Neoral 100 mg/ml concentrate for oral solution

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Ciclosporin

Saatavilla:

Novartis Ireland Limited

ATC-koodi:

L04AD; L04AD01

INN (Kansainvälinen yleisnimi):

Ciclosporin

Annos:

100 milligram(s)/millilitre

Lääkemuoto:

Concentrate for oral solution

Prescription tyyppi:

Product subject to prescription which may be renewed (B)

Terapeuttinen alue:

Calcineurin inhibitors; ciclosporin

Valtuutuksen tilan:

Marketed

Valtuutus päivämäärä:

1995-10-16

Pakkausseloste

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NEORAL
® 100 MG/ML CONCENTRATE FOR ORAL SOLUTION
ciclosporin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See Section 4.
WHAT IS IN THIS LEAFLET
1.
What Neoral is and what it is used for
2.
What you need to know before you take Neoral
3.
How to take Neoral
4.
Possible side effects
5.
How to store Neoral
6.
Contents of the pack and other information
1.
WHAT NEORAL IS AND WHAT IT IS USED FOR
WHAT NEORAL IS
The name of your medicine is Neoral. It contains the active substance
ciclosporin. This belongs to a
group of medicines known as immunosuppressive agents. These medicines
are used to lower the
body’s immune reactions.
WHAT NEORAL IS USED FOR AND HOW NEORAL WORKS
•
IF YOU HAVE HAD AN ORGAN TRANSPLANT, BONE MARROW AND STEM CELL
TRANSPLANTATION
, the
function of Neoral is to control your body’s immune system. Neoral
prevents rejection of
transplanted organs by blocking the development of certain cells which
would normally attack
the transplanted tissue.
•
IF YOU HAVE AN AUTOIMMUNE DISEASE
, in which your body’s immune response attacks your
body’s own cells, Neoral stops this immune reaction. Such diseases
include eye problems which
threaten your vision (endogenous uveitis, including Behçet's
uveitis), severe cases of certain
skin diseases (atopic dermatitis, or eczema and psoriasis), severe
rheumatoid arthritis and a
kidney disease called nephrotic syndrome.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NEORAL
If you are taking Neoral following a transplant it will only be
prescribed fo

Valmisteyhteenveto

Health Products Regulatory Authority
04 July 2023
CRN00DPGN
Page 1 of 21
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Neoral 100 mg/ml concentrate for oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of concentrate for oral solution contains 100 mg ciclosporin.
Excipients with known effect:
Ethanol: 94.70 mg/ml. Neoral oral solution contains 12% v/v ethanol
(9.5% m/v).
Propylene glycol: 94.70 mg/ml.
Macrogolglycerol hydroxystearate/Polyoxyl 40 hydrogenated castor oil:
383.70 mg/ml.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for oral solution.
Clear, faintly yellow to brownish yellow solution.
The formulation of Neoral is a microemulsion preconcentrate.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Transplantation indications
_Solid organ transplantation_
Prevention of graft rejection following solid organ transplantation.
Treatment of transplant cellular rejection in patients previously
receiving other immunosuppressive agents.
_Bone marrow transplantation_
Prevention of graft rejection following allogeneic bone marrow and
stem cell transplantation.
Prevention or treatment of graft-versus-host disease (GVHD).
Non-transplantation indications
_Endogenous uveitis_
Treatment of sight-threatening intermediate or posterior uveitis of
non-infectious aetiology in patients in whom conventional
therapy has failed or caused unacceptable side effects.
Treatment of Behçet uveitis with repeated inflammatory attacks
involving the retina in patients without neurological
manifestations.
_Nephrotic syndrome_
Steroid-dependent and steroid-resistant nephrotic syndrome, due to
primary glomerular diseases such as minimal change
nephropathy, focal and segmental glomerulosclerosis, or membranous
glomerulonephritis.
Neoral can be used to induce and maintain remissions. It can also be
used to maintain steroid-induced remission, allowing
withdrawal of steroids.
_Rheumatoid arthritis_
Treatment of severe, active rheumatoid arthritis.
Health Products Regulatory