Urilin 40 mg/ml syrup for dogs

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

Compra'l ara

Fitxa tècnica Fitxa tècnica (SPC)
12-06-2017

ingredients actius:

Phenylpropanolamine

Disponible des:

Dechra Ltd

Codi ATC:

QG04BX91

Designació comuna internacional (DCI):

Phenylpropanolamine

Dosis:

40 milligram(s)/millilitre

formulario farmacéutico:

Syrup

tipo de receta:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupo terapéutico:

Dogs

Área terapéutica:

phenylpropanolamin

indicaciones terapéuticas:

Hormone

Estat d'Autorització:

Authorised

Data d'autorització:

2010-09-03

Fitxa tècnica

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Urilin 40 mg/ml syrup for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
Active substance:
Phenylpropanolamine
40.29 mg
(equivalent to 50.0 mg phenylpropanolamine hydrochloride)
Excipients:
Sodium methyl parahydroxybenzoate (E219)
1.5 mg
Sodium propyl parahydroxybenzoate
0.15 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Syrup.
Clear viscous solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs (bitches).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of urinary incontinence associated with acquired
urethral sphincter incompetence in the bitch only.
The efficacy of phenylpropanolamine has only been demonstrated in
ovariohysterectomised bitches.
4.3 CONTRAINDICATIONS
Please see section 4.7.
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.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
It is not appropriate to use the product for the behavioural cause of
inappropriate urination.
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4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Because phenylpropanolamine is a sympathomimetic agent, it may affect
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