Country: Portugal
Language: English
Source: HMA (Heads of Medicines Agencies)
phenylpropanolamine hydrochloride 50 mg/ml
Dechra Limited
QG04BX91
Syrup
Phenylpropanolamin
Dogs
2010-04-28
Revised 27/08/2010 – AN 00637/2009 Page 1 of 5 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Urilin 40 mg/ml Syrup for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 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 (E217) 0.15 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Syrup Clear viscous solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES_ _ Dogs 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. Revised 27/08/2010 – AN 00637/2009 Page 2 of 5 4.5 SPECIAL PRECAUTIONS FOR USE (I) 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 Read the complete document