Country: France
Language: English
Source: HMA (Heads of Medicines Agencies)
ephedrine hydrochloride 10 mg
Ecuphar N.V.
QG04BX90
Tablet
ephedrine
Dogs
2012-02-22
1 SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET 2 SUMMARY OF PRODUCT CHARACTERISTICS 3 1. NAME OF THE VETERINARY MEDICINAL PRODUCT UK, NL, IT, BE, DE, ES: ENURACE 10, 10 mg tablets for dogs FR: ENURACE petit chien, comprimé 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCE: 8.1 mg Ephedrine equivalent to 10 mg Ephedrine Hydrochloride. EXCIPIENTS: Ponceau 4R (E124) 0.08 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets. Round, pink tablet with break line on one side and inscription ENURACE 10 on the other side. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Ovariohysterectomised female dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of urinary incontinence caused by urethral sphincter mechanism incompetence in ovariohysterectomised female dogs. 4.3 CONTRAINDICATIONS Do not use in dogs with glaucoma. Do not use in case of hypersensitivity to Ephedrine or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES This product is not suitable for treatment of inappropriate urination resulting of behaviour problems. 4.5 SPECIAL PRECAUTIONS FOR USE I. SPECIAL PRECAUTIONS FOR USE IN ANIMALS The safety and the efficacy of the product has not been assessed in dogs under 5 kg. Do not use the product in dogs under 5 kilogram of bodyweight. As ephedrine is an alpha and beta adrenergic receptor agonist, the product should be used with caution in dogs with cardiovascular disease and only after a Read the complete document
1 SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET 2 SUMMARY OF PRODUCT CHARACTERISTICS 3 1. NAME OF THE VETERINARY MEDICINAL PRODUCT UK, NL, IT, BE, DE, ES: ENURACE 10, 10 mg tablets for dogs FR: ENURACE petit chien, comprimé 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCE: 8.1 mg Ephedrine equivalent to 10 mg Ephedrine Hydrochloride. EXCIPIENTS: Ponceau 4R (E124) 0.08 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets. Round, pink tablet with break line on one side and inscription ENURACE 10 on the other side. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Ovariohysterectomised female dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of urinary incontinence caused by urethral sphincter mechanism incompetence in ovariohysterectomised female dogs. 4.3 CONTRAINDICATIONS Do not use in dogs with glaucoma. Do not use in case of hypersensitivity to Ephedrine or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES This product is not suitable for treatment of inappropriate urination resulting of behaviour problems. 4.5 SPECIAL PRECAUTIONS FOR USE I. SPECIAL PRECAUTIONS FOR USE IN ANIMALS The safety and the efficacy of the product has not been assessed in dogs under 5 kg. Do not use the product in dogs under 5 kilogram of bodyweight. As ephedrine is an alpha and beta adrenergic receptor agonist, the product should be used with caution in dogs with cardiovascular disease and only after a Read the complete document