PROSOGAN

Valsts: Indonēzija

Valoda: indonēziešu

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

Aktīvā sastāvdaļa:

LANSOPRAZOLE

Pieejams no:

TAKEDA INDONESIA - Indonesia

SNN (starptautisko nepatentēto nosaukumu):

LANSOPRAZOLE

Deva:

30 MG

Zāļu forma:

SERBUK INJEKSI

Vienības iepakojumā:

DUS, MAX 30 CARTON DUS @ 10 VIAL @ 30 MG

Ražojis:

TAKEDA PHARMACEUTICAL COMPANY - Japan

Autorizācija datums:

2016-10-31

Produkta apraksts

PROSOGAN
® INJECTION
LANSOPRAZOLE 30 MG
1
NAME OF THE MEDICINAL PRODUCT
PROSOGAN
®
INJECTION 30 mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1
EACH VIAL CONTAINS 30 MG OF LANSOPRAZOLE.
3
PHARMACEUTICAL FORM
White to yellowish-white mass or powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Patients with the following diseases who are unable to take the oral
formulations :
Gastric ulcer, duodenal ulcer, acute stress ulcer, and acute gastric
mucosal lesion (accompanied
by bleeding).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Usually, for adults, PROSOGAN
®
Injection 30 mg is mixed with isotonic sodium chloride solution
or 5% glucose injection and administered by intravenous drip twice a
day; alternatively,
PROSOGAN
®
Injection 30 mg is dissolved in 20 mL of isotonic sodium chloride
solution or 5%
glucose
injection
and
administered
slowly
by
intravenous
injection
twice
a
day.
1.
As PROSOGAN
®
Injection 30 mg was shown to have high hemostatic effect based on the
data up to 3 days after starting treatment, once the patient is able
to take medications
orally, therapy should be switched to an oral formulation and this
drug should not be
administered aimlessly for a long period.
2.
There is no clinical experience of treatment over 7 days in Japanese
clinical trials.
SPECIAL PATIENT POPULATIONS
PROSOGAN
®
Injection 30 mg should be administered with care in the following
patients :
1.
Patients with a history of drug hypersensitivity.
2.
Patients with hepatic disorders. (A delay in the metabolism and
excretion of PROSOGAN
®
Injection 30 mg may occur). Intravenous dose reduction in patients
with severe hepatic
disease should be considered. These patients should be kept under
regular supervision.
3.
Elderly patients : since physiological function is generally decreased
in elderly patients,
PROSOGAN
®
Injection 30 mg should be carefully administered. A daily dose of 30
mg
should not be exceeded. Renal impairment patients do not require
dosage adjustment.
4.
Pediatric use : The safety of PROSOGAN
®
Injection