TRIMETHOTAB 480 TRIMETHOPRIM 80MG AND SULFADIAZINE 400MG PER ANTIBACTERIAL TABLET

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

TRIMETHOPRIM; SULFADIAZINE

Available from:

ELANCO AUSTRALASIA PTY LTD

INN (International Name):

trimethoprim(80mg/Tb)+sulfadiazine(400mg/Tb)

Pharmaceutical form:

ORAL TABLET

Composition:

TRIMETHOPRIM PYRIMIDINE Active 80.0 mg/Tb; SULFADIAZINE SULFANYL Active 400.0 mg/Tb

Units in package:

100 Tablets

Class:

VM - Veterinary Medicine

Manufactured by:

BAYER AUSTRALIA

Therapeutic group:

DOG - LARGE | DOG - MEDIUM | CASTRATE

Therapeutic area:

ANTIBIOTIC & RELATED

Therapeutic indications:

BACTERIAL INFECTION | INFECTIONS OF THE ALIMENTARY TRACT | INFECTIONS OF THE RESPIRATORY TRACT | INFECTIONS OF THE UROGENITAL TRACT | ACUTE RESPIRATORY INFECTIONS | AMOXYCILLIN SENSITIVE BACTERIA | ASSOCIATED WITH VIRAL DISEASE | BRONCHISEPTICA | BRONCHITIS | CYSTITIS | GRAM NEGATIVE ORGANISMS | GRAM POSITIVE ORGANISMS | METRITIS | NEPHRITIS | PHARYNGITIS | PNEUMONIA | POST PARTURIENT BACTERIAL INFE | PRIMARY BACTERIAL INFECTION | SULFADIAZINE SENSITIVE BACTERI | TONSILLITIS | TRIMETHOPRIM SENSITIVE BACTERI | TYLOSIN SENSITIVE BACTERIA

Product summary:

Poison schedule: 4; Withholding period: WHP: NOT APPLICABLE; Host/pest details: DOG - LARGE: [BACTERIAL INFECTION, INFECTIONS OF THE ALIMENTARY TRACT, INFECTIONS OF THE RESPIRATORY TRACT, INFECTIONS OF THE UROGENITAL TRACT]; DOG - MEDIUM: [BACTERIAL INFECTION, INFECTIONS OF THE ALIMENTARY TRACT, INFECTIONS OF THE RESPIRATORY TRACT, INFECTIONS OF THE UROGENITAL TRACT]; Poison schedule: 4; Withholding period: ; Host/pest details: DOG - LARGE: [BACTERIAL INFECTION, INFECTIONS OF THE ALIMENTARY TRACT, INFECTIONS OF THE RESPIRATORY TRACT, INFECTIONS OF THE UROGENITAL TRACT]; DOG - MEDIUM: [BACTERIAL INFECTION, INFECTIONS OF THE ALIMENTARY TRACT, INFECTIONS OF THE RESPIRATORY TRACT, INFECTIONS OF THE UROGENITAL TRACT]; For the treatment of infections sensitive to trimethoprim /sulfadiazine sensitive micro-organisms, especially infections of the respiratory tract, urogenital tract and alimentary tract.Do not give to cats. Contra-indicated in severe hepatic or renal impairment. Teratogenetic at high doses in some species. Drug interactions will displace other protein based drugs. See ADVERSE EFFECTS on leaflet also.

Authorization status:

Stopped

Authorization date:

