TRIVETRIN INJECTION

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

TRIMETHOPRIM; SULFADOXINE

Available from:

INTERVET AUSTRALIA PTY LIMITED

INN (International Name):

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

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

TRIMETHOPRIM PYRIMIDINE Active 40.0 mg/ml; SULFADOXINE SULFANYL Active 200.0 mg/ml

Units in package:

100mL

Class:

VM - Veterinary Medicine

Manufactured by:

INTERVET AUSTRALIA

Therapeutic group:

CAT | CATTLE | DOG | HORSE | PIGS | SHEEP | BEEF | BITCH | BOAR | BOS INDICUS | BOS TAURUS | BOVINE | BUFFALO | BULL | BULLOCK |

Therapeutic area:

ANTIBIOTIC & RELATED

Therapeutic indications:

BACTERIAL INFECTION | 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: MEAT: (CATTLE SHEEP PIGS): DO NOT U SE less than 14 days before slaughter for human consumption. (HORSES): DO NO T USE less than 28 days before slaug hter for human consumption. MILK: Milk collected from cows and ewes within 36 hours (3 milkings) following a single treatment or 72 hours (6 milkings) foll owing the last of multiple treatments MUST NOT BE USED for human consumption or processing. This milk should not be fed to bobby calves.; Host/pest details: CAT: [BACTERIAL INFECTION]; CATTLE: [BACTERIAL INFECTION]; DOG: [BACTERIAL INFECTION]; HORSE: [BACTERIAL INFECTION]; PIGS: [BACTERIAL INFECTION]; SHEEP: [BACTERIAL INFECTION]; Poison schedule: 4; Withholding period: ; Host/pest details: CAT: [BACTERIAL INFECTION]; CATTLE: [BACTERIAL INFECTION]; DOG: [BACTERIAL INFECTION]; HORSE: [BACTERIAL INFECTION]; PIGS: [BACTERIAL INFECTION]; SHEEP: [BACTERIAL INFECTION]; For the treatment of infections caused by organisms sensitive to trimethoprim and sulfadoxine in cattle, sheep, pigs, horses, cats and dogs.Contraindicated prior to and after treatment with sedatives and anaesthetics when horse is recumbent. In addition the subcutaneous and IM routes are not recommended in horses. The use of IV route in cats for cases of acute infection is contraindicated.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

TRIVETRIN
INJ
ECTION
-36308
TEMPLATE
FOR
RELEVANT
LABEL
PARTICULARS
(RLPs)
(Veterinary
Products)
Select appropriate:
[J
New
Product
(include
all
applicable
RLPs)
OR
[EJ
Variation
(highlight
instructions
that
are
being
varied).
Approval
no
.
of
label
being
varied:
[APVMA No.
36308/1
OOml/021
0]
Signal heading:
PRESCRIPTION
ANIMAL
REMEDY
KEEP
OUT
OF
REACH
OF
CHILDREN
FOR
ANIMAL
TREATMENT
ONLY
Product name:
Trivetrin®
Injection
Active
TRIMETHOPRIM 40
mg/mL
constituent/s:
SULFADOXINE
200
mg/mL
Statement of
For
the
treatment
of
infections
caused
by
organisms
sensitive
to
trimethoprim
claims:
and
sulfadoxine
in
cattle,
sheep,
pigs,
horses,
cats
and
dogs
.
Trivetrin
Injection
contains 40 mg/mL trimethoprim, a synthetic antibacterial developed
in
•
the
Wellcome
Research Labora
torie
s,
and
200 mg/mL sulfadoxine, a long-acting sulfonamide
.
Trivetrin
is
effective against
most
Gram-positive and Gram-negative bacteria. The
two
•
components
of
Trivetrin
produce a sequential double blockade
of
bacterial metabolism giving
a level
of
activity many times greater than
that
obtained
from
either
drug alone.
INDICATIONS
:
RLP
Trivetrin
Injection
is indicated
for
the systemic
treatment
of:
Appro
ved
Respiratory
infections
of
bacterial origin including pneumoni
a,
bronchitis
and
secondary
bacterial infections following virus pneumonia.
Urogenital
tract
infections
including cystitis, vaginitis, urethritis, nephritis
an
d metritis.
Alimentary
tract
infections
including
E.
_coli _
infections and
sa
lmonellosis.
Post-operative
and
most
post-parturient
uses
, wound infections
and
septicaemias.
Trivetrin
is active
in
vitro
against Gram-positive
and
Gram-negative organisms including
_Actinomyces _
spp.,
_Bacillus _
_anthracis, _
_Bordetella _
spp.
,
_Bru_
_c_
_ella _
spp
.,
_Clo_
_stri_
_dium _
spp.,
_Corynebacterium _
spp.,
_Escherichia _
_coli, _
_Haemophilus _
spp.,
_Klebsiella _
spp.
,
_Shigella _
spp
.,
_Staphylo_
_cocci, _
_Streptococci_
_, _
_Pasteurella _
spp.,
_Salmonella _
spp
.,
_Fusiformis _
spp
.,
and
_Campylobacter _
spp
.

