LYLIAN

Država: Indonezija

Jezik: indonezijščina

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

Enote v paketu:

DUS, 1 VIAL @ 10 MG

Datum dovoljenje:

2022-09-24

Lastnosti izdelka

Page 1 of 7
LEAFLET OF ILAPRAZOLE SODIUM FOR INJECTION
Please read the instructions carefully and use it under the guidance
of a physician
[NAME OF THE MEDICINAL PRODUCT]
Generic Name: Ilaprazole Sodium for Injection
Brand Name: Lylian
English Name: Ilaprazole Sodium for Injection
[INGREDIENTS]
The active ingredient is Ilaprazole Sodium.
Chemical Name:
5-(1_H_-pyrrol-1-yl)-2-[[(4-methoxy-3-methyl-2-pyridyl)-methyl]sulfinyl]-1_H_-
benzimidazole sodium dihydrate
Chemical Structural Formula:
OCH
3
N
O
H
3
C
S
N
Na
,2H
2
O
N
Molecular Formula: C
19
H
17
N
4
NaO
2
S·2H
2
O
Molecular Weight: 424.45
[DESCRIPTION]
The product is white or off-white loose cakes or powder.
[INDICATION]
Peptic ulcer bleeding.
[STRENGTH]
10 mg (calculated based on C
19
H
18
N
4
O
2
S).
[DOSAGE AND ADMINISTRATION]
The product is given intravenously at an initial dose of 20 mg,
followed by 10 mg once per
day for two consecutive days. Oral medication may be appropriate after
the course of
treatment.
PRECAUTIONS IN USE:
1.
Endoscopic hemostasis should be taken into account as a priority in
populations who are at
a high risk of squirt bleeding or extravasation bleeding, and who are
endoscopically observed
with visible vessels.
2.
The product is used for intravenous infusion: reconstitute 10 mg
thoroughly with 100 ml of
0.9% sodium chloride solvent, and give intravenously within 30 minutes
through an
infusion device. When the drug is given at an initial dose of 20 mg,
the product should be
thoroughly reconstituted in 200 ml of 0.9% sodium chloride solvent.
The drug should be
used within 3 hours after preparation.
N
DISETUJUI OLEH BPOM : 01/09/2022
EREG10028912100052
Page 2 of 7
3.
This product can only be reconstituted with 0.9% sodium chloride
solvent for intravenous
infusion. The prepared solution cannot be used in a pharmacy admixture
program.
[ADVERSE REACTIONS]
355
patients
in
a
Phase
III
clinical
trial
were
given
Ilaprazole
Sodium
for
Injection
intravenously, once daily, with the initial dose of 20 mg followed by
10 mg for a course of 3
days