AMBEX FIVE BROAD SPECTRUM WORMER FOR DOGS & CATS

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)

01-07-2013

Active ingredient:

LEVAMISOLE AS LEVAMISOLE HYDROCHLORIDE; NICLOSAMIDE

Available from:

ELANCO AUSTRALASIA PTY LTD

INN (International Name):

niclosamide(500mg/Tb)+levamisole as HCl(21mg/Tb)

Pharmaceutical form:

ORAL TABLET

Composition:

LEVAMISOLE AS LEVAMISOLE HYDROCHLORIDE ANTHELMINTIC Active 21.0 mg/Tb; NICLOSAMIDE ANTHELMINTIC Active 500.0 mg/Tb

Units in package:

100 Tabs

Class:

VM - Veterinary Medicine

Manufactured by:

BAYER AUSTRALIA

Therapeutic group:

Therapeutic area:

PARASITICIDES

Therapeutic indications:

Product summary:

Poison schedule: 5; Withholding period: WHP:N/A; Host/pest details: CAT: [HOOKWORM, HOOKWORM - ANCYLOSTOMA SPP., ROUNDWORM, ROUNDWORM - TOXASCARIS LEONINA, TAPEWORM]; DOG: [HOOKWORM, HOOKWORM - ANCYLOSTOMA SPP., ROUNDWORM, ROUNDWORM - TOXASCARIS LEONINA, TAPEWORM]; Poison schedule: 5; Withholding period: ; Host/pest details: CAT: [HOOKWORM, HOOKWORM - ANCYLOSTOMA SPP., ROUNDWORM, ROUNDWORM - TOXASCARIS LEONINA, TAPEWORM]; DOG: [HOOKWORM, HOOKWORM - ANCYLOSTOMA SPP., ROUNDWORM, ROUNDWORM - TOXASCARIS LEONINA, TAPEWORM]; For the control of roundworm, hookworm and tapeworms (except hydatid) in dogs and cats.Does not control heartworm or Hydatid tapeworms. Gastrointestinal upset may occur in rare cases. DO NOT OVERDOSE.

Authorization status:

Stopped

Authorization date:

2023-07-01

Patient Information leaflet

_VERSION CONTROLLED DRAFT LABEL_
_AMBEX_
_FIVE_
_BROAD_
_SPECTRUM_
_WORMER FOR DOGS_
&
_CATS_
_Last Edited 18-12-00 11:50_
_pm_
_Page_
J
_of2_
CAUTION
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
AMBEXFIVE
BROAD SPECTRUM WORMER FOR DOGS & CATS
ACTIVE
CONSTITUENTS Each Tablet Contains.:
NICLOSAMIDE
500mg
&
LEVAMISOLE
BASE
21mg
(AS LEV
AMISOLE
HYDROCHLORIDE)
For
the
control
of
roundworms
_(Toxocara_
spp
&
_Toxascaris leonina),_
hookworms
_(Uncinaria stenocephala_
&
_Ancylostoma_
spp) and tapeworms
_(Taenia_
spp
&
_Dipylidium caninum)_
(excluding
_Hydatids)_
in dogs and cats.
Does
not
control
heartworm.
100 TABLETS
Registered to Bomac Laboratories
Distributed by Pharm Tech Pty Limited
DIRECTIONS FOR
USE
DOSAGE AND ADMINISTRATION
Give one tablet per 5kg bodyweight before or with a small meal.
It
is recommended
that
tablets be crushed and added to food.
For kittens and
old
cats divide the dose,
giving
_Y,_
tablet per 5kg in
the
morning
and
repeating this 8-12 hours later.
DO
NOT
OVERDOSE.
TREATMENT REGIMES
I
Roundworms
&
Hookworms (dogs)
Roundworms
&
Hookworms (cats)
Tapeworms (excluding hydatids) (cats and dogs)
Pregnant cats and dogs
I
APPROV~·~·~~
(TEXT)
I
Label
No:
,;?I;;P.1Q.{9~
..
1
Date:
....
§..I..~
.....
.I':2
..
I....
t~~2~n..~_tu_re
__
:_
..
_o~_o"_oof»._o._o~_oo_.oo_o~_.~_
..
_:.~-J0-
Treat at 2, 4, 8 and 12 weeks
of
age,
and thereafter every 12 weeks.
Treat at 6, 8 and 12 weeks
of
age,
and thereafter every 12 weeks.
Treat every 12 weeks.
Adequate
flea control should be maintained
year-round.
Treat at mating, before birth
of
kittens/puppies, then every 12
weeks.
_Version Controlled Draft Label_
_AMBEX_
_FIVE_
_BROAD_
_SPECTRUM_
_WORMER FOR DOGS_
&
_CATS_
_Last Edited 18-12-00_
_1l:50_
_pm_
_Page_
2
_of2_
Ifwonn
problems persist consult a Veterinary Surgeon.
Gastrointestinal upset may occur in rare cases.
First
Aid:
If
poisoning occurs contact a doctor
or
Poisons
Information
Centre.
Phone 131126.
Registered to Bomac Laboratories Limited.
Distributed by:
Phann Tech Pty Limited ACN 084 248 206

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Summary of Product characteristics

Page 1 of 6

SAFETY DATA SHEET

A18243/03/AUS


AMBEX FIVE BROAD SPECTRUM WORMER FOR DOGS AND CATS

SECTION 1 – IDENTIFICATION, CONTACTS, HAZARDOUS NATURE

Bayer Australia Ltd
875 Pacific Highway
Pymble NSW 2073

EMERGENCY TELEPHONE NUMBER
1800 033 111
24 hour Emergency Service Australia Wide, Toll Free

CONTACT POINT (FOR NON-EMERGENCY CALLS)
Animal Health Division
(02) 9391 6000
Full Product Name
AMBEX FIVE BROAD SPECTRUM WORMER FOR DOGS
AND CATS
Other Names
N/A

Product Use
FOR ANIMAL TREATMENT ONLY
For the control of roundworms, hookworms and tapeworms
(excluding _Hydatids_) in dogs and cats.

Creation Date
21
st
March 2011

Revision Date
2 October 2013

SECTION 2 – HAZARDS IDENTIFICATION
Hazard Classification
CLASSIFIED AS A HAZARDOUS SUBSTANCE
NOT CLASSIFIED AS DANGEROUS GOODS when transported by
road or rail within Australia under Special Provision AU01
of the
Australian Dangerous Goods Code, 7th Edition.
CLASSIFIED AS DANGEROUS GOODS when transported by sea
or air.
Poison Schedule S5
Risk Phrases
R21 Harmful in contact with skin.
R50/53 Very toxic to aquatic organisms, may cause long term
adverse effects in the aquatic environment.
Safety Phrases
S(2) Keep out of the reach of children.
S36/37 Wear suitable protective clothing and gloves.
S60 This material and its container must be disposed
of as hazardous
waste.
S61 Avoid release to the environment. Refer to
special instructions/
Safety Data Sheet.

A18243/03/AUS  AMBEX FIVE BROAD SPECTRUM WORMER FOR
DOGS AND CATS
Page 2 of 6

SECTION 3 – COMPOSITION
INGREDIENTS
CAS NO
PROPORTION
Niclosamide

50-65-7
500mg/tablet
Levamisole Hydrochloride
16595-80-5
21mg/tablet
This is a commercial produc

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