Summary of Product characteristics

MATERIAL SAFETY DATA SHEET
PRODUCT NAME: TRIVETRIN INJECTION
Issue Date: June 2007
QAF140
Page 1 of 3
STATEMENT OF HAZARDOUS NATURE
NOT CLASSIFIED AS HAZARDOUS ACCORDING TO CRITERIA OF NOHSC AUSTRALIA
COMPANY DETAILS
Company:
Jurox Pty Limited,
Address:
85 Gardiners Road, Rutherford NSW 2320
Telephone:
[phone] or 1800 023 312
Emergency Telephone No.:
[phone] or 1800 023 312
IDENTIFICATION
Product Name:
Trivetrin Injection
Other Names:
Manufacturer’s Product Code:
60250
UN Number:
None Allocated
Dangerous Goods Class:
None Allocated
Subsidiary Risk:
None Allocated
Hazchem Code:
None Allocated
Poisons Schedule Number:
4
Use:
Antibiotic injection for the treatment of susceptible bacterial
infection in cattle pigs, sheep and horses.
PHYSICAL PROPERTIES / DESCRIPTION
Appearance:
A clear yellow solution.
Boiling Point/Melting Point:
Vapour Pressure:
Specific Gravity:
1.23 – 1.25
Flashpoint:
Flammability Limits:
Solubility in Water:
Miscible
pH:
9.0 – 10.5
OTHER PROPERTIES
INGREDIENTS
CHEMICAL ENTITY
CAS NUMBER
PROPORTION
Sulphadoxine
2447-57-6
20.0%
Trimethoprim
738-70-5
4.0%
Water
7732-18-5
to 100%
MATERIAL SAFETY DATA SHEET
PRODUCT NAME: TRIVETRIN INJECTION
Issue Date: June 2007
QAF140
Page 2 of 3
HEALTH & HAZARD INFORMATION
HEALTH EFFECTS
ACUTE
Swallowed:
May lead to nausea, vomiting and possibly convulsions
Eye:
Severe eye irritant.
Skin:
Moderate skin irritant. May result in skin rash and dermatitis, and
sensitisation reactions in certain individuals.
Inhaled:
Does not present an inhalation problem.
Injected:
Effects will vary in severity according to the quantity involved, from
localised site reaction (pain, redness, swelling), to acute systemic
reaction.
CHRONIC
Due to the presence of Trimethoprim, proloned or repeated contact may
lead to skin rash, pruritis
and dermatitis. Due to the presence of Sulphadoxine, prolonged or
repeated contact may lead to
sensitisation and allergic reactions.
FIRST AID
If poisoning occurs, contact a doctor or Poisons Information Centre,
phone 13 11 26.
_ _
Swallo

Safety Data Sheet

WWW.JUROX.COM.AU
Customer Service 1800 023 312
® Registered Trademark of Jurox Pty Limited
TECHNICAL NOTES
ACTIVE CONSTITUENTS
Trimethoprim 40 mg/mL, sulfadoxine 200 mg/mL.
ACTIONS
Effective against most Gram-positive and Gram-negative bacteria. The
two compounds produce a sequential double blockade of
bacterial metabolism, giving a level of activity many times greater
than that obtained from either drug alone.
INDICATIONS
Trivetrin solution is indicated for the systemic treatment of:
RESPIRATORY INFECTIONS of bacterial origin including pneumonia,
bronchitis, and secondary bacterial infections following virus
pneumonia.
UROGENITAL TRACT INFECTIONS including cystitis, vaginitis, urethritis,
and metritis.
ALIMENTARY TRACT INFECTIONS including _E. coli_ infections and
salmonellosis.
OTHER INFECTIONS, such as foul-in-the-foot, severe mastitis, bacterial
agalactia of sows, post-operative and post-parturient uses, wound
infections and septicaemias.
NOTE: The following pathogens are not sensitive to Trivetrin:
_Erysipelothrix, Leptospira, Pseudomonas_ and_ Mycobacterium
tuberculosis_.
CONTRAINDICATIONS
Known sulfonamide sensitivity. Hepatic damage. Blood dyscrasias. Prior
to and after treatment with sedatives or anaesthetics in still
recumbent horses.
WITHHOLDING PERIODS
MEAT: DO NOT USE less than 14 days (cattle, sheep, pigs) or 28 days
(horses) before slaughter for human consumption.
MILK: 36 hours (single dose), 72 hours (multiple doses).
Milk taken from animals within 36 hours following a single treatment
or 72 hours (3 days) following the last treatment, MUST NOT be
used for human consumption.
TRIVETRIN
®
Injection
WWW.JUROX.COM.AU
Customer Service 1800 023 312
® Registered Trademark of Jurox Pty Limited
TECHNICAL NOTES
ADVERSE REACTIONS
Trivetrin is well tolerated. Very occasionally, effects at the
injection site are encountered. These are seen as local irritating
swellings
of a temporary nature.
DOSAGE AND ADMINISTRATION
CATTLE, SHEEP, HORSES, PIGS: 1 mL/15 kg bodyweight daily. In cases of
severe infection the