PROPALIN

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

PHENYLPROPANOLAMINE HYDROCHLORIDE

Available from:

VETOQUINOL AUSTRALIA PTY LTD

INN (International Name):

phenylpropanolamine HCl(50mg/mL)

Pharmaceutical form:

ORAL SOLUTION/SUSPENSION

Composition:

PHENYLPROPANOLAMINE HYDROCHLORIDE AMMONIUM-QUATERNARY Active 50.0 mg/ml

Units in package:

100mL; 30mL

Class:

VM - Veterinary Medicine

Therapeutic group:

DOG - FEMALE (BITCH) | BITCH | CASTRATE

Therapeutic area:

GENITOURINARY SYSTEM

Therapeutic indications:

URINARY INCONTINENCE (SPAYED BITCH) | INCONTINENCE

Product summary:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: DOG - FEMALE (BITCH): [URINARY INCONTINENCE (SPAYED BITCH)]; Poison schedule: 4; Withholding period: ; Host/pest details: DOG - FEMALE (BITCH): [URINARY INCONTINENCE (SPAYED BITCH)]; For use in bitches in the control of urinary incontinence associated with urethral sphincter incompetence.DO NOT use in pregnant bitches. DO NOT use above recommended dose. Effects on lactation have not been reported.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

Product Name:
APVMA Approval No:
PROPALIN
53680/134717
Label Name:
PROPALIN
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
50 mg/mL PHENYLPROPANOLAMINE HYDROCHLORIDE
Claims:
For use only by or under supervision of a registered veterinarian.
For use in bitches as an aid in the control of urinary incontinence
associated with urethral
sphincter incompetence.
Net Contents:
30 mL
100 mL
Directions for Use:
Restraints:
DO NOT USE in pregnant animals.
DO NOT USE in conjunction with other hypertensive drugs.
Contraindications:
Precautions:
Use with caution as the effects of Phenylpropanolamine on lactation
have not been
reported.
Side Effects:
Sympathomimetics may produce a wide range of effects, most of which
mimic the results
of excessive stimulation of sympathetic nervous system. Headache,
hypertension and
dizziness have been reported in humans.
Propalin contains sorbitol which has laxative properties. However,
such activity is unlikely at
the recommended dose. RLP APPROVED
It is probable that over dosage of Phenylpropanolamine would produce
symptoms of
excessive stimulation of the sympathetic nervous system.
Aggressiveness and restlessness have been noted in some animals
following treatment.
Lethargy and inappetence have been reported in a dog following an
overdose
(2.5 mg/kg 3 times daily).
Treatment should be symptomatic. No specific antidote is available.
Dosage and
Administration:
Use the contents within 3 months of first broaching the syringe.
Discard the unused portion.
IN BITCHES:
3 mg/kg daily in divided dose given with food i.e. 1.5 mg/kg twice
daily or 1.0 mg/kg three
times daily, e.g. for 25 kg dog give 0.75 mL twice daily or 0.5 mL
three times daily for a total
daily dose of 1.5 mL (75mg).
General Directions:
Withholding Periods:
Trade Advice:
Safety Directions:
First Aid Instructions:
If poisoning occurs, contact a doctor or Poisons Information Centre.
Phone Australia 13 11
26.
First Aid Warnings:
Additional User
Safety:
Ingesti

