FLUSAPEX TABLETS DIURETIC

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:

FUROSEMIDE

Available from:

DECHRA VETERINARY PRODUCTS (AUSTRALIA) PTY. LTD.

INN (International Name):

furosemide(40mg/Tb)

Pharmaceutical form:

ORAL TABLET

Composition:

FUROSEMIDE SULFANYL Active 40.0 mg/Tb

Units in package:

100 Tabs; 1000 Tabs

Class:

VM - Veterinary Medicine

Manufactured by:

APEX LABORATORIES

Therapeutic group:

Therapeutic area:

GENITOURINARY SYSTEM

Therapeutic indications:

Product summary:

Poison schedule: 4; Withholding period: WITHHOLDING PERIOD: MEAT: Zero (0) day s.; Host/pest details: CAT: [DIURETIC, ACIDIFIER OR ALKALINISER]; DOG: [DIURETIC, ACIDIFIER OR ALKALINISER]; HORSE: [DIURETIC, ACIDIFIER OR ALKALINISER]; As an aid in the treatment of oedema in cats, dogs and horses.This product is contraindicated for use in animals with impaired renal or hepatic function.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

For Official Use Only
E-LABEL APPLICATION (DRAFT)
COMPANY NAME:
APEX LABORATORIES PTY LTD
PRODUCT NAME:
FLUSAPEX TABLETS DIURETIC
ELABEL APPLICATION NO:
DC13-77897897E50
APVMA APPROVAL NO:
35638/100553
PRODUCT NO:
35638
VERSION NO:
8.0
APPLICATION STARTED:
2014-Sep-26 15:37:42
VERSION CREATED:
2014-Nov-19 10:37:12
STARTED BY:
Rebecca Skinner
PRINTED:
2014-Nov-19 10:40:12
LABEL NAME:
FLUSAPEX TABLETS DIURETIC
SIGNAL HEADINGS:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
CONSTITUENT
STATEMENTS:
Each tablet contains: 40 mg FRUSEMIDE
CLAIMS:
As an aid in the treatment of oedema in cats, dogs, horses and cattle.
NET CONTENTS:
100 Tabs
1000 Tabs
DIRECTIONS FOR USE:
CONTRAINDICATIONS:
This product is contraindicated for use in animals with impaired renal
or hepatic function.
PRECAUTIONS:
Electrolyte balance should be monitored if animals are on prolonged
medication.
DOSAGE AND
ADMINISTRATION:
Give orally in divided doses.
Dog & Cat: 2-5 mg/kg bodyweight daily.
Horses & Cattle: 5mg/kg bodyweight daily or as directed by the
veterinary surgeon.
WITHHOLIDNG
PERIODS:
MEAT WITHHOLDING PERIOD: Zero (0) days.
FIRST AID
INSTRUCTIONS:
If poisoning occurs contact a doctor or Poisons Information Centre.
Phone Australia 131
126. RLP APPROVED
DCNV-96572296E33
35638/101531
dogs and horses.
Give orally in divided doses.
Dog & Cat: 2-5 mg/kg bodyweight daily.
Horses: 5mg/kg bodyweight daily or as directed by the veterinary
surgeon
For Official Use Only
FIRST AID WARNINGS:
DISPOSAL:
Dispose of empty container by wrapping with paper and putting in
garbage.
STORAGE:
Store below 25°C (air conditioning)
Protect from light.
NAME AND ADDRESS:
Apex Laboratories Pty Ltd
61 Chivers Road, Somersby
NSW 2250 Australia.
(02) 4372 1661

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Summary of Product characteristics

Flusapex Tablets
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Material Safety Data Sheet
Reviewed March 2014
Apex Laboratories Pty Ltd MATERIAL SAFETY DATA SHEET
FLUSAPEX TABLETS
NOT CLASSIFIED AS HAZARDOUS ACCORDING TO THE CRITERIA OF NOHSC
SECTION I
IDENTIFICATION OF THE MATERIAL AND SUPPLIER
Product Name
Flusapex Tablets Diuretic
Recommended Use
Diuretic used to treat oedema such as that associated with
congestive heart failure, surgery and trauma.
Supplier details
Apex Laboratories Pty Ltd
ACN 000 397 240
61 Chivers Road
Somersby NSW 2250
+61 2 4372 1661 (Business hours – 8.30am – 5.30pm)
+61 2 4372 1668 (fax)
www.apexlabs.com.au
Emergency contact
As above or Poisons Information Centre 131126 (Australia)
SECTION II
HAZARD IDENTIFICATION
Classification
Not classified as hazardous according to the criteria of NOHSC
Risk Phrases
None allocated
Safety Phrases
None allocated
ADG Class
None allocated
Hazchem Code
None allocated
Poisons Schedule
S4
SECTION III
COMPOSITION
Ingredients
CAS No
Proportion
TWA
mg/m
3
STEL
mg/m
3
Frusemide
54-31-9
10-<30%
not set
not set
Other non hazardous ingredients
to 100%
The TWA exposure value is the average airborne concentration of a
particular substance when calculated over a
normal 8 hour working day for a 5 day working week over an entire
working lifetime. The TWA exposure standard
set by Worksafe Australia for dusts not otherwise specified is 10mg/m
3
. The STEL (Short Term Exposure Limit) is an
exposure value that should not be exceeded for more than 15 minutes
and should not be repeated for more than 4
times per day. There should be at least 60 minutes between successive
exposures at the STEL.
Flusapex Tablets
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