NEO-SULCIN SCOUR TABLETS

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Active ingredient:

NEOMYCIN SULFATE; HYOSCINE AS HYOSCINE METHOBROMIDE; SULFADIMIDINE; SULFADIAZINE; VITAMIN B2 = RIBOFLAVIN; VITAMIN B1 HYDROCHLORIDE = THIAMINE HYDROCHLORIDE

Available from:

JUROX PTY LIMITED

INN (International Name):

sulfadiazine(750mg/Tb)+sulfadimidine(750mg/Tb) + others

Pharmaceutical form:

ORAL TABLET

Composition:

NEOMYCIN SULFATE ANTIBIOTIC Active 250.0 mg/Tb; HYOSCINE AS HYOSCINE METHOBROMIDE ALKALOID Active 1.52 mg/Tb; SULFADIMIDINE SULFANYL Active 750.0 mg/Tb; SULFADIAZINE SULFANYL Active 750.0 mg/Tb; VITAMIN B2 = RIBOFLAVIN VITAMIN-B2 Active 3.0 mg/Tb; VITAMIN B1 HYDROCHLORIDE = THIAMINE HYDROCHLORIDE VITAMIN-B1 Active 2.0 mg/Tb

Units in package:

40 Tablets

Class:

VM - Veterinary Medicine

Therapeutic group:

CALF | HORSE | BEEF CALF | BOVINE | CALF - PODDY | CALF - PREWEANING | CALF - SUCKER | COLT | DAIRY CALF | DONKEY | ENDURANCE HO

Therapeutic area:

ALIMENTARY + ANTIBIOTIC

Therapeutic indications:

BACTERIAL CALF SCOURS | BACTERIAL ENTERITIS | POST-WEANING BACTERIAL ENTERIT

Product summary:

Poison schedule: 4; Withholding period: WHP: Meat: DO NOT USE less than 14 days (calves) or 28 days (horses) before slau ghter for human consumption. EXPORT S LAUGHTER INTERVAL (ESI): This product do es not have an ESI established; Host/pest details: CALF: [BACTERIAL CALF SCOURS, BACTERIAL ENTERITIS]; HORSE: [BACTERIAL CALF SCOURS, BACTERIAL ENTERITIS]; Poison schedule: 4; Withholding period: WHP: Meat: DO NOT USE less than 14 days (calves) or 28 days (horses) before s laughter for human consumption. EXPORT SLAUGHTER INTERVAL (ESI): This product does not have an ESI established; Host/pest details: CALF: [BACTERIAL CALF SCOURS, BACTERIAL ENTERITIS]; HORSE: [BACTERIAL CALF SCOURS, BACTERIAL ENTERITIS]; Poison schedule: 4; Withholding period: ; Host/pest details: CALF: [BACTERIAL CALF SCOURS, BACTERIAL ENTERITIS]; HORSE: [BACTERIAL CALF SCOURS, BACTERIAL ENTERITIS]; For the treatment of scours and enteritis of bacterial origin sensitive to neomycin or sulphonamides in calves and horses.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

                                NEO-SULCIN
SCOUR TABLETS
APVMA FILE: 46414_49816_40Tab_immediate_MPL_V01.pdf
Dimensions: label = 109mm (wide) x 51mm (high)
Scale: 100% of A4
Date: 25 June 2010
Each tablet contains:
750 mg SULFADIAZINE
750 mg SULFADIMIDINE
250 mg NEOMYCIN SULFATE
1.52 mg HYOSCINE (as methobromide)
2 mg THIAMINE HYDROCHLORIDE
3 mg RIBOFLAVINE
FOR THE TREATMENT OF SCOURS AND ENTERITIS OF BACTERIAL ORIGIN
SENSITIVE
TO NEOMYCIN OR SULPHONAMIDES IN CALVES AND HORSES.
DIRECTIONS FOR USE: 1 TABLET per 35kg bodyweight administered
orally twice daily. Repeat treatment daily until 2 days after symptoms
have subsided except in cases of salmonellosis where treatment should
continue for a minimum of 5 consecutive days.
WITHHOLDING PERIOD: MEAT: DO NOT USE LESS THAN 14
DAYS (CALVES) OR 28 DAYS (HORSES) BEFORE SLAUGHTER FOR
HUMAN CONSUMPTION.
TRADE ADVICE
EXPORT SLAUGHTER INTERVAL (ESI): THIS PRODUCT DOES
NOT HAVE AN ESI ESTABLISHED. FOR ADVICE ON THE ESI CONTACT
JUROX PTY LIMITED ON 1800 023 312 BEFORE USING THIS PRODUCT.
DISPOSE of empty container by wrapping
in paper and putting in garbage.
STORE BELOW 30°C (Room Temperature) PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
40 TABLETS
APVMA 46414/40/0410
JUROX Pty. Limited.
85 Gardiner Road,
Rutherford NSW 2320
AUSTRALIA.
Infoline 1800 023 312.
405212 RLP APPROVED
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Summary of Product characteristics

                                NEO-SULCIN TABLETS
Page 1 of 5
ISSUED:
01 JULY 2011
MATERIAL SAFETY DATA SHEET
SECTION 1: IDENTIFICATION OF CHEMICAL PRODUCT AND COMPANY
PRODUCT NAME:
NEO-SULCIN SCOUR TABLETS
PRODUCT CODE:
60340 (40s)
RECOMMENDED USE:
Tablets for the treatment of scours and enteritis of bacterial origin
sensitive
to neomycin or sulphonamides in calves and horses.
COMPANY IDENTIFICATION:
Jurox Pty Limited
ADDRESS:
85 Gardiner Road
Rutherford NSW 2320
Australia
CUSTOMER CENTRE:
1800 023 312
NATIONAL POISONS INFORMATION CENTRE:
131126 (Australia-wide)
EMERGENCY TELEPHONE NUMBER:
1800 023 312 (Monday – Friday, 9.00 a.m. – 5.00 p.m).
SECTION 2: HAZARDS IDENTIFICATION
HAZARD CLASSIFICATIONS:
CONSIDERED A HAZARDOUS SUBSTANCE ACCORDING TO THE CRITERIA OF NOHSC
AUSTRALIA.
NOT CONSIDERED A DANGEROUS GOOD ACCORDING TO THE CRITERIA OF THE
AUSTRALIAN
DANGEROUS GOODS (ADG) CODE.
POISONS SCHEDULE:
S4
RISK PHRASES:
Harmful if swallowed
Irritating to eyes, respiratory system and skin
May cause SENSITISATION by inhalation and skin contact
May impair fertility
May cause harm to the unborn child
Inhalation and/or skin contact may produce health damage (limited
evidence)
Cumulative effects may result following exposure (limited evidence)
Limited evidence of a carcinogenic effect
SAFETY PHRASES:
Keep locked up
In case of sufficient ventilation, wear suitable respiratory equipment
Use only in well-ventilated areas
Keep container in a well ventilated place
Avoid exposure – obtain special instructions before use
Use water and detergent to clean the floor and all objects
contaminated by this
material
This material and its container must be disposed of in a safe way
Keep away from food, drink and animal feeding stuffs
In case of contact with eyes, rinse with plenty of water and contact a
Doctor or
Poisons Information Centre
NEO-SULCIN TABLETS
Page 2 of 5
SECTION 3: COMPOSITION / INFORMATION ON INGREDIENTS
INGREDIENT
CAS NO.
CONTENT
Sulfadiazine
68-35-9
31%
Sulfamethazine
(Syn: sulfadimidine)
57-68-1
31%
Neomycin sulfate
1405-10-3
10%
Riboflavin
83-8
                                
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