NUFLOR LA INJECTABLE SOLUTION

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

FLORFENICOL

Available from:

INTERVET AUSTRALIA PTY LIMITED

INN (International Name):

florfenicol(300mg/mL)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

FLORFENICOL ANTIBIOTIC Active 300.0 mg/ml

Units in package:

100mL; 250mL

Class:

VM - Veterinary Medicine

Manufactured by:

INTERVET AUSTRALIA

Therapeutic group:

CATTLE | PIGS | BEEF | BOAR | BOS INDICUS | BOS TAURUS | BOVINE | BUFFALO | BULL | BULLOCK | CALF | COW | DAIRY COW | GILT | HEI

Therapeutic area:

ANTIBIOTIC & RELATED

Therapeutic indications:

ACTINOBACILLUS PLEUROPNEUMONIAE (HAEMOPH | BACTERIAL INFECTION | BOVINE RESPIRATORY DISEASE | FOOTROT - DICHELOBACTER NODOSUS | FUSOBACTERIUM NECROPHORUM | HAEMOPHILUS SPP. | MYCOPLASMA SPP. | PASTEURELLA MULTOCIDA | PINK-EYE | STREPTOCOCCUS SUIS | SWINE DYSENTERY | AMOXYCILLIN SENSITIVE BACTERIA | ASSOCIATED WITH VIRAL DISEASE | FOWL CHOLERA | GRAM NEGATIVE ORGANISMS | GRAM POSITIVE ORGANISMS | HAEMOPHILUS AGNI | HAEMOPHILUS BOVIS | HAEMOPHILUS PARAINFLUENZAE | HAEMOPHILUS PARASUIS | HAEMOPHILUS PLEUROPNEUMONIAE | HAEMOPHILUS SOMNUS | HAEMOPHILUS SUIS | POST PARTURIENT BACTERIAL INFE | PRIMARY BACTERIAL INFECTION | SHIPPING FEVER | SULFADIAZINE SENSITIVE BACTERI | TRIMETHOPRIM SENSITIVE BACTERI | TYLOSIN SENSITIVE BACTERIA

Product summary:

Poison schedule: 4; Withholding period: CATTLE: MILK: DO NOT USE in female catt le which are producing or may in the fut ure produce milk that may be used or pro cessed for human consumption. MEAT: DO NOT USE less than 42 days before slaught er for human consumption. PIGS: MEAT: DO NOT USE less than 12 days before slau ghter for human consumption. Any vari ation by the prescribing veterinarian to the approved dose, frequency, duration, route, disease or target species may re quire extending the approved withholding period. CATTLE: DO NOT USE less than 4 2 days before slaughter for export. PIG S: DO NOT USE less than 12 days before s laughter for export. Before using this product, confirm the current ESI from MS D Animal Health on 1800 033 461 or the A PVMA website (www.apvma.gov.au/residues) .; Host/pest details: CATTLE: [BACTERIAL INFECTION, BOVINE RESPIRATORY DISEASE, FOOTROT - DICHELOBACTER NODOSUS, FUSOBACTERIUM NECROPHORUM, HAEMOPHILUS SPP., PASTEURELLA MULTOCIDA, PINK-EYE]; PIGS: [ACTINOBACILLUS PLEUROPNEUMONIAE (HAEMOPH, BACTERIAL INFECTION, MYCOPLASMA SPP., PASTEURELLA MULTOCIDA, STREPTOCOCCUS SUIS, SWINE DYSENTERY]; Poison schedule: 4; Withholding period: WHP: CATTLE: MILK: Do not use in female cattle which are producing or may in t he future produce milk or milk products for human consumption. MEAT: Do not u se less than 42 days before slaughter f or human consumption. PIGS: MEAT: Do no t use less than 12 days before slaughte r for human consumption. TRADE ADVICE: ESI: CATTLE: DO NOT USE less than 42 da ys before slaughter for export. PIGS: DO NOT USE less than 12 days before sla ughter for export. The ESI on this labe l was correct at the time of label appr oval. Before using this product confir m the current ESI from the manufacturer on 1800 810 511 or the APVMA website. (www.apvma.gov.au/ residues//ESI.shtml); Host/pest details: CATTLE: [BACTERIAL INFECTION, BOVINE RESPIRATORY DISEASE, FOOTROT - DICHELOBACTER NODOSUS, FUSOBACTERIUM NECROPHORUM, HAEMOPHILUS SPP., PASTEURELLA MULTOCIDA, PINK-EYE]; PIGS: [ACTINOBACILLUS PLEUROPNEUMONIAE (HAEMOPH, BACTERIAL INFECTION, MYCOPLASMA SPP., PASTEURELLA MULTOCIDA, STREPTOCOCCUS SUIS, SWINE DYSENTERY]; Poison schedule: 4; Withholding period: ; Host/pest details: CATTLE: [BACTERIAL INFECTION, BOVINE RESPIRATORY DISEASE, FOOTROT - DICHELOBACTER NODOSUS, FUSOBACTERIUM NECROPHORUM, HAEMOPHILUS SPP., PASTEURELLA MULTOCIDA, PINK-EYE]; PIGS: [ACTINOBACILLUS PLEUROPNEUMONIAE (HAEMOPH, BACTERIAL INFECTION, MYCOPLASMA SPP., PASTEURELLA MULTOCIDA, STREPTOCOCCUS SUIS, SWINE DYSENTERY]; For the treatment of bacterial infections in cattle and pigs susceptible to florfenicol.Not for use in cattle and pigs intended for breeding. DO NOT USE in female cattle which are producing or may in the future produce milk or milk products for human consumption. DO NOT USE in calves to be processed for veal. DO NOT exceed 10mL at any one s

