TRIBRISSEN 20 TABLETS

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

TRIMETHOPRIM; SULFADIAZINE

Available from:

INTERVET AUSTRALIA PTY LIMITED

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 Tabs

Class:

VM - Veterinary Medicine

Manufactured by:

INTERVET AUSTRALIA

Therapeutic group:

CAT | DOG | BITCH | CASTRATE | CAT - QUEEN | CAT - TOM | KITTEN | PUPPY

Therapeutic area:

ANTIBIOTIC & RELATED

Therapeutic indications:

BACTERIAL INFECTION | ORGANISMS SENSITIVE TO COMBINATION OF | AMOXYCILLIN SENSITIVE BACTERIA | ASSOCIATED WITH VIRAL DISEASE | GRAM NEGATIVE ORGANISMS | GRAM POSITIVE ORGANISMS | POST PARTURIENT BACTERIAL INFE | PRIMARY BACTERIAL INFECTION | SULFADIAZINE SENSITIVE BACTERI | TRIMETHOPRIM SENSITIVE BACTERI | TYLOSIN SENSITIVE BACTERIA

Product summary:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: CAT: [BACTERIAL INFECTION, ORGANISMS SENSITIVE TO COMBINATION OF]; DOG: [BACTERIAL INFECTION, ORGANISMS SENSITIVE TO COMBINATION OF]; Poison schedule: 4; Withholding period: ; Host/pest details: CAT: [BACTERIAL INFECTION, ORGANISMS SENSITIVE TO COMBINATION OF]; DOG: [BACTERIAL INFECTION, ORGANISMS SENSITIVE TO COMBINATION OF]; For the treatment of infections in dogs and cats caused by organisms sensitive to trimethoprim - sulfadiazine combinations (Treatment and control of a wide range of bacterial diseases and coccidiosis in dogs and cats).Cats will salivate copiously if protective coating is broken.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

TRIBRISSEN 20 TABLETS
FRONT PANEL
VIAL LABEL
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
TRIBRISSENB 20 TABLETS
Trimethoprim 20 mg
Sulfadiazine 100 mg
For the treatment of infections in dogs and cats
caused by organisms sensitive to trimethoprim
-
sulfadiazine
combinations
100 TABLETS
JUROX LOGO
(154.96)
h:\wp\proddev\labels\trib20.doc
TRIBRISSEN 20 TABLETS
SIDE PANEL
-
RIGHT
\
.,
i . ’
INDICTIONS:
Treatment and control of a wide/range ‘of bacterial diseases
pd
coccidiosis in
dogs and cats.
DIRECTIONS FOR USE: 30mg (combined active ingredients) per kg daily.
Dogs: 1 tablet
per 4kg bodyweight daily.
The tablets may be given as a single dose daily or as half the daily
dose every 12 hours. For severe infection in dogs give initial loading
dose followed by one
half the dose every 12 hours.
Continue treatment for 5 days or until 2 days after the
symptoms have subsided.
CATS:
(over 1 kg bodyweight) 1 tablet daily. Cats will salivate
copiously if protective coating is broken.
TRIBRISSEN 20 TABLETS
SIDE PANEL
-
LEFT
Made in Australia by: Jurox Pty. Ltd. Unit 22, Slough Estate, Holker
St., Silverwater, NSW
2 128, Australia.
Under
licence
from Mallinckrodt Veterinary Limited.
@
Mallinckrodt Veterinary Limited Registered Trade Mark.
DISPOSE of container by wrapping with paper and putting in garbage.
PROTECT from light.
STORE below 25°C (Air Conditioning).
NRA Approval No. 3 6
122/O
1
0
B
EXP.
h:\wp\pddevUahelskrib2Odoc
1510496

