Phenoleptil 12.5 mg tablets for dogs

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

Phenobarbital

Disponível em:

Le Vet BV

Código ATC:

QN03AA02

DCI (Denominação Comum Internacional):

Phenobarbital

Dosagem:

12.5 mg/tablet

Forma farmacêutica:

Tablet

Tipo de prescrição:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupo terapêutico:

Dogs

Área terapêutica:

phenobarbital

Indicações terapêuticas:

Neurological Preparations

Status de autorização:

Authorised

Data de autorização:

2011-06-17

Características técnicas

1
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
PHENOLEPTIL 12.5 mg tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 80 mg tablet contains:
ACTIVE SUBSTANCES:
Phenobarbital
12.5 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White to off white, circular, biconvex tablet with brown speckles and
a score line on one side (6 mm
diameter). The tablets cannot be divided.
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.
Do not use in dogs weighing less than 5 kg body weight.
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
2
Special precautions for use in animals
These tablets should not be divided. Doses for smaller dogs can not be
adjusted in accordance with the
recommended 20% regime, and therefore special care should be taken in
monitoring these