CLOSAMAX CLOSANTEL SUSTAINED ACTION ORAL ANTHELMINTIC AND FLUKICIDE FOR SHEEP AND LAMBS

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Patient Information leaflet (PIL)

20-06-2017

Summary of Product characteristics (SPC)

01-07-2013

Active ingredient:

CLOSANTEL

Available from:

ELANCO AUSTRALASIA PTY LTD

INN (International Name):

closantel(37.5g/L)

Pharmaceutical form:

ORAL SOLUTION/SUSPENSION

Composition:

CLOSANTEL ANTHELMINTIC Active 37.5 g/L

Units in package:

1L; 20L; 5L

Class:

VM - Veterinary Medicine

Manufactured by:

BAYER AUSTRALIA

Therapeutic group:

Therapeutic area:

PARASITICIDES

Therapeutic indications:

Product summary:

Poison schedule: 6; Withholding period: WITHHOLDING PERIODS: MEAT: DO NOT USE less than twenty-eight (28) days before slaughter for human consumption. MILK : DO NOT USE in Ewes which are producin g or may in the future produce milk tha t may be used or processed for human co nsumption. TRADE ADVICE: EXPORT SLAUGH TER INTERVAL (ESI): DO NOT USE less tha n 60 days before slaughter for export.; Host/pest details: LAMB: [BARBER'S POLE WORM-HAEMONCHUS CONTORTUS, INTERNAL PARASITE, LIVER FLUKE, NASAL BOT]; SHEEP: [BARBER'S POLE WORM-HAEMONCHUS CONTORTUS, INTERNAL PARASITE, LIVER FLUKE, NASAL BOT]; Poison schedule: 6; Withholding period: ; Host/pest details: LAMB: [BARBER'S POLE WORM-HAEMONCHUS CONTORTUS, INTERNAL PARASITE, LIVER FLUKE, NASAL BOT]; SHEEP: [BARBER'S POLE WORM-HAEMONCHUS CONTORTUS, INTERNAL PARASITE, LIVER FLUKE, NASAL BOT]; For the sustained control of barbers pole worm and control of liver fluke and nasal bots in sheep and lambs.DO NOT use in ewes which are producing or may in the future produce milk that may be used for human consumption.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

POISON
KEEP OUT OF REACH OF CHILDREN
READ SAFETY DIRECTIONS
FOR ANIMAL TREATMENT ONLY
RLP
Approved
CLOSAMAX™
CLOSANTEL SUSTAINED ACTION ORAL
ANTHELMINTIC AND FLUKICIDE FOR
SHEEP AND LAMBS
Active Constituent: 37.5g/L CLOSANTEL
FOR THE SUSTAINED CONTROL OF BARBER'S POLE WORM AND
CONTROL OF LIVER FLUKE AND NASAL BOTS IN SHEEP AND LAMBS
IL,
SL,
20L
CLOSAMAXTM CLOSANTEL SUSTAINED ACTION ORAL
ANTHELMINTIC AND FLUKICIDE FOR
SHEEP
AND LAMBS
contains
Closantel (37.5g/L), a member
of
the salicylanilide and substituted phenol family
of
drenches.
It
is effective against internal parasites sensitive to this family
including the
following parasites.
_Haemonchus contortus _
Barber's Pole Worm
_Fasciola hepatica _
Liver Fluke
_Oestrus avis _
Nasal Bots
CLOSAMAX™ provides sustained protection against the reinfestation
of
both mature
and immature stages
of
Barber's Pole Worm in sheep for 4 weeks after dosing.
CLOSAMAX™ also controls both mature and immature stages
of
Liver Fluke
as
well
as all stages
ofNasal
Bots.
Infopest
Verified
DIRECTIONS
FOR
USE:
RESTRAINTS
DO NOT USE in Ewes which are producing
or
may in the
future
produce milk
that
may be used
or
processed for
human
consumption.
DOSAGE AND ADMINISTRATION:
Shake container well before using this product.
CLOSAMAX™ can be administered orally through standard accurate
drenching
equipment. Clean equipment thoroughly before and after use.
DOSE RATES:
Use
lmL
ofCLOSAMAX™/5kg bodyweight.
Dose sheep orally to the heaviest animal
by
liveweight in each group (ewes, rams and
lambs) and these should be weighed with scales or weighband. Do not
overdose.
Where there is a large variation in size within the group, dose rate
should be based on
the label directions for each weight range. Drafting into two
or
more lines may be
appropriate to avoid excessive overdosing.
20L
SL
lL
Bodyweight
Dose Volume
CLOSAMAX
CLOSAMAX
CLOSAi\IAX
TM
TM
Ti\1
Treats
Treats
Treats
Under 15kg
3mL
6666
1666
333
16-25g
5.0mL
4000
1000
200
26-35kg
7.0mL
2857
714
142
36-40kg
8.0mL
2500
625
125
41-45kg
9.0mL

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Summary of Product characteristics

PAGE 1 OF 6

SAFETY DATA SHEET

A18268/02/AUS


CLOSAMAX ORAL ANTHELMINTIC AND FLUKICIDE

SECTION 1 – IDENTIFICATION, CONTACTS

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
CLOSAMAX CLOSANTEL SUSTAINED ACTION ORAL
ANTHELMINTIC AND FLUKICIDE FOR SHEEP AND
LAMBS
Other Names
Nil.

Product Use
FOR ANIMAL TREATMENT ONLY
For the sustained control of barber’s pole worm and
control of liver
fluke and nasal bots in sheep and lambs.
Creation Date
14
th
April 2011

Revision Date
12 August 2013

SECTION 2 – HAZARDS IDENTIFICATION
Hazard Classification
CLASSIFIED AS HAZARDOUS SUBSTANCE
CLASSIFIED AS A NON DANGEROUS GOOD
according to criteria of NOHSC Australia and ADG Code.
Poison Schedule 6
Risk Phrases
R36 Irritating to eyes

Safety Phrases
S25 Avoid contact with eyes

SECTION 3 – COMPOSITION
INGREDIENTS
CAS NO
PROPORTION
Closantel

61438-64-0
3.75% w/v
This is a commercial product whose
exact ratio of components may vary slightly. Other non-
hazardous ingredients are also present.

A18268/02/AUS  CLOSAMAX ORAL ANTHELMINTIC AND FLUKICIDE

PAGE 2 OF 6

SECTION 4 – FIRST AID MEASURES
Label Regulated First
Aid Statement
If poisoning occurs, contact a doctor or Poisons Information
Centre.
Phone Australia 131126.
Scheduled Poisons
Poison Schedule S6.
Poisons Information Centres in each State capital city can
provide
additional assistance for scheduled poisons. Phone 131126.
Inhalation
Move individual to fresh air. If unconsciousness occurs, seek
immediate medical
attention.�

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