PENTASA

Land: Indonesien

Språk: indonesiska

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

Aktiva substanser:

MESALAZINE

Tillgänglig från:

ABBOTT INDONESIA - Indonesia

INN (International namn):

MESALAZINE

Dos:

1 G

Läkemedelsform:

ENEMA

Enheter i paketet:

DUS, 7 BOTOL PLASTIK @ 100 ML

Tillverkad av:

FERRING-LECIVA, A.S - Czech Republic

Tillstånd datum:

2020-02-09

Produktens egenskaper

PROPOSED PACKAGING MATERIAL
Code
PENSUS-I-ID-02.02
Size
NA
Submission
☐
NDA
☐
Renewal
☒
Variation change detail no.: CR 129438, 165591, 148998
Code of previous version
PENSUS-I-ID-01.01
Changes
BPOM Deficiency letter date 19Mar2021 (Revision on contraindication
and interactions)
Reference
☒
CCDS version: CCDS Ver.17 (Jan 2021)
☐
Core PIL version:
☐
SPC country/version/date:
☐
LAC no.:
Name & Date
IRM, 07-Dec-2021
1
PENTASA
®
MESALAZINE
Enema 1g
COMPOSITION
Each enema contains 1 g mesalazine.
Excipients: Disodium edetate, sodium metabisulphite, sodium acetate,
purified water, hydrochloric acid
for pH adjustment.
PHARMACEUTICAL DOSAGE FORM
Enema (rectal suspension)
White to slightly yellow suspension with a pH value between 4.4 and
5.0.
INDICATIONS
Treatment of mild to moderate ulcerative proctosigmoiditis
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology: _
1 enema at bedtime
_ _
_Paediatric population: _
Not recommended
_ _
_Method of administration: _
A visit to the toilet is recommended before administration of enemas.
_Instructions for use: _
Shake the enema container well before use. The enema is protected by
an aluminium foil bag and
should be used immediately after opening of the bag.
The enema may colour the linen and toilet.
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 reactions, such as