SANDIMMUN NEORAL CAPSULE 25MG

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

CYCLOSPORIN A

Boleh didapati daripada:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

CYCLOSPORIN A

Unit dalam pakej:

50Capsule Capsules

Dikeluarkan oleh:

Catalent Germany Eberbach GmbH

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP)_
SANDIMMUN NEORAL
®
Ciclosporin (25 mg, 100 mg Soft Gelatin Capsule & 100mg/mL Oral
Solution)
1
WHAT IS IN THIS LEAFLET
1.
What Sandimmun Neoral is used for
2.
How Sandimmun Neoral works
3.
Before you use Sandimmun Neoral
4.
How to use Sandimmun Neoral
5.
While you are using Sandimmun
Neoral
6.
Side effects
7.
Storage and Disposal of Sandimmun
Neoral
8.
Product Description
9.
Manufacturer and Product Registration
Holder
10.
Date of Revision
WHAT SANDIMMUN NEORAL IS USED FOR
The name of your medicine is Sandimmun
Neoral and it contains the active substance
ciclosporin. It is one of a group of
medicines known as immunosuppressive
agents. These medicines are used to
diminish the body’s immune reactions.
HOW SANDIMMUN NEORAL WORKS
If you have received a graft transplant the
function of Sandimmun Neoral is to control
your body’s immune system. Sandimmun
Neoral prevents rejection of transplanted
organs by blocking the development of
special cells which would normally attack
the transplanted tissue.
If you suffer from a non-transplant
disease
where your body’s own immune response
attacks the cells in your body (autoimmune
diseases), Sandimmun Neoral suppresses
immunoreactions in those diseases. Such
autoimmune diseases are vision-threatening
eye disease (intermediary or posterior
uveitis and Behçet's uveitis), severe cases of
certain skin diseases (psoriasis), severe
rheumatoid arthritis and a kidney disease,
called nephrotic syndrome.
BEFORE YOU USE SANDIMMUN NEORAL
If you are receiving Sandimmun Neoral for
transplantation, it will only be prescribed
for you by a doctor with experience in
transplantation medicine.
You will notice that the advice contained in
this leaflet may vary depending on whether
you are receiving this medicine for
transplantation or taking it for your
autoimmune disease.
Follow all the doctor’s instructions
carefully. They may differ from the general
information contained in this leaflet.
_ _
_ _
_ _
_When you must not use it _
If you are

Ciri produk

Novartis
Page 2
Malaysian Package Leaflet
18-Jul-2022
Sandimmun Neoral
SANDIMMUN NEORAL

SANDIMMUN

Immunosuppressive agents, calcineurin inhibitors
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORMS
SANDIMMUN NEORAL SOFT-GELATIN CAPSULES.
25 mg: blue-grey oval shaped gelatin capsule, soft, imprinted with
“NVR 25mg” in red
100 mg: blue-grey oblong shaped gelatin capsule, soft, imprinted with
“NVR 100mg” in red
SANDIMMUN NEORAL ORAL SOLUTION:
clear, faintly yellow to browning yellow solution for oral
administration. The formulation of Sandimmun Neoral is a microemulsion
preconcentrate.
SANDIMMUN
CONCENTRATE
FOR
SOLUTION
FOR
INFUSION:
clear,
brown-yellow,
oleaginous
concentrate to be diluted before parenteral administration.
ACTIVE SUBSTANCE
Each capsule contains 25 or 100 mg of ciclosporin.
The oral solution contains 100 mg of ciclosporin per mL. Each bottle
of 50 mL contains
5000 mg of ciclosporin.
Sandimmun Neoral is a pharmaceutical form of the active ingredient
ciclosporin based on the
microemulsion principle, which reduces the variability of
pharmacokinetic parameters and
provides dose linearity of ciclosporin exposure with a more consistent
absorption profile and
less influence from concomitant food intake. The Sandimmun Neoral
formulation is a
microemulsion preconcentrate, which in pharmacokinetic and clinical
studies has demonstrated
that the correlation between trough concentration and exposure to
ciclosporin is much stronger
when ciclosporin is given as Sandimmun Neoral than when it is given as
Sandimmun. The
formation of the microemulsion itself takes place in the presence of
water, either in the form of
a beverage or in the form of the gastric fluid.
The concentrate for solution for infusion contains 50 mg per mL. Each
ampoule of 1 mL
contains 50 mg of ciclosporin. Each ampoule of 5 mL contains 250 mg of
ciclosporin.
Certain dosage strengths and dosage forms may not be available in all
countries.
EXCIPIENTS
SOFT GELATIN CAPSULES
Capsule content: alpha–tocopherol, ethanol anhydrous, propyl