Pentasa 1 g prolonged-release tablets

দেশ: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

Mesalazine

থেকে পাওয়া:

Ferring Ireland Ltd

এটিসি কোড:

A07EC; A07EC02

INN (আন্তর্জাতিক নাম):

Mesalazine

ডোজ:

1 gram(s)

ফার্মাসিউটিকাল ফর্ম:

Prolonged-release tablet

প্রেসক্রিপশন টাইপ:

Product subject to prescription which may be renewed (B)

থেরাপিউটিক এলাকা:

Aminosalicylic acid and similar agents; mesalazine

অনুমোদন অবস্থা:

Marketed

অনুমোদন তারিখ:

2011-01-07

পণ্য বৈশিষ্ট্য

Health Products Regulatory Authority
02 June 2023
CRN00DDL5
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pentasa 1 g prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains mesalazine 1 g.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet
White-grey to pale brown, speckled, oval tablet. Embossing on both
sides: PENTASA
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of mild to moderate ulcerative colitis and Crohn's
disease.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ULCERATIVE COLITIS
_Adults:_
Active treatment: Individual dosage, up to 4 g mesalazine once daily
or in two or three divided doses.
Maintenance treatment: Recommended dosage, 2 g mesalazine once daily.
CROHN’S DISEASE
_Adults:_
Active treatment: Individual dosage, up to 4 g mesalazine daily in two
or three divided doses.
Maintenance treatment: Individual dosage, up to 4 g mesalazine daily
in two or three divided doses.
PAEDIATRIC POPULATION
There is only limited documentation for an effect in children (age
6-18 years).
ULCERATIVE COLITIS
Treatment of active disease:
Children 6 years of age and older: To be determined individually,
starting with 30-50 mg/kg/day in divided doses. Maximum
dose: 75 mg/kg/day in divided doses. The total dose should not exceed
4 g/day (maximum adult dose).
_MAINTENANCE TREATMENT: _
Children 6 years of age and older: To be determined individually,
starting with 15-30 mg/kg/day in divided doses. The total
dose should not exceed 2 g/day (recommended adult dose).
It is generally recommended that half the adult dose may be given to
children up to a body weight of 40 kg; and the normal
adult dose to those above 40 kg.
CROHN’S DISEASE
Treatment of active disease:
Children 6 years of age and older: To be determined individually,
starting with 30-50 mg/kg/day in divided doses. Maximum
dose: 75 mg/kg/day in divided doses. The total dose should not exceed
4 g/day (maximum adult dose).
Health Produ