Neoral

País: Nueva Zelanda

Idioma: inglés

Fuente: Medsafe (Medicines Safety Authority)

Ingredientes activos:

Ciclosporin 50mg;  

Disponible desde:

Novartis New Zealand Ltd

Designación común internacional (DCI):

Ciclosporin 50 mg

Dosis:

50 mg

formulario farmacéutico:

Soft gelatin capsule

Composición:

Active: Ciclosporin 50mg   Excipient: Corn oil dl-Alpha tocopherol Ethanol Gelatin Glycerol Polyethylene glycol hydrogenated castor oil Propylene glycol   Titanium dioxide

Unidades en paquete:

Blister pack, 30 capsules

clase:

Prescription

tipo de receta:

Prescription

Fabricado por:

Novartis Pharma AG

indicaciones terapéuticas:

Solid organ transplantation Prevention of graft rejection following kidney, liver, heart, combined heart-lung, lung or pancreas allogeneic transplantations. Treatment of transplant rejection in patients previously receiving other immunosuppressive agents. Bone marrow transplantation Prevention of graft rejection following bone marrow transplantation. Prevention or treatment of graft-versus-host disease (GVHD).

Resumen del producto:

Package - Contents - Shelf Life: Blister pack, - 30 capsules - 24 months from date of manufacture stored at or below 25°C - Blister pack, - 50 capsules - 24 months from date of manufacture stored at or below 25°C

Fecha de autorización:

1994-03-28

Información para el usuario

__________________________________________________________________________________________________
Neoral

1
NEORAL

_25mg, 50mg, 100mg capsules _
_100mg/ml solution _
_cyclosporin_
_____________________________________________________________________________________
CONSUMER MEDICINE INFORMATION
_________________
WHAT IS IN THIS LEAFLET
_________________________________
This leaflet answers some common
questions about Neoral
.
It does not contain all the available
information
.
It does not take the place
of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
You should ensure that you speak to
your pharmacist or doctor to obtain
the most up-to-date information on
the medicine. You can also download
the most up-to-date leaflet from
www.medsafe.govt.nz
.
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Neoral
against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
________________________
WHAT NEORAL IS
USED FOR
________________________
Neoral contains the active ingredient,
cyclosporin. It belongs to a group of
medicines called immunosuppressive
agents. These medicines help to
control your body's immune system.
Neoral is used for people who have
received a graft transplant of a
kidney, heart, lung, pancreas, or
liver. Neoral is also used in bone
marrow transplantation.
Neoral prevents the rejection of the
transplanted organ by blocking the
development of special cells, which
would normally attack the
transplanted tissue.
Neoral is also used to treat several
other non-transplant conditions,
known as autoimmune diseases,
which are thought to be caused by a
problem with your body’s immun

Ficha técnica

NEW ZEALAND DATA SHEET
Page 1 of 26
1 PRODUCT NAME
NEORAL
®
25 mg Soft Gelatine Capsules
NEORAL
®
50 mg Soft Gelatine Capsules
NEORAL
®
100 mg Soft Gelatine Capsules
NEORAL
®
100 mg/ml Oral Solution
_(ciclosporin) _
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Neoral
®
soft gelatine capsules containing 25 mg, 50 mg, or 100 mg ciclosporin.
Neoral
®
oral solution containing 100 mg ciclosporin per mL. Each bottle of 50
mL contains 5000 mg of
ciclosporin.
For a full list of excipients see Section 6.1.
3 PHARMACEUTICAL FORM
NEORAL SOFT GELATINE CAPSULES FOR ORAL ADMINISTRATION
25 mg: blue-grey oval shaped gelatin capsule, soft, imprinted with
“NVR 25mg” in red
50 mg: yellow-white oblong shaped gelatin capsule, soft, imprinted
with “NVR 50mg” in red
100 mg: blue-grey oblong shaped gelatin capsule, soft, imprinted with
“NVR 100mg” in red
NEORAL ORAL SOLUTION FOR ORAL ADMINISTRATION
A clear, faintly yellow to browning yellow solution for oral
administration. The formulation is a
microemulsion preconcentrate.
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 formulation is a microemulsion pre concentrate, 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 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.
NEW ZEALAND DATA SHEET
Page 2 of 26
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Transplantation indications
_Solid organ transplantation _
Prevention of graft rejection following kidney, liver, heart, combined
heart-lung, lung or pancreas
allogeneic transplantations.