Propalin Syrup 40 mg/ml Dogs

Negara: Inggris

Bahasa: Inggris

Sumber: VMD (Veterinary Medicines Directorate)

Bahan aktif:

Phenylpropanolamine

Tersedia dari:

Vetoquinol UK Ltd

Kode ATC:

QG04BX91

INN (Nama Internasional):

Phenylpropanolamine

Bentuk farmasi:

Syrup

Jenis Resep:

POM-V - Prescription Only Medicine – Veterinarian

Kelompok Terapi:

Dogs

Area terapi:

Neurological Agent

Status otorisasi:

Authorized

Tanggal Otorisasi:

1993-01-27

Karakteristik produk

Revised: September 2021
AN: 00517/2021 & 00518/2021
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
PROPALIN Syrup, 40 mg/ml Dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Phenylpropanolamine
40.28 mg
(Equivalent to 50 mg phenylpropanolamine hydrochloride)
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Syrup.
Colourless to slightly yellow-brown solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of urinary incontinence associated with urethral sphincter
incompetence in
the bitch.
Efficacy has only been demonstrated in ovariohysterectomised bitches.
4.3
CONTRAINDICATIONS
The use of Propalin is not appropriate for the treatment of
behavioural causes of
inappropriate urination. Do not administer to patients treated with
non-selective
monoamine oxidase inhibitors.
Do not use in case of known hypersensitivity to active substance or to
any of the
excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Revised: September 2021
AN: 00517/2021 & 00518/2021
Page 2 of 5
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Phenylpropanolamine,
a
sympathomimetic
drug,
may
affect
the
cardiovascular
system, especially blood pressure and heart rate, and should be used
with caution in
animals with cardiovascular diseases.
Care
should
be
exercised
in
treating
animals
with
severe
renal
or
hepatic
insufficiency, diabetes mellitus, hyperadrenocorticism, glaucoma,
hyperthyroidism or
other metabolic disorders.
In bitches less than 1 year old the possibility of anatomical
disorders contributing to
incontinence should be considered prior to treatment.
Special precautions to be taken by the person administering the
veterinary medicinal
product to animals
Phenylpropanolamine Hydrochloride is toxic when overdoses are
ingested. Adverse
effects may include dizziness, headache, nausea, insomnia or
restlessness, and
increased blood p