Enurace 10
Country: United Kingdom
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 10 mg
Available from:
Ecuphar N.V.
ATC code:
QG04BX90
Pharmaceutical form:
Tablet
Therapeutic group:
ephedrine
Therapeutic area:
Dogs
Authorization date:
2012-02-22
Patient Information leaflet
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
Summary of Product characteristics
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
