Phenoleptil 50 mg tablets for dogs

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Phenobarbital

Предлага се от:

Dechra Regulatory B.V.

АТС код:

QN03AA02

INN (Международно Name):

Phenobarbital

Лекарствена форма:

Tablet

Вид предписание :

POM: Prescription Only Medicine as defined in relevant national legislation

Терапевтична област:

phenobarbital

Дата Оторизация:

2011-06-17

Данни за продукта

2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
PHENOLEPTIL 50 mg tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
Phenobarbital
50 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White to off white, circular, biconvex tablets with brown speckles and
a score line on one side (9 mm
diameter). The tablet can be divided into two equal parts.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dog
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Prevention of seizures due to generalised epilepsy in dogs.
4.3
CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substance or to
other barbiturates.
Do not use in animals with serious impaired hepatic function.
Do not use in animals with serious renal or cardiovascular 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.
General recommendations for initiating therapy include a single
seizure occurring more than once
every 4-6 weeks, cluster seizure activity (i.e. more than one seizure
within 24 h) or status epilepticus
regardless of frequency.
To achieve successful therapy, administration of tablets must be at
the same time each day.
Withdrawal or transition from other types of antiepileptic therapy
should be made gradually to avoid
precipitating an increase in the frequency of seizures.
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.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Caution is recommended in animals with impaired hepatic and renal
function, hypovolemia, anaemia
and cardiac or respiratory dysfunction.
3
The chance of hepatotoxic side effects can be diminished or delayed
using an effective dose that is as