Urilin 40 mg/ml syrup for dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Phenylpropanolamine hydrochloride

Available from:

Dechra Regulatory B.V.

ATC code:

QG04BX91

INN (International Name):

Phenylpropanolamine hydrochloride

Dosage:

40 milligram(s)/millilitre

Pharmaceutical form:

Syrup

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

phenylpropanolamin

Authorization status:

Authorised

Authorization date:

2010-09-03

Summary of Product characteristics

Health Products Regulatory Authority
07 January 2019
CRN008S6X
Page 1 of 5
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.
Health Products Regulatory Authority
07 January 2019
CRN008S6X
Page 2 of 5
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
It is not appropriate to use the product for the behavioural cause of
inappropriate
urination.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Because phenylpropanolamine is a sympathomimetic agent, it may affect
the
cardiovascular system, especially blood pressure and heart rate, and
therefore 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 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 for the person administering the veterinary
medicinal product to
animals
·People with known hypersensiti