PENTASA

Țară: Indonezia

Limbă: indoneziană

Sursă: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Unități în pachet:

DUS, 60 SACHET @ GRANUL PELEPASAN LAMBAT 2 G

Data de autorizare:

2022-06-10

Caracteristicilor produsului

1
PROPOSED PACKAGING MATERIAL
Code
PENSAC2-I-ID-01.03
Size
NA
Submission
☒
NDA
☐
Renewal
☐
Variation change detail no.:
Code of previous version
NA
Changes
NA
Reference
☒
CCDS version: CCDS Ver.17 (Jan 2021)
☐
Core PIL version:
☐
SPC country/version/date:
☐
LAC no.:
Name & Date
IRM, 24-Jan-2022
PENTASA
®
MESALAZINE
Prolonged release granules 2g
COMPOSITION
Each sachet contains 2 g mesalazine.
Excipients: Ethylcellulose, povidone.
PHARMACEUTICAL DOSAGE FORM
Prolonged release granules.
White-grey to pale white-brown granules.
INDICATIONS
Treatment of mild to moderate ulcerative colitis.
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology: _
ULCERATIVE COLITIS
Treatment of active disease:
Adults: Individual dosage, up to 4 g given once daily or in divided
doses.
Maintenance treatment:
Adults: Individual dosage. Recommended dosage, 2 g mesalazine once
daily. Can also be taken in
divided doses.
_Method of administration: _
PENTASA granules must not be chewed. The contents of the sachet should
be emptied onto the
tongue and washed down with some water or juice. Alternatively the
entire content of the sachet
can be taken with yogurt and consumed immediately.
CONTRAINDICATIONS
Hypersensitivity to mesalazine, any of the excipients, or salicylates.
Severe liver or renal impairment.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Most patients who are intolerant or hypersensitive to sulphasalazine
are able to take PENTASA
without risk of similar reactions. However, caution is recommended
when treating patients allergic to
sulphasalazine (risk of allergy to salicylates). Severe cutaneous
adverse reactions, including
Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN),
have been reported in
association with mesalazine treatment. In case of acute intolerance
reactions such as abdominal
cramps, acute abdominal pain, fever and severe headache and/or the
first appearance of signs and
symptoms of severe skin rash, mucosal lesions, or any other signs of
hypersensitivity, therapy
should be discontinued immediatel