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

F O R I N F O R M AT I O N O N LY
REPLACES OLD CODE
N/A
DATE OF START UP
02dec2008
COUNTRY
AUSTRALIA
DTP
APM
CO
GVOS
PROFILE
SEG-CA100
SIZE (MM)
A55,00 x B55,00 x H103,00
SUPPLIER 1
SEGRE/PDF/FTP
SUPPLIER 2
N/A
NEW CODE
S2198B 12_2008
SUBMISSION
2.1
PRODUCTNAME
Nufl or
CONCENTRATION
N/A
PRESENTATION
100ml
COLORS
2
PANTONE 201 C
BLACK
N/A
N/A
N/A
N/A
N/A
N/A
N/A
NUFLOR
®
LA Injectable Solution is indicated for the treatment
of cattle with bacterial infections susceptible to florfenicol,
especially the causative organisms of pink-eye _ (Moraxella _
_bovis)_,
bovine
respiratory
disease
(including
_Mannheimia _
_haemolytica, Pasteurella multocida _and _Haemophilus somnus_)
and
footrot
of
cattle
(_Fusobacterium _
_necrophorum _
and
_Bacteroides melaninogenicus_), and for the treatment of pigs
with swine respiratory disease associated with _Actinobacillus _
_pleuropneumoniae, Pasteurella multocida, Mycoplasma spp._
and _Streptococcus suis _Type 2.
READ THE ENCLOSED LEAFLET BEFORE USING THIS
PRODUCT.
DIRECTIONS FOR USE
Restraints:
DO NOT USE in female cattle which are
producing or may in the future produce milk
or milk products for human consumption.
DO NOT USE in calves to be processed for veal.
DO NOT exceed 10mL at any one injection
site (subcutaneous or intramuscular).
Contra-indications and Special Precautions for Use:
Not for use in cattle and pigs intended for breeding.
Clinical improvement should be evident in most treated subjects
within 24 hours of initiation of therapy. If a positive response
is not seen within 24 hours after the second injection, the
diagnosis should be reconfirmed.
Susceptibility discs containing 30 μg of florfenicol are available
for sensitivity testing.
Mild, transient inappetence, decreased water consumption or
diarrhoea may occur in cattle following treatment. Transient
diarrhoea and/or perianal erythema/swelling may occur in
pigs following treatment. These symptoms should return to
normal shortly after treatment.
The effect of florfenicol on bovine and porcine reproductive
performanc

