Libromide 325 mg Tablets for Dogs

Pajjiż: Ingilterra

Lingwa: Ingliż

Sors: VMD (Veterinary Medicines Directorate)

Ingredjent attiv:

Potassium Bromide

Disponibbli minn:

Dechra Limited

Kodiċi ATC:

QN05CM11

INN (Isem Internazzjonali):

Potassium Bromide

Għamla farmaċewtika:

Tablet

Tip ta 'preskrizzjoni:

POM-V - Prescription Only Medicine – Veterinarian

Grupp terapewtiku:

Dogs

Żona terapewtika:

Neurological Agent antiepileptic

L-istatus ta 'awtorizzazzjoni:

Authorized

Data ta 'l-awtorizzazzjoni:

2010-02-04

Karatteristiċi tal-prodott

Revised: January 2024
AN: 02246/2023 & 02424/2023
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Libromide 325 mg tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 tablet contains:
ACTIVE SUBSTANCE:
Potassium bromide
325 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Plain white circular biconvex 9.5 mm tablet with a single scored line
on one face.
The tablets can be divided into halves.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
An anti-epileptic agent for use as an adjunct to phenobarbital in the
control of
refractory cases of epilepsy in dogs.
4.3
CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to bromide, or to any of
the
excipients.
Do not use in dogs with severe renal insufficiency.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
It is advisable not to change the dog’s diet during therapy due to
the effect of
chloride intake on serum bromide concentrations, see section 4.8.
Revised: January 2024
AN: 02246/2023 & 02424/2023
Page 2 of 6
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Do not abruptly discontinue therapy as this may precipitate seizures.
In renal insufficiency, excretion of bromide is reduced. To prevent
bromide
accumulation, and a relative overdose of potassium bromide (see
section 4.10),
administer a reduced dose of Libromide and monitor the serum bromide
concentration closely.
A reduction in chloride intake could cause bromide intoxication (see
section 4.8).
Administration on an empty stomach may induce vomiting.
Dogs weighing less than 11 kg cannot be accurately dosed with the
recommended
initial dose rate of 15 mg/kg twice daily as the minimum dose
achievable by division
of the Libromide 325 mg tablet is 162.5 mg, see section 4.9.
Potentially severe side effects can be associated with the use of
potassium bromide
in cats.
Special precautions to be taken by the person administering the
veterinary
medic