URILIN 40 MG/ML SYRUP FOR DOGS

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Compra

Scarica Scheda tecnica (SPC)
29-09-2015

Principio attivo:

PHENYLPROPANOLAMINE

Commercializzato da:

Dechra Limited

Codice ATC:

QG04BX91

INN (Nome Internazionale):

PHENYLPROPANOLAMINE

Dosaggio:

40 Mg/Ml

Forma farmaceutica:

Syrup

Tipo di ricetta:

POM

Gruppo terapeutico:

Canine

Area terapeutica:

Phenylpropanolamin

Indicazioni terapeutiche:

Hormone

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2010-09-03

Scheda tecnica

                                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.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 14/09/2015_
_CRN 7021612_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Because phenylpropanolamine is a sympathomimetic agent, it may affect the cardiovascular system, especially blood
pressure and heart rate, and therefore 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 or other metabolic disorders.
In bitches
                                
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