CLAVULOX PALATABLE DROPS BROAD SPECTRUM ANTIBIOTIC

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Patient Information leaflet (PIL)

19-06-2017

Summary of Product characteristics (SPC)

19-06-2017

Active ingredient:

AMOXYCILLIN AS AMOXYCILLIN TRIHYDRATE; CLAVULANIC ACID AS POTASSIUM CLAVULANATE

Available from:

ZOETIS AUSTRALIA PTY LTD

INN (International Name):

clavulanic acid as K salt(12.5mg/mL) + others

Pharmaceutical form:

ORAL SOLUTION/SUSPENSION

Composition:

AMOXYCILLIN AS AMOXYCILLIN TRIHYDRATE ANTIBIOTIC Active 50.0 mg/ml; CLAVULANIC ACID AS POTASSIUM CLAVULANATE ANTIBIOTIC Active 12.5 mg/ml

Units in package:

15mL

Class:

VM - Veterinary Medicine

Manufactured by:

ZOETIS AUSTRALIA

Therapeutic group:

Therapeutic area:

ANTIBIOTIC & RELATED

Therapeutic indications:

Product summary:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: CAT: [ENTERITIS, ESCHERICHIA COLI (E. COLI), INFECTIONS OF THE SKIN, INFECTIONS OF THE URINARY TRACTS, KLEBSIELLA SPP., RESPIRATORY DISEASE, SALMONELLA, STAPHYLOCOCCUS SPP.]; DOG: [ENTERITIS, ESCHERICHIA COLI (E. COLI), INFECTIONS OF THE SKIN, INFECTIONS OF THE URINARY TRACTS, KLEBSIELLA SPP., RESPIRATORY DISEASE, SALMONELLA, STAPHYLOCOCCUS SPP.]; For treatment of infections sensitive to clavulanic acid/amoxycillin in dogs and cats.Do not administer to administer to small herbivores (e.g. guinea pigs) or animals with a history of allergic reactions to penicillins.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

READ
ENCLOSED
LEAFLET
-
BEFORE
USING
THIS
PRODUCT
Shake
well
before
using.
Prescription
Animal
Rellllltly
jP.A.R)
Class
1.
Foruseonly
following
a
veterinary
consultation,
Licensed
underthe
Animal
Remedies
Act
1967,
No,
4925.
NRA
Approval
No.
35843/02.
Dispose
of empty
container
by
wrapping
with
paper
and
putting in
garbage.
'CLAVULOX
is
0
trodemort
awnod
ood
used
under
licOOS9
from
Smi1f1K1ine
Beecham
PM45ZB3
r,1
PRESCRIPTION
ANIMAL
REMEDY
KEEP
OUT
OF
REACH
OF
CHILDREN
FOR
ANIMAL
TREATMENT
ONLY
'\~f
Clavulox
.~
Palatable Drops
_Broad_
_Spectrum_
_Antibiotic_
When reconstitutedcontains
12.5mg/mL
CLAVULANIC
ACID
as
Potassium
Glavulanate.
5Dmg/mL
AMDXYCILLIN
as
Amoxvcillin
Trihydrate
,
162.5mglml
GlAVUlOX)
_15mL_
_when_
_reconstituted_
NRA
Approval
No.
_35843102._
Store
Below25'C (Air
Conditioningl
in a
Dry
Place
NRA
ADAPTED
LABEL
11111111
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IIIII111
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a
_lnJ_
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_J1_
ual/M
_7_
_w_
_§_
_I_
sdoJ.G
aNel~l~d
XOILLAEIJ
For
treatment
of
infections
sensitive
to
Clavulanic
Acid/Amoxycillin
in
dogs
and
cats.
DIRECTIONS
FOR
USE:
DO
NOT
administer
to
sman
herbivores
(e.g.
gllinea
pillSt
or
animals
with
a
history
of
allergic
reactions
to
pflnicil&ns.
DIRECTIONS
FOR
MIXING:
Add
14ml
water
and
shake
vigorously.
Store
made
up
suspension
at
2-B"C
IRefrigsme).
Discard
any
unused
suspension
after
10
days.
DOSE:
12.5mglkg
(1
mlJ5kgl
twice
daily
by
mouth.
See
leeflet
for
further
dosage
information.
Mille
i1
tho
U.S.A.
fer
Animal
Health
A
di~Bion
of
PfIZ8f
Ply.
LirMod
WhaIf
Road,
West
Ryde,/(SW
2114,
Australia.
Licensed
10IrId
distribulod
in
New
Zo*'d
by
I'filIr
laboratories
Ltd.
Otteriey
Wwt,
M.nu~u
City.
-

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Summary of Product characteristics

PRODUCT NAME: CLAVULOX PALATABLE DROPS
PAGE: 1 OF 4
THIS REVISION ISSUED: OCTOBER, 2015
MATERIAL SAFETY DATA SHEET
Issued by: Zoetis Australia Pty Ltd
Phone: 1800 814 883
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND)
- IDENTIFICATION OF THE MATERIAL AND SUPPLIER
ZOETIS AUSTRALIA PTY LTD
ABN 94 156 476 425
Level 6, 5 Rider Blvd
Rhodes NSW 2138 AUSTRALIA
Tel: 1800 814 883
Fax: (02) 8876 0444
Email: australia.animalhealth@zoetis.com
CHEMICAL NATURE:
Clavulanic acid is a is a naturally derived beta-lactamase inhibitor;
amocycillin is a β-
lactam antibiotic
TRADE NAME:
CLAVULOX PALATABLE DROPS
PRODUCT USE:
Broad spectrum antibiotic for use in treating cats and dogs for
infections listed on
product label.
CREATION DATE:
SEPTEMBER, 2006
THIS VERSION ISSUED:
OCTOBER, 2015
and is valid until August 2016.
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as:
Not classified as hazardous according to the criteria of SWA.
Not a Dangerous Good according to the Australian Dangerous Goods (ADG)
Code.
RISK PHRASES:
Not Hazardous - No criteria found.
SAFETY PHRASES:
S22, S45. Do not breathe dust. In case of accident or if you feel
unwell, contact a doctor or
Poisons Information Centre immediately (show the label where
possible).
SUSMP CLASSIFICATION:
S4
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
UN NUMBER:
None allocated
E
E
E
M
M
M
E
E
E
R
R
R
G
G
G
E
E
E
N
N
N
C
C
C
Y
Y
Y
O
O
O
V
V
V
E
E
E
R
R
R
V
V
V
I
I
I
E
E
E
W
W
W
PHYSICAL DESCRIPTION & COLOUR
: White powdered solid (reconstituted with water prior to use).
ODOUR:
Mild bubblegum odour.
MAJOR HEALTH HAZARDS:
no significant risk factors have been found for this product. A
significant ingredient is an
antibiotic. Any person with a history of allergies to this class of
substances should avoid all contact with this product
as it may cause sensitisation.
P
P
P
O
O
O
T
T
T
E
E
E
N
N
N
T
T
T
I
I
I
A
A
A
L
L
L
H
H
H
E
E
E
A
A
A
L
L
L
T
T
T
H
H
H
E
E
E
F
F
F
F
F

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