Phenotab Flavoured 60 mg Tablets for dogs

দেশ: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

Phenobarbital

থেকে পাওয়া:

CP-Pharma Handelsgesellschaft mbH

এটিসি কোড:

QN03AA02

INN (আন্তর্জাতিক নাম):

Phenobarbital

ডোজ:

60 mg/tablet

ফার্মাসিউটিকাল ফর্ম:

Tablet

প্রেসক্রিপশন টাইপ:

POM: Prescription Only Medicine as defined in relevant national legislation

থেরাপিউটিক এলাকা:

phenobarbital

অনুমোদন অবস্থা:

Authorised

অনুমোদন তারিখ:

2020-09-11

পণ্য বৈশিষ্ট্য

Health Products Regulatory Authority
11 September 2020
CRN0093S9
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Phenotab Flavoured 60 mg Tablets for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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Each tablet contains:
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ACTIVE SUBSTANCE
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Phenobarbital 60 mg
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EXCIPIENTS:
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For the full list of excipients, see section 6.1.
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3 PHARMACEUTICAL FORM
Tablet.
White, speckled with brown spots, round and convex tablet with a
cross-shaped break line on one side.
Tablets can be divided into 2 or 4 equal parts.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Prevention of seizures due to generalised epilepsy.
4.3 CONTRAINDICATIONS
Do not use in known cases of hypersensitivity to the active substance,
any of the excipients or other barbiturates. Do not use in
animals with severe liver disease.
Do not use in animals with serious renal or cardiovascular disorders.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
It is recommended that the clinical pathology of the patient is
monitored, the first time 2-3 weeks after initiation of therapy
and subsequently every 4-6 months. It is important to know that the
effects of hypoxia can cause increased levels of hepatic
enzymes after a seizure.
Long-term therapy with phenobarbital results in habituation and
dependence, which
can lead to a spontaneous return of symptoms upon sudden
discontinuation of therapy.
To achieve successful therapy, administration of tablets at the same
time each day is essential.
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 required in animals with impaired liver and / or renal
function, hypovolaemia, anemia and cardiac or respiratory
dysfunction.
Health Products Regulatory Authority
11 Sept