Libromide 325 mg tablets for dogs

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Potassium bromide

Verfügbar ab:

Dechra Regulatory B.V.

ATC-Code:

QN05CM11

INN (Internationale Bezeichnung):

Potassium bromide

Dosierung:

325 mg/tablet

Darreichungsform:

Tablet

Verschreibungstyp:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapiebereich:

bromides

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2011-11-18

Fachinformation

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.
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 medicinal product to
animals
Do not handle this product if you are pregnant, think you are pregnant
or if you are breast feeding.
Do not handle this product if you