TRIBRISSEN 80 TABLETS
Country: Australia
Language: English
Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)
Patient Information leaflet
(PIL)
19-06-2017
Summary of Product characteristics
(SPC)
19-06-2017
Safety Data Sheet
(SDS)
18-07-1997
Active ingredient:
TRIMETHOPRIM; SULFADIAZINE
Available from:
INTERVET AUSTRALIA PTY LIMITED
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:
500 Tabs; Unit=1 Tab
Class:
VM - Veterinary Medicine
Manufactured by:
INTERVET AUSTRALIA
Therapeutic group:
DOG | BITCH | CASTRATE | 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: DOG: [BACTERIAL INFECTION, ORGANISMS SENSITIVE TO COMBINATION OF]; Poison schedule: 4; Withholding period: ; Host/pest details: DOG: [BACTERIAL INFECTION, ORGANISMS SENSITIVE TO COMBINATION OF]; For the treatment of infections in dogs caused by organisms sensitive to trimethoprim-sulfadiazine combinations (Treatment and control of a wide range of bacterial diseases and coccidiosis in dogs).
Authorization status:
Registered
Authorization date:
2023-07-01
Patient Information leaflet
TRIBRISSEN 80 TABLETS
,
PRESCRIPTION ANTMALREMEDY
500 Tablets
J-UROX LOGO
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL, TREATMENT ONLY
TRIBRISSENB
80 Tablets
ACTIVE CONSTITUENTS:
Trimethoprim 80 mg
Sulfadiazine 400 mg
For the treatment of
infections
in dogs
caused by organisms sensitive to
trimethoprim
-
sulfadiazine combinations
FRONT PANEL
VIAL
LABEL
PICTURE OF
TABLET
(13.6.97)
TRIBRISSEN 80 TABLETS
SIDE PANEL
-
LEFT
Indications:
Treatment and control of a wide range of bacterial diseases and
coccidiosis in dogs.
Directions for Use:
30mg (combined active ingredients) per kg bodyweight daily.
1 tablet per 16 kg bodyweight
daily.
The tablets may be given as a single dose or as
half
the
daily dose every 12 hours. For
severe infection 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.
TRIBRISSEN 80 TABLETS
SIDE PANEL
-
RIGHT
Made in Australia by: Jurox Pty. Ltd. Unit 22, Slough Estate,
Holker St., Silverwater, NSW 2141, Australia.
CALL 02-714 3222, ALL HOURS.
Under
licence
from Mallinckrodt Veterinary Limited.
@
Mallinckrodt Veterinary Limited Registered Trade Mark.
DISPOSE of container by wrapping with paper and putting in garbage.
STORE below 25°C (Air Conditioning).
0
B
PROTECT from light.
EXP.
NRA Approval No.
36119/01
.
-
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Summary of Product characteristics
MATERIAL SAFETY DATA SHEET
PRODUCT NAME: TRIBRISSEN 80 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:
(02) 4931 8200 or 1800 023 312
Emergency Telephone No.:
(02) 4931 8200 or 1800 023 312
IDENTIFICATION
Product Name:
Tribrissen 80 Tablets
Other Names:
Manufacturer’s Product Code:
60430
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 oral treatment of infection in dogs caused by
organisms sensitive to trimethoprim-sulphadiazine
combinations.
PHYSICAL PROPERTIES / DESCRIPTION
Appearance:
White, bi-convex, half-scored tablets
Boiling Point/Melting Point:
Vapour Pressure:
Specific Gravity:
Flashpoint:
Non-flammable
Flammability Limits:
Solubility in Water:
Partly soluble-disintegrate
Table Weight:
764 mg
OTHER PROPERTIES
INGREDIENTS
CHEMICAL ENTITY
CAS NUMBER
PROPORTION
Sulphadiazine
68-35-9
52%
Trimethoprim
738-70-5
10%
Cellulose
9004-34-6
to 100%
MATERIAL SAFETY DATA SHEET
PRODUCT NAME: TRIBRISSEN 80 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-irritant. May cause sensitisation reaction in certain individuals.
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 pruritis.
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 or bland fluids to drink.
Seek medical advice. Show this MSDS to a medical practitioner.
Eye:
Sk
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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
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