TRIZINE TRIMETHOPRIM - SULFADIAZINE ORAL POWDER FOR HORSES

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:

CEVA ANIMAL HEALTH PTY LTD

INN (International Name):

sulfadiazine(650mg/g)+trimethoprim(130mg/g)

Pharmaceutical form:

ORAL POWDER, PRE-MIX

Composition:

TRIMETHOPRIM PYRIMIDINE Active 130.0 mg/g; SULFADIAZINE SULFANYL Active 650.0 mg/g

Units in package:

210g

Class:

VM - Veterinary Medicine

Manufactured by:

CEVA ANIMAL HEALTH

Therapeutic group:

Therapeutic area:

ANTIBIOTIC & RELATED

Therapeutic indications:

Product summary:

Poison schedule: 4; Withholding period: WHP (HORSES): MEAT - DO NOT USE LESS T HAN 28 DAYS BEFORE SLAUGHTER FOR HUMAN CONSUMPTION.; Host/pest details: HORSE: [ANTIBIOTICS - ORAL, PARENTERAL]; Poison schedule: 4; Withholding period: ; Host/pest details: HORSE: [ANTIBIOTICS - ORAL, PARENTERAL]; For the treatment of infections in horses caused by organisms sensitive to sulfadiazine, trimethoprim and/or the antimicrobial combination.NOTE: Erysipelothrix, Leptospira, Pseudomonas or Mycobacterium tuberculosis are not sensitive to this product.

Authorization status:

Stopped

Authorization date:

2020-07-01

Patient Information leaflet

FILE NAME: TRIZINE 210g POWDER 40010/210/0108
Date: 24/6/08
Label Dimensions (in mm): 263 x 37
Scale when printed on A4 paper: 100% . COLOUR: 335C
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
D E LVET PTY. LT D .
B4, 26 POWERS ROAD
SEVEN HILLS NSW 2147
PH: 9624 8844 FAX: 9624 1544
TRIZINE
TRIMETHOPRIM - SULFADIAZINE
ORAL POWDER FOR HORSES
ACTIVE CONSTITUENTS: SULFADIAZINE 650MG/G,
TRIMETHOPRIM 130MG/G
210G NET
APPLE FLAVOURED GRANULES
FOR BATCH NUMBER AND EXPIRY DATE, SEE BOTTOM OF CONTAINER.
APVMA APPROVAL NUMBER 40010/210/0108
FIRST AID: IF POISONING OCCURS, CONTACT A DOCTOR OR POISONS
INFORMATION CENTRE. PHONE AUSTRALIA 131 126;
NEW ZEALAND 0800 764 766.
STORE BELOW 30°C (ROOM TEMPERATURE)
DISPOSE OF EMPTY CONTAINER BY WRAPPING WITH
PAPER AND PUTTING IN GARBAGE.
INDICATIONS: FOR THE TREATMENT OF INFECTIONS IN
HORSES CAUSED BY ORGANISMS SENSITIVE TO
SULFADIAZINE, TRIMETHOPRIM, AND/OR THE
ANTIMICROBIAL COMBINATION. NOTE: ERYSIPELOTHRIX,
LEPTOSPIRA AND PSEUODOMONAS ARE NOT SENSITIVE TO TRIZINE
POWDER, AND NEITHER IS MYCOBACTERIUM TUBERCULOSIS.
DIRECTIONS FOR USE.
DOSAGE: THE RECOMMENDED 12-HOUR DOSING INTERVAL IS
BASED ON THE HALF-LIVES OF TRIMETHOPRIM AND SULFADIAZINE,
AND THE DOSE RATE COMPENSATES FOR THE INCOMPLETE SYSTEMIC
A V A I L A B I L I T Y (DUE TO FIRST-PASS EFFECT) OF TRIMETHOPRIM.
HORSES: 21G (TWO LARGE LEVEL SCOOPS) TWICE DAILY FOR
A 450KG ADULT HORSE.
FOR SMALLER ANIMALS, GIVE ONE FULL ROUNDED SMALL
SCOOP (3.5G) PER 75 KG OF BODYWEIGHT, TWICE DAILY. DOUBLE-
ENDED SCOOP ENCLOSED. GIVE THE PRODUCT AT LEAST ONE H O U R
B E F O RE MORNING AND EVENING FEEDS. MIX THE GRANULES WITH
A LITTLE WET FEED OR WITH HONEY OR MOLASSES. TREAT FOR TWO
DAYS AFTER SYMPTOMS SUBSIDE OR FOR A MAXIMUM OF FIVE DAYS.
MEAT WITHHOLDING PERIOD (HORSES): DO NOT USE LESS
THAN 28 DAYS BEFORE SLAUGHTER FOR HUMAN CONSUMPTION.
APPROVED
LABEL
Info
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Summary of Product characteristics

PRODUCT NAME: TRIZINE PRODUCTS
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POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND)
SECTION 1 IDENTIFICATION OF CHEMICAL PRODUCT AND COMPANY
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SUBSTANCE:
Blend of Sulfadiazine and Trimethoprim in a ratio of 5:1 in a suitable
carrier.
TRADE NAME:
TRIZINE PRODUCTS
OTHER NAMES:
This MSDS is intended for three products; Trizine Oral Powder for
Horses, Trizine
120 Tablets and Trizine 480 Caplets.
APVMA CODE:
Trizine Powder 40010; Trizine 120 Tablets 36681; Trizine 480 Caplets
36683
PRODUCT USE:
Broad spectrum antibiotic for animal use.
CREATION DATE:
OCTOBER, 2008
THIS REVISION ISSUED:
OCTOBER, 2008
SECTION 2 HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as:
Not classified as hazardous according to the criteria of ASCC.
Not a Dangerous Good according to the Australian Dangerous Goods (ADG)
Code.
RISK PHRASES:
Not Hazardous No criteria found.
SAFETY PHRASES:
S22, S25. Do not breathe dust. Avoid contact with eyes.
SUSDP CLASSIFICATION:
S4
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
UN NUMBER:
None allocated
EMERGENCY OVERVIEW
PHYSICAL DESCRIPTION & COLOUR
: Tablets, caplets or granules, depending on product.
ODOUR:
No data (granules are apple flavoured).
MAJOR HEALTH HAZARDS:
no significant risk factors have been found for this product. This is
an antibiotic preparation.
Any person with a history of allergies to this class of substances
should avoid all contact with this product as it may
cause sensitisation. This is also a physiologically active product and
so contact should be minimised, especially if the
user is taking a form of medication, as interactions can sometimes
give unexpected and un

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