NORFENICOL 300 MG/ML SOLUTION FOR INJECTION FOR CATTLE AND PIGS

Ország: Ausztrália

Nyelv: angol

Forrás: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Aktív összetevők:

FLORFENICOL

Beszerezhető a:

NORBROOK LABORATORIES AUSTRALIA PTY LIMITED

INN (nemzetközi neve):

florfenicol(300mg/mL)

Gyógyszerészeti forma:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Összetétel:

FLORFENICOL ANTIBIOTIC Active 300.0 mg/ml

db csomag:

100mL; 250mL; 500mL; 50mL

Osztály:

VM - Veterinary Medicine

Terápiás terület:

ANTIBIOTIC & RELATED

Termék összefoglaló:

Poison schedule: 4; Withholding period: WITHHOLDING PERIODS: CATTLE: MILK: DO NOT USE in cows which are producing or may in the future product milk that ma y be used or processed for human consum ption. MEAT: DO NOT USE less than 42 da ys before slaughter for human consumpti on. PIGS: MEAT: DO NOT USE less than 1 8 days before slaughter for human consu mption. TRADE ADVICE EXPORT SLAUGHTE R INTERVAL (ESI): CATTLE: DO NOT USE le ss than 42 days before slaughter for ex port. PIGS: DO NOT USE less than 22 day s before slaughter for export. Before using this product confirm the current ESI from the distributor on 1800 665 8 66 or the APVMA website (www.apvma.gov. au/residues).; Host/pest details: CATTLE: [BACTERIAL INFECTION, BOVINE RESPIRATORY DISEASE, FOOT ROT - F. NECROPHORUM, HAEMOPHILUS SPP., MANNHEIMIA HAEMOLYTICA, PASTEURELLA MULTOCIDA, PINK-EYE]; PIG: [ACTINOBACILLUS PLEUROPNEUMONIAE (HAEMOPH, MYCOPLASMA SPP., PASTEURELLA MULTOCIDA, STREPTOCOCCUS SUIS TYPE 2]; Poison schedule: 4; Withholding period: ; Host/pest details: CATTLE: [BACTERIAL INFECTION, BOVINE RESPIRATORY DISEASE, FOOT ROT - F. NECROPHORUM, HAEMOPHILUS SPP., MANNHEIMIA HAEMOLYTICA, PASTEURELLA MULTOCIDA, PINK-EYE]; PIG: [ACTINOBACILLUS PLEUROPNEUMONIAE (HAEMOPH, MYCOPLASMA SPP., PASTEURELLA MULTOCIDA, STREPTOCOCCUS SUIS TYPE 2]; For the treatment of cattle with bacterial infections susceptible to florfenicol, especially the causative organisms of pink-eye, bovine respiratory disease and footrot of cattle, and for the treatment of pigs with swine respiratory disease associated...DO NOT USE in cows which are producing or may in the future produce milk that ay be used or processed for human consumption. See RESTRAINTS, PRECAUTIONS, SIDE EFFECTS etc. on label.

Engedélyezési státusz:

Registered

Engedély dátuma:

2023-07-01

Betegtájékoztató

APPENDIX 2
Australian Government
Australian Pesticides
and
Veterinary Medicines Authority
RLP
Approved
TEMPLATE FOR RELEVANT
LABEL
PARTICULARS (RLPs)
(Veterinary
Products)
Select appropriate:
0
New Product (include all applicable RLPs)
OR
D
Variation (highlight instructions that are being varied). Approval no.
of
label being
varied:
................
.
Signal
heading:
Product
name:
Active constituentls:
Statement of
claims:
Net
contents:
Directions for
Use
Heading:
Restraints:
Contraindications:
Precautions:
Side
effects:
PRESCRIPTION
ANIMAL
REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR
ANIMAL
TREATMENT ONLY
NORFENICOL 300
mg/mL
SOLUTION FOR INJECTION FOR CATTLE AND
PIGS
ACTIVE CONSTITUENT: 300
mg/mL
FLORFENICOL
NORFENICOL 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 pleuropneumonia,
Pasteurella multocida, Mycoplasma
spp. and
Streptococcus
suis Type
2.
50/1 00/250/500
m L
READ THE ENCLOSED
LEAFLET
BEFORE USING THIS PRODUCT.
DIRECTIONS FOR USE
Restraints:
DO NOT USE
in
cows
which
are
producing
or
may
in
the
future
produce
milk
that
may
be
used
or
processed
for
human
consumption.
DO NOT USE
in
calves
to
be
processed
for
veal.
Cattle:
DO NOT retreat.
For
single
use
only.
DO NOT exceed 10
mL
at
any
one
injection
site
(subcutaneous)
for
cattle.
Pigs:
DO NOT
administer
more
than
2
two
injections
to
any
pig.
DO NOT repeat
treatment
regimen.
DO NOT exceed 3
mL
at
any
one
injection
site
(intramuscular)
for
pigs.
Contraindications
Not for use
in
cattle and pigs intended for breeding
as
the effect
of
florfenicol on
bovine and porcine reproductive performance and pregnancy has not been
assessed.
Precautions
This product should not
be
used

Termékjellemzők

PRODUCT NAME: NORFENICOL 300 MG/ML SOLUTION FOR INJECTION FOR CATTLE
AND PIGS
PAGE: 1 OF 5
THIS REVISION ISSUED: AUGUST, 2017
SAFETY DATA SHEET
Issued by: Norbrook Laboratories Australia Pty Ltd
Freecall: 1800 665 866
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND)
SECTION 1 - IDENTIFICATION OF CHEMICAL PRODUCT AND COMPANY
NORBROOK LABORATORIES AUSTRALIA PTY LTD
FREECALL: 1800 665 866
UNIT 7/1 TRADE PARK DRIVE
TULLAMARINE, VIC 3043 AUSTRALIA
CHEMICAL NATURE:
Injection containing florfenicol
TRADE NAME:
NORFENICOL 300 MG/ML SOLUTION FOR INJECTION FOR CATTLE AND PIGS
PRODUCT CODE:
66803
PRODUCT USE:
Antibiotic for use in cattle and pigs
CREATION DATE:
AUGUST, 2017
THIS VERSION ISSUED:
AUGUST, 2017
and is valid for 5 years from this date.
POISONS INFORMATION CENTRE: PHONE 13 1126 FROM ANYWHERE IN AUSTRALIA
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as:
Xn, Harmful. Hazardous according to the criteria of SWA.
Not a Dangerous Good according to Australian Dangerous Goods (ADG)
Code, IATA or IMDG/IMSBC criteria.
SUSMP CLASSIFICATION:
S4
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good according to Australian Dangerous
Goods (ADG)
Code, IATA or IMDG/IMSBC criteria.
UN NUMBER:
None allocated
GHS SIGNAL WORD: WARNING
Acute Toxicity Oral Category 4
Acute Toxicity Inhalation Category 4
Reproductive Toxicity Category 2
Specific Target Organ toxicity - repeated exposure Category 2
HAZARD STATEMENT:
H302: Harmful if swallowed.
H332: Harmful if inhaled.
H361: Suspected of damaging fertility or the unborn child.
H373: May cause damage to organs through prolonged or repeated
exposure.
PREVENTION
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and
understood.
P260: Do not breathe fumes, mists, vapours or spray.
P262: Do not get in eyes, on skin, or on clothing.
P264: Wash contacted areas thoroughly after handling.
P270: Do not eat, drink or smoke when using this product