TRIMETHOTAB 120 ANTIBACTERIAL TABLETS

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:

ELANCO AUSTRALASIA PTY LTD

INN (International Name):

trimethoprim(20mg/Tb)+sulfadiazine(100mg/Tb)

Pharmaceutical form:

ORAL TABLET

Composition:

TRIMETHOPRIM PYRIMIDINE Active 20.0 mg/Tb; SULFADIAZINE SULFANYL Active 100.0 mg/Tb

Units in package:

100 Tablets

Class:

VM - Veterinary Medicine

Manufactured by:

BAYER AUSTRALIA

Therapeutic group:

Therapeutic area:

NUTRITION & METABOLISM

Therapeutic indications:

Product summary:

Poison schedule: 4; Withholding period: WHP: NOT APPLICABLE; Host/pest details: CAT: [BACTERIAL INFECTION, INFECTIONS OF THE ALIMENTARY TRACT, INFECTIONS OF THE RESPIRATORY TRACT, INFECTIONS OF THE UROGENITAL TRACT]; DOG - SMALL OR TOY: [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: CAT: [BACTERIAL INFECTION, INFECTIONS OF THE ALIMENTARY TRACT, INFECTIONS OF THE RESPIRATORY TRACT, INFECTIONS OF THE UROGENITAL TRACT]; DOG - SMALL OR TOY: [BACTERIAL INFECTION, INFECTIONS OF THE ALIMENTARY TRACT, INFECTIONS OF THE RESPIRATORY TRACT, INFECTIONS OF THE UROGENITAL TRACT]; For the treatment of bacterial infections sensitive to sulfadiazine and trimethoprim of the respiratory tract, urogenital tract and alimentary tract in cats and small dogs.Contra-indicated in sever 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

PAGE
05
Trlm8thoprlm
BOmg
SulfadiazIne
400mg
TRIMETHOTAB
480·
Trlmethoprlm
80mg and
Sulfadiazine 400mg
per
Antibacterial
Tablet
DESCRIPTION
White
crtJlaI
scored tablets.
Each tablel
contaIns :
DIRECTIONS FOR USE
Trlmethotab-480
tab leta
.hould
not
be
given
to
c:ata_
For the treatment
of
medium sized and large dogs.
For
oral
USIl
ooly .
30mg of
combined active constituents
I
kg bodyweight
daily
equivalent to 1 tablet per
16kg bodyweight
lJiJN
l,
UKKiJCK
!CAUTION
1S4
SUPPLY
WITHOUT PRESCRIPTION
ILLEGAL
KEEP
OUT
OF REACH OF CHILDREN
FOR
ANIMAL
TREATMENT
ONLY
TRIMDHOTAB
480
-
TrlllMthoprllll
80m
..
and
SuH_dl.zlne
400mg
per
AntIbac-
terial
Tablet
TRIMn'IIOTAB
120
- TII
If
...
20m
...
nd
SUIf
..........
100
r
Antlb.e-
'-riBl
Tablet
tJl/
_tJ1Il':J':J1_
->
I~
BOMACLABORATORIES
PTY
LTD
\......J
Unit
3.14 Anella
AlItlnllO
,
CasU'
Hill, NSW 2154. Auslralla
STORAGE:
Store below 25
~
C (Air Conditioning)
Keep lid
tlgntly
closed when not
in use
Preferably the dose should be divided In half
and
giv8n
twice
dally.
Repeat treatment for 5
days or for at teast 2
days
alter
the symptoms
have subsided.
DISPOSAL:
Dispose of
empty container
by
.....
rapping
with
paper and placing In
garbage .
1/2
tablet
,
tablets
1 1/2 tablslS
2 tablebl
_2 V.2_
tablets
3 l!lbleta
Skg
16kg
24kg
32kg
40kg
48kg
Dogs
up to
MODE
OF
ACTION
The combination aets
by
irhibiling sequential
steps In the blosyn-
thetlc
pathway that Is used by micro-organisms In their synthesis
of
folate co- factors .
Sulfadhulne Inhibits !he incorporatlon
of
para-
aminobenzoIc acid
(PABA) Into folic acid
and
Trimelhoprim Inhibits
the enzyme dlhydrofolate reductase.
whIch converts dlhydrofollc
acld
Into tetrahydrofolic acid.
In
comblnatlon the
two
active constillJents have a bactericidal
actIvity against
moet
gram-positive and gram-negallve paUlOgenlc
bacteria Including Staphylococd.
Streptococci. E.coll.
Puteul1llla
epp.
Bordetells lIpP, Salmonella epp. PrWlUS spp,
Klebsiella spp,
Baclllls anthracis. Corynebacterium sPp.VlblIospp
and
Haemophllus
spp.
."
Trlmetnotab veterinlll)'
p

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Summary of Product characteristics

MATERIAL SAFETY DATA SHEET
Page 1 of 5
http://www.bomac.co.nz/Prduct%20pgs/MSDS/TRIMETHO%20120.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 120 UN Number: N/A
Other Names: N/A Dangerous Goods Class: N/A
Animal Remedies Board (ARB) Subsidiary Risk: N/A
Product Licence Number: 7065 HAZCHEM Code: N/A Toxic Substances
Schedule: N/A
Use: For the treatment and control of infections due to
Sulphadiazine/Trimethoprim
sensitive
microorganisms
in
cats
and
small
dogs,
especially
infections
of
the
respiratory, urogenital and alimentary tracts.
Physical Description: A white to off white,
biconvex, circular tablet.
Active Ingredients: Sulphadiazine 100mg CAS*
No. 68-35-9
Trimethoprim 20mg 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: (09) 262-3169 Facsimile: (09) 262-3008
HEALTH HAZARD INFORMATION
________________________________________
MATERIAL SAFETY DATA SHEET
Page 2 of 5
http://www.bomac.co.nz/Prduct%20pgs/MSDS/TRIMETHO%20120.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 Registry Number
PRODUCT: Trimethotab 120 ARB Licence No: 7065 Page: 2

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