Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
Phenylpropanolamine hydrochloride
Alfasan Nederland B.V
QG04BX91
Phenylpropanolamine hydrochloride
Oral solution
POM: Prescription Only Medicine as defined in relevant national legislation
phenylpropanolamin
2023-07-07
[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 Olvassa el a teljes dokumentumot