Libromide 325 mg tablets for dogs

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Potassium bromide

Tilgængelig fra:

Dechra Ltd

ATC-kode:

QN05CM11

INN (International Name):

Potassium bromide

Dosering:

325 mg/tablet

Lægemiddelform:

Tablet

Recept type:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutisk gruppe:

Dogs

Terapeutisk område:

bromides

Terapeutiske indikationer:

Neurological Preparations

Autorisation status:

Authorised

Autorisation dato:

2011-11-18

Produktets egenskaber

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.
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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