FLUSAPEX DROPS DIURETIC FOR DOGS & CATS
Country: Australia
Language: English
Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)
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(10mg/mL)
Pharmaceutical form:
ORAL SOLUTION/SUSPENSION
Composition:
FUROSEMIDE SULFANYL Active 10.0 mg/ml
Units in package:
100 mL; 25mL
Class:
VM - Veterinary Medicine
Manufactured by:
APEX LABORATORIES
Therapeutic group:
CAT | DOG | BITCH | CASTRATE | CAT - QUEEN | CAT - TOM | KITTEN | PUPPY
Therapeutic area:
GENITOURINARY SYSTEM
Therapeutic indications:
OEDEMA | PHYSIOLOGICAL OF THE MAMMARY G
Product summary:
Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: CAT: [OEDEMA]; DOG: [OEDEMA]; As an aid in the treatment of oedema in dogs and cats.This product is contraindicated for use in animals with impaired renal or hepatic function. Electrolyte balance should be monitored if animals are on prolonged medication.
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 DROPS DIURETIC FOR DOGS & CATS
ELABEL APPLICATION NO:
DC13-4444111E47
APVMA APPROVAL NO:
35636/100561
PRODUCT NO:
35636
VERSION NO:
6.0
APPLICATION STARTED:
2014-Sep-26 15:16:05
VERSION CREATED:
2014-Nov-18 16:23:05
STARTED BY:
Rebecca Skinner
PRINTED:
2014-Nov-18 16:30:54
LABEL NAME:
FLUSAPEX DROPS DIURETIC FOR DOGS & CATS
SIGNAL HEADINGS:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
CONSTITUENT
STATEMENTS:
10 mg/ml FRUSEMIDE
CLAIMS:
As an aid in the treatment of oedema in dogs and cats.
NET CONTENTS:
25mL
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.
Cats 0.1mL-0.2mL/kg bodyweight daily
Dogs 0.2mL-0.4mL/kg bodyweight daily
FIRST AID
INSTRUCTIONS:
If poisoning occurs, contact a doctor or Poisons Information Centre.
Phone Australia 131
126.
FIRST AID WARNINGS:
DISPOSAL:
Dispose of empty container by wrapping with paper and putting in
garbage. RLP APPROVED
For Official Use Only
STORAGE:
Store below 30ºC (room temperature)
Protect from light.
NAME AND ADDRESS:
Apex Laboratories Pty Ltd
61 Chivers Rd Somersby NSW 2250 Australia
(02) 4372 1661
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Summary of Product characteristics
MATERIAL SAFETY DATA SHEET
FLUSAPEX DROPS DIURETIC FOR DOGS AND CATS
NOT CLASSIFIED AS HAZARDOUS ACCORDING TO THE CRITERIA OF NOHSC
Product Name
Flusapex Drops Diuretic for Dogs and Cats
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 Number
000 397 240
Street
61 Chivers Road
Suburb
Somersby
State
NSW
Country
Australia
Post Code
2250
Phone
+61 2 4372 1661 (Business hours – 8.30am – 5.00pm)
Fax
+61 2 4372 1668 (fax)
Website
http://www.apexlabs.com.au
Emergency contact
As above or Poisons Information Centre 131126 (Australia)
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
INGREDIENTS
CAS NO
PROPORTION
TWA MG/M3
STEL MG/M3
Frusemide
54-31-9
<10%
not set
not set
Diethanolamine
111-42-2
<10%
not set
not set
Sodium Hydroxide
1310-73-2
<10%
2
not set
Other non hazardous ingredients
NA
to 100%
NA
NA
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/m3. 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.
Ingestion
If swallowed rinse mouth out with water, give water to drink, DO NOT
induce vomiting and seek medical advice.
Eye
Irrigate with copious quantities of lukewarm water for 10 minutes and
seek
medical advice.
Skin
Wash well with soap and water and if concerned seek medical advice.
Inhalation
Generally not required. If concerned move to fresh air and seek
medical
advice.
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