SIMULECT

Negara: Indonesia

Bahasa: Bahasa Indonesia

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

Bahan aktif:

BASILIXIMAB

Tersedia dari:

NOVARTIS INDONESIA - Indonesia

INN (Nama Internasional):

BASILIXIMAB

Dosis:

20 MG

Bentuk farmasi:

SERBUK INJEKSI

Unit dalam paket:

DUS, 1 VIAL @ 20 MG + 1 AMPUL PELARUT @ 5 ML

Diproduksi oleh:

NOVARTIS PHARMA STEIN AG - Switzerland

Tanggal Otorisasi:

2019-07-03

Karakteristik produk

SIMULECT

Immunosuppressant
DESCRIPTION AND COMPOSITION
COMPOSITION
One vial of Simulect

20 mg contains 20 mg basiliximab. An ampoule containing 5 ml water
for injection is supplied for dissolution.
PHARMACEUTICAL FORM
Glass vial containing sterile freeze-dried powder fir intravenous
infusion or injection after
reconstitution. with 5 mL water for injection.
ACTIVE SUBSTANCE
Basiliximab
EXCIPIENTS
A vial of Simulect contains, in addition to basiliximab, potassium
dihydrogen phosphate,
disodium phosphate, anhydrous, sodium chloride, sucrose, mannitol, and
glycine. A solvent
ampoule contains water for injection. No preservatives are included.
INDICATIONS
Simulect
is
indicated
for
the
prophylaxis
of
acute
organ
rejection
in
_de _
_novo _
renal
transplantation and is to be used concomitantly with ciclosporin for
microemulsion- and
corticosteroid-based immunosuppression. In patients with panel
reactive antibodies less than
80 %.
DOSAGE AND ADMINISTRATION
GENERAL TARGET POPULATION:
ADULT
_RECOMMENDED DOSE _
The standard total dose in adults is 40 mg, given in two doses of 20
mg each. The first 20 mg
dose should be given within 2 hours prior to transplantation surgery.
The second 20 mg dose
should be given 4 days after transplantation. The second dose should
be held if postoperative
complications such as graft loss occur. (see Special warnings and
special precaution for use).
Simulect should
be
prescribed
only
by
physicians
who
are
experienced in
the use of
immunosuppressive therapy following organ transplantation. Simulect
should be administered
under qualified medical supervision.
SPECIAL POPULATIONS:
PEDIATRIC PATIENTS (1-17 YEARS)
The safety and efficacy of Simulect in pediatric patients has not been
established. Very
limited pharmacokinetic data are available.
GERIATRIC PATIENTS (≥ 65 YEARS)
There are limited data available on the use of Simulect in elderly,
but there is no evidence that
elderly patients require a different dosage from younger adult
patients.
METHOD OF ADMINISTRATION
Reconstituted Simulect