Proin 15 mg chewable tablets for dogs

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Phenylpropanolamine hydrochloride

Prieinama:

Cyton Biosciences Ltd

ATC kodas:

QG04BX91

INN (Tarptautinis Pavadinimas):

Phenylpropanolamine hydrochloride

Dozė:

15 mg/tablet

Vaisto forma:

Tablet

Recepto tipas:

POM: Prescription Only Medicine as defined in relevant national legislation

Farmakoterapinė grupė:

Dogs

Gydymo sritis:

phenylpropanolamin

Terapinės indikacijos:

Hormone

Autorizacija statusas:

Authorised

Leidimo data:

2018-03-23

Prekės savybės

Health Products Regulatory Authority
12 April 2018
CRN000TRT
Page 1 of 6
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Proin 15 mg chewable tablets for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
Phenylpropanolamine Hydrochloride 15 mg
(as phenylpropanolamine) 12.1 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 15 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.
Health Products Regulatory Authority
12 April 2018
CRN000TRT
Page 2 of 6
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.
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 use of
the produ