NUFLOR ORAL FOR PIGS

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Active ingredient:
FLORFENICOL
Available from:
Intervet Australia Pty Limited
INN (International Name):
florfenicol(23g/L)
Pharmaceutical form:
ORAL SOLUTION/SUSPENSION
Composition:
FLORFENICOL ANTIBIOTIC Active 23.0 g/L
Units in package:
2.2L; Bottle; in 4L; plastic
Class:
VM - Veterinary Medicine
Manufactured by:
INTERVET AUSTRALIA
Therapeutic group:
PIGS | BOAR | GILT | PIGLET | SOW | SWINE
Therapeutic area:
ANTIBIOTIC & RELATED
Therapeutic indications:
ACTINOBACILLUS PLEUROPNEUMONIAE (HAEMOPH | MYCOPLASMA SPP. | PASTEURELLA MULTOCIDA | STREPTOCOCCUS SUIS TYPE 2 | FOWL CHOLERA
Product summary:
Poison schedule: 4; Withholding period: WHP: MEAT: REMOVE ALL MEDICATED WATER 12 days before slaughter for human cons umption.; Host/pest details: PIGS: [ACTINOBACILLUS PLEUROPNEUMONIAE (HAEMOPH, MYCOPLASMA SPP., PASTEURELLA MULTOCIDA, STREPTOCOCCUS SUIS TYPE 2]; Poison schedule: 4; Withholding period: ; Host/pest details: PIGS: [ACTINOBACILLUS PLEUROPNEUMONIAE (HAEMOPH, MYCOPLASMA SPP., PASTEURELLA MULTOCIDA, STREPTOCOCCUS SUIS TYPE 2]; For use in the treatment of pig respiratory disease associated with Actinobacillus pleuropneumoniae, Pasteurella multicoda, Mycoplasma spp. and Streptococcus suis Type 2.DO NOT use in pigs intended for breeding.
Authorization status:
Registered
Authorization number:
52325
Authorization date:
2020-07-01

File Name:

52325_1003c.doc

Prepared By:

L. Wirth

Preparation Date:

14/7/1999

Last Revised:

2/7/2003

Schering-Plough Label & Printer Specifications:

CCP **

[Note: Instructions in square brackets & in

italics are not part of the label]

Version:

(30/9/2003)

Page 1 of 4

NUFLOR ORAL FOR PIGS (2.2L in 4L bottle)

LABEL - MAIN PANEL

IMMEDIATE CONTAINER

PRESCRIPTION ANIMAL REMEDY

KEEP OUT OF REACH OF CHILDREN

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

FOR ANIMAL TREATMENT ONLY

NUFLOR ® ORAL

For Pigs

ACTIVE CONSTITUENT:

FLORFENICOL 23 g/L

Indicated for use in the treatment of pig respiratory disease

associated with Actinobacillus pleuropneumoniae, Pasteurella

multocida, Mycoplasma spp. and Streptococcus suis Type 2.

Schering-Plough Animal Health

2.2 Litres

DRUMMUSTER

ELIGIBLE

CONTAINER

Info

pest

Verified

File Name:

52325_1003c.doc

Prepared By:

L. Wirth

Preparation Date:

14/7/1999

Last Revised:

2/7/2003

Schering-Plough Label & Printer Specifications:

CCP **

[Note: Instructions in square brackets & in

italics are not part of the label]

Version:

(30/9/2003)

Page 2 of 4

NUFLOR ORAL FOR PIGS (2.2L in 4L bottle)

LABEL - ANCILLIARY PANEL/S

IMMEDIATE CONTAINER

Nuflor

®

Oral

For Pigs

Florfenicol, the active ingredient in NUFLOR Oral For Pigs, is a synthetic, broad spectrum

antibiotic active against many gram-negative and gram-positive bacteria isolated from domestic

animals. Florfenicol acts by inhibiting bacterial protein synthesis at the ribosomal level.

Indications

NUFLOR Oral For Pigs is indicated for use in the treatment of pig respiratory disease associated

with

Actinobacillus

pleuropneumoniae,

Pasteurella

multocida,

Mycoplasma

spp.

Streptococcus suis Type 2.

DIRECTIONS FOR USE:

Restraints

USE ONLY in pigs for treatment of respiratory infections.

Contra-indications

This product is contra-indicated for use in pigs intended for breeding.

Precautions and Side Effects

This product should not be used or stored in galvanised metal watering systems or containers.

Chlorinators must not be operated while administering medication.

This product is not recommended for use in automatic water proportioners if water hardness is

greater than 275 ppm.

Water proportioners should be tested for accuracy before use.

Perianal inflammation may occur transiently in pigs following treatment.

Further Information on Target Animal Safety

A target animal safety study was conducted to address the tolerance and safety of NUFLOR

Oral For Pigs when administered to pigs at a rate of 0, 100, 300 and 500 ppm (0x, 1x, 3x and 5x

the clinical dose rate, respectively) for 15-16 consecutive days (3x the clinical duration). This

study also evaluated safety and tolerance of the drug when administered orally at 1000 ppm at a

clinical duration of 5-6 consecutive days (10x clinical dose rate, 1x clinical duration). This study

demonstrates that NUFLOR Oral For Pigs is safe and well tolerated by pigs when orally

administered according to the recommended clinical regiment of 100 ppm for 5 consecutive

days via the drinking water.

