Uriphex 50 mg/ml oral solution for dogs

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Phenylpropanolamine hydrochloride

Disponible des:

Alfasan Nederland B.V

Codi ATC:

QG04BX91

Designació comuna internacional (DCI):

Phenylpropanolamine hydrochloride

formulario farmacéutico:

Oral solution

tipo de receta:

POM: Prescription Only Medicine as defined in relevant national legislation

Área terapéutica:

phenylpropanolamin

Data d'autorització:

2023-07-07

Fitxa tècnica

[Version 9, 11/2022]
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Uriphex 50 mg/ml, oral solution for dogs
(NL/AT/BE/BG/HR/CY/CZ//DE/EL/HU/IT/LV/LT/LU/PL/PT/RO/SK/SI/ES)
Uriphex 50 mg/ml oral solution for dogs (EE)
Uriphex Vet 50 mg/ml, oral solution for dogs (DK/NO/SE/FI/IS)
Uriphex, oral solution for dogs (FR/IE/UKNI)
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.
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.
Speci