PENTASA

Страна: Индонезия

Язык: индонезийский

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

Активный ингредиент:

MESALAZINE

Доступна с:

ABBOTT INDONESIA - Indonesia

ИНН (Международная Имя):

MESALAZINE

дозировка:

1 G

Фармацевтическая форма:

SUPPOSITORIA

Штук в упаковке:

Dus, 4 blister @ 7 suppositoria

Производитель:

FERRING INTERNATIONAL CENTER SA - Switzerland

Дата Авторизация:

2019-09-28

Характеристики продукта

PROPOSED PACKAGING MATERIAL
Code
PENSUP-I-ID-04.03
Size
NA
Submission
☐
NDA
☐
Renewal
☒
Variation change detail no.:
CR 188030, 129438, 165591
Code of previous version
PENSUP-I-ID-04.02
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 | P a g e
PENTASA
®
_Mesalazine _
Suppositories 1g
COMPOSITION
Each suppository contains 1 g mesalazine.
Excipients: magnesium stearate, talc, povidone, macrogol 6000.
PHARMACEUTICAL DOSAGE FORM
Suppositories
INDICATIONS
Treatment of ulcerative proctitis.
DOSAGE AND ADMINISTRATION
Adults : 1 suppository 1-2 times daily.
INSTRUCTION FOR USE
1.
A visit to the toilet is recommended before inserting a suppository.
2.
Open the foil bag at the tear mark.
3.
The suppository is inserted in the rectum until resistance is felt and
disappeared again.
4.
In order to facilitate the administration, the suppository can be
moistured with water or
moisture cream.
5.
If the suppository is discharged within the first 10 minutes, another
can be inserted.
CONTRAINDICATIONS
Children under the age of 15 years.
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 skin rash, mucosal lesions, or any other signs of
hyp