Neoral

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Ciclosporin 100 mg/mL;  

Available from:

Novartis New Zealand Ltd

INN (International Name):

Ciclosporin 100 mg/mL

Dosage:

100 mg/mL

Pharmaceutical form:

Oral solution

Composition:

Active: Ciclosporin 100 mg/mL   Excipient: Corn oil dl-Alpha tocopherol Ethanol Polyethylene glycol hydrogenated castor oil Propylene glycol

Units in package:

Bottle, glass, 50 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Novartis Pharma AG

Therapeutic indications:

Transplantation indications 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).

Product summary:

Package - Contents - Shelf Life: Bottle, glass, closed with a bromobutyl stopper and aluminium cap - 50 mL - 36 months from date of manufacture stored at or below 30°C

Authorization date:

1994-03-28

Patient Information leaflet

__________________________________________________________________________________________________
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

Summary of Product characteristics

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.