HEXASOL LA (OXYTETRACYCLINE/FLUNIXIN) INJECTION FOR CATTLE

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

OXYTETRACYCLINE AS THE DIHYDRATE; FLUNIXIN AS FLUNIXIN MEGLUMINE

Available from:

NORBROOK LABORATORIES AUSTRALIA PTY LIMITED

INN (International Name):

oxytetracycline as dihydrate(300mg/mL)+flunixin as meglumine(20mg/mL)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

OXYTETRACYCLINE AS THE DIHYDRATE ANTIBIOTIC Active 300.0 mg/ml; FLUNIXIN AS FLUNIXIN MEGLUMINE BENZENE Active 20.0 mg/ml

Units in package:

100mL; 250mL; 500mL; 50mL

Class:

VM - Veterinary Medicine

Therapeutic group:

CATTLE | BEEF | BOS INDICUS | BOS TAURUS | BOVINE | BUFFALO | BULL | BULLOCK | CALF | COW | DAIRY COW | HEIFER | STEER

Therapeutic area:

ANTIBIOTIC & RELATED

Therapeutic indications:

BOVINE RESPIRATORY DISEASE | ORGANISMS SENSITIVE TO OXYTETRACYCLINE | ENTERIC BACTERIAL INFECTION | RESPIRATORY INFECTION | SHIPPING FEVER

Product summary:

Poison schedule: 4; Host/pest details: CATTLE: [BOVINE RESPIRATORY DISEASE, ORGANISMS SENSITIVE TO OXYTETRACYCLINE]; Poison schedule: 4; Withholding period: WHP: MEAT: DO NOT USE LESS THAN 28 DAYS BEFORE SLAUGHTER FOR HUMAN CONSUMPTION . MILK: DO NOT USE IN LACTATING COWS OR WITHIN 30 DAYS OF CALVING WHERE MILK OR MILK PRODUCTS MAY BE USED FOR HUMAN CONSUMPTION. SHOULD COWS CALVE EARLIER THAN 30 DAYS AFTER TREATMENT MILK COUL D CONTAIN RESIDUES. THIS MILK MUST NOT BE USED FOR HUMAN CONSUMPTION OR SUPPL IED FOR PROCESSING FOR AT LEAST 30 DAY S FOLLOWING TREATMENT. THIS MILK MUST N OT NE FED TO BOBBY CALVES DURING THIS T IME. EXPORT SLAUGHTER INTERVAL (ESI): D O NOT USE less than 28 days before slau ghter for export.; Host/pest details: CATTLE: [BOVINE RESPIRATORY DISEASE, ORGANISMS SENSITIVE TO OXYTETRACYCLINE]; Poison schedule: 4; Withholding period: ; Host/pest details: CATTLE: [BOVINE RESPIRATORY DISEASE, ORGANISMS SENSITIVE TO OXYTETRACYCLINE]; For the treatment of bovine respiratory disease associated with pasteurellosis and other conditions in cattle caused by, or assoc. with, oxytet-sensitive organisms where an anti-inflammatory/anti-pyretic effect is required in the 24 hours post treatment.Restraints & Contra-Indications - Refer to product leaflet

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

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PRESCRIPTION
ANIMAL
REMEDY
KEEP OUT
OF
REACH
OF
CHILDREN
F
OR
ANIMAL
TREATMENT ONLY
HEXASOL
LA
(Oxytetracycline/Flunixin)
Injection
for
Cattle
300
mg/ml
OXYTETRACYCLINE
(a
s
oxytetracy
cli
ne
dihyd
ra
t e)
and
20 mg/mL FL
UNIXIN
(as
flunixin megluminel
For
the
treatment
of
bov
i
ne
respiratory
disease
associated
with
_Mannheimia _
_haemolytic _
_a _
(Pasteure
llo
sis),
where
an
anti-inflammatory
and
anti-pyretic effect
is
req
u
ired
in
the
24
ho
u
rs
post
treatment
For
treatment
of
con
d
itions
caused
by,
or
assoc
i
ated
with, or
ganis
ms
sensitive
to
oxytetracycline
in
cattle
where
bo
th
an
anti-inf
lammatory
and anti-pyretic
effect is
required
in
the
24
ho
ur
s
post
treatment
Contents: 250
ml
NorbrooJi
~
File Name:
Dimensions:
Scale:
Date:
READ
Tl!E
ENCLOSED
LEAFI.ET
BEFORE
USING
T111S
PRODUCT
DIRECTIONS
FOR
USE
Restraints:
DO
NOT
USE
in
lactating
cows
or
within
30
days
of
calving
wflere
milk
or
milk
products
may
be
used
for
human
consumption
.
Treated
animals
must
be
clearly
identified
in
such
a
way
that
they
will
maintain
their
identity
during
the
withholding
period
.
Precautions
:
Use
in
any
animals
less
than
6
weeks
of
age
or
in
aged
animals
may
involve
additional
risk.
If
such
use
cannot
be
avoided,anunals
may
requ
i
re
a
reduced
dosage
a.
nd
careful
clinical
management
This
product
does
not
contain
an
antimicrobial8rnervative
.
Swab
the
aeptwn
before
removing
each
dose.
se
a
aterile
neadle
and
syringe.
Avoid
administration
of
other
NSAIDs
concurrently
or
within
24
hours
of
this
product.
Concurrent
use
of
potentially
nephrotoxic
drugs
should
be
avoided.
The
stated
doae
or
duration
of
treatment
should
not
be
exceeded.
The
use
of
tetracyclines
during
the
period
of
tooth
and
bone
development,
including
late
pregnanc

Summary of Product characteristics

PRODUCT NAME: HEXASOL LA (OXYTETRACYCLINE/FLUNIXIN) INJECTION FOR
CATTLE
PAGE: 1 OF 4
THIS REVISION ISSUED: JULY, 2009
MATERIAL 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
SUBSTANCE:
Oxytetracycline is an antibiotic.
TRADE NAME:
HEXASOL LA (OXYTETRACYCLINE/FLUNIXIN) INJECTION FOR CATTLE
PRODUCT USE:
Anti-bacterial/anti-inflammatory for the treatment of a wide range of
infections caused
by oxytetracycline susceptible organisms.
CREATION DATE:
JULY, 2009
THIS VERSION ISSUED:
JULY, 2009
and is valid for 5 years from this date.
SECTION 2 - HAZARDS IDENTIFICATION
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:
R25. Toxic if swallowed.
SAFETY PHRASES:
Not Hazardous - No criteria found.
SUSDP CLASSIFICATION:
S4
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
UN NUMBER:
None allocated
EMERGENCY OVERVIEW
PHYSICAL DESCRIPTION & COLOUR
: Clear, dark amber solution.
ODOUR:
No odour.
MAJOR HEALTH HAZARDS:
toxic if swallowed. 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.
POTENTIAL HEALTH EFFECTS
INHALATION:
SHORT TERM EXPOSURE:
Available data indicates that this product is not harmful. In addition
product is unlikely to
cause any discomfort or irritation.
LONG TERM EXPOSURE:
No data fo