Vetbromide 600 mg Tablets for Dogs

국가: 영국

언어: 영어

출처: VMD (Veterinary Medicines Directorate)

유효 성분:

Potassium Bromide

제공처:

Regivet BV

ATC 코드:

QN03AX91

INN (국제 이름):

Potassium Bromide

약제 형태:

Tablet

처방전 유형:

POM-V - Prescription Only Medicine – Veterinarian

치료 그룹:

Dogs

치료 영역:

Neurological Agent antiepileptic

승인 상태:

Authorized

승인 날짜:

2021-03-05

제품 특성 요약

Revised: April 2021
AN: 02130/2020
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Vetbromide 600 mg tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
600 mg potassium bromide
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White round tablet with 2 score-lines on each side.
Tablets can be divided into 2 or 4 equal parts.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
An antiepileptic agent for use in the control of idiopathic epileptic
seizures, either as a
single agent or as an adjunct to phenobarbital in the control of
refractory cases of
idiopathic epilepsy.
4.3
CONTRAINDICATIONS
Do not use in known cases of hypersensitivity to the active substance,
or to any of
the excipients.
Do not use in dogs with severe renal insufficiency.
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 may vary between individuals
(see section 4.9).
The presence of cluster seizures/status epilepticus, due to the
severity of the seizure
Revised: April 2021
AN: 02130/2020
Page 2 of 7
activity, is often associated with poor response to anti-epileptic
treatment. In these
cases, remission (seizure freedom) may be difficult to achieve.
For dogs with normal hepatic function, phenobarbital is generally
considered the first-
choice antiepileptic drug. However, potassium bromide can be
recommended as
alternative, especially in dogs with hepatic dysfunction or in dogs
with concurrent
disorders requiring life-long administration of potentially
hepatotoxic medications,
since potassium bromide is not metabolised in the liver (see section
5.2).
A high chloride intake can increase the elimination of bromide (see
section 4.8). An
increase in the dog’s salt intake may require an adjustment in
bromide dose. The salt
content of a dog’s diet during the treat