AMBEX TWO 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 BASE); NICLOSAMIDE

Available from:

ELANCO AUSTRALASIA PTY LTD

INN (International Name):

niclosamide(200mg/Tb)+levamisole as HCl(8.5mg/Tb)

Pharmaceutical form:

ORAL TABLET

Composition:

LEVAMISOLE (AS LEVAMISOLE BASE) ANTHELMINTIC Active 8.5 mg/Tb; NICLOSAMIDE ANTHELMINTIC Active 200.0 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 Roundworms, Hookworms 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

_NRA Approved Text Label_
_AMBEX TWO BROAD SPECTRUM WORMER FOR DOGS & CATS_
_LAST EDITED 05-02-01 9:54 PAGE 1 of 2_
CAUTION
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
AMBEX TWO
BROAD SPECTRUM WORMER FOR DOGS & CATS
ACTIVE CONSTITUENTS Each Tablet Contains:
NICLOSAMIDE 200mg & LEVAMISOLE BASE 8.5mg (AS LEVAMISOLE
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 2kg 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 ½ tablet per 2kg in
the morning and
repeating this 8-12 hours later. DO NOT OVERDOSE.
TREATMENT REGIMES
Roundworms & Hookworms (dogs)
Treat at 2, 4, 8 and 12 weeks of age, and
thereafter every 12 weeks.
Roundworms & Hookworms (cats)
Treat at 6, 8 and 12 weeks of age, and
thereafter every 12 weeks
Tapeworms (excluding hydatids)(cats and dogs) Treat every 12 weeks.
Adequate flea control
should be maintained year-round.
Pregnant cats and dogs
Treat at mating, before birth of
kittens/puppies, then every 12 weeks.
If worm 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.
Info
PEST
✔
Verified
_NRA Approved Text Label_
_AMBEX TWO BROAD SPECTRUM WORMER FOR DOGS & CATS_
_LAST EDITED 05-02-01 9:54 PAGE 2 of 2_
Registered to Bomac Laboratories Limited
Distributed by:
Pharm Tech Pty Limited ACN 084 248 206
8 Apollo Avenue
West Pymble NSW 2073 Australia
Orders & Product Information Call 0500 886 668
DISPOSAL:
Dispose of empty container by wrapping with paper and placing in
garbage.
STORAGE:
Below 30
o
C (R

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Summary of Product characteristics

Page 1 of 6

SAFETY DATA SHEET

A18245/02/AUS


AMBEX TWO 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 TWO 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
12 July 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.

A18245/01/AUS  AMBEX TWO BROAD SPECTRUM WORMER FOR DOGS AND
CATS
Page 2 of 6

SECTION 3 – COMPOSITION
INGREDIENTS
CAS NO
PROPORTION
Niclosamide

50-65-7
200mg/tablet
Levamisole Hydrochloride
16595-80-5
8.5mg/tablet
This is a commercial product whos

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