Dosage and Administration

Bulk Tank: To treat pigs drinking 10% of their bodyweight, at the dose of 10 mg/kg: add

NUFLOR Oral For Pigs to the drinking water in the bulk tank. Use one 2.2L bottle of NUFLOR

Oral For Pigs for every 500 litres of water. This corresponds to a 100 ppm drinking water

concentration.

Proportioner: Two convenient proportioner settings for the use of NUFLOR Oral For Pigs in

the drinking water are 10% and 1%.

File Name:

52325_1003c.doc

Prepared By:

L. Wirth

Preparation Date:

14/7/1999

Last Revised:

2/7/2003

Schering-Plough Label & Printer Specifications:

CCP **

[Note: Instructions in square brackets & in

italics are not part of the label]

Version:

(30/9/2003)

Page 3 of 4

NUFLOR ORAL FOR PIGS (2.2L in 4L bottle)

LABEL - ANCILLIARY PANEL/S

IMMEDIATE CONTAINER

10% Setting: To treat 5000 kg of pigs, drinking 10% of their bodyweight, at the dose of 10

mg/kg, empty the contents of one 2.2L bottle of NUFLOR Oral For Pigs into the proportioner

and make up to 50 L with drinking water and mix thoroughly. Set the proportioner on 10%.

Turn on the proportioner and verify that the drinkers are operational.

1% Setting: To treat 5000 kg of pigs, drinking 8% of their bodyweight, at the dose of 10

mg/kg, empty the contents of one 2.2L bottle of NUFLOR Oral For Pigs into the proportioner

and make up to 4 L with drinking water and mix thoroughly. Set the proportioner on 1%.

Turn on the proportioner and verify that the drinkers are operational.

The medicated water should be administered as the only source of drinking water for 5

consecutive days. Medication should be initiated promptly when swine respiratory disease is

diagnosed.

Do not use this product differently than as described above. This may result in a precipitation of

the product. Solutions prepared by diluting drinking water containing Florfenicol concentrate at

concentrations between 1.2g and 12g of Florfenicol per litre will precipitate.

Any variation by the prescribing veterinarian to the approved dose, frequency, duration, route,

disease or target species may require extending the approved withholding period.

WITHHOLDING PERIOD

MEAT:

REMOVE

ALL

MEDICATED

WATER

12

days

before

slaughter

for

human

consumption.

Export of Treated Produce

The withholding period stated on this label applies only to produce destined for the Australian

domestic market. Some export markets may apply different standards. If necessary, details of

overseas standards should be obtained prior to the use of this product. Contact Schering-

Plough Animal Health for further information.

SAFETY DIRECTIONS

Will irritate the eyes and skin. Avoid contact with eyes and skin. When opening the

container and preparing solution, wear elbow length PVC or nitrile gloves. Wash hands

after use. After each day’s use, wash gloves.

FIRST AID

If poisoning occurs, contact a doctor or Poisons Information Centre (Phone 131126).

Additional information is listed in the material safety data sheet.

For further information contact Schering-Plough Animal Health Customer Service on 1

800 226 511.

Website www.nuflor.com.

Warranty

Schering-Plough Pty Ltd (SPPL) warrants that this product is of merchantable quality and fit for

its intended purpose. SPPL’s liability for any loss, including consequential losses or injury

caused by any act or omission, including negligent acts or omissions, by SPPL or its agent, is

limited to replacing or repairing the product at the option of SPPL. If possible, a sample of any

product causing concern should be retained or delivered to SPPL within 30 days for a scientific

examination.

File Name:

52325_1003c.doc

Prepared By:

L. Wirth

Preparation Date:

14/7/1999

Last Revised:

2/7/2003

Schering-Plough Label & Printer Specifications:

CCP **

[Note: Instructions in square brackets & in

italics are not part of the label]

Version:

(30/9/2003)

Page 4 of 4

NUFLOR ORAL FOR PIGS (2.2L in 4L bottle)

LABEL - ANCILLIARY PANEL/S

IMMEDIATE CONTAINER

(CONTINUED)

DISPOSAL

Thoroughly empty entire contents of the container during treatment. Triple or (preferably)

pressure rinse into the medicated water. Do not dispose of undiluted chemicals on site.

Return clean container for recycling where this is an option or for disposal at a landfill authorised

to accept that waste. If neither of these options are available, bury the container below 500mm

in a disposal pit specifically marked and set up for this purpose clear of waterways, vegetation

and roots. Empty containers should not be burned.

Containers should be taken after cleaning as indicated to an approved collection centre.

STORE below 25

C (Air Conditioning).

Schering-Plough Animal Health

(A Division of Schering-Plough Pty Ltd)

11 Gibbon Road, Baulkham Hills NSW 2153

BATCH

EXP

NRA Approval No. 52325/1003

® Schering-Plough Pty Ltd Registered Trademark

Schering-Plough Pty Ltd 2003

[Note: Printer’s code to be determined.

Location of Batch and Expiry on label will be

confirmed once artwork is generated with overseas contractor]

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