Vetbromide 600 mg tablets for dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Potassium bromide

Available from:

Regivet BV

ATC code:

QN03AX91

INN (International Name):

Potassium bromide

Dosage:

600 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

potassium bromide

Authorization status:

Authorised

Authorization date:

2021-01-22

Summary of Product characteristics

Health Products Regulatory Authority
22 January 2021
CRN009HJY
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Vetbromide 600 mg tablets for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
600 mg potassium bromide
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White round tablet with 2 score-lines on each side.
Tablets can be divided into 2 or 4 equal parts.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
An antiepileptic agent for use in the control of idiopathic epileptic
seizures, either as a single agent or as an adjunct to
phenobarbital in the control of refractory cases of idiopathic
epilepsy.
4.3 CONTRAINDICATIONS
Do not use in known cases of hypersensitivity to the active substance,
or to any of the excipients.
Do not use in dogs with severe renal insufficiency.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
The concentration of bromide in serum, the clinical response and the
therapeutic effect of administration of the product may
vary between individuals (see section 4.9). The presence of cluster
seizures/status epilepticus, due to the severity of the seizure
activity, is often associated with poor response to anti-epileptic
treatment. In these cases, remission (seizure freedom) may be
difficult to achieve.
For dogs with normal hepatic function, phenobarbital is generally
considered the first-choice antiepileptic drug. However,
potassium bromide can be recommended as alternative, especially in
dogs with hepatic dysfunction or in dogs with concurrent
disorders requiring life-long administration of potentially
hepatotoxic medications, since potassium bromide is not
metabolised in the liver (see section 5.2).
A high chloride intake can increase the elimination of bromide (see
section 4.8). An increase in the dog's salt intake may
require an adjustment in bromide dose. The salt content of a dog's
diet during the treatment period should be mainta