Proin 50 mg chewable tablets for dogs

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Phenylpropanolamine hydrochloride

Tilgængelig fra:

Pegasus Laboratories Ireland Limited

ATC-kode:

QG04BX91

INN (International Name):

Phenylpropanolamine hydrochloride

Dosering:

50 mg/tablet

Lægemiddelform:

Chewable tablet

Recept type:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutisk område:

phenylpropanolamin

Autorisation status:

Authorised

Autorisation dato:

2018-03-23

Produktets egenskaber

Health Products Regulatory Authority
05 April 2019
CRN008ZJX
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
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Each tablet contains:
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​
​
​
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ACTIVE SUBSTANCE:
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Phenylpropanolamine Hydrochloride
​50
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mg
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(as phenylpropanolamine)
​40.3
​
mg
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​
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EXCIPIENTS:
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Dark Brown lake LB506
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For the full list of excipients, see section 6.1.
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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.
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.
Health Products Regulatory Authority
05 April 2019
CRN008ZJX
Page 2 of 5
Phenylpropanolamine has been shown to increase mean arterial blood
pressure resulting in hyperte