Summary of Product characteristics

PRODUCT NAME: PROPALIN® SYRUP
PAGE: 1 OF 5
THIS VERSION ISSUED: OCTOBER, 2015
SAFETY DATA SHEET
Issued by: Vetoquinol Australia Pty Ltd
Phone: [phone]
(BUSINESS HOURS)
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND)
SECTION 1 - IDENTIFICATION OF THE MATERIAL AND SUPPLIER
VETOQUINOL AUSTRALIA PTY LTD
PHONE: [phone] (BUSINESS HOURS)
UNIT 302/2, 6-12 BORONIA ROAD, DA VINCI BUSINESS PARK,
FAX: [phone]
BRISBANE AIRPORT, QLD 4008
CHEMICAL NATURE:
Phenylpropanolamine acts as an alpha-adrenergic receptor and
beta-adrenergic
receptor agonist as well as a dopamine receptor D1 partial agonist.
TRADE NAME:
PROPALIN® SYRUP
APVMA CODE:
53680
PRODUCT USE:
Sympathomimetic (phenylpropanolamine) in oral solution against the
urinary
incontinence associated with urethral sphincter incompetence of female
dogs.
CREATION DATE:
OCTOBER, 2015
THIS VERSION ISSUED:
OCTOBER, 2015
and is valid for 5 years from this date.
POISONS INFORMATION CENTRE: PHONE 13 1126 FROM ANYWHERE IN AUSTRALIA
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as:
Not classified as hazardous according to the criteria of SWA.
Not a Dangerous Good according to Australian Dangerous Goods (ADG)
Code, IATA or IMDG/IMSBC criteria.
RISK PHRASES:
Not Hazardous - No criteria found.
SAFETY PHRASES:
S25, S36. Avoid contact with eyes. Wear suitable protective clothing.
SUSMP CLASSIFICATION:
S4
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good according to Australian Dangerous
Goods (ADG)
Code, IATA or IMDG/IMSBC criteria.
UN NUMBER:
None allocated
GHS SIGNAL WORD: NONE. NOT HAZARDOUS.
PREVENTION
P102: Keep out of reach of children.
P262: Do not get in eyes, on skin, or on clothing.
P281: Use personal protective equipment as required.
RESPONSE
P353: Rinse skin or shower with water.
P301+P330+P331: IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
P370+P378: Not combustible. Use extinguishing media suited to burning
materials.
STORAGE
P411: Store at temperatures not

Safety Data Sheet

_P_
_ROPALIN®_
_P_
_ROPALIN®_
_P_
_HENYLPROPANOLAMINE HYDROCHLORIDE 50MG/ML_
READ THE ENCLOSED LEAFLET
BEFORE USING THIS PRODUCT
DIRECTIONS FOR USE
To be used by, or under direction of, a
registered veterinarian.
IN BITCHES:
3mg/kg
daily
in
divided
dose
given
with food i.e. 1.5mg/kg twice daily or
1.0mg/kg
three
times
daily
e.g.
for
25 kg dog give 0.75 mL twice daily or
0.5 mL three times daily for a total daily
dose of 1.5mL (75mg).
CONTRAINDICATION AND
PRECAUTIONS
Contraindicated in pregnant bitches.
Use above the recommended dose is
contraindicated.
The effects of Phenylpropanolamine on
lactation have not been reported.
HUMAN SAFETY INFORMATION
Ingestion
of
this
product
by
a
child
could
cause
harm.
Therefore,
always
ensure
the
child-resistant
closure
is
replaced securely after each administration.
Please also refer to the pack and the
leaflet.
FIRST AID:
If poisoning occurs, contact a doctor
or Poisons Information Centre. Phone
Australia 131126
_P_
_ROPALIN®_
FOR USE IN BITCHES
IN THE CONTROL OF
URINARY INCONTINEN-
CE ASSOCIATED WITH
URETHRAL SPHINCTER
INCOMPETENCE
Following
withdrawal
of
the
first
dose, the product should be used
within 3 months.
Any
unused
product
should
be
discarded.
Manufactured by:
VETOQUINOL S.A.,
MAGNY VERNOIS,
70200 Lure (France)
Distributed by:
VETOQUINOL AUSTRALIA PTY LTD
Unit 302/2, 6-12 Boronia Road,
DaVinci Business Park,
Brisbane Airport, Qld, 4008
Phone: [phone]
[e-mail]
Store below 25˚C (Air conditioning)
Dispose
of
empty
containers
by
wrapping in paper and putting in
garbage.
APVMA Approval N° 53680/100mL/0604
441500 0615 C
_PHENYLPROPANOLAMINE HYDROCHLORIDE 50MG/ML_
SIDE EFFECTS
Sympathomimetics may produce a wide
range of effects, most of which mimic
the results of excessive stimulation of the
sympathetic nervous system. Headaches,
hypertension and dizziness have been
reported in man. Sorbitol has laxative
properties but such activity is unlikely at
the recommended dosage.
It
is
probable
that
overdosage
of
Phenylpropanolamine
would
produce
sym