRECTIONS FOR USE:
Restraints
DO
NOT USE in female sheep
or
goats
which
are producing
or
may in the
future
produce
milk
or
milk
products
for
human consumption.
Intravenous injection should
be
administered
as
slowly
as
reasonably practicable
to
avoid
possible shock.
Not recommended for cats
and
kittens.
DOSAGE
&
ADMINISTRATION:
Use
the contents of the vial within
28
days of initial broaching
and
discard any unused
portion.
Dosage: 3
ml
per
50
kg
body weight
in
all
species.
Administration:
Horses,
Dogs:
Slow intravenous injection
only.
Cattle, Sheep, Goats: Intramuscular, subcutaneous or slow intravenous
injection.
Pigs:
Intramuscular
or
slow intravenous injection
in
acute cases.
WITHHOLDING PERIODS:
MEAT:
DO
NOT
USE
less than 14 days (cattle, sheep, goats and pigs),
28
days
(horses) before slaughter
for
human consumption
MILK:
CATTLE-
Milk collected from cows
within
72
hours
(6
milkings)
following
treatment MUST NOT
BE
USED
for
human consumption
or
processing,
or
fed
to
bobby
calves.
MILK: SHEEP
&
GOATS-
DO
NOT
USE
in female sheep
or
goats
which
are
producing
or
may in the future produce
milk
or
milk
products
for
human consumption.
TRADE ADVICE:
EXPORT SLAUGHTER INTERVAL (ESI): This
product
does
not
have as
ESI
established. For advice on the ESI,
contact
the
distributor
on
02
8090 7187 before
usi

Summary of Product characteristics

First Effective Date: 4
th
of Nov. 2013
Page 1 of 6
_ _
ABBEY ANIMAL HEALTH PTY LTD
MATERIAL SAFETY DATA SHEET
SUPPLIER COMPANY DETAILS: Abbey Animal Health Pty Ltd
ADDRESS: 165 Sharp ST, Cooma NSW 2630
TELEPHONE NUMBER: 02 8090 7187
FACSIMILE NUMBER: 02 9475 0775
EMERGENCY NUMBER: Australian Poisons Information Centre: 13 11 26 (24
Hour service).
PRODUCT NAME: BIMOTRIM INJECTION
OTHER NAMES: None allocated
APPEARANCE: A Yellowish coloured, clear aqueous solution, essentially
free of particulate
matter.
USE: Veterinary intravenous or intramuscular injection for the
treatment of a wide range of
diseases caused by bacteria sensitive to Sulfadoxine / Trimethoprim
therapy in cattle,
sheep, goats, pigs, dogs and horses.
POISONS SCHEDULE: S4
POTENTIAL ACUTE HEALTH EFFECTS:
HUMAN: Occasionally skin sensitisation may occur. The active
ingredient is potentially
hazardous to Sulfonamide sensitive individuals.
GLASS VIALS MAY EXPLODE AT HIGH TEMPERATURE.
ENVIRONMENT: Non-hazardous.
INGREDIENTS: CAS NO.
CONTENT (CONC.)
Sulfadoxine
2447-57-6 200mg/mL
Trimethoprim
738-70-5
40mg/mL
_ BIMOTRIM INJECTION _
SECTION 1- IDENTIFICATION OF PRODUCT AND SUPPLIER
SECTION 2- HAZARDS IDENTIFICATION
SECTION 3- COMPOSITION / INFORMATION ON INGREDIENTS
First Effective Date: 4
th
of Nov. 2013
Page 2 of 6
EYES: Holding eyelids apart, wash immediately with plenty of eyewash
solution or clean water for
at least 15 minutes. Seek medical advice.
SKIN: Using gloves, remove contaminated clothing. Wash off immediately
with water. Obtain
urgent medical attention immediately.
INGESTION: If swallowed accidentally, obtain immediate medical
attention. Rinse mouth with water.
INHALATION: Remove patient to fresh air. If there is respiratory
distress, give oxygen, then obtain
urgent medical attention.
ACCIDENTAL INJECTION: In cases of accidental injection obtain
immediate medical attention.
FOR ADVICE CONTACT VETERINARIAN OR THE POISONS INFORMATION CENTRE
(PHONE 13 11 26).
EXTINGUISHING MEDIA: Not classified as flammable. During fire, may
emit noxious fumes b