产品特点
Revised: June 2013
AN: 01432/2012
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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Libromide 325 mg Tablets for Dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Potassium bromide
325 mg
For 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 equal 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
i
Special precautions for use in animals
Do not abruptly discontinue therapy as this may precipitate
seizures.
In cases of renal insufficiency, in order to prevent bromide
accumulation (see section 5.2), administer a reduced dose of
Libromide and monitor the dog closely.
A reduction in chloride intake could cause bromide intoxication
(see section 4.8).
Revised: June 2013
AN: 01432/2012
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Administration on an empty stomach may induce vomiting.
Dogs weighing l
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