Uriphex, Oral Solution for Dogs

Land: Storbritannien

Sprog: engelsk

Kilde: VMD (Veterinary Medicines Directorate)

Aktiv bestanddel:

Phenylpropanolamine Hydrochloride

Tilgængelig fra:

Alfasan Nederland B.V.

ATC-kode:

QG04BX91

INN (International Name):

Phenylpropanolamine Hydrochloride

Lægemiddelform:

Oral solution

Recept type:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutisk gruppe:

Dogs

Terapeutisk område:

Neurological Agent

Autorisation status:

Authorized

Autorisation dato:

2023-10-11

Produktets egenskaber

Issued: October 2023
AN: 03023/2021
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Uriphex, oral solution for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Phenylpropanolamine
40.28 mg
(equivalent to 50 mg phenylpropanolamine hydrochloride)
EXCIPIENTS:
QUALITATIVE COMPOSITION OF EXCIPIENTS
AND OTHER CONSTITUENTS
Sorbitol, liquid (non-crystallising)
A colourless to yellow-brownish viscous oral solution.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Dog (bitch).
3.2
INDICATION FOR USE FOR EACH TARGET SPECIES
Treatment of urinary incontinence associated with urethral sphincter
incompetence in
the bitch. Efficacy has only been demonstrated in
ovariohysterectomised bitches
3.3
CONTRAINDICATIONS
Do not use in animals treated with non-selective monoamine oxidase
inhibitors.
Do not use in cases of known hypersensitivity to the active substance
or to any of the
excipients.
3.4
SPECIAL WARNINGS
In bitches less than 1 year old,
the possibility of anatomical conditions contributing to
incontinence should be considered before treatment is initiated.
The use of the product is not appropriate for the treatment of
behavioral causes of
inappropriate urination.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species
Because phenylpropanolamine is a sympathomimetic agent, it may affect
the
cardiovascular system, especially blood pressure and heart rate, and
should
therefore be used with caution in animals with cardiovascular disease.
Issued: October 2023
AN: 03023/2021
Page 2 of 6
Administration to dogs with hyperthyroidism should be made with
caution as the risk of
arrhythmias is increased.
Caution should be exercised when treating animals with severe renal or
hepatic
insufficiency, diabetes
mellitus, hyperadrenocorticism, glaucoma or other metabolic
disorders.
Special precautions to be taken by the person administering the
veterinary medicinal
product to animals
Phenylpropanolamine hydrochloride is toxic when ingested at