Proin 50 mg Chewable Tablets for Dogs

Nazione: Regno Unito

Lingua: inglese

Fonte: VMD (Veterinary Medicines Directorate)

Principio attivo:

Phenylpropanolamine Hydrochloride

Commercializzato da:

Pegasus Laboratories UK Limited

Codice ATC:

QG04BX91

INN (Nome Internazionale):

Phenylpropanolamine Hydrochloride

Forma farmaceutica:

Chewable tablet

Tipo di ricetta:

POM-V - Prescription Only Medicine – Veterinarian

Gruppo terapeutico:

Dogs

Area terapeutica:

Neurological Agent

Stato dell'autorizzazione:

Authorized

Data dell'autorizzazione:

2018-03-26

Scheda tecnica

Unlimited Renewal: August 2022
AN: 01131/2022
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
PROIN 50 mg chewable tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
Phenylpropanolamine Hydrochloride 50 mg
(as phenylpropanolamine)
40.3 mg
EXCIPIENTS:
Dark Brown lake LB506
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Chewable tablet
Liver-flavoured, brown coloured, round, biconvex, un-coated tablets,
with a break-line
on one side and embossed with “PROIN 50” on the other side.
The tablets can be divided into halves.
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 use in hypertensive animals or in animals that become
hypertensive after
initiating therapy.
Do not administer to patients treated with non-selective monoamine
oxidase
inhibitors.
Do not use in case of known hypersensitivity to active substance or to
any of the
excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
In bitches less than 1 year old the possibility of anatomical
disorders contributing to
incontinence should be considered prior to treatment.
Do not use the product for the treatment of behavioural causes of
inappropriate
urination.
Unlimited Renewal: August 2022
AN: 01131/2022
Page 2 of 5
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.
Phenylpropanolamine has been shown to increase mean arterial blood
pressure
resulting in hypertension over time. Animals administered the product
should
therefore be monitored for signs of hypertension, particularly with
prolonged u