DERAMAXX 100MG CHEWABLE TABLETS FOR DOGS

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Buy It Now

Patient Information leaflet (PIL)

14-02-2006

Summary of Product characteristics (SPC)

01-07-2013

Active ingredient:

DERACOXIB

Available from:

ELANCO AUSTRALASIA PTY LTD

INN (International Name):

deracoxib(100mg/Tb)

Pharmaceutical form:

ORAL BOLUS, CHEWABLE

Composition:

DERACOXIB ANTI-INFLAMMATORY-NON-STEROIDA Active 100.0 mg/Tb

Units in package:

30 Tablets; 7 Tablets; 90 Tablets; bottle

Class:

VM - Veterinary Medicine

Manufactured by:

ELANCO AUSTRALASIA

Therapeutic group:

DOG | BITCH | CASTRATE | PUPPY

Therapeutic area:

MUSCULOSKELETAL SYSTEM

Therapeutic indications:

Product summary:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: DOG: [ANALGESIC, MUSCOSKELETAL DISCOMFORT, MUSCULOSKELETAL CONDITIONS, ORTHOPAEDIC - INFLAMATION]; Poison schedule: 4; Withholding period: ; Host/pest details: DOG: [ANALGESIC, MUSCOSKELETAL DISCOMFORT, MUSCULOSKELETAL CONDITIONS, ORTHOPAEDIC - INFLAMATION]; For the control of pain and inflammation associated with osteoarthritis or orthopaedic surgery in dogs.Contraindicated for use in cats. See CONTRAINDICATIONS, PRECAUTIONS & SIDE EFFECTS on label also.

Authorization status:

Stopped

Authorization date:

2023-07-01

Patient Information leaflet

N
0
0
_?ft. _
111111111111
9
11
326895
002396
11
>
APVMAApproval
No.
58697/7T/1006
NOV
ARTIS
Animal
Health
Australasia
Pty
Limited
ACVM
No.
A9600
P.A.R.
Class
I
Novartis
New
Zealand
Ltd.
3669-11-06A
Store
below
30°C
(Room
Temperature}.
~
....
"'T'I
n
0
0
:::r
0
QJ
:::::
S"
3
_I"-!. _
0
~
1'6
C"'
u:::::!
_\7 _
9:-8.8
~
n
OQJ:::::I
n
:::r
z
....,.-g~q-
0
tD
_(\) _
c..
!2..
:::s
::e
0
.....
~
~-
S,
S"
Q.l
.....-4
Q.l
"'
-
"'C
-·
C"'
........
C""
c::
:::r
QJ
:::s
-
....._
-
....
0
-·
Ill
tD
~tDI.C"':::::I
.....
1-!-j
.-+
(\)~QJ
0
.....
~
"'..:c:!o:::::J
o
Q.l
.....J
__
QJ
c..
-
""'""]
::I
;::::!.
::;·
3
::..
c..
=r
::::!:3
I;,Q
tD
-
Vl
0
-·QJ
-
~
&·3
c
11'1
·
o
3m
-
....
QJ
::a
0
!::!".
l>
...
on
C
::I
0
><
0
-u:::::!
ca
"'
~
~
5I
=
;::~~~~::.,
"'"m:::a
omm
::a
""a"'
;~>On
zC:::a
--1:;;
:3:o
.....
:l>"'"o
r-:::az
-1m)>
~~z
!i::ci:
:3:0)>
m"'"r-
zn:::a
-I::Cm
Oi=:3:
zCm
<~5!
z
READ
THE
ATTACHED
LEAFLET
BEFORE
USING
THIS
PRODUCT
DIRECTIONS
FOR
USE
DERAMAXX
Tablets
should
be
given
by
mouth,
with
or
without
food.
The
tablets
are
half-scored
for
more
flexible
dosing.
The
recommended
dose
rate
should
not
be
exceeded.
For
control
of
pain
and
inflammation
associated
with
osteoarthritis:
The
recommended
dose
rate
is
1·2
mg/kg
bodyweight
once
daily.
For
control
of
pain
and
inflammation
associated
with
orthopaedic
surqerv:
The
recommended
dose
rate
is
3·4
mg/kg
bodyweight
once
daily
for
7
days.
The
attached
leaflet
describes
directions
for
use
and
precautions
to
follow
when
administering
DERAMAXX
Tablets.
Dispose
of
empty
containers
by
wrapping
in
paper
and
putting
in
garbage.
c.:::>
-·o
~:::>
5'-c
CD
:::::::!.
a:
:::>
co
_w _
C)
......
u,:.,.
_...... _
w----~
,...._
____
1\.J-...j
3u:!
2,"
111111111111111111111111111111
9
326895
002396
>
APVMAApproval
N~
58697nT/1006
NOV
ARTIS
Animal
Health
Australasia
Pty
Limited
ACVM
No.A9600
PAR.
Closs
I
Novartis
New
Zealand
Lid.
3669·
1
1·06A
Store
below
30"C
(Room
Temperature).
5I
...
~
...
...
om::a
~
=-;;C~
Qi
j;sQ
:!1
!!:o:!l
=
iii
~i!
~~;
m"".-
zn00
®
.....
:!:m
.....
!!:

Read the complete document

Summary of Product characteristics

PRODUCT NAME: DERAMAXX
®
100 MG CHEWABLE TABLETS FOR DOGS

                 PAGE NO:
1 OF 3

                 DATE OF ISSUE:  NOVEMBER 2008


MATERIAL SAFETY DATA SHEET
Novartis Animal Health Australasia Pty Ltd

SECTION 1 - IDENTIFICATION OF CHEMICAL PRODUCT AND COMPANY
COMPANY DETAILS:
NOVARTIS ANIMAL HEALTH AUSTRALASIA PTY LIMITED
PHONE: (02) 9805 3555
A.C.N. 076 745 198
FAX: (02) 9888 8387
54 WATERLOO ROAD

NORTH RYDE NSW 2113

PRODUCT NAME:
Deramaxx
®
100 mg Chewable Tablets for Dogs
ACTIVE INGREDIENTS:

Deracoxib
PRODUCT USE:

For the control of pain and inflammation associated with
osteoarthritis or
orthopaedic surgery in dogs.
REVISION DATE:

November 2008

SECTION 2 HAZARDS IDENTIFICATION
HAZARD CLASSIFICATION:
Hazardous Substance
Non-Dangerous Goods
RISK PHRASES:
None
SAFETY PHRASES:
None
SUSDP CLASSIFICATION:
4
UN NUMBER:
None Allocated
SECTION 3 COMPOSITION / INFORMATION ON INGREDIENTS
INGREDIENTS CAS
NO.
CONTENT
(MG/TABLET)
Deracoxib [169590-41-4]
100
other ingredients determined not to be hazardous
-
up to 2000

This is a commercial product whose exact ratio of components may
vary slightly. Minor quantities of other
non hazardous ingredients are also possible.
SECTION 4 FIRST AID MEASURES
LABEL REGULATED FIRST
AID STATEMENT:
If poisoning occurs immediately contact a Doctor or Poisons
Information
Centre (Phone 131126).
SCHEDULED POISONS :
Product is an S
4
scheduled poison. Poisons

Read the complete document