البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
Phenylpropanolamine
Dechra Ltd
QG04BX91
Phenylpropanolamine
40 milligram(s)/millilitre
Syrup
POM: Prescription Only Medicine as defined in relevant national legislation
Dogs
phenylpropanolamin
Hormone
Authorised
2010-09-03
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. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _1_ _4_ _/_ _0_ _9_ _/_ _2_ _0_ _1_ _5_ _C_ _R_ _N_ _ _ _7_ _0_ _2_ _1_ _6_ _1_ _2_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Because phenylpropanolamine is a sympathomimetic agent, it may affect the card اقرأ الوثيقة كاملة