Summary of Product characteristics

PRODUCT NAME: NUFLOR LA INJECTABLE SOLUTION
MATERIAL SAFETY DATA SHEET
THIS REVISION ISSUED: AUGUST, 2009
PAGE: 1 OF 5
MATERIAL SAFETY DATA SHEET
Issued by: Intervet Australia Pty Limited Phone: [phone]
(Business Hours)
Poisons Information Centre: 13 11 26 from anywhere in Australia, (0800
764 766 in New Zealand)
SUBSTANCE:
Florfenicol in a suitable solvent system.
TRADE NAME:
NUFLOR LA INJECTABLE SOLUTION
RECOMMENDED USE:
For the treatment of bacterial infections in cattle and pigs
susceptible to florfenicol.
APVMA NO:
52201
CREATION DATE:
August, 2009
THIS VERSION ISSUED:
August, 2009
and is valid for 5 years from this date.
STATEMENT OF HAZARDOUS NATURE:
THIS PRODUCT IS CLASSIFIED AS:
T, Toxic. Not classified as hazardous according to the criteria of
SWA.
Not a Dangerous Good according to the Australian Dangerous Goods (ADG)
Code.
RISK PHRASES:
R62, R63, R48/20. Possible risk of impaired fertility. Possible risk
of harm to the unborn child. Harmful:
danger of serious damage to health by prolonged exposure through
inhalation.
SAFETY PHRASES:
S24/25. Avoid contact with skin and eyes.
SUSDP CLASSIFICATION:
S4
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
UN NUMBER:
None allocated
PHYSICAL DESCRIPTION & COLOUR:
Clear light yellow to straw coloured slightly viscous liquid.
ODOUR:
No data.
MAJOR HEALTH HAZARDS:
possible risk of impaired fertility, possible risk of harm to the
unborn child. 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 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 undesired
results.
INHALATION:
SHORT TERM EXPOSURE:
Available data indicates that this product is not harmful. However
product may be mildly
irritating, although unlikely to cause anything more than mild
transient discomfort.
LONG TERM EXPOSUR

Safety Data Sheet

NUFLOR
®
LA Injectable Solution is indicated for the treatment
of cattle with bacterial infections susceptible to florfenicol,
especially the causative organisms of pink-eye _ (Moraxella _
_bovis)_,
bovine
respiratory
disease
(including
_Mannheimia _
_haemolytica, Pasteurella multocida _and _Haemophilus somnus_)
and
footrot
of
cattle
(_Fusobacterium _
_necrophorum _
and
_Bacteroides melaninogenicus_), and for the treatment of pigs
with swine respiratory disease associated with _Actinobacillus _
_ _
_pleuropneumoniae, Pasteurella multocida, Mycoplasma spp._
and _Streptococcus suis _Type 2.
READ THE ENCLOSED LEAFLET BEFORE USING THIS
PRODUCT.
DIRECTIONS FOR USE
Restraints:
DO NOT USE in female cattle which are producing or may
in the future produce milk or milk products for human
consumption.
DO NOT USE in calves to be processed for veal.
DO NOT exceed 10mL at any one injection site (subcuta-
neous or intramuscular).
Contra-indications and Special Precautions for Use:
Not for use in cattle and pigs intended for breeding.
Clinical improvement should be evident in most treated subjects
within 24 hours of initiation of therapy. If a positive response
is not seen within 24 hours after the second injection, the
diagnosis should be reconfirmed.
Susceptibility discs containing 30 μg of florfenicol are available
for sensitivity testing.
Mild, transient inappetence, decreased water consumption or
diarrhoea may occur in cattle following treatment. Transient
diarrhoea and/or perianal erythema/swelling may occur in
pigs following treatment. These symptoms should return to
normal shortly after treatment.
The effect of florfenicol on bovine and porcine reproductive
performance and pregnancy has not been assessed.
As seen with many antibiotics high dosage and/or prolonged
administration may lead to superinfections by non-sensitive
organisms such as yeasts and fungi.
TRADE ADVICE
EXPORT SLAUGHTER INTERVAL (ESI): CATTLE: DO NOT USE
less than 42 days before slaughter for export. PIGS: DO NOT
USE less than 12 days before slaughter