Summary of Product characteristics

MATERIAL SAFETY DATA SHEET
PRODUCT NAME: TRIBRISSEN 20 TABLETS
Issue Date: 01FEB08
QAF140
Page 1 of 3
STATEMENT OF HAZARDOUS NATURE
HAZARDOUS ACCORDING TO CRITERIA OF NOHSC AUSTRALIA
COMPANY DETAILS
Company:
Jurox Pty Limited,
Address:
85 Gardiner Road, Rutherford NSW 2320
Telephone:
[phone] or 1800 023 312
Emergency Telephone No.:
[phone] or 1800 023 312
IDENTIFICATION
Product Name:
Tribrissen 20 Tablets
Other Names:
Manufacturer’s Product Code:
60420
UN Number:
None Allocated
Dangerous Goods Class:
None Allocated
Subsidiary Risk:
None Allocated
Hazchem Code:
None Allocated
Poisons Schedule Number:
4
Use:
Tablets for the treatment of susceptible infections in dogs and
cats.
PHYSICAL PROPERTIES / DESCRIPTION
Appearance:
White, sugar coated tablets with white core
Boiling Point/Melting Point:
Vapour Pressure:
Specific Gravity:
Flashpoint:
Non-flammable
Flammability Limits:
Solubility in Water:
Partly soluble-disintegrates.
Table Weight:
~350mg
OTHER PROPERTIES
INGREDIENTS
CHEMICAL ENTITY
CAS NUMBER
PROPORTION
Sulphadiazine
68-35-9
28%
Trimethoprim
738-70-5
6%
Cellulose
9004-34-6
to 100%
MATERIAL SAFETY DATA SHEET
PRODUCT NAME: TRIBRISSEN 20 TABLETS
Issue Date: 01FEB08
QAF140
Page 2 of 3
HEALTH & HAZARD INFORMATION
HEALTH EFFECTS
ACUTE
Swallowed:
Rapidly absorbed from the gastrointestinal tract. May result in
headache, nausea and vomiting.
Eye:
Non-harmful due to the nature of the product.
Skin:
Non-harmful due to the nature of the product.
Inhaled:
CHRONIC
Due to the presence of Sulphadiazine, prolonged or repeated exposure
may lead to sensitisation
reactions. Due to the presence of Trimethoprim, prolonged or repeated
contact may lead to
nausea, vomiting, skin rash and purities.
FIRST AID
If poisoning occurs, contact a doctor or Poisons Information Centre,
phone 13 11 26
Swallowed:
Rinse mouth with water. Give plenty of water of bland fluids to drink.
Induce vomiting. Seek medical attention. Show this MSDS to a
medical practitioner.
Eye:
Skin:
Remove all contaminated clothing. Wash well with soap a

Safety Data Sheet

WWW.JUROX.COM.AU
Customer Service 1800 023 312
® Registered Trademark of Jurox Pty Limited
TECHNICAL NOTES
ACTIVE CONSTITUENTS
Tribrissen 20: Trimethoprim 20 mg per tablet, sulfadiazine 100 mg per
tablet.
Tribrissen 80: Trimethoprim 80 mg per tablet, sulfadiazine 400 mg per
tablet.
ACTIONS
The two components act synergistically to block the synthesis of
bacterial folates at two separate stages. Folates are essential to
the bacterial cell for multiplication and survival; this blocking
agent kills a wide range of susceptible bacteria, and also reduces the
possibility of bacterial resistance.
Trimethoprim/sulfadiazine in combination are active against the common
Gram-positive and Gram-negative organisms found in small
animals, including staphylococci and_ _streptococci_, Escherichia
coli, Bacillus, Bordetella, Brucella, Corynebacterium, Fusiformis,
Haemophilus _
and _Klebsiella _spp_., Listeria monocytogenes, Nocardia, Pasteurella,
Salmonella, Shigella _and _Proteus_ spp.
_Erysipelothrix, Leptospira, Pseudomonas _and _Mycobacterium
tuberculosis_ organisms are not susceptible.
INDICATIONS
Treatment of infections in dogs (Tribrissen 20 and Tribrissen 80) and
cats (Tribrissen 20 only) caused by organisms sensitive to
trimethoprim - sulfadiazine combinations.
CONTRAINDICATIONS
Administration to animals with known sulfonamide sensitivity, hepatic
damage or blood dyscrasias.
Administration of Tribrissen 20 tablets to cats weighing less than 1
kg.
PRECAUTIONS
Do not break Tribrissen 20 tablets when giving to cats; salivation
occurs in this species if the uncoated drug comes in contact with
buccal mucosa.
TRIBRISSEN
®
Tablets
WWW.JUROX.COM.AU
Customer Service 1800 023 312
® Registered Trademark of Jurox Pty Limited
TECHNICAL NOTES
ADVERSE REACTIONS
Transient drowsiness sometimes occurs in cats.
DOSAGE AND ADMINISTRATION
TRIBRISSEN 20
Cats (over 1 kg): 1 tablet daily.
Dogs: Average daily dose is 30 mg (combined active ingredients) / kg
bodyweight, i.e. 1 tablet/4 kg bodyweight daily.
Tribrissen 80 tablets may be preferred