Enurace 50
Country: Spain
Language: English
Source: HMA (Heads of Medicines Agencies)
Patient Information leaflet
(PIL)
24-01-2013
Summary of Product characteristics
(SPC)
24-01-2013
Active ingredient:
ephedrine hydrochloride 50 mg
Available from:
Ecuphar N.V.
ATC code:
QG04BX90
Pharmaceutical form:
Tablet
Therapeutic group:
ephedrine
Therapeutic area:
Dogs
Authorization date:
2011-10-11
Patient Information leaflet
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
UK, NL, IT, BE, DE, ES:
ENURACE 50, 50 mg tablets for dogs
FR:
ENURACE grand chien
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
40.7 mg Ephedrine equivalent to 50 mg Ephedrine Hydrochloride.
EXCIPIENTS:
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets.
Round, white tablet with break line on one side and inscription ENURACE 50 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
Do not use the product in dogs under 20 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 comprehensive risk/benefit analysis by the
attending veterinarian.
_The dog’s cardiovascular functionality should be carefully assessed before the start of the treatment _
_with the product and it should be periodically monitored during the treatm
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
UK, NL, IT, BE, DE, ES:
ENURACE 50, 50 mg tablets for dogs
FR:
ENURACE grand chien
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
40.7 mg Ephedrine equivalent to 50 mg Ephedrine Hydrochloride.
EXCIPIENTS:
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets.
Round, white tablet with break line on one side and inscription ENURACE 50 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
Do not use the product in dogs under 20 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 comprehensive risk/benefit analysis by the
attending veterinarian.
_The dog’s cardiovascular functionality should be carefully assessed before the start of the treatment _
_with the product and it should be periodically monitored during the treatm
Read the complete document
