Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
Phenylpropanolamine hydrochloride
FATRO S.p.A.
QG04BX91
Phenylpropanolamine hydrochloride
40 milligram(s)/millilitre
Syrup
POM: Prescription Only Medicine as defined in relevant national legislation
phenylpropanolamin
Authorised
2019-10-11
Health Products Regulatory Authority 02 January 2020 CRN009FZT Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT CONTINENCE 40 mg/ml syrup for dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains: ACTIVE SUBSTANCE: Phenylpropanolamine 40.28 mg equivalent to phenylpropanolamine hydrochloride 50 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Syrup. Clear colourless to pale yellow solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the management of urinary incontinence associated with urethral sphincter incompetence in the bitch, particularly that associated with ovariohysterectomy. 4.3 CONTRAINDICATIONS Do not administer to patients 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. Do not administer to pregnant or lactating bitches. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES The product should be avoided in hypertensive individuals. In bitches less than 1 year old the possibility of anatomical disorders contributing to incontinence should be considered prior to treatment. The use of the product is not appropriate for the treatment of behavioural causes of inappropriate urination. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Phenylpropanolamine, a sympathomimetic drug, may affect the cardiovascular system, especially blood pressure and heart rate, and 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, hyperthyroidism or other metabolic disorders. Special precautions to be taken by the person administering the veterinary medicinal product to animals Phenylpropanolamine hydrochloride is toxic when overdoses are Perskaitykite visą dokumentą