NEORAL 100 Mg/Ml Concentrate for Oral Solution

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

CICLOSPORIN

Disponível em:

Novartis Pharmaceuticals UK Ltd

Código ATC:

L04AD01

DCI (Denominação Comum Internacional):

CICLOSPORIN

Dosagem:

100 Mg/Ml

Forma farmacêutica:

Concentrate for Oral Solution

Tipo de prescrição:

Product subject to prescription which may be renewed (B)

Área terapêutica:

Calcineurin inhibitors

Status de autorização:

Authorised

Data de autorização:

1995-10-16

Folheto informativo - Bula

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.
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 N

Características técnicas

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
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