Bromilep 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

L-istatus ta 'awtorizzazzjoni:

Expired

Karatteristiċi tal-prodott

Issued: April 2011
AN: 02030/2010
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Bromilep 325 mg Tablets for Dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Potassium bromide
For full list of excipients see Section 6.1
325 mg
3.
PHARMACEUTICAL FORM
Tablet.
Plain white circular biconvex tablet with a single scored line on one
face.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
This product is indicated for use as an anti-epileptic therapy adjunct
to
phenobarbital in refractory cases of epilepsy in dogs.
4.3
CONTRAINDICATIONS
None.
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 vary between individuals (see
section 4.9).
A high chloride intake can increase the elimination of bromide (see
section 4.8).
Therefore, whilst it is not necessary for dogs receiving this product
to be on a low
salt diet, an increase in the dogs salt intake may require an
adjustment in bromide
dose. The salt content of a dogs diet during the treatment period
should not be
altered drastically, and should be maintained at a stable level. It is
advisable not
to change the dog’s diet during therapy.
Page 1 of 6
Issued: April 2011
AN: 02030/2010
4.5
SPECIAL PRECAUTIONS FOR USE
i. Special precautions for use in animals
Do not abruptly discontinue therapy as this may precipitate seizures.
This product should be used with caution in dogs with renal
insufficiency
(see section 4.6 and 4.10).
A reduction in chloride intake could cause bromide intoxication (see
section 4.8 and 4.10).
ii. Special precautions for the person administering the veterinary
medicinal
product to animals.
This product can cause skin and eye-irritation. Avoid contact with the
eyes. Wash hands thoroughly _immediately _after breaking or handling
any
tablets and before touching eyes. If the product comes in to contact
with
the eyes, rinse the eyes immedi