2023-07-01

Patient Information leaflet

\CAUTION
I
S4
SUPPLY
WITHOUT
PRESCRIPTION
ILLEGAL
KEEP
OUT
OF REACH OF CHILDREN
FOR
ANIMAL
TREATMENT
ONLY
TRIMETHOTAB
480 -
Trimethoprim
80mg
and
Sulfadiazine
400mg
per
Antibacterial
Tablet
DIRECTIONS FOR USE
Tr imethotab-4BO tablets
should
not
be
given
to
cats
.
For the treatment of medium sized and large dogs.
For oral
use only.
30mg of combined active constituents /
kg bodyweight
daily
equivalent to 1 tablet
per
16kg bodyweight
TRIMETHOTAB
120
-
Trimethoprim
20mg
and
Sulfadiazine
100mg
per
Antibac-
terial
Tablet
TRIMETHOTAB
480
-
Trimethoprim
80mg
and
Sulfadiazine
400mg
per
Antibac-
terial
Tablet
DESCRIPTION
White cross scored tablets .
Each tablet contains:
Trimethoprim
Sulfadiazine
BOmg
400mg
.~
BOMACLABORATORIES
PTY
LTD
'-.'"
Unit3,14 Anella
Avenue
, CastleHill, NSW2154,
Australia
Preferably the dose should be divided in half and given twice daily.
Repeat treatment for 5 days or for at least 2 days after the symptoms
have subsided.
Trimethotab veterinary preparations are formulated with synthetic
chemotherapeutic agents Trimethoprim and Sulfadiazine in a ratio
of
1 : 5.
MODE OF ACTION
The combination acts by inhibiting sequential steps in the biosyn-
thetic pathway that is used by micro-organisms in their synthesis of
folate co-factors.
Sulfadiazine inhibits the incorporation of
para-
aminobenzoic acid (PABA) into folic acid and Trimethoprim inhibits
the enzyme dihydrofolate reductase , which converts dihydrofolic
acid into tetrahydro folic acid.
Dogs up to
Bkg
16kg
24kg
32kg
40kg
4Bkg
1/2 tablet
1 tablets
1 1/2 tablets
2 tablets
2 1/2 tablets
3 tablets
In comb ination the two active constituents have a bactericidal
activity against most gram-positive and gram-negative pathogenic
bacteria including Staphylococci,
Streptococci, E.coli, Pasteurella
spp,
Bordetella spp, Salmonella spp, Proteus spp, Klebsiella spp,
Bacillis anthracis, Corynebacterium spp, Vibriospp and Haemophilus
spp.
Pseudomonas
aerug
inosa
,
Erys ipelothrix ,
Leptospira and
Mycobacterium tube rculosis are not sensitive .
INDICATIONS
For the

Summary of Product characteristics

MATERIAL SAFETY DATA SHEET
Page 1 of 5
http://www.bomac.co.nz/Prduct%20pgs/MSDS/TRIMETHO%20480.html
28/08/2000
MATERIAL SAFETY DATA SHEET (MSDS)
_BOMAC LABORATORIES LIMITED URGES RECIPIENT OF THIS MSDS TO STUDY IT
CAREFULLY_
_TO BECOME AWARE OF, AND UNDERSTAND, THE HAZARDS ASSOCIATED WITH THE
PRODUCT._
_TO PROMOTE SAFE HANDLING, EACH RECIPIENT SHOULD NOTIFY ITS EMPLOYEES,
AGENTS AND OTHERS WHO _
_WILL USE THIS MATERIAL AND ANY OTHER INFORMATION REGARDING HAZARDS OR
SAFETY._
Page 1 of 3
___________________________________________________________________________
IDENTIFICATION
___________________________________________________________________________
Product name: Trimethotab 480 UN Number: N/A 
Other Names: N/A Dangerous Goods Class:N/A 
Animal Remedies Board (ARB) Subsidiary Risk: N/A 
Product Licence Number:7013 HAZCHEM Code: N/A 
Toxic Substances Schedule:N/A 
Use: For the treatment and control of infections due to
Sulphadiazine/Trimethoprim sensitive 
microorganisms in dogs especially infections of the respiratory,
urogenital and alimentary tracts.
Physical Description: A white, round, cross-
scored tablet with a bevelled edge.
Active Ingredients: Sulphadiazine 400mg CAS* 
No. 68-35-9
Trimethoprim 80mg CAS* No. 738-70-5
Manufacturer: BOMAC Laboratories Ltd
Cnr Wiri Station Road & Hobill Avenue
P O Box 76-369, Manukau City, Auckland, New Zealand
Phone: [phone] Facsimile: [phone]
________________________________________
HEALTH HAZARD INFORMATION
________________________________________
MATERIAL SAFETY DATA SHEET
Page 2 of 5
http://www.bomac.co.nz/Prduct%20pgs/MSDS/TRIMETHO%20480.html
28/08/2000
HEALTH EFFECTS
Swallowed: Ingestion may cause nausea, 
vomiting, diarrhoea, headache, dizziness, drug 
fever, skin rashes and other allergic reactions.
Eye: May cause transient stinging or redness if 
accidental eye contact occurs. 
Keratoconjuntivitis sicca (dry eye) which may 
be irreversible or acute, hypersensitivity 
reactions have been recorded.
*CAS, Chemical Abstracts Service Regist