Epiphen 60 mg Tablets

国家: 英国

语言: 英文

来源: VMD (Veterinary Medicines Directorate)

有效成分:

Phenobarbital

可用日期:

Vetoquinol UK Ltd

INN（国际名称）:

Phenobarbital

药物剂型:

Tablet

处方类型:

POM-V - Prescription Only Medicine – Veterinarian

治疗组:

Dogs

治疗领域:

Neurological Agent antiepileptic

授权状态:

Authorized

授权日期:

1996-04-11

产品特点

Revised: December 2022
AN: 01687/2022
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Epiphen 60 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: 60 mg of Phenobarbital per tablet
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Tablet
White, circular bioconvex tablet with stamp ‘60’ on surface.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dog
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Phenobarbital is an antiepileptic agent for use in the control of
epilepsy in the
dog.
4.3
CONTRA-INDICATIONS
Not for use in pregnant animals.
Do not administer to animals with impaired hepatic function.
Do not use in cases of hypersensitivity to the active substance(s), to
any other
barbiturates or to any of the excipients
Do not use in animals with serious renal and/or
cardiovascular/respiratory
disorders.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
The decision to start antiepileptic drug therapy with phenobarbital
should be
evaluated for each individual case and depends on number, frequency,
duration
and severity of seizures in dogs.
To achieve successful therapy, administration of tablets should occur
at the
same time(s) each day and should be co-ordinated with feeding times in
a
consistent manner.
Revised: December 2022
AN: 01687/2022
Page 2 of 8
Withdrawal or transition from other types of antiepileptic therapy
should be made
gradually to avoid precipitating an increase in the frequency of
seizures.
Some dogs are free of epileptic seizures during the treatment, but
some dogs
show only a seizure reduction, and some dogs are considered to be non-
responders.
4.5
SPECIAL PRECAUTIONS FOR USE
i.
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Caution is recommended in animals with:
-
impaired hepatic and renal function
-
hypovolemia, anaemia and
-
cardiac or respiratory dysfunction
The chance of hepatotoxic side effects can be diminished or delayed
using an
effective dose that is as low as possible. Monitoring of hepatic
parameters is
r