Epityl 60mg Flavoured Tablets for Dogs

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

Phenobarbital

Mevcut itibaren:

Chanelle Pharmaceuticals Manufacturing Limited

ATC kodu:

QN03AA02

INN (International Adı):

Phenobarbital

Doz:

60 mg/tablet

Farmasötik formu:

Chewable tablet

Reçete türü:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapötik grubu:

Dogs

Terapötik alanı:

phenobarbital

Terapötik endikasyonlar:

Neurological Preparations

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2013-09-13

Ürün özellikleri

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Epityl 60mg Flavoured Tablets for Dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
Phenobarbital 60 mg
EXCIPIENTS:
QUALITATIVE COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS_ _
Lactose monohydrate
Microcrystalline cellulose
Magnesium stearate
Maize starch
Talc
Grilled meat flavour
White, circular tablet with cross breakline on one side.
The tablets can be divided into two or four equal parts.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Dogs
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Prevention of seizures due to generalised epilepsy in dogs.
3.3
CONTRAINDICATIONS
Do not use in animals with serious impaired hepatic function.
Do not use in animals with serious renal or cardiovascular disorders.
Do not use in dogs weighing less than 6 kg body weight.
Do not use in case of hypersensitivity to the active substance or to
any other barbiturates or to any of
the excipients.
3.4
SPECIAL WARNINGS
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.
Some of the dogs are free of epileptic seizures during the treatment,
but some of the dogs show only a
seizure reduction, and some of the dogs are considered to be
non-responders.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
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
recommended in case of a prolonged therapy.
It is recommended to assess the clinical pathology of the patient 2-3
weeks after start of treatment and
afterwards every 4-6 months, e.g. measurement of hepatic enzymes and
serum bile acids. It is important
to know that the effects of hypoxia etc. do cause incre