País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
Potassium bromide
Regivet BV
QN03AX91
Potassium bromide
600 milligram(s)
Tablet
POM: Prescription Only Medicine as defined in relevant national legislation
potassium bromide
Authorised
2021-01-22
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 Llegiu el document complet