Phenoleptil 50 mg tablets for dogs

Quốc gia: Ai-len

Ngôn ngữ: Tiếng Anh

Nguồn: HPRA (Health Products Regulatory Authority)

Thành phần hoạt chất:

Phenobarbital

Sẵn có từ:

Le Vet BV

Mã ATC:

QN03AA02

INN (Tên quốc tế):

Phenobarbital

Liều dùng:

50 mg/tablet

Dạng dược phẩm:

Tablet

Loại thuốc theo toa:

POM: Prescription Only Medicine as defined in relevant national legislation

Nhóm trị liệu:

Dogs

Khu trị liệu:

phenobarbital

Chỉ dẫn điều trị:

Neurological Preparations

Tình trạng ủy quyền:

Authorised

Ngày ủy quyền:

2011-06-17

Đặc tính sản phẩm

1
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
PHENOLEPTIL 50 mg tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 320 mg tablet contains:
ACTIVE SUBSTANCES:
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, anemia
and cardiac or respiratory dysfunction.
2
The chance of hepatotoxic side effects can be diminished or delayed
using